Received Dec 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
gout episode; gout epidode; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 65-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GOUT (non-serious), CONDITION AGGRAVATED (non-serious), outcome "recovered" and all described as "gout episode". Additional information: After receiving the Covid 19 vaccine, the patient reported that her left big toe and inner foot became red and sensitive to touch; she had a history of gout for three decades but had not experienced an episode in twenty years, and she had consumed a small portion of crab cake high in purine prior to symptom onset. The gout episode lasted over two weeks, and the patient questioned whether the vaccine might have impacted individuals with autoimmune diseases more dramatically, while also acknowledging the possible role of the crab cakes. When clarified regarding the concern, the patient stated that immediately after receiving the shot at [name withheld] Pharmacy, a gout reaction occurred, noting prior vaccinations at [name withheld] Pharmacy without issue. The patient confirmed that the gout reaction to the Covid 19 shot had been previously reported to Pfizer via an online form and that a response had been received requesting additional details, though a callback had not been expected. The patient expressed a general concern regarding worldwide reports of Covid 19 related deaths under investigation and stated that the gout reaction, which had not occurred in twenty years, prompted reporting. The patient declined to provide further information, reiterated that the shot was received at [name withheld] Pharmacy and that gout symptoms began the following morning with toe enlargement and redness on the inside of the foot, and stated that the episode had resolved and occurred in November. The patient denied having a question regarding causality, stated that the intent was only to report the experience, and requested to close the call. Further probing could not be performed as the patient was unwilling to proceed with the report; therefore, product details, purchase details, and other information were unknown, resulting in limited information available from the call. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: Gout