Received Mar 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Passed out; Fever; Chills; Feeling unwell; This spontaneous case, initially received on 19-Feb-2026, was reported by a health professional and concerns an elderly male patient. Administration of company suspect drug: On 04-Oct-2023, the patient received Fluad (TIV) for an indication not reported, dose regimen: not reported, route of administration: not reported, anatomical location, Lot number: No batch number available and would be requested upon follow-up. Non-company suspect drugs: On 04-Oct-2023, the patient received Arexvy (RSV vaccine prot. subunit PreF3) for an indication not reported, dose regimen: not reported, route of administration: not reported, anatomical location, Lot number: Not reported. On 04-Oct-2023, the patient received Comirnaty (Tozinameran) for an indication not reported, dose regimen: not reported, route of administration: not reported, anatomical location, Lot number: Not reported. Adverse reactions/events and outcomes: On 05-Oct-2023, 1 day after vaccination, the patient experienced Passed out (Disability, outcome: Not Reported), Fever (Disability, outcome: Not Reported), Chills (Disability, outcome: Not Reported), Feeling unwell (Disability, outcome: Not Reported). Patient received three immunizations at once, had fever and chills and was felt unwell after. The next day patient reported he passed out, but he was not hospitalized immediately. He later went to his regular physician and then a cardiologist who determined patient needed a pacemaker. Patient believed one of the vaccines might have contributed to this. Fluad (TIV) action taken: Not Applicable Reporter assessment: The reporter assessed all of the events as serious (Disability) and causality assessment was not reported.; Reporter's Comments: Due to the spontaneous nature of the case, all events are considered related for the reporting purposes. There is close temporal relationship between the reported events (malaise, chills, pyrexia and loss of consciousness) and suspect product (next day of vaccination). Of note, co-suspect vaccines Comirnaty and arexvy acts as confounder.
Comments: None