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Found 42772 cases where Vaccine is HPV4

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VAERS ID: 506648 (history)  
Form: Version 1.0  
Age: 42.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-08
Entered: 2013-10-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Chest X-ray normal, Cough, Dyspnoea, Impaired work ability, Pneumonia, Pneumonia chlamydial, Pneumonia mycoplasmal, Total lung capacity decreased
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: 11/2012, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: CHest X-ray, Clean not provided
CDC Split Type: WAES1310DNK002943

Write-up: Case received from healthcare professional via company representative on 20-Sep-2013. The primary reporter was a physician. Additional information received from the physician on 02-oct-2013. A 42 year old female patient had received the second dose of GARDASIL (batch number not reported) via not reported route of administration and site of administration on administration date in february 2013 and later on she developed bad breathing, chlamydia pneumonia, pneumonia mycoplasma, daily coughing attack and reduced lung capacity. After the second GARDASIL vaccination she developed bad breathing. It came slowly, like a little asthma. Thereafter she developed pneumonia. She was treated with unspecified treatment and was controlled and recovered, but had daily coughing attacks. She developed again pneumonia, this time due to mycoplasma. Patient was examined and thorax X-ray was clean but she can still not breath. Has only 44 % of her lung capacity and can not function as normal. According to the patient''s physician batch number is not available as the patient was vaccinated by her sister (who is another physician). The patient visited the reporting physician on 22-Feb-2013. At first she started to cough and then the cough infiltrated both lungs. She received penicillin therapy, the infiltration went away. After a few months the infiltration was back, the diagnose was chlamydia pneumonia. She received another treatment (brand not reported) and was referred to a respiratory ward at a hospital. They have given her a treatment but do not understand her sickness. Patient was completely healthy (respiratory) before Feb-2013. She has not smoked and has no allergies. Now she has only 1/3 of lung capacity and cough all the time. She has maximum asthma treatment and high doses of prednisolone treatment. The doctor says that the patient has lost her job and it is very tragic. Patient had previously received the first primary dose of GARDASIL (Batch number not reported) via not reported route of administration in not reported site of administration in Nov-2012. Patient received the third dose of GARDASIL (batch number not reported) via not reported route of administration and site of administration on unspecified date in Aug-2013. Company assessed seriousness criteria as other medically important event due to total lung capacity decreased. Discrepancy: Patient reported that she first experienced pneumonia and then again pneumonia due to mycoplasma. But the physician reported that she had first pneumonia and then chlamydia pneumonia. It is uncertain how many times she had pneumonia as well as chronological order of the events.


VAERS ID: 506650 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-16
Onset:0000-00-00
Submitted: 2013-10-09
Entered: 2013-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Blood glucose increased, Decreased appetite, Depression, Emotional distress, Fatigue, Pollakiuria, Polydipsia, Somnolence, Type 1 diabetes mellitus, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: 12/11/2008, GARDASIL, Immunisation, Weight decreased; 10/09/2008, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Blood glucose, Increased
CDC Split Type: WAES1310DNK003420

Write-up: Case received from a consumer via the patient insurance company via the Health Authorities on 25-Sep-2013 under the reference number 22249747. The primary reporter was a lawyer/patient insurance company. The case is not medically confirmed. A 17 year old female patient had received a third injection of GARDASIL (batch number unknown) via not reported route of administration in not reported site of administration on 16-Apr-2009 and post vaccination she experienced weight loss, tiredness, loss of energy, drink water all the time, appetite lost, urinate 10-20 times a day, weight loss, hospitalized with high blood sugar (unspecified dates). She was diagnosed with diabetes type 1 on 19-May-2013. She is depressed because of diabetes. Case reported to HA by patient insurance company on 17-Sep-2013, with reference number J-nr 13-5738, as patient''s own report to the patient insurance company. Note that the Patient Insurance Association has not taken a decision on the matter yet. Description of Course from the patient: I got my first HPV vaccine on 09-Oct-2008 and second on 11-Dec-2008. After my second vaccine, I started to lose a lot of weight. I got my third vaccination on 16-Apr-2009, and I kept losing weight, I went from 68 to 52 kg in about 4-5 months time (from March to July 2009). I did nothing to lose weight and still ate the same and without any exercise. I began to be tired all the time for a very long time, I did not want to eat, I drank water all the time and had no energy. I did nothing but sleep and I had to urinate 10-20 times a day. The 19-May-2011 I went to see the doctor because I could not take it anymore. I took urine sample and the doctor told me there was a high possibility that I had diabetes type 1. I was shocked and upset and could not understand it. There is no one in my family who has diabetes. How could this happen to me? I was quick hospitalized with very high blood sugar and received treatment promptly. The doctors could not give me an answer why it has happen to me, since no one in my family has diabetes, and I do not eat unhealthy or live badly. It''s hard to live a whole new life and change everything and take medication every day so my body could be ok. A few months ago I found out that HPV vaccine, GARDASIL, has triggered my diabetes (no more information provided), it has for sure made a lot of changes in the cells in my body. If I knew that the HPV vaccine could cause so many symptoms, I would have not taken it as diabetes has changed and ruined my life completely! I cannot live my life as before, because I always need to take care of myself and think about what I eat and what I do. Patient''s life after the side effects: Diabetes will always be troublesome, because it follows me, my whole life and I can never stop it. I''m depressed because of my diabetes and I had lived a difficult life after I got the diagnose. Treatment of the adverse events: I get insulin and it is vital for me and I have control visit at Hospital. Health authority has been in telephone contact with the patient''s general practitioner to get the batch numbers on GARDASIL vaccines. These are not available. Medical history includes 2 doses of GARDASIL. First vaccination of GARDASIL (batch number unknown) via not reported route in not reported site on 09-Oct-2008. Second vaccination of GARDASIL (batch number unknown) via not reported route in not reported site on 11-Dec-2008 and on unspecified date she experienced weight loss. At the time of reporting, outcome of diabetes and depression is not recovered and outcome of the other adverse events was unknown.


