Age: 32.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abortion spontaneous, Pain, Pregnancy test, Pregnancy test urine, Ultrasound biliary tract
Clinical narrative: Miscarriage; Pain/soreness; This is a solicited report based on the information received by Pfizer (manufacturer control number: 21K-163-4056010-00).  A contactable consumer (patient) reported that a pregnant 32-year-old female patient received bnt162b2 (BNT162B2), dose 1 via intramuscular on 25May2021 (Lot Number: EW0183; Expiration Date: Aug2021) (at the age of 32-year-old) as single dose for covid-19 immunisation and adalimumab (HUMIRA, Solution for injection in pre-filled syringe), via subcutaneous from an unspecified date to 2021 (Lot Number: 1143165), at 40 mg, weekly for plaque psoriasis, psoriatic arthritis. The patient had a relevant medical history of weight loss surgery from 25Sep2019, polycystic ovary syndrome, obesity, Psoriatic arthritis, Asthma, high blood pressure and Bipolar. The patient was Alcohol use and Non-tobacco user. The family medical history of high blood pressure on maternal side, family medical history of endometrial cancer on maternal side and family medical history of diabetes on maternal side. Concomitant medications included human chorionic gonadotropin taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for asthma, start and stop date were not reported; lurasidone hydrochloride (LATUDA) taken for bipolar, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for bipolar, start and stop date were not reported; metoprolol taken for high blood pressure, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported; chorionic gonadotrophin (OVIDREL) taken for an unspecified indication, start and stop date were not reported; letrozole taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for supplementation therapy, start and stop date were not reported. The patient had other concomitant therapy of Prenatal Multivitamins. The patient previously took ciprofloxacin (CIPRO) and experienced itchiness, ciprofloxacin lactate (CIPRODEX) and experienced ear itchiness, hydrocodone bitartrate; paracetamol (VICODIN) and experienced hallucination and paranoia, naloxone hydrochloride (NARCAN) and experienced hallucination and paranoia. The patient previously took adalimumab (HUMIRA), via subcutaneous from Nov2020 (Batch/Lot Number: 1143165) to 2021, at 40 mg, weekly for plaque psoriasis, psoriatic arthritis and experienced Gallbladder stone in Apr2021 and Weight gain in 2020. In 2021, the patient experienced soreness. On an unknown date, the patient experienced maternal exposure during pregnancy. On 10Jun2021, the patient experienced miscarriage. BNT162b2 was also considered suspect. On 01Jun2021, the pregnancy was confirmed via home pregnancy test and pregnancy test by blood. Last menstrual period (LMP) was 03May2021. It was her first pregnancy after starting on HUMIRA. The fetus was exposed to maternal use of HUMIRA in utero. The estimated date of delivery (EDD) was 07Feb2022. On 10Jun2021, the fetus died. She was off of HUMIRA for three weeks when she had the miscarriage because of a recent gall bladder surgery as of 02Sep2021. The alternative etiology of the reporter for miscarriage was COVID 19 vaccine. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. On 25May2021, she received first dose COVID-19 Vaccine manufactured by Pfizer. In Jun2021, she received second dose COVID-19 Vaccine manufactured by Pfizer via intramuscular. The patient underwent lab tests and procedures which included pregnancy test by blood: positive on 01Jun2021, home pregnancy test: positive on 01Jun2021, gall bladder ultrasound: gall bladder stones were seen in Apr2021. The action taken in response to the events for adalimumab was Post-Therapy and therapy ongoing from 10Jun2021, at 40 mg, weekly. The outcome of the event pain/soreness was recovered in 2021, the outcome of the event Miscarriage was unknown.  The reporter's causality for the event(s) of miscarriage with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of gall bladder surgery and maternal exposure during pregnancy was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of miscarriage, gall bladder surgery and maternal exposure during pregnancy are related to HUMIRA(ADALIMUMAB).   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the reported event  Abortion spontaneous and Pain is possibly related to BNT162B2.