Received May 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
Covid 2 or 3 times; Covid 2 or 3 times; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2026-794776, MOD-2026-794775. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Covid 2 or 3 times". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative; positive. Clinical course: Patient received Spikevax Nos multiple doses approx 1 with last administration on Sep2024 and experienced sore arm after receiving covid vaccine pain in arm on Mar2025, outcome event was recovered/Resolved and experienced flu like symptoms on Mar2025 outcome of event was recovered/resolved. Patient had covid test COVID-19 virus test with result negative. Patient received Influenza vaccine on Sep2024. Patient relevant medical history (vaccines within the past 4 weeks, medical conditions): healthy. Has always gotten Pfizer Covid vaccines.-Product Details-Product Name: Pfizer Covid vaccines patient had Covid 2 or 3 times despite always getting Pfizer Covid vaccines. has had COVID twice with the Pfizer. When got it tested positive. Patient had just kinda had like a cold, you know, and respiratory symptoms. Patient had got COVID at least twice, maybe 3 times and patient had respiratory symptoms for a week. Or 8 days. Not a fever like had. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The events COVID-19 and DRUG INEFFECTIVE are assessed as related to the administration of the COVID-19 vaccine (BNT162b2), based on the reported occurrence of repeated SARS-CoV-2 infections despite vaccination. While COVID-19 vaccines are effective in reducing severity and risk of infection, breakthrough infections are recognized and documented. The temporal pattern of multiple infections ("Covid 2 or 3 times") despite prior vaccination supports the reporting of drug ineffective in this context. However, given the known limitations of vaccine efficacy (e.g., waning immunity, viral variants), this does not necessarily indicate a product defect. In the absence of alternative explanations, a causal relationship is considered reasonably possible.
Test Name: COVID-19 virus test; Test Result: Negative ; Test Name: COVID-19 virus test; Test Result: Positive