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VAERS Report 2136741

Case Report Section

Vaer Report Details

Age: 66 years old

Gender: Male

State: Outside US

Patient Died?
No
Vaccine information

Name: COVID19 (COVID19 (PFIZER-BIONTECH))

Type: Coronavirus 2019 vaccine

Manufacturer: PFIZER

Lot: unknown


Date report was received
2022-02-24
Date form completed
Date Vaccinated
2021-06-19
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

sudden left deafness as of 02jul2021. same day the ear, nose and throat specialist started double dose of prednisone; increase in tinnitus in terms of sound; reaction at or around the injection site: pain; this is a spontaneous report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory authority-web. regulatory number: nl-lrb-00737709. a 66 year-old male patient received bnt162b2 (comirnaty), administration date 19jun2021 (batch/lot number: unknown) at the age of 66 years as dose 2, single for covid-19 immunisation. relevant medical history included: "tinnitus" (ongoing), notes: there was pre-existing tinnitus for about ten years. concomitant medication(s) included: tamsulosin; perindopril erbumine; solifenacin; finasteride; carbasalate calcium. vaccination history included: comirnaty (dose 1; batch/lot# unknown), administration date: 12may2021, for covid-19 immunisation, reaction(s): "vaccination site pain". the following information was reported: deafness unilateral (medically significant) with onset 02jul2021, outcome "not recovered", described as "sudden left deafness as of 02jul2021. same day the ear, nose and throat specialist started double dose of prednisone"; vaccination site pain (non-serious) with onset 19jun2021, outcome "recovered" (24jun2021), described as "reaction at or around the injection site: pain"; tinnitus (non-serious) with onset 02jul2021, outcome "recovering", described as "increase in tinnitus in terms of sound". the events "sudden left deafness as of 02jul2021. same day the ear, nose and throat specialist started double dose of prednisone" and "increase in tinnitus in terms of sound" were evaluated at the physician office visit. the patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18nov2021) positive. therapeutic measures were taken as a result of deafness unilateral. reporter comment: summary of reporters comments: biontech/pfizer vaccine (comirnaty) past drug therapy biontech/pfizer vaccine (comirnaty): yes adrs: painful arm particularly at injection site date: 12may2021. sudden deafness as of 02jul2021. referred to ear, nose and throat specialist by general practitioner on 02jul2021. started a 10-day course of prednisone. : there was pre-existing tinnitus for about ten years. however, since 02jul2021, the volume of the tinnitus has increased by a factor of 25. previous covid-19 infection: disease symptoms: little no follow-up attempts are possible; information about lot/batch number cannot be obtained. no further information is expected.; reporter's comments: summary of reporters comments: biontech/pfizer vaccine (comirnaty) past drug therapy biontech/pfizer vaccine (comirnaty): yes adrs: painful arm particularly at injection site date: 12may2021. sudden deafness as of 02jul2021. referred to ear, nose and throat specialist by general practitioner on 02jul2021. started a 10-day course of prednisone. : there was pre-existing tinnitus for about ten years. however, since 02jul2021, the volume of the tinnitus has increased by a factor of 25. previous covid-19 infection: disease symptoms: little; sender's comments: linked report(s) : nl-pfizer inc-202200291330 same patient, dose/ different ae, dose;nl-pfizer inc-202200301447 the same patient/different dose/different adverse event

Lab Data
test date: 20211118; test name: corona, confirmed with test; test result: positive
List of symptoms
tinnitus sars-cov-2 test deafness unilateral vaccination site pain
Patient Died?
No
Date Died
NA
Birth defect
false
Vaccine Administered By:
Other
Vaccine Purchased By:
Unknown
Patient visit ER?
No
Patient Hospitalized?
No
Stay in hospital
No
Days in hospital
Unspecified
Permanent disability?
No
Allergies:
na
Current Illness
tinnitus (there was pre-existing tinnitus for about ten years)