Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chest X-ray, Computerised tomogram, Cough, Dyspnoea
Clinical narrative: COVID-19 pneumonia; Lost 17 pounds in 6 six days; Shortness of breath; Pain localised; Fever; Cough; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A and 028A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    The patient's past medical history included Alcohol use from 1964 to 26-Dec-1989, Cigarette smoker from 1964 to 09-Sep-2010 and Ulcerative colitis. Concurrent medical conditions included Emphysema (Severe emphysema from smoking, started in 2003 or 2004.) since 2003 and Diabetes since 2013. Concomitant products included INSULIN ASPART (NOVOLOG), DULAGLUTIDE (TRULICITY) and INSULIN DEGLUDEC (TRESIBA) for Diabetes, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for Emphysema, FISH OIL, ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]) and FOLIC ACID for Supplementation therapy.   In 2014, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg twice a day. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization and medically significant), COUGH (Cough) and PYREXIA (Fever). On 10-Mar-2021, the patient experienced WEIGHT DECREASED (Lost 17 pounds in 6 six days), DYSPNOEA (Shortness of breath) and PAIN (Pain localised). The patient was hospitalized for 7 days due to COVID-19 PNEUMONIA. On 16-Mar-2021, WEIGHT DECREASED (Lost 17 pounds in 6 six days) and PAIN (Pain localised) had resolved. At the time of the report, COVID-19 PNEUMONIA (COVID-19 pneumonia) was resolving, DYSPNOEA (Shortness of breath) had resolved and COUGH (Cough) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive for CoVid 19 vaccine. On 10-Mar-2021, Chest X-ray: abnormal (abnormal) COVID pneumonia. In March 2021, Computerised tomogram: inconclusive (Inconclusive) No significant finding.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 PNEUMONIA (COVID-19 pneumonia), WEIGHT DECREASED (Lost 17 pounds in 6 six days) and PAIN (Pain localised) to be not related. No further causality assessments were provided for DYSPNOEA (Shortness of breath), COUGH (Cough) and PYREXIA (Fever).    Concomitant medications also included and unspecified probiotic.  Treatment for the events included remdesivir, prednisone, paracetamol, and rivaroxaban.  This case concerns a 68-year-old male with a serious unexpected event of COVID-19 pneumonia, and nonserious unexpected cough, dyspnea, pain, weight decreased, and expected pyrexia. Latency 2 days after first mRNA-1273 dose. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-108848 (Patient Link).; Sender's Comments: This case concerns a 68-year-old male with a serious unexpected event of COVID-19 pneumonia, and nonserious unexpected cough, dyspnea, pain, weight decreased, and expected pyrexia. Latency 2 days after first mRNA-1273 dose. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.