Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling hot, Hypersomnia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (it was very hard to get up), HYPERSOMNIA (terrible night of sleep/kept waking up and falling asleep/slept 10 straight hours/kept falling asleep every 2 hours), LETHARGY (really lethargic), NASOPHARYNGITIS (felt very cold) and FEELING HOT (face got really hot/felt really hot from cheekbones down to chin, including ears) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032HZ1A, 022BZ1A and 016CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM for Hypothyroidism, FEXOFENADINE, LOSARTAN POTASSIUM, ESCITALOPRAM OXALATE, APIXABAN (ELIQUIS) and FLUVASTATIN SODIUM for an unknown indication. On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021 at 5:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, the patient experienced HYPOKINESIA (it was very hard to get up), HYPERSOMNIA (terrible night of sleep/kept up waking up and falling asleep/slept 10 straight hours/kept falling asleep every 2 hours), LETHARGY (really lethargic), NASOPHARYNGITIS (felt very cold), CHILLS (really strong chills/could not get away from the chills/tremendous amount of chills/strongest chills he has ever had), FATIGUE (really fatigued/tremendously fatigued) and VACCINATION SITE PAIN (pain at the injection site). On 21-Dec-2021, the patient experienced FEELING HOT (face got really hot/felt really hot from cheekbones down to chin, including ears), PRURITUS (itching on the extreme left side of his torso area) and DIZZINESS (felt incredible dizzy/ afraid to walk down the stairs because he felt incredible dizzy, and was afraid to fall down/strongest dizziness he has ever had). On an unknown date, the patient experienced PYREXIA (fever). On 21-Dec-2021 at 9:00 PM, DIZZINESS (felt incredible dizzy/ afraid to walk down the stairs because he felt incredible dizzy, and was afraid to fall down/strongest dizziness he has ever had) had resolved. On 23-Dec-2021, PRURITUS (itching on the extreme left side of his torso area) had resolved. At the time of the report, HYPOKINESIA (it was very hard to get up), HYPERSOMNIA (terrible night of sleep/kept up waking up and falling asleep/slept 10 straight hours/kept falling asleep every 2 hours), LETHARGY (really lethargic), NASOPHARYNGITIS (felt very cold), FEELING HOT (face got really hot/felt really hot from cheekbones down to chin, including ears), FATIGUE (really fatigued/tremendously fatigued), VACCINATION SITE PAIN (pain at the injection site) and PYREXIA (fever) outcome was unknown and CHILLS (really strong chills/could not get away from the chills/ tremendous amount of chills/strongest chills he has ever had) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient did not experience any symptoms after receiving the first dose, he stated it was like a walk in the park. The patient was surprised that this happened because he did not have a history of having bad reactions to things. No treatment was given for his symptoms. Company comment: This is a spontaneous case concerning a 78-year-old male patient with no relevant medical history reported, who experienced the non-serious, according CCDS, AESI event of Hypersomnia and other non-serious such as lethargy, hypokinesia, nasopharyngitis and others. The events occurred approximately 7 months and 15 days after the third dose of mRNA-1273 vaccine. The rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2021-424496, MOD-2021-424502 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 78-year-old male patient with no relevant medical history reported, who experienced the non-serious, according CCDS, AESI event of Hypersomnia and other non-serious such as lethargy, hypokinesia, nasopharyngitis and others. The events occurred approximately 7 months and 15 days after the third dose of mRNA-1273 vaccine. The rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.