National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

Found 2107 cases where Vaccine is HPV4 and Disabled

Case Details (Sorted by Age)

This is page 2 out of 3

Result pages: prev   1 2 3   next


VAERS ID: 659267 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Male  
Location: Florida  
Vaccinated:2014-01-25
Onset:2015-12-10
   Days after vaccination:684
Submitted: 2016-10-13
   Days after onset:307
Entered: 2016-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J011272 / 3 AR / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Biopsy bone marrow, Full blood count, Rash erythematous
SMQs:, Anaphylactic reaction (broad), 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy: phenergan, factor 9
Allergies:
Diagnostic Lab Data: CBC, bone marrow biopsy
CDC Split Type:

Write-up: Red rashes were noted on his body, would stay for days and then go away. 12/2015 we went to the allergist and labs were drawn.


VAERS ID: 669963 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Utah  
Vaccinated:2008-10-25
Onset:2009-03-08
   Days after vaccination:134
Submitted: 2016-12-06
   Days after onset:2830
Entered: 2016-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. PL-0572X / 2 RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Seizure
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? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: 1963

Write-up: Had her first seizure on Sunday morning while attending church. No history of seizures, and no family history of seizures.


VAERS ID: 688226 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2012-07-17
Onset:2012-09-01
   Days after vaccination:46
Submitted: 2017-03-27
   Days after onset:1668
Entered: 2017-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0331Z / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4053AA / 1 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B062AA / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Asthenia, Balance disorder, Blood test, Bradyphrenia, Clumsiness, Electroencephalogram, Fall, Gait disturbance, Hypermetabolism, Hypotonia, Hypovitaminosis, Mood altered, Pneumonia, Positron emission tomogram, Posture abnormal, Seizure, Somnolence, Speech disorder
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (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 (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KEPPRA - ZONEGRAN - FOLIC ACID
Current Illness: None
Preexisting Conditions: Epilepsy
Allergies:
Diagnostic Lab Data: EEG - PETSCAN - BLOODWORK
CDC Split Type:

Write-up: Began dragging left foot/loss of muscle tone - pronated arms and feet - extreme mood changes - sudden pneumonia - refractory seizures - vitamin D depleted - speech changed - core weakness - slower processing - somnolence - hyper metabolic temporal lobes - clumsiness/constant falling - loss of balance.


VAERS ID: 698769 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Arkansas  
Vaccinated:2016-05-12
Onset:2016-11-01
   Days after vaccination:173
Submitted: 2017-06-08
   Days after onset:219
Entered: 2017-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. L024993 / 3 AR / SYR

Administered by: Private       Purchased by: Other
Symptoms: Apathy, Biopsy bone marrow, Blood oestrogen decreased, Blood test, Cardiac monitoring, Dehydration, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Electroencephalogram normal, Fatigue, Headache, Hypersensitivity, Immune thrombocytopenic purpura, Inappropriate schedule of drug administration, Influenza B virus test positive, Irritability, Loss of consciousness, Migraine, Mood altered, Nuclear magnetic resonance imaging normal, Pain, Platelet count decreased, Postural orthostatic tachycardia syndrome, Ultrasound pelvis
SMQs:, Torsade de pointes/QT prolongation (broad), Angioedema (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (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), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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, 1 days
   Extended hospital stay? No
Previous Vaccinations: headaches; fatigue; body aches; changes in mood~HPV (no brand name)~2~13.50~Patient
Other Medications: Zyrtec; Flonase; vitamins
Current Illness: None noted immediately after.
Preexisting Conditions: sulfa and penicillin allergies; gluten sensitivity
Allergies:
Diagnostic Lab Data: numerous blood tests; 2 MRIs; MRI-V; pelvic ultrasound; EKG; heart monitor for 48 hours; bone marrow biopsy; EEG; heart echo
CDC Split Type:

Write-up: Date of last GARDASIL vaccine was noted to be 5/12/2016, however, daughter was given two prior to this on 5/12/2015 and 7/16/2015. Several months after the second vaccine, daughter began having daily headaches with migraines at times. She lived with these by taking Motrin or Tylenol that did not alleviate the headaches. In November of 2016 her headaches were progressing in severity and she started experiencing fatigue and body aches. Her mood and motivation also declined. An MRI was ordered with normal results. APN started amitriptyline 10 mgs, which was increased to 20 then 30 and finally 40 mgs with no relief. All these mentioned symptoms continued and in January of this year she began passing out upon standing up and walking. The first incident resulted in an ER visit which test showed mild dehydration and low platelet levels. We followed up with the pediatrician that following week and physician ordered more tests indicating low platelets. After a couple of more appointments and blood tests, with no symptom relief, pediatrician had daughter admitted to hospital. During this hospital stay, results indicated Flu B and low platelets. An MRI-V was ordered with normal results. Oncologist wanted us to follow up with her to monitor blood counts to see if recovery of flu would result in normal platelet and white blood cell count. After hospital discharged daughter, we followed up with cardiologist, neurologist, gynecologist and oncologist. Neurologist diagnosed daughter with POTS and increased amitriptyline to 50 mgs, after EEG was normal. Still no relief of headaches. Cardiologist ran EKG and had daughter wear halter monitor of heart. Gynecologist''s tests indicated low estrogen which no cyst on ovaries and is now ordering an MRI to look at pituitary gland. Daughter had bone marrow biopsy on June 6, 2017 and has now been diagnosed with ITP. She continues to suffer daily with headaches, irritability, hypersensitivity, body aches, fatigue and low platelets.


VAERS ID: 703960 (history)  
Form: Version 2.0  
Age: 14.0  
Gender: Female  
Location: Maryland  
Vaccinated:2010-07-20
Onset:2010-12-19
   Days after vaccination:152
Submitted: 0000-00-00
Entered: 2017-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1577Y / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Adenotonsillectomy, Blood iron increased, Blood test abnormal, Colonoscopy normal, Cortisol increased, Dehydroepiandrosterone decreased, Gastric emptying study, Gastrointestinal tube insertion, Gene mutation identification test positive, Histamine intolerance, Hypovitaminosis, Immunoglobulin therapy, Impaired gastric emptying, Laboratory test abnormal, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, Plasmapheresis, Postural orthostatic tachycardia syndrome, Serum ferritin decreased, Sinus operation, Thyroid disorder, Thyroid function test abnormal
SMQs:, Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific dysfunction (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Dehydration (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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Sinusitis
Allergies: None
Diagnostic Lab Data: Cunningham Panel (2016)=high on all markers, Blood Work=(2010-2017 multiple) vitamin deficiencies, thyroid off, low Ferritin, high iron, high cortisol, low DHEA. GI emptying test= slow, GI Sids Markers= slow, Colonoscapy= good results, Genetic Testing=Some mutations
CDC Split Type:

Write-up: Pediatric Autoimmune Neuropsychiatric Syndrome, Postural Orthostatic Tachycardia, Gastroparesis, Histamine Intolerance, Vitamin Deficiency, Thyroid Off, TREATMENTS: Plasma Exchange, IVIG, Feeding Tube, Special Diets, Prescription Drugs, Supplements, Detox protocols, Therapy, T&A out, Sinus Surgery. OUTCOME: better than before but still disabled.


VAERS ID: 708071 (history)  
Form: Version 2.0  
Age: 14.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2008-11-19
Onset:2010-01-01
   Days after vaccination:408
Submitted: 0000-00-00
Entered: 2017-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS U2710AA / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0575X / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2733AA / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Acne, Amnesia, Anxiety, Blood urine absent, Borrelia test negative, Computerised tomogram head normal, Confusional state, Drug level therapeutic, Electroencephalogram abnormal, Eosinophil count increased, Epilepsy, Fatigue, Feeling cold, Gene mutation, Generalised tonic-clonic seizure, Glucose urine absent, Glutathione decreased, Hallucination, Irritability, Loss of consciousness, Lymphadenopathy, Musculoskeletal stiffness, Neutrophil count decreased, Nuclear magnetic resonance imaging abnormal, Oestradiol increased, Pain, Petit mal epilepsy, Progesterone decreased, Protein urine absent, Scan with contrast abnormal, Seizure, Sinusitis, Somnambulism, Stereotypy, Stress, Tremor, Urine ketone body absent, Visual impairment, White blood cells urine negative
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic leukopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Arthritis (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? No
Previous Vaccinations:
Other Medications: Rhinocort Aqua, Singulair, Serevent
Current Illness:
Preexisting Conditions: Allergies, mild asthma
Allergies: Tree nuts, biaxcin
Diagnostic Lab Data: MRI with & without contrast 10-10-11- Sinus Infection Detected, EEG 10-19-11- Diagnosis: Abnormal, MRI with & without contrast 1-27-12 - Sinus Disease Notation. EEG 1-30-12 - Diagnosis: Abnormal. CT with & without Contrast 2-3-12 - No acute intracranial abnormality. Labs 2-23-12: Estradiol Elevated, Progesterone Low, Neutrophils Low, Eosinophils High, Glucose, Protein & Ketone Urine - Negative, Leukocytes Neg, Blood Neg. 6-28-12 - Diagnosis: Axillary lymphadenopathy. Medication Check 7-12-12 - Therapeutic Level. EEG 7-19-12 - Diagnosis: Normal. EEG 8-2-12 - Diagnosis: Normal. 4-30-12 - Glutathione Low. 4-30-12 - Lyme IFA Test - Negative.
CDC Split Type:

Write-up: Absence & Tonic Clonic Seizures & blackouts, memory loss, sleep walking, excessively fatigued & stressed, confusion, unexplained stiffness & soreness, irritability, anxiety, shaky hands & repetitive hand motions, acne, complains of being cold even when room temp is 74 degrees, sinus infections, vision problems, 1 hallucination. She was diagnosed with Epilepsy 10-19-11. Neurologist gave no info with the diagnosis. 2nd Neurologist we saw said that the Epilepsy was caused by a genetic mutation and told her that she needed to have an eye exam after looking at her eyes. She is now seeing a 3rd Neurologist & taking Lamictal XR 300mg twice daily & Aptiom 600mg once daily. She has had a few break-thru seizures even while taking her meds.


VAERS ID: 723334 (history)  
Form: Version 2.0  
Age: 14.0  
Gender: Female  
Location: Florida  
Vaccinated:2014-07-08
Onset:2014-11-01
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2017-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006236 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Abdominal pain, Abdominal pain upper, Anxiety, Arthralgia, Asthenia, Central pain syndrome, Condition aggravated, Constipation, Depression, Disturbance in attention, Dizziness, Dysmenorrhoea, Eczema, Educational problem, Epstein-Barr virus test positive, Fatigue, Feeling abnormal, Headache, Hypersensitivity, Hypersomnia, Insomnia, Laboratory test, Loss of personal independence in daily activities, Memory impairment, Menstrual disorder, Nausea, Oesophagitis, Oesophagogastroduodenoscopy abnormal, Oropharyngeal pain, Pain, Panic attack, Social anxiety disorder, Temperature intolerance, Ventricular extrasystoles
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Ventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (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 inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations: First set of vaccinations after she was born. Severe congestion afterwards
Other Medications: VYVANSE; Clonidine
Current Illness: None
Preexisting Conditions: ADHD, Allergies, Eczema (prior to HPV Vaccinations)
Allergies: ABILIFY
Diagnostic Lab Data: Patient has received a laundry list of medical tests and labs over the past three years. Too many to list.
CDC Split Type:

Write-up: Patient had all three HPV (GARDASIL) Quadrivalent shots at three different locations. 1. 05/06/2014 @ 2:30 pm in Left Arm HPV 4 Lot H020901 expired 7/05/2015. 2. 07/08/2014 Not sure of time in Left Arm HPV 4 Lot J006236 expired 02/25/2016 Department of Health. 3. 04/11/2016 @ 11 am in Left Arm HPV 9 Lot L044475 expired 5/12/2017. Prior to the two HPV vaccinations, patient was a very high functioning person. She was in advanced classes, cheerleader, tennis, babysitting, took her college entrance exam, highly social, etc.


VAERS ID: 317981 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-17
Onset:2008-06-04
   Days after vaccination:79
Submitted: 2008-06-30
   Days after onset:26
Entered: 2008-07-01
   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: Disorientation, Drug screen, Electroencephalogram normal, Gait disturbance, Nervous system disorder, Personality change, Sensorimotor disorder, Somnolence
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Parkinson-like events (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypoglycaemia (broad), Dehydration (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? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Pollen allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Electroencephalography, normal; Blood drug screen, 0.7 mg lorazepam; Urine drug screen, 0.7 mg lorazepam.
CDC Split Type: WAES0806USA08420

Write-up: Information has been received from a paediatrician concerning a 14 year old female patient with a history of pollen allergy who was vaccinated with the first dose of GARDASIL on 17-MAR-2008 (IM, upper arm). It was well tolerated). On 13-MAY-2008, the patient was vaccinated with the second dose of GARDASIL, lot # not provided, IM into the upper arm. On 04-JUN-2008, the patient developed neurological and sensorimotor disorders including disorientation, gait instability, personality change and somnolence. She was hospitalized and received lorazepam 0.7 mg. There were no inflammatory signs and EEG was normal. She recovered after 2 days. On 17-JUN-2008, the patient experienced a similar episode. The final outcome was unknown. Other business partner numbers included: E2008-05763. No further information is available.


VAERS ID: 348843 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-02-06
Onset:2008-08-01
   Days after vaccination:177
Submitted: 2009-06-09
   Days after onset:312
Entered: 2009-06-10
   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: Acute tonsillitis, Antibody test normal, Blood bicarbonate increased, Blood creatinine increased, Blood glucose decreased, Blood immunoglobulin A, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood osmolarity increased, Blood pH decreased, Blood urea normal, Diabetic ketoacidosis, Familial risk factor, General physical health deterioration, Glycosylated haemoglobin, Ketoacidosis, PCO2 decreased, Polydipsia, Polyuria, Protein total increased, Rash pruritic, Somnolence, Tri-iodothyronine decreased, Type 1 diabetes mellitus, Urine analysis, Urine ketone body present, Urticaria, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None; Family history of diabetes
Allergies:
Diagnostic Lab Data: Unknown; diagnostic laboratory test, 26Aug08, 26.1, Diabetic acidosis ABB; arterial blood pCO(2), 26Aug08, 16.7; arterial blood pH, 26Aug08, 7.04; plasma HCO(3), 26Aug08, 44.8; serum blood urea, 26Aug08, 6.7; serum creatinine, 26Aug08, 117; serum glucose, 26Aug08, 27 mmol/L; serum glucose, 26Aug08, 34.6; total serum protein, 26Aug08, 75; urinalysis, 26Aug08, Glucose increased; urinalysis, 26Aug08, Protein increased; urinalysis, keton possitive; whole blood glycosylated hemoglobin, 26Aug08, 7.0; free serum triodothyronine test, 26Aug08, 2.2 pmol/L; serum osmolality test, 26Aug08, 324; whole blood glycosylated hemoglobin, 08Sep08, 10.5; serum gliadin IgA antibody, 10Sep08, Normal; serum gliadin IgG antibody, 10Sep08, Normal; serum glucose, 10Sep08, 5.7 mmol/L; serum tissue transglutaminase IgA, 10Sep08, Normal; serum immunoglobulin A test, 10Sep08, Normal
CDC Split Type: WAES0906USA00947

Write-up: Information has been received from a gynecologist that a 14 year old female patient who was vaccinated IM with a first dose of GARDASIL (lot number and injection site not reported) on 06-FEB-2008. On unspecified date ("in a temporal relationship to GARDASIL vaccination"), the patient developed diabetes mellitus type I. The patient had not recovered at the time of reporting. Upon internal review on 04-JUN-2009, the case was considered medically significant. Type I diabetes mellitus was considered to be disabling by the gynecologist. Other business partner numbers included (E2009-04463). No further information is available. Follow up has been received on 16-JUN-2009. The hospital report was provided. The patient was hospitalized from 26-AUG-2008 until 12-SEP-2008. Hospital diagnosis: "Manifestation of diabetes mellitus type I with ketoacidosis and precoma diabeticum". Since a "few weeks before hospitalization" the patient experienced polydipsia and polyuria and lost 7 kg of weight. Since about 2 weeks before hospitalization her general condition began to reduce. Since one week she suffered from angina tonsillaris which was treated with antibiotics. Symptoms worsened remarkably and she was hospitalized on 26-AUG-2008. At the time the patient was slightly drowsy (Glasgow coma scale 14) showed Kussmaul respiration and signs of exsiccosis Hyperglycemia (27 mmol/L) had been determined by the physician on emergency. Therapy was started with rehydratation and insulin intravenous. Intensive insulin therapy (LANTUS and NOVORAPID) was started from the third day of hospitalization. In the course of the quantity of insulin could be measurably reduced. In the meantime the patient developed a pruritic, partly urticarial rash which was successfully treated with FENYSTIL. Lab findings see lab comments: Gliadin-IgA and Gliadin-IgG, tTG(endomysium) Ig A were normal. The patient had a family Medical history of Diabetes mellitus type 2 (maternal grand father). The patient was discharged in a good general condition. Duration and outcome was not reported for each symptom. This is an amended report. Information received date was updated in the narrative from 16-JAN-2009 to 16-JUN-2009. Gliadin-IgM was changed to Gliadin-IgG and lab data field was updated. File is closed. No further information is available. This is a corrected report, as amended.


VAERS ID: 353518 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-11-09
Onset:2008-12-09
   Days after vaccination:30
Submitted: 2009-08-07
   Days after onset:240
Entered: 2009-08-10
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Antibody test normal, Antinuclear antibody negative, Arthralgia, Blood creatine phosphokinase normal, Blood immunoglobulin A increased, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood lactate dehydrogenase normal, C-reactive protein normal, Electroencephalogram normal, Electromyogram normal, Musculoskeletal pain, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Pain in extremity, Sensory disturbance, Troponin, Ultrasound scan normal, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Hypersensitivity (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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Psychiatric symptom
Allergies:
Diagnostic Lab Data: electromyography, ??Jan09, 4 limbs electromyography normal; electroencephalography, ??Jan09, normal; ultrasound, ??Jan09, left shoulder echotomography normal; X-ray, ??Jan09, normal; magnetic resonance imaging, ??Jan09, shoulder MRI normal; magnetic resonance imaging, ??Jan09, cerebral MRI normal; Smith antigen antibodies, ??Jan09, normal; ribonucleoprotein antigen antibodies, ??Jan09, normal; serum C-reactive protein, ??Jan09, normal; serum LDH, ??Jan09, normal; serum anti-La, ??Jan09, normal; serum anti-Ro, ??Jan09, normal; serum creatine kinase, ??Jan09, normal; serum troponin quantitative test, 01Jan09, normal; serum immunoglobulin M test, ??Jan09, normal; serum immunoglobulin G test, ??Jan09, normal; serum immunoglobulin A test, ??Jan09, 2.78, high
CDC Split Type: WAES0908USA00116

Write-up: Case received from the Health Authorities on 31-JUL-2009 under the reference numbers MA20091226 and 09-2228. Information has been received from an agency concerning a 14-year-old female patient who had been followed within a child in psychiatry environment from the age of 18 months to 12 years old received the first dose of GARDASIL (batch number not reported) via intramuscular route at the level of the left upper limb on 09-NOV-2008. One month later, she developed pain starting in the left upper limb, at the level of the scapular belt, then reaching the left leg, followed by right arm and then the right leg. After a consultation she was hospitalized from 27-JAN-2009 to 30-JAN-2009 at the Child Neurology Unit. The following work-up were performed and were normal: standard x-ray examination, left shoulder echotomography, shoulder MRI, cerebral MRI, 4 limbs electromyography, electroencephalography. Troponin, C-Reactive Protein, creatine kinase, lactic dehydrogenase, anti-Sm and anti-RNP antibodies, anti-SSA/Ro and anti-SSB/La antibodies, immunoglobulins M and immunoglobulins G were normal. Only the immunoglobulins A were a little high at 2.78. These pains, accompanied with sensitivity disorders, evoked a Parsonage-Turner syndrome but it was ruled out due to the resistance to corticotherapy. Final diagnosis was "rebel pain with a functional component". The teenager was treated with LAROXYL, EFFERALGAN CODEINE and MYOLASTAN following to a consultation to a pain center. At the time of report, the patient had not yet recovered. Sensory disturbance and pain in the joint involving the shoulder region, lower leg and limb were considered to be disabling. Other business partner numbers included E2009-07668.


VAERS ID: 387595 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-04-04
Onset:0000-00-00
Submitted: 2010-05-14
Entered: 2010-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Autonomic nervous system imbalance, Chest pain, Dizziness, Dyspnoea, Fatigue, Nausea, Oropharyngeal pain, Pharyngitis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1005USA01078

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail concerning a 14 year old female patient who on 04-APR-2008 was vaccinated with a dose of GARDASIL (lot number not reported). Subsequently the patient experienced fatigue, nausea, dizziness, antonomic instability, fainting, breathlessness, pain in stomach, chest, sore throat and recurrent throat infections. The patient was graded return to activity. At the time of the report, the patient had not yet recovered. The reporter felt that fatigue, dizziness, pharyngitis and syncope were possibly related to GARDASIL. Fatigue, dizziness, pharyngitis and syncope were considered to be disabling. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 449031 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-03-01
Onset:2011-09-01
   Days after vaccination:184
Submitted: 2012-02-06
   Days after onset:158
Entered: 2012-02-07
   Days after submission:1
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, Affective disorder, Alanine aminotransferase normal, Amenorrhoea, Amnesia, Appetite disorder, Arthralgia, Arthropod bite, Aspartate aminotransferase normal, Asthenia, Back pain, Blood alkaline phosphatase normal, Blood bilirubin decreased, Blood cortisol normal, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased, Blood test normal, Borrelia test negative, Cardiac electrophysiologic study normal, Chest discomfort, Crying, Depression, Disturbance in attention, Dizziness, Dyspnoea, Dyspnoea exertional, Echocardiogram, Echocardiogram normal, Electrocardiogram ambulatory normal, Electrocardiogram normal, Electroencephalogram normal, Electromyogram normal, Electrophoresis normal, Epstein-Barr virus antibody positive, Family stress, Fatigue, Gamma-glutamyltransferase normal, General physical health deterioration, Heart rate decreased, Human chorionic gonadotropin decreased, Hyperhidrosis, Hypersensitivity, Hypersomnia, Joint lock, Laboratory test normal, Loss of consciousness, Malaise, Menstrual disorder, Movement disorder, Muscle spasms, Myalgia, Narcolepsy, Nervous system disorder, Nuclear magnetic resonance imaging brain normal, Pain in extremity, Pallor, Peripheral coldness, Postictal state, Red blood cell sedimentation rate increased, Sleep disorder, Sleep study abnormal, Social problem, Somnolence, Thyroid function test normal, Ultrasound Doppler normal, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Akathisia (broad), Dyskinesia (broad), 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), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Fertility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad), 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? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Scoliosis; Congenital hip dislocation
Allergies:
Diagnostic Lab Data: Cardiac electrophysiology, 23Nov11, normal; Electroencephalography, 24Nov11, strictly normal with a normal somnolence and sleep for her age; Magnetic resonance imaging, 02Jan12, brain: did not find any patent anomaly; Blood pressure measurement, 10.5-10.6; Electrocardiogram; Carotid artery massage, did not show any hyper reflexivity; Electrocardiogram, normal; Ultrasound, Doppler tissue imaging screening: a mitral annulus normal; Ultrasound, Echodoppler; Holter monitoring, normal; Sleep study, 14, Epworth Sleepiness Scale; Electromyography, did not show any anomaly; Sleep study, 8-10 24H, Epworth Sleepiness Scale; Physical examinatin, normal; Blood LDH, 22Nov11, 609 IU/I; Serum beta-human chorionic gonadotropin, 22Nov11, <2 IU/I; Serum creatine kinase, 22Nov11, 736 IU/I, creatine phosphokinase; Erythrocyte sedimentation rate, 22Nov11, 9 mmmm/h, first hour; Erythrocyte sedimentation rate, 22Nov11, 27 mm/h, second hour; Total serum cortisol, 23Nov11, 15.17 microg/dl; Epstein-Barr virus antibodies, 24Nov11, IgG VCA and EBNA highly positive; Serum alanine aminotransferase, 24Nov11, 13 IU/I; Serum alkaline phosphatase, 24Nov11, 130 IU/I; Serum aspartate aminotransferase, 24Nov11, 26 IU/I; Serum creatine kinase, 24Nov11, 281 IU/I, creatine phosphokinase; Serum gamma glutamyl transferase, 24Nov11, 13 IU/I; Total serum bilirubin, 24Nov11, 4.2 umol/l; Laboratory test, Biological work-up, blood work-up, ionogram, thyroidal work-up and electrophoresis were
CDC Split Type: WAES1111USA00812

