Found 41 cases where Age is 12-or-more-and-under-17 and Vaccine is 6VAX-F or ADEN or ADEN_4_7 or ANTH or BCG or CEE or CHOL or DF or DPIPV or DPP or DT or DTAP or DTAPH or DTAPHEPBIP or DTAPIPV or DTAPIPVHIB or DTIPV or DTOX or DTP or DTPHEP or DTPHIB or DTPIHI or DTPIPV or DTPPHIB or DTPPVHBHPB or EBZR or FLU(H1N1) or FLU3 or FLU4 or FLUA3 or FLUA4 or FLUC3 or FLUC4 or FLUN(H1N1) or FLUN3 or FLUN4 or FLUR3 or FLUR4 or FLUX or FLUX(H1N1) or H5N1 or HBHEPB or HBPV or HEP or HEPA or HEPAB or HEPATYP or HIBV or HPV2 or HPV4 or HPV9 or HPVX or IPV or JEV or JEV1 or JEVX or LYME or MEA or MEN or MENB or MENHIB or MER or MM or MMR or MMRV or MNC or MNQ or MNQHIB or MU or MUR or OPV or PER or PLAGUE or PNC or PNC10 or PNC13 or PPV or RAB or RUB or RV or RV1 or RV5 or RVX or SMALL or SSEV or TBE or TD or TDAP or TDAPIPV or TTOX or TYP or UNK or VARCEL or VARZOS or YF and Symptom is Acute endocarditis or Atypical mycobacterium pericarditis or Autoimmune myocarditis or Bacterial pericarditis or Carditis or Cytomegalovirus pericarditis or Endocarditis or Endocarditis bacterial or Endocarditis enterococcal or Endocarditis noninfective or Endocarditis staphylococcal or Endocarditis viral or Eosinophilic myocarditis or Fungal endocarditis or Giant cell myocarditis or Hypersensitivity myocarditis or Immune-mediated myocarditis or Lupus endocarditis or Lyme carditis or Meningococcal carditis or Myocarditis or Myocarditis bacterial or Myocarditis infectious or Myocarditis post infection or Myocarditis septic or Myopericarditis or Pericarditis or Pericarditis constrictive or Pericarditis infective or Pericarditis lupus or Pericarditis meningococcal or Pericarditis rheumatic or Pericarditis tuberculous or Pericarditis uraemic or Pleuropericarditis or Purulent pericarditis or Streptococcal endocarditis or Subacute endocarditis or Viral myocarditis or Viral pericarditis and Vaccination Date on/before '2020-11-30'

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Biopsy heart, Blood culture negative, Body temperature increased, Chills, Chromaturia, Culture stool negative, Culture throat negative, Culture urine negative, Echocardiogram abnormal, Eosinophilic myocarditis, Epstein-Barr virus antibody negative, Heart rate increased, Hepatitis B core antigen, Hepatitis B surface antigen negative, Hepatosplenomegaly, Influenza serology negative, Leukocytoclastic vasculitis, Mycoplasma serology, Myocarditis, Necrosis, Oliguria, Oxygen saturation normal, Pyrexia, Rash erythematous, Rash maculo-papular, Renal failure, Respiratory rate increased, Shock, Virus serology test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (narrow), Vasculitis (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (narrow), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ibuprofen
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Adenovirus test, negative; Biopsy endomyocardial, see text; Blood culture, negative; Blood pressure, 85/40mmHg; Body temperature, 38.7deg C; Culture throat, negative; Echocardiography, see text; Epstein-Barr virus test, negative; Heart rate, 120/minute; Hepatitis B core antigen, negative; Hepatitis B surface antigen, negative; Influenza antibody test, negative; Mycoplasma serology, negative; Oxygen saturation, 100%; Respiratory rate, 22/minute; Stool culture, negative; Urine culture, negative
CDC Split Type: B0544882A

Write-up: This case was reported in a literature article and described the occurrence of eosinophilic myocarditis in a 12-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject had no history of vaccine reaction, drug allergy and was healthy. No concomitant medication. Previous vaccination included ENGERIX B (GlaxoSmithKline, unknown route) given on an unspecified date. On an unspecified date, the subject received 2nd dose of ENGERIX B (unknown route, lot number not provided). 1 day after vaccination with ENGERIX B, the subject experienced fever, weakness and chills. The following day, she experienced vomiting, dark colored urine and oliguria. 3 days after vaccination the subject received ADVIL. Laboratory tests were performed and showed: Body temperature: 38.7 deg C; Heart rate: 120/min; Blood pressure: 84/50 mmHg; Respiratory rate: 22/min; Oxygen saturation: 100%. At Clinical examination: No murmurs, rub, or gallop rhythm were detected. Her chest was clear on auscultation. Hepatosplenomegaly was found and erythematous maculopapular rash. Echocardiography showed moderately diminished biventricular function (ejection fraction of 30%), consistent with a diagnosis of myocarditis. Histopathology examination of a myocardial biopsy showed eosinophilic infiltration in the presence of myocyte necrosis. Histologic examination of a skin biopsy specimen revealed perivascular lymphocytic infiltrates, coupled with the myocardial biopsy findings, this supported a diagnosis of hypersensitivity vasculitis. Hepatitis B core antibody: negative; Stool culture: negative; Throat culture: negative: serology for Mycoplasma: negative; Epstein-Barr virus: negative; Adenovirus: negative; Influenza test: negative; Blood culture: negative; Urine culture: negative; The subject was admitted to the intensive care unit on hospital on day 7 after immunization, with renal failure and shock. The subject was treated with milrinone, ceftriaxone, methylprednisolone, prednisone, and dobutamine. No further antibiotics were given as her fever abated promptly, cultures were negative, and her findings were consistent with a hypersensitivity reaction. At the time of reporting the events were improved. Clinical improvement was observed by day 7 of corticosteroid therapy with gradual normalization of cardiac function in the ensuing 8 weeks. The author considered the events were related to vaccination with ENGERIX B. No additional information expected therefore the case has been closed.

