Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Alcohol use (A BOTTLE OF UNSPECIFIED ALCOHOL PER WEEK) from February 2017 to March 2017. Concurrent medical conditions included Rheumatoid arthritis, Fruit allergy (All fruits except citrus allergy manifested by uncontrollable diarrhea, stomach pain, nausea), Blood pressure abnormal, Heart rate abnormal, Muscle spasm, Tremor, Anxiety, Depression and Non-smoker. Concomitant products included BUSPIRONE for Anxiety and Depression, METOPROLOL SUCCINATE for Blood pressure abnormal and Heart rate abnormal, BACLOFEN for Muscle spasm, PRIMIDONE for Tremor.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 15-Jan-2022, the patient experienced COVID-19 (COVID-19). On 21-Jan-2022, COVID-19 (COVID-19) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2022, SARS-CoV-2 test: 0 no unit. On an unknown date, Blood test: liver enzymes were elevated slightly.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 15-Jan-2022, the patient experienced COVID. On 21-Jan-2022, the COVID resolved. No treatment medication information was provided.  Company comment: This spontaneous case concerns a 23-years-old male patient with relevant medical history of Rheumatoid Arthritis that was treated with co-suspect HUMIRA (ADALIMUMAB), who experienced the unexpected, non-serious AESI event of COVID-19 that occurred on an unknown date in context to first dose of mRNA-1273 vaccine. No additional information is available regarding diagnostic work-up to support the current diagnosis and treatment details. The event outcome was resolved. The medical history of Rheumatoid Arthritis treated with HUMIRA the co-suspect remains a risk factor to the event. Ongoing pandemic remains a confounder. 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-2022-645353 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 23-years-old male patient with relevant medical history of Rheumatoid Arthritis that was treated with co-suspect HUMIRA (ADALIMUMAB), who experienced the unexpected, non-serious AESI event of COVID-19 that occurred on an unknown date in context to first dose of mRNA-1273 vaccine. No additional information is available regarding diagnostic work-up to support the current diagnosis and treatment details. The event outcome was resolved. The medical history of Rheumatoid Arthritis treated with HUMIRA the co-suspect remains a risk factor to the event. Ongoing pandemic remains a confounder. 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.