Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | 00069-2528-10 | LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 58160-0912-52 | LA |
Heart racing; hard to sleep; headache; body aches; This is a spontaneous report received from a Consumer or other non HCP. A 48-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 18Oct2025 at 15:30 as dose 1, single (Lot number: 00069-2528-10) at the age of 48 years, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 18Oct2025 as dose number unknown, single (Lot number: 58160-0912-52), in left arm for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: HEPATITIS B VACCINE taken for immunisation, on 30Sep2025 as dose number unknown, single. The following information was reported: PALPITATIONS (non-serious) with onset 18Oct2025 at 22:00, outcome "recovering", described as "Heart racing"; PAIN (non-serious) with onset 18Oct2025 at 22:00, outcome "recovering", described as "body aches"; INSOMNIA (non-serious) with onset 18Oct2025 at 22:00, outcome "recovering", described as "hard to sleep"; HEADACHE (non-serious) with onset 18Oct2025 at 22:00, outcome "recovering". Therapeutic measures were not taken as a result of palpitations, insomnia, headache, pain. Additional information: The patient had no known allergies. The patient was not taking any other medications within 2 weeks of the event starting.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None