VAERS ID: 506664 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-09
Entered: 2013-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Peripheral vascular disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1310DEU002923

Write-up: This case has been reported through a market research study for GARDASIL vaccination on 27-Sep-2013. Case is medically confirmed. This case is poorly documented. A female patient in her early twenties received a dose of GARDASIL (lot-no., injection route and site not reported) on an unspecified date about 3 years ago. On the same day, she was hospitalised due to suspicion of peripheral circulatory disorder. Duration and outcome were not reported. According to the reporter the reaction was related to the vaccination.


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: 506812 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-19
Onset:2013-09-19
   Days after vaccination:0
Submitted: 2013-10-09
   Days after onset:20
Entered: 2013-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005992 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Chills, Dizziness, Erythema, Headache, Hypoaesthesia, Induration, Injection site reaction, Malaise, Nausea, Oedema peripheral, Pallor, Pyrexia, Skin swelling, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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 pressure, 103/62 mmHg; Heart rate, 125 min
CDC Split Type: WAES1310POL002269

Write-up: Patient female on 19 September 2013 at 10:00 AM was vaccinated wtih Silgard (volume 0.5 ml) intramuscular in left arm (lot# J005992/ exp 11/2015), On reporting form of post-vaccine reaction (other than BCG) were noted the following adverse events: fever above 40.5 Celsius degrees, up to 48 hours, chills, vomiting, numbness of limbs, severe injection site reactions with a diameter greater than 10 cm. In the narrative part of the form the physician reported: About 45 minutes after vaccination: dizziness. About 2 PM severe headache, later edema and redness of left arm with thick, linear ridge running vertically in the direction of the elbow. Numbness of left hand and right leg. About 6 PM severe chills fever initially 39 Celsius degrees, at 12 PM 40.6 Celsius degrees, at 4:30 AM 39.5 Celsius digress. At examination in physician office- state average, pale, hard, swollen skin, chills, blood pressure 103/62 mmHg, cor - 125. Headache, nausea, vomiting. Feeling generally unwell. The patient was directed to hospital. According to reporting form reaction occurred on 19-SEP-2013 at 11:00. Medical outcome: the child is still traded at home. Case comment: In the past the patient did not experience any post-vaccine reactions.


VAERS ID: 506830 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-09
Entered: 2013-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Amylase, Antiphospholipid antibodies positive, Arthralgia, Asthenia, Autoimmune disorder, Autoinflammatory disease, Blood culture negative, Cardiolipin antibody positive, Culture throat negative, Culture urine negative, Decreased appetite, Erythema, Headache, Normochromic normocytic anaemia, Nuclear magnetic resonance imaging brain normal, Oropharyngeal pain, Protein urine absent, Pyrexia, Serum amyloid A protein increased, Skin lesion
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Raynaud''s phenomenom, defined by nailfold capillaroscopy
Preexisting Conditions: Beta haemolytic streptococcal infection, 1 year before admission; Tonsillitis, during childhood; Penicillin, Drug indication: Beta haemolytic streptococcal infection
Allergies:
Diagnostic Lab Data: Laboratory workup (date unspecified): revealed normochromic normocytic anemia; Autoantibodies profile (date unspecified): demonstrated persistent positivity of anti-cardiolipin IgM and LAC; Magnetic resonance imaging of the brain (date unspecified): excluded the presence of brain abnormalities consistent with antiphospholipid syndrome; Culture (unspecified date); Pharyngeal culture as well as urine and blood culture excluded active infections; Laboratory workup revealed normochromic normocytic anemia, slight increase of serum amyloid A (SAA) levels of 9 mg/l. Proteinuria was absent. Autoantibodies profile demonstrated persistent positivity of anti-cardiolipin IgM and lupus anticoagulant. Body temperature, Rose up to 39 degrees C, Increased
CDC Split Type: WAES1309ISR001892

