Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased
Clinical narrative: 2nd dose-18-APR-2021,Dose 3-AUG-2021; Elevated sedimentation rate; This spontaneous case was reported by a consumer and describes the occurrence of RED BLOOD CELL SEDIMENTATION RATE INCREASED (Elevated sedimentation rate) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose-18-APR-2021,Dose 3-AUG-2021) in a 59-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.    The patient's past medical history included Bursitis in 2015, Tendon disorder NOS in 2015 and Knee arthroscopy in November 2015. Concurrent medical conditions included Neuropathy since 2015, Rheumatoid arthritis, Allergy NOS, Blood cholesterol increased, Stomach discomfort and Blood pressure management. Concomitant products included SIMVASTATIN (ZOCOR) for Blood cholesterol increased, GABAPENTIN (NEURONTIN) for Neuropathy, METHOTREXATE for Rheumatoid arthritis, ESOMEPRAZOLE SODIUM (NEXIUM MUPS [ESOMEPRAZOLE SODIUM]) and FAMOTIDINE (PEPCID AC) for Stomach discomfort, FOLIC ACID, VITAMIN D3 and MECOBALAMIN (VITAMIN B12 [MECOBALAMIN]) for Supplementation therapy.   In 2015, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.8ML, 1 in 14 D. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40MG/0.4ML, 1 in 14 D. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2022, the patient experienced RED BLOOD CELL SEDIMENTATION RATE INCREASED (Elevated sedimentation rate). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose-18-APR-2021,Dose 3-AUG-2021). At the time of the report, RED BLOOD CELL SEDIMENTATION RATE INCREASED (Elevated sedimentation rate) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose-18-APR-2021,Dose 3-AUG-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Red blood cell sedimentation rate: 53 MM/HR. In February 2022, Red blood cell sedimentation rate: 39 MM/HR. In 2022, Red blood cell sedimentation rate: 29 MM/HR.         Patient took Hyzaar (HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM) 50mg/12.5mg orally on an unknown date for unspecified blood pressure condition. Percocet for unknown indication. It was unknown if patient was enrolled in COVID-19 vaccine trial. Causality for Humira (Adalimumab) 40MG/0.4ML: The reporter's causality for the event of Elevated sed rate 2021 Elevated sed rate onset in Feb-2022 with Humira (Adalimumab) 40MG/0.4ML with no reasonable possibility.  No treatment details were reported. 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.