Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Postpartum haemorrhage, Pre-eclampsia, Pyrexia, SARS-CoV-2 test
Clinical narrative: DELAYED POSTPARTUM HEMORRHAGE; SEVERE PRE-ECLAMPSIA; MATERNAL EXPOSURE DURING PREGNANCY; NASAL CONGESTION; SINUS PAIN; CHILLS; FEVER; This solicited pregnancy report received from a consumer concerned a 34 year old female. The patient was enrolled in a non-company sponsored study  The patient's weight was 127 kilograms, and height was 178 centimeters. The patient's past medical history included covid-19 (tested positive on 30-NOV-2021), alcohol use and body mass index increased (40.16). Concurrent conditions included body mass index increased. Patient had no relevant obstetrical history, no history of tobacco or recreational drug use. The first day of the last menstrual period (LMP) was reported to be 10-Feb-2021. The estimated delivery date (EDD) was calculated to be 17-Nov-2021. Type of pregnancy was reported as singleton. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, 1 total administered on 06-MAR-2021 for covid-19 immunisation (Dose number in series 1). Drug start period and end period was 250 days. Concomitant medications included cetirizine hydrochloride, ferrous sulfate, labetalol, nifedipine, and paracetamol and Prenatal vitamins. On 06-MAR-2021, patient experienced maternal exposure during pregnancy. On 07-MAR-2021, about 12 to 15 hours after vaccination, she woke up with chills and fever. She took Tylenol and rested all day. On 08-MAR-2021, she recovered from chills and fever. On 17-JUL-2021, she experienced mild nasal congestion and bad sinus pain in right nasal cavity which occurred after eating that lasted for an hour and got repeated at random times, usually after dinner. On 20-JUL-2021, she recovered from nasal congestion and sinus pain. However, she had concerning nasal congestion with some lasting effects. On 11-NOV-2021, she was diagnosed with severe pre-eclampsia, which led to her hospitalisation. Her blood pressure was 218/113 mmHg and there were proteins in urine. She was sent for labor induction and was put on Magnesium drip. The pregnancy resulted in a live birth. The patient gave birth via natural birth to a 2.94 kilogram, 18 inch, male baby. Birth outcome was unknown. She spent five days in the hospital for the delivery. After the delivery, she was in the hospital's intensive care unit (ICU) because she was bleeding a lot. She ended up haemorrhage and needed three blood transfusions and surgery to repair the laceration in the vagina. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from maternal exposure during pregnancy on 13-NOV-2021, nasal congestion, and sinus pain on 20-JUL-2021, and chills, and fever on 08-MAR-2021, and was recovering from severe pre-eclampsia, and delayed postpartum hemorrhage. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and severe pre-eclampsia, and delayed postpartum hemorrhage as not related, and between covid-19 vaccine ad26.cov2.s and nasal congestion, sinus pain, chills, and fever as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s and maternal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s and maternal exposure during pregnancy was not related and between covid-19 vaccine ad26.cov2.s and nasal congestion, sinus pain, chills and fever was related. This report was serious (Hospitalization Caused / Prolonged).  This case was reassessed as serious based on additional information received from consumer on 01-Dec-2021, the following information was updated and incorporated into case narrative: Patient details, Pregnancy information, Medical history, events postpartum hemorrhage and pre-eclampsia added, outcome of chills, fever, sinus pain, nasal congestion updated, Concomitant and drug used to treat AE information updated, Lab data added, narrative updated.; Sender's Comments: V1: The version updates Patient details, Pregnancy information, Medical history, events, outcome of chills, fever, sinus pain, nasal congestion, Concomitant and drug used to treat AE, Lab data, narrative.  20210756883-COVID-19 VACCINE AD26.COV2.S-severe pre-eclampsia, delayed postpartum hemorrhage. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY [Underlying obesity (BMI 40.16) and first pregnancy are confounding factors for event of pre-eclampsia and labour itself which caused laceration in the vagina is alternative etiology for the event of postpartum haemorrhage]  20210756883-COVID-19 VACCINE AD26.COV2.S-maternal exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS