Adverse Event Reporting
| VAERS ID | 1789388 |
|---|---|
| Gender | Female |
| Age | 61 |
| StateCode | FR |
| Pharmaceutical Company | MODERNA |
| Lot Number | 3004223 |
| Number of vaccinations | |
| Vaccinated | 2001-09-27 |
| Onset | 2021-09-27 |
| Condition | Permanent Disability Recovered |
Symptoms
- Fatigue
- Headache
- Chills
- Nausea
- Abdominal pain upper
- Influenza like illness
- SARS-CoV-2 test
- Influenza
Current Illness
Preexisting Conditions
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20210927; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
Write-up
shivering; headache; tiredness; stomach cramps; flu like symptoms; nausea; Flu; This case was received (Reference number: GB-MHRA-WEBCOVID-202110090534124640-N1HF0) on 10-Oct-2021 and was forwarded to Moderna on 10-Oct-2021.
This regulatory authority case was reported by an other health care professional and describes the occurrence of CHILLS (shivering), HEADACHE (headache), FATIGUE (tiredness), ABDOMINAL PAIN UPPER (stomach cramps), INFLUENZA LIKE ILLNESS (flu like symptoms), NAUSEA (nausea) and INFLUENZA (Flu) in a 61-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no.
3004223) for COVID-19 vaccination.
No Medical History information was reported.
On 27-Sep-2001, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form.
On 27-Sep-2021, the patient experienced INFLUENZA (Flu) (seriousness criterion disability).
On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion disability), HEADACHE (headache) (seriousness criterion disability), FATIGUE (tiredness) (seriousness criterion disability), ABDOMINAL PAIN UPPER (stomach cramps) (seriousness criterion disability), INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criterion disability) and NAUSEA (nausea) (seriousness criterion disability).
On 30-Sep-2021, INFLUENZA (Flu) had resolved.
At the time of the report, CHILLS (shivering), HEADACHE (headache), FATIGUE (tiredness), ABDOMINAL PAIN UPPER (stomach cramps), INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (nausea) outcome was unknown.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative.
The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.
For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient had body ache after vaccination.
Lab data include temperature occur in unknown date and unknown result.
Concomitant medication not provided.
Treatment information not provided.
This case concerns a 61-year-old, female patient with no relevant medical history, who experienced the unexpected events of Chills, Headache, Fatigue, Abdominal pain upper, Influenza-like illness, Nausea and Influenza.
The events of Chills, Headache, Fatigue and Nausea are unexpected as they are retained as serious per the RA source document.
The events occurred after a dose of Moderna CoviD-19 Vaccine.
The rechallenge was unknown since no information about the events of the first dose was disclosed.
The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.
Event seriousness assessed as per Regulatory Authority reporting, there was information in the source document supporting that the events resulted in a Disabling/Incapacitating outcome.
It was also noted that in the SD it appears to have a typing error on the date of start of drug, where it was reported to be on 27-Sep-2001 which is scientifically implausible since the drug was introduced just almost year ago.
; Sender's Comments: This case concerns a 61-year-old, female patient with no relevant medical history, who experienced the unexpected events of Chills, Headache, Fatigue, Abdominal pain upper, Influenza-like illness, Nausea and Influenza.
The events of Chills, Headache, Fatigue and Nausea are unexpected as they are retained as serious per the RA source document.
The events occurred after a dose of Moderna CoviD-19 Vaccine.
The rechallenge was unknown since no information about the events of the first dose was disclosed.
The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.
Event seriousness assessed as per Regulatory Authority reporting, there was information in the source document supporting that the events resulted in a Disabling/Incapacitating outcome.
It was also noted that in the SD it appears to have a typing error on the date of start of drug, where it was reported to be on 27-Sep-2001 which is scientifically implausible since the drug was introduced just almost year ago.