Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatic steatosis, Inappropriate schedule of product administration, SARS-CoV-2 test, Total lung capacity, Traumatic lung injury
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ATYPICAL PNEUMONIA (Walking pneumonia) in a 23-year-old male patient who received mRNA-1273 (Spikevax) 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 Alcohol use (alcohol use/a bottle of unspecified alcohol per week) from February 2017 to March 2017 and COVID-19 from 15-Jan-2022 to 21-Jan-2022. Concurrent medical conditions included Rheumatoid arthritis, Fruit allergy (all fruits except citrus allergy manifested by uncontrollable diarrhea, stomach pain, and nausea), Non-smoker, Muscle spasm, Tremor, Anxiety, Depression, Blood pressure management and Heart rate. Concomitant products included BUSPIRONE for Anxiety and Depression, METOPROLOL SUCCINATE for Blood pressure management and Heart rate, BACLOFEN for Muscle spasm, PRIMIDONE for Tremor. In May 2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In November 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. In May 2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In May 2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on May-21 and Dose 2 on May-22). In 2022, the patient experienced ATYPICAL PNEUMONIA (Walking pneumonia) (seriousness criterion medically significant). On 09-Sep-2022, the patient experienced TRAUMATIC LUNG INJURY (LUNG DAMAGE). On an unknown date, the patient experienced HEART RATE INCREASED (HEART RATE SPIKED WITH COVID VACCINE), HEPATIC ENZYME INCREASED (LIVER ENZYMES ELEVATED), HEPATIC STEATOSIS (Fatty liver) and GASTROOESOPHAGEAL REFLUX DISEASE (GASTRIC REFLUX). At the time of the report, ATYPICAL PNEUMONIA (Walking pneumonia), HEART RATE INCREASED (HEART RATE SPIKED WITH COVID VACCINE), HEPATIC ENZYME INCREASED (LIVER ENZYMES ELEVATED), HEPATIC STEATOSIS (Fatty liver), GASTROOESOPHAGEAL REFLUX DISEASE (GASTRIC REFLUX), TRAUMATIC LUNG INJURY (LUNG DAMAGE) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on May-21 and Dose 2 on May-22) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2022, SARS-CoV-2 test: 0 no unit.. On 09-Sep-2022, Total lung capacity: Lung damage. On an unknown date, Blood test: liver enzymes were elevated slightly. On 08-Jun-2022, the patient experienced bleeding on the injection site, the needle bent and the medication ran down thigh and lifted the pen up and medicine ran down abdomen/received partial medication. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment information was not provided. Company comment: This spontaneous case concerns a 23-years-old male patient with relevant concurrent medical condition of Rheumatoid Arthritis that was treated with co-suspect HUMIRA (ADALIMUMAB), who experienced the unexpected, serious (medically significant) event of atypical pneumonia that occurred on an unknown date in context to second dose of mRNA-1273 vaccine. Total lung capacity was Lung damage, and Blood test with liver enzymes were elevated. It was also reported that the patient experienced bleeding on the injection site, the needle bent and the medication ran down thigh and lifted the pen up and medicine ran down abdomen/received partial medication. No additional information is available regarding diagnostic work-up to support the current diagnosis and treatment details. The event outcome was unknown. The concomitant medical condition of Rheumatoid Arthritis treated with HUMIRA the co-suspect remains a risk factor to the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information. This case was linked to MOD-2022-645341 (Patient Link). Sender's Comments: This spontaneous case concerns a 23-years-old male patient with relevant concurrent medical condition of Rheumatoid Arthritis that was treated with co-suspect HUMIRA (ADALIMUMAB), who experienced the unexpected, serious (medically significant) event of atypical pneumonia that occurred on an unknown date in context to second dose of mRNA-1273 vaccine. Total lung capacity was Lung damage, and Blood test with liver enzymes were elevated. It was also reported that the patient experienced bleeding on the injection site, the needle bent and the medication ran down thigh and lifted the pen up and medicine ran down abdomen/received partial medication. No additional information is available regarding diagnostic work-up to support the current diagnosis and treatment details. The event outcome was unknown. The concomitant medical condition of Rheumatoid Arthritis treated with HUMIRA the co-suspect remains a risk factor to the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.