Age: 32.0
Sex: F
Vaccine: COVID19, FLUC4, COVID19, FLUC3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy
Clinical narrative: Miscarriage; Flucelvax Quadrivalent and Novavax vaccines were administered on the same day in the same arm; Positive pregnancy tests on 1/4, 1/5, and 1/8. Vaccine administered on 1/5.; This spontaneous case was retrieved on 07-Feb-2024 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2730811-1), reported by other non-healthcare professional (consumer) and concerned a 32-year-old, pregnant female patient.  The patient had no relevant medical history and was not taking any concomitant medications. The patient had no allergies.  The patient's obstetrical history was not reported. The patient's estimated delivery date (EDD) was reported as 14-Sep-2024. The patient's corrected estimated delivery date (CEDD), last menstrual period (LMP) and pregnancy type were not reported.   On 04-Jan-2024, the patient had a positive pregnancy test.  On 05-Jan-2024, the patient was vaccinated with a non-company, co-suspect co-suspect COVID-19 vaccine (reported as both 'Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula)' and 'COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (SARS-CoV-2 SPIKE PROTEIN (Omicron variant XBB.1.5))') (dose: 0.5 ml, route of administration: intramuscular (IM), anatomical location: left arm (LA)) for COVID-19 immunisation.The batch number reported was 5683MF012.  On the same date, the patient was vaccinated with with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular (IM), anatomical location: left arm (LA), dose: not reported) for active immunization against influenza disease (explicitly coded as 'Vaccine exposure during pregnancy' and 'Product administration error'). The batch number reported was 944499.   On the same date, the patient had a positive pregnancy test.  On 08-Jan-2024, the patient had a positive pregnancy test.  On 09-Jan-2024, four days after receiving Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine, the patient's miscarriage started.  On the same date, the patient had recovered from the event of miscarriage.  The reporter did not provide a causality assessment.  The event of miscarriage was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance Department.  Additional information was received on 19-Feb-2024 from Novavax (reference number: 2024NVX-US-000000220) via Med Communications (reference number: SEQW24-00675), reported by other non-healthcare professional: The Reporter type was changed from 'Other Health Professional' to 'Other Non Health Professional'. Medically confirmed and Health Care Professional were updated from 'Yes' to 'No'. Medical confirmation by a healthcare professional (HCP) was modified from 'Yes' to 'No' for all three events. The co-suspect was changed from 'Novavax COVID-19 Vaccine (covid-19 vaccine prot. subunit (nvx cov2373)' to 'COVID-19 vaccine'. Indication added for Flucelvax Quadrivalent. Indication, and dose added for co-suspect vaccine. Additional reference numbers were added. The narrative was updated accordingly.  Company comment: On 05-Jan-2024, a 32-year-old pregnant female patient was vaccinated with Flucelvax Quadrivalent (anatomical location: left arm) and non-company, co-suspect COVID-19 Vaccine (anatomical location: left arm) (explicitly coded as : 'Vaccine exposure during pregnancy' and 'Product administration error'). Four days after the vaccination, the patient had spontaneous abortion. The patient's estimated delivery date (EDD) was reported as 14-Sep-2024. The patient's obstetrical history, corrected estimated delivery date (CEDD), last menstrual period (LMP) and pregnancy type were not reported. Considering that EDD was 14-Sep-2024, we can assume that on 09-Jan-2024 the patient was at the bare beginning of the pregnancy, probably in first month of the gestation, when spontaneous abortions are not rare. Reportedly, the patient had no relevant medical history and was not taking any concomitant medication. Causality is confounded by concurrently administered co-suspect vaccine. Nevertheless, causality for spontaneous abortion is unassessable, due to lack of above-mentioned relevant information. Product administration error and vaccine exposure during pregnancy are assessed as not related as per company specific guidelines.; Sender's Comments: On 05-Jan-2024, a 32-year-old pregnant female patient was vaccinated with Flucelvax Quadrivalent (anatomical location: left arm) and non-company, co-suspect COVID-19 Vaccine (anatomical location: left arm) (explicitly coded as : 'Vaccine exposure during pregnancy' and 'Product administration error'). Four days after the vaccination, the patient had spontaneous abortion. The patient's estimated delivery date (EDD) was reported as 14-Sep-2024. The patient's obstetrical history, corrected estimated delivery date (CEDD), last menstrual period (LMP) and pregnancy type were not reported. Considering that EDD was 14-Sep-2024, we can assume that on 09-Jan-2024 the patient was at the bare beginning of the pregnancy, probably in first month of the gestation, when spontaneous abortions are not rare. Reportedly, the patient had no relevant medical history and was not taking any concomitant medication. Causality is confounded by concurrently administered co-suspect vaccine. Nevertheless, causality for spontaneous abortion is unassessable, due to lack of above-mentioned relevant information. Product administration error and vaccine exposure during pregnancy are assessed as not related as per company specific guidelines.