Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Anion gap, Aspartate aminotransferase, Basophil count, Beta globulin
Clinical narrative: SEXUAL DYSFUNCTION; CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY; REACTIVE AIRWAY DISEASE; CANE BRADYCARDIA SYNDROME; BENIGN ESSENTIAL HYPERTENSION; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; ITCHY RASH ON UPPER/LOWER BACK AND CHEST; PAPULAR RASH ON UPPER/LOWER BACK AND CHEST; WEIGHT LOSS; This spontaneous report received from a patient via a company representative via social media concerned a 55 year old male. The patient's height was not reported and weight was 260 pounds. The patient's past medical history included: esophagitis, gastritis, MVA restrained driver and concurrent conditions included: multiphasic inflammatory polyradiculoneuropathy, chronic gerd, insomnia, alcohol use (socially), upper back pain, neck pain, hiatal hernia, obesity, pollen allergy, drug allergy (Apixaban) (breaks out in hives, blisters, and rash), asthma, cervical radiculopathy, non smoker (electronic cigarette, never (less than 100 in lifetime)), polyradiculopathy, wheezing, shortness of breath and other pre-existing medical conditions included: No family history of neuropathy, no known medication allergies. General alert and oriented, well nourished, no acute distress. Eye pupil, equal, round, reactive to light, Extraocular Movements Intact, normal conjunctiva. head, ears, nose, and throat, normocephalic, normal hearing, moist oral mucosa, no scleral icterus. Neck supple, non-tender, no lymphadenopathy. Lungs: Clear to auscultation in all fields, non-labored respiration. Heart: Regular rate, regular rhythm, no murmur, gallop, rubs or edema. Abdomen: Soft, non-tender, non-distended, normal bowel sounds. Musculoskeletal: Normal range of motion and strength, no tenderness or swelling. Skin: Skin was warm, dry and pink, no rashes. Neurologic: Awake, alert, and oriented X3, CN II-XII intact. Patient has diminished reflexes and strength of the lower extremity 2 or 5, sensation appears to be intact to sharp touch, psychiatric: Cooperative, appropriate mood and affect. The patient received 5 doses of the IVIG. No family history of neuropathy. The patient did not have substance abuser. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A expiry: unknown) dose was not reported, 1 total administered at left arm on 18-MAY-2021 for prophylactic vaccination. Age at the time of vaccination was 55 years. Concomitant medications included midazolam for anesthesia, cefazolin for prophylaxis, sulfamethoxazole/trimethoprim for prophylaxis, arformoterol, azithromycin, bisacodyl, budesonide, calcium carbonate, cetirizine, colecalciferol, dextromethorphan, Xanax, dextromethorphan hydrobromide/guaifenesin, docusate sodium/senna alexandrina, duloxetine, enoxaparin, fluticasone propionate/salmeterol xinafoate, heparin, loratadine, macrogol 3350, melatonin, methylprednisolone, methylprednisolone sodium succinate, naloxone, omeprazole, ondansetron, pantoprazole, pantoprazole sodium sesquihydrate, and pethidine. On 25-MAY-2021, the patient experienced numbness and tingling in fingers, feet and legs, the patient was initially presented with subacute progressive bilateral lower limb weakness and numbness with associated sciatica type pain in his low back 7 to 9 days after receiving first dose of J and J covid vaccine in MAY-2021. It was reported that, the patient experienced inflammatory demyelinating polyradiculoneuropathy, guillain barre syndrome, cannot stand up more than 5 minutes, symptoms started six days after vaccination/abnormal sensation and strength, upper back pain, and weakness. Initial