Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | LM2210 | OT / LA |
had a slight headache every time; tinnitus/it gets worse every time I get a covid vaccine; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 16Oct2024 as dose 1, 0.3 ml, single (Lot number: LM2210) at the age of 72 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, 0.3 mL, SINGLE, Lot number: FG3527, Intramuscular in the right arm), administration date: 08Nov2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "Headache", "Tinnitus"; BNT162b2 (DOSE 2, 0.3 mL, SINGLE, Lot number: GJ3277, Intramuscular in the right arm), administration date: 12Oct2022, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "Headache", "tinnitus/it gets worse every time I get a covid vaccine"; BNT162b2 (DOSE 3 (BOOSTER), 0.3 mL, SINGLE, Lot number: HG2282, Intramuscular in the left arm), administration date: 09Oct2023, when the patient was 71-year-old, for COVID-19 Immunization, reaction(s): "Headache", "tinnitus/it gets worse every time I get a covid vaccine"; BNT162b2 (DOSE 4 (BOOSTER), 0.3 mL, SINGLE, Lot number: HN0477, Intramuscular in the right arm), administration date: 24Apr2024, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "Headache", "tinnitus/it gets worse every time I get a covid vaccine". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "had a slight headache every time"; TINNITUS (non-serious), outcome "unknown", described as "tinnitus/it gets worse every time I get a covid vaccine". Additional information: The patient experienced headache which has been her reaction to previous COVID-19 vaccines. She has a slight headache every time. Also, she experienced tinnitus and it got worse every time she gets a COVID vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500192477 same patient/suspect vaccine; different dose; similar events;