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Found 1922 cases where Vaccine is HPV4 and Disabled

Case Details (Sorted by Age)

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VAERS ID: 350235 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2009-06-13
Onset:2009-06-13
   Days after vaccination:0
Submitted: 2009-06-25
   Days after onset:12
Entered: 2009-06-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1312X / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Blood glucose normal, Lethargy, Nausea, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: vital sign, 06/13/09, normal; blood glucose, 06/13/09, normal
CDC Split Type: WAES0906USA02614

Write-up: Information has been received from a Physician Assistant (P.A) concerning a 15 year old female patient who on 13-JUN-2009 was vaccinated with the first dose of GARDASIL (Lot # not reported). It was reported that the patient fainted right after receiving the first dose of GARDASIL on 13-JUN-2009. It was reported that the patient was was brought to the emergency room and stayed there for a few hours. The patient was not admitted to the hospital. The patient sought medical attention with the Physician Assistant. There was a blood work performed (results not provided). It was reported that the adverse event had improved at the time of the report. All telephone attempts to contact the reporter have been unsuccessful. Follow up information was received from a Physician Assistant (P.A) on 23-JUN-2009 via telephone reported that the patient with no pertinent medical history or known drug allergies was vaccinated with the first dose of GARDASIL (Lot # 661846/1312X) on 13-JUN-2009. On 13-JUN-2009 the patient was very anxious and hadn''t eaten since the night before. There were no concomitant medications and no other vaccinations given that day. After having fainted for only a few seconds, the patient was monitored in the office for the next 45 minutes. The vital signs and blood sugars were normal, but the patient was nauseous, lethargic and pale. She was transported to the emergency room. It was unknown what tests - other than blood work - were performed. The event was considered disabling for about five hours. The patient had fully recovered. The reporter considered fainted, nauseous, lethargic and pale to be significant disability/disabling. No further information is available.


VAERS ID: 350858 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2008-09-04
Onset:0000-00-00
Submitted: 2009-07-06
Entered: 2009-07-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB264A / 2 UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0250X / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Cough, Eye oedema, Eye swelling, Inappropriate schedule of drug administration, Malaise, Nausea, Vaccine positive rechallenge, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0906USA05239

Write-up: Initial information has been received from a physician concerning a 14 year old female patient who received the second dose of GARDASIL and experienced "swelling and edema of the eye" and saw treatment at ER where she was given BENADRYL. The physician stated that she had the same experience after the first dose. The patient was due for her third dose in about a week and she was planning on receiving it. The swelling resolved after about a week, the patient had recovered. Follow up information has been received from a registered nurse concerning the 15 year old (initial reported as 14 year old) female patient who on 04-SEP-2008 was vaccinated with the first dose of GARDASIL (Lot # 0250X) and concomitantly received the second dose of HAVRIX (Lot # AHAVB264A). On 02-JAN-2009, the patient received the second dose of GARDASIL (lot# 0947X). On 24-Jun-2009, the patient was seen by the physician with complaints of a cough and wheezing. At the time of the physician''s visit the patient''s father stated that after the patient had received the first dose of GARDASIL, the patient was ill and nauseous and missed 1 week of school. The patient also had swelling and edema of both eyes. After the patient received the second dose of GARDASIL, the patient had swelling and edema of both eyes. The patient went to the Emergency Room and was treated with BENADRYL (route unknown to the reporter). The patient was not admitted to the hospital. The registered nurse stated that the patient was scheduled to receive the third dose of GARDASIL on 29-JUN-2009. The registered nurse requested to speak with a Merck physician prior to administering the third dose of GARDASIL to the patient. Follow up information has been received from a memo indicated that a Merck physician had spoken to the registered nurse. They have decided to not administer the third dose on 29-JUN-2009. Missing 1 week of school was considered to be disabling by the physician. Additional information has been requested.


VAERS ID: 351867 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2008-07-23
Onset:2008-07-25
   Days after vaccination:2
Submitted: 2009-07-17
   Days after onset:357
Entered: 2009-07-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Areflexia, Asthenia, Brain oedema, Confusional state, Demyelination, Disorientation, Dysstasia, Electroencephalogram, General physical health deterioration, Guillain-Barre syndrome, Hypokinesia, Lumbar puncture, Nuclear magnetic resonance imaging abnormal, Presyncope
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Optic nerve disorders (broad), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: spinal tap, no permanent damage
CDC Split Type: WAES0907USA02007

Write-up: Information has been received from a nurse practitioner. The nurse practitioner reported that "she was sent an email by one of her patient''s mothers who received it from another mother stated that a 15 year old female patient, who was not patient of the nurse practitioner, on 23-JUL-2008 was vaccinated with the first dose of GARDASIL and then two days later the patient almost passed out and was weak for hours. Through the rest of the summer and school year the patient complained that she could not run as fast and was weak. Then on October 17, 2008 the patient received her second dose of GARDASIL and on October 21st the patients mother received an urgent message from the school nurse to take her daughter immediately to her pediatrician. The patient was experiencing confusion, was disoriented, barely could stand, had no reflexes in her feet, and couldn''t remember anything that happened that day. The patient was then taken to her pediatrician''s office who advised her to see a neurologist. A week later when she saw the neurologist they did a EEG and a MRI because they thought she had a brain tumor, and the patients memory was slowly coming back. Then a second MRI was done which showed she had a demyelination that usually occurs either with GUILLAIN BARRE or with multiple sclerosis. Then later on the patient was diagnosed with GUILLAIN BARRE. The patient was given a spinal tap which showed no permanent damage, inflammation of her brain is going down, she has no debility". GUILLAIN BARRE was considered to be disabling by the nurse practitioner. Additional information has been requested.


VAERS ID: 359622 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2008-01-02
Onset:2009-03-29
   Days after vaccination:452
Submitted: 2009-10-05
   Days after onset:190
Entered: 2009-10-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1522U / 3 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain, Blood amylase increased, Blood test normal, Gallbladder operation, Laboratory test, Lipase increased, Pancreatitis acute
SMQs:, Acute pancreatitis (narrow), Retroperitoneal fibrosis (broad), Gallbladder related disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: PMH: none; Allergies: NKDA.
Allergies:
Diagnostic Lab Data: diagnostic laboratory 08/31/09, Blood tests were normal; serum amylase test, 03?/??/09, 3200; serum lipase test, 03?/??/09, 2000 01/07/10 and 01/08/10 MR and DC summary received for DOS 03/29/09-04/01/09. DX studies: no electrolyte abnormalities, amylase 860, lipase 206; Abd. U/S: normal.
CDC Split Type: WAES0909USA04548

Write-up: Information has been received from a Registered Nurse concerning her 16 year old daughter who on 29-JUN-2007 was vaccinated with a first dose of GARDASIL (lot # not reported). On 29-AUG-2007 she received second dose of GARDASIL (lot # not reported). On 02-JAN-2008 she received third dose of GARDASIL (lot # not reported). On 29-APR-2009 the patient experienced acute pancreatitis and was hospitalized. On an unspecified date the patient recovered from acute pancreatitis. Laboratory test revealed: Amylase level: 3200 and lipase level 2000. Follow up information has been received on 30-SEP-2009 via telephone call from Medical Assistant (the patient''s mother) (previously reported as Registered Nurse). The Medical Assistant stated that her daughter received first dose of GARDASIL (lot # 657736/0389U) on 29-JUN-2007. On 29-AUG-2007 she received second dose of GARDASIL (lot # 657736/0389U). On 02 - JAN-2008 (previously reported as 02-JAN-2007) she received third dose of GARDASIL (lot # 659055/1522U). The patient did not receive any concomitant vaccinations when GARDASIL vaccinations were administered. The Medical Assistant stated that the patient experienced abdominal pain on 29-MAR-2009. The patient was taken to the hospital but was not admitted. Later that day, the patient was taken to other hospital. The patient was admitted with complaint of abdominal pain on 29-MAR-2009 (previously reported as 29-APR-2009) and was diagnosed with acute pancreatitis. The patient was discharged on 01-APR-2009. The patient had recovered. The name of the Primary Care physician was provided. The patient complained of abdominal pain, (date not reported). In May 2009 the patient had her gall bladder removed (hospitalization dates unknown to reporter). On an unspecified date the patient recovered. On 31-AUG-2009, the patient complained of abdominal pain and was taken to the hospital. The patient''s blood tests (test unspecified) were normal. The patient was not admitted to the hospital. The Medical Assistant stated that the patient had experienced abdominal pain "now and then". The mother (medical assistant) felt that acute pancreatitis was immediately life-threatening and was disabling. "A lot check has been initiated." Additional information has been requested. A standard lot check investigation has been finalized. All in-process quality checks for the lots number 653055/15220 and 657736/0389U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information received from the physician indicated that patient was vaccinated with her first and second doses into her left arm at 15:00 on 29-JUN-2007 and 29-AUG-2007, respectively. She received her third dose in her right arm at 15:00 on 02-JAN-2008. It was reported that the 29-MAR-2009 hospitalization lasted 4 days. On 04-MAY-2008 the patient had recurrent pancreatitis and was treated at the hospital again. The physician stated there was no evidence of any relation to HPV rL1 6 12 16 18 VLP vaccine (yeast) given 2 years later. The patient recovered on SEP-2009. The physician felt that acute pancreatitis and recurrent pancreatitis were immediately life-threatening and they required medical/surgical intervention. No further information is available. 01/07/10 and 01/08/10 MR and DC summary received for DOS 03/29/09-04/01/09. DX: Acute pancreatitis. Pt NPO, clear diet. Tx: IVF, Dilaudid, Zofran, Hydrocodone. Pancreas enzyme levels high on admission, but improved on discharge. Pt started a normal diet. Pt improved and discharged home. Pt to follow up with GI specialist.


VAERS ID: 360163 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Illinois  
Vaccinated:2009-02-13
Onset:2009-03-03
   Days after vaccination:18
Submitted: 2009-10-08
   Days after onset:218
Entered: 2009-10-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0650X / 3 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Antinuclear antibody negative, Blood thyroid stimulating hormone normal, C-reactive protein increased, Parvovirus B19 serology negative, Red blood cell sedimentation rate increased, Rheumatoid arthritis, Rheumatoid factor increased, Rheumatoid factor positive
SMQs:, Arthritis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID
Current Illness: Hypothyroidism; Eczema; Acne
Preexisting Conditions: Adverse drug reaction. 10/19/09 Primary Care Records and Rheumatology consult received for dates of service 2/14/00-9/18/09. PMH: Eczema, hypothyroidism, acne, tonsillectomy, fracture of R radius, NKDA.
Allergies:
Diagnostic Lab Data: serum rheumatoid factor, 08/18/09, 347 IU/m, erythrocyte, 08/18/09, 41 mm/h; erythrocyte, 06/09/09, 17 mm/h; serum ANA, 06/09/09, negative; serum rheumatoid factor, 06/09/09. 38 IU/M; serum C-reactive, 06/09/09, 1.06 mg/d; serum cyclic citrulline, 06/09/09, 20 unit; erythrocyte, 05/02/09, 11 mm/h; serum rheumatoid factor, 05/02/09, 21 IU/m; serum C-reactive, 05/02/09, 0.26 mg/d; serum B19 virus IgM, 05/02/2009, <0.9; serum TSH, 05/02/09, 3.36 mIU/. 10/19/09 Primary Care Records and Rheumatology consult received for dates of service 2/14/00-9/18/09. Labs and diagnostics: Rheumatoid Factor 347 (H), Sed. rate 41 (H), C-Reactive protein-1.06 (H). BUN 22 (H), Glucose 100 (H), WBC 16.7 (H), Hgb 11.0 (L), Neutorphil 76.2% (H), Lymphocyte 17.5% (L), Neutrophil absolute 12.7 (H), Monocyte absolute 1.0 (H), Peptide (CCP) AB (IGG) 20 (H). Venous blood flow UNI- no evidence of DVT. X-ray Right hand-Negative.
CDC Split Type: WAES0909USA01491

Write-up: Information has been received from a medical assistant concerning a 16 year old female with hypothyroidism, eczema and acne who on 06-JUN-2008 was vaccinated with the first dose of GARDASIL (0.5ml, IM). The patient received the second dose of GARDASIL (0.5ml, IM) on unspecified date. On 13-FEB-2009 the patient received the third dose of GARDASIL (0.5ml, IM). The patient was diagnosed with viral or early rheumatoid arthritis by a rheumatologist. Her symptoms began 1 month after the third vaccination. The rheumatologist evaluated the patient in May 2009 where he said it was either viral arthritis or early rheumatoid arthritis. The rheumatologist said the patient was not in acute distress but joints were sensitive. The rheumatologist said he was leaning to early rheumatoid arthritis because of the duration of symptoms. At the reporting time the patient had not recovered. Follow-up information has been received from a clinical manager: The patient had previous drug reaction (vomiting) to codeine and CEFTIN. The patient was vaccinated with GARDASIL series as following: the first dose on 06-JUN-2008, lot# 658558/1061U; the second dose on 28-JUL-2008, lot# 658558/1061U; the third dose on 13-FEB-2009, lot# 661764/0650X; no other vaccines given on these dates. Concomitant therapy included SYNTHROID. The consult report from a rheumatologist from May 2009 showed "early rheumatoid arthritis". The report from the rheumatologist from 25-AUG-2009 showed that the patient was started on ENBREL, 50 mg weekly and methotrexate, 12.5 mg weekly for rheumatoid arthritis (RA). Follow-up information was received from the medical assistant via medical records indicating that the patient was a student and was vaccinated with three doses of GARDASIL IM in the left arm. The patient''s symptoms occurred on 03-MAR-2009. On 02-MAY-2009 parvovirus B-19 antibody (IGM) was negative (<0.9), rheumatoid factor was 21 IU/ml, C-reactive protein was 0.26 mg/dl, thyroid-stimulating hormone (TSH) was 3.36 mIU/L and sed rate was 11 mm/h. She was diagnosed with rheumatoid arthritis at the end of May 2009. On 09-JUN-2009 rheumatoid factor was 38 IU/ml, C-reactive protein was 1.06 mg/dl, cyclic citrullinated peptide IgG antibody was 20 unites, sed rate was 17 mm/h and antinuclear antibodies was negative. On 18-AUG-2009 rheumatoid factor was 347 IU/ml and sed rate was 41 mm/h. At the time of reporting, the patient had not recovered from rheumatoid arthritis. The reporter considered rheumatoid arthritis to be disabling. Additional information is not expected. All available medical records will be provided upon request. 10/19/09 Primary Care Records and Rheumatology consult received for dates of service 2/14/00-9/18/09 Dx: Rheumatoid Arthritis Assessment: Per rheumatologist: Pt. c/o pain in feet and hands and wrists since 8/08. Her fingers have started to swell and she has significant morning stiffness. For several weeks she has been stiff when she wakes up and it is difficult to get out of bed, with the stiffness lasting several hours. There is no family history of arthritis. On exam she has multiple tender small joints in her hands. Her MCP and PIP joints are swollen. There is tenderness in the wrists. She is tender over the metatarsal area of the feet and the area has trace swelling. There is a possibility of another autoimmune disease such as lupus or other inflammatory arthritis. Medrol Dosepak prescribed with plan to switch to Naprosyn BID. Also started on Methotrexate weekly, sulfasalazine and folic acid. Later switched to Enbrel weekly.


VAERS ID: 369060 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Illinois  
Vaccinated:2009-09-18
Onset:2009-11-07
   Days after vaccination:50
Submitted: 2009-11-19
   Days after onset:12
Entered: 2009-11-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 9116111 / 3 UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0671Y / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram normal, Convulsion, Drug screen negative, Full blood count normal, Laboratory test normal, Metabolic function test normal, Nuclear magnetic resonance imaging, Pregnancy test urine negative
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: Learning disability; Cognitive impairment
Preexisting Conditions: FMH: Patient has first cousin with epilepsy./rem 12//8/09 Inpatient hospital records received. Service dates 11/7/09 to 11/9/09. Sickle Cell Trait (+). "Shakes a lot". Head trauma in 2002 and 2003. Learning difficulty. Behavioral problems. Stutters.
Allergies:
Diagnostic Lab Data: Magnetic resonance, results pending; computed axial, normal; diagnostic laboratory, normal 11/23/2009: LABS and DIAGNOSTICS: Cat scan WNL, BMP WNL, CBC WNL, urine pregnancy test negative and urine drug screen negative. 12//8/09 Inpatient hospital records received. Service dates 11/7/09 to 11/9/09. LABS and DIAGNOSTICS: CBC - MPV 11.5 FL (H) MONO ABS 0.5 CT/MM3 (L), MICRO 2+, ANISO 1+, TARG 1+, HYPO 1+, G.PLT Present. CHEM - ALT 9 IU/L (L) Prolactin 30 NG/ML (H). CT Brain - WNL.
CDC Split Type: WAES0911USA02419

Write-up: Information has been received from a physician concerning a 15 year old female patient with no drug reactions/allergies and a history of learning disability and cognitive impairment who on 23-JAN-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot # 660557/0072X). There was no concomitant medication. On 20-MAR-2009 the patient received the second dose of GARDASIL (lot # 660557/0072X) and on 18-SEP-2009 the patient received the third dose of GARDASIL (lot # 663452/0671Y). On 07-NOV-2009 the patient developed a seizure and was hospitalized for 2 to 3 days. The physician saw the patient on 13-NOV-2009 "today" and the patient''s mother said the patient was "fine". The patient was on an unspecified antiseizure medication. A neurology consult was pending. MRI results were pending, cat scan and blood tests were normal. Seizure was considered to be immediately life-threatening and disabling. Additional information has been requested. 11/23/2009 Out-patient progress notes and laboratory test reports received for DOS 09/18/2009-11/13/2009. Assessment: Seizure Disorder Patient had generalized seizure (2 episodes). Hospitalized 11/07/2009 through 11/09/2009. Progress note of 11/13/2009 notes patient alert and oriented X3 and neuro intact. 12//8/09 Inpatient hospital records received. Service dates 11/7/09 to 11/9/09. Assessment: Generalized Tonic/Clonic Seizure. Mother heard strange noise, found patient stiff, head turned to left. Tonic/Clonic movements of limbs followed by postictal state. Urinary incontinence. Presents unresponsive. Seizure in ER. Cold sensation. Headache. Hand grasp weak. Slow to answer questions.


VAERS ID: 374963 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2007-05-14
Onset:2009-07-10
   Days after vaccination:788
Submitted: 2009-12-24
   Days after onset:167
Entered: 2009-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1447F / 2 RA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Arthralgia, Musculoskeletal pain, Rheumatoid arthritis, Rheumatoid factor positive
SMQs:, Rhabdomyolysis/myopathy (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: RA factor found in blood tests, positive for Rheumatoid Arthritis
CDC Split Type:

Write-up: Pain in shoulders mostly and other joints, knees, feet, elbows, jaw.


VAERS ID: 375693 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Texas  
Vaccinated:2008-01-08
Onset:2008-03-01
   Days after vaccination:53
Submitted: 2010-01-03
   Days after onset:673
Entered: 2010-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1062U / 1 AR / IM

Administered by: Private       Purchased by: Private
Symptoms: Abdomen scan, Abdominal pain upper, Acne, Anxiety, Blood test, Computerised tomogram, Depression, Dyspepsia, Fatigue, Feeling abnormal, Influenza like illness, Malaise, Myalgia, Stool analysis, Ulcer, Urine analysis, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Dementia (broad), Gastrointestinal ulceration (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Muscle Aches
Preexisting Conditions: Allergies-Sulfur Drugs
Allergies:
Diagnostic Lab Data: All kinds of blood labs, x-rays, stomach scans, ct scan, urine/stool analysis
CDC Split Type:

Write-up: Between 1st & 2nd shot of Gardasil patient developed severe stomach pain, cramping, and burning that lasted weeks. Muscle aches and overall feeling of not being well. In August 2009 patient had flu like symptoms, anxiety, depression, fatigue, ulcers, acne, overall feeling of illness or impending death.


VAERS ID: 376004 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2009-06-22
Onset:2009-06-25
   Days after vaccination:3
Submitted: 2010-01-05
   Days after onset:194
Entered: 2010-01-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702X / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Anxiety, Aura, Blood potassium decreased, Dizziness, Dyskinesia, Dyspnoea, Erythema, Facial palsy, Fatigue, Feeling abnormal, Feeling hot, Flushing, Heart rate increased, Hypoaesthesia, Hypokalaemia, Joint contracture, Loss of consciousness, Memory impairment, Muscle spasms, Musculoskeletal stiffness, Myalgia, Palpitations, Panic attack, Paraesthesia, Postictal state, Respiratory rate increased, Sinus bradycardia, Somnolence, Speech disorder, Staring, Tachypnoea, Tremor, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol; ALLEGRA; ALEVE; vitamins (unspecified)
Current Illness: Penicillin allergy; asthma; smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 09/06/09, 142/105, initial; blood pressure, 09/06/09, 124/84, discharged; electrocardiogram, 09/06/09, see narrative; physical examination, 09/06/09, normal; blood pressure, 09/08/09, 116/70; diagnostic laboratory, 09/08/09, cardiology: palpitations and increased heart rate; blood pressure, 10/22/09, 126/64; blood pressure, 11/18/09, 118/80; physical examination, 11/18/09, eyes: ERRLA; blood pressure. 11/20/09, 122/79; physical examination, 11/20/09, normal; physical examination, 11/18/09, Psych: mood appropriate; physical examination, 11/18/09, alert, oriented and fatigue; physical examination, 10/22/09, normal; physical examination, 09/08/09, normal; neurological, 09/08/09, confusion and numbness; neurological, 09/06/09, dizziness, numbness and difficulty with speech; body temp, 09/06/09, 99.4, initial; body temp, 09/08/09, 99.1; arterial blood O2, 09/08/09, 98; serum potassium, 09/06/09, 3.3; respiratory rate, 11/20/09, 16; total heartbeat count, 11/20/09, 70; body temp, 11/20/09, 99; arterial blood O2, 11/18/09, 95; total heartbeat count, 11/18/09, 68; body temp, 11/18/09, 98.0; total heartbeat count, 10/22/09, 80; body temp, 10/22/09, 92.3; total heartbeat count, 09/08/09, 59; total heartbeat count, 09/06/09, 115, initial; pulse rate, 09/06/09, 62, discharged; arterial blood O2, 09/06/09, 100, discharged; respiratory rate, 09/06/09, 16, discharged; arterial blood O2, 09/06/09, 100, initial; respiratory rate, 09/06/09, 28, initial
CDC Split Type: WAES0909USA04914

Write-up: Information has been received from a physician concerning a 15 year old female patient, who on 22-JUN-2009 was vaccinated with the first 0.5 ml dose of GARDASIL, intramuscularly. Concomitant therapy included ALEVE and ALLEGRA. On 25-JUN-2009 the patient had a 5 minute period where she was unresponsive, her fingers were stiff and she was generally dazed. On 18-AUG-2009 the patient was given a second 0.5 ml dose of GARDASIL, intramuscularly. On 20-AUG-2009 she had a similar episode that lasted 15-20 minutes. On 06-SEP-2009, the patient had another episode that lasted 30-40 minutes. She was brought to an ER. The hospital staff told her that they thought that is was a panic attack and told her to take potassium supplements. The mother decided to not complete the series. At the time of reporting the patient had recovered. Follow up information has been received from a physician via medical records concerning the patient with penicillin allergy and smoker who on 22-JUN-2009 was vaccinated with the first dose of GARDASIL (Lot number 0702X) IM in the left deltoid and on 18-AUG-2009 with the second dose of GARDASIL (Lot number 0162Y) IM in the right deltoid. Concomitant therapies included albuterol and multivitamin. On 06-SEP-2009, the patient presented to the emergency room with chief complaint of possible anxiety, trouble breathing. The patient was sitting in church and began having trouble breathing. Patient began increased breathing. The patient began tingling of face and contracture of hands. The patient had trouble talking. The episode resolved after breathing slowed. At the ER, the patient felt hot. The patient had similar episode recently at school, 2 weeks ago stated by the mother and lasted 10 minutes. The patient''s initial temperature was 99.4, pulse 115, respiration 28, blood pressure 142/105 and SaO2 100 and the discharge pulse rate was 62, respiration 16, blood pressure 124/84 and SaO2 was 100. Electrocardiogram was performed and showed sinus bradycardia with a heart rate of 58 bmp. The neurological/physiological evaluation showed dizziness, numbness and difficulty with speech. The physical exam was normal. Blood work revealed the patient''s potassium level was 3.3 and she received 20mEq of KCL. At 20:48, the patient was discharged stable, and was ambulatory. The admitting diagnosis was short of air and the clinical impression was palpitations, anxiety and hypokalaemia. On 08-SEP-2009, the patient''s blood pressure was 116/70, temperature 99.1, pulse 59, RR 16 and SO2 98. The patient had facial paralysis and was seen in her physician''s office. Regarding the patient''s history present illness, she had a first episode at 05:00 of being glassy-eyed with hand cramp and increased breathing; the second episode was at 10:00, with the same symptoms (occurred at school); and with the third episode she went to the emergency room very glassy-eyed, she could not follow directions, and her hand and mouth were cramped. She did not remember all of event and she was sleepy when she came out of it. Review of systems showed: neurological as confusion and numbness, respiratory as tachypnic with no SOA, cardiological as palpitations and increased heart rate. The patient''s past medical history and family history was unchanged. The physician''s clinical impression was questionable seizure activity, "doesn''t sound anxiety-related, especially with a history of head trauma". Physical exam (general, head, eyes, cardiac and physiological) was performed and normal. Patient had neuro exam and if negative, will have cardiac evaluation. On 22-OCT-2009, the patient''s blood pressure was 126/64, temperature 92.3 and pulse 80. The patient did not have further episodes and doing fine. The patient''s past medical history, social history and family history unchanged and the impression was questionable seizure-like activity post GARDASIL. The patient had physical exam, general and psychological were performed and normal. Physician instructed patient not to receive third dose of GARDASIL. On 18-NOV-2009, the patient''s blood pressure was 118/80, temperature 98.0, pulse 68, RR 16 and SO2 95. At 11:55, the patient had an episode, the patient felt hot, appeared red in color with shaking and facial paralysis. The patient''s history of present illness: she remained upright, she did not collapse. Her last meal was at 07:00 am and she had a soft drink at 10:15. The patient had finger constructions, muscles still sore and had no new anxieties. At 12:08, the patient''s face flushed and did not space out. Regarding the past medical history, the social history and family history unchanged. The physical exam showed: GEN, alert and oriented and fatigue; eyes: pupil, ERRLA and psych: mood appropriate. Physician''s impression was "recurrent episode". Physician wanted an EEG and her labs checked. On 20-NOV-2009 the patient presented to the ER at 15:10. The history of present illness was described as chief complaint of seizure, single episode, witnessed by her classmates. The patient was sitting in class, had an aura then a questionable seizure. The patient had generalized motor activity and then fatigue as postictal symptom and did not have injury. The patient''s last menstrual period was on 01-NOV-2009. The patient had previous seizures as past medical history. The patient was treated with KEPPRA 500mg, oral, daily started 2 days ago. In the patient''s physical exam, general appearance, EENT, neck/back, respiratory, CVS, abdomen, skin, extremities and neuro/psychological were normal. The clinical impression was seizure-like activity with stable condition and disposition at home. Regarding the emergency department documentation, the patient arrived at 14:40, ESI level 3, arrived by ambulance and the chief complaint was new seizure. The patient''s temperature was 99.5, pulse 70, respiration 16, blood pressure 122/79 and weight 130 lbs. The assessment for airway, breathing, breath sounds, circulation, skin and disability were normal. The patient received a 20 gauge IV in the ambulance and her accucheck was 100 prior to arrival to the ER. The patient did not have chronic illness. The notes stated that at 14:45, the patient had seizure at school, had one last Wednesday, had seizure in September and the patient saw the physician on Wednesday. At 14:50, ambulatory to bathroom and was steady on feet. At 15:20, was instructed by the physician about medications. At 14:45, the patient''s eyes open evaluation was 4 in Glasgow coma scale, best verbal response was 5 and best motor response was 6. At 15:20, eyes open was 4, best verbal response was 5 and best motor response was 6. The patient was discharged to home in stable condition with the ER''s Clinical Impression of Seizure-like activity. Seizure activity was considered to be disability by the reporter. Additional information has been requested.


