Received Sep 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
Got Vaccines in the past the Pfizer Vaccines (Pfizer COVID-19 Vaccine); Prescribed the medication (Paxlovid) today; I have taken Paxlovid once before; Got Vaccines in the past the Pfizer Vaccines (Pfizer COVID-19 Vaccine); Prescribed the medication (Paxlovid) today; I have taken Paxlovid once before; sick; This is a spontaneous report received from a Consumer or other non HCP. A 77-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 treatment. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid, notes: I have taken Paxlovid once before. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Got Vaccines in the past the Pfizer Vaccines (Pfizer COVID-19 Vaccine); Prescribed the medication (Paxlovid) today; I have taken Paxlovid once before"; ILLNESS (non-serious), outcome "not recovered", described as "sick". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The call was transferred from the Patient Support Program regarding a patient who reported an adverse event related to Paxlovid. The agent stated that the patient had previously received Pfizer COVID-19 vaccines and had been prescribed Paxlovid that day, which the patient confirmed as correct after the concern was paraphrased. The patient was informed about the role of Pfizer Drug Safety. The patient mentioned a height of approximately five feet three and a quarter inches, though it was not clarified further. Regarding the prescribing healthcare professional, the patient stated that she was an intern with their doctor, possibly an internist or primary care physician, but this was not certain. When asked about follow-up consent, the patient questioned why contact would be needed and declined, preferring not to have the healthcare provider bothered. The patient described details on the Paxlovid packaging, including numbers under the expiration date and above the lot number, as well as a UPC number on the barcode. The patient reported testing positive for COVID and explained that they had not yet started Paxlovid, as they had just picked it up from the pharmacy and would take the first dose once at home. When asked about COVID-19 vaccination history, the patient stated that they had not received the most recent dose but were up to date on vaccines and had previously taken Paxlovid. The patient confirmed that they had received Pfizer COVID-19 vaccines and Paxlovid in the past and had now been prescribed Paxlovid again. Further probing was not possible as the patient ended the call abruptly, resulting in limited information being available. A product complaint was also reported, and the information on the batch and lot number for BNT162B2 was to be requested and submitted if and when received. On follow-up, additional information was provided, including confirmation of the patient's gender and the addition of a new event, sick. During the call, the patient explained that they had signed up for the card to get a discount on Paxlovid, that they were sick, and that they needed to take the medication. While waiting for payment to process, the patient commented positively about Pfizer and their COVID vaccines, expressing appreciation for the work done to keep people healthy and help them recover. The call was then transferred to a DSU pharmacist, though the safety information provided was incomplete, and the source document was sent to include that the patient was sick. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Test Name: Covid; Test Result: Positive