Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
vasculitis; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A patient (age and gender not provided) 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 and concomitant medications were not reported. The following information was reported: VASCULITIS (non-serious), outcome "unknown". Additional information:Submitted by Call Centre 1 Ref: System Reference: Selected Report Type: Initial Is the patient also the reporter?: No Reporter consent to contact given: Yes Reporter type: Consumer or other non health professional HCP postal address: Is COVID-19 Vaccine a Pfizer product? Yes COVID-19 Vaccine manufacturer:unspecified NDC number of COVID-19 Vaccine:Unknown UPC number of COVID-19 Vaccine:Unknown Reason for no lot number: of COVID-19 Vaccine: Caller unwilling to complete the report Expiry Date of COVID-19 Vaccine: Unknown Additional Context: Reporter stated, "I was given this extension from a different part of Pfizer. I was calling today to try to see, I read a few article saying that Vasculitis was severe but rare side-effect of the COVID Vaccine (clarified as Pfizer COVID-19 Vaccine) and I was just trying to see if there was documentation anywhere of that being a side effect but you guys are able to provide me for a workers comp claim that I have." When paraphrased the concern, reporter stated, "That is correct." Reporter was informed about the role of Pfizer Drug Safety and informed about Pfizer Medical Information. Reporter stated, "I think that's who I just got off the phone with that provided to you but if you want to transfer me over, I will try again." In response to further probing, reporter stated, "No, I am just trying to get this done firs please." Further probing could not be done as the reporter was unwilling to complete the report. Thus,product details (LOT#, NDC#, UPC# and expiration date) and purchase details were unknown. Hence, limited information was available over the call. Call was transferred to Pfizer Medical Information. However, reporter hung up the call before conferencing. QR Comment:AE Filed Conservatively. -This might be a split case however number of patients could not be clarified over the call hence split not made. -Permission to contact reporter is unknown as question could not be probed. However, Consent to Contact field in report populated as YES due to being a mandatory field. -Reporter type could not be probed hence captured as Consumer or other non-health professional in tab by default. Country of incidence could not be clarified hence b default captured. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.