Received Jan 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Covid-19; Covid-19; stroke; he's very compromised; lung problems; He's hurt- He's in a lot of pain; He's already been sick for two days; PATIENT SUPPORT PROGRAM This is a solicited report received from a Consumer or other non HCP, Program ID. A 71-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "he's very compromised"; LUNG DISORDER (non-serious), outcome "unknown", described as "lung problems"; PAIN (non-serious), outcome "unknown", described as "He's hurt- He's in a lot of pain"; ILLNESS (non-serious), outcome "unknown", described as "He's already been sick for two days". Clinical course: During an inbound call for financial assistance, the patient's spouse stated that she was trying to see if she can get a discount on the Paxlovin. So she was trying to get her husband. Patient was bedbound. He had a stroke and it's the first time he's ever been sick. After advising that the patient was not eligible stated that patient will have to go to the hospital and insurance will have to cover him then. Patient was already been sick for two days. He has lung problems too after the stroke. He's hurt- He's in a lot of pain. Towards the end of the call stated that No, patient did have the Pfizer vaccine. But he was very compromised so it's not helping too much. The reporter's assessment of the causal relationship of "covid-19", "stroke", "he's very compromised", "lung problems", "he's hurt- he's in a lot of pain" and "he's already been sick for two days" with the suspect product(s) BNT162b2 omicron (lp.8.1) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported event drug ineffective, COVID-19 cannot be ruled out. Although it is difficult to establish temporal association between the reported events "stroke", "he's very compromised", "lung problems", "he's hurt- he's in a lot of pain", "he's already been sick for two days" and the suspect drug BNT162b2 based on the limited information provided, the causal association between the reported events and the suspect drug cannot be excluded as there is no concrete evidence available to eliminate the causal association. Case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.