VAERS ID: 379853 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-02-28
Onset:2007-10-01
   Days after vaccination:215
Submitted: 2010-02-05
   Days after onset:858
Entered: 2010-02-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1213F / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0012U / 2 UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2562AA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Benign intracranial hypertension, Bronchitis, CSF pressure increased, Decreased activity, Headache, Lumbar puncture, Muscle twitching, Nausea, Paraesthesia, Rash, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Bronchitis
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown ``02/15/10 LABS and DIAGNOSTICS: Ct-normal, MRI-abnormal (abnormal clivus), LP-abnormal (elevated opening pressure), CSF cult-neg., Bone scan-normal (no abnormality or bony lesion of the clivus), Three-view cervical spine x-ray-normal (no evidence of instability), Venography MR of brain- neg (congenitally small L. transverse & sigmoid sinuses[normal variant], No evidence of thrombosis or occlusion of sinuses of brain), Thyroid antibody thyroid function test-normal, Iron studies-normal, Vit A- WNL, ANA-neg., .
CDC Split Type: WAES1001USA03372

Write-up: Information has been received from a health professional concerning her daughter an 18 year old female who in October 2007, was vaccinated with the first dose of GARDASIL (lot number not reported). There were no pertinent medical history and drug reactions/allergies. Concomitant therapy included RECOMBIVAX HB (unspecified). The healthcare worker reported that her daughter developed "stabbing head pain associated with a twitch" in approximately October 2007 about 2 weeks after she received her first dose of GARDASIL. The patient had been diagnosed with pseudotumor cerebri which limited her physical activity and she was hospitalized. The patient''s pseudotumor cerebri persisted. The patient underwent lumbar puncture to relieve fluid pressure. Multiple unspecified blood tests and diagnostic studies were performed with results not report. Pseudotumor cerebri was considered to be disabling, immediately life-threatening and an other important medical event by the healthcare worker. Follow up information was received from a healthcare professional who reported the patient was vaccinated with the first dose of GARDASIL on 28-FEB-2007, the second dose of GARDASIL on 15-OCT-2007, and the third dose of GARDASIL on 01-JUL-2008 (lot numbers not reported). Concomitant vaccine included MENACTRA received on 28-FEB-2007 and VAQTA (unspecified) received on 28-FEB-2007 and 15-OCT-2007 (lot number not reported). At the 28-FEB-2007 office visit, the patient had bronchitis. At the 15-OCT-2007 office visit, there was no mention of any adverse event. On 23-OCT-2007, the patient was seen for hives and ZYRTEC was given. On 30-OCT-2007, the patient complained of pins and needles all over, rash was gone. On 28-NOV-2007, the patient complained of blurred vision, and a neuro consult was directed. In November and December 2007, the patient was admitted to the hospital (no other details available). In November 2008, the patient was admitted for nausea, vomiting and headache (no other details). On 05-JUN-2009, the patient was last seen in their office. Additional information has been requested.


VAERS ID: 381241 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2009-01-09
Onset:2009-02-15
   Days after vaccination:37
Submitted: 2010-02-24
   Days after onset:374
Entered: 2010-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 6050X / 1 LA / UN

Administered by: Public       Purchased by: Other
Symptoms: Arthralgia, Rheumatoid arthritis
SMQs:, Arthritis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Started having joint pains that have steady and progressively gotten worse. She is now currently being seen by a Rheumatologist at Hospital and being treated for Rheumatoid arthritis symptoms, although she is not actually diagnosed with the disease as yet.


VAERS ID: 390807 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2009-07-30
Onset:2009-07-30
   Days after vaccination:0
Submitted: 2010-06-14
   Days after onset:319
Entered: 2010-06-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0558X / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activities of daily living impaired, Blindness transient, Blood test, Computerised tomogram, Convulsion, Dizziness, Electrocardiogram, Electroencephalogram, Fatigue, Headache, Hypoaesthesia, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Ovarian cyst, Paraesthesia, Paralysis, Postural orthostatic tachycardia syndrome, Syncope, Urine analysis
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: None
Allergies:
Diagnostic Lab Data: EKG; video EEG; CAT scan; urinalysis; MRI; MRA; multiple blood work-ups
CDC Split Type:

Write-up: My formerly healthy 15 yr. old daughter received her one and only dose of the GARDASIL vaccine on July 30, 2009. Since then, she has been plagued with headaches, fatigue, dizziness, numbness and tingling of the legs and feet, non-epileptic seizures, temporary paralysis/blindness, fainting, ovarian cysts, etc. She was hospitalised once and has been to the ER 5 times. She missed nearly the entire school year due to her adverse reaction to the vaccination. She has been evaluation by a psychologist and a psychiatrist both of whom state she is psychologically healthy and well-adjusted. She was recently diagnosed with POTS by a cardiologist. She is on numerous medications and cannot be left alone. I have since learned that there are thousands of other girls experiencing the same thing. If it''s not the vaccine, what is it? Please take this vaccine off the market for further study before more innocent lives are compromised.


VAERS ID: 396220 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2009-03-23
Onset:2010-08-08
   Days after vaccination:503
Submitted: 2010-08-20
   Days after onset:12
Entered: 2010-08-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0651X / 1 UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Anxiety, Aphasia, Arrhythmia, Asthenia, Cerebrovascular accident, Chest pain, Chorea, Convulsion, Electrocardiogram abnormal, Fatigue, Headache, Immunoglobulin therapy, Lethargy, Lupus-like syndrome, Memory impairment, Myalgia, Nausea, Nervous system disorder, Pyrexia, Renal disorder, Syncope, Systemic lupus erythematosus, Tremor, Vasculitis cerebral
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Vasculitis (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Electrocardiogram, 06/??/10, arrhythmias
CDC Split Type: WAES1008USA01851

Write-up: Information has been received from a physician concerning her 15 year old daughter with no pertinent medical history or drug allergies who in September 2009, was vaccinated with a first dose of GARDASIL (lot # not reported). No concomitant medications were reported. It was reported that in September 2009, very soon after the injection of GARDASIL, the patient developed fatigue and nausea. When the patient was on leaving the physician''s office she experienced syncope. The patient began having symptoms of high fever, headache and sore muscles. The patient was lethargic for months after she received GARDASIL. In June 2010 the patient had chest pain and went to the Emergency Room where she was diagnosed with anxiety. The EKG showed arrhythmias. The patient became weak and had to quit the Track Team at school. In June 2010 the patient was tired and lethargic and began to forget things. Approximately three weeks ago, in approximately August 2010, the patient developed a tremor in her left hand and she was unable to speak. The patient developed chronic seizures with chorea. On 08-AUG-2010 the patient was admitted to hospital. On 15-AUG-2010 the patient developed a stroke and was non verbal. The patient was diagnosed with drug induced systemic lupus erythematous with chorea. It was reported that there was central nervous system (CNS) involvement and the patient had vasculitis of the brain. The physician did not report what type of diagnostic testing the patient had received. The patient was being treated with ten different medications reported as follows: intravenous immune globulin (IVIG), antibiotics, anti hypertensive medications due to kidney involvement and high doses of IV prednisone. The physician stated that today, on 17-AUG-2010, the patient was to begin chemotherapy with IV cytotoxin for a duration of 24 hours. Currently, the patient had her voice back and was able to move all of her extremities except the left arm. As of 16-AUG-2010 the patient had not recovered from drug induced systemic lupus erythematosus with chorea, anxiety and arrhythmias. The patient was presently in hospital. The reporter felt that drug induced systemic lupus erythematosus with chorea was related to therapy with GARDASIL. Drug induced systemic lupus erythematosus with chorea, anxiety and arrhythmias were considered to be disabling, another important medical event and immediately life-threatening. Additional information has been requested.


VAERS ID: 398110 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2009-07-15
Onset:2009-07-15
   Days after vaccination:0
Submitted: 2010-08-04
   Days after onset:385
Entered: 2010-09-08
   Days after submission:35
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activities of daily living impaired, Condition aggravated, Eczema, Fatigue
SMQs:, Dementia (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Eczema
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0907USA02568

Write-up: Information has been received from a pharmacist concerning a 15 year old female with eczema who on 15-JUL-2009 was vaccinated with the first dose of GARDASIL. On 15-JUL-2009 the patient experienced extreme fatigue and an exacerbation of pre existing eczema after her first dose. The patient sought medical attention. Severe fatigue was considered to cause a disability because the patient could not get out of bed. At the report time the patient had not recovered. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.


VAERS ID: 405873 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Missouri  
Vaccinated:2007-06-22
Onset:2008-07-23
   Days after vaccination:397
Submitted: 2010-10-28
   Days after onset:827
Entered: 2010-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0319U / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2296AA / 1 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Rash pruritic, Type 1 diabetes mellitus
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: 2 Hospitals diagnosed with Diabetes Type 1.
CDC Split Type:

Write-up: Had strange itchy rash months before diagnosis, doctors recommended taking Claritan, did not diagnose. Also had DM Type 1 symptoms months before diagnosis.


VAERS ID: 415253 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-01-21
Entered: 2011-01-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1101USA01378

Write-up: Information has been received from a physician concerning a 15 year old female patient he heard about (it was unknown if this was a patient of a clinical colleague or an acquaintance of him), that "was healthy as a horse" who on an unspecified date was vaccinated with GARDASIL (it is unknown which dose this was in the series). The physician reported that "within two weeks of administration of the vaccine she is in the hospital with seizures and is a picture of death". At the time of the report, the patient had not recovered. The patient''s symptoms were considered to be disabling and immediately life-threatening by the physician. No further information is available.


VAERS ID: 425246 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Florida  
Vaccinated:2011-05-26
Onset:2011-05-26
   Days after vaccination:0
Submitted: 2011-06-10
   Days after onset:15
Entered: 2011-06-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0180AA / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Dyspnoea, Feeling abnormal, Headache
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES1106USA00881

Write-up: Information has been received from a certified medical assistant concerning a 15 year old female patient with no pertinent medical history and no drug reactions or allergies who on 26-MAY-2011 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL in her right arm (lot # 667878/0180AA, expiration: 08-MAR-2013). There was no concomitant medication or vaccines administered on 26-May-2011. The certified medical assistant reported that on 26-MAY-2011 ("the same day") the patient began to experience shortness of breath, which the patient described as "she walked a few steps and she could not catch her breath". The patient was a dancer who normally danced 4 times per week, she had been unable to dance or perform daily activities due to the shortness of breath. The dyspnea was not improving and shortness of breath was reported as "severe". The certified medical assistant also reported a constant headache, and just an overall feeling of being "off". No treatment was given for the adverse events and no lab diagnostics studies were performed. At the time of reporting, the patient had not recovered. The patient was referred to her primary physician for follow-up. The reporter considered the events to be disabling as the patient was having difficulties with her activities and routines. Additional information has been requested.


VAERS ID: 425342 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2008-03-17
Onset:2008-03-18
   Days after vaccination:1
Submitted: 2011-06-13
   Days after onset:1182
Entered: 2011-06-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1446N / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Paralysis, Sensory loss
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1106USA00358

Write-up: Information has been received from a nurse, concerning her daughter, a 17 year old female (relevant medical history unspecified), who in 2010 ("last year") was vaccinated with the second dose of GARDASIL (lot #, route and injection site not reported). There were no other vaccinations or concomitant medications at the same visit. In 2010, the day after the vaccination, the patient became paralyzed from the waist down and lost feeling in her legs. She was taken to the Emergency Room (hospital unknown). She was not admitted and 3-5 days later she recovered. Vaccination with GARDASIL was discontinued after the second dose. Paralyzed from the waist down and lost feeling in legs was considered to be significant disability or incapacity by the reporter. Additional information has been requested.


VAERS ID: 437141 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Florida  
Vaccinated:2011-08-25
Onset:2011-09-01
   Days after vaccination:7
Submitted: 2011-10-06
   Days after onset:35
Entered: 2011-10-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0841AA / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Asthenia, Blood test normal, Chest pain, Computerised tomogram normal, Convulsion, Dyskinesia, Dyspnoea, Dysstasia, Grip strength decreased, Head titubation, Laboratory test normal, Nuclear magnetic resonance imaging normal, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Hypersensitivity; Heavy periods
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: diagnostic laboratory, 09/??/11, blood work normal; computed axial, 09/26/11, negative; magnetic resonance, 09/26/11, negative
CDC Split Type: WAES1109USA03241

Write-up: Information has been received from a consumer (patient''s mother) and the physician concerning a 15 year old female patient with allergy to BENADRYL, with heavy menses and no medical history who on 25-AUG-2011 (not 16 or 17 days prior to 28-SEP-2011 as reported by consumer), was vaccinated with the first dose of GARDASIL (lot number: 668262/0841AA, route not reported). There was no concomitant medication. Consumer reported that one week after her daughter was vaccinated, she experienced shortness of breath and 14 days after vaccination, she also started to experience "seizures" every 45 minutes. Consumer described the seizures as, "she jumps up and down and her chest hurts". Consumer reported that the seizures lasted for 30 seconds. Consumer also reported that while her daughter was sleeping, she experienced tremors in the legs, arms and head, and that in addition to the seizures, her daughter also felt weak, and she could "barely stand up or hold a pencil". Consumer and the physician reported that the patient went to two different emergency rooms before seeing the reporting physician, and, "the bloodwork is all normal". Physician reported that the patient did not receive any treatment for the adverse events. On 26-SEP-2011, the patient was seen by the reporting physician for the events and it was reported that the physician saw no seizure activity but could confirm tremors and weakness. A computed axial tomography (CT) and magnetic resonance imaging (MRI) were negative. The patient was referred to a pediatric neurologist. Consumer reported that her daughter had an appointment today to see a pediatric neurologist. The reporting physician could not address the life threatening criterion, but did not feel the events were disabling. No inpatient hospital confinement. The physician reported that, the patient had not recovered. Additional information has been requested.


VAERS ID: 443714 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-01-20
Onset:2011-03-01
   Days after vaccination:40
Submitted: 2011-11-28
   Days after onset:272
Entered: 2011-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0664Z / 1 UN / UN

Administered by: Unknown       Purchased by: Military
Symptoms: Amenorrhoea, Smear cervix, Ultrasound scan
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My daughter was given the Gardasil shot this year, she has stopped her period completely and has not recovered it. She had the last shot in October of 2011 and still no period so I got concerned and took her two different Dr.''s. My daughter has has two ultrasounds and a pap smear to see what is going on. I have her going to an actual OB/GYN and having her seen and see if there is a way to force her period other than medicines, we already have tried that. My daughter had healthy periods and was regular till she received the shot and I am upset and concerned because it wasn''t written as a side affect. I have did research online and my daughter is not the only one, there are a number of females that has experienced the same thing and are also concerned.


VAERS ID: 443777 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-11-17
Onset:2011-11-17
   Days after vaccination:0
Submitted: 2011-11-28
   Days after onset:11
Entered: 2011-11-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1317AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Blood test normal, Chest X-ray normal, Chest pain, Dizziness, Drug screen, Electrocardiogram normal, Fatigue, Hyperhidrosis, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Blood pressure, 11/18/11, 138/8; diagnostic laboratory, 11/18/11, Blood test: Normal; chest X-ray, 11/18/11, CxR Normal; electrocardiogram, 11/18/11, Normal; blood pressure, 120/8
CDC Split Type: WAES1111USA02846

Write-up: Information has been received from a physician concerning a 15 year old female patient with no pertinent medical history, drug reactions or allergies who on 19-JAN-2010, was vaccinated with a first dose of GARDASIL (lot number not reported), on 08-APR-2010 was vaccinated with a second dose of GARDASIL (lot number not reported) and on 17-NOV-2011 was vaccinated intramuscularly with a 0.5 ml third dose of GARDASIL (669795/1317AA, expiration date 13-OCT-2013). There was no concomitant medication. The physician reported that on 17-NOV-2011 the patient felt well after receiving the third dose until late in the evening 8 hours after vaccine administration the patient experienced syncope, dizziness, weakness, shakiness and chest pain. The patient was seen in the office the following day (on 18-NOV-2011) her blood pressure was 138/80 and was sweaty. The patient was sent to the emergency room where work up (blood tests, Chest X-Ray (CxR), Electrocardiogram (EKG)) were performed and all normal, urine drug screen was also performed (results not provided). The patient continued to feel tired dizzy and had a noticeable tremor of the right hand (BP 120/80). The physician inquired about recommendations regarding treatment for syncope, dizziness, weakness, shakiness and chest pain related to the third dose of GARDASIL given to the patient. At the time of the report the patient''s events persisted. No treatment was given for the events. A neurology consult was being request. Syncope, dizziness, shakiness, weakness and chest pain were considered to be disabling by the physician. Additional information has been requested.


VAERS ID: 449831 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-11-15
Onset:2011-12-30
   Days after vaccination:45
Submitted: 2012-02-13
   Days after onset:45
Entered: 2012-02-20
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0692AA / 1 RA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 454508 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Vermont  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-26
Entered: 2012-04-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Amnesia, Conversion disorder, Convulsion, Headache, Injury, Loss of consciousness, Musculoskeletal chest pain, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Magnetic resonance, Brain: Conversion
CDC Split Type: WAES1204USA02620

Write-up: Information has been received from a consumer concerning currently 15 year old female patient with no pertinent medical history and no drug reactions/allergies who on an unspecified date, was vaccinated with the second dose of GARDASIL (lot # and route not reported) 0.5 ml. There was no concomitant medication. Consumer reported that on an unspecified date, minutes after getting her second GARDASIL dose, the patient had a seizure and was taken to the emergency room (ER) of an unspecified hospital. They did a magnetic resonance imaging (MRI) of her brain and the diagnosis was a conversion, which was a misfiring of the electrons in her brain due to traumatic bodily injury. Since this happened, she had had headaches, passed out all the time. she had tingling in her hands and feet, blurry vision, pain in her rib area, and a loss of memory of the last three years. She went to an unspecified neurologist, who could not pin it to the vaccine. She had missed 55 days of school since the event started. The patient''s mother said that physician dismissed the idea that it was due to the vaccine, so she switched to an unspecified doctor in the same practice. The consumer had been to the emergency room (ER) multiple times. It was reported that the events occurred after reintroduction. It was also reported that these events were a significant disability. It was not know if the days of school the consumer missed were consecutive and if the patient was ever admitted to the hospital. At the time of the report, the patient''s outcome was unknown. Therapy with GARDASIL was discontinued after the events happened. Additional information has been requested.


VAERS ID: 458325 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: California  
Vaccinated:2011-12-01
Onset:2011-12-01
   Days after vaccination:0
Submitted: 2012-06-27
   Days after onset:208
Entered: 2012-06-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia, Vascular test normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Vascular evaluation, negative for thrombus
CDC Split Type: WAES1206USA03632

Write-up: Information has been received from a physician (neurologist) concerning a 15 year old female patient with no drug reactions or allergies and no pertinent medical history who in December 2011, was vaccinated with the first dose of GARDASIL, 0.5 mL, intramuscular in the left deltoid (lot number not reported). There was no concomitant medication. The physician was reporting the patient was referred to her by primary care physician for evaluation on 20-JUN-2012 of persistent left arm paresthesia and muscle weakness following the first dose of GARDASIL in December 2011. The left arm pain diminished after 1 week, but muscle weakness, especially involving the pronator and supinator muscles and paresthesia had persisted. Therapy with GARDASIL was discontinued. There was no treatment given for persistent left arm paresthesia, muscle weakness, especially involving the pronator and supinator muscles and the left arm pain. At the time of the report the patient''s outcome was recovering. Vascular studies were performed on an unknown date, with a result of negative for thrombus. The patient sought medical attention via office visit. Therapy with GARDASIL was not reintroduced. Persistent left arm paresthesia, muscle weakness, especially involving the pronator and supinator muscles and left arm pain were considered to be disabling by the reporter. Additional information has been requested.


VAERS ID: 503294 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Washington  
Vaccinated:2007-08-14
Onset:2007-08-14
   Days after vaccination:0
Submitted: 2013-09-15
   Days after onset:2224
Entered: 2013-09-20
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0384U / 1 AR / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2183AA / 1 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Abasia, Abdominal distension, Abdominal pain upper, Abnormal loss of weight, Activities of daily living impaired, Alopecia, Anxiety, Arthralgia, Autism, Back pain, Bladder disorder, Blindness, Blindness unilateral, Blister, Blood test, Bone pain, Chest pain, Chronic fatigue syndrome, Coccydynia, Computerised tomogram, Constipation, Convulsion, Deafness, Decreased appetite, Depression, Diarrhoea, Dizziness, Dysarthria, Dyslexia, Dyspnoea, Electroencephalogram, Erythema, Fatigue, Feeling abnormal, Feeling of body temperature change, Functional gastrointestinal disorder, Hallucination, Headache, Hemiplegia, Hepatomegaly, Hyperacusis, Influenza like illness, Injection site pain, Injection site pruritus, Laboratory test, Local swelling, Lumbar puncture, Migraine, Multiple chemical sensitivity, Muscle spasms, Muscle tightness, Muscle twitching, Myalgia, Nausea, Neoplasm, Neuralgia, Nuclear magnetic resonance imaging, Oedema, Oropharyngeal pain, Pallor, Panic attack, Paraesthesia, Parosmia, Personality change, Photophobia, Pneumonia, Pruritus, Pyrexia, Rash, Renal disorder, Sleep disorder, Swelling, Syncope, Temperature intolerance, Thrombosis, Tooth disorder, Tremor, Tumour excision, Urinary incontinence, Urinary tract infection, Uterine spasm, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological tumours of unspecified malignancy (narrow), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: EEG''s; Numerous testing. Blood work, MRI''s, CAT scans, lumbar punctures.
CDC Split Type:

Write-up: August 14, 2007 - lot # 0384U - afternoon shot injection site itchy, sore. Flu like symptoms. Sore joints and muscles in the months to follow. Exhaustion. Dr.''s office said the symptoms were normal. November 14, 2007 - lot # 0927U - afternoon shot. Injection site more itchy, sore, red, swelling. Flu like symptoms for days. Sore joints and muscles, headaches, hair loss, exhaustion. Dr. office was not worried about symptoms. February 14, 2008 - lot # 12APR10 - vomiting, shaking, feverish, itchy/sore injection site, redness, swelling entire arm. Sore joints, muscles, fatigue, hair loss (more) migraine, home from school 1 1/2 wks flu like symptoms. Many, many, many Dr. visits, hospitalization ER visits until October 2009 when she became paralyzed on right side, loss of vision, hearing loss. Stay for couple weeks, home recovery. Learned to walk again. Repeat of above January 2011. Week stay. Hospitalization for seizures (4 days). Medical diagnoses: Perfectly healthy until GARDASIL now suffers daily from: Leaky Gut Syndrome, pins/needles in extremities, dizziness, dental issues, brain fog, sensitivities to chemicals, chest pains, constipation/diarrhea, enlarged liver, sound sensitivity, anxiety, extreme pain tailbone, fainting, fevers and blisters, back pain, hot/cold intolerance, sleep problems, itching, joint pain, knee pain, light sensitivity, blindness (right side), depression, personality changes, panic attacks, loss of bladder control, bladder issues, muscle aches, spasms, muscle tension tumor in left tibia, paleness, chronic fatigue syndrome paralysis, pneumonia, severe nerve pain, shortness of breath, slurred speech, smell sensitivity, sore throat stomach pain, swelling/edema, tremors, random twitching of extremities, bloating, uterine spasms, blood clotting, numerous UTI''s, kidney problems, vision loss, stomach aches, nausea, rashes, appetite loss, vomiting, dyslexia, hallucinations, large weight loss, seizures, autistic behaviors. Tumor removed December 2010.


VAERS ID: 503396 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: California  
Vaccinated:2012-06-21
Onset:2012-06-26
   Days after vaccination:5
Submitted: 2013-09-21
   Days after onset:452
Entered: 2013-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1696AA / 1 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Cardiomyopathy, Echocardiogram abnormal, Electroencephalogram abnormal, Hemiparesis, Ischaemic stroke, Nuclear magnetic resonance imaging brain abnormal, Ventricular arrhythmia
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Insulin
Current Illness: No
Preexisting Conditions: Diabetes, toe walker
Allergies:
Diagnostic Lab Data: Echo Cardio gram showing LV noncompaction cardiomyopathy; MRI of brain showing stroke right ischemic stroke; EEG showing ventricular arrthymias; He was transferred to another hospital
CDC Split Type:

Write-up: I do not know the time of the incident. But he presented to ER with left sided weakness. He was found to have had a stroke and to have LV noncompaction cardiomyopathy.


