sickness; headache; this case was received via regulatory authority (reference number: gb-mhra-adr 26657314) on 28-feb-2022 and was forwarded to moderna on 28-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of illness (sickness) and headache (headache) in a 63-year-old female patient who received mrna-1273 (moderna covid-19 vaccine) for an unknown indication. concurrent medical conditions included suspected covid-19 since 28-oct-2020. concomitant products included covid-19 vaccine nrvv ad (chadox1 ncov-19) (covid-19 vaccine astrazeneca) for an unknown indication. on 25-feb-2022, the patient received third dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 26-feb-2022, the patient experienced illness (sickness) (seriousness criterion medically significant) and headache (headache) (seriousness criterion medically significant). at the time of the report, illness (sickness) had not resolved and headache (headache) was resolving. diagnostic results (normal ranges are provided in parenthesis if available): on 30-oct-2020, sars-cov-2 test: positive covid-19 test (positive) positive covid-19 test. the action taken with mrna-1273 (moderna covid-19 vaccine) (unknown) was unknown. patient experienced sickness, nausea, severe body pain, blurred vision, sore arm at injection site, chills and fever. patient has not tested positive for covid-19 since having the vaccine. patient was not enrolled in clinical trial. it was reported that the report was not related to possible inflammation of the heart (myocarditis or pericarditis). company comment: this case concerns a 63-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of illness and headache 1 day after the third dose of mrna-1273. additionally, the patient experienced nausea, severe body pain, blurred vision, vaccination site pain, chills, and pyrexia. seriousness assessment has been retained as per regulatory authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. the benefit-risk relationship of mrna-1273 is not affected by this report.; sender's comments: this case concerns a 63-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of illness and headache 1 day after the third dose of mrna-1273. additionally, the patient experienced nausea, severe body pain, blurred vision, vaccination site pain, chills, and pyrexia. seriousness assessment has been retained as per regulatory authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. the benefit-risk relationship of mrna-1273 is not affected by this report

test date: 20201030; test name: covid-19 virus test; test result: positive ; result unstructured data: positive covid-19 test

na

suspected covid-19