Received Dec 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
Miller Fisher Syndrome Following Administration of Combined Tetanus, Diphtheria and Pertussis (Tdap) Vaccine; bilateral upper and lower extremity (LE) weakness/ right bicep weakness; bilateral upper and lower extremity (LE) pain; right bicep pain/bilateral shoulder pain; decreased/absent sensation in BUE; ophthalmoplegia; asymmetric, sensorimotor, predominantly demyelinating polyneuropathy with evidence of axonal loss; respiratory distress; ataxia; areflexia; falls; <p>CASE: The patient is a 60-year-old male with a past medical history of hypertension, coronary artery disease, history of Lyme disease and Bell's palsy who presented to the hospital for bilateral upper and lower extremity (LE) weakness and pain. He stated that his symptoms started about a week ago with right bicep pain and weakness leading to bilateral shoulder pain and eventually bilateral LE pain causing falls. The patient denied recent infections. He reported receiving the Tdap vaccine for a neck wound two weeks before his symptoms began. Vital signs were unremarkable. Physical examination was remarkable for 4/5 and 3/5 muscle strength in bilateral upper extremities (BUE) and bilateral hips respectively, decreased biceps, brachioradialis and triceps reflexes, absent patellar and Achilles tendon reflexes, decreased/absent sensation in BUE and ophthalmoplegia. Magnetic resonance imaging (MRI) of the brain and lumbar spine showed no acute abnormalities. Electromyography findings were consistent with asymmetric, sensorimotor, predominantly demyelinating polyneuropathy with evidence of axonal loss. GQ1b ganglioside autoantibody (GQ1bGA) was negative. While admitted, the patient developed respiratory distress requiring BiPAP. He was treated with intravenous immunoglobulin (IVIG) for 5 days for Miller Fisher syndrome (MFS), which improved his symptoms and was discharged to a rehabilitation center. IMPACT/DISCUSSION: MFS is a rare variant of Guillian Barre Syndrome with a worldwide incidence of 1-2 per million people. It has a male predominance and is commonly seen in early middle age. It is caused by molecular mimicry, leading to an inflammatory response against myelin-producing Schwann cells. Axonal degeneration can occur as a secondary response. The main autoantibody is directed against ganglioside GQ1b. It typically presents with the clinical triad of ophthalmoplegia, ataxia and areflexia, also seen in our case. Other associated symptoms can be ptosis, facial nerve palsy, para/hypoesthesia and respiratory muscle weakness. Although infections cause most cases, other causes can include certain drugs, autoimmune diseases, surgery and vaccines. While there are multiple reported cases of postinfluenza vaccine MFS, only a couple cases of Tdap-induced MFS were found. Diagnosis is clinical and can be supported by cerebrospinal fluid albuminocytologic dissociation, the presence of GQ1bGA (seen in 85-90% of cases), MRI spine showing thickening and enhancement of the intrathecal spinal nerve roots and cauda equina, and electrodiagnostic studies showing reduced or absent sensory responses without slowing of conduction velocities, as highlighted here. Treatment is supportive along with IVIG or plasmapheresis, both are known to be equally effective. The prognosis is good with the patients recovering in 8-12 weeks. Relapse occurs in <3% of patients. CONCLUSION: MFS is a rare complication of Tdap vaccine. Early recognition and treatment is associated with complete recovery.</p> Initial information received on 01-Dec-2025 via Other healthcare professional regarding an unsolicited valid serious case issued from a literature article This case involves a 60 year old male patient who experienced Miller Fisher Syndrome Following Administration of Combined Tetanus, Diphtheria and Pertussis (Tdap) Vaccine (Miller fisher syndrome) (latency: unspecified). The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient with a past medical history of hypertension, coronary artery disease, history of Lyme disease and Bell's palsy On an unknown date, he reported receiving the Tdap (Diphtheria, Tetanus And Acellular Pertussis) vaccine produced by unknown manufacturer via unknown route in unknown administration site for a neck wound two weeks before his symptoms began. On an unknown date, he stated that his symptoms started about