Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pre-eclampsia
Clinical narrative: Pre-eclampsia; Maternal exposure during pregnancy; On 29-AUG-2022, a non-serious initial sponsored trial safety report received from COVID-19 Vaccines was received from a consumer and was sent to Novavax on 28-SEP-2022.  A 38-year-old female of an unspecified race was vaccinated with Nuvaxovid 10 ug/mL suspect Covid-19 vaccine unspecified dose on 18-AUG-2022.  The following medical history was reported: In vitro fertilization, Multi gravida (past one pregnancy and one live baby), and Narcolepsy.  The following concomitant medications were reported: prenatal vitamins (minerals nos; vitamins nos) daily (used for supplementation therapy), levothyroxine daily (18-JAN-2022, 2 weeks gestation period at time of exposure), Aspirine (acetylsalicylic acid) daily (14-MAR-2022, 10 weeks gestation period at time of exposure), Unisom 2 (doxylamine succinate) daily (18-JAN-2022, 2 weeks gestation period at time of exposure), melatonin daily (18-JAN-2022, 2 weeks gestation period at time of exposure), Cetrizine (cetirizine hydrochloride) daily (18-JAN-2022, 2 weeks gestation period at the time of exposure), and Flonase Allergy Relief (fluticasone propionate) daily (18-JAN-2022, 2 weeks gestation period at the time of exposure).  On 18-AUG-2022, after vaccination, the individual experienced maternal exposure during pregnancy (PT: Maternal exposure during pregnancy).  At the time of reporting, the event outcome of Maternal exposure during pregnancy was unknown.   The reporter did not assess the causality between the vaccine and reported events: Maternal exposure during pregnancy.  Lot number was not provided in the report.  Narrative as provided as follows: This case refers to a 38-year-old study participant in the "COVID - 19.  On 10-JAN-2023, follow up information was received by COVID-19 Vaccines from a consumer and was sent to Novavax on 17-JAN-2022. It was reported that the individual gave birth to a full-term live female child on 21-Sep-2022 (37 weeks and 6 days gestation) via cesarean. The lot number of Nuvaxovid suspect Covid-19 vaccine was provided. Concomitant medication, daily Famotidine was reported, with a start date of 03-AUG-2022. An additional serious event was reported: On 04-SEP-2022 the individual experienced pre-eclampsia (PT: Pre-eclampsia)(Serious: Medically Significant). The event was reported as recovered/resolved with a stop date of 21-Sep-2022. assessed the causality of the event Pre-eclampsia as Not related.   narrative was provided as follows:  This case, received on 29-Aug-2022, concerns a 38-year-old female participant in the post-marketing study  The study participant's medical history included narcolepsy. Concomitant medication included prenatal vitamins, famotidine, Flonase, cetirizine, melatonin, Unisom, Aspirin, and levothyroxine.  The study participant's obstetrical history included one previous pregnancy, resulting in a live birth. The study participant had no history of alcohol, tobacco, or recreational drug use.  The first day of the last menstrual period (LMP) was calculated to be 30-Dec-2021. The estimated delivery date (EDD) was reported to be 06-Oct-2022. Type of pregnancy was reported as singleton.  On 18-Aug-2022, at gestational age 33 weeks, the study participant received the first dose of the Novavax (Nuvaxovid) vaccine for the prevention of COVID-19. Reported batch number was 4302MF023.  On 04-Sep-2022, the study participant was diagnosed with pre-eclampsia.  On 21-Sep-2022, at gestational age 37 weeks and six days, the study participant delivered a live, full-term, female neonate via caesarean method of delivery (C-section). Primary reason for C-section was reported to be pre-eclampsia. The study participant spent two days at the hospital for the delivery. Neonate's birth weight was 5 pounds and 5 ounces, body length 18 inches.  On the same day, the event of pre-eclampsia resolved.  The study participant did not provide a causality assessment.  Additional information received on 10-Jan-2023 from the study participant: Pre-eclampsia added as an adverse event. Case upgraded to serious. Concomitant medication updated. Narrative updated accordingly.  Assessments: The event of pre-eclampsia is serious and unexpected for the Novavax (Nuvaxovid) vaccine. Advanced maternal age and in vitro fertizilation are known risk factors for development of pre-eclampsia. Chronology is not suggestive. Due to lack of any probable mechanism connecting the vaccine with the development of pre-eclampsia, causality is assessed as not related. Sender's Comments: This 38-year-old female experienced: Pre-eclampsia and Maternal exposure during pregnancy after vaccination with Nuvaxovid 10 ug/mL. The event Pre-eclampsia was reported as serious. The event Maternal exposure during pregnancy was reported as non-serious. Considering the current knowledge of the vaccine, the causal relationship between Nuvaxovid and Maternal exposure during pregnancy was assessed as related, Nuvaxovid and Pre-eclampsia was assessed as not related.