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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| Event Outcome | Count | Percent |
| Emergency Doctor/Room | 1 | 2.44% |
| Office Visit | 8 | 19.51% |
| Recovered | 10 | 24.39% |
| None of the Above | 23 | 56.1% |
| TOTAL | † 42 | † 102.44% |
| † 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 41 (the number of cases found), and the Total Percent is greater than 100. | ||
| Case Details (Sorted by State) |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Fever; Nausea; This spontaneous case from the was received on 12-Mar-2024 from other healthcare professional via Med Communications (reference number: SEQW24-00881) and concerned a patient of unreported age and gender. The patient''s medical history and concomitant medications were not reported. The patient did not have any chronic or long-standing health condition. On 26-Oct-2023, the patient was vaccinated with non-company, co-suspects COVID-19 vaccine (reported as mRNA-1273.815 Moderna COVID-19 vaccine 2023-2024 (andusomeran)) (dose: 0.5 ml (it was reported that the patient was given 0.5 ml when it needed to be 0.25 ml), route of administration: intramuscular, batch number: AU5558B and anatomical location: not reported) for Covid-19 prophylaxis, and Vaxneuvance (pneumococcal vaccine conj 15v (crm197); dose: reported as ''one dosage form (1 DF)''; route of administration: intramuscular, batch number: X020316, anatomical location and indication: not reported). On 26-Dec-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as ''one dosage form (1 DF)'', route of administration: intramuscular, anatomical location and indication: not reported). The reported batch number was 373546. On same day, the patient was vaccinated with non-company, co-suspects Vaxelis (diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid; dose: reported as ''one dosage form (1 DF)'', route of administration: intramuscular, batch number: V7295AA, indication and anatomical location: not reported) and Rotateq (rotavirus vaccine live reassort oral 5v; dose: reported as ''one dosage form (1 DF)''; route of administration: oral, and batch number: X007337, anatomical location and indication: not reported). On unspecified date in Dec-2023, an unknown amount of time after receiving Flucelvax Quadrivalent and non-company, co-suspects Moderna Covid-19 vaccine, Vaxneuvance, Vaxelis and Rotateq, the patient experienced fever for two days and nausea. The outcome of the events was unknown. The reporter did not provide the causality assessment. The case was assessed as non-serious. Company comment: The events of fever and nausea are assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship, although causality was confounded by the administration of the co-suspect vaccines Moderna Covid-19 vaccine, Vaxneuvance, Vaxelis and Rotateq.; Sender''s Comments: The events of fever and nausea are assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship, although causality was confounded by the administration of the co-suspect vaccines Moderna Covid-19 vaccine, Vaxneuvance, Vaxelis and Rotateq. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Some cough; Fever; Achy shot site; This spontaneous case from the (Privacy) was received on 06-Feb-2024 from an other healthcare professional via Med Communications (reference number SEQW24-00530) and concerned a 7-month-old, male patient. The patient''s concurrent condition included exposure to COVID-19, as it was reported that mom/dad had COVID. The patient had no known allergies. The patient''s concomitant medications were not reported. On 26-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: not reported, route of administration: intramuscular and anatomical location: left thigh) as active immunization against influenza disease. The batch number reported was 373546. On the same date, the patient was vaccinated with a non-company, co-suspect Moderna COVID-19 vaccine (elasomeran; dose: 0.5 ml (instead of recommended 0.25ml), route of administration: intramuscular, anatomical location: right thigh and indication: not reported). The batch number reported was AU5558B. On an unspecified date in 2023, an unknown amount of time after receiving Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine, the patient experienced achy shot site. The patient also experienced some cough and fever, as reported and so had to receive the protocol for cold/flu/COVID. On an unspecified date in 2023, the patient recovered from all events. The reporter did not provide causality assessment. The case was assessed as non-serious. Company comment: A 7-month-old patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine, on the same date. On unspecified date in 2023, an unknown amount of time after the vaccination, the patient experienced vaccination site pain, cough and pyrexia. The patient''s concurrent condition included exposure to COVID-19, as it was reported that mom/dad had COVID. Based on anatomical plausibility, causality for vaccination site pain is assessed as possibly related. Causality for cough and pyrexia are unassessable due to unclear temporal relationship and reported exposure to COVID-19 infection.; Sender''s Comments: A 7-month-old patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine, on the same date. On unspecified date in 2023, an unknown amount of time after the vaccination, the patient experienced vaccination site pain, cough and pyrexia. The patient''s concurrent condition included exposure to COVID-19, as it was reported that mom/dad had COVID. Based on anatomical plausibility, causality for vaccination site pain is assessed as possibly related. Causality for cough and pyrexia are unassessable due to unclear temporal relationship and reported exposure to COVID-19 infection. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: Extreme pain in left shoulder; upper back pain on left side; left arm pain; numbness and tingling in fingers of left hand; numbness and tingling in fingers of left hand; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 34-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 11Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (BOOSTER) Completed, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (BOOSTER) Completed, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 12Oct2023, outcome "not recovered", described as "Extreme pain in left shoulder"; PAIN IN EXTREMITY (non-serious) with onset 12Oct2023, outcome "not recovered", described as "left arm pain"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 12Oct2023, outcome "not recovered" and all described as "numbness and tingling in fingers of left hand"; BACK PAIN (non-serious) with onset 12Oct2023, outcome "not recovered", described as "upper back pain on left side". The events "extreme pain in left shoulder", "upper back pain on left side", "left arm pain" and "numbness and tingling in fingers of left hand" required physician office visit. Therapeutic measures were taken as a result of arthralgia, back pain, pain in extremity, hypoaesthesia, paraesthesia. Additional information: Treatment for adverse events was diclofenac. 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: Pharmacy Purchased by: ? Life Threatening? No Write-up: Eyes felt sore the day after vaccination; Sore arm; Eyebrows twiched involuntarily; Really sick on Sunday night after she got the vaccine; Sharp, stabbing pains felt behind her eyes/Headache; Felt fatigued; A low grade fever; Flucelvax Quadrivalent and Moderna COVID-19 vaccine were administered on the same day at the same anatomical location; Body/aches/General body pain; This spontaneous case was received on 07-Feb-2024 from other non-healthcare professional via Med Communications (reference number SEQW24-00548) and a 63-year-old, female patient. The patient''s concurrent condition included osteoporosis. The patient''s concomitant medications included clonazepam for anxiety, Alendronate (alendronate sodium) and cholecalciferol, both used for osteoporosis. The patient had no known allergies. The patient''s historical vaccines included three doses of Pfizer BioNTech COVID-19 vaccine, the first dose received on 19-Feb-2021, the second dose received on 09-Mar-2021 and the third dose received 09-Oct-2021, all three received for unspecified indication, and three doses of COVID-19 vaccine (reported as Spikevax 2023-2024), the first dose received on 06-May-2022 (dose, route of administration, anatomical location and indication: not reported; batch number: 056M21A), the second dose received on 06-Oct-2022 (dose: 0.5 ml, anatomical location: left arm; route of administration and indication: not reported; batch number: 055F22B) and the third dose received on 04-Jun-2023 (dose: 0.5 ml; anatomical location: left arm; route of administration and indication: not reported; batch number: A57642B), after each of six COVID-19 vaccinations the patient experienced head and body/aches, fever and fatigue, as reported. On 01-Oct-2023, at 3:00 pm, the patient was vaccinated with non-company, co-suspect COVID-19 vaccine (reported as SPIKEVAX 2023-2024 (active ingredients not specified); dose: 0.5 ml; anatomical location: left arm; route of administration and indication: not reported). The batch number reported was AU3832B. On the same date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: left arm; route of administration: injection; dose: not reported) (explicitly coded as ''Product administration error'') for active immunization against influenza disease. The batch number reported was 944456. On the same date, Sunday night, as reported, after receiving Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine, the patient felt really sick and typically had a fever. The patient experienced sharp, stabbing pains behind her eyes, body aches, and fatigue. On 02-Oct-2023, one day after the vaccination, as reported, the patient''s eyes felt sore and eyebrows twitched involuntarily. The headache was more severe. For the following six days, the patient felt fatigued (like carrying weight on my shoulders), body/aches/general body pain, a sore arm, and a low-grade fever. As each day wore on the fever lessened gradually as the days progressed, as reported. On 10-Oct-2023, the patient had recovered from the event of ''pain in extremity''. On an unspecified date in Oct-2023, (discrepantly reported as 09-Oct and 10-Oct), the patient had recovered from the event of ''headache''. The outcome of the events of ''eye pain'', ''spasms'', and ''sickness'' was not reported. At the time of initial reporting, the patient had not recovered from the events of ''general body pain'', fatigue, and ''pyrexia''. The reporter did not provide a causality assessment. The case was assessed as non-serious. Company comment: A 63-year-old patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine in the left arm (explicitly coded as ''Product administration error''). On the same day following vaccination, the patient experienced pain, illness, headache, fatigue and pyrexia. One day later, the patient also experienced eye pain, pain in extremity and muscle spasms. Product administration error is assessed as not related as per company''s conventions. Although causality is confounded by administration of co-suspect COVID-19 vaccine, it is assessed as possible for pain, illness, headache, fatigue, pyrexia, eye pain, pain in extremity and muscle spasms, due to chronological plausibility.; Sender''s Comments: A 63-year-old patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine in the left arm (explicitly coded as ''Product administration error''). On the same day following vaccination, the patient experienced pain, illness, headache, fatigue and pyrexia. One day later, the patient also experienced eye pain, pain in extremity and muscle spasms. Product administration error is assessed as not related as per company''s conventions. Although causality is confounded by administration of co-suspect COVID-19 vaccine, it is assessed as possible for pain, illness, headache, fatigue, pyrexia, eye pain, pain in extremity and muscle spasms, due to chronological plausibility. