drug ineffective; covid-19 virus test positive; temperature 39 / temperature 38/39 degrees; rash on feet day 2, full body rash day 4 / urticaria type rash / non vesicular with multiple hives resolved on day; rash on feet day 2, full body rash day 4; rigours; this is a spontaneous report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory authority-web. regulatory number: ie-hpra-2022-090506 (regulatory authority). other case identifier(s): ie-hpra-cvarr2022011224280 (regulatory authority). a 7 year-old male patient received bnt162b2 (comirnaty), administration date 08jan2022 (lot number: fn4071) as dose 1, single for covid-19 immunisation. relevant medical history included: "alopecia areata" (unspecified if ongoing), notes: active at the moment and being treated with topical steroids that he has used before; "viral infection nos", start date: jan2021 (unspecified if ongoing), notes: patient referred to ed for assessment. they deduced it was a virus. the patient's concomitant medications were not reported. the following information was reported: drug ineffective (medically significant) with onset feb2022, outcome "unknown", described as "drug ineffective"; covid-19 (medically significant) with onset feb2022, outcome "unknown", described as "covid-19 virus test positive"; rash (non-serious) with onset 09jan2022, outcome "not recovered", described as "rash on feet day 2, full body rash day 4"; pyrexia (non-serious) with onset 11jan2022, outcome "recovered", described as "temperature 39 / temperature 38/39 degrees"; urticaria (non-serious) with onset 09jan2022, outcome "recovered", described as "rash on feet day 2, full body rash day 4 / urticaria type rash / non vesicular with multiple hives resolved on day"; chills (non-serious), outcome "recovered", described as "rigours". the patient underwent the following laboratory tests and procedures: body temperature: (jan2022) 38/39 degrees; body temperature: (11jan2022) 39 day 4/5; sars-cov-2 test: (jan2022) negative, notes: pcr to rule out covid (negative); (feb2022) positive. no follow-up attempts are possible. no further information is expected. follow-up (08feb2022): new information received from a contactable consumer downloaded from the regulatory authority-web, included that new reported relevant medical history "viral infection nos" was captured. follow-up (21feb2022): new information received from the same contactable consumer from the regulatory authority-web included lab data (covid-19 virus test) included new event: drug ineffective, sars-cov-2 test positive, classification

test date: 202201; test name: body temperature; result unstructured data: test result:38/39 degrees; test date: 20220111; test name: body temperature; result unstructured data: test result:39 day 4/5 centigrade; test date: 202201; test name: covid-19 pcr test; result unstructured data: test result:negative; comments: pcr to rule out covid (negative).; test date: 202202; test name: covid-19 virus test; test result: positive

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