Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Chills, Gestational hypertension, Headache
Clinical narrative: Preeclampsia; Three areas of infarct on the placenta; Anxiety; High blood pressure (started in this pregnancy); Delivery at 36 weeks; Sore arm; Chills; Maternal exposure during pregnancy; Headache; Muscle pain; Fever; Nausea; On 21-JUN-2023, this non-serious, initial sponsored trial safety report was received from a nurse via the Registry and was sent to Novavax on 21-JUL-2023.  A 35-year-old female of an unspecified race was vaccinated with Nuvaxovid 10 ug/mL suspect Covid-19 vaccine unspecified dose on 21-JUN-2023. Route of administration of vaccine was unknown.  Medical history included COVID-19 on 10-AUG-2022, Miscarriage (past 2 pregnancies), Multi gravida (past 10 pregnancies with 8 live babies), and Body mass index high.  Concomitant medications included unspecified prenatal vitamins daily, Aspirin 81 (acetylsalicylic acid) daily (From start date on 24-MAR-2023, 13 weeks gestation period at time of exposure), and vitamin D 3 daily (From start date on 01-FEB-2023, 5 weeks gestation period at time of exposure).  On 21-JUN-2023, at the time of 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.   Registry's narrative was provided as follows: This case refers to a 35 year-old study participant.  On 17-JUL-2023, significant follow-up information was received from a nurse via the Registry, and was sent to Novavax on 16-AUG-2023. The following information has been updated in the case:  On 12-JUL-2023, the individual was vaccinated with a second unspecified dose of intramuscular Nuvaxovid 10 ug/mL suspect Covid-19 vaccine.  On 12-JUL-2023, the same day after vaccination, the individual experienced headache (PT: Headache), muscle pain (PT: Myalgia), and sore arm (PT: Pain in extremity). On 13-JUL-2023, 1 day after vaccination, the individual experienced fever (PT: Pyrexia), chills (PT: Chills), and nausea (PT: Nausea).  On 14-JUL-2023, the event outcomes of Pyrexia, Chills, and Nausea were recovered/resolved. At the time of reporting, the event outcomes of Headache, Myalgia, and Pain in extremity were recovering/resolving.  The Sponsor assessed the causality between the vaccine and the events Headache, Myalgia, Pain in extremity, Pyrexia, Chills, and Nausea as Related, and the causality between the vaccine and the event Maternal exposure during pregnancy as Not Applicable.  Registry's follow-up narrative was provided as follows:   This case refers to a 35 year-old study participant.  Additional information received on 17-Jul-2023 from the study participant: Second dose of Novavax (Nuvaxovid) added. Pyrexia, Chills, Headache, Myalgia, Nausea and Pain in extremity added as adverse events.  On 22-SEP-2023, significant follow-up information was received from a nurse via registry and was sent to Novavax on 29-SEP-2023. During processing of the follow-up a significant case correction was identified. The report type was updated from Sponsored Trial to Non-Interventional Study. The case was upgraded to serious, and the following information has been updated in the case:  Concomitant medications were updated as follows: vitamin D 3 was updated to vitamin D NOS, taken daily since 01-FEB-2023, and Aspirin 81 (acetylsalicylic acid) was updated to Aspirin Low, taken daily since 24-MAR-2023.  On 20-JUL-2023, 8 days after the last vaccination, the individual experienced anxiety (PT: Anxiety). On 24-AUG-2023, 1 month 12 days after vaccination, she experienced high blood pressure, which started in this pregnancy (PT: Gestational hypertension). On 31-AUG-2023, 1 month 19 days after vaccination, the individual experienced pre-eclampsia (PT: Pre-eclampsia) (Serious: Hospitalization and Medically Significant), and was hospitalized. On 01-SEP-2023, she delivered at 36 weeks (PT: Premature delivery). On an unreported date in 2023, the individual experienced 3 areas of infarct on the placenta (PT: Placental infarction).  On 01-SEP-2023, the event outcome of Maternal exposure during pregnancy was recovered/resolved. On 05-SEP-2023, the event outcome of Pre-eclampsia was recovered/resolved. At the time of reporting, the event outcomes of Anxiety and Gestational hypertension were not recovered/not resolved, and Premature delivery and Placental infarction were unknown.  The Sponsor assessed the causality between the vaccine and the events Anxiety, Gestational hypertension, Pre-eclampsia, Premature delivery, and Placental infarction as Not related.  Registry's follow-up narrative was provided as follows:   This case, received on 21-Jun-2023, refers to a 35 year-old study participant.  The study participant's concurrent condition included body mass index high (40.344). Historical condition included COVID-19 on 10-Aug-2022. Concomitant medications included prenatal vitamins, vitamin D and Adult Low Dose Aspirin (acetylsalicylic acid).  The study participant's obstetrical history included 10 previous pregnancies with eight live babies and two miscarriages. The study participant had no history of tobacco, e-cigarettes, alcohol or recreational drug use.  