Received Oct 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUBLOK) | SANOFI PASTEUR | 1 | — | RA |
Chronic heartburn; chronic acid reflux; This is a spontaneous report received from a Consumer or other non HCP. A 58-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 22Sep2025 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; influenza vaccine rha 3v (baculovirus) (FLUBLOK), on 22Sep2025 as dose 1, single, in right arm. The patient had no relevant medical history. Concomitant medication(s) included: NITROFURANTOIN, start date: 02Sep2025, stop date: 09Sep2025. The following information was reported: DYSPEPSIA (non-serious) with onset 23Sep2025, outcome "not recovered", described as "Chronic heartburn"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 23Sep2025, outcome "not recovered", described as "chronic acid reflux". Therapeutic measures were not taken as a result of dyspepsia, gastrooesophageal reflux disease. Additional information: Started the day after the vaccinations and progressively got worse. 1 week later, still had symptoms. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
NITROFURANTOIN