Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Computerised tomogram, Dyspnoea, Electrocardiogram
Clinical narrative: Tested positive for Covid-19; Couldn't breath; Couldn't talk; Felt like if there was an elephant sitting on his chest; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for Covid-19), DYSPNOEA (Couldn't breath), SPEECH DISORDER (Couldn't talk) and CHEST DISCOMFORT (Felt like if there was an elephant sitting on his chest) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced COVID-19 (Tested positive for Covid-19) (seriousness criterion hospitalization), DYSPNOEA (Couldn't breath) (seriousness criterion hospitalization), SPEECH DISORDER (Couldn't talk) (seriousness criterion hospitalization) and CHEST DISCOMFORT (Felt like if there was an elephant sitting on his chest) (seriousness criterion hospitalization). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency and OXYGEN at an unspecified dose and frequency. In August 2021, COVID-19 (Tested positive for Covid-19), DYSPNOEA (Couldn't breath), SPEECH DISORDER (Couldn't talk) and CHEST DISCOMFORT (Felt like if there was an elephant sitting on his chest) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: covid-19, variant delta. (abnormal) Covid-19, Variant Delta.. On an unknown date, Electrocardiogram: covid-19, variant delta. (abnormal) Covid-19, Variant Delta.. On an unknown date, SARS-CoV-2 test: positive for covid-19 (Positive) positive for COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient got sick with COVID-19 symptoms and tested positive after receiving 2 doses of the Moderna COVID-19 Vaccine. A few months later he couldn't breath, couldn't talk which were cardiac related signs and symptoms he also felt like if there was an elephant sitting on his chest, and was hospitalized for a month. Symptoms started on 09-Aug-2021 after his second dose and resolved at the end of Aug-2021. Patient was 10 days on event. There was no history of COVID-19 infection as well as Myocarditis/pericarditis.  Company comment: This case concerns a 46-year-old male patient, with no reported medical history, who experienced the serious, unexpected events of Covid-19, dyspnea, chest discomfort and speech disorder after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient had Covid-19 symptoms and tested positive for Covid-19. He had had dyspnea, chest discomfort and couldn't talk. Onset latency of events are unknown since the dates of the vaccines were not provided. The patient was said to have been hospitalized for a month and was on vent for 10 days. Events have resolved at the time of report.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-358790, MOD-2021-358836 (Patient Link).; Sender's Comments: This case concerns a 46-year-old male patient, with no reported medical history, who experienced the serious, unexpected events of Covid-19, dyspnea, chest discomfort and speech disorder after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient had Covid-19 symptoms and tested positive for Covid-19. He had had dyspnea, chest discomfort and couldn't talk. Onset latency of events are unknown since the dates of the vaccines were not provided. The patient was said to have been hospitalized for a month and was on vent for 10 days. Events have resolved at the time of report.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.