Sex: F
Vaccine: COVID19
Symptoms: Complement factor C3, Complement factor C4, Deep vein thrombosis, Double stranded DNA antibody, Gastrointestinal haemorrhage
Clinical narrative: PLATELET COUNT OF 118000/UL; DIAPHORESIS; BLOOD PRESSURE 87/47MMHG; GUILLAIN BARRE SYNDROME/DYSPNEA/BELLS PALSY; ACUTE FEMORAL AND POPLITEAL DEEP VEIN THROMBOSIS /PAINLESS LEFT LOWER EXTREMITY SWELLING; GASTROINTESTINAL HAEMORRHAGE/BLOODY LOOSE STOOLL; UREMIC GASTROPATHY; OBSTRUCTIVE UROPATHY/NON-ANION GAP METABOLIC ACIDOSIS/POTASSIUM OF 8.0; This spontaneous report was received from literature: This report concerned a 59 year old female of unspecified race and ethnicity. The objective of the study is that Guillain Barre Syndrome (GBS) is a rare neurologic disorder in which the immune system mistakenly attacks the peripheral nervous system due to molecular mimicry. GBS symptoms can range from a mild episode of weakness to devastating paralysis and respiratory failure. The exact cause of GBS is unknown, but it is often thought to be due to a preceding viral infection or rarely due to vaccination. This case was in the treatment cohort of the Ad26.COV2.S clinical trial, and another parallel case of GBS occured in the control group of that same trial. With a relative risk of 1 for this adverse event during the trial, and population wide vaccination efforts, it is estimated that for every billion vaccinated patients, roughly 708 incidental cases of GBS syndrome may occur within two weeks of vaccination The patient's height, and weight were not reported. The patient's past medical history included: blood transfusion, permacatheter, foley catheter, and hemodialysis, and concurrent conditions included: hypertension, gastroesophageal reflux disease, bipolar disorder, hyperlipidemia, and non-insulin dependent diabetes mellitus, and other pre-existing medical conditions included: The patient was independent in all activities of daily living and ambulatory. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, 1 total administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date APR-2021, after 2 weeks of receiving vaccine, the patient presented to a neighboring emergency department due to difficulty walking, right facial droop, and slurred speech. She was diagnosed with Bell's palsy and discharged from the hospital. 0n an unspecified date MAY-2021, The patient continued to experience difficulty ambulating due to worsening lower extremity weakness, and experienced new and increasing weakness to her proximal bilateral upper extremity. At its worst, she endorsed being unable to brush her hair. She stayed in bed for several days. Two days prior to her arrival at hospital, she noticed painless left lower extremity swelling. The night of admission, she awoke at approximately 2 am with diffuse low back pain. After being assisted to the restroom and was diagnosed has Guillain barre syndrome, she sustained an episode of dark, red, and bloody loose stool After five repeat episodes, On an unspecified date the patient experienced fatigue, dyspnea, and diaphoresis and she was admitted to the hospital. On an unspecified date, Laboratory data included: Anti-dsDNA antibody: 153 U/mL, Anti-glomerular basement membrane antibody: less than 1.0 AI, Antibody test: less than 1.0 AI, Antimitochondrial antibody: less than 20.0 AI, Antineutrophil cytoplasmic antibody: Myeloperoxidase Ab, Antinuclear antibody: Negative, Arterial blood gases: non-anion gap metabolic acidosis, Bladder scan: more than 2L of retained urine, Blood pressure: 87/47 mmhg (Decreased), Blood urea nitrogen: 204 mg/dL, Body mass index: 26.79 kg/m2, Body temperature: 34.9 C, Complement factor C3: 97 mg/dL, Complement factor C4: 25 mg/dL, Creatine kinase: 653 IU/L, Diagnostic ultrasound: left lower leg showed acute femoral and popliteal deep vein thrombosis (DVT). She received an inferior vena cava (IVC) filter as the risk of heparinization exceeded the possible benefit, given her recent gastrointestinal hemorrhage, Erythrocyte sedimentation rate: 19 mm/h, Heart rate: 75 bpm, Hematocrit: 19.1 %, Hemoglobin: 6.2 g/dL(decreased) MRI Lumbar Spine demonstrating abnormal T2 bright signal within the left psoas muscle and bilateral erector spinae, failed, Nuclear magnetic resonance imaging thoracic: Not reported, Oxygen saturation :100 %, Physical examination demonstrated right sided facial droop with no sparing of the forehead, decreased left forehead wrinkles, slurred speech, weakness and reduced sensation to the bilateral lower extremities, diminished deep tendon reflexes to the lower extremity, distended bladder, and decreased rectal tone, Platelet count: 118000 uL, Potassium: 8(increased), Red blood cell count : 2.12 M/uL, Respiratory rate: 19 cycle pm, Rheumatoid factor: less than 14 IU/mL, Serum creatinine: 5.81 mg/dL, White blood cell count: 11500 uL, and pH: 7.1. The patient was admitted to intensive care unit on 13-MAY-2021, On an unspecified date MAY-2021 the patient experienced gastrointestinal hemorrhage, secondary to uremic gastropathy, due to obstructive uropathy. Treatment medications (dates unspecified) included: The patient received urgent blood transfusion and was placed on a Protonix drip. A portacatheter was placed for urgent hemodialysis, as well as a foley catheter. On 14-MAY-2021, the patient's laboratory values had stabilized and she was downgraded from the ICU (intensive care unit). Her dialysis access was removed on 18-MAY-2021 as she no longer required dialysis. She continued to experience urinary retention during voiding trials. Her muscular strength mildly improved throughout her hospital course, without any targeted intervention such as corticosteroids, IVIg, or plasmapheresis. The number of days of hospitalization was not reported and the patient was ultimately discharged, with Foley in place, to sub-acute rehabilitation on 21-MAY-2021, with plans for outpatient rheumatologic, neurologic, and urologic follow up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the guillain barre syndrome/dyspnea/bell's palsy, gastrointestinal haemorrhage/bloody loose stool, uremic gastropathy, obstructive uropathy/non-anion gap metabolic acidosis/potassium of 8.0, acute femoral and popliteal deep vein thrombosis /painless left lower extremity swelling, diaphoresis, platelet count of 118000/ul and blood pressure 87/47mmhg was not reported. The authors concluded that, unfortunately due to failure to obtain LP and EMG, it is only possible to diagnose Guillain Barre syndrome with Level 3 diagnostic certainty using the Brighton criteria .As the Ad26.COV2.S vaccine is reintroduced for widespread inoculation efforts, incidental cases of GBS are expected to occur. Only with ongoing vigilant reporting, can a meaningful association between Ad26.COV2.S vaccine and Guillain Barre syndrome be established. This case represents the first of such a report for receiving the Ad26.COV2.S vaccine and the development of Guillain Barre syndrome. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220316514-covid-19 vaccine ad26.cov2.s-guillain barre syndrome, acute femoral and popliteal deep vein thrombosis,  platelet count of 118000/ul . This event(s) is labeled per RSI and is therefore considered potentially related. 20220316514-covid-19 vaccine ad26.cov2.s-gastrointestinal haemorrhage, uremic gastropathy, obstructive uropathy, diaphoresis, blood pressure 87/47mmhg . 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). Therefore, this event(s) is considered unassessable