Administered by: Private       Purchased by: Other
Symptoms: Abdominal pain lower, Antiphospholipid antibodies negative, Asthenia, Asthma, Blood alkaline phosphatase increased, Chest pain, Cognitive disorder, Computerised tomogram, Convulsion, Costochondritis, Depressed level of consciousness, Dizziness, Drug screen negative, Dyspnoea, Electrocardiogram, Electrocardiogram ST segment elevation, Encephalitis, Endotracheal intubation, Eye irritation, Hepatic enzyme increased, Hypoaesthesia, Hypokalaemia, Laboratory test, Loss of consciousness, Lumbar puncture, Multiple sclerosis, Myelitis transverse, Nausea, Neuralgia, Nuclear magnetic resonance imaging, Oesophageal spasm, Optic neuritis, Pericarditis, Peripheral sensorimotor neuropathy, Pleuritic pain, Pyrexia, Rehabilitation therapy, Sensory loss, Sinus tachycardia, Sinusitis, Syncope, Tachypnoea, Unresponsive to stimuli, Urine analysis abnormal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (narrow), Cardiomyopathy (broad), Demyelination (narrow), Corneal disorders (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Ocular infections (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (narrow), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Clonazepam
Current Illness: Gasoline in eyes and mouth.
Preexisting Conditions: Asthma, Anxiety, partial ileal resection for necrotic bowel as infant, episodes of recurrent otitis media with ear tubes x 2. Recurrent UTIs, Umbilical hernia repair.
Allergies:
Diagnostic Lab Data: 8/24/2005 Unremarkable. Head CT and CT of C-spine negative. MRI of head and neck showed swelling in the spinal cord at C2 to C5-6. 8/29/2005 MRI Lumbar spine normal. 10/15/2005 LP normal, Cranial MRI normal. Lupus panal-normal, Mycoplasma in the lower range. 12/05/05 WNL, drug screen negative. 1/24/2006 Hypokalemia, EKG non-specific ST and T wave changes, prominent E waves, prolonged QT. CT of head WNL. 2/05/2006 K-3.2, Tox screen negative, EKG: sinus tachycardia. 3/02/2006 LABS and DIAGNOSTICS: EKG- Normal Sinus rhythm with slight ST elevation in lead V2, but not seen in V1 or V3. Labs significant for elevated Liver Enzymes. 3/27/2006 labs unremarkable except elevated Alk. Phos., tox screen negative, Strep A screen negative. 9/10/2006 labs normal, CT of the head: normal. 9/12/2006 Labs remarkable for K of 3.5, Alk. Phos. of 256. UA shows 3-5 white cells. EKG shows some non-specific ST and T wave changes. 9/27/2006 Labs unremarkable except Alk. Phos. of 256. CXR normal. EKG sinus rhythm-no ST changes. 10/09/2006 Echocardiogram which was reported normal.
CDC Split Type: AK200676

Write-up: Pt received update with DipTes after getting chemical burns to eyes. 1 week later he presented with extreme weakness. He was transferred to hospital where he was hospitalized and then required rehabilitation. He still is having problems. Was given a diagnosis of transverse myelitis as leading DX. Annual followup 01/4/2010 I don''t know that it is related at all. He developed transverse myelitis and still suffers from it. 11/01/2006 Lengthy hospital MR received which documents 11 distinct ER admissions and several admissions and/or transfers to pediatric ICUs beginning on 8/15/2005 when he received a TD booster. PMH: Asthma, recurrent UTI''s, partial ileal resection for necrotic bowel as an infant, ear tubes x 2, umbilical hernia repair. He initially presented approximately 1 week after his Td, with c/o motor sensory neuropathies bilaterally in the legs, with rapidly progressing lower extremity numbness and weakness. He was given a diagnosis of encephalomyelitis/ transverse myelitis and transferred to a PICU, where he apparently was treated with steroids and placed in rehab./pc The first ER visit of 12/05/2005 was for increased weakness. LABS: WNL, drug screen negative. There is reference to another ER visit of Jan. 24th where he presented in an obtunded state and with nausea and vomiting. LABS and DIAGNOSTICS: WNL except for hypokalemia, EKG non-specific ST and T wave changes, prominent E waves, prolonged QT. CT of head WNL. He was intubated and transferred to a PICU, where he apparently awakened 14 hours later and was fine. Transfer DIAGNOSIS: Obtundation-etiology unclear, ? recurrence or exacerbation. Nausea, Vomiting and abdominal pain. He returned to the ER on Feb. 05, 2006 via ambulance unconscious. LABS: WNL except for a K of 3.2. Tox screen negative. EKG: sinus tachycardia. Upon transfer to the ICU he awakened, but was unable to speak. Admitted for observation and discharged on Feb. 07, 06. Assessment: ? Atypical seizures or possible chronic encephalomyelitis. Final Discharge DX: Obtundation-etiology unclear, Hx of encephalomyelitis and transverse myelitis. Next ER visit on March 02,2006 was for c/o chest pain which dissipated in the ER. LABS and DIAGNOSTICS: EKG- Normal Sinus rhythm with slight ST elevation in lead V2, but not seen in V1 or V3. Labs significant for elevated Liver Enzymes. Discharged home to F/U as needed. Next ER visit was March 27,2006 was for vague chest pain followed by loss of consciousness. Awakened in ER where his exam was normal. LABS: unremarkable except elevated Alk. Phos., tox screen negative, Strep A screen negative. To continue with scheduled sleep study. Assessment: Syncopal episode vs. seizure. Next ER visit on April 11,2006 for an exacerbation of asthma. Tx''s with albuterol MDI, Flovent and azithromycin. Presented in the ER again on April with c/o facial tenderness and fever. Assessment: Sinusitis txd with Augmentin. ER visit of 09/10/06 after being found in the bathroom unresponsive. He had reported feeling sick to his stomach, having some chest pain, and feeling like he was going to faint. There was evidence that he had vomited. LABS: normal CT of the head: normal. He awakened in the ER and had a normal exam with the exception of some resistance to having his eyes opened, and eyes deviating to the left. Assessment: Acute episode of unresponsiveness of unclear etiology, but recurrent. Discharged home in stable condition. ER visit of 09/12/2006 for c/o stabbing chest pain and Right upper and lower quadrant abdominal pain. LABS and DIAGNOSTICS: Labs remarkable for K of 3.5, Alk. Phos. of 256. UA shows 3-5 white cells. EKG shows some non-specific ST and T wave changes. Impression: Pleuritic chest pain 2'' to pleurisy or pericarditis, etiology unclear. ER visit of 09/21/2006 for c/o SOB and increase in asthma symptoms. Assessment : Atypical chest pain, Tachypnea and possible anxiety reaction, exacerbated by use of albuterol, hx. of transverse myelitis with residual neurological problems. Discharged home. ER visit of 09/27/2006 for sudden onset of anterior chest pain. LABS and Diagnostics: Labs unremarkable except Alk. Phos. of 256. CXR normal. EKG sinus rhythm-no ST changes. Assessment: Pleuritic chest discomfort of non-apparent etiology. ? reflux issues with lower esophageal spasm. ? Costochondritis. To F/U with MD for echocardiogram which was reported normal on 10/09/2006 11/03/2006: Additional MR requested for PICU admissions and another hospital in another city./pc 11/06/2006: Faxes of 11/03 to Hosp. did not go through, resent today-completed./pc 11/13/2006: Letter from Hosp received stating that patient is being followed for a possible dx. of multiple sclerosis. Suggested Brain MRI if not already done. Hosp. is awaiting records from treating MD in another city./pc 11/21/2006: 4 separate discharge summaries received from Medical Center. DISCHARGE DX: for Admit 8/24/2005-8/30/2005 1) Transverse Myelitis 2) Improved mental status changes, as well as sensory and motor neuropathy 3) Neuropathic pain DISCHARGE DX: for Admit 8/30/2005-9/09/2005 to inpatient rehab 1) Encephalomyelitis of unknown etiology 2) Impaired high cognition 3) Weakness in the 4 extremities, more involving the lower extremities along with severe sensory loss. DISCHARGE DX: for Admit 10/15/2005-10/21/2005 1) Exacerbation of Transverse Myelitis 2) Optic neuritis, which is medically stable. Discharge note for Admit of 1/24/2006-1/27/2006 reports that most recent symptoms (obtundation) were c/w transverse myelitis./pc Per 60 day follow up: It is now felt this patient has multiple sclerosis (or similar) ? concidiental timing.

