red spots; raised spots are very itchy; 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 authority (ra). regulatory number: gb-mhra-webcovid-202202202200331820-elzce. other case identifier(s): gb-mhra-adr 26626455. a 71 year-old male patient received bnt162b2 (comirnaty), administration date 21nov2021 (lot number: fh3220) as dose 3 (booster), single for covid-19 immunisation. relevant medical history included: "extrasystoles" (unspecified if ongoing). concomitant medication(s) included: tegretol taken for extrasystoles, start date: 01jun2017. vaccination history included: covid-19 vaccine astrazeneca (dose 1 single,), administration date: 05dec2020, for covid-19 immunization; covid-19 vaccine astrazeneca (dose 2 single), administration date: 30apr2021, for covid-19 immunization. the following information was reported: off label use (medically significant) with onset 21nov2021, outcome "unknown", described as "off label use"; interchange of vaccine products (medically significant) with onset 21nov2021, outcome "unknown", described as "interchange of vaccine product"; rash macular (medically significant), outcome "unknown", described as "red spots"; rash pruritic (medically significant), outcome "not recovered", described as "raised spots are very itchy". the patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: no - negative covid-19 test. therapeutic measures were taken as a result of rash macular, rash pruritic. the raised spots are very itchy and if scratched spread into larger patches. spots are aggravated when taking a shower or bath or warm environment or when over heated by wearing too many clothes; spots and rash are also on head. the doctor prescribed antihistamines and emollient cream (e45) together with betamethasone cream. the patient had no symptoms associated with covid-19. patient has not tested positive for covid-19 since having the vaccine, not enrolled in clinical trial. no follow-up attempts are possible. no further information is expected

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

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