investigation revealed cytoalbuminologic dissociation CSF and was treated as Guillain Barre syndrome with IVIG without improvement. The patient subsequently developed worsening weakness and numbness in rehab to the point that he was not able to lift his legs antigravity over the course of 2 months from the initial symptom onset. The patient was then readmitted and given another course of IVIG without any improvement. The patient with a history of Guillain-Barre syndrome hospitalized last year intermittently for 3 months after his covid vaccination. He subsequently developed CIPD and was on rituximab. The patient was hospitalized on 14-JUN-2021 and diagnosed with cane bradycardia syndrome. It started with falling down a lot, patient's legs were collapsing. The patient was finally hospitalized since he lost ability to walk. On 26-JUN-2021, the patient experienced reactive airway disease. Several consecutive nights with mild oxygen desaturation - most likely related to atelectasis but would pursue CT chest to r/o PE noting elevated VTE risk. Lab: Alanine aminotransferase (NR: not provided) 130 U/L, Aspartate aminotransferase (NR: not provided) 63 U/L, and Systolic blood pressure (NR: not provided) 141 mmHg. On JUL-2021, Lab: Cerebrospinal fluid abnormal Elevated protein of 178, 57 white blood cells, glucose 54, CSF paraneoplastic panel negative, CSF flow cytometry was negative; EMG. Needle EMG showed poor to absent activation of multiple lower limb muscles. Profuse fibrillation potentials in the right proximal thigh and hip girdle muscles); MRI Diffuse enhancement cauda equina, more pronounced involving the anterior roots; and Positron emission tomography no FDG avid uptake. On 17-JUL-2021, the patient presented to ED for his symptoms associated with 30 lb weight loss. On 19-JUL-2021, the patient experienced itchy papular rash on chest, weakness of lower extremity, Eliquis appears to be a systemic reaction to an allergy which was not in the scope of the wound ostomy department. They thought patient might be allergic to Eliquis. Hydrocortisone cream had been ordered and being applied BID and PRN. Lab: Alanine aminotransferase (NR: not provided) 70 U/L, 70 U/L, Eosinophils (NR: not provided) 4.49 10*9/L, 0.49 10*9/L, Glucose (NR: not provided) 152 mg/dL and polycythaemia (NR: not provided) 15.0 %, 15.0 %. On 20-JUL-2021, Lab: Anion gap 6 low, 31.885 (No acute intracranial process, extensive chronic paranasal sinusitis which was unchanged from most recent prior 16-JUN-2021), Anion gap 6 low, 31.885, and polycythaemia (NR: not provided) 14.8 %, 14.8 %. On 22-JUL-2021, Lab: Albumin (NR: not provided) 98.1 mg/dL, CSF 48.89 h, AChR ganglionic neuronal Ab, S 0.04 H, P/Q-Type calcium channel Ab 0.07 H, 98.1 mg/dL, 98.1 mg/dL. No organisms seen. Stain performed on concentrated cytospin (A), 31.880, 31.881, IgG 0.34 high, IgG (NR: not provided) 32.9 mg/dL, Immunoglobulin G (NR: not provided) 32.9 mg/dL, Lymphocytes (NR: not provided) 35 %, 35 %, Monocytes (NR: not provided) 7 %, 7 %, Neutrophils (NR: not provided) 52 %, 52 %, Nucleated red cells 57.8 /mcL, Polycythaemia (NR: not provided) 14.8 %, 14.8 %, Protein (NR: not provided) 178 mg/dL, 178 mg/dL, TSH (NR: not provided) 14.8 %, 4.9 microg/mL. On 23-JUL-2021, Patient had red, raised, rash on upper/lower back and chest. Patient reported it was very itchy. Lab: Albumin 0.53 high, Anion gap 6 (low), 141/82 mmHg2, mixed axonal demyelinating polyradiculoneuropathy (low amplitude of lower limb CMAPs and all SNAPs, median conduction velocity of 35, prolonged distal latencies, prolonged F-wave latencies, R1 was 12.8, no conduction block or temporal dispersion. Needle EMG showed poor to