Write-up: Information has been received from a physician on 20-OCT-2011. Case reported as serious (hospitalization and disability). Case medically confirmed. A 17-year-old female patient had received the third dose of GARDASIL (batch number not reported) on an unspecified date. One month after vaccination, the patient experienced myalgia, shortness of breath and had no more strength. At the time of reporting, the outcome was not provided. To be noted that the patient was followed by a cardiologist, and that according to the patient''s mother, the events were due to the vaccine. Follow-up information received on 24-JAN-2012: The patient was 14-year-old at the time of the events instead of 17 as previously reported. The patient had received the first dose of GARDASIL (batch number not reported) on 01-MAR-2011, the second dose (batch number NM23050) on 27-MAY-2011, and the third dose (batch number NM45890) on 29-AUG-2011. She had concomitantly received NEISVAC-C (other manufacturer, batch number VN914776) on 18-JUN-2011. Starting in the middle of September-2011, the patient was found severe asthenia, concentration impaired, appetite disorder, menstrual disorder and movements disorder. The patient also experienced narcolepsy accompanies by fine movements disorder. The disorders rapidly deteriorated. The patient was referred to a cardiologist dud to chest oppression and shortness of breath, and to a rheumatologist due to diffuse joint pain. She was subsequently hospitalized. Consultation at the cardiologist on 19-OCT-2011: The patient who used to practice high sporting activity up to the last summer presented since then severe asthenia with a need for prolonged sleep period furthermore, she also presented with malaises, some of them occurring just after practice sport with a sensation of slow heart beat which necessitated that she sat down, then followed by lipothymia without loss of consciousness. Other malaises occurred when she was in a sitting position, during the meal, or even lying down. It was difficult to assess whether she had lost consciousness. There was no familial history of heart disease, in particular no history of rhythmology anomaly which could have led to early serious events. Blood pressure was 10.5-6, hear sounds were regular, there was no sound or pathological add- on murmur. Distal pulse could be heard, there was no cervical murmur, lung auscultation was correct. Electrocardiogram showed sinusal rhythm 94/mm, PR interval 0-16, QRS axis superior to 40, supple repolarization, Q-T interval 0-28 for a theorical basis of 0-31. Carotid sinus massage did not show any hyper reflexivity. Echodoppler was reassuring with a good global and segmentary contractility and no stigma of pulmonary arterial hypertension, no shunt, no cavitary dilatation particularly left artrial. Doppler tissue imaging screening showed a mitral annulus normal. To be noted that the patient had experienced cutaneous hyper reactivity consequently to mosquito bites. The cardiologist suspected a possible tick bite which could lead to search for arguments suggestive of Lyme disease. 24h-ECG Holter monitoring was recommended. Consultation at hospital on 17-NOV-2011: The patient used to practice piano, dancing and sailing. During the last summer she had practiced sailing and cycling in a sport summer camp. To be note that the patient had started to have her periods from 9 years old to 11 years old. She now had her periods since the age of 13 under treatment with DUPHASTON which had recently been interrupted. On examination she presented with malaises with sensation for cardiac arrest. She presented with 4 malaises apparently with no prodrome, accompanied by hypersomnia (the patient slept for approximately 1 hour). When she was seen by her family and friends circle, she was found to have a sensation of white and cold hands and sweating. There was no notion of aura before these malaises, no loss of urine and no tonic-clonic movements. But the patient presented with postictal amnesia. The patient experienced pain and cramps at the level of the lower limb associated with sensation of locked knee. She also presented with fatigability and dyspnea exertional, as well as severe asthenia since the end of last summer. She stopped any leisure or sporting activity. Biological work-up, blood work-up, ionogram, thyroidal work-up and electrophoresis had been performed. Results were normal. There was no inflammatory syndrome. Lyme serology was negative. The patient had been seen by a rheumatologist who concluded to back pain on a growth spinal dystrophy with a slight kyphotic attitude for which she was followed by a physiotherapist. Cardiac work-up, including ECG, holter and echocardiogram, was normal. Physical examination was strictly normal. Cardiac and pulmonary auscultation were normal. There was no peripheral adenopathy, no neurological anomaly and particularly no motor deficiency. The osteotendinous reflexes were all present. There was no pyramidal irritation and no cranial nerve anomaly. The patient also presented with food disorders and difficulties in relationship with her family and friends. An electrophysiological work-up was performed on 23-NOV- 2011, which was normal and which could not explain the pain that the patient felt in her left quadriceps. Hospital report on 06-DEC-2011. The patient was hospitalized in the paediatrics service from 22 to 25-NOV-2011 due to asthenia accompanied by recurrent malaises. She had a history of scoliosis and congenital hip discoloration. In end of AUG-2011, during the week-end preceding the beginning of the school year, the patient experienced a malaise without loss of consciousness associated with dizzy spells and filmy vision which spontaneously resolved after 5 minutes of rest. A few days later, malaises were recurrent during a meal, without loss of consciousness and without prodrome, followed by falling asleep during approximately one hour. In the same time, the patient was found to have mechanical back pain which partially regressed under paracetamol as well as mood disorder, particularly characterized by arguing with her parents. Two repeated episodes of muscular cramps in the internal face of both thighs were also reported. Infectiolous work-up had been performed and was normal. On admission, physical examination was normal, particularly from a neurological standpoint, except for amenorrhea which lasted since one month. Clinical investigations were normal for biology except for a slight increase of Creatine phosphokinase at 736 on 22-NOV-2011 but which had reduced at 280 two days later. Hepatic work-up was normal, patient''s evolution within the service: The patient reported two episodes of falling asleep. Physical examination was still normal. Epworth Sleepiness Scale was performed due to hypersomnia and revealed 8-10/24, i.e. moderate sleep debt. Check-up for malaises was completed by electroencephalogram on 24-NOV-2011, which was strictly normal with a normal somnolence and sleep for her age and a non REM stage after falling asleep physiologically Electromyography did not show any anomaly either which could explain the pain that the patient felt. The neurologist specialized in sleep could not see any formal indication for the moment to treat a potential narcolepsy as the diagnosis was unlikely. The patient was seen by a child psychiatrist who put forward a dimension of depression without signs of seriousness characterized by a decrease in external investments and inexplicated crying when she was on her own. To be noted that episodes of malaises and falling asleep never occurred when she was on her own. The child psychiatrist suggested that the depressive symptomatology could explain at least partially the different malaises. The functional origin as only source of these malaises would only be confirmed once the patient would have seen the neurologist and if no other cause found to explain hypersomnia. The patient was discharged on 25-NOV-2011. The hospital report concluded to malaises and sleep disorder without aetiology at the moment except for depressive syndrome. Brain MRI performed on 02-JAN-2012 did not find any patent anomaly. See lab data for further results: on 22-NOV-2011, blood lactate dehydrogenase was 609, human chorionic gonadotropin was <2, erythrocyte sedimentation was 9 at fist hour and 27 at the second hour, cortisol was 15.17; on 24-NOV-2011, Epstein-Barr virus serology showed IgG VCA and EBNA highly positive, aspartate aminotransferase was 26, alanine aminotransferase was 13, gamma-glutamyl transferase was 13, alkaline phosphatase was 130 and serum bilirubin was 4.2. Consultation at the neurologist on 14-DEC-2011 (only the 1st part of the letter was received): the patient felt asleep either at school, during meals, and she reported that one she fell asleep while standing and speaking and that time her parents had difficulties in waking her up. Epworth Sleepiness Scale was 14. Both hospitalization and disability were reported as seriousness criterion. To be noted that according to the reporter the suspected diagnosis was neurological disease induced by vaccination with GARDASIL or its adjuvants. The patient''s outcome was reported as deterioration. Other business partner numbness include E201106476. Additional information has been requested.


VAERS ID: 449952 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-08-29
Onset:2011-09-01
   Days after vaccination:3
Submitted: 2012-02-17
   Days after onset:169
Entered: 2012-02-21
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NM45890 / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activities of daily living impaired, Affective disorder, Aggression, Alanine aminotransferase normal, Amenorrhoea, Amnesia, Appetite disorder, Arthralgia, Aspartate aminotransferase normal, Asthenia, Back pain, Blood bilirubin decreased, Blood cortisol, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased, Borrelia test negative, Cardiac electrophysiologic study normal, Chest discomfort, Crying, Depression, Disturbance in attention, Dizziness, Dyspnoea, Dyspnoea exertional, Echocardiogram normal, Electrocardiogram ambulatory normal, Electrocardiogram normal, Electroencephalogram normal, Electrophoresis normal, Epstein-Barr virus antibody positive, Fatigue, Fundoscopy normal, Gamma-glutamyltransferase normal, General physical health deterioration, Heart rate decreased, Human chorionic gonadotropin, Hyperhidrosis, Hypersomnia, Liver function test normal, Malaise, Menstrual disorder, Movement disorder, Muscle spasms, Myalgia, Narcolepsy, Nervous system disorder, Nuclear magnetic resonance imaging brain normal, Pain in extremity, Partner stress, Peripheral coldness, Red blood cell sedimentation rate increased, Somnolence, Thyroid function test normal, Ultrasound Doppler normal, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (broad), Akathisia (broad), Dyskinesia (broad), 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), Hostility/aggression (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Fertility disorders (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), 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? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NEISVAC-C 18Jun11
Current Illness:
Preexisting Conditions: Scoliosis; Congenital hip dislocation
Allergies:
Diagnostic Lab Data: Cardiac electrophysiology, 23Nov11, electrophysiological work-up: normal; electroencephalography, 24Nov11, strictly normal with a normal somnolence; magnetic resonance imaging, 02Jan12, Brain MRI: did not find any patent anomaly; blood pressure measurement, 10.5-6; ultrasound, Doppler tissue imaging screening: a mitral annulus normal; electrocardiogram, normal; physical examination, normal; echocardiography, normal; ophthalmoscopy, Funduscopy: clear papilla; Holter monitoring, normal; serum LDH, 22Nov11, 609 IU/I; serum creatine kinase, 22Nov11, 736 IU/I, creatine phosphokinase; total serum human chorionic gonadotropin, 22Nov11, <2 IU/I; erythrocyte sedimentation rate, 22Nov11, 1st hr 9 mmmm; erythrocyte sedimentation rate, 22Nov11, 2nd hr 27mm; total serum cortisol, 23Nov11, 15.17 microg/dI; serum alanine aminotransferase, 24Nov11, 13 IU/I; serum alkaline phosphatase, 24Nov11, 130 IU/I; serum aspartate aminotransferase, 24Nov11, 26 IU/I; serum creatine kinase, 24Nov11, 281 IU/I, creatine phosphokinase; serum gamma glutamyl transferase, 24Nov11, 13 IU/I; total serum bilirubin, 24Nov11, 4.2 umol/l; serum Epstein-Barr virus antibody test, 24Nov11, IgG VCA and EBNA highly positive; Lyme disease assay (ELISA), negative
CDC Split Type: WAES1202USA01961

Write-up: Case received from a physician on 20-OCT-2011 and medically confirmed. A 17-year-old female patient had received the third dose of GARDASIL (batch number not reported) on an unspecified date. One month after vaccination, the patient experienced myalgia, shortness of breath and had no more strength. At the time of reporting, the outcome was not provided. To be noted that the patient was followed by a cardiologist, and that according to the patient''s mother, the events were due to the vaccine. Follow up information received on 24-JAN-2012: The patient was 14 year old at the time of the events instead of 17 as previously reported. The patient had received the first dose of GARDASIL (batch number not reported) on 01-MAR-2011, the second dose (batch number NM23050) on 27-MAY-2011, and the third dose (batch number NM45890) on 29-AUG-2011. She had concomitantly received NEISVAC-C (other manufacturer, batch number VN914776) on 18-JUN-2011. Starting in the middle of September 2011, the patient was found severe asthenia, concentration impaired, appetite disorder, menstrual disorder and movements disorder. The patient also experienced narcolepsy accompanied by fine movements disorder. The disorders rapidly deteriorated. The patient was referred to a cardiologist due to chest oppression and shortness of breath, and to a rheumatologist due to diffuse joint pain. She was subsequently hospitalized. Consultation at the cardiologist on 19-OCT-2011: The patient who used to practice high sporting activity up to the last summer presented since then severe asthenia with a need for prolonged sleep period. Furthermore, she also presented with malaises, some of them occurring just after practicing sport with a sensation of slow heart beat which necessitated that she sat down, then followed by lipothymia without loss of consciousness. Other malaises occurred when she was in a sitting position, during the meal, or even lying down. It was difficult to assess whether she had lost consciousness. There was no familial history of heart disease, in particular no history of rhythmology anomaly which could have led to early serious events. Blood pressure was 10.5-6, heart sounds were regular, there was no sound or pathological add-on murmur. Distal pulse could be heard, there was no cervical murmur, lung auscultation was correct. Electrocardiogram showed sinusal rhythm 94/min, PR interval 0-16, QRS axis superior to 40, supple repolarization, Q-T interval 0-28 for a theorical basis of 0-31. Carotid sinus massage did not show any hyper reflexivity. Echo doppler was reassuring with a good global and segmentary contractility and no stigma of pulmonary arterial hypertension, no shunt, no cavitary dilatation particularly left atrial. Doppler tissue imaging screening showed a mitral annulus normal. To be noted that the patient had experienced cutaneous hyper reactivity consequently to mosquito bites. The cardiologist suspected a possible tick bite which could lead to search for arguments suggestive of Lyme disease. 24h-ECG Holter monitoring was recommended. Consultation at hospital on 17-NOV-2011: The patient used to practice piano, dancing and sailing. During the last summer she had practiced sailing and cycling in a sport summer camp. To be note that the patient had started to have her periods from 9 years old to 11 years old. She now had her periods since the age of 13 under treatment with DUPHASTON which had recently been interrupted. On examination she presented with malaises with sensation of cardiac arrest. She presented with 4 malaises apparently with no prodrome, accompanied by hypersomnia (the patient slept for approximately 1 hour). When she was seen by her family and friends circle, she was found to have the sensation of white and cold hands and sweating. There was no notion of aura before these malaises, no loss of urine and no tonic-clonic movements. But the patient presented with postictal amnesia. The patient experienced pain and cramps at the level of the lower limb associated with sensation of locked knee. She also presented with fatigability and dyspnea exertional, as well as severe asthenia since the end of last summer. She stopped any leisure or sporting activity. Biological work-up, blood work-up, ionogram, thyroidal work-up and electrophoresis had been performed. Results were normal. There was no inflammatory syndrome. Lyme serology was negative. The patient had been seen by a rheumatologist who concluded to back pain on a growth spinal dystrophy with a slight kyphotic attitude for which she was followed by a physiotherapist. Cardiac work-up, including ECG, Holter and echocardiogram, was normal. Physical examination was strictly normal. Cardiac and pulmonary auscultation were normal. There was no peripheral adenopathy, no neurological anomaly and particularly no motor deficiency. The Osteotendinous reflexes were all present. There was no pyramidal irritation and no cranial nerve anomaly. The patient also presented with food disorders and difficulties in relationship with her family and friends. An electrophysiological work-up was performed on 23-NOV-2011, which was normal and which could not explain the pain that the patient felt in her left quadriceps. Hospital report on 06-DEC-2011: The patient was hospitalized in the paediatrics service from 22-NOV-2011 to 25-NOV-2011 due to asthenia accompanied by recurrent malaises. She had a history of scoliosis and congenital hip dislocation. In end of August 2011, during the weekend preceding the beginning of the school year, the patient experienced a malaise without loss of consciousness associated with dizzy spells and filmy vision which spontaneously resolved after 5 minutes of rest. A few days later, malaises were recurrent during a meal, without loss of consciousness and without prodrome, followed by falling asleep during approximately one hour. In the same time, the patient was found to have mechanical back pain which partially regressed under paracetamol as well as mood disorder, particularly characterized by arguing with her parents. Two repeated episodes of muscular cramps in the internal face of both thighs were also reported. Infectiolous work-up had been performed and was normal. On admission, physical examination was normal, particularly from a neurological standpoint, except for amenorrhea which lasted since one month. Clinical investigations were normal for biology except for a slight increase of Creatine phosphokinase at 736 on 22-NOV-2011 but which had reduced at 280 two days later. Hepatic work-up was normal. Patient''s evolution within the service: The patient reported two episodes of falling asleep. Physical examination was still normal. Epworth Sleepiness Scale was performed due to hypersomnia and revealed 8-10/24, i.e. moderate sleep debt. Check-up for malaises was completed by electroencephalogram on 24-NOV-2011, which was strictly normal with a normal somnolence and sleep for her age and a non REM stage after falling asleep physiologically. Electromyography did not show any anomaly either which could explain the pain that the patient felt. The neurologist specialized in sleep could not see any formal indication for the moment to treat a potential narcolepsy as the diagnosis was unlikely. The patient was seen by a child psychiatrist who put forward a dimension of depression without signs of seriousness characterized by a decrease in external investments and inexplicated crying when she was on her own. To be noted that episodes of malaises and falling asleep never occurred when she was on her own. The child psychiatrist suggested that the depressive symptomatology could explain at least partially the different malaises. The functional origin as only source of these malaises would only be confirmed once the patient would have seen the neurologist and if no other cause found to explain hypersomnia. The patient was discharged on 25-NOV-2011. The hospital report concluded to malaises and sleep disorder without aetoiology at the moment except for depressive syndrome. Brain MRI performed on 02-JAN-2012 did not find any patent anomaly. See lab data for further results. Consultation at the neurologist on 14-DEC-2011 (only the 1st part of the letter was received): the patient fell asleep either at school, during meals, and she reported that once she fell asleep while standing and speaking and that time her parents had difficulties in waking her up. Epworth Sleepiness Scale was 14. Both hospitalization and disability were reported as seriousness criterion. To be noted that according to the reporter, the suspected diagnosis was neurological disease induced by vaccination with GARDASIL or its adjuvants. The patient''s outcome was reported as deterioration. Follow-up information received from the neurologist letter via the patient''s mother on 08-FEB-2012: The patient''s mother had a history of thyroid cancer in remission, and her father and brother both experienced hypercholesterolemia. The patient started to have her periods from 9 to 11 years old but now experienced amenorrhea. There was no sleep paralysis, no hypnagogic hallucinations, no clear cataplexia although she sometimes needed to sit when she was walking, and no weight increase. Physical examination was normal. Funduscopy showed clear papilla. The neurologist concluded to excessive diurnal somnolence, and put forward three hypotheses: two organics, i.e. sleep pathology or linked to sleep deficiency (sleep lasted generally 7 hours), or psychophysiological hypersomnia. At the time of reporting, the patient had not recovered. Other business partner numbers include: E2011-06476. Additional information has been requested.


VAERS ID: 452777 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-09-14
Onset:2010-11-03
   Days after vaccination:50
Submitted: 2012-03-30
   Days after onset:513
Entered: 2012-04-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NJ49370 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anxiety, Cervical spine flattening, Computerised tomogram normal, Convulsion, Electroencephalogram abnormal, Fatigue, Goitre, Insomnia, Intervertebral disc disorder, Intervertebral disc protrusion, Kyphosis, Muscle spasms, Neck pain, Neurological examination normal, Nuclear magnetic resonance imaging normal, Nuclear magnetic resonance imaging spinal cord abnormal, Paraesthesia, Sensation of heaviness, Sleep disorder, Spinal myelogram normal, Thyroid cyst, Ultrasound thyroid abnormal
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Osteoporosis/osteopenia (broad), Generalised convulsive seizures following immunisation (narrow), 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:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Ultrasound, 03Nov10, Thyroid: micro cysts of 2 to 3 mm in diameter/thyroid whose volume was at the upper limit; Neurological examination, ??11, Normal; Diagnostic procedure, ??11, Cervical hyperextension: contact of the upper marrow with the cervical canal; Computed axial tomography, 26May11, Cervical spine: without notion of trauma, no significant disc or vertebral anomaly; Magnetic resonance imaging, 09Jun11, Loss of cervical spine lordosis with discrete kyphosis; Electroencephalography, 01Jul11, Diffuse acute theta waves in hyperpnea; Neurological examination, 07Jul11, There was no electrical neuromuscular anomalies; Magnetic resonance imaging, 16Jan12, Lumbar spine: L3/L4 discopathy and L4/L5 protrusion; Computed axial tomography, normal; Laboratory test, Caliber canal was at the lower limit of the normal
CDC Split Type: WAES1202USA01420

Write-up: Case received from a pharmacist on 24-NOV-2011 and medically confirmed. A female patient aged 14 or 15 years old with no relevant medical history had received the three doses of GARDASIL (batch number not reported) according to the recommended schedule, and the third dose in January 2011. On an unspecified onset of time after the third dose, she experienced spasmophilia, painful muscle spasms, anxiety and extreme fatigue. For some time now she also developed insomnia and needed sleep inducing drug to fall asleep. She was also given analgesics and vitamins as corrective treatment. Computed axial tomography (CT) Scan was normal, so as the consultation at the ophthalmologist. It was noteworthy that the first two doses had been administered on unspecified dates, and the tolerance had not been reported. The patient used to be in good general health Status. At the time of reporting, the patient had not recovered. Follow-up information received on 19-MAR-2012 through PV form and laboratory reports. Case upgraded to serious upon the basis of the information received. The patient was 14 years old. She had received the first dose of GARDASIL (batch number NL53400, lot number NJ49370) on 14-SEP-2010 and the second GARDASIL (batch number NL50390, lot number NJ53440) on 08-NOV-2010. She received the third dose (batch number NN22980, lot number NK05070) via intramuscular route in the left deltoid on 09-MAY-2011. On an unspecified onset of time she developed fatigue, pain in neck, heaviness in legs, tetany fits and sleep disorder. Thyroid ultrasound was performed on 03-NOV-2010 and showed thyroid whose volume was at the upper limit especially the right lobe. Intraparenchymatous micro cysts of 2 to 3 mm in diameter were present in both lobes. There was no nodular formation. Thyroid goiter was suspected. Cervical spine computed tomography was performed on 26-MAY-2011 due to heaviness of both upper limbs prevailing on the right, without notion of trauma but following the cervical spine handling. It showed no significant disc or vertebral anomaly. Medullar magnetic resonance imaging (MRI) was performed on 09-JUN-2011 due to repeated malaises when stretching the neck associated with paraesthesia of upper limbs. Neurological examination and cervical CT scan were normal. MRI showed loss of cervical spine lordosis with discrete kyphosis. Cervical hyperextension showed a contact of the upper marrow with the cervical canal. Electroencephalography (EEG) performed on 01-JUL-2011 showed diffuse acute theta waves in hyperpnea but no asymmetry, focused or paroxysmal anomaly. The neurological examination concluded that there was no electrical neuromuscular anomalies. Lumbar spine MRI was performed on 16-JAN-2012 due to pain accompanied by formication in legs and trauma one month before. It revealed L3/L4 discopathy with marked central elevation which coming into contact with the dural sac and the L4 right and left emergencies. It also showed a small L4/L5 protrusion with no clear root impingement. Calibar canal was at the lower limit of the normal. The patient was given corrective treatment with CORTANCYL, VOLTAREN, paracetamol, omeprazole, and from 30-MAY-2011 she was also given HEPT-A-MYL tid during 15 days, CORAMINA-GLUCOSA 1 dosage from oad or bid in case of fit, and "ATEPADENE" bid during one month. On 06-JUN-2011, she was prescribed UVEDOSE 1 dosage form, L72 (homepathy) 30 drops at dinner and 60 drops before going to bed, and ADVIL tid if fever. Vaccination file was provided and was up to date. The reporter mentioned that the patient was unable to practice any physical activities during two months. It was noteworthy that no criterion of serious was ticked by the reporter. The events were considered to be disabling. Other business partner number included: E2011-07490. No further information is available.


VAERS ID: 457484 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-10-01
Onset:2010-10-01
   Days after vaccination:0
Submitted: 2012-06-14
   Days after onset:622
Entered: 2012-06-15
   Days after submission:1
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, Allergy to metals, Arthralgia, Back pain, Blood culture, Blood iron decreased, Blood test normal, Crying, Discomfort, Fibromyalgia, Gait disturbance, Immune system disorder, Insomnia, Laboratory test normal, Lymphadenopathy, Middle insomnia, Neck pain, Pain, Stress, Toe walking, Ultrasound scan abnormal, X-ray limb normal
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (broad), Arthritis (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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Joint X-ray, 01?Oct11, X-rays of wrists - nothing showed; Ultrasound, 01?Oct11, swollen lymph node; X-ray, 15?Nov11, nothing showed; Diagnostic laboratory test, 15?Nov11, Blood tests come negative for juvenile arthritis (JA); Diagnostic laboratory test, 06Feb12, No cancer, no lupus, or rheumatoid arthritis; Plasma iron assay, 15?Novv11, Iron very low; Blood culture, ??Feb?12
CDC Split Type: WAES1206USA01230

Write-up: Information has been received from a female consumer via internet (local reference # CA12-005831) concerning her 14 year old daughter who in October 2010 was vaccinated with the first dose of GARDASIL (dose, route, lot number not reported), in January 2011 with the second of GARDASIL (dose, route, lot number not reported) and on 03-APR-2011 with the third dose of GARDASIL (dose, route, lot number not reported). In October 2010, right after first shot, the patient experienced back pain. In January 2011, after the patient got the second dose of GARDASIL, the back pain persisted and her knees began to hurt as well. In April 2011, immediately after the third shot of GARDASIL, her knees and back hurt so much that she would cry. In approximately June 2011, in summer the patient''s pain moved to her hips as well and walking was becoming painful. The physician diagnosed over use. In September 2011, yet the pain never went away, she was in pain every hour of every day. The anti-inflammatories did not really help, but the extra strength of ADVIL took the edge off a bit. At the beginning of October 2011, the patient''s both wrist ached and her back, knee, neck and hip pain were still very much present. One night, the patient experienced lump and the next day, went back to the doctor and he determined that it was swollen lymph node and he send her for X-rays on her wrist and an ultrasound on her swollen lymph node. The Xrays showed nothing and the ultrasound showed a swollen lymph. By November 2011, the patient''s pain was pretty much everywhere - her knees, hips, wrists, elbows, shoulders, neck and back and she cried many times from the pain and the only relief she got was when she lied on the ground with ice packs everywhere. It was reported that at the beginning of November she stopped doing her activities as they were just too painful. The patient was never pain free. Mid November the mother went back to the doctor and at this time she told him that she want a juvenile arthritis test and the doctor also send more x-rays of her back, knees and hips. The blood tests came negative for juvenile arthritis (JA), but the patient''s iron was very low and the X-rays showed nothing. On 14-DEC-2011, MRI and more blood work were performed (results not provided), the patient was also testing for cancer, lupus, rheumatoid arthritis. After each season she was in more agony. It was reported that the mother back pain to the doctors and she explained that the patient was taking ADVIL, followed 2 hours later by TYLENOL and that brought her pain from 9/10 to a 5/10. She was never pain free. In approximately January 2012, the patient had trouble sleeping as the pain waked her up and without sleep body did not heal, which meaned more pain and discomfort. On 21-JAN-2012, the patient''s pain was severe. She had not slept much. On 27-JAN-2012, the patient could not walk down the hall and walk on her tip toes, she had fibromyalgia and she was stressful. On 06-FEB-2012, results of previous tests were that there was no cancer, lupus or RA. The physician ordered more blood work, for vitamin D deficiency and celiac disease. She also was certain that she did not have fibromyalgia and did not occur with that sick kid said. The patient''s quality of life had been greatly affected. On Sunday 12-FEB-2012, the mother called the physician and he actually asked her what was changed in the past year and what vaccines she had she told him the only change was the GARDASIL and he informed her that these vaccines were full of heavy metals. And the patient had a heavy metal allergy. The patient had a live blood culture done that showed her white blood cells going crazy, being under stress, it also showed all the toxins, lots of metals, her liver was under stress, her blood cells trying to rid themselves of the toxins. It also showed kidneys, immune system was attacking itself due to heavy metal allergy, which explained why her lymph node was swollen. The patient started down the detox road. She was boosting her immune system with high doses of OMEGA 3, lots of vitamin D, glucosamine and natural products. At the time of the report the patient''s outcome was unknown. Upon internal review, stopped doing her activities as they were too painful, could not walk down the hall and walk on her tip toes, her quality of life had been greatly affected, heavy metal allergy, white blood cells going crazy and immune system was attacking itself were considered to be disabling. No further information is available.