Write-up: Information initially received and was described in linked case E2013-03484 which was updated with information of patient n. 1. The other 4 patients reports of the article were described in linked cases E2013-06723; E2013-06725; E2013-06727 and E2013-06728 (same vaccine, similar events, different patients). This case concerns patient n. 4. This literature marketed report as received from a physician refers to a 16 year old female patient. Her medical history was remarkable for recurrent tonsillitis during childhood and a streptococcus group B infection 1 year before admission, treated with penicillin. In addition the patient suffered from Raynaud''s phenomenon grade II, defined by nailfold capillaroscopy. Her family history was also remarkable for Raynaud disease of patient''s mother. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient was admitted the hospital with a preliminary diagnosis of FUO (fever of unknown origin), which appeared for the first time 3 weeks after the second dose of GARDASIL. Fever was prolonged, mainly present in the morning, and rose up to 39 degree Celsius (C). In addition, pharyngodynia, erythematous skin lesions of elbows and knees, generalized asthenia, anorexia, polyarthralgia, and headaches were present. Pharyngeal culture as well as the urine and blood cultures excluded active infections. Laboratory workup revealed normochromic normocytic anemia, slight increase of serum amyloid A (SAA) levels of 9 milligrams/liter. Proteinuria was absent. Autoantibodies profile demonstrated persistent positivity of anti-cardiolipin IgM and lupus anticoagulant (LAC). Magnetic resonance imaging of the brain excluded the presence of brain abnormalities consistent with antiphospholipid syndrome. Her medical history was remarkable for recurrent tonsillitis during childhood and a streptococcus group B infection 1 year before admission, treated with penicillin. In addition, the patient suffered from Raynaud''s phenomenon grade II, defined by nailfold capillaroscopy. Her family history was also remarkable for Raynaud disease of patient''s mother. On an unknown date, the patient was diagnosed with fever in a patient with antiphospholipid antibodies, possibly related to GARDASIL vaccination, compatible with the autoimmune/auto inflammatory syndrome induced by adjuvants (ASIA). She was treated with naproxen 500 milligrams (mg)/day for 2 months and omega-3 polyunsaturated fatty acids 2,000 mg/day for 4 months. The doses were very gradually tapered down. She was discharged with instructions to avoid sun exposure and to avoid further vaccination. At follow-up visit, the patient was in remission and in good health. The authors mentioned that based on the current data, a causal link between HPV vaccine and onset or relapse of SLE was plausible. The patient considered the event to be possibly related to GARDASIL. This is one of the several reports from the same source. Additional information has been requested. It has been determined that case # 1309ITA004643 is a duplicate of case # 1309ISR001892. Therefore, case # 1309ITA004643 is being deleted from our files and the cases consolidated into case # 1209ISR001892.


VAERS ID: 506842 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-18
Onset:2013-09-18
   Days after vaccination:0
Submitted: 2013-10-09
   Days after onset:21
Entered: 2013-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019633 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310IRL003239

Write-up: This case was received from the health authority on 30-Sep-2013. REF 2013-018318. This case is medically confirmed as it was reported by a physician. A 12 year old female patient, with a medical history of mild asthma, received on 18-Sep-2013 an injection of GARDASIL (batch number H019633) 0.5 mL intramuscularly, dose in series and site of administration not reported. On 18-Sep-2013, five minutes post vaccination, the patient experienced rash on trunk and face. It was also reported the patient presented with acute hypersensitivity reaction on 18-Sep-2013. The reporter indicated the patient''s vitals were stable and the patient had no bronchospasm. The patient received a corrective treatment with PIRITON 4 mg orally on an unreported date. Both reactions lasted only three hours. At the time of reporting, the patient had fully recovered. The regulatory authority considered that case serious due to be medically significant.