absent activation of multiple lower limb muscles. Profuse fibrillation potentials in the right proximal thigh and hip girdle muscles).17, Erythrocyte abnormality NOS (NR: not provided) 4.30 10*12/L, 4.30 10*12/L, Erythrocytes abnormal (NR: not provided) 4.30 10*12/L, Hemoglobin (NR: not provided) 13.0 g/dL, 13.0 g/dL, 13.0 g/dL, IgG 0.53 (high), Immunoglobulin G (NR: not provided) 1910 mg/dL, 1910 mg/dL, 1910 mg/dL, and Polycythaemia (NR: not provided) 14.9 %, 14.9 %. On 24-JUL-2021, Lab: Beta globulin (NR: not provided) 0.5 g/dL, 0.5 g/dL, 0.5 g/dL, Fibrinogen (NR: not provided) 174 mg/dL, 174 mg/dL, 174 mg/dL, Polycythaemia (NR: not provided) 14.6 %, 14.6 %, 14.6 %, and Protein (NR: not provided) 5.9 g/dL, 5.9 g/dL, 5.9 g/dL. On 25-JUL-2021, Lab: Polycythaemia (NR: not provided) 14.8 %, 14.8 %. On 26-JUL-2021, Lab: Polycythaemia (NR: not provided) 14.7 %, 14.7 %, 14.7 %. On 27-JUL-2021, Lab: Fibrinogen (NR: not provided) 159 mg/dL, 159 mg/dL, 159 mg/dL. On 28-JUL-2021, Lab: Alkaline phosphatase (NR: not provided) 36 U/L, 36 U/L, 36 U/L, Fibrinogen (NR: not provided) 166 mg/dL, 166 mg/dL, 166 mg/dL, and Protein total decreased (NR: not provided) 5.5 g/dL (31.872). On 29-JUL-2021, Lab: Anion gap 131/96 mmHg8, 5 (low), 5 (low), Anion gap 131/96 mmHg8, 5 (low), 5 (low), Anion gap 131/96 mmHg8, 5 (low), 5 (low), Chloride (NR: not provided) 108 mmol/L, 108 mmol/L, 108 mmol/L, Creatinine (NR: not provided) 0.73 mg/dL, 0.73 mg/dL, 0.73 mg/dL, Erythrocyte abnormality NOS (NR: not provided) 4.13 10*12/L, 4.13 10*12/L, 4.13 10*12/L, Fibrinogen (NR: not provided) 117 mg/dL, 117 mg/dL, 117 mg/dL, Hemoglobin (NR: not provided) 12.7 g/dL, 12.7 g/dL, 12.7 g/dL, and Polycythaemia (NR: not provided) 14.8 %, 14.8 %, 14.8 %. On 30-JUL-2021, Lab: Fibrinogen (NR: not provided) 166 mg/dL, 166 mg/dL, 166 mg/dL. On 31-JUL-2021, Lab: Fibrinogen (NR: not provided) 134 mg/dL, 134 mg/dL, 134 mg/dL. On AUG-2021, Lab: Sural nerve biopsy mild decreased density of myelinated fibers with increased rate of segmental demyelination, axonal degeneration, and myelin remodeling (Type C 46%, Type E 17%, 2 fibers with onion bulb appearance). There were individual endoneurial inflammatory cells. No comments on onion bulb in semithin section. Treatment medications included: methylprednisolone, gabapentin. On 01-AUG-2021, Lab: Creatinine (NR: not provided) 0.72 mg/dL, 0.72 mg/dL, 0.72 mg/dL, Erythrocyte abnormality NOS (NR: not provided) 4.17 10*12/L, 4.17 10*12/L, 4.17 10*12/L, Fibrinogen (NR: not provided) 170 mg/dL, 170 mg/dL, 170 mg/dL, Hemoglobin (NR: not provided) 12.8 g/dL, 12.8 g/dL, 12.8 g/dL, and Polycythaemia (NR: not provided) 14.6 %, 14.6 %. On 02-AUG-2021, Lab: Creatinine (NR: not provided) 4.28 10*12/L, and Erythrocyte abnormality NOS (NR: not provided) 4.28 10*12/L, 4.28 10*12/L, biopsy sural nerve (Right) (removal central venous catheter). On 03-AUG-2021, Lab: Creatinine (NR: not provided) 0.69 mg/dL, 0.69 mg/dL, 0.69 mg/dL, Eosinophils (NR: not provided) 0.57 10*9/L, 0.57 10*9/L, 0.57 10*9/L, Erythrocyte abnormality NOS (NR: not provided) 4.28 10*12/L, Erythrocytes abnormal (NR: not provided) 4.28 10*12/L, and Hemoglobin (NR: not provided) 13.1 g/dL, 4.28 10*12/L, 13.1 g/dL, 13.1 g/dL. On 06-AUG-2021, Lab: BUN (NR: not provided) 31.1 mg/dL, 0.59 mg/dL, 31.1 mg/dL, 31.1 mg/dL, Creatinine (NR: not provided) 0.59 mg/dL, 0.59 mg/dL, Erythrocyte abnormality NOS (NR: not provided) 4.08 10*12/L, 4.08 10*12/L, Erythrocytes abnormal (NR: not provided) 4.08 10*12/L, 4.08 10*12/L, Hemoglobin (NR: not provided) 12.6 g/dL, 12.6 g/dL, 12.6 g/dL, 12.6 g/dL, and White blood cell count (NR: not provided) 9.7 10*9/L, 9.7 10*9/L, 9.7 (units unspecified), 9.7 