shaking; shivering; tiredness; this case was received via regulatory authority (reference number: gb-ra-adr 26630047) on 24-feb-2022 and was forwarded to moderna on 24-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of tremor (shaking), chills (shivering) and fatigue (tiredness) in a 71-year-old male patient who received mrna-1273 (moderna covid-19 vaccine) (batch no. 3004675) for an unknown indication. the patient's past medical history included steroid therapy (taking regular steroid treatment (e.g. orally or rectally)). concurrent medical conditions included rheumatoid arthritis (taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...) and immunodeficiency (has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). concomitant products included prednisolone and mycophenolate mofetil (sandoz mycophenolate mofetil) for arthritis rheumatoid, covid-19 vaccine nrvv ad (chadox1 ncov-19) (covid-19 vaccine astrazeneca) from 14-may-2021 to an unknown date for revaccination, covid-19 vaccine nrvv ad (chadox1 ncov-19) (covid-19 vaccine astrazeneca) from 09-feb-2021 to an unknown date for vaccination, calcium carbonate, colecalciferol (adcal d3) and pantoprazole for an unknown indication. on 16-nov-2021, the patient received third dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 16-nov-2021, the patient experienced tremor (shaking) (seriousness criterion medically significant), chills (shivering) (seriousness criterion medically significant) and fatigue (tiredness) (seriousness criterion medically significant). on 17-nov-2021, tremor (shaking), chills (shivering) and fatigue (tiredness) had resolved. diagnostic results (normal ranges are provided in parenthesis if available): on an unknown date, sars-cov-2 test: negative (negative) no - negative covid-19 test. the action taken with mrna-1273 (moderna covid-19 vaccine) (unknown) was unknown. no treatment medication were provided. patient reaction came several hours after vaccination and lasted through the night - and tiredness through next day.patient had not tested positive for covid-19 since having the vaccine. patient is not enrolled in clinical trial. this report is not related to possible inflammation of the heart myocarditis or pericarditis company comment: this regulatory authority case of interchange of vaccine products, concerns a 71-year-old male patient, with relevant medical history of steroid therapy, rheumatoid arthritis, immunodeficiency, and previous vaccinations with covid-19 vaccine astrazeneca, who experienced the unexpected serious (medically significant) events of tremor, chills and fatigue the events occurred on the same day after receiving the booster dose of mrna-1273 vaccine. at the time of the report the outcome of the events was resolved. the patient's medical history of steroid therapy, rheumatoid arthritis, and immunodeficiency remain as confounders for the occurrence of the events. event seriousness assessed as per regulatory authority report. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report. sender's comments: this regulatory authority case of interchange of vaccine products, concerns a 71-year-old male patient, with relevant medical history of steroid therapy, rheumatoid arthritis, immunodeficiency, and previous vaccinations with covid-19 vaccine astrazeneca, who experienced the unexpected serious (medically significant) events of tremor, chills and fatigue the events occurred on the same day after receiving the booster dose of mrna-1273 vaccine. at the time of the report the outcome of the events was resolved. the patient's medical history of steroid therapy, rheumatoid arthritis, and immunodeficiency remain as confounders for the occurrence of the events. event seriousness assessed as per regulatory authority report. the benefit-risk relationship of mrna-1273 vaccine 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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immunodeficiency (has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); rheumatoid arthritis (taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)