Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
severe chest pain; stomach cramps; shortness of breath; headache; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP, Program ID. A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 11Sep2024, outcome "unknown"; CHEST PAIN (non-serious) with onset 11Sep2024, outcome "unknown", described as "severe chest pain"; DYSPNOEA (non-serious) with onset 11Sep2024, outcome "unknown", described as "shortness of breath"; ABDOMINAL PAIN UPPER (non-serious) with onset 11Sep2024, outcome "unknown", described as "stomach cramps". The events "severe chest pain", "stomach cramps", "shortness of breath" and "headache" required physician office visit. Therapeutic measures were taken as a result of chest pain, abdominal pain upper, dyspnoea, headache. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.