Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arrhythmia
Clinical narrative: Arrhythmia due to colonoscopy preparation two days after having covid 19 booster shot; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia due to colonoscopy preparation two days after having covid 19 booster shot) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Dec-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, Solution for injection in pre-filled pen. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free, Solution for injection in pre-filled pen. On 20-Dec-2021, the patient experienced ARRHYTHMIA (Arrhythmia due to colonoscopy preparation two days after having covid 19 booster shot) (seriousness criteria hospitalization and medically significant). At the time of the report, ARRHYTHMIA (Arrhythmia due to colonoscopy preparation two days after having covid 19 booster shot) had resolved.            No concomitant medication was provided.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Patient had taken booster dose.  The reporter's causality for Humira for the event(s) of ARRHYTHMIA was not provided.  Treatment included in Mar 2022, she had ablation for Arrhythmia.  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.  Company comment: This spontaneous case concerns a 59 year old female patient with no relevant medical history, who experienced the unexpected serious (hospitalization, medically significant) event of Arrhythmia, about 15 days after receiving the third dose (booster dose) of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also received the first 2 doses of primary series as per the recommended schedule with no reported adverse events. The patient had arrhythmia due to colonoscopy preparation, two days after the booster shot. However, the date of administration of booster shot was reported as 15 days before the event. It was reported that she was in the hospital. She underwent ablation for arrhythmia in about 3 months. No information on detailed clinical course, and relevant investigations was available in the report. The event resolved. Co suspect adalimumab could be confounding to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.    Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Significant Follow up was received. Patient  demographics, event information. suspect drug information and narrative description was updated. Sender's Comments: This spontaneous case concerns a 59 year old female patient with no relevant medical history, who experienced the unexpected serious (hospitalization, medically significant) event of Arrhythmia, about 15 days after receiving the third dose (booster dose) of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also received the first 2 doses of primary series as per the recommended schedule with no reported adverse events. The patient had arrhythmia due to colonoscopy preparation, two days after the booster shot. However, the date of administration of booster shot was reported as 15 days before the event. It was reported that she was in the hospital. She underwent ablation for arrhythmia in about 3 months. No information on detailed clinical course, and relevant investigations was available in the report. The event resolved. Co suspect adalimumab could be confounding to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.