Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUAD) | SEQIRUS, INC. | 1 | — | OT / LA |
could not stand; LIVE TELEPHONIC VACCINE ASSESSMENT PROGRAM This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID. An 88-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 10Oct2025 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 88 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 10Oct2025 at 13:15 as dose 1, single intramuscular, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSSTASIA (hospitalization) with onset 11Oct2025 at 08:00, outcome "not recovered", described as "could not stand". The event "could not stand" required emergency room visit. Clinical course: Patient stated that the next morning he could not stand after getting both the FLU and COVID vaccine. He recalled being admitted to the ER/hospital for several days. No medications or new diagnosis were reported post hospital stay. The patient felt that his body had not fully recovered from this event. The reporter's assessment of the causal relationship of "could not stand" with the suspect product(s) BNT162b2 omicron (lp.8.1) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported event dysstasia and the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.