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This is VAERS ID 523105

History of Changes from the VAERS Wayback Machine

First Appeared on 6/14/2014

523105
VAERS Form:
Age:14.0
Gender:Female
Location:Foreign
Vaccinated:2013-06-11
Onset:0000-00-00
Submitted:2014-02-19
Entered:2014-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Back pain, Decreased interest, Fatigue, Gait disturbance, Guillain-Barre syndrome, Headache, Memory impairment, Mental impairment, Neuropathy peripheral, Nuclear magnetic resonance imaging, Parosmia, Sluggishness, Somnolence, Mobility decreased, Abasia, Grip strength decreased, Orthostatic intolerance

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALONAL; IMIGRAN; METLIGINE
Current Illness: Orthostatic intolerance; Headache
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 03/19/2013, Body temperature, 36.8 degrees; 06/11/2013, Body temperature, 36.9 degrees C; 12/24/2013, Body temperature, 36.6 degrees C
CDC 'Split Type': WAES1402JPN008216

Write-up:Initial information has been received from a physician via Pharmaceutical and Medical Devices Agency concerning a 14 year old female patient who on 11-JUN-2013 was intramuscularly vaccinated for the second time with GARDASIL injection drug (Lot No.: 9QN08R), 0.5 ml once a day in the upper-third level of the left upper arm of cervix carcinoma. Information including underlying/concomitant diseases and past medical history was not obtained. According to the medical history interview sheet (allergy, underlying disease, status of growth, history of vaccination/disease during recent one month, etc.), the patient had no problem. She had no family history. Other concomitant medications are shown in therapy information. On 19-MAR-2013, the patient''s body temperature was 36.8 degrees Celsius. She was intramuscularly vaccinated with GARDASIL for the first time in the upper-third level of the left upper arm (Lot No.: 9QN08R). There was no concomitant from the patient. On 11-JUN-2013, the patient''s body temperature was 36.9 degrees Celsius. She was intramuscularly vaccinated with GARDASIL for the second time in the upper-third level of the left upper arm (Lot No.: 9QN08R), as stated above. After vaccination, the patient began to fall asleep during meals and also made frequent complaint of headache. The headache persisted for about 2 weeks. The patient somewhat began to lose interest quickly. She took CALONAL and IMIGRAN at times of headache. Also, she was told to have developed orthostatic dysregulation, and was prescribed with METLIGINE to be taken on awakening and at bedtime. In June 2013, the headache that developed after vaccination was diminishing. On an unspecified date (around summer), the patient became unable to walk since she felt that exhaust gases outside smelled extremely bad. On 24-DEC-2013, the patient''s body temperature was 36.6 degrees Celsius. At 4:07 p.m., she was intramuscularly vaccinated with GARDASIL for the third time in the upper-third level of the left upper arm (Lot No.: 9QN12R). At around 6:00 p.m., after returning home, the headache that had been diminishing aggravated. The patient felt pain as if she was being hit on the head with a hammer. She also cold not put strength in both hands, especially in the left hand, so that she dropped her rice bowl. Her gait was abnormal and sluggish. She could run normally and could cross the street before the crossing light changed. At the end of 2013, tears continuously flowed to the lean side when the patient lay down. The patient complained that she was rapidly forgetting what she had learned. She quickly lost interest in her favorite television program and could not watch it continuously. She could not continue taking a meal because both her hands become tired. The patient used to love reading books, but she could no longer recognize the characters. She could not open a milk bottle with her hands or open a plastic bag of bread. On an unspecified date, higher brain dysfunction and Guillain-Barre syndrome developed. On an unspecified date, the patient had MRI taken at the pediatrics department of Hospital A and also visited the department of ophthalmology. On 01-FEB-2014, the patient visited the reporting physician''s hospital with her mother. On 05-FEB-2014, at night, the patient experienced back pan and headache so severe that she could not get up. On 06-FEB-2014, the patient had severe pain in head to the extent that she could not take a painkiller, and slept for more than 18 hours. The patient woke up for a short time at night and took a small amount of meal, and then slept again. She had been absent from school. In February 2014, the patient had no headache with oral painkiller. As of the time of this report, the outcomes of higher brain dysfunction and Guillain-Barre syndrome were not recovered/resolved. The outcomes of orthostatic dysregulation, back pain, sleeping during meals, quick loss of interest, inability to put strength in both hands, abnormal gait, continuous


Changed on 9/14/2017

523105 Before After
VAERS Form:(blank) 1
Age:14.0
Gender:Female
Location:Foreign
Vaccinated:2013-06-11
Onset:0000-00-00
Submitted:2014-02-19
Entered:2014-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UNK LA / IM

Administered by: Other      Purchased by: Other
Symptoms: Back pain, Decreased interest, Fatigue, Gait disturbance, Guillain-Barre syndrome, Headache, Memory impairment, Mental impairment, Neuropathy peripheral, Nuclear magnetic resonance imaging, Parosmia, Sluggishness, Somnolence, Mobility decreased, Abasia, Grip strength decreased, Orthostatic intolerance

