Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
headache; chills; fever/night fever; body aches; weak; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789973 (Moderna), AE-00230870 (Moderna), AE-00230887 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Nov2024, outcome "recovered", described as "body aches"; PYREXIA (non-serious) with onset Nov2024, outcome "recovered", described as "fever/night fever"; HEADACHE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown"; ASTHENIA (non-serious), outcome "unknown", described as "weak". Additional information: Day of suspect product administration and onset date of both events (Nov2024). caller informed that had side effects from previous Pfizer OVID-19 vaccine that took last Nov2024. Caller stated that had fever and body aches on the day of vaccination. Batch/lot number is not provided, and it cannot be obtained.