Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest discomfort, Chest pain, Electrocardiogram, SARS-CoV-2 antibody test
Clinical narrative: positive COVID-19 test; Chest discomfort; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest discomfort), CHEST PAIN (Chest pain) and SARS-COV-2 TEST POSITIVE (positive COVID-19 test) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037620A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes mellitus, Hypertension and Cholesterol.Concomitant products included LISINOPRIL and AMLODIPINE for Blood pressure high, METFORMIN for Diabetes mellitus, ATORVASTATIN for High cholesterol.On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest discomfort) and CHEST PAIN (Chest pain). On 28-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive COVID-19 test). In August 2021, CHEST DISCOMFORT (Chest discomfort) and CHEST PAIN (Chest pain) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (positive COVID-19 test) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):In January 2021, SARS-CoV-2 antibody test: positive (Positive) SARS-CoV-2 antibody test: Positive.On an unknown date, Cardiac stress test: normal (normal) Cardiac stress test: normal.On an unknown date, Electrocardiogram: normal (normal) Electrocardiogram: NORMAL.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No treatment medication information was provided.Company comment: This case concerns a 51-year-old male patient with medical history of Diabetes mellitus and Hypertension, who developed non-serious unexpected events of Chest pain, Chest discomfort and SARS-COV-2 test positive. The events of Chest pain and Chest discomfort occurred four days after the administration of the first dose of the mRNA-1273 vaccine, while the patient was tested positive for COVID-19 nine days after this vaccination, however, it was confirmed that the patient had no symptoms of COVID-19 disease. Reportedly, the events of Chest pain and Chest discomfort were not overwhelming. The patient felt some kind of dull pain, as well as sharp pain sometimes, which was intermittent. The patient recovered from these events, however, it was stated that the events occurred after the patient had received the booster dose of the vaccine, therefore, the re-challenge for these two events is considered positive. The patient's underlying medical history remains a significant confounding factor for these two events. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for SARS-COV-2 test positive is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.This case was linked to MOD-2021-411049 (Patient Link).; Sender's Comments: This case concerns a 51-year-old male patient with medical history of Diabetes mellitus and Hypertension, who developed non-serious unexpected events of Chest pain, Chest discomfort and SARS-COV-2 test positive. The events of Chest pain and Chest discomfort occurred four days after the administration of the first dose of the mRNA-1273 vaccine, while the patient was tested positive for COVID-19 nine days after this vaccination, however, it was confirmed that the patient had no symptoms of COVID-19 disease. Reportedly, the events of Chest pain and Chest discomfort were not overwhelming. The patient felt some kind of dull pain, as well as sharp pain sometimes, which was intermittent. The patient recovered from these events, however, it was stated that the events occurred after the patient had received the booster dose of the vaccine, therefore, the re-challenge for these two events is considered positive. The patient's underlying medical history remains a significant confounding factor for these two events. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for SARS-COV-2 test positive is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.