Received Apr 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | UNK | — | SYR |
Poor feeding; Problems with breathing; Born at 34 weeks; Fever; Foetal exposure during pregnancy; Initial information received on 24-Feb-2026 regarding a solicited valid serious case received from a non-healthcare professional, in the scope of patient support program. Study Title: To evaluate obstetric, neonatal, and infant outcomes among women vaccinated during pregnancy with a COVID-19 vaccine. This case received on 11-Mar-2025 refers to a male neonate whose mother was a 34-year-old study participant in the COVID -19 Vaccines Registry, protocol. Maternal medical history included anxiety. Concomitant medication included sertraline, Unisom (doxylamine succinate) and prenatal vitamins (unspecified vitamins and minerals), both for unknown indication. Maternal past vaccinations included three doses of Pfizer- BioNTech (Comirnaty) COVID-19 vaccine on 19-Mar-2021, 19-Apr-2021 and 20-Nov-2021. Maternal obstetrical history included one previous pregnancy with live birth. The mother of neonate had no history of e-cigarette, tobacco, alcohol or recreational drug use. Maternal first day of last menstrual period was calculated to be 25-Jun-2024. Estimated delivery date was reported to be 01-Apr-2025. The type of pregnancy was reported as singleton. On 16-Dec-2024, at gestational age of 24 weeks and six days, the mother of infant received a fourth dose of the Novavax (NVX- CoV2373) vaccine for the prevention of COVID-19. Batch number was not reported. at a gestational age of 34 weeks, the mother experienced premature preterm ruptured of membranes and delivered vaginally a live, male, pre-term neonate. The mother spent four days in hospital for the delivery. The neonate's birth weight was 5 pounds and 12 ounces, body length was unknown. On the same day, after delivery the neonate was transferred to Neonatal Intensive Care Unit (NICU) due to premature birth, problems with breathing and poor feeding. The neonate was treated with ampicillin for possible infection. On 23-Feb-2025, the neonate recovered from problems with breathing. On 07-Mar-2025, the baby recovered from poor feeding. On 11-Feb-2026, the baby experienced fever. The outcome of premature baby 33 to 36 weeks and fever was unknown. The study participant did not provide causality assessment. This case is linked to 2024-US-00017 (the corresponding mother case). Additional information received on 23-Feb-2026 from participant: Non-serious adverse event added. Narrative updated accordingly. Principal Investigator assessments: The events of feeding disorder, neonatal dyspnoea and premature baby are serious and unexpected for the Novavax (Nuvaxovid) vaccine. Temporal relationship is not suggestive. Due to lack of any plausible mechanism connecting the vaccine with development of reported events, causality is considered as not related. Reporter causality: Not related for feeding disorder, neonatal dyspnoea, premature baby, pyrexia and foetal exposure during pregnancy. Company causality: Not reportable for feeding disorder, neonatal dyspnoea, premature baby, pyrexia and foetal exposure during pregnancy.
Sertraline; Prenatal vitamins; Unisom
Test Date: 202502; Test Name: Acoustic stimulation tests; Result Unstructured Data: Baby passed the hearing test; Test Date: 202502; Test Name: Cardiac function test; Result Unstructured Data: Baby's heart is fine; Comments: Baby's heart is fine