Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
COVID After Pfizer Shots; COVID After Pfizer Shots; This is a spontaneous report received from a Consumer or other non HCP. A 68-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID After Pfizer Shots". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: During an inbound call for financial assistance, the patient stated, "I have the COVID, and my doctor ordered that Paxlovid" Later on, patient stated, "Yeah and they usually give it to me, because I have asthma and then it goes into my lungs and then I get double pneumonia, so they try to get me this medicine right away. But last year when I bought it, the medicine didn't cost that much" After providing to 2 options for completing the enrollment, patient stated, "I don't even feel like looking at a computer right now." When obtaining the date of birth patient stated, "I'm going to be 69 next month." Later on, patient stated, "If I didn't have asthma, I wouldn't worry about it so much. But last time, I wound up getting double pneumonia, and I had to go to the hospital for 4 weeks when it first came out, for COVID" When confirming that she has taken Paxlovid for COVID previously, patient stated, "Yeah, so last year when I got the COVID, I think it was last believe it or not, I think it was last October that I got the COVID and took that medicine then, but it didn't cost this much" While gathering information to create the account patient stated, "I'm sorry I have to blow my nose." Later on, patient stated, "Okay, I took the Pfizer shots too, for the COVID." At the end of the call, patient stated, "Faster I get well, the better It'll be." The call was transferred to a DSU Pharmacist, reference number. However, the reportable safety information provided to the DSU Pharmacist was incomplete. Sending this source document to include: Patient currently has asthma, previously went to the hospital for double pneumonia, and previously caught COVID last October, and also took the Pfizer shots. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Asthma