a week ago with right bicep pain (Arthralgia) and weakness (muscular weakness) leading to bilateral shoulder pain (Arthralgia) and eventually bilateral LE pain causing falls (fall). The patient presented to the hospital for bilateral upper and lower extremity (LE) weakness and pain (Pain in extremity) (muscular weakness). The patient denied recent infections. Vital signs were unremarkable. Physical examination was remarkable for 4/5 and 3/5 muscle strength in bilateral upper extremities (BUE) and bilateral hips respectively, decreased biceps, brachioradialis and triceps reflexes, absent patellar and Achilles tendon reflexes, decreased/absent sensation in BUE (sensory loss) and ophthalmoplegia. Magnetic resonance imaging (MRI) of the brain and lumbar spine showed no acute abnormalities. Electromyography findings were consistent with asymmetric, sensorimotor, predominantly demyelinating polyneuropathy with evidence of axonal loss (Demyelinating polyneuropathy). GQ1b ganglioside autoantibody (GQ1bGA) was negative. While admitted, the patient developed respiratory distress requiring Bilevel Positive Airway Pressure (BiPAP). He was treated with intravenous immunoglobulin (IVIG) for 5 days for Miller Fisher syndrome (MFS), which improved his symptoms and was discharged to a rehabilitation center. MFS is a rare variant of Guillian Barre Syndrome with a worldwide incidence of 1-2 per million people. It has a male predominance and is commonly seen in early middle age. It is caused by molecular mimicry, leading to an inflammatory response against myelin-producing Schwann cells. Axonal degeneration can occur as a secondary response. The main autoantibody is directed against ganglioside GQ1b. It typically presents with the clinical triad of ophthalmoplegia, ataxia and areflexia, also seen in this case. Other associated symptoms can be ptosis, facial nerve palsy, para/hypoesthesia and respiratory muscle weakness. Although infections cause most cases, other causes can include certain drugs, autoimmune diseases, surgery and vaccines. While there are multiple reported cases of postinfluenza vaccine MFS, only a couple cases of Tdap-induced MFS were found. Diagnosis is clinical and can be supported by cerebrospinal fluid albuminocytologic dissociation, the presence of GQ1bGA (seen in 85-90% of cases), MRI spine showing thickening and enhancement of the intrathecal spinal nerve roots and cauda equina, and electrodiagnostic studies showing reduced or absent sensory responses without slowing of conduction velocities, as highlighted here. Treatment is supportive along with IVIG or plasmapheresis, both are known to be equally effective. The prognosis is good with the patients recovering in 8-12 weeks. Relapse occurs in <3% of patients. MFS is a rare complication of Tdap vaccine. Early recognition and treatment is associated with complete recovery. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Seriousness Criteria: Medically significant Action taken: Not applicable Outcome: recovered Corrective treatment: Immunoglobulins and rehabilitation. Reporter Causality: related; Sender's Comments: Sanofi Company Comment dated 09-Dec-2025: This case involves a 60 year old male patient who experienced Miller Fisher Syndrome Following Administration of Combined Tetanus, Diphtheria and Pertussis (Tdap) Vaccine. Based on the limited information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed completely.
Bell's palsy; Coronary artery disease; Hypertension; Lyme disease
Test Name: GQ1b ganglioside autoantibody (GQ1bGA); Test Result: Negative ; Test Name: Electromyography findings; Result Unstructured Data: were consistent with asymmetric, sensorimotor, predominantly demyelinating polyneuropathy with evidence of axonal loss.; Test Name: Magnetic resonance imaging (MRI) of the brain; Result Unstructured Data: showed no acute abnormalities; Test Name: Magnetic resonance imaging (MRI) of the lumbar spine; Result Unstructured Data: showed no acute abnormalities; Test Name: Physical examination; Result Unstructured Data: was remarkable for 4/5 and 3/5 muscle strength in bilateral upper extremities (BUE) and bilateral hips respectively, decreased biceps, brachioradialis and triceps reflexes, absent patellar and Achilles tendon reflexes, decreased/absent sensation in BUE and ophthalmoplegia; Test Name: Vital signs; Result Unstructured Data: were unremarkable