Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Feeling abnormal, Gastrointestinal disorder, Lymphadenopathy, X-ray
Clinical narrative: Patient to ER, patient was kept in observation for 18 hours and was diagnosed with tachycardia and A-fib which patient states she had never had prior.; gastric discomfort; feeling and looking terrible and almost collapsed into a chair.; swollen glands; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (Patient to ER, patient was kept in observation for 18 hours and was diagnosed with tachycardia and A-fib which patient states she had never had prior.) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism ((diagnosed prior to receiving any Covid vaccine)) and Sulfonamide allergy (allergic to Sulfa (diagnosed as an infant)). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 05-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 05-Oct-2023, the patient experienced GASTROINTESTINAL DISORDER (gastric discomfort), FEELING ABNORMAL (feeling and looking terrible and almost collapsed into a chair.) and LYMPHADENOPATHY (swollen glands). On 14-Oct-2023, the patient experienced ATRIAL FIBRILLATION (Patient to ER, patient was kept in observation for 18 hours and was diagnosed with tachycardia and A-fib which patient states she had never had prior.) (seriousness criteria hospitalization and medically significant). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency; METOPROLOL at an unspecified dose and frequency and DILTIAZEM (CARDIZEM [DILTIAZEM]) at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (Patient to ER, patient was kept in observation for 18 hours and was diagnosed with tachycardia and A-fib which patient states she had never had prior.) had not resolved and GASTROINTESTINAL DISORDER (gastric discomfort), FEELING ABNORMAL (feeling and looking terrible and almost collapsed into a chair.) and LYMPHADENOPATHY (swollen glands) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: A-fib and tachycardia.         Patient did not you receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that patient had all 5 previous doses were Moderna. It was reported that patient woke up the following morning "feeling and looking terrible and almost collapsed into a chair and looked really white like a ghost." Patient also reported she had gastric discomfort, stated she took her scheduled levothyroxine that morning which caused her to wretch up the water. She developed swollen glands to the right side, (traveled from ear to ear as the days passed). Rested over the weekend, went for a hike, felt her "heart pounding out of her chest". Patient stated was started feeling better but then on 14-OCT-2023 at 21:30, husband discovered patient was tachycardic. Patient was kept in observation for 18 hours and was diagnosed with tachycardia and A-fib which patient stated she had never had prior. Patient received IV Cardizem and tachycardia and A-fib resolved. Patient sent home with Eliquis, Metoprolol, patient stated eliquis was very expensive. It was reported that patient had F/U with PCP 19-OCT-2023 and PCP found A-fib and tachycardia had resumed, PCP prescribed second daily dose of Metoprolol. On 23-OCT-2023 patient awoke with same symptoms as right after the dose. Patient remained in ER throughout the day, restarted cardizem, patient was discharged now on daily cardizem. ER cardiologist referred to outpatient cardiology and ordered "several cardiac exams." Patient had now been referred to an electrophysiologist. Patient stated she now has a chronic condition and will be on these medications for the rest of her life. Patient specifically denied being diagnosed with myo/pericarditis. No other details given.   This case was linked to MOD-2021-027391 (Patient Link).  Company Comment: This is a spontaneous case concerning a 77-year-old, female patient with relevant medical history of Hypothyroidism and Allergies to Sulfa, who experienced the serious (due to medically significant and hospitalization) unexpected AESI of Atrial fibrillation, among other non-serious events. The event Atrial fibrillation occurred approximately 10 days after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) received as the six dose of COVID-19 vaccination schedule; the rest of the events occurred the following morning after vaccination. It was reported that patient woke up the following morning "feeling and looking terrible and almost collapsed into a chair and looked really white like a ghost." Patient also reported she had gastric discomfort and stated that she took her scheduled levothyroxine that morning which caused her to wretch up the water. She developed swollen glands to the right side, reported as "traveled from ear to ear as the days passed". The patient also stated that she started feeling better but then on 14-OCT-2023 at 21:30, her husband discovered that she was tachycardic, so she went to ER where she was diagnosed with tachycardia and A-fib. The treatment included IV Cardizem, Metoprolol and Eliquis. On 23-OCT-2023, the patient awoke with same symptoms as right after the dose, so she attended the ER again and remained at hospital throughout the day. The patient was restarted on Cardizem and was discharged with the advice to be followed up in the outpatient cardiology clinic. The outcome of the event was reported as not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.