Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Maternal exposure during pregnancy
Clinical narrative: Bells palsy; Maternal exposure during pregnancy; On 14-OCT-2023, this non-serious, initial non-interventional study safety report; (US-PREGISTRY-2023-US-00172) and was sent to Novavax on 11-NOV-2023.  A 34-year-old female of an unspecified race was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect COVID-19 vaccine dose 1 (dose 5 of COVID-19 vaccine) on 14-OCT-2023 at 5 weeks of gestation.  Medical history included Body mass index increased (30.10), Anxiety, and Asthma. On 23-AUG-2022, the individual tested positive for COVID-19, with flu-like symptoms for 5 days, and recovered on an unspecified day in AUG-2022. Prior to this pregnancy, medical history included Substance use. Previous vaccinations included Comirnaty COVID-19 vaccine (tozinameran) dose 1 on 16-DEC-2020, dose 2 on 06-JAN-2021, and dose 3 on 03-OCT-2021, and Spikevax Bivalent Original/Omicron (elasomeran, imelasomeran) dose 1 on 15-OCT-2022.  Concomitant medications included unspecified prenatal vitamins daily since an unspecified date, and Singulair (montelukast sodium) daily, Claritin Allergic (oxymetazoline hydrochloride) daily for COVID-19 immunisation, Celexa (celecoxib) daily, pramipexole twice daily, and Symbicort (budesonide, formoterol fumarate) daily since 05-SEP-2023.  On 14-OCT-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.  The Sponsor assessed the causality between the vaccine and the event Maternal exposure during pregnancy as Not Applicable.   Narrative was provided as follows:   This case refers to a 34 year-old study participant.  Discrepancies were identified in the source document. The route of administration for the suspect product was reported as unknown, but assessed as intramuscular use. Additionally, the reported indication for the concomitant medication Claritin Allergy was COVID-19 immunisation. The indication was retained to mirror the source document.  On 27-JAN-2024, significant additional information was received from a consumer (US-PREGISTRY-2023-US-00172), and was sent to Novavax on 03-FEB-2024. The following information was updated in the case:   Additional concomitant medications included aspirin low (acetylsalicylic acid) daily since 22-JAN-2024.  On 26-DEC-2023, 2 months 13 days after vaccination, the individual experienced Bell's palsy (PT: Bell's Palsy) (Serious: Medically Significant). The case was upgraded to serious.  At the time of reporting, the event outcome of Bell's palsy was recovering/resolving.  The Sponsor assessed the causality between the vaccine and the event Bell's palsy as Not Related.  Follow-up narrative was provided as follows:   The study participant's concurrent conditions included anxiety, asthma and body mass index (BMI) high (30.109). Historical condition included COVID-19. The study participant's concomitant medications included prenatal vitamins, Singulair, Claritin, Celexa, pramipexole, Symbicort and Aspirin. Historical vaccines included first ,second and third doses of Pfizer-BioNTech (Comirnaty) vaccine on 16-Dec-2020, 06-Jan-2021, 03-Oct-2021, respectively and fourth dose of Moderna (Spikevax) vaccine on 15-Oct-2022.   The study participant had no obstetrical history and no history of tobacco, e-cigarettes and alcohol use, while she reported recreational drug use before pregnancy.  The first day of last menstrual period (LMP) was reported to be 05-Sep-2023. The estimated delivery date was calculated to be 11-Jun-2024. Type of pregnancy was reported as singleton.   On 14-Oct-2023, at gestational age five weeks and four days, the study participant received the fifth dose of Novavax (Nuvaxovid) vaccine for prevention of COVID-19 disease. The batch number reported was 6190413N.   On 26-Dec-2023, at gestational age 16 weeks, the study participant experienced paralysis of right side of face, loss of taste and difficulty swallowing and was admitted to hospital. There, the study participant was diagnosed with Bell's palsy and treatment included Prednisone, every day and Valtrex, three times daily for one week.  On 02-Jan-2024, the study participant stopped treatment with Prednisone and Valtrex.   At the time of follow-up report on 27-Jun-2024, the study participant was recovering from Bell's palsy.   The study participant did not provide causality assessment.   Additional information received on 27-Jan-2024 from the study participant: Aspirin low dose added as concomitant medication. Bell's palsy added as new adverse event and case upgraded to serious. Narrative updated accordingly.  Principal Investigator's assessments: The event of Bell's palsy is serious and unexpected for the Novavax (Nuvaxovid) vaccine. The study participant developed Bell's palsy, also known as acute peripheral facial palsy of unknown cause, 2 months and 13 days following Nuvaxovid vaccination. Bell's palsy can occur at any age, and it affects all races and both sexes equally. Although often related to having a viral infection, current research has not found a significant link between the COVID-19 vaccine and Bell's palsy. A person is more likely to develop the latter from developing COVID-19 than from having the vaccine. Taking into account underlying risk factors (obesity (BMI 30.109), pregnancy and historical COVID-19 infection) and time to onset of the diagnosis not compatible with acute nature of the condition, causality is assessed as not related.; Sender's Comments: This 34 year-old female experienced: Bell's palsy and Maternal exposure during pregnancy after vaccination with Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The event Bell's palsy 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 Novavax Covid-19 Vaccine and Adjuvanted (2023-2024 Formula) and Maternal exposure during pregnancy was assessed as related, Novavax Covid-19 Vaccine and Adjuvanted (2023-2024 Formula) and Bell's palsy was assessed as unlikley related.