Information Center
Your Health. Your Family. Your Choice.
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National Vaccine Information Center Your Health. Your Family. Your Choice. |
MedAlerts.org |
| Table |
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| Age | Event Outcome | Count | Percent |
| 3-5 Years | Hospitalized | 2 | 3.45% |
| Emergency Doctor/Room | 4 | 6.9% | |
| Office Visit | 1 | 1.72% | |
| Recovered | 2 | 3.45% | |
| total | 9 | 15.52% | |
| 6-17 Years | Death | 4 | 6.9% |
| Life Threatening | 4 | 6.9% | |
| Hospitalized | 32 | 55.17% | |
| Hospitalized, Prolonged | 1 | 1.72% | |
| Emergency Doctor/Room | 15 | 25.86% | |
| Office Visit | 12 | 20.69% | |
| Recovered | 19 | 32.76% | |
| None of the Above | 8 | 13.79% | |
| total | 95 | 163.79% | |
| TOTAL | † 104 | † 179.31% | |
| † Because VAERS cases can have multiple vaccinations, symptoms, and event outcomes, a single case can account for multiple entries in this table. This is why the Total Count is greater than 58 (the number of cases found), and the Total Percent is greater than 100. | |||
| Case Details (Sorted by State) |
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Administered by: Private Purchased by: ? Life Threatening? No Write-up: 3 days after his 2nd dose of the COVID-19 vaccine, patient had acute onset chest pain in the setting of 3 days of fever, headache and fatigue. Was found to have elevated troponin level indicating myocarditis. Was observed in the hospital overnight, troponin levels continued to down-trend and EKGs were normal, patient discharged home medically stable with close outpatient cardiology follow-up. Total 1 night stay in the hospital |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: The patient''s mom stated the patient felt severe chest tightness and pain for about 8 hours after the vaccine then came back 2 days later and still having signs and symptoms. |
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Administered by: Public Purchased by: ? Life Threatening? Yes Write-up: Patient was a healthy 12-year old boy with no prior instances of illness (and he did not ever test positive for Covid) when he suffered from a headache, low fever, and fatigue. On the third day of symptoms, he said he had chest pains only after trying to eat. We were currently living in an another country and he was taken to the hospital ICU. One day later, he suffered cardiac arrest and was put on ECMO because his heart was not functioning well. He was later diagnosed with acute myocarditis and needed a heart transplant. Unfortunately, after the transplant operation, he suffered a severe subarachnoid intracranial hemorrhage and lost all brain stem functions. He never recovered. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: Patient has a fever of 104 and she has chest pain. A complication of the COVID-19 Vaccines in Children is Myocarditis. Patient will need to be further evaluated for possible Myocarditis. Parent has been told to take patient to the Emergency Room for further evaluation. |
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Administered by: Private Purchased by: ? Life Threatening? No Write-up: 12-year-old boy with post-COVID-vaccine-associated myocarditis who had presented with chest pain x1 day and recent fever (2 days prior to admission) after dose #2 of Pfizer vaccine. Of note, history of acute COVID infection on 12/29/2021, but negative COVID during admission. COVID-vaccine-induced myocarditis was suspected with low clinical suspicion for MIS-C given time course, no recent fever, and mildly elevated CRP, with no other concerning symptoms. Troponins peaked at 1.66 and downtrended until 0.21 at time of discharge with recommendation for troponin recheck at 1 week while outpatient. Cardiology were consulted by the team, who recommended echo, which was unremarkable. EKG showed sinus rhythm. For chest pain, ibuprofen PRN was first-line, but patient denied chest pain and specific complaints for most of the hospital course. Patient was discharged in stable condition to home with appointment placed with cardiology and repeat troponin scheduled for 1 week post-discharge. Recommendation was to avoid strenuous activity and competitive sports for 3 months until clearance with treadmill. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: A fast heartbeat that lasted for a few hours; He went to the ER for treatment where they ruled out myocarditis and thinks it was anxiety; He went to the ER for treatment where they ruled out myocarditis and thinks it was anxiety; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 13Dec2021 18:00 (Batch/Lot number: unknown) at the age of 11 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), ANXIETY (non-serious) all with onset 13Dec2021, outcome "unknown" and all described as "He went to the ER for treatment where they ruled out myocarditis and thinks it was anxiety"; HEART RATE INCREASED (non-serious) with onset 13Dec2021 20:00, outcome "recovered" (Dec2021), described as "A fast heartbeat that lasted for a few hours". The events "he went to the er for treatment where they ruled out myocarditis and thinks it was anxiety", "a fast heartbeat that lasted for a few hours" and "he went to the er for treatment where they ruled out myocarditis and thinks it was anxiety" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (13Dec2021) fast heartbeat. The clinical course of events was as follows: An 11 year old male patient received his first dose of Pfizer Biontech covid 19 vaccine on 13Dec2021 at 6 PM and at 8 PM he developed a fast heartbeat that lasted for a few hours. He went to the ER for treatment where they ruled out myocarditis and thinks it was anxiety. Caller seeking information if the patient should get a his second dose. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the information provided, it is not clear if myocarditis was diagnosed. The reported symptom of fast heartbeat was possibly due to anxiety. Additional information has been requested. The case will be re-evaluated if more information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. |
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Administered by: Private Purchased by: ? Life Threatening? No Write-up: - Clinically suspected COVID-19 Vaccine Associated Myocarditis consistent with "Probable" CDC case definition (chest pain and elevated troponin with no other identified cause on 12/26/21, 3 days after Pfizer vaccine #2 on 12/23/21) - status post ibuprofen for 1 day, symptoms self resolved. - Troponin rechecked 12/28/2021 was already low, near normal. - POCUS echocardiogram exam today normal |
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Administered by: Private Purchased by: ? Life Threatening? No Write-up: Patient developed chest pain and tachycardia. Diagnosed with pericarditis. Symptoms started 11/24, hospitalized 11/30. Discharged 12/1 and improving 12/2 with scheduled NSAIDs. |
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Administered by: Private Purchased by: ? Life Threatening? No Write-up: patient presented with chest pain, elevated troponin and was diagnosed with myocarditis. Treated with IVIG 2g/kg (12/2), ICU admission (12/2-12/5), stabilized and transferred to the peds floor 12/5. Admission date 12/2/2021 to present. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Myocarditis; Chest pain, dizziness and mild cough; Chest pain, dizziness and mild cough; Chest pain, dizziness and mild cough; This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis), CHEST PAIN (Chest pain, dizziness and mild cough), DIZZINESS (Chest pain, dizziness and mild cough) and COUGH (Chest pain, dizziness and mild cough) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Family history included COVID-19 (Parents were COVID-19 infection (both end quarantine; mother 30-May - 06-Jun; father 1-Jun - 8-Jun). Patient and Patient brother''s COVID-19 test were negative so far.). On 16-May-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jun-2022, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion hospitalization), CHEST PAIN (Chest pain, dizziness and mild cough) (seriousness criterion hospitalization), DIZZINESS (Chest pain, dizziness and mild cough) (seriousness criterion hospitalization) and COUGH (Chest pain, dizziness and mild cough) (seriousness criterion hospitalization). The patient was hospitalized from 19-Jun-2022 to 24-Jun-2022 due to CHEST PAIN, COUGH, DIZZINESS and MYOCARDITIS. At the time of the report, MYOCARDITIS (Myocarditis), CHEST PAIN (Chest pain, dizziness and mild cough), DIZZINESS (Chest pain, dizziness and mild cough) and COUGH (Chest pain, dizziness and mild cough) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2022, Electrocardiogram: mild STE over V4-V5. On 19-Jun-2022, SARS-CoV-2 test: (Negative) COVID-19 was negative. On 20-Jun-2022, Electrocardiogram: sinus tachycardia, ST elevation. On an unknown date, Troponin I: Elevation. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. On 16 May 2022 patient had 1st Moderna COVID-19 vaccination. 17 June 2022: 2nd Moderna COVID-19 vaccination On 18 June 2022 at midnight patient had fever developed then subsided. 19 Jun 2022 patient had Sudden onset chest pain was noted since this morning. Dizziness and mild cough occurred. patient appetite and activity were decreased. On 22 June 2022 no fever, no chest pain, no dizziness, fair appetite and spirit On 23 June 2022 patient was plan to be transferred to ordinary ward for further treatment On the same day, the test for COVID-19 was negative (the parents had been diagnosed with COVID-19 before and after June 1). The patient was sent to the ICU in hospital for hospitalization after suspected myocarditis, with Trop-I: Elevation showed; ECG (June 19) showed: mild STE over V4-V5; ECG (June 20) showed sinus tachycardia, ST elevation, etc. The symptoms of fever and chest pain of the patient were relieved on June 22, and the patient was transferred to the ordinary ward on June 23 and was discharged on June 24 due to symptom improvement. On June 27, 2022, request was made to follow up and care the patient and supervision was made to upload the abstract of medical consultations and treatments. Patient had no systemic disease or congenital anomaly before. Parents were COVID-19 infection (both end quarantine; Mother May 30 - June 6; father June 1 - June 8). Patient and his brother''s COVID-19 test were negative so far. Patient age was 7.8 years. ID no was.TW-TFDA-TVS-1110004557 Company Comment: This is a regulatory case concerning a 7 year-old, male patient with no relevant medical history, who experienced the serious (due to hospitalization) expected, AESI of myocarditis and the serious (due to hospitalization) unexpected, events of chest pain, Dizziness and cough, 2 days after the second dose of mRNA-1273 vaccine. The patient developed fever the day after vaccination. Two days after vaccination he began to have chest pain, dizziness, mild cough and other symptoms, and the child''s activity and appetite were also decreased. On the same day, the test for COVID-19 was negative. The patient was sent to the ICU for suspected myocarditis, with Troponin-I elevation, ECG showed: mild STE over V4-V5 and a second ECG the day after showed: Sinus tachycardia and ST elevation. Patient was discharged 5 days after due to symptom improvement. No information on treatment was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 7 year-old, male patient with no relevant medical history, who experienced the serious (due to hospitalization) expected, AESI of myocarditis and the serious (due to hospitalization) unexpected, events of chest pain, Dizziness and cough, 2 days after the second dose of mRNA-1273 vaccine. The patient developed fever the day after vaccination. Two days after vaccination he began to have chest pain, dizziness, mild cough and other symptoms, and the child''s activity and appetite were also decreased. On the same day, the test for COVID-19 was negative. The patient was sent to the ICU for suspected myocarditis, with Troponin-I elevation, ECG showed: mild STE over V4-V5 and a second ECG the day after showed: Sinus tachycardia and ST elevation. Patient was discharged 5 days after due to symptom improvement. No information on treatment was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: Myocarditis; off label use; interchange of vaccine products; Chest discomfort; Costochondritis; Decreased appetite; Dyspnoea; Gastrooesophageal reflux disease; Headache; Lethargy; Musculoskeletal pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 701761 (RA ADR#). A 10 year-old male patient received bnt162b2 (COMIRNATY), administration date 14Jan2022 (Batch/Lot number: unknown) at the age of 10 years as dose 2 (tris), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1, Single), administration date: 20Sep2021, for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant) with onset 14Jan2022, outcome "recovering", described as "Myocarditis"; OFF LABEL USE (non-serious) with onset 14Jan2022, outcome "recovering", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 14Jan2022, outcome "recovering", described as "interchange of vaccine products"; CHEST DISCOMFORT (non-serious) with onset 14Jan2022, outcome "recovering", described as "Chest discomfort"; COSTOCHONDRITIS (non-serious) with onset 14Jan2022, outcome "recovering", described as "Costochondritis"; DECREASED APPETITE (non-serious) with onset 14Jan2022, outcome "recovering", described as "Decreased appetite"; DYSPNOEA (non-serious) with onset 14Jan2022, outcome "recovering", described as "Dyspnoea"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 14Jan2022, outcome "recovering", described as "Gastrooesophageal reflux disease"; HEADACHE (non-serious) with onset 14Jan2022, outcome "recovering", described as "Headache"; LETHARGY (non-serious) with onset 14Jan2022, outcome "recovering", described as "Lethargy"; MUSCULOSKELETAL PAIN (non-serious) with onset 14Jan2022, outcome "recovering", described as "Musculoskeletal pain". Medicine (Onset Time in Days): COMIRNATY COVID-19 vaccine (tozinameran) - Suspect (0 days); COVID-19 Vaccine AstraZeneca (ChAdOx1-S (Viral vector)) - Suspect (116 days). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 713553 (ADR#). A 10 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Jan2022 (Batch/Lot number: unknown) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant) with onset 27Jan2022, outcome "unknown", described as "Pericarditis". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. |
