Received Mar 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 3 | — | — |
Covid; Covid; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 01May2024, this case now contains all required information to be considered valid. This is a spontaneous report and received from Consumer or other non HCPs, Program ID. An 89-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Immobile" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: During an inbound call for financial assistance, the caller states, "I have COVID and I am supposed to be on this new medication. I'm in assisted living." When advised that the processing information can be provided to the pharmacy over the phone or in person, the caller responds "Well I'm immobile. " At the end of the call, the caller states" Covid has really thrown me for a loop because this is the second time I've had it, and I've had three shots, all Pfizer and it's just that, I don't know I never have any symptoms all I know is that test procedure's great". Patient was treated with Paxlovid. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Medical History/Concurrent Conditions: COVID-19; Immobile
Test Name: SARS COV-2 test; Result Unstructured Data: Test Result:Positive