Your Health. Your Family. Your Choice.
Administered by: Military Purchased by: ?
Life Threatening? Yes
Write-up: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a consumer concerned a 57 year old male of unspecified race and ethnicity. The patient''s height and weight were not reported. The patient''s past medical history included previous back injury, and concurrent conditions included alcohol intake 2-3 beers a day, and smoking 1-2 cigarettes per month, and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, dose and vaccination site not reported, batch number: 1808607 or 1808609, expiry: UNKNOWN) administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, patient experienced pain and tingling sensation on his back but he still went to work. On 16-APR-2021, he did not go to work, tingling sensation started going on his hands. On 17-APR-2021, patient went to the emergency clinic, and was told the symptoms might be cause by herniated disc. On 19-APR- 2021, he went to fill out worker''s compensation and was seen by his worker''s comp doctor. X-ray was taken and showed some abnormality in the neck area. On 20-APR-2021, symptoms worsened and patient was paralyzed from the shoulder down. On 21-APR-2021, patient went to the hospital and was admitted. Magnetic resonance imaging (MRI) found nothing on patient''s neck and showed old back injury, but per patient''s doctor it should not cause the paralysis. Unspecified additional tests were done, and Guillain-Barre Syndrome was diagnosed. On 25-APR-2021, hospital physician ruled out other causes and confirmed that Guillain-Barre Syndrome (GBS) was caused by Janssen COVID vaccine. At the time of report, the patient was intubated at the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Guillain-Barre Syndrome. This report was serious (Life Threatening).; Sender''s Comments: V0: 20210456333-covid-19 vaccine ad26.cov2.s-Guillain-Barre Syndrome . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166