VAERS ID: 506957 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-02-02
Onset:2012-05-01
   Days after vaccination:89
Submitted: 2013-10-10
   Days after onset:527
Entered: 2013-10-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN12610 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Alanine aminotransferase increased, Antinuclear antibody, Antinuclear antibody positive, Arthralgia, Aspartate aminotransferase increased, Autoantibody positive, Blood 25-hydroxycholecalciferol decreased, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased, Body temperature increased, Cell marker increased, Chest pain, Complement factor C3, Complement factor normal, Computerised tomogram thorax abnormal, Constipation, Depressed mood, Dysphagia, Fatigue, Frequent bowel movements, Gastrointestinal hypomotility, Haematochezia, Headache, Interstitial lung disease, Lipase normal, Local swelling, Muscle enzyme increased, Musculoskeletal pain, Myalgia, Myositis, Night sweats, Oesophageal disorder, Overlap syndrome, Pain in extremity, Peripheral coldness, Polymyositis, Raynaud's phenomenon, Respiratory distress, Scleroderma, Synovitis, Ultrasound abdomen abnormal, Ultrasound joint, Ultrasound scan abnormal, Vitamin D decreased, Vitamin D deficiency
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Myocardial infarction (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Tumour markers (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Hypersensitivity (broad), Arthritis (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (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? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation, Dose 1. Lot number G005824.
Allergies:
Diagnostic Lab Data: Ultrasound joint: slight synovitis of both wrist. Ultrasound abdomen: expanded liver veins. CT scan: subpleural interstitial changes of lung tissue. ANA: positive. Autoantibody test: Anti-PM-Scl positive; 06/06/2013, Alanine aminotransferase, 55 U/L; 06/21/2013, Alanine aminotransferase, 48 U/L; Antinuclear antibody, Positive; 06/06/2013, Aspartate aminotransferase, 79 U/L; 06/21/2013, Aspartate aminotransferase, 84 U/L; Autoantibody test, Anti-PM/Scl positive; 06/06/2013, Blood 25-hydroxycholecalciferol, 9.9 ng/mL; 06/06/2013, Blood creatine phosphokinase, 1352 U/L; 06/06/2013, Blood creatine phosphokinase, 1763 U/L; 06/06/2013, Blood lactase dehydroginase, 393 U/L; Blood lactase dehydroginase, 415 U/L; Body temperature increased, 37.5 to 37.8 degrees C; 06/06/2013, Cell marker, Neopterin 17.4 mmol/l; 06/06/2013, Complement factor C3, 96 mg/dL; Computerised tomogram, subpleural interstitial changes of lung tissue; 06/21/2013, Lipase, 51 U/L
CDC Split Type: WAES1310DEU002902

Write-up: Case received from a health care professional on 30-Sep-2013. Case is medically confirmed. Case is linked to non-serious case E2013-5989 (same reporter, same vaccine, different reaction, different patient). A 15-year-old female patient (weight 59.9 kg, height 167 cm) received the second dose of GARDASIL (batch-no G017722, lot number NP00860) on 29-May-2012. On an unspecified date in May-2012, the patient developed polymyositis/scleroderma-overlap-syndrome including Raynaud''s pnenomenon, swollen fingers, changes to the capillary arteries, dysfunction of the oesophagus, suspicion of intestinal pseudoobstruction, intestinal lung disease, myositis with increased muscle enzymes. In the lab test ANA was positive with a nuclear pattern and anti-PM/Scl was positive. Since this time she was hospitalised frequently. The patient was hospitalised in May-2013. During this hospital stay a high-definition CT of the lung revealed subpleural interstitial changes of the lung tissue. Therapy with URBASONE was continued, azathioprine was replaced by MYFORTIC. Additionally, the patient started therapy with QUENSYL and rituximab. Furthermore, a therapy with amlodipine was started as well as MOVICOL. The patient received regular physiotherapy, massage and ergotherapy. Despite all this, there was no significant improvement of the symptoms. Since end of that hospitalization the patient experienced progressive health problems with continuing pronounced bifrontal headache, stomach ache, muscle and joint pain. The patient described periods of pronounced fatigue and persistent pain in both knees. Her temperature was slightly increased (37.5 to 37.8 degree C) and she experienced night sweat. All fingers were painful and cold. The patient experienced nightly respiratory distress with left-sided precordial chest pain. The patient was hospitalised from 05-Jun-2013 to 22-Jun-2013 with persisting symptoms including daily chronic headache, chronic cramp-like epigastric stomach pain, dysphagia, frequent defecation with hematochezia, arthralgia of the knees, myalgia of the right calf and pronounced swelling of the fingers with Raynaud''s phenomenon. Examination of joints showed pronounced constriction of active movement; passively a complete fist could be formed under pain. Both knees could be moved freely under pain. Ultrasound of the joints of both wrists showed a slight synovitis. Ultrasound of the abdomen revealed expanded liver veins with a diameter of 1.5 cm. Lab tests on 06-Jun-2013 revealed GOT 79/l, GPT 55 U/l, LDH 393 U/l, CK 1352 U/l, C3 96 mg/dl, Neopterin 17.4 nmol/l and 25-OH vitamin D 9.9 ng/ml. Lab tests on 21-Jun-2013 revealed GOT 84 U/l, GPT 48 U/l, LDH 415 U/l, CK 1763 U/l and Lipase 51 U/l. A secondary pain syndrome with daily chronic headaches and arthromyalgia was suspected. Vitamin-D deficiency was diagnosed and treated with Vigantoletten. After rituximab therapy methylprednisolone could be reduced and the patient''s depressive mood improved. For the persistent myositis with pronounced increased muscle enzymes and neopterin (as a marker for interferon-activated macrophages) an additional therapy with GAMUNEX IV was started. Further medication included: MYFORTIC, QUENSYL, MOVICO and SORBITOL due to chronic obstipation. At the time of reporting, the patient had not recovered. According to the reporter, the reactions were definitely related to the vaccination. Previous dose of GARDASIL (D1, batch-no. G005824, lot number NN12610, Exp. Date: 20-SEP-2013) was given on 02-Feb-2012. Toleration was not reported.