VAERS ID: 517633 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-07-26
Onset:2013-08-01
   Days after vaccination:6
Submitted: 2013-12-24
   Days after onset:145
Entered: 2013-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020692 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Balance disorder, Dizziness, Dysstasia, Gait disturbance, Headache, Nausea, Palpitations
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YAZ
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1312USA009931

Write-up: This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient. Patient was not pregnant. The patient had no pertinent medical history. Drug reactions/allergies were none. On 26-JUL-2013 the patient was vaccinated with GARDASIL, intramuscular (dose, dosage, lot not reported). Concomitant therapies included YAZ. On an unknown date of August-2013 the patient experienced headache, nausea, heart palpitations, dizziness and trouble with balance after receiving the vaccine. The patient has had difficulty standing (disability) and trouble walking (disability) and because of this has been out of school for 2 months. The patient saw the physician and sought medical attention. It was also reported that the patient will not continue with the series. The outcomes of the reported events were unknown at the time of the report. The events difficulty standing and trouble walking were considered to be serious due to disability. Additional information has been requested.


VAERS ID: 519290 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2011-10-19
Onset:2011-10-23
   Days after vaccination:4
Submitted: 2014-01-14
   Days after onset:814
Entered: 2014-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0476AA / 2 LA / SYR

Administered by: Public       Purchased by: Other
Symptoms: Abdominal pain upper, Asthenia, Back pain, Biopsy, Blood test, Dizziness, Dyspepsia, Endoscopy gastrointestinal, Fatigue, Headache, Hyperacusis, Hypersomnia, Muscle spasms, Nausea, Pain in extremity, Photophobia, Protein urine present, Vomiting
SMQs:, Acute renal failure (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth Control Pills; Birth Control Patch-1 day; Birth Control Shot
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: 2 biopsies; GI scope; many blood tests; urine test-protein in urine
CDC Split Type:

Write-up: Nausea, vomiting, muscle spasms, excruciating headaches, fatigue, sleeping 20 hours per day, back and leg pain, sensitivity to light and sound, weakness, stomach cramps, lightheadedness, digestive issues.


VAERS ID: 526286 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-01-18
Onset:2013-06-01
   Days after vaccination:865
Submitted: 2014-03-20
   Days after onset:292
Entered: 2014-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0096Z / 2 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Lupus-like syndrome, Wheelchair user
SMQs:, Systemic lupus erythematosus (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1403USA008798

Write-up: This spontaneous report as received from a physician via a field employee refers to a female teenager of unknown age. In June 2013 (9 months ago) the patient was vaccinated with a dose of GARDASIL (lot #, expiration date and dose unspecified). The representative did not know which dose in the GARDASIL series the patient received "9 months ago". In June 2013 (9 months ago) the patient developed lupus-like symptoms and the patient was "basically wheel-chair bound". The field employee did not know any other details of the patient''s condition beyond the fact that the patient had not received a confirmed diagnosis. The patient had sought medical attention. The event outcome was reported as not recovered/not resolved. The reporter considered the event to be disability. Additional information has been requested.


VAERS ID: 528923 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: New York  
Vaccinated:2011-03-08
Onset:2011-03-20
   Days after vaccination:12
Submitted: 2014-04-14
   Days after onset:1121
Entered: 2014-04-21
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0664Z / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Abdominal discomfort, Computerised tomogram head normal, Delusional perception, Drug screen negative, Electroencephalogram normal, Hallucination, Headache, Immediate post-injection reaction, Psychotic disorder, Pyrexia, Staring, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: EEG, CAT scan of brain, Street Drug Tested - negative
CDC Split Type:

Write-up: Immediate upset stomach, headache, fever - eleven days later - vomiting, hallucinating and delusional, 6 hour vertical blank stare, loss of faculties - full psychotic break. 4 wk. hospitalized and again 6 months later.


VAERS ID: 536399 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2014-07-07
Onset:2014-07-09
   Days after vaccination:2
Submitted: 2014-07-11
   Days after onset:2
Entered: 2014-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020901 / 2 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Blindness unilateral, Echocardiogram abnormal, Ophthalmological examination abnormal, Pupil dilation procedure, Pupillary reflex impaired, Retinal artery thrombosis
SMQs:, Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Fluoxetine and Risperidone
Current Illness: Major Depression
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Patient was diagnosed with occlusion/thrombosis of retinal artery. He has been evaluated for stroke/hypercoaguability. Results are pending. Cardiac echo revealed minimal right to left shunting making thromboembolic event possible etiology.
CDC Split Type:

Write-up: Patient presented to the Emergency Room with acute onset of unilateral vision loss. Exam notable for absent pupillary reflex. Was transferred to an eye specialist. Dilated eye exam was suspicious for thrombosis of retinal artery.


VAERS ID: 541913 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-01
Entered: 2014-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1408USA016371

Write-up: This spontaneous report was received from a physician via company representative refers to a 15 year old female patient. There was not pertinent medical history. On an unknown date the patient was vaccinated with the second dose of GARDASIL injection, 1 single shot, (lot number, expiration date, route and dosage were not reported). Concomitant therapy was not reported. The physician informed that on an unknown date within a month of receiving the second dose of GARDASIL the patient began experiencing severe shoulder pain. No adverse effects were reported with the first dose. The patient needed physical therapy as treatment for the adverse event, a magnetic resonance imaging (MRI) was performed as diagnostic study. The patient sought an unspecified medical attention for the adverse event. The reporter determined that the shoulder pain was significant disability or incapacity. Additional information has been requested.


VAERS ID: 546267 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2006-07-01
Onset:2006-07-01
   Days after vaccination:0
Submitted: 2014-10-02
   Days after onset:3015
Entered: 2014-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Abdominal pain upper, Appendicectomy, Attention deficit/hyperactivity disorder, Bladder scan, Cognitive disorder, Computerised tomogram, Cystitis interstitial, Emotional disorder, Food intolerance, Gastrointestinal disorder, Gastrooesophageal reflux disease, Headache, Hyperacusis, Hypotension, Laboratory test, Menstrual disorder, Mental impairment, Migraine, Nuclear magnetic resonance imaging, Ovarian cyst, Parosmia, Photophobia, Sleep disorder, Ultrasound scan
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None.
Current Illness: Dizziness, felt like she was going to faint.
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: MRIs; CT scans; ultrasound; lab work; bladder testing.
CDC Split Type:

Write-up: Headaches/migraines; appendectomy; ovarian cyst; low blood pressure; stomach pain; reflux; interstitial cystitis; cognitive issues; attention deficit; light sensitivity; noise sensitivities; food intolerances; mental/emotional issues; changes in menstrual cycles; sensitivity to odors; intolerance to citric acid; gastrointestinal issues; sleep disruption.


VAERS ID: 558292 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2013-06-06
Onset:2013-08-01
   Days after vaccination:56
Submitted: 2014-12-16
   Days after onset:502
Entered: 2014-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H021346 / 1 RA / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood test, Bone scan, Nerve conduction studies, Nuclear magnetic resonance imaging, Organ failure, Pain, Ultrasound Doppler, Venogram, X-ray
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Allergies:
Diagnostic Lab Data: Nerve Conduction Tests, Blood drawn numerous times, Bone Scan, Vein studies, Doppler scans, x-rays, MRIs
CDC Split Type:

Write-up: Patient began complaining of aches and pains. They were unexplained and no injury found. By the September the pain became too much and her body began to shut down.


VAERS ID: 566379 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: Rhode Island  
Vaccinated:2013-08-21
Onset:2013-12-11
   Days after vaccination:112
Submitted: 2015-02-21
   Days after onset:437
Entered: 2015-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H015555 / 3 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Blood test, Confusional state, Convulsion, Dysarthria, Electroencephalogram, Epilepsy, Eye movement disorder, Fall, Gait disturbance, Head banging, Laboratory test, Nuclear magnetic resonance imaging, Speech disorder
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergy to amoxil
Allergies:
Diagnostic Lab Data: Was diagnosed with Epilepsy by his Neurologist after bloodwork, EEG, MRI and other tests
CDC Split Type:

Write-up: Walking around, stumbling, mumbling, banging his head on a cabinet, falling over, eyes moving all over, slurred speak and then confusion. It lasted about 15 minutes and was considered a seizure in January 2014 following an ER visit due to a seizure.


VAERS ID: 567659 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2012-10-24
Onset:2013-02-09
   Days after vaccination:108
Submitted: 2015-03-02
   Days after onset:751
Entered: 2015-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H013831 / 2 RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Anal haemorrhage, Anal ulcer, Surgery
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Patient has had four surgeries to close the ulcer located near his anus. All have been unsucessful.
CDC Split Type:

Write-up: Went to have bowel movement and started bleeding profusely from anal area. No prior symptoms.


VAERS ID: 579217 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2009-08-13
Onset:2009-08-13
   Days after vaccination:0
Submitted: 2015-05-23
   Days after onset:2109
Entered: 2015-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0294Y / 3 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood test normal, Borrelia test negative, Complex regional pain syndrome, Deep brain stimulation, Dystonia, Fatigue, Fibromyalgia, Gait disturbance, Malaise, Muscular weakness, Nuclear magnetic resonance imaging normal, Pain, Seizure like phenomena, Tic, Tourette's disorder, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Dyskinesia (broad), Dystonia (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Aspergers Syndrome, Endometriosis, seasonal allergies, peanut allergy
Allergies:
Diagnostic Lab Data: Bloodwork to test for Lyme, MS, lupus, arthritis...all negative; MRI for lesions...negative; medications didn''t help; deep brain stimulation; wheelchair
CDC Split Type:

Write-up: After the 3rd vaccine was given on 8/13/2009 patient complained of not feeling well. Is extremely fatigued. Then in March of 2010 she started having episodes of extreme all over body pain so bad we took her to the ER twice. An MRI in April 2010 showed nothing. Patient then started a neck tic in June 2010. August 15, 2010 @ 2:30am patient started having seizure like episodes and weak legs to the point she can''t walk very far and needs a wheel chair. She was diagnosed with Tourettes, dystonia, fibromyalgia and RSD. June 16 2013 patient had to undergo deep brain stimulation but she still suffers with bad dystonia and chronic pain and still uses a wheelchair.


VAERS ID: 590336 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2013-06-25
Onset:2015-06-09
   Days after vaccination:714
Submitted: 2015-08-17
   Days after onset:69
Entered: 2015-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J010668 / 3 LA / UN

Administered by: Private       Purchased by: Other
Symptoms: Asthenia, Dizziness, Electrocardiogram, Electroencephalogram, Moaning, Tachycardia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Birth Control Tripreverin
Current Illness: None
Preexisting Conditions: Yes. She was diagnosed with amplified pain syndrome in March of 2013. Pains in legs, foggy feeling, weakness. June 2016 Diagnosed with POTS.
Allergies:
Diagnostic Lab Data: EEG in hospital; EKG
CDC Split Type:

Write-up: Light headed, moaning weakness, trembling, tachycardia.


VAERS ID: 607813 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2011-10-12
Onset:2012-08-04
   Days after vaccination:297
Submitted: 2015-11-05
   Days after onset:1188
Entered: 2015-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 AR / SYR

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Cardiac stress test normal, Dizziness, Echocardiogram, Electrocardiogram ambulatory, Electrocardiogram normal, Electroencephalogram normal, Epilepsy, Eye movement disorder, Hypotension, Impaired driving ability, Inappropriate schedule of drug administration, Loss of consciousness, Major depression, Moaning, Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain, Pallor, Postictal state, Presyncope, Suicidal ideation, Syncope, Tilt table test, Tinnitus, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Suicide/self-injury (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Reaction to food additive
Preexisting Conditions: Tonsillectomy
Allergies:
Diagnostic Lab Data: The patient had had 5 multi-day video electroencephalograph (EEG) sleep deprived assessments. These were all "normal". They placed him on anticonvulsant (as empirical therapy) but he is still having breakthrough events. One event was caught while the patient was wearing an electrocardiograph (ECG) Halter; his heart rate was 50 beats per minutes when it occurred but there was no evidence of serious erythema, or of vagal slowing. He had a magnetic resonance imaging (MRI) head up tilt table test, an Echocardiogram and a take-home ECG halter. The patient was also an emergency medical technician (EMT) and tracked his own blood pressure. His blood pressure was very low. He currently had a 24 hour blood pressure cuff on a halter. He had a stress today that came up "normal". They plan on running antibody assays with a rheumatologist. 10/12/2015, Blood pressure diastolic, 38; 10/10/2015, Blood pressure measure, 97 over 42; 10/10/2015, Heart rate, 52 bpm
CDC Split Type: WAES1511USA001865

Write-up: Information has been received from a father referring to his 15 year old male son. The patient had allergy to monosodium glutamate (MSG). The father noted that the patient was "normal before the shot". His medical history prior to the shot was clean and there was no history of epilepsy on either side of the family. He had no issues at birth and the only noteworthy event during his childhood was an uneventful tonsillectomy. On 12-OCT-2011, 26-OCT-2012 and 26-SEP-2013, the patient was vaccinated with the first, second and third dose of GARDASIL (1 dose, route: injection) in the deltoid separately. Lot numbers were reported as 1860AA, 0636AA and H011350 (unsure if lot numbers were provided in dose order). On 04-AUG-2012, the patient was found unconscious on the laundry room floor and seemed stiff and postictal. Then on the same day, the patient was hospitalized. However, the first observed occurrence for his loss of consciousness happened in March 2013. On 08-MAR-2013, the patient was admitted for the emergency room. The patient had experienced multiple adverse experiences after completing therapy with GARDASIL including relapsing syncope with reoccurring tonic clonic movements. Description of the Syncope events: Each event followed the same template. The patient heard a gradual increase in roaring in his ears. He became lightheaded and pallor developed in his face. This "pre-syncope period" lasted for about 15 seconds. During the Syncope phase, his eyes roll upwards and he experienced tonic clonic movements for about 20-30 seconds. There was some vocalization (groaning). These events reoccurred on about a monthly basis over the last three years. He could recognize when an event will occur and can reverse the pending effect by lying down and bicycling his feet in the air. He had experienced these events while sleeping, while awake, while defecating, and one occurred after the patient moved from a sauna to take a shower. He has had two events at a hall cafeteria while ingesting a meal. Sleep deprivation seemed to make him more susceptible. All events occurred while he in a sedentary state and most events occurred in the late evening to early morning. On unknown dates, the patient also experienced, major depression and suicidal ideation. Cardiovascular adverse experience included hypotension. The patient had been "effectively diagnosed with epilepsy" and was "on anti-consultants empirically". These issues had caused major lifestyle complications which included restrictions on driving, swimming, bathing and the implied diagnosis of epilepsy was a major concern for the family. The patient had also admitted to the emergency room on 22-APR-2013, 28-MAR-2014 and 12-JAN-2015. The patient had had 5 multi-day video electroencephalograph (EEG) sleep deprived assessments. These were all "normal". They placed him on anticonvulsant (as empirical therapy) but he is still having breakthrough events. One event was caught while the patient was wearing an electrocardiograph (ECG) Halter; his heart rate was 50 beats per minutes when it occurred but there was no evidence of serious erythema, or of vagal slowing. He had a magnetic resonance imaging (MRI) head up tilt table test, an Echocardiogram and a take-home ECG halter. The patient was also an emergency medical technician (EMT) and tracked his own blood pressure. His blood pressure was very low. On Saturday 10-OCT-2015, the father measured his blood pressure at "97 over 42" and "his heart-rate was 52 beats per minute". He measured a diastolic blood pressure of 38 when he "woke up on 12-OCT-2015". He currently had a 24 hour blood pressure cuff on a halter. He had a stress on reporting day that came up "normal". They plan on running antibody assays with a rheumatologist. The outcome of events was reported as not recovered/not resolved. Upon internal review, suicidal ideation and epilepsy were considered to be medically significant. Additional information has been requested.


VAERS ID: 629804 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2013-07-22
Onset:2013-07-24
   Days after vaccination:2
Submitted: 2016-03-29
   Days after onset:979
Entered: 2016-03-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003727 / 1 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Amenorrhoea, Anti-Muellerian hormone level, Autonomic nervous system imbalance, Contusion, Dizziness, Fatigue, Headache, Hypoaesthesia, Menstrual disorder, Muscle spasms, Mydriasis, Pain, Pallor, Paraesthesia, Postural orthostatic tachycardia syndrome, Tilt table test
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: giant urticaria, petechiae, epistaxis, achiness, malaise, fatigue~Varicella (Varivax)~2~10.83~Patient|fatigue, achiness, develop
Other Medications: fexofenedene for seasonal allergies and reactions to insect stings/bites Sibling received the IPV and DTaP in separate injections. He also experienced previous and subsequent vaccine reactions but my session is about to time out.
Current Illness: No known illness at the time of the vaccination.
Preexisting Conditions: Seasonal allergies, possible hyper mobility, previous immediate vaccine reaction to varicella booster(giant urticaria followed by petechiae, nose bleeds, fatigue and achiness lasting for months)
Allergies:
Diagnostic Lab Data: AMH levels and tilt table testing and full assessment available upon request.
CDC Split Type:

Write-up: Increased bruising noted. 8/2013 greatly decreased menstrual bleeding noted after 3 years of regular periods. Also noticed episodic dizziness and feeling faint, fatigue, generalized achiness, dilated pupils, HAs. 9/2013 Severe muscle spasm and episodic dizziness, HAs, dilated pupils continue. Menstrual period very very light, again. 10/23/2013 HPV #2 given. 11/2013 amenorrhea. Began to notice periods of facial and extremity duskiness and pallor along with above symptoms. Numbness and tingling also noted. 12/2013 AMH (antimullerian hormone which indicates ovarian reserve) is found to be similar to perimenopausal woman. Amenorrhea continues along with other symptoms. 6 through 8/2014 diagnosed with POTS/Dysautonomia.


VAERS ID: 631572 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-02
Entered: 2016-04-14
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Nonspecific reaction, Personality change
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEXPLANON; TOPAX; XANAFLEX; IMITREX; BOTOX injections in forehead and neck; gabapentin; GEODON; ZOFRAN; trazodone; LAMICTAL; daily vitamin; magnesium; MOTRIN; APAP; ZANTAC; PEPCID AC
Current Illness:
Preexisting Conditions: Migraines. Possible Schizoaffective disorder, anxiety, depression, fibromyalgia, herniated discs lower spine, chronic back pain, hyperlypasemia. No known allergies. Had none of these health issues or problems prior to the GARDASIL series. I wish I never allowed the vaccinations to be given. I believe this series of vaccinations has greatly contributed to my daughter''s health issues.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My daughter has had several odd and unusual health issues since having these vaccinations. She was an otherwise healthy and happy child prior to this. She has had a complete turn around in personality and numerous health issues of unknown origin. I can only attribute many of these to this vaccine.


VAERS ID: 632624 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: Washington  
Vaccinated:2015-06-25
Onset:2015-06-25
   Days after vaccination:0
Submitted: 2016-04-23
   Days after onset:303
Entered: 2016-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K006960 / 1 UN / SYR

Administered by: Private       Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Blood test, Dizziness, Fatigue, Headache, Malaise, Muscular weakness, Nausea, Pain in extremity, Vomiting, X-ray, X-ray with contrast upper gastrointestinal tract
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Omeprazole
Current Illness: Yearly physical
Preexisting Conditions: Ulcer
Allergies:
Diagnostic Lab Data: X-rays, upper GI, blood work
CDC Split Type:

Write-up: Vomting, joints hurt, frequent headaches, general feeling of unwell, feeling dizzy, painful hands, feet, arms, legs, nausea, muscle weakness, tiredness, missing more school from not feeling good.


VAERS ID: 650279 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: New York  
Vaccinated:2015-07-20
Onset:2015-10-31
   Days after vaccination:103
Submitted: 2016-08-31
   Days after onset:305
Entered: 2016-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. L009445 / UNK LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K016966 / 1 RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Abdominal distension, Abdominal pain, Colitis ulcerative, Colonoscopy, Culture stool, Enema administration, Full blood count, Laboratory test, Nuclear magnetic resonance imaging abdominal, Rectal discharge, Rectal haemorrhage, Stool analysis
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Colonoscopy, MRI of abdomen, stool analysis and culture, CBC, GI analysis
CDC Split Type:

Write-up: Blood and mucus from rectum, abdominal cramping, bloating and pain. Diagnosed with ulcerative colitis and is currently on hydrocortisone enemas qd, Melamine rectal suspension qd and Pentasa 500mg two capsules by mouth three times daily.


VAERS ID: 683800 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-11-27
Onset:0000-00-00
Submitted: 2017-02-23
Entered: 2017-02-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Condition aggravated, Electroencephalogram, Epilepsy, Generalised tonic-clonic seizure, Myoclonic epilepsy, Petit mal epilepsy
SMQs:, Systemic lupus erythematosus (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LAMICTAL
Current Illness:
Preexisting Conditions: Epilepsy; Amoxicillin; no familial history
Allergies:
Diagnostic Lab Data: EEG
CDC Split Type:

Write-up: My daughter experienced a tonic clonic seizure. She was diagnosed with epilepsy. After consulting with the doctor we established she was likely having absence and myoclonic seizures since around 2014. She had her last GARDASIL shot on 11-27-2013. There is no familial history of seizures and she does not follow the typical JME seizure pattern.


VAERS ID: 698118 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2008-09-09
Onset:2008-11-01
   Days after vaccination:53
Submitted: 2017-06-05
   Days after onset:3138
Entered: 2017-06-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 90649 / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain upper, Acne cystic, Alopecia, Anxiety, Apoptosis, Cervicectomy, Cervix carcinoma, Constipation, Cow's milk intolerance, Depression, Food intolerance, Fungal infection, Gallbladder pain, Hypoaesthesia, Menstrual disorder, Pain, Raynaud's phenomenon, Skin discolouration, Streptococcal infection, Temperature intolerance, Tremor, Urinary tract infection, Vitamin B12 decreased, Weight increased
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Gallbladder related disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Uterine and fallopian tube malignant tumours (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Do not currently have them...need to get them from out of state doctor
CDC Split Type:

Write-up: Severe, sudden weight gain, all over hair loss, cystic acne, menstrual cycle disruption, Raynaud''s Syndrome, cervical cancer, 1/4" of cervix taken out due to cervical cancer cells, food intolerance of-wheat, corn, soy, dairy, eggs, canola, cold intolerance, numbness in arms, hands, and feet, chronic UTI''s, chronic yeast infections, chronic, severe stomach aches, severe constipation, random, unexplainable aches and pains, gallbladder pains, hands and feet turning purple/blue/black, arms and hands shaking (nervous system damage), anxiety and depression, chronically low B12, DNA damage, strep virus all over body (internally).


VAERS ID: 705914 (history)  
Form: Version 2.0  
Age: 15.0  
Gender: Female  
Location: California  
Vaccinated:2008-10-13
Onset:2009-01-15
   Days after vaccination:94
Submitted: 0000-00-00
Entered: 2017-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500540P / 4 NS / IN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0548X / 3 LA / IM

Administered by: Private       Purchased by: 0
Symptoms: Menarche, Menstruation irregular
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Patient fainted after receiving Typhoid, Tetanus (Td 7yrs-adult), and Hepatitis A (1st of 2 doses) vaccination injections in the
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient''s first menstrual cycle occurred weeks after the vaccine, and has been very irregular ever since. The patient is now 24 years old and still has irregular menstrual cycles. It is currently unknown whether sterility has occurred. However, reproductive viability seems questionable as the menstrual cycles do not exceed 21 days on average. The typical range is 17-22 days per cycle.


VAERS ID: 725058 (history)  
Form: Version 2.0  
Age: 15.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2013-02-19
Onset:2013-07-10
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2017-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1359AA / 1 UN / UN

Administered by: Private       Purchased by: 0
Symptoms: Anxiety, Dyskinesia, Electroencephalogram abnormal, Gastric disorder, Headache, Impaired driving ability, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: Not before vaccine
Allergies: PCN
Diagnostic Lab Data: EEG, Neurologist
CDC Split Type:

Write-up: Patient has to take (Propranolol ER) 60 mg 2x''s daily (TOPAMAX) 100 mg 2x''s daily has headaches, stomach issues, anxiety, jerking spells. Did EEG showed underlying seizure disorder all issues started after taking first shot. She hasn''t and can''t get driver''s license due to this issue.


VAERS ID: 286414 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-05-15
Onset:2007-05-17
   Days after vaccination:2
Submitted: 2007-07-31
   Days after onset:75
Entered: 2007-08-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bedridden, Muscle spasms, Neck pain
SMQs:, Dystonia (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: sertraline HCl Unk - Unk
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707AUS00225

Write-up: Information was obtained on request by the Company from the agency via a Case Line Listing and a Public Case Detail form. The patient was a 15 year old female who on 15-MAY-2007 was vaccinated with Gardasil. Concomitant therapy included sertraline HCl. On 17-MAY2007 the patient experienced painful muscle spasm in neck which was diagnosed as "acute wry neck" by a physician. The patient was bedridden for 2 days. On 23-MAY-2007, it was reported to the agency that the patient still had a sore neck but no where near as severe as before. The agency considered that painful muscle spasm in possibly were related to therapy with Gardasil. Painful muscle spasm in neck was considered to be disabling by the agency. Additional information is not expected.


VAERS ID: 299033 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-05-30
Onset:2007-09-19
   Days after vaccination:112
Submitted: 2007-12-06
   Days after onset:78
Entered: 2007-12-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crohn's disease, Intestinal perforation, Peritonitis
SMQs:, Gastrointestinal premalignant disorders (narrow), Gastrointestinal perforation (narrow), Ischaemic colitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA01297

Write-up: Information has been received from a physician, concerning a 15 year old female patient, who in December 2006 was vaccinated with the first dose, in January 2007 with the second dose, and on 30-MAY-2007 with the third dose of Gardasil (lot #654740/0859F; batch NE26610). On 19-SEP-2007, approximately 3 and 1/2 months after the third vaccination, the patient experienced peritonitis, secondary to perforation of the small intestine, and was hospitalized. A diagnosis of Crohn''s disease was determined. The patient had not prior history of related symptoms before the events occurred. At the time of this report, the patient had not recovered from the events. The reporting physician felt that Crohn''s disease was possibly induced by therapy with Gardasil. The physician considered the events to be immediately life-threatening, and significantly disabling/incapacitating. Other business partner numbers included: E2007-08859.