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: High blood pressure / Essential hypertension; Bronchitis, mucopurulent recurrent; Ankle swelling; This spontaneous case was received on 07-Feb-2024 from other healthcare professional via Med Communications (reference number: SEQW24-00546), reported by other healthcare professional and concerned a 57-year-old, female patient. The patient''s concurrent conditions included milk allergy, asthma, chest infection, chronic bronchitis, primary hypertension (blood pressure used to be 130/80, as reported), fasting blood glcose increased, vasomotor rhinitis, insect bite of shoulder and upper arm, non-venomous infected, anxiety, lower back pain, lyme disease, non-smoker, allergy to codeine phosphate and NSAIDs and weight loss. Historical condition included alcohol abuse. Past procedures included colonoscopy and tonsillectomy. The patient''s concomitant medications included clonazepam for anxiety, Ventolin hfa (salbutamol sulfate) for asthma, Breo ellipta (fluticasone furoate, vilanterol trifenatate), montelukast sodium, multivitamin (multi for her), turmeric, glucosamine and vitamin C (ascorbic acid), for unknown indication. The patient''s historical vaccines included three doses of Covid-19 vaccine (reported as Moderna), the first dose received on 30-Mar-2021 at 1:00 pm (route of administration: intramuscular (IM), anatomical location: arm, dose and indication: not reported, the batch number reported was 018BZ1A), the second dose received on 28-Apr-2021 (route of administration: IM, anatomical location: arm, dose and indication: not reported, the batch number reported was 045B21A) and the third dose received on 02-Dec-2021 (route of administration: IM, anatomical location: arm, dose and indication: not reported, the batch number reported was 0Y5J21A). On 13-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 1, route of administration: IM, anatomical location: arm, indication: not reported) as influenza vaccine, as reported. The batch number reported was 348366. On the same date, the patient was vaccinated with non-company, co-suspect Spikevax COVID-19 vaccine (elasomeran; route of administration: IM, anatomical location: arm, dose and indication: not reported). The batch number reported was A57165B. On the same date, after receiving Flucelax Quadrivalent and non-company, co-suspect Covid-19 vaccine, the patient experienced blood pressure increased from the low side of normal to high (as reported, the blood pressure prior to vaccine was 138/62). Also, the patient felt that asthma which was well controlled prior to vaccine and had worsened after last vaccine and had been more poorly managed after vaccination and noticed some ankle swelling. On 13-Dec-2022, the patient visited physician''s room, and the physician made the assessments of essential hypertension, ankle edema and bronchitis, mucopurulent recurrent. The patient''s treatment medications included Amlodipine at a dose of 5 mg, qd. At the time of initial reporting, the patient had not recovered from the event of ''blood pressure high'', and the outcome of the events ''ankle edema'' and ''mucopurulent chronic bronchitis'' was not reported. The reporter did not provide a causality assessment. The case is assessed as non-serious. Company comment: A 57-year-old patient was vaccinated with Flucelvax Quadrivalent and with non-company, co-suspect Spikevax. On the same day following vaccination, the patient experienced essential hypertension, oedema peripheral and bronchitis bacterial. The patient''s concurrent conditions included asthma, chest infection, chronic bronchitis, primary hypertension, blood glucose increased. Based on biological implausibility (for bronchitis bacterial) and multiple confounding factors, causality for the reported events of essential hypertension and bronchitis bacterial is assessed as not related. Causality is assessed as possible for oedema peripheral, due to suggestive chronology.; Sender''s Comments: A 57-year-old patient was vaccinated with Flucelvax Quadrivalent and with non-company, co-suspect Spikevax. On the same day following vaccination, the patient experienced essential hypertension, oedema peripheral and bronchitis bacterial. The patient''s concurrent conditions included asthma, chest infection, chronic bronchitis, primary hypertension, blood glucose increased. Based on biological implausibility (for bronchitis bacterial) and multiple confounding factors, causality for the reported events of essential hypertension and bronchitis bacterial is assessed as not related. Causality is assessed as possible for oedema peripheral, due to suggestive chronology. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Achy shot site; This spontaneous case was received on 05-Feb-2024 from other healthcare professional via Med Communications (reference number: SEQW24-00501) with additional information received on 13-Feb-2024 (being processed together), and concerned a 2-year-old female patient. The patient''s medical history included Covid-19. The patient''s concurrent condition included allergy to cats and the patient was not taking any concomitant medication. On 27-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular; anatomical location: right thigh; dose and indication: not reported). The reported batch number was 370667, and the expiry date was 30-Jun-2024. On the same date, the patient was vaccinated with a non-company, co-suspect Moderna COVID-19 vaccine (elasomeran; dose: 0.5 ml (instead of recommended 0.25 ml), route of administration: intramuscular; anatomical location: left thigh; indication: not reported). The reported batch number was A05558B. On an unspecified date in 2023, an unknown amount of time after receiving Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine, the patient experienced achy shot site. On an unspecified date in 2023, the patient recovered from the event. The reporter did not provide a causality assessment. The case was assessed as non-serious. This case is linked with case 202400716 (the same reporter). Company comment: The event of vaccination site pain is assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship, although causality was confounded by the administration of the co-suspect vaccine.; Sender''s Comments: Company comment: The event of vaccination site pain is assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship, although causality was confounded by the administration of the co-suspect vaccine. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: Formed a large lump, under my arms; Underarms started to hurt; Started feeling chills; This spontaneous case was received on 26-Oct-2023 from other non healthcare professional (consumer) via Pfizer, Inc. (reference number US-PFIZER INC-PV202300168237) and concerned a patient of unreported age and gender. The patient''s concurrent conditions included asthma. The patient''s concomitant medication included albuterol for asthma. The patient''s historical vaccines included an unspecified number of COVID-19 booster vaccines received in Oct-2022, after which the patient experienced chills. On 07-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact split 4v; dose: 0.15 ml; route of administration, anatomical location, and indication: not reported). The batch number reported was 944463 (reported batch number was identified by Seqirus to be correct batch number). The expiry date reported was 30-Jun-2024. On the same day, the patient was vaccinated with non-company co-suspect Comirnaty vaccine (tozinameran; dose: 0.3 ml; anatomical location: left arm; route of administration: intramuscular; and indication: ''I don''t want to catch COVID. I want to prevent it as much as I can'', as reported). The batch number reported was HF9275. On the same day, later in the day, as reported, after receiving Flucelvax and Comirnaty vaccines, the patient started feeling, where about chills, and that was all that the patient was expecting. Later in the day, as reported, the patient''s underarms started to hurt, and it formed a large lump under arms. The patient used warm compresses and took ibuprofen and Tylenol (paracetamol). At the time of the initial reporting, the patient was recovering from the event of ''axillary lump''. The patient reported the lump was going down, but it was still there. The outcome of the events ''axillary pain'' and chills was unknown. The reporter did not provide a causality assessment. Company comment: A patient of unreported age and gender was vaccinated with Flucelvax Quadrivalent and non-company co-suspect Comirnaty vaccine, on the same date. Reportedly, on the same date, patient started to feel chills, and later complained of axillary pain. In addition, patient noticed that was formed a large mass in the underarms. Relevant laboratory and diagnostic findings were not provided. Causality is confounded by concurrently administered non-company co-suspect Comirnaty vaccine. Despite confounding by co-suspect vaccine, causal role of the suspect vaccine cannot be excluded due to suggestive temporal relationship and biological plausibility, therefore is assessed as possibly related for all reported events (chills, axillary pain and axillary mass).; Sender''s Comments: A patient of unreported age and gender was vaccinated with Flucelvax Quadrivalent and non-company co-suspect Comirnaty vaccine, on the same date. Reportedly, on the same date, patient started to feel chills, and later complained of axillary pain. In addition, patient noticed that was formed a large mass in the underarms. Relevant laboratory and diagnostic findings were not provided. Causality is confounded by concurrently administered non-company co-suspect Comirnaty vaccine. Despite confounding by co-suspect vaccine, causal role of the suspect vaccine cannot be excluded due to suggestive temporal relationship and biological plausibility, therefore is assessed as possibly related for all reported events (chills, axillary pain and axillary mass). |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: Sore arm at injection site; Got Flucelvax in the same left arm at the same time as Comirnaty; This spontaneous case was received on 26-Oct-2023 from Seqirus via Pfizer (reference number: 202300322326), reported by other non-healthcare professional (consumer) and concerned a patient of an unreported age and gender. The patient''s concurrent conditions included penicillin allergy. The patient''s concomitant medications were not reported. On 08-Oct-2023 at 10:30 am, the patient was vaccinated with the fifth dose of a non-company, co-suspect Comirnaty vaccine (tozinameran; anatomical location: left arm, dose, route of administration and indication: not reported). The batch number was not reported. On the same date, at the same time as reported, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: left arm, dose, route of administration and indication: not reported) (explicitly coded as ''Product administration error''). The batch number was not reported. On the same date, after receiving Flucelvax Quadrivalent and non-company, co-suspect Comirnaty, the patient experienced a sore arm at the injection site. At the time of initial reporting, the patient was recovering from the event of ''vaccination site pain''. The reporter did not provide a causality assessment. The case was assessed as non-serious. Company comment: The event of vaccination site pain is assessed as possibly related to Flucelvax Quadrivalent due to a plausible temporal relationship. However, the causality is confounded by administration of non-company co-suspect COVID-19 vaccine.; Sender''s Comments: The event of vaccination site pain is assessed as possibly related to Flucelvax Quadrivalent due to a plausible temporal relationship. However, the causality is confounded by administration of non-company co-suspect COVID-19 vaccine. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: Vision very blurry; Vision became ''strained'' next day after injection and continually worsened until became blurry with shadows then started cleaning on the fourth day; The patient had sore arm at the injetion site and it was minor; This spontaneous case was received on 08-Feb-2024, from other non-healthcare professional (consumer) via Communications (reference number: SEQW24-00567), and concerned a 79-year-old, non-pregnant, female patient. The patient''s concurrent conditions included allergy to sulfa. The patient was not taking any concomitant medications. The patient has not been ever diagnosed with/tested positive for COVID-19 with no acute illnesses at the time of vaccination up to one month before and with no chronic or long-standing health conditions. The patient''s historical vaccines included four doses of Moderna Covid-19 vaccine, the first dose was received on 10-Feb-2021 (batch number: D15M20A), the second dose on 10-Mar-2021 (batch number: 03DA21A), the third dose on 26-Nov-2021 (batch number: 055H21A) and the fourth dose on 31-May-2022 (batch number: 004M21A), all for an unreported indication. On 24-Nov-2023, on Friday, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; anatomical location: arm and route of administration: not reported) as active immunization for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine. The batch number was not reported. On the same date, the patient was vaccinated with a non-company, co-suspect COVID-19 vaccine (reported as ''Spikevax (covid-19 vaccine, mRNA (2023-2024 formula)'' (active ingredients not specified); dose, anatomical location, route of administration and indication: not reported). The batch number was not reported. On 25-Nov-2023, one day after receiving Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine, the patient experienced vision impaired. Vision became ''strained'' next day after injection and continually worsened until became blurry with shadows then started cleaning on the fourth day, as reported. On 27-Nov-2023, three days after receiving Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine, the patient experienced vision very blurry. On 29-Nov-2023, the patient seek medical care and visited the physician''s office/urgent care. Also, the patient visited physician''s office/urgent care on 04-Dec-2023, as reported. On an unspecified date in Nov-2023, an unknown amount of time after receiving Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine, the patient experienced soreness in arm at the injection site, that was minor. On 02-Dec-2023, the patient recovered with with sequelae from the event of ''vision blurred''. Residual effects were reported as on and off poor vision. There were still times when vision was poor for short period, 1/2 a day, as reported. At the time of initial reporting, the patient had not recovered from ''visual impairment'' and ''vaccination site pain''. The reporter did not provide a causality assessment. Vision impaired and vision very blurry was reported as mostly likely caused by mRNA-1273, as reported. Additionally, the patient did not experienced a similar event in the past, as reported. The case was assessed as non-serious. Company comment: A 79-year-old patient developed blurry vision, visual impairment, and vaccination site pain within six days after receiving the suspect product Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine. Despite confounding by co-suspect vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to compatible temporal relationship.; Reporter''s Comments: Vision impaired and vision very blurry was reported as mostly likely caused by mRNA-1273, as reported. Additionally, the patient did not experienced a similar event in the past, as reported.; Sender''s Comments: A 79-year-old patient developed blurry vision, visual impairment, and vaccination site pain within six days after receiving the suspect product Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine. Despite confounding by co-suspect vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to compatible temporal relationship. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Stumbling around/ staggering across at his lawn; Felt dizzy; Tiredness; This spontaneous case was received on 03-Jan-2023 from other healthcare professional via Med Communications (reference number: SEQW23-00030) and concerned a 66-year-old, male patient. The patient was enrolled in an Astellas sponsored patient support program (enzalutamide_Astellas PSP). The patient''s concurrent conditions included secondary malignant neoplasm of bone and prostate cancer. The patient''s historical conditions included other specified diseases of the liver. The patient''s concomitant medications included Lupron (leuprorelin acetate), Metamucil sugar free (Plantago ovata), and Zometa (zoledronic acid), all used for unreported indications, and Xtandi (enzalutamide) used for prostate cancer. The patient had no known allergies. On 22-Oct-2022, Saturday, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine. The batch number was not reported. On the same date, the patient was vaccinated with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; dose: reported as ''fourth, booster'', route of administration, anatomical location, and indication: not reported). The batch number was not reported. On 27-Oct-2022, five days after receiving Flucelvax Quadrivalent and co-suspect Pfizer BioNTech COVID-19 vaccine, and about 30 minutes after morning dose of Xtandi (enzalutamide), the patient was stumbling around/staggering across at his lawn, felt dizzy and the patient experienced tiredness. It was reported that the patient did not take blood pressure medications just leuprorelin acetate and zoledronic acid. The patient might switch routine in taking it (enzalutamide) and would try eating before rather than after (as reported). The patient was encouraged to reach out to the doctor since dizziness was preventing him from working. On 28-Oct-2022, the dose of Xtandi (enzalutamide) was changed from 160 mg daily to 120 mg daily. On an unspecified day, the patient recovered from the events of ''gait disturbance'' and dizzy. At the time of initial reporting, the patient had not recovered from the event of tiredness. The reporter did not provide causality assessment. The case was assessed as non-serious. Company comment: A 66-year-old male patient experienced dizziness, gait disturbance and fatigue five days after vaccination with Flucelvax Quadrivalent and co-suspect Pfizer BioNTech COVID-19 vaccine, and about 30 minutes after morning dose of Xtandi (enzalutamide). The patient''s concurrent conditions included secondary malignant neoplasm of bone and prostate cancer. The patient was on treatment with Xtandi (enzalutamide) used for prostate cancer. Reportedly, the patient might switch routine in taking enzalutamide. The dose of enzalutamide was reduced. Common side effects of Xtandi (enzalutamide) included fatigue and dizziness, which is probable cause for all events due to suggestive temporal relationship. Therefore, causality for all events is assessed as not related to the suspect vaccine due to alternative aetiology provided. Sender''s Comments: A 66-year-old male patient experienced dizziness, gait disturbance and fatigue five days after vaccination with Flucelvax Quadrivalent and co-suspect Pfizer BioNTech COVID-19 vaccine, and about 30 minutes after morning dose of Xtandi (enzalutamide). The patient''s concurrent conditions included secondary malignant neoplasm of bone and prostate cancer. The patient was on treatment with Xtandi (enzalutamide) used for prostate cancer. Reportedly, the patient might switch routine in taking enzalutamide. The dose of enzalutamide was reduced. Common side effects of Xtandi (enzalutamide) included fatigue and dizziness, which is probable cause for all events due to suggestive temporal relationship. Therefore, causality for all events is assessed as not related to the suspect vaccine due to alternative aetiology provided. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Cramping; Upset stomach; Muscle aches; Asthma attacks; Broncho spams; Body aches; Nausea; Chills; Low grade fever (highest temperature 100.2F); Headaches; This spontaneous case was received on 22-Nov-2022 from other non-health professional (consumer) via Regulatory Communications with an additional information received on the same day (being processed together) (reference numbers: SEQW22-06008) and concerned a 49-year-old, female patient. The patient''s concurrent conditions included gastrooesophageal reflux disease (GERD), irritable bowel syndrome (IBS), asthma, and vision impairment. The patient''s concomitant medications included omeprazole for GERD, amitriptyline for IBS, and Ventolin (salbutamol sulfate) for asthma. The patient''s past medical history included an aneurysm. The patient''s historical procedure included a loop electrosurgical excision procedure (LEAP), upper endoscopy and implantation of two metal clips in the right forehead. The patient''s historical vaccines included three doses of Pfizer/Biontech Covid-19 vaccine: first dose received on 31-Mar-2021, in the left arm, batch number: EW0150, second dose received on 25-Apr-2021, in the left arm, batch number: EW0170 and third dose (booster) received on 25-Nov-2021, in the left arm, batch number: FF2590. All were used for unreported indication, after which the patient experienced unspecified adverse events including vomiting and swollen lymph node in the left armpit after the first dose. The patient''s historical vaccines also included vaccine against measles, mumps and rubella (MMR), Tuberculosis vaccines (TB), Hepatitis A (HepA), Hepatitis B vaccine (HepB), tetanus, flu, and polio vaccine, all received on an unspecified date(s), used for unreported indications, and after which the patient experienced sore arm. The patient''s mother''s medical history included high cholesterol and asthma, and the patient''s father''s medical history included high cholesterol. On 11-Feb-2021, 28-Jun-2021, 02-Feb-2022, and on 03-Jun-2022, the patient had Human papilloma virus (HPV) tests done and all were negative. On 30-Sep-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: left arm, dose and route of administration: not reported) for active immunization against influenza caused by influenza virus subtypes A and types B contained in the vaccine. The batch number reported was AS45038, closest to be the actual lot number AS4503A. On 19-Oct-2022, the patient was also vaccinated with non-company, co-suspect Pfizer-BioNTech COVID-19 vaccine (tozinameran; anatomical location: left arm, dose, route of administration, and indication: not reported). The batch number reported was GH9693. On the same date, around 02:00 PM, after receiving non-company, co-suspect Pfizer-BioNTech COVID-19 vaccine and 19 days after receiving Flucelvax Quadrivalent, the patient experienced headaches, and at 09:00 PM chills. Around 11:00 PM the patient experienced a fever. On 20-Oct-2022 at 01:30 AM, one day after receiving non-company, co-suspect Pfizer-BioNTech COVID-19 vaccine and 20 days after receiving Flucelvax Quadrivalent, the patient took 450 mg of Tylenol (paracetamol) orally. Nausea started half an hour later but ginger ale reduced it. At the same time, the patient also experienced asthma attacks/broncho spasms, which stopped with Ventolin. On the same date, at 08:00 AM, the patient experienced body aches, low grade fever (highest temperature 100.2 Fahrenheit (F)), and muscle aches. No medication was taken. In addition, the patient also experienced an upset stomach and cramping at the same time, which forced the patient into a liquid diet. On 19-Oct-2022, the patient recovered from the event of chills. On 20-Oct-2022, the patient recovered from the events of asthmatic attack, bronchial spasm, low grade fever and muscle ache. On 21-Oct-2022, the patient recovered from the events of cramps and upset stomach. On an unspecified date in 2022, the patient recovered from the events of general body pain, nausea and headache. The reporter did not provide a causality assessment. The case was assessed as non-serious. Company comment: A 49-year-old female patient experienced headache and chills 19 days after being vaccinated with the suspect Flucelvax Quadrivalent vaccine and on the same date after being vaccinated with co-suspect Pfizer-BioNTech COVID-19 vaccine. Next day, the patient experienced nausea, asthma, bronchospasm, pain, pyrexia and myalgia, muscle spasms and abdominal discomfort. The patient''s concurrent conditions included asthma and irritable bowel syndrome. Considering implausible temporal relationship, and confounding with co-suspect vaccine and concurrent conditions, causality for all events is assessed as not related to the suspect vaccine.; Sender''s Comments: A 49-year-old female patient experienced headache and chills 19 days after being vaccinated with the suspect Flucelvax Quadrivalent vaccine and on the same date after being vaccinated with co-suspect Pfizer-BioNTech COVID-19 vaccine. Next day, the patient experienced nausea, asthma, bronchospasm, pain, pyrexia and myalgia, muscle spasms and abdominal discomfort. The patient''s concurrent conditions included asthma and irritable bowel syndrome. Considering implausible temporal relationship, and confounding with co-suspect vaccine and concurrent conditions, causality for all events is assessed as not related to the suspect vaccine. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Flu; Sinus literally killing me; Horrible body ache; Have no energy; Appetite have been exhausted/no appetite; Have been so sick; Threw up few times; Excruciating Headache; Nauseous; Fever 102.5/100; Not feeling great; Have been exhausted; Hives; This spontaneous case was received on 26-Oct-2023 from other non-healthcare professional (consumer) via Pfizer (reference number: US-PFIZER-INC-202300316345) and concerned a female patient of an unspecified age and gender. