Received Mar 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
atypical GBS; Lymphomatous meningitis; Lyme disease; Paraneoplastic syndrome; Meningoencephalitis; CNS leukemia; Progressive neuropathy; This serious case was reported in a literature article and described the occurrence of neuropathy in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Literature Reference. The patient's past medical history included percutaneous nephrolithotomy (11 days post-vaccination) and ureteral stent insertion (11 days post-vaccination). Concurrent medical conditions included tobacco user, hypertension, hypothyroidism, insomnia, postmenopausal bleeding, urinary calculus, urinary retention, renal stone (weighing 2.3 g), drug allergy (Sulfa, Amoxicillin, Altenelol, Zestril, Trazadone.), pharyngitis and sulfonamide allergy. Concomitant products included losartan, levothyroxine, amlodipine besilate (Norvasc) and cyanocobalamin-tannin complex (B12). On 07-JUL-2022, the patient received Shingrix. On 19-JUL-2022, 12 days after receiving Shingrix, the patient experienced neuropathy (Verbatim: Progressive neuropathy) (serious criteria hospitalization, disability and GSK medically significant). On an unknown date, the patient experienced guillain barre syndrome (Verbatim: atypical GBS) (serious criteria hospitalization, disability and GSK medically significant), lymphomatous meningitis (Verbatim: Lymphomatous meningitis) (serious criteria hospitalization and GSK medically significant), lyme disease (Verbatim: Lyme disease) (serious criteria hospitalization and GSK medically significant), paraneoplastic syndrome (Verbatim: Paraneoplastic syndrome) (serious criteria hospitalization and GSK medically significant), meningoencephalitis (Verbatim: Meningoencephalitis) (serious criteria hospitalization and GSK medically significant) and central nervous system leukemia (Verbatim: CNS leukemia) (serious criteria hospitalization). The patient was treated with doxycycline, meropenem, dexamethasone, vancomycin, immunoglobulins nos (Immunoglobulin I.V) and ceftriaxone sodium (Rocephin). The outcome of the neuropathy, guillain barre syndrome, lymphomatous meningitis, lyme disease, paraneoplastic syndrome, meningoencephalitis and central nervous system leukemia were resolving. The reporter considered the neuropathy, guillain barre syndrome, lymphomatous meningitis, lyme disease, paraneoplastic syndrome, meningoencephalitis and central nervous system leukemia to be probably related to Shingrix. The company considered the neuropathy and guillain barre syndrome to be related to Shingrix. The company considered the lymphomatous meningitis, lyme disease, paraneoplastic syndrome, meningoencephalitis and central nervous system leukemia to be unrelated to Shingrix. Additional Information: GSK Receipt date 26-Feb-25 Author reported a 64-year-old woman with a previous medical history significant for tobacco usage, hypertension, hypothyroidism, insomnia, post-menopausal bleeding, urinary calculus, and urinary retention presented with a series of symptoms following Shingrix vaccine administration eleven days post-vaccination. The initial presentation of symptoms included bilateral paresthesia through her wrists, arms, and lower extremities, as well as headaches, fevers, and muscle aches in her hips and back. The patient received no other medications or vaccinations during the visit in which she received the Shingrix vaccine. Eleven days post-vaccination, the patient presented to her primary care provider's office with paresthesia spreading bilaterally through the wrists, arms, and lower body with increasing progression for about 3 to 4 days. The patient reported new-onset headaches, fever, and muscle aches in her hips and back. An at-home COVID-19 test was negative, and no upper respiratory symptoms were reported. A history and physical examination performed by her primary care provider found pharyngitis and cephalgia. The working diagnosis was Lyme disease or another tick-borne illness causing meningoencephalitis, which was reported to the patient. The patient reported no known tick or insect bites, though she reported it was difficult to be sure. General lab work and a Lyme/tick panel were ordered. The patient was prescribed doxycycline to be taken twice daily for 21 days. Her Lyme and tick panels both came back negative. Within hours of her primary care office visit, the patient presented to the emergency department with fevers, numbness, tingling in her body, and a shuffling, stiff gait. A lumbar puncture showed a white cell count of 452, subsequently leading to treatment for suspected meningitis with meropenem, dexamethasone, and vancomycin. The patient was then admitted to the hospital 12 days post-vaccination due to her rapidly progressive neurological symptoms. Upon admission, her MRI results were as follows: unremarkable for brain pathology, multilevel disc disease with mild spinal canal stenosis of C4-C7, posterior disc bulge at T7-T8 with flattening of the ventral thecal sac and deformity of the ventral spinal cord, and moderate neural foraminal narrowing of L4-S1. The MRI showed no concerns associated with cord signaling in any region. A chest CT with contrast showed that there was no evidence of an intrathoracic malignancy as a contributing factor for her ascending weakness. The EEG showed a normal awake state record, no definite spikes or paroxysms of significance, and no significant epileptiform activities. No electrographic seizures were recorded. No significant focal or lateralizing abnormalities were seen. Even with the patient's leg shaking, no significant EEG abnormalities were recorded. Thirteen days post-vaccination, a second MRI without contrast was performed to assess her progressive lower extremity weakness. The MRI found no