Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, Investigation, Myalgia
Clinical narrative: Developed symptomatic COVID-19 infection, with a positive result by rapid antigen testing; Developed symptomatic COVID-19 infection, with a positive result by rapid antigen testing; Pharyngitis; Headache; Rhinitis; Myalgia; Low-grade fever; Chills; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 13Jan2021 as dose 2, single (Lot number: EK9231), in left arm and on 09Nov2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Elevated coronary artery calcium score" (unspecified if ongoing), notes: Elevated coronary artery calcium score; "Essential thrombocythemia" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 14Apr2021, stop date: 24Apr2022. Past drug history included: Atorvastatin, reaction(s): "Known allergies: Drug allergy", notes: Known allergies: Atorvastatin. The following information was reported: CHILLS (non-serious) with onset Apr2022, outcome "recovering"; HEADACHE (non-serious) with onset Apr2022, outcome "recovering"; PYREXIA (non-serious) with onset Apr2022, outcome "recovering", described as "Low-grade fever"; MYALGIA (non-serious) with onset Apr2022, outcome "recovering"; PHARYNGITIS (non-serious) with onset Apr2022, outcome "recovering"; RHINITIS (non-serious) with onset Apr2022, outcome "recovering"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Apr2022, outcome "unknown" and all described as "Developed symptomatic COVID-19 infection, with a positive result by rapid antigen testing". The patient underwent the following laboratory tests and procedures: Coronary artery calcium score: (unspecified date) Elevated, notes: Elevated coronary artery calcium score; SARS-CoV-2 test: (24Apr2022) Positive, notes: Positive result by rapid antigen testing; (29Apr2022) Negative; (27May2022) Positive, notes: 2 different rapid antigen tests, and they were both positive; (27May2022) Positive, notes: 2 different rapid antigen tests, and they were both positive; (31May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19, pharyngitis, headache, rhinitis, myalgia, pyrexia, chills. Clinical course: COVID 19 Treatment: Treatment start date: 24Apr2022 and 28Apr2022. On Sunday 24Apr2022, patient developed symptomatic COVID-19 infection, with a positive result by rapid antigen testing. Symptoms included pharyngitis, headache, rhinitis, myalgia, and low-grade fever and chills. Patient started Paxlovid on Sunday 24Apr2022 and completed a 5 day course. Rapid antigen test was negative on 29Apr2022 and symptoms resolved. On 25May2022, patient had severe fatigue, followed by rhinitis, pharyngitis, myalgia, and headache. Patient tested on 27May2022 with 2 different rapid antigen tests and they were both positive for symptomatic COVID-19. Patient started a 2nd course of Paxlovid on 27May2022, and would complete the course on 01Jun2022. Patient symptoms improved, and tested negative by rapid antigen test for COVID-19 on 31May2022. Device Date : 01Jun2022.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19,  Vaccination failure and the administration of the vaccine cannot be excluded.