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration, anatomical location, dose, and indication: not reported). The batch number reported was 942309 and expiry date reported was Jun-2023. As reported, the patient did not receive flu shot in 2023. On an unspecified date, the patient was vaccinated with first dose of non-company, co-suspect COVID-19 vaccine (reported as Moderna unspecified vaccine, active ingredients not specified; dose, anatomical location, route of administration and indication: not reported). The batch number reported was 027A2119. On an unspecified date, the patient was vaccinated with second dose of non-company, co-suspect COVID-19 vaccine (reported as Moderna unspecified vaccine, active ingredients not specified; dose, anatomical location, route of administration and indication: not reported). The batch number reported was 064H21A. On an unspecified date, the patient was vaccinated with third dose of non-company, co-suspect COVID-19 vaccine (reported as Moderna unspecified vaccine, active ingredients not specified; dose, anatomical location, route of administration and indication: not reported). The batch number was not reported. On an unspecified date, the patient was vaccinated with non-company, co-suspect COVID-19 vaccine (reported as Pfizer COVID-19 vaccine, active ingredients not specified; dose, anatomical location, route of administration and indication: not reported. The batch number reported was FN2908 and expiry date reported was Sep-2022. On an unspecified date, the patient was vaccinated with non-company, co-suspect COVID-19 vaccine (reported as Pfizer COVID-19 bivalent vaccine, active ingredients not specified; dose, anatomical location, route of administration and indication: not reported. The batch number reported was GJ3274 and expiry date reported was May-2023. On 30-Sep-2023 at about 11.20 am, reported as on Saturday, the patient was vaccinated with non-company, co-suspect Comirnaty vaccine (tozinameran; anatomical location: left deltoid, dose: 0.3 ml, route of administration and indication: not reported). The batch number reported was HG4628 and expiry date reported was Nov-2023. On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent vaccine, and non-company co-suspect unspecified Moderna COVID-19 vaccine, the patient had rough time and experienced flu for two days. On 30-Sep-2023, an unknown amount of time after receiving Flucelvax Quadrivalent and non-company co-suspect unspecified Moderna COVID-19 vaccines, non-company co-suspect unspecified Pfizer and Pfizer bivalent COVID-19 vaccine and Comirnaty vaccine, the patient was felling so sick. The patient was nauseous and was not feeling great. The patient threw up few times, had no appetite, and have been exhausted. It was reported that sinus was literally killing the patient. At three o''clock, the patient experienced excruciating headache. At six o''clock patient experienced body ache and at eight o''clock terrible fever of 102.5. On an unspecified date in 2023, reported as 24 hours later, the patient woke up with hives. The patient still had headache. Fever was improved to 100. Patient was not throwing up, and sinus was better when patient was up right. The patient took Tylenol (paracetamol) at dose of 325 mg three times a day. On an unspecified date in 2023, reported as this morning, the patient took one Tylenol 325 mg. At the time of initial reporting, the patient was recovering from event fever. The outcome of all events flu, sinus disorder, general body pain, loss of energy, appetite lost, sickness, vomiting, headache, hives, nauseous, feeling unwell and exhaustion was not reported. The reporter did not provide a causality assessment. The event flu was considered to be medically significant by Physician within Seqiruss. Company comment: A patient of unspecified age experienced influenza an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent vaccine, and non-company co-suspect unspecified Moderna COVID-19 vaccine. The patient also developed sinus disorder, general body pain, asthenia, decreased appetite, illness, vomiting, headache, urticaria, nausea, fever, malaise, and fatigue at least approximately nine months after vaccination. The patient''s medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the event influenza is unassessable. For the rest of the events causality is assessed as not related, based on implausible temporal relationship.; Sender''s Comments: A patient of unspecified age experienced influenza an unknown amount of time after receiving the suspect product Flucelvax Quadrivalent vaccine, and non-company co-suspect unspecified Moderna COVID-19 vaccine. The patient also developed sinus disorder, general body pain, asthenia, decreased appetite, illness, vomiting, headache, urticaria, nausea, fever, malaise, and fatigue at least approximately nine months after vaccination. The patient''s medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the event influenza is unassessable. For the rest of the events causality is assessed as not related, based on implausible temporal relationship. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: Painful when touched; Raised, hard, warm red welt about 2 inches in diameter.; This spontaneous case was received on 26-Oct-2023 from Seqirus via Pfizer (reference number 202300315925) reported by other non-healthcare professional and concerned a patient of unknown age and gender. The patient''s medical history included allergy. The patient''s concomitant medications included Shingrix (varicella zoster vaccine rgE (CHO)), received on 10-Sep-2023 for unknown indication. On 30-Sep-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: right arm; dose, route of administration and indication: not reported). The batch number reported was 944484 (reported batch number was identified by Seqirus to be correct batch number). On the same date, the patient was vaccinated with six non-company co-suspect Covid-19 vaccines: Covid-19 vaccine (Comirnaty bivalent; route of administration: intramuscular; anatomical location: left arm; dose and indication: not reported). The batch number reported was HD9876. Four Covid-19 vaccines (Pfizer; anatomical location: left arm; route of administration, dose and indication: not reported). The batch numbers reported were GH9703, FF8841, EW0102 and EPP6955. Covid-19 vaccine (Moderna; anatomical location: left arm; route of administration, dose and indication: not reported). The batch number reported was 066K21A. On 01-Oct-2023, an unspecified amount of time after receiving Flucelvax Quadrivalent and 6 Covid-19 vaccines, the patient experienced red, hard, warm red welt about 2 inches in diameter. Painful to touch. At the time of initial reporting, the patient was recovering from the events ''welts'' and ''pain''. The reporter did not provide a causality assessment. Company comment: A patient of unknown age and gender was vaccinated with Flucelvax Quadrivalent and six non-company co-suspect Covid-19 vaccines on the same day. One day following vaccination, the patient experienced urticaria and pain. Although causality was confounded by six co-suspect Covid-19 vaccines, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for events pain and urticaria due to plausible temporal relationship.; Sender''s Comments: A patient of unknown age and gender was vaccinated with Flucelvax Quadrivalent and six non-company co-suspect Covid-19 vaccines on the same day. One day following vaccination, the patient experienced urticaria and pain. Although causality was confounded by six co-suspect Covid-19 vaccines, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for events pain and urticaria due to plausible temporal relationship. |
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Administered by: Private Purchased by: ? Life Threatening? No Write-up: Achy shot site; The 3-year-old patient received Flucelvax Quadrivalent and Varivax on the same date on te same site; This spontaneous case was received on 06-Feb-2024 from other non-healthcare professional via Med Communications (reference number SEQW24-00529) and concerned a 3-year-old, female patient. The patient''s medical history and concomitant medications were not reported. On 26-Oct-2023, the patient was vaccinated with non-company, co-suspect Moderna COVID-19 vaccine (elasomeran; dose: 0.5ml, route of administration: intramuscular (IM), anatomical location: right thigh (RT) and indication: not reported). The batch number reported was AU55588. On the same date, the patient was vaccinated with non-company, co-suspect Vaxneuvance (pneumococcal vaccine conj 15v (CRM197); route of administration: intramuscular (IM), anatomical location: right tight (RT); dose and indication: not reported). The batch number reported was XO11424. On the same date, the patient was vaccinated with non-company, co-suspect Varivax (varicella zoster vaccine live (Oka/Merck); route of administration: subcutaneous (sq), anatomical location: left thigh (LT); dose and indication: not reported). The batch number reported was XO10374. On the same date, the patient was vaccinated with non-company, co-suspect Vaqta (hepatitis A vaccine inact; route of administration: intramuscular (IM), anatomical location: right thigh (RT); dose and indication: not reported). The batch number reported was XO10374. On the same date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4V; route of administration: intramuscular (IM), anatomical location left thigh (LT); dose: not reported) (explicitly coded as ''Product administration error'') for influenza immunization. The batch number reported was 373546. On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent and non-company, co-suspects Moderna COVID-19 vaccine, Vaxneuvance, Varivax and Vaqta, the patient experienced achy shot site. The outcome of the event was not reported. The reporter did not provide a causality assessment. The case was assessed as non-serious. Company comment: The event of ''vaccination site pain'' is assessed as possibly related to Flucelvax Quadrivalent due to anatomical plausibility.''Product administration error'' is assessed as unrelated per company''s conventions.; Sender''s Comments: The event of ''vaccination site pain'' is assessed as possibly related to Flucelvax Quadrivalent due to anatomical plausibility.''Product administration error'' is assessed as unrelated per company''s conventions. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Could not walk for 3 days; Was very sick; Fever; This spontaneous case was received on 08-Mar-2024 from other healthcare professional via Company (reference number: SEQW24-00863) and concerned a female patient of an unreported age. The patient had no concurrent conditions. The patient''s concomitant medications were not reported. It was unknown if the patient ever been diagnosed with/tested for COVID-19. The patient had no allergies. The patient did not have any acute illnesses at the time of vaccination and up to one month before. On 24-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4V; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported. On the same date, the patient was vaccinated with a Covid-19 vaccine (reported as ''mRNA-1273.815 (SPIKEVAX 2023-2024)'', active ingredients not specified; dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported), for Covid-19 prophylaxis. The reported batch number was 031322, Quadracel vaccine (diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid; dose, route of administration, anatomical location and indication: not reported), Recombivax vaccine (hepatitis b vaccine rHBsAg (yeast); dose, route of administration, anatomical location and indication: not reported), and Vaqta vaccine (hepatitis a vaccine inact; dose, route of administration, anatomical location and indication: not reported). The batch numbers were not reported. On an unspecified day in Oct-2023, an unspecified amount of time after receiving Flucelvax Quadrivalent , Covid-19 vaccine, Quadracel, Recombivax and Vaqta, the patient was very sick, could not walk for three days and had fever for three days. Events did not even cause the patient to seek medical care. The patient did not have any other potential causes. The patient did not experience a similar event in the past. Treatment medications use information was not provided by reporter. On an unspecified day in Oct-2023, the patient was doing better. On an unspecified day in Oct-2023, the patient recovered from the events. The reporter did not provide a causality assessment. The case was assessed as non-serious. Company comment: A female patient of an unreported age was vaccinated with Flucelvax Quadrivalent and non-company, co-suspects COVID-19 vaccine, Quadracel, Recombivax and Vaqta. Within seven days following vaccination, the patient experienced gait inability, illness and pyrexia. Although confounded by administration of co-suspect vaccines, causality is assessed as possible for all reported events, due to chronological plausibility.; Sender''s Comments: female patient of an unreported age was vaccinated with Flucelvax Quadrivalent and non-company, co-suspects COVID-19 vaccine, Quadracel, Recombivax and Vaqta. Within seven days following vaccination, the patient experienced gait inability, illness and pyrexia. Although confounded by administration of co-suspect vaccines, causality is assessed as possible for all reported events, due to chronological plausibility. