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This is VAERS ID 815291

Case Details

VAERS ID: 815291 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2011-08-22
Onset:2013-12-01
   Days after vaccination:832
Submitted: 0000-00-00
Entered: 2019-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anti-ganglioside antibody positive, Antiacetylcholine receptor antibody positive, Antibody test positive, Autoimmune disorder, Autoimmune encephalopathy, Dyskinesia, Hyperventilation, Muscular weakness, Single photon emission computerised tomogram abnormal, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (narrow), Eosinophilic pneumonia (broad), Vasculitis (broad), Hypersensitivity (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dermatitis atopic
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131610JPN009728

Write-up: Hyperventilation attack; Weakness of lower extremities; Tremor; Autoimmune encephalopathy; Autoimmune disease; ^^Information has been received from the following published conference abstract, entitled as stated below. ^^Follow up^^ information has been received from a physician concerning a 16 year old female patient with a medical history of atopic dermatitis who on 25-FEB-2012 was intramuscularly vaccinated with the recombinant quadrivalent human papillomavirus vlp vaccine (yeast) (MSD) injection drug (dose and indication not reported). The patient had no underlying/ concomitant disease. No other concomitant drug was reported. On 22-AUG-2011, the patient received the first dose of the recombinant quadrivalent human papillomavirus vlp vaccine (yeast). On 24-SEP-2011, the patient received the second dose of the recombinant quadrivalent human papillomavirus vlp vaccine (yeast). On 25-FEB-2012, the patient received the third dose of the recombinant quadrivalent human papillomavirus vlp vaccine (yeast). In December 2013, the patient developed tremor of left upper extremity. The patient had waxing and waning of the symptom. On 30-NOV-2015, the patient was admitted to the reporting department for the first time. On an unspecified date, the patient was recovering from the symptom with treatment with oral drugs and was discharged from the hospital. On 04-JAN-2016, the patient developed weakness of extremities and was admitted to the reporting hospital for the second time. On an unspecified date, the patient was recovering from the symptom with immunoadsorption therapy and was discharged from the hospital. On 07-MAR-2016, the patient experienced weakness and involuntary movements and was admitted to the reporting hospital for the third time. On an unspecified date, the patient was recovering from the symptom with immunoadsorption therapy and was discharged from the hospital. On 13-APR-2016, the patient developed tremor and hyperventilation attack, and was admitted to the reporting hospital for the fourth time, where immunoadsorption therapy was performed. On 06-JUN-2016, the patient developed tremor and was admitted to the reporting hospital for the fifth time, where immunoadsorption therapy was performed. On 20-JUL-2016, the patient was admitted to the reporting hospital for the sixth time. On an unspecified date, the patient was discharged from the hospital after treatment with oral drugs. On an unspecified date, the patient developed autoimmune disease and ^^autoimmune encephalopathy^^. On an unspecified date, laboratory test result was positive for gangrioside antibody, anti-ganglionic acetylcholine receptor (anti-gAChR) antibody and anti-glutamate receptor (anti-GluR) antibody in cerebrospinal fluid and a single photon emission computerised tomography (SPECT) revealed multiple decreases in blood flow. At the time of the report on 14-OCT-2016, weakness of lower extremities and tremor had not resolved. The outcomes of hyperventilation attack and autoimmune disease were unknown. The patient was making hospital visits for outpatient treatment. ^^At the time of the report on 16-MAY-2019, weakness of lower extremities and tremor had not resolved. The outcomes of hyperventilation attack and autoimmune disease and autoimmune encephalopathy were unknown. The patient was making hospital visits for outpatient treatment.^^ This is one of several reports received from the same source.^^ Reporter''s comment: As the patient developed autoimmune disease after vaccination with the recombinant quadrivalent human papillomavirus vlp vaccine (yeast), the causality could not be ruled out. The patient had waxing and waning of the symptoms. The reporting physician considered that weakness of lower extremities, tremor and hyperventilation attack were serious due to hospitalization and did not assess the seriousness of autoimmune disease and ^^autoimmune encephalopathy ^^. Upon internal review, autoimmune disease and ^^autoimmune encephalopathy ^^ was considered to be serious due to other important medical event. The reporting physician considered that weakness of lower extremities and tremor and ^^autoimmune encephalopathy ^^ were related to the recombinant quadrivalent human papillomavirus vlp vaccine (yeast) without other causative factors. The reporting physician did not assess the causal relationship of hyperventilation attack and autoimmune disease to the recombinant quadrivalent human papillomavirus vlp vaccine (yeast). No further information is available. Ver 001 Source: A physician on a CRF Reportability: reportable as an individual case report Received date: 14-OCT-2016 Updated information received on 16-MAY-2019 from the physician has been marked with a double caret (^^). Literature information was added.; Sender''s Comments: JP-MSD-BA201307823002: JP-MSD-BA201307823002:


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