Received Oct 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 5 | GJ6738 | OT |
Extreme fatigue; developed gradually balance problem; tremor; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 5 (booster), single (Lot number: GJ6738) at the age of 76 years intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no other diagnosed illnesses/medical history/chronic health conditions to report. The patient is not allergic to any previous vaccination, medications, food or other products. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Location of injection/shot: arm, lot number: EW0150), administration date: 12Apr2021, when the patient was 75-year-old, for Covid-19 immunization, reaction(s): "Extreme fatigue", "developed gradually balance problem", "Tremor"; BNT162b2 (Dose 2, Location of injection/shot: arm, lot number: ER8735), administration date: 04May2021, when the patient was 75-year-old, for Covid-19 immunization, reaction(s): "Surgery to remove cancerous kidney", "Extreme debilitating fatigue, longterm", "couldn't walk at all", "developed gradually balance problem/can't stand for more than a couple of seconds", "Tremor"; BNT162b2 (Dose 3, Location of injection/shot: arm, lot number: FJ1620), administration date: 29Nov2021, when the patient was 75-year-old, for Covid-19 immunization, reaction(s): "extreme debilitating fatigue, long term", "developed gradually balance problem", "Tremor"; BNT162b2 (Dose 4, Location of injection/shot: arm, lot number: FJ4991), administration date: 13May2022, when the patient was 76-year-old, for Covid-19 immunization, reaction(s): "Extreme fatigue", "increasing balance problems/I can't stand for more than a couple of seconds at a time", "Tremor", "gradually decreased walking to 15 mins, then 10 mins, then 5 ending at her door gasping for breath". The following information was reported: FATIGUE (Medically Significant), outcome "not recovered", described as "Extreme fatigue"; BALANCE DISORDER (non-serious), outcome "unknown", described as "developed gradually balance problem"; TREMOR (non-serious), outcome "unknown". The event "extreme fatigue" required physician office visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500107080 same patient, different dose and event;
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none