Received Sep 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA0587 | LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 73BN2 | LA |
stuffy nose and headache on day 3; body aches and headache on day 2; body aches and headache on day 2; Injection site sore, red, inflamed; Injection site sore, red, inflamed; Injection site sore, red, inflamed; This is a spontaneous report received from a Consumer or other non HCP. A 38-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 05Sep2025 at 18:30 as dose 1, 0.3 ml single (Lot number: NA0587) at the age of 38 years, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 05Sep2025 (Lot number: 73BN2), in left arm for immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "walnuts allergy" (unspecified if ongoing); "nickel allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE INFLAMMATION (non-serious) all with onset 05Sep2025 at 18:45, outcome "unknown" and all described as "Injection site sore, red, inflamed"; PAIN (non-serious), HEADACHE (non-serious) all with onset 06Sep2025, outcome "unknown" and all described as "body aches and headache on day 2"; NASAL CONGESTION (non-serious) with onset 07Sep2025, outcome "unknown", described as "stuffy nose and headache on day 3". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site erythema, vaccination site inflammation, pain, headache, nasal congestion. No follow-up attempts are possible.
Medical History/Concurrent Conditions: Allergy to nuts; Fibromyalgia; Nickel allergy