Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Guillain-Barre syndrome, Magnetic resonance imaging, Muscular weakness, Pain
Clinical narrative: DEATH; BACK PAIN; CONDITION AGGRAVATED; GAIT DISTURBANCE; PAIN; PARAESTHESIA; MUSCULAR  WEAKNESS; GUILLAIN-BARRE SYNDROME; This spontaneous report was received from a health care provider via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID: 1181925). The patient's height, and weight were not reported. The patient's past medical history included heart failure in 2017, heart attack (within the last four years), stroke in 2019, and a car accident on 26-Feb-2021. Concurrent conditions included hypertension, diabetes, neck pain and lumbar pain due to the car accident. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, and batch number: 1805018, and expiry: unknown) dose was not reported, 1 total, administered on left arm on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021 (5 days after the vaccination), the patient complained of extreme back pain and trouble walking. His pain/condition increasingly worsened. On 23-MAR-2021, the patient was taken to the hospital in an ambulance. On an unspecified date, an magnetic resonance imaging (MRI), computerized tomogram and protein test on spinal fluid was done (results not provided for all tests). The patient felt as if his lower body was separated from his torso. He had visible trouble walking following which he was prescribed with Valium, an X-ray was done (result not provided) and he was sent home. On an unspecified date, in MAR-2021, the patient experienced leg weakness, tingling of hands and feet, and extreme pain due to which on 27-MAR-2021, he was taken back to the hospital. On an unspecified date, he was diagnosed with Guillain-Barre Syndrome (GBS). The patient completed a course of immunoglobulin therapy for GBS and was put on mechanical ventilation. However, on 06-APR-2021, the patient died after spending 11 days in the hospital, and 6 days on a ventilator. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 06-APR-2021 and had not recovered from back pain, condition aggravated, gait disturbance, muscular weakness, pain and paraesthesia at the time of death. The outcome of Guillain-Barre syndrome was fatal. This report was serious (Death, Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening).  This case, involving the same patient is linked to 20210728318.  Additional information was received from consumers/non-health professionals via EZ Reporter and news article on 12-JUL-2021. The following information was updated and incorporated into the case narrative: past medical history of heart attack (within the last four years) was added. Reporter details added to structured fields. Upon review, the following information was amended: outcome updated from fatal to not recovered/not resolved in structure fields for back pain, condition aggravated, gait disturbance, muscular weakness, pain and paraesthesia, and event of death added to structured field as cause of death. Narrative was updated to reflect lead in sentence with a health care provider and not the patient himself. Serious criteria of Other Medically Important Condition added for events of Death and Guillain-Barre syndrome.; Sender's Comments: V1:  Follow up from a news media article provided additional clinical details. This spontaneous report from a health care provider obtained via VAERS (VAERS ID 1181925) concerns a 57-year-old male who developed Guillain-Barre Syndrome (GBS) and subsequently died 22 days after receiving the Janssen Covid-19 vaccine. Medical history included hypertension, diabetes, neck pain & lumbar pain due to a car accident which occurred 17 days prior to vaccination, heart failure in 2017, stroke in 2019, and heart attack within the last 4 years. Concomitant medications were not reported. On post-vaccination day 5 (PVD5), the patient complained of extreme back pain and trouble walking. His pain increasingly worsened. PVD8, he was taken to the hospital via ambulance. He felt as if his lower body was separated from his torso. An x-ray was performed (results not provided) and he was sent home with diazepam.  PVD12, he went back to the hospital due to leg weakness, tingling in his hands and feet, and extreme pain.  He was hospitalized and diagnosed with GBS.  CT scan, MRI, and cerebrospinal fluid protein test were performed on unspecified dates (results not provided). The patient was treated with immunoglobulin therapy. He died after 11 days in the hospital, including 6 days with mechanical ventilation. The occurrence of GBS could represent background incidence in the general population. However, considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.; Reported Cause(s) of Death: DEATH