VAERS ID: 322817 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-04-23
Onset:2008-04-23
   Days after vaccination:0
Submitted: 2008-08-20
   Days after onset:119
Entered: 2008-08-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1949U / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808AUS00146

Write-up: Information was obtained on request by the Company from the agency via a Case Line Listing and a Public Case Detail Form concerning a 15 year old female who on 23-APR-2008 was vaccinated with the first dose of GARDASIL (Batch # K0532, Expiry date 12-JUN-2010, Lot # 659053/1949U). On 23-APR-2008, 6 hours after vaccination with GARDASIL, the patient experienced chest pain. It was described as thoracic pain that has failed to settle to date. At the time of reporting to the agency on 14-MAY-2008 the patient had not yet recovered from the chest pain. The agency considered that chest pain was possibly related to therapy with GARDASIL. The original reporting source was not provided. Chest pain was considered to be disabling by the reporting agency. Additional information is not expected.


VAERS ID: 337814 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-07-23
Onset:2008-03-01
   Days after vaccination:222
Submitted: 2009-01-20
   Days after onset:325
Entered: 2009-01-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1518F / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Condition aggravated, Dissociative disorder, Electroencephalogram normal, Facial pain, Headache, Nuclear magnetic resonance imaging normal, Sensory disturbance, Spinal X-ray normal
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Glaucoma (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: electroencephalography, 24Oct08, Showed no changes; Physical examination, 28Nov08, normal results; Magnetic resonance imaging, showed normal results; Spinal X-ray, showed normal results
CDC Split Type: WAES0901USA01666

Write-up: Information has been received from a foreign health authority (reference No. PEI2008021013) concerning a 15 year old female patient with history of headache (onset some years ago, at least since March 2007) and family anamnesis of migraine (patient''s mother) was vaccinated with a first dose of GARDASIL (batch number NF2330, lot #1518F), route and site not reported on 23-JUL-2007, with a second dose of GARDASIL (batch #NG00010, lot # 1401F) on 27-OCT-2007 and with a third dose of GARDASIL (batch # NF58540, lot # 0253U) on 18-FEB-2008. The frequency of the pre-existing headache increased during the last years and the patient developed chronic headaches and took frequently analgesics. CCT in April-2008 showed normal results. Tension headache and development of headache due to analgesics were suspected. Atypical face pain and dissociative sensory disturbance were diagnosed when the patient presented at the physician practice for follow-up examination on 24-OCT-2008. EEG on 24-OCT-2008 showed no changes. MRI and x-ray cervical spine showed normal results. Examination at an ENT physician was pending at the time of reporting. As the sensory disturbance (hemihypaesthesia) was limited to the median area a psychogenic cause was suspected, but the final cause could not clarified. At a control on 28-NOV-2008 the physical examination revealed normal results. Several therapies including acupuncture and osteopathy have been tried, but without success. HA coded only cephalgia. File closed. Other business partner number include: E2009-00147. No further information is available.


VAERS ID: 338236 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-11-01
Onset:2008-12-07
   Days after vaccination:36
Submitted: 2009-01-23
   Days after onset:47
Entered: 2009-01-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Diplopia, Headache, Nasopharyngitis, Nuclear magnetic resonance imaging abnormal, Paresis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious meningitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Magnetic resonance imaging, 18Dec08, hyperintense enhancement in the caudal salivary nucleus left
CDC Split Type: WAES0901USA02992

Write-up: Information has been received from Health Authority on 15-JAN-2009 (reference #2009-00031) concerning a 15 year old female adolescent who was intramuscularly vaccinated with the first 0.5 ml dose of GARDASIL (batch number not reported, site of administration not reported) in October 2008. In November 2008 she received the second 0.5 ml dose of GARDASIL, IM. From 07-DEC-2008 until 11-DEC-2008 she developed headache. On 11-DEC-2008 she noted a diplopia, which was progressive and she had symptoms of common cold. A paresis of the left abducent nerve was diagnosed. On 18-DEC-2008 an MRI showed hyperintense enhancement in the caudal salivary nucleus left. An acute disseminated encephalitis was diagnosed. Other business partner numbers include E2009-00291. No further information is available.


VAERS ID: 339684 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-12-23
Onset:2008-12-25
   Days after vaccination:2
Submitted: 2009-02-13
   Days after onset:50
Entered: 2009-02-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1941U / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal neoplasm, Azotaemia, Chemotherapy, Coma, Haemorrhage, Rhabdomyosarcoma, Surgery
SMQs:, Acute renal failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Chronic kidney disease (narrow), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0902USA01285

Write-up: Information has been received from a Foreign Authority (reference number DK-DKMA-20090203) concerning a 15 year old female patient who was vaccinated intramuscularly with the first dose of GARDASIL (lot # 1941U, batch # NJ01850, site of administration not reported) on 23-DEC-2008. It was reported that the patient experienced rhabdomyosarcoma on 25-Dec-2008. She was diagnosed with rhabdomyosarcoma (date of diagnose not reported). The sarcoma presumably had its origin in the patient''s uterus (not confirmed). The patient was hospitalized (date not reported) and placed in coma (date not specified) at the hospital intensive unit. The patient''s abdomen was opened due to an inoperable, rapidly growing tumor which at the time of acute operation had grown rapidly to the size of a full term pregnancy (date not specified). The patient received chemotherapy (onset date not specified) and experienced complications in form of uraemia and bleeding (not further specified). The course of the disease was reported as unexpectedly fast and aggressive. Initially, before the expansion of the abdomen, the adverse event was interpreted as appendicitis. At the time of report to the Health Authorities the condition of the patient was stable and she was scheduled to be taken out of coma the next day (date not reported). It was reported that the patient was healthy and did not suffer from any known diseases at the time of vaccination. The patient received no concomitant vaccinations or medication. At the time of report the patient had not recovered. Other business partner numbers include: E2009-01070. No further information is available.


VAERS ID: 340966 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-17
Onset:2007-11-17
   Days after vaccination:31
Submitted: 2009-03-02
   Days after onset:471
Entered: 2009-03-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiolipin antibody positive, Condition aggravated, Osteonecrosis, Red blood cell sedimentation rate increased, Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (narrow), Osteonecrosis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: chloroquine
Current Illness: Systemic lupus erythematosus
Preexisting Conditions: Steroid therapy
Allergies:
Diagnostic Lab Data: Erythrocyte sedimentation rate, 17Nov07, increased; Cardiolipin antibody test, 17Nov07, increased
CDC Split Type: WAES0902USA04284

Write-up: Information has been received from a physician concerning a 15 year old female with systemic lupus erythematosus (diagnosed at 14 years old) maintained on chloroquine. The patient received seven weeks of steroids at the onset of her disease after which she passed into remission. In September 2007, the patient received her first dose of GARDASIL. On approximately 17-OCT-2007 was vaccinated with the second dose of GARDASIL via I.M. On 17-NOV-2007 the patient developed reactivation of her SLE disease with elevation of ESR, anticardiolipin antibodies (IgM) and bilateral avascular necrosis of femoral heads. As of 24-FEB-2009 the patient symptoms persisted. The patient''s bilateral avascular necrosis of femoral heads persisted. The outcome of the patient''s reactivation of the SLE was not reported. The avascular necrosis of the femoral heads was considered to be disabling and Other Important Medical Event by the physician. No further information is available.


VAERS ID: 360946 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-12-01
Onset:2009-01-01
   Days after vaccination:31
Submitted: 2009-10-14
   Days after onset:285
Entered: 2009-10-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anxiety, Arthralgia, Asthenia, Convulsion, Dizziness, Influenza, Monoplegia, Myalgia, Neurological examination abnormal, Pain in extremity, Paralysis, Vaccine positive rechallenge
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: neurological examination, paralysis of extremities
CDC Split Type: WAES0910USA01110

Write-up: Information has been received on 06-OCT-2009 by Health Authority (HA ref. DK-DKMA-20092549) concerning a 15 year old female who in ultimo December 2008, was vaccinated with the first dose of GARDASIL intramuscularly (lot#, batch# and site of administration not reported). There was no concomitant medication. It was reported that on 01-JAN-2009 the patient experienced muscular pain, convulsions, joint pain, dizziness and weakness. The patient was diagnosed with influenza by the doctor from the emergency service and received treatment with PANODIL (manufactured by GlaxoSmithKline, dose not reported, no dates reported). According to the patient''s parents, the symptoms were not consistent with influenza, thus the patient''s GP was contacted a few days later. The patient was referred for a neurological examination that revealed no abnormalities except paralysis of extremities. It was not specified which examinations that were performed or the date of neurological examination. One week later, the patient''s condition had not improved. The patient was seen by a reflexologist who stated that the patient was "cold" (not further specified). The patient was treated with warmth, reflexology and diet advice (not further specified). It was reported that patient''s condition improved slowly and the patient recovered on an unspecified date. It was reported that the symptoms returned in February 2009 (not further specified), and that the patient also experienced anxiety due to the uncertainty regarding causality. The neurological examination was repeated with the same conclusion (no abnormalities except paralysis of extremities). After a week, the symptoms had declined and the patient recovered. In primo March 2009, the patient was vaccinated with the second dose of GARDASIL intramuscularly (lot#, batch# and site of administration not reported). No adverse reactions were reported. In primo May 2009, the patient was vaccinated with the third dose of GARDASIL intramuscularly (lot#, batch# and site of administration not reported). It was reported that on 18-MAY-2009 the patient experienced convulsions, joint pain, dizziness and weakness. The patient recovered on an unspecified date. In ultimo June 2009, the patient experienced dizziness and pain in hands after low intense physical activity. Immediately rest improved the patient''s condition rapidly (not further specified). Psychiatric examination excluded functional disorder. It was reported that the patient had not recovered. Convulsion, muscular pain, anxiety, joint pain, weakness, dizziness and transient paralysis of limb were considered to be disabling by the reporter. Other business partner number included: E200909365. Additional information has been requested.


VAERS ID: 422164 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-10-11
Onset:0000-00-00
Submitted: 2011-05-03
Entered: 2011-05-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: CSF oligoclonal band present, Central nervous system lesion, Demyelination, Encephalopathy, Lumbar puncture, Multiple sclerosis, Multiple sclerosis relapse, Neurological examination abnormal, Nuclear magnetic resonance imaging brain abnormal, Visual acuity reduced, Visual evoked potentials abnormal, Walking disability, Wheelchair user
SMQs:, Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Chronic kidney disease (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Spinal tap, ??Oct?10, Oligoclonal bands; Neurological examination, ??Oct?10, Abnormal results; Magnetic resonance imaging, ??Oct?10, Suspected acute demyelinating encephalopathy; Visual evoked potential, ??Oct?10, Abnormal
CDC Split Type: WAES1104USA04016

Write-up: Case received from a consumer on 18-APR-2011. Case not medically confirmed. A 15 year old female patient had received a first dose of GARDASIL (batch number not reported) on an unspecified date and following vaccination the patient developed multiple sclerosis experiencing 3 relapses in 2 months. According to the reporter, the patient''s father, the patient had serious sequelae. Additional information received from the Health Authorities on 22-APR-2011 under the reference number BX20110458. Case medically confirmed. The patient had received a first dose of GARDASIL (batch number not reported) intramuscularly on 11-OCT-2010 and experienced the first symptoms 2 to 3 weeks after vaccination. The patient had experienced 4 acute demyelinating attacks since that time. An MRI was performed resulting in suspect acute demyelinating encephalopathy with lesions, a lumbar puncture revealed oligoclonal bands and a neurological examination showed abnormal results. Visual evoked potentials were altered. The patient was diagnosed with multiple sclerosis. The patient would had been hospitalized twice (to be confirmed) and she received twice 3 days of corticosteroid bolus IV injection. The patient received a second dose of GARDASIL (batch number not reported) on 13-DEC-2010. Patient''s family medical history included her brother, father and grand father with insulin dependent diabetes mellitus and cousins with immune dysfunction disease. At then time of the reporting, the patient had not recovered and the outcome was reduced visual acuity and walking disability: wheelchair user. The Health Authorities assessed the causal relationship between the reported reaction and vaccination as doubtful (C1 S1 11) according to the method of assessment. Multiple sclerosis was considered by agency to be disabling. Other business partner numbers included: E2011-2535. No further information is available.


VAERS ID: 425781 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-09-03
Onset:2010-06-01
   Days after vaccination:271
Submitted: 2011-06-20
   Days after onset:384
Entered: 2011-06-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER A81CA257A / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal sleep-related event, Arthropathy, Asthenia, Cataplexy, Confusional state, Disturbance in attention, Dyssomnia, Fight in school, HLA marker study, Hypnagogic hallucination, Insomnia, Joint injury, Laboratory test normal, Limb injury, Middle insomnia, Muscular weakness, Narcolepsy, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Otitis media, Sleep disorder, Sleep paralysis, Sleep study, Sleep study abnormal, Somnolence, Spinal column injury
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Sleep difficult; Allergy to animal
Preexisting Conditions: Otitis media serous; Injury
Allergies:
Diagnostic Lab Data: Diagnostic laboratory test, 26Jan11, Biological work-up was normal; Sleep study, Normal hypnogram; Sleep study, 4 sleep latency test: she felt asleep in 3 min and paradoxical sleep cycles were observed 3 times; Sleep study, 16/24, In Epworth scale without medication; Magnetic resonance imaging, Normal; Sleep study, 15/24, In Epworth scale with MODIODAL; Diagnostic laboratory test, Genotyping was DRB1 07, DQB1 03 on one of the genes and DRB1 13, DQB1 06 on the other
CDC Split Type: WAES1106USA01848

Write-up: Case received from the Health Authorities on 08-JUN-2011 under the reference number: PP20110180. Case medically confirmed. A 15 year old female patient had received a dose of yellow fever virus vaccine on 07-DEC-2006, the first dose of GARDASIL (lot and batch number not reported) on 03-SEP-2009 and the second dose of GARDASIL (lot and batch number not reported) on 09-FEB-2010. On 15-DEC-2009, the patient received a dose of PANDEMRIX (batch number A81CA257A), and on 12-JUL-2010, she received the third dose of GARDASIL (lot and batch number not reported). In January 2009 as the patient was going to another country for 3 months, she was found to have difficulty in getting asleep from the first night on, in a context of seromucous otitis. Then she woke up at night every two hours. These insomnias persisted for almost two years. In June 2010, the patient developed somnolence at the end of the school academic year. In September 2010, when the patient went back to school, she started to fight in classroom not to get asleep and to have extended naps on Wednesdays afternoons - i.e. during two hours - from which she woke up confused. In December 2010, the hypersomnolence clearly increased, associated with frank concentration disorders in classroom, with her mind going blank, getting asleep once during an exam, and getting asleep once or twice a day in classroom, in the beginning and end of day. The patient experienced excessive somnolence during the whole academic year 2009-2010, with her mind going blank and difficulty to get up in the morning. At the time of reporting, the following symptoms were present: significant diurnal somnolence with an Epworth scale at 16/24 without medication and 15/24 with 300 mg of MODIODAL, need of 2 to 3 naps a day with medication, one with medication. The patient had short and restful naps - rares hypnagogic hallucinations: auditory (first name, alarm clock), sensation of a presence (somebody coming into her room), sensation of a body sleeping next to her or of a tee-shirt on her body - sleep paralysis: only one episode at three times during the night, in a context of fatigue - cataplexies: the patient experienced weakness sometimes when laughing, as well as one atypical knee giving away. There was no fall - dyssomnia: initially the patient presented with sleep disorder and did not get asleep before 2 am, associated with phases of two hours of sleep interrupted by long awakening, and sensation of excessive sleepiness in the morning. Since the patient had been taking MODIODAL, she had more continuous sleeps with easier awakenings. Dysexecutive disorders: attention disorders. It bothered her in the acquisition of a new and more complex strategy, the patient worked in an automatic way. On a biological level, genotyping was DRB1 07, DQB1 03 on one of the genes and DRB1 13, DQB1 06 on the other. A brain magnetic resonance imaging (MRI) was performed and was normal. Biological work-up performed on 26-JAN-2011 [Due to memory limitations, the remainder of this text could not be compared.] AN-2011 was normal. To be noted that the patient was allergic to cat hair. There was no familial history of narcolepsy. She had experienced several traumas in 2010 (knee, coccyx, finger). At the time of reporting, the patient had not recovered. The Health Authorities assessed the causal relationship between the reported reaction and vaccinations with PANDEMRIX as doubtful (C1 S2 11) according to the method of assessment. Additional information received on 14-JUN-2011: A sleep night study was performed in another ward and resulted in normal hypnogram (no further information was available). The patient''s night sleep was correct but during the 4 sleep latency tests she felt asleep in 3 minutes on average and paradoxical sleep cycles were observed 3 times. This was characteristic of narcolepsy. Cataplexy started in February 2011. At the time of reporting, the patient had not recovered. The Health Authorities assessed the causal relationship between the reported reaction and vaccinations with PANDEMRIX as doubtful (C1 S2 11) according to the method of assessment. Narcolepsy and cataplexy were considered to be disabling. Other business partner number included: E2011-03559. No further information is available.


VAERS ID: 435763 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-06-25
Onset:2011-07-29
   Days after vaccination:34
Submitted: 2011-09-26
   Days after onset:59
Entered: 2011-09-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AABVB963AA / 1 UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN52070 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CONCERTA
Current Illness: Attention deficit disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1109USA01837

Write-up: Case received from the Health Authorities on 13-SEP-2011 under the reference number 2011-02931 via the local site Sanofi Pasteur MSD. A 15-year-old female patient, who had been taking CONCERTA for Attention Deficit Syndrome without any problems for a long time, had received the first dose of GARDASIL, (batch number NN52070) 0.5 ml. Secondary suspect therapy included the first dose of ENGERIX B, other manufacturer (batch number, AABVB963AA) 1 ml both via intramuscular route on 25-JUN-2011. On 29-JUL-2011 the patient developed sensory disturbances over the left side of her face that extended from the hairline to the middle of the cheek. An appointment was made with a neurologist to diagnose the symptoms, but there was no explanation for the patient''s symptoms. The patient was not given any specific treatment, and the symptoms have persisted until the present time. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as unlikely concerning GARDASIL and possible concerning ENGERIX B. Sensory disturbance was considered to be disabling by the reporter. Other business partner numbers included: E2011-05553. No further information available.


VAERS ID: 453102 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-12-22
Onset:0000-00-00
Submitted: 2012-04-05
Entered: 2012-04-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Blood count, Blood culture negative, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, C-reactive protein increased, Complement factor C3, Complement factor C4, DNA antibody negative, Differential white blood cell count, Finger deformity, Joint ankylosis, Laboratory test normal, Musculoskeletal stiffness, Myalgia, Pain in extremity, Red blood cell sedimentation rate, Viral test negative
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: DNA Ab immunoprecipitation, negative; Serum C-reactive protein, 2; Blood culture, normal: Blood count and differential white count; Serum immunoglobulin A test, normal; Component C3 test, normal; Clinical serology test, virus serology test negative; Component C4 test, normal; Serum immunoglobulin M test, normal; Serum immunological G test, normal; Erythrocyte sedimentation rate, 5/17
CDC Split Type: WAES1105USA04184

Write-up: Information has been received from a consumer on 10-MAY-2011 and not medically confirmed. A Female patient (age unknown) had received the second dose of GARDASIL (lot and batch number not reported) on unspecified date. On an unspecified onset of time she experienced significant joints pain. At the time of reporting the patient had still not recovered. Additional information received from a pediatrician on 28-MAY-2011. Case medically confirmed. The patient was 15 year old and had no relevant medical history. She had received the first dose of GARDASIL (lot and batch number not reported) on 22-DEC-2010 together with a dose of MENINGITEC (other manufacturer), and the second dose of GARDASIL (lot and batch number not reported) on 23-FEB-2011. Eight days after the second dose, she complained from violent pain in hands and feet, which awoke her in the morning and disturbed her in her daily activities and went increasing during the weeks. She was seen by the reporter on 26-MAR-2011 for arthralgia, sensation of ankylosis, but without morning stiffness. The examination showed joints which were not edematous, nor swollen but it showed a deformation of fingers in lateral valgue. Those pain spread to the wrists. There was no fever. A work-up was performed and was normal: Blood count and differential white count, sedimentation rate: 5/17, C-reactive protein (CRP): 2. Latex, Waler Rose, anti-DNA antibodies were negative; Immunoglobulins G, A, M were normal, C3 and C4 normal. As those pain persisted, spread to toes and were invalidating regards to school, the patient went to see a rheumatologist, who confirmed the absence of systemic disease or rheumatological disease. Viral serologies were negative. At the time of reporting, the pains had been persisting for two months and were not decreasing. The patient needed APRANAX 2 to 3 times a day. Follow up received on 26-OCT-2011. Fifteen days after the second dose (and not 8 as previously reported), the patient experienced migratory arthralgia from fingers to wrists and to ankles. She had morning stiffness. The pain was increased on efforts. She also complained from lumbar pain. The inflammatory work-up was normal. She was seen by a rheumatologist. The physical examination was normal. An appointment with an internal medicine physician was scheduled. The patient was seen for her lumbar pain. The physical examination showed sensitivity on 3 vertebras. The patient was due to be seen again. At the time of reporting, the patient had not recovered. Follow-up information received on 28-MAR-2012: case upgraded to serious upon the basis on the following information: The patient had no swelling, no redness and no inflammation. She observed having fingers deformity. She had difficulties writing in her daily life and need school assistance. Furthermore, she could not longer practice sport. An individual plan had been put into place at school. The patient was suffering since several months and experienced pain in whole body of myalgia type. No diagnosis had been made. The physician agreed to consider this case as serious due to the patient''s daily life difficulties leading to disability. Other business partner numbers include E2011-02891. No further information is available.


VAERS ID: 460891 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-05-31
Onset:2012-06-03
   Days after vaccination:3
Submitted: 2012-08-02
   Days after onset:60
Entered: 2012-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NP14780 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Expired drug administered, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal, Ophthalmological examination abnormal
SMQs:, Optic nerve disorders (broad), Demyelination (narrow), Corneal disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness:
Preexisting Conditions: Expired drug used; Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1208DEU000718

Write-up: Case of misuse (expired vaccine administered) was received from the Health Authorities on 27-Jul-2012 (reference number PEI2012023882). Case is medically confirmed. A 15-year-old female patient received the complete immunisation series with three doses of GARDASIL (lot-no. NP14780, expiry date Mar-2012) IM on 16-Feb-2012 (D1), on 08-Apr-2012 (D2) and on 31-May-2012 (D3). Three days later, on 03-Jun-2012, she experienced multiple sclerosis (no symptoms reported) leading to hospitalisation. Diagnosis was established by MRI and ophthalmologic findings. The following diagnoses were excluded: systemic lupus erythematosus, collagenosis, infectious encephalitis and sarcoidosis. It was reported that the symptoms were ongoing. According to the reporter, the outcome was ''permanent disability''. Upon medical review the company judged relevant to code the following misuse: expired vaccine used which was not coded by CA.


VAERS ID: 494392 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-10-31
Onset:2011-12-01
   Days after vaccination:31
Submitted: 2013-06-18
   Days after onset:564
Entered: 2013-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NM26350 / 3 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Headache, Polyarthritis, Serology abnormal, X-ray abnormal
SMQs:, Systemic lupus erythematosus (broad), Arthritis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 07/2011, Abdominal distension, lasting for 3-4 months; 07/2011, Headache, lasting for 3-4 months; 07/2011, Abdominal pain, lasting for 3-4 months; 06/20/2011, GARDASIL, Abdominal distension; 06/20/2011, GARDASIL, Headache; 06/20/2011, GARDASIL, Abdominal pain, D2 of GARDASIL (lot-no. NP12170) was given into the left upper arm on 20-JUN-2011; 04/11/2011, GARDASIL, D1 of GARDASIL (lot-no. NL31810, this batch was imported from another country and not released by HA) was given into the left upper arm on 11-Apr-2011 and was well tolerated, No adverse event
Allergies:
Diagnostic Lab Data: In Dec-2011, the patient developed headache and polyarthritis. Diagnosis was confirmed by serology and X-ray (not further specified)
CDC Split Type: WAES1306DEU006752

Write-up: Case was received from the Health Authorities on 07-Jun-2013 (reference no. PEI2013031797). Case is medically confirmed. This case is linked to E2013-04281 (same patient, same reporter, same vaccine). A 15-year-old female patient received the third dose of GARDASIL (lot-no. NP39700) into the left upper arm on 31-Oct-2011. On an unspecified date in Dec-2011, the patient developed headache and polyarthritis. Diagnosis was confirmed by serology and X-ray (not further specified). The patient received unspecified outpatient treatment. At the time of reporting the patient had not recovered. It was reported, that the patient had lasting damage from the vaccination. D1 of GARDASIL (lot-no. NL31810, this batch was imported from another country and not released by HA) was given into the left upper arm on 11-Apr-2011 and was well tolerated. D2 of GARDASIL (lot-no. NP12170) was given into the left upper arm on 20-Jun-2011. In Jul-2011 the patient developed abdominal pain, headache and bloating, lasting for 3-4 months. During medical review the company considered to additionally select "Disability" as a seriousness criterion. Lasting damage was mentioned in the report, but not coded by HA.