VAERS ID: 506968 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-05
Onset:2013-10-06
   Days after vaccination:1
Submitted: 2013-10-11
   Days after onset:5
Entered: 2013-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0989AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Asthenia, Blood test normal, Cold sweat, Crying, Dysstasia, Gait disturbance, Headache, Hypoaesthesia, Insomnia, Laboratory test normal, Malaise, Pain, Sensory disturbance, X-ray normal
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Laboratory test (unspecified) (06-OCT-2013): no abnormalities were found; 10/06/2013, Blood test, normal, no abnormalities N/A
CDC Split Type: WAES1310JPN005136

Write-up: Initial information has been received from a physician concerning a 13-year-old female patient with no underlying disease or medical history. On 05-OCT-2013, the patient received the third time vaccination with a GARDASIL IM injection drug (dose, injection site and not provided). No concomitant medication was reported. On an unspecified date, the patient received the first time vaccination with the GARDASIL ()batch number: 9QN07R, lot number: 0788AA, expiry date: 05-JUN-2014). On an unspecified date, the patient received the second time vaccination with the GARDASIL (batch number: 9QN08R, lot number: 0989AA, expiry date: 21-JUN-2014) at a nearby internal medicine clinic. One hour later, she had cold sweat and malaise. After she went home, she repeated 3-hour-sleep and waking up for strange sensation, but she had an appetite. On 06-OCT-2013, around 1:00 in the midnight, the patient had symptoms with numbness of four limbs (joints lower than elbow and knees). She also had headache, abdominal pain and malaise. She could not sleep because of pain, but the pain disappeared in the morning. She was seeing what''s happening and then became unable to stand up due to weakness. The headache and numbness reappeared around at 14:00 and 16:00, respectively. She then urgently visited and was admitted to the reporting physician''s hospital because frequency of these symptoms gradually increased. At presentation to the hospital, the patient seemed to have difficulty walking and to be crying and suffering. She received only drip infusion at admission. No abnormalities were found in blood tests or radiographic findings. On 07-OCT-2013, the malaise and numbness of four limbs (joints lower than elbows and knees improved. The outcome of the cold sweat, headache, abdominal pain, and weakness was unknown. Mild numbness of legs was still persisted in the morning then disappeared in the early evening. Reporter''s comment: none. The reporting physician did not assess the causal relationship of the malaise, numbness of four limbs (joints lower than elbows and knees) as serious (hospitalization) and did not assess the seriousness of the cold sweat, headache, abdominal pain and weakness. Additional information has been requested.


VAERS ID: 506972 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-22
Onset:2009-07-01
   Days after vaccination:70
Submitted: 2013-10-11
   Days after onset:1563
Entered: 2013-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0773X / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Amnesia, Aphasia, Arthralgia, Blood test, Chest pain, Disorientation, Dissociation, Dizziness, Ear, nose and throat examination, Eczema, Fatigue, Hypersensitivity, Impaired driving ability, Insomnia, Memory impairment, Muscle spasms, Palpitations, Photopsia, Radioallergosorbent test positive, Tremor, Vestibular function test, Visual acuity reduced
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), 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? No
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; Obsessive-compulsive disorder; Multiple allergies, Positive RAST; Altermaria; Timothy and Mugwort
Preexisting Conditions: Chest pain; Palpitations; Dermatitis atopic, on hands; 12/17/2008, GARDASIL, immunisation, Dose 2; 10/15/2008, GARDASIL, Immunisation, Dose 1
Allergies:
Diagnostic Lab Data: Several blood samples has been taken, abdomen has been examined, an ear-nose-throat specialist has examined the balance nerve. Unknown date vestibular function test was performed (no result was provided) Radioallergosorbent test, Positive RAST, Altermaria Timothy and Mugwort
CDC Split Type: WAES1309DNK001383

