Adverse Event Reporting

VAERS ID 2012593
Gender Female
Age 49
StateCode FR
Pharmaceutical Company MODERNA
Lot Number 3
Number of vaccinations
Vaccinated
Onset 2021-12-19
Condition
Symptoms
  • Body temperature increased
  • SARS-CoV-2 test

Current Illness

Suspected COVID-19

Preexisting Conditions

Medical History/Concurrent Conditions: Coughing; Flu like symptoms (1st vaccine ill for 48hrs in bed flu like symptoms.)

Other Medications

Previous Vaccinations

Allergies

Laboratory Data

Test Date: 20211222; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test

Write-up

Temperature elevation; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26395885) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021.
This regulatory authority case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature elevation) in a 49-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no.
3) for an unknown indication.
The patient's past medical history included Coughing and Flu like symptoms (1st vaccine ill for 48hrs in bed flu like symptoms.
).
Concurrent medical conditions included Suspected COVID-19 since 19-Dec-2021.
On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form.
On 19-Dec-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature elevation) (seriousness criterion medically significant).
At the time of the report, BODY TEMPERATURE INCREASED (Temperature elevation) was resolving.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test.
The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.
After 1st vaccine the patient was ill for 48hrs in bed flu like symptoms.
After 2nd vaccine it was fine.
Booster in bed for 48hrs, still coughing and high temperature.
Patient is not pregnant.
Patient is not currently breastfeeding.
It was verbally reported that, Early hours of 19-Dec-2021 after having booster on 18-Dec-2021 up during night sickness, headache, continuous coughing, high temperature, couldn't feel.
legs, flu like symptoms.
So concerned took covid19 test - was negative.
Fine and well before booster.
Patient has not tested positive for COVID-19 since having the vaccine.
Patient is not enrolled in clinical trial.
Company Comment: This case concerns a 49-year-old female patient with a relevant medical history of Coughing and Flu like symptoms reported as after the first unspecified vaccine and concurrent suspected COVID-19, who experienced the serious unexpected event of Body temperature increased.
The event occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273).
It was reported that the patient experienced sickness, headache, continuous coughing, high temperature, couldn't feel legs and flu like symptoms.
Suspected COVID-19 could remain a confounder however Covid19 test was negative.
Although the first vaccine was not specified as Modena's Covid-19 vaccine and details were not provided, in a conservative way a positive rechallenge could be identified for cough and flu like symptoms.
Events seriousness assessed as per Regulatory Authority report and retained for consistency.
The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
; Sender's Comments: This case concerns a 49-year-old female patient with a relevant medical history of Coughing and Flu like symptoms reported as after the first unspecified vaccine and concurrent suspected COVID-19, who experienced the serious unexpected event of Body temperature increased.
The event occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273).
It was reported that the patient experienced sickness, headache, continuous coughing, high temperature, couldn't feel legs and flu like symptoms.
Suspected COVID-19 could remain a confounder however Covid19 test was negative.
Although the first vaccine was not specified as Modena's Covid-19 vaccine and details were not provided, in a conservative way a positive rechallenge could be identified for cough and flu like symptoms.
Events seriousness assessed as per Regulatory Authority report and retained for consistency.
The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.