The first day of the last menstrual period (LMP) was calculated to be 23-Dec-2022. The estimated delivery date (EDD) was reported to be 29-Sep-2023. Type of pregnancy was reported as singleton.  On 21-Jun-2023, at gestational age of 25 weeks and four days, the study participant received the first dose of Novavax (Nuvaxovid) vaccine for the prevention of COVID-19. Batch number reported was 5433MF001.  On 12-Jul-2023, at gestational age of 28 weeks and four days, the study participant received the first dose of Novavax (Nuvaxovid) vaccine for the prevention of COVID-19. Batch number reported was 5433MF001.  On the same day, a couple of hours after vaccination, the study participant experienced headache. It started with migraine-like qualities but quickly was throughout entire head. The study participant had sensitivity to light and sound, as well as movement would make it worse. The headache did not go away, but was improved with Tylenol. Additionally, the study participant experienced muscle pain that started as the injection site but then lead to generalized muscle aches. By the end of day, the whole arm become sore.  On 13-Jul-2023, overnight the study participant started getting chills. It would wake her and then go away for about 30 minutes and come back little later. During the day, the study participant noted fever of 101.7 degrees Fahrenheit. Fever was on and off that day and night, but resolved with Tylenol. Additionally, the study participant experienced intense intermittent nausea that required the use of Zofran.   On 14-Jul-2023, the study participant recovered from chills, fever and nausea.  On 20-Jul-2023, the study participant started having anxiety with shortness of breath.  On 24-Aug-2023, the study participant experienced high blood pressure with headache and visual changes like blurry vision and seeing stars. She had swelling in hands and face. Headache did not improve with medication.   On 31-Aug-2023, the study participant developed severe pre-eclampsia and was admitted to hospital due to it. The mother had severe range blood pressure and persistent headache and dizziness, was seeing spots and flashes of light.   At gestational age 36 weeks, the study participant delivered a live, preterm, male neonate by cesarean section (C-section). Primary reason for C-section was reported to be severe preeclampsia with prior C-section due to which they needed to deliver as quickly as possible. The study participant spent four days in hospital for the delivery. Neonate's birth weight was 7 pounds and 4 ounces, body length was 19 inches.   On the same day, after delivery, the baby was transferred to Neonatal Intensive Care Unit (NICU) due to problems with breathing as the baby experienced respiratory distress requiring surfactant. Treatment included ampicillin.   On 05-Sep-2023, the study participant recovered from pre-eclampsia.    On 09-Sep-2023, the neonate recovered from respiratory distress.   On an unspecified date in 2023, the pathology showed three areas of infarction on the placenta.   At the time of this report on 22-Sep-2023, the study participant had not recovered from high blood pressure and anxiety, while she was recovering from headache, muscle pain and sore arm.   Outcome of placental infarction and premature delivery was not reported.   The study participant did not provide causality assessment.  The case is linked with 2023-US-00164 (corresponding baby case).  Additional information received on 17-Jul-2023 from the study participant: Second dose of Novavax (Nuvaxovid) added. Pyrexia, Chills, Headache, Myalgia, Nausea and Pain in extremity added as adverse events.  Additional information received on 22-Sep-2023 from the study participant: Pregnancy outcome provided. Events premature delivery, placental infarction, gestational hypertension, anxiety and pre-eclampsia were added. Case upgraded from non-serious to serious. Narrative updated accordingly.  Principal Investigator's assessments: The event of pre-eclampsia is serious and unexpected for the Novavax (Nuvaxovid). Temporal relationship is not compatible. Advanced maternal age and increased BMI (40.344) are confounding factors. Based on the provided information, causality is assessed as not related.; Sender's Comments: This 35 year-old female experienced: Pre-eclampsia, Placental infarction, Maternal exposure during pregnancy, Headache, Myalgia, Pain in extremity, Chills, Nausea, Pyrexia, Anxiety, Gestational hypertension and Premature delivery after vaccination with Nuvaxovid 10 ug/mL. The event Pre-eclampsia was reported as serious. The events Placental infarction, Maternal exposure during pregnancy, Headache, Myalgia, Pain in extremity, Chills, Nausea, Pyrexia, Anxiety, Gestational hypertension and Premature delivery were reported as non-serious. Considering the current knowledge of the vaccine, the causal relationship between Nuvaxovid and Maternal exposure during pregnancy, Nuvaxovid and Headache, Nuvaxovid and Myalgia, Nuvaxovid and Pain in extremity, Nuvaxovid and Chills, Nuvaxovid and Nausea, Nuvaxovid and Pyrexia and Nuvaxovid and Anxiety were assessed as related, Nuvaxovid and Placental infarction, Nuvaxovid and Gestational hypertension, Nuvaxovid and Pre-eclampsia and Nuvaxovid and Premature delivery were assessed as not related.