Adverse Event Reporting
|Number of vaccinations||3|
- Abdominal pain
- Abortion spontaneous
- Maternal exposure during pregnancy
Medical History/Concurrent Conditions: Maternal exposure during pregnancy, first trimester (vaccine exposure during pregnancy week: In the first week. End of week 6 - miscarriage)
Miscarriage; Huge abdominal pain day after vaccination; This was the third (booster) Covid vaccination, which took place at a pregnancy duration of about 3 weeks.
; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB.
Regulatory number: NL-LRB-00792635 (RA).
A 40-year-old female patient (pregnant) received BNT162b2 (COMIRNATY), on 04Jan2022 as dose 3 (booster), single (Lot number: Unknown) for covid-19 immunisation.
The patient's relevant medical history included: "Maternal exposure during pregnancy, first trimester" (unspecified if ongoing), notes: vaccine exposure during pregnancy week: In the first week.
End of week 6 - miscarriage.
The patient was 3 weeks pregnant at the time of exposure to BNT162b2.
The patient was 8 weeks pregnant at the event onset.
The patient's concomitant medications were not reported.
Vaccination history included: comirnaty (DOSE 1 0.
3ML, SINGLE), administration date: 27Jun2021, for covid-19 immunisation, reaction(s): "No adverse reaction"; comirnaty (DOSE 2 0.
3ML, SINGLE), administration date: 02Aug2021, for covid-19 immunisation, reaction(s): "No adverse reaction".
The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 04Jan2022, outcome "unknown", described as "This was the third (booster) Covid vaccination, which took place at a pregnancy duration of about 3 weeks.
"; ABDOMINAL PAIN (non-serious) with onset 05Jan2022, outcome "unknown", described as "Huge abdominal pain day after vaccination"; ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "Miscarriage".
The pregnancy resulted in spontaneous abortion.
Therapeutic measures were taken as a result of abdominal pain with paracetamol.
No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No further information is expected.