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Administered by: Other Purchased by: ? Life Threatening? Yes Write-up: troponin elevation by CK, decreased cardiac contraction by echo, electrocardiogram abnormal, Cardiomegaly by XP; troponin elevation by CK, decreased cardiac contraction by echo, electrocardiogram abnormal, Cardiomegaly by XP; Positive with corona antigen kit; Cardiomegaly; chest pain; no energy/energy decreased; decreased food intake/no appetite/Poor feeding/appetite impaired; redness of the pharynx; Coug/mild cough; Diarrhoea/Worsening of diarrhoea and vomiting; Pyrexia/Prolonged Pyrexia/pyrexia around 38 degrees Centigrade, up to 39.0 degrees Centigrade.; vomiting/Worsening of diarrhoea and vomiting; general malaise/increased malaise; Abdominal pain; This is a spontaneous report received from contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: v2110034789, v2110034868. A 7 year-old male patient received bnt162b2 (COMIRNATY FOR 5 TO 11 YEARS OLD), administration date 13Mar2022 09:00 (Lot number: FN5988, Expiration Date: 30Apr2022) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ANHIBA. Clinical course: The patient was a 7-year and 2-month-old male. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations, and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The course of the event was as follows: On 13Mar2022, the patient recived the 1st dose of Corona vaccine (9:00). On 14Mar2022 at 10: 00, the patient experienced pyrexia around 38 degrees Centigrade, up to 39.0 degrees Centigrade. On 14Mar2022 vomiting, and general malaise appeared. On 15Mar2022, the patient experienced 38.5 degrees Centigrade, Coughing, diarrhoea symptoms appeared, Prolonged Pyrexia. On 16Mar2022, Visited hospital, able to eat and drink, prescribed antipyretic and returned home. On 16Mar2022, the patient was introduced to our department at 38.5 degrees Centigrade, with diarrhoea, appetite, Anhiba prescription. On 17Mar2022, worsening of diarrhoea and vomiting, decreased food intake, increased malaise, and prolonged Pyrexia. On 17Mar2022, pyrexia subsided(as reported), the patient experienced chest pain, no energy. On 18Mar2022, Revisited previous doctor, troponin elevation by CK, decreased cardiac contraction by echo, electrocardiogram abnormal, Cardiomegaly by XP, transferred to the hospital, admitted to ICU. On 18Mar2022, the patient had no vomiting, no diarrhoea, mild cough, no pyrexia(as reported), but no energy and no appetite, after ECG and Blood sampling diagnosed myocarditis, transferred to hospital. On 19Mar2022, decline of Pyrexia, troponin decreased by CK, ST changes in electrocardiogram, and improvement by echo findings were observed. On 21Mar2022, Transferred to general ward. On 23Mar2022, Continued symptom observation at hospitalization. On 23Mar2022, Positive with corona antigen kit at hospital, no special treatment, recovering. Clinical course in Myocarditis Investigation Form: On 14Mar2022, the patient experienced Acute chest pain or chest pressure sensation, Palpitations, Malaise, Sweaty, Vomiting, Abdominal pain, Vomiting. On 15Mar2022, the patient experienced Cough. On 17Mar2022, the patient experienced Acute chest pain or chest pressure sensation, Poor feeding/appetite impaired, energy decreased. Clinical course in Pericarditis Investigation Form: On 14Mar2022, the patient experienced Acute chest pain or chest pressure sensation, Palpitations, Feelings of weakness, Queasy/vomiting/diarrhoea, Sweaty, Malaise, Intermittent pyrexia. On 15Mar2022, the patient experienced Cough. On 17Mar2022, the patient experienced Poor feeding/appetite impaired, Energy decreased. The reporting physician classified the event Myocarditis and Pericarditis as serious (hospitalization, Life-threatening) and assessed that the events were related to BNT162B2. Other possible cause of the events such as any other diseases was Viral pharyngitis. The reporting physician commented as follows: Symptoms from the day after vaccination were judged to be causally related. On 16Mar2022(as reported), the patient had redness of the pharynx on admission to our hospital, with findings of viral pharyngitis, which may led to myocarditis, events happened after corona vaccine, and vaccine-induced myocarditis could not be ruled out. Test findings On 18Mar2022: The patient had Cardiac ultrasonography which showed Left ventricular ejection fraction (39.7%), Localized or diffuse dysfunction of the right or left ventricle (e.g., reduction in ejection fraction), Reduction or abnormality in systolic function or diastolic function of the entire cardiac ventricle, Ventricular enlargement, Change in left ventricular wall thickness, Pericardial effusion. The patient had chest X-ray which showed Cardiomegaly (CTR 61 %). The patient had Electrocardiography which showed ST elevated or negative T wave, Poor R progression, low voltage, Q wave abnormal. Test findings On 18Mar2022: The patient experienced Troponin T elevated to 1954 ng/mL, Troponin I elevated to 9792.9 ng/mL (also reported Troponin I elevated to 9772.9 pg/mL(as reported),), CK elevated to 411 U/L, CK-MB elevated to 34 U/L, CRP elevated to 1.27 mg/dL, D-dimer elevated to 2.5 ug/mL. The patient had Cardiac ultrasonography which showed Abnormal pericardial effusion, Inflammatory findings of pericardia. The patient had Chest radiography which showed Findings of cardiomegaly. The patient had Electrocardiography which showed II, III, V2-V4, aVF ST increased, V5-V6 ST Decreased, Negative T wave. and others (AST 115 ALT 37 LPH 657 serum NaB2 as reported). The patient had chest X-ray which showed Abnormal (CTR 56 %). Other diseases (e.g. myocardial infarction, pulmonary embolism, and mediastinitis) accountable for clinical symptoms/findings are ruled out. Cardiac MRI examination would be performed at a later date (as reported). No follow-up attempts are possible. No further information is expected. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: Myocarditis; Paroxysmal supraventricular tachycardia; Arrythmia sinus; Retrosternal chest pain; Tachycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. A 8 year-old female patient received bnt162b2 (COMIRNATY), administration date 06Dec2021 (Lot number: FK5618) at the age of 8 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered", described as "Myocarditis"; CHEST PAIN (hospitalization) with onset 06Dec2021, outcome "recovered", described as "Retrosternal chest pain"; TACHYCARDIA (hospitalization) with onset 06Dec2021, outcome "recovered", described as "Tachycardia"; SUPRAVENTRICULAR TACHYCARDIA (hospitalization), outcome "recovered", described as "Paroxysmal supraventricular tachycardia"; SINUS ARRHYTHMIA (hospitalization), outcome "recovered", described as "Arrythmia sinus". No follow-up attempts are possible. No further information is expected. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: CHEST PAIN, STABBING IN CHARACTER, GRADED 7/10; MYOCARDITIS; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300140644 . An 11-year-old male patient received BNT162b2 (COMIRNATY), on 12Feb2022 as dose 1, single (Lot number: FR8392) and on 12Mar2022 as dose 2, single (Lot number: FR8392) at the age of 11 years, all intramuscular for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset 17Mar2022 at 06:54, outcome "recovered" (18Mar2022 at 06:57); CHEST PAIN (hospitalization), outcome "unknown", described as "CHEST PAIN, STABBING IN CHARACTER, GRADED 7/10". The patient underwent the following laboratory tests and procedures: Pain assessment: (17Mar2022) 7/10, notes: CHEST PAIN, STABBING IN CHARACTER, GRADED 7/10. No follow-up attempts are possible. No further information is expected. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: exacerbation of the myocarditis; pain localized; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: v2210000546. An 11-year-old male patient received BNT162b2 (COMIRNATY FOR 5 TO 11 YEARS OLD), on 16Mar2022 as dose 1, single (Lot number: FN5988, Expiration Date: 31Jul2022) at the age of 11 years for covid-19 immunisation. The patient''s relevant medical history included: "block due to acute myocarditis", start date: 27May2017 (unspecified if ongoing), notes: following up the patient condition has continued once a year.; "block due to acute myocarditis", start date: 27May2017 (unspecified if ongoing), notes: following up the patient condition has continued once a year.; "Cardiac failure", stop date: Feb2019, notes: following up the patient condition has continued once a year.; "cardiac function was detected" (unspecified if ongoing), notes: After that, since exacerbation of cardiac function was detected, the patient was connected to an ECMO machine and monitored.; "myocarditis", start date: 14Aug2018 (unknown if ongoing). The patient''s concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 16Mar2022, outcome "recovering", described as "pain localized"; MYOCARDITIS (medically significant) with onset 05Apr2022, outcome "recovering", described as "exacerbation of the myocarditis". The event "exacerbation of the myocarditis" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) no abnormal findings, notes: indicating ischaemia presented and the value of troponin I decreased. performed one week later; Echocardiogram: (unspecified date) good condition of the patient cardiac contraction, notes: this time; Electrocardiogram: (05Apr2022) some strange findings in QS pattern and, notes: of negative T wave, and it was different from before; Magnetic resonance imaging: (05Apr2022) myocarditis was diagnosed, notes: No remarkable findings showed in T2-weighted imaging, EGE imaging and LGE imaging, but quantitative native T1 mapping showed a remarkable increase; Scan myocardial perfusion: (unspecified date) no abnormal findings, notes: indicating ischaemia presented and the value of troponin I decreased. performed one week later; Troponin I: (14Aug2018) definitely became negative; (05Apr2022) extremely positive, notes: no symptoms. Clinical course: The patient was a 11-year and 1-month-old male. (at vaccination). On 16Mar2022 after the patient received the vaccination. There were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) including on 27May2017, for medical treatment of the block due to acute myocarditis, transvenous pacing was conducted. After that, since exacerbation of cardiac function was detected, the patient was connected to an ECMO machine and monitored. Also the patient received administration of drugs for the treatment for cardiac failure. In Feb2019, because of an improvement of condition, the administration was finished. Since then, following up the patient condition has continued once a year. On 16Mar2022 after the patient received the vaccination, pain localized occurred, but no pyrexia and no chest pain. On 05Apr2022, when the patient visited the hospital for an annual check, following up on the past myocarditis, an electrocardiogram showed some strange findings in QS pattern and of negative T wave, and it was different from before. From a blood test, troponin I was extremely positive. Since no symptoms were observed, a blood sample was recollected for testing and myocardial scintigraphy was performed one week later. But no abnormal findings indicating ischaemia presented and the value of troponin I decreased. Enhancement MRI was conducted for diagnosis. No remarkable findings showed in T2-weighted imaging, EGE imaging and LGE imaging, but quantitative native T1 mapping showed a remarkable increase. Based on this finding, myocarditis was diagnosed. On 05Apr2022 (20 days after the vaccination), the patient experienced myocarditis. On 14Apr2022 (29 days after the vaccination), the outcome of the event was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. Other possible causes of the event such as any other diseases were there could be some possibility of exacerbation of the myocarditis the patient used to suffer from. The reporting physician commented as follows: Although there could be some possibility of exacerbation of the myocarditis the patient used to suffer from, on 14Aug2018, the reporter confirmed that the collected blood showed that value of troponin I definitely became negative. After that, and at this time, echo showed good condition of the patient cardiac contraction. Now, the patient was diagnosed with myocarditis from the blood test, electrocardiogram findings, MRI findings, although no chest pain, and also because there was no alternative causal disorder to myocarditis. No follow-up attempts are possible. No further information is expected. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: pericardial effusion (3.23mm at the most); CK-MB of 3.4ng/ml it was mild increased; queasy; Pericarditis/transient pericarditis; chills; chest pain; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: v2210000625. An 8-year-old male patient received BNT162b2 (COMIRNATY FOR 5 TO 11 YEARS OLD), on 27Mar2022 as dose 1, single (Batch/Lot number: unknown) at the age of 8 years for covid-19 immunisation. The patient''s family history included: "Kawasaki''s disease" (unspecified if ongoing), notes: younger brother (4-year-old) had Kawasaki''s disease when the patient younger brother 2-year-old. The patient''s concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant) with onset 28Mar2022, outcome "recovered" (15Apr2022), described as "Pericarditis/transient pericarditis"; CHEST PAIN (non-serious) with onset 28Mar2022, outcome "recovered" (15Apr2022); CHILLS (non-serious) with onset 28Mar2022, outcome "recovered" (15Apr2022); NAUSEA (non-serious) with onset 06Apr2022, outcome "recovered" (15Apr2022), described as "queasy"; BLOOD CREATINE PHOSPHOKINASE MB INCREASED (non-serious) with onset 08Apr2022, outcome "recovered" (15Apr2022), described as "CK-MB of 3.4ng/ml it was mild increased"; PERICARDIAL EFFUSION (medically significant) with onset 08Apr2022, outcome "recovered" (15Apr2022), described as "pericardial effusion (3.23mm at the most)". The events "pericarditis/transient pericarditis", "pericardial effusion (3.23mm at the most)", "chills", "chest pain", "queasy" and "ck-mb of 3.4ng/ml it was mild increased" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase MB: (08Apr2022) 3.4 ng/ml, notes: it was mild increased; Body temperature: (27Mar2022) 36.8 Centigrade, notes: before vaccination; Chest X-ray: (08Apr2022) did not show cardiomegaly; Echocardiogram: (08Apr2022) little pericardial effusion (3.23mm at the most); Electrocardiogram: (08Apr2022) no change in ST. Clinical course: The patient was a 8-year and 7-month-old male (at vaccination). The patient had family history of the patient younger brother (4-year-old) had Kawasaki''s disease when the patient younger brother was 2-year-old and there was no other family history to note. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Clinical course: On 27Mar2022, the patient received Comirnaty for 5 to 11 years old, lot number unknown. On 28Mar2022 (1 day after the vaccination), the patient experienced pericarditis. On 15Apr2022 (19 days after the vaccination), the outcome of the event was recovered. The course of the event was as follows: The next day of vaccination day chills and chest pain appeared. Chills without pyrexia disappeared immediately but chest pain continued, 10 days after vaccination on 06Apr2022 chest pain peaked and queasy also appeared. Queasy disappeared in a few hours, chest pain also improved but continued so on 08Apr2022 the patient went to hospital. Electrocardiogram showed no change in ST, chest Xp did not show cardiomegaly. Blood test showed CK-MB of 3.4ng/ml it was mild increased, cardiac ultrasound showed little pericardial effusion (3.23mm at the most). Cardiac contractility was good. When the patient went to hospital again a week later, mild chest pain continued but tended to improve, and pericardial fluid had disappeared. Considered that it was an acute transient change, diagnosed it as suspected pericarditis along with clinical symptoms, and decided to forgo dose 2. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient did not have many indefinite complaints and this was the first time for the patient to complain of chest pain. Since there was no previous episode of viral infection and symptoms appear after vaccination, the reporter thought there was a high possibility of transient pericarditis after vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: Pericarditis; Chest pain; Dyspareunia; Electrocardiogram abnormal; Palpitations; Skin discolouration; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 731096 An 11-year-old male patient received BNT162b2 (COMIRNATY), on 25Jan2022 as dose 1, single (Batch/Lot number: unknown) at the age of 11 years for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 25Jan2022, outcome "recovered"; DYSPAREUNIA (non-serious) with onset 25Jan2022, outcome "recovered"; ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 25Jan2022, outcome "recovered"; PALPITATIONS (non-serious) with onset 25Jan2022, outcome "recovered"; PERICARDITIS (medically significant) with onset 25Jan2022, outcome "recovered"; SKIN DISCOLOURATION (non-serious) with onset 25Jan2022, outcome "recovered". The patient underwent the following laboratory tests and procedures: Electrocardiogram: (25Jan2022) abnormal; Troponin: (25Jan2022) unknown results. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: cardiac failure acute which was acute myocarditis-like; Cardio-respiratory arrest; from the evening of 30Apr2022, respiratory failure was noted; Bradycardia; cyanosis / systemic cyanosis; Gradually the pulse was decreased; Blood pressure decreased; blood pressure could no longer be measured / blood pressure became unmeasurable; Tachycardia / heart rate was 130-150/min; Cold sweat; Fatigue; Malaise developed 22 hours after the vaccination; cardiac failure acute which was acute myocarditis-like / Suspected acute myocarditis; Energy decreased; Palpitations; Sweaty; This is a spontaneous report received from contactable reporter(s) (Physician) from Agency and Regulatory Authority. Regulatory number: v2210000748, v2210000758. Other Case identifier(s): v2210000748, v2210000758. An 11-year-old female patient received BNT162b2 (COMIRNATY FOR 5 TO 11 YEARS OLD), on 28Apr2022 at 14:00 as dose 2, single (Lot number: FN5988, Expiration Date: 31Oct2022) at the age of 11 years intramuscular for covid-19 immunisation. The patient''s relevant medical history included: "Severe neonatal asphyxia at birth", start date: 2011, stop date: 2011; "Hypoxic-ischaemic encephalopathy", start date: 2011, stop date: 2011; "Immediately after birth, the patient was placed ventilator management", start date: 2011, stop date: 2011; "Immediately after birth, the patient was placed ventilator management", start date: 2011, stop date: 2011; "Cerebral palsy" (unspecified if ongoing); "The patient was a medically dependent child and she had been hospitalized for a long time at the severe mentally and physically handicapped department", start date: Jun2014 (unspecified if ongoing); "The patient was a medically dependent child and she had been hospitalized for a long time at the severe mentally and physically handicapped department", start date: Jun2014 (unspecified if ongoing); "The patient was a medically dependent child and she had been hospitalized for a long time at the severe mentally and physically handicapped department", start date: Jun2014 (unspecified if ongoing). There was nothing special with family history. The patient''s concomitant medications were not reported. Vaccination history included: comirnaty for 5 to 11 years old (1st single dose, Lot number unknown;, Route of administration: Intramuscular), administration date: 07Apr2022, for COVID-19 immunisation, reaction(s): "no adverse reaction or progressed". The following information was reported: ASTHENIA (non-serious) with onset 29Apr2022, outcome "unknown", described as "Energy decreased"; PALPITATIONS (non-serious) with onset 29Apr2022, outcome "unknown"; HYPERHIDROSIS (non-serious) with onset 29Apr2022, outcome "unknown", described as "Sweaty"; MYOCARDITIS (death, medically significant) with onset 29Apr2022, outcome "fatal", described as "cardiac failure acute which was acute myocarditis-like / Suspected acute myocarditis"; COLD SWEAT (non-serious) with onset 29Apr2022 at 12:00, outcome "unknown"; FATIGUE (non-serious) with onset 29Apr2022 at 12:00, outcome "unknown"; MALAISE (non-serious) with onset 29Apr2022 at 12:00, outcome "unknown", described as "Malaise developed 22 hours after the vaccination"; TACHYCARDIA (non-serious) with onset 29Apr2022 at 12:00, outcome "unknown", described as "Tachycardia / heart rate was 130-150/min"; BLOOD PRESSURE DECREASED (death, medically significant) with onset 30Apr2022, outcome "fatal"; BRADYCARDIA (death, medically significant) with onset 30Apr2022, outcome "fatal"; HEART RATE DECREASED (death, medically significant) with onset 30Apr2022, outcome "fatal", described as "Gradually the pulse was decreased"; BLOOD PRESSURE IMMEASURABLE (death, medically significant) with onset 30Apr2022, outcome "fatal", described as "blood pressure could no longer be measured / blood pressure became unmeasurable"; CYANOSIS (death, medically significant) with onset 30Apr2022, outcome "fatal", described as "cyanosis / systemic cyanosis"; RESPIRATORY FAILURE (death, medically significant) with onset 30Apr2022, outcome "fatal", described as "from the evening of 30Apr2022, respiratory failure was noted"; CARDIO-RESPIRATORY ARREST (death, medically significant) with onset 30Apr2022 at 20:32, outcome "fatal"; CARDIAC FAILURE ACUTE (death, medically significant), outcome "fatal", described as "cardiac failure acute which was acute myocarditis-like". The patient underwent the following laboratory tests and procedures: Aspartate aminotransferase: (30Apr2022) 88; Blood creatine phosphokinase: (30Apr2022) 1246 IU/l, notes: increased; Blood lactate dehydrogenase: (30Apr2022) 515; Blood test: (27Apr2022) No abnormal findings.; Body temperature: (28Apr2022) 36.7 degrees, notes: before vaccination; Chest X-ray: (30Apr2022) No abnormalities.; C-reactive protein: (30Apr2022) 32.8 mg/dl, notes: increased; Electrocardiogram: (unspecified date) No obvious arrhythmia was observed.; Heart rate: (29Apr2022) 130~150, notes: /min. Therapeutic measures were taken as a result of respiratory failure, cyanosis, blood pressure immeasurable. The patient date of death was 30Apr2022. Reported cause of death: "from the evening of 30Apr2022, respiratory failure was noted", "Cardio-respiratory arrest", "cardiac failure acute which was acute myocarditis-like", "cardiac failure acute which was acute myocarditis-like / Suspected acute myocarditis", "cyanosis / systemic cyanosis", "Bradycardia", "Gradually the pulse was decreased", "Blood pressure decreased", "blood pressure could no longer be measured / blood pressure became unmeasurable". It was not reported if an autopsy was performed. On 29Apr2022 at 12:20 (22 hours and 20 minutes after the vaccination), the patient experienced adverse events. On 30Apr2022 (2 days after the vaccination), the outcome of the events was fatal. The course of the event was as follows: Severe neonatal asphyxia at birth. Hypoxic-ischaemic encephalopathy. Immediately after birth, the patient was placed ventilator management. Cerebral palsy was noted. The patient was a medically dependent child and she had been hospitalized for a long time at the severe mentally and physically handicapped department of the reporting hospital from Jun2014. The patient received the first dose of COMIRNATY Intramuscular injection for 5 to 11 years old on 07Apr2021(as reported). The patient had no adverse reaction or progressed. The second dose was administered at 14:00 on 28Apr2022. Heart rate was 130-150/min from past 12:00 on 29Apr2022. Tachycardia, cold sweat and fatigue appeared. The course was observed, but from the evening of 30Apr2022, respiratory failure was noted. Gradually the pulse was decreased, and blood pressure was decreased. Cardio-respiratory arrest was noted at 20:32 and confirmed the patient''s death. The reporting physician classified the event as serious (death) and assessed that the causality between the events and BNT162b2 was unassessable. There was no other possible cause of the event such as any other diseases. Myocarditis Investigation Form. Histopathological examination(s) was not performed. In the clinical symptoms findings, Palpitations, Sweaty, Malaise, and Energy decreased appeared on 29Apr2022. Findings from the test on 30Apr2022 included: Creatine kinase (reported as CK) was 1246 U/L, elevated; C-reactive protein (reported as CRP) was 32.8 mg/dL, elevated; Aspartate Aminotransferase (reported as AST) was 88; Lactate Dehydrogenase (LDH) was 515. No abnormalities was found through Plain chest x-ray on 30Apr2022. On the electrocardiogram monitor at the ward did not show obvious arrhythmia. Other disease(s) accountable for clinical symptom(s)/findings cannot be ruled out. The patient received the second single dose intramuscular. On 29Apr2022, the patient experienced suspected acute