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Anxiety, Back pain, Blood test normal, Chest pain, Colonoscopy, Colonoscopy normal, Confusional state, Contusion, Ear pain, Endoscopy, Endoscopy normal, Fatigue, Gastrointestinal disorder, Gastrooesophageal reflux disease, Headache, Insomnia, Intestinal functional disorder, Laparoscopy, Laparoscopy normal, Lymphadenopathy, Migraine, Myalgia, Nausea, Neck pain, Pelvic pain, Pericarditis, Photophobia, Pleural effusion, Pyrexia, Rash, Swelling, Thrombosis, Vomiting, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Colonoscopy, endoscopy, laproscopy, blood work up - normal results
CDC Split Type:

Write-up: Pleural effusion, stomach/pelvic pain - ER visit - no treatment. Nausea, headaches, weight loss, anxiety, pericarditis, light sensitivity, sore muscles, back pain, no recovery, swollen lymph nodes, acid reflux - no treatment. Chest pain, confusion, rashes, fatique, fevers, migrains, bruises, neck pain, and vomiting. 7/23/10 swelling, insomnia, blood clots, and intestinal problems and earaches.

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, Cardiac arrest, Death, Myocarditis, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-08-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy.
CDC Split Type:

Write-up: Victim was found unresponsive/cardiac arrest in bed at home in the morning of 8/20/13. Autopsy showed cause of death was myocarditis.

Administered by: Other       Purchased by: Other
Symptoms: Alpha 1 globulin, Alpha 2 globulin, Band neutrophil percentage increased, Basophil percentage increased, Beta globulin, Blood albumin increased, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood immunoglobulin G increased, Body temperature increased, Borrelia burgdorferi serology negative, Bundle branch block, C-reactive protein increased, Chest pain, Cough, Coxsackie virus serology test, Coxsackie virus serology test positive, Echocardiogram, Echocardiogram abnormal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Eosinophil percentage increased, Epstein-Barr virus antibody positive, Fatigue, Herpes simplex serology positive, Hypoventilation, Immunoglobulins, Lymphocyte percentage increased, Monocyte percentage increased, Myocarditis, Myoglobin blood increased, Myopericarditis, Neutrophil percentage decreased, Painful respiration, Pericardial effusion, Pericarditis, Pleural effusion, Pleurisy, Protein total normal, Pyrexia, Troponin I increased, White blood cell count decreased, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (narrow), Anaphylactic reaction (broad), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up:

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Myocarditis, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Biopsy of heart, 11/9/99, results: allergic myocarditis
CDC Split Type: 1999032437

Write-up: 03-Nov-99 pt recv 2nd Engerix-B, 10 mcg. 9-Nov-99 pt exp heart failure, complicated into kidney failure. Heart biopsy confirmed allergic myocarditis, noted as severe. Events related to Engerix-B per reporter. As of 10-Dec-99, outcome UNK.

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Bacterial infection, Cardiomegaly, Chest pain, Endocarditis, Headache, Laboratory test abnormal, Leukocytosis, Pericarditis, Pharyngitis, Pyrexia, Sepsis, Shock
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-04-27
   Days after onset: 46
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Neuro-myopathy; Scoliosis; Congenital multiplex arthrogryposis; Motor activity retarded; breathing difficult; recurrent respiratory tract infections; Hepatosis
Allergies:
Diagnostic Lab Data: Leucocytosis; Chest x-ray; Echocardiography; Body temp 39C; Blood culture negative; Clinical serology test negative; Blood culture: staph warneri.
CDC Split Type: WAES0408USA00802

Write-up: Information has been received from a health professional concerning a 12 year old female with a history of neuromyopathy (unknown origin), scoliosis, congential multiplex arthrogryposis, motor activity retarded, breathing difficult, recurrent respiratory tract infections and hepatosis (unknown origin) who on 2/19/03 was vaccinated with one dose of pneumococcal 23v polysaccharide vaccine (lot # HR46990) (lot # 639404/0446L) IM in the upper arm. On 3/11/03, she presented with a headache. The child''s pharynx was slightly reddened and a pulmonary examination was normal. On 3/18/03, she presented again with asthenia. She was treated with antibiotics. On 3/20/03, a chest x-ray revealed no pneumonia but an enlarged heart. An echocardiography showed normal results. Since 3/24/03, symptoms improved a bit but relapsed on 4/21/03. Additionally she showed fever up to 39 C and cardialgia. A blood sample was taken and showed leucocytosis. Another antibiotic was administered and on 4/2/03 she was admitted to the hospital. Fever relapsed immediately when antibiotic treatment was stopped. Blood cultures (17) and virus serology were all negative. A diagnosis of endocarditis of the mitral valve and pericarditis was established. On 4/22/03 condition worsened (start of sepsis) and she was referred to the cardiology department of another hospital. On 4/25/03 blood culture showed Staphylococcus warneri. Antibiotics were changed again but therapy did not lead to improvement. On 4/27/03 the patient died. The cause of death was septic shock. An autopsy was refused by the parents. The reporter felt that septic shock, endocarditis and headache were not related to therapy with pneumococcal 23v polysaccharide vaccine. Additional information is not expected. File closed.

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest discomfort, Chills, Dyspnoea, Electrocardiogram abnormal, Enzyme abnormality, Laboratory test abnormal, Medication error, Myocarditis, Palpitations, Pyrexia, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: electrocardiogram 03Dec04 ECG alteration, negative T waves, serum TnT elevated 03Dec04, serum creatine kinase elevated.
CDC Split Type: WAES0504USA01845

Write-up: Information has been received from a health authority (HA ref 2005000929) concerning a 15 year old male who on 15Oct04 was vaccinated with his first dose of 10mcg hep B virus vaccine rHBsAg (yeast) (thimerosal free). Five days after the first dose, on 20Oct04, the pt experienced dyspnea on effort, palpitations, elevated heart rate and chills. On 30Nov04, the pt was vaccinated intramuscularly with a second 10mcg dose, rather than 5 mcg, of hep B virus vaccine rHBsAg (yeast) (thimerosal free). It was reported that three days later, on 03Dec04, he experienced fever, chills, elevated heart rate, and chest pressure. He probably was admitted to the hospital. He had elevated cardiac enzymes and also showed ECG alterations. Suspected diagnostic was myocarditis and he was treated with IV antibiotics for 5 days. No infectious agent could be detected. The pt recovered. Other business partner numbers included: E200501372. Additional information has been requested.

