Received Sep 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
migraine level headache; joint and body aches; joint and body aches; extreme nausea; exhaustion; About 24 hours after the injection I went to sleep for almost 16 hours then awake for 1 hour and asleep again until the next morning; This is a spontaneous report received from a Consumer or other non HCP. A 72-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: other health problems. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization, reaction(s): "mild headache". The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "migraine level headache"; ARTHRALGIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "joint and body aches"; NAUSEA (non-serious), outcome "unknown", described as "extreme nausea"; FATIGUE (non-serious), outcome "unknown", described as "exhaustion"; HYPERSOMNIA (non-serious), outcome "unknown", described as "About 24 hours after the injection I went to sleep for almost 16 hours then awake for 1 hour and asleep again until the next morning". Additional information: Just wanted you to know how the new Covid vaccine affected her. In the past 5 years every time all she got after the shot was a mild headache. This one however left her with migraine level headache, joint and body aches, extreme nausea, and exhaustion. About 24 hours after the injection, she went to sleep for almost 16 hours then awake for 1 hour and asleep again until the next morning. She had diabetes and other health problems. Let me know if you have any questions. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Diabetes (other health problems)