muscle weakness; large arm swelling; armpit pain; sweating increased armpits; this case was received via regulatory authority (reference number: gb-mhra-adr 26647972) on 27-feb-2022 and was forwarded to moderna on 27-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of peripheral swelling (large arm swelling), axillary pain (armpit pain), hyperhidrosis (sweating increased armpits) and muscular weakness (muscle weakness) in a 38-year-old female patient who received mrna-1273 (moderna covid-19 vaccine) (batch no. 000059a) for an unknown indication. no medical history information was reported. on 22-feb-2022, the patient received third dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 22-feb-2022, the patient experienced hyperhidrosis (sweating increased armpits) (seriousness criterion medically significant). on 23-feb-2022, the patient experienced peripheral swelling (large arm swelling) (seriousness criterion medically significant) and axillary pain (armpit pain) (seriousness criterion medically significant). on 24-feb-2022, the patient experienced muscular weakness (muscle weakness) (seriousness criterion medically significant). at the time of the report, peripheral swelling (large arm swelling), axillary pain (armpit pain), hyperhidrosis (sweating increased armpits) and muscular weakness (muscle weakness) had not resolved. diagnostic results (normal ranges are provided in parenthesis if available): on an unknown date, sars-cov-2 test: no - negative covid-19 test (negative) no - negative covid-19 test. the action taken with mrna-1273 (moderna covid-19 vaccine) (unknown) was unknown. no concomitant medication was reported. patient had not had symptoms associated with covid-19. patient was not pregnant. patient was not currently breastfeeding. patient had not tested positive for covid-19 since having the vaccine. patient was not enrolled in clinical trial. the dosage text was reported as dose 3c. no treatment information was reported. company comment: this is a regulatory case concerning a 38-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant), events of peripheral swelling, axillary pain, hyperhidrosis and muscular weakness. the events occurred within two days after the first third dose of mrna-1273 vaccine for the indication of covid-19 vaccination. there was no information provided about the first 2 doses. at the time of report outcome of the event was not resolved. further details about the events are not provided. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report. the case was assessed as serious as per regulatory authority report.; sender's comments: this is a regulatory case concerning a 38-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant), events of peripheral swelling, axillary pain, hyperhidrosis and muscular weakness. the events occurred within two days after the first third dose of mrna-1273 vaccine for the indication of covid-19 vaccination. there was no information provided about the first 2 doses. at the time of report outcome of the event was not resolved. further details about the events are not provided. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report. the case was assessed as serious as per regulatory authority report

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

na

na