Administered by: Unknown       Purchased by: Unknown
Symptoms: Myocarditis, Nausea, Pyrexia, Ventricular extrasystoles
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ventricular tachyarrhythmias (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Rhinitis allergic
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA04287

Write-up: Information has been received from a hospital pediatrician concerning a 16 year old female with a history of allergic rhinitis who on 06-JUL-2007 was vaccinated IM into the upper arm with a first dose of Gardasil (Lot #1466F and batch #NF15720). The same day the patient experienced fever and complained about nausea and subsequently she recovered. On 31-JUL-07 ventricular extrasystoles were detected. She was admitted to the hospital where myocarditis was diagnosis. She was referred to ICU for 7 days. Treatment was started with magnesium and beta blockers. At the time of this report, her symptoms were ongoing. The hospital pediatrician considered myocarditis to be life-threatening. Other business partner numbers included E2007-06340. Additional information is not available.

Administered by: Other       Purchased by: Other
Symptoms: Injection site induration, Myopericarditis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up:

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Asthenia, Bedridden, Chronic fatigue syndrome, Cognitive disorder, Eosinophilic myocarditis, Fibromyalgia, Headache, Neuralgia, Photophobia, Sleep disorder
SMQs:, Peripheral neuropathy (narrow), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (narrow), Corneal disorders (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up:

Administered by: Other       Purchased by: Other
Symptoms: Alpha 2 globulin increased, Anisocytosis, Anti-SS-A antibody positive, Anti-SS-B antibody positive, Antibody test positive, Antinuclear antibody positive, Antiphospholipid antibodies positive, Arthritis, C-reactive protein increased, Cardiolipin antibody negative, DNA antibody positive, Epstein-Barr virus test positive, Haematocrit decreased, Haemoglobin decreased, Immunoglobulins increased, Neutrophil count decreased, Pericarditis, Polychromasia, Red blood cell count decreased, Red blood cell sedimentation rate increased, Russell's viper venom time abnormal, Systemic lupus erythematosus, Urine analysis normal, White blood cell count decreased
SMQs:, Agranulocytosis (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (narrow), Vasculitis (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Alpha 2 globulin, 16 Sep2009, 12.7%; Anti-DNA antibody, 16Sep2009, 1/640; Anti-DNA antibody, 23Sep2009, 1/1280; Anti-Ro antibody, 23Sep2009, reactive; Anti-SS-A antibody, 16Sep2009, 44BUA/ml; Anti-SS-B, 16Sep2009, 184UA/ml; Anticardiolipin antibodies, 16Sep2009,19 (weekly) gpl u; Antinuclear factor, 16Sep2009, see text; Antinuclear factor, 23Sep2009, 1/640mg/dl; EPSTEIN-BARR virus test, 16Sep2009, regent; Gama globulin, 16Sep2009, 23.6%, 10.6, 18.8; Hematocrit, 16Sep2009, 28.4%; Hematocrit, 23Sep2009, 30.6%; Hemoglobin, 16Sep2009, 10g/dl; Hemoglobin, 23Sep2009, 10.2g/dl; High-sensitivity C-reactive pr 16Sep2009, 3.92mg/dl; High-sensitivity C-reactive pr, 23Sep2009, 0.54mg/dl; Leukocyte count NOS, 23Sep2009, 2.700/mm3; Neutrophils, 23Sep2009, 1.370/mm3; Red blood cell count, 16Sep2009, 3.09million/mm3; Red blood cell count, 23Sep2009, 3.34millions/mm3; Red blood cell sedimentation r, 16Sep2009, 73mm; Red blood cell sedimentation r, 23Sep2009, 49mm; Russell''s viper venom time, 16Sep2009, 54.61s; Urine analysis, 28Sep2009, normal
CDC Split Type: B0596403A

Write-up: This case was reported by a physician (subject''s father) and described the occurrence of lupus erythematous in an 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In 2009 the subject received 1st dose of CERVARIX (unknown) lot number not provided. In 2009, 15 days after vaccination with CERVARIX, the subject experienced lupus erythematous with severe pericarditis but without pericardial effusion. This case was assessed as medically serious by GSK. Relevant test results done on 16 September 2009 revealed anisocytosis and polychromasia: erythrocytes 3.09 x 10^6/mm3, hemoglobin 10g/dl, hematocrit 28.4%, red blood sedimentation rate (1st hour) 73 mm, dilute Russell Viper Venom time (LA1) 54.6l s, LA1/LA2 relation 1.62 (mildly positive), alpha 2 globulin 12.7%, gamma globulin 23.6%, antinuclear factor reactive (for titers higher than 1/80), high sensitive C-reactive protein 3.92 mg/dl, anti DNA antibody 1/640 reagent, EPSTEIN-BARR virus IgG reagent, anticardiolipin IgG antibody 19 (weakly reactive) GPL U/ml, anti SSB/LA antibody 184 (reagent), anti SSA antibody 448 (reactive) and lupus anticoagulant was present. On 23 September 2009 relevant test showed red blood cell count 3.34 10^6/mm3, hemoglobin 10.2 g/dl, hematocrit 30.6%, leucocytes count 2.700/mm3, neutrophils 1.370/mm3, blood sedimentation rate (1st hour) 49 mm, high sensitive C-reactive protein 0.54 mg/dl, antinuclear factor ANF (reagent if less or equal to 1/640), ANF metaphase chromosome plate (reagent if less or equal to 1/640), anti DNA antibody reagent (until 1/1280) and anti RO/SS A antibody reactive. On 28 September 2009 urine exam was normal. At the time of reporting the outcome of the events was unspecified. In the follow up received on 14 October 2009 it was mentioned that the subject presented pericardial rub due to pericarditis which was typical of lupus. On 11 October 2009 she presented migratory arthritis. The subject was treated with prednisone and acetylsalicylic acid. According to the physician the events were considered unrelated to vaccination with CERVARIX. At the time of reporting the events were unresolved. The reporter considered the events were clinically significant. After several attempts no further information could be obtained, therefore on 17 December 2009 this case has been closed. In the follow up receive on 18 January 2010 it was confirmed that this case was closed as all the attempts to obtain further information were unsuccessful.

