off-label use; interchange of vaccine products; lips angioedema; extensive urticaria; this is a spontaneous report received from a contactable reporter(s) (physician) from the regulatory authority-web. regulatory number: nl-lrb-00737160. a 62-year-old male patient received bnt162b2 (comirnaty), administration date 23dec2021 (batch/lot number: unknown) at the age of 62-year as dose 3 (booster), single for covid-19 immunisation; naproxen (naproxen), from 01nov2021 (batch/lot number: unknown) to 24dec2021 at 1 df 2x/day for back disorder; tramadol (tramadol), since 01nov2021 (batch/lot number: unknown) at 1 df 3x/day. relevant medical history included: "back problems" (unspecified if ongoing). the patient's concomitant medications were not reported. vaccination history included: astrazeneca vaccin (vaxzevria) (dose 2, single), administration date: 14jul2021, for covid-19 immunisation; astrazeneca vaccin (vaxzevria) (dose 1, single), administration date: 03may2021, for covid-19 immunisation. the following information was reported: off label use (medically significant) with onset 23dec2021, outcome "unknown", described as "off-label use"; interchange of vaccine products (medically significant) with onset 23dec2021, outcome "unknown", described as "interchange of vaccine products"; angioedema (medically significant) with onset 23dec2021, outcome "not recovered", described as "lips angioedema"; urticaria (non-serious) with onset 23dec2021, outcome "not recovered", described as "extensive urticaria". the action taken for tramadol was dosage not changed. the action taken for naproxen was dosage permanently withdrawn on 24dec2021. clinical course: time interval between beginning of drug administration and start of reaction / event was 3 hours. no follow-up attempts are possible; information about lot/batch number cannot be obtained. no further information is expected