Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Immunisation, Oropharyngeal pain, Productive cough
Clinical narrative: Positive rapid Covid test on 31Dec2021; Positive rapid Covid test on 31Dec2021; Sore throat; fever; productive cough; head and chest congestion; head and chest congestion; loss of taste; Dose number=3; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Sep2021 (Lot number: 301308A) at the age of 59 years as dose 3 (booster), single, administered in arm left, administration date 13Feb2021 (Lot number: EM9810) as dose 2, single and administered in arm left, administration date 23Jan2021 (Lot number: EL8982) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing), notes: Known allergies: No; "GERD" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for weight decreased, start date: Aug2021; OZEMPIC taken for weight decreased, start date: Aug2021. The following information was reported: IMMUNISATION (medically significant) with onset 27Sep2021, outcome "unknown", described as "Dose number=3"; COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 31Dec2021, outcome "recovering" and all described as "Positive rapid Covid test on 31Dec2021"; OROPHARYNGEAL PAIN (non-serious) with onset 28Dec2021, outcome "recovering", described as "Sore throat"; PYREXIA (non-serious) with onset 28Dec2021, outcome "recovering", described as "fever"; PRODUCTIVE COUGH (non-serious) with onset 28Dec2021, outcome "recovering", described as "productive cough"; RESPIRATORY TRACT CONGESTION (non-serious), UPPER RESPIRATORY TRACT CONGESTION (non-serious) all with onset 28Dec2021, outcome "recovering" and all described as "head and chest congestion"; AGEUSIA (non-serious) with onset 28Dec2021, outcome "recovering", described as "loss of taste". The events "positive rapid covid test on 31dec2021", "positive rapid covid test on 31dec2021", "sore throat", "fever", "productive cough", "head and chest congestion", "head and chest congestion" and "loss of taste" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of immunisation, covid-19, vaccination failure, oropharyngeal pain, pyrexia, productive cough, respiratory tract congestion, upper respiratory tract congestion, ageusia.  Clinical Information: Patient received Advil and mucinex as a treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow up attempts are possible. No further information was expected.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  events Immunisation,  Covid 19 ,oropharyngeal pain , pyrexia, productive cough ,respiratory tract congestion , upper respiratory tract congestion, ageusia,  vaccination failure ,and the suspect drug BNT162B2 cannot be excluded.   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.