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Culture negative, Death, Headache, Hypersensitivity, Myocarditis, Pyrexia, Skin lesion
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Culture, Apr2010, NEGATIVE
CDC Split Type: A0854882A

Write-up: This case was reported by a healthcare professional (nurse) and described the occurrence of acute myocarditis in a 15-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 1 April 2010 the subject received unspecified dose of BOOSTRIX (unknown). On 1 April 2010, less than one day after vaccination with BOOSTRIX, the subject experienced possible hypersensitivity reaction and lesion nos. On 2 April 2010, one day after vaccination with BOOSTRIX, the subject experienced headache and fever. On the 4 April 2010, the subject felt fine, "went out and seemed to be ok". The subject''s mother found the subject dead the next morning. The subject died on 4 or 5 April 2010 from acute myocarditis. An autopsy was performed. It could not be excluded that the acute myocarditis was due to a hypersensitivity reaction. It was suspected that the lesions were due to hypersensitivity since they were 2-5 days old which was around the time of the vaccination. The cause was not viral since all the cultures came back negative.

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alanine aminotransferase normal, Anaemia, Antinuclear antibody negative, Aspartate aminotransferase normal, Blood alkaline phosphatase normal, Blood creatine phosphokinase normal, Blood creatinine normal, Blood electrolytes normal, C-reactive protein increased, Cardiomegaly, Chest X-ray abnormal, Chest pain, Coxsackie virus test negative, Cytomegalovirus test negative, Dyspnoea, Echocardiogram abnormal, Electrocardiogram T wave inversion, Electrocardiogram abnormal, Gamma-glutamyltransferase, General physical condition abnormal, HIV test negative, Haematocrit decreased, Haemoglobin normal, Hypophonesis, Immunology test normal, Laboratory test normal, Mean cell volume decreased, Orthopnoea, Pericardial effusion, Pericardial rub, Pleural effusion, Pleuritic pain, Pleuropericarditis, Red blood cell count decreased, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Sinus tachycardia, Thrombocytosis, Toxoplasma serology negative, White blood cell count normal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (narrow), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Electrocardiogram; a sinus tachycardia at 107 beats per minute with negative T waves in leads V1 through V4.; Chest X-ray; moderate cardiomegaly with a moderate right pleural effusion.; echocardiography; a small pericardial effusion without hemodynamic compromise.; WBC count; normal; hematocrit; 0.29 l/l; hemoglobin; 10 g/dl; serum ANA; negative; serum C-reaction protein; 112 g/l; serum aspartate aminotransferase; normal; serum creatinine; normal; serum rheumatoid factor; negative; erythrocyte sedimentation rate; 119 mm/h; red blood cell count; 3.82 x 10RXP12/l; Toxoplasma antibody screen; negative; serum electrolytes test; normal; mean corpuscular volume; 77.3 fl
CDC Split Type: WAES1009USA03634

Write-up: Information has been received from a published article on 13-SEP-2010, concerning a 15 year-old male patient with unknown illness, and had not received any previous dose of measles- mumps-rubella vaccine. Case medically confirmed. According to the article the patient had arrived "2 months ago". There was no evidence of previous illnesses therefore, the health protocol for immigration was applied, thus the patient received the first dose of MMR II (manufacturer unknown and batch number, route not reported) at an unspecified date. Two days after vaccination the patient presented with retrosternal pain with pericardial features, pleuritic pain in the right base with dyspnoea and orthopnea. The patient was diagnosed with pleuropericarditis. Upon hospital admission, physical examination showed a 70/50mmHg blood pressure; a significant impact on the patient''s general condition was noticed. The auscultation showed hypophonesis in the right side lung base. The heart sounds were rhythmic, pericardial rub was detected. The patient did not present paradoxical pulse nor jugular engorgement, the rest of the examination was normal. Blood analysis unveiled thrombocytosis with 530 x 10EXP9/l and an erythrocyte sedimentation rate (ESR) of 119 mm/h, C reactive protein 112g/I, blood count showed anemia with hematocrit of 0.29 l/l, Red Blood cells 3.83 x 10 xEXP 12/l. Hemoglobin of 10 g/dl, with volume (mean corpuscular volume) of 77.3 fl. The leukocytes were normal, as well as creatinine, electrolytes, Glutamic-oxaloacetic transaminase, Glutamic-pyruvic transaminase, gamma glutamyl transpeptidase, alkaline phosphatase and creatine phosphokinase. Immunological and serological study for antinuclear antibody, rheumatoid factor, human immunodeficiency virus, antibodies against coxsackie, cytomegalovirus, and toxoplasma were all negative. The electrocardiogram showed a sinus tachycardia at 107 beats per minute with negative T waves in leads V1 through V4. A chest X-ray showed moderate cardiomegaly with a moderate right pleural effusion. The Echocardiography detected a small pericardial effusion without hemodynamic compromise. The patient was treated with 4 g of aspirin per day with good response. A few days late, the pain was gone, and chest radiography was normal after 2 weeks. The patient was not recovered. No further information is available. Other business partner numbers include E2010-05467.

Administered by: Unknown       Purchased by: Unknown
Symptoms: Ear, nose and throat examination normal, Gastroenteritis, Laboratory test normal, Myocarditis, Serology test
SMQs:, Cardiomyopathy (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1110USA03637

Write-up: Case received from an allergist on 20-OCT-2011 and medically confirmed. A 15-year-old female patient with no relevant medical history was hospitalized on 28-MAY-2011 due to reversible myocarditis 5 days after receiving the first dose of GARDASIL (batch number not reported). 3 days before hospitalization, she also experienced gastroenteritis. She was given KARDEGIC for a few days. Cardiovascular work-up was performed but results were not reported. Peadiatric work-up, ENT and abdominal investigations and laboratory tests were all unremarkable. Results for infectious serology were not available. The patient recovered on 30-MAY-2011 and was discharged on the same day. Myocarditis and gastroenteritis were considered serious events as they required hospitalization. Other business partner numbers included: E2011-06382. No further information was reported.

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Amylase decreased, Antinuclear antibody, Asthenia, Basophil count, Basophil count normal, Blood albumin normal, Blood bilirubin normal, Blood calcium normal, Blood creatinine normal, Blood potassium normal, Blood sodium normal, Blood thyroid stimulating hormone normal, Blood urea increased, C-reactive protein normal, Dermatitis, Eosinophil count increased, Haemoglobin normal, Lymphocyte count normal, Monocyte count normal, Nausea, Neutrophil count normal, Pericardial effusion, Pericarditis, Platelet count normal, Protein total normal, Pyrexia, Red blood cell count normal, Red blood cell sedimentation rate increased, Rheumatoid factor negative
SMQs:, Acute renal failure (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up:

Administered by: Other       Purchased by: Other
Symptoms: Fall, Headache, Myocarditis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 25Apr2012, up to 40degC
CDC Split Type: D0075421A

Write-up: This case was reported by a physician and described the occurrence of myocarditis in a 15-year-old male subject who was vaccinated with TWINRIX pediatric (GlaxoSmithKline). On 25 April 2012, the subject received the third dose of TWINRIX pediatric (unknown route and administration site). In the evening of vaccination with TWINRIX pediatric, the subject developed high fever of 39 degC and fell at home. At the time of reporting, high fever was unresolved. Written follow-up information received from the physician on 11 May 2012. The subject had no concurrent disease or risk factors. Previous vaccinations with TWINRIX pediatric were well tolerated. On 25 April 2012, the subject received the third dose of TWINRIX pediatric (intramuscular, left deltoid). On the same day of vaccination with TWINRIC pediatric, the subject developed fever up to 40 degC and headache. The subject was diagnosed with myocarditis. The subject was hospitalised. This case was upgraded to serious on follow-up. At the time of reporting, the events were unresolved. The physician considered the events were probably related to vaccination with TWINRIX pediatric.

