Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Blood pressure measurement, Fatigue, Hypertension, Influenza like illness
Clinical narrative: ENLARGED PROSTATE; Blood pressure high; Tiredness; Nasal stuffiness; Flu like symptoms; Shoulder discomfort; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal stuffiness), INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCULOSKELETAL DISCOMFORT (Shoulder discomfort), PROSTATOMEGALY (ENLARGED PROSTATE) and HYPERTENSION (Blood pressure high) in a 79-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.    The patient's past medical history included Basal cell carcinoma in 2016, Upper back pain, Back strain, Chemical exposure, Aortic aneurysm, Stroke, Fusion of vertebra, Endovascular aortic aneurysm repair and Cancer surgery. Family history included Mastectomy (Patient's sister) and Cancer (Mother and grandmother died due to cancer). Concurrent medical conditions included Alcohol use (one glass of wine a day), Tobacco user, Ex-smoker, Anticoagulant therapy and Iron supplementation. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, IRON for Supplementation therapy.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, received third 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) 1 dosage form. On 18-Jan-2021, the patient experienced NASAL CONGESTION (Nasal stuffiness), INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCULOSKELETAL DISCOMFORT (Shoulder discomfort) and FATIGUE (Tiredness). On an unknown date, the patient experienced PROSTATOMEGALY (ENLARGED PROSTATE) and HYPERTENSION (Blood pressure high). On 18-Jan-2021, NASAL CONGESTION (Nasal stuffiness), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MUSCULOSKELETAL DISCOMFORT (Shoulder discomfort) had resolved. At the time of the report, PROSTATOMEGALY (ENLARGED PROSTATE) and HYPERTENSION (Blood pressure high) outcome was unknown and FATIGUE (Tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2016, Biopsy: Basal cell carcinoma-skin cancer. On an unknown date, Blood pressure measurement: high.         In 2016, the patient was diagnosed with basal cell carcinoma, a skin cancer and had surgery to cut it all out.   It was a sore first that did not heal, so he went to his dermatologist to had biopsy. No chemotherapy and radiation therapy done. He felt the slight reaction on two or three in the afternoon after he got his first dose of Covid-19 Vaccine in the morning of on 18 Jan 2021. He had flu like symptoms for about 24 hours after the first covid vaccine. Next morning all of the symptoms already resolved. He did not experience any signs and symptoms from the second dose and booster shot of Covid 19 vaccine. Primary reporter does not have the lot number of Covid 19 vaccines because he did not have the vaccination card with him at the time of the call since he was not at home. He was taking medications for enlarged prostate, high blood pressure, for blood flow, and heart medicines.  The reporter did not provide any causality assessment for the events of enlarged prostate and blood pressure high with Humira. The reporter assessed rest of the events to be not related to Humira.  The reporter did not provide any causality assessment for the events of enlarged prostate and blood pressure high with Moderna vaccine. The reporter assessed the events of tiredness, flu like symptoms and shoulder discomfort as probably related while the event of nasal stuffiness as possibly 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.