10*9/L. On 19-AUG-2021, Lab: BUN (NR: not provided) 28.5 mg/dL, 28.5 mg/dL, 28.5 mg/dL, Eosinophils (NR: not provided) 0.00 10*9/L, 0.00 10*9/L, 0.00 10*9/L, Glucose (NR: not provided) 152 mg/dL, 152 mg/dL, Lymphocytes (NR: not provided) 0.92 10*9/L, 0.05 10*9/L, 0.92, 0.05, 0.92 10*9/L, Monocytes 0.05 10*9/L, Neutrophils (NR: not provided) 10.09, 10.09, 10.09, Protein Elevated protein of 178, 57 white blood cells (traumatic tap with 28333 red blood cells), glucose 54, CSF paraneoplastic panel negative, CSF flow cytometry was negative 0.05, TRACE (A) (No acute intracranial process, extensive chronic paranasal sinusitis which is unchanged from most recent prior 16-JUN-2021), Protein Elevated protein of 178, 57 white blood cells (traumatic tap with 28333 red blood cells), glucose 54, CSF paraneoplastic panel negative, CSF flow cytometry was negative.05, TRACE (A), and White blood cell count 11.1, 11.1, 11.1 10*9/L. On 25-AUG-2021, Lab: Creatinine, 0.71 mg/dL. On 31-OCT-2021, Lab: Blood pressure 131/96 mmHg, and Pulse rate 58 (beats)/min. In JAN-2022, the patient was still in a wheelchair, but recently was able to use a cane instead. Patient still cannot stand up more than 5 minutes on his own. At the time of reporting, he still need to go to the hospital to received intravenous treatment regarding his condition. On FEB-2022, the patient experienced cough, congestion, SOB with exertion covid, ((suspected covid-19 infection) and suspected clinical vaccination failure), patient had an ongoing non-productive cough which was paroxysmal in nature, the patient came in now 3 weeks post covid infection with ongoing cough symptoms. The patient was using NyQuil at home with no improvement in symptoms. The patient had an ongoing non-productive cough which is paroxysmal in nature, has no chest pain or productive sputum. Patient denies nausea vomiting abdominal pain or any fever. Uses Vicks vapor rub at night for symptom control which appears to help somewhat. On 24-APR-2022, Lab: Blood pressure 141/82 mmHg, and body mass index 31.88. The patient had to use a wheelchair, he was then paralyzed from the neck down. The patient had to stay in the hospital for 3 months and a half. Patient was diagnosed with CIDP (Chronic inflammatory demyelinating polyneuropathy) on 25-MAY-2022, a version of the Guillain- Barre syndrome. Patient was then administered with a drug name Rituximab that helped his condition from getting worse. Laboratory data (dates unspecified) included: Basophils 1 %, Blood glucose abnormal, 96 mg/dL, Blood glucose abnormal 132, 96 mg/dL, Blood pressure Diffuse enhancement cauda equina, more pronounced involving the anterior roots.3, Diffuse enhancement cauda equina, more pronounced involving the anterior roots.4, Blood pressure Diffuse enhancement cauda equina, more pronounced involving the anterior roots.3, Diffuse enhancement cauda equina, more pronounced involving the anterior roots.4, CT abnormal The brain parenchyma appears age appropriate. There was no intra-axial or extra-axial bleed seen. There was no mass or mass effect. There was no evidence of hydrocephalus. The orbital contents appear unremarkable. Chronic paranasal sinusitis again noted. No significant interval change. No fracture was present; Creatinine (NR: not provided) 0.71 mg/dL, Diastolic blood pressure. Diastolic blood pressure Needle EMG showed poor to absent activation of multiple lower limb muscles. Eosinophils 5 %, Granulocytes abnormal 0.3 %, HIV infection Negative, Hepatitis C Negative, Lymphocytes 27 %, Monocytes 8 %, Neutrophils 59 %, PCR Negative, Protein Diffuse enhancement cauda equina, more pronounced involving the anterior roots.7, Pulse