myocarditis. The course of the event was as follows: Malaise developed 22 hours after the vaccination. The patient was followed-up, but in the evening of the following day (30Apr), respiratory failure occurred. Bradycardia then progressed and her blood pressure could no longer be measured; she developed cyanosis and died. Additional information: Case: The patient had no spontaneous respiration, and was solely on mechanical ventilation, gavage, with inability to communicate and being invalid. The family member did not wish any life-support measures in times of critical conditions. There was no change in facial expression, but the patient was responding to pain stimulation to the extent of slightly grimacing. Course: The patient had respiratory failure (bagging with 100 percent O2), systemic cyanosis, and blood pressure became unmeasurable. Drip infusion was performed. Blood collection was difficult (but approximately 1.5 ml could finally be collected). Due to a holiday, no more test items could be performed. The system did not allow to perform echocardiogram. From the circumstances, it was thought to be cardiac failure due to acute myocarditis. There were no abnormal findings on the blood tests performed on 27Apr2022. The reporting physician commented as follows: The causality is unknown. In this case, the patient died of cardiac failure acute which was acute myocarditis-like. There was no other factor, and since the symptoms appeared the following day of COVID-19 vaccination, adverse reaction was suspected. This report met the criteria of Myocarditis. SUSPECT PRODUCT is under agreement with Agency.; Reported Cause(s) of Death: Bradycardia; Gradually the pulse was decreased; blood pressure could no longer be measured / blood pressure became unmeasurable; cyanosis / systemic cyanosis; cardiac failure acute which was acute myocarditis-like; cardiac failure acute which was acu |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: Cardiomyopathy; collagen disorder; loss of consciousness for several seconds; crumpled and fell over; Atrioventricular block complete; suspected myocarditis/myocarditis following viral infection; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: v2210001104. An 8-year and 9-month-old female patient received BNT162b2 (COMIRNATY FOR 5 TO 11 YEARS OLD), on 11May2022 at 09:15 as dose 2, single (Lot number: FN5988, Expiration Date: 31Oct2022) at the age of 8 years for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. Body temperature before vaccination was 36.5 degrees Centigrade. The patient had no special note in family history, no heart disorder. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccination and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The following information was reported: ATRIOVENTRICULAR BLOCK COMPLETE (hospitalization, medically significant) with onset 21May2022 at 14:30, outcome "recovering"; FALL (hospitalization) with onset 21May2022 at 14:30, outcome "recovering", described as "crumpled and fell over"; LOSS OF CONSCIOUSNESS (hospitalization, medically significant) with onset 21May2022 at 14:30, outcome "recovering", described as "loss of consciousness for several seconds"; MYOCARDITIS (hospitalization, medically significant) with onset 21May2022 at 14:30, outcome "recovering", described as "suspected myocarditis/myocarditis following viral infection"; CARDIOMYOPATHY (hospitalization, medically significant), outcome "recovering"; COLLAGEN DISORDER (hospitalization), outcome "recovering". The patient was hospitalized for atrioventricular block complete, myocarditis, cardiomyopathy, loss of consciousness, fall, collagen disorder (start date: 21May2022). The events "atrioventricular block complete", "suspected myocarditis/myocarditis following viral infection", "cardiomyopathy", "loss of consciousness for several seconds", "crumpled and fell over" and "collagen disorder" required emergency room visit. The patient underwent the following laboratory tests and procedures: Angiocardiogram: (31May2022) no Coronary artery stenosis; Blood creatine phosphokinase: (21May2022) 114 IU/l, notes: no increased; Blood creatine phosphokinase MB: (21May2022) 1.6 IU/l, notes: no increased; Body temperature: (11May2022) 36.5 Centigrade, notes: before vaccination; Brain natriuretic peptide: (21May2022) 6.5; C-reactive protein: (21May2022) 0.02 mg/dl, notes: no increased; Echocardiogram: (21May2022) good cardiac contraction, notes: and no pericardial effusion, and there was no ST change suggestive of ischaemia coronary artery also on 12-lead electrocardiogram; (21May2022) no abnormal findings, notes: Left ventricular ejection fraction was 60; (31May2022) no abnormal findings, notes: Left ventricular ejection fraction was 60; Ejection fraction: (21May2022) 60; (31May2022) 60; Electrocardiogram: (21May2022) atrioventricular block complete appeared, notes: every five minutes, but the patient''s consciousness recovered within five to 10 seconds, and the symptoms repeated. No escape rhythms from cardiac ventricles often occurred during atrioventricular block complete. The patient experienced loss of consciousness for five to 10 seconds, but her consciousness recovered, and the symptoms repeated; (21May2022) Atrioventricular conduction delay, notes: or defect conduction intraventricular (I~III degree atrioventricular block, newly appeared bundle branch block). During III degree atrioventricular block, no escape rhythms from cardiac ventricles appeared, syncope appeared with ventricular stands III (as reported), and within several seconds, sinus rhythm and the patient''s consciousness also recovered; Magnetic resonance imaging heart: (26May2022) Contrast-enhanced and no abnormal findings; Troponin I: (22May2022) 0.023 ng/ml, notes: increased; White blood cell count: (21May2022) 8700. Therapeutic measures were taken as a result of atrioventricular block complete, myocarditis, cardiomyopathy, loss of consciousness, fall, collagen disorder. On 21May2022 at 14:30(10 days 5 hours 15 minutes after the vaccination), the patient experienced Atrioventricular block complete and suspected myocarditis. On 21May2022 (10 days after the vaccination), the patient was admitted to the hospital. On 26May2022 (15 days after the vaccination), the outcome of the events were recovering. The course of the events was as follows: At 14:30 on 21May2022, the patient experienced loss of consciousness for several seconds. The patient was sitting on a chair, but she crumpled and fell over, and her consciousness recovered within around five seconds. At 19:00 on the same day, when the patient was sitting in a chair during dinner, she lost her consciousness and fell over in the same way, and her consciousness recovered within around five seconds. As the same symptoms occurred five minutes later and repeated, emergency services were requested, and the patient visited our hospital. Upon arrival, atrioventricular block completes appeared every five minutes on ECG monitor, but the patient''s consciousness recovered within five to 10 seconds, and the symptoms repeated. No escape rhythms from cardiac ventricles often occurred during atrioventricular block complete. The patient experienced loss of consciousness for five to 10 seconds, but her consciousness recovered, and the symptoms repeated. Emergency pacing was judged to be accommodated, a pacemaker lead was placed in the right ventricle by catheter, and the patient was admitted to ICU. Echocardiography found good cardiac contraction and no pericardial effusion, and there was no ST change suggestive of ischaemia coronary artery also on 12-lead electrocardiogram. There was no antecedent infection, and blood test results were CRP: 0.02, CK: 114, BNP: 6.5, and WBC: 8700. PREDNISOLONE was administered. Five days later, atrioventricular block complete improved, and the pacemaker lead was removed. Myocarditis Investigation Form 1. Histopathological examination was not performed. 2.Clinical symptom(s)/ findings: Giddiness/syncope(21May2022) 3. Test findings: Troponin I (test date 22May2022) was 0.023ng/mL, increased. CK (test date 21May2022) was 114 U/L, no increased. CK-MB (test date 21May2022) was 1.6 U/L, no increased. CRP (test date 21May2022) was 0.02 mg/dL, no increased. 4. Imaging examination(s). On 26May2022, the patient did a Cardiac MRI examination, the result was Contrast-enhanced and no abnormal findings. On 31May2022, the patient did a Coronary artery CT, the result was no Coronary artery stenosis. On 21May2022 and 31May2022, the patient did a Cardiac ultrasonography, the result was no abnormal findings. Left ventricular ejection fraction was 60. 5.Electrocardiography On 21May2022, the patient did an Electrocardiography, Atrioventricular conduction delay or defect conduction intraventricular (I~III degree atrioventricular block, newly appeared bundle branch block), During III degree atrioventricular block, no escape rhythms from cardiac ventricles appeared, syncope appeared with ventricular stands III (as reported), and within several seconds, sinus rhythm and the patient''s consciousness also recovered. 6. Differential diagnosis Other disease(s) accountable for clinical symptom(s)/findings cannot be ruled out. The reporting physician classified the event as serious (Hospitalized from 21May2022) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the events such as any other diseases were Cardiomyopathy, collagen disorder, myocarditis following viral infection. No follow-up attempts are possible. No further information is expected. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: DIZZINESS; SORE; FAINT; she was informed of the possible symptoms of myocarditis and told to continue observation; leucocyte was slightly higher; OVERDOSE; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party (BIONTECH SE) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1110004227. Other Case identifier(s): TW-Fosun-2022FOS003955. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1110004227. A 10-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: unknown) on 29-May-2022 via unknown route at 0.5 ml with unspecified dosing frequency for COVID-19 immunization(overdose). Medical history, concomitant medications and past product were not reported. The patient experienced dizziness, sore, faint on 29-May-2022. On 29-May-2022 , the patient received 1st dose of BNT vaccine, and she was felt dizziness, sore, faint during the break, then the patient was rushed to the emergency room for treatment. The patient was not hospitalized and returned home after emergency treatment. On an unknown date, the patient was admitted to Pediatric Department of hospital for cardiac examination including electrocardiogram, cardiac ultrasound, etc. On 02-Jun-2022, the patient discharged from hospital, there was no obvious abnormality except for the leucocyte was slightly higher, the myocardial index was normal. The patient had not reported any discomfort, and she was informed of the possible symptoms of myocarditis and told to continue observation. Dizziness, sore, faint met the seriousness criterion of hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. On 02-Jun-2022, the outcomes of the events were recovered. The patient was discharged on 02-Jun-2022. Initial report was received on 08-Jun-2022. Follow-up closed, no further information is possible. Comirnaty is under agreement with BioNTech SE Causality Assessment for events Dizziness; Pain; Faint; Overdose Per Reporter = Possible; Per BioNTech SE= Possible |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: Off label use; Interchange of vaccine products; Myocarditis; Chest discomfort; Costochondritis; Decreased appetite; Dyspnoea; Gastrooesophageal reflux disease; Headache; Lethargy; Musculoskeletal pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 741214 (ADR#). A 10-year-old male patient received BNT162b2 (COMIRNATY), on 14Jan2022 as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown) at the age of 10 years for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: coviD-19 vaccine astrazeneca (dose 1), administration date: 20Sep2021, for COVID-19 immunisation. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 14Jan2022, outcome "recovering"; COSTOCHONDRITIS (non-serious) with onset 14Jan2022, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 14Jan2022, outcome "recovering"; DYSPNOEA (non-serious) with onset 14Jan2022, outcome "recovering"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 14Jan2022, outcome "recovering"; HEADACHE (non-serious) with onset 14Jan2022, outcome "recovering"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Jan2022, outcome "unknown"; LETHARGY (non-serious) with onset 14Jan2022, outcome "recovering"; MUSCULOSKELETAL PAIN (non-serious) with onset 14Jan2022, outcome "recovering"; MYOCARDITIS (medically significant) with onset 14Jan2022, outcome "recovering"; OFF LABEL USE (medically significant) with onset 14Jan2022, outcome "unknown". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: Feeling sick; Chest pain; Vomited; Fatigue; Age: 9 years; Age: 9 years; Myopericarditis; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: V2123735 (Regulatory Authority). This information was initially reported to Health Authority On 11Aug2021 from Hospital. A 9 year-old male patient received BNT162B2, administration date 03Aug2021 (Lot number: FD7206) at the age of 9 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single, manufacturer unknown), for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant, time to onset in minutes: 900) with onset 03Aug2021, outcome "not recovered", described as "Myopericarditis"; MALAISE (non-serious, time to onset in minutes: 1440) with onset 04Aug2021, outcome "not recovered", described as "Feeling sick"; CHEST PAIN (non-serious, time to onset in minutes: 1440) with onset 04Aug2021, outcome "not recovered", described as "Chest pain"; VOMITING (non-serious, time to onset in minutes: 1440) with onset 04Aug2021, outcome "not recovered", described as "Vomited"; FATIGUE (non-serious) with onset 04Aug2021, outcome "not recovered", described as "Fatigue". The events "myopericarditis", "feeling sick", "chest pain", "vomited" and "fatigue" were evaluated at the emergency room visit. 9 year-old is off label age for BNT162B2. The patient underwent the following laboratory tests and procedures: SARS-COV-2 test: negative. No follow-up attempts are possible. No further information expected. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Skin rash (non-injection site); Myocarditis; This regulatory authority case was reported by an other health care professional and describes the occurrence of RASH (Skin rash (non-injection site)) and MYOCARDITIS (Myocarditis) in a 10-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Urticaria localised (complained local urticaria at the time of vaccination). On 25-Jun-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2022, the patient experienced RASH (Skin rash (non-injection site)) (seriousness criterion hospitalization) and MYOCARDITIS (Myocarditis) (seriousness criterion hospitalization). The patient was hospitalized on 26-Jun-2022 due to MYOCARDITIS and RASH. The patient was treated with DICLOFENAC SODIUM (intramuscular) on 26-Jun-2022 at a dose of 50 mg IM ST; DIPHENHYDRAMINE (intravenous) on 26-Jun-2022 at a dose of 30 mg IV ST; HYDROCORTISONE (intravenous) on 26-Jun-2022 at a dose of 100 mg IV ST and ASPIRIN [ACETYLSALICYLIC ACID] (oral) on 26-Jun-2022 at a dose of 300 mg 2 tab PO ST. At the time of the report, RASH (Skin rash (non-injection site)) and MYOCARDITIS (Myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, Vital signs measurement: stable stable. On 26-Jun-2022, Blood pressure measurement: 104/70 104/70 mmHg. On 26-Jun-2022, Body temperature: 39.6 39.6 C. On 26-Jun-2022, C-reactive protein: 14.98 14.98 mg/dl. On 26-Jun-2022, Echocardiogram: mild pericardial effusion mild pericardial effusion. On 26-Jun-2022, Heart rate: 150 150 BPM. On 26-Jun-2022, Red blood cell sedimentation rate: 47 47 mm/hr. On 26-Jun-2022, Troponin I: 334.6 334.6 pg/ml. On 26-Jun-2022, Weight: 63 63 kg. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company comment: This regulatory authority case reported by other health care professional, concerns a 10 year old male patient with ongoing localized urticaria and weighing 63 kg, who experienced the expected, serious (hospitalization) AESI of Myocarditis and unexpected, serious (hospitalization) event of Rash, on the next day of receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The vaccination was recommended after evaluation by his doctor. On the day of vaccination, patient experienced chest tightness, fever, systemic rash and respiratory asthma and his urticaria aggravated. The patient took antihistaminics reportedly at his own discretion. However, the symptoms did not improve and there was dizziness. The following day, patient consulted the emergency department and myocarditis caused by the vaccine was suspected. He was then hospitalized and his investigations showed elevated C- reactive protein, troponin I and ESR; Heart rate was 150 bpm and echocardiogram showed mild pericardial effusion. He was diagnosed with Myocarditis and treated with NSAIDs, aspirin and hydrocortisone. No further information on details pertaining to the first dose was available in the report. The events were resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness retained as per Regulatory Authority reporting.; Sender''s Comments: This regulatory authority case reported by other health care professional, concerns a 10 year old male patient with ongoing localized urticaria and weighing 63 kg, who experienced the expected, serious (hospitalization) AESI of Myocarditis and unexpected, serious (hospitalization) event of Rash, on the next day of receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The vaccination was recommended after evaluation by his doctor. On the day of vaccination, patient experienced chest tightness, fever, systemic rash and respiratory asthma and his urticaria aggravated. The patient took antihistaminics reportedly at his own discretion. However, the symptoms did not improve and there was dizziness. The following day, patient consulted the emergency department and myocarditis caused by the vaccine was suspected. He was then hospitalized and his investigations showed elevated C- reactive protein, troponin I and ESR; Heart rate was 150 bpm and echocardiogram showed mild pericardial effusion. He was diagnosed with Myocarditis and treated with NSAIDs, aspirin and hydrocortisone. No further information on details pertaining to the first dose was available in the report. The events were resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness retained as per Regulatory Authority reporting. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Myocarditis; Chest pain; This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis) and CHEST PAIN (Chest pain) in a 9-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient''s past medical history included Urethroplasty (Status post urethroplasty) on 11-Sep-2013. Concurrent medical conditions included Hypospadias and UTI. On 16-May-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jun-2022, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion hospitalization) and CHEST PAIN (Chest pain) (seriousness criterion hospitalization). The patient was hospitalized from sometime in 2022 to 04-Jul-2022 due to CHEST PAIN and MYOCARDITIS. The patient was treated with AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) in June 2022 for UTI, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Myocarditis) and CHEST PAIN (Chest pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jun-2022, C-reactive protein: 44.4 44.4. On 25-Jun-2022, Electrocardiogram: diffuse st elevation Diffuse ST Elevation. On 25-Jun-2022, Troponin I: 2.148 2.148 ng/mL. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The age of the patient was reported to be 9.3 years. 16-May-2022: Patient received 1st Modem COVID-19 vaccine, And no obvious reactogenicity was noted at that time, 24-Jun-2022: Received 2nd Moderna COVID-19 vaccine. Fever development on June 24 midnight. Associated symptom, include headache and vomiting. 25-Jun-2022: Intermittent chest pain was also complained. Associated symptoms included dizziness and lethargy. patient appetite and activity were decreased, Due to above, Under the impression of myocarditis, patient was transferred to PICU for further evaluation and management, 26-Jun-2022: Better spirit and appetite. Intermittent chest pain, no obvious attack after admission, No fever, no headache, no dizziness 29-Jun-2022: Transfer to ordinary ward for further care continue antibiotic therapy with augmentin for UTI The following is the follow-up outcome. 04-Jul-2022: The patient has been discharged and returned home. At present, the conditions are still stable. Concomitant product was not provided by the reporter. Company comment: This regulatory authority case reported by a health care professional, concerns a 09 year old male patient, with no reported medical history, who experienced the expected, serious (Hospitalization) AESI of Myocarditis, and the unexpected, serious (Hospitalization) event of Chest pain, occurred 01 day after receiving an 2 dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient received the 1 dose with Moderna vaccine about 38 days prior to the 2 dose. Inappropriate schedule of product administration was noted. On the night of taking the 2 dose, patient had fever, headache and vomiting. Associated symptoms included dizziness and lethargy. Patient appetite and activity were decreased and was Hospitalized. Concurrent medical conditions included Hypospadias and UTI. The patient was treated with Amoxicillin sodium, clavulanate potassium in June 2022 for UTI. Investigations were done on the day of event onset, ECG showed Diffuse ST elevation, C Reactive protein was 44.4mg/l and Troponin was 2.148 ng/mL. No further information on comorbidities, risk factors, detailed clinical course, concomitant medications was available in the report. The events outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory authority case reported by a health care professional, concerns a 09 year old male patient, with no reported medical history, who experienced the expected, serious (Hospitalization) AESI of Myocarditis, and the unexpected, serious (Hospitalization) event of Chest pain, occurred 01 day after receiving an 2 dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient received the 1 dose with Moderna vaccine about 38 days prior to the 2 dose. Inappropriate schedule of product administration was noted. On the night of taking the 2 dose, patient had fever, headache and vomiting. Associated symptoms included dizziness and lethargy. Patient appetite and activity were decreased and was Hospitalized. Concurrent medical conditions included Hypospadias and UTI. The patient was treated with Amoxicillin sodium, clavulanate potassium in June 2022 for UTI. Investigations were done on the day of event onset, ECG showed Diffuse ST elevation, C Reactive protein was 44.4mg/l and Troponin was 2.148 ng/mL. No further information on comorbidities, risk factors, detailed clinical course, concomitant medications was available in the report. The events outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: Myocarditis; pyrexia of 39s degrees C, the body temperature repeated rises and falls.; This is a spontaneous report received from contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: v2210001899. A 7-year-old male patient received BNT162b2 (COMIRNATY FOR 5 TO 11 YEARS OLD), on 21Jun2022 as dose 2, single (Lot number: FP0362, Expiration Date: 30Nov2022) at the age of 7 years for covid-19 immunisation. The patient''s relevant medical history included: "Premature and extremely low birth weight infant" (unspecified if ongoing), notes: Premature and extremely low birth weight infant (the gestational age was 25 weeks and 2 days); "Premature and extremely low birth weight infant" (unspecified if ongoing), notes: Premature and extremely low birth weight infant (the birth weight was 379 g); "neonatal chronic lung disease" (unspecified if ongoing); "retinopathy of prematurity (already treated)" (unspecified if ongoing); "femur fracture and the right humerus associated with prematurity osteopenia, after left radius fracture (healed)" (unspecified if ongoing); "femur fracture and the right humerus associated with prematurity osteopenia, after left radius fracture (healed)" (unspecified if ongoing); "congenital hypothyroidism" (unspecified if ongoing); "postoperative inguinal hernia" (unspecified if ongoing); "postoperative inguinal hernia" (unspecified if ongoing); "feeding disorder" (unspecified if ongoing); "eosinophilia" (unspecified if ongoing), notes: He has a medical history of admission for eosinophilia and tubular dysfunction.; "tubular dysfunction" (unspecified if ongoing), notes: He has a medical history of admission for eosinophilia and tubular dysfunction. Concomitant medication(s) included: BIOFERMIN [BACILLUS SUBTILIS;ENTEROCOCCUS FAECALIS;LACTOBACILLUS ACIDOPHILUS] oral; CARBOCISTEINE oral; ENEVO oral; ELENTAL-P oral; GLYCERIN [GLYCEROL]. Vaccination history included: comirnaty (Dose 1, Lot: FP0362, Expiration date: 30Nov2022), administration date: 31May2022, for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset 22Jun2022, outcome "recovering", described as "pyrexia of 39s degrees C, the body temperature repeated rises and falls."; MYOCARDITIS (hospitalization, medically significant) with onset 24Jun2022, outcome "recovering". The patient was hospitalized for myocarditis (start date: 24Jun2022, discharge date: 11Jul2022, hospitalization duration: 17 day(s)). The events "myocarditis" and "pyrexia of 39s degrees c, the body temperature repeated rises and falls." required physician office visit. The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase MB: (24Jun2022) 39.6 ng/ml; Body temperature: (22Jun2022) 39s, notes: On 22Jun2022, the patient started to have a pyrexia of 39s degrees C, the body temperature repeated rises and falls; N-terminal prohormone brain natriuretic peptide: (24Jun2022) 10793 pg/mL; Troponin I: (24Jun2022) 2.83 ng; White blood cell count: (24Jun2022) 38000 uL, notes: The unit was /microlitre. Therapeutic measures were taken as a result of myocarditis, pyrexia. Clinical course: The patient was a 07-year and 10-month-old male at time of vaccination. Vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) was as below: He has a medical history of admission for eosinophilia and tubular dysfunction. Oral drugs to be taken: BIOFERMIN COMBINATION POWDER, carbocisteine dry syrup, ENEVO, ELENTAL P, GLYCERIN ENEMA 50%. Allergic history was none. On 24Jun2022, the patient experienced adverse events (as reported). On 15Jul2022, the outcome of the events was recovering. The course of the event was as follows: On 21Jun2022, the patient received the vaccination (the 2nd time, COMIRNATY, Pfizer, Lot: FP0362 expiration date: 30Nov2022). On 22Jun2022, the patient started to have a pyrexia of 39s degrees C, the body temperature repeated rises and falls. So, the patient was being worried, and the patient was taken to the department of outpatient pediatrics on 24Jun2022. Blood test showed elevation levels of WBC (White blood cell) at 38000 (/microlitre), NT-ProBNP at 10793 (pg/mL), CK-MB at 39.6 (ng/mL) and TnI (Troponin I) at 2.83 (ng), thus myocarditis was recognized, and the patient was hospitalized. Treatment with transfusion and drip infusion of heparin was initiated. On 11Jul2022, the patient showed a tendency of improvement and a good general condition, and thus he was discharged. The patient was placed under follow-up as an outpatient. The reporting physician classified the event as serious (hospitalization from 24Jun2022 to 11Jul2022) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: As already reported, myocarditis was considered as an adverse reaction to the novel coronavirus vaccine. This report meets the criteria of myocarditis. