Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Drug ineffective, Dyspnoea, Feeding disorder, Fluid intake reduced
Clinical narrative: COVID-19; Cardiomegaly; Pulmonary edema; Pneumonia; Congestive heart failure; Respiratory tract infection bacterial; Atrial fibrillation; Fluid intake reduced; Unable to eat\could not drink; Sinus infection; shortness of breath; Lack of drug effect; Ankles swelling; This spontaneous case was reported by a consumer and describes the occurrence of CARDIOMEGALY (Cardiomegaly), PULMONARY OEDEMA (Pulmonary edema), PNEUMONIA (Pneumonia), CARDIAC FAILURE CONGESTIVE (Congestive heart failure), RESPIRATORY TRACT INFECTION BACTERIAL (Respiratory tract infection bacterial), ATRIAL FIBRILLATION (Atrial fibrillation) and COVID-19 (COVID-19) in a 71-year-old female 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 Ulcerative colitis and Crohn's disease.    Previously administered products included for No adverse event: Feldene and PENICILLIN. Past adverse reactions to the above products included Product used for unknown indication with Feldene and PENICILLIN. Concurrent medical conditions included Drug allergy (Manifestated with swelling/big welts on face/bruising) and Penicillin allergy (MANIFESTATED WITH  RASH). Concomitant products included FUROSEMIDE SODIUM (LASIX [FUROSEMIDE SODIUM]), AMILORIDE, APIXABAN (ELIQUIS), ASPIRIN [ACETYLSALICYLIC ACID], PANTOPRAZOLE, LEVOTHYROXINE, METOPROLOL, ROPINIROLE, TAGETES SPP. (LUTEIN [TAGETES SPP.]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), CELECOXIB (CELEXA [CELECOXIB]), GABAPENTIN (NEURONTIN), LOSARTAN, FAMOTIDINE, SEMAGLUTIDE (OZEMPIC), NIACIN, ATORVASTATIN, FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]) and INSULIN (NOVOLIN 30R [INSULIN]) for an unknown indication.   In 2013, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In November 2021, the patient experienced CARDIOMEGALY (Cardiomegaly) (seriousness criterion hospitalization), PULMONARY OEDEMA (Pulmonary edema) (seriousness criteria hospitalization and medically significant), PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant), CARDIAC FAILURE CONGESTIVE (Congestive heart failure) (seriousness criteria hospitalization and medically significant), RESPIRATORY TRACT INFECTION BACTERIAL (Respiratory tract infection bacterial) (seriousness criterion hospitalization) and JOINT SWELLING (Ankles swelling). On 13-May-2022, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant), FLUID INTAKE REDUCED (Fluid intake reduced), FEEDING DISORDER (Unable to eat\could not drink), SINUSITIS (Sinus infection) and DYSPNOEA (shortness of breath). The patient was hospitalized until 30-May-2022 due to COVID-19. The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) at an unspecified dose and frequency. At the time of the report, CARDIOMEGALY (Cardiomegaly), PULMONARY OEDEMA (Pulmonary edema), PNEUMONIA (Pneumonia), RESPIRATORY TRACT INFECTION BACTERIAL (Respiratory tract infection bacterial) and JOINT SWELLING (Ankles swelling) was resolving, CARDIAC FAILURE CONGESTIVE (Congestive heart failure), COVID-19 (COVID-19) and DYSPNOEA (shortness of breath) had not resolved and ATRIAL FIBRILLATION (Atrial fibrillation), FLUID INTAKE REDUCED (Fluid intake reduced), FEEDING DISORDER (Unable to eat\could not drink), SINUSITIS (Sinus infection) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Chest X-ray: cardiomegaly, congestive heart failure, pulmonary (abnormal) Cardiomegaly, congestive heart failure, pulmonary edema and suspected pneumonia. In November 2021, Computerised tomogram: unknown respiratory bacteria (abnormal) unknown respiratory bacteria. In March 2022, Heart rate: 161 161. On 13-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Company comment: This spontaneous case concerns a 71-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically significant, Hospitalization) AESI of Pulmonary oedema, Cardiac failure congestive, unexpected, serious (Hospitalization) AESI of COVID-19, unexpected, serious (Medically significant) AESI of Atrial fibrillation, unexpected, serious event of Pneumonia (Medically significant, Hospitalization), Respiratory tract infection bacterial (Hospitalization) and (Medically significant) event of Cardiomegaly. The events Cardiomegaly, Pulmonary oedema, Pneumonia, Cardiac failure congestive and Respiratory tract infection bacterial occurred approximately 8 months after administration of second dose of mRNA-1273, no specific date was reported. The exact date of onset of the event Atrial fibrillation was not specified in respect to the administration of a dose of mRNA-1273. The event COVID-19 occurred 62 days after administration of second dose of mRNA-1273, the first dose was administered 30 days prior. The event Drug ineffective was also reported. In November 2021, Chest X-ray was done which revealed cardiomegaly, congestive heart failure, pulmonary (abnormal) cardiomegaly, congestive heart failure, pulmonary edema and suspected pneumonia, computerised tomogram was done with the result of unknown respiratory bacteria. On May 13, 2022, SARS-CoV-2 test was done which revealed a positive result. It has been reported that patient was hospitalized for 3 days pneumonia and congestive heart failure, was discharged but still had shortness of breath. Patient started to experience atrial fibrillation upon starting Humira, patient sought consult to a cardiologist and was later diagnosed with COVID-19 and was subsequently admitted, after discharge patient still experience chronic sickness and nasal congestion. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 71-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Medically significant, Hospitalization) AESI of Pulmonary oedema, Cardiac failure congestive, unexpected, serious (Hospitalization) AESI of COVID-19, unexpected, serious (Medically significant) AESI of Atrial fibrillation, unexpected, serious event of Pneumonia (Medically significant, Hospitalization), Respiratory tract infection bacterial (Hospitalization) and (Medically significant) event of Cardiomegaly. The events Cardiomegaly, Pulmonary oedema, Pneumonia, Cardiac failure congestive and Respiratory tract infection bacterial occurred approximately 8 months after administration of second dose of mRNA-1273, no specific date was reported. The exact date of onset of the event Atrial fibrillation was not specified in respect to the administration of a dose of mRNA-1273. The event COVID-19 occurred 62 days after administration of second dose of mRNA-1273, the first dose was administered 30 days prior. The event Drug ineffective was also reported. In November 2021, Chest X-ray was done which revealed cardiomegaly, congestive heart failure, pulmonary (abnormal) cardiomegaly, congestive heart failure, pulmonary edema and suspected pneumonia, computerised tomogram was done with the result of unknown respiratory bacteria. On May 13, 2022, SARS-CoV-2 test was done which revealed a positive result. It has been reported that patient was hospitalized for 3 days pneumonia and congestive heart failure, was discharged but still had shortness of breath. Patient started to experience atrial fibrillation upon starting Humira, patient sought consult to a cardiologist and was later diagnosed with COVID-19 and was subsequently admitted, after discharge patient still experience chronic sickness and nasal congestion. The benefit-risk relationship of mRNA-1273 is not affected by this report.