rate (NR: not provided) 86, 75, 76 (beats)/min, Pulse rate (NR: not provided) 86, 75, 76 (beats)/min, Pulse rate (NR: not provided) 86, 75, 76 (beats)/min, Systolic blood pressure 145, 161 mmHg. Profuse fibrillation potentials in the right proximal thigh and hip girdle muscles).3, 131, 138 mmHg. Additional treatment medications included: paracetamol, sodium chloride, oxycodone hydrochloride/paracetamol, immunoglobulin human normal, diphenhydramine, acetaminophen, ondansetron, and docusate sodium/sennoside, albuterol (ProAir HFA), immune globulin (human) 10 percent infusion 30 g (gammagard) Stopped 31-OCT-2021 2:34 PM for polyneuritis demyelinating inflammatory chronic, sodium chloride 0.9 % injection 10 mL Last given 31-OCT-2021 2:33 PM for weakness upper extremity, polyethylene glycol (Take 1 packet (17 g total) by mouth daily. Dissolve each 17 g dose in 240 mLs (8 ounces) of beverage), sennosides-docusate sodium 8.6-50 mg per tablet (Take 1 tablet by mouth 2 (two) times a day), mirtazapine, alteplase. On an unspecified date, the patient experienced benign essential hypertension and sexual dysfunction, the patient continues to have some sexual dysfunction but that was improved from what it was at its worst in the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sexual dysfunction, had not recovered from chronic inflammatory demyelinating polyneuropathy, and suspected covid-19 infection, and the outcome of reactive airway disease, cane bradycardia syndrome, itchy rash on upper/lower back and chest, benign essential hypertension, papular rash on upper/lower back and chest, weight loss and suspected clinical vaccination failure was not reported.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with a product quality complaint: 90000234403. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as reported complaints were adverse events) based on the PQC evaluation/investigation performed.  This case was reassessed as serious based on additional information received on 06-JUN-2022, the following information was updated and incorporated into case narrative: general (case updated to valid), person (reporters added), patient (DOB, age, race, ethnicity, hospitalization and discharge date, concurrent condition, patient history), events, product (date of vaccination, batch number, route, vaccination site, vaccine facility name, concomitant drugs, drugs used to treat AE), lab were added, DD were scheduled, PQMS number and PQC results were added.; Sender's Comments: V1-Version updates- patient (DOB, age, race, ethnicity, hospitalization and discharge date, concurrent condition, patient history), events, product (date of vaccination, batch number, route, vaccination site, vaccine facility name, concomitant drugs, drugs used to treat AE), lab, DD were scheduled, PQMS number and PQC results. Case reassessed as serious.  20220454581-covid-19 vaccine ad26.cov2.s- Chronic inflammatory Demyelinating Polyneuropathy, Cane bradycardia syndrome. Follow-up received regarding Clinical Details. 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.  20220454581-covid-19 vaccine ad26.cov2.s-Sexual dysfunction. Follow-up received regarding Clinical Details.  The event(s) has an unknown/unclear 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.  20220454581-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. Follow-up received regarding Clinical Details. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.  20220454581-covid-19 vaccine ad26.cov2.s-Reactive Airway Disease. Follow-up received regarding Clinical Details. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE. Therefore, this event(s) is considered not related. (Asthma)