Received Oct 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 1 | — | — |
Massive red spot on arm with pain and itching; Massive red spot on arm with pain and itching; Massive red spot on arm with pain and itching; This is a spontaneous report received from a consumer. A 51-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 04Oct2025 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 13), on 04Oct2025 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years, in arm for immunisation; influenza vaccine (INFLUENZA VACCINE), on 04Oct2025 as dose number unknown, single for immunisation. The patient's relevant medical history included: "Allergy to sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH MACULAR (non-serious), PAIN IN EXTREMITY (non-serious), PRURITUS (non-serious) all with onset Oct2025, outcome "not recovered" and all described as "Massive red spot on arm with pain and itching". Therapeutic measures were not taken as a result of rash macular, pain in extremity, pruritus. Additional Information: The facility where vaccine was administered was in a pharmacy or drugstore. It was unknown if the patient was taking any other medications within 2 weeks of the event starting. The patient did not receive any other vaccines within 4 weeks prior to the suspect vaccines. The patient received Comirnaty, Prevnar (reported as Prevnar 23; pending clarification), and Influenza Vaccines. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: Sulfonamide allergy