Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Constipation, Fatigue, Guillain-Barre syndrome, Insomnia, Laboratory test abnormal
Clinical narrative: PARALYSIS; GUILLAIN BARRE SYNDROME; DIFFICULTY SLEEPING; FELL DOWN; FEVER; SORE ARM; This spontaneous report was received from a patient and concerned a 62 year old female. Initial information was processed with additional information received from the patient via an outreach telephone call on 21-Jul-2021. The patient's height and weight were not reported. The patient's concurrent conditions included blood pressure (not specified if high or low), early stages of cataract formation in left eye, no known drug allergies, non-smoker, did not exercise and was generally healthy. She had no infectious illness prior to the vaccination, nor any recent vaccinations or hospitalizations 6 weeks prior to the onset of events. The patient did not have any of the following:  common cold, flu, or infection with Epstein-Barr, Herpes simplex, Herpes Zoster, adenovirus infection, cytomegalovirus, respiratory syncytial virus infection, coxsackievirus, diarrhea or bloody diarrhea, or Lyme disease. Her HIV status was negative. There was no history in the patient or her family for any malignancies, neurologic or autoimmune diseases. There was also no recent travel. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin. not reported, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 to her left arm for prophylactic vaccination. Batch number was not reported and has been requested. Concomitant medications included amlodipine for blood pressure. On an unspecified date the patient had the results of a COVID-19 test as negative. On 11-MAR-2021, several hours post vaccination, the patient experienced a little fever and sore arm and took 2 TYLENOL (paracetamol).  One week later, (also reported as approximately 22-MAR-2021) the patient started having soreness in the lower left lower arm, felt some weakness and throbbing, "weird sensation", like a circulation issues in her lower left arm.  It was not disabling but it kept coming and going for several weeks then it stopped.  About 3 weeks post vaccination, she had new onset of symptoms which continued for another few weeks. She had bad fatigue that continued and got worse over time and never stopped. She had difficulty sleeping for more than a hour or two at a time. She started to feel a "weird sensation" in the calf of the right leg then at one point a week or two after, it moved to the back of her thigh (pain and weakness). The patient thought it might be "clotting"  but if felt more like a circulatory problem (similar to the feeling she had in the arm) but when she took 2 paracetamol the pain would go away so she didn't think much of it as she was busy. On 09-MAY-2021, she felt great, had a lot of energy and spend the day with her family.  On 10-MAY-2021 (around 1 pm),  she suddenly lost the ability to stand up, her legs gave away then later that afternoon, her legs gave away again and she fell down. The patient reported her symptoms started abruptly. On 11-MAY-2021, she called the ambulance and she was admitted to the hospital neurology floor. An electromyogram was performed (date unspecified) with results of subacute progressive weakness in left extremity and now affecting upper extremity. Motor weakness more prominent than sensory. The patient also reported having a magnetic resonance imaging (MRI) and lumbar puncture (dates and results not provided). Her symptoms kept getting worse but did not spread and she reported she had no strength in her legs and deep tendon reflexes (DTR) showed no response. The patient stated she ended up being paralyzed from her mid body down with her upper body being weak and tingling in both hands and finger. The weakness was bilateral. Her feet and ankles were swollen. At one point she was about to lose her ability to talk (she had problems talking). Left eye was blurry (history of early stages of cataract formation); no problems with breathing, chewing and swallowing. She was diagnosed with acute Guillain-Barre Syndrome on an unspecified date. She stayed in the hospital for 5 weeks and received intravenous antibody treatment which didn't work for her, then received plasma treatment for consecutive 5 days. Few days after receiving the plasma treatment, she was still weak but felt some improvement, so she was transferred to the rehabilitation. At the rehabilitation facility, patient started to stand using a walker and started to walk  little by little. She gained her strength to walk.  On 10-JUN-2021, the patient was discharged home. At the time of report, she was much better and no longer paralyzed; still saw her doctors and went for outpatient treatment. She still has concerns with balance and always careful when walking. Her right ankle "feels weird" but she regained most of her upper body strength. Parts of her lower body was still a little weak, she was still using a walker outside of her house and made sure that her husband was with her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and fever on 12-MAR-2021, was recovering from Guillain-Barre Syndrome, and paralysis, and the outcome of difficulty sleeping and fell down was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report was received from a patient concerned a 62-year-old female who experienced Guillain Barre syndrome (GBS) 60 days after vaccine. Concurrent conditions included hypertension. She had no recent infections/vaccinations/hospitalization. Concomitant medications included amlodipine for blood pressure. On an unspecified date the patient had a negative COVID-19 test. On day 59, she felt great.  On day 60, she suddenly lost the ability to stand up. She was admitted to the hospital neurology floor. An electromyogram was performed with results of subacute progressive weakness in left extremity and now affecting upper extremity. Motor weakness more prominent than sensory. The patient also reported having a magnetic resonance imaging and lumbar puncture (dates and results not provided). Her symptoms kept getting worse but did not spread and she reported she had no strength in her legs and deep tendon reflexes showed no response. The patient stated she ended up being paralyzed (bilateral) from her mid body down with her upper body being weak and tingling in both hands and finger. No problems with breathing, chewing and swallowing. She was diagnosed with acute Guillain-Barre Syndrome on an unspecified date. She stayed in the hospital for 5 weeks and received intravenous antibody treatment which didn't work for her, then received plasma treatment for consecutive 5 days. Few days after receiving the plasma treatment, she was still weak but felt some improvement. She gained her strength to walk. At the time of report, she was much better and no longer paralyzed; still saw her doctors and went for outpatient treatment. Information regarding other potential etiologies was insufficient, and the occurrence of GBS could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.