pain at the site of inoculation and headache (associated with fever above 37) persisting from 12:00 until the next day after administration.; pain at the site of inoculation and headache (associated with fever above 37) persisting from 12:00 until the next day after administration.; pain at the site of inoculation and headache (associated with fever above 37) persisting from 12:00 until the next day after administration.; active administration monitoring this is a non-interventional study report from the ra. regulatory number: it-minisal02-843236. a 49 year-old female subject received bnt162b2 (comirnaty), intramuscular, administration date 13oct2021 (lot number: ff2382, expiration date: 31mar2022) at the age of 49 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. the subject'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: headache (medically significant), pyrexia (medically significant), vaccination site pain (medically significant) all with onset 13oct2021 12:00, outcome "recovered" (15oct2021) and all described as "pain at the site of inoculation and headache (associated with fever above 37) persisting from 12:00 until the next day after administration.". the subject underwent the following laboratory tests and procedures: body temperature: (13oct2021) above 37. therapeutic measures were taken as a result of headache, pyrexia, vaccination site pain. the reporter's assessment of the causal relationship of the "pain at the site of inoculation and headache (associated with fever above 37) persisting from 12:00 until the next day after administration." with the suspect product 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: the reported events were assessed as probably related to suspected vaccine bnt162b2 on the basis of temporal relation and known drug safety profile