Adverse Event Reporting
|Number of vaccinations||1|
- Deafness neurosensory
Medical History/Concurrent Conditions: Penicillin allergy
Moderate to severe headache 24-48 hours post injection.
Complete sensorineural hearing loss in left ear 1 week after injection; Moderate to severe headache 24-48 hours post injection.
Complete sensorineural hearing loss in left ear 1 week after injection; This is a spontaneous report from a contactable physician (patient).
A 37-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 17:15 at single dose on her left arm for covid-19 immunization.
Medical history included known allergies to penicillin.
The patient had no other medical history.
There were no concomitant medications.
The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient was not received list of any other medications within 2 weeks of vaccination.
Prior to vaccination, the patient was not diagnosed with COVID-19.
Since the vaccination, the patient had not been tested for COVID-19.
The patient experienced moderate to severe headache 24-48 hours post injection.
Complete sensorineural hearing loss in left ear 1 week after injection on 23Dec2020.
These events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage.
The patient had received prednisone to treat the events.
The outcome of the events was not recovered.
; Sender's Comments: A possible contribution role of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of sensorineural hearing loss in left ear and headache cannot be excluded due to temporal relationship.
The case will be reassessed should additional information become available.
The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as 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.