Received Oct 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | LA |
aches; 100.0 temperature; headache; fatigue; swelling at injection site; severe pain at injection site; itching at injection site; This is a spontaneous report received from a Consumer or other non HCP. A 40-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 23Oct2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 23Oct2025 at 18:00, outcome "recovering", described as "100.0 temperature"; PAIN (non-serious) with onset 23Oct2025 at 18:00, outcome "recovering", described as "aches"; FATIGUE (non-serious) with onset 23Oct2025 at 18:00, outcome "recovering"; HEADACHE (non-serious) with onset 23Oct2025 at 18:00, outcome "recovering"; VACCINATION SITE PRURITUS (non-serious) with onset 23Oct2025 at 18:00, outcome "recovering", described as "itching at injection site"; VACCINATION SITE PAIN (non-serious) with onset 23Oct2025 at 18:00, outcome "recovering", described as "severe pain at injection site"; VACCINATION SITE SWELLING (non-serious) with onset 23Oct2025 at 18:00, outcome "recovering", described as "swelling at injection site". The patient underwent the following laboratory tests and procedures: Body temperature: (23Oct2025) 100 Centigrade. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. Additional information : Facility where vaccine was administered: Pharmacy or Drug Store. Did the patient receive any other vaccines on the same date as the vaccine(s) for which you are reporting?: No. Did the patient receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting?: No Were you/Was the patient taking any other medications within 2 weeks of the event starting?: Yes . Reported Event: 100.0 temperature, aches, headache, fatigue, swelling at injection site, severe pain at injection site, itching at injection site.
Test Date: 20251023; Test Name: Body temperature; Result Unstructured Data: Test Result:100 Centigrade