breathlessness; dizziness; fatigue; long covid; this case was received via the ra (reference number: gb-mhra-adr 26655755) 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 dyspnoea (breathlessness), dizziness (dizziness), fatigue (fatigue) and post-acute covid-19 syndrome (long covid) in a 48-year-old male patient who received mrna-1273 (moderna covid-19 vaccine) (batch no. lot 000040a) for an unknown indication. the patient's past medical history included eczema (have suffered from eczema for last 8-12 yrs), cold (similar symptoms occurred prior to pandemic in 2019 as a reaction to a possible (cold/flu) virus, but milder and for a shorter period.) and suspected covid-19 from 18-mar-2020 to 26-mar-2020. on 10-jan-2022, the patient received third dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 17-jan-2022, the patient experienced post-acute covid-19 syndrome (long covid) (seriousness criterion medically significant). on an unknown date, the patient experienced dyspnoea (breathlessness) (seriousness criterion medically significant), dizziness (dizziness) (seriousness criterion medically significant) and fatigue (fatigue) (seriousness criterion medically significant). at the time of the report, dyspnoea (breathlessness), dizziness (dizziness), fatigue (fatigue) and post-acute covid-19 syndrome (long covid) 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. concomitant product use was not provided by the reporter. previous vaccine doses 1 and 2 (both astra-zeneca) and previous c19 infection (march 2020) have also caused long covid symptoms, but not as severe. current symptoms included dizziness, slow thinking, fatigue, gut pains, mild breathlessness. patient has not tested positive for covid-19 since having the vaccine. patient was not enrolled in clinical trial. report not related to possible inflammation of the heart (myocarditis or pericarditis). treatment information was not provided. company comment: this regulatory authority case concerns a 48-year-old male patient, with history of previous covid-19, who experienced the serious (medically significant) unexpected events of dyspnoea, dizziness and fatigue. onset date was not provided; hence, temporal association cannot be assessed. post-acute covid syndrome was also reported as a serious event occurring one week after mrna-1273 vaccination. patient had previously received 2 doses of chadox-1 ncov-19 vaccine and it is reported that he experienced "long-covid symptoms" but not as severe, after both doses and as well as having covid-19. patient's mentioned history remains as a confounder. the benefit-risk relationship of mrna-1273 is not affected by this report.; sender's comments: this regulatory authority case concerns a 48-year-old male patient, with history of previous covid-19, who experienced the serious (medically significant) unexpected events of dyspnoea, dizziness and fatigue. onset date was not provided; hence, temporal association cannot be assessed. post-acute covid syndrome was also reported as a serious event occurring one week after mrna-1273 vaccination. patient had previously received 2 doses of chadox-1 ncov-19 vaccine and it is reported that he experienced "long-covid symptoms" but not as severe, after both doses and as well as having covid-19. patient's mentioned history remains as a confounder. the benefit-risk relationship of mrna-1273 is not affected by this report

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

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