Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Memory impairment, Nausea, Pain
Clinical narrative: Vaccination site erythema; Vaccination site pain; Memory impaired; Inappropriate schedule of vaccine administered; Pain/ General body pain; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Memory impaired), PAIN (Pain/ General body pain), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PAIN (Vaccination site pain) and NAUSEA (Nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Hysterectomy, Tonsillectomy and Chemotherapy (completed before starting Rinvoq). Previously administered products included for Product used for unknown indication: Enbrel (Enbrel allergy). Past adverse reactions to the above products included Rash with Enbrel. Concurrent medical conditions included Dizziness since 2020, Headache (minor headache most days that came and went) since October 2020, Food intolerance since 2020, Papular rash since 2020, Stomach ache since October 2020, Fibromyalgia since 2020, Skin breakout since October 2020, Diarrhea (occurred once or twice a week) since 2020, Muscle pain since 2020, Chest pain since 2020, Achilles tendonitis since 2020, Rheumatoid arthritis flare up (Joint aches and pains before Rinvoq but improved after Rinvoq) since 2020, Swelling of legs, Potassium supplementation, Breast cancer female (remission) since April 2019, Drug allergy (Enbrel), Non-tobacco user and Abstains from alcohol. Concomitant products included POTASSIUM for Potassium supplementation, HYDROXYCHLOROQUINE for Rheumatoid arthritis, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) for Swelling of legs.   In October 2020, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram. On 25-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In 2021, the patient experienced PAIN (Pain/ General body pain), NAUSEA (Nausea) and FATIGUE (Fatigue). On an unknown date, the patient experienced MEMORY IMPAIRMENT (Memory impaired), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, MEMORY IMPAIRMENT (Memory impaired), PAIN (Pain/ General body pain), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PAIN (Vaccination site pain) had not resolved and NAUSEA (Nausea), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            Patient took Rinvoq.  Patient had muscle aches and pains in her shoulders and neck since RINVOQ started and that usually happened every day. She had occasionally these symptoms in the past, but not for this length of time that happened every day. She noticed that she got a stomach ache in the area ?? below her ribs and that happened for every few days which typically lasted a few hours. She was diagnosed to have fibromyalgia last Nov or Dec-2020.   As of 22-Feb-2021, she was getting headaches and said eggs caused diarrhea. She was getting stomach aches in the morning but they were going away and still had aches and pains. When she first began RINVOQ her whole scalp broke out with bumps and it seemed to be better and cleared up in last few weeks. She explained that diarrhea occurred once or twice a week. She was more watchful with what she eats. The alternative etiology of diarrhea was food. She had chest pain and Achilles tendonitis. She had flare up also had all body soreness joint pain, pain in neck, hips, feet, hands, shoulders and knees. The patient had stiffness, lumps on knuckles and weather change causing flares.  No treatment medication was reported.  The reporter assessed all the events as not reasonably possible to Humira.  The reporter did not provide any causality assessment for the events of vaccination site pain, vaccination site erythema, memory impairment and general body pain. The reporter assessed the events of pain, fatigue and nausea as not related to Moderna vaccine.  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.   This case was linked to MOD-2022-622281.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow up contains updated event details, therapy dates and narrative. On 20-Apr-2022: Follow up contains updated narrative.