Adverse Event Reporting
| VAERS ID | 1845758 |
|---|---|
| Gender | Female |
| Age | 24 |
| StateCode | FR |
| Pharmaceutical Company | MODERNA |
| Lot Number | |
| Number of vaccinations | 2 |
| Vaccinated | 2021-07-02 |
| Onset | 2021-07-02 |
| Condition | Recovered |
Symptoms
- Body temperature increased
- Vaccination site pain
- Maternal exposure during pregnancy
- Prenatal screening test
- Abortion
Current Illness
Preexisting Conditions
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20210804; Test Name: Antrnetal Examination; Result Unstructured Data: Patient was normal and 19 week pregnant.
; Test Date: 20210908; Test Name: Antrnetal Examination; Result Unstructured Data: Fetus had no heartbeat
Write-up
Abortus; slightly higher body temperature; mild pain at the injection site; Maternal exposure during pregnancy; This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION (Abortus) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.
3004223-CDC) for COVID-19 vaccination.
The occurrence of additional non-serious events is detailed below.
No Medical History information was reported.
On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.
On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.
Last menstrual period and estimated date of delivery were not provided.
On 02-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).
On 06-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BODY TEMPERATURE INCREASED (slightly higher body temperature) and VACCINATION SITE PAIN (mild pain at the injection site).
On 08-Sep-2021, the patient experienced ABORTION (Abortus) (seriousness criterion medically significant).
The delivery occurred on 08-Sep-2021, which was reported as Spontaneous Abortion.
For foetus 1, The outcome was reported as Spontaneous Abortion NOS.
On September 8, patient underwent Week 24 antenatal examination, and found that the fetus had no heartbeat.
On 06-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.
In August 2021, BODY TEMPERATURE INCREASED (slightly higher body temperature) and VACCINATION SITE PAIN (mild pain at the injection site) had resolved.
At the time of the report, ABORTION (Abortus) outcome was unknown.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, Prenatal screening test: normal (normal) Patient was normal and 19 week pregnant.
.
On 08-Sep-2021, Prenatal screening test: fetus had no heartbeat (abnormal) Fetus had no heartbeat.
No concomitant and treatment medication were provided Patient age was given as 24.
2.
Company comment: This case concerns a 24 year old female with no reported medical history , who experienced Serious , unexpected event of Spontaneous abortion which occurred 1 month 2 days after vaccination with the 2nd dose of mRNA-1273 (Moderna Covid 19 vaccine.
).
This was accompanied by other non-serious expected events of vaccination site pain and unexpected event of Body temperature increased which occurred on an unknown time after vaccination with the 2nd dose.
Non-serious event of maternal exposure during pregnancy was also coded.
The patient received the vaccine at 19 weeks AOG for dose 1 and for dose 2 at 24 weeks AOG, while Spontaneous Abortion occurred during the 30 weeks AOG.
The re-challenge for this case is not applicable.
The benefit-risk relationship of mRNA-1273 (Moderna Covid 19 vaccine ) is not affected by this report.
Per medical reviewer's assessment agree that event Spontaneous Abortion serious : Medically Significant.
; Sender's Comments: This case concerns a 24 year old female with no reported medical history , who experienced Serious , unexpected event of Spontaneous abortion which occurred 1 month 2 days after vaccination with the 2nd dose of mRNA-1273 (Moderna Covid 19 vaccine.
).
This was accompanied by other non-serious expected events of vaccination site pain and unexpected event of Body temperature increased which occurred on an unknown time after vaccination with the 2nd dose.
Non-serious event of maternal exposure during pregnancy was also coded.
The patient received the vaccine at 19 weeks AOG for dose 1 and for dose 2 at 24 weeks AOG, while Spontaneous Abortion occurred during the 30 weeks AOG.
The re-challenge for this case is not applicable.
The benefit-risk relationship of mRNA-1273 (Moderna Covid 19 vaccine ) is not affected by this report.
Per medical reviewer's assessment agree that event Spontaneous Abortion serious : Medically Significant.