Received Jun 30, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | No batch number | IM |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | IM |
Heart attack; Feeling weak; Tired; Overall unwell; Vaccines were administered at the same time in the same arm; This spontaneous case, initially received on 23-Jun-2026, was reported by a health professional and concerns an elderly male patient. Administration of company suspect drug(s): On 18-Oct-2022, the patient received Fluad (TIV) for Indication not reported, Route of administration: Intramuscular, Anatomical location: Arm, Lot Number: No batch number available and will be requested upon follow up. Non-company suspect drugs: On 18-Oct-2022, the patient received , Pfizer BioNTech COVID-19 vaccine (Tozinameran) for Indication not reported., Route of administration: Intramuscular, Anatomical location: Arm, Lot Number: No batch number available and will be requested upon follow up. Adverse reactions/events and outcomes: On 18-Oct-2022, the patient experienced Vaccines were administered at the same time in the same arm (outcome: Not Reported). On 01-Nov-2022, the patient experienced Heart attack (Hospitalized, Life-threatening, outcome: Not Reported). On an unknown date in Nov-2022, the patient experienced Feeling weak (Hospitalized, Life-threatening, outcome: Not Reported), Tired (Hospitalized, Life-threatening, outcome: Not Reported), Overall unwell (Hospitalized, Life-threatening, outcome: Not Reported). Vaccines were administered at the same time in the same arm. Two weeks later the patient had a heart attack. A couple days leading up to the heart attack the patient reported feeling weak, tired, and overall unwell. The patient was taken to the emergency department mid-morning and stayed overnight while waiting for a room to open up.The patient stayed at for a week. The patient had to undergo an MRI. Fluad (TIV) action taken: Not Applicable Lab data : MRI Reporter's assessment: The primary reporter assessed events Heart attack , Overall unwell, Feeling weak and Tired as serious (Hospitalized, Life-threatening) and for event Vaccines were administered at the same time in the same arm did not provide seriousness and for all events did not provide causality assessment.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, events are considered related for reporting purposes. Considering plausible temporal relationship for heart attack (2 weeks after vaccination). Events feeling weak, tired, unwell probably attributed to heart attack (occurred couple of days after heart attack). Of note, concomitant administration of COVID-19 vaccine and both vaccines administered in same arm might be considered as confounders.
Medical History/Concurrent Conditions: MRI