VAERS ID: 497100 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-03-07
Onset:2012-03-07
   Days after vaccination:0
Submitted: 2013-07-17
   Days after onset:496
Entered: 2013-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB338AA / 3 UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. G004524 / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Headache, Hypoaesthesia, Inappropriate schedule of drug administration, Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Vitamin D
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Demyelination (narrow), 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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Nuclear magentic resonance ima, 23Oct2012, multiple sclerosis; Vitamin D, 13Nov2012, 17.1ng/mL
CDC Split Type: B0864068A

Write-up: This case was reported by a healthcare professional and described the occurrence of multiple sclerosis in a 15-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline) and GARDASIL (non-gsk). Historic vaccination included hepatitis B;GlaxoSmithKline;unknown given on an unspecified date. Concurrent vaccination included hpv vaccine (non-gsk) ;non-GSK manufacturer;unknown;unknown given on 14 December 2011. On 7 March 2012, the subject received 3rd dose of ENGERIX B (administration site and route unknown, batch number not provided) and 2nd dose of GARDASIL (unknown). The 1st and 2nd doses of ENGERIX B were given 5 years earlier. The vaccination schedule was therefore lengthened. By the end of March 2012, less than one month after vaccination with GARDASIL and ENGERIX B, the subject experienced numbness in the lower limbs extended to hip. Hospital diagnoses were inconclusive. The healthcare professional considered the events were clinically significant (or requiring intervention). On October 2012, a magnetic resonance imaging brain was performed. Multiple sclerosis was suspected. Later on, this diagnosis was confirmed. At the time of reporting, multiple sclerosis was unresolved. The healthcare professional considered multiple sclerosis was possibly related to vaccination with ENGERIX B and GARDASIL. Follow-up information received on 6 March 2013: The DOB and patient''s initials were provided. The lot number of ENGERIX B was provided. The healthcare professional no more considered the case as clinically significant (or requiring intervention) but aw disabling. In March 2012, in addition to the above mentioned events, the subject experienced leg paresthesia. Multiple sclerosis was the hypothesis diagnosis. Follow-up information received on 16 April 2013: In October 2012, multiple sclerosis was diagnosed. Follow-up information received on 22 April 2013: This case was also reported by a physician via a regulatory authority (PT-INFARMED-S201304-63). In March 2012, 3 weeks after vaccination with GARDASIL and ENGERIX B, the subject experienced leg paresthesia and headache. The regulatory authority considered the events were clinically significant (or requiring intervention). Despite treatment, the events were unresolved. Follow-up information received on 21 June 2013: The magnetic resonance imaging brain performed on 23 October 2012 detected multiple dispersed lesions in the white substance of the cerebral tissue. Multiple sclerosis could be present before or after vaccination. The regulatory authority considered multiple sclerosis and leg paresthesia were unlikely related to vaccination with ENGERIX B and GARDASIL. Headache was possibly related. Follow-up information received on 8 July 2013: The regulatory authority considered multiple sclerosis and leg paresthesia were possibly related to vaccination with ENGERIX B and GARDASIL.


VAERS ID: 503495 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-08-23
Onset:0000-00-00
Submitted: 2013-09-23
Entered: 2013-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Back pain, Dysmenorrhoea, Fatigue, Headache, Insomnia, Mood swings, Nausea, Neck pain, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (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: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation; GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK007720

Write-up: Case of misuse (drug dose administration interval too long) received from a health care professional via the Health Authorities on 11-Sep-2013 under the references DK-DKMA-ADR 22231077 and DK-DKMA-EFO6735. Case is medically confirmed. A female patient (weight 60 kg, height 165 cm), had received a complete vaccination series with three doses of GARDASIL IM on 24-Mar-2010 (D1, batch no not reported), on 15-Jun-2011 (D2, batch no. not reported) and on 23-Aug-2012 (D3, batch no. not reported). On an unspecified date, the patient developed headache, nausea, sleeplessness, tremor, mood swings, chronic pain in joints, neck and back, abdominal pain, increased menstrual pain and tiredness. It was unknown if laboratory tests were performed. The patient had 6 days of absence during the academic year 2011/2012 and 40 days of absence during the academic year 2012/2013. At the time of reporting, the patient had not recovered. Drug administration interval too long between D1 and D2 and between D2 and D3.


VAERS ID: 506668 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2009-10-01
Submitted: 2013-10-09
   Days after onset:1469
Entered: 2013-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Chronic fatigue syndrome
SMQs:, Dementia (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:
CDC Split Type: WAES1310GBR002905

Write-up: This case was received from the health authority on 27-Sep-2013. GB-MHRA-ADR 22251540. This case is not medically confirmed as it was reported by a consumer. A 14-year-old female patient (weight 53 kg), with no reported medical history, received on an unreported date an injection of human papilloma virus vaccine (mfr unknown; batch n., route, dose, dose in series and site of administration not reported) and in Oct-2009 she developed chronic fatigue syndrome. On an unreported date she also experienced activities of daily living impaired. She was unable to attend school or carry on normal life. At the time of reporting the patient had not recovered. The agency considered this case to be serious due to disability/incapacity and as an other medically important condition.


VAERS ID: 511315 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-04-02
Onset:0000-00-00
Submitted: 2013-11-05
Entered: 2013-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H015737 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Disturbance in attention, Dizziness, Electromyogram normal, Fatigue, Flail chest, Headache, Musculoskeletal pain, Nervous system disorder, Peripheral coldness, Sensorimotor disorder, Sensory disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (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: Electromyogram, No neuropathy
CDC Split Type: WAES1306FRA000082

Write-up: A 14-yer-old female patient had received the first dose of GARDASIL (batch number not reported) on 02-Apr-2013. On 03-Apr-2013, the patient presented with paradoxal movements during sleep (seen by her mother who slept with her), cold hands, musculoskeletal pain, headache and dizziness. The patient''s mother informed the physician who saw the patient again on 08-Apr-2013. She had then recovered from sensitive disorders i.e. paradoxal movements, cold hands, musculoskeletal pain and dizziness. Only cephalgia, concentration impairment and extreme fatigue persisted. Follow-up information received on 29-Oct-2013: The patient received the vaccine (batch and lot number H015737, exp. 28-FEB-2015) via intramuscular route in the left arm. The physician reported that dizziness occurred 12 hours post-vaccination and lasted 3 days. He considered this symptom as moderate. Paradoxal movements at night occurred 4 hours post-vaccination and lasted 24 hours. The reporter considered this symptom as minimal. The patient also experienced subjective disturbances 12 hours post-vaccination and recovered within 3 days, symptom of moderate severity according to the reporter. The physician also reported that the patient experienced shifting widespreading pain 12 hours post-vaccination, symptom he considered as severe and which resolved within 3 months. Concentration impairment, headache and extreme fatigue were no more reported. The final diagnosis assessed by the reporter was sensorymotor neurological disturbances following a first injection of GARDASIL. According to the reporter, it was an atypical picture with predominance of subjective disturbances: sensory, algetic (difficult to assess) but compatible timewise (starting on day 0, 12 hours post-vaccination, continuing the following days) with relatedness between vaccine administration and the reported reactions which were already listed in the summary of product characteristics. Considering how invalidating and prolonged the diffuse pains were, the patient consulted a neurologist and an electromyography of upper and lower limbs was performed. No objective evidence of neuropathy was found. No corrective treatment was given. Upon internal review, the company judged relevant to upgrade the case and add the following criterion of severity: "involved persistence or significant disability or incapacity." To be noted that the reported considered the case as non serious.


VAERS ID: 514893 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-10-18
Onset:0000-00-00
Submitted: 2013-11-26
Entered: 2013-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1537F / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Abscess, Acute abdomen, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Aphthous stomatitis, Aspiration bone marrow normal, Asthenia, Bacterial test negative, Biopsy muscle normal, Biopsy skin normal, Blood creatine phosphokinase increased, Blood pressure systolic abnormal, Body temperature increased, Cardiolipin antibody, Cardiolipin antibody negative, Chlamydia test positive, Colonoscopy normal, Complement factor C3, Complement factor C4, Complement factor normal, Computerised tomogram thorax normal, Constipation, Coxsackie virus test, Diarrhoea, Ear swelling, Electrocardiogram normal, Endoscopy normal, Fatigue, General physical health deterioration, HLA marker study, Headache, Hepatitis A antibody positive, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative, Hepatitis C antibody negative, Hypertension, Hypokinesia, Immunology test normal, Infection, Joint effusion, Lip swelling, Lymphadenopathy, Microscopy, Myalgia, Mycoplasma test, Myopathy, Myosclerosis, Nausea, Nerve compression, Neuralgia, Night sweats, Nuclear magnetic resonance imaging abnormal, Oedema peripheral, Oesophagogastroduodenoscopy abnormal, Ophthalmological examination normal, Pain, Pain in extremity, Panniculitis, Paraesthesia, Pulmonary function test normal, Quality of life decreased, Rheumatoid arthritis, Rheumatoid factor negative, Sleep disorder, Ultrasound Doppler normal, Urine analysis normal, Varicella virus test positive, Weight increased
SMQs:, Rhabdomyolysis/myopathy (narrow), Cardiac failure (broad), Liver infections (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (broad), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Drug hypersensitivity; Immunisation
Preexisting Conditions: Febrile convulsion; Tonsillitis; 11/2006, Musculoskeletal discomfort; 04/11/2007, GARDASIL
Allergies:
Diagnostic Lab Data: Thorax CT on 27-Oct-2010 was without pathological findings; MRI of the abdomen on 04-Nov-2010 was without pathological findings; Lab tests on 08-Nov-2010 showed CK at 1740 U/l; body temperature of approximately 38 degrees C; Rheumatoid diagnostic revealed normal ranges of complement factor C3 and C4, and overall complement CH50, cardiolipin IgG and IgM were within normal ranges; Microbiological serology revealed Chlamydia pneumonia IgG 303.9 AU/ml (positive), IgA 26.3 AU/ml (marginal positive) and Mycoplasma pneumonia MPP titer <1:40 (negative); Virological serology revealed Coxsackie-virus antibody KBR* titer 1:20, VZV IgG positive, VZV IgM negative, HIV antigen/antibody negative, HAV IgG positive, anti-HAV IgM negative, HBs-antigen negative, anti-HBs $g 1000 mIU/ml, anti-HBc negative, and anti-HCV negative; Immunopathology was without pathological findings, p- and cANCA were not evident and there were no signs of connective tissue disease; Sonography of wrists showed a mild effusion in left wrist. Lab tests on 14-Jan-2011 showed leukocytes 15210 1/ul and TSH 2.54 mU/l; A whole body MRI was conducted on 09-Feb-2011 due to increased CK up to 1700 of unknown etiology at the end of 2010, pain in wrist joint and for examination of the sacroiliac joint; An MRI of the wrists on 07-Mar-2011 revealed a slight increase in carpal and carpometacarpal joint effusion of the left side; Yersinia serology and QuantiFERON test were negative, bone marrow examination was without pathological findings, and stool examination did not show signs of salmonella, shigella and campylobacter. Sonography revealed submandibular enlarged lymph nodes in accordance with reactive enlargement and several enlarged lymph nodes inguinal on the left side; MRI of the left foot on 09-Mar-2011 showed findings in accordance with panniculitis in the tarsus below the calcaneus and the dorsal part of the fascia plantaris, as a differential diagnosis the MRI signs could have simply be stress-induced. Histological examination of biopsies taken from muscles, fascia and skin of the right lower leg revealed no signs of rheumatoid disease or inflammation and no signs of malignant events; Serological testing for rheumatoid factors revealed ASL 165 IU/ml, RF negative, ANA 1:40 (negative), HLA-B27 negative. MRI of the lower legs on 05-Apr-2011 did not reveal any changes and still indicated pre-tibial edema in line with a circumscript pleural effusion but showed a decline of the epifascial changes of the lower limb. Lung function testing was without pathological findings and in accordance with the patient''s age. Microscopic capillary examination did not reveal any pathological findings. Ophthalmological examination did not show signs of rheumatoid iridocyclitis; Rheumatoid factor, ANA, AMA, ACE and HLA-B27 were negative; In the immunopathological examination on 16-Sep-2013 there were no signs of a connective tissue disease during serological testing. No antibodies in immunoefflorescence analysis and immune diffusion were seen, in particular myositis relevant core antibodies were not detected; 01/14/2011, Antineutrophil cytoplasmic antibody, Negative; 01/14/2011, Antinuclear antibody, Negative; 05/18/2011, Biopsy, no signs of celiac disease, M. Whipple, lambliasis; 05/14/2011, Colonoscopy, Normal; 03/05/2010, Electrocardiogram, Normal; 06/08/2012, Endoscopy, Normal; 03/05/2010, Laboratory test, no sign of pheochromocytoma; 11/04/2010, Nuclear magnetic resonance imaging, epifascial inflammatory changes of torso; 05/14/2011, Oesophagogastroduodenoscopy, mild C-gastritis; 03/05/2010, Ultrasound Doppler, Normal; Urine analysis, 24 h - normal, Normal
CDC Split Type: WAES1311DEU010666

Write-up: Information has been received from Sanofi Pasteur MSD (DE-1577272925-E2013-09192) on 22-NOV-2013 as part of a business agreement via a consumer on 12-Nov-2013, additional information received on 14-Nov-2013. Reporting form was received from a health care professional on 21-Nov-2013. Case is medically confirmed. A female patient, received a complete vaccination series with three doses of GARDASIL IM on 11-Apr-2007 (D1, batch-no. NE45050, lot-no. 655376/0572F, 05-MAY-2009), on 11-Jun-2007 (D2, batch-no. NE35170, lot-no. 655101/0513F, exp 01-MAY-2009) and on 18-Oct-2007 (D3, batch-no. NF37110, lot-no. 1537F, exp 15-DEC-2009). In fall 2007 at the age of 14 years, some time between D2 and D3, the patient developed muscle induration affecting the whole body with changing localisation, abdominal cramps and severe watery and foamy diarrhoea, pain with changing localisation, but especially of the back and frequent infections. Recurrent episodes occurred during 2008 and 2009 and the patient''s health deteriorated. Since 2010, the intensity increased and the patient''s quality of life was extremely reduced. During an outpatient consultation on 05-Mar-2010 due to juvenile hypertension diagnosed one year before with systolic blood pressure values fluctuating profoundly between 70 and 230, therapy with BLOPRESS was suggested. ECG and colour Doppler echocardiography on 05-Mar-2010 were without pathological findings. Lab tests on 05-Mar-2010 did not show any signs of pheochromocytoma. Thorax CT on 27-Oct-2010 was without pathological findings. MRI of the abdomen on 04-Nov-2010 was without pathological findings. Lab tests on 08-Nov-2010 showed CK at 1740 U/l. The patient was hospitalized from 17-Nov-2010 to 18-Nov-2010 due to unclear temporary increase of CK, severe fatigue since about half a year, pain localized in various areas and intermittent headache. The patient reported, that her feet hurt after only about 20 min of walking. Towards the evening she regularly suffered from leg oedema up to the middle of the lower leg. The patient experienced a weight gain of 10 kg within 1 year and subfebrile body temperature of approximately 38 degrees C. Furthermore, she reported of diffuse pressure pain on the chest. Medication on admission included candesartan cilexetil and SYMBICORT. 24-hour collected urine test was without pathological findings. Rheumatoid diagnostic revealed normal ranges of complement factor C3 and C4, and overall complement CH50, cardiolipin IgG and IgM were within normal ranges. Microbiological serology revealed Chlamydia pneumonia IgG 303.9 AU/ml (positive), IgA 26.3 AU/ml (marginal positive) and Mycoplasma pneumonia MPP titer <1:40 (negative). Virological serology revealed Coxsackie-virus antibody KBR* titer 1:20, VZV IgG positive, VZV IgM negative, HIV antigen/antibody negative, HAV IgG positive, anti-HAV IgM negative, HBs-antigen negative, anti-HBs $g1000 mIU/ml, anti-HBc negative, and anti-HCV negative. Immunopathology was without pathological findings, p-and cANCA were not evident and there were no signs of connective tissue disease. During the hospital stay malignoma and myositis were excluded. On 04-Jan-2011 the patient experienced severe back pain. An emergency doctor diagnosed a nerve compression. The symptoms improved under TRAMAL and tetrazepam therapy. On 14-Jan-2011, the patient presented to the outpatient ward of a medical clinic with the diagnosis of juvenile hypertension. Sonography of wrists showed a mild effusion in left wrist. Lab tests on 14-Jan-2011 showed leukocytes 15210 1/ul and TSH 2.54 mU/l. It was reported, that since corticosteroid therapy (start date not reported) the symptoms had improved slightly, but the condition was "not good". The patient''s symptoms had improved slightly under corticosteroid therapy (oral prednisolone). A whole body MRI was conducted on 09-Feb-2011 due to increased CK up to 1700 of unknown etiology at the end of 2010, pain in the wrist joint and for examination of the sacroiliac joint. Epifascial inflammatory changes of the torso (lower thorax and abdomen), both lower legs and also minimally of the distal upper legs were detected. There was no sign of muscular, osseous or articular lesions. The patient was hospitalized from 02-Mar-2011 to 09-Mar-2011 due to increased CK of unknown etiology and suspected syndrome of aggravating pain. On admission the patient reported of night sweat as a new symptom. The symptoms were more pronounced during cold weather. She experienced tingling and pain in her fingers for about 10-15 minutes when she was outside. Shortly before Christmas, she also experienced pain in both feet (more pronounced on the right foot) for a couple of days. An MRI of the wrists on 07-Mar-2011 revealed a slight increase in carpal and carpometacarpal joint effusion of the left side. Yersinia serology and QuantiFERON test were negative, bone marrow examinatioin was without pathological findings, and stool examination did not show signs of salmonella, shigella and campylobacter. Sonography revealed submandibular enlarged lymph nodes in accordance with reactive enlargement and several enlarged lymph nodes inguinal on the left side. MRI of the left foot on 09-Mar-2011 showed findings in accordance with panniculitis in the tarsus below the calcaneus and the dorsal part of the fascia plantaris, as a differential diagnosis the MRI signs could have simple be stress-induced. Histological examination of biopsies taken from muscles, fascia and skin of the right lower leg revealed no signs of rheumatoid disease or inflammation and no signs of malignant events. During hospital stay panniculitis was excluded. In the further course the patient had sleep disorder due to cortisone therapy. The patient was hospitalized from 29-Mar-2011 to 28-Apr-2011. Due to suspicion of medication-induced problems (CK elevation) and change of medication from candesartan to amlodipine therapy. Serological testing for rheumatoid factors revealed ASL 165 IU/ml, RF negative, ANA 1:40 (negative), HLA-B27 negative. MRI of the lower legs on 05-Apr-2011 did not reveal any changes and still indicated pre-tibial edema in line with a circumscript pleural effusion but showed a decline of the epifascial changes of the lower limb. Lung function testing was without pathological findings and in accordance with the patient''s age. Microscopic capillary examination did not reveal any pathological findings. Ophthalmological examination did not show signs of rheumatoid iridocyclitits. Currently, there were no signs from either clinical examination, sonography or lab tests for a rheumatoid disease. On 14-May-2011 the patient had an outpatient gastroenterological examination. She had been suffering from nausea for some time, followed by three to four watery stools per day about three to four times a week. The patient gained 16 kg of weight. Esophagus-duodeno-endoscopy did not reveal any pathological findings except for mild C-gastritis. Colonoscopy was without pathological findings. Examination of biopsies taken from duodenum, antrum, corpus and ora serrata on 18-May-2011 showed no signs of celiac disease, Morbus Whipple or lambliasis. Furthermore, there were no signs of mucosal atrophia or metaplasia, no signs of Barrett metaplasia, fungal infection or malignant events. Final diagnosis were with recurrent nausea and diarrhea of unknown etiology and suspicion of rheumatoid disease. On 28-Jul-2011 the patient consulted a gynaecologist for dysmenorrhoea and lower abdominal pain. On 09-Dec-2011 the patient presented to the doctors and suspicion of psoriatic arthritis was established. Rheumatoid factor, ANA, AMA, ACE and HLA-B27 were negative. The family''s medical history revealed psoriasis vulgaris (father) and polyarthritis (grandmother). Therapy with methotrexate and folic acid was started. Additionally she was treated with prednisolone. On 23-Apr-2012 the patient presented to the ER with pain in the lower right abdomen for approximately 3 days and recurrent diarrhoea for the last 8 months. Acute abdomen was diagnosed. The patient was hospitalized from 23-Apr-2012 to 27-Apr-2012 and appendicitis was excluded. On 08-Jun-2012 an endoscopy of the articular capsule due to chronic diarrhoea and constipation was performed and did not reveal any pathological findings. On 18-Aug-2012 the patient presented to the ER for acute neuralgia of the intercostal space. Analgetic therapy was started. On 29-Nov-2012 the patient had experienced swelling of the lips and the ears on both sides the previous night. The patient suffered from an infection since the previous day. Methotrexate had been discontinued three weeks ago, because after initial better health condition under this therapy her condition deteriorated again. The patient was hospitalized from 27-Aug-2013 to 28-Aug-2013 and was diagnosed with a chronic abscess at the furrow of the left thigh. An excision in toto was performed on 27-Aug-2013. On 28-Aug-2013 the patient presented to the endocrinologic policlinic and was diagnosed with myopathy and lymphadenopathy of unknown etiology. Current therapy included torasemide. The patient had been suffering from troubles with her muscles for some time, in form of muscle induration, movement restrictions, pronounced muscle pain in the mornings and loss of strength. Furthermore, the patient often developed oral aptha and abscess formations. The most plausible cause according to the treating physician was a systemic autoimmune disease. In the immunopathological examination on 16-Sep-2013 there were no signs of a connective tissue disease during serological testing. No antibodies in immunoefflorescence analysis and immune diffusion were seen, in particular myositis relevant core antibodies were not detected. Nevertheless this would never exclude the diagnosis since the antibodies can only be detected in 10-15% of the patients. Antibodies against thyroid globulins and thyroid peroxidase were missing. At the time of reporting, the patient had not recovered and was under permanent medical treatment since 2010. CK levels had normalised after an unspecified time. Outcome of swelling of lips and ears not reported. According to the reporter the events were possibly related to the vaccinations. Patient''s medical history included allergy against NSAIDs, Andrews lesion of the right shoulder (Nov-2006) and recurrent tonsillitis during childhood with suspicion of fever cramps. The patient''s family history included psoriasis vulgaris (father), polyarthritis (grandmother), ischemic stroke (2x, mother aged 38), persisting foramen ovale (mother, sister), tachycardia (sister).


VAERS ID: 517115 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-06
Onset:2013-07-01
   Days after vaccination:237
Submitted: 2013-12-18
   Days after onset:170
Entered: 2013-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Eye pain, Immunology test abnormal, Multiple sclerosis, Neurological examination abnormal, Nuclear magnetic resonance imaging abnormal, Ophthalmological examination abnormal, Optic neuritis, Optic neuropathy, Scotoma, Vision blurred, Visual acuity reduced, Visual evoked potentials abnormal
SMQs:, Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Ocular infections (broad), Hypersensitivity (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: Migraine
Allergies:
Diagnostic Lab Data: Ophthamological examination: vision: 3/10 on right, central scomtoma.; Visual evoked potentials: consistent with optic neuropathy.; MRI: consistent with multiple sclerosis.; Neurological examination: right haze vision, no sensorimotor deficiency and no pyramidal nor cerebellar syndrome.
CDC Split Type: WAES1312FRA007615

Write-up: Case received from the Health Authorities in a foreign country on 12-Dec-2013 under the reference number TO20132233. Information has been received from Sanofi Pasteur as a part of business agreement (manufacturer control # FR-1577272925-E2013-10696) on 17-DEC-2013. A 15-year-old female patient with a medical history of migraines had received the three doses of GARDASIL (batch number not reported) via intramuscular route on 10-Jul-2012, 24-Sep-2012 and 06-NOv-2012. In the middle of Jul-2013, the patient presented with visual disorders associated with retro orbital pain in the right eye. Retrobulbar optic neuritis was diagnosed. Indeed, right vision had decreased to 3/10 P4, which confirmed the presence of central scotoma and visual evoked potentials were consistent with optic neuropathy. SOLUMEDROL 1g led to a regression of the retrobulbar optic neuritis. MRI and autoimmune work-up were consistent with multiple sclerosis. Non drug-induced etiologies ruled out: Neurological examination was unremarkable except for right haze vision. There was no sensorimotor deficiency, no pyramidal nor cerebellar syndrome. Treatment with BETAFERON was initiated, and repeat encephalic and medullar MRI was recommended at 3 months. At the time of reporting, the patient had not recovered from multiple sclerosis, and had recovered with sequelae from retrobullar optic neuritis. To be noted that the patient''s father had a medical history diabetes. The patient was not taking any disease-modifying treatment. Upon medical review the company judged relevant to code the adverse event retrobulbar optic neuritis which was mentioned by the Health Authorities in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C2 S1 I1) according to the Foreign method of assessment.


VAERS ID: 521719 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-06-14
Onset:0000-00-00
Submitted: 2014-02-04
Entered: 2014-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Appendicectomy, Arthralgia, Borrelia infection, Borrelia test positive, CSF test abnormal, Chest X-ray normal, Chills, Fatigue, Headache, Infectious mononucleosis, Listless, Nuclear magnetic resonance imaging brain normal, Post viral fatigue syndrome, Syncope, Ultrasound abdomen normal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (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) (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (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: 06/19/2013, Borrelia test, serum IgG 1300% of cutoff; 06/19/2013, CSF test, Borrelia IgG positive; 02/20/2013, Nuclear magnetic resonance imaging, MR brain normal; 07/29/2013, Ultrasound scan, abdomen normal; 05/23/2013, X-ray, Thorax no pathological findings
CDC Split Type: WAES1401NOR001829

Write-up: Information has been received from Sanofi Pasteur (manufacturer control # NO-1577272925-E2013-11390) on 31-JAN-2014. Case received from a health professional via the Health Authorities on 27-Dec-2013 under the reference number NO-NOMAADVRE-FHI-2013-16784. Case is medically confirmed. Primary reporter was a physician. A 13-year-old female patient received a complete vaccination series with three doses of GARDASIL (batch numbers not reported) via parenteral route into not reported site of administration on 11-Nov-2010 (D1), 17-Feb-2011 (D2) and on 14-Jun-2011 (D3). On an unspecified date, the patient experienced listlessness and syncope. The patient developed tiredness between D1 and D2. After about one year, the patient developed shivering, abdominal pain and headache. At the time of reporting, the outcome of syncope was unknown and the patient had not recovered from all other events. According to the HA, the events were possibly related to all 3 vaccinations. Persisting symptoms after GARDASIL. According to the reporter, the patient was followed up in hospital. Case considered as non-serious by HA. Follow up information received from the health authority on 29-Jan-2014. The case has been upgraded by the HA to serious due to hospitalization and disabling. According to the reporter, the girl is followed up in hospital. The HA received additional information 20-Jan-2014: Discharge summary from 05-Nov-2013- 08-Nov-2013, which summarize the adverse events from autumn 2011. Girl born, vaccinated with GARDASIL 11-Nov-2010, 27-Feb-2011, 14-Jun-2011. According to mother the daughter''s symptoms started between the first and the second dose of GARDASIL. Autumn 2011 she apparently was diagnosed with mononucleosis (coded as medical history by HA). She had repeating syncope episodes in the lessons of physical education, point of time is not further described. She had to be performed from these lessons. Symptoms as listlessness, tiredness, shivering, abdominal pain, headache and pain in joints had been going on for more than one year when she was carefully examined in course of spring and summer 2013. MR brain, X-ray thorax, U/S abdomen revealed no pathology. Borrelia IgG was (19-Jun-2013) measured to 1300% of cutoff, increased from an earlier measurement of 150% (time of point not reported). There was also findings of Borrelia IgG in CSFF (19-Jun-2013) She was treated with Doxyline for 14 days. Diagnosis according to the discharge summary: Post viral fatigue syndrome. The discharge summary describes follow-up planning: Her family doctor will participate in developing a responsibility group, with a comprehensive plan for the school work the next years. The girl will also be followed up by a physiotherapist and the health care visitor. The patient''s sister got the diagnosis ME in 2006. This is the final report. All events are assessed as possible to the three doses. Upon medical review the company judged relevant to code borrelia infection, mentioned in the narrative but not coded. The company judged it relevant to code mononucleosis and appendectomy as adverse reaction and not as medical history as by the HA, since it started after vaccination. HA comment: HPV vaccine is a non-living vaccine and can not cause infections. General malaise may occur the first few days after many vaccines. The symptoms of the report are not common side effects after HPV vaccine. In a recent publication no increased risk of fatigue syndrome after HPV vaccination can be found. Agency has found no literature that supports a causal relationship between HPV vaccine and ME.