indications of flow limiting stenosis or occlusion of proximal intracranial arteries. An electromyogram of the right upper and bilateral lower extremities came back normal, with the electrodiagnostic evaluation revealing no findings suggestive of cervical radiculopathy, brachial plexopathy, lumbosacral radiculopathy/plexopathy, other peripheral mono/polyneuropathy, or any myopathic process affecting the right upper and bilateral lower extremities. The working diagnosis for this patient remained broad, but included Lyme disease with atypical presentation, atypical GBS, primary lymphomatous meningitis, CNS leukemia, or a paraneoplastic syndrome. An infectious disease consultation ordered syphilis, HIV, and HSV tests, which all came back negative. Neurology was consulted and started the patient on IVIG and Rocephin. Her neuropathy showed improvement with the initiation of IVIG and Rocephin. Fourteen days post-vaccination, the patient was entered into evaluation for physical therapy with the goal of ambulating independently on level surfaces, as her neurological symptoms had significantly impacted her mobility. Twice daily physical therapy was performed with the plan to discharge her to a skilled rehabilitation facility when ready. Her physical therapy treatments continued for 16 days. During this visit, a large calcium oxalate kidney stone weighing 2.3 g was also diagnosed. The patient underwent percutaneous nephrolithotomy with ureteral stent placement 11 days post-vaccination. The kidney stone was reported to be incidental and unlikely to be related to her chief complaint on presentation. Upon discharge 17 days post-vaccination, the confirmed diagnosis was never determined for the presenting symptoms of fever, numbness, tingling, and paresthesia, though it was eventually presumed to be a neurological event stemming from the Shingrix vaccination by her providers due to her response to IVIG. The patient reported improvement, albeit minimal, with continuing numbness, tingling, and weakness. Continued improvement was reported to her primary care provider, extending all the way to 74 days post-vaccination, but numbness in her feet and groin persisted, as seen in the complete timeline of symptoms and treatments. At present, the patient reports that her symptoms have nearly (but not completely) subsided, with occasional numbness in her feet and groin. She reports frustration concerning her perceived delay in treatment as well as the lack of an eventual diagnosis. Her case was reported to VAERS in the hope that it can increase patient and provider vigilance. The patient's inconclusive diagnosis remains due to incomplete testing as well as the broad differential upon admission that did not include rare adverse events, leaving the patient unsure of how to proceed medically. These lingering questions can persist for patients and providers, leaving all parties involved to speculate based on the circumstances. With continued patient and provider education, author remained hopeful that both parties involved utilize resources, such as VAERS, in order to consider rare, but serious events. Although a conclusive diagnosis was not reached for this patient, a presumed diagnosis of an adverse neurological event, such as GBS, following vaccine administration was eventually reached. Her symptom onset at 11 days post-vaccination was consistent with the pathophysiology surrounding GBS. She also was taking no other medications and received no other vaccines at the time. Her CSF studies were inconsistent with a typical GBS but failed to produce any microbial growth indicating infection. In addition, it was less likely that an infection would continue to produce neurologic symptoms as far as 74 days after an event. Lastly, her improvement was seen with the initiation of IVIG, not with the initial treatment regimen that included coverage for meningitis with meropenem and vancomycin. Confounding factors, such as an infection, may have been present, but author believed the likely source of this patient's prolonged neuropathy to be related to her Shingrix vaccination. The treatment with (and outcome after using) IVIG suggests a grade 4 serious adverse event (SAE) from the Shingrix vaccine in this patient. Author hypothesize that some sort of immune cross-reactivity may have led to her neurological symptoms, although a number of factors could be involved in her symptomatology. The Q2-S1 molecule found in the AS01 adjuvant may be a culprit for the cross-reactivity noted in this case. Author reported a probable serious adverse event associated with the Shingrix vaccine. A confirmed diagnosis was never reached, with a working diagnosis that was eventually ruled out. The prevalence of neuropathy associated with Shingrix was low, however not unheard of, as a black box warning for GBS included on the label. Author advocated for the continued awareness of serious neuropathy after Shingrix vaccination to allow for improved patient care and peace of mind, with the goal of educating both patients and providers about this rare event in order to improve awareness, destigmatize efficacious vaccines, and increase surveillance regarding long-term or delayed side effects following vaccinations. This article is not available for regulatory reporting purpose due to copyright restrictions.; Sender's Comments: Metastases to meninges, Lyme disease, Paraneoplastic syndrome, Encephalitis and Central nervous system leukaemia are unlisted events which are considered unrelated to GSK vaccine Shingrix. Neuropathy peripheral is an unlisted event which, due to the following criteria (strong temporal association, Guillain-Barre syndrome ) is considered related to GSK vaccine Shingrix. Guillain-Barre syndrome is a listed event which is considered related to GSK vaccine Shingrix.