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-078595. An 11-year-old female patient received BNT162b2 (COMIRNATY), on 03May2022 at 16:10 as dose 2, single (Batch/Lot number: unknown) at the age of 11 years for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant) with onset 03May2022, outcome "unknown". Clinical information: Primary injury was reported as Myocarditis, unspecified. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Electrocardiogram ST segment elevation; Pericarditis; Chest discomfort; Chest pain; Electrocardiogram abnormal; Feeling hot; Oropharyngeal pain; Abdominal pain; Diarrhoea; Arthralgia; fatigue; Headache; This regulatory authority case was reported by an other health care professional and describes the occurrence of ELECTROCARDIOGRAM ST SEGMENT ELEVATION (Electrocardiogram ST segment elevation) and PERICARDITIS (Pericarditis) in a 6-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Mar-2022, the patient experienced ELECTROCARDIOGRAM ST SEGMENT ELEVATION (Electrocardiogram ST segment elevation) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant), CHEST DISCOMFORT (Chest discomfort), CHEST PAIN (Chest pain), ELECTROCARDIOGRAM ABNORMAL (Electrocardiogram abnormal), FEELING HOT (Feeling hot), OROPHARYNGEAL PAIN (Oropharyngeal pain), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhoea), ARTHRALGIA (Arthralgia), FATIGUE (fatigue) and HEADACHE (Headache). At the time of the report, ELECTROCARDIOGRAM ST SEGMENT ELEVATION (Electrocardiogram ST segment elevation), PERICARDITIS (Pericarditis), CHEST DISCOMFORT (Chest discomfort), CHEST PAIN (Chest pain), ELECTROCARDIOGRAM ABNORMAL (Electrocardiogram abnormal), FEELING HOT (Feeling hot), OROPHARYNGEAL PAIN (Oropharyngeal pain), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhoea), ARTHRALGIA (Arthralgia), FATIGUE (fatigue) and HEADACHE (Headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2022, Electrocardiogram: abnormal. On 24-Mar-2022, Electrocardiogram ST segment: elevation. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Treatment information was not provided. The reference number was reported as AU-TGA-0000755787 - 20221025041618. Company comment: This regulatory authority case concerns a 6 year old female patient with no cardiovascular pathology reported, and no known prior COVID 19 infection, who experienced the expected, serious (medically significant) AESI of Pericarditis and the unexpected, serious (medically significant) event of Electrocardiogram ST segment elevation, unknown days after receiving an unspecified dose of mRNA-1273 vaccine. The patient had chest discomfort, chest pain, oropharyngeal and abdominal pain along with the events. Echocardiogram was reported as abnormal. The event resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 6 year old female patient with no cardiovascular pathology reported, and no known prior COVID 19 infection, who experienced the expected, serious (medically significant) AESI of Pericarditis and the unexpected, serious (medically significant) event of Electrocardiogram ST segment elevation, unknown days after receiving an unspecified dose of mRNA-1273 vaccine. The patient had chest discomfort, chest pain, oropharyngeal and abdominal pain along with the events. Echocardiogram was reported as abnormal. The event resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: Myocarditis; Injection site inflammation; Injection site pain; Pyrexia; Palpitations; Tachycardia; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: AEFI-A-072752. An 11-year-old male patient received bnt162b2 (COMIRNATY), on 11Mar2022 as dose number unknown (orange cap), single (Batch/Lot number: unknown) at the age of 11 years for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE INFLAMMATION (non-serious) with onset 11Mar2022, outcome "unknown", described as "Injection site inflammation"; VACCINATION SITE PAIN (non-serious) with onset 11Mar2022, outcome "unknown", described as "Injection site pain"; MYOCARDITIS (medically significant) with onset 11Mar2022, outcome "unknown"; PALPITATIONS (non-serious) with onset 11Mar2022, outcome "unknown"; PYREXIA (non-serious) with onset 11Mar2022, outcome "unknown"; TACHYCARDIA (non-serious) with onset 11Mar2022, outcome "unknown". Additional Information: case was assessed non-serious by Regulatory Authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: Pericarditis; Chest discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: AEFI-A-076539. A 7-year-old male patient received bnt162b2 (COMIRNATY), on 17Mar2022 as dose number unknown (orange cap), single (Batch/Lot number: unknown) at the age of 7 years for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 17Mar2022, outcome "unknown"; PERICARDITIS (medically significant) with onset 17Mar2022, outcome "unknown". Additional Information: case was assessed non-serious by Regulatory Authority. Onset: 0 min. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: Myocarditis; Chest pain; Lymphadenopathy mediastinal; Musculoskeletal chest pain; Pyrexia; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 700090. A 7 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Jan2022 (Batch/Lot number: unknown) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset 20Jan2022, outcome "recovering", described as "Myocarditis"; CHEST PAIN (non-serious) with onset 20Jan2022, outcome "recovering", described as "Chest pain"; LYMPHADENOPATHY MEDIASTINAL (non-serious) with onset 20Jan2022, outcome "recovering", described as "Lymphadenopathy mediastinal"; MUSCULOSKELETAL CHEST PAIN (non-serious) with onset 20Jan2022, outcome "recovering", described as "Musculoskeletal chest pain"; PYREXIA (non-serious) with onset 20Jan2022, outcome "recovering", described as "Pyrexia". The patient underwent the following laboratory tests and procedures: electrocardiogram: (20Jan2022) unknown results. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Fever; chills; cold sweat; fatigue extreme; migraine; Chest pain; chest pressure sensation; Myopericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (chills), COLD SWEAT (cold sweat), FATIGUE (fatigue extreme), MIGRAINE (migraine), CHEST PAIN (Chest pain), CHEST DISCOMFORT (chest pressure sensation) and MYOCARDITIS (Myopericarditis) in a 2-decade-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization), CHILLS (chills) (seriousness criterion hospitalization), COLD SWEAT (cold sweat) (seriousness criterion hospitalization), FATIGUE (fatigue extreme) (seriousness criterion hospitalization), MIGRAINE (migraine) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization), CHEST DISCOMFORT (chest pressure sensation) (seriousness criterion hospitalization) and MYOCARDITIS (Myopericarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, PYREXIA (Fever), CHILLS (chills), COLD SWEAT (cold sweat), FATIGUE (fatigue extreme), MIGRAINE (migraine), CHEST PAIN (Chest pain), CHEST DISCOMFORT (chest pressure sensation) and MYOCARDITIS (Myopericarditis) had not resolved. The report was received from the CAEFISS program with CAEFISS ID V2126523. No concomitant medication reported. No Treatment Medication reported. Age Group of patient was mentioned as 20 to 24 years Company Comment: This case concerns adult male patient with no medical history, who experienced the unexpected events of pyrexia, chills, cold sweat, fatigue, migraine, chest pain, chest discomfort and expected event of myocarditis, which required hospitalization. The events occurred in the same month after the second dose of mRNA-1273. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns adult male patient with no medical history, who experienced the unexpected events of pyrexia, chills, cold sweat, fatigue, migraine, chest pain, chest discomfort and expected event of myocarditis, which required hospitalization. The events occurred in the same month after the second dose of mRNA-1273. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: myocarditis; 6-years-old male patient; 6-years-old male patient; This is a spontaneous report from a contactable physician (patient''s parent). A 6-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: Unknown), at the age of 6 years old, via intramuscular in left arm on 01Sep2021 at single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history was none. The patient did not receive any other vaccines within 4 weeks and any other medications within 2 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (Lot Number: Unknown), at the age of 6 years old, via intramuscular in left arm on 07Aug2021 at single dose for COVID-19 immunisation. The patient experienced myocarditis on 05Sep2021 at 01:00. Event resulted in hospitalization. Duration of hospitalization was 8 days. The patient also experienced off label use and product use in unapproved population on 01Sep2021. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative (test type was other) on 13Sep2021 (also reported as 03Sep2021). No treatment received for event myocarditis. Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported event Myocarditis and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. |
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Administered by: Private Purchased by: ? Life Threatening? No Write-up: Chief Complaint Neurologic problem (Complaint of) Arrival Date/Time: 01/21/2022 13:05:00 History of Present Illness 5 yo M with hx of autism (non-verbal) presenting with unresponsive episode. Pt was in usual state of health last night when he received his 2nd COVID-19 vaccine. He awoke today with fatigue and malaise that seemed to improve so pt went to school where he was sent home for malaise and fever (temp unknown). After arriving home, father went to change his pull up and while laying down pt was unresponsive and drooling and did not appear to be breathing. His eyes were open and rolled backwards. He appeared limp. No rhythmic jerking but family did say he seemed shaky earlier today. He turned blue during the episode so family called EMS and when police showed up, cyanosis resolved and pt had rapid, shallow breathing. He was sleepy afterwards but slowly improving. POC glucose 185 en route. PIV placed. No meds or interventions performed. Tachy en route 140-150''s. He was given tylenol earlier today. PMHx: Autism (non-verbal) Home meds: None. NKDA FMHx: NO hx of seizure or febrile seizure. Social Hx: Lives with family. Attends school. Review of Systems General: +fever, +decerased appetite today Neuro: no headache or focal weakness. Skin: no rashes, bruising. HEENT: no vision changes, nasal congestion, sore throat. Cardiac: no chest pain. Respiratory: no cough, difficulty breathing, shortness of breath. GI: no recent nausea, vomiting, diarrhea. GU: no dysuria, hematuria. MSK: no joint pain or swelling. 10 ROS reviewed and otherwise negative Physical Exam Vitals & Measurements T HR RR BP Sp02 First Set 37.4 DegC (01/21/22 13:15:25) 140 bpm (01/21/22 13:25:13) 28 br/min (01/21/22 13:25:13) 121/63 mmHg (01/21/22 13:25:13) 100 % (01/21/22 13:25:13) VS as above. GEN: sleepy, non-verbal, intermittently follows commands. No acute distress. HEENT: PERRL, clear conjunctiva, oropharynx clear, moist mucous membranes. NECK: supple, full neck ROM. No LAD. CV: RRR, no murmurs. RESP: CTAB. ABD: soft, nontender, non-distended. EXT: warm, well perfused. NEURO: Moves all extremities equally. He is unable to cooperate with strength exam but full strength in lower extremities noted when touching his feet. Normal gait but slow. Normal balance. No tremors. Medical Decision Making 5 yo M with autism (non-verbal) presenting with unresponsive episode with cyanosis in the setting of malaise and fever post-COVID vaccine last night. DDx: febrile seizure, epileptic seizure, syncope, arrhythmia, myocarditis (post-vaccine), acute COVID-19 infection. Plan: chemistry, troponin, EKG, ibuprofen, COVID PCR, observe Reexamination/Reevaluation 15:45 - Pt is still sleeping. Feels warm to touch. HR downtrending. Labs significant for mild hyponatremia (Na 134), neg trop, neg rapid COVID/FLU/RSV PCRs. EKG normal. Will continue to observe to re-assess after waking. 16:57 - Pt is awake, alert and at baseline. Eating a banana. Care instructions and return precautions given to family. Family will follow-up with his primary Neurologist. Given this was a simple febrile seizure, he does not require Neuro consultation in ED or urgent EEG/imaging. Final Diagnosis 1. Febrile seizure Additional information for Item 19: Problem List/Past Medical History Ongoing Autism Global developmental delay Low muscle tone Relative macrocephaly Historical No qualifying data Procedure/Surgical History No Procedure History Family/Social History Basic Social History Living Arrangement Parent(s)/Guardian. Legal Guardian: Parent. Lives With: Mother, Father, Sister. Language Spoken at Home. Medications Prescribed This Visit Prescription No prescriptions for this encounter Allergies No known allergies Most Recent Results Current Encounter Lab Results - Current Encounter Sodium: 134 mmol/L Low (01/21/22 14:32:00) Potassium: 4.38 mmol/L (01/21/22 14:32:00) Chloride: 102 mmol/L (01/21/22 14:32:00) CO2: 20 mmol/L Low (01/21/22 14:32:00) Anion Gap: 12 mmol/L (01/21/22 14:32:00) Glucose Level: 99 mg/dL (01/21/22 14:32:00) BUN: 11 mg/dL (01/21/22 14:32:00) Creatinine: 0.35 mg/dL (01/21/22 14:32:00) Calcium: 9.4 mg/dL (01/21/22 14:32:00) Phosphorus: 4 mg/dL (01/21/22 14:32:00) Magnesium: 2 mg/dL (01/21/22 14:32:00) Troponin T: <0.01 (01/21/22 14:32:00) SARS-CoV-2 POCT: BINEG (01/21/22 14:32:00) Influenza A POCT: BINEG (01/21/22 14:32:00) Influenza B POCT: BINEG (01/21/22 14:32:00) RSV POCT: BINEG (01/21/22 14:32:00) Diagnostic Results EKG: sinus tachycardia, normal intervals, normal axis. rsR'' in V1 which is likely normal variant. No pre-excitation, WPW, Brugada, or prolonged QTc. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: myocarditis, pericarditis, admitted to PICU for monitoring, anti-inflammatory treatment |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: possible pericarditis; chest pain; feeling tired; harder to breath than normal; irregular heartbeat; fever hovering at 102 for 3 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 09:45 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient was not diagnosed with COVID prior vaccination. There were no concomitant medications in two weeks. The patient did not receive any other vaccination within the four weeks before the vaccination. Facility where the most recent COVID-19 vaccine was administered: Doctor''s office/urgent care. The following information was reported: PERICARDITIS (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "possible pericarditis"; CHEST PAIN (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "chest pain"; FATIGUE (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "feeling tired"; DYSPNOEA (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "harder to breath than normal"; HEART RATE IRREGULAR (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "irregular heartbeat"; PYREXIA (non-serious) with onset Nov2021, outcome "recovering", described as "fever hovering at 102 for 3 days". The patient was hospitalized for pericarditis, chest pain, fatigue, dyspnoea, heart rate irregular (hospitalization duration: 1 day(s)). The events "possible pericarditis", "chest pain", "feeling tired", "harder to breath than normal" and "irregular heartbeat" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: (unspecified date) irregular heartbeat; (unspecified date) irregular heartbeat; body temperature: (09Dec2021) 102; sars-cov-2 test: (09Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of pericarditis, chest pain, fatigue, dyspnoea, heart rate irregular, pyrexia. Clinical course: Child was taken in ambulance to hospital. Emergency medical technician (EMT) found irregular heartbeat on Electrocardiogram (EKG)/ Electrocardiogram (ECG). Same was found in hospital. Released with possible pericarditis and request to follow up with pediatrician for chest x-ray and covid test (which was negative). A week later, he had a fever hovering at 102 for 3 days. The lot number for bnt162b2 was not provided and will be requested during follow up. |
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Administered by: School Purchased by: ? Life Threatening? No Write-up: Developed midsternal chest pain and shortness of breath 11/16/21. Seen at Urgent Care x 2, given Ventolin inhaler. Seen at on 11/23/21 for continued chest pain and intermittent SOB, to r/o myocarditis |
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Administered by: Private Purchased by: ? Life Threatening? No Write-up: The patient presented to the hospital 11/20/21 with signs and symptoms consistent with MIS-C as detailed next, felt to be triggered by previous COVID-19 infection (SARS-COV-2 nucleocapsid antibody was positive). Symptoms began the same day sh received influenza and COVID-19 vaccinations and in the context of known exposure to siblings with cold-like symptoms 1.5 months prior to admission. In detail, her symptoms began 11/15/21 with fevers of 102 -103 degF, occurring hours after receiving an influenza vaccine and her first COVID-19 vaccine (Pfizer) at a well child visit earlier in the day. On day 2 of illness, she developed abdominal pain, nausea, loose stools, and her fevers continued. On day 3-4 of illness, she developed a diffuse confluent sunburn-like rash on her abdomen, chest, and face, which spread to her arms (no involvement of palms/soles). Conjunctival injection developed by day 4 of illness and the rash worsened. She was brought to the ED on day 5 of illness when she felt her vision was a little blurry, where she was found to be hypotensive requiring a fluid bolus and she was admitted to the PICU. She was found to have multisystem inflammation with acute kidney injury, coagulopathy, myocarditis with elevated serum troponins but no compromised function, and vasodilatory shock. Studies were consistent with MISC with hepatomegaly, splenomegaly, increased echogenicity of the kidneys on ultrasound, acute kidney injury with Cr of 3.6, elevated CRP, pro-calcitonin, ESR, BNP, troponin, D-dimer, and fibrinogen, hypoalbuminemia, thrombocytopenia, as well as lymphopenia (normal WBC and low absolute lymphocyte count of 800 cells/uL). Her echocardiogram showed normal ventricular function, coronary arteries and anatomy. EKG was normal. CXR was normal. Initial differential diagnosis included MISC, shock KD, toxic shock syndrome, sepsis, less likely tick-born illness (no high risk exposures). Lower extremity dopplers were normal. Sepsis/ID workup was negative by blood cultures, respiratory viral multiplex nasopharyngeal PCR panel, COVID-19 nasopharyngeal PCR, ehrlichia and anaplasma serologies and PCRs, rickettsia rickettsii serologies, and a strep A PCR test from outside pediatrics clinic was negative 2 days prior to admission. COVID-19 serologies were positive for SARS-CoV-2 nucleocapsid antibody (qualitative) and spike antibody (titer of 182 U/mL; normal reference < 0.8 U/mL), indicating a past infection which was felt to be the trigger for her MIS-C. She was treated for MIS-C with IVIG, steroids, lovenox, and high dose aspirin. Lisinopril was given for elevated blood pressures presumably secondary to steroids. Empirical antibiotics for possible sepsis or toxic shock syndrome (ceftriaxone, clindamycin, vancomycin) were discontinued 48 hours of blood culture negativity and with no evidence of focal infection. She had excellent clinical recovery on MIS-C treatments. Pressors with norepinephrine were weaned off within 12 hours of admission, and her rash and fevers quickly resolved along with her other presenting symptoms. Inflammatory markers eventually were all improving by the day of discharge 11/24/22. She was discharged to home on weaning oral steroids, lovenox, aspirin, lisinopril. Upon hematology and cardiology outpatient follow up over the next two months (visits on 12/1/21 and 1/12/22 with repeat labs 1/3/22), she was doing well without any cardiac symptoms of chest pain, shortness of breath, palpitations, or syncope. She was noted to have demonstrated full recovery and with no recurrence of symptoms or inflammation on repeat labs (1/3/22) after coming off the steroids (completed 12/27/21). Lovenox was stopped 12/1/21. Aspirin was stopped 1/12/22 after her vW and FVIII levels normalized indicating resolution of vasculitis. She received her second COVID-19 vaccine (Pfizer) on 1/13/22. A cardiac MRI was normal on 1/24/22. |
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Administered by: Private Purchased by: ? Life Threatening? No Write-up: Primary Care Physician at Discharge: MD Admission Date: 7/10/2022 Discharge Date: 9/12/2022 PRESENTING PROBLEM: Unbalanced common AV canal [Q21.2] L-TGA, levo-transposition of great arteries with ventricular inversion [Q20.5] S/P right ventricle to pulmonary artery (RV-PA) conduit replacement [Z98.890] Patient is a 7 y.o. male with heterotaxy syndrome and complex congenital heart disease including dextrocardia [I,L,L] with unbalanced left-dominant complete atrioventricular canal with hypoplastic right heart and pulmonary atresia, TAPVR, and bilateral SVC, s/p right sided bidirectional Glenn and 1.5 ventricular repair including atrioventricular canal repair, complex VSD patch, RV to PA conduit, RPA division, and fenestrated ASD closure in 2/2018. He also has a history of protein losing enteropathy, chronic diastolic heart failure, CLD/central sleep apnea, GERD, CKD, Hx thrombosis (occlusive IC thrombus), GDD, and functional asplenia and a recent admission for endocarditis with enterobacter cloacae via Karius test and completed a 4 week antibiotic course on 7/2/22. He was readmitted on 7/10/22 for planned cardiac cath that was delayed due to AKI. He underwent the cardiac cath for hemodynamic study on 7/14 that demonstrated significantly elevated pulmonary pressures with end diastolic pressure elevated to 20 mmHg and severe conduit stenosis with free conduit insufficiency and severe bilateral AV valve insufficiency. Because of this, he went to OR on 7/28/22 for a redo sternotomy and replacement of his RV to PA conduit with a 21 mm pulmonary homograft with right and left atrioventricular valve repairs. On 8/21, he tested positive for COVID with minimal symptoms (tested due to maternal illness.). He completed a 5 day course of Remedisvir per ID recommendations. |
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Administered by: Private Purchased by: ? Life Threatening? Yes Write-up: Breathing issues and high heart rate. Life support 1.5 days layer. Myocardidtis. Cloting issues. Left side weakness. Seizures. Lots of abnormal things that happened. Was on life support 6 wks. Then needed a trach and vent. |
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Administered by: Private Purchased by: ? Life Threatening? No Write-up: Patient developed fever (101F), acute chest pain and was brought to care at the local ED. He was found to have symptoms and labs consistent with myocarditis. CXR/AXR WNL. His peak troponin was 2.01 (occurring approximately 3d after the vaccine). He had a normal echocardiogram and EKG. Additional labs included a WBC count of 9, normal BNP, mildly elevated CRP at 2.5, and positive COVID-19 RNA. Symptoms improved with ibuprofen provided orally. Hospitalized overnight at a HCF for ongoing monitoring. Discharged ~24h later with down-trending troponin of 0.68. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: The day following vaccination the patient had chest pain and went to the hospital. labwork pending, suspected myocarditis. Patients mother is awaiting confirmation. The patient is still in the hospital as of 12/01/2021 |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: 01/13/2022 10-year-old male without significant past medical or surgical history presenting for evaluation of 6 days of fever, nausea/vomiting and decreased p.o. intake, diffuse abdominal pain, headache, fatigue, and migratory rash. Patient reportedly COVID-positive 12/6/2021, received initial COVID-vaccine in late November. Patient denying any chest pain, cough, or shortness of breath. Constellation of symptoms is concerning for Kawasaki versus MIS-C. Exam notable for diffuse rash with palmar involvement and early bullae/vesicles, straw berry tongue. There is no conjunctival injection, no perineal involvement. No focal neurologic deficits, diffuse abdominal tenderness without focality. Vital signs are stable hough notable for mild hypotension. Laboratory studies overall consistent with MISC (elevations in ESR/CRP, ferritin, etc. with elevations in troponin and BNP consistent with myocarditis. Electrolyte abnormalities including hyponatremia, hypokalemia, hypocalcemia consistent with inadequate oral intake and diarrhea. Hospital course: MIS-C associated with COVID-19, S/p CTX x2, negative blood cultures, S/p IVIG 1/14, Solumedrol 1/14-1/15, Transitioned to PO Prednisolone 1/16 Lovenox switched to ASA 1/1 Acute respiratory failure with hypoxia, Required HFNC on arrival to PICU, Stable on RA day of d/c. Myocarditis, LVEF 45-50% on 1/14 Discharge: Pt tolerating regular diet well. No N/V. Pt denies any pain. Rash to BLE and bilateral hands/arms improved. Follow up with PMD in one week, Rheumotology in one week, Cardiology in one month |
