Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dysphonia, Fatigue, Hot flush
Clinical narrative: Two covid home tests and he was positive/his employer (Name) performed a covid test and he is also positive; Two covid home tests and he was positive/his employer (Name) performed a covid test and he is also positive; hot and cold flashness; throat tingling; dry cough; nasal congestion; throat hoarseness; hot and cold flashness; feeling tired; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 37 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Feb2022 (Lot number: FJ6369) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Pfizer biontech vaccine (Dose Number: 2, Batch/Lot No: EL9261, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 25Jan2021, when the patient was 36  old, for COVID-19 immunization; Pfizer biontech vaccine (Dose Number: 1, Batch/Lot No: EK9231, Location of injection: Arm Left), administration date: 06Jan2021, when the patient was 36 years old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 13Mar2022, outcome "unknown", COVID-19 (medically significant) with onset 13Mar2022, outcome "not recovered" and all described as "Two covid home tests and he was positive/his employer (Name) performed a covid test and he is also positive"; NASOPHARYNGITIS (non-serious), HOT FLUSH (non-serious) all with onset 13Mar2022, outcome "not recovered" and all described as "hot and cold flashness"; PHARYNGEAL PARAESTHESIA (non-serious) with onset 13Mar2022, outcome "not recovered", described as "throat tingling"; COUGH (non-serious) with onset 13Mar2022, outcome "not recovered", described as "dry cough"; NASAL CONGESTION (non-serious) with onset 13Mar2022, outcome "not recovered", described as "nasal congestion"; DYSPHONIA (non-serious) with onset 13Mar2022, outcome "not recovered", described as "throat hoarseness"; FATIGUE (non-serious) with onset 13Mar2022, outcome "not recovered", described as "feeling tired". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Mar2022) positive. Therapeutic measures were not taken as a result of covid-19, nasopharyngitis, pharyngeal paraesthesia, cough, nasal congestion, dysphonia, hot flush, fatigue.  Reporter was Pfizer employee and registered nurse. Yesterday, on Sunday,13Mar2022 my husband woke up withthroat tingling, dry cough, nasal congestion, throat hoarseness, hot and cold flashness and feeling tired. I performed two covid home tests and he was positive. Today, Monday 14Mar2022, his employer [Withheld] performed a covid test and he is also positive.Patient did not receive any other vaccines in 4 weeks of vaccination and did not receive any other medications in 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not have history of known allergies. The patient not visited emergency room or hospitalization due to events.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out