Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, COVID-19 immunisation, Hypersomnia, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; Revaccination with different COVID-19 vaccine; Slept a lot; Sick with COVID; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept a lot), COVID-19 (Sick with COVID), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 011M20A and 027L0A) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    The patient's past medical history included Tobacco user (Stopped 1998.) in 1998. Concurrent medical conditions included Dizziness, Tuberculosis, Rheumatoid arthritis, Arthritis, Drug allergy (Statin allergy) and Abstains from alcohol. Concomitant products included MELOXICAM for Arthritis, MECLOZINE HYDROCHLORIDE (MECLIZINE [MECLOZINE HYDROCHLORIDE]) for Dizziness, LEFLUNOMIDE and FOLIC ACID for Rheumatoid arthritis, PREDNISONE, DILTIAZEM, CITALOPRAM, LISINOPRIL, TOPIRAMATE, PREGABALIN, ONDANSETRON, BENZONATATE, MONTELUKAST and PRAVASTATIN for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, 40mg/0.4ml, (40 mg,1 in 2 wk). On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jun-2022, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 21-Aug-2022, the patient experienced HYPERSOMNIA (Slept a lot) and COVID-19 (Sick with COVID). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. On 28-Aug-2022, HYPERSOMNIA (Slept a lot) and COVID-19 (Sick with COVID) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2022, SARS-CoV-2 test: (Positive) Positive. On 28-Aug-2022, SARS-CoV-2 test: (Negative) Negative. On an unknown date, Body temperature: 99.8 99.8 F.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with PAXLOVID and no further information was provided.  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 concerning a 70-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse events of special interest of Hypersomnia and COVID-19, approximately 8 months after receiving the third dose of mRNA-1273 vaccine. The patient reported to have slept a lot and got sick with COVID (swab test positive) and was treated with Paxlovid. The events had resolved after 7 days. Revaccination with different COVID-19 vaccine and Interchange of vaccine products were also reported as the patient received a dose of other COVID-19 vaccine (Pfizer/Biontech) approximately 6 months after the third dose of mRNA-1273/2 months prior to the events of Hypersomnia and COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-623654 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 70-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse events of special interest of Hypersomnia and COVID-19, approximately 8 months after receiving the third dose of mRNA-1273 vaccine. The patient reported to have slept a lot and got sick with COVID (swab test positive) and was treated with Paxlovid. The events had resolved after 7 days. Revaccination with different COVID-19 vaccine and Interchange of vaccine products were also reported as the patient received a dose of other COVID-19 vaccine (Pfizer/Biontech) approximately 6 months after the third dose of mRNA-1273/2 months prior to the events of Hypersomnia and COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.