VAERS ID: 523105 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-11
Onset:0000-00-00
Submitted: 2014-02-19
Entered: 2014-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Back pain, Decreased interest, Fatigue, Gait disturbance, Grip strength decreased, Guillain-Barre syndrome, Headache, Memory impairment, Mental impairment, Mobility decreased, Neuropathy peripheral, Nuclear magnetic resonance imaging, Orthostatic intolerance, Parosmia, Sluggishness, Somnolence
SMQs:, Peripheral neuropathy (narrow), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), 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: CALONAL; IMIGRAN; METLIGINE
Current Illness: Orthostatic intolerance; Headache
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 03/19/2013, Body temperature, 36.8 degrees; 06/11/2013, Body temperature, 36.9 degrees C; 12/24/2013, Body temperature, 36.6 degrees C
CDC Split Type: WAES1402JPN008216

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


VAERS ID: 527997 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-01-29
Onset:0000-00-00
Submitted: 2014-04-10
Entered: 2014-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Alopecia, Malaise, Mental disorder, Overdose, Pain, Polyarteritis nodosa, Suicide attempt
SMQs:, Suicide/self-injury (narrow), Interstitial lung disease (broad), Dementia (broad), Drug abuse and dependence (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow), Medication errors (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: 2006, Polyarteritis nodosa
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1404DNK005807

Write-up: Information received from Sanofi Pasteur MSD (reference DK-1577272925-E2014-03016) on 08-APR-2014. Case received from consumer via patient insurance company (ref. no 13-5730) and the Health Authority on 03-APR-2014 under the reference number DK-DKMA-ADR 22453466. The primary reporter was the patient''s parent. A 14 year old female patient, had received first dose of GARDASIL (batch number not reported) via not reported route of administration in not reported site of administration on 29-Jan-2009 and later on a non-specified date in the beginning of 2009 (in connection to vaccination) she developed symptoms reoccurrence of PAN (polyarteritis nodosa). In addition, on a non-specified date, the patient developed psychological stress reactions, hair loss, pain, stretch mark and malaise. According to the reporter these reactions resulted in a severe suicide attempt with an overdoses of paracetamol (other MFR) and HJERTEMAGNYL (other MFR). The patient had no other concomitant medications. As the PAN symptoms came soon after the vaccination, the hospital visits started already in Feb-2009. The reporter states that there was a clear association with the vaccination and onset of symptoms as the patient had not developed any form of infection which could have triggered the symptoms. The physicians rejected the reporter''s suspicion. The suspicion from the parent was so strong that the patient was not allowed further vaccination than that single time. Since the flare-up in 2009, the physician have not been able to control the patient''s disease (over 4-years progression), and she is constantly investigated at the hospital. The disease itself, and the strong medications prednisolone (other MFR), MYFORTIC (other MFR), ROACTEMRA (infusion, other MFR) and NEXIUM (other MFR) (during the time at the rheumatology department in hospital) has given irreversible physical injury. In addition, psychologically it has been a major load for the patient, especially after she turned 14 years. The patient has given up on her studies and ability to work, as the disease is so painful and inhibitory for long periods. The patient has in rounds tried to start with her education, but has been forced to cancel since her absence has been too much. The patient''s medical history includes polyarteritis nodosa (unknown if continuing) which she was diagnosed with in 2006. The patient was in that context investigated at a hospital during a 3-year period, where the disease, came at rest, and the patient experienced no problems or symptoms. At the time of reporting, the outcome was not recovered for PAN, pain, disability and psychological stress reactions. The outcome was unknown for all other events.


VAERS ID: 528794 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-12-01
Onset:2014-01-01
   Days after vaccination:31
Submitted: 2014-04-18
   Days after onset:106
Entered: 2014-04-18
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, Allodynia, Blood test normal, Fatigue, Fibromyalgia, Insomnia, Myalgia, Neck pain, Pain, Pain in extremity, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On an unknown date, the patient current condition was described as healthy by the physician. On an unknown date, unspecified blood tests with a result normal. On an unknown date, 18 tender point positive for fibromyalgia (units). On an unknown date, infection, inflammation or autoimmune disease were ruled out.
CDC Split Type: WAES1404MEX009808

Write-up: This spontaneous report as received from a physician refers to a 14 year old female patient. According to the physician, the patient does not have any trauma, anxiety or depression history, she lives in a harmonious home. The patient''s current condition reported as "described as healthy by the physician". On an unknown date, the patient received the first of a GARDASIL. On an unknown date, approximately in December 2013, the patient was vaccinated with the second dose of a GARDASIL 0.5 ml (lot# not available). On an unknown date, approximately in January 2014, a month after receiving the second dose, the patient experienced intense cervical pain that few weeks later was extended to arms and legs and in addition developed paresthesia in her 4 extremities and insomnia and fatigue (both approximately in 2014). The patient''s symptoms prevented her to go to school. On an unknown date, a physical examination was performed; it showed a desperate adolescent because of the pain and paresthesia. According to the physician, there was an evident generalised allodynia accompanied by the 18 tender points positive for fibromyalgia. Any infection, inflammation or autoimmune disease were ruled out as cause of her symptoms. At the time of the report, three months have passed and the patient continued experiencing generalised pain and paresthesia that have disabled her. According to the reporter, the probable diagnosis was syndrome like fibromyalgia that appeared a month later (approximately in January 2014) of vaccination with GARDASIL. The outcome of paresthesia and fibromyalgia was reported as not recovered/not resolved. The outcome of generalised allodynia, fatigue and insomnia was unknown. Reporting physician considered paresthesia in all extremities and generalised pain disabling. This case is now of two from the same source reports. Additional information has been requested.


VAERS ID: 531010 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-20
Onset:2013-06-21
   Days after vaccination:1
Submitted: 2014-05-15
   Days after onset:328
Entered: 2014-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J000396 / 1 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Depression, Lymphoedema, Manual lymphatic drainage, Oedema peripheral, Ultrasound scan abnormal, Venogram abnormal
SMQs:, Cardiac failure (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (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, 16 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 17-OCT-2013: Sonogram: lymphoedema grade II; 18-OCT-2013, Phlebography: lymphoedema
CDC Split Type: WAES1405DEU006905

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # DE-1577272925-E2014-04013) on 13-MAY-2014. Case was received from a physician on 08-May-2014. Case is medically confirmed. A 14-year-old female patient (weight: 45.2 kg; height: 152 cm) received a first dose of GARDASIL (lot-no. J000396, Exp. Date: 31-JUL-2015 - this batch was not released by HA for SPMSD) IM into the deltoid muscle on 20-Jun-2013. One day later, on 21-Jun-2013, she developed lymphoedema of the right upper ankle joint. During the further course the oedema was spreading to the right lower leg. On 20-Aug-2013 the patient received the second dose of GARDASIL (lot-no. J001201, Exp. Date: 04-JUL-2015) IM into the deltoid muscle. The patient was hospitalised from 12-to 27-Sep-2013, the report was not provided. On 17-Oct-2013 duplex sonography showed lymphoedema grade II. On 18-Oct-2013 diagnosis of lymphoedema of the upper ankle joint was confirmed by phlebography. Since 17-Feb-2014 she additionally developed lymphoedema of the right wrist. On 24-Feb-2014 she received the third dose of GARDASIL (lot-no. J004473, Exp. Date: 12-OCT-2015) IM into the deltoid muscle. The patient was treated with support stockings and lymph drainage twice a week. Since Feb-2014 the patient additionally developed depressive episodes due to lymphoedema. She was treated with psychotherapy. At the time of reporting the patient had not recovered and the reporter assessed a "persisting damage". According to the reporter, the reaction was possibly related to vaccination.


VAERS ID: 539557 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-12-15
Onset:2011-12-15
   Days after vaccination:0
Submitted: 2014-08-12
   Days after onset:970
Entered: 2014-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Depression, Diplopia, Dizziness, Syncope, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Ocular motility disorders (broad), Hypotonic-hyporesponsive episode (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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1408ESP006858

Write-up: Information has been received from SPMSD (Manufacturer Control Number E2014-06987) on 11-AUG-2014. Case received from the Health Authorities, reported to them by a consumer on 06-AUG-2014, under the reference number: ES-AGEMED-105206338. Case not medically confirmed. A 14 years-old female patient (according to the narratives the patient was 16 years-old, probably meaning the age at the time of reporting) received a dose of GARDASIL (batch number not reported), via intramuscular on 15-DEC-2011 and on the same day the patient presented with convulsions, depression, blurred vision, syncope, double vision and dizziness. According to the HA''s narratives the patient received the first dose of GARDASIL on 15-DEC-2011 and she experienced dizziness. After last dose administration (batch number, route and date not reported), convulsions, dizziness and vision disorders appeared, from which the patient had not recovered. According to the email sent to the HAs from the patient on JUL-2014: she was 16 years-old, she received the first dose of GARDASIL on JUN-2012 and she presented with dizziness and with the last dose (administration date not reported) she presented with convulsions and dizziness. According to the comments from the PV department from HAs the patient didn''t report the adverse event to the physician or pharmacist. The patient didn''t receive any treatment in order to improve the symptomatology. There are several discrepancies between HAs narrative and patient''s narrative regarding number in doses and dates. Case reported as serious by the Health Authorities with hospital admission (admission and discharge date not reported), disability and life threatening as criteria. At the time of this report the patient had not recovered from depression, blurred vision, double vision and dizziness. The outcome from convulsions and syncope was unknown. No further information reported.


VAERS ID: 540042 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-23
Onset:0000-00-00
Submitted: 2014-08-15
Entered: 2014-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005447 / 2 RA / SC

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain lower, Activities of daily living impaired, Appendicitis, Asthenia, Blood test normal, Computerised tomogram normal, Condition aggravated, Fatigue, Malaise, Muscular weakness, Myalgia, Nausea, Nuclear magnetic resonance imaging normal, Ultrasound scan normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 2006, 2009, Petit mal epilepsy; 12/2001, Varicella
Allergies:
Diagnostic Lab Data: Blood test, normal; Computerised tomogram, normal; Nuclear magnetic resonance imaging, negative; Ultrasound scan, normal
CDC Split Type: WAES1408FRA008554

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (E2014-07127) on 13-AUG-2014. Case received from the Health Authorities on 11-Aug-2014 under the reference number LY20141047. A 14-year-old female patient had received the first dose of GARDASIL (invalid batch number HD16386) subcutaneously in the left arm on 12-Jun-2013 and after vaccination, she experienced a loss of sensation in the arm intermittently for 2 weeks and permanent fatigue. On 23-Aug-2013 she received the second dose of GARDASIL (batch number J005447, 31-OCT-2015) subcutaneously in the right arm and, subsequently her fatigue worsened. The patient had a medical history of varicella in Dec-2001 and absence seizure from 2006 to 2009. On 25-Nov-2013, in the evening, she experienced very sharp pain in the right iliac fossa and nausea without vomiting. Corrective treatment with DOLIPRANE and SPASFON was ineffective. On 26-Nov-2013 she was hospitalised due to suspected appendicitis. Blood workup and investigations including ultrasound and CT-scan were normal. Pain score was assessed at 9/10. She was discharged from hospital on analgesics in the evening of 27-Nov-2013. In December 2013 she was seen in the emergency unit several times following bouts of pain associated with malaise and giving way of the right leg. These painful episodes hampered school attendance and led to exemption from physical exercise and to implementation of a project of individualized learning. Laboratory tests were normal. In mid-December 2013, when she consulted the general practitioner, she experienced sharp pain in lumbar area and in the course of the crural nerve with functional impairment of gait. Spinal MRI was negative. She underwent sessions of acupuncture which relieved pain. Severity of chronic pain decreased to 3/10 but violent episodes persisted at the slightest effort. Physiotherapy was started but with little effect. In late April 2014 she consulted a neurologist (medical report not available) and neuralgia of inguinal nerve was reported (word ''inguinal'' was used by the initial reporter). Treatment with TEGRETOL was started half tablet twice a day. On 21-May-2014 the most violent episodes and chronic pain ceased on treatment with TEGRETOL. However moderate pain persisted at the slightest physical effort. Fatigue was still very marked. In conclusion, prompt onset of asthenia after the first injection of GARDASIL, aggravation of asthenia after the second injection, then 3 months later, onset of disabling chronic pain of the right iliac fossa and neuromuscular weakness of the right lower limb. Improvement was observed on treatment with TEGRETOL. No aetiology was found. The third injection was not administered. At the time of reporting the patient had not recovered from fatigue but muscle pain and neuromuscular weakness were resolving. Upon medical review the company considered relevant to encode inappropriate route of vaccination that was not encoded by the Health Authorities. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as likely (C3 S1 I3) according to the foreign method of assessment.


VAERS ID: 544229 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-10-02
Onset:0000-00-00
Submitted: 2014-09-18
Entered: 2014-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Activities of daily living impaired, Aggression, Anxiety, Aphasia, Arthralgia, Back pain, Breast pain, Breast swelling, Cold sweat, Cystitis, Decreased appetite, Diplegia, Dissociation, Distractibility, Disturbance in attention, Dizziness, Dysmenorrhoea, Dysphagia, Dyspnoea, Dysstasia, Fall, Fatigue, Fibromyalgia, Frustration, Genital disorder female, Genital infection, Grip strength decreased, Headache, Hot flush, Hyperacusis, Hyperventilation, Immediate post-injection reaction, Impaired driving ability, Incoherent, Influenza like illness, Insomnia, Intervertebral disc protrusion, Labia enlarged, Lymph node pain, Lymphadenopathy, Major depression, Malaise, Memory impairment, Muscle contractions involuntary, Muscle spasms, Myalgia, Nausea, Nightmare, Nuclear magnetic resonance imaging spinal abnormal, Onychomycosis, Pain in extremity, Pallor, Palpitations, Paraesthesia, Parosmia, Pelvic pain, Photophobia, Presyncope, Pyrexia, Restlessness, Sensory disturbance, Skin burning sensation, Skin striae, Stress, Suicidal ideation, Tension, Tension headache, Throat tightness, Tonsillitis, Tremor, Vaccination site swelling, Visual impairment, Vomiting, Weight increased, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Suicide/self-injury (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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 (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (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 (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Lipodystrophy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Unknown
Preexisting Conditions: 06/2009, Intervertebral disc protrusion, MRI scanning showed 2 disc prolapses; Bulimia nervosa; Decreased appetite
Allergies:
Diagnostic Lab Data: 2009, Body temperature, fever not provided; 2009, Nuclear magnetic resonance imaging, showed 2 disc prolapse; Weight, Increased,gain 9 kg
CDC Split Type: WAES1409DNK007998

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control number E2014-08318) on 16-SEP-2014. Case received from Patient Insurance Company via Health Authorities on 11-Sep-2014 under the reference number DK-DKMA-ADR 22680511 and PIC 14-7379. The primary reporter was a lawyer. The case is considered not medically confirmed. A 13-year-old female patient with a medical history of invertebral disc prolapse, bulimia and anorexia, had received three doses of GARDASIL (batch number not reported) via unspecified route of administration in unspecified site of administration of 14-Jan-2009, 11-Mar-2009 and 02-Oct-2009. Later on unspecified date in 2009, she developed pain in arms and legs, seems like flu with tender lymph, fever and shiny eyes, dizziness and feeling of near fainting, tension in neck and shoulders, joint pain in knees, elbows, shoulder, fingers/pain in hip, pale skin, sensation of paralysis in legs periodically/difficulty holding things, swollen lymph nodes in throat with coating smelling bad, pain in back, fever and nausea. On unspecified date in 2001 she developed fibromyalgia. Further, on unspecified dates she developed frequent headache not relieved by medication, exhausted, concentration impairment, trouble remembering, distracted and forgets her appointments, trouble finding words and speaks incoherently, vomiting, clumsy and falls often, sensory disturbance in feet, legs, arms, hands and face: nose, gain of weight immediately post vaccination, about 9 kg, abdominal pain and cramps, decreased appetite with nausea and disgust at smell of food, anxiety with anxiety attacks, hyperventilation, difficulty breathing, periodically, feels like her throat locks, often suffers from tonsillitis, often has bladder infection, light sensitivity, tingling in hands and feet, restlessness in body, and hand tremor, difficulty with high noise causing anxiety or nausea, feeling remote, trouble sleeping, nightmares almost every night, eyes flicker, difficulty reading, foggy vision periodically, restless and difficulty to relax, easily feeling stressed, swelling at vaccinated site during long period ($g6 months), suddenly swollen labia, severe menstrual pain, breasts swelled un-normally quick with painful tension and stretch marks, tendency to melancholia and depression, frequent palpitations, burning feeling of skin, varying in body and mouth, muscle pain, used wheel chair for one year, suicidal thought, genital problems/genital infections, muscle contraction in both feet and nose, very short temper, long term problems with nail, seems like fungus, pain in pelvis, drops a lot of things, cannot swallow, hot flushes and cold sweat. It was reported that the PIC had received the patient''s request for compensation. The PIC has not yet processed/made a decision regarding the case. (These non-processed Patient insurance cases, are from a starting-point, obviously not medically confirmed). It was reported that the patient received treatment with penicillin (other mfr), of swollen lymph nodes in throat, which was not working (dates or dose not reported). The muscle contractions in both feet caused the little toes to point upward, and also muscle cramps at the bridge of the nose. The patient tried to treat the arthralgia with fish oil (results not reported). The patient also received different types of contraceptive pills, to try to alleviate menstrual pain. She develops physical pain when she is feeling sad or tired. She cannot stand up for a long time, as that worsens pain in back and hips. She often suffers from fever and gets hot flushes or cold sweat. Massage is used to alleviate her muscle pain, but can sometimes not be performed due to too much pain. The patient could not take part in regular education during 7, 8, 9 and 10: th grade. A lot of absence, and could not perform all exams. In school she had her own "office chair" in an attempt to decrease her back- and neck pain. She also took regular breaks to rest, and used a desk with adjustable height. She used a wheel chair for more than one year, due to pain and dizziness. She quit her education due to abdominal pain and muscle pain. She got a driver''s license for automatic gear car, as she, due to pain in back, knees and legs, cannot drive a manual shift car. She is not very socially active due to pain and a trip to the mall with friends is very hard both physically and psychologically. She cannot do physical exercise in the same manner as others, and has not participated to Physical education since 8th grade. She cannot participate to class field trips or travel. Normally, she cannot walk very far, approx. 200 m, but on good days a bit further. She needs to sit or lie down on soft surface. Hard surface worsens the pain in back and hips. She can only work a few hours and not every day. That cause pain in back, shoulders and hips, and after she develops tension headache. Too many appointments during one week cause stress and frustration, with worsened nausea and abdominal pain. She is dependent on car, as bus or train is very stressful and causes pain. She seldom uses public transport. She always needs to have a "life line" when she is in social occasions, when she gets severe pain or nausea etc. She has difficulties with daily duties, as she cannot life very much and easily gets tired. Gets slight pain in the back and hips and shoulders by making beds, vacuuming and difficulty cooking because she cannot stand for long. It is hard to hold on to things when her hands are numb. She is at times very sad and has suicidal thoughts-feel that life is taken from her. She has a hard time seeing a future- afraid to have children. Has difficulty staying focused in social contexts, as she does not feel she is present. In the beginning of 2009 she received her HPV-vaccination, and after this the pain in head, neck, shoulders, back and legs start. Her neck and shoulder gets very swollen, and she was told by her physician that she has muscle infiltrations. She develops sensory disturbances in legs, feet, arms and hands, nausea, dizziness and headache. It seems as she has influenza with swollen lymph nodes and she is feverish and pale in skin- the doctors cannot explain why. An MRI scanning performed in June 2009 shows 2 disc prolapses, which still cannot explain all her pain and other symptoms. After this she has a series of hospitalization, many visits to emergency and specialists, without any recovery. In 2011 she was diagnosed with fibromyalgia by a rheumatologist. The patient was also diagnosed with bulimia and anorexia. She tried to start school again in 2013, but had to give up due to muscle- and abdominal pain and further hospitalizations. Still no clear explanations for her pain. She tried to take a job. It turned out that she could work 4-6 hours daily, but often with 1-2 sick days per week. When returning from work she is very tired and needs to rest, often until next day. She started taking a course and the absence is already high. The patient is distracted and has a hard time focusing, so her mother is still accompanying her to all visits to physician. The patient herself fells she has lost her entire youth, which was filled with pain and feeling sick. She feels something was taken from her and she is tired of the fact that there is always something wrong with her. She uses a lot of medication and gets help by many different treatment providers, which can help and relieve some. The patient is sometimes on the edge of giving up, and has sometimes no desire to live. In these periods her mother is there to listen and talk until she is better. She is now seeing a psychiatrist, which seems to be a good help. The patient has a medical history including bulimia and anorexia, unknown if continuing. In June 2009 the patient suffered from invertebral disc prolapse, as MRI scanning showed 3 disc prolapse (coded as part of history, by HA). The patient was at the time of reporting using medication: Acetylsalicylic acid andcodeienphosphathemihydrat (Kodimagnyl), ZOFRAN, PANODIL, KURACID, Magnesia, Imozop sleeping pills, propranolol betablocker, potassium chloride with MOVICOL and ARAX (MFR, doses and dates not reported). Upon medical review the company considered relevant to code hand tremor, which was mentioned in HA narrative, although not coded. At the time of reporting, the patient had not recovered. HA considered the case serious due to hospitalization and disability.


VAERS ID: 544989 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-01-23
Onset:2009-01-25
   Days after vaccination:2
Submitted: 2014-09-24
   Days after onset:2067
Entered: 2014-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Autonomic nervous system imbalance, Cardiac arrest, Cognitive disorder, Dyspnoea, Fatigue, Headache, Heart rate increased, Menstruation irregular, Muscle twitching, Muscular weakness, Myalgia, Nausea, Neuralgia, Orthostatic intolerance, Pain, Poor quality sleep, Syncope, Tilt table test normal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (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; Mononucleosis syndrome
Preexisting Conditions: 12/12/2008, GARDASIL
Allergies:
Diagnostic Lab Data: Heart rate increased, 64-123 bpm; Tilt table test, POTS criteria not filled
CDC Split Type: WAES1409DNK011311

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) [Manufacturer Control Number DK-1577272925-E2014-08470] on 22-SEP-2014. Case received from a Health Care Professional via Health Authorities on 17-Sep-2014 under the reference number DK-DKMA-ADR 22690475. The primary reporter was a physician. A 14-year-old female patient (weight: 64 kg; height: 170 cm) with a medical history of mononucleosis, had second and third doses of GARDASIL (batch number not reported) via I.M. route of administration in unspecified site of administration on 23-Jan-2009 and 29-May-2009. Later in 25-Jan-2009 she developed autonomic dysfunction, neuropathic pain, arthralgia, fatigue extreme, headache, muscle pain, pain burning, orthostatic intolerance including syncope, abdominal pain, nausea, cognitive impairment, twitching, weakness of limbs and dyspnoea. On 15-Jan-2013 she developed syncope vasovagal, and on 25-Jan-2013 she developed allodynia (primarily in hands and feet). Further the patient developed menstruation irregular and poor quality sleep on unspecified date post vaccination. It was reported that the patient developed autonomic dysfunction, neuropathic pain, arthralgia, syncope vasovagal, fatigue extreme. Alongside the course of the adverse events she experienced symptoms such as headache, muscle pain and joint, burning pain and allodynia (primarily in hands and feet), orthostatic intolerance including syncope, abdominal pain, nausea, fatigue, cognitive impairment, twitching, weakness in limbs in arms and legs, dyspnoea, irregular menstruation, poor quality sleep. The symptoms first occurred closely after the second dose as regards time in 2008-2009 (somewhat contradictory to coded onset dates previously mentioned). A worsening of the adverse events was seen after a long-lasting mononucleosis-process in 2011-2012. During a tilt-table test in May 2014, a distinct increased pulse (65-$g123 bpm) was noticed, but the pulse stabilized on a lower level and does not fulfill the criteria for POTS. The patient experience asystole in 8 seconds during the tilt-table test. Other vaccines and other medicine when the adverse events occurred are unknown. The patient developed mononucleosis during the same period of time as the adverse events, however according to the Health Authority this is a part of her medical history. The patient have had mononucleosis during the period 2011-2012. The patient received first GARDASIL vaccination on 12-Dec-2008. At the time of reporting, the patient the outcome of syncope vasovagal was recovering, whereas other events were not yet recovered.


