Received Mar 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
early acute inflammatory demyelinating polyradiculopathy (also known as Guillain-Barre syndrome); This serious case was reported in a literature article and described the occurrence of acute inflammatory demyelinating polyradiculopathy in a 29-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. Literature Reference: On an unknown date, the patient received Tdap Vaccine. On an unknown date, 3 weeks after receiving Tdap Vaccine, the patient experienced acute inflammatory demyelinating polyradiculopathy (Verbatim: early acute inflammatory demyelinating polyradiculopathy (also known as Guillain-Barre syndrome)) (serious criteria hospitalization and GSK medically significant). The patient was treated with ceftriaxone, doxycycline and immunoglobulins. The outcome of the acute inflammatory demyelinating polyradiculopathy was resolved. The reporter considered the acute inflammatory demyelinating polyradiculopathy to be possibly related to Tdap Vaccine. The company considered the acute inflammatory demyelinating polyradiculopathy to be unrelated to Tdap Vaccine. Additional Information: GSK received date: 03-MAR-2026 A patient presented to the emergency department with bilateral facial numbness and numbness of hands and feet. The symptoms started one week prior to presentation, beginning with a posterior headache, followed by numbness over tongue, progressing to involve entire face, hands, and feet. Patient mentioned that patient received the Tdap (tetanus, diphtheria, acellular pertussis) vaccine about three weeks prior to presentation. Comprehensive metabolic panel, complete blood count and inflammatory markers were done and were unremarkable. Urine toxicology screen was negative. On physical exam, the patient was unable to close eyes, indicating bilateral facial nerve palsy and, interestingly, throughout the hospital course, patient had preserved reflexes, with the exception of absent ankle reflex. Lumbar puncture was performed during hospital stay, which showed increased protein (109 mg/dL). The rest of studies were negative. CT of the head, computed tomography angiography (CTA) head and neck, and a CT perfusion study were all negative. Magnetic Resonance Imaging (MRI) brain was done, which showed bilateral enhancement of the distal meatal, labyrinthine, tympanic and mastoid segments of the facial nerves. The patient completed 14 days of ceftriaxone and doxycycline until Rickettsial panel resulted negative and therefore a rickettsial infection was ruled out. Electromyography (EMG) was done with nerve conduction studies carried out in various nerves in the upper and lower extremities bilaterally. The studies revealed that distal motor latencies are prolonged in bilateral median, bilateral peroneal, and bilateral tibial nerves. Amplitudes were low in most nerves examined. Conduction blocks were seen in bilateral ulnar nerves at the elbow and bilateral peroneal nerves at tibial heads. Conduction velocities were slow in both tibial nerves. F waves were prolonged in various nerves. Sensory action potentials were essentially normal with normal distal latencies except for the right median sensory action potential being absent. In summary, the study was suggestive of early acute inflammatory demyelinating polyradiculopathy (also known as Guillain-Barre syndrome), for which the patient was started on IVIG 0.4 mg/kg x 5 days. The patient was later seen as an outpatient several weeks following discharge with complete resolution of symptoms and no limitation on daily activities, having responded well to treatment. This case illustrates an atypical presentation of Guillain-Barre syndrome (GBS) characterized by bilateral facial nerve palsy with preserved deep tendon reflexes, highlighting the diagnostic challenges posed by variants that deviate from classic clinical criteria. It also discusses the possible role vaccination can play as a trigger for GBS. The patient's initial diagnostic workup appropriately excluded central causes such as stroke, tumor, and demyelinating disorders. The absence of findings on brain CT and MRI, except for bilateral facial nerve enhancement, shifted focus toward peripheral nervous system involvement. Lumbar puncture findings of elevated cerebrospinal fluid protein without pleocytosis (albuminocytologic dissociation) are highly suggestive of GBS [6] and further support this diagnosis. A particularly notable feature of this case was the preservation of deep tendon reflexes throughout most of the hospital course. The