Adverse Event Reporting
| VAERS ID | 1828148 |
|---|---|
| Gender | Female |
| Age | 40 |
| StateCode | FR |
| Pharmaceutical Company | MODERNA |
| Lot Number | |
| Number of vaccinations | 2 |
| Vaccinated | 2021-10-15 |
| Onset | 2021-10-15 |
| Condition |
Symptoms
- Axillary pain
- Maternal exposure during pregnancy
Current Illness
Pregnancy (Estimated due date: 20220124)
Preexisting Conditions
Other Medications
ASPIRIN [ACETYLSALICYLIC ACID]; FOLIC ACID
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Maternal exposure during pregnancy; Armpit pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26103110) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021.
This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Armpit pain) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination.
Concurrent medical conditions included Pregnancy (Estimated due date: 20220124).
Concomitant products included FOLIC ACID for Folic acid supplementation, ASPIRIN [ACETYLSALICYLIC ACID] for Normal pregnancy.
On 15-Oct-2021, the patient received second 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 24-Jan-2022.
On 15-Oct-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant).
On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant).
At the time of the report, AXILLARY PAIN (Armpit pain) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown.
The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.
Treatment information was not provided.
Since the patient received the second dose of the vaccine the patient experienced: - pain on the arm where the injection was made; lasted 1 day; resolved.
- pain and swollen lymph nodes in armpit where (same arm the injection was made); slightly less painful however still swollen; not resolved.
- muscular pain thought the body, overnight during the first night; resolved.
Patient was exposed to the medicine first-trimester (1-12 weeks).
COMPANY COMMENT: This case of Maternal exposure during pregnancy concerns a 40-year-old, female patient with no relevant medical history, who experienced the unexpected event of Axillary pain.
The patient received the second dose of vaccine in the 1st trimester of gestation.
The event occurred on the day of the second dose of Moderna CoviD-19 Vaccine with an unknown outcome.
The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.
; Sender's Comments: This case of Maternal exposure during pregnancy concerns a 40-year-old, female patient with no relevant medical history, who experienced the unexpected event of Axillary pain.
The patient received the second dose of vaccine in the 1st trimester of gestation.
The event occurred on the day of the second dose of Moderna CoviD-19 Vaccine with an unknown outcome.
The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.