Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
diarrhea; nausea; headache; severe fatigue; arm pain; This is a spontaneous report received from a Consumer or other non HCP. A 30-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 01Oct2025 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Peanuts allergy" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Vancomycin, reaction(s): "Allergy"; Morphine, reaction(s): "Allergy". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Oct2025, outcome "recovered" (03Oct2025), described as "arm pain"; DIARRHOEA (non-serious) with onset 01Oct2025, outcome "recovered" (03Oct2025), described as "diarrhea"; HEADACHE (non-serious) with onset 01Oct2025, outcome "recovered" (03Oct2025); NAUSEA (non-serious) with onset 01Oct2025, outcome "recovered" (03Oct2025); FATIGUE (non-serious) with onset 01Oct2025, outcome "recovered" (03Oct2025), described as "severe fatigue". Therapeutic measures were not taken as a result of diarrhoea, nausea, headache, fatigue, pain in extremity. Additional information: The patient did not receive any other vaccines on the same date as the vaccine for which reporting. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine for which reporting. The patient was taking other medications within 2 weeks of the event starting. In the ~36 hours following the vaccine patient had diarrhea, nausea, headache, severe fatigue and arm pain. Patient got the vaccine at 6 pm on a Wednesday and felt 100% better by Friday morning. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: Peanut allergy