Received Oct 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
hot flushes; horrible body ache; crying hysterically; bedridden; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 25Sep2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN; reported as: always gotten Moderna, never had a problem), for COVID-19 immunisation, reaction(s): "no adverse event". The following information was reported: BEDRIDDEN (non-serious) with onset 26Sep2025, outcome "unknown"; CRYING (non-serious) with onset 26Sep2025, outcome "unknown", described as "crying hysterically"; PAIN (non-serious) with onset 26Sep2025, outcome "unknown", described as "horrible body ache"; HOT FLUSH (non-serious) with onset 26Sep2025, outcome "unknown", described as "hot flushes". Additional information: The patient reported that she woke up the next day after vaccination, crying hysterically and bedridden for 5 days. She also had hot flushes and horrible body ache. It was the worst she's ever felt in her life (as reported). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.