Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Coronavirus infection, Drug ineffective, SARS-CoV-2 test, Tuberculin test
Clinical narrative: Coronavirus infection; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of CORONAVIRUS INFECTION (Coronavirus infection) in a 74-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 Plaque psoriasis.    The patient's past medical history included Ex-tobacco user (UP TO A PACK OF CIGARETTES PER DAY) from 1972 to 2021, Ex-alcohol user (VODKA AND GRAPE JUST SOCIALLY ON WEEKENDS) in 1992 and Atrial fibrillation. Previously administered products included for Infection: Prednisone. Past adverse reactions to the above products included Sugar blood level increased with Prednisone. Concurrent medical conditions included Blood pressure high since 1992, Plaque psoriasis since 2010, Chronic obstructive pulmonary disease since 2017, Type 2 diabetes mellitus and Fatty liver. Concomitant products included APIXABAN (ELIQUIS) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for Atrial fibrillation, METOPROLOL for Blood pressure high, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]), BUDESONIDE (PULMICORT) and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (DUONEB) for Chronic obstructive pulmonary disease, SERTRALINE for Depression, FUROSEMIDE (LASIX [FUROSEMIDE]) for Fluid retention, FERROUS SULFATE for Iron supplementation, GABAPENTIN for Restless legs, CLONAZEPAM (KLONOPIN) and TRAZODONE for Sleepy, GLIMEPIRIDE (AMARYL) for Sugar blood increased, POTASSIUM, VITAMIN D3, VITAMIN C [ASCORBIC ACID], VITAMIN B12 [VITAMIN B12 NOS] and ZINC for Supplementation therapy, MONTELUKAST for Unspecified injury of lung without open wound into thorax.   In 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free (1 in 2 wk), 2.5 mg. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced CORONAVIRUS INFECTION (Coronavirus infection) (seriousness criteria hospitalization and medically significant) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with PREDNISONE for Infection, at an unspecified dose and frequency. In March 2021, DRUG INEFFECTIVE (Lack of drug effect) had resolved. At the time of the report, CORONAVIRUS INFECTION (Coronavirus infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Tuberculin test: Unknown.         In Mar 2021 patient contracted the coronavirus, between his complete vaccination series and the booster. He experienced trouble breathing and a fever, but no other symptoms. He wore a mask for protection.  He received an unknown infusion in the hospital over the course of two hours the day after he tested positive for the virus. He could not recall admission or discharge dates or details, but does recall he received an unknown antibiotic and prednisone dose unknown, to treat the infection.  The alternative etiology as per reporter for event of hemorrhage was Eliquis use, for event of trouble breathing was chronic obstructive pulmonary disease and coronavirus, for event of fever of 101 was coronavirus. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Company comment: This is a spontaneous case reported by a consumer concerning a 74-year-old male patient with relevant medical history of Chronic obstructive pulmonary disease, Blood pressure high,  and moderate to severe chronic plaque psoriasis treated with Adalimumab (reported as co-suspect drug), who experienced the unexpected, serious (due to medically significant and hospitalization), event of coronavirus infection (AESI), on an unknown date on the next month after the second dose of mRNA-1273, with appropriate schedule of vaccination. Drug ineffective was considered an additional event. Coronavirus infection had resolved at the time of the last observation. He experienced trouble breathing and a fever, but no other symptoms. He wore a mask for protection. He received an unknown infusion in the hospital over the course of two hours the day after he tested positive for the virus. He could not recall admission or discharge dates or details, but does recall he received an unknown antibiotic and prednisone dose unknown, to treat the infection. It is unclear whether Adalimumab (date onset of administration unknown) could have decreased the efficacy of the vaccination. The medical history of Chronic obstructive pulmonary disease, Blood pressure high and Type 2 diabetes mellitus could exacerbate the severity of coronavirus infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-630803 (Patient Link).; Sender's Comments: This is a spontaneous case reported by a consumer concerning a 74-year-old male patient with relevant medical history of Chronic obstructive pulmonary disease, Blood pressure high,  and moderate to severe chronic plaque psoriasis treated with Adalimumab (reported as co-suspect drug), who experienced the unexpected, serious (due to medically significant and hospitalization), event of coronavirus infection (AESI), on an unknown date on the next month after the second dose of mRNA-1273, with appropriate schedule of vaccination. Drug ineffective was considered an additional event. Coronavirus infection had resolved at the time of the last observation. He experienced trouble breathing and a fever, but no other symptoms. He wore a mask for protection. He received an unknown infusion in the hospital over the course of two hours the day after he tested positive for the virus. He could not recall admission or discharge dates or details, but does recall he received an unknown antibiotic and prednisone dose unknown, to treat the infection. It is unclear whether Adalimumab (date onset of administration unknown) could have decreased the efficacy of the vaccination. The medical history of Chronic obstructive pulmonary disease, Blood pressure high and Type 2 diabetes mellitus could exacerbate the severity of coronavirus infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.