patient received both comirnaty and flucelvax tetra on 18oct2021; pain at the injection site in the first 12-24 after administration of the vaccine associated with fever above 37 degrees; pain at the injection site in the first 12-24 after administration of the vaccine associated with fever above 37 degrees; active surveillance co-administration this is a non-interventional study report from the regulatory authority-web. regulatory number: it-minisal02-843292. a 59 year-old male patient received bnt162b2 (comirnaty), intramuscular, administration date 18oct2021 (lot number: ff2382, expiration date: 31mar2022) at the age of 59 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation; influenza vaccine inact sag 4v (flucelvax tetra [influenza vaccine inact sag 4v]), intramuscular, administration date 18oct2021 (lot number: unknown) for immunisation. the patient's relevant medical history and concomitant medications were not reported. vaccination history included: covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunisation; covid-19 vaccine (dose 2, manufacturer unknown), for covid-19 immunisation. the following information was reported: product use issue (medically significant) with onset 18oct2021, outcome "unknown", described as "patient received both comirnaty and flucelvax tetra on 18oct2021"; vaccination site pain (medically significant), pyrexia (medically significant) all with onset 18oct2021, outcome "recovered" (20oct2021) and all described as "pain at the injection site in the first 12-24 after administration of the vaccine associated with fever above 37 degrees". the patient underwent the following laboratory tests and procedures: body temperature: (18oct2021) above 37 degrees. therapeutic measures were taken as a result of vaccination site pain, pyrexia and treatment included simultaneous intake of tachipirina. the reporter's assessment of the causal relationship of the "patient received both comirnaty and flucelvax tetra on 18oct2021" and "pain at the injection site in the first 12-24 after administration of the vaccine associated with fever above 37 degrees" with the suspect product(s) bnt162b2 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 currently known drug safety profile, a causal association between the reported events pyrexia and vaccination site pain and bnt162b2 cannot be excluded

test date: 20211018; test name: body temperature; result unstructured data: test result:above 37 degrees

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