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Chest pains; Floating blood pressure; Diarrhea; Fatigue; This spontaneous case from the was received on 21-Oct-2021 from other non-healthcare professional and concerned a 45-year-old, female patient. The patient''s concurrent condition included low blood pressure. The patient''s concomitant medications included Vitamin d (ergocalciferol) and Iron pills (ferrous sulfate), both used for unreported indication. On 06-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 308444; expiration date: 25-Jun-2022. On the same date, the patient was vaccinated with non-company co-suspect COVID-19 vaccine (brand not specified, dose, route of administration, indication and anatomical location: not reported). The batch number was not reported. On 08-Oct-2021, two days after receiving Flucelvax Quadrivalent and non-company co-suspect Covid-19 vaccine, the patient experienced diarrhoea, fatigue and floating blood pressure. After a while she felt chest pains. Her doctor told her she should see a cardiologist. She wanted to know if the flu vaccine was a legit flu vaccine. On an unspecified date in Oct-2021, the patient received treatment with Tramadol (tramadol hydrochloride) for the events. At the time of initial reporting, the patient had not recovered from the event of ''chest pain'' as the patient was still experiencing symptom. The outcome of the all other events were not reported. The reporter assessed the event of ''chest pain'' related to Flucelvax Quadrivalent. It was reported that consumer stated she never experienced ''chest pain'' after getting flu vaccines. This is the first time she got Flucelvax Quad. The reporter did not provide a causality assessment for the other events. The case was assessed as non-serious. Case updated on 26-Apr-2022: Correction made to information received on 21-Oct-2021: Regulatory authority was deleted from Intermediary field and Report Sent to Regulatory Authority by Reporter was changed from ''Yes'' to ''Unk''. No changes in the narrative. Company comment: A 45-year-old female patient experienced diarrhea, fatigue, chest pain and floating blood pressure 2 days after receiving Flucelvax Quadrivalent and non-company co-suspect product Covid-19 vaccines. The patient''s past medical history included low blood pressure. Thus, causality for the event floating blood pressure is assessed as not related. Despite confounding by co-suspect Covid-19 vaccine, causality for all other events is assessed as possibly related based on plausible temporal relationship.; Sender''s Comments: A 45-year-old female patient experienced diarrhea, fatigue, chest pain and floating blood pressure 2 days after receiving Flucelvax Quadrivalent and non-company co-suspect product Covid-19 vaccines. The patient''s past medical history included low blood pressure. Thus, causality for the event floating blood pressure is assessed as not related. Despite confounding by co-suspect Covid-19 vaccine, causality for all other events is assessed as possibly related based on plausible temporal relationship. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Achy shot site; This spontaneous case was received on 05-Feb-2024 from other non-healthcare professional (reference number: SEQW24-00499) and concerned a 2-year-old female patient. The patient''s medical history and concomitant medications were reported as none. The patient had no known allergies. On 26-OCT-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular (IM); anatomical location: left thigh (LT); dose and indication: not reported). The reported batch number was 373546. On the same date, the patient was vaccinated with a non-company, co-suspect Moderna COVID-19 vaccine (elasomeran; dose: 0.5 ml, route of administration: intramuscular (IM); anatomical location: right thing (RT); indication: not reported). The reported batch number was A055588. On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent and non-company co-suspect Moderna COVID-19 vaccine, the patient experienced achy shot site. The outcome of the event was not reported. The case was assessed as non-serious. This case is linked with case 202306679 (the same reporter). Company comment: The event of vaccination site pain is assessed as possibly related to Flucelvax Quadrivalent due to suggestive anatomical location..; Sender''s Comments: The event of vaccination site pain is assessed as possibly related to Flucelvax Quadrivalent due to suggestive anatomical location. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: Nasal congestion; Tested Ag positive / Tested for COVID-19; Flucelvax Quadrivalent and Pfizer BioNTech COVID-19 vaccine administered in the same arm on the same date; This spontaneous case was received on 25-Jan-2024 from Pfizer, Inc. (reference number: US-PFIZER INC- 202400019627), reported by other healthcare professional (nurse) and concerned a patient of redacted age and gender. The patient''s medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26-Oct-2023, the patient was vaccinated with a non-company, co-suspect Pfizer-BioNTech COVID-19 vaccine (tozinameran; dose: reported as ''4''; route of administration: intramuscular; anatomical location: arm right, indication: not reported). The batch number reported was HF9275. On the same date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: right upper deltoid, dose, route of administration, and indication: not reported) (explicitly coded as ''Product administration error''). The batch number reported was 944457. On 19-Jan-2024, at 08:00, two months and 24 days after receiving Flucelvax Quadrivalent and non-company, co-suspect Pfizer-BioNTech COVID-19 vaccine, the patient got a nasal congestion. On the same date, the patient was tested antigen (Ag) positive for COVID-19 from nasal swab. The outcome of the events of COVID-19 and nasal congestion was not reported. The reporter did not provide a causality assessment. The case was assessed as non-serious. Company comment: A patient of unreported age received the suspect product Flucelvax Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 vaccine on the same day and in the same anatomical location: right arm (explicitly coded as ''Product administration error''). The patient got a nasal congestion, and a COVID-19 nasal swab antigen (Ag) test was positive, two months and 24 days after vaccination. Based on biological and chronological implausibility, causal role of the suspect vaccine is assessed as not related. Product administration error is assessed as unrelated per company''s conventions.; Sender''s Comments: A patient of unreported age received the suspect product Flucelvax Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 vaccine on the same day and in the same anatomical location: right arm (explicitly coded as ''Product administration error''). The patient got a nasal congestion, and a COVID-19 nasal swab antigen (Ag) test was positive, two months and 24 days after vaccination. Based on biological and chronological implausibility, causal role of the suspect vaccine is assessed as not related. Product administration error is assessed as unrelated per company''s conventions. |
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Administered by: Work Purchased by: ? Life Threatening? No Write-up: Cot nasal congestion on 19Jan and tested Ag positive; Cot nasal congestion on 19Jan and tested Ag positive; This is a spontaneous report received from a Nurse from product quality group. A 42-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 as dose 1, single (Lot number: HF9275) at the age of 42 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 26Oct2023 as ose number unknown, single (Lot number: 944457), in right deltoid for 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 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jan2024 at 08:00, outcome "unknown" and all described as "Cot nasal congestion on 19Jan and tested Ag positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test (nasal swab) on 19Jan2024 was positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible.; Sender''s Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: bulluous pemphigoid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 11Nov2022 as unk, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FH8028, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 18Nov2021, when the patient was 46-year-old, for Covid-19 immunization, reaction(s): "bulluous pemphigoid", "itchy blisters on my skin", "itchy blisters on my skin"; Covid-19 vaccine (Dose Number: 2, manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose Number: 1, manufacturer unknown), for Covid-19 immunization. The following information was reported: PEMPHIGOID (medically significant) with onset 21Nov2022, outcome "not recovered", described as "bulluous pemphigoid". The event "bulluous pemphigoid" required physician office visit. Therapeutic measures were taken as a result of pemphigoid. Clinical course: The patient was given oral and topical steroid and it improved. This time it is lasting longer. The blisters begin as itchy and if she scratched them they would pop and turn into a scab to heal. She has never had any of these symptoms before receiving the covid vaccine. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202300120267 same patient/vaccine, different dose/events;US-PFIZER INC-202300120268 same patient/vaccine/event, different dose; |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: Sore throat; Dry mouth; This spontaneous case from the Regulatory Authority was received on 12-Oct-2022 from a physician via Pfizer (reference number: 202201191501), with additional information received via Med Communications on 13-Oct-2022 (reference number: SEQW22-04455) and on 17-Oct-2022 (reference number: SEQW22-04582) and retrieved on 14-Oct-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2465271-1) (being processed together), and concerned an adult male patient of an unspecified age. The patient''s medical history and concomitant medications were not reported. The patient''s historical vaccine included three doses of Covid-19 vaccine (brand not specified), two doses received on an unspecified date and third dose (booster) received on an unspecified date in Oct-2021, all used for Covid-19 immunisation. On 23-Sep-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; anatomical location: deltoid; route of administration: not reported) for immunisation and prevention of Influenza disease. The batch number was not reported. The patient has not experienced COVID prior to the vaccination. On the same date, the patient was vaccinated with non-company co-suspect Pfizer-BioNTech COVID-19 Vaccine (tozinameran; dose: reported as ''4 (booster)''; route of administration: intramuscular; anatomical location and indication: not reported). The batch number was not reported. On 24-Sep-2022, 24 hours after receiving Flucelvax Quadrivalent and co-suspect Pfizer-BioNTech COVID-19 Vaccine, the patient experienced persistent and severe sore throat associated with dry mouth. No fever or exudates. The patient was taking ibuprofen with minimal relief. On an unspecified date in 2022, the patient underwent COVID-19 antigen test two times and nasal swab, and the results were negative. On an unspecified date in Sep-2022, the patient recovered from the events. As reported, they lasted about six days and resolved. The reporter did not provide a causality assessment. The case was assessed as non-serious. Company comment: A patient of unreported age experienced oropharyngeal pain and dry mouth one day after receiving the suspect product Flucelvax Quadrivalent and co-suspect Pfizer-BioNTech COVID-19 Vaccine. Despite confounding by co-suspect vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to plausible temporal relationship.; Sender''s Comments: A patient of unreported age experienced oropharyngeal pain and dry mouth one day after receiving the suspect product Flucelvax Quadrivalent and co-suspect Pfizer-BioNTech COVID-19 Vaccine. Despite confounding by co-suspect vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to plausible temporal relationship. