Report #2874720

Received Nov 24, 2025

A note on interpretation. VAERS reports are unverified and may be incomplete or coincidental. A report does not establish that a vaccine caused an event, and counts should not be used to calculate incidence or infer causation. Full disclaimer

Overview

Sex: Female
Age: Age unknown
State: —
Recovered: Unknown
Vaccinated: —
Onset: —
Days to onset: —
Hospital days: —

Vaccines (1)

Type	Name	Manufacturer	Dose	Lot	Route / Site
COVID19	COVID19 (COVID19 (PFIZER-BIONTECH))	PFIZER\BIONTECH	1	—	—

Symptoms (2)

Ear disorderEar pain

Symptom narrative

Ear was hurting the next day (fluid); Ear was hurting the next day (fluid); This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-021594 (BioNTech), 2025SA310818 (Sanofi). An 80-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), as 300 mg every 4 weeks (Lot number: FW0377, Expiration Date: 31Jul2027) subcutaneous for nasal polyps. The patient's relevant medical history included: "Drug hypersensitivity" (ongoing). Concomitant medication(s) included: CARMELLOSE SODIUM; GUAIFENESIN; PARACETAMOL; SODIUM BICARBONATE; SODIUM CHLORIDE; ASCORBIC ACID; BETACAROTENE; CUPRIC OXIDE; TOCOPHERYL ACETATE; ZINC OXIDE; BIOTIN; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHROMIUM NICOTINATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM HYDROXIDE; MANGANESE GLUCONATE; NICOTINAMIDE; PHYTONADIONE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL; RIBOFLAVIN; SELENOMETHIONINE; SODIUM MOLYBDATE; THIAMINE HYDROCHLORIDE; ZINC GLUCONATE; VITAMIN D3; SALBUTAMOL SULFATE. The following information was reported: EAR PAIN (non-serious), EAR DISORDER (non-serious), outcome "unknown" and all described as "Ear was hurting the next day (fluid)". The action taken for dupilumab was unknown. Additional information: It was not reported if the patient received a corrective treatment for the events. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.

Current illness

Drug hypersensitivity

Other medications

CARMELLOSE SODIUM; GUAIFENESIN; PARACETAMOL; SODIUM BICARBONATE; SODIUM CHLORIDE; ASCORBIC ACID; BETACAROTENE; CUPRIC OXIDE; TOCOPHERYL ACETATE; ZINC OXIDE; BIOTIN; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHROMIUM NICOTINATE; COLECALCIFERO