Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Positron emission tomogram, Scleroderma-like reaction, Therapy non-responder, Ultrasound Doppler
Clinical narrative: FOOT DROP; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; NEUROPATHY PERIPHERAL ON HANDS AND FEET; SCLERODERMA-LIKE REACTION; DYSGEUSIA / LOST TASTE, CAN ONLY TASTE SWEET; WEIGHT DECREASED / LOST 130 POUNDS; BLOOD CREATINE PHOSPHOKINASE; C-REACTIVE PROTEIN NORMAL; ELECTROPHORESIS ABNORMAL; NERVE STIMULATION TEST ABNORMAL; VITAMIN B12 NORMAL; This spontaneous report received from a patient via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System); concerned a 56-year-old female. The patient's height, and weight were not reported. The patient had been overweight morbidly obese for 15 years and not had any known health conditions prior to the vaccination other than the obesity, and Patient had no known allergies, Patient had no known illnesses within two months prior of the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-MAR-2021 in left arm for an unspecified indication. Age at time of vaccination 56 years old. Concomitant medications included multivitamins for women.  On an unspecified date since mid to late MAR-2021, the patient had some lost of taste and can only taste sweet and had persistent metallic taste in her mouth (dysgeusia) and began developing neuropathies (neuropathy peripheral) in her hands and feet at the same time. They would come and go but did not went. Patient lost 130 pounds weight without trying but because nothing tastes good. The patient also experienced scleroderma-like reaction, the patient was advised by neurologist to not take any kind of vaccine anymore. In OCT-2021, doctor told that one of tests had indicate that there were no antibodies against covid-19 in blood. The patient had foot drop. On an unspecified date the patient was hospitalized for 1 week (7 days) for conditions. Laboratory data included: Blood creatine phosphokinase (NR: not provided) Normal, C-reactive protein (NR: not provided) Normal, Electrophoresis (NR: not provided) Abnormal, Scleroderma (Laboratory test) (NR: not provided) Normal, Nerve stimulation test (NR: not provided) Showed abnormal reactions, Vitamin B12 plus Folate (NR: not provided) Normal, and Weight (NR: not provided) Decreased.  Laboratory data (dates unspecified) included: Amino acid level (methylmalonic acid) (NR: not provided) Normal, Ankle brachial index (NR: not provided) Normal, myelin-associated glycoprotein antibodies (Antibody test) (NR: not provided) Normal, Anti-neuronal nuclear antibody-2 (NR: not provided) Normal, Antibody test (Sjogren Antibody Panel) (NR: not provided) Normal, Antinuclear antibody (NR: not provided) Normal, Kappa Light Chains Free Lambda Light Chains (Light chain analysis) (NR: not provided) kappa light chains elevated, Lyme Disease Deoxyribonucleic acid (DNA) (Polymerase chain reaction) (NR: not provided) Normal, and Rheumatoid factor (NR: not provided) Normal, Nerve Biopsy (NR: not provided) Unknown, Blood test (NR: not provided) Unknown, Bone marrow biopsy (NR: not provided) Unknown, Doppler scan (NR: not provided) Unknown, Lumbar puncture (NR: not provided) Unknown, X-ray (NR: not provided) Unknown, Positron emission tomogram (NR: not provided) Unknown, Magnetic resonance imaging (NR: not provided) Unknown, COVID-19 antibody test (NR: not provided) No antibody against covid-19 in blood. Patient had visited physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood creatine phosphokinase, c-reactive protein normal, dysgeusia / lost taste, can only taste sweet, electrophoresis abnormal, nerve stimulation test abnormal, neuropathy peripheral on hands and feet, scleroderma-like reaction, vitamin b12 normal, and weight decreased / lost 130 pounds, and the outcome of confirmed immunological vaccine failure and foot drop was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with a product quality complaint: 90000236848.  Additional information was received from patient on 20-JUN-2022. The following information was updated and incorporated into the case narrative: Patient name, address, contact details added, patient initials, race, ethnic origin updated, RRT of event dusgusia, neuropathy peripheral, weight decreased updated, event immunological vaccine failure, foot drop added, Lab data Nerve Biopsy, Blood test, Bone marrow biopsy, Doppler scan, Lumbar puncture, X-ray, Positron emission tomogram, Magnetic resonance imaging, COVID-19 antibody test added. Along with information received on 22-JUN-2022. The following information was updated and incorporated into the case narrative: product quality complaint number added.; Sender's Comments: V1:Follow up information in this version updates, patient name, address, contact details added, patient initials, race, ethnic origin updated, RRT of event dysgeusia, neuropathy peripheral, weight decreased updated, event immunological vaccine failure, foot drop added, Lab data Nerve Biopsy, Blood test, Bone marrow biopsy, Doppler scan, Lumbar puncture, X-ray, Positron emission tomogram, Magnetic resonance imaging, COVID-19 antibody test added. Along with information received on 22-JUN-2022. The following information was updated and incorporated into the case narrative: product quality complaint number added. 20211033114-covid-19 vaccine ad26.cov2.s- confirmed immunological 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. 20211033114-covid-19 vaccine ad26.cov2- Foot drop. 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 20211033114-COVID-19 VACCINE AD26.COV2.S-Neuropathy peripheral, Scleroderma-like reaction. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.