sickness; shivers; headache; this case was received via regulatory authority (reference number: gb-ra-adr 26652842) 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 chills (shivers), headache (headache) and illness (sickness) in a 44-year-old female patient who received mrna-1273 (moderna covid-19 vaccine) for an unknown indication. patient had not had symptoms associated with covid-19. patient was not pregnant and was not currently breastfeeding. on 24-feb-2022, the patient received third dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 24-feb-2022, the patient experienced chills (shivers) (seriousness criterion medically significant) and headache (headache) (seriousness criterion medically significant). on 25-feb-2022, the patient experienced illness (sickness) (seriousness criterion medically significant). at the time of the report, chills (shivers), headache (headache) and illness (sickness) was resolving. diagnostic results (normal ranges are provided in parenthesis if available):on 08-feb-2021, sars-cov-2 test: positive (positive) yes - positive covid-19 test.the action taken with mrna-1273 (moderna covid-19 vaccine) (unknown) was unknown.concomitant medication was not provided.patient had passed urine every hour about 8 hours after the injection. patient was not enrolled in clinical trial. treatment information was not reported.patient had not tested positive for covid-19 since having the vaccine. company comment: this is a regulatory authority case concerning a 44-year-old female patient, with no medical history reported, who experienced the unexpected and serious (medically significant) events of chills, headache, and illness. the events occurred within the first day after the third dose of mrna-1273 vaccine. at the time of the report, the events were resolving. seriousness assessed by the regulatory authority. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report.; sender's comments: this is a regulatory authority case concerning a 44-year-old female patient, with no medical history reported, who experienced the unexpected and serious (medically significant) events of chills, headache, and illness. the events occurred within the first day after the third dose of mrna-1273 vaccine. at the time of the report, the events were resolving. seriousness assessed by the regulatory authority. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report

test date: 20210208; test name: covid-19 virus test; test result: positive; result unstructured data: yes - positive covid-19 test

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