Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: she started to have shortness of breath in the evening; She realized she couldn't do as much as she normally does. She said she tried; Tested positive for Covid-19 after both doses of Covid-19 Vaccine; she tested positive for the COVID-19 Virus on 05May2021; Now she had zero taste and smell; Now she had zero taste and smell; she had congestion; This is a spontaneous report from a contactable other-HCP. A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1284 and expiration date was not reported), via an unspecified route of administration in deltoid left on 11Jan2021 as 2nd single dose, for COVID-19 immunization. Medical history included hypertension from 2015 and ongoing, hyperthyroidism from Aug2019 and ongoing, ongoing seasonal allergy stated she has had seasonal allergies since she was a kid. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Lot number-EH9899 and expiration date was not reported), via unspecified route of administration on 20Dec2021 for COVID-19 immunization. On 05May2021 the patient experienced tested positive for COVID-19 after both doses of covid-19 vaccine. Upon follow-up received on 07May2021, she tested positive for the covid-19 virus on 05May2021. The patient now she had zero taste and smell (ageusia) (medically significant) the patient the patient with outcome of not recovered, On May2021 the patient experienced now she had zero taste and smell, she said she had congestion and couldn't taste and smell. She said on 06May2021 she started to have shortness of breath in the evening. She said because she was a cardiopulmonary specialist, she thought her shortness of breath was mild, but her family members thought she sounded winded. She said yesterday, she realized she couldn't do as much as she normally does. She said she tried to mop the floor yesterday and couldn't finish mopping the floor because she was short of breath. She said she doesn't feel sick. She realized she couldn't do as much as she normally does. She said she tried to mop the floor yesterday and couldn't finish mopping the floor-Activities of daily living impaired. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05May2021, sars-cov-2 test positive: positive on 05May2021. Therapeutic measures were taken as a result of now she had zero taste and smell (ageusia), now she had zero taste and smell (anosmia), she had congestion (nasal congestion), she started to have shortness of breath in the evening (dyspnoea), she realized she couldn't do as much as she normally does. she said she tried (loss of personal independence in daily activities). The outcome of event was Not recovered.  Follow-up(07May2021): New Information received from the contactable consumer includes updated events and dates, Past drug events and allergy and questions regarding events.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  Vaccination failure,Covid19,loss of smell,taste. The case will be reassessed once new information is 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