VAERS ID: 502889 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-12-12
Onset:2009-01-15
   Days after vaccination:34
Submitted: 2013-09-18
   Days after onset:1706
Entered: 2013-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Blister, Blood test, Cystitis, Depersonalisation, Depression, Diarrhoea, Disturbance in attention, Dizziness, Dysmenorrhoea, Ear pain, Ear, nose and throat examination, Enuresis, Fatigue, Feeling cold, Hot flush, Hyperacusis, Infection, Inflammation, Influenza, Insomnia, Joint swelling, Lymphadenopathy, Memory impairment, Migraine, Myalgia, Nausea, Nocturia, Nuclear magnetic resonance imaging brain, Ophthalmological examination, Oral herpes, Pain in jaw, Photosensitivity reaction, Presyncope, Restlessness, Sensory disturbance, Skin papilloma, Speech disorder, Tonsillar hypertrophy, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Dementia (broad), Pseudomembranous colitis (broad), Akathisia (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Repeated blood sampling performed (blood tests not specified) on unspecified dates. Ear, nose and throat examination performed on an unspecified date. Investigation at an Infectious Diseases clinic on an unspecified date. Ophthalmological examination performed by ophthalmologist on an unspecified date. MR-scan of head on an unspecified date. Investigated at a dizziness clinic on an unspecified date. Investigated by a rheumatologist on an unspecified date. Has been extensively examined, however without diagnosis.
CDC Split Type: WAES1309DNK001386

Write-up: Case received from a patient/consumer via Health Authority in a foreign country on 22-Aug-2013 under reference numbers EFO6602 and 22216740. Case not confirmed. A 15 year old female patient had received an injection of GARDASIL (dose, batch number, route and site not reported) on 18-Dec-2008 and later on 15-Jan-2009 she developed infections, migrainous headache, dizziness, near fainting, nausea, severe tiredness, sleeplessness, restlessness in the body, concentration problems, memory problems, visual disturbance, speech disorder, self-estrangement, feeling cold, hot flashes, chronic muscle pain and joint pain in neck, shoulder, back, lower back, hips and knees, swelling in the knee, jaw pain, swollen tonsils, swollen lymph, cold sores, warts on legs, inflammation, pain in ears, significant menstrual pain, flu symptoms, nighttime urination 2-5 per night, permanent diarrhea, bladder infection, depressed, sensitive to sound, photosensitive, blisters on the eye and pain in ears. The patient has earlier always been healthy and active and performed sport at a very high level, which she not has been able to during the last couple of years and she has not been/is able to take an education at prescribed time. It is mentioned by HA that neither former doctor or the patient herself has been aware of the relationship, despite the fact that especially after the second vaccination the patient suddenly got health problems. As it is reported by HA that patient''s health problems started especially after vaccination no. 2 (all events started 15-Jan-2009) it is considered that the vaccination date (19-Jun-2009) mentioned by HA is vaccination 3. The patient was previously probably vaccinated with GARDASIL (batch number, route and site not reported) on an unspecified date. The patient has not earlier had any health problems in general. Several examinations have been performed. No results provided. Repeat blood sampling performed (blood tests not specified) on unspecified dates. Ear, nose and throat examination performed on an unspecified date. Investigation at an Infectious Diseases clinic on an unspecified date. Ophthalmological examination performed by ophthalmologist on an unspecified date. MR-scan of head on an unspecified date. Investigated at a dizziness clinic on an unspecified date. Investigated by a rheumatologist on an unspecified date. At the time of reporting, the outcome was not recovered. Follow-up information received from health care professional via Health Authority in a foreign country on 10-Sep-2013. The side effects sensory disturbance was added, the side effect infection has been changed to recurrent infection and adverse reaction urination involuntary changed to nocturnal enuresis. The case has changed from not serious to serious and is not medically confirmed. The patient''s doctor has reported side effects: dizziness, joint pain, severe tiredness, sensory disturbances, vision and speech disturbances, concentration problems, nausea, headache, sleeplessness, restlessness, tendency to infection, flu symptoms, nocturia, depression and photosensitivity. The patient''s physician reported that the patient after 2 doses of GARDASIL experienced multiple symptoms and she has been extensively examined, however without diagnosis. Previously, the patient was very active soccer player at a high level and now she can barely cope with everyday life and school. The patient''s doctor has reported that the side effects resulted in disability or significant loss of function. The doctor reports that the patient was first shot on 12-Dec-2008 and second vaccine on 13-Feb-2009. Batch numbers of the vaccines are unknown. The vaccines are given intramuscularly. The patient had no other vaccines or other medicines used as side effects occurred. Based on the information reported, the date of first dose GARDASIL was changed from 18-Dec-2008 to 12-Dec-2008. The latency is changed to 34 days for all events (previously 28 days). The outcome is not recovered for all events. Contradictory in HA report: The doctor reported first vaccination date as 12-Dec-2008 and second vaccination date as 13-Feb-2009. Onset of AE was reported as 15-Jan-2009 but HA also mentioned that AE onset was after second vaccination.


VAERS ID: 516529 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-24
Onset:2012-04-01
   Days after vaccination:190
Submitted: 2013-12-13
   Days after onset:621
Entered: 2013-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Blood immunoglobulin E increased, Diarrhoea, Eosinophil count increased, Gait disturbance, Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging normal, Oedema peripheral, Pain, Pain in extremity, Vomiting, Walking aid user, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 11/11/2011, Blood immunoglobulin E, 2117; 11/11/2011, Eosinophil count, 1100; 10/2011, Nuclear magnetic resonance imaging, revealed no abnormality
CDC Split Type: WAES1312JPN005813

Write-up: Initial information has been received from a physician concerning a 15-year-old female patient. On 24-SEP-2011, the patient received a GARDASIL syringe injection drug intramuscularly (dose, injection site, and lot number not reported). No concomitant medication was reported. On 24-SEP-2011, the patient vaccinated with GARDASIL as stated above. On 27-SEP-2011, three days after the above vaccination, the patient experienced numbness in left hand. On an unspecified date, pain in extremities developed in the patient. In October 2011, orthopedic consultation and general examination (except head) by magnetic resonance imaging (MRI) revealed no abnormality. On 11-NOV-2011, laboratory test of eosinophil count and IgE showed 1100 and 2117 respectively. On 15-NOV-2011, the patient experienced pain in metacarpal phalangeal (MP) joint of right all fingers and oedema in right hand. In April 2012, the patient experienced pain and difficulty in walking. She became to use crutches to walk. On an unspecified date, the patient recovered from difficulty in walking. On 08-APR-2013, the patient experienced vomiting and diarrhoea. At the beginning of April 2013, numbness, pain, and muscle weakness of lower extremities were developed because of onset of vomiting and diarrhoea and the patient relapsed into difficulty in walking. On an unspecified date, the patient visited various kinds of health-care facilities. On 04-DEC-2013, the patient was admitted to the department of neurology in the hospital. She had numbness below knees (especially sole of feet) and used a wheelchair, but she had no numbness in hands. At the time of reporting on 09-DEC-2013, the patient was still hospitalized at the department of neurology in the hospital. The patient recovered from numbness in left hand (4, 5 fingers), difficulty in walking (the first one), and pain. She did not recovered from pain in extremities, numbness, pain, and muscle weakness of lower extremities, and difficulty in walking (the second time). The outcome of pain in MP joint of right all fingers, oedema in right hand, vomiting, and diarrhoea was unknown. Reporter''s comment: The causal relationship of the events to GARDASIL is highly likely because the symptom appeared three days after the vaccination. The reporting physician considered that numbness in left hand (4, 5 fingers), pain in extremities, pain, difficulty in walking (the second time), and numbness, pain and muscle weakness of lower extremities were related to GARDASIL and did not assess the causality of pain in MP joint of right all fingers, oedema in right hand, vomiting, and diarrhoea to GARDASIL. The reporting physician considered difficulty in walking (the first time) as serious (disability), and numbness, pain, and muscle weakness of lower extremities, and difficulty in walking (the second time) as serious (hospitalization), and also considered numbness in left hand (4, 5 fingers), pain in extremities as non-serious. The reporting physician did not assess the seriousness of pain in MP joint of right all fingers, oedema in right hand, vomiting, and diarrhoea. Additional information has been requested.


VAERS ID: 517245 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-09-03
Onset:2011-01-01
   Days after vaccination:120
Submitted: 2013-12-19
   Days after onset:1083
Entered: 2013-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Epilepsy, Fatigue, Feeling abnormal, Foaming at mouth, Hallucination, Influenza like illness, Muscle spasms, Muscular weakness, Tongue biting, Urinary incontinence
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1312SWE008018

Write-up: Information has been received from Sanofi Pasteur MSD (E2013-10704) on 11-DEC-2013. Case was received from a non health care professional via the Health Authorities in a foreign country on 11-DEC-2013 under the reference MPA-2013-000265. Case is not medically confirmed. Primary source was a consumer. A 15-year-old female patient with no medical history reported, had received the unspecified dose number in series of GARDASIL (batch number not reported) via not reported route and site of administration on 15-Feb-2009. On 27-Apr-2009, the patient developed weakness of limbs. On 03-Nov-2009, the patient developed nightly hallucinations and cramps. The patient had also received the unspecified dose number in series of GARDASIL (batch number not reported) via not reported route and site of administration on 03-09-2010 (contradictory: HA mentioned 03-Sep-2013 in the narrative). On 01-Jan-2011, the patient additionally developed fully developed epileptic seizures. The patient was hospitalised. The patient reported "feels like I am falling. I try to scream but cannot open my mouth." "During the seizure I develop foaming at the mouth, has urine output, bite my tongue and hallucinate." The day after she was very tired and suffered from flu-like symptoms. She was treated with lamotrigine (Other MFR) due to the events. It was unknown how many doses of GARDASIL she had received. Upon medical review the company judged relevant to code the following adverse events: tiredness and flu-like symptoms which were not reported. According to the HA, the events were possibly related to the vaccination. The case was regarded serious by the consumer, because of hospitalization, life threatening reaction and continuing disability.


VAERS ID: 517251 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-12-01
Onset:2013-02-15
   Days after vaccination:76
Submitted: 2013-12-19
   Days after onset:307
Entered: 2013-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Amenorrhoea, Blood follicle stimulating hormone increased, Blood luteinising hormone increased, Incorrect route of drug administration, Menstrual disorder, Nuclear magnetic resonance imaging abnormal, Ovarian atrophy, Ovarian disorder, Ultrasound ovary abnormal
SMQs:, Fertility disorders (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MRI: Left side ovarian atrophy, no visual of the ovary on the right side, normal uterus; Ultrasound scan: ovarian cannot be visualized; Blood follicle stimulating hormone, significantly elevated (77) IU/l; Blood luteinising hormone, 42 IU/l; Nuclear magnetic resonance imaging, No visual of ovary right side; Nuclear magnetic resonance imaging, Normal uterus; Nuclear magnetic resonance imaging, Left side ovarian atrophy; Ultrasound scan, Ovarian not visualized
CDC Split Type: WAES1312SWE006850

Write-up: Information has been received from a physician via SPMSD as part of a business agreement (Sender''s case report number SE-1577272925-E2013-10636) on 13-DEC-2013. Case of vaccination error with adverse events received from health care professional via Health Authority in a foreign country on 10-Dec-2013 under the reference number SE-MPA-133490. The primary reporter was a physician. Case is medically confirmed. This is a case of vaccination error (unknown whether it was in- or unintentional) since the patient received the vaccine via subcutaneous route of administration (hence inappropriate route of administration). A 15 year-old female patient (initials not reported), with no medical history reported, had received the third dose of GARDASIL (batch number unknown, 0.5 ml) via subcutaneous route of administration in not reported site of administration on 01-Dec-2012 and later on, 15-Feb-2013 she developed ovarian atrophy and amenorrhoea. The patient sought medical care in June (year not specified by HA) for absent menstruation. The investigation resulted in ovarian atrophy and premature ovarian disorder with unknown cause. She has almost no ovarian function at all. According to the parents, menstrual disturbance began in connection with the third GARDASIL vaccination that the patient had received in the previous year. No medical association but time associated. HA received additional information from the reporter, copies of medical journal: examinations and test results: significantly elevated FSH (77 IU/L) and LH (42 IU/L) levels. Ovarian cannot be visualized using ultrasound. MRI shows left side ovarian atrophy and no visual of the ovary on the right side but normal uterus. Referral response (29-Oct-2013) from the children''s clinic: it was assessed that the patient does not have a primary insufficient ovary with a incomplete progression of puberty (no further information provided). She has received estrogen (Other MFR) treatment and she will continuously be monitored at the children''s clinic for the time being. At the time of reporting, the patient had not recovered. According to the HA, the reactions are possibly related to vaccination.


VAERS ID: 517395 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-08-12
Onset:0000-00-00
Submitted: 2013-12-20
Entered: 2013-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Activities of daily living impaired, Appendicitis, Asthenia, Asthma, Back pain, Balance disorder, Biopsy lymph gland normal, C-reactive protein increased, Chest discomfort, Chills, Chronic fatigue syndrome, Clumsiness, Confusional state, Constipation, Contusion, Coordination abnormal, Diarrhoea, Disturbance in attention, Dizziness, Dyspnoea, Educational problem, Eye pain, Feeling abnormal, Feeling cold, Gastric disorder, Headache, Hearing impaired, Hyperacusis, Hyperhidrosis, Hypersomnia, Hypotonia, Infection, Influenza like illness, Insomnia, Lactose intolerance, Lymphadenopathy, Malaise, Memory impairment, Menorrhagia, Muscular weakness, Myalgia, Nausea, Neck pain, Oropharyngeal pain, Pain, Pain in extremity, Palpitations, Paraesthesia, Photophobia, Pollakiuria, Post viral fatigue syndrome, Pyrexia, Restlessness, Rhinorrhoea, Toothache, Visual impairment, Vitamin C deficiency, Wheezing
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Akathisia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On an unknown date, C-reactive protein often elevated.
CDC Split Type: WAES1312DNK007000

Write-up: Information has been received from Sanofi Pasteur MSD (DK-1577272925-E2013-10614) on 10-DEC-2013. Case of adverse event received from non-health care professional via Health Authorities on 10-Dec-2013 under the reference number DK-DKMA-ADR 22333686 and EFO7608. The primary reporter was the mother to the patient. A 15 year old female patient (weight: 62 kg; height: 170 cm) with no other health problems in general, had received the first dose of GARDASIL (batch number not reported) via not reported route of administration in not reported site of administration on 11-Feb-2009 and thereafter, the same day (11-Feb-2009), all the adverse events began. She developed: never completely rested, difficulty sleeping or sleeping constantly, memory impaired (can read a page in a book and no recall), fever with unknown cause, confused (become easily confused and find it difficult to follow a conversation) feel general malaise (sick), headache (severe headache daily), swollen lymph glands (many swollen lymph nodes in the neck and groin) and she has been hospitalized and had taken a biopsy of the lymph glands (without any conclusion). Often influenza symptoms, stabbing tingling pain in muscles without cause, heavy menstrual bleeding, chills (time and again). Having a hard time keeping warm, lactose intolerant (have suddenly become lactose intolerant), joint pain (constant pain in the joints), lack of coordination (it is hard to concentrate on anything in longer period of time (few minutes)), severe abdominal pain (the patient has been hospitalized several times with suspected appendicitis), often elevated CRP, infection in the body but no cause can be found, pain behind the eyes, throat pain, wheezing (when she lies down, her breathing wheeze (conclusion = asthma (no further information provided)), leg pain, back pain, sleep 18-20 hours a day, shortness of breath (quickly out of breath and feel no air comes into the lungs), strong sound sensitivity, strong sensitivity to light, dizziness (cannot stand for long periods without being dizzy, darken before the eyes (the HA coded LLT near fainting), muscular weakness (according to the mother, the doctor says that she has lost muscle mass), toothache, chest tightness (worst when she is lying down), foggy hearing/brain (can hear what people say, but do not understand what they say, the HA coded LLT foggy feeling in head), unexplained bruising (often unexplained bruising on the legs), unusual tiredness and weakness that does not improve even after sleeping long hours, breathing problems (she has been hospitalized several times (dates not reported) with trouble breathing). Diffuse pain in the legs, arms, neck or whole body. It can be stabbing pain, tingling pain, and they can wander around. Palpitations, chest tightness, chronic vitamin D deficiency, frequent urination. Stomach problems with either constipation or diarrhea, nausea, bloating. Sweat attack, running nose, balance problems and clumsiness (drop things and go into chairs and door frames). Patient''s mother says that her daughter in 2010 was diagnosed with ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) of hospital, but many doctors believe differently. And that a doctor at Infectious Diseases clinic, felt that her mind might play her tricks to believe that she is sick. Note: she has been a perfectly normal healthy and active girl. She was active in school, loved to ride and was at the riding school several times a week and also she played soccer as often as she can. She has since she was 13 years been working in several places after school. She was a diligent and hard-working girl who put great pride in getting things done. She was very well-liked at school and at work. Unfortunately changed everything for her. She struggled in vain to keep up at school. Fought to pass the 9th and 10th grade, but had to give up when she was sick all the time. The family reported it in a concern report to the municipality in 2011. She had to end work, as it was too exhausting for her as well. She no longer had the energy go out to the stables, being with her friends and could no longer play football or other physical activities, as these things always trigger significant deterioration of all the symptoms she has. From being a healthy energetic girl, her life has been completely debilitating. She has been sick for the last 4-5 years now. The HA has requested patient''s physician medical confirmation and reply is awaited. Upon medical review the company judged relevant to code the following adverse events: her mind might play her tricks to believe that she is sick (onset date not reported) and lost muscle mass (onset date 11-Feb-2009). The patient had received the second dose (batch number not reported, vaccination date not reported) and the third dose (batch number not reported, on 12-Aug-2009) of GARDASIL. At the time of reporting, outcome of all AE were not recovered except for that her mind might play her tricks to believe that she is sick and lost muscle mass, which were not reported.


VAERS ID: 517751 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-11-03
Onset:2011-11-04
   Days after vaccination:1
Submitted: 2013-12-27
   Days after onset:784
Entered: 2013-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NP14780 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Angiogram normal, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody increased, CSF oligoclonal band absent, CSF protein increased, CSF test normal, Central nervous system inflammation, Dizziness, Double stranded DNA antibody, Ear, nose and throat examination normal, Eating disorder, Electroencephalogram normal, Endoscopy upper gastrointestinal tract, Epstein-Barr virus antibody positive, Epstein-Barr virus infection, Escherichia test positive, Fatigue, Helicobacter test negative, Histology abnormal, Human chorionic gonadotropin normal, Malaise, Morbillivirus test positive, Mycoplasma test positive, Nausea, Neurological examination normal, Nuclear magnetic resonance imaging brain abnormal, Ophthalmological examination normal, Rubivirus test positive, Rubulavirus test positive, Simplex virus test positive, Sinusitis, Syncope, Thyroid function test normal, Ultrasound abdomen normal, Urine analysis normal, Varicella virus test positive, Visual evoked potentials normal, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Demyelination (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: 10/2011, Dizziness; Gastritis; Immunisation
Preexisting Conditions: Gastroenteritis; Epstein-Barr virus infection; 12/10/1996, Developmental hip dysplasia; 08/09/1996, Caesarean section
Allergies:
Diagnostic Lab Data: Angiogram, Normal; Antineutrophil cytoplasmic antibody, normal; Antinuclear antibody, increased at 1:80; Antinuclear antibody, Negative; 02/07/2012, CSF test, HSV antibody index 1.7, VZV antibody index 1.5; 04/30/2012, CSF test, Normal; 04/30/2012, CSF test, serology: HSV IgG titre 252; Culture stool, positive for EPEC; 02/07/2012, Culture stool, Negative for worm test; Double stranded DNA antibody, Normal; 02/13/2012, Ear, nose and throat examination, Normal; 02/09/2012, Electrocardiogram, normal; 02/09/2012, Electroencephalogram, normal; 03/27/2012, Electroencephalogram, Normal; 02/09/2012, Endoscopy upper gastrointestinal tract, fundus cascade; 02/07/2012, Epstein-Barr virus antibody, positive; Helicobacter test, Negative; Histology, showed chronic gastritis; 02/07/2012, Human chorionic gonadotropin normal; Laboratory test, past mycoplasma infection; Laboratory test, past varicella infection; Laboratory test, past MMR infection or vaccination; 12/09/2011, Laboratory test, Normal; 02/07/2012, Laboratory test, Normal; 10/25/2012, Laboratory test, Normal; 11/05/2012, Laboratory test, Normal; 03/27/2012, Neurological examination, Normal; 10/25/2012, Neurological examination, suspicion of chronic inflammatory CNS disease; 11/05/2012, Neurological examination, Normal; 11/15/2012, Nuclear magnetic resonance imaging, no new findings, T1 hypointensities regressing; 02/13/2013, Nuclear magnetic resonance imaging, Normal; 02/08/2012, Nuclear magnetic resonance imaging brain, periventricular signal intense areas, sinusitis; 04/16/2012, Nuclear magnetic resonance imaging brain, new small foci in anterior horn; 04/16/2012, Nuclear magnetic resonance imaging brain, + gadolinium: no enhancement; 05/04/2012, Nuclear magnetic resonance imaging brain, unchanged; 05/03/2013, Nuclear magnetic resonance imaging brain, unchanged lesions of white matter; 02/09/2012, Ophthalmological examination, normal; 05/07/2012, Ophthalmological examination, Normal; 02/07/2012, Physical examination, Normal; 11/05/2012, Physical examination, Normal; 12/09/2011, Serology test, EBV-EBNA IgG $g600 U/ml, EBV-IgG Immuno; 12/09/2011, Serology test, EBV-VCA IgM 55.8 U/ml, EBV-VCA IgG 113.0 U/ml; 04/30/2012, Serology test, HSV IgG 1:28000, positive HSV-1 IgG; 05/02/2012, Thyroid function test, Normal; 02/07/2012, Ultrasound abdomen, normal; 12/07/2012, Urine analysis, Normal; Visual evoked potentials, normal
CDC Split Type: WAES1312DEU011435

Write-up: Information was received from sanofi pasteur with manufacturer number of E2013-10994 on 19-Dec-2013. Case was received from the Health Authorities on 19-Dec-2013 (reference no. PEI2013077167). Case is medically confirmed. A 15-year-old female patient received the first dose of GARDASIL (lot-no. NP14780, expiry date Mar-2012) IM into the left upper arm on 03-Nov-2011. On 04-Nov-2011, the patient developed dizziness attacks and tiredness and felt unwell. Patient''s medical history included EBV-infection, gastroenteritis (exact onset not reported) and chronic gastritis and since Oct-2011 intermittent dizziness. U1 (first examination of newborn program) on 19-Aug-1996 showed that the patient was born by Caesarean section because of existing disproportion. U4 on 10-Dec-1996 showed dysplasia of both hips requiring abduction diapers. Family anamnesis included rheumatoid arthritis. Lab data of 09-12-2011 was normal. Serology tests on 09-Dec-2011 revealed EBV-VCA IgM 55.8 U/l, EBV-VCA IgG 113.0 U/ml, EBV-EBNA IgG $g600 U/ml and EBV-IgG Immuno blot was positive. Based on these findings a reactivated acute infection was assumed. The patient was hospitalized from 07-Feb-2012 to 16-Feb-2012 due to persisting nausea, dizziness attacks (occurring once or twice per months, then about 3 times per day) and one time syncope. Diagnosis was "suspicion of postinfectious changes in cranial MRI". On admission, physical examination, lab tests, beta-HCG in urine, and urine analysis were normal. Stool was negative for worm eggs. Serology was negative for Borrelia, Lues and Toxoplasmosis antibodies. Furthermore, serology was positive for suspicion of recent EBV infection, past measles, mumps and rubella infection or vaccination, past varicella infection and mycoplasma infection. Cerebral fluid showed an increased HSV and VZV antibody index of 1.7 and 1.5, respectively. ENA was negative, ANA increased at 1:80, ANCA serology and double-stranded DNA antibodies were normal. Stool culture revealed enteropathogenic E. coli (EPEC). Ultrasound of abdomen on 07-Feb-2012 was normal as well as EEG, ECG and eye examination on 09-Feb-2012. Neurological examination showed normal visual evoked potentials. MRI of brain on 08-Feb-2012 showed periventricular signal intense areas. 3 out of 4 Barkhof criteria for diagnosis of disseminated encephalomyelitis were met, differential diagnosis was ADEM. Cerebral microangiopathies could not be excluded but were assumed as unlikely due to patient''s age. Secondary MRI finding included sinusitis. Gastroscopy on 09-Feb-2012 revealed fundus cascade, otherwise was normal. Helicobacter test was negative. Histology showed chronic gastritis. MRI of spine on 13-Feb-2012 was normal as well as ear, nose and throat examination. Based on these findings a postinfectious event was considered as the most probable cause. The patient was discharged in good general condition. On 27-Mar-2012 the patient presented to the neuropediatric ward for check-up of the postinfectious changes seen in the brain MRI on 08-Feb-2012. The patient reported no more dizziness attacks and only mild ongoing nausea. Neurological examination and EEG were normal. On 16-Apr-2012 the patient presented to the doctor and reported that since Feb-2012 she had had symptom free days alternating with days of mild headache, nausea and tiredness. Physical examination was normal. MRI of brain revealed new small foci in the anterior horn compared to the previous MRI. After IV gadolinium administration, no signs of enhancements were seen. ADEM, multiple sclerosis or other demyelinating disease was suspected. The patient was hospitalized from 26-Apr-2012 to 07-May-2012. Physical examination was normal. CSF test on 30-Apr-2012 was normal. CSF serology on 30-Apr-2012 showed HSV IgG titre of 252. Serum serology on 30-Apr-2012 showed HSV IgG antibodies 1:28000 and positive HSV-1 IgG antibodies (ELISA). Laboratory test on 02-May-2012 showed normal thyroid function. MRI of brain on 04-May-2012 was unchanged. TOF-angiography was normal. Eye examination on 07-May-2012 was normal. Therapy included ANTRA for gastritis. During hospitalization, the patient hardly had nausea and only mild dizziness. On 21-Jun-2012 the patient presented to the neuropediatrician. Patient''s development anamnesis was without pathological findings. At that time, onset of dizziness was reported as "October 2011" (before vaccination). An EBV-associated ADEM was assumed but could not be proven by CSF tests because of no EBV-DNA had been detected. Since discharge from hospital the patient had not experienced dizziness. However, the patient had no physical or other stress, had been sleeping a lot, and after getting up in the early afternoon, she had been sitting or lying most of the time. Nausea was still persisting. However, the symptoms of nausea had changed in terms of stomach pain or rather feeling of pressure in the abdomen which lasted for about 1 hour and spontaneously regressed. The patient herself discontinued omeprazole therapy. Since 29-Jun-2012 the patient received physiotherapy focused on children''s central nervous system. On 25-Oct-2012 the patient was presented to a consulting neurologist. Suspicion of "chronic inflammatory CNS disease with known fatigue symptoms" was stated. Laboratory values of the same day were normal. The patient was again hospitalized from 05-Nov-2012 to 09-Nov-2012. At that time, "ADEM post vaccination" was mentioned the first time. It was reported that "following HPV vaccination in November 2011, the girl developed persistent daytime tiredness". Physical and neurological examinations were normal as well as laboratory values of 05-Nov-2012. It was reported that "previous lumbar punctures showed no oligoclonal bands but existing barrier disturbance and increased CSF proteins" (no date was reported, this is in discrepancy with previous CSF findings). Vasculitis screening was normal. McDonald criteria for multiple sclerosis were not met. Medication included metoclopramide (MCP) drops and VOMEX. MRI of cervical spine and head on 15-Nov-2012 revealed no new findings. Even though T1 hypointensities were regressing, ADEM was suspected. On 10-Jan-2013 an unspecified "psychological disorder" was suspected. On 03-May-2013, the patient presented for emergency to the outpatient unit. Since Jan-2013 she had been feeling well, however on 29-Apr-2013 dizziness and nausea reoccurred, and she felt unwell. Rehabilitation in 2012 had not been successful because of bad experiences in the psychosomatic clinic with addicted patients. Therefore rehabilitation had been stopped after few days. MRI of head on 03-May-2013 showed unchanged lesions of white matter, no new lesions and no barrier disturbance were detected. Based on all findings, the current symptoms were suspected to be a psychosomatic origin (several hospitalizations in the past months, a lot of stress, abnormal eating behavior including weight loss, tragic family fate). Final diagnosis was "suspicion of EBV-associated ADEM". At the time of reporting, the patient had not recovered. Upon internal medical review the company added the following AEs which were mentioned in the source documents but not coded by HA: reactivation of EBV infection, chronic inflammatory CNS disease, syncope, psychosomatic disease.


