seizure; coughing; chronic cough; headache; this case was received via ra (reference number: gb-mhra-adr 26574079) on 25-feb-2022 and was forwarded to moderna on 25-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of seizure (seizure), headache (headache), cough (coughing) and cough (chronic cough) in a 62-year-old male patient who received mrna-1273 (moderna covid-19 vaccine) (batch no. 000123a) for covid-19 vaccination. the patient's past medical history included encephalitis (in 2014 i had a seizure related to encephalitis), cough (cough was caused by having covid in early to mid december), seizure (in 2014 i had a seizure related to encephalitis,) in 2014, covid-19 (in early to mid-december) and short-term memory impairment (i have short term memory issues but this is the only seizure i have had since). concomitant products included omeprazole for esophageal reflux, sacubitril, valsartan (entresto) for heart failure, furosemide, covid-19 vaccine nrvv ad (chadox1 ncov-19) (covid-19 vaccine astrazeneca) from 21-feb-2021 to 05-may-2021, fexofenadine, bisoprolol, levothyroxine and folic acid for an unknown indication. on 02-feb-2022, the patient received third dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 03-feb-2022, the patient experienced headache (headache) (seriousness criterion hospitalization) and cough (chronic cough) (seriousness criterion hospitalization). on an unknown date, the patient experienced seizure (seizure) (seriousness criterion hospitalization) and cough (coughing) (seriousness criterion hospitalization). at the time of the report, seizure (seizure) had resolved, headache (headache) and cough (coughing) had not resolved and cough (chronic cough) was resolving. diagnostic results (normal ranges are provided in parenthesis if available): on 02-feb-2022, 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 medications were reported. medical history included patient thought cough was caused by having covid in early to mid-december. in 2014 patient had a seizure related to encephalitis. patient has short term memory issues but this was the only seizure patient have had since. patient did not believe that he suddenly developed epilepsy, besides the first seizure was definitely provoked. patient was not seen by a specialist during his 1 day in hospital. patient has not had symptoms associated with covid-19. company comment: this regulatory authority case concerns a 62-year-old male patient, with relevant medical history of an episode of seizure related to encephalitis 8 years ago, heart failure (according to concomitant medication reported) and cough, who experienced the serious (hospitalization) unexpected events of seizure (aesi), headache and cough (reported as coughing and chronic cough) after the third dose of mrna-1273. the events headache and chronic cough occurred the next day after vaccination, while for the events seizure and coughing no dates reported. event seizure outcome recovered. additionally, the patient was previously vaccinated with two doses of covid-19-vaccine astrazeneca. patient�s mentioned medical history remains a confounder. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report.; sender's comments: this regulatory authority case concerns a 62-year-old male patient, with relevant medical history of an episode of seizure related to encephalitis 8 years ago, heart failure (according to concomitant medication reported) and cough, who experienced the serious (hospitalization) unexpected events of seizure (aesi), headache and cough (reported as coughing and chronic cough) after the third dose of mrna-1273. the events headache and chronic cough occurred the next day after vaccination, while for the events seizure and coughing no dates reported. event seizure outcome recovered. additionally, the patient was previously vaccinated with two doses of covid-19-vaccine astrazeneca. patient�s mentioned medical history remains a confounder. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report

test date: 20220202; test name: covid-19 virus test; test result: negative ; result unstructured data: no - negative covid-19 test

na

na