drug ineffective; sars-cov-2 infection; card vaccine monitor this is a solicited report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory authority and product quality group for a sponsored program. a 17 year-old male patient received bnt162b2 (comirnaty), administration date 23jan2022 (lot number: fn1664) as dose 3 (booster), single, administration date 23oct2021 (lot number: fg6431) as dose 2, single and administration date 24aug2021 (lot number: fe8830) as dose 1, single for covid-19 immunisation. the patient's relevant medical history and concomitant medications were not reported. the following information was reported: drug ineffective (medically significant) with onset 07feb2022, outcome "unknown", described as "drug ineffective"; suspected covid-19 (medically significant) with onset 07feb2022, outcome "recovered" (17feb2022), described as "sars-cov-2 infection". the patient underwent the following laboratory tests and procedures: heart rate: normal, notes: considered normal; magnetic resonance imaging: unknown results, notes: unknown results. clinical information: patient had not had symptoms associated with covid-19. not had a covid-19 test. patient was not pregnant. patient was not currently breastfeeding. had been monitored for an irregular heart beat but was considered normal for him and of no concern. there may be a follow up mri at some point. patient was not enrolled in clinical trial. the reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. since no determination has been received, the case is managed based on the company causality assessment. no follow-up attempts are possible. no further information is expected.; sender's comments: based on the information currently available, lack of efficacy of the suspected vaccine bnt162b2 cannot be completely excluded.,linked report(s) : gb-pfizer inc-202101105576 same patient same product different dosage and different event

test name: heart beat; result unstructured data: test result:normal; comments: considered normal; test name: mri; result unstructured data: test result:unknown results; comments: unknown results

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