Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
Injection Site Pain; fatigue; This is a spontaneous report received from a Consumer or other non HCP. A 59-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 12Sep2025 at 07:00 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Sep2025 at 02:00, outcome "recovering", described as "Injection Site Pain"; FATIGUE (non-serious) with onset 13Sep2025 at 02:00, outcome "recovering". Therapeutic measures were taken as a result of vaccination site pain, fatigue. Additional information: treatment received was Advil. The patient did receive any other vaccines on the same date nor within 4 weeks PRIOR COMIRNATY (2025-2026 FORMULA). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None