Adverse Event Reporting
| VAERS ID | 1841645 |
|---|---|
| Gender | Female |
| Age | 41 |
| StateCode | FR |
| Pharmaceutical Company | MODERNA |
| Lot Number | 3002332 |
| Number of vaccinations | 1 |
| Vaccinated | 2021-05-27 |
| Onset | 2021-05-28 |
| Condition | Recovered |
Symptoms
- Pain in extremity
- Pyrexia
- Rash
- Maternal exposure during pregnancy
Current Illness
Pregnancy (Estimated due date: 07-Mar-2022).
Preexisting Conditions
Medical History/Concurrent Conditions: Suspected COVID-19.
Other Medications
FOLIC ACID
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Maternal exposure during pregnancy; Skin rash; Fever; Painful arm; Painful arm; Fever; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26116056) on 26-Oct-2021 and was forwarded to Moderna on 26-Oct-2021.
This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of RASH (Skin rash), the first episode of PYREXIA (Fever), the second episode of PYREXIA (Fever), the first episode of PAIN IN EXTREMITY (Painful arm), the second episode of PAIN IN EXTREMITY (Painful arm) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 41-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no.
3002332) for COVID-19 vaccination.
The patient's past medical history included Suspected COVID-19 from 23-Mar-2020 to 02-Apr-2020.
Concurrent medical conditions included Pregnancy (Estimated due date: 07-Mar-2022).
Concomitant products included FOLIC ACID for Folic acid supplementation.
On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form.
The patient's last menstrual period was on an unknown date and the estimated date of delivery was 07-Mar-2022.
On 28-May-2021, the patient experienced the first episode of PYREXIA (Fever) (seriousness criterion medically significant) and the first episode of PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant).
On 05-Oct-2021, the patient experienced the second episode of PYREXIA (Fever) (seriousness criterion medically significant) and the second episode of PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant).
On 06-Oct-2021, the patient experienced RASH (Skin rash) (seriousness criterion medically significant).
On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant).
On 07-Oct-2021, last episode of PAIN IN EXTREMITY (Painful arm) had resolved.
On 11-Oct-2021, RASH (Skin rash) and the last episode of PYREXIA (Fever) had resolved.
At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.
The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.
Treatment information was not provided.
Company Comment: This case involves a 41-year-old female subject with a medical history of suspected Covid-19 (ended prior to vaccination) and the current condition of pregnancy (date of LMP and pregnancy test not provided) who experienced the serious unexpected adverse events of pyrexia (first episode closely after her vaccination on 27 May 2021), pain in extremity (first episode closely after her vaccination with mRNA-1273 also within days), rash (months later) and a second episode both of pyrexia and pain in extremity months after her first vaccination.
An exposure during pregnancy is possible.
All events were assessed by the regulatory authority as serious (other) without any evidence provided in the report.
The first episodes of pyrexia and pain in extremity are known adverse events in close timely context with a vaccination with mRNA-1273.
Their occurrence months after the vaccination does not appear to be likely even in a timely correlation to this vaccination from a medical point of view.
No treatment for the adverse events has been reported.
The benefit-risk relationship of mRNA-1273 was not affected by this report.
; Sender's Comments: This case involves a 41-year-old female subject with a medical history of suspected Covid-19 (ended prior to vaccination) and the current condition of pregnancy (date of LMP and pregnancy test not provided) who experienced the serious unexpected adverse events of pyrexia (first episode closely after her vaccination on 27 May 2021), pain in extremity (first episode closely after her vaccination with mRNA-1273 also within days), rash (months later) and a second episode both of pyrexia and pain in extremity months after her first vaccination.
An exposure during pregnancy is possible.
All events were assessed by the regulatory authority as serious (other) without any evidence provided in the report.
The first episodes of pyrexia and pain in extremity are known adverse events in close timely context with a vaccination with mRNA-1273.
Their occurrence months after the vaccination does not appear to be likely even in a timely correlation to this vaccination from a medical point of view.
No treatment for the adverse events has been reported.
The benefit-risk relationship of mRNA-1273 was not affected by this report.