Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypersomnia, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: severe chills/Later on Sunday patient had Chills; Fever; Patient went to sleep and slept for 12 hours./slept for 12 hours and feels fine.; Within 24 hours the patient had severe upper and lower body ache/Later on Sunday patient had Body Aches/Patient had to lie down; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Patient went to sleep and slept for 12 hours./slept for 12 hours and feels fine.), VACCINATION SITE PAIN (Sore left arm), MYALGIA (Within 24 hours the patient had severe upper and lower body ache/Later on Sunday patient had Body Aches/Patient had to lie down), CHILLS (severe chills/Later on Sunday patient had Chills) and PYREXIA (Fever) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2022, the patient experienced HYPERSOMNIA (Patient went to sleep and slept for 12 hours./slept for 12 hours and feels fine.) and MYALGIA (Within 24 hours the patient had severe upper and lower body ache/Later on Sunday patient had Body Aches/Patient had to lie down). In January 2022, the patient experienced VACCINATION SITE PAIN (Sore left arm). On 16-Jan-2022, the patient experienced CHILLS (severe chills/Later on Sunday patient had Chills) and PYREXIA (Fever). In January 2022, HYPERSOMNIA (Patient went to sleep and slept for 12 hours./slept for 12 hours and feels fine.), MYALGIA (Within 24 hours the patient had severe upper and lower body ache/Later on Sunday patient had Body Aches/Patient had to lie down), CHILLS (severe chills/Later on Sunday patient had Chills) and PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore left arm) outcome was unknown.            No concomitant medications were reported. No treatment details were provided.  Company comment: This case concerns a 61-year-old male patient with no medical history provided who experienced non-serious unexpected event of Hypersomnia and non-serious expected events of Vaccination site pain, Myalgia, Pyrexia and Chills. The events occurred on the same day or one day after the third, booster dose of mRNA-1273. At the time of the report, outcome of the event Vaccination site pain was unknown whereas all the other events resolved. The rechallenge for the events Chills and Hypersomnia was positive. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-455271 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2022: Follow up information received on 18/Jan/2022: Non-Significant Follow up received.; Sender's Comments: This case concerns a 61-year-old male patient with no medical history provided who experienced non-serious unexpected event of Hypersomnia and non-serious expected events of Vaccination site pain, Myalgia, Pyrexia and Chills. The events occurred on the same day or one day after the third, booster dose of mRNA-1273. At the time of the report, outcome of the event Vaccination site pain was unknown whereas all the other events resolved. The rechallenge for the events Chills and Hypersomnia was positive. The benefit-risk relationship of mRNA-1273 is not affected by this report.