Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amniotic cavity infection, Delivery, Exposure during pregnancy, Premature delivery
Clinical narrative: Chorioamnionitis due to a staph aureus infection; staph aureus infection; fever; preterm labor; My baby did not survive; headaches; fatigue; chills; body aches; This is a spontaneous report from a contactable healthcare professional, the patient. This 38-year-old pregnant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route in the left deltoid on 17Mar2021 (at the age of 38-years-old) as a single dose for COVID-19 immunization. The patient's medical history included atopic dermatitis. The patient had allergies to ibuprofen, Aspirin, and Nuvaring. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9261) via an unspecified route in the left arm on 24Feb2021 (at the age of 38-years-old) as a single dose for COVID-19 immunization and experienced  headaches, fatigue, chills, and body aches. The patient did not have COVID prior to the vaccination. The patient did not receive any other vaccine in four weeks. Concomitant medication included prenatal vitamin. The patient went into preterm labor on 29Mar2021 which was 12 days after her second dose. She delivered on 30Mar2021 at 21 weeks and 5 days. The patient was diagnosed with chorioamnioitis due to a staph aureus infection. The baby did not survive. Leading up to the hospital admission and after her first and second vaccines, she had frequent headaches and fatigue which she related to the vaccine. She also had chills and body aches. Event start date was reported as 21Mar2021. On admission she had a fever. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization. The patient was hospitalized for 2 days. She stated that she is reporting this because she is very healthy and developed an unusual uterine infection after the vaccine. She felt that her immune system was affected post vaccine which may have contributed to her ability to fight off infection. The patient did not receive treatment for pre-term labor, baby did not survive, chorioamnioitis, staph aureus infection, frequent headaches, fatigue, chills, body aches, and fever. The clinical outcome of the events pre-term labor, baby did not survive, chorioamnioitis, staph aureus infection, frequent headaches, fatigue, chills, body aches, and fever was unknown. The patient was tested for COVID post vaccination with nasal swab on 30Mar2021, with test result Negative.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Limited information can not support a complete medical assessment. A possible contributory role between BNT162B2 vaccine and the reported events can not be excluded based on current available information and temporal relationship.  Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021392327 same report/patient, different dose/AE