Adverse Event Reporting
|Number of vaccinations||1|
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Complete loss of smell and taste; Complete loss of smell and taste; This is a spontaneous report from a contactable physician reported for herself.
A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: PfizerbioNtech, lot number: EH9888) intramuscularly at left arm on 17Dec2020 at 03:00 PM at a single dose (dose number: 1) for COVID-19 immunization.
Medical history was reported as none.
No known allergies (no allergies to medications, food, or other products).
The patient was not pregnant.
The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
No other medications the patient received within 2 weeks of vaccination.
Facility where the most recent COVID-19 vaccine was administered was at hospital.
The patient experienced adverse event complete loss of smell and taste on 19Dec2020 at 07:00 AM.
The event was considered as serious due to resulted in disability or permanent damage.
No treatment received for the event.
The outcome of event was not resolved.
Prior to vaccination, the patient was not diagnosed with COVID-19.
Since the vaccination, the patient had not been tested for COVID-19.
; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events complete loss of smell and taste cannot be totally excluded.
The case will be reassessed if additional information becomes 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.