Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19
Clinical narrative: Real sick; Upset stomach; Didn't feel well; Fever; Chills; Headache; Felt like the patient had COVID again; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Dec-2021 and was forwarded to Moderna on 10-Dec-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Real sick), ABDOMINAL DISCOMFORT (Upset stomach), MALAISE (Didn't feel well), PYREXIA (Fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (Real sick), ABDOMINAL DISCOMFORT (Upset stomach), MALAISE (Didn't feel well), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and SUSPECTED COVID-19 (Felt like the patient had COVID again). At the time of the report, ILLNESS (Real sick), ABDOMINAL DISCOMFORT (Upset stomach), MALAISE (Didn't feel well), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and SUSPECTED COVID-19 (Felt like the patient had COVID again) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The patient decided not to get the second shot of the vaccine due to the adverse reactions.  The reporter asked if the patient had to take the second dose as of now, then how would it work, whether the patient would be getting the second or booster dose or not.  Company Comment: This case concerns a male patient of unknown age with a history of COVID-19 in November 2020 who experienced the unexpected adverse event of special interest of suspected COVID-19 which occurred on an unknown date relative to vaccination with mRNA-1273 vaccine. The medical history of COVID-19 remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Dec-2021: Significant Follow up : reporter email address updated, reporter occupation updated and new event of missed dose was added; Sender's Comments: This case concerns a male patient of unknown age with a history of COVID-19 in November 2020 who experienced the unexpected adverse event of special interest of suspected COVID-19 which occurred on an unknown date relative to vaccination with mRNA-1273 vaccine. The medical history of COVID-19 remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.