VAERS ID: 523248 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-09-18
Onset:2010-03-01
   Days after vaccination:164
Submitted: 2014-02-21
   Days after onset:1453
Entered: 2014-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0773X / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac stress test, Dyspnoea, Echocardiogram, Electrocardiogram, Palpitations, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 05/29/2009, GARDASIL, immunisation; 03/12/2009, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Cardiac stress test, not provided; Echocardiogram, not provided; Electrocardiogram, not provided
CDC Split Type: WAES1402DNK009464

Write-up: Information has been received from SPSMD (manufacturer control # DK1577272925-E2014-01393) in 19-FEB-2014. Case was received from a health professional via the Health Authorities on 14-Feb-2014 under the references DK-DKMA-ADR 22409359 and DK-DKMA-EFO8127. Case is medically confirmed. Primary source was a physician. Case assessed as serious. A 15-year-old female patient (weight, height not reported) with no medical history reported received the third dose of GARDASIL (batch # NJ50800, lot #: 0773X, expired date: 16-JUN-2011) via intramuscular route on 18-Sep-2009. In March 2010, the patient developed tachycardia, breathlessness and palpitations. The patient was a soccer player who did not play in winter. Upon re-start of soccer in March 2010, she cold not play due to the adverse events. Cardiac investigations including medications were given. At the time of reporting, the patient had not recovered. Previous doses of GARDASIL were given via intramuscular route on 12-Mar-2009 (dose 1, batch#, NK36120, lot#: NJ33240, expired date: 30-SEP-2011) and on 29-May-2009 (dose 2, batch # NK05560, lot# 0773Z, expired date: 16-JUN-2011). Toleration was not reported.


VAERS ID: 525647 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-13
Entered: 2014-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Blood test normal, Electrocardiogram normal, Endometriosis, Fatigue, Hypertension, Hypothyroidism, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Hypertension (narrow), Hypothyroidism (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL
Allergies:
Diagnostic Lab Data: Blood test, inflammatory values: normal; Electrocardiogram, normal
CDC Split Type: WAES1403DEU006601

Write-up: Information has been received from Sanofi Pasteur MSD (report number DE-1577272925-E2014-02099) on 12-MAR-2014. Case was received from a healthcare professional on 07-Mar-2014. Case is medically confirmed. An about 15 year-old female patient received a third dose of GARDASIL (lot-no., injection route and site not reported) on an unspecified date in 2009. Mid of 2012, at the age of about 18 years, she developed tachycardia, arterial hypertension, hypothyroidism and endometriosis. She also felt exhausted. ECG and inflammatory values showed normal results, myocarditis as other cardiac diseases were ruled out. She was medicated with beta-blockers (not otherwise specified), BELLA HEXAL and unspecified thyroid drugs. She also received psychotherapy. Due to exhaustion, the patient was only able to work for four hours per day. At the time of reporting she had not recovered. According to the reporter, the events were not related to vaccination. Patient received two doses of GARDASIL on unspecified dates, toleration was not reported. Upon medical judgement the company assessed the case as serious due to disability (not able to work normally) and duration of the events.


VAERS ID: 529131 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-05-01
Submitted: 2014-04-23
   Days after onset:357
Entered: 2014-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Asthenia, Blood test normal, Computerised tomogram abdomen normal, Computerised tomogram thorax normal, Headache, Myalgia, Nuclear magnetic resonance imaging brain normal, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood test, unremarkable biologic exploration; Computerised tomogram, normal thoraco-abdominal scan; Nuclear magnetic resonance imaging brain, normal
CDC Split Type: WAES1404FRA011567

Write-up: Information has been received from Sanofi Pasteur MSD (E2014-03479) on 18-APR-2014. Case received from the Health Authorities on 16-Apr-2014 under the reference number MP20140253. A 15 year-old-female patient with no relevant medical history had received a first dose of GARDASIL (batch number not reported) via intramuscular route in March or April 2013. In May 2013, she developed headache, skin eruption, asthenia, arthralgia and myalgia which evolved. The patient received the second dose of GARDASIL (batch number not reported) via intramuscular route in July 2013. The causal link between the symptoms and vaccination was suggested since all the symptoms worsened following the second injection. The work-ups realised in December 2013 and February 2014 showed a normal brain MRI, normal thoraco-abdominal scan and a blood test with unremarkable biologic exploration. At the time of the report, the outcome was unknown. The Health Authorities assessed the causal relationship between the reported reactions and the vaccination as doubtful (C1 S2 I1) according to the method of assessment. It is noteworthy that the Health Authorities coded life-threatening and disability as seriousness criteria.


VAERS ID: 530790 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-29
Onset:2013-10-01
   Days after vaccination:186
Submitted: 2014-05-14
   Days after onset:225
Entered: 2014-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0989AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Electrocardiogram normal, Epilepsy, Neck pain
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Electrocardiogram, no abnormality
CDC Split Type: WAES1405JPN006016

Write-up: Initial information has been received from a physician concerning a 15-year-old female patient who on 29-MAR-2013 was vaccinated with the third dose of GARDASIL IM injection drug (dose, injection site, and indication not provided). Batch number: 9QN08R and lot number: 0989AA with expiry date 21-JUN-2014. No information on concomitant medication was reported. On 19-SEP-2012, the patient was vaccinated with the first dose of GARDASIL at hospital A. On 29-NOV-2012, the patient was vaccinated with the second dose of GARDASIL at hospital A. On 29-MAR-2013, the patient was vaccinated with the third dose of GARDASIL at hospital A. On 29-AUG-2013, the patient was in a bad condition and presented to the department of orthopedics at hospital B. She had a diagnosis of a posterior cervical pain and was prescribed LOXONIN. On an unspecified date, as the posterior cervical pain did not recover, the patient visited hospital A again. An electrocardiogram was performed, but showed no abnormality. She was prescribed a pain-relief lotion. Around October-2013, the patient experience epilepsy after two months and presented to the department of pediatrics at nearby hospital C. A detailed examination was performed at the department of psychiatry at hospital C, but causality was unknown. The patient was scheduled to visit an epilepsy center. At the time of report on 09-MAY-2014, the outcome of epilepsy was not recovered, and that of posterior cervical pain was unknown. Reporters comment: not provided. The reporting physician did not assess the causal relationship of epilepsy and the posterior cervical pain to GARDASIL. (A psychiatrist at hospital C felt that the causality between epilepsy and GARDASIL was unknown). The reporting physician considered that epilepsy was serious (disability and other important medical event), and did not assess the seriousness of the posterior cervical pain. Additional information has been requested.


VAERS ID: 541076 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-06-01
Onset:0000-00-00
Submitted: 2014-08-25
Entered: 2014-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Myelitis transverse, Paraplegia
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1408DEU014061

Write-up: Information has been received from Sanofi Pasteur (Mfr control no. DE-1577272925-E2014-07330) on 22-AUG-2014. Case was received from a health care professional on 19-Aug-2014. Case is medically confirmed. Case is poorly documented. A 15-year-old previously healthy female patient received a first dose of GARDASIL, (lot-no. not reported) on an unspecified date in Jun-2014. 4 weeks later, she developed paraplegia within four hours. Diagnosis of transverse myelitis was established. She was hospitalised and currently stays in a neurological rehabilitation clinic (outcome not recovered).


VAERS ID: 542595 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-05
Entered: 2014-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Movement disorder, Muscular weakness, Pyrexia, Skin discolouration, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1409COL000608

Write-up: This spontaneous report as received from a consumer (also reported as father) refers to a 15 year old female patient. On an unknown date in 2013 the patient was vaccinated with a dose of GARDASIL, (strength 0.5 ml), (lot number and expiry date unknown) intramuscularly. No concomitant medications were reported. On an unknown date patient felt that the legs do not respond, experienced fever, vomiting, purple spots on the skin, could not give a step because the legs did not respond her. Doctor said that the presence of the child at the hospital was given by a picture of muscle weakness. The outcome of events was unknown. Action taken was reported as unknown. Causality was unknown. Additional information is not expected.


VAERS ID: 553998 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-05-19
Onset:2012-08-01
   Days after vaccination:74
Submitted: 2014-10-31
   Days after onset:821
Entered: 2014-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 9QN03R / 2 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Acoustic stimulation tests normal, Activities of daily living impaired, Asthenia, Atonic seizures, Deafness, Deafness bilateral, Dizziness, Fear of crowded places, Gait disturbance, Headache, Hypoacusis, Hypoaesthesia, Laboratory test normal, Malaise, Memory impairment, Muscular weakness, Nausea, Nuclear magnetic resonance imaging normal, Photophobia, Schizophrenia, Seizure, Visual field defect
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYPREXA
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 08/2012, Acoustic stimulation tests, found no abnormalities; 2012, Medical observation, no abnormalities; 08/2012, Nuclear magnetic resonance imaging, without abnormalities
CDC Split Type: WAES1410JPN015952

Write-up: This spontaneous report as received from a physician refers to a 17 year old female patient with no concomitant disease, medical history. On 19-MAR-2012, the patient was vaccinated with a first dose of GARDASIL (dose and lot # not reported) intramuscularly and on 19-MAY-2012, the patient received the second dose of GARDASIL (dose and lot # not reported) intramuscularly. Concomitant therapies included ZYPREXA. One month later, in July 2012, the patient experienced malaise, headache and weakness. In August 2012, she became hard of hearing and visited hospital (otolaryngology). A diagnosis of moderate deafness was given. Then she visited another hospital (brain surgery) where MRI examination was performed without abnormalities. Then the patient visited another hospital (neurology) due to dizziness and feeling queasy. Then she visited another hospital (psychosomatic medicine). In the same month, she experienced visual field constriction and visited another hospital (ophthalmology) without abnormalities. She became deafness bilaterally while hearing test found no abnormalities. In the middle of September 2012, deafness resolved. On an unspecified date in 2012, the patient experienced unspecified symptoms on the back and weakness of hands. She became having difficulty in walking and tend to absent from school. Examinations on internal medicine found no abnormalities. As of 2013, she was able to keep attending to school. In January 2014, her parents heard from some of her friends that the patient had hallucination, talking strange things. The patient visited another hospital (stress clinic) where a diagnosis of schizophrenia was given. On an unspecified date in 2014, the patient became bad at memorization and visited another hospital where olanzapine was prescribed. She also experienced atonic seizures and numbness of limbs. She became unable to go to school. The patient was wearing sunglasses in the house due to photophobia and she seemed to have a fear of crowd of people. On an unspecified date, she also experienced convulsion. As of 28-OCT-2014, the patient was recovered from deafness. The outcome of malaise, headache, weakness, dizziness, feeling queasy, difficulty in walking, hallucination, bad at memorization, numbness of limbs, photophobia and convulsion was not recovered. The outcome of visual field constriction, weakness of hands, schizophrenia, atonic seizures and school refusal was unknown. Reporter comments: The patient asked the association who commented that her symptoms might be due to GARDASIL. The reporting physician felt that malaise, dizziness, feeling queasy, headache, weakness, deafness, difficulty in walking, photophobia, convulsion, hallucination, bad at memorization and numbness of limbs were related to GARDASIL. The reporting physician did not assess the relationship of visual field constriction, weakness of hands, schizophrenia, atonic seizures and school refusal to the vaccine. The reporting physician felt that malaise, dizziness, feeling queasy, headache, weakness, deafness, difficulty in walking, photophobia, convulsion, hallucination, bad at memorization and numbness in limbs were serious due to disability. The reporting physician did not assess the seriousness of visual field constriction, weakness of hands, schizophrenia, atonic seizures and school refusal. Upon internal review atonic seizures, convulsion and bilateral deafness were determined as serious due to an other important medical event. Additional information has been requested.


VAERS ID: 581619 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2010-09-01
Submitted: 2015-06-08
   Days after onset:1741
Entered: 2015-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Blood test, Confusional state, Discomfort, Dizziness postural, Drug intolerance, Fatigue, Food allergy, Gluten sensitivity, Headache, Joint laxity, Lactose intolerance, Loss of personal independence in daily activities, Tendon laxity, Tendon pain, Visual impairment, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, dose 2, Immunisation; 2009, GARDASIL, dose 1, Immunisation
Allergies:
Diagnostic Lab Data: Examinations and tests: blood tests, test for deficiency in vitamins/minerals, blood pressure, diabetes. Test with wires through nose to stomach, Vega test.
CDC Split Type: WAES1506DNK003172

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # 06098) on 04-JUN-2015. Case received from consumer or other non health professional via the Health Authorities on 01-Jun-2015 under the reference number DK-DKMA-ADR 23007679 and DK-DKMA-EFO12185. Case is not medically confirmed. A 15-year-old female patient (weight 65 kg, height 175 cm) with no medical history reported had received three injections of GARDASIL, (batch number not reported) on an unspecified date in 2009 (D1), on an unspecified date (D2) and on an unspecified date in 2010 (D3) via intramuscular route into not reported sites of administration. In Sep-2010, the patient experienced headache, tiredness and confusion and on an unspecified date in 2010 suspicion of development of allergies (gluten, lactose and eggs). In Mar-2011, the patient experienced involuntary vomiting (food/water returned in the mouth), and on an unspecified date in 2011, the patient developed aching joints, tendon pain, join and tendon laxity when she tried to exercise. In 2012, the patient developed dizziness (when she stood up), frequent attacks of total discomfort in the body (could only lie down and look at the air), drug intolerance NOS (e.g. morphine, analgesics (at hospitalization)), black spots before eyes and on an unspecified date loss of energy. The following examinations or test had been performed: blood tests, test for deficiency in vitamins/minerals, blood pressure, diabetes. Test with wires through nose to stomach, Vega test. The patient had received the following treatment for the adverse reactions: acupuncture, analgesics, dietary change. The patient had not been hospitalized due to the adverse reactions. There were no other medications. It was reported that the patient was certain that all these symptoms she had came from the HPV vaccines. Before, she was an energetic girl, who loved to practice sports several hours per day. In addition to that, she had lots of energy to both school, family and friends. After the vaccines, the patient had energy only for a few things and often none. There had been a struggle to get through high school properly and the patient had involuntary had to abandon many leisure activities and friends and other social things, as she did not have energy for that much. For periods, nothing. Today, the patient was uncertain, how she shall manage a full time education, while possibly having a part time job and living alone. Every day, when the patient went to bed, she did not know if the next day was a day that she would get through or a day she must stay in bed (disabling). At the time of reporting, the patient had recovered from involuntary vomiting and had not recovered from all the other events. Regulatory Authority has requested medical confirmation.


VAERS ID: 582131 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-17
Onset:0000-00-00
Submitted: 2015-06-15
Entered: 2015-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Blood test, Chest pain, Confusional state, Cystitis, Disturbance in attention, Drug hypersensitivity, Dyspepsia, Dysstasia, Electrocardiogram, Emotional distress, Headache, Heart rate increased, Hyperaesthesia, Hypotension, Immune system disorder, Infection, Insomnia, Laboratory test, Malaise, Memory impairment, Muscle tightness, Muscular weakness, Nasal congestion, Oropharyngeal pain, Peripheral coldness, Pyrexia, Rash, Stress, Temperature intolerance, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Seasonal allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On an unknown date the patient experienced high pulse, low blood pressure, fever every day, rapid heart rate. The following examinations and/or laboratory tests had been performed: countless of blood tests and Electrocardiogram (ECG) on an unspecified date. The results was not reported.
CDC Split Type: WAES1506DNK007138

Write-up: Information has been received from Sanofi Pasteur MSD (SPMSD)(Mfr. control#DK-1577272925-E2015-06526) on 12-JUN-2015. Case received from consumer or other non health care professional via the Health Authorities on 09-JUN-2015 under the reference number DK-DKMA-ADR 23012447 and DK-DKMA-EFO12234. Case is not medically confirmed. A 14-year-old female patient (weight: 51 kg, height: 165 cm), with a medical history of grass allergy, had received three injections of GARDASIL (batch number not reported) via intramuscular route into not reported site of administration on 22-OCT-2008 (D1), on 16-DEC-2008 (D2) and on 17-APR-2009 (D3). On 12-MAR-2009, the patient developed dizzy. On an unknown date the patient experienced high pulse, low blood pressure, concentration impaired, weakness in muscles arms/legs (could not stand up), very poor immune system (sick several times every month), headache, pain in throat, hives, rash, anxiety, sleeplessness, fever every day, infections, pain in chest, stomach acid, cystitis, hypersensitivity to drug and touch, memory impaired, sensitive to cold, cold hands/feet, muscle tension, stress, nose congestion, rapid heart rate, confused and had difficulty coping with things. The following examinations and/or laboratory tests had been performed: countless of blood tests and electrocardiogram (ECG). Other vaccines: no. Other medications: no. Agency had requested medical confirmation. The patient was hospitalized with fever. At the time of reporting, the patient had not recovered.


VAERS ID: 582132 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2010-11-15
Submitted: 2015-06-15
   Days after onset:1672
Entered: 2015-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Disability, Fatigue, Pain, Post herpetic neuralgia
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Gabapentin
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1506GBR006887

Write-up: This spontaneous report as received from a consumer via the Agency refers to a 15 year old female patient who on an unknown date was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown), parenteral. Concomitant therapies included gabapentin. On 15-NOV-2010 the patient experienced chest pain, post herpetic neuralgia and fatigue. "Have just read reports that there are doubts about this medication, and something clicked, she only started with the pain since she received the injections, and the doctors can find no reason why". Seek Advice Details: Severe pain, tiredness. Now under specialist neurological care and constant medication. The outcome of the chest pain, post hepatic neuralgia and fatigue was reported as not recovered. The Agency considered chest pain, post herpetic neuralgia and fatigue serious due to disability and medically significant. The Agency did not assess the relationship between chest pain, post herpetic neuralgia, fatigue and vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown). Additional information is not expected as no follow up can be obtained from Regulatory Authorities.


VAERS ID: 582287 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-12-22
Onset:2009-01-15
   Days after vaccination:24
Submitted: 2015-06-15
   Days after onset:2341
Entered: 2015-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0747X / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Asthenia, Back pain, Balance disorder, Chest pain, Contusion, Disturbance in attention, Ear pain, Educational problem, Exercise tolerance decreased, Fatigue, Headache, Heart rate increased, Hyperacusis, Hypersomnia, Hypotonia, Lack of satiety, Memory impairment, Migraine, Nausea, Neck pain, Pain, Pain in extremity, Pain in jaw, Paraesthesia, Photophobia, Presyncope, Restlessness, Social avoidant behaviour, Tension headache
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Akathisia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1506DNK007263

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control number DK-1577272925-E2015-06517) on 12-JUN-2015. Case received from a health care professional via the Health Authorities on 09-Jun-2015 under the reference number DK-DKMA-ADR 23012453 and DK-DKMA-EFO12238. Case is medically confirmed. Primary source was a physician. A 15-year-old female patient (weight and height not reported), with no medical history reported, had received three injections of GARDASIL via intramuscular route into not reported site of administration on 31-Oct-2008 (D1, batch number NJ01850, lot # 1941U, expiration date 12-DEC-2010), on 22-Dec-2008 (D2, batch number NJ38950, lot # 0747X, expiration date 20-MAY-2011) and on 30-Apr-2009 (D3, batch number NK05560, lot # expiration date, expiration date 16-JUN-2011). On 15-Jan-2009, the patient developed headache, high resting pulse (rapid pulse) and dizziness. On an unknown date, the patient experienced migraine, nausea, muscle flaccidity, tension, jelly legs, weakness, loss of satiety, tiredness, chest pain and became distant and felt that she will faint. On an unknown date, she was unconcentrated (no overview) and also developed pain in ears, memory impaired, light/sound sensitivity, pain in joint, back and neck, sensitivity, pain in hands, restlessness in the body, bruises, tingling of arms and legs, pain in jaw, temples and slept 12-13 hours at a time. She consulted own doctor for the first time on 24-Feb-2009 with dizziness and headache. The patient was up till then a very well functioning girl, who participated in dance at high level (2-3 hours three times per week, and running the other days). The patient had to stop this sport due to headache and dizziness. The patient was quickly referred to neurological department due to headache. She had been medicated with some medication and diagnosed with migraine, tension headache had been mentioned. Due to high resting pulse, she had been to cardiologists at hospital. The last was a progression at pain center, where the diagnosis was chronic non-malignant pain condition. "The patient is currently medicated with venlafaxine, sumatriptan, saroten, propranolol, noritren and harmonet." The patient had also been referred to headache center where she had an appointment for pre-evaluation in October 2015. She was additionally referred to consultant at the pediatric department, due to suspicion of possible HPV adverse reactions. "If in need for additional information, I recommend you to contact hospital, neurological department, cardiological department, medicine department, pain center for discharge summaries. Currently, the patient has with much hassle completed a hairdressing education, but is now on sick leave." Other medications were not provided. The patient had been evaluated by neurologists (hospital), cardiologists (hospital) and by physicians at pain center. At the time of reporting, the patient had not recovered. The events were considered as disability by the reporter.


VAERS ID: 582289 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-15
Onset:0000-00-00
Submitted: 2015-06-16
Entered: 2015-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Arthralgia, Blood test, Depression, Disturbance in attention, Dizziness, Fatigue, Headache, Heart rate increased, Hemiparesis, Hypoacusis, Lumbar puncture, Muscle spasms, Muscular weakness, Myalgia, Palpitations, Paralysis, Petit mal epilepsy, Photophobia, Scan, Sensory disturbance, Speech disorder, Syncope, Tremor, Ultrasound chest, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: The patient was hospitalized in May 2014, where blood tests, scans, lumbar puncture and all tests and evaluations for blood clot in the brain and sclerosis had been performed. In addition, there had been done ultrasound scan of the patient''s heart and special lung scan. She was evaluated at neurological and cardiological department, an explanation had not been found yet.
CDC Split Type: WAES1506DNK007195

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control #DK-1577272925-E2015-06508) on 12-JUN-2015. Case received from a health care professional and the patient''s insurance company (15-4495) via the Health Authorities on 09-Jun-2015 under the reference number DK-DKMA-ADR 22987897 and DK-DKMA-EFO12026. Case is medically confirmed. Primary source was a physician, consumer and lawyer. A 15-year-old female patient (weight: 99 kg, height: 167 cm), with no medical history reported, had received three injections of GARDASIL, batch number not reported via intramuscular route into not reported site of administration on 06-Oct-2008 (D1), on 17-Dec-2008 (D2) and on 15-Apr-2009 (D3). On an unspecified date in 2009, the patient developed speech impairment on/off, concentration impairment and persistent depression. On an unspecified date in Apr-2009, the patient experienced cramp-like attack (especially during sleep), constant tiredness and exhaustion. Furthermore, she was uncontactable (absence-like event) on an unspecified date in Apr-2009. On an unspecified date in 2012, the patient developed anxiety. On 01-Dec-2013, the patient developed tremor in body, joint and muscle pain. On an unspecified date in 2014, the patient developed rapid resting pulse, decreased vision and hearing and palpitations. On an unspecified date in May-2014, the patient experienced intermittent paralysis, paralysis in the entire body, muscle weakness (difficulty noticing if she has grasped things - grasps too hard or too little), weakness in right side all the time and sensory disturbance (in right side constantly and in left side on/off). On an unknown date the patient developed chronic headache, light sensitivity, chronic dizziness and fainting. The patient had been treated for the adverse reactions with SAROTEN, MFR unknown, CIPRALEX, MFR unknown, venlafaxine (MFR unknown), acupuncture, chiropractor and physical rehabilitation. The patient went from the last vaccine up till May 2014, where no physician took her attacks seriously. The patient mentioned the vaccine again in May 2014, and got rejected by physician at neurological department. She was subsequently elevated, see "test". The patient was hospitalized in May 2014, where blood tests, scans, lumbar puncture and all tests and evaluations for blood clot in the brain and sclerosis had been performed. In addition, there had been done ultrasound scan of the patient''s heart and special lung scan. She was evaluated at neurological and cardiological department, an explanation had not been found yet. "She is now referred to HPV-center." Adverse reactions reported by the patient''s general practitioner: The patient had throughout 1 1/2 years experienced intermittent paralysis, headache, high pulse, tremor in body, absence-like event and joint and muscle pain. Other vaccines: no. Other medications: no. The reporter considered the adverse events to be disabling. Agency comment: duplicate identified (DK-DKMA-ADR 22987897/ DK-DKMA-EFO12061) and merged with this master. The master received from the patient''s general practitioner and duplicate received from the patient. Duplicate identified before being sent to Agency. Agency has therefore not received the duplicate (DK-DKMA-ADR 22987897 / DK-DKMA-EFO12061) and received the master first in version 2. PIC had sent the patient''s initial injury claim, reference number, 15-4495. PIC had not yet made a decision regarding the case. At the time of reporting, the patient had not recovered.


