Sex: F
Vaccine: COVID19
Symptoms: Neurological examination, Physical examination, Protein total, Red blood cell count, White blood cell count
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a literature article and also from a consumer via a company representative via social media.  The author's objective was to report the first case of guillain-barre following the COVID-19 vaccination with the Johnson & Johnson COVID-19 vaccine. This report concerned concerned a 53 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypothyroidism, and bell's palsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on 09-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications reported. On 09-AUG-2021, minutes after receiving the vaccine the patient reported that patient started feeling the development of a rash in palms, followed by the appearance of numbness and tingling in the distal left upper extremity. Hours after, the numbness progressed slowly in an ascending fashion through the left lower extremity, and overnight it extended to the contralateral lower extremity and left side of the face. The numbness was later accompanied by lower thoracic and lumbar pain. Because of patient's symptomatology, patient went to see primary care provider, who prescribed a short course of steroids and valganciclovir after suspecting a new episode of peripheral facial palsy. Due to the lack of improvement in patient's symptoms and a near syncopal episode at patient's home, patient decided to came to Emergency Department with complaints of a two-week history of progressive lower extremity weakness, paresthesias, and difficulty walking that started after receiving the COVID-19 J and J vaccination 14 days before presentation. At the time, the neurological examination revealed mild left-sided weakness in the left side of her body when compared to the contralateral side and intact reflexes throughout. MRI of the brain without contrast done during this first encounter was negative for any acute intracranial pathology, and patient was advised to continue to follow up with neurology as an outpatient and to consider electromyography and nerve conduction studies. Five days later, the patient presented again to institution due to progressive proximal weakness, paresthesias, and difficulty standing up from a chair and walking. At the time, patient denied any dyspnea, dysphagia, or diurnal variation in the weakness. On neurological exam, patient's mental status was alert, attentive, and oriented to person, place, and time. The speech was clear and fluent, with a good repetition, comprehension, and naming. Patient recalled 3/3 objects after five minutes. Cranial Nerves were intact, with full visual fields for confrontation. Pupils were round and reactive to light and accommodation. Extraocular movements were normal, and no nystagmus or diplopia was apparent. Patient's facial sensation was intact in all three branches of the trigeminal nerve bilaterally; the face was symmetric with normal eye closure and smile, the palate elevated symmetrically, phonation was normal, head-turning and shoulder shrug were intact, tongue protruded towards the midline, with normal movements and no atrophy. On motor exam, patient was noted to have proximal weakness 4/5 in hip flexors and hip extensors bilaterally, 4/5 knee extensors and flexors, 4/5 plantar flexion, 4/5 dorsiflexion bilaterally, 4/5 shoulder abductors and adduction, 4/5 elbow extensor and flexors. Reflex examination was pertinent for 2 plus reflexes in the biceps and triceps 2plus, knees, and 1plus Achilles' tendon reflex bilaterally. Sensory examination revealed normal sensation to light touch, pinprick, position sense, and vibration in fingers and toes. Coordination was normal, with rapid alternating movements intact. Gait was steady with normal steps, base arm swing, and turning. Heel and toe walking and tandem gait was normal. An MRI of the lumbar spine with and without contrast revealed subtle enhancement of the cauda equina nerve roots without overt thickening, suggestive of acute inflammatory demyelinating polyradiculoneuropathy (AIDP). Patient was admitted to the hospital out of suspicion of probable Guillain-Barre Syndrome. Due to this concern, the patient was started with intravenous immunoglobulin. Subsequent Lumbar puncture and CSF analysis reported a clear appearance, a very mild elevated protein with a slightly elevated mononuclear pleocytosis, and normal glucose levels (Protein 47 mg/dL, Albumin 25 mg/dL, Glucose 63 mg/dL, red blood cells [RBCs] 0/mcL, WBC 1/mcL 100% mononuclear, venereal disease research laboratory test [VDRL] non-reactive, lactate dehydrogenase [LDH] 23 IU/L). GM1 and GQ1b antibodies were reported as negative. The patient started to feel improvement in weakness from day two of IVIg and continued to receive this treatment for a total of five days without any complications or adverse effects. Patient's physical exam on the day of discharge showed 5/5 proximal and distal strength in all patient's extremities and normal deep tendon reflexes. Patient was discharged home with home health care, with outpatient physical therapy, and was scheduled for follow-up as an outpatient in our neurology clinic. The Centers for Disease Control Vaccine Adverse Event Reporting System (VAERS) was notified about this abnormal reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from guillain-barre syndrome. The authors concluded that to the best of their knowledge, they report the first real-life case of guillain-barre syndrome associated with the Johnson & Johnson Covid-19 vaccine. While there is insufficient evidence to establish a temporal correlation, they strongly believe that physicians should remain watchful, have a high degree of suspicion, and be able to recognize neurological complications associated with the Covid-19 vaccination. Early diagnosis and subsequent management can prevent disability. The risk of neurological complications after the Covid-19 vaccination is low, and the benefits of the vaccination outweigh the risks and side effects. This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20220618274.  Additional information was received from a literature article on 09-JUN-2022. The following information was updated and incorporated into the case narrative: Literature article information and authors information, author's objective and conclusion, case level and event level updated to medically confirmed, onset date for the event, therapy start date, and upon follow up, case validity assessment was updated to valid from the previously assessment of non-valid. It was determined that deletion was required for Manufacturer Report Number 20220618274 as it was duplicate of Manufacturer Case Number 20220437168. All relevant information regarding Manufacturer Report Number 20220618274 will be submitted under Manufacturer Case Number 20220437168.; Sender's Comments: V1: This follow up version updates information: Literature article information and authors information, author's objective and conclusion, onset date for the event, therapy start date, and case validity assessment was updated to valid from the previously assessment of non-valid. All relevant information regarding Manufacturer Report Number 20220618274 will be submitted under Manufacturer Case Number 20220437168. The follow up information does not change the causality of the previous reported events. 20220437168-covid-19 vaccine ad26.cov2.s-guillain-barre syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.