Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 3 | — | OT / LA |
covid; covid; This is a spontaneous report received from a Consumer or other non HCP. A 68-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 26Sep2025 as dose 3, single (Batch/Lot number: unknown) at the age of 68 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Asthma, Diagnosed about 15 years ago. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 29Sep2025, outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: Covid test: (29Sep2025) Positive, notes: Unit: Not Provided. Clinical course: Warm transfer from (Withheld) calling from (Withheld). Patient stated that he went to take the Covid-19 vaccine on Friday and reported that he had body aches that hit him like a freight train, he could not swallow, and he was feeling whoozy. He went to (Withheld) and was diagnosed with Covid and was prescribed Paxlovid. Caller reported that he never had that issue before and he has had 2 previous doses of the covid-19 vaccine.The caller verified the information provided by the transferring agent. Caller clarified that the previous 2 doses were the Pfizer Covid 19 vaccines as well.Lot/expiry: Does not remember the Pharmacy giving them any paperwork. Caller said that his wife was going to reach out to the pharmacy to get the product details. Description of Product Complaint: Description of complaint: he went to take the Covid-19 vaccine on Friday. He went to (Withheld) and was diagnosed with Covid 29Sep2025. Lot/expiry: Does not remember the Pharmacy giving them any paperwork. Caller said that his wife was going to reach out to the pharmacy to get the product details. The information on the batch/lot number for [BNT162B2 OMICRON (LP.8.1)] has been requested and will be submitted if and when received.
Asthma (Asthma Diagnosed about 15 years ago.)
Test Date: 20250929; Test Name: Covid test; Test Result: Positive ; Comments: Unit: Not Provided