有害事象報告詳細
| VAERS ID | 1393181 |
|---|---|
| 性別 | 女性 |
| 年齢 | |
| 州コード | FR |
| 製薬会社 | ファイザー |
| ロット番号 | EW2243;EAN:05 |
| ワクチン接種回数 | 1 |
| 接種日 | 2021-04-08 |
| 発生日 | 2021-05-16 |
| 状態 | 回復 |
症状
- 腹痛(Abdominal pain)
- 自然流産(Abortion spontaneous)
- 妊娠中の母親の曝露(Maternal exposure during pregnancy)
罹患中の病気
持病
Medical History/Concurrent Conditions: Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
その他医療
FOLIC ACID; LUTEINE [PROGESTERONE]; PROGESTERONE; DROTAVERINE
以前のワクチン接種
アレルギー
臨床検査
症状詳細
abdomen pain; Maternal exposure during pregnancy; Miscarriage; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA).
The regulatory authority report number is GB-MHRA-WEBCOVID-202105261342361520-JLZ5Q,Safety Report Unique Identifier GB-MHRA-ADR 25364390.
A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 08Apr2021 (Batch/Lot Number: EW2243; EAN: 05909991445492) at first dose, single for COVID-19 immunization.
Medical history included abort Miscarriage and pregnancy (Patient no longer pregnant at the time of reporting).
Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test; Patient is not enrolled in clinical trial; Patient is not currently breastfeeding.
Concomitant medications included folic acid (FOLIC ACID) taken for vitamin supplementation, start and stop date were not reported; luteine [progesterone] (LUTEINE [PROGESTERONE]) taken for an unspecified indication from 16May2021 to an unspecified stop date; progesterone taken for an unspecified indication, start and stop date were not reported; drotaverine taken for an unspecified indication, start and stop date were not reported; and dydroprogesterone.
The patient experienced miscarriage on 16May2021 that recovered on 23May2021; abdomen pain on an unspecified date with outcome of unknown; and maternal exposure during pregnancy on an unspecified date with outcome of unknown.
The events caused prolonged hospitalization.
It was reported that bleeding started at 8th week of being pregnant.
Drugs prescribed: folic acid, drotaverine, progesterone, dydroprogesterone, resting and being in beg.
After the bleeding finished the strong abdomen pain happened within a few days and finished with miscarriage in 9th week.
Patient has not tested positive for COVID-19 since having the vaccine.
The patient didn't know about being pregnant at the time then vaccine was administered.
Patient was exposed to the medicine first-trimester (1-12 weeks).
No follow-up attempts are possible.
No further information is expected.