Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Fall, Foot fracture, Heart rate, Heart rate irregular
Clinical narrative: Pass out; Misfire heartbeat; Heart episode/heart now permanently damaged; Fell; Broke foot; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Pass out) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had Covid in the first part of February 2020, and as a driver, the patient picked up some people from the airport, and some from casinos. They were wearing masks and the patient asked him about it.  The patient's past medical history included COVID-19 (Patient had Covid the first part of February 2020, was sick for 10 weeks) in February 2020. Previously administered products included for COVID-19 vaccination: COVID-19 vaccine (Dose 1) on 20-Apr-2021 and COVID-19 vaccine (Dose 2) on 13-May-2021. Past adverse reactions to the above products included No adverse event with COVID-19 vaccine and COVID-19 vaccine. Concurrent medical conditions included Seasonal allergy (Seasonal allergies) and Drug allergy (allergic to Ibuprofen).    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Pass out) (seriousness criterion medically significant), HEART RATE IRREGULAR (Misfire heartbeat), CARDIAC DISORDER (Heart episode/heart now permanently damaged), FALL (Fell) and FOOT FRACTURE (Broke foot). At the time of the report, LOSS OF CONSCIOUSNESS (Pass out), HEART RATE IRREGULAR (Misfire heartbeat), CARDIAC DISORDER (Heart episode/heart now permanently damaged), FALL (Fell) and FOOT FRACTURE (Broke foot) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: Patient had a misfire heartbeat and not an irregular heart. At every 3rd, 4th, and 5th beat, it would misfire..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received the initial booster dose of Moderna vaccine on 23-Dec-2021.  Patient had a heart episode in January and it was really bad. Patient thought that he was having a heart attack. The patient's heart was now permanently damaged. The patient's heart beats but not pumping blood to brain and since it was not getting oxygen, hence patient passes out. Patient had a total of 5 episodes. The patient reported that he had a really bad episode about 3 weeks ago. Patient confirmed that he had not been hospitalized after any episodes. The patient went to the hospital because he passed out, fell and broke the foot. X-Ray was conducted at last hospital visit (result not reported) and HCP (healthcare provider) had wrapped the foot. Patient could not walk and work and was under Regulatory Authority care and housing support. Patient had undergone an EKG (electrocardiogram) test and was on heart monitor in Jan of 2022. Heart specialist did not provide a diagnosis but mentioned that patient had a misfire heartbeat and not an irregular heart. He wore a heart monitor so that it could be seen that at every 3rd, 4th, and 5th beat, it would misfire. It was not beating normally. He explained what happened to his physician. HCP asked the patient about the vaccines. Patient told him about the episodes after the booster dose. The physician stated that it happened because of the vaccine. One of the physicians who the patient saw for his foot told that they were supposed to cover it because patient absolutely would not. The patient stated that this incident prompted him to do some research about the Moderna vaccine and he was reading about autopsies that they were doing on people who got these vaccines and boosters and the patient found it to be appalling.  No treatment information was provided.  Company comment : This spontaneous case concerns a male patient aged 59 years with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Loss of consciousness and unexpected non-serious AESI of Heart rate irregular that occurred in the context of third dose of mRNA-1273 vaccination in covid -19 vaccination series. Latency cannot be assessed since onset date of events was not disclosed. It was reported that patient had a heart episode, he thought he was having a heart attack. He states that his heart beats, but not pumping blood to his brain and so it's not getting oxygen. He had a total of 5 episodes of passing out. He went to the hospital because he passed out, fell and broke his foot. X-Ray was conducted and HCP wrapped the foot. Patient stated, he can't walk, can't work. Patient had an EKG and was on Heart monitor, Heart specialist mentioned that patient have a misfire heartbeat and not an irregular heart. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not resolved at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient aged 59 years with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Loss of consciousness and unexpected non-serious AESI of Heart rate irregular that occurred in the context of third dose of mRNA-1273 vaccination in covid -19 vaccination series. Latency cannot be assessed since onset date of events was not disclosed. It was reported that patient had a heart episode, he thought he was having a heart attack. He states that his heart beats, but not pumping blood to his brain and so it's not getting oxygen. He had a total of 5 episodes of passing out. He went to the hospital because he passed out, fell and broke his foot. X-Ray was conducted and HCP wrapped the foot. Patient stated, he can't walk, can't work. Patient had an EKG and was on Heart monitor, Heart specialist mentioned that patient have a misfire heartbeat and not an irregular heart. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not resolved at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.