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit? (V2.0) No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALONAL; IMIGRAN; METLIGINE
Current Illness: Orthostatic intolerance; Headache
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 03/19/2013, Body temperature, 36.8 degrees; 06/11/2013, Body temperature, 36.9 degrees C; 12/24/2013, Body temperature, 36.6 degrees C
CDC 'Split Type': WAES1402JPN008216

Write-up:Initial information has been received from a physician via Pharmaceutical and Medical Devices Agency concerning a 14 year old female patient who on 11-JUN-2013 was intramuscularly vaccinated for the second time with GARDASIL injection drug (Lot No.: 9QN08R), 0.5 ml once a day in the upper-third level of the left upper arm of cervix carcinoma. Information including underlying/concomitant diseases and past medical history was not obtained. According to the medical history interview sheet (allergy, underlying disease, status of growth, history of vaccination/disease during recent one month, etc.), the patient had no problem. She had no family history. Other concomitant medications are shown in therapy information. On 19-MAR-2013, the patient''s body temperature was 36.8 degrees Celsius. She was intramuscularly vaccinated with GARDASIL for the first time in the upper-third level of the left upper arm (Lot No.: 9QN08R). There was no concomitant from the patient. On 11-JUN-2013, the patient''s body temperature was 36.9 degrees Celsius. She was intramuscularly vaccinated with GARDASIL for the second time in the upper-third level of the left upper arm (Lot No.: 9QN08R), as stated above. After vaccination, the patient began to fall asleep during meals and also made frequent complaint of headache. The headache persisted for about 2 weeks. The patient somewhat began to lose interest quickly. She took CALONAL and IMIGRAN at times of headache. Also, she was told to have developed orthostatic dysregulation, and was prescribed with METLIGINE to be taken on awakening and at bedtime. In June 2013, the headache that developed after vaccination was diminishing. On an unspecified date (around summer), the patient became unable to walk since she felt that exhaust gases outside smelled extremely bad. On 24-DEC-2013, the patient''s body temperature was 36.6 degrees Celsius. At 4:07 p.m., she was intramuscularly vaccinated with GARDASIL for the third time in the upper-third level of the left upper arm (Lot No.: 9QN12R). At around 6:00 p.m., after returning home, the headache that had been diminishing aggravated. The patient felt pain as if she was being hit on the head with a hammer. She also cold not put strength in both hands, especially in the left hand, so that she dropped her rice bowl. Her gait was abnormal and sluggish. She could run normally and could cross the street before the crossing light changed. At the end of 2013, tears continuously flowed to the lean side when the patient lay down. The patient complained that she was rapidly forgetting what she had learned. She quickly lost interest in her favorite television program and could not watch it continuously. She could not continue taking a meal because both her hands become tired. The patient used to love reading books, but she could no longer recognize the characters. She could not open a milk bottle with her hands or open a plastic bag of bread. On an unspecified date, higher brain dysfunction and Guillain-Barre syndrome developed. On an unspecified date, the patient had MRI taken at the pediatrics department of Hospital A and also visited the department of ophthalmology. On 01-FEB-2014, the patient visited the reporting physician''s hospital with her mother. On 05-FEB-2014, at night, the patient experienced back pan and headache so severe that she could not get up. On 06-FEB-2014, the patient had severe pain in head to the extent that she could not take a painkiller, and slept for more than 18 hours. The patient woke up for a short time at night and took a small amount of meal, and then slept again. She had been absent from school. In February 2014, the patient had no headache with oral painkiller. As of the time of this report, the outcomes of higher brain dysfunction and Guillain-Barre syndrome were not recovered/resolved. The outcomes of orthostatic dysregulation, back pain, sleeping during meals, quick loss of interest, inability to put strength in both hands, abnormal gait, continuous flow of tears to the lean side on laying down, rapid forgetting of learned information, feeling abnormal bad smell of exhaust gasses and peripheral nerve disorder were unknown. Reporter''s comment: The patient was considered to have developed higher brain dysfunction and peripheral nerve dysfunction. The reporting physician considered higher brain dysfunction and Guillain-Barre syndrome as serious due to disability, and did not assess the seriousness of headache, orthostatic dysregulation, Back pain, sleeping during meals, quick loss of interest, inability to put strength in both hands, abnormal gait, continuous flow of tears to the lean side on laying down, rapid forgetting of learned information, feeling abnormal bad smell of exhaust gasses and peripheral nerve disorder. The reporting physician felt that higher brain dysfunction and Guillain-Barre syndrome were related to GARDASIL and considered that there was no other causative factor. The reporting physician did not assess the causal relationship of headache, orthostatic dysregulation, back pain, sleeping during meals, quick loss of interest, inability to put strength in both hands, abnormal gait, continuous flow of tears to the lean side on laying down, rapid forgetting of learned information, feeling abnormal bad smell of exhaust gasses and peripheral nerve disorder to GARDASIL. Additional information has been requested.


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