Adverse Event Reporting
| VAERS ID | 2128880 |
|---|---|
| Gender | Male |
| Age | 28 |
| StateCode | FR |
| Pharmaceutical Company | MODERNA |
| Lot Number | M216038 |
| Number of vaccinations | 3 |
| Vaccinated | 1993-01-16 |
| Onset | 2022-01-16 |
| Condition | Permanent Disability |
Symptoms
- Pyrexia
- Dizziness
- Chills
- COVID-19 immunisation
Current Illness
Preexisting Conditions
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Revaccination with different COVID-19 vaccine; Frissons; Dizziness, voltage drops; Fever; This case was received via Regulatory Authority (Reference number: BE-FAMHP-DHH-N2022-114343) on 16-Feb-2022 and was forwarded to Moderna on 16-Feb-2022.
This regulatory authority case was reported by a consumer and describes the occurrence of COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), CHILLS (Frissons), DIZZINESS (Dizziness, voltage drops) and PYREXIA (Fever) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no.
M-216038) for COVID-19 immunisation.
Previously administered products included for Product used for unknown indication: Comirnaty on 27-Jun-2021 and COMIRNATY on 01-Aug-2021.
Past adverse reactions to the above products included No adverse event with COMIRNATY and Comirnaty.
On 16-Jan-1993, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form.
On 16-Jan-2022, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) (seriousness criterion disability), CHILLS (Frissons) (seriousness criterion disability), DIZZINESS (Dizziness, voltage drops) (seriousness criterion disability) and PYREXIA (Fever) (seriousness criterion disability).
On 17-Jan-2022, COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), CHILLS (Frissons), DIZZINESS (Dizziness, voltage drops) and PYREXIA (Fever) was resolving.
No concomitant medications were reported.
The suspect drug(mRNA-1273) start date was reported as 16-JAN-1993.
COMPANY COMMENT : This regulatory case concerns a 28 year-old male patient with no medical history reported,who experienced unexpected serious events of covid-19 immunisation ,chills, dizziness ,pyrexia seriousness criterion disability) which occurred on unknown date (discrepancy noted date of third dose of vaccine administered on 16 jan-1993) after the third dose of the mRNA-1273 vaccine .
The patient was noted to have received two doses with COMIRNATY unknown date prior to current vaccination with mRNA-1273 (Interchange of vaccine products).
At the time of report events was resolving.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Event seriousness assessed as per Regulatory Authority reporting.
; Reporter's Comments: Treatment - Unknown Evolution of the ADR - In Healing Examinations - No ADR description - On the evening of the day of the injection I had severe chills and a lot of pyrexia and the next morning I had dizziness, blood pressure drops I am still in a state of significant fatigue.
; Sender's Comments: This regulatory case concerns a 28 year-old male patient with no medical history reported,who experienced unexpected serious events of covid-19 immunisation ,chills, dizziness ,pyrexia seriousness criterion disability) which occurred on unknown date (discrepancy noted date of third dose of vaccine administered on 16 jan-1993) after the third dose of the mRNA-1273 vaccine .
The patient was noted to have received two doses with COMIRNATY unknown date prior to current vaccination with mRNA-1273 (Interchange of vaccine products).
At the time of report events was resolving.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Event seriousness assessed as per Regulatory Authority reporting.