VAERS ID: 546083 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-01
Entered: 2014-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Antinuclear antibody, Antinuclear antibody negative, Morphoea, Pruritus, Rheumatoid factor negative, Skin plaque
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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: No other medications
Current Illness: Seasonal allergy; Food allergy, itching in the mouth when eating peach, apple and kiwi
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Antinuclear antibody (27-SEP-2013): 40; Anti-SCL-70 antibody (27-SEP-2013): negative; Rheumatoid factor (27-SEP-2013): 0; Antinuclear antibody (08-MAR-2014): 40; Anti-SCL-70 antibody (08-MAR-2014): negative; Rheumatoid factor (08-MAR-2014): 0; Light brown plaque with mild infiltration (27-SEP-2013): (25 x 7 mm in size)
CDC Split Type: WAES1408JPN001444

Write-up: Initial Follow-up information has been received from a physician concerning a 14 year old girl patient with pollinosis, fruit allergy (itching in the mouth when eating peach, apple and kiwi) and with no medical history who on an unknown dates was placed on therapy with the first and second dose of GARDASIL intramuscular injection (dose and lot number were not reported). In around January to February 2013, the patient received the third vaccination of GARDASIL (dose and lot number were not reported) (as the vaccination was performed at another hospital, Lot No. and vaccination status were unknown). Other concomitant medications were not reported. In around June 2013, suspected linear scleroderma developed. On 27-SEP-2013, the patient made the first visit to the hospital for symptoms of localized scleroderma (in the right thigh with itching). Light brown plaque with mild infiltration (25 x 7 mm in size) was observed on the extensor side of the right thigh. External use of METHADERM cream was started. Antinuclear antibody was detected (1:40), anti-topoisomerase (anti-SCL-70) (units not provided) antibody was negative and rheumatoid factor (RF) was 0. On 31-OCT-2013, slight improvement was observed. Therapy with METHADERM cream was continued. On 07-DEC-2013, slight improvement was observed. Therapy with METHADERM was continued. On 08-MAR-2014, slight improvement was observed. Therapy with METHADERM was continued. Antinuclear antibody was detected (1:40), anti-SCL-70 antibody was negative and RF was 0 (units not provided). On 28-MAR-2014, slight improvement was observed. Therapy with METHADERM was continued. On 30-JUL-2014, there was a question about the causal relationship between the event and GARDASIL. Suspected linear scleroderma (localized scleroderma) was not resolved. At the time of report on 27-AUG-2014, suspected linear scleroderma (localized scleroderma) had not yet improved and the patient was making visits to the reporting hospital. At the time of report on 26-SEP-2014, suspected linear scleroderma (localized scleroderma) was not resolved. Reporter''s comment (at the time of report on 27-AUG-2014): The causal relationship was unknown. Although the event was not considered to be serious, the seriousness could not be determined conclusively given that the event had not yet improved. Reporter''s comment (at the time of report on 26-SEP-2014): The event was not serious but it seemed that the symptoms would persist for a long time. The causal relationship was unknown. The reporting physician considered suspected linear scleroderma as serious due to disability. The reporting physician felt that the causal relationship of suspected linear scleroderma to GARDASIL was unknown, and considered that other causative factor was also unknown. Additional information has been requested.


VAERS ID: 546373 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-05-10
Onset:2011-05-10
   Days after vaccination:0
Submitted: 2014-10-03
   Days after onset:1242
Entered: 2014-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN33040 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Alopecia, Asthenia, Back pain, Chills, Clumsiness, Disturbance in attention, Dizziness, Dry skin, Dyspnoea, Fatigue, Headache, Hyperacusis, Hyperhidrosis, Insomnia, Laboratory test, Loss of consciousness, Malaise, Memory impairment, Menstrual disorder, Mouth ulceration, Muscular weakness, Musculoskeletal pain, Narcolepsy, Neck pain, Pain, Pain in extremity, Paraesthesia, Personality change, Pruritus, Seizure, Syncope, Urticaria, Visual acuity reduced
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (narrow), 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), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), 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 (broad), Hostility/aggression (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (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 (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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: Amitriptyline hydrochloride; MICROLITE
Current Illness: Immunisation
Preexisting Conditions: 02/2011, GARDASIL, Dose 2; 09/28/2010, GARDASIL, Dose 1
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1410IRL000643

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (Manufacturer control number E2014-08855) on 01-OCT-2014. Serious case received under reference IE HPRA 2014-021605 on 26-Sep-2014. This case is medically confirmed. A 14-year-old female patient, with no medical history reported, a concomitant medication including amitriptyline and microlite and analgesia as required, received an injection of GARDASIL (batch number NM11420), dose 1, via intramuscular route, site not reported, on the 28/Sep/2010, GARDASIL (batch number NN01990) 0.5 ml, dose 2, via intramuscular route, site not reported, in Feb/2011 and GARDASIL (batch number NN33040) 0.5 ml, dose 3, via intramuscular route, site not reported, on the 10/May/2011. The reporter indicated that it ws unclear whether the patient was taking any concomitant medications at the time of vaccination with GARDASIL. Since 10/May/2011, the patient has been experiencing on-going serious ill health for the past three years after completion of the HPV immunisation course. The patient experienced severe continuous headaches, leg pains and fatigue, seizures, insomnia, ''narcolepsy'', loss of concentration, changed personality, recurrent mouth ulcers, sensitivity to noise, failing vision, general weakness and loss of power of muscles, chills, sweating, pins and needles, hair falling out, clumsiness, forgetfulness, recurrent hives, dizziness, fainting, black out, itchy dry skin, problem with menstrual bleeding, shortness of breath, general malaise, chronic pain in her neck, head, shoulders and back, and she was unable to attend school due to ill health. Laboratory tests performed, in 2014, under the care of a neurologist did not establish any diagnosis. The reporter commented that the patient''s mother believed there was a link between the onset of her daughter''s ill health and vaccination with GARDASIL, based on a suggestion made to her by a fibromyalgia specialist, as per the patient''s mother''s history. The reporter stated that the patient has attended doctors and specialists for a number of unspecified investigations and tests but all have come back clear. The patient has been treated with medication for migraine, however, the patient''s mother stated that her daughter did not have migraine, but severe continuous headaches caused by GARDASIL. At this time of the reporting the outcome was not recovered. The regulatory authority considered the case serious for persistent or significant disability/incapacity reasons.


VAERS ID: 547671 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-12
Entered: 2014-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Crying, Discomfort, Fibromyalgia, HLA marker study, Laboratory test normal, Neck pain, Pain, Paraesthesia, Poor quality sleep, Tenderness
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (broad), 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: Familial risk factor; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Physical examination showed an uncomfortable-looking girl crying in pain. The remainder of the physical examination was normal. Extensive diagnostic workup was negative. No infectious, inflammatory, or autoimmune illness could be detected. HLAB27 was negative.
CDC Split Type: WAES1410MEX003645

Write-up: This literature market report has been received from the author of the published literature article. The objective of this communication was to describe 2 previously healthy girls who developed a chronic incapacitating fibromyalgia-like illness after HPV vaccination. Case 2. A healthy 14-year-old girl developed severe neck pain 4 weeks after her second GARDASIL shot. For the ensuing weeks, pain spread to her arms and then to her legs. She developed paresthesias in the 4 extremities. Because of her symptoms, she could not sleep well or attend school. She lived in a harmonic household, and there was no personal history of trauma, anxiety, or depression. She has a family history of spondyloarthropathy. Physical examination showed an uncomfortable-looking girl crying in pain. She had exquisite tenderness at palpations all over her body including all 18 fibromyalgia tender point sites. The remainder of the physical examination was normal. There was no arthritis or enthesopathy. Extensive diagnostic workup was negative. No infectious, inflammatory, or autoimmune illness could be detected. HLAB27 was negative. Several analgesic, corticosteroid, or antineuropathic medication provided only transient mild relief. Five months after the onset of her illness, she still had widespread pain and paresthesias. The author discussed that in case 2, vaccination-pain relationship is less clear; her intriguing illness developed 4 weeks after her second vaccine injection. In both instances, multiple specialist consultations and diagnostic procedures found no other plausible explanation for a severe persistent fibromyalgia-like illness developing at their young age. The author suggested that the medical community and regulatory agencies be aware of these possible adverse effects in order to define their real magnitude, and if indicated, to take corrective actions. The event was considered as disability because the patient could not attend to school. This is one of several reports received from the same literature. Additional information has been requested.


VAERS ID: 548004 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-11-01
Onset:2012-12-23
   Days after vaccination:418
Submitted: 2014-10-15
   Days after onset:660
Entered: 2014-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Amenorrhoea, Endoscopy, Fatigue, Gastritis erosive, Ovarian failure, Scan abnormal, Skin discolouration, Weight decreased, pH body fluid
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal nonspecific inflammation (narrow), Fertility disorders (narrow), Hypotonic-hyporesponsive episode (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: Endoscopy, Not reported; Scan, Ovary shut down; pH body fluid, Not reported
CDC Split Type: WAES1410GBR005829

Write-up: This spontaneous report as received from a consumer via regulatory authority [Agency number # ADR 22710335] refers to a 14 year old female patient. On 01-NOV-2011 the patient was vaccinated with HPV4 (manufacturer unknown) parenteral. No concomitant medication was reported. On 23-DEC-2012, the patient experienced loss of period. The consumer reported that her periods stopped and then later she lost a significant amount of weight, she felt tired all the time and could not be bothered to do anything, and her skin tone looks grey. Laboratory tests were done regarding her symptoms at the hospital but no reason could be found. On an unknown date the patient experienced ovarian failure and gastritis erosive. The consumer stated the specialists had conducted a scan and found her ovaries have shut down. The had also taken top and bottom endoscopy with pH study. The consumer believed the patient''s health had deteriorated since having the HPV4 vaccine (manufacturer unknown) injections. The consumer had to watch the patient fall into a ball of nothing. The events were considered serious due to hospitalization, medically significant and disability. The outcome of gastritis erosive and ovarian failure was unknown. The outcome of the rest of the events were reported as not recovered. The causality of the events were unknown for HPV4 (manufacturer unknown). Additional information has been requested.


VAERS ID: 555437 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-09-29
Onset:0000-00-00
Submitted: 2014-11-05
Entered: 2014-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K002850 / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Muscular weakness, Seizure, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), 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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation, D1
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1410DEU016688

Write-up: Case was received from a physician via a company representative on 29-Oct-2014 from Sanofi Pasteur (reference # DE-1577272925-E2014-10163) on 30-OCT-2014. Case is medically confirmed and poorly documented. A 14-year-old female patient received a second dose of GARDASIL (lot-no. not reported) on an unspecified date in 2014. Fourteen days later she developed convulsions and weakness of her legs leading to the need of a wheelchair. At the time of reporting the patient was treated in a rehabilitation centre. At the time of reporting the patient had not recovered. First dose of GARDASIL was given on an unspecified date. Toleration was not reported.


VAERS ID: 570822 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-01-14
Onset:2009-02-02
   Days after vaccination:19
Submitted: 2014-12-23
   Days after onset:2150
Entered: 2014-12-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Asthenia, Autonomic nervous system imbalance, Chest discomfort, Cognitive disorder, Condition aggravated, Dizziness, Dysaesthesia, Fatigue, Fibromyalgia, Headache, Insomnia, Muscle twitching, Pain, Palpitations, Postural orthostatic tachycardia syndrome, Psychomotor hyperactivity, Sensory disturbance, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (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; 2008, Back pain
Preexisting Conditions: 2008, Fall
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1412DNK010249

Write-up: Information has been received from Agency (HA# 22793113) via Sanofi Pasteur MSD (MFR control# E2014-12665) on 19-DEC-2014. Case was received from a health professional via the Health Authorities on 15-Dec-2014 under the reference number DK-DKMA-ADR 22793113. Case is medically confirmed. Primary source was a physician. A 14-year-old female patient (weight 58 kg, height 173 cm) with a medical history of fall in autumn 2008 and back pain since then received the first injection of GARDASIL (batch number not reported) via intramuscular route into not reported site of administration on 14-Jan-2009. On 02-Feb-2009, the patient developed postural orthostatic tachycardia syndrome, autonomic dysfunction, dysaesthesia, chronic headache, widespread pain, cognitive dysfunction, muscular hyperactivity, fatigue extreme, fibromyalgia, sensory disturbance, syncopes, dizziness, chest pressure, palpitations, abdominal pain, sleeping problems, muscle twitch, intermittent feeling of reduced strength in arms and legs, and worsening of back pain. The patient had received the diagnosis of fibromyalgia due to widespread pain. D2 and D3 of GARDASIL were given on 11-Mar-2009 and 02-Oct-2009, respectively (batch numbers not reported). At the time of reporting, the patient had not recovered. A relationship between events and vaccination was suspected due to the temporal relationship between vaccination and onset.


VAERS ID: 574067 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-16
Onset:2013-06-11
   Days after vaccination:26
Submitted: 2015-01-26
   Days after onset:594
Entered: 2015-01-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. HD17156 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autoimmune disorder
SMQs:

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: WAES1501ESP009095

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR control# E2015-00458) on 23-JAN-2015. Case received from the Health Authorities, reported to them by a consumer (by a patient''s family), on 22-JAN-2015, under the reference number: ES-AGEMED-305172347. Case not medically confirmed. A 14 years-old female patient, with no medically history reported, received a dose of GARDASIL, (batch/lot number reported as: HD17156) route intramuscular on 16-MAY-2013 and 26 days later, on 11-JUN-2013, the patient presented with autoimmune disorder. The patient received corticosteroids as treatment for alleviate the outbreaks. According to the report the patient didn''t recover at the time of the reporting. Case reported as serious by the Health Authorities with hospitalization (admission and discharge dates not reported) and disability as criteria. According to the primary reporter this adverse event was not reported to a healthcare professional. No further information was reported.


VAERS ID: 574038 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-19
Onset:0000-00-00
Submitted: 2015-01-27
Entered: 2015-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache, Malaise, Orthostatic hypotension, Photophobia, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad), Dehydration (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:
CDC Split Type: WAES1501JPN010421

Write-up: Initial information has been received from a physician via the Agency (# A201500607) concerning a 14 year old girl who on 19-MAR-2013 received the third dose of GARDADIL, intramuscular injection drug, (lot no. and dose were unknown). It was unknown about the special notes on the pre-vaccination interview form (including underlying disease, allergy, vaccination/disease within the last 1 month, medications currently taken, history of adverse drug reaction and growth status). Information including the patient''s primary/concomitant diseases, medical history and family history was not obtained. Other concomitant medications were not reported. On 22-AUG-2012, the patient received GARDASIL the first time (lot no. and dose unknown). On 08-NOV-2012, the patient received GARDASIL for the second time (lot no. and dose unknown). On 19-MAR-2013, the patient GARDASIL for the third time (lot no. and dose unknown). In 2013 (around summer), the patient experienced headache and general malaise, and became unable to wake up in the morning. She developed photophobia and orthostatic hypotension. On 06-AUG-2014, the patient was recovering from photophobia, orthostatic hypotension, headache and general malaise. At the time of the report on 22-JAN-2015, the outcome of the photophobia, orthostatic hypotension, headache and general malaise was recovering/resolving. Reporter''s comment: The symptoms were improving. The reporting physician considered that photophobia, orthostatic hypotension, headache and general malaise were serious due to possible disability. The reporting physician felt that the causality of photophobia, orthostatic hypotension, headache and general malaise to GARDASIL was unknown and did not assess whether or not there were other possible causative factors (including other diseases) for the events. Additional information has been requested.


VAERS ID: 574504 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-02-04
Entered: 2015-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Exercise tolerance decreased, Fatigue, Fine motor skill dysfunction, Heart rate increased, Herpes zoster, Immune system disorder, Infection susceptibility increased, Muscular weakness, Temperature intolerance, Tremor, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Dehydration (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: 11/16/2009, GARDASIL, immunisation, toleration was not reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1502SWE001430

Write-up: Information has been received from Sanofi Pasteur MSD (E2015-00829) on 03-FEB-2015. Case was received from a consumer or other non health professional via the Health Authorities on 30-Jan-2015 under the reference number MPA-2015-000556. The case is not medically confirmed. A 14-year-old female patient (weight 62 kg, height 184 cm) with no medical history reported received the second dose of GARDASIL (batch no. not reported) via not reported route and site of administration on an unspecified date in 2010. On an unspecified date in 2010, the patient developed severe tiredness and recurring infections. On an unspecified date in 2012, the patient also experienced tremor, high pulse, weight loss, diarrhea, muscle weakness, zoster infection (shingles), sensitivity to exertion and sensitivity to cold. The reporter writes that the symptoms have impacted her daily life even years after the vaccinations. For example, the tremors were treated daily with INDERAL and the girl had fine-motor difficulties due to the tremors. Also, she experienced that her immune response has become worse after the vaccinations and she has had multiple infections during the last years. Moreover, she has lost 15 kg in weight without changing any dietary- or exercise habits. She has contacted numerous doctors during the years without any diagnosis being established. She wrote "thoughts about POTS (postural tachycardia syndrome) exist". At the time of reporting, the patient had not recovered. According to the HA, the events were possibly related to the vaccination. The third dose was not administrated due to the adverse reactions, after the second administration.


VAERS ID: 575462 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-01
Onset:2013-01-01
   Days after vaccination:0
Submitted: 2015-03-04
   Days after onset:792
Entered: 2015-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Blood pressure orthostatic normal, Chronic fatigue syndrome, Constipation, Disturbance in attention, Hyperhidrosis, Iron deficiency, Memory impairment, Physical disability, Poor quality sleep, Skin test, Spirometry, Syncope, Vitamin D deficiency
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (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: Unknown
Preexisting Conditions: Hypersensitivity, Patient''s medical history included allergy. 10/02/2012, GARDASIL, Immunisation, Previous doses of GARDASIL were given on 01-Apr-2012 (D1) and on 01-Oct-2012 (D2). Toleration was not reported. 04/01/2012, GARDASIL, Immunisation, Previous doses of GARDASIL were given on 01-Apr-2012 (D1) and on 01-Oct-2012 (D2). Toleration was not reported.
Allergies:
Diagnostic Lab Data: Investigation, POTS test negative; Skin test, not reported; Spirometry, not reported
CDC Split Type: WAES1503DNK000760

Write-up: Case received from health professional via the Health Authorities on 26-Feb-2015 under the reference number DK-DKMA-ADR 22885108. Case medically confirmed. Primary source was a physician. A 14-year-old female patient (weight 48 kg, height 159 cm) with a medical history of allergy had received the third injection of GARDASIL, (batch number not reported) via intramuscular route into not reported) via intramuscular route into not reported site of administration on 01-Jan-2013. On the same day, the patient developed abdominal pain, chronic fatigue syndrome, bloating, constipation, poor night sleep, impaired concentration, impaired memory, faints in between, vitamin D deficiency and iron deficiency. She could no longer perform physical exercise and was sweating a lot. Examinations included: POTS-test negative. For spirometry, NO, prick test results were not reported. The patient was treated with magnesium and MOVICOL. Concomitant medication was not reported. At the time of reporting, the patient had not recovered. Previous doses of GARDASIL were given on 01-Apr-2012 (D1) and on 01-Oct-2012 (D2). Toleration was not reported.


VAERS ID: 576086 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-13
Onset:2014-02-15
   Days after vaccination:94
Submitted: 2015-03-18
   Days after onset:395
Entered: 2015-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autonomic nervous system imbalance, Cognitive disorder, Dizziness, Exercise tolerance decreased, Headache, Hypersomnia, Hypotension, Labile blood pressure, Meningitis, Mental impairment, Psychomotor hyperactivity, Pyrexia, Tilt table test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Hostility/aggression (broad), Hypertension (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: Dizziness; Immunisation
Preexisting Conditions: Meningitis, The patient''s medical history was relevant for an about 10-year-old severe meningitis sequelae in form of attacks approximately once a month with transient dizziness; 06/24/2013, GARDASIL; Drug indication: Immunisation; 04/25/2013, GARDASIL; Drug indication: immunization, previous doses of GARDASIL were given on 25-Apr-2013 (D1) and 24-Jun-2013 (D2). Toleration was not reported.
Allergies:
Diagnostic Lab Data: Tilt table test, very labile, low blood pressure, but no POTS not provided
CDC Split Type: WAES1503DNK007325

Write-up: Information has been received from Sanofi Pasteur MSD [DK-1577272925-E2015-02545] on 13-MAR-2015. Case received from health professional via the Health Authorities on 11-Mar-2015 under the reference number DK-DKMA-ADR 22900714 and DK-DKMA-EFO11346. Case was medically confirmed. Primary source was a physician. A 15-year-old female patient (weight 55 kg, height 156 cm) had received the third injection of GARDASIL (batch number not reported, dose 0.5 ml) intramuscularly into not reported site of administration on 13-Nov-2013. The patient''s medical history was relevant for an about 10-year-old severe meningitis sequelae in form of attacks approximately once a month with transient dizziness. Previous doses of GARDASIL were given on 25-Apr-2013 (D1) and 24-Jun-2013 (D2). Toleration was not reported. Approximately 3 months after the third vaccination, on 15-Feb-2024, the dizziness suddenly was constant (dizziness aggravated) and the patient developed also developed autonomic dysfunction, muscular hyperactivity (tremor/twitch), severe cognitive dysfunction, sleep excessive (increased need for sleep), feeling feverish, and very pronounced intolerance to both physical and mental activity. On 05-Apr-2014, the patient also experienced chronic headaches. The patient was hospitalized on an unspecified date. It was unknown whether examinations were performed or lab samples were taken. A tilt table showed very labile and low blood pressure, but not really orthostatic hypertension and did not meet the criteria for POTS. It was unknown whether other vaccines or medications were administered. Both the patient''s family and the reported had doubts about what was due to meningitis sequelae and what was suspected to be a reaction to the GARDASIL vaccine. The patient''s condition as slowly improving. She had been home from school for months but was now slowly coming back again. At the time of reporting, the patient was recovering from the event of chronic headaches. The outcome of the events feeling feverish and exercise intolerance was unknown. The patient had not recovered from all other events.


VAERS ID: 576303 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-05-09
Onset:2015-01-08
   Days after vaccination:244
Submitted: 2015-03-23
   Days after onset:73
Entered: 2015-03-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Chest X-ray, Chest pain, Cyanosis, Dyspnoea, Echocardiogram, Electrocardiogram, Exercise tolerance decreased, Gait disturbance, Hypoaesthesia, Mental impairment, Mobility decreased, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Oxygen saturation decreased, Syncope, Vitamin D decreased, Vitamin D deficiency, Wheelchair user
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (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? 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: Blood test, vitamin D deficiency; Chest X-ray, Not provided; Echocardiogram, Not provided; Electrocardiogram, Not provided; Nuclear magnetic resonance imaging, Head and spine; Oxygen saturation, Significantly low
CDC Split Type: WAES1503GBR009990

Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number GB-1577272925-E2015-02692) on 19-MAR-2015. Initial case received on 16-Mar-2015 from the health authority GB-MHRA ADR 228896372. This case is not medically confirmed. A 14 year old female patient (weight 76 kg), with no medical history reported, received an injection of GARDASIL, (batch number not reported) on 09-Oct-2013 and an injection of GARDASIL (batch number not reported) on 09-May-2014, doses in series, routes and sites of administration not reported. On 08-Jan-2015, when the patient was talking with friends, she suddenly could not breathe and collapsed. On the same date, she could not walk down the stairs and took the lift, she collapsed again and then she experienced chest pain. The patient''s mother was called and school reported that the patient presented with blueness round her mouth and her lips were fully blue. The patient''s mother advised accident and emergency and shortness of breath continued until accident and emergency. Oxygen saturation levels in accident and emergency were significantly low and the patient was admitted to ward immediately. Chest pain was treated with pain killer paracetamol, ibuprofen and codeine. On 08-JAN-2015, the patient noticed that she could not feel her feet and hands and this increased to numbness of whole legs to hip and arms to shoulder. Physiotherapy treatment was introduced. Then, the patient could not move arms and legs but was able to stand on her legs and walk. On an unreported date after the vaccine, the patient had difficulty exerting either mentally of physically for long periods of time. On an unreported date, blood test, chest X-ray, electrocardiogram, echocardiogram and MRI of head and spine were performed and it was only suggested vitamin D deficiency. The patient was in ward hospital for a month. She saw a paediatric psychologist for support with mobility change. The patient was in wheelchair bound and downstairs living. The patient''s symptoms have not worsened but stayed the same since admittance, except for breathing issues which worsen when chest pain increased. On an unreported date, the patient had recovered from syncope. At the time of reporting, the outcome for cyanosis and vitamin D deficiency was unknown and the patient had not yet recovered from the other adverse events. The case was considered as serious due to the patient''s hospitalization and disability.


VAERS ID: 576713 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Male  
Location: Foreign  
Vaccinated:2015-01-13
Onset:2015-01-13
   Days after vaccination:0
Submitted: 2015-04-06
   Days after onset:82
Entered: 2015-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J010618 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Inflammatory marker increased, Joint swelling
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), 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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown test: acute phase reactant increased
CDC Split Type: WAES1504DNK001473

Write-up: Information has been received from regulatory authority (agency # 22926090) via Sanofi Pasteur MSD (MCN # DK-1577272925-E2015-03085) on 02-APR-2015. Case received from health professional via the Health Authorities on 30-Mar-2015 under the reference number DK-DKMA-ADR 22926090 and DK-DKMA-EFO11489. Case is medically confirmed. Primary source was a physician. A 14-year-old male patient (weight, height not reported) with no medical history reported received an injection of GARDASIL, lot number J010618, expiry date 29-FEB-2016 via intramuscular route into not reported site of administration on 13-Jan-2015. On the same day, subsequently, the patient developed joint pain and joint swelling in hips, knees and ankles. Results of tests and procedures (not further specified) revealed increased acute phase reactants. Concomitant medication was not reported. At the time of reporting, the patient had not recovered.


VAERS ID: 577485 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-05-20
Onset:2010-08-01
   Days after vaccination:73
Submitted: 2015-04-22
   Days after onset:1725
Entered: 2015-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Autonomic nervous system imbalance, Headache, Postural orthostatic tachycardia syndrome, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (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: Syncope; 01/15/2010, GARDASIL: Drug indication: Immunisation, (D2). Toleration not reported; 11/02/2009, GARDASIL; Drug indication: Immunisation, (D1). Toleration not reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1504DNK018866

Write-up: Information has been received from Sanofi Pasteur MSD (Case Report N. DK-1577272925-E2015-03644) on 20-APR-2015. Case received from health care professional via Health Authorities on 15-Apr-2015 under the reference number DK-DKMA-ADR 22948215 and DK-DKMA-EFO11668. Case is medically confirmed. Primary source was a physician. A 14-year-old female patient (weight 70 kg, height 165 cm) had received the third injection of GARDASIL (batch number not reported) via intramuscular route into not reported site of administration on 20-May-2010. Patient''s medical history included a single syncope episode before the vaccines. Patient''s family medical history included unspecified heart disease. On an unspecified date in Aug-2010, the patient developed postural orthostatic tachycardia syndrome, autonomic dysfunction, headache, syncopal attack and abdominal pain. Patient was hospitalized on an unknown date and diagnosed of POTS based on the following criteria: 1) Heart disease 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). 2) Symptoms worsen with standing and improved with recumbence. 3) Symptoms last greater than or equal to 6 months. 4) Absence of other overt cause of orthostatic symptoms or tachycardia (e.g. active bleeding, acute dehydration, medications). In addition, an additional criteria for patients between 12-19 years was used to avoid false positives: Need a pulse increase greater than 40 bpm to set the diagnosis with the reason that adolescents have a stronger physiological pulse response to standing up. It was unknown whether further tests or examinations were performed. It was unknown whether other medications or vaccines were administered. Previous doses of GARDASIL (batch number not reported) were given on 02-Nov-2009 (D1) and on 15-Jan-2010 (D2), toleration was not reported. At the time of reporting, the patient was recovering.


