Age: 72.0
Sex: F
Vaccine: COVID19, UNK, UNK, UNK, UNK, UNK
Symptoms: Atrial fibrillation, Fall, Vaccination site pain
Clinical narrative: She went into Atrila Fibrillation after this fall in the bathroom\fibrillation; The patient slipped in the bathroom on October 29, 2022 and hit her head on the bathroom cabinet. She went into Atrila Fibrillation after this fall in the bathroom.; The patient had a sore injection site arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Dec-2022 and was forwarded to Moderna on 09-Dec-2022.    This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (She went into Atrila Fibrillation after this fall in the bathroom\fibrillation) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products APIXABAN (ELIQUIS) for an unknown indication, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication, FLECAINIDE for an unknown indication, ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication and METOPROLOL SUCCINATE for an unknown indication.    Concurrent medical conditions included Atrial fibrillation and Hypothyroidism.   On 23-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient started APIXABAN (ELIQUIS) (unknown route) 5 milligram twice a day, LEVOTHYROXINE SODIUM (SYNTHROID) (unknown route) 100 milligram twice a day, FLECAINIDE (unknown route) 5 milligram twice a day, ROSUVASTATIN CALCIUM (CRESTOR) (unknown route) 100 milligram once a day and METOPROLOL SUCCINATE (unknown route) 25 milligram twice a day. On 29-Oct-2022, the patient experienced ATRIAL FIBRILLATION (She went into Atrila Fibrillation after this fall in the bathroom\fibrillation) (seriousness criterion medically significant), FALL (The patient slipped in the bathroom on October 29, 2022 and hit her head on the bathroom cabinet. She went into Atrila Fibrillation after this fall in the bathroom.) and VACCINATION SITE PAIN (The patient had a sore injection site arm). At the time of the report, ATRIAL FIBRILLATION (She went into Atrila Fibrillation after this fall in the bathroom\fibrillation), FALL (The patient slipped in the bathroom on October 29, 2022 and hit her head on the bathroom cabinet. She went into Atrila Fibrillation after this fall in the bathroom.) and VACCINATION SITE PAIN (The patient had a sore injection site arm) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The patient received first primary series dose on January 28, 2021 lot number 029L20A expiration date was not known. The patient had a sore injection site arm. The patient received second Primary Series dose on 25-Feb-2021 lot number 023M20A expiration date is not known. The patient reports no adverse reactions. The patient received her first Moderna Covid-19 booster dose on 16-Nov-2021 lot number 069F21A expiration date is not known. The patient received her second Moderna Covid-19 booster dose on 31-May-2022 lot number 037A22B expiration date is not known.  The patient experienced atrial fibrillation on 29-Oct-2022. The patient slipped in the bathroom on 29-Oct-2022 and hit her head on the bathroom cabinet. She went into Atrial Fibrillation after this fall in the bathroom. The patient was still in Atrial Fibrillation. No treatment information was provided. Company comment: This spontaneous case concerns a 72-year-old, female patient with current medical history of Atrial fibrillation and Hypothyroidism, who experienced the unexpected, serious (Medically significant) AESI of Atrial fibrillation. The event occurred 36 days after administration of fourth dose of mRNA-1273 BIVALENT, the initial two doses of unknown vaccine were administered approximately 20 months prior, the interval between the two doses is 28 days, the third dose of Moderna was administered 9 months later. It has been reported that the patient experienced atrial fibrillation resulting to disorientation and trauma to her head. The event has not resolved at the time of the report. The patient's medical history of Atrial fibrillation and Hypothyroidism could be confounders to the event. The benefit-risk relationship of mRNA-1273 BIVALENT is not affected by this report. Events' seriousness retained as per medical judgment.; Sender's Comments: This spontaneous case concerns a 72-year-old, female patient with current medical history of Atrial fibrillation and Hypothyroidism, who experienced the unexpected, serious (Medically significant) AESI of Atrial fibrillation. The event occurred 36 days after administration of fourth dose of mRNA-1273 BIVALENT, the initial two doses of unknown vaccine were administered approximately 20 months prior, the interval between the two doses is 28 days, the third dose of Moderna was administered 9 months later. It has been reported that the patient experienced atrial fibrillation resulting to disorientation and trauma to her head. The event has not resolved at the time of the report. The patient's medical history of Atrial fibrillation and Hypothyroidism could be confounders to the event. The benefit-risk relationship of mRNA-1273 BIVALENT is not affected by this report. Events' seriousness retained as per medical judgment.