Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chest X-ray, Computerised tomogram, Pain, SARS-CoV-2 test
Clinical narrative: pain localised; COVID-19 pneumonia; Could not move his arm after second dose of vaccine; lost weight; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain localised) and COVID-19 PNEUMONIA (COVID-19 pneumonia) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A and 012A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Alcohol use (Beer, wine, wisky,) from 1964 to 26-Dec-1989, Tobacco user (one pack of cigarette a day) from 1964 to 09-Sep-2010 and Ulcerative colitis. Concurrent medical conditions included Emphysema (from smoking) since 2003 and Diabetes since 2013. Concomitant products included ADALIMUMAB (HUMIRA 40MG/0.8ML) for Colitis ulcerative, 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) and FOLIC ACID for Supplementation therapy.   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 prolonged and medically significant). On 10-Mar-2021, the patient experienced PAIN (pain localised) (seriousness criterion hospitalization prolonged) and WEIGHT DECREASED (lost weight). On 29-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move his arm after second dose of vaccine). On 16-Mar-2021, PAIN (pain localised) and WEIGHT DECREASED (lost weight) had resolved. On 31-Mar-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move his arm after second dose of vaccine) had resolved. At the time of the report, COVID-19 PNEUMONIA (COVID-19 pneumonia) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, SARS-CoV-2 test: (Positive) positive for Covid-19 virus. On 10-Mar-2021, Chest X-ray: (Positive) Covid Pneumonia. On 10-Mar-2021, Weight decreased: Decreased LOST 17 POUNDS. In March 2021, Computerised tomogram: Normal NO SIGNIFICANT FINDINGS.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient advised that he has qualifiy to clinical trial, so went hospital and given antibody infusion.  Treatment included Remdesvir, Prednisone, Paracetamol and  Xarelto  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Based on biological implausibility, the event of COVID-19 pneumonia causality is assessed as not applicable in related to mRNA-1273.   This case was linked to MOD-2021-150019 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Upon internal review on 08-Dec-2022 non-significant correction was performed to update "case received from field" to blank; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Based on biological implausibility, the event of COVID-19 pneumonia causality is assessed as not applicable in related to mRNA-1273.