Adverse Event Reporting
| VAERS ID | 2013685 |
|---|---|
| Gender | Male |
| Age | 34 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | FE3430 |
| Number of vaccinations | |
| Vaccinated | 2021-08-17 |
| Onset | 2021-12-11 |
| Condition | Died |
Symptoms
- Dyspnoea
- Chest pain
- Oropharyngeal pain
- Oxygen saturation decreased
Current Illness
Preexisting Conditions
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Chest pain; Sore throat; DOB; Oxygen saturation low; This regulatory authority case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest pain), OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (DOB) and OXYGEN SATURATION DECREASED (Oxygen saturation low) in a 34-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no.
055ez1a) for an unknown indication.
Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.
No Medical History information was reported.
On 17-Aug-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form.
On 27-Sep-2021, the patient received dose of TOZINAMERAN (COMIRNATY) (Intramuscular) at an unspecified dose.
On 11-Dec-2021 at 5:00 PM, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion death), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion death), DYSPNOEA (DOB) (seriousness criterion death) and OXYGEN SATURATION DECREASED (Oxygen saturation low) (seriousness criterion death).
The reported cause of death was Chest pain, Sore throat, dob and Oxygen saturation low.
It is unknown if an autopsy was performed.
For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments.
No relevant concomitant medications was reported.
Treatment information was not provided.
It was reported that Patient referred for sudden onset of chest pain accompanied by DOB and Desaturation.
Chief Complaint prior to detection: Cough for 3 days and Sore throat with DOB Company Comment: This regulatory case concerns a 34-year-old, male patient with history of co-administration of the Comirnaty (tozinameran) COVID-19 vaccine, who experienced the unexpected, serious events of chest pain, oropharyngeal pain, dyspnoea and oxygen saturation decreased.
The events, which resulted in a fatal outcome, occurred 3 months, 24 days after administration of the first dose of the Moderna mRNA-1273 vaccine.
The patient initially experienced cough for 3 days and sore throat with difficulty of breathing (DOB).
He was then referred due to sudden onset of chest pain accompanied by DOB and desaturation.
No further details were provided.
The history of co-administration of the Comirnaty (tozinameran) COVID-19 vaccine remains a confounder.
The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
; Sender's Comments: This regulatory case concerns a 34-year-old, male patient with history of co-administration of the Comirnaty (tozinameran) COVID-19 vaccine, who experienced the unexpected, serious events of chest pain, oropharyngeal pain, dyspnoea and oxygen saturation decreased.
The events, which resulted in a fatal outcome, occurred 3 months, 24 days after administration of the first dose of the Moderna mRNA-1273 vaccine.
The patient initially experienced cough for 3 days and sore throat with difficulty of breathing (DOB).
He was then referred due to sudden onset of chest pain accompanied by DOB and desaturation.
No further details were provided.
The history of co-administration of the Comirnaty (tozinameran) COVID-19 vaccine remains a confounder.
The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
; Reported Cause(s) of Death: Chest pain; Sore Throat; DOB; Oxygen saturation low