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: Other vaccine same date product: Pfizer; dose number: 3; Other vaccine same date product: Moderna; dose number: 4; Raised, hard, warm red welt about 2 inches in diameter. Painful when touched; Raised, hard, warm red welt about 2 inches in diameter. Painful when touched; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An adult female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 12:30 as dose 6 (booster), single (Lot number: HD9876) intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 30Sep2023 as dose 1, single (Lot number: 944484), in right arm. The patient''s relevant medical history included: "known allergies: Yes" (unspecified if ongoing), notes: Name of Drug as Reported: Yes, Reaction: Allergy. Concomitant medication(s) included: SHINGRIX, on 10Sep2023 as dose 1, single. Vaccination history included: Bnt162b2;bnt162b2 omi ba.4-5 (Proprietary medicinal product name: Pfizer, Dose: 05, Batch/lot number: GH9703, Anatomical Location: Arm left, Date of start of drug: 30Sep2023), for COVID-19 Immunization; Moderna covid-19 vaccine (Proprietary medicinal product name: Moderna, Dose: 04, Batch/lot number: 066K21A , Anatomical Location: Arm left, Date of start of drug: 30Sep2023), for COVID-19 Immunization; Bnt162b2 (Proprietary medicinal product name: Pfizer, Dose: 03, Batch/lot number: FF8841, Anatomical Location: Arm left, Date of start of drug: 30Sep2023), for COVID-19 Immunization; Bnt162b2 (Proprietary medicinal product name: Pfizer, Dose: 02, Batch/lot number: EW0102, Anatomical Location: Arm left, Date of start of drug: 30Sep2023), for COVID-19 Immunization; Bnt162b2 (Proprietary medicinal product name: Pfizer, Dose: 01, Batch/lot number: EPP6955, Anatomical Location: Arm left, Date of start of drug: 30Sep2023), for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious), PAIN (non-serious) all with onset 01Oct2023 at 10:00, outcome "recovering" and all described as "Raised, hard, warm red welt about 2 inches in diameter. Painful when touched"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Other vaccine same date product: Pfizer; dose number: 3; Other vaccine same date product: Moderna; dose number: 4". Therapeutic measures were not taken as a result of urticaria, pain. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: hair falling/ her hair has always been full and now it''s thin; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient. A 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 20:00 as DOSE 3 (BOOSTER), SINGLE (lot number: GJ2524) at the age of 27 years old, administered in the left arm for COVID-19 immunization; influenza vaccine inact sag 3v (FLUCELVAX), on 14Oct2022 as DOSE 1, SINGLE (batch/lot number: unknown), administered in the right arm for immunization. The patient had no relevant medical history and no known allergies. Concomitant medications included: METFORMIN. Vaccination history included: BNT162b2 (first dose, at 04:00 PM, via an unspecified route of administration, administered in the left arm, (lot number: EY0584) as DOSE 1, SINGLE), administration date: 29Jun2021, when the patient was 26 years old, for COVID-19 immunization; BNT162b2 (second dose, at 03:00 PM, via an unspecified route of administration, administered in the left arm, (lot number: EW0180) as DOSE 2, SINGLE), administration date: 20Jul2021, when the patient was 26 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 06Nov2022 at 14:30, outcome "not recovered", described as "hair falling/ her hair has always been full and now it''s thin." The events "hair falling/ her hair has always been full and now it''s thin" required physician office visit. The patient underwent the following laboratory tests and procedures: tests: normal. Therapeutic measures were not taken as a result of alopecia. Additional information: Patient was not diagnosed with COVID prior vaccination and has not tested for COVID post vaccination. Patient has not received any other vaccine in four weeks. The patient noticed her hair falling in 06Nov2021 when she sent her mom a message, because she was worried, and then Dec was worse, and keep falling, a lot. She never had issues with her hair, her hair has always been full and now it''s thin. She went to the doctor at the end of Jan2023 to see what this can be, she made all tests and return normal. The doctor asked her if she had COVID, but she had only the shots. Then she reminded and searched about the dates when she took her last COVID shot, and when started to fall. And now looking at the Twitter she saw a lot of people with the same problem. She asked, "By any change that you know how long this will take or all my hair will fall?" |
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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: |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: plum sized, hot, hard lump on my left arm where I got the shot; plum sized, hot, hard lump on my left arm where I got the shot; It is sore if I touch it or move a certain way.; I am a little worried that this is infected, because it''s starting to itch a little.; off label use; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 17:30 (Lot number: FE3590) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), administered in arm right, administration date 18Nov2021 (Batch/Lot number: unknown) as 0.5ml for immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "edema in ankles" (unspecified if ongoing); "Known allergy: Latex bandaids itch" (unspecified if ongoing), notes: Latex bandaids itch; "Known allergy: Fake gold and silver" (unspecified if ongoing), notes: Fake gold and silver. Concomitant medication(s) included: ESTRADIOL; PROGESTERONE; IRON; PRILOSEC [OMEPRAZOLE]; MELATONIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Right), administration date: 10Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Right), administration date: 13Mar2021, for COVID-19 immunization. The following information was reported: VACCINATION SITE WARMTH (non-serious), VACCINATION SITE MASS (non-serious) all with onset 22Nov2021, outcome "not recovered" and all described as "plum sized, hot, hard lump on my left arm where I got the shot"; PAIN IN EXTREMITY (non-serious) with onset 18Nov2021, outcome "not recovered", described as "It is sore if I touch it or move a certain way."; PRURITUS (non-serious) with onset 18Nov2021, outcome "not recovered", described as "I am a little worried that this is infected, because it''s starting to itch a little."; OFF LABEL USE (non-serious) with onset 18Nov2021, outcome "unknown", described as "off label use"; PRODUCT USE ISSUE (non-serious) with onset 18Nov2021, outcome "unknown", described as "Product use for unapproved combination". Therapeutic measures were not taken as a result of vaccination site warmth, vaccination site mass, pain in extremity, pruritus. Additional information: With the two previous shots, she did not have these symptoms and was a little worried that this was infected. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccine facility type was Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: Diagnosed as erythema multiforme; Developed an all over body rash 9 days after vaccine; Other vaccine same date product: Flucelvax Quadrivalent Serqirus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 12-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 20:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 12 years, in right arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), on 10Oct2022 as dose 1, single (Batch/Lot number: unknown), in right deltoid for immunisation. The patient''s relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Patient did not have any known allergies. Concomitant medication(s) included: AMOXICILLIN. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Arm Right), administration date: 18Jun2021, when the patient was 11-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0187, Location of injection: Arm Right), administration date: 28May2021, when the patient was 11-year-old, for COVID-19 immunization Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 10Oct2022, outcome "unknown", described as "Other vaccine same date product: Flucelvax Quadrivalent Serqirus"; RASH (medically significant) with onset 19Oct2022 at 06:00, outcome "not recovered", described as "Developed an all over body rash 9 days after vaccine"; ERYTHEMA MULTIFORME (medically significant) with onset 19Oct2022 at 06:00, outcome "not recovered", described as "Diagnosed as erythema multiforme". The events "diagnosed as erythema multiforme" and "developed an all over body rash 9 days after vaccine" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Oct2022) Negative, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of erythema multiforme, rash with Medrol dose pack- d/c after day 1 and Benadryl. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: Broke out in hives from head to toe; Difficulty breathing at night; Got both COVID 19 updated booster and Flucelvax shot the same day; Got both COVID 19 updated booster and Flucelvax shot the same day; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 11:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 61 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 14Sep2022 as dose 1, single (Lot number: 942404) intramuscular for immunisation. The patient''s relevant medical history included: "Known allergy: Latex" (unspecified if ongoing); "Known allergy: Preservatives" (unspecified if ongoing), notes: Known allergy: Preservatives. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Manufacturer unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 14Sep2022 at 11:00, outcome "unknown" and all described as "Got both COVID 19 updated booster and Flucelvax shot the same day"; URTICARIA (non-serious) with onset 15Sep2022 at 20:00, outcome "recovered" (Sep2022), described as "Broke out in hives from head to toe"; DYSPNOEA (non-serious) with onset 15Sep2022 at 20:00, outcome "recovered" (Sep2022), described as "Difficulty breathing at night". It was unknown if therapeutic measures were taken as a result of urticaria, dyspnoea. Additional information: Patient got both COVID 19 updated booster and Flucelvax shot the same day at the pharmacy, on Wednesday 14Sep2022. She said she broke out in hives from head to toe and had difficulty breathing at night on 15Sep2022. Events were reported as non-serious. No follow-up attempts are possible. No further information is expected. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: Arm twitches/she was experiencing some muscle twisting in the arm she got Flucelvax vaccine; This spontaneous case was received on 27-Oct-2021 from pharmacist (reference number: SEQW21-04647) and concerned a 49-year-old, female patient.The patient''s medical history and concomitant medications were not reported.On 08-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid, arm) for influenza prophylaxis. The batch number reported was 308477 and expiry date: 30-Jun-2022.On the same date, the patient was vaccinated with non-company co-suspect COVID-19 vaccine (brand not specified; anatomical location: arm, dose, route of administration and indication: not reported). The batch number was not reported. The patient got vaccines in separate arms.On the same day, after receiving Flucelvax Quadrivalent and non-company co-suspect Covid-19 vaccine, the patient''s arm twitched and she was experiencing some muscle twisting in the arm she got Flucelvax vaccine. The patient did not receive any treatment measures.The outcome of the event was unknown.The reporter did not provide a causality assessment. The case was assessed as non-serious.Company comment: On the same day, after receiving Flucelvax Quadrivalent and non-company co-suspect Covid-19 vaccine, the patient''s arm twitched. As reported the patient experienced some muscle twisting in the arm where she got Flucelvax vaccine. Considering suggestive time relationship and biological plausibility, causal role of the suspect vaccine is assessed as possibly related. Sender''s Comments: On the same day, after receiving Flucelvax Quadrivalent and non-company co-suspect Covid-19 vaccine, the patient''s arm twitched. As reported the patient experienced some muscle twisting in the arm where she got Flucelvax vaccine. Considering suggestive time relationship and biological plausibility, causal role of the suspect vaccine is assessed as possibly related. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: Pain in the chest, on the left side. For a few seconds, a few sensations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 39-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 14:45 as dose 1, single (Lot number: HO9835) at the age of 39 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient''s relevant medical history included: "Subclinical hypothyroidism" (unspecified if ongoing), notes: Over the last few years. I do not take any medications associated with it. Concomitant medication(s) included: B12 [CYANOCOBALAMIN]; D3. The following information was reported: CHEST PAIN (non-serious) with onset 29Sep2023 at 21:30, outcome "recovered" (Sep2023), described as "Pain in the chest, on the left side. For a few seconds, a few sensations". Therapeutic measures were not taken as a result of chest pain. Additional information: Patient reported pain in the chest on the left side for a few seconds and a few sensations. It was unusual and unexpected. He had to stop other activities, sat on the sofa and waited till it went away and then he went to sleep. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. He had no known allergies. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: Severe cramp-like burning sensation radiating down forearm to wrist, veins felt bulging and twisted; Severe cramp-like burning sensation radiating down forearm to wrist, veins felt bulging and twisted; Paresthesia along upper back, starting at Right deltoid, radiated to left posterior shoulder blade and around to anterior pectoral area, extending to unilateral upper and lower extremities, right side; Rash; Redness; Swelling at injection site; Right upper extremity muscle soreness; Weakness; Neck soreness; Nausea; Cold sweats; Light headedness; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Oct2021 18:00 (Lot number: Ws1486) at the age of 26 years as dose 1, single for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), administered in deltoid left, administration date 27Oct2021 (Lot number: 308520) as dose 1, single. Relevant medical history included: "Hashimotos thyroidosis" (unspecified if ongoing), notes: Hashimotos thyroidosis/ Elevated ATG and TPO/ thyroiditis/autoimmune thyroiditis; "Elevated ATG" (unspecified if ongoing), notes: other medical history: Elevated ATG; "TPO" (unspecified if ongoing), notes: other medical history: Elevated ATG and TPO; "Thyroiditis" (unspecified if ongoing), notes: other medical history: thyroiditis; "Autoimmune thyroiditis" (unspecified if ongoing), notes: other medical history: autoimmune thyroiditis. There were no concomitant medications. Past drug history included: Known allergies: bactrim, reaction(s): "Allergy", notes: known allergies Bactrim. The following information was reported: MUSCLE SPASMS (non-serious), BURNING SENSATION (non-serious) all with onset 27Oct2021 18:15, outcome "recovering" and all described as "Severe cramp-like burning sensation radiating down forearm to wrist, veins felt bulging and twisted"; PARAESTHESIA (non-serious) with onset 27Oct2021 18:15, outcome "recovering", described as "Paresthesia along upper back, starting at Right deltoid, radiated to left posterior shoulder blade and around to anterior pectoral area, extending to unilateral upper and lower extremities, right side"; RASH (non-serious) with onset 27Oct2021 18:15, outcome "recovering", described as "Rash"; ERYTHEMA (non-serious) with onset 27Oct2021 18:15, outcome "recovering", described as "Redness"; VACCINATION SITE SWELLING (non-serious) with onset 27Oct2021 18:15, outcome "recovering", described as "Swelling at injection site"; MYALGIA (non-serious) with onset 27Oct2021 18:15, outcome "recovering", described as "Right upper extremity muscle soreness"; ASTHENIA (non-serious) with onset 27Oct2021 18:15, outcome "recovering", described as "Weakness"; NECK PAIN (non-serious) with onset 27Oct2021 18:15, outcome "recovering", described as "Neck soreness"; NAUSEA (non-serious) with onset 27Oct2021 18:15, outcome "recovering", described as "Nausea"; COLD SWEAT (non-serious) with onset 27Oct2021 18:15, outcome "recovering", described as "Cold sweats"; DIZZINESS (non-serious) with onset 27Oct2021 18:15, outcome "recovering", described as "Light headedness"; DYSPNOEA (non-serious) with onset 27Oct2021 18:15, outcome "recovering", described as "Shortness of breath". Therapeutic measures were not taken as a result of muscle spasms, burning sensation, paraesthesia, rash, erythema, vaccination site swelling, myalgia, asthenia, neck pain, nausea, cold sweat, dizziness, dyspnoea. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was reported as not applicable. Prior to vaccination, it was unknown whether patient diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: This spontaneous case from was retrieved on 02-May-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2238063-1), reported by other non-healthcare professional (consumer) and concerned a 47-year-old, male patient. The patient had no relevant medical history and was not taking any concomitant medications. On 23-Nov-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as one, route of administration: injection (SYR), anatomical location: right arm and indication:not reported). The batch number reported was 308433. On the same day, the patient was vaccinated with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; dose: reported as three, route of administration: injection (SYR), anatomical location: left arm and indication: not reported). The batch number reported was FJ1620. On an unspecified date, reported as around December, an unknown amount of time after receiving Flucelvax Quadrivalent and Pfizer BioNTech COVID-19 vaccine, the patient noticed tinnitus in both ears got louder, with ringing louder than it used to be. On 11-Jan-2022, the patient went to audiologist, where the acoustic stimulation tests were performed and resulted in no identified issues, results of hearing test were normal. At the time of initial reporting, the patient had not recovered from the event ''tinnitus''. The reporter did not provide a causality assessment. The reporter was not sure that it was a result of the vaccine, but after reading an article on this possibility, thought to report this. The case was assessed as non-serious. Company comment: A 47-year-old male patient developed tinnitus after receiving Flucelvax Quadrivalent and non-company co-suspect Pfizer BioNTech COVID-19 vaccines. The acoustic stimulation tests and hearing test were normal. Elapsed time between vaccinations and the onset of the event is unknown. Due to lack of information, causality is unassessable. Sender''s Comments: A 47-year-old male patient developed tinnitus after receiving Flucelvax Quadrivalent and non-company co-suspect Pfizer BioNTech COVID-19 vaccines. The acoustic stimulation tests and hearing test were normal. Elapsed time between vaccinations and the onset of the event is unknown. Due to lack of information, causality is unassessable. |
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Administered by: Other Purchased by: ? Life Threatening? No Write-up: Swollen lymph nodes; Painful lymph nodes; Body aches; Weak; Arm soreness; Tired; The patient received Fucelvax that was exposed to a temperature excursion; Flucelvax was stored at 57 degrees Fahrenheit for approximately 48 hours; This spontaneous case was received on 12-Jan-2023 from Other Health Professional via Communications (reference number: SEQW23-00214), and from Seqirus on 16-Jan-2023 (being processed together), and concerned a 61-year-old male patient. The patient''s medical history and concomitant medications were not reported. On an unspecified day, in Dec-2022, between 02-Dec-2022 and 05-Dec-2022, Flucelvax Quadrivalent (influenza vaccine inact sag 4v, subunit) had a temperature excursion lasting approximately 48 hours with a maximum temperature of 57 degrees Fahrenheit (explicitly coded as ''Product storage error temperature too high''). The batch number reported was 353556 and expiry date: 30-Jun-2023. On 05-Dec-2022, after temperature excursion, the patient was vaccinated with Flucelvax Quadrivalent (dose: not reported, route of administration: intramuscular, anatomical location: left deltoid, and indication: not reported) (explicitly coded as ''Product administration error''). On the same date, the patient was vaccinated with non-company, co-suspect Prevnar 20 (pneumococcal vaccine conj 20v (crm197); dose: not reported, route of administration: intramuscular, anatomical location: right deltoid, and indication: not reported). The batch number reported was GD8455. On an unspecified date, the patient was vaccinated non-company, co-suspect Covid-19 vaccine (brand not specified; anatomical location: left arm, dose, route of administration, and indication: not reported). The batch number was not reported. On an unknown date, an unspecified amount of time after receiving Flucelvax, Previnar 20 and Covid-19 vaccine, the patient experienced swollen and painful lymph nodes, weakness, tiredness, body aches and arm soreness. The outcome of ''swollen lymph nodes'', ''lymph node pain'', ''ache'', ''weakness'', ''tiredness'', and ''pain in arm'' was not reported. The reporter did not provide a causality assessment. Company comment: A 61-year-old male patient was vaccinated with Flucelvax Quadrivalent, after it suffered a temperature excursion, and non-company, co-suspect Prevnar 20, on the same day (explicitly coded as ''Product administration error'' and ''Product storage error temperature too high''). Reportedly, the temperature excursion reached a maximum temperature of 57 degrees Fahrenheit. In addition, on an unknown day, patient was vaccinated with non-company, co-suspect Covid-19 vaccine. An unknown amount of time following vaccination and on an unknown day, patient reported fatigue, pain in extremity, asthenia, pain, lymph node pain, and lymphadenopathy. Considering limited information provided, lack of information regarding the events onset date, and unclear temporal relationship, causality of the suspect vaccine is unassessable. Product administration error and product storage error temperature too high are assessed as not related per company''s conventions.; Sender''s Comments: A 61-year-old male patient was vaccinated with Flucelvax Quadrivalent, after it suffered a temperature excursion, and non-company, co-suspect Prevnar 20, on the same day (explicitly coded as ''Product administration error'' and ''Product storage error temperature too high''). Reportedly, the temperature excursion reached a maximum temperature of 57 degrees Fahrenheit. In addition, on an unknown day, patient was vaccinated with non-company, co-suspect Covid-19 vaccine. An unknown amount of time following vaccination and on an unknown day, patient reported fatigue, pain in extremity, asthenia, pain, lymph node pain, and lymphadenopathy. Considering limited information provided, lack of information regarding the events onset date, and unclear temporal relationship, causality of the suspect vaccine is unassessable. Product administration error and product storage error temperature too high are assessed as not related per company''s conventions. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: Both flu and covid vaccine in left arm/ administration date = 19Dec2022; Both flu and covid vaccine in left arm/ administration date = 19Dec2022; Body aches; weak; tired; arm soreness; swollen lymph nodes; Painful lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2022 at 16:45 as dose 1, single (Lot number: FR2587) at the age of 61 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 19Dec2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 19Dec2022, outcome "recovering", described as "Body aches"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 19Dec2022, outcome "unknown" and all described as "Both flu and covid vaccine in left arm/ administration date = 19Dec2022"; LYMPH NODE PAIN (non-serious) with onset 19Dec2022, outcome "recovering", described as "Painful lymph nodes"; PAIN IN EXTREMITY (non-serious) with onset 19Dec2022, outcome "recovering", described as "arm soreness"; LYMPHADENOPATHY (non-serious) with onset 19Dec2022, outcome "recovering", described as "swollen lymph nodes"; FATIGUE (non-serious) with onset 19Dec2022, outcome "recovering", described as "tired"; ASTHENIA (non-serious) with onset 19Dec2022, outcome "recovering", described as "weak". Therapeutic measures were taken as a result of pain, asthenia, fatigue, pain in extremity, lymphadenopathy, lymph node pain. Additional information: it was reported that no other vaccine in four weeks. Took 1000 mg. Tylenol 16 hours after injection, switched to Alleve 24 hours after injections. Tylenol 1,000 mg 38 hours after injections. It was reported that no treatment received for AE (not updated in tab). No covid prior vaccination and no covid tested post vaccination. