Adverse Event Reporting
| VAERS ID | 1517099 |
|---|---|
| Gender | Female |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | FA4598 |
| Number of vaccinations | 1 |
| Vaccinated | 2021-05-16 |
| Onset | 2021-06-23 |
| Condition | Hospitalized |
Symptoms
- Histology
- Abortion incomplete
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Appendectomy; Caesarean section (gave birth to a healthy boy); Diabetes in pregnancy; Migraine; Pneumothorax spontaneous; Pregnant (gravidity); Tonsillectomy; Uterine repair
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 2021; Test Name: Histology; Result Unstructured Data: Test Result:has not found any abnormality of the foetus, place; Comments: has not found any abnormality of the foetus, placenta or umbilical cord.
No signs of chorioamnionitis was found.
Write-up
incomplete abortion; This is a spontaneous report received from a contactable consumer downloaded from the regulatory authority-WEB.
The regulatory authority report number HU-OGYI-608921.
A 30-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 16May2021 (Batch/Lot Number: FA4598) as DOSE 1, 30 ug SINGLE for covid-19 immunisation.
Medical history included Tonsillectomy not ongoing, Pneumothorax spontaneous not ongoing, uterine repair in 2019 not ongoing (underwent a surgery for uterine reconstruction, because after the previous labour, her uterine was deformed, the left side fallopian tube was sutured to the uterine and atrophied, therefore she was unable for normal conception), Diabetes in pregnancy from 2016 not ongoing, migraine unknown if ongoing, caesarean section (gave birth to a healthy boy on 02Mar2016 with caesarean section), Appendectomy not ongoing, pregnancy (gravidity) from an unknown date to 02Mar2016 (birth to a healthy boy).
The patient conducts a healthy lifestyle, she is not smoking or drinking alcohol; does not have any regular medicines.
The patient's concomitant medications was none.
The patient experienced incomplete abortion on 23Jun2021.
Detail course was provided as this is a serious, medically confirmed report for patient describes the occurrence of incomplete abortion after vaccination with COMIRNATY.
On 16May2021, the 30 years old gravid (over the first trimester) female patient received the first dose of COMIRNATY.
On 22Jun2021, in the afternoon during rest, the patient water has just broke in her 18th week of pregnancy.
She was hospitalized in Jun2021, she had incomplete abortion which was completed with intervention.
Before, the foetus and foetal movement was normal.
The foetus was unviable because of immaturity.
Histology in 2021 has not found any abnormality of the foetus, placenta or umbilical cord.
No signs of chorioamnionitis was found.
The patient family doctor suspected the contribution of vaccination to the abortion.
The event outcome was recovering.
Sender's comment: Incomplete abortion is not expected adverse event of COMIRNATY.
TTO was 37 days.
The patient had a previous gravidity without any abnormality.
After she had uterine reconstruction surgery, which might have affected her gravidity.
Based on the above, causality between abortion and COMIRNATY is assessed unlikely.
The case is serious because of hospitalisation and the medical importance of abortion.
No further information is expected.