Administered by: Unknown       Purchased by: Unknown
Symptoms: C-reactive protein increased, Chest pain, Electrocardiogram abnormal, Pericardial effusion, Pericarditis, Troponin increased
SMQs:, Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CASA2016SA068166

Write-up: Initial unsolicited report received from a pharmacist via health authority (reference number 000667520) on 04 April 2016. This case involves a 16-year-old male patient who was vaccinated with a suspension intramuscular dose of FLUZONE QUADRIVALENT (frequency once, batch number, dose and site of administration were not reported) on an unspecified date. The patient''s medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced pericardial effusion, pericarditis, C-reactive protein increased, chest pain, electrocardiogram abnormal and troponin increased. On an unspecified date, patient was hospitalized. The patient''s lab data and corrective treatment were not reported. On an unspecified date, patient had recovered. List of documents held by sender: None. Sender''s Comments: Pericarditis or pericardial effusion may occur due to inflammation of the pericardium due to viral, bacterial, fungal or parasitic infections, following a heart surgery or a heart attack (Dressler''s syndrome), autoimmune disorders, such as rheumatoid arthritis or lupus, uremia, hypothyroidism, trauma or puncture wound near the heart, certain medications for high blood pressure, epileptic seizures. Additional information including medical history, concomitant medications, history of present illness including any acute cardiac injury, final diagnosis is needed to further assess this case. Based on the available information, the role of vaccine cannot be assessed.

Administered by: Unknown       Purchased by: ?
Symptoms: Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NUROFEN-L; PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ0095075132210NZL006079

Write-up: Pericarditis; Information has been received from regulatory authority, referring to a 12-year-old male patient. Information of concurrent condition, medical history was not reported. Concomitant medications included ibuprofen lysinate (NUROFEN-L) and paracetamol. On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided). On an unknown date, the patient experienced pericarditis. At the time of reporting, the outcome of the event pericarditis was not reported. The causality assessment between the suspect products and event was not provided. Upon internal review, pericarditis has been determined as medically significant.

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Antimitochondrial antibody positive, Arthralgia, Bedridden, Blood heavy metal increased, Blood test normal, Chest pain, Discomfort, Dysstasia, Fatigue, Fibromyalgia, Headache, Laboratory test normal, Neurological examination normal, Pain, Pericarditis, Pyrexia, Urinary tract infection
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 20 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up:

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Bronchitis, C-reactive protein increased, CSF test, Carditis, Chest pain, Death, Enterovirus test negative, Epstein-Barr virus test negative, Generalised tonic-clonic seizure, Haemoglobin increased, Heart rate increased, Oropharyngeal pain, Pericardial haemorrhage, Pericarditis, Pericarditis rheumatic, Platelet count normal, Polymerase chain reaction, Pulmonary congestion, Pyrexia, Streptococcal infection, Syncope, Toxicologic test normal, Varicella virus test negative, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up:

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Fatigue, Pericarditis, Rash, Weight decreased
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up:

Administered by: Other       Purchased by: Other
Symptoms: Brain scan normal, Chest pain, Computerised tomogram thorax normal, Electrocardiogram normal, Headache, Pericarditis, Pleuritic pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up:

Administered by: Other       Purchased by: Other
Symptoms: Palpitations, Pericarditis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0904USA03414

Write-up: Information has been received from a physician concerning a 16 year old female who was vaccinated with three doses of GARDASIL (Lot # not reported). After first dose she had a fainting spell and she recovered. Approximately a month after she received third dose of GARDASIL she started to experience heart palpitations. The patient saw a cardiologist and was diagnosed with pericarditis. Additional information has been requested.

Administered by: Unknown       Purchased by: Public
Symptoms: Decreased appetite, Fatigue, Inflammation, Pericarditis, Rash, Systemic lupus erythematosus, Weight decreased
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: No prescription medications taking during the time of vaccination
Current Illness: No
Preexisting Conditions: Allergies - Pollen, Dogs, Cats
Allergies:
Diagnostic Lab Data: Diagnosed with Lupus
CDC Split Type:

Write-up: First signs of lupus started to appear. Rash on my face, loss of appetite, weight loss, fatigue, inflammation, pericarditis.

Administered by: Private       Purchased by: Unknown
Symptoms: Chest pain, Electrocardiogram abnormal, Myocarditis
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Extended hospital stay? Yes
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions: no relevant history
Allergies:
Diagnostic Lab Data: Autopsy revealed a grossly normal pancreas. Additional info. requested.
CDC Split Type: WAES90060971

Write-up: Pt vacc. /w Mumpsvax 1st dose in response to local mumps epidemic, 2 wks later he developed chest pain & abnormal ECG. Admitt to hospital & died 2 days later /p admission /w DX of myocarditis.MD could not establish a causal relationship.

Administered by: Unknown       Purchased by: Unknown
Symptoms: Angiogram, Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, Cardiac enzymes increased, Chest pain, Computerised tomogram normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Immunoglobulins, Laboratory test normal, Malaise, Myalgia, Myocarditis, Pyrexia, Troponin increased
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: History of peptic ulcer disease (H.pylori positive) - resolved. PMH: H. pylori peptic ulcer diease.
Allergies:
Diagnostic Lab Data: Elevated cardiac enzymes. Abnormal EKG. Normal echo and CT angio. Negative respiratory viral panel and parvovirus antibodies. Labs and Diagnostics: EKG with inferior ST elevation. Echocardiogram showed mild RV enlargement. CXR WNL. Troponin 3.0. CPK 345. CK-MB 28. Cardiac enzymes WNL by d/c. EKG and Echo prior to D/C WNL.
CDC Split Type:

Write-up: Patient given TDaP and meningococcus vaccines on 11/27/07. The next day, he developed muscle aches, malaise and low grade fever. That night, he had chest pain. The chest pain worsened over 24 hours. He was admitted to the hospital on 11/29/07 with myocarditis. His function was normal on echo and CT angio. His ekg showed inferior lead ST elevation. His troponin peaked at about 9 and his CPK and CK-MB were both quite elevated. He was treated with IVIG and NSAIDs. His chest pain resolved over 24 hours and his cardiac enzymes returned to normal over about 72 hours. He had no ectopy. 12/06/2007 MR received for OV 11/27/07 for 15yr WCC and hospital DOS 11/30-12/03/2007 with D/C DX: Myocarditis. Child presented to ER on 11/30/07 with chest pain/heaviness x 2 days. Pt developed muscle aches and fever 1 day after receiving Menactra and Adacel vax. That night pt developed squeezing chest pain which was worsening. Pain increased on laying down. ROS (+) for chest pain and near syncope. Cardiac Consult with DX: Likely vaccination related myopericarditis. Txd with IVIG and Indocin. By D/C Chest pain resolved EKG and Echo WNL

