Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Swelling
Clinical narrative: Slept all the next day/ Sleep excessive; Tired/ Tiredness; Arm swelled from shoulder to elbow/ Swelling; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept all the next day/ Sleep excessive), SWELLING (Arm swelled from shoulder to elbow/ Swelling) and FATIGUE (Tired/ Tiredness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 23-Apr-2022, the patient experienced SWELLING (Arm swelled from shoulder to elbow/ Swelling). On 24-Apr-2022, the patient experienced HYPERSOMNIA (Slept all the next day/ Sleep excessive) and FATIGUE (Tired/ Tiredness). At the time of the report, HYPERSOMNIA (Slept all the next day/ Sleep excessive) and FATIGUE (Tired/ Tiredness) outcome was unknown and SWELLING (Arm swelled from shoulder to elbow/ Swelling) was resolving.            Relevant concomitant medications were not reported.  On 29-Oct-2021, patient received first booster dose of Moderna COVID-19 vaccine. On Apr-2022, patient received second booster dose of Moderna COVID-19 vaccine.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  The reporter's causality for the event of tired, slept all the next day and arm swelled from shoulder to elbow with HUMIRA was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case reported by a consumer. A 67-year-old female patient, with concurrent condition of rheumatoid arthritis, experienced non serious events of hypersomnia (AESI), swelling and fatigue after receiving fourth dose of mRNA-1273 vaccine. Exact vaccination date was not provided, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Concurrent condition of rheumatoid arthritis could be a contributory factor for all the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 67-year-old female patient, with concurrent condition of rheumatoid arthritis, experienced non serious events of hypersomnia (AESI), swelling and fatigue after receiving fourth dose of mRNA-1273 vaccine. Exact vaccination date was not provided, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Concurrent condition of rheumatoid arthritis could be a contributory factor for all the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.