有害事象報告詳細

VAERS ID 1492603
性別 女性
年齢 28歳
州コード FR
製薬会社 ファイザー
ロット番号 EY0578
ワクチン接種回数 2
接種日 2021-06-18
発生日 2021-06-19
状態
症状
  • 痛み(Pain)
  • 感覚鈍麻経口(Hypoaesthesia oral)
  • 顔面神経麻痺(Facial paralysis)
  • 耳の痛み(Ear pain)
  • 敏感肌(Sensitive skin)
  • 運動機能低下症(Hypokinesia)
  • 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: Urinary tract infection (Previously Disease Treatment: cephalexin)

その他医療

以前のワクチン接種

アレルギー

臨床検査

症状詳細

Gestation week: 26; left side facial paralysis; Pain/Sensitivity; Pain/Sensitivity; Limited movement; otalgia/earache; tongue numbness; numbness in the mouth; This is a spontaneous report from a non-contactable Other Health Professional.
This is a report received from the regulatory authority via email.
Regulatory authority report number is 16536-7.
This other Healthcare Professional reported information for mother.
This is a maternal report.
A 28-years-old female patient (patient was pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EY0578, Expiration date: 01Oct2021) intramuscular, administered in left arm on 18Jun2021 at 12 noon (age at vaccination was 28 years) as dose 2, single for COVID-19 immunization.
Medical history included urinary tract infection (previously disease treatment: cephalexin).
The patient did not have any allergies.
The patient's concomitant medications were not reported.
The patient previously took cephalexin [Cefalexin] for urinary tract infection.
The patient did not have infectious disease in the last 15 days prior to vaccination.
The patient was healthy before vaccination.
The onset date of first symptom was 19Jun2021.
The timeframe between vaccination and starting of symptoms was 19 hours.
The mother reported she became pregnant while taking BNT162B2.
The mother was 26 weeks pregnant at the onset of the event.
The gestation week was 26.
On 19Jun2021 at 7:00 am, the patient experienced pain/sensitivity, limited movement, otalgia/earache, tongue numbness and numbness in the mouth.
On 20Jun2021, the patient experienced left side facial paralysis.
It was reported that 26 weeks pregnant female was vaccinated last Friday 18Jun2021 at approximately 12 noon and started symptoms the next day around 7 am (19 hrs later) with earache, numbness in the mouth and the next day (Sunday 20Jun2021) with facial paralysis on the left side, for which she went to the neurologist and gynecologist who installed treatment.
No treatment was received before receiving medical attention.
The patient received treatment with complex b + nucleus cmp forte + deflazacort + acyclovir + artificial tears drops.
The outcome of the events was resolved with sequel and the sequel was reported as facial paralysis.
No follow-up attempts are possible.
No further information is expected.