Received Apr 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Guillain- Barre Syndrome/inflammatory demyelinating polyradiculoneuropathy; lower back and extremity pain; lower back and extremity pain; Respiratory failure; weakness; Paresthesias; flaccid paralysis; difficulty breathing; The patient received Tdap (Adacel) during pregnancy; areflexia; 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: Study Title: This case involves 30-years-old female patient (in her 30's) who experienced Guillain-Barre Syndrome/inflammatory demyelinating polyradiculoneuropathy after receiving diphtheria-2/tetanus/5 ac pertussis vaccine (Latency: 11 days). The patient's past medical treatment(s), vaccination(s), and family history were not provided. On an unknown date, the patient received (Tdap) tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Adacel) (Dose, route, formulation, frequency: Unknown) (Exposure during pregnancy) and 11 days later presented with lower back and extremity pain (Muscle strain) (Pain in extremity). This was followed by weakness (Asthenia), paresthesias (Paraesthesia), and flaccid paralysis (Paralysis), leading to difficulty breathing (Dyspnoea) for which she was hospitalized, requiring intubation due to respiratory failure. The patient was admitted to the intensive care unit (ICU) and also treated for a subdural hematoma. A healthy male infant was delivered at 37 weeks gestation by emergency cesarean section. Three EMGs (electromyography) demonstrated severe axonal damage consistent with a diagnosis of acute inflammatory demyelinating polyradiculoneuropathy. She was treated with two courses of intravenous immunoglobulin and five sessions of PLEX (plasma exchange) with improvement of her symptoms. Following improvement, the patient was transferred to the general medicine floor and discharged to a rehabilitation facility in stable condition. This report also meets the Brighton Collaboration case definition for GBS (Level of Certainty 1) due to weakness, areflexia, and positive LP (Lumbar puncture) and EMG. This case report of GBS (Guillain-Barre Syndrome) involved who received Tdap (Adacel). 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: PLEX Outcome: Recovered/Resolved Reporter s causality: Related Company causality: Unassessable/Unclassified
Test Name: EMGs; Result Unstructured Data: demonstrated severe axonal damage consistent with a diagnosis of acute inflammatory demyelinating polyradiculoneuropathy; Test Name: Lumbar puncture; Test Result: Positive ; Test Name: EMGs; Test Result: Positive