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Administered by: Private Purchased by: ? Life Threatening? No Write-up: 2/9/22 11 y/o male who had COVID-19 in December, presented to the ER with 8 days of fever, pleuritic chest pain, headache, and malaise. Also 3 to 4 days of periorbital and lip swelling with a macular rash that resolved. Hypotensive 76/43, tachycardia at 126. MIS-C vs Kawasaki. Admitted to ICU. Resp: remained stable on RA. ID: He was given IVIG x1 on 2/10 and started on Methylprednisolone 1mg/kg BID. Blood & urine cultures were negative. 2/9 CXR - small left effusion, EKG w/right bundle branch block. Echo-good contractility, mitral valve insufficiency consistent w/myocarditis. 2/11 Inflammatory markers downtrending, transfer to floor. CV: BP''s were stable and he did not require any pressors. He was started on Aspirin 81mg daily and Lovenox. Evidence of mild myocarditis with tachycardia and mildly elevated troponin, which downtrended prior to transfer to regular floor. Repeat Chest Xray on 2/11 showed small left basilar pleural effusion unchanged from previous examination. It also showed subsegmental consolidation left base, suspicious pneumonia, and WBC also increased to 26.52, patient was started on Ampicillin. Ampicillin later changed to PO Amoxicillin as PO tolerance improved and clinical impression improved. Methylprednisolone was also changed to PO Prednisone. Blood and urine cultures showed no growth after 5 and 2 days, respectively. 2/14 Repeat Echo showed trivial-to-small pericardial effusion located posteriorly behind the heart, with excellent biventricular function. Patient remained afebrile while on floor. Inflammatory markers and LFTs continued to downtrend. Electrolyte abnormalities resolved. Discharged 2/15/2022. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Pericarditis- presented to my office 5 days after receiving the vaccine and his chest pain had already resolved and ECG had normalized. Normal echocardiogram. Therefore, no treatment started. Labs ordered are pending. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Pediatric Infectious Disease is following this patient for elevated troponin, hypotension, red eyes, chest pain, and abdominal pain with concern for possible MIS-C vs atypical KD. He has remained afebrile throughout his hospital admission. Overnight he was starting on IVIG and steroids due to rising BNP and inflammatory markers for suspicion of MIS-C. He was able to be weaned off norepinephrine. His labs show stable inflammation, but improving troponin, WBC, ALC, and Cr. ASO titer negative; antiDNAse b pending. CMV and EBV studies negative. COVID Ab sent. He reports sore throat resolved, abdominal pain improving, still with some chest pain. Red eyes resolved per mom. Mom at bedside and provided additional history: Tues 3/1: Started with headache/neck pain after being hit by a football at school Wednesday 3/2: Episode of vomiting, not wanting to get up/not feeling well Thursday 3/3: Sore throat started Friday 3/4: Admitted Patient received his COVID vaccines on 12/10 and 12/30 per mom. His father had COVID 1/2/22, but was not living at home and did not have contact until he came over 1/16 when he had a negative test. He is currently staying with them to help care for the other children. No one else at the home has been sick; none of them have had COVID. He did have one episode about a month ago where he complained of sore throat that quickly resolved; no other illnesses recently. Lives at home with mom, dad, 25 year old brother (who is moving out), and 5 other siblings (ages 4, 6, 7, 13 and 17). His 7 year old sibling has ADHD; otherwise everyone is healthy. No history of immunodeficiencies, MRSA. He is UTD on vaccines except yearly influenza. REVIEW OF SYSTEMS: General: No fever and feeling better overall, HEENT: sore throat resolved. Eye redness resolved. , Respiratory: reports breathing better with O2 on, Cardiovascular: Hemodynamically stable and off pressors, Gastrointestinal: No abdominal pain/diarrhea, Musculoskeletal: No history of joint swelling, joint pain, or loss of range of motion., Neuro: No headaches and vision improved and Skin: Negative for lesions, rash, and itching PHYSICAL EXAMINATION: BP 88/52 | Pulse 107 | Temp (Src) 97.9 (Axillary) | Resp 42 | Ht 4'' 3.575" (1.31m) | Wt 77 lb 2.6 oz (35.0kg) | SpO2 97% | BMI 20.40 kg/(m^2). O2 Therapy: Nasal Cannula, Liters: 2 General: Well appearing, no acute distress and sitting in bed, cooperative, mom at bedside Head: Normocephalic Eyes: Conjunctiva clear, no drainage Mouth: Moist mucous membranes and no red/cracked lips Oropharynx: Normal and normal tongue, no oral lesions noted, no difficulty opening mouth Lymph Nodes: No significant lymphadenopathy Cardiovascular: regular rate; murmur heard yesterday at apex not appreciable on exam today Lungs: tachypnic, but clear bilaterally with NC in place Abdomen: Abdomen is soft, nontender Extremities: Normal exam without deformities. Joints are without edema or erythema Neurological: Awake, alert and Answering questions appropriately Skin: Without lesions or rash Ultrasound abdomen 3/5/22: 1. Nonspecific gallbladder wall thickening without other findings of cholecystitis. This may relate to adjacent hepatic inflammatory process such as hepatitis, hepatic congestion or low protein state. Correlation with LFTs and albumin is recommended. 2. 0.9 cm hyperechoic focus adjacent to the falciform ligament most consistent with focal fatty infiltration. 3. Moderate free fluid in all 4 abdominal quadrants. Small bilateral pleural effusions. Patient is a 9 year old male who presented with 3 days of sore throat, bilateral conjunctivitis, abdominal pain, nausea/vomiting, and chest pain with one episode of fever (38.3C in ED) who presented with hypotension and evidence of inflammation and troponin leak with MIS-C vs viral myocarditis. ARF unlikely with negative ASO titer, GAS testing, and no further fevers. He was started on IVIG and steroids last night due to worsening labs for presumed MIS-C with improvement in blood pressure as well as some lab parameters (WBC, Cr, troponin). Plan/Recommendation: o Recommend discontinuing ceftriaxone and vancomycin if cultures negative at 48 hours o Monitor fevers and clinical course o Continued therapy for MIS-C with guidance of Rheumatology o Will follow pending COVID Ab, antiDNAse B, and throat culture |
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Administered by: School Purchased by: ? Life Threatening? No Write-up: Started 5 days after 1st vaccine with headaches then severe joint pain that lasted for 5 days then the heart and chest pain started and has been going on now for 4 weeks. We went to urgent care the er and pediatrician. He had high levels of inflammatory marker and after a echocardiogram the ER doctor said most likely pericarditis. Pain in chest and lungs worse when laying down. My 9 you cannot walk long distances or at a fast pace cannot play and had been taking ibuprofen on and off for almost 4 weeks now. It is NOT heart burn because antacids do not help his shortness of breath and chest pain. |
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Administered by: Unknown Purchased by: ? Life Threatening? Yes Write-up: myocarditis with troponin leak and EKG abnormalities and ectopy, MRI scheduled |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: On January 14, 2022 patient came home from school with symptom of shortness of breath only. She was seen at an urgent care that day and tested negative for COVID. The physician there was concerned for refiux so she was given a medicine to treat this. She developed fever on 1/15 up to 105. That same day she was seen by the PCP as she also developed chill, body aches and had continued SOB. She was admitted to hospital. During the course of her admission, she was found to have elevated inflammatory markers. Given the concern for her new murmur, an echo was obtained. It demonstrated a large, circumferential pericardial effusion with concern for possible tamponade physiology. Cardiology, rheumatology, and infectious disease were brought on board. While there was some initial concern for MIS-C, the clinical history, only mildly elevated inflammatory markers, and single organ involvement did not fit MIS-C and the decision was made to begin treating patient for pericarditis. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: She developed inflamed lymph nodes (lymphadenitis), all over the body rash, ongoing fever for more than 3 weeks. She was diagnosed with MIS-C, her heart, intestines, lungs, skin and liver were inflamed. She was hospitalized and treated with immunoglobulin, steroids, anticoagulant, fever reducing medications, etc. By the second treatment, her belly started getting distended, her lungs were filled with liquids. She was transferred to ICU and her heart stopped beating right there. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: Subsequent Covid-19 infection resulting in Hemorrhagic Myocarditis and death. |
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Administered by: Private Purchased by: ? Life Threatening? No Write-up: Patient received his 4th dose of the pfizer 5-11 year covid vaccine on 5/31. On 6/3 he awoke with 3-4 episodes of emesis and fever with a tmax of 100.2 with chest pain that was worsening with inspiration. Based on EKG changes and and elevated BNP with normal troponins he was diagnosed with pericarditis and admitted to the hospital. He had an echocardiogram which was normal. He was treated with scheduled ibuprofen and released from the hospital on 6/4 with continued scheduled ibuprofen and short interval follow up. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: post vaccine myocarditis, symptoms 2 days after vaccination, came in the morning of 12/10. CXR and EKG normal, CRP 1.1 (mildly elevated) troponin 7.94 (elevated. Admitted to a local Hospital |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Myocarditis; This is a spontaneous report from a non-contactable consumer. An 8-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on Nov2021, at the age of 8-years-old, (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received Pfizer vaccine and was in ICU with myocarditis within 2 days (unspecified day of Nov2021). He was "totally healthy and active" prior to vaccination. The outcome of the event was unknown. Treatment was received for the events. The lot number for (BNT162B2), was not provided and will be requested during follow-up. |
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https://medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=AGE&GROUP2=CAT&EVENTS=ON&PERPAGE=600&ESORT=STATE&SYMPTOMS[]=Acute+endocarditis+%2810049001%29&SYMPTOMS[]=Atypical+mycobacterium+pericarditis+%2810055036%29&SYMPTOMS[]=Autoimmune+myocarditis+%2810064539%29&SYMPTOMS[]=Bacterial+pericarditis+%2810004050%29&SYMPTOMS[]=Carditis+%2810062746%29&SYMPTOMS[]=Cytomegalovirus+pericarditis+%2810056721%29&SYMPTOMS[]=Endocarditis+%2810014665%29&SYMPTOMS[]=Endocarditis+bacterial+%2810014666%29&SYMPTOMS[]=Endocarditis+enterococcal+%2810014671%29&SYMPTOMS[]=Endocarditis+noninfective+%2810062608%29&SYMPTOMS[]=Endocarditis+staphylococcal+%2810014684%29&SYMPTOMS[]=Endocarditis+viral+%2810061837%29&SYMPTOMS[]=Eosinophilic+myocarditis+%2810014961%29&SYMPTOMS[]=Fungal+endocarditis+%2810017529%29&SYMPTOMS[]=Giant+cell+myocarditis+%2810083635%29&SYMPTOMS[]=Hypersensitivity+myocarditis+%2810081004%29&SYMPTOMS[]=Immune-mediated+myocarditis+%2810082606%29&SYMPTOMS[]=Lupus+endocarditis+%2810058225%29&SYMPTOMS[]=Lyme+carditis+%2810078417%29&SYMPTOMS[]=Meningococcal+carditis+%2810027270%29&SYMPTOMS[]=Myocarditis+%2810028606%29&SYMPTOMS[]=Myocarditis+bacterial+%2810065218%29&SYMPTOMS[]=Myocarditis+infectious+%2810066857%29&SYMPTOMS[]=Myocarditis+post+infection+%2810064550%29&SYMPTOMS[]=Myocarditis+septic+%2810028615%29&SYMPTOMS[]=Myopericarditis+%2810028650%29&SYMPTOMS[]=Pericarditis+%2810034484%29&SYMPTOMS[]=Pericarditis+constrictive+%2810034487%29&SYMPTOMS[]=Pericarditis+infective+%2810062491%29&SYMPTOMS[]=Pericarditis+lupus+%2810058149%29&SYMPTOMS[]=Pericarditis+meningococcal+%2810034492%29&SYMPTOMS[]=Pericarditis+rheumatic+%2810034496%29&SYMPTOMS[]=Pericarditis+tuberculous+%2810055069%29&SYMPTOMS[]=Pericarditis+uraemic+%2810034498%29&SYMPTOMS[]=Pleuropericarditis+%2810059361%29&SYMPTOMS[]=Purulent+pericarditis+%2810051071%29&SYMPTOMS[]=Streptococcal+endocarditis+%2810073742%29&SYMPTOMS[]=Subacute+endocarditis+%2810042276%29&SYMPTOMS[]=Viral+myocarditis+%2810047470%29&SYMPTOMS[]=Viral+pericarditis+%2810047472%29&VAX=COVID19&WhichAge=range&LOWAGE=5&HIGHAGE=12
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