Adverse Event Reporting
| VAERS ID | 1830462 |
|---|---|
| Gender | Female |
| Age | 31 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | 2 |
| Vaccinated | 2021-06-18 |
| Onset | 2021-06-18 |
| Condition | Hospitalized |
Symptoms
- Maternal exposure during pregnancy
- Placental disorder
- Labour complication
- Umbilical cord abnormality
Current Illness
Preexisting Conditions
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Labor complication/complicated delivery; Placental disorder/Never seen a placenta like this; Umbilical cord complication/umbilical cord had detached from the placenta; vaccine exposure during pregnancy 31 weeks; This is a spontaneous report from a contactable physician downloaded from the regulatory agency-WEB NL-LRB-00697089.
This physician reported information for both mother and fetus/baby.
This is the first of two cases for maternal exposure for 1st and 2nd dose.
This case describes events for maternal 2nd dose, additional fetal case is linked.
A 31-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: unknown), at the age of 31 years old, via an unspecified route of administration on 18Jun2021 at single dose for COVID-19 immunisation.
The patient's medical history and concomitant medications were not reported.
Patient had no previous COVID-19 infection.
The patient previously received the first dose of BNT162B2 (lot number: EX7823) on 13May2021 at single dose for COVID-19 immunisation and experienced vaccine exposure during pregnancy week (27 weeks).
Patient received BNT162B2 during pregnancy on 13May2021 and 18Jun2021.
She gave birth on 18Aug2021.
The patient experienced labor complication (hospitalization), umbilical cord complication (other medically important condition), placental disorder (other medically important condition) following maternal exposure during pregnancy.
The maternal vaccinations took place at a pregnancy duration of 27 weeks (dose 1) and 31 weeks (dose 2).
Patient had a very complicated delivery.
Labour took place at a pregnancy duration of 39 weeks and 5 days, the baby was in very bad condition, almost died and needed resuscitation (described in separate report).
Patient was urgently transferred from one hospital to another in that place.
They told her that they had never seen such a placenta.
The umbilical cord had detached from the placenta.
Her medical indication was suspected fetal distress.
The placenta was poorly developed, weight 380 gram, the umbellical cord had become detached from the placenta.
The placenta will be examined.
Kleihauer test was performed.
She gave birth by vacuum extraction (vaginal) on 18Aug2021.
The delivery started spontaneously with contractions.
Dilation went smoothly.
She received no pain medication.
During first-line expulsion, there was fetal distress on CH3+.
There is immediately a vacuum extraction performed with 3 tractions.
At 11:03, a woman called PRIVACY.
The Apgar scores were: after one minute 0 and after five minutes 2.
The placenta and membranes came spontaneously and were 380 grams.
The child was resuscitated and transferred to the other hospital in that place.
PA examination at the hospital was unknown.
A Klehauer was taken and the placenta was sent for PA.
The mother was pregnant with 1 baby.
APGAR Score 1 was 0, APGAR Score 2 was 2, APGAR Score 3 was not provided.
Outcome of event vaccine exposure during pregnancy 31 weeks was unknown.
Outcome of other events was not recovered.
No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No further information is expected.
; Sender's Comments: Linked Report(s) : NL-PFIZER INC-202101385403 1st/2nd dose mother;NL-PFIZER INC-202101379468 mother/child