Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral, Post-acute COVID-19 syndrome, SARS-CoV-2 test
Clinical narrative: COVID-19 / long covid; NEUROPATHY; Diabetes; GLAUCOMA; Arthritis; ASTHMA; LONG TERM DEPRESSION; Blood pressure high; high level of Hemoglobin a1c; Confused; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (COVID-19 / long covid), NEUROPATHY PERIPHERAL (NEUROPATHY), DIABETES MELLITUS (Diabetes) and GLAUCOMA (GLAUCOMA) in a 65-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 products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included COVID-19 virus test positive in October 2021. Concurrent medical conditions included Seasonal allergy, Non-tobacco user, Abstains from alcohol, Tiredness, Blood cholesterol abnormal, Thyroid disorder, Overweight and Rheumatoid arthritis.   On 17-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg Citrate Free, every 2 weeks. On 27-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg, every 2 weeks. In January 2022, the patient experienced POST-ACUTE COVID-19 SYNDROME (COVID-19 / long covid) (seriousness criterion hospitalization) and CONFUSIONAL STATE (Confused). In February 2022, the patient experienced GLYCOSYLATED HAEMOGLOBIN INCREASED (high level of Hemoglobin a1c). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (NEUROPATHY) (seriousness criterion medically significant), DIABETES MELLITUS (Diabetes) (seriousness criterion medically significant), GLAUCOMA (GLAUCOMA) (seriousness criterion medically significant), ARTHRITIS (Arthritis), ASTHMA (ASTHMA), DEPRESSION (LONG TERM DEPRESSION) and HYPERTENSION (Blood pressure high). The patient was hospitalized on 04-Jan-2022 due to POST-ACUTE COVID-19 SYNDROME. At the time of the report, POST-ACUTE COVID-19 SYNDROME (COVID-19 / long covid) and CONFUSIONAL STATE (Confused) was resolving and NEUROPATHY PERIPHERAL (NEUROPATHY), DIABETES MELLITUS (Diabetes), GLAUCOMA (GLAUCOMA), ARTHRITIS (Arthritis), ASTHMA (ASTHMA), DEPRESSION (LONG TERM DEPRESSION), GLYCOSYLATED HAEMOGLOBIN INCREASED (high level of Hemoglobin a1c) and HYPERTENSION (Blood pressure high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: (Positive) Positive. In February 2022, Glycosylated haemoglobin: high level of HBA1c. On an unknown date, Blood pressure measurement: High Blood Pressure.         It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  Treatment information was not provided.  Company comment: This is a spontaneous case reported by a consumer. A 65-year-old male patient, previously vaccinated with 3 doses of Tozinameran, with medical history of COVID-19 and with concurrent medical conditions of overweight, blood cholesterol abnormal, thyroid disorder and rheumatoid arthritis treated with Adalimumab, experienced serious (hospitalization) event of Long COVID after receiving booster dose of  mRNA-1273 vaccine. Patient was hospitalized 8 days after vaccination due to COVID -19 and felt tired. On an unknown date, patient experienced medically significant events of neuropathy peripheral, diabetes mellitus and glaucoma. In addition, he experienced non serious events of arthritis (AESI), asthma, depression, glycosylated hemoglobin increased, confusional state and hypertension. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Thyroid disorder could be a contributory factor for depression. Rheumatoid arthritis could be a contributory factor for arthritis. Overweight is a risk factor for diabetes mellitus and hypertension. Diabetes is a risk factor for glycosylated hemoglobin increased, glaucoma and neuropathy peripheral. Adalimumab is a confounding factor for diabetes mellitus, depression, neuropathy, hypertension, asthma and COVID-19.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case reported by a consumer. A 65-year-old male patient, previously vaccinated with 3 doses of Tozinameran, with medical history of COVID-19 and with concurrent medical conditions of overweight, blood cholesterol abnormal, thyroid disorder and rheumatoid arthritis treated with Adalimumab, experienced serious (hospitalization) event of Long COVID after receiving booster dose of  mRNA-1273 vaccine. Patient was hospitalized 8 days after vaccination due to COVID -19 and felt tired. On an unknown date, patient experienced medically significant events of neuropathy peripheral, diabetes mellitus and glaucoma. In addition, he experienced non serious events of arthritis (AESI), asthma, depression, glycosylated hemoglobin increased, confusional state and hypertension. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Thyroid disorder could be a contributory factor for depression. Rheumatoid arthritis could be a contributory factor for arthritis. Overweight is a risk factor for diabetes mellitus and hypertension. Diabetes is a risk factor for glycosylated hemoglobin increased, glaucoma and neuropathy peripheral. Adalimumab is a confounding factor for diabetes mellitus, depression, neuropathy, hypertension, asthma and COVID-19.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.