Drug allergy (Sulfa, Amoxicillin, Altenelol, Zestril, Trazadone.); Hypertension; Hypothyroidism; Insomnia; Pharyngitis; Postmenopausal bleeding; Renal stone (weighing 2.3 g); Sulfonamide allergy; Tobacco user; Urinary calculus; Urinary retention
Medical History/Concurrent Conditions: Percutaneous nephrolithotomy (11 days post-vaccination); Ureteral stent insertion (11 days post-vaccination)
LOSARTAN; LEVOTHYROXINE; NORVASC; B12
Test Name: Alkaline Phosphatase; Result Unstructured Data: (Test Result:128, High,Unit:IU/L,Normal Low:,Normal High:); Test Name: Glucose; Result Unstructured Data: (Test Result:127, high,Unit:mg/dL,Normal Low:,Normal High:); Test Name: C-Reactive Protein; Result Unstructured Data: (Test Result:1.1, high,Unit:mg/dL,Normal Low:,Normal High:); Test Name: CSF Glucose; Result Unstructured Data: (Test Result:76, high,Unit:mg/dL,Normal Low:,Normal High:); Test Name: CSF Protein; Result Unstructured Data: (Test Result:90, critical,Unit:mg/dL,Normal Low:,Normal High:); Test Name: CSF RBC Count; Result Unstructured Data: (Test Result:19 CMM, High,Unit:unknown,Normal Low:,Normal High:); Test Name: CSF WBC Count; Result Unstructured Data: (Test Result:452 CMM, High,Unit:unknown,Normal Low:,Normal High:); Test Name: Hematocrit; Result Unstructured Data: (Test Result:33.9, low,Unit:%,Normal Low:,Normal High:); Test Name: Hemoglobin; Result Unstructured Data: (Test Result:11.4, Low,Unit:g/dL,Normal Low:,Normal High:); Test Name: HSV test; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Name: HIV test; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20220719; Test Name: lumbar puncture; Result Unstructured Data: (Test Result:WBC count of 452,Unit:unknown,Normal Low:,Normal High:); Test Name: Mean Platelet Volume; Result Unstructured Data: (Test Result:12.6, High,Unit:unknown,Normal Low:,Normal High:); Test Name: Total Protein; Result Unstructured Data: (Test Result:8.2, High,Unit:g/dL,Normal Low:,Normal High:); Test Name: Red Blood Cell Count; Result Unstructured Data: (Test Result:3.55, low,Unit:M/uL,Normal Low:,Normal High:); Test Name: Sedimentation Rate; Result Unstructured Data: (Test Result:43, high,Unit:mm/h,Normal Low:,Normal High:); Test Date: 20220718; Test Name: COVID-19 test; Result Unstructured Data: (Test Result:negative, no upper respiratory symptoms reported,Unit:unknown,Normal Low:,Normal High:); Comments: On unknown date Lyme and tick panels both came back negative. On unknown date upon admission, her MRI results were as follows: unremarkable for brain pathology, multilevel disc disease with mild spinal canal stenosis of C4-C7, posterior disc bulge at T7-T8 with flattening of the ventral thecal sac and deformity of the ventral spinal cord, and moderate neural foraminal narrowing of L4-S1.The MRI showed no concerns associated with cord signaling in any region. On unknown date EEG showed a normal awake state record, no definite spikes or paroxysms of significance, and no significant epileptiform activities. No electrographic seizures were recorded. No significant focal or lateralizing abnormalities were seen. Even with the patient's leg shaking, no significant EEG abnormalities were recorded. On unknown date thirteen days post-vaccination, a second MRI without contrast was performed to assess her progressive lower extremity weakness. The MRI found no indications of flow limiting stenosis or occlusion of proximal intracranial arteries. On unknown date electromyogram of the right upper and bilateral lower extremities came back normal, with the electrodiagnostic evaluation revealing no findings suggestive of cervical radiculopathy, brachial plexopathy, lumbosacral radiculopathy/plexopathy, other peripheral mono/polyneuropathy, or any myopathic process affecting the right upper and bilateral lower extremities.