Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hypersomnia, Hypoaesthesia
Clinical narrative: Been sleeping 10 hours a night when he normally sleeps half of that; Migraines  ever since and he can't get rid of it; Been feeling terrible ever since/Not bad enough to go to the hospital/body feels terrible; Portions of his body going numb (like his face or an arm); headaches ever since and he can't get rid of it; Exhausted; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Been sleeping 10 hours a night when he normally sleeps half of that), MIGRAINE (Migraines  ever since and he can't get rid of it), FEELING ABNORMAL (Been feeling terrible ever since/Not bad enough to go to the hospital/body feels terrible), HYPOAESTHESIA (Portions of his body going numb (like his face or an arm)) and HEADACHE (headaches ever since and he can't get rid of it) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 002C21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 23-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSOMNIA (Been sleeping 10 hours a night when he normally sleeps half of that), MIGRAINE (Migraines  ever since and he can't get rid of it), FEELING ABNORMAL (Been feeling terrible ever since/Not bad enough to go to the hospital/body feels terrible), HYPOAESTHESIA (Portions of his body going numb (like his face or an arm)), HEADACHE (headaches ever since and he can't get rid of it) and FATIGUE (Exhausted). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in December 2021 at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) in December 2021 at an unspecified dose and frequency. On 20-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, HYPERSOMNIA (Been sleeping 10 hours a night when he normally sleeps half of that), MIGRAINE (Migraines  ever since and he can't get rid of it), FEELING ABNORMAL (Been feeling terrible ever since/Not bad enough to go to the hospital/body feels terrible), HYPOAESTHESIA (Portions of his body going numb (like his face or an arm)), HEADACHE (headaches ever since and he can't get rid of it) and FATIGUE (Exhausted) had not resolved.            No concomitant medications were reported.  Company Comment:  This is a spontaneous case of Inappropriate schedule of vaccine administered, concerning a 67-year-old, male patient with no medical history reported, who experienced the unexpected non-serious event of Hypersomnia (AESI). The event occurred on the same day after the vaccination with the booster dose of mRNA-1273 vaccine. Patient received the first two doses with an interval of 46 days. Patient reported that he was exhausted after the booster dose and sleep for 10 hours. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-430397 (Patient Link).; Sender's Comments: This is a spontaneous case of Inappropriate schedule of vaccine administered, concerning a 67-year-old, male patient with no medical history reported, who experienced the unexpected non-serious event of Hypersomnia (AESI). The event occurred on the same day after the vaccination with the booster dose of mRNA-1273 vaccine. Patient received the first two doses with an interval of 46 days. Patient reported that he was exhausted after the booster dose and sleep for 10 hours. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.