Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
Sore arm at injection site; aches and pains throughout body; This is a spontaneous report received from a Consumer or other non HCP. A 28-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 17Sep2025 at 13:30 as dose 1, single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "hyperthyroidism" (unspecified if ongoing); "Amoxicillin allergy" (unspecified if ongoing); "allergy to lamb (when eaten)" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Sep2025 at 04:00, outcome "recovering", described as "Sore arm at injection site"; PAIN (non-serious) with onset 18Sep2025 at 04:00, outcome "recovering", described as "aches and pains throughout body". Therapeutic measures were not taken as a result of vaccination site pain, pain. Additional information: the patient did not receive any other vaccines on the same date as the vaccine, or any other vaccines within 4 weeks prior to the vaccine. The patient took other medications within 2 weeks of the event starting. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: Anxiety; Asthma; Depression; Hyperthyroidism; Meat allergy; Penicillin allergy