Received Oct 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
Acute vestibular neuritis.; This is a spontaneous report received from a Consumer or other non HCP. A 56-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 04Oct2025 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: VESTIBULAR NEURONITIS (hospitalization, medically significant) with onset 14Oct2025 at 20:15, outcome "not recovered", described as "Acute vestibular neuritis.". The patient was hospitalized for vestibular neuronitis (hospitalization duration: 1 day(s)). The event "acute vestibular neuritis." required emergency room visit. Therapeutic measures were taken as a result of vestibular neuronitis. Clinical course: No other vaccine on same date. No other vaccine in four weeks. Unknown if other medications in two weeks. Event Acute vestibular neuritis resulted in emergency room trip and an overnight stay for observation. Event occurred 11 days after vaccination dose. Treatment: Meclizine. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Asthma; Hypertension