Administered by: Private       Purchased by: Private
Symptoms: Cardiac disorder, Chest pain, Inappropriate schedule of drug administration, Malaise, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: NOVOLOG; ADDERALL; albuterol; LEVEMIR
Current Illness: Asthma; Attention deficit/hyperactivity disorder; Diabetes mellitus; Overweight
Preexisting Conditions: 07/10/2014, HAVRIX, 1st dose, lot number N434L, expiry date 19 February 2016; 2013, GARDASIL, Influenza like illness and a bad virus afterwards
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2014GSK027181

Write-up: This case was reported by a other health professional via call center representative and described the occurrence of pain in chest in a 16-year-old male patient who received HAVRIX (batch number A7HC5, expiry date 13th August 2016). Previously administered products included GARDASIL with an associated reaction of influenza like illness (and a bad virus afterwards) and HAVRIX (1st dose, lot number N434L, expiry date 19 February 2016). Concurrent medical conditions included asthma, attention deficit disorder, diabetes and overweight. Concomitant products included NOVOLOG, ADDERALL, albuterol and LEVEMIR. On 21st August 2014, the patient received the 2nd dose of HAVRIX .5 ml. On 21st August 2014, an unknown time after receiving HAVRIX, the patient experienced drug dose administration interval too short. On 1st September 2014, the patient experienced pain in chest (serious criteria hospitalization and life threatening), heart issue (serious criteria hospitalization) and felt sick. On 5th September 2014, the patient experienced pericarditis (serious criteria hospitalization and GSK medically significant). The patient was treated with steroids nos. On an unknown date, the outcome of the pain in chest, pericarditis and felt sick were recovered/resolved and the outcome of the heart issue and drug dose administration interval too short were unknown. It was not reported if the reporter considered the pain in chest, pericarditis, heart issue and felt sick to be related to HAVRIX. Additional details were provided: The patient received medical attention at Inpatient hospital. The patient had a family medical history of heart problems and the patient''s brother has diabetes too.

Administered by: Private       Purchased by: Private
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Echocardiogram normal, Pericarditis, Ultrasound Doppler normal
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: AMOXIL; BACTRIM; KEFLEX
Allergies:
Diagnostic Lab Data: Echo and Doppler
CDC Split Type:

Write-up: Patient seen thru ER for chest pain/pressure and shortness of breath; suspected pericarditis. Referred to cardiologist and was given NAPROSYN Rx also had Echo and Doppler results neg. ER visit 8/28/13.

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest pain, Dyspnoea, Pericardial effusion, Pericarditis
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ventolin, Prednisone, Zithromax, Ibuprofen
Current Illness: NONE
Preexisting Conditions: Asthma 6/3/08-records received- PMH: asthma. PMH: bronchial asthma. Penicillin allergy, peanut allergy, allergy to pertussis vaccine.
Allergies:
Diagnostic Lab Data: 6/3/08-records received-D-dimer mildly elevated, CK increased 198, WBC 15.4, eosinophils % low 0.1, total protein elevated 8.8, anion gap elevated 17, globulin elevated 4.0. CT scan showed evidence of mild pericardial effusion.6/6/08-lab report received ANA positive, ANA pattern speckled, antinuclear AB 1:640 increased.
CDC Split Type:

Write-up: 05/31/08- SOB and chest pain 06/01/08- Chest pain, pericardial effusion, Pericarditis 6/3/08-records received for DOS 5/31-6/2/08-DC DX: Pericarditis. Presented with chest pain for about 10 days and 2 days after vaccination for human papilloma virus.

Administered by: Private       Purchased by: Private
Symptoms: Collagen disorder, Pericarditis, Pleural disorder
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CXR, echocardiagram;EKG
CDC Split Type: NC99088

Write-up: pt seen 1sx w/pericarditis, pruritus & costochondritis;ER visit x 2 10/21/99;MD visit 10/22/99;

Administered by: Private       Purchased by: Public
Symptoms: Cardiac enzymes increased, Chest pain, Echocardiogram abnormal, Electrocardiogram abnormal, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Myocardial infarction (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Muscular Dystrophy Duchenne
Allergies:
Diagnostic Lab Data: Abnormal EKG; Cardiac enzymes; and Echocardiogram
CDC Split Type:

Write-up: Got shot on Tues. 16, Wed 17, started having chest pain, and stabbing pains came back to clinic, then Thurs. 18, patient was still in pain so I took him to Emergency room --$g Dx pericarditis, onset 24 hrs after immuniz.

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood product transfusion, Chest pain, Myocarditis, Troponin increased
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none. PMH: 7/31/09 Hospital records received DOS 6/28/09 to 7/1/09. Migraine headaches.
Allergies:
Diagnostic Lab Data: troponin 6.0 elevated heart CK. 7/31/09 Hospital records received DOS 6/28/09 to 7/1/09. LABS and DIAGNOSTICS: EKG - elevated ST segments. Echocardiogram - WNL. Troponin I 2.8 NG/ML (elevated). CK-MB 32.3 NG/ML (elevated). CPK 2412 U/L (elevated). EBV IGM AB (-). Cocksackie virus (-). Adenovirus GP ABS (-)
CDC Split Type:

Write-up: chest pain, myocarditis treated with IVIG. 7/31/09 Hospital records received DOS 6/28/09 to 7/1/09. Assessment: Myocarditis. Patient presents with fever followed by sharp, nonradiating, substernal chest pain. Worse when lying down and improved with sitting up. Pain left elbow. Emesis. Headache frontal, bilateral pulsatile, with photophobia. 10/13/09 ICD-9 Codes Received: 422.90 Acute myocarditis unpsecified, 346.90 Migraine unspecified not noted as intractable.

