Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram, Headache, Heart rate irregular, Immunisation reaction
Clinical narrative: Pericarditis; Headache; Painful breathing; Pain in throat; Throat pain; Shortness of breath/ he walked up the stairs it was bad; Heart racing and it pounding/heart felt like it was pounding out of chest/palpitations/racing heart; Chest pain; feeling dizzy; Headache; irregular heart rhythm/irregular heart rate; Strong, scare acute symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (irregular heart rhythm/irregular heart rate) and PERICARDITIS (Pericarditis) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient did not had problems with his heart or lungs. There was no history of COVID-19 infection and Myocarditis/pericarditis.  Concomitant products included TAMSULOSIN for Enlarged prostate.    On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced ARRHYTHMIA (irregular heart rhythm/irregular heart rate) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Throat pain), DYSPNOEA (Shortness of breath/ he walked up the stairs it was bad), PALPITATIONS (Heart racing and it pounding/heart felt like it was pounding out of chest/palpitations/racing heart), CHEST PAIN (Chest pain), DIZZINESS (feeling dizzy) and the first episode of HEADACHE (Headache). On 15-Apr-2022, the patient experienced DYSPNOEA (Painful breathing), OROPHARYNGEAL PAIN (Pain in throat) and the second episode of HEADACHE (Headache). In April 2022, the patient experienced VACCINATION COMPLICATION (Strong, scare acute symptoms). On 17-Apr-2022, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 09-Apr-2022, ARRHYTHMIA (irregular heart rhythm/irregular heart rate), PALPITATIONS (Heart racing and it pounding/heart felt like it was pounding out of chest/palpitations/racing heart), CHEST PAIN (Chest pain) and DIZZINESS (feeling dizzy) had resolved, OROPHARYNGEAL PAIN (Throat pain) and DYSPNOEA (Shortness of breath/ he walked up the stairs it was bad) had resolved with sequelae. At the time of the report, PERICARDITIS (Pericarditis), VACCINATION COMPLICATION (Strong, scare acute symptoms), DYSPNOEA (Painful breathing), OROPHARYNGEAL PAIN (Pain in throat) and the last episode of HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: not found anything wrong (normal) not found anything wrong. On an unknown date, Cardiac function test: electrocardiogram normal (normal) electrocardiogram normal. On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Heart rate irregular: irregular (abnormal) Irregular. On an unknown date, Magnetic resonance imaging: not performed Not performed. On an unknown date, Troponin: below 3 nanograms per liter below 3 nanograms per liter.         Patient called to report after receiving 2nd booster dose of the Moderna COVID-19 vaccine on 07-Apr-2022, the day after the vaccine, he experienced heart racing and it pounded, irregular heart rhythm. He said he could take his own pulse and his heart felt like it was pounding out of his chest, he experienced shortness of breath. He reports if he walked up the stairs it was bad, he experienced chest pain, throat pain, feeling dizzy, a headache, palpitations, irregular heart rate, racing heart. It lasted all afternoon, that evening and the next day it was gone. He reported a week later, on 15-Apr-2022, he started to experience the same symptoms of headache, pain in throat, painful breathing, all these symptoms were new to him, as there was no medical explanation in his history. He reported that, he does not remember that he received NSAID. Batch number and Expiration date was reported as unknown.   Patient provided and update on his AE.  He went to the ER and blood tests was conducted but did not found anything wrong and he was informed that everything was normal. On 17-Apr-2022 his Doctor diagnosed him with Pericarditis. He said that past 3 days he experienced strong, scare acute symptoms. He took ibuprofen for symptoms. Some Myo/Pericarditis specific information was obtained from the patient: Cardiac Lab values (ECG, cardiac test, cardiac enzymes)   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Follow-up received wherein new events, lab data, treatment drug, medical history and case narrative updated.  Company Comment: This is a spontaneous case concerning  a  59-year-old, male patient with Concomitant products of Tamsulosin, who experienced the unexpected serious (medically significant) event of Arrhythmia and expected serious (medically significant) event of Pericarditis and unexpected non-serious events of Vaccination complication, Dyspnoea, Oropharyngeal pain, Oropharyngeal pain, Dyspnoea, Palpitations, Chest pain, and expected non-serious events of Dizziness, Headache, Headache. The events Arrhythmia, Oropharyngeal pain, Dyspnea, Palpitations, Chest pain, Dizziness, Headache occurred 1 day after the fourth dose of mRNA-1273 COVID 19 Vaccine. While the events Dyspnea, Oropharyngeal pain, Headache occurred 8 days after the fourth dose mRNA-1273 COVID 19 Vaccine. Event pericarditis occurred 10 days after the fourth dose  of mRNA-1273 COVID 19 Vaccine. The event  Vaccination complication occurred on an unspecified date of April 2022. The event Arrhythmia, Palpitations, dizziness resolved on April 9, 2022. While the events Oropharyngeal pain, Dyspnea resolved with sequelae. The events Pericarditis, Vaccination complication, Dyspnea, Oropharyngeal pain, headache outcome was unknown. Patients laboratory test showed normal results (Blood test, Electrocardiogram, Troponin).  The Concomitant products use of Tamsulosin remains a confounder for event Dizziness. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  59-year-old, male patient with Concomitant products of Tamsulosin, who experienced the unexpected serious (medically significant) event of Arrhythmia and expected serious (medically significant) event of Pericarditis and unexpected non-serious events of Vaccination complication, Dyspnoea, Oropharyngeal pain, Oropharyngeal pain, Dyspnoea, Palpitations, Chest pain, and expected non-serious events of Dizziness, Headache, Headache. The events Arrhythmia, Oropharyngeal pain, Dyspnea, Palpitations, Chest pain, Dizziness, Headache occurred 1 day after the fourth dose of mRNA-1273 COVID 19 Vaccine. While the events Dyspnea, Oropharyngeal pain, Headache occurred 8 days after the fourth dose mRNA-1273 COVID 19 Vaccine. Event pericarditis occurred 10 days after the fourth dose  of mRNA-1273 COVID 19 Vaccine. The event  Vaccination complication occurred on an unspecified date of April 2022. The event Arrhythmia, Palpitations, dizziness resolved on April 9, 2022. While the events Oropharyngeal pain, Dyspnea resolved with sequelae. The events Pericarditis, Vaccination complication, Dyspnea, Oropharyngeal pain, headache outcome was unknown. Patients laboratory test showed normal results (Blood test, Electrocardiogram, Troponin).  The Concomitant products use of Tamsulosin remains a confounder for event Dizziness. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.