Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hypersomnia, Impaired work ability, SARS-CoV-2 test
Clinical narrative: Slept for 24 hours; tested positive when she woke up; Stayed home for 14 days; This spontaneous case was reported by a patient and describes the occurrence of HYPERSOMNIA (Slept for 24 hours), COVID-19 (tested positive when she woke up) and IMPAIRED WORK ABILITY (Stayed home for 14 days) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Multisystem inflammatory syndrome in adults ((MIS-A)) and Allergy (everything patient comes into contact with).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HYPERSOMNIA (Slept for 24 hours), COVID-19 (tested positive when she woke up) and IMPAIRED WORK ABILITY (Stayed home for 14 days). In March 2021, IMPAIRED WORK ABILITY (Stayed home for 14 days) had resolved. At the time of the report, HYPERSOMNIA (Slept for 24 hours) and COVID-19 (tested positive when she woke up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient stated that prior to Mar-2021 patient weight was 170 pounds and after last round of bloodwork patient weight was 210 lbs. Patient had been retaining fluid and gained substantial amount of weight through this illness. No treatment medications were reported. Events sick and malaise subsumed under the event Covid-19  Company comment- This spontaneous case concerns a 57-year-old female patient with no relevant medical history, who experienced unexpected, non-serious AESI Hypersomnia, which occurred on the same month of vaccination with a first dose of mRNA-1273. Latency between vaccination and the event could not be assessed since the exact onset date of the event was not provided. The patient reported that after she received her vaccine, she didn't feel well and slept for 24 hours. When she woke up, she tested positive for Covid-19. She then quarantined for 14 days. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-653642 (Patient Link).; Sender's Comments: This spontaneous case concerns a 57-year-old female patient with no relevant medical history, who experienced unexpected, non-serious AESI Hypersomnia, which occurred on the same month of vaccination with a first dose of mRNA-1273. Latency between vaccination and the event could not be assessed since the exact onset date of the event was not provided. The patient reported that after she received her vaccine, she didn't feel well and slept for 24 hours. When she woke up, she tested positive for Covid-19. She then quarantined for 14 days. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.