Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb injury, Muscular weakness, Paralysis, Peripheral swelling
Clinical narrative: FELT PARALYSED; DIAGNOSED WITH GUILLEN BARRE SYNDROME; INJURED RIGHT FOOT; NUMBNESS IN FACE; LEFT LEG WEAKNESS; SWELLING IN LEGS; TIREDNESS; FEELINGS OF WEAKNESS; NUMBNESS IN LEFT HAND; This spontaneous report received from a consumer concerned a 46 year old female. The patient's weight was 113 kilograms, and height was 66 inches.  The patient's pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 01-MAY-2021 to left arm for prophylactic vaccination. Concomitant medications included immunoglobulin human normal for guillen barre syndrome.  On 01-MAY-2021, the subject experienced feelings of weakness, numbness in left hand. On 28-MAY-2021, the subject experienced tiredness. On 29-MAY-2021, the subject experienced left leg weakness and swelling in legs. On 02-JUN-2021, the subject experienced numbness in face. On 09-JUN-2021, the subject experienced diagnosed with guillen barre syndrome, and was hospitalized. On an unspecified date, the subject experienced injured right foot, and felt paralysed, and was hospitalized on 08-Jun-2021. On 01-MAY-2021, the patient developed numbness in her hand on the left side and felt weak. The patient travelled overseas and had a connection to a country and her husband stated that she started to have swelling in her legs. When she reached her destination, she was admitted to the hospital and was diagnosed with Guillen Barre Syndrome by the neurologist per her husband's recollection. In the hospital she was given Immunoglobulin G for 5-7 days and she did regain some feeling in her legs. Based on patient's husband recollection this may have occurred "maybe tired due to travelling," but when she arrived to the country that was when her left leg weak and requested a wheelchair. The patient then injured her "right foot" in another country, but "she didn't feel it and she requested help because she couldn't walk." per her husband. After she reached her final destination, she felt tired and then she completely fell. It was reported that she could not "control herself and felt paralyzed." On 08-JUN-2021, she entered the hospital and was still in hospital at the time of this report. Her husband states that he "does not know any side effect from any vaccine" that caused this in the past. Lastly, he mentioned "she may have numbness in her face when she reached original country". He also stated that the  on 04-JUN-2021, doctors conducted a computerized tomography scan and did not find a blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feelings of weakness, swelling in legs, diagnosed with guillen barre syndrome, numbness in left hand, tiredness, left leg weakness, numbness in face, injured right foot and felt paralysed was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This is a spontaneous report received from consumer concerning a 46 year old female, unknown ethnicity, who experienced weakness and numbness of the left hand on the same day after receiving the Janssen Covid-19 vaccine and was diagnosed with Guillain-Barre Syndrome 39 days after.   Patient's height was 66 inches and weight was 113 kilograms. Past medical, previous surgery, current illnesses and medications taken as well as history of allergy, smoking,  drug abuse and alcohol abuse were not reported. On the same day as the vaccine was given, patient developed weakness and numbness on the left hand. Patient still travelled. Twenty-eight (28) days post vaccine, patient experienced left leg weakness and swelling on the legs. Patient was noted to feel tired the day before. Thirty-two (32) days post vaccine, patient developed numbness on the face. Computerized Tomography (CT) scan was done and there was no blood clot found. Thirty-eight (38) days post vaccine, patient felt 'paralyzed' and injured her right foot. Patient was brought to the hospital the following day and was subsequently admitted. Patient was diagnosed with Guillain-Barre Syndrome and was given IVIG. Information regarding other potential etiologies was insufficient. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.