VAERS ID: 578915 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-09-02
Onset:2014-09-02
   Days after vaccination:0
Submitted: 2015-05-20
   Days after onset:260
Entered: 2015-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K005028 / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Diplegia, Gait disturbance, Pain in extremity, Vaccination site pain
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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? 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: WAES1505BRA008357

Write-up: This spontaneous report as received from patient''s mother via business partner (MFR # unknown) refers to a 14 year old female patient. Patient is not pregnant. Medical history and concomitant medications were not reported. On an unknown date, patient received GARDASIL (Dose 1, 0.5 ml, intramuscular). On 02-SEP-2014 the patient was vaccinated with GARDASIL lot # K005028, expiry: unknown, dose 2, 0.5 ml, intramuscular in the left deltoid. On 02-SEP-2014 the patient experienced paralysis of lower limbs (disability and medically significant), walking difficulty (disability), pain in legs and pain at vaccination site for 30 minutes. Patient was not hospitalized, however she received medical attention. Patient recovered from pain at vaccination site. Patient did not recover from paralysis in lower limbs, walking difficulty and pain in legs. The relatedness for adverse events to GARDASIL was not provided. Additional information is not expected as reporter could not provide patient''s physician contact details.


VAERS ID: 579479 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-12-21
Onset:2009-12-21
   Days after vaccination:0
Submitted: 2015-05-26
   Days after onset:1981
Entered: 2015-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test abnormal, Cystitis, Disturbance in attention, Fatigue, Neuralgia, Neutrophil count decreased, Pain
SMQs:, Haematopoietic leukopenia (narrow), Peripheral neuropathy (narrow), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (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: Pain; Cognitive disorder; Depression; Cystitis
Allergies:
Diagnostic Lab Data: A large number of blood test have been analysed by several different medical specialists.
CDC Split Type: WAES1505DNK013466

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # E2015-05502) on 21-MAY-2015. Case received from health care professional via Health Authorities on 21-May-2015 under the reference number DK-KMA-ADR 22985644, DK-DKMA-EFO11997. The primary reporter was a physician. A 14-year-old female patient with a medical history of Long lasting chronic pain, Recurrent cystitis, Depression and cognitive problems, had received a dose of GARDASIL (batch number NJ50800) via i.m. administration (injection site not reported) on 21-Apr-2009 and later on 21-Dec-2009, she developed Chronic pain, Tiredness, Symptoms of cystitis, Neurogenic pain, Concentration impaired and Neutrophils low. There was an long lasting course of the disease without any good explanation. Other medication not reported. At the time of reporting, the patient had not recovered.


VAERS ID: 580283 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-08
Onset:2012-12-01
   Days after vaccination:23
Submitted: 2015-05-28
   Days after onset:907
Entered: 2015-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H011751 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood glucose, Blood test, Body temperature fluctuation, Discomfort, Disturbance in attention, Dizziness, Fatigue, Headache, Hyperacusis, Insomnia, Investigation, Memory impairment, Muscle spasms, Muscular weakness, Nausea, Pain, Photophobia, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), 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), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular 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: Unknown
Preexisting Conditions: Immunisation
Allergies:
Diagnostic Lab Data: Blood glucose; Blood test; Investigation; Investigation
CDC Split Type: WAES1505DNK013810

Write-up: Information has been received from Sanofi Pasteur MSD (MFR control no DK-1577272925-E2015-05493) as part of business agreement on 26-MAY-2015. Case was received from a health care professional via the Health Authorities on 20-May-2015 under the references DK-DKMA-ADR 2294461 and DK-DKMA-EFO12067. Case is medically confirmed. The primary reporter was a physician. A 14-year-old female patient (weight and height not reported) with no medical history received the first dose GARDASIL, batch number H011751) intramuscularly into not reported site of administration on 08-Nov-2012. She developed gradually headache, pain in entire body, pain in feet and hips, tiredness, poor concentration, memory impairment, dizziness, nausea, light sensitivity and sound sensitivity, vision disturbances, heavy legs and sense of decreased strength in arms, cramps in leg, sense of temperature alternately goes up an down, severe sleeplessness. No other medicines or vaccines were administered. The following examinations and laboratory tests were performed: arthritis tests, vitamin B12 and D. Infection counts, borrelia, metabolism, hemoglobin and diabetes tests were reported. At the time of reporting, the patient had not recovered. Noteworthy: Upon medical review the company judged relevant to code pain in feet and hips separately, which were mentioned separately in the narrative by the HA but coded with pain in entire body, pain in feet and hips together.


VAERS ID: 581051 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-01-08
Onset:0000-00-00
Submitted: 2015-06-03
Entered: 2015-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1334X / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Cystitis, Headache, Laboratory test normal, Pharyngitis, Surgery, Tic, Vertigo
SMQs:, Agranulocytosis (broad), Dyskinesia (broad), Dystonia (broad), Oropharyngeal infections (narrow), Vestibular disorders (narrow), Arthritis (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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 02/2015, Laboratory test, normal
CDC Split Type: WAES1505DNK015534

Write-up: Information has been received from Sanofi Pasteur MSD (MFR Control Number E2015-05843) on 29-MAY-2015, as a part of business agreement. Case received from healthcare professional via Health Authorities on 27-MAY-2015 under the reference number DK-DKMA-ADR 22998647 and DK-DKMA-EFO12108. The primary reporter was a physician. A 15-years old female patient with no known medical history, had received three doses of GARDASIL, D1: batch# NK36120, lot # NJ33240, expiration date 30-SEP-2011, D2: not reported, D3: batch # NL12890, lot # 1334X, expiration date 17-OCT-2011) via intramuscular route of administration in not reported site of administration on 17-JUN-2009, 04-SEP-2009 and 08-JAN-2010 and later on an unspecified date she developed cystitis recurrent, recurrent throat infections, cephalgia, arthralgia, vertigo and tics. The patient has been investigated several times and ENT specialist and had surgery for throat abscess. The recurrent cystitis has been examined at gynecologist ward. Lab test (not further specified) from February 2015 normal. The patient had no other medications or vaccines. The case was assessed as serious by HA due to disability (not further specified). At the time of reporting, the patient had not recovered.


VAERS ID: 581611 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-09-10
Onset:2010-11-18
   Days after vaccination:69
Submitted: 2015-06-08
   Days after onset:1662
Entered: 2015-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Headache, Laboratory test, Pain
SMQs:

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: Migraine
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1506DNK003627

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # DK-1577272925-E2015-06330) on 05-JUN-2015. Case received from a health care professional via the Health Authorities on 02-JUN-2015 under the reference numbers DK-DKMA-ADR 23009987 and DK-DKMA-EFO12214. Case is medically confirmed. Primary source was a physician. A 14-year-old female patient (weight 52 kg, height 167 cm) with a medical history of migraine-like headaches as a child had received a dose of GARDASIL via intramuscular route into not reported site of administration on 10-SEP-2010. 3 batch numbers were reported (NL48770, NM16750 and NM46920), it was unclear which of these was used. On 18-NOV-2010, approximately 2 months after the vaccination, the patient developed chronic headache, chronic pain in the entire body and chronic tiredness. There were no other vaccines or medications. The patient had been examined by a pediatrician and neurologist, and at the Headache Center. Unspecified laboratory tests had also been performed. Results were not provided. At the time of reporting, the patient had not recovered.


VAERS ID: 581614 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-16
Onset:2013-04-28
   Days after vaccination:102
Submitted: 2015-06-08
   Days after onset:771
Entered: 2015-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Anxiety, Asthenia, Back pain, Biopsy, Body temperature fluctuation, Bone cyst, Bone pain, Depression, Dysmenorrhoea, Fall, Fatigue, Femur fracture, Influenza like illness, Somnolence, Syncope, Tremor, X-ray limb abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Osteoporosis/osteopenia (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MICROGYN; SANDOSTATIN LAR; PROGLYCEM
Current Illness: Hypoglycaemia; Dysmenorrhoea
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Biopsy, benign conditions; X-ray, bone cyst
CDC Split Type: WAES1506DNK003639

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer # E2015-06338) on 05-JUN-2015. Case was received from a health care professional via the Health Authorities under the references DK-DKMA-ADR 22212798, DK-DKMA-EFO6575, DK-DKMA-ADR 22997607 and from a lawyer, the Patient Insurance Company on 02-JUN-2015. Case is medically confirmed. The primary source was a physician. A 13-year-old female patient (weight 49.2 kg and height 166 cm) with medical history of nonketotic hypoglycemia (unknown cause) had received the first dose of GARDASIL, batch number not reported via intramuscular route into not reported site of administration on 25-MAR-2010. The second dose of GARDASIL was administered on 27-MAY-2010. The third dose was given on 07-OCT-2010. Co-suspect medication included MICROGYN, MFR other orally for dysmenorrhea on 16-JAN-2013, SANDOSTATIN LAR, MFR other intramuscularly from 18-APR-2012 to 05-MAR-2014 for hypoglycemia, and PROGLYCEM TEVA/GATE orally for hypoglycemia given with compassionate use permit on 20-MAR-2012. On an unknown date, the patient had fracture of femur trochanter after a trivial fall. On 28-APR-2013, the patient developed benign bone cyst which was revealed by X-ray. Result of biopsy showed benign conditions. The patient had received bone transplant. Treatment was unchanged. However, she wanted to withdraw, on 13-SEP-2013, SANDOSTATIN LAR. No other medications were reported. On 14-APR-2014, the following information had been received from the reporter at the request of Novartis: end date for treatment with SANDOSTATIN LAR was 05-MAR-2014. If the adverse reaction regressed could not be answered as the adverse reaction resulted in a surgical intervention. Although, it had not been recurrent after the surgical intervention despite continued treatment. The patient recovered on an unknown date. No other relevant information existed. On 12-MAY-2015, case had been received from the Patient Insurance Company (PIC). PIC had sent the patient''s initial injury claim. At the time of reporting, PIC had not made a decision regarding the case. The patient reported a number of symptoms, including bone cyst and fracture as adverse reactions to GARDASIL. Furthermore, the patient developed daily fainting, extreme tiredness, tenderness in bones, loss of energy, weakness, pain in stomach, tremors in the body, fast body temperature fluctuation, pain in especially back, severe menstrual pain, drowsiness, influenza-like symptoms. She reported depression and anxiety that followed after the disease progression with many fainting. The patient had been treated since December 2013 for these psychological problems. It was not clear whether the patient still experienced the other symptoms. She had reported to be in treatment for these until 23-JAN-2015 at various hospitals. The patient had been hospitalized several times and was in April 2015 still on sick leave. GARDASIL was added as suspect drug to this case. The patient''s other symptoms that were only related to GARDASIL were established in ADR 22997607. At the time of reporting, the patient had recovered from benign bone cyst and fracture of femur trochanter on unknown date. She had not recovered from anxiety and depression. The outcome for all other events was unknown. Agency comment: The patient had been treated with GARDASIL also experienced the adverse reaction bone cyst and hip fracture (28-APR-2013). However, these were also adverse reactions related to treatment with MICROGYN, PROGLYCEM "Teva/Gate" and SANDOSTATIN LAR and were therefore registered in related case ADR 22212798. Noteworthy: There is a discrepancy regarding start date of hip fracture. HA had not code the event onset date in the structured field but mentioned in the narrative that the patient experienced hip fracture (28-APR-2013).


VAERS ID: 583100 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-08-04
Onset:0000-00-00
Submitted: 2015-06-17
Entered: 2015-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Chest pain, Disturbance in attention, Dizziness, Dyspnoea, Educational problem, Fatigue, Feeling abnormal, Feeling of body temperature change, Hyperacusis, Hyperhidrosis, Migraine, Muscle tightness, Photophobia, Social problem, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), 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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1506DNK008347

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # DK-1577272925-E2015-06557) on 16-JUN-2015. Case received from a consumer or other non health professional via the Health Authorities on 11-JUN-2015 under the reference number DK-DKMA-ADR 23023110 and DK-DKMA-EFO12337. Case is not medically confirmed. A female patient (weight: 51 kg; height: 159 cm), with no medical history reported, had received three doses of GARDASIL, (batch number not reported) via intramuscular route into not reported site of administration on 02-DEC-2008 (D1), on 16-MAR-2009 (D2) and on 04-AUG-2009 (D3). On unknown dates, the patient was very tired and developed loss of energy, concentration impaired, constant chest pain, severe migraine, shaking during migraine attack, back and neck tension, difficulty breathing (in connection to the above). She was very sensitive to light and sound and experienced dizziness, swings from feeling hot to feeling cold, sweaty hands/feet (also in minus degrees). The patient could not manage school due to her migraine (she became really miserable). The patient could not handle too many people at the same time. She took PANODIL Zapp (MFR other) against migraine. Laboratory tests has been performed but results were not reported. HA had requested medical confirmation. At the time of reporting, the patient had not recovered.


VAERS ID: 583747 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-01-13
Onset:0000-00-00
Submitted: 2015-06-23
Entered: 2015-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Disability, Hypersomnia, Incorrect route of drug administration, Vaccination error
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), 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: 09/21/2010, GARDASIL, Immunisation, a second dose of GARDASIL, batch number NN25310, on 21-Sep-2010; 06/29/2010, GARDASIL, Immunisation, the patient had received a first dose of GARDASIL, batch number: unknown, on 29-Jun-xxxx (probably in 2010 but the full date was not specified in the vaccination card)
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1506FRA010348

Write-up: Information has been received from Sanofi Pasteur MSD(SPM) (manufacturer # FR-1577272925-E2015-06715) on 19-JUN-2015. Case received from Health Authority on 16-Jun-2015 under the reference number PP20150186. A 14-year-old female patient, with no reported medical history, had received a third dose of GARDASIL, batch number NN22980 by subcutaneous route, site of administration not reported on 13-Jan-2011. To be not noted that the vaccine should be administered by intramuscular route. Three months post-vaccination, the patient developed excessive diurnal hypersomnia. She was treated with MODIODAL and melatonin. The patient had not recovered at the time of reporting. The patient had received a first dose of GARDASIL, batch number: unknown, on 29-Jun-xxxx (probably in 2010 but the full date was not specified in the vaccination card) and a second dose of GARDASIL, batch number NN25310, on 21-Sep-2010. It is noteworthy that the Health Authorities coded disability as seriousness criteria. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as C2 S1 I1 according to the method of assessment. Upon medical review, the company added the coding wrong route of administration and vaccination error.


VAERS ID: 583850 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-12-06
Onset:2010-12-06
   Days after vaccination:0
Submitted: 2015-06-26
   Days after onset:1662
Entered: 2015-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN01990 / 2 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Dizziness, Dysmenorrhoea, Fatigue, Headache, Nausea, Post viral fatigue syndrome
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular 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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1506IRL012914

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control #E2015-07057) on 24-JUN-2015. Serious case received from the HPRA under reference IE HPRA 2015-023820 on 19/Jun/2015. This case is not medically confirmed. This case is linked to E2015-07056 and E2015-07067 as the patient was the same. A 14-year-old female patient, with medical history an injection of GARDASIL, batch number NM11420, in left arm, dose 1, route not reported, on the 01/Oct/2010, no concomitant medication reported, received and injection of GARDASIL, batch number reported as NN01990, in left arm dose 2, and route not reported, on the 06/Dec/2010. On 06/Dec/2010, within minutes, the patient experienced dizzy/lightheaded/felt faint. The reporter enclosed a copy of a letter from a sleep specialist that the patient was referred to: the letter stated that the patient also experienced tiredness, was feeling weak, headaches, nausea, period type pains in abdomen. On unspecified date in 2013, a diagnostic of myalgic encephalomyelitis and the doctor who made the diagnostic felt that the patient would improve with time. At this time of the reporting the outcome was not recovered. The Agency considered the case serious for disability and other medically significant reasons. Upon internal review the adverse event myalgic encephalomyelitis was added.


VAERS ID: 583915 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-04-01
Onset:2011-04-01
   Days after vaccination:0
Submitted: 2015-06-26
   Days after onset:1547
Entered: 2015-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN10800 / 3 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Activated partial thromboplastin time shortened, Alanine aminotransferase normal, Asthenia, Basophil count, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood creatinine normal, Blood glucose increased, Blood iron normal, Blood lactate dehydrogenase increased, Blood sodium normal, Blood thyroid stimulating hormone decreased, Blood urea normal, Disturbance in attention, Dizziness, Educational problem, Eosinophil count, Eye disorder, Fatigue, Feeling abnormal, Fibromyalgia, Food intolerance, Gamma-glutamyltransferase normal, Globulin, Haematocrit normal, Headache, Hyperacusis, Iron binding capacity total normal, Lacrimation disorder, Lymphocyte count, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Memory impairment, Monocyte count, Neutrophil count, Nucleated red cells, Ovarian cyst, Pain, Platelet count normal, Post viral fatigue syndrome, Protein total normal, Prothrombin time prolonged, Red blood cell count, Red blood cell sedimentation rate normal, Red cell distribution width, Social avoidant behaviour, Transferrin saturation, Vaccine positive rechallenge, White blood cell count normal
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Corneal disorders (broad), Retinal disorders (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Lacrimal disorders (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Post viral fatigue syndrome; GARDASIL, Abdominal pain; GARDASIL, Nausea; GARDASIL, Headache; GARDASIL, fatigue; GARDASIL, Asthenia; 12/06/2010, GARDASIL, Dizziness; GARDASIL, Asthenia; 10/01/2010, GARDASIL, Dizziness
Allergies:
Diagnostic Lab Data: 01/04/2013, Activated partial thromboplastin time, 29; 01/04/2013, Alanine aminotransferase, 31; 01/04/2013, Basophil count, 0.14; 01/04/2013, Blood albumin, 44; 01/04/2013, Blood alkaline phosphatase, 67; 01/04/2013, Blood bilirubin, 8; 01/04/2013, Blood chloride, 107; 01/04/2013, Blood creatine, 75; 01/04/2013, Blood glucose, 6.8; 01/03/2013, Blood iron, 22; 01/04/2013, Blood lactate dehydrogenase, 194; 01/04/2013, Blood sodium, 139; 01/04/2013, Blood thyroid stimulating hormone, 1.825; 01/04/2013, Blood urea, 5; 01/04/2013, Eosinophil count, 0.14; 01/04/2013, Gamma-glutamyltransferase, 23; 01/04/2013, Globulin, 34; 01/04/2013, Haematocrit, 0.433; 01/04/2013, Haemoglobin, 14.8; 01/03/2013, Iron binding capacity total, 72; 01/03/2013, Iron binding capacity unsaturated, 50; 01/04/2013, Lacrimation disorder, 4.8; 01/04/2013, Lymphocyte count, 2.79; 01/04/2013, Mean cell haemoglobin, 29.8; 01/04/2013, Mean cell haemoglobin concentration, 34.3; 01/04/2013, Mean cell volume, 87; 01/04/2013, Mean cell volume, 87; 01/04/2013, Monocyte count, 0.54; 01/04/2013, Neutrophil count, 3.2; 01/04/2013, Nucleated red cells, 0; 01/04/2013, Platelet count, 331; 01/04/2013, Protein total, 78; 01/04/2013, Prothrombin time, 13; 01/04/2013, Red blood cell count, 11.1; 01/04/2013, Red blood cell sedimentation rate, 16; 01/04/2013, Red cell distribution width, 4.97; 01/03/2013, Transferrin saturation, 31; 01/04/2013, White blood cell count, 6.8;
CDC Split Type: WAES1506IRL013076

Write-up: Serious case received from the RA under reference IE HPRA 2015-023821 on 19/Jun/2015. This case is not medically confirmed. This case is linked to E2015-07057 and E2015-07056 as the patient was the same. A 14-year-old female patient, received an injection of GARDASIL, batch number/ lot number reported as NN10800, in left arm dose 3, and route not reported, on the 01/Apr/2011. On 01/Apr/2011, within minutes, the patient experienced dizzy/lightheaded. The patient also developed headaches, chronic fatigue, fibromyalgia, ovarian cyst, pain, eye disturbances, noise sensitivity, food intolerance, poor short term memory, poor concentration/foggy brain, myalgic encephalomyelitis. The patient was unable to function like a normal girl of her age. The patient had received very little education since and was unable to go to school at all. Social interaction were minimal. Most of the day were spent in bed or sofa. The patient loved to play basketball, cycle, and row with high hopes and a bright future. Corrective treatment included bed rest. Laboratory tests are available for 3/Jan/2013 and 4/Jan/2013 (please see lab comments). Medical history was: dose 1 of GARDASIL, batch number NM114200 in left arm, series and route not reported, on the 01/Oct/2010 after which the patient was dizzy/lightheaded, weak. The patient received GARDASIL, batch number NN01990, in left arm dose 2, and route not reported, on the 06/Dec/2010 after which the patient experienced dizzy/lightheaded/felt faint, tiredness, was feeling weak, headaches, nausea, period type pains in abdomen. In 2013, a doctor diagnosed the patient with myalgic encephalomyelitis. The patient had positive rechallenge compared to dose 2 to the events: headaches, dizzy/lightheaded. At this time of the reporting the outcome was not recovered. The RA considered this case serious for disability and other medically significant reasons.


VAERS ID: 583782 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-04-17
Onset:2012-04-17
   Days after vaccination:0
Submitted: 2015-06-29
   Days after onset:1168
Entered: 2015-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Cataplexy, Disturbance in attention, Dizziness, Educational problem, Fall, Fatigue, Injection site swelling, Menstruation irregular, Mood swings, Photophobia, Pyrexia, Wheelchair user
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Fertility disorders (broad), Arthritis (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: Petit mal epilepsy; Attention deficit/hyperactivity disorder; Dyslexia; Asperger''s disorder; Ehlers-Danlos syndrome
Allergies:
Diagnostic Lab Data: On 17-APR-2012, the patient experienced fever, body temperature increased.
CDC Split Type: WAES1506IRL014089

Write-up: Information has been received from Sanofi Pasteur MSD (MFR control no IE-1577272925-E2015-07389) as part of business agreement on 26-JUN-2015. This case was received from the health authority on 22-Jun-2015. Ref IE-HPRA-2015-023835. This case is not medically confirmed as the reporter was a consumer. A 14 year old female patient (68kg) with a medical history of Ehlers-Danlos syndrome, Asperger''s disorder, dyslexia, attention deficit/hyperactivity disorder, petit mal epilepsy, received three doses of GARDASIL (batch/lot number was reported as NN33040, expiry date was unknown, batch/lot number G005669, expiry date 31-JUL-2013 and batch/lot number was reported as G01934, expiration date was unknown), route and site not reported, on 28-Sep-2011, an unreported date, and 17-Apr-2012. On 17-Apr-2012, post vaccination, the patient experienced swelling at the injection site, fever, cataplexy, chronic fatigue, abdominal pain, joint pain, poor concentration, change in periods, mood swings, dizziness and light sensitivity. The patient was treated with sertraline for cataplexy. The reporter indicated that the patient required a wheelchair when her symptoms were bad. The patient had been unable to finish school and had been turned down by the national learning network as a health and safety risk due to the number of falls she had due to cataplexy. At the time of reporting the patient''s symptoms were persisting. The RA considered the events to be serious due to disability and medically important event.


VAERS ID: 583787 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-10-01
Submitted: 2015-06-29
   Days after onset:271
Entered: 2015-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK AR / SYR

Administered by: Other       Purchased by: Other
Symptoms: Complex regional pain syndrome, Injection site reaction, Laceration
SMQs:, Accidents and injuries (narrow), 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: Cetirizine hydrochloride; NASONEX; VENTOLIN
Current Illness: Immunisation; Failure to thrive; Asthma, The patient had asthma and failure to thrive
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1506GBR014077

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer # GB-1577272925-E2015-07370) on 26-JUN-2015. Serious case received from the HA under reference GB MHRA ADR 23023936 on 22/Jun/2015. This case is medically confirmed as the reporter was a physician. A 14-year-old female patient, with medical history of asthma and failure to thrive, concomitant medication reported as cetirizine 1DF daily, NASONEX 2 DF daily, VENTOLIN 2 DF daily, received an injection of GARDASIL, (batch number not reported), series site and route not reported, on unreported date. On 01-OCT-2014, the patient experienced complex regional pain syndrome. The reporter mentioned that algodystrophy seemed triggered. Initially started in the arm of the injection site but subsequently a cut has caused similar problems on the other side and progressed to legs. The reporter mentioned that the hospital had never seen this before. At this time of the reporting the outcome was not recovered. The MHRA considered the case serious for disability reasons.


VAERS ID: 585756 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2010-05-15
Submitted: 2015-07-14
   Days after onset:1886
Entered: 2015-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain lower, Abdominal pain upper, Allodynia, Cognitive disorder, Dizziness, Dysuria, Fatigue, Headache, Infectious mononucleosis, Menstrual disorder, Muscular weakness, Orthostatic intolerance, Pain, Palpitations, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular 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: No other medications
Current Illness: Immunisation
Preexisting Conditions: Mononucleosis syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1507DNK005533

Write-up: Initial information has been received from Sanofi Pasteur MSD (reference No. DK-1577272925-E2015-08060) on 08-JUL-2015 as a part of a business agreement. Case received from health care professional via Health Authorities on 08-JUL-2015 under the reference numbers DK-DKMA-ADR 23057185 and DK-DKMA-EFO12621. The primary reporter was a physician. A 14 year old female patient (weight: 60 kg; height: 174 cm) with a medical history of mononucleosis, had received unspecified doses of GARDASIL (batch/lot number not reported) via i.m route of administration in unspecified site of administration on unspecified date in 2009-2010 and later on 15-MAY-2010 she developed orthostatic intolerance, headache, dizziness, muscle weakness, fatigue extreme, general body pain and sleep disorder. The physician cannot provide the vaccination dates. The patient reports that sleep disorder, headache, general body pain, dizziness and muscle weakness started in the pre-summer of 2010 (the physician has reported 15-MAY-2010 estimated together with the patient). Significantly worsening of symptoms and new ones developed in connection with mononucleosis in 2013. The patient also has other symptoms which are recognizable from other patient with suspect adverse events due to GARDASIL; menstrual disturbances, severe lower abdomen pain, allodynia, palpitations, stomach pain, urination problems, cognitive dysfunction etc. However, as the patient is not certain if these symptoms have developed after mononucleosis, why they are not reported as suspect events. Other vaccines or medicines: unknown. At the time of reporting, the patient had not yet recovered.


