Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Impaired quality of life, Malaise, Pain
Clinical narrative: All covid vaccinations caused pain with Humira; Not felt good/similar to indigestion; Sleeping two or three times; Impacted life on daily basis; Get tired easily/get fatigued on daily basis; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (All covid vaccinations caused pain with Humira), MALAISE (Not felt good/similar to indigestion), HYPERSOMNIA (Sleeping two or three times), IMPAIRED QUALITY OF LIFE (Impacted life on daily basis) and FATIGUE (Get tired easily/get fatigued on daily basis) 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 14-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2022, received third 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 an unknown date, the patient experienced PAIN (All covid vaccinations caused pain with Humira), MALAISE (Not felt good/similar to indigestion), HYPERSOMNIA (Sleeping two or three times), IMPAIRED QUALITY OF LIFE (Impacted life on daily basis) and FATIGUE (Get tired easily/get fatigued on daily basis). At the time of the report, PAIN (All covid vaccinations caused pain with Humira), MALAISE (Not felt good/similar to indigestion), HYPERSOMNIA (Sleeping two or three times), IMPAIRED QUALITY OF LIFE (Impacted life on daily basis) and FATIGUE (Get tired easily/get fatigued on daily basis) outcome was unknown.            Concomitant medications were not reported.  The patient had received booster dose. The patient had received first dose on 14-Jan-2020 and second dose on 15-Mar-2020.  Treatment information was not reported.  Company comment: This spontaneous case concerns a 67 year old female patient with concurrent Rheumatoid arthritis, on adalimumab, who experienced the unexpected non serious AESI of Hypersomnia, unknown days after receiving the third dose(booster) of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the primary series with the same vaccine in an interval of 2 months. Inappropriate schedule of product administration was noted. No further information on detailed clinical course and management of the event was available in the report. Co-suspect adalimumab could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-588245, MOD-2022-588246 (Patient Link).; Sender's Comments: This spontaneous case concerns a 67 year old female patient with concurrent Rheumatoid arthritis, on adalimumab, who experienced the unexpected non serious AESI of Hypersomnia, unknown days after receiving the third dose(booster) of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the primary series with the same vaccine in an interval of 2 months. Inappropriate schedule of product administration was noted. No further information on detailed clinical course and management of the event was available in the report. Co-suspect adalimumab could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.