Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Erythema, Headache
Clinical narrative: A rapid COVID test was taken and he was positive; A rapid COVID test was taken and he was positive; fever of a 101; bright red cheek; headache; body chills; itchy throat; pain in his throat; minor congestion; runny nose; This is a spontaneous report received from a non-contactable reporter (Pharmacist) from product quality group. The reporter is the parent.  A 10-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 (Lot number: FK5618) at the age of 10 years as dose 2, single and intramuscular, administered in arm left, administration date 10Nov2021 (Lot number: FK5618) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Known allergies were none. The patient took concomitant medication which included Children's multivitamin received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Device Date was reported as 30Mar2022.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 24Mar2022, outcome "unknown", COVID-19 (medically significant) with onset 24Mar2022, outcome "recovering" and all described as "A rapid COVID test was taken and he was positive"; THROAT IRRITATION (non-serious) with onset 23Mar2022, outcome "recovering", described as "itchy throat"; OROPHARYNGEAL PAIN (non-serious) with onset 23Mar2022, outcome "recovering", described as "pain in his throat"; PYREXIA (non-serious) with onset 24Mar2022, outcome "recovering", described as "fever of a 101"; ERYTHEMA (non-serious) with onset 24Mar2022, outcome "recovering", described as "bright red cheek"; HEADACHE (non-serious) with onset 24Mar2022, outcome "recovering", described as "headache"; CHILLS (non-serious) with onset 24Mar2022, outcome "recovering", described as "body chills"; NASAL CONGESTION (non-serious) with onset Mar2022, outcome "recovering", described as "minor congestion"; RHINORRHOEA (non-serious) with onset Mar2022, outcome "recovering", described as "runny nose". The events "a rapid covid test was taken and he was positive", "a rapid covid test was taken and he was positive", "itchy throat", "pain in his throat", "fever of a 101", "bright red cheek", "headache", "body chills", "minor congestion" and "runny nose" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (24Mar2022) 101; influenza virus test: (24Mar2022) negative; sars-cov-2 test: (24Mar2022) positive, notes: Nasal Swab (covid test type post vaccination was reported as Nasal Swab); (25Mar2022) positive; streptococcus test: (24Mar2022) negative. Therapeutic measures were taken as a result of covid-19, throat irritation, oropharyngeal pain, pyrexia, headache, chills, nasal congestion, rhinorrhoea. Therapeutic measures were not taken as a result of erythema.  Clinical course: On 23Mar2022, the patient came home from school complaining of an itchy throat and pain in his throat. He was given Advil and Claritin. On the morning of the 24Mar, the patient woke up with a fever of a 101, bright red cheeks, severe throat pain, headache and body chills. A rapid COVID test was taken and, he was positive. He was then taken to urgent centre where he was tested for COVID, FLU, and Strep. The rapid strep test and flu test came back negative. On the 25Mar the patient's PCR test returned positive. To treat his symptoms, he was given Dayquil and NyQuil round the clock through 28Mar2022. After this he has been given it once a day. He would be returning to school on 31Mar2022. At this time, he has minor congestion and runny nose. The reporter assessed events as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Vaccination failure, Covid 19  cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.