Write-up: Case received from a patient/consumer via a Health Authority on 21-Aug-2013 under the reference numbers EFO6579 and 22213483. Case not medically confirmed. A 19 year old female patient had received an injection of GARDASIL (dose, batch number, route and site not reported) on an unspecified date in 2009 and later on an unspecified date in 2009, she developed memory loss, dizziness. allergy and abdominal cramps. According to the reporter she has not been treated for the events and not hospitalized for the events. Several blood samples has been taken, abdomen has been examined, an ear-nose-throat specialist has examined the balance nerve. He has coded patient age as adolescent but according to data entry rules entered as adult. The patient was previously vaccinated with GARDASIL (dose, batch number, route and site not reported) on an unspecified date in 2008. The patient has a history of atopic eczema on hands, palpitations and chest pain. At the time of reporting, the outcome was not recovered. Follow up information from health care professional via health authority on 27-Sep-2013 under the reference number 22251473 and EFO6952. The reporter was a physician. On 02-Oct-2013 the HA confirmed that is was a duplicate identified with their case and merged with this current case. The following adverse reactions with different start date in 2009 were reported by the reporting physician: dizziness (Jul-2009), feeling remote (gold fish sensation) (Jul-2009), abdominal cramps (2009) poor memory and memory loss(Jul-2009), shaking of hands (Jul-2009), heart palpitations (Jul-2009), pain in chest (Jul-2009), eczema (Jul-2009), poor vision (Jul-2009), blackening and flickering for the eyes (Jul-2009), difficult finding words, sleeplessness (Jul-2009), orientation difficulty (Jul-2009), can not find words (Jul-2009), dares no longer drive, (start date not specified) cramp in left leg (Jul-2009), abnormally tired (Jul-2009), pain in knee and hip joint (Jul-2009). Has been examined by a number by a number of specialist physicians; ear-nose-throat physician, dermatologist, rheumatologist and orthopedic surgeon as well as psychiatrist because of OCD (but before the vaccination). The third dose was given 22-Apr-2009, batch number NK05560 with lotnumber 0773X and expiration date 16-JUN-2011. The patient was previously vaccinated with GARDASIL (dose 1 and 2, batch number NJ01850 with lotnumber 1941U and expiration date 12-DEC-2010 and NH31140 with lotnumber 1477U and expiration date 17-SEP-2010), intramuscular route, site not reported) on 15-Oct-2008 and 17-Dec-2008. The physician reports the following medical history; atopic eczema on hands, multiple allergy (positive RAST Altermaria, Timothy and Mugwort), palpitations and chest pain. Allergy was reported as an reaction by the patient.


VAERS ID: 507438 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-13
Onset:2013-06-21
   Days after vaccination:8
Submitted: 2013-10-11
   Days after onset:112
Entered: 2013-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. G016868 / 3 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Albuminuria, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Electrophoresis normal, Flank pain, Glomerulonephritis acute, Haematuria, Inappropriate schedule of drug administration, Lymphadenopathy, Ultrasound abdomen abnormal, Ultrasound kidney normal
SMQs:, Acute renal failure (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 12/13/2012, GARDASIL, No adverse event; 02/28/2012, GARDASIL, No adverse event
Allergies:
Diagnostic Lab Data: 01-JUL-2013: Blood pressure 90/60, Heart rate 60, Ultrasound abdomen slight unsharp parenchyma of right and left kidney, Ultrasound Doppler renal arteries normal; 25-SEP-2013: Electrophoresis normal; 27-JUN-2013: ANA negative, p-ANCA negative; c-ANCA negative
CDC Split Type: WAES1310DEU004983