VAERS ID: 583775 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-06-20
Onset:2009-07-01
   Days after vaccination:376
Submitted: 2015-06-24
   Days after onset:2184
Entered: 2015-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NG23900 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acne, Alcohol intolerance, Anxiety, Back pain, Blood test, Body temperature fluctuation, Chest discomfort, Condition aggravated, Constipation, Dizziness, Fatigue, Headache, Hyperacusis, Increased tendency to bruise, Infection susceptibility increased, Lumbar puncture, Musculoskeletal pain, Nausea, Pain in extremity, Palpitations, Photophobia, Throat tightness
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Dermatitis contact; 2007, Anxiety; 02/22/2008, GARDASIL, Immunisation; 12/19/2007, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Blood test, not reported; Lumbar puncture, not reported
CDC Split Type: WAES1506DNK010892

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (DK-1577272925-E2015-06855) on 22-JUN-2015. Case received from an other health care professional via the Health Authorities on 17-Jun-2015 under the reference number DK-DKMA.ADR 23029568 and DK-DKMA-EFO12388. Case is medically confirmed. Primary source was a physician. A 15-year-old female patient (weight: 77kg; height: 169 cm) with a medical history of allergy to lanolin and anxiety with start in 2007 had received the third injection of GARDASIL, batch number, lot number reported as NG23900 via intramuscular route into a not reported site of administration on 20-JUN-2008. 11 days later, on 01-JUL-2008, the patient developed tiredness and headache and one year later, on 01-JUL-2009 the patient experienced pain in leg and feet, temperature fluctuations, pain in back and lumbar, nausea, dizziness, frequent bruising in the skin, palpitations, pain in eyes, frequent infections and obstipation, acne, deterioration of anxiety, feeling of pressure in chest, light and sound sensitivity, pain in body when drinking alcohol, pain in shoulder and sensation of contraction in throat. The patient had been investigated by several specialist physicians (ENT physician, psychiatrist, psychologist, oral surgeon and specialist dentist). Blood tests and lumbar puncture were performed. Previous doses of GARDASIL were given intramuscularly (D1, batch number unknown) on 19-DEC-2007 and (D2, batch number/lot number NF124000) on 22-FEB-2008. Toleration was not reported. Other medicines: unknown. At the time of reporting, the patient was recovering from acne and had not recovered from the other events. Suspected adverse events related to GARDASIL. All the adverse events were considered to be disability by the reporter. Additional information is expected.


VAERS ID: 588494 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-11-04
Onset:2014-11-13
   Days after vaccination:9
Submitted: 2015-07-29
   Days after onset:257
Entered: 2015-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Postural orthostatic tachycardia syndrome
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: fludrocortisone
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1507GBR012524

Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number GB-1577272925-E2015-08465) on 27-JUL-2015. Serious case received from the RA under reference GB-MHRA-ADR 23070395 on 22-JUL-2015. This case is not medically confirmed. A 15-year-old female patient, no medical history reported and concomitant medication including fludrocortisone, received an injection of GARDASIL batch number not reported, series site and route not reported, on 04-NOV-2014. On 13-NOV-2014, the patient experienced postural orthostatic tachycardia syndrome. The patient visited school nurse who called paramedic. Paramedic took daughter to paediatric assessment unit and urgently requested to see cardiologist. The cardiologist was seen 3 times since. At this time of the reporting the outcome was not recovered. The RA considered the case serious for other medically significant and disability reasons.


VAERS ID: 607643 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-12-22
Onset:2015-05-01
   Days after vaccination:860
Submitted: 2015-08-20
   Days after onset:111
Entered: 2015-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0700AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Fibromyalgia, Gait inability, Hypoaesthesia, Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508JPN007181

Write-up: Initial and follow up information has been received from a physician regarding a 15 year old female patient. Medical history and concurrent were not provided. On 30-JUN-2012, the patient received the first dose of GARDASIL intramuscularly, 0.5 ml (lot number and expiry date were not reported) of cervix carcinoma at hospital. There was no concomitant medication provided. On 02-JUL-2012, back pain appeared and juvenile fibromyalgia developed. On 08-SEP-2012, the patient was intramuscularly vaccinated with the second dose of GARDASIL 0.5 ml intramuscularly. After the vaccination, shoulder pain appeared. Then, on 22-DEC-2012, the patient was intramuscularly vaccinated with the third dose of GARDASIL 0.5 ml intramuscularly. In the middle of May 2015, human papillomavirus vaccination associated with neuropathic syndrome (HANS) developed (neuropathy peripheral). On 12-MAY-2015, numbness in hands and feet appeared and on 03-JUN-2015, the patient suddenly became unable to walk. On 24-JUL-2015, diagnoses of juvenile fibromyalgia and (neuropathy peripheral) were made by a physician of hospital, and the patient was treated with steroids and vitamins. At the time of the report on 13-AUG-2015, the outcome of juvenile fibromyalgia and (neuropathy peripheral was unknown but in the middle of August 2015, the patient was recovering from (neuropathy peripheral). At the time of the report on 17-AUG-2015, the outcome of juvenile fibromyalgia was unknown, and neuropathy peripheral was resolving also reported as stop date: in August 2015. Reporter''s comment: Not provided. The reporting physician of hospital did not assess the seriousness of juvenile of fibromyalgia. The reporting physician of hospital felt that the causal relationship between HANS and GARDASIL was unknown. The reporting physician of hospital did not assess the causal relationship between juvenile fibromyalgia and GARDASIL. The reporting physician of hospital considered that neuropathy peripheral was serious due to disabling. Additional information has been requested.


VAERS ID: 607781 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-07-14
Onset:2014-07-14
   Days after vaccination:0
Submitted: 2015-08-23
   Days after onset:405
Entered: 2015-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J007500 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Bursitis, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol; fluticasone; MERCILON; ferrous sulfate
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508NZL007107

Write-up: Information was obtained on a request by the Company from the agency (HA # 113088) via a Case Line Listing on 17-AUG-2015 (the initial report was published on the internet in August 2014) concerning a 15 years old female patient. The patient medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot #, expiration date, dose and route of administration were not reported). On an unknown date, the patient also started with MERCILON tablet, orally (lot number, expiration date, dose, frequency and indication were not reported), salbutamol, fluticasone and ferrous sulfate (dose, frequency, route of administration and indication for all products were not reported). On an unknown date, the patient experienced injection site pain and bursitis. Action taken with MERCILON, salbutamol, fluticasone and ferrous sulfate was unknown. The outcome of the events was unknown. The relatedness between the events and suspect products was not reported. Follow up information was received on19-AUG-2015 from the regulatory authority (HA # 113088) referring to the aforementioned patient. The patient had no pre-existing hepatic disease and no known allergy. The agency confirmed the suspect vaccine was GARDASIL (Batch # J007500, intramuscular, 0.5 ml, administered on 14-JUL-2014, onset latency was less than 12 hours). Concomitant therapies included salbutamol, fluticasone, MERCILON and ferrous sulfate. The Agency reported that the onset date of injection site pain and bursitis was on 14-JUL-2014. No improvement was noted and the patient had not yet recovered from the events. The Agency assessed the events were serious since they were causing persisting disability. The Agency also considered the events were probably related to GARDASIL. Additional information is not expected as no further information could be obtained from the local regulatory authority. Product was updated. Event and narrative were added and updated.


VAERS ID: 608531 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-05-01
Onset:0000-00-00
Submitted: 2015-09-01
Entered: 2015-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arrhythmia, Asthma, Blood potassium decreased, Food allergy, Gastric disorder, Gitelman's syndrome, Gluten sensitivity, Mite allergy
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Congenital, familial and genetic disorders (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation, no information on medical history provided
Preexisting Conditions: 06/2011, GARDASIL, the patient received one unspecified dose of GARDASIL (batch number unknown) in June 2011
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508SWE013554

Write-up: Information has been received from Sanofi Pasteur MSD (MFR Control number SE-1577272925-E2015-09725) on 28-AUG-2015. Case received from non-health professional via Health Authorities on 25-AUG-2015 under the reference number SE-MPA-2015-005170. The primary reporter was a consumer. A 15 year-old female patient with no information on medical history provided, had received dose 3 of GARDASIL, (batch/lot number not known) via unspecified route of administration in unspecified site of administration on May 2012 and later in 2012 she developed cardiac arrhythmia, asthma, stomach problems, low potassium, gluten intolerance, house dust mite allergy and food allergy. The patient received one unspecified dose of GARDASIL (batch/lot number unknown) in June 2011. It was reported that the girl started her GARDASIL vaccination in the summer of 2011. In connection with dose 3 her stomach problems started in the summer of 2012. Low potassium level which resulted in heart arrhythmia. Hospitalized and investigated, for among all, Gitelman''s syndrome without confirmed diagnosis. The patient received KAJOS (mfr other) during one year. In 2013, she had an allergy shock. Was diagnosed with gluten intolerance, asthma, allergy towards house dust mite and some food. According to the reporter, the other members of the family do not have allergies, hence she suspects GARDASIL. At the time of reporting, the patient had recovered with sequelae. According to the health authority, the reactions were possibly related to vaccination.


VAERS ID: 608598 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-02
Entered: 2015-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Idiopathic intracranial hypertension
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: aspirin; hemp; diazepam; domperidone; ibuprofen; acetaminophen; sumatriptan; tramadol; hydrochloride
Current Illness: Immunisation, relevant medical history and concurrent conditions: none reported
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1509GBR000956

Write-up: Information has been received from Sanofi Pasteur MSD [GB-1577272925-E2015-09736] on 01-SEP-2015. This case was received from the health authority on 25-AUG-2015. Ref GB-MHRA-ADR 23111878. This case is not medically confirmed as the reporter was a consumer. A 15 year old female patient who was taking concomitant aspirin, cannabis, diazepam, domperidone, ibuprofen, paracetamol, sumatriptan and tramadol for unknown indications, received an injection of GARDASIL, batch number not reported, route and site not reported, on an unreported date. On an unreported date, post vaccination, the patient had four surgeries due to her reaction as she had idiopathic intracranial hypertension. At the time of reporting the patient had not yet recovered. The reporter considered the event to be serious due to disability, hospitalisation, life threatening and medically significant. Upon internal review, the adverse event: idiopathic intracranial hypertension was added.


VAERS ID: 608899 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-26
Onset:0000-00-00
Submitted: 2015-09-08
Entered: 2015-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NP26080 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Blood iron decreased, Decreased immune responsiveness, Dizziness, Fatigue, Gastrooesophageal reflux disease, Irritable bowel syndrome, Loss of personal independence in daily activities, Menorrhagia, Migraine, Oropharyngeal pain, Rash, Seizure, Syncope, Tonsillectomy, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation, the patient was a healthy child prior to vaccination
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood test, result not reported; Nuclear magnetic resonance imaging, results not reported
CDC Split Type: WAES1509IRL003765

Write-up: Information has been received from Sanofi pasteur (MSD) (SPM) (manufacturer control # E2015-10041) as part of business agreement on 07-SEP-2015. Serious case received from the RA under reference IE HPRA 2015-024394 on 01-SEP-2015. This case is not medically confirmed. A 14-year-old female patient, no medical history, with concomitant medication reported as DITEBOOSTER, received injections of GARDASIL, (lot number NM31130), dose 1, via IM route, site not reported, on 06-OCT-2010, GARDASIL, (Batch number NN01990), dose 2, via IM route, site and route not reported, on unreported date, and GARDASIL (batch number NP26080), dose 3, via IM route, site and route not reported, on 26-SEP-2011. On unreported date, following first dose, the patient experienced seizures, skin rashes, joint pain, migraines, sore throat, reflux, IBS symptoms, fatigue, dizzy spells, blurred vision, low on reserves, heavy periods. The reporter indicated that the patient''s immune system was low and all the symptoms followed post vaccination. the reporter indicated that the patient collapsed with no warning. She could be out crossing a road or walking down a stairs. She has also collapsed behind a locked door (door needed to be taken off the hinges to get to the patient). The patient has missed two years of school and has been home-schooled. The reporter indicated that the patient required constant supervision. Corrective treatment: The patient was on unspecified medication for reflux, migraine and heavy periods. The patient was undergoing ongoing medical tests including blood tests and MRI (results not provided). The patient had her tonsils taken out due to recurring sore throats. The patient was also on anti-convulsants for seizures/epilepsy. At this time of the reporting the outcome was not recovered. Upon internal review, the adverse event: collapses, LLT syncope was added to HA coding. The RA considered the case serious for other medically significant reasons.


VAERS ID: 609606 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-14
Onset:0000-00-00
Submitted: 2015-09-17
Entered: 2015-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Computerised tomogram head, Disturbance in attention, Dizziness, Echocardiogram, Electrocardiogram ambulatory, Electroencephalogram, Fatigue, Headache, Muscle spasms, Nausea, Nuclear magnetic resonance imaging brain, Postural orthostatic tachycardia syndrome, Syncope, Tilt table test
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown date: CT brain scan, Echocardiography, Holter monitoring, EEG, MRI brain and Tilt table test: results not reported.
CDC Split Type: WAES1509DNK009077

Write-up: Information has been received via SPMSD (Sender''s case unique identifier DK-1577272925-E2015-10243) on 16-SEP-2015. Case received from Health Care Professional via Health Authorities on 11-Sep-2015 with additional information received on 14-Sep-2015 under the reference number DK-DKMA-ADR 23138930. The case is medically confirmed. The primary reporter was a physician. A 15-year-old female patient had received three doses of GARDASIL, batch numbers not reported via i.m route of administration in unspecified site of administration on 06-OCT-2008, 08-DEC-2008 and 14-APR-2009 and later on unspecified day in February 2009, she developed headache, fainting with cramps, tiredness, concentration impairment and dizziness. On not reported date, she developed abdominal pain, nausea and POTS. One has found that it is a matter of POTS. The case is serious due to seriousness criteria hospitalization and disability. No other medications or vaccines. The patient has been extensively investigated at neurological and cardiological departments with CT of cerebrum, EEG, MRI of the brain, ECHO, Holter monitoring, tilt table test etc (not further specified). At the time of reporting, the patient was recovering from fainting with cramps. The patient had not recovered from the remaining reactions. Additional information received on 14-SEP-2015. Upon a clarification request to Agency from the company regarding why the seriousness criteria Life Threatening was ticked yes. The HA responded that they had mistakenly ticked the seriousness criteria Life threatening instead of the seriousness criteria disability. This has been amended.


VAERS ID: 610233 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-10-23
Onset:2013-05-01
   Days after vaccination:190
Submitted: 2015-09-23
   Days after onset:875
Entered: 2015-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 9QN06R / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Muscular weakness, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1509JPN010756

Write-up: Initial information has been received from a physician concerning a 15 year old female patient who on 17-APR-2012 was initially vaccinated with GARDASIL injection intramuscularly, 0.5 ml once a day (Lot number was 9QN02R, expiration date unknown). The patient had no primary disease, concurrent disease or any history disease. Other concomitant medication was not reported. On 19-JUN-2012, the patient was vaccinated with GARDASIL injection intramuscularly, 0.5 ml once a day for the second time (Lot number was 9QN04R, expiration date unknown). On 23-OCT2012, the patient was vaccinated with GARDASIL injection intramuscularly, 0.5 ml once a day for the third time (Lot number was 9QN06R, expiration date unknown). Around in May 2013, the patient developed muscular weakness. On an unspecified date (about three years past after the vaccination of third time), the patient came to the reporter''s hospital by wheelchair. At the time of this report, the patient was still under treatment in hospital. The patient had not recovered from muscular weakness. The reporter did not know the relation to adverse event. The reporting physician considered that the muscular weakness was serious due to disabling. The reporting physician did not assess the relationship of muscular weakness to GARDASIL. Additional information has been requested.


VAERS ID: 613557 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-08-08
Onset:2008-08-27
   Days after vaccination:19
Submitted: 2015-10-02
   Days after onset:2592
Entered: 2015-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Asthenia, Blood test normal, Body temperature fluctuation, Chest discomfort, Chills, Depressed mood, Discomfort, Dizziness, Fatigue, Feeling abnormal, Headache, Hyperacusis, Infection susceptibility increased, Influenza, Memory impairment, Musculoskeletal chest pain, Myalgia, Oropharyngeal pain, Pain, Palpitations, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood test (date unspecified): Normal
CDC Split Type: WAES1510DNK000865

Write-up: Information has been received from Sanofi Pasteur MSD [Manufacturer control # E2015-10810] on 01-OCT-2015. Case received from Health Care Professional via Health Authorities on 29-Sep-2015 under the reference number DK-DKMA-ADR 23168961. The case is medically confirmed. The primary reporter was a physician. A 15-year old female patient had received the first dose of the GARDASIL (batch number: NH15430) via intramuscular route of administration in unspecified site of administration on 08-Aug-2008 and later on 27-Aug-2008, she developed headache, pain in the entire body, heaviness in the body, weakness in the body, fluctuating temperature, feeling of fever, palpitations, chills, unpleasant feeling, pain in the throat, pain in the muscles, pain in the joints, chest pressure/tenderness in the chest when she breathes, total lack of energy, sadness, influenza symptoms, dizziness, memory impaired, pain in the shoulders, infection tendency and tiredness. The patient received an unspecified dose of GARDASIL (batch number not reported) via i.m route of administration in unspecified site of administration on 14-Oct-2008. The case is serious due to seriousness criterion Disability. Unknown whether there are other medications. No information on other vaccines provided. The patient has undergone blood tests that were normal (not further specified). No information on medical history provided. At the time of reporting, the outcome was unknown for the reactions tiredness. The patient had not recovered from the remaining reactions.


VAERS ID: 613962 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-03-26
Onset:0000-00-00
Submitted: 2015-10-14
Entered: 2015-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005033 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Blood pressure decreased, Blood pressure increased, Cold sweat, Computerised tomogram head, Dizziness, Echocardiogram, Fatigue, Headache, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging liver, Nuclear magnetic resonance imaging renal, Pain, Palpitations, Skin discolouration, Syncope, Tremor, Ultrasound scan
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 05/17/2015, Blood pressure, 140/100; 05/17/2015, Blood pressure, Low; Computerised tomogram head, Inconclusive; Echocardiogram, , Inconclusive; Nuclear magnetic resonance imaging, Inconclusive; Ultrasound scan, Not reported
CDC Split Type: WAES1510IRL006013

Write-up: Information has been received from SPMSD (case report number IE-1577272925-E2015-11168) on 12-OCT-2015. This case was received from the health authority on 07-Oct-2015. IE-HPRA-2015-024674. This case is medically confirmed. A 15 year old female patient, concomitant medications unknown, received dose one of GARDASIL (lot number HD13135 which is an invalid lot number for quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine) on 17-Sep-2013, dose two (lot number HD13137 which is an invalid lot number for quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine) 20-Nov-2013, and dose three (lot and batch number J005033, expiration date 31-AUG-2015), on 26-Mar-2014, all IM, sites not reported. On 17-May-2015, post vaccination, the patient experienced palpitations and a racing heart, she felt weak, when her BP was taken it was raised at 140/100. The patient also had low blood pressure the same day. The patient was admitted over the following two weeks to the ward and numerous tests and an ultrasound were carried out. The patient was referred to a cardiologist. The patient was subsequently admitted to hospital in July 2015 under a team of specialists (nephrologist and neurologist). The patient had many tests including MRI brain, kidneys and liver, CT brain, five echocardiograms, the results of which were inconclusive. The patient can experience episodes of being very grey, clammy, shaking with severe headaches, tiredness, fatigue, body ache and fainting, dizziness. At the time of reporting the patient had not recovered. The reporter considered the events to be serious due to disability.


VAERS ID: 614084 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-07-29
Onset:0000-00-00
Submitted: 2015-10-20
Entered: 2015-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0513U / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Acne, Acupuncture, Alopecia, Amnesia, Arthralgia, Asthenia, Back pain, Blood count normal, Blood pressure decreased, Chest pain, Chiropractic, Cognitive disorder, Condition aggravated, Contusion, Developmental hip dysplasia, Disturbance in attention, Dizziness, Dizziness postural, Dysmenorrhoea, Dyspnoea, Fall, Fatigue, Frustration tolerance decreased, General physical health deterioration, Groin pain, Headache, Heart rate increased, Hyperhidrosis, Hypermobility syndrome, Hypotension, Infection, Initial insomnia, Insomnia, Joint crepitation, Joint lock, Kinesitherapy, Loss of personal independence in daily activities, Malaise, Middle insomnia, Mood altered, Muscle spasms, Muscle tightness, Muscular weakness, Musculoskeletal chest pain, Myalgia, Orthostatic hypotension, Pain in extremity, Palpitations, Peripheral coldness, Postural orthostatic tachycardia syndrome, Presyncope, Sleep disorder, Syncope, Temperature regulation disorder, Tension, Tinnitus, Visual analogue scale, Visual impairment, Weight decreased, X-ray of pelvis and hip normal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Osteonecrosis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SYMBICORT TURBOHALER
Current Illness: Immunisation; Arthralgia
Preexisting Conditions: Hypermobility syndrome; Asthma
Allergies:
Diagnostic Lab Data: Blood pressure (February 2008): low. Blood count, normal; Heart rate, high; 2009, Visual analogue scale, 8.5; 06/29/2009, Visual analogue scale, 7; Weight, loss; 01/21/2009, X-ray, normal hips
CDC Split Type: WAES1410DNK012533

