Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: fatigue; congestion; runny nose; cough; headache; temp 100; PCR test positive for COVID; PCR test positive for COVID; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient received bnt162b2 (BNT162B2), administration date 15Oct2021 (Lot number: EW0187) at the age of 58 years as dose 3 (booster), single, administration date 18Mar2021 (Lot number: EL3247) as dose 2, single and administration date 25Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sjogrens syndrome" (unspecified if ongoing); "history of breast cancer with lumpectomy" (unspecified if ongoing); "bilateral spinal fusion" (unspecified if ongoing); "cholecystectomy" (unspecified if ongoing); "rhinoplasty" (unspecified if ongoing); "Epstein Barr" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "bee stings" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE; ATORVASTATIN; CALCIUM. Past drug history included: Erythromycin, reaction(s): "Allergy: erythromycin", notes: erythromycin, bee stings. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "recovering" and all described as "PCR test positive for COVID"; IMMUNISATION (non-serious) with onset 15Oct2021, outcome "unknown", described as "Booster"; FATIGUE (non-serious) with onset 28Dec2021, outcome "recovering", described as "fatigue"; NASAL CONGESTION (non-serious) with onset 28Dec2021, outcome "recovering", described as "congestion"; RHINORRHOEA (non-serious) with onset 28Dec2021, outcome "recovering", described as "runny nose"; COUGH (non-serious) with onset 28Dec2021, outcome "recovering", described as "cough"; HEADACHE (non-serious) with onset 28Dec2021, outcome "recovering", described as "headache"; BODY TEMPERATURE INCREASED (non-serious) with onset 28Dec2021, outcome "recovering", described as "temp 100". The events "pcr test positive for covid", "pcr test positive for covid", "fatigue", "congestion", "runny nose", "cough", "headache" and "temp 100" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: body temperature: (28Dec2021) 100; sars-cov-2 test: (28Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19, fatigue, nasal congestion, rhinorrhoea, cough, headache, body temperature increased.Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19. Prior to vaccination and Since the vaccination, has been tested for COVID-19. Treatment received for adverse events are Prednisone, doxycycline and promethazine DM.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and events  cannot be completely excluded.