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VAERS ID: 2272635

AGE: 47| SEX: M|State: FR

Description

Myocarditis; Embolism pulmonary; Fever; Dyspnea; This case was received via regulatory authority on 09-May-2022 and was forwarded to Moderna on 09-May-2022. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis), PULMONARY EMBOLISM (Embolism pulmonary), PYREXIA (Fever) and DYSPNOEA (Dyspnea) in a 47-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 000010A) for COVID-19 vaccination. The patient's past medical history included Obesity and Smoker. On 06-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In January 2022, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and DYSPNOEA (Dyspnea) (seriousness criterion medically significant). January 2022, the patient experienced PULMONARY EMBOLISM (Embolism pulmonary) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had not resolved and PULMONARY EMBOLISM (Embolism pulmonary), PYREXIA (Fever) and DYSPNOEA (Dyspnea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2022, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Dosage text of Spikevax was reported as R1. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. Company comment: This is a regulatory case concerning a 47 year-old, male patient with a history of obesity and Tobacco user, who experienced the serious (due to medically important condition) expected, AESI of Myocarditis and the serious (due to medically important condition) unexpected, events of Pulmonary embolism (AESI), Pyrexia and Dyspnoea. The event Pulmonary embolism occurred approximately 7 days after the mRNA-1273 vaccine, dose number not provided, the rest of the events occurred the same month of vaccination, exact date not available, thus temporal association cannot be assessed. The outcome of the event Myocarditis was reported as not recovered and the rest of the events as recovered. The mentioned medical history remain as confounders for the events Pulmonary embolism and Dyspnoea. The event dyspnoea could be associated with the events myocarditis and pulmonary embolism. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a regulatory case concerning a 47 year-old, male patient with a history of obesity and Tobacco user, who experienced the serious (due to medically important condition) expected, AESI of Myocarditis and the serious (due to medically important condition) unexpected, events of Pulmonary embolism (AESI), Pyrexia and Dyspnoea. The event Pulmonary embolism occurred approximately 7 days after the mRNA-1273 vaccine, dose number not provided, the rest of the events occurred the same month of vaccination, exact date not available, thus temporal association cannot be assessed. The outcome of the event Myocarditis was reported as not recovered and the rest of the events as recovered. The mentioned medical history remain as confounders for the events Pulmonary embolism and Dyspnoea. The event dyspnoea could be associated with the events myocarditis and pulmonary embolism. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Symptoms

Dyspnoea, Myocarditis, Pulmonary embolism, Pyrexia, SARS-CoV-2 test

Vaccines

VAX DATE: 05 January 2022 | ONSET DATE: 31 December 2021 | DAYS TO ONSET:
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • COVID19
  • MODERNA
  • COVID19 (COVID19 (MODERNA))
  • UNK
  • OT
  • 000010A

RECVDATE:11 May 2022
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
DATEDIED:
L_THREAT:
ER_VISIT:
HOSPITAL:
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:N
LAB_DATA:Test Date: 20220113; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
V_ADMINBY:UNK
OTHER_MEDS:
CUR_ILL:
HISTORY:Medical History/Concurrent Conditions: Obesity; Smoker
PRIOR_VAX:
SPLTTYPE:FRMODERNATX, INC.MOD20225
FORM_VERS:2
TODAYS_DATE:10 May 2022
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
ALLERGIES:
V_FUNDBY:
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