Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: diagnosed with PVC/heart started to beat like crazy like it was coming out of her chest; minor side effects; severe weakness; chills; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR EXTRASYSTOLES (diagnosed with PVC/heart started to beat like crazy like it was coming out of her chest) 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.     Previously administered products included for Product used for unknown indication: flu vaccine (had reactions to the flu vaccine before). Past adverse reactions to the above products included Adverse reaction with flu vaccine.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced VENTRICULAR EXTRASYSTOLES (diagnosed with PVC/heart started to beat like crazy like it was coming out of her chest) (seriousness criterion hospitalization), VACCINATION COMPLICATION (minor side effects), ASTHENIA (severe weakness), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nausea). The patient was hospitalized from sometime in May 2021 to sometime in May 2021 due to VENTRICULAR EXTRASYSTOLES. In 2021, VACCINATION COMPLICATION (minor side effects), ASTHENIA (severe weakness), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown. At the time of the report, VENTRICULAR EXTRASYSTOLES (diagnosed with PVC/heart started to beat like crazy like it was coming out of her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. The treatment information were unknown.  Company Comment: This spontaneous case concerns a 73-year-old, female patient with no relevant medical history, who experienced the unexpected, serious AESI of ventricular extrasystoles and other associated unexpected and expected non-serious events after administration of the first dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. In 2 to 3 days after vaccination, the patient experienced chills, fatigue, minor side effects, nausea and severe weakness. Then after about 5 to 6 days, her heart started to 'beat like crazy like it was coming out of her chest'. She was brought to the Emergency Room where she was diagnosed with premature ventricular contraction. She stayed in the hospital overnight to ensure symptoms were under control. Laboratory test/s and treatment information were not provided. The patient was also referred to a Cardiologist. No further details were provided. The report stated that the 'same thing happened again 2 to 3 times over the months of June, July and August 2021' and the patient thought she was having a heart attack. The primary doctor told the patient that the symptoms were part of the vaccine side effects. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 73-year-old, female patient with no relevant medical history, who experienced the unexpected, serious AESI of ventricular extrasystoles and other associated unexpected and expected non-serious events after administration of the first dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. In 2 to 3 days after vaccination, the patient experienced chills, fatigue, minor side effects, nausea and severe weakness. Then after about 5 to 6 days, her heart started to 'beat like crazy like it was coming out of her chest'. She was brought to the Emergency Room where she was diagnosed with premature ventricular contraction. She stayed in the hospital overnight to ensure symptoms were under control. Laboratory test/s and treatment information were not provided. The patient was also referred to a Cardiologist. No further details were provided. The report stated that the 'same thing happened again 2 to 3 times over the months of June, July and August 2021' and the patient thought she was having a heart attack. The primary doctor told the patient that the symptoms were part of the vaccine side effects. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.