Adverse Event Reporting

VAERS ID 2558974
Gender Female
Age 58
StateCode FR
Pharmaceutical Company MODERNA
Lot Number
Number of vaccinations 2
Vaccinated 2022-01-19
Onset 2022-02-01
Condition
Symptoms
  • Urticaria chronic

Current Illness

Preexisting Conditions

Medical History/Concurrent Conditions: Allergy (allergies); COVID-19

Other Medications

Previous Vaccinations

Allergies

Laboratory Data

Write-up

Chronic urticaria; This regulatory authority case was reported by a consumer and describes the occurrence of URTICARIA CHRONIC (Chronic urticaria) in a 58-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 prophylaxis.
The patient's past medical history included COVID-19.
Concurrent medical conditions included Allergy (allergies).
On 19-Jan-2022, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form.
On 01-Feb-2022, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced URTICARIA CHRONIC (Chronic urticaria) (seriousness criterion medically significant).
At the time of the report, URTICARIA CHRONIC (Chronic urticaria) had not resolved.
No concomitant medications were reported.
Treatment information was not provided.
Sender's comments: The case was serious and unlabelled.
Due to temporal relationship and the known safety profile of the vaccine, the causality was assessed as possible.
Company Comment: This is a regulatory case concerning a 58 year-old, female patient with a history of Hypersensitivity, who experienced the serious (due to medically significant) unexpected, event of Urticaria chronic, which occurred 13 days after the second dose of mRNA-1273 vaccine.
The outcome was reported as not recovered.
The mentioned medical history remains as a confounder.
The company causality for the event is considered as related to the vaccine.
No further clinical information was available for medical review.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Event´s seriousness assessed as reported.