VAERS ID: 586833 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-06-06
Onset:2015-03-05
   Days after vaccination:272
Submitted: 2015-07-22
   Days after onset:138
Entered: 2015-07-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003267 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Complex regional pain syndrome, Disability, Nuclear magnetic resonance imaging, Ultrasound scan, X-ray
SMQs:

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: WAES1507DNK009526

Write-up: Information has been received from SPMSD (case report # DK-1577272925-E2015-08295) on 20-JUL-2015. Case received from consumer via Health Authorities on 16-JUL-2015 under the reference number DK-DKMA-ADR 23069964 and DK-DKMA-WBS-0000421. The primary reporter was a consumer. A 15 years-old female patient (weight: 55 kg; height: 172 cm) with no health problems in general, had received two doses of GARDASIL, batch number J003267, J003267 both with expiration date of 30-JUN-2015 via i.m route of administration in unspecified site of administration on 16-JAN-2014 and 06-JUN-2014 and later on 05-MAR-2015 she developed CRPS/reflex dystrophy in left foot. The patient have received the following treatment to treat the adverse event: physiotherapy, craniosacral therapy, hypnosis, vitamins and massage. The patient has not been hospitalized due to the adverse event and no other medicines. The patient has performed many blood tests, several times, X-ray, ultrasound, MRI-scan and has been examined by orthopedic surgeons and at the pediatric department. Test results not provided. On 15-JUL-2015 the Agency received follow up information from a physician (duplicate DK-DKMA-ADR 23072732/DK-DKMA-WBS-0000456) which has not been sent to Sanofi Pasteur MSD before the initial report. The physician report reflex dystrophy in left foot and disability. No more information provided. At the time of reporting, the patient had not yet recovered.


VAERS ID: 607306 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-09-12
Onset:0000-00-00
Submitted: 2015-08-12
Entered: 2015-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Asthenia, Asthenopia, Chest pain, Condition aggravated, Confusional state, Constipation, Crying, Decreased appetite, Depression, Diarrhoea, Disturbance in attention, Dizziness, Dyspepsia, Dysphagia, Dysphonia, Dyspnoea, Ear discomfort, Eye pain, Eyelid oedema, Fatigue, Feeling drunk, Gait disturbance, Genital pain, Headache, Hot flush, Hypersensitivity, Injection site pain, Insomnia, Learning disability, Malaise, Memory impairment, Mental disorder, Mood swings, Nausea, Oesophageal pain, Oropharyngeal pain, Pain, Paraesthesia, Skin disorder, Sleep disorder, Stress, Tinnitus, Tremor, Vision blurred
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (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 (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; 2006, Migraine; 2006, Headache
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508DNK004426

Write-up: Information has been received from Sanofi Pasteur MSD (reference No. DK-1577272925-E2015-09105) as a part of a business agreement on 11-AUG-2015. Case received from health professional via Health Authorities on 06-Aug-2015 under the reference number DK-DKMA-ADR 23093310 and DK-DKMA-WBS-0000581. The primary reporter was physician. A 14-years-old female patient (weight: 73kg; height: 168cm) with a medical history of headache and migraine, had received three doses of GARDASIL, batch/lot number not reported for dose 1 and 3 and NG43420 for dose 2 via im. route of administration in not reported site of administration on 14-Mar-2008, 09-May-2008 and 12-Sep-2008 and later on 30-Nov-2008 she developed abdominal pain (abdominal cramp tender in abdominal pain in abdomen), headache (pain in head pain cranial pain) (aggravated) and stress (easy stressed) and on unspecified date concentration problems, learning difficulties, very bad memory cannot remember much, cannot cope handle several things at the same time cannot cope manage much, pain in eyes, heavy eyelid, swollen eyelid, blurred vision, difficult focusing, pressures in ear, diarrhoea, constipation, difficult swallowing, pain in esophagus, pain in throat, genital pain, chest pain, unsteady walking, sleeplessness, sleep problems, easy to cry, mental unstable, mood swings, periodic tinnitus, heartburn, hoarseness, pain when looking up to the side, turn the head, shock throughout the body and head every time in whole body, tenderness at the injection site, very unclean skin and ugly skin, severe red stribes, patches and marks, migraine aggravation, raising on skin, malaise, feeling ill, feeling that she has been very hard affected by the disease, dizziness, almost constant feeling of sensitivity, shoulder pain, pain in neck, pain in back, unnormal tiredness lack of energy and tired, weakness in hands, fingers, and arms, shaking hands and arms, tingling pricken sensation in body, muscle pain, joint pain, pain in knee, nausea, strong menstrual pain, reduces appetite, easy confused, restless in body, restlessness, can never relax properly, restlessness in whole body, feel fast the she get suffocated of warm and bad air constant need of air, feeling drunk, not normal weakness, lack of energy no strengths, depression, pain in legs feet, easy pain in tailor bone and collarbone, have it really bad constantly. The physician reports that some of the symptoms were present before vaccination but got worse. The physician had reported the following reactions: headache, abdominal pain, and stress. In addition the physician informs that the patient says that she has experienced the reported reactions. The dates and symptoms are fictive, as the symptoms have come continuously during the years after vaccination. The patient describes that a typical day proceeds with abdominal pain, headache, feeling ill, dizziness, feeling of being hard affected of the disease, lack of energy and tired, hot flushes, too hot all the time, constant need of air, feel fast the she get suffocated of warm and bad air, almost constant feeling of fainting, feeling drunk, tingling and restlessness in body, restless, cannot figure out how to relax, cannot handle, manage, remember very much. Need to fight every day to be able to keep something out. Have constantly and continuously it very bad. Has very hard to attend school and work. Have many sick days. Has very hard to concentrate and to learning. Never experiences a normal day with normal health. The patient has been thoroughly examined for abdominal pain with blood test and hospital evaluation. The patient has a medical history of headache and migraine since 2006. At the time of reporting, the patient had recovered from depression not recovered for headache abdominal pain and stress and unknown for all others. The case has been considered as serious according to the disability criteria.


VAERS ID: 607485 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-01-21
Onset:2009-04-01
   Days after vaccination:70
Submitted: 2015-08-18
   Days after onset:2330
Entered: 2015-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood count, Dizziness, Electroencephalogram, Fatigue, Headache, Sensory disturbance, Syncope, Tilt table test
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Seasonal allergy; Seasonal allergy
Preexisting Conditions: 10/22/2008, GARDASIL
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1508DNK006061

Write-up: Information has been received from Sanofi Pasteur MSD (reference # DK-1577272925-E2015-09222) on 13-AUG-2015. Case received from health care professional via Health Authorities on 11-Aug-2015 under the reference numbers DK-DKMA-ADR 23101039 and DK-DKMA-WBS-0000640. The primary reporter was a physician. A 14 year-old female patient (weight: 72 kg; height: 172 cm) had received unspecified dose of GARDASIL, batch number not noted via i.m route of administration in unspecified site of administration on 21-Jan-2009 and later on 01-Apr-2009 she developed headache, severe tiredness, fainting, dizziness and in 2015 at times sensory disturbance in the fingers. Dose 1 of GARDASIL (batch number not noted) has been administered via i.m route and unspecified site of administration 22-Oct-2008. The patient has a medical history of grass allergy and birch pollen allergy and she has repeatedly fell off a horse. Laboratory tests and examinations: blood count, EEG and heart examination with TILT test (test results not reported). The patient has received physiotherapy. Other vaccines: unknown. The batch numbers are not noted. At the time of reporting, the outcome for at times sensory disturbance in the fingers was unknown, whereas not recovered from all other events.


VAERS ID: 609309 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-09-01
Onset:2009-10-12
   Days after vaccination:41
Submitted: 2015-09-14
   Days after onset:2163
Entered: 2015-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Feeling hot, Hypoaesthesia, Narcolepsy, Peripheral coldness, Sensory disturbance, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (narrow), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: 06/29/2009 to 06/29/2009, GARDASIL, D1 Batch # NK05560, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1509DNK006919

Write-up: Information has been received from Sanofi Pasteur MSD (reference # DK-1577272925-E2015-10098) on 11-SEP-2015. Case received from Health Care Professional via Health Authorities on 07-SEP-2015 under the reference numbers DK-DKMA-ADR 23137216 and DK-DKMA-WBS-0000915. The case is medically confirmed. The primary reporter was a physician. A 14-year old female patient (weight: 80 kg; height: 170 cm) had received the second and third dose of GARDASIL, (batch numbers: not reported) via intramuscular route of administration in unspecified site of administration on 01-SEP-2009 and 06-JAN-2010. On 12-OCT-2009, she developed fainting. On 01-JUL-2010, she developed narcolepsy, abnormal sensation in leg, warm hands and warm sensation in the head, numb sensation in leg and cold hands. The patient received all three vaccines, during that period the physician and patient did not have suspicion of adverse reactions. The patient has been hospitalized with fainting and evaluated at neurological department for narcolepsy. The case is serious due to seriousness criteria hospitalization and disability. No other medications. No information on other vaccines provided. The patient has undergone a long investigational procedure at the neurological department in regards to narcolepsy. Was hospitalized in isolation in 2009 in regards to the fainting (not further specified). No information on medical history provided. Previous dose of GARDASIL (D1, batch number: NK05560, lot # 0773X, expiry date 16-JUN-2011) was given via IM route of administration in unspecified site of administration on 29-JUN-2009. At the time of reporting, the patient had not recovered.


VAERS ID: 613640 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-06-15
Onset:2009-08-01
   Days after vaccination:47
Submitted: 2015-10-05
   Days after onset:2256
Entered: 2015-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypnagogic hallucination, Lumbar puncture, Narcolepsy, Sleep paralysis
SMQs:, Convulsions (broad), Psychosis and psychotic disorders (narrow), Generalised convulsive seizures following immunisation (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: GARDASIL, immunisation; GARDASIL, immunisation
Allergies:
Diagnostic Lab Data: Lumbar puncture (unknown date): awaiting for response
CDC Split Type: WAES1510DNK001000

Write-up: Information has been received from Sanofi Pasteur MSD (reference No. DK-1577272925-E2015-10811) as a part of a business agreement on 01-OCT-2015. Case received from Health Care Professional via Health Authorities on 29-SEP-2015 under the reference number DK-DKMA-ADR 23166827 and DK-DKMA-WBS-0001156. The case is medically confirmed. The primary reporter was a physician. A 14-year old female patient had received the third dose of the GARDASIL (batch number: not reported) via intramuscular route of administration in unspecified site of administration on 15-Jun-2009 and later on 01-Aug-2009, she developed narcolepsy. On unspecified day in Aug-2009, she developed hypnagogic hallucinations and sleep paralysis. 15-Jun-2009 third dose of GARDASIL, unknown when the patient received the 1st and 2nd dose. Aug-2009 symptoms of narcolepsy with hypnagogic hallucinations and sleep paralysis. Long progression at psychiatrist, which means that the symptoms are of psychiatric character. 2015 referred to sleep clinic, where the sleep analysis is consistent with narcolepsy. The case is serious due to seriousness criterion disability. No other medications. No information on other vaccines provided. The patient has undergone sleep analysis, which was consistent with narcolepsy. Awaiting results of lumbar puncture (not further specified). Previous doses of GARDASIL (D1-D2, batch numbers not reported) were given via I.M. route of administration in unspecified site of administration on not reported dates. No other information on medical history provided. At the time of reporting, the outcome was unknown for the reactions hypnagogic hallucinations and sleep paralysis. The patient had not recovered from narcolepsy.


VAERS ID: 614227 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-06-30
Submitted: 2015-10-21
   Days after onset:478
Entered: 2015-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Electroencephalogram normal, Fatigue, Gastrooesophageal reflux disease, Headache, Investigation, Malaise, Monoplegia, Muscle spasms, Muscle twitching, Seizure, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Screening test (unknown date): multiple all normal. Electroencephalogram, epilepsy was ruled out; Investigation, multiple all normal
CDC Split Type: WAES1510GBR009045

Write-up: Information has been received from Sanofi Pasteur MDS (manufacturer control number E2015-11420) on 19-OCT-2015. This case was received from the health authority on 15-Oct-2015. Ref GB-MHRA-ADR 23177890. This case is not medically confirmed as the reporter was a consumer. A 14 year old female patient received an injection of GARDASIL, batch number not reported, route and site not reported, on an unreported date. On 30-Jun-2014, post vaccination, the patient experienced vomiting (three months), severe headache, she was investigated for a brain tumor, fatigue, admitted to hospital with chronic back pain, seizures, spasms and paralysis of leg. Following the vaccine the patient suffered sickness, spasm reflux up to 25 times a day for three months. This continued for four months. The patient was admitted back into hospital for 10 days with severe back pain. Multiple diagnostic tests were all normal. Recently the back pain continues alongside spasms, twitching and seizures. Epilepsy was ruled out after electroencephalogram. Continuing worsening symptoms and possible complex regional pain syndrome (CRPS) following vaccination. It resulted in repeated admissions to hospital - all common tests normal but continued ill health. At the time of reporting the patient had not yet recovered. The reporter considered the events to be serious due to hospitalisation, disability and medically significant. Upon internal medical review the event of CRPS was coded.


VAERS ID: 614233 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2015-09-08
Onset:2015-09-27
   Days after vaccination:19
Submitted: 2015-10-21
   Days after onset:24
Entered: 2015-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K006781 / 2 UN / UN
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Back pain, Fatigue, Henoch-Schonlein purpura, Malaise, Myalgia, Nausea, Pain, Purpura, Tearfulness
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vasculitis (narrow), Hypersensitivity (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Loperamide; mebeverine
Current Illness: Food allergy
Preexisting Conditions: 2010, Pain; Hypotonia; 2010, Diarrhoea; Bronchiolitis; 2010, Abdominal distension, The patient had a history of bloating, diarrhoea and pain in 2010, and bronchiolitis, hypotonia and allergy to gluten; BECOTIDE; albuterol, The patient had previously received salbutamol and BECOTIDE for unknown indications. The patient''s mother had a history of multiple miscarriages and had taken aspirin and folic acid.
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1510GBR009331

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR Control No: GB-1577272925-E2015-11397) on 19-OCT-2015. This case was received from the health authority on 15-Oct-2015 and 16-Oct-2015. Ref GB-MHRA-ADR 23178687 and GB-MHRA-ADR 23178064. This case is medically confirmed. A 14 year old female patient (67 kg) who was taking concomitant loperamide and mebeverine for unknown indications received an injection of GARDASIL, (batch number K006781, expiry 01-2017), route and site not reported, on 08-Sep-2015. On 08-Sep-2015, the day of vaccination, the patient developed left loin pain (the patient described as back pain). It resolved over the weekend so the parents didn''t take her to the GP. The patient was then under the weather (clingy and tearful) for a couple of weeks but not unwell enough to go to the GP. She developed intermittent abdominal pain which is continuing. This was followed by nausea and fatigue and she then developed a purpuric rash and was seen as an emergency by the GP and paediatrician and diagnosed with Henoch Schonlein purpura on 27-SEP-2015. The patient has been in bed almost the whole time since then. She has been extremely fatigued - she can get up for about an hour and then has to lie down and rest/sleep. She developed muscle pain in her upper arm which hurts when she tries to reach for or lift even light items. The patient''s parents thought she may have had appendicitis. The HCP stated that the patient remains very unwell with severe fatigue, abdominal pain, nausea and muscular pain in her right arm when elevating. The patient had a history of bloating, diarrhoea and pain in 2010, and bronchiolitis, hypotonia and allergy to gluten. The patient had previously received salbutamol and BECOTIDE for unknown indications. The patient''s mother had a history of multiple miscarriages and had taken aspirin and folic acid. At the time of reporting the outcome of clingy, tearful was unknown, the patient recovered from loin pain on an unreported date and had not recovered from the other events. The events were considered serious due to hospitalisation, disability and medically significant.


VAERS ID: 614325 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-11-12
Onset:0000-00-00
Submitted: 2015-10-23
Entered: 2015-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Headache, Migraine, Oesophagitis, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular 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: No other medications
Current Illness: Immunisation; Eczema; Seasonal allergy; Tobacco user
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1510DNK010670

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # E2015-11556) on 22-OCT-2015. Case received from Health Care Professional via Health Authorities on 19-Oct-2015 under the reference number DK-DKMA-ADR 23194204. The case is medically confirmed. The primary reporter was a physician. A 14-year-old female patient (weight: 75 kg; height: 175 cm), with a medical history of smoker, hay fever and eczema, had received the first dose of GARDASIL, (batch number unknown) via intramuscular route of administration in unspecified site of administration on 12-Nov-2008 and later on unspecified day in Nov-2008, she developed migraine, chronic headaches, esophagitis, dizziness and vomiting. HPV-vaccinated in Nov-2008 and develops the same month headache, dizziness and vomiting. The headache is now daily. In addition migraine tendency and esophagitis, which the patient did not have before the HPV vaccinations. The case is serious due to seriousness criterion disability. No other medications or vaccines. No examinations or laboratory tests have been performed. At the time of reporting, the patient had not recovered.


VAERS ID: 614393 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-09-14
Onset:2011-01-27
   Days after vaccination:135
Submitted: 2015-10-27
   Days after onset:1733
Entered: 2015-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Blepharospasm, Dyskinesia, Fatigue, Feeling cold, Headache, Loss of consciousness, Muscle spasms, Myalgia, Nightmare, Quality of life decreased, Seizure, Sleep disorder
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (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), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1510IRL012157

Write-up: Information has been received from Sanofi Pasteur MSD (reference No. IE-1577272925-E2015-11728) as a part of a business agreement on 23-OCT-2015. This serious AE case was reported by the HPRA, on 21/Oct/2015. IE-HPRA-2015-024850. This case is not medically confirmed as it was reported by a consumer. A 14 year-old female patient, with no previous medical history reported as a healthy teenager, received two injections of GARDASIL, batch/lot No. and expiration date were not reported, route and site series not reported, dose 1 on 14/Sep/2010 and dose 2, on 14/Mar/2012. Following the vaccination, on 27/Jan/2011 patient''s problems started. Patient initially presented with muscle pain, chronic fatigue, and muscle spasms, eye flickering and full blown seizures. Patient also experienced muscle jerks, headaches, black outs, broken sleep, vivid night mares and feeling cold. Patient received unspecified epilepsy medication. At the time of reporting the patient''s synptoms were persisting. The reporter added that since receiving GARDASIL, the patient''s life has changed dramatically. She suffers daily, which ultimately limits her life choices, her achievements, her goals, her milestones and her future. At the time of reporting the outcome of the AEs were reported as not recovered. The HPRA considers this case as serious as life threatening, patient disability/incapacity, patient hospitalization and other medically significant event.


VAERS ID: 615455 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-04
Entered: 2015-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Fatigue, Functional gastrointestinal disorder
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: ELTROXIN
Current Illness: Immunisation
Preexisting Conditions: Hydrocephalus; Thyroid disorder; Growth retardation; Astrocytoma, low grade; 09/10/2014, GARDASIL, first dose
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1511IRL001857

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # E2015-12163) as part of business agreement on 03-NOV-2015. This case was received from the health authority on 29-Oct-2015. Ref IE-HPRA-2015-024908. This case is not medically confirmed as the reporter is a consumer. A 14 year old female patient with a history of pilocytic astrocytoma, growth retardation, thyroid disorder and hydrocephalus, and taking ELTROXIN for an unknown indication, and who received dose one of GARDASIL (batch number not reported) on 10-Sep-2014, received dose two of GARDASIL, (batch number not reported), routes and sites not reported, 0.5 mls, on an unreported date. On an unreported date, post vaccination, the patient began to experience fatigue. The patient spent all the following Summer in bed with fatigue and also experienced stomach and bowel problems at the time. The patient could not stay up past 7.30 every evening due to exhaustion. The patient subsequently received the third dose of GARDASIL on 24-Mar-2015. At the time of reporting the patient had not yet recovered. The reporter considered the events to be serious due to disability.


VAERS ID: 619484 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2014-11-26
Onset:0000-00-00
Submitted: 2015-12-14
Entered: 2015-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H013055 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Loss of personal independence in daily activities, Malaise, Pain, Post viral fatigue syndrome, Rheumatoid factor positive
SMQs:, Dementia (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: CIRCADIN; gabapentin; melatonin; acetaminophen (+) codeine phosphate; Amitriptyline Hydrochloride; ibuprofen
Current Illness: Immunisation
Preexisting Conditions: Rheumatoid factor positive, Persistance presence of a positive high rheumatoid factor in recent blood tests; Hypersensitivity
Allergies:
Diagnostic Lab Data: Rheumatoid factor (ate not provided):positive; Weight (2014): under 6.5 stone
CDC Split Type: WAES1512GBR005584

Write-up: This spontaneous report as received from a patient''s mother via Agency (ADR 23256758) refers to a 14 year old female patient. The patient''s medical history included hypersensitivity and rheumatoid factor positive. On 26-NOV-2014, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) lot # H013055 (expiration date and dose were not reported), parenteral for human papilloma virus immunization. Concomitant therapies included CIRCADIN, gabapentin, melatonin, acetaminophen, co-codamol, amitriptyline hydrochloride (manufacturer unknown) and ibuprofen. On an unknown date, the patient experience myalgic encephalomyelitis, chronic pain and generalized illness. The patient was unable to get of bed, she stopped school, learning and everyday activities. On an unknown date, the patient was hospitalized (reported as "is no in full-time hospital"). Lab diagnostic studies showed persistence presence of a positive high rheumatoid factor in recent blood tests. The outcome of adverse events was reported as not recovered. The relatedness between adverse events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine)manufacturer unknown) was not reported. The reported considered events of myalgic encephalomyelitis, chronic pain and generalized illness as medically significant, life threatening and disability. Additional information is not expected since no further follow up information can be obtained from Local Health Authority. Agency narrative: My daughter had no experienced myalgic encephalomyelitis after taking the vaccination, she is very ill and is now in full-time hospital. My daughter had hypersensitivity and was at a weight which was under 6.5 stone, which seems dangerous to give the vaccine. She is unable to get of bed, stopped school and learning, everyday activities have stopped. Her body is now at the age of an old woman. Chronic pain.


VAERS ID: 619802 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-09-01
Onset:2009-09-01
   Days after vaccination:0
Submitted: 2015-12-18
   Days after onset:2299
Entered: 2015-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Acne, Angiopathy, Cognitive disorder, Condition aggravated, Dizziness, Fatigue, Headache, Hyperacusis, Hypertension, Laboratory test normal, Muscular weakness, Nausea, Peripheral coldness
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hearing impairment (narrow), Vestibular 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: Immunisation; Headache, already had headaches after prev. concussion
Preexisting Conditions: Concussion
Allergies:
Diagnostic Lab Data: Laboratory test, she dose not fulfill the criteria for postural orth
CDC Split Type: WAES1512DNK009441

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # 2015001032) on 17-DEC-2015. Case received from a physician via health authority on 15-DEC-2015 under reference number DK-DKMA-WBS-0002035. A 14-year-old female adolescent patient received GARDASIL, (batch number unknown, Dose 1) via intramuscular route in Mar-2009, GARDASIL, (batch number unknown, Dose 2) via intramuscular route in May-2009, GARDASIL, (batch number unknown, Dose 3) via intramuscular route in Sep-2009. The patient experienced Headache (except migraine) aggravated in SEP-2009, Vascular abnormalities on an unknown date, Dizziness on an unknown date, Nausea on an unknown date, Abdominal pain on an unknown date, Acne on an unknown date, Fatigue on an unknown date, Cognitive disorder on an unknown date, Limb weakness on an unknown date, Sound sensitivity on an unknown date and cold hands and feets on an unknown date. Patient reports that she first developed aggravated headache (already had headaches after prev. concussion), thereafter she developed cold hands and feet. The departments investigations shows that she does not fulfill the diagnostic criteria for POTS., but she has a significant initial hypertension. Other medicines or vaccines: unknown. The patient had a medical history of: Headache -Concussion. The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 619982 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-22
Entered: 2015-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Central nervous system inflammation, Hypoaesthesia, Myelitis transverse
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1512DEU010595

Write-up: Information has been received from Sanofi Pasteur MSD (reference # DE-1577272925-2015001134) on 18-DEC-2015. Case was received from a lawyer on 15-Dec-2015. This case was mentioned in a lay press. A 14-year-old female adolescent patient received GARDASIL, (batch number unknown) in 2014. Four weeks later the girl developed back pain in the morning. During the trip to school the pain worsened and suddenly her legs were deaf. The patient was hospitalized. The numbness from the chest downward alerts the physician. After several examinations the physician diagnosed transverse myelitis (inflammation of the central nervous system). The gynecologist could not said, if this disease have already been drowses in the patient or if the vaccination was the cause of the occurrence of the disease. The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 620207 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-08
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 pain, Arthralgia, Back pain, Decreased activity, Dizziness, Dyspnoea, General physical health deterioration, Headache, Infection, Influenza, Influenza like illness, Insomnia, Muscular weakness, Nausea, Orthostatic intolerance, Pain, Photophobia, Pneumonia, Presyncope, Tic, Tilt table test positive, Tonsillitis
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dyskinesia (broad), Dystonia (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (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), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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: HPV immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: At the border to meet the diagnostic criteria for POTS after a tilt table test.
CDC Split Type: WAES1512DNK011741

Write-up: Information has been received from Sanofi Pasteur MSD (MFR number # DK-1577272925-2015001185) on 22-DEC-2015. Case received from a physician on 17-DEC-2015 via the Agency under the case identification number DK-DKMA-WBS-0002050. A 13-year-old female adolescent patient received GARDASIL, (batch number unknown, Dose 1) via intramuscular route on 01-NOV-2010. Other suspect products included: GARDASIL, (batch number unknown, Dose 2) administrated via intramuscular route on 21-Mar-2011. GARDASIL, (batch number unknown, Dose 3) administered via intramuscular route on 08-SEP-2011. The patient experienced Influenza relapse / often influenza-like symptoms on an unknown date, Tonsillitis acute on an unknown date, Pneumonia on an unknown date, Orthostatic intolerance on an unknown date, Near syncope 27-NOV-2013, Headache on an unknown date, General body pain on an unknown date, Joint pain on an unknown date, Dizziness on an unknown date, Nausea on an unknown date, Acne on back on an unknown date, Dyspnea on an unknown date, Sleep difficult on an unknown date, tics eye on an unknown date, Muscle weakness generalized on an unknown date, Abdominal pain on an unknown date, Light sensitivity to eye on an unknown date, Recurrent infections on an unknown date, 6 months after dose 1 trouble with physical activity in 2011/5 months post injection and Reduced general condition on an unknown date. Other vaccines or medicines: unknown. At the border to meet the criteria for POTS after a tilt table test.


