red raised bumpy itchy rash on face and neck; skin rash; off label use; interchange of vaccine product; this is a spontaneous report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory agency. the reporter is the patient. regulatory number: gb-mhra-webcovid-202202161828108230-xxcuv. other case identifier(s): gb-mhra-adr 26611331. a 51 year-old female patient (not pregnant) received bnt162b2 (comirnaty), administration date 16dec2021 (batch/lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. relevant medical history included: "suspected covid-19", start date: 07mar2020, stop date: 14mar2020. concomitant medication(s) included: influenza virus taken for immunisation, administration date 09nov2021. vaccination history included: covid-19 vaccine astrazeneca (dose 1), administration date: 18mar2021, for covid-19 immunisation; covid-19 vaccine astrazeneca (dose 2), administration date: 01jun2021, for covid-19 immunization. the following information was reported: off label use (medically significant) with onset 16dec2021, outcome "unknown", described as "off label use"; interchange of vaccine products (medically significant) with onset 16dec2021, outcome "unknown", described as "interchange of vaccine product"; rash pruritic (medically significant), outcome "not recovered", described as "red raised bumpy itchy rash on face and neck"; rash (medically significant) with onset 24dec2021, outcome "recovered with sequelae" (01feb2022), described as "skin rash". the events "red raised bumpy itchy rash on face and neck" and "skin rash" were evaluated at the physician office visit. the patient underwent the following laboratory tests and procedures: blood test: normal; sars-cov-2 test: negative, notes: no - negative covid-19 test. therapeutic measures were taken as a result of rash pruritic, rash. clinical course: patient was not breastfeeding at the time of this report. patient had red raised bumpy itchy rash on face and neck. red raised bumpy non-itchy rash on left arm and hand, both legs, bum. non blanching on lower legs and around nostrils. not hives. patient took antihistamines but they didn't make any difference. spoke to 111 and out of hours gp. told to take antihistamines and get a blood test. blood test was ok. patient has not tested positive for covid-19 since having the vaccine. patient is not enrolled in clinical trial. no follow-up attempts are possible; information about lot/batch number cannot be obtained. no further information is expected

test name: blood test; result unstructured data: test result:normal; test name: covid-19 virus test; test result: negative ; comments: no - negative covid-19 test

na

na