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: Last two nights could not sleep; Hives started on ankles and proceeded up body; Hives itching; This spontaneous case was retrieved on 21-Oct-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1759421-1), reported by other health professional and concerned a 61-year-old male patient. The patient''s current medical conditions included diabetes and asthma. The patient''s concomitant medication details included Medformin (Metformin hydrochloride) 1000mg, Simvastatin 20mg, Glipizide 5mg and Aspirin (Acetylsalicylic acid) 59mg, all for unknown indication. On unspecified date, the patient was vaccinated with the first dose of non-company co-suspect Pfizer Covid-19 vaccine (Tozinameran; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported. On unspecified date, the patient was vaccinated with the second dose of non-company co-suspect Pfizer Covid-19 vaccine (Tozinameran; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported. On 24-Sep-2021, the patient was vaccinated with Flucelvax Quadrivalent vaccine (influenza vaccine, seasonal; dose: not reported, route of administration: intramuscular, anatomical location: arm and indication: not reported). The batch number was not reported. On the same date, the patient was vaccinated with the third dose of non-company co-suspect Pfizer Covid-19 vaccine (Tozinameran; dose: not reported, route of administration: intramuscular, anatomical location: arm and indication: not reported). The batch number: FC3180. On 30-Sep-2021, six days after receiving Flucelvax Quadrivalent vaccine, the patient developed hives on ankles which proceeded up to body and sleep disorder due to itching hives. It was reported that the hives due to bugs were ruled out as the patient''s partner who sleeps in the same bed did not have hives. At the time of this report, outcomes of the events of sleep disorder, urticaria and pruritus were not resolved. Causality assessment was not provided. This case was assessed as non serious case. Company comment: A 61-year-old male patient was vaccinated with Flucelvax Quadrivalent, first dose of non-company co-suspect Pfizer Covid-19 vaccine, second dose of non-company co-suspect Pfizer Covid-19 vaccine and third dose of non-company co-suspect Pfizer Covid-19 vaccine. Six days following vaccination with Flucelvax Quadrivalent, the patient experienced urticaria, pruritus and sleep disorder. Causality is confounded by concurrent administration of co-suspect vaccine. The event of sleep disorder was due to urticaria and pruritus as reported, therefore not related to the vaccine. Causal role of the suspect vaccine is assessed as possibly related for other events, due to biological and chronological plausibility.; Sender''s Comments: A 61-year-old male patient was vaccinated with Flucelvax Quadrivalent, first dose of non-company co-suspect Pfizer Covid-19 vaccine, second dose of non-company co-suspect Pfizer Covid-19 vaccine and third dose of non-company co-suspect Pfizer Covid-19 vaccine. Six days following vaccination with Flucelvax Quadrivalent, the patient experienced urticaria, pruritus and sleep disorder. Causality is confounded by concurrent administration of co-suspect vaccine. The event of sleep disorder was due to urticaria and pruritus as reported, therefore not related to the vaccine. Causal role of the suspect vaccine is assessed as possibly related for other events, due to biological and chronological plausibility. |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: chills; headache; body aches; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient. A 61-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Oct2023 at 10:30 as dose 1, single (Lot number: HG4664) at the age of 61 years, in right arm for covid-19 immunisation; for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 21Oct2023 as dose 1 (Lot number: 375291), in left arm. The patient''s relevant medical history included: "MCTD" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; PREDNISONE; PANTOPRAZOLE; CETIRIZIN. Past drug history included: Bactrim, reaction(s): "Drug allergy: Bactrim". Vaccination history included: Covid-19 vaccine (DOSE 1, manufacturer unknown), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 2, manufacturer unknown), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 3 (BOOSTER), manufacturer unknown), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 4 (BOOSTER), manufacturer unknown), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 5 (BOOSTER), manufacturer unknown), for COVID-19 IMMUNIZATION. The following information was reported: PAIN (non-serious) with onset 22Oct2023 at 06:30, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 22Oct2023 at 06:30, outcome "recovering"; HEADACHE (non-serious) with onset 22Oct2023 at 06:30, outcome "recovering". Therapeutic measures were not taken as a result of chills, headache, pain. No follow-up attempts are possible. No further information is expected. |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Muscle twitching at injection site for Covid vaccine (left arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 20Oct2023 as dose 1, single (Lot number: 70461032303), in right arm for influenza immunisation. The patient''s relevant medical history included: "covid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION SITE REACTION (non-serious) with onset 21Oct2023 at 10:30, outcome "not recovered", described as "Muscle twitching at injection site for Covid vaccine (left arm)". Therapeutic measures were not taken as a result of vaccination site reaction. Additional information: The patient had no known allergies. Patient did not tested COVID post 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: Unknown Purchased by: ? Life Threatening? No Write-up: Fever; Nausea; Was given 0.5 ml when it needed to be 0.25 ml; This spontaneous case was reported by a medical assistant and describes the occurrence of OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml), PYREXIA (Fever) and NAUSEA (Nausea) in a 6-month-old female patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. AU5558B) for COVID-19 prophylaxis. Co-suspect products included non-company products INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) for an unknown indication, VAXELIS for an unknown indication, PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) for an unknown indication and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for an unknown indication. No Medical History information was reported. On 26-Oct-2023, the patient received first dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) .5 milliliter and third dose of PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) (Intramuscular use) 1 dosage form. On 26-Dec-2023, the patient received first dose of INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) (Intramuscular use) 1 dosage form, third dose of VAXELIS (Intramuscular use) 1 dosage form and third dose of ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (Oral use) 1 dosage form. On 26-Oct-2023, the patient experienced OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml). In December 2023, the patient experienced PYREXIA (Fever) and NAUSEA (Nausea). At the time of the report, OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) had resolved and PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) was unknown. For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use), the reporter considered OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) to be not related. No further causality assessments were provided for PYREXIA (Fever) and NAUSEA (Nausea). This case is reported for patient 25 out of 29 patients. After vaccination had fever for 2 days. Patient did not have any chronic or long-standing health condition. Patient did not experience any side effects. No treatment and concomitant medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2023-747540 (E2B Linked Report).; Sender''s Comments: US-MODERNATX, INC.-MOD-2023-747540:Patient 1 (Master case) |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: Cough; Fever; Achy shot site; Was given 0.5 ml when it needed to be 0.25 ml; 7 month old administered with Spikevax 2023- 2024 formula instead of Moderna Covid-19 vaccine 2023-2024 formula; This spontaneous case was reported by a medical assistant and describes the occurrence of COUGH (Cough), PYREXIA (Fever), VACCINATION SITE PAIN (Achy shot site), ACCIDENTAL OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) and WRONG PRODUCT ADMINISTERED (7 month old administered with Spikevax 2023- 2024 formula instead of Moderna Covid-19 vaccine 2023-2024 formula) in a 7-month-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU5558B) for COVID-19 prophylaxis. Co-suspect product included non-company product INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) for an unknown indication. No Medical History information was reported. On 26-Oct-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter and second dose of INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) (Intramuscular use) 1 dosage form. On 26-Oct-2023, the patient experienced ACCIDENTAL OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) and WRONG PRODUCT ADMINISTERED (7 month old administered with Spikevax 2023- 2024 formula instead of Moderna Covid-19 vaccine 2023-2024 formula). On an unknown date, the patient experienced COUGH (Cough), PYREXIA (Fever) and VACCINATION SITE PAIN (Achy shot site). At the time of the report, COUGH (Cough), PYREXIA (Fever), VACCINATION SITE PAIN (Achy shot site) and WRONG PRODUCT ADMINISTERED (7 month old administered with Spikevax 2023- 2024 formula instead of Moderna Covid-19 vaccine 2023-2024 formula) outcome was unknown and ACCIDENTAL OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) had resolved. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter considered ACCIDENTAL OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) to be not related. No further causality assessments were provided for COUGH (Cough), PYREXIA (Fever), VACCINATION SITE PAIN (Achy shot site) and WRONG PRODUCT ADMINISTERED (7 month old administered with Spikevax 2023- 2024 formula instead of Moderna Covid-19 vaccine 2023-2024 formula). Patient had no known allergies. Patient had not been diagnosed/tested positive for COVID-19. Patient had no acute or chronic long-standing health conditions at the time of vaccination. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case contains information for 26th patient out of 29 patients described by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2023-747540 (E2B Linked Report).; Sender''s Comments: US-MODERNATX, INC.-MOD-2023-747540:Patient 1 (Master case) |
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Administered by: Unknown Purchased by: ? Life Threatening? No Write-up: achy shot site; Was given 0.5 ml when they should had 0.25 ml/The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial; This spontaneous case was reported by a medical assistant and describes the occurrence of VACCINATION SITE PAIN (achy shot site) and ACCIDENTAL OVERDOSE (Was given 0.5 ml when they should had 0.25 ml/The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial) in a 24-month-old female patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. AU5558B) for COVID-19 prophylaxis. Co-suspect product included non-company product INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) for an unknown indication. The patient''s past medical history included COVID-19 on 12-Jan-2022. Concurrent medical conditions included Allergy to animal (Cat). On 27-Oct-2023, the patient received first dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) .5 milliliter and first dose of INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) (Intramuscular use) 1 dosage form. On 27-Oct-2023, the patient experienced ACCIDENTAL OVERDOSE (Was given 0.5 ml when they should had 0.25 ml/The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial). On an unknown date, the patient experienced VACCINATION SITE PAIN (achy shot site). At the time of the report, VACCINATION SITE PAIN (achy shot site) and ACCIDENTAL OVERDOSE (Was given 0.5 ml when they should had 0.25 ml/The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial) outcome was unknown. For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use), the reporter considered ACCIDENTAL OVERDOSE (Was given 0.5 ml when they should had 0.25 ml/The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial) to be not related. No further causality assessment was provided for VACCINATION SITE PAIN (achy shot site). This case belongs to patient No. 29 out of 29. Patient had no acute or chronic long-standing health conditions at the time of vaccination. No relevant concomitant medications were reported. No treatment medication reported. This case was linked to US-MODERNATX, INC.-MOD-2023-747540 (E2B Linked Report).; Sender''s Comments: US-MODERNATX, INC.-MOD-2023-747540:Patient 1 (Master case) |
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Administered by: Pharmacy Purchased by: ? Life Threatening? No Write-up: sore arm at injection site. I also got Flucelvax in the same left arm at the same time.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 08Oct2023 at 10:30 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for immunisation. The patient''s relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 02, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 03, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 04, Manufacturer: Unknown), for COVID-19 immunization; Flucelvax (Dose: 01, Manufacturer: Unknown), for immunisation; Flucelvax (Dose: 02, Manufacturer: Unknown), for immunisation; Flucelvax (Dose: 03, Manufacturer: Unknown), for immunisation; Flucelvax (Dose: 04, Manufacturer: Unknown), for immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Oct2023, outcome "recovering", described as "sore arm at injection site. I also got Flucelvax in the same left arm at the same time.". Therapeutic measures were not taken as a result of vaccination site pain. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received. |
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