patient's recent Tdap vaccination could represent a potential trigger for GBS development. This case also underscored the importance of considering a broad differential diagnosis for bilateral facial palsy, including Lyme disease, sarcoidosis, and other infectious etiologies. This case report highlighted an atypical presentation of GBS with bilateral facial nerve palsy with preserved reflexes as the predominant feature. This case also illustrates the importance of a comprehensive diagnostic evaluation in patients presenting with unusual neurological symptoms. This article is not available for regulatory reporting purpose due to copyright restriction.; Sender's Comments: A case of Guillain-Barre syndrome (BCWG Level 1), 3 weeks after receiving Tdap Vaccine, in a 29-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility
Test Name: Alanine aminotransferase (ALT); Result Unstructured Data: (Test Result:37,Unit:u/L,Normal Low:7,Normal High:56); Test Name: CTA head and neck; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Name: Anion gap; Test Result: 9 {DF}; Test Name: Aspartate aminotransferase (AST); Result Unstructured Data: (Test Result:34,Unit:u/L,Normal Low:10,Normal High:40); Test Name: Albumin; Test Result: 5 mg/dl; Test Name: Alkaline phosphatase; Result Unstructured Data: (Test Result:57,Unit:u/L,Normal Low:44,Normal High:147); Test Name: Calcium; Test Result: 9.5 mg/dl; Test Name: Chloride; Test Result: 105 {DF}; Test Name: Creatinine; Test Result: 0.6 mg/dl; Test Name: Glucose; Test Result: 56 mg/dl; Test Name: Glucose; Test Result: 88 mg/dl; Test Name: Magnesium; Test Result: 2.1 {DF}; Test Name: Phosphorus; Test Result: 5 mg/dl; Test Name: Potassium; Test Result: 3.8 {DF}; Test Name: Sodium; Test Result: 137 {DF}; Test Name: BUN; Test Result: 14 mg/dl; Test Name: Carbon dioxide; Test Result: 23 {DF}; Test Name: CT of the head; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Name: C-reactive protein; Result Unstructured Data: (Test Result:less than 0.5,Unit:mg/dL,Normal Low:,Normal High:1.0); Test Name: CSF Protein; Test Result: 109 mg/dl; Test Name: CSF red blood cell; Result Unstructured Data: (Test Result:2,Unit:cells per microlitre,Normal Low:,Normal High:0); Test Name: CSF Appearance; Result Unstructured Data: (Test Result:Clear,Unit:unknown,Normal Low:,Normal High:Clear); Test Name: CSF Color; Result Unstructured Data: (Test Result:Colorless,Unit:unknown,Normal Low:,Normal High:Colorless); Test Name: CSF white blood cell; Result Unstructured Data: (Test Result:3,Unit:cells per microlitre,Normal Low:0,Normal High:5); Test Name: Hematocrit; Test Result: 33.9 %; Test Name: Hemoglobin; Result Unstructured Data: (Test Result:11.3,Unit:g/dL,Normal Low:12.0,Normal High:16.0); Test Name: Mean corpuscular volume (MCV); Test Result: 79.0 fL; Test Name: Platelet count; Result Unstructured Data: (Test Result:333,Unit:x10(3)/uL,Normal Low:150,Normal High:400); Test Name: Procalcitonin; Result Unstructured Data: (Test Result:0.04,Unit:ng/mL,Normal Low:,Normal High:0.05); Test Name: Protein, total; Test Result: 8 mg/dl; Test Name: Red blood cells; Result Unstructured Data: (Test Result:4.29,Unit:x10e6/microL,Normal Low:4.2,Normal High:5.4); Test Name: Red cell distribution width (RDW); Test Result: 16.5 %; Test Name: Urine toxicology screen; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Name: White blood cells; Result Unstructured Data: (Test Result:8.9,Unit:x10(3)/uL,Normal Low:4.0,Normal High:11.0); Comments: Comprehensive metabolic panel, complete blood count and inflammatory markers were done and were unremarkable. On physical exam, the patient was unable to close eyes, indicating bilateral facial nerve palsy. The rest of studies were negative. CT perfusion study was negative. MRI brain was done, which showed bilateral enhancement of the distal meatal, labyrinthine, tympanic and mastoid segments of the facial nerves. Electromyography (EMG) was done with nerve conduction studies carried out in various nerves in the upper and lower extremities bilaterally. The studies revealed that distal motor latencies are prolonged in bilateral median, bilateral peroneal, and bilateral tibial nerves. Amplitudes were low in most nerves examined. Conduction blocks were seen in bilateral ulnar nerves at the elbow and bilateral peroneal nerves at tibial heads. Conduction velocities were slow in both tibial nerves. F waves were prolonged in various nerves. Sensory action potentials were essentially normal with normal distal latencies except for the right median sensory action potential being absent.