Adverse Event Reporting
| VAERS ID | 1844987 |
|---|---|
| Gender | Female |
| Age | 29 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | FF4204 |
| Number of vaccinations | 1 |
| Vaccinated | 2021-09-08 |
| Onset | 2021-09-08 |
| Condition | Hospitalized Life Threatening |
Symptoms
- Blood test
- Streptococcus test
- Premature rupture of membranes
- Streptococcus test positive
- Body temperature
- Investigation
- Maternal exposure during pregnancy
- Culture
- Serology test
- Histology
- Amniotic cavity infection
- Funisitis
Current Illness
Preexisting Conditions
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Name: Blood sampling; Result Unstructured Data: Test Result:no significant inflammatory findings were observed; Comments: no significant inflammatory findings were observed.
; Test Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:36.
4 Centigrade; Comments: before vaccination; Test Name: vaginal culture; Result Unstructured Data: Test Result:no significant infection findings; Test Date: 20210915; Test Name: placental pathological examination; Result Unstructured Data: Test Result:The villi showed some findings of chorioamnionitis; Comments: The villi showed some findings of chorioamnionitis with a marked increase in blood vessels.
Neutrophil infiltration was seen in the chorion, with some extending slightly to the amniotic membrane.
; Test Date: 20210915; Test Name: umbilical cord pathological examination; Result Unstructured Data: Test Result:two arteries and one vein were seen, both of which; Comments: two arteries and one vein were seen, both of which were patent.
Neutrophil infiltration was seen on the vessel wall and extended to the interstitium around the vessel.
; Test Name: Ante-natal check-up; Result Unstructured Data: Test Result:no abnormality; Test Name: serology tests; Result Unstructured Data: Test Result:no results; Test Date: 20210915; Test Name: GBS; Test Result: Positive
Write-up
GBS positive; chorangiosis and chorioamnionitis; Funisitis; Premature rupture of membranes; was pregnant for 33 weeks and 4 days on the day of vaccination; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA).
Regulatory authority report number is v21128223.
This physician reported information for both mother and fetus.
This is the maternal report.
A 29-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FF4204, Expiration date 31Jan2022) dose 1 via intramuscular on 08Sep2021 at 13:50 (at 29-year-old) as single dose for COVID-19 immunisation.
Body temperature before vaccination was 36.
4 degrees Centigrade.
The patient medical history and concomitant medications were not reported.
On 08Sep2021 at 13:50 (the day of the first vaccination), the patient received the 1st dose of vaccination.
The patient was pregnant for 33 weeks and 4 days on the day of vaccination.
The first day of last menstrual period was unknown.
The date of conception was unknown.
The estimated delivery date was 23Oct2021.
During this pregnancy, the patient did not smoke, did not drink alcohol or did not use illicit drugs.
The patient did not have maternal medical history.
The patient did not have treatment for infertility.
There were no results of serology tests.
Ante-natal check-up was no abnormality.
On 10Sep2021 (2 days after vaccination), the patient was transported by a former doctor due to the premature rupture of membranes (33 weeks 6 days pregnant) and measures were taken.
The patient was admitted to a hospital.
No increase in pyrexia or inflammatory findings was observed during transportation.
The patient received betamethasone (RINDERON) injection to promote lung maturation of the baby.
On 11Sep2021 (3 days after the first vaccination), betamethasone intravenous drip and ritodrine intravenous drip was administered.
On 12Sep2021 (4 days after the first vaccination), ritodrine discontinued.
After administration of antibiotics such as ampicillin (VICCILLIN) and erythromycin (ERYTHROCIN), no significant inflammatory findings were observed in pyrexia or blood sampling, and no significant infection findings that could cause vaginal culture were observed.
On 15Sep2021 at 07:13 (7 days after vaccination), she gave birth to a baby (34 weeks 4 days).
There was no problem before, during, or after delivery.
Mode of delivery was natural birth/ vaginal delivery.
The postpartum course was good.
Group B strep (GBS) positive.
The patient performed pathological examination.
Pathological diagnosis was as follows: Placenta, 34 weeks, delivery: 380 gms weight at 25-50th percentile for gestational age, chorangiosis and chorioamnionitis.
Umbilical cord: funisitis.
The comment: #1-10 (placenta): The placenta weighs 380g, which was equivalent to the number of weeks.
The villi showed some findings of chorioamnionitis with a marked increase in blood vessels, and it was considered that the villi were hypoxic.
Neutrophil infiltration was seen in the chorion, with some extending slightly to the amniotic membrane.
#11,12 (umbilical cord), two arteries and one vein were seen, both of which were patent.
Neutrophil infiltration was seen on the vessel wall and extended to the interstitium around the vessel.
On 19Sep2021 (11 days after the first vaccination), the patient was discharged from the hospital due to the good progress after delivery.
On 29Sep2021 at 13:51 (the day of the second vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF2782, Expiration date 28Feb2022) via intramuscular as a single dose for COVID-19 immunization.
The reporter classified the event as serious (Life-threatening and caused Hospitalized from 10Sep2021 to 19Sep2021) and assessed that the event was related to bnt162b2 and the causality between the event and bnt162b2 as unassessable (as reported) (Reason was Premature delivery occurred due to infectious disease).
For premature delivery, placental pathological examination revealed neutrophil infiltration from the chorion to some amniotic membrane, which may be caused by chorioamnionitis.
The outcome of the events was unknown.
Follow-up (25Oct2021): New information received from the same contactable physician including: vaccination information, pathology result, new event (Premature rupture of membranes, GBS positive, funisitis, chorioamnionitis), update of physician comment and clinical course.
This case upgraded to serious.
Follow-up attempts are completed.
No further information is expected.
; Sender's Comments: Linked Report(s) : JP-PFIZER INC-202101295911 child case