Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | RA |
Headache; chills; lethargy; This is a spontaneous report received from a Consumer or other non HCP. A 53-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 17Sep2025 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 17Sep2025 as dose 1, single, in right arm. The patient's relevant medical history included: "Blood cholesterol increased" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 18Sep2025 at 08:00, outcome "recovering"; CHILLS (non-serious) with onset 18Sep2025 at 08:00, outcome "recovering"; LETHARGY (non-serious) with onset 18Sep2025 at 08:00, outcome "recovering". Therapeutic measures were not taken as a result of headache. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s) for which they were reporting. The patient was not taking any other medications within 2 weeks of the event starting. Co-suspect drug reported as "Proprietary medicinal product name: Flu". Patient had no past drug allergy. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: High cholesterol