Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | RA |
Extreme Golf Ball Sized Redness; Itching; Swelling (not much but hasn't gone down); This is a spontaneous report received from a Consumer or other non HCP. A 57-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 19Oct2025 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in arm for covid-19 immunisation; pneumococcal vaccine conj 21v (CRM197) (CAPVAXIVE), on 19Oct2025 as dose number unknown, 0.5 ml single, in right arm for immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious) with onset 19Oct2025 at 10:30, outcome "recovering", described as "Extreme Golf Ball Sized Redness"; PRURITUS (non-serious) with onset 19Oct2025 at 10:30, outcome "recovering", described as "Itching"; SWELLING (non-serious) with onset 19Oct2025 at 10:30, outcome "recovering", described as "Swelling (not much but hasn't gone down)". Therapeutic measures were not taken as a result of erythema, pruritus, swelling. Additional information: The patient has no known allergy. The patient did not receive any other vaccines within 4 weeks prior to the reported vaccination and was not taking any other medications within 2 weeks of the event onset. The patient was not hospitalized for the events. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Ulcerative colitis