Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Diabetes mellitus, Glycosylated haemoglobin, Musculoskeletal stiffness, Neuropathy peripheral
Clinical narrative: CATARACT LEFT AND RIGHT EYE; Diabetes; Neuropathy; Feet stiffness; VACCINE BOOSTER CAUSED SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (CATARACT LEFT AND RIGHT EYE), DIABETES MELLITUS (Diabetes) and NEUROPATHY PERIPHERAL (Neuropathy) in a 59-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 ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth 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) UNK, Citrate Free. On an unknown date, the patient experienced CATARACT (CATARACT LEFT AND RIGHT EYE) (seriousness criterion medically significant), DIABETES MELLITUS (Diabetes) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Feet stiffness) and VACCINATION SITE PAIN (VACCINE BOOSTER CAUSED SORE ARM). At the time of the report, CATARACT (CATARACT LEFT AND RIGHT EYE), DIABETES MELLITUS (Diabetes), NEUROPATHY PERIPHERAL (Neuropathy) and MUSCULOSKELETAL STIFFNESS (Feet stiffness) outcome was unknown and VACCINATION SITE PAIN (VACCINE BOOSTER CAUSED SORE ARM) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glycosylated haemoglobin: 5.7 5.7.         No concomitant medication reported. The patient's feet were stiff and sometimes after walking around for a little the right foot gets better but not the left. This was may be tied to diabetes. Tingling would start in patient toes then the bottom of her feet would numb (PARAESTHESIA). Patient toes got numb (HYPOAESTHESIA). Physician said, she had neuropathy. She had left and right cataract. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. Causality for Humira: Reporters causality for cataract left and right eye, vaccine booster caused sore arm, toes got numb was no reasonable possibility. Reporters causality for tingling on toes and numb feet, diabetes, neuropathy was not provided. No treatment medication reported.  Company comment: This spontaneous case concerns a 59-year-old female patient with no medical history reported, who experienced the unexpected serious events of Cataract ,Diabetes mellitus and Neuropathy peripheral (seriousness criteria medically significant ) which occurred on unspecified day after the fourth dose of mRNA-1273 vaccine .The patient  had started ADALIMUMAB (HUMIRA)  a non-company product as co-suspect which could be contributory to the event Neuropathy peripheral and cataracts. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 59-year-old female patient with no medical history reported, who experienced the unexpected serious events of Cataract ,Diabetes mellitus and Neuropathy peripheral (seriousness criteria medically significant ) which occurred on unspecified day after the fourth dose of mRNA-1273 vaccine .The patient  had started ADALIMUMAB (HUMIRA)  a non-company product as co-suspect which could be contributory to the event Neuropathy peripheral and cataracts. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.