Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: Congestive heart failure; Pneumonia; Vertigo; Fall; Black eye; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (Congestive heart failure), PNEUMONIA (Pneumonia), VERTIGO (Vertigo) and FALL (Fall) in a 73-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 Crohn's disease and Ulcerative colitis.    Concurrent medical conditions included Crohn's disease (MODERATE TO SEVERE ADULT CROHN'S DISEASE) and Ulcerative colitis (MODERATE TO SEVERE ULCERATIVE COLITIS).   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure) (seriousness criteria hospitalization and medically significant), PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant), VERTIGO (Vertigo) (seriousness criterion hospitalization) and FALL (Fall) (seriousness criterion hospitalization). In February 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced EYE CONTUSION (Black eye). The patient was hospitalized on sometime in 2021 due to CARDIAC FAILURE CONGESTIVE, FALL, PNEUMONIA and VERTIGO. On 09-Mar-2022, COVID-19 (COVID-19) had resolved. At the time of the report, CARDIAC FAILURE CONGESTIVE (Congestive heart failure), PNEUMONIA (Pneumonia), VERTIGO (Vertigo) and FALL (Fall) outcome was unknown and EYE CONTUSION (Black eye) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test: (Positive) positive.    Company comment : This spontaneous case concerns a 73-year-old, female patient with medical history of Moderate-to-severe Crohn's disease and Moderate-to-severe Ulcerative colitis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (hospitalization and medically significant) events of cardiac failure congestive (AESI) and pneumonia, the unexpected, serious (hospitalization) events of vertigo and fall, and the unexpected, non-serious events of eye contusion and COVID-19 (AESI). The events cardiac failure congestive, pneumonia, vertigo and fall occurred unknown number of days after receiving the third dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. The event eye contusion occurred unknown number of days after receiving the third dose of the mRNA-1273 vaccine. Of note, the event onset date was not provided, hence, the onset latency could not be assessed. The event COVID-19 occurred approximately 2 months after receiving the third dose of the mRNA-1273 vaccine. Approximately 1 to 2 months after vaccination, it was reported that the patient had been in and out of the hospital due to congestive heart failure, pneumonia, and she had fallen with vertigo. The patient was on ventilator for 3 days. No further clinical information (including details about hospitalization, diagnostic test/s, clinical course and treatment) was available for medical review. At the time of the report, the patient had two black eyes from the fall due to vertigo. Approximately 2 months after vaccination, the patient tested positive for COVID-19. No symptoms were reported and treatment information was unknown. However, the event had resolved at the time of the report. The patient's advanced age (high risk for infections) remains a confounder for the events pneumonia and COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.     No concomitant medications were reported.  On an unknown date in 2021, for over the past three months the patient had been in and out of the hospital due to congested heart failure, pneumonia, and had fallen with vertigo. On Jan-2022, patient was in hospital. Patient was on ventilator for 3 days.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.; Sender's Comments: This spontaneous case concerns a 73-year-old, female patient with medical history of Moderate-to-severe Crohn's disease and Moderate-to-severe Ulcerative colitis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (hospitalization and medically significant) events of cardiac failure congestive (AESI) and pneumonia, the unexpected, serious (hospitalization) events of vertigo and fall, and the unexpected, non-serious events of eye contusion and COVID-19 (AESI). The events cardiac failure congestive, pneumonia, vertigo and fall occurred unknown number of days after receiving the third dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. The event eye contusion occurred unknown number of days after receiving the third dose of the mRNA-1273 vaccine. Of note, the event onset date was not provided, hence, the onset latency could not be assessed. The event COVID-19 occurred approximately 2 months after receiving the third dose of the mRNA-1273 vaccine. Approximately 1 to 2 months after vaccination, it was reported that the patient had been in and out of the hospital due to congestive heart failure, pneumonia, and she had fallen with vertigo. The patient was on ventilator for 3 days. No further clinical information (including details about hospitalization, diagnostic test/s, clinical course and treatment) was available for medical review. At the time of the report, the patient had two black eyes from the fall due to vertigo. Approximately 2 months after vaccination, the patient tested positive for COVID-19. No symptoms were reported and treatment information was unknown. However, the event had resolved at the time of the report. The patient's advanced age (high risk for infections) remains a confounder for the events pneumonia and COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.