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control #E2014-09162) on 15-OCT-2015. Case was received from a health care professional via the Health Authority on 29-Sep-2014 under the reference DK-DKMA-ADR 22693127. Case is medically confirmed. Primary source was a physician. A 16-year-old female patient (weight, height not reported) with a medical history of pain in multiple joints received the third dose of GARDASIL (batch no. NG25940, lot#0513U, expiry date 02-APR-2010) via intramuscular route into not reported site of administration on 29-Jul-2008. On an unspecified date in 2008, the patient developed aggravated pain and pain in multiple joints. On an unspecified date in 2012, the patient also developed orthostatic hypotension. No other medication was received. At the time of reporting, the patient was recovering from aggravated pain and pain in multiple joints. The patient had not recovered from orthostatic hypotension. Previous doses of GARDASIL were given on 28-Jan-2008 (D1, batch no. NF12400, lot# 1340F, expiry date 18-NOV-2009) and on 28-Mar-2008 (D2, batch no. NF27890, lot# 1537F, expiry date 15-DEC-2009). Toleration was not reported. Follow up information received on 08-Jul-2015 from HA. The Agency received the follow up information 06-Jun-2015 as a duplicate (DK-DKMA-EFO 12643 / DK-DKMA-ADR 23059129) from the patient. This information was intended to be included in the previous version. Adverse events: joint pain, locked joints, muscle cramps, insomnia, concentration problems, hair loss, memory loss, low blood pressure, headache over the right eye, fainting, dizziness, acne on the face, neck, chest, arms and back, abdominal pain associated with menstruation, sweating, cold hands and feet, spontaneous tinnitus and flicker and dot eyes. The patient describes that since she was vaccinated, she fainted three times. All three fainting occurred in the summer of 2014. She describes the fainting happened while she was standing up. The first time was for a concert. The fainting was affected by heat. She has not fainted since the summer of 2014. She often experience the feeling of being close to fainting. The patient has not been treated for the adverse reaction. The patient has not been hospitalized due to the adverse reactions. No concurrent medicines. The following information is added to the case on the basis of duplicate: Patient''s weight (56 kg) and height (175 cm), tests (blood tests) relevant medical history and concurrent disease (asthma and hypermobility syndrome) start month aggravation in joint pain (February). Adverse events joint lock (onset date 2014, outcome not recovered), muscle spasms (onset date 2008, outcome not recovered), sleep problems (onset date 2008, outcome not recovered), concentration impairment (onset date 2008, outcome recovering), hair loss (onset date 2008, outcome recovering), memory impairment (onset date 2008, outcome not recovered), hypotension (onset date Feb-2008, outcome recovering), headache (onset date 2008, outcome not recovered), fainting (onset date 2014 cessation 2014, outcome recovered), dizziness (onset date Jan-2008, outcome recovering), acne (onset date 2008, outcome not recovered), menstrual pain (onset date 2008, outcome recovering), sweating (onset date 2008, outcome not recovered), cold hands and feet (onset date 2008, outcome not recovered), tinnitus (onset date 2008, outcome not recovered), near fainting (onset date not reported, outcome not recovered) and visual impairment (onset date 2008, outcome not recovered). The following information is changed in the case on the basis of duplicate: The patient''s age at the start of reaction is changed from 16 to 15, the adverse event aggravation of existing disorder which was previously coded by HA has been removed because joint pain is coded instead as adverse event. Noteworthy: company noted that onset date for several newly added adverse events were before vaccination date of suspect dose 3, therefore all 3 doses are now coded as suspect by HA and company. Follow up information received from the Patient Insurance Company (PIC) via HA on 13-Oct-2015. Follow up information received from PIC on 06-Oct-2015. The PIC has not made a decision of the matter yet. The patient received dose 3 of GARDASIL when she was 15 years old. Then she started in 10th grade at School (school year 2008/2009). She thrives at school with friends and schooling, follows the school''s gymnastics program and has the theater as her major. She has knee pain, hip pain and periodic back pain and will therefore be examined at the orthopedic clinic at Hospital. The pain worsens and becomes more widespread: she experiences sudden pain and shock in her knees, which is worse than before. Her knees say crack every time she takes a step. After she sits down, her knees sometimes get stuck and say a loud crack, followed by a lot of pain. She experienced cramps in the knee that leads to tension in the whole body, and then she just cannot walk. Her hips hurts by sitting for a while and when cycling. When walking a crack sound occurs - typically on the right side. Crack from groin too. Pain in the ribs which she experiences many times at night to the lower ribs locks, where she gets the feel of a band around the ribs, which means that she cannot breathe. Many times, one of them on 08-Nov-2008, she was brought home because the pain was too great, and she has no desire to be there when she is like this. She wakes up every night due to pains, and find it difficult to keep the concentration when the pain is too large. In March 2009, she takes about 10 analgesics (Paracetamol 6x2, 3x1 IBUMETIN, 1 Codeine) just to calm the top of the pain so she can get through the day. The pain is so strong and disturbing that she rarely gets slept at night. It affects her schooling because she some days are too tired / weak / have too much pain to attend classes. Other days, she had to leave class because of pain from sitting or because she simply is too weak. The months pass with negative progress. The patient''s mother contacts the patient''s physician on 06-May-2009 where the mother writes that the patient has gotten considerably worse in recent weeks. No concentration, insomnia, exam is a challenge. She is otherwise always positive, but is about to be give up. During the written exam, she cannot sit out the 4-5 hour exam time, and will need to take frequent breaks along the way and runs out of time. While she goes to boarding school, she occasionally is seen a chiropractor. It is a relief to feel that everything loosens up, unfortunately, often only a few hours of power. The chiropractor comes with several suggestions on what the cause of the patient''s pain can be for example Lyme disease, something chemical, metabolic or rheumatic disease. Blood count, shows no sign that anything is out of order. After she finished the boarding school, she admitted three weeks on arthritis hospital. Their diagnosis is Hypermobile syndrome. She receives information about the diagnosis, a training schedule and knowledge of what her future looks like. It was some really tough week to get through, not only due to the pain all the time, she had to learn to live with the fact that it was probably how it would be the rest of her life. She now receives more medicine: PANODIL RETARD 2 plus 2 and Todolac 200 mg x 2. Furthermore PAMOL 1 gram at night max x 2 and Todolac 1 at night). She starts high school in Aug-2009. Before starting school the patient''s mother and the patient make an agreement with the school, to find a way she can complete high school in the best way. She is offered to take it over 4 years, but she declines. They agree that there will be a couch for her to use when she gets tired. She borrows two sets of books, one for home and one located at the school to avoid bringing them back and forth. She borrows a chip, so she can us the elevator to avoid having to climb the stairs, as it was a painful and time consuming hurdle for her. She will also have stand-supporting chair for school and granted taxi service to and from school every day. She starts some treatments at a manual therapist. After a few months of high school, there is still no improvement, but she takes more painkillers. She now takes DOLOL and SAROTEN night. She will be referred to a pain clinic, with a pre-visit in Jan-2010. In Jun-2010 she completed the pain clinic, drug free. She had in the first year in high school a total absence of 35%. In the second year virtually no absences due to pains. She did not need pain medication following discharge from the pain clinic. The patient''s adverse events during the 2008-2010 period and how it is currently: Joint pain knees: sudden pain and shock at the knees, the knees locked. To get movement in the knees, she had to provoke a loud crack with many pains to follow. Her knees said crack every time she took a step. Her knees cramped, which led to tension in the body, and she could hardly walk. She still struggling with her knees crack when she goes, and she can sometimes feel a mild pain but it is not in the same way as before. Her knee cannot be bent for long periods of time, without almost getting stuck. Joint pain hips: hips ached when she had been sitting a while. Hips break still occasionally - especially at slow walking. But she has no pain at that time. Joint pain groin: crack in the groin with great pain to follow. Groin break still for instance at cross-legged; but does not particularly hurt. Joint pain back: Experiencing the back/ribs locked was a daily problem, the patient''s mother''s husband learned from a chiropractor how he could help unlock again, a great help to the patient. She is still experiences back lock, but not to the same extent as previously. She breaks its back now, for this to unlock. Joint pain lower back, especially lower back locked in the sitting position several times a day. Fatigue and insomnia: many days she had to stay home from school when she had not slept at night. The school had arranged a bed for her, which she could rest if she was tired from class. Her sleep is not optimal, she has difficulty falling asleep and often wake up several times a night - not because of the pain. Pain memory: She remembers very little from the last six months at the boarding school until the second year of high school. She is challenged on concentration and memory. It is a big challenge for her to read a book, to remember what she was reading. Today she depends on do lists. Some days she''s very difficult to remember, for example names - even if it''s people she knows very well. Weakness: little strength, for example she had to sit on the floor when she took a bath because she did not have the strength to stand, sometimes helped by her mother. Sometimes she had to crawl to the bathroom because she had not the strength to go. She could not go up or down stairs. She walked slowly and would ideally like to have something to lean on. No weakness currently. Headache: within the last six years she has experienced about a few times a month, she gets a hard pounding sensation in the head, which comes and goes after 15-20 seconds. It goes on a bit. Sometimes occurs in the case of dizziness. Dizziness: Has endured as long as she can remember, that she gets dizzy when she stands up in the same position, or if she gets up too fast. At the same time, spots for the eyes which can take from a few minutes to an hour to disappear. She has a feeling that is has deteriorated over the last few years. It happens more often and sometimes she gets a tinnitus-like sound in the ears afterward. Fainting: She fainted twice in 2014, which she has not experienced before. The first time she stood up too quickly. She thought she had mastered it and wanted to sit down, but suddenly darkened it for her, and she fell. She is contactable immediately and quickly recovers. She is, however, slightly weak afterwards. The second time was at a concert where she had stood too long. She felt dizzy, and wanted to get water, but after three steps it darkened, and she finds herself sitting on the ground. Both cases are the days when it was really hot. Heart palpitations and high pulse: Often during less activity she gets fast racing pulse and heart palpitations. Impure skin: She has been spotty skin, which has not previously been a problem. Back, arms, chest, neck and face. Hair Loss: Before the vaccine, she had very thick hair. She lost hair and the hair has not come back. Ice-cold hands and feet. Weight loss. The heat/sweat: The patient has great difficulty with changing temperatures, and can in a short time get really hot. This causes dizziness and weakness, so here she must be close to a chair. Dressing should therefore preferably be planned for her. She easily sweats, and shortly after she is completely wet with sweat. Menstrual pain: Severe menstrual pain, hormone spiral improved the pain. Pain in the ribs: the ribs locks which affects breathing. When lying on the side during breathing a cut is felt from the ribs to the rib. The patient looked at adverse events described by HPV-update and Merck, and has indicated that she has had: Joint pain. Fatigue. Weakness. General malaise. Pain in the chest. Leg pain. Muscle weakness. Bruising. Headache. Infections. Blemished skin. Insomnia Attacks on the locomotive system and connective tissue, including muscle and joint pains. Fainting, including Postural Tachycardia Syndrome (POTS). Memory failure. Other cognitive disorders difficulty concentrating. Other medicines: SYMBICORT TURBOHALER. After viewing the TV documentary about the vaccinated girls, the patient and family began to see the connection. The patient went to see the her physician for the first time a while after dose 2 of GARDASIL, as she gradually developed the adverse events for the first time, and they worsened after dose 3 and continues only then to deteriorate. Laboratory tests and examination: Blood samples that could not explain the undesirable events. Examinations from 21-Jan-2009, Hospitals - Orthopedic clinic - right-sided hip dysplasia, but X-rays show normal hips. 31-Mar-2009; Hospital - Department of orthopedic surgery. 29-Jun-2009: Hospitalization at the arthritis hospital, due to possible rheumatic disorder for 3 weeks. The patient describes at admission, the pain has worsened in the last six months. After discharge, she describes pain - VAS to be 8.5 against 7 at admission. 01-Sep-2009: Diagnosis: benign Hyper Mobile Syndrome. 10-Sep-2009: Hospital - rheumatology clinic. 15-Sep-2009: Arthritis hospital - telephone contact between the patient''s mother and hospital. Frustrated by the situation. The patient is significantly influenced by pain secondary to her hypermobility and significantly hampered in everyday life both physically and mentally. Discussion SAROTEN but not recommended. Talk about the Department of Rheumatology and other Institute. 10-Dec-2009: Hospital - Anesthesiology Department, Pain Clinic. 14-Dec-2009: Hospital - X-ray department. Radiological examination. 16-Nov-2014: Hospital - Dizziness. Alternative treatments: manual therapist, 10 treatments. Chiropractor, 10 treatments kinesiology, 3 treatments. Acupuncturist, 1 treatment. The following has been added by HA based on the follow up: seriousness criteria Hospitalized due to reaction and Disability/Incapacity is added (the case has been upgraded by the HA). Adverse events: Back pain (onset 2008, outcome unknown), Muscle tightness (onset 2008, outcome unknown), Rib pain (onset 2008, outcome recovering), Dyspnoea (onset 2008, outcome unknown), Weakness (onset Mar-2009, outcome unknown), Insomnia (onset 2009, outcome unknown), Altered mood (onset 2009, outcome unknown), Tiredness (onset Mar-2009, outcome unknown), Hypermobility syndrome (onset 2009, outcome unknown), Activities of daily living impaired (onset Aug-2009, outcome unknown), Heart pounding (onset not reported, outcome unknown), Pulse rate increased (onset not reported, outcome unknown), Weight loss (onset not reported, outcome unknown), Temperature regulation disorder (onset not reported, outcome not recovered), Muscular weakness (onset not reported, outcome unknown), Malaise (onset not reported, outcome unknown), Chest pan (onset not reported, outcome unknown), Leg pain (onset not reported, outcome unknown), Tendency to bruise easily (onset not reported, outcome unknown), Infection (onset not reported, outcome unknown) and Postural orthostatic tachycardia syndrome (onset not reported, outcome unknown). Concomitant drug (SYMBICORT TURBOHALER, mfr other). The following has been changed by HA: Case has been upgraded to serious. Onset date for Joint lock is changed from 2014 (was coded Aug-2008 in previous version) to 2008. Outcome for Joint pain from not recovered to recovering. Outcome for Dizziness is changed from recovering to not recovered.


VAERS ID: 614262 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-09-01
Onset:2010-09-01
   Days after vaccination:0
Submitted: 2015-10-22
   Days after onset:1877
Entered: 2015-10-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Disturbance in attention, Dizziness, Dizziness postural, Electroencephalogram, Epilepsy, Fatigue, Fibromyalgia, Headache, Hyperacusis, Hypersomnia, Immediate post-injection reaction, Lumbar puncture, Memory impairment, Menorrhagia, Mobility decreased, Ovulation pain, Pain, Palpitations, Photophobia, Postural orthostatic tachycardia syndrome, Quality of life decreased, Seizure
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KEPPRA
Current Illness: Immunisation
Preexisting Conditions: Epilepsy
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1510IRL010171

Write-up: Information has been received from the business partner Sanofi Pasteur MSD (SPM) (manufacturer control # IE-1577272925-E2015-11528) on 21-OCT-2015. This serious AE case was reported by the RA, on 16/Oct/2015 in the ROI. IE-HPRA 2015-024801. This case is not medically confirmed as it was reported by a consumer. A 15 year-old female patient, with a previous medical history of epilepsy described as well controlled on a break from medication, received three injections of GARDASIL, lot not reported, route and site not reported, between 1/Sep/2010 and 1/Apr/2011. The reporter indicated that immediately post vaccination, the patient experienced multiple symptoms. The patient felt faint and dizzy and suffered from headaches since 30/Sep/2010. She took paracetamol as corrective treatment. The reporter indicated that these symptoms had been getting progressively worse and the patient was essentially housebound due to them. The patient suffered from seizures since the same date and is being treated with KEPPRA and LAMICTAL for same. The reporter indicated that the patient''s epilepsy returned and her medication had to be restarted. Patient was admitted to hospital for spinal tap and EEG tests (results not provided) the patient suffered from extreme pain (fibromyalgia) that was ongoing every day since the same date. She was being treated with CYMBALTA. The patient had also been attending a rheumatologist and had been in hospital for tests and treatment. The patient suffered from POTS since the same day and has been treated with iron tablets but they had not been effective for the patient. Due to the POTS, the patient got very dizzy when standing and experienced heart palpitations which limits her mobility. The patient experienced memory problems and mental agility problems since 01/Oct/2010. The reporter indicated that the patient''s memory problems and concentration were very poor. The patient experienced very heavy menstrual and mid cycle ovulation pain that was treated with contraception. The reporter indicated that this did not work for the patient either. The patient was also sensitive to light and sound since 1/Dec/2010. As a result the patient wore glasses with a tint. The patient suffered from extreme fatigue and could sleep excessively (up to 22 hours a day) since this date also. The reporter added that the patient''s life had been totally ruined, she had zero quality of life and spent most of her time or on the couch and was in constant pain. At the time of reporting the patient''s symptoms were persisting. The RA considers this case as serious due to patient hospitalisation, disability, congenital anomaly and as other medically significant event.


VAERS ID: 619810 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-05-06
Onset:0000-00-00
Submitted: 2015-12-22
Entered: 2015-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Alopecia, Arthralgia, Disturbance in attention, Dyskinesia, Dyspnoea, Fatigue, Food intolerance, Headache, Hypoaesthesia, Impaired work ability, Influenza, Myalgia, Orthostatic intolerance, Postural orthostatic tachycardia syndrome, Psoriasis, Pyrexia, Sleep disorder, Temperature regulation disorder, Tilt table test positive, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test examinations: tilt table test, fulfills the criteria for POTS.
CDC Split Type: WAES1512DNK011065

Write-up: Information has been received from Sanofi Pasteur MSD (MFR number# DK-1577272925-2015001181) on 21-DEC-2015. Case received from a physician via health authority on 17-DEC-2015 DK-DKMA-WBS-00020883. A 15-year-old female adolescent patient received GARDASIL (batch number unknown, Dose 1) via intramuscular route on 29-OCT-2008, GARDASIL (batch number unknown, Dose 2) via intramuscular route on 07-JAN-2009, GARDASIL (batch number unknown, Dose 3) on 06-MAY-2009. The patient experienced Influenza recurrent in MAY-2009, fever on an unknown date, Fatigue on an unknown date, Headache on an unknown date, Hair loss on an unknown date, Dyspnoea on an unknown date, Sleeping disorder on an unknown date, Concentration ability impaired on an unknown date, Involuntary muscle movement on an unknown date, Numbness arm and legs on an unknown date, Food intolerance on an unknown date, Vomiting on an unknown date, Muscle pain on an unknown date, Joint pain on an unknown date, Psoriasis localized on an unknown date, Temperature regulation disorder in hands on an unknown date, Orthostatic intolerance on an unknown date and POTS on an unknown date. Additional investigations included Tilt Table Test pots on an unknown date. Onset after 3rd vaccination with recurrent influenza like symptoms. After that the other reactions. Reduced functional ability and a lot of absence from her training as office clerk - around 25%. The patient''s outcome was reported as Not Recovered/Not resolved.


VAERS ID: 619844 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-03-01
Onset:0000-00-00
Submitted: 2015-12-22
Entered: 2015-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Cognitive disorder, Decreased activity, Dizziness, Dysuria, Fatigue, Headache, Loss of personal independence in daily activities, Nausea, Palpitations, Photophobia, Postural orthostatic tachycardia syndrome, Presyncope, Sleep disorder, Syncope, Tilt table test positive, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: HPV immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: During tilt table test at the reporter''s department, the patient fulfills the diagnostic criteria for POTS.
CDC Split Type: WAES1512DNK010424

Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number DK-1577272925-2015001037) on 18-DEC-2015. Case received from a physician via HA on 15-DEC-2015 under the reference number DK-DKMA-ADR 23274784 and DK-DKMA-WBS-0002029. A 15-year-old female adolescent patient received GARDASIL, (lot/batch number unknown, Dose 1) via intramuscular route in MAR-2009, GARDASIL, (lot/batch number unknown, Dose 2) via intramuscular route in MAY-2009, GARDASIL, (lot/batch number unknown, Dose 3) via intramuscular route in JUN-2009. The patient experienced Fatigue extreme in MAR-2009, Recurrent syncope in 2009, Near syncope on an unknown date, Headache on an unknown date, Dizziness on an unknown date, Palpitations on an unknown date, Abdominal crampy pains on an unknown date, Voiding dysfunction on an unknown date, Sleep disorder on an unknown date, Cognitive disorder on an unknown date, Light sensitivity to eye on an unknown date, Blurred vision on an unknown date, Nausea on an unknown date and POTS on an unknown date. The patient describes that the first symptoms were increased tiredness and syncope, which started after the first vaccination in MAR/APR 2009. Subsequently, the other reported reactions developed. During tilt table test at the reporter''s department the patient fulfills the diagnostic criteria for POTS. The patient describes decreased functional level and has had many short days at her work place. Unknown whether there are concomitant vaccines or medications. Criteria for diagnosis of POTS: Heart rate increases greater than or equal to 30 bpm from supine to standing (10 min) in the absence of orthostatic hypotension (decrease in BP greater than 20/10 mmHg). Symptoms worsen with standing and improved with recumbence. Symptoms last greater than or equal to 6 months. Absence of other overt cause of orthostatic symptoms or tachycardia (e.g., active bleeding, acute dehydration, medications). In addition hospital uses an additional criterion for patient''s between 12-19 years: Require a pulse increase greater than 40 bpm to confirm the diagnosis, based on that young people have a greater physiological pulse response upon standing up. They are this additional criterion to avoid false positive. The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 620111 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-23
Entered: 2015-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Cognitive disorder, Constipation, Dizziness, Dry eye, Dry mouth, Hyperhidrosis, Myalgia, Nausea, Orthostatic intolerance, Photophobia, Postural orthostatic tachycardia syndrome, Rash macular, Syncope, Tilt table test positive
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Depressed mood; GARDASIL, dose 2; GARDASIL, dose 1;
Allergies:
Diagnostic Lab Data: Tilt table test (in 2011): possible explanation to syncopes. 2015, Tilt table test, POTS.
CDC Split Type: WAES1512DNK010940

Write-up: Information has been received from Sanofi Pasteur MSD (MFR Control Number 2015001186) on 21-DEC-2015, as a part of business agreement. Case received from a physician via HA on 17-DEC-2015 under the reference number DK-DKMA-WBS-0002079 and DK-DKMA-ADR 23277206. A 15-year-old female adolescent patient received GARDASIL via intramuscular route in 2008. The patient experienced Syncope in 2009, Muscle pain in 2009, Nausea in 2009, Dizziness on an unknown date, Orthostatic intolerance on an unknown date, Eyes dry on an unknown date, Dry mouth on an unknown date, Skin blotches on an unknown date, Sweating abnormal on an unknown date, Bloated feeling on an unknown date, Obstipation on an unknown date, Light sensitivity to eye on an unknown, Cognitive function abnormal on an unknown date and POTS on an unknown date. Symptom debut in 2009 with muscle pain and syncope, hospitalized at least 2 times for investigation without diagnosing. Tilt table test in 2011 show possible explanation of syncope. Significant disabling condition. The reporter does not have exact vaccination dates (possibly 2008). Tilt table test at the reporter''s department showed that the patient fulfills the diagnostic criteria for POTS. Unknown whether there were other medications and vaccines. The patient was admitted to hospital on an unspecified date. The patient had a medical history of Depressed mood. Additional investigations included: Tilt Table Test possible explanation to syncopes in 2011, Tilt Table Test POTS in 2015. At the time of reporting, the outcome was unknown for POTS. The patient had not recovered from the other reactions.


VAERS ID: 620173 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-03-24
Onset:0000-00-00
Submitted: 2015-12-23
Entered: 2015-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NJ38950 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Cognitive disorder, Constipation, Diarrhoea, Dizziness, Dyspnoea, Dysuria, Fatigue, Headache, Hyperventilation, Loss of personal independence in daily activities, Menorrhagia, Muscle spasms, Pain in extremity, Presyncope, Stress, Temperature regulation disorder, Tilt table test normal, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: A tilt table test showed normal condition.
CDC Split Type: WAES1512DNK011672

Write-up: Information has been received from Sanofi Pasteur MSD (MFR Control number DK-1577272925-2015001199) on 22-DEC-2015. Case received from a physician on 17-DEC-2015. A female adolescent patient of unknown age received GARDASIL, batch number unknown, Dose 1 via intramuscular route on 20-JAN-2009. Other suspect products included GARDASIL, batch/lot number unknown, Dose 2 administered via intramuscular route on 24-MAR-2009. The patient experienced Headache on an unknown date, Knee pain on an unknown date, Pain feet on an unknown date, Dizziness on an unknown date, Near syncope on an unknown date, Abdominal pain on an unknown date, Abdominal cramp on an unknown date, Obstipation on an unknown date, Diarrhea on an unknown date, Voiding difficulty on an unknown date, Dyspnoea on an unknown date, Menses regular with excessive bleeding on an unknown date, Hyperventilation on an unknown date, Fatigue / tired on an unknown date, Cognitive disturbance on an unknown date, Cramps on an unknown date, Stress in 2014, Temperature regulation disorder on an unknown date and Blurred vision on an unknown date. No other vaccines or medicines: unknown. Patient received two doses vaccine in the beginning of 2009, at 14/15-year-old. In ninth grade, patient experienced symptoms such as dizziness, sore knees, severe headache and was very tired. Subsequently, other reported symptoms develops. A tilt table test at the department show normal. Patient describes that she has been forced to abandon her education program. Has social assistance. Stress for a long period in 2014.


VAERS ID: 620631 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-03-01
Onset:2011-03-01
   Days after vaccination:0
Submitted: 2016-01-12
   Days after onset:1778
Entered: 2016-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Blood test, Chest pain, Computerised tomogram, Depression, Dizziness, Dysmenorrhoea, Dyspnoea, Endoscopy upper gastrointestinal tract, Fatigue, Feeling abnormal, Gluten sensitivity, Headache, Irritable bowel syndrome, Lethargy, Lumbar puncture, Menstruation irregular, Migraine, Nausea, Nuclear magnetic resonance imaging, Rash, Sleep disorder, Syncope, X-ray, X-ray gastrointestinal tract
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1601IRL002529

Write-up: Information has been received Sanofi Pasteur MSD (SPM) with (MFR# IE-1577272925-2016000040) on 08-JAN-2016. This case was received from the RA health authority on 05-JAN-2016. Initial report was received by the RA on 21-DEC-2015 from a member of the public which concerns a 15 year old female patient who experienced Headache, Nausea, Chest pain, Dyspnoea, Back pain, Rash, Abdominal pain upper, Arthralgia, Dizziness, Syncope, Fatigue, Lethargy, Feeling abnormal, Sleep disorder, Gluten sensitivity, Irritable bowel syndrome (IBS), Menstruation irregular, Dysmenorrhoea, Migraine and Depression following vaccination with GARDASIL. Concomitant medications: None. Medical history/concurrent conditions: None. The reporter indicated that the patient was perfectly healthy prior to vaccine. The patient was vaccinated with three doses of GARDASIL on 18-JAN-2011 (batch no. NN33040), 01-MAR-2011 (batch no. NN40800) and 24-MAY-2011 (NN40800). On 01-MAR-2011, the patient started to experienced headaches, nausea, chest pain, shortness of breath, back pain, rash, stomach cramps, pain in joints, dizziness, fatigue, lethargy, brain fog, irregular sleep, gluten intolerance, IBS, irregular periods and very painful, migraines and depression. Corrective treatment: Painkillers, depression tablets, steroids, magnesium, vitamin B complex, calcium and liquid silver. The patient was also given inhalers for asthma and was tried on a number of therapies for IBS. The patient was hospitalised for various tests, had a camera up and down, bloods taken, a lumbar puncture, X-rays, CT scans, MRIs. At the time of reporting the patient''s symptoms were persisting. The patient outcome was not recovered/not resolved.


VAERS ID: 628873 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-07-30
Onset:0000-00-00
Submitted: 2016-02-09
Entered: 2016-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NJ34850 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Alopecia, Anxiety, Arthralgia, Asthenia, Blood test, Decreased appetite, Depression, Disturbance in attention, Dizziness, Dysaesthesia, Echocardiogram, Electrocardiogram ambulatory, Fatigue, Gastrointestinal motility disorder, Headache, Hypertension, Nausea, Nuclear magnetic resonance imaging, Pallor, Palpitations, Rash, Rash erythematous, Stress, Tilt table test, Tinnitus, Vomiting, Weight decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal obstruction (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Hypermobility syndrome
Allergies:
Diagnostic Lab Data: MR scanning, blood test, tilt table test, ECHO, Holter monitoring 24 h, blood pressure measurement
CDC Split Type: WAES1602DNK004545

Write-up: Information has been received from Sanofi Pasteur MSD [DK-1577272925-2016000881] on 08-FEB-2016. Case received from a physician via health authority on 04-FEB-2016 under reference number DK-DKMA-WBS-0002590. A 15-year-old female adolescent patient received GARDASIL (batch number unknown dose 1) via intramuscular route on 05-JAN-2009, GARDASIL (batch number unknown, Dose 2) via intramuscular route on 04-MAR-2009, GARDASIL (batch number NJ34850, Dose 3) via intramuscular route on 30-JUL-2009. The patient experienced depression on an unknown date, memory problems in 2012, anxiety on an unknown date, concentration problems in 2012, hair loss in 2013, Tinnitus in 2013, stress on an unknown date, pale in mouth in 2013, rash, red patches on chest and knobs in face in 2013, Hypertension in 2015, weight loss in 2010, nausea in 2010, joint pain in MAR-2009, tiredness in 2011, vomiting in 2010, alternating stool in 2011, palpation in 2011, dizziness in 2011, dysesthesia in 2011, reduced appetite in 2010, headache in April 2009 and loss of energy in 2011. Has been confirmed with anxiety, stress and depression and have been at centrum for functional disorders with severe Bodily distress syndrome (BDS). Investigations: MR scanning, blood test, tilt table test, ECHO, Holter monitoring 24 h, blood pressure measurement. The patient had a medical history of Hypermobility syndrome. No other vaccines or medicines. The patient''s outcome was reported as recovering for rash, nausea, reduced appetite and weight loss and Not Recovered/Not Resolved for the other reported reaction.


VAERS ID: 629839 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-03-13
Onset:2013-07-09
   Days after vaccination:483
Submitted: 2016-03-03
   Days after onset:968
Entered: 2016-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. G005669 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Activities of daily living impaired, Fatigue, Headache, Lethargy, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1603IRL000441

Write-up: Information has been received from Sanofi Pasteur (MFR # IE-1577272925-2016001778) on 01-MAR-2016. This is the initial spontaneous report received from a Community Care Doctor via (Ref no. -025996) on 26-FEB-2016 which concerns a 15 year old female patient who experienced headache, nausea, lethargy, malaise, abdominal pain and fatigue following vaccination with GARDASIL. Concomitant medications: None. Medical history/concurrent conditions: Nil. the patient was vaccinated with three 0.5 ml doses of GARDASIL all via intramuscular route on 29-SEP-2011 (batch ni. NP26080/lot # NM26350, exp March 2013, Dose 1), 29-NOV-2011 (batch no. G005669, exp 31-JUL-2013, dose 2) and 13-MAR-2012 (batch no. G005669, exp: 31-JUL-2013, dose 3). Post vaccination, reported as 09-JUL-2013, the patient developed headache, nausea, lethargy, malaise, abdominal pain and fatigue. the reporter indicated that the patient''s symptoms are ongoing and the patient is unable to attend school due to the lethargy and exhaustion. the patient has been seen by her GP and was referred to a paediatrician with a query re possible ME. Corrective treatment: Nil. the reporter assessed the causal relationship between the adverse reaction and GARDASIL as unknown. the patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 632374 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-06
Onset:0000-00-00
Submitted: 2016-04-20
Entered: 2016-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired,