Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac operation, Fatigue, Headache, Nausea
Clinical narrative: AFTER MODERNA BOOSTER PATIENT FELT TIRED AND NAUSEOUS WITH HEADACHE; AFTER MODERNA BOOSTER PATIENT FELT TIRED AND NAUSEOUS WITH HEADACHE; AFTER MODERNA BOOSTER PATIENT FELT TIRED AND NAUSEOUS WITH HEADACHE; HEART SURGERY; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC OPERATION (HEART SURGERY) in a 64-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) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2020, the patient experienced CARDIAC OPERATION (HEART SURGERY) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (AFTER MODERNA BOOSTER PATIENT FELT TIRED AND NAUSEOUS WITH HEADACHE), HEADACHE (AFTER MODERNA BOOSTER PATIENT FELT TIRED AND NAUSEOUS WITH HEADACHE) and FATIGUE (AFTER MODERNA BOOSTER PATIENT FELT TIRED AND NAUSEOUS WITH HEADACHE). At the time of the report, CARDIAC OPERATION (HEART SURGERY), NAUSEA (AFTER MODERNA BOOSTER PATIENT FELT TIRED AND NAUSEOUS WITH HEADACHE), HEADACHE (AFTER MODERNA BOOSTER PATIENT FELT TIRED AND NAUSEOUS WITH HEADACHE) and FATIGUE (AFTER MODERNA BOOSTER PATIENT FELT TIRED AND NAUSEOUS WITH HEADACHE) had resolved.            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.  It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  No concomitant product use was reported.  The patient received both doses including booster of moderna vaccine one in once. Humira (Adalimumab) was citrate free.  No treatment information was provided.  The reporter's causality for the events of heart surgery and after moderna booster patient felt tired and nauseous with headache Humira (Adalimumab) was no reasonable possibility.  Company comment: This is a spontaneous case reported by a consumer. A 64-year-old male patient with current condition of ulcerative colitis treated with Adalimumab, received 2 doses of mRNA-1273 vaccine and experienced medically significant event of cardiac operation. Vaccination dates were not provided, latency cannot be assessed. In addition, patient experienced non serious events of fatigue, nausea and headache after receiving mRNA-1273 booster dose. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Ulcerative colitis could be a contributory factor for fatigue. Adalimumab could be a contributory factor for headache and nausea. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 64-year-old male patient with current condition of ulcerative colitis treated with Adalimumab, received 2 doses of mRNA-1273 vaccine and experienced medically significant event of cardiac operation. Vaccination dates were not provided, latency cannot be assessed. In addition, patient experienced non serious events of fatigue, nausea and headache after receiving mRNA-1273 booster dose. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Ulcerative colitis could be a contributory factor for fatigue. Adalimumab could be a contributory factor for headache and nausea. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.