headache; nausea; muscle ache; fatigue; diarrhea; sore eyes; this case was received via mhra (reference number: gb-mhra-adr 26657157) 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 headache (headache), nausea (nausea), myalgia (muscle ache), fatigue (fatigue), diarrhoea (diarrhea) and eye pain (sore eyes) in a 54-year-old male patient who received mrna-1273 (moderna covid-19 vaccine) (batch no. 000050a) for an unknown indication. the patient's past medical history included suspected covid-19 (unsure when symptoms started unsure when symptoms stopped), immunodeficiency (has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...) and jejunostomy (long term (18 years) enteral feed via jejunostomy.). concomitant products included lansoprazole for increasing indigestion, domperidone for nausea. on 17-feb-2022, the patient received dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on an unknown date, the patient experienced headache (headache) (seriousness criterion disability), nausea (nausea) (seriousness criterion disability), myalgia (muscle ache) (seriousness criterion disability), fatigue (fatigue) (seriousness criterion disability), diarrhoea (diarrhea) (seriousness criterion disability) and eye pain (sore eyes) (seriousness criterion disability). at the time of the report, headache (headache), nausea (nausea), myalgia (muscle ache), fatigue (fatigue), diarrhoea (diarrhea) and eye pain (sore eyes) was resolving. diagnostic results (normal ranges are provided in parenthesis if available): on 17-sep-2020, sars-cov-2 test: yes - positive covid-19 test (positive) yes - positive covid-19 test. the action taken with mrna-1273 (moderna covid-19 vaccine) (unknown) was unknown. patient has not tested positive for covid-19 since having the vaccine and patient was not enrolled in clinical trial. dosage text for suspect moderna covid-19 vaccine reported as dose 4c. reactions began approximately 8 hours after vaccination. serious enough to prohibit most daily functions for the following 9 days. report not related to possible inflammation of the heart (myocarditis or pericarditis). treatment information was not provided. company comment: this is a regulatory case concerning a 54-year-old male patient with medical history of immunodeficiency and jejunostomy and concomitant use of lansoprazole for increasing indigestion and domperidone for nausea, who experienced the serious unexpected events of headache, nausea, myalgia, fatigue, diarrhoea and eye pain. the events occurred 8 hours after a dose of mrna-1273 received as th 4th dose for covid-19 vaccination. the medical history, underlying indigestion and nausea remain as confounder for mentioned signs and symptoms. no treatment information was reported. events seriousness assessed as per regulatory authority report and retained for consistency. the benefit-risk relationship of covid-19 vaccine moderna (mrna-1273) is not affected by this report.; sender's comments: this is a regulatory case concerning a 54-year-old male patient with medical history of immunodeficiency and jejunostomy and concomitant use of lansoprazole for increasing indigestion and domperidone for nausea, who experienced the serious unexpected events of headache, nausea, myalgia, fatigue, diarrhoea and eye pain. the events occurred 8 hours after a dose of mrna-1273 received as th 4th dose for covid-19 vaccination. the medical history, underlying indigestion and nausea remain as confounder for mentioned signs and symptoms. no treatment information was reported. events seriousness assessed as per regulatory authority report and retained for consistency. the benefit-risk relationship of covid-19 vaccine moderna (mrna-1273) is not affected by this report