Received Apr 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Bell's palsy; numbness in tongue, face, eye; numbness in tongue, face, eye; numbness in tongue, face, eye; immobility in left side of face; The patient received Tdap (Adacel) during pregnancy; Objective: To assess the safety of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in pregnant women using data from the Vaccine Adverse Event Reporting System (VAERS). Design, Setting: We searched VAERS for reports of Tdap in pregnant women vaccinated during July 2015 through September 2023. We reviewed reports and available medical records for pregnancy and non-pregnancy specific adverse events (AEs) in Tdap recipients. Reporting rates were estimated for reports of preterm birth, hypertensive disorders of pregnancy (HDP), and stillbirths and compared to published background rates for these conditions. Results: VAERS received a total of 654 reports after Tdap vaccine in pregnancy and 137 (20.9%) were serious; no maternal or infant deaths were reported. The most common pregnancy specific conditions reported were preterm birth (45, 6.9%), hypertensive disorders of pregnancy (40, 6.1%), and stillbirth (18, 2.8%). Two reports of verified Guillain-Barr Syndrome (GBS) were reported. The most common non-pregnancy specific conditions reported were pain (120, 18.3%), nausea (93, 14.2%), and fever (87, 13.3%). Reporting rates for preterm birth, HDP, and stillbirths were below background rates for these conditions. Conclusion: Most reports were non-serious and the most common AEs were similar to those observed in pre- and post-licensure studies. No new or unexpected AE was identified. Initial information received on 13-Apr-2026 via other health care professional regarding a solicited valid serious case issued from a literature article: This case linked to US-SA- 2026SA0037592 (Cluster case). Study Title: AIM: To assess the safety of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in pregnant women using data from the Vaccine Adverse Event Reporting System (VAERS). This case involves 20-years-old female patient (in her 20's) who experienced Bell's palsy after receiving diphtheria-2/tetanus/5 ac pertussis vaccine (Latency: 7 days). The patient's past medical treatment(s), vaccination(s), and family history were not provided. The patient was a pregnant and she was vaccinated with (Tdap) (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis) (Adacel) Suspension for injection (Exposure during pregnancy) (Dose, route, frequency: unknown) and 7days later, at 36 weeks gestation, presented with numbness in tongue, face, eye (Hypoaesthesia eye) (Hypoaesthesia) (Hypoaesthesia oral) and immobility in left side of face (Facial paralysis). She went to the emergency department where she was diagnosed with Bell's palsy. She was discharged the same day of her admission and 18days later she delivered her infant at 39 weeks gestation. No adverse events in the infant were reported. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Seriousness criteria: medically significant and hospitalization Action taken: Not applicable Corrective treatment: unknown Outcome: Unknown Reporter s causality: Related Company causality: Unassessable/Unclassified