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Myocarditis, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-03-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: aortic and mitral valve insufficiency, unknown aetiology
Allergies:
Diagnostic Lab Data: ER LABS of 3/8/07: ABG pH 7.23, po2 62. Serum glucose 353, Creat 1.7, albumin 2.6, total protein 4.9, SGPT 62, SGOT 359. Blood c/s was neg. 2005 Cardiology LABS: echocardiogram revealed mild mitral valve & aortic valve insufficiency. Mitral valve leaflets were slightly thickened.
CDC Split Type:

Write-up: presented to ED with Ventricular tachycardia. Preliminary autopsy finding of myocarditis. 4/3/07 Spoke w/ME who stated prelim COD as acute myocarditis, presumably viral. States patient had PMH of heart murmur which was evaluated by ped cardiologist who found mild aortic & mitral valve insufficiency & regurgitation. ME states did not see evidence of that on autopsy but did find cardiomegaly. Also states patient had been taken to ER on day of death for abdominal pain w/fever & was dx w/gastroenteritis. CXR at that time revealed cardiomegaly. No EKG or cultures were done. Was d/c to home & continued to not feel well. Parent found patient in bathroom unresponsive at approx 2AM & was transported to a second ER where she expired. ME states patient had approx 2 week hx of cough & runny nose prior to death. 6/12/07 Received final Autopsy Report which reveals COD as acute probable viral etiology myocarditis & manner of death as natural. 6/29/07 Received ER records from hospital where patient expired which reveal patient was in respiratory arrest & had been intubated by EMS. ACLS measures were unsuccessful & patient pronounced. 8/24/07 Received cardiology consult which reveals patient evaluated for heart murmur in 2005 which had been diagnosed for long time but never evaluated. Patient admitted to palpitations & nervousness. Patient history did not reveal any evidence of rheumatic fever. Antibiotic endocarditis prophylaxis recommended prior to dental & surgical procedures. Patient was to f/u w/cardiology in 2-3 yearrs to document progress of valvular insufficiency. FINAL Cardiology DX: Aortic & mitral valve insufficiency of unknown etiology.

Administered by: Private       Purchased by: Other
Symptoms: Cardiac failure, Lethargy, Myocarditis, Pyrexia, Troponin T increased, Vomiting
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-08-25
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 22 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported.
Preexisting Conditions: None elicited.
Allergies:
Diagnostic Lab Data: 8/3/2014 08:00 Troponin T: 10.090 (H)
CDC Split Type:

Write-up: Fever, lethargy. Later developed vomiting and went into heart failure. Preliminary diagnosis of Acute myocarditis.

Administered by: Public       Purchased by: Public
Symptoms: Arthralgia, Cardiovascular disorder, Enteritis, Laboratory test abnormal, Nuchal rigidity, Osteoarthritis, Pericarditis, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (narrow), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
Extended hospital stay? Yes
Previous Vaccinations: NA~ ()~~~In patient
Other Medications: DDAVP
Current Illness: parent denies
Preexisting Conditions: allergic to red dye & bees;
Allergies:
Diagnostic Lab Data: r/o lyme disease & meningitis;
CDC Split Type: OH98071

Write-up: 18 days p/vax pt had T102-104;temp for 4mos, rash, stiff neck, joint swelling & pain (ongoing);hosp;pericarditis in AUG w/abn ECHO regarding two valves;dx systemic juvenile enteritis;

Administered by: Private       Purchased by: Unknown
Symptoms: Blood creatine phosphokinase MB increased, Brain natriuretic peptide increased, Chest pain, Culture positive, Echocardiogram normal, Electrocardiogram ST segment elevation, Enterovirus infection, Headache, Influenza virus test negative, Mycoplasma test positive, Myocarditis, Parvovirus B19 test positive, Polymerase chain reaction, Pyrexia, Toxoplasma serology, Troponin increased, Viral test negative, Viral test positive, Vomiting
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Echo with good fxn; Nasal wash viral cx (P). Serology for Toxoplasmosis; Parvo B19; Mycoplasma (P); Serum & plasma being held for possible future serology, Viral PCR.
CDC Split Type:

Write-up: Vomiting, fever, then chest pain -$g documented acute myocarditis with increased CK (MB fxn), increased Troponin, increased BNP, marked ST elevation admission 2d after vaccine. Also with 2d increased T & HA after vaccine. No rash. USV infectious w/u being pursued feel enterovirus most likely. Nasal viral panel negative DFA for influenza & other resp viruses; CX positive.

Administered by: Public       Purchased by: Public
Symptoms: Ascites, Coordination abnormal, Coronary artery thrombosis, Ear pain, Encephalitis, Generalised oedema, Headache, Hypertonia, Hypokinesia, Infection, Meningitis, Myalgia, Myocarditis, Neck pain, Neuropathy, Otitis externa, Otitis media, Sepsis, Splenomegaly, Thinking abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Parkinson-like events (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-08-01
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MMR & Td in ''98 w/o problem; none
Current Illness: none
Preexisting Conditions: Lorabid & PCN allergies; severe ear infections, usually otitis externa, H/A for many years, controlled w/ ibuprofen; no sz hx
Allergies:
Diagnostic Lab Data: CSF-no growth p/72hr;blood culture-no growth p/48hr; CT-nl; MRI-lt mastoiditis; CSF gram stain smear-mod. segmented WBC-no organisms
CDC Split Type: PA9956

Write-up: pt seen by FMD c/o lt ear pain; dx: otitis externa;7/26 c/o lt ear pain;h/a;off balance;dx OM;tx:Bactrim DS; 7/28-severe h/a,neck pain;difficulty walking;change in mental status,+ Kernig''s sign;hosp;IV Claforan, Vanco, Acyclovir; expired 8/

Administered by: Private       Purchased by: Private
Symptoms: Chest pain, Dyspnoea, Infectious mononucleosis, Influenza like illness, Nausea, Pericarditis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YAZ; DORYX; DIFFERIN; BENZACLIN
Current Illness: Mononucleosis - recovering
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data: None in our office
CDC Split Type:

Write-up: Patient received dose #1 GARDASIL on 10/29/9 - mother stated pt had flu-like s/s for 2 days post injection, did not report such to our office until after 2nd immuz. On 12/29/2009 received 2nd GARDASIL injection (diagnosed with mononucleosis on 12/4/2009), developed CP, SOB, nausea, vomiting on 2/5/10. Seen by Dr (cardiologist) dx with pericarditis, placed on ibuprofen 800 mg PO TID and taken out of sports, spoke to mother on 2/10/10 - Patient better, mother convinced recurrent s/s related to adverse effect from #2 GARDASIL.

Administered by: Private       Purchased by: Other
Symptoms: Pericarditis, Pleural disorder, Rheumatoid arthritis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Solumedrol,Prednisone
Current Illness: NONE
Preexisting Conditions: Systemic onset juvenile rheumoatoid arthritis
Allergies:
Diagnostic Lab Data: Blood tests, chest xray
CDC Split Type:

Write-up: 1 mon after vax pt had major flare & systemic onset juvenile rheumatoid arthritis w/ pleuritis & pericarditis requiring corticosteroid treatment.

Administered by: Unknown       Purchased by: Private
Symptoms: Blood culture positive, CSF culture positive, Immunodeficiency, Meningitis meningococcal, Meningococcal bacteraemia, Meningococcal infection, Myocarditis, Neisseria test positive
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Cultures of CSF and blood (collected 1/16/10) positive for Neisseria meningitidis serogroup Y.
CDC Split Type:

Write-up: Culture-confirmed meningococcal infection (serogroup Y), bacteremia and meningitis with probable myocarditis. (Note: Patient received meningococcal conjugate vaccine Menactra 3/28/2007. Patient was diagnosed with complement [C3] deficiency after developing meningococcal disease.)