Age: 67.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Blood pressure measurement, Colonoscopy, Fall, Feeling abnormal
Clinical narrative: Hemorrhoids; COLONOSCOPY SHOWED POLYPS; WEAKNESS; FALLING SENSATION; OSTEOPOROSIS; FEELING DIFFERENT; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (WEAKNESS), FALL (FALLING SENSATION), OSTEOPOROSIS (OSTEOPOROSIS), FEELING ABNORMAL (FEELING DIFFERENT) and HAEMORRHOIDS (Hemorrhoids) in a 67-year-old male 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 ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    It was unknown if the patient was enrolled in any covid 19 vaccine trial.  Previously administered products included for Allergy: AMBIEN and OXYCONTIN. Past adverse reactions to the above products included Feeling abnormal with AMBIEN and OXYCONTIN. Concurrent medical conditions included Rheumatoid arthritis, Non-smoker, Abstains from alcohol, Acid reflux (esophageal), Pain, Arthritis and Vitamin supplementation (Vitamin D1,Vitamin B12,FISH OIL,FIBER ,vitamin C). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), FOLIC ACID for Arthritis, METFORMIN for Diabetes, TRAMADOL for Pain, METHOTREXATE and PREDNISONE for Rheumatoid arthritis, POLYCARBOPHIL CALCIUM (FIBER), FISH OIL and VITAMIN D1 for Supplementation therapy, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for Vitamin B12 supplementation, VITAMIN C [ASCORBIC ACID] for Vitamin C supplementation, PRIMIDONE, CLOPIDOGREL BISULFATE (PLAVIX), CELECOXIB (CELEXA [CELECOXIB]), ISOSORBIDE MONONITRATE (IMDUR) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   In February 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In March 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 27-Apr-2021, the patient experienced HAEMORRHOIDS (Hemorrhoids) and LARGE INTESTINE POLYP (COLONOSCOPY SHOWED POLYPS). In 2021, the patient experienced ASTHENIA (WEAKNESS), FALL (FALLING SENSATION), OSTEOPOROSIS (OSTEOPOROSIS) and FEELING ABNORMAL (FEELING DIFFERENT). At the time of the report, ASTHENIA (WEAKNESS), FALL (FALLING SENSATION), OSTEOPOROSIS (OSTEOPOROSIS) and FEELING ABNORMAL (FEELING DIFFERENT) outcome was unknown and HAEMORRHOIDS (Hemorrhoids) and LARGE INTESTINE POLYP (COLONOSCOPY SHOWED POLYPS) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Colonoscopy: Polyps, Hemorrhoids. In 2021, Blood pressure measurement: Blood pressure went crazy/ abnormal. In July 2021, Haemoglobin: Low.         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.  The daily dose of Humira drug was reported as citrate free and it was taken as 40 mg, once in two weeks.  The treatment medication was not provided.