Write-up: Case of misuse (vaccination series completed after more than one year) received from a health care professional on 01-Oct-2013. Case is medically confirmed. A 17-year-old female patient (weight 62 kg, height 172 cm) received the third dose of GARDASIL (lot-no. G016868) IM into the upper arm on 13-Jun-2013. Concomitant medication included contraceptives since several months before vaccination. Eight days later on 21-Jun-2013, the patient developed an acute glomerulonephritis with albuminuria and microscopic hematuria. Additionally the patient had flank pain on both sides with changing intensity and swollen lymph nodes at the left side of the neck and left axilla. Electrophoresis performed on 26-Sep-2013 was within normal range. Laboratory tests performed on 27-Jun-2013 revealed negative ANA, c-ANCA and p-ANCA. Examinations performed on 01-Jul-2013 revealed blood pressure of 90/60 and heart rate of 60, sonography of the upper abdomen was normal except for slight unsharp parenchyma in the right and left kidney, and ultrasound Doppler of renal arteries was normal. Laboratory tests performed on 02-Jul-2013 were all normal. At the time of reporting, acute glomerulonephritis had resolved, renal function and proteinuria had normalised. Outcome of swollen lymph nodes and microscopic hematuria was not reported. The reporter considered the symptoms as possibly to probably related to the vaccination with GARDASIL. Previous doses of GARDASIL given on 28-Feb-2012 (D1) and on 13-Dec-2012 (D2) were well tolerated. Upon medical judgment the company assessed the case as serious.


VAERS ID: 507445 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-09-26
Onset:0000-00-00
Submitted: 2013-10-11
Entered: 2013-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H007039 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Eye pain, Formication, Hypoaesthesia, Multiple sclerosis, Paraesthesia, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1310FRA005000

Write-up: Case received from the Health Authorities in a foreign country under reference number LL20131194 on 04-Oct-2013. A 17-year-old female patient had received the first dose of GARDASIL (batch/lot number H007039) on 26-Sep-2012 and the second dose (batch/lot number not reported) on 26-Nov-2012. In Nov-2012 she experienced a first episode of sensory disturbance, i.e. no sensitivity in both legs. Symptoms had fully resolved within 3 weeks. In May-2013 she experienced a second episode of sensory disturbance in feet, which gradually spread up to the abdomen. Sensory disturbance improved within 3 weeks. Insensitivity of hands appeared as well as an episode of eye pain. In Jul-2013 the patient was hospitalized in the neurology department. Diagnosis of multiple sclerosis was made. According to the Health Authorities, the patient had not recovered from paraesthesia, formication, eye pain and multiple sclerosis. Outcome for hypoesthesia was unknown. To be noted that the case was reported as non-serious by the Health Authorities. Upon medical review, the company judge relevant to consider the case as serious due to serious criterion "Hospitalization". The Health Authority assessed the causal relationship between the reported reaction and vaccination as doubtful (C2 S1 B1 I1) according to the updated foreign method of assessment. The Health Authorities specified that "causality was assessed without being detrimental to the findings of any investigation which might be performed in the context of legal or out-of-court procedures for compensation". Additional information received on 10-Oct-2013. The Health Authorities confirmed that the case was serious (and not non-serious as initially reported) and will be upgraded. Lot number for the other dose was provided: H008693.


VAERS ID: 507449 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-02-09
Submitted: 2013-10-14
   Days after onset:246
Entered: 2013-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Type 1 diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (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? No
Previous Vaccinations:
Other Medications: Insulin
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR005165

Write-up: This case was received from the health authority on 04-Oct-2013. GB-MHRA-ADR 22256326. This case is not medically confirmed as it was reported by a consumer. A 12-year-old female patient (weight: 31 kg), with no reported medical history, received on an unreported date an injection of GARDASIL, (batch n. not reported), route, dose in series and site of administration not reported) and on 09-Feb-2013 she experienced type 1 diabetes mellitus. It was unknown if the reaction was treated. However, it was reported that concomitant medication included insulin. At the time of reporting the patient had not recovered. The MHRA considered this case to be serious due to disability, hospitalisation and as a life threatening condition.


VAERS ID: 507450 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-03
Onset:2013-10-03
   Days after vaccination:0
Submitted: 2013-10-11
   Days after onset:8
Entered: 2013-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006838 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Angioedema, Convulsion, Encephalitis, Neurological symptom
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Systemic lupus erythematosus (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Oropharyngeal allergic conditions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: WAES1310KAZ005452

Write-up: Information was received via medical advisor from Deputy Minister of Ministry of Health concerning a 12 year old female patient. On 03-OCT-2013, at 11:50, the patient was vaccinated with a dose of GARDASIL, suspension for i/m injection, 0.5 ml, intramuscular for HPV prophylaxis (Lot # J006838; expiration date 19-OCT-2015). After vaccination in the doctors room the patient experienced neurological symptoms, anaphylactic reaction like Quincke''s edema, encephalic reaction, convulsive syndrome. The patient was hospitalized. The patient state improved, it was reported that the patient recovered in 2013. GARDASIL, was discontinued. The reporter felt that adverse reactions were definitely related to therapy with GARDASIL. Upon internal review convulsive symptom was considered to be medically significant. Additional information has been requested.