VAERS ID: 619741 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-11-26
Onset:0000-00-00
Submitted: 2015-12-24
Entered: 2015-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Chest pain, Constipation, Diarrhoea, Dizziness, Dry mouth, Dysuria, Fatigue, Headache, Muscle twitching, Muscular weakness, Myalgia, Nausea, Neuralgia, Palpitations, Postural orthostatic tachycardia syndrome, Presyncope, Skin disorder, Sleep disorder, Tilt table test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Dyskinesia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (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: Tilt table test, at Hospital, showed POTS, but with good blood pressure regulation
CDC Split Type: WAES1512DNK011688

Write-up: Information has been received from Sanofi Pasteur MSD (MFR Control number DK-1577272925-2015001272) on 22-DEC-2015. Case received from a physician via HA on 19-Dec-2015, under the reference number DK-DKMA-WBS-0002126 and DK-DKMA-ADR 23278249. A 15-year-old female adolescent patient received GARDASIL, (batch number unknown, Dose 1) via intramuscular route on 28-May-2010, GARDASIL, (batch number unknown, Dose 2) via intramuscular route on 18-Aug-2010, GARDASIL, (batch number unknown, Dose 3) via intramuscular route on 26-Nov-2010. The patient experienced Dizziness in 2012, Headache in 2012, Chest pain on an unknown date, Muscle pain in the arm on an unknown date, Neuropathic pain on an unknown date, Near syncope on an unknown date, Palpitation on an unknown date, Nausea on an unknown date, Abdominal pain on an unknown date, Voiding difficulty on an unknown date, Skin disorder on an unknown date, Sleep disorder on an unknown date, Fatigue on an unknown date, limb weakness on an unknown date, Dry mouth on an unknown date, Diarrhea on an unknown date, Obstipation on an unknown date, twitching in arms in 2012 and POTS on an unknown date. The patient describes that she in 2012 started experiencing dizziness, twitching in arms and headache. Tilt table test, at hospital, showed POTS, but with good blood pressure regulation. The center uses the following criteria to confirm the diagnosis 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, an additional criteria is used in patients between 12-19 years old: 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. This additional criterion is used to avoid false positives. Unknown whether there were other vaccines or medications. Dizziness, headache, chest pain, neuropathic pain, near syncope, palpitation, nausea, abdominal pain, voiding difficulty, skin disorder, sleep disorder, fatigue, dry mouth, diarrhea, obstipation, muscle pain in the arm, limb weakness, paresthesia upper limb. Tilt table test, at Hospital, showed POTS, but with good blood pressure regulation. At the time of reporting, the outcome was unknown for the reactions chest pain and twitching in arms. The patient had not recovered from the other reactions.


VAERS ID: 619758 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-06-16
Onset:0000-00-00
Submitted: 2015-12-24
Entered: 2015-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NK05560 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Dyspnoea, Dysuria, Eczema, Fatigue, Headache, Increased tendency to bruise, Muscle spasms, Muscular weakness, Myalgia, Orthostatic intolerance, Tilt table test normal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Dystonia (broad), 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), Hypersensitivity (narrow), 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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: HPV immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: A tilt-table test shows no POTS.
CDC Split Type: WAES1512DNK011279

Write-up: Information has been received from Sanofi Pasteur MSD (reference # DK-1577272925-2015001193) on 21-DEC-2015. Muscle pain. Abdominal pain. Fatigue extreme. Headache. Joint pain. Muscle spasms. Orthostatic intolerance. Voiding difficulty. Eczema. Dyspnea. Muscle weakness. Case received from a physician on 17-Dec-2015. A female adolescent patient of unknown age received GARDASIL, (batch/lot number, expiration date unknown) via intramuscular route on 15-Dec-2008. Other suspect products included: GARDASIL, (batch/lot number, expiration date unknown, Dose 2) administered via intramuscular route on 11-Feb-2009; GARDASIL, (batch/lot number, expiration date unknown, Dose 3) administered via intramuscular route on 16-Jun-2009. The patient experienced Muscle pain on an unknown date, Abdominal pain on an unknown date, Fatigue extreme on an unknown date, Headache on an unknown date, Joint pain on an unknown date, Muscle spasms on an unknown date, Orthostatic intolerance on an unknown date, Voiding difficulty on an unknown date, Eczema on an unknown date, Dyspnea on an unknown date, Bruises easily on an unknown date, Muscle weakness on an unknown date. Additional investigations included Tilt Table Test no POTS n/a on an unknown date. The reporter has difficulty to decide the temporal connection between vaccination and start of symptoms. The patient informs abdominal pain is the first symptom she experienced and also the one symptom that she is most troubled by. Maybe symptom start in 2011.


VAERS ID: 620270 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-25
Entered: 2015-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Cognitive disorder, Dyspnoea, Fatigue, Headache, Muscle spasms, Muscular weakness, Palpitations, Postural orthostatic tachycardia syndrome, Sleep disorder, Syncope, Tilt table test positive
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Hypoglycaemia (broad), Dehydration (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; Hepatitis A immunisation; Hepatitis B immunistion
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: POTS during tilt table test
CDC Split Type: WAES1512DNK012324

Write-up: Information has been received from Sanofi Pasteur MSD (MFR number# DK-1577272925-2015001423) on 23-DEC-2015. Case received from a physician via health authority on 22-DEC-2015 under reference number DK-DKMA-WBS-0002135 and DK-DKMA-ADR 23278256. A 14-year-old female adolescent patient received GARDASIL, (batch number unknown , Dose 1) via intramuscular route on 06-OCT-2011, GARDASIL, (batch number unknown, Dose 2) via intramuscular route on 14-DEC-2011, GARDASIL, (batch number unknown, Dose 3) via intramuscular route on 02-MAY-2012. Other suspect products included Hepatitis A Virus, (batch number unknown) in 2014 Hepatitis B Virus, (batch number unknown) in 2014. The patient experienced Postural orthostatic tachycardia syndrome on an unknown date, Headache on an unknown date, Joint pain on an unknown date, Syncope on an unknown date, Palpitations on an unknown date, Abdominal pain on an unknown date, Dyspnea on an unknown date, Sleep disorder on an unknown date, Fatigue extreme on an unknown date, Cognitive disorder on an unknown date, Muscular spasm on an unknown date, muscular weakness on an unknown date and Subfebril on an unknown date. A bit uncertain regarding the timing of the progression HPV vaccinated 2011-2012 and hepatitis A abd B summer 2014. A bit uncertain if the symptoms started before the hepatitis vaccination, but at least the symptoms added/worsen the symptoms after hepatitis vaccination POTS with tilt table test: Criteria for 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 or tachycardia (e.g., active bleeding, acute dehydration, medications) In addition, the Hospital uses further criterion in patients between 12-19 years: requires a heart rate increase of greater than 40 bpm to make the diagnosis, the reasons for this is that young people have stronger physiological heart rate response when standing up. The additional criterion is used to avoid false positives. Other vaccines or medicines: unknown The patient''s outcome was reported as not recovered/not resolved.


VAERS ID: 620620 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2015-02-16
Onset:0000-00-00
Submitted: 2016-01-12
Entered: 2016-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cognitive disorder, Disturbance in attention, Dizziness, Dyskinesia, Dyspnoea, Exercise tolerance decreased, Fatigue, Headache, Hypoaesthesia, Loss of personal independence in daily activities, Musculoskeletal pain, Nausea, Postural orthostatic tachycardia syndrome, Presyncope, Social problem, Syncope, Tic, Tilt table test positive, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (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), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (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: Human papilloma virus immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Fulfills the diagnostic criteria for POTS during tilt table test. Blood pressure measurement, decrease greater than 20/10 mmHg; Heart rate, increases greater than 40 bpm
CDC Split Type: WAES1601DNK002808

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # 2016000050) on 08-JAN-2016. Case received from physician via health Authority on 05-Jan-2016 under reference number DK-DKMA-WBS-0002162. Case received from a physician via health Authority on 05-Jan-2016 under reference number DK-DKMA-WBS-002162. A 13-year-old female adolescent patient received GARDASIL (batch number unknown, Dose 1) via intramuscular route on 08-Oct -2013, GARDASIL (batch number unknown, Dose 2) via intramuscular route on 17-Dec-2013, GARDASIL (batch number J0101618, Dose 3) via intramuscular route on 16-Feb-2015. The patient experienced Can not ride as she did earlier on an unknown date, faints 1-2 times per week on an unknown date, Involuntary muscle movement on an unknown date, Shortness of breath on an unknown date, Nausea on an unknown date, headache in 2013, problem keeping a social network on an unknown date, Postural orthostatic tachycardia syndrome on an unknown date, dizziness in 2015, numb areas in fingers and arms on an unknown date, Exhausted / fatigue on an unknown date, shaking/tics in right hand on an unknown date, near fainting 1-2 times per day on an unknown date, concentration problems on an unknown date, Cognitive disorder on an unknown date, can not go to school on an unknown date and shoulder pain on 07-OCT-2015. The patient''s outcome was reported as Not Recovered/Not Resolved. The HA has received the report from the hospital and another physician. The patient has reported to the center that she was vaccinated 5 times, unknown dates. She describes that the symptom started in 2013, when she developed headache that lasted approximately for a month. In 2015 the headache returned and is now constant, but varies in intensity. Dizziness started also in 2015. She describes that she faint in average 1 time per week. Tilt table test shows that she fulfills the diagnostic criteria for POTS. The patient describes that this has consequences for her, she has problem keeping her social network, and can not go to school and she can not ride as she used to. Until vaccination she was riding 5-6 times per week, 1-1,5 h per time. Diagnostic criteria for 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 the hospital uses further criterion in patients between 12-19 years: requires a heart rate increase of greater than 40 bpm to make the diagnosis, the reasons for this is that young people have a stronger physiological heart rate response when standing up. The additional criterion is used to avoid false positives. Other vaccines or medicines: Not known. The other physician reports the following: headache, dizziness constant, fainting 1-2 times per week, near fainting 1-2 times per day, tiredness, shaking/tics in right hand, numb area in fingers and arm. She can not read or write, as the headache and dizziness get worse. Concentration problems. She has not been in school for 6 months. Medical record 07-Oct-2015: Medical history She has fainted today again at home. She had 5 minutes before got up from the sofa, walked around in the house, and goes to lie down, next thing she remember is the she woke up on the floor and has shoulder pain. No warning that she should faint. Thus no sensation of warmth, redness, sweating tendency, increased dizziness, or vision disturbance before she faint. She has constant headache, does not wake up of it, but has headache when she wakes up. The headache has over the last months increases. It got worse when she should read or write. Turn of the subtitles from the TV, but can follow when she watch TV, and does not get worse headache. There are attempted physiotherapy of this (optapening of shoulder, manipulation of the neck, stretching exercises) no effect. Has been seen by optician, that does not find a need of glasses. Is constant dizzy, dizziness of nautical character. Better when she lie down with her eyes closed, but doesn''t disappear totally. No double vision. The symptoms are so profound that she has only been school a few days since the summer break. Has previously liked school, has good friends. Parents are very concerned, see their daughter that has been very active and now only sit at home. Are worried that she has something in her head and which a scan of the head. DKMA comment: The HA has been in contact with the treating physician to clarify the vaccination dates. From the medical records they can inform that she was vaccinated 08-Oct-2013, 17-Dec-2013 and 16-Feb-2015.


VAERS ID: 620631 (history)  
Form: Version 1.0  
Age: 14.0  
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. NN40800 / 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: 620648 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-12
Entered: 2016-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Angiopathy, Arthralgia, Cognitive disorder, Constipation, Diarrhoea, Dizziness, Dyspnoea, Fatigue, Headache, Heart rate increased, Loss of personal independence in daily activities, Muscular weakness, Nausea, Palpitations, Photophobia, Postural orthostatic tachycardia syndrome, Presyncope, Syncope, Tilt table test positive, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (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), Arthritis (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Dehydration (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: Fulfill the diagnostic criteria for POTS with tilt table test.
CDC Split Type: WAES1601DNK003031

Write-up: Information has bee received from Sanofi Pasteur MSD (SPM) (manufacturer control # 2016000048) on 08-JAN-2016. Case received from a physician via health authority on 05-Jan-2016 under reference number DK-DKMA-WBS-0002164. A 14-year-old female adolescent patient received GARDASIL (batch number unknown, Dose 1) via intramuscular route in 2011, GARDASIL (batch number unknown, Dose 2) via intramuscular route in 2011, GARDASIL (batch number unknown, Dose 3) via intramuscular route in 2011. The patient experienced Joint pain in 2011, Headache in 2011, Syncope on an unknown date, Near syncope on an unknown date, Dizziness on an unknown date, Palpitations on an unknown date, Nausea on an unknown date, Abdominal pain on an unknown date, Diarrhea on an unknown date, Obstipation on an unknown date, Dyspnosea on effort on an unknown date, Fatigue extreme on an unknown date, Cognitive dysfunction on an unknown date, Limb weakness on an unknown date, Vascular abnormalities on an unknown date, Light sensitivity to eye on an unknown date, Blurred vision on an unknown date and POTS on an unknown date. Vaccination dates not known (probably in 2011), therefore not possible for a time relationship between the vaccine and that symptoms. First symptoms were joint pain and headache a couple of months after 3 dose, thereafter the other reported symptoms. During tilt table test is the patient fulfilling the diagnostic criteria for POTS. The patient has previously danced on high level, but has stopped due to joint pain. The patient describes reduced function, and has a lot of sick leave from her education (30-35 % absence). Diagnostic criteria for 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 the hospital uses further criterion in patients between 12-19 years: requires a heart rate increase of greater than 40 bpm to make the diagnosis, the reasons for this is that young people have a stronger physiological heart rate response when standing up. The additional criterion is used to avoid false positives. Other vaccines or medicines: Not known. The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 620746 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-09-12
Submitted: 2016-01-19
   Days after onset:1224
Entered: 2016-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Decreased appetite, Depression, Fatigue
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (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: WAES1601IRL005248

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer number# IE-1577272925-2016000210 on 15-JAN-2016. This case was received from the health authority on 13-Jan-2016. Initial report was received by the HA on 14-DEC-2015 from a Community Pharmacist concerning a 14 year old female patient who experienced decreased appetite, depression, abdominal pain and fatigue following vaccination with GARDASIL. The patient was not receiving any concomitant medications. The patient''s medical history/concurrent conditions were not reported. The patient was vaccinated with three doses of GARDASIL (lot numbers # also reported as "GO19345", "HO08259", "HO13055") intramuscularly between 12/Sep/2012 and 06/Jun/2013. On 12/Sep/2012, the patient developed anorexia, depression, abdominal pain and fatigue which the reporter considered to be persistently or significantly disabling/incapacitating. The events was also considered to be medically significant. At the time of reporting the patient outcome was reported as not recovered/not resolved. Lot numbers # G019345, H008259 and H013055 are valid on 18-JAN-2016.


VAERS ID: 620868 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2015-05-20
Onset:2015-05-20
   Days after vaccination:0
Submitted: 2016-01-21
   Days after onset:246
Entered: 2016-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Contusion, Dizziness, Haemorrhage, Headache, Hypoaesthesia, Immune thrombocytopenic purpura
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (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? 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: WAES1601IRL007335

Write-up: Information has been received from Sanofi Pasteur MSD [IE-1577272925-2016000290] on 20-JAN-2016. This case was received from the health authority on 15-JAN-2016. Ref IE-HPRA-2015-025523. Initial report was received by the HA on 15-DEC-2015 from a member of the public (patient herself) concerning a 14 year old female patient who experienced hypoaesthesia, headache, dizziness, contusion and immune thrombocytopenic purpura following vaccination with GARDASIL. The patient was not receiving any concomitant medications. The patient had no medical history/concurrent conditions. The patient was vaccinated with three doses of GARDASIL (lot number NM1142D, NM1142D, NN0199O) at a dose of 0.5 ml each time on dates between 20-MAY-2010 and 31-DEC-2010. After the first vaccination on 20-MAY-2010, the patient''s arm was numb and she developed ''constant'' headaches and dizziness. In the weeks after the vaccination, the patient developed ''bleeding and bruising all over the body''. The patient''s GP was contacted and she was sent to the emergency department and subsequently hospitalised. The patient has been attending hospitals and specialist/consultants for the past 6 years and is being treated (unspecified) for idiopathic thrombocytopenic purpura (ITP). The reporter indicated that the patient has ''no understanding where the disorder (ITP) came from'' and that she is at ''high risk of haemorrhaging and prolonged bleeding''. At the time of reporting the patient was not recovered.


VAERS ID: 630655 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-11-11
Onset:2009-11-16
   Days after vaccination:5
Submitted: 2016-03-07
   Days after onset:2303
Entered: 2016-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Amnesia, Craniocerebral injury, Dizziness, Dysarthria, Emotional distress, Haematoma, Headache, Impaired work ability, Nausea, Nervous system disorder, Pain, Seizure, Skin abrasion
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1603CAN002762

Write-up: Information has been received from a lawyer regarding a case in litigation concerning a 14 year old female patient, who on 11-NOV-2009 was vaccinated with her first dose of GARDASIL (dosage, lot number and route of administration not provided). On 16-NOV-2009, the patient experienced a seizure and was taken to the emergency department presenting with slurred speech, hematoma, nausea, and abrasions. On or about February or March 2010, the patient was administered a second dose of GARDASIL, and a third dose was administered in or about May 2010 (dosages, lot numbers and routes of administration not provided). The patient suffered further seizures on or about 29-JUL-2010 and 12-NOV-2012. As a result, the patient sustained serious personal injuries including, but not limited to: traumatic brain injury, neurological damage and disorder, memory loss, headaches, and lightheadedness (onset not provided), as well as seizures, slurred speech, hematoma, abrasions and nausea. As a result of the injuries suffered, the patient has experienced pain and suffering and loss of the amenities of life and has been forced to undergo and will continue in the future to require lengthy and painful therapy and treatments for her rehabilitation. As a further result of her injuries, the patient has suffered and will continue to suffer loss of income as a result of being restricted in her ability to work, and required ongoing care to assist with all activities of daily living. The outcome of the seizures, lightheadedness, headache, memory loss, neurological damage and disorder, traumatic brain injury, abrasions, nausea, hematoma and slurred speech is unknown. Upon internal review, seizures (16-NOV-2009, 29-JUL-2010 and 12-NOV-2012) were determined to be medically significant. Seizures, traumatic brain injury, neurological damage and disorder, slurred speech, hematoma, abrasions, memory loss, headaches, lightheadedness, and nausea were considered to be disabling. Additional information has been requested.


VAERS ID: 631925 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-15
Entered: 2016-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Arthropathy, Dizziness, Headache, Immune system disorder, Migraine, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (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? 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: WAES1604DNK009322

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control number DK-1577272925-2016003711) on 14-APR-2016. Please remember to use the Worldwide unique case identification number for this case: DK-DKMA-ADR 23359847. Also, please note that information should not be deleted from the case (especially not the Patient Characteristics). Case received from a lawyer via health authority on 11-Apr-2016 under reference number DK-DKMA-ADR 23359847. The HAs received the patient''s initial notification to the patient insurance. The patient insurance has not taken a decision in the case. A 14-year-old female adolescent patient received GARDASIL (batch number unknown) in 2010. The patient experienced dizziness in 2012, nausea in 2012, joint pain in 2012, headache in 2012, migraine in 2012, reduced immune system in 2012 and reduced joint function in 2012. The reactions started gradually in 2012 with much reduced immune defence, migraine. The patient contacted the physician several times and was prescribed PRIMPERAN 20 mg for nausea in 2013 and IMIGRAN for migraine in 2013. It culminated in 2015, with hospitalization with dizziness, reduced joint function, nausea and migraine. The patient was discharged with a prescription of EMEPERAL, without improvement. Symptoms of dizziness, joint pain, headache and migraine. The patient has been on sick leave since October 2015 and is still not back. The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 634213 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-03-13
Onset:2012-03-14
   Days after vaccination:1
Submitted: 2016-05-03
   Days after onset:1511
Entered: 2016-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. GO14502 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Dyspnoea, Fatigue, Head injury, Headache, Injection site swelling, Palpitations, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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? 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: WAES1604IRL017976

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # IE-1577272925-2016004775) as part of business agreement on 28-APR-2016. This case was received from RA in Ireland (Ref no. IE-HPRA-2016-026477) on 27-APR-2016. Initial case received from a consumer/other non health professional concerns a 14-year-old female adolescent patient received GARDASIL (batch number NN40800) on 14-SEP-2011, GARDASIL (batch number NP26080) on an unknown date, GARDASIL (batch number GO14502) on 13-MAR-2012. Concomitant medications: None. Medical history/concurrent conditions: Not reported. The patient experienced headaches, swelling of injection site, difficulty breathing, severe chest pain, postural tachycardia syndrome, palpitations, seizures - with many bangs on the head on 14-MAR-2012, constantly fainting and chronic fatigue on an unknown date. The reporter assessed the causal relationship between Headache, Swelling of injection site, Difficulty breathing, Chest pain, Postural orthostatic tachycardia, Palpitations, Seizures, Fainting, Chronic fatigue and GARDASIL as Unknown. Corrective treatment: The patient has attended GPs and hospitals and has commenced sodium, SSRI medication and an additional medication (to be confirmed). The patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 635288 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-10-29
Onset:2008-12-01
   Days after vaccination:33
Submitted: 2016-05-05
   Days after onset:2711
Entered: 2016-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Activities of daily living impaired, Angiopathy, Cognitive disorder, Dizziness, Dry eye, Dyskinesia, Dyspnoea, Fatigue, Headache, Heart rate increased, Loss of consciousness, Muscular weakness, Nausea, Neuralgia, Orthostatic intolerance, Palpitations, Photophobia, Sleep disorder, Tilt table test normal, Vision blurred, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (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), Dyskinesia (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (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: Have examinations and/or laboratory tests been conducted: Yes. Tilt Table Test: The patient does not meet the diagnostics criteria for POTS but it showed high resting heart rate. On an unknown date the patient experienced high resting heart rate.
CDC Split Type: WAES1605DNK002329

Write-up: Information has been received from Agency (DKMA) (DK-DKMA-WBS 0003322) via SPMSD (manufacturer control # DK-1577272925-2016004920) on 04-MAY-2016. Case received from a physician on 29-APR-2016. A 14-year-old female adolescent patient received GARDASIL (batch number lot not rep, Dose 1) via intramuscular route on 29-OCT-2008, GARDASIL (batch number lot not rep, Dose 2) via intramuscular route on 02-JAN-2009, GARDASIL (batch number lot not rep, Dose 3) via intramuscular route on 14-MAY-2009. the patient experienced blurred vision on 01-DEC-2008, fatigue extreme on an unknown date, orthostatic intolerance on an unknown date, High resting heart rate on an unknown date, headache on an unknown date, neuropathic pain on an unknown date, blacked out on an unknown date, dizziness on an unknown date, palpitations on an unknown date, nausea on an unknown date, abdominal pain on an unknown date, dyspnea on an unknown date, disordered sleep on an unknown date, Cognitiv dysfunction on an unknown date, involuntary muscle movement on an unknown date, limb weakness on an unknown date, vascular abnormalities on an unknown date, dry eyes on an unknown date, feeling bloated on an unknown date, light sensitivity to eyes on an unknown date, impaired functioning on an unknown date and have been absent from school a lot due to sickness. the school year 2008/2009 she was on sick leave for 3 months. Have had to abandon training and tried to so Higher Preparatory Examination on an unknown date. Approximately 1 month after the first vaccination the patient experienced that she found it difficult to see and focus her eyes. Subsequently, the other reported symptoms followed. According to a tilt table test at our office the patient does not fulfill the diagnostic criteria for POTS, however shows a high resting heart rate. Clinically appearance of a patient with orthostatic intolerance. Patient reports decreased level of functioning and a lot of sick leave. During the school year 2008/2009, she was on sick leave for three months. Has had to abandon training and tried to do Higher Preparatory Examination in single subjects. Other vaccines: Do not know. Other Medicines: Do not know. the patient was admitted to hospital on an unspecified date. Additional investigations included Tilt table test not meet POTS criteria on an unknown date. the patient''s outcome was reported as Not Recovered/Not Resolved.


VAERS ID: 635400 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-07-02
Onset:2009-10-01
   Days after vaccination:91
Submitted: 2016-05-09
   Days after onset:2412
Entered: 2016-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Activities of daily living impaired, Arthralgia, Back pain, Discomfort, Disturbance in attention, Dizziness postural, Fatigue, Headache, Infection susceptibility increased, Influenza like illness, Muscle contractions involuntary, Muscle spasms, Nausea, Oropharyngeal pain, Palpitations, Vision blurred, Visual impairment
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (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: No other medications
Current Illness: Human papilloma virus, immunisation; Hypermobility syndrome, Hypermobilitet
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Carried out studies and / or laboratory tests: No
CDC Split Type: WAES1605DNK002395

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control number # 2016004929) as part of business agreement on 04-MAY-2016. Case received from a HCP via Health Authority on 02-MAY-2016 with the reference number DK-DKMA-WBS-0003335. Case from a physician. A 14-year-old female adolescent patient received GARDASIL, (batch number LOT NOT REP, Dose 1) via intramuscular route on 04-Jul-2008, GARDASIL, (batch number unknown, Dose 2) on 04-Feb-2009, GARDASIL, (batch number unknown, Dose 3) on 02-Jul-2009. The patient experienced Arthralgia in OCT-2009, back pain in OCT-2009, fasciculation skeletal muscle in 2010, discomfort bodily, most legs in 2011, influenza symptoms of joint pain/cramps in 2010, infection tendency in 2010, tiredness in 2010, headache in 2012, visual disturbance, difficulty focusing in 2012, orthostatic dizziness in 2012, concentration difficulty in 2012, throat pain in 2010, abdominal pain in 2011, nausea in 2011, palpitations in 2012, influenza symptoms of joint pain / cramps in 2010, difficulty concentrating in 2012 and could not complete high school, is on education aid on an unknown date. The patient had a medical history of Hypermobility syndrome. The patient''s outcome was reported as not recovered/not resolved. History around adverse reaction: Could not complete high school, is on education aid. Other vaccines: No. Other medicines: Yes.


VAERS ID: 635490 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-11
Entered: 2016-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Blood test, Chest pain,