Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Computerised tomogram, Deafness unilateral, Laboratory test, Magnetic resonance imaging
Clinical narrative: deafness right ear/ lost hearing in right ear; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer (patient), based on information received by Pfizer(Mfr Control No. 21K-163-3815436-00).  A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 2 intramuscular at age of 77 years on 13Feb2021 10:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA, 40 mg/0.8 ml), subcutaneous from 17Jan2021 to 17Jan2021, at 40 mg[(1 in 14 D)], subcutaneous from 29Jan2021 to 29Jan2021, at 40 mg[(1 in 14 D)], subcutaneous from 24Feb2021 (Batch/Lot number was not reported) to an unspecified date, at 40 mg[(1 in 14 D)] for Moderate to severe Rheumatoid Arthritis. Medical history included no tobacco use, abstains from alcohol, allergic reaction.Concomitant medications included insulin detemir (LEVEMIR FLEXPEN); biotin (BIOTIN); acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]); alprazolam (ALPRAZOLAM); atenolol (ATENOLOL) ; atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]) ; bupropion hydrochloride (BUPROPION HCL XL) ; clopidogrel bisulfate (PLAVIX) ; famotidine (FAMOTIDINE) ; glipizide (GLIPIZIDE XL) ; losartan potassium (COZAAR) ; mirtazapine (MIRTAZAPINE) ; pioglitazone hydrochloride (ACTOS) ; sodium bicarbonate (SODIUM BICARBONATE) ; sucralfate (SUCRALFATE) ; iron (IRON) ; calcium (CALCIUM) ; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) ; fish oil (FISH OIL) ; coenzyme q10 [ubidecarenone] (COENZYME Q10 [UBIDECARENONE]) ; cyanocobalamin (B 12) ; acetylsalicylic acid (ASPIRIN). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular on 23Jan2021 at age of 77 years (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient experienced deafness right ear/ lost hearing in right ear since 13Feb2021 18:00. The patient took HUMIRA shot on 17Jan2021. Physician said it was ok to take HUMIRA as long as and did not take  it the same day as Covid Vaccine since she had reaction and physician did not able to tell for which shot it might be allergic too if she had a reaction. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received first dose COVID-19 Vaccine shot on 23Jan2021. She took next Humira on 29Jan2021. On 13Feb2021 around 10 AM, patient took her second COVID-19 Vaccine manufactured by Pfizer.  On 13Feb2021 about 6 pm (18:00) or thereabout, she started hearing a ticking in right ear and by the 8 pm hearing was completely gone in the right ear. On 14Feb2021, she went to the immediate care center and was checked for no reason. Then she went to emergency room where she had a CT scan on 14 Feb 2021 for no reason and referred to ENT physician on 17Feb2021. She had a hearing test. She had two steroid injections in ear on 17Feb2021 and 26Feb2021 with no improvement. On 01Mar2021, she had MRI but no explanation was found. She was being fitted with a hearing aid in left and right ear as of 29Apr2021 and was having a little problem adjusting. The patient had lab tests in 2021 with unknown results. The reporter's causality for the event(s) of lost hearing in right ear with Humira 40MG/0.8ML (Adalimumab) was a reasonable possibility/ Possible. AbbVie's opinion is that there is no reasonable possibility that the event of lost hearing in right ear is related to Humira 40 mg/0.8 ml (Adalimumab). Causality with BNT162b2 for Deafness right ear (Deafness unilateral) per reporter was Probable. The action taken in response to the event for adalimumab was unknown. The outcome of the event was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on current available information and a temporal association, the causal association between the event and the suspect drug BNT162B2 is assessed as possibly related. Consider also possible contribution from co-suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.