Received Oct 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | OT / LA |
nausea; reflux; vomiting; This is a spontaneous report received from a Consumer or other non HCP. A 55-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 04Oct2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 55 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "portal hypertension" (unspecified if ongoing); "liver NRH" (unspecified if ongoing); "Reflux" (unspecified if ongoing). Concomitant medication(s) included: LETROZOLE; CARVEDILOL; BRIMONIDINE; BIMATOPROST. Past drug history included: No, reaction(s): "Hypersensitivity". The following information was reported: NAUSEA (non-serious) with onset 05Oct2025 at 14:00, outcome "recovered"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 05Oct2025 at 14:00, outcome "recovered", described as "reflux"; VOMITING (non-serious) with onset 05Oct2025 at 14:00, outcome "recovered". Therapeutic measures were not taken as a result of nausea, gastrooesophageal reflux disease, vomiting. Additional information: The patient received the Comirnaty vaccine at a doctor office or urgent care facility. No other vaccines were administered on the same day or within the prior four weeks. The patient was taking other medications within two weeks of the event. Approximately 25 hours after vaccination, she experienced nausea, reflux, and two episodes of vomiting. The batch/lot number was not available to the reporter at the time of report completion. The event was documented on 06 October 2025. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: Acid reflux (esophageal); Nodular regenerative hyperplasia; Portal hypertension
LETROZOLE; CARVEDILOL; BRIMONIDINE; BIMATOPROST