VAERS ID: 507452 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-10-03
Submitted: 2013-10-14
   Days after onset:11
Entered: 2013-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006838 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Angioedema, Convulsion, Encephalitis, Neurological symptom
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Systemic lupus erythematosus (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Oropharyngeal allergic conditions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: WAES1310KAZ005066

Write-up: This spontaneous report was received via medical advisor from Deputy Minister of Ministry of Health refers to a 12 year old female patient. On 03-OCT-2013 at 11:50 the patient was placed on therapy with GARDASIL, suspension for i/m injection, 0.5 ml, intramuscularly (lot # J006838, expiration date 19-OCT-2015). After vaccination in the doctors room the patient experienced neurological symptoms, anaphylactic reaction like Quincke''s edema, encephalic reaction and convulsive syndrome. The patient was hospitalized. The patient''s condition improved. GARDASIL was discontinued. The reporter felt that adverse reactions were definitely related to therapy with GARDASIL. Upon internal review, "convulsive syndrome" was considered to be a medically significant event. Additional information is not expected.


VAERS ID: 507802 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-04
Onset:2013-07-04
   Days after vaccination:0
Submitted: 2013-10-11
   Days after onset:99
Entered: 2013-10-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Fall, Head injury, Loss of consciousness, Pallor, Suture insertion
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: WAES1310FRA004996

Write-up: Case received from the Health Authorities in a foreign country on 02-Oct-2013 under the reference number RN20131310. A 14-year-old female patient with no relevant medical history had received a dose of REPEVAX (batch number unknown) and a first dose of GARDASIL (batch number unknown) both via intramuscular route on 04-Jul-2013. Administration of both vaccines had been uneventful but whilst she was getting dressed she turned pale, fell backward and lost consciousness. She hit her head on the floor. The physician took her blood pressure. It was 8. She was given sugar, rehydration treatment and she regained consciousness. She was taken to the emergency room and she had one stitch. It is noteworthy that she had no long-standing treatment. At the time of reporting the patient had recovered. Early Sep-2013, the patient received the second dose of GARDASIL as per the vaccination schedule. A follow-up was scheduled. The Health Authorities considered the case as serious due to the criterion ''other medically important condition''. The Health Authorities assessed the causal relationship between the reported events and both vaccines as doubtful (C2 S1 I1) according to the foreign method of assessment. The Health Authorities specified that "causality was assessed without being detrimental to the findings of any investigations which might be performed in the context of legal or out-of-court procedures for compensation". Upon medical review, the company judged relevant to code "loss of consciousness" and "head injury" which was mentioned by the Health Authorities in the narrative but not coded.


VAERS ID: 507807 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-17
Onset:2013-09-17
   Days after vaccination:0
Submitted: 2013-10-11
   Days after onset:24
Entered: 2013-10-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019633 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Fall, Headache, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: WAES1310IRL005014

Write-up: This case was received from the health authority in a foreign country on 03-Oct-2013. IMB-REF 2013-018317. This case is part of a cluster of 5 cases after human papilloma virus vaccination (same batch number, same period of vaccination, all received from the IMB) and is linked with cases E2013-07661, E2013-07663, E2013-07664, E2013-07670. It is unknown whether the initial reporter was the same for the five cases. This case is medically confirmed as it was reported by a physician. A 16-year-old female patient, with no relevant medical history, received on 17-Sep-2013 an injection of GARDASIL (batch and lot n. H019633), route, dose, dose in series and site of administration not reported. Eighty minutes post-vaccination, the patient was found lying on school corridor. She complained of very painful head. The patient was conscious but could not remember what had happened. The reporter indicated that the patient must have fainted and fallen backwards. The reporter indicated that due to the nature of the accident, the patient was sent to A&E by ambulance to rule out any head injury. No evidence of injury was discovered on investigations. The reporter indicated that the patient was observed for 8 hours in causality and discharged home. At the time of reporting the patient had made a full recovery. The IMB considered this case to be serious as an other medically important condition because it required intervention.


VAERS ID: 507823 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-17
Onset:0000-00-00
Submitted: 2013-10-14
Entered: 2013-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Surgery
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310KOR002880

Write-up: This spontaneous report was received from a female consumer of unknown age reporting on herself via a company representative reporting on herself. Medical history or concurrent conditions were not reported. On 10-JUN-2013, the patient was vaccinated with first dose of GARDASIL injection (vials) (concentration and lot number were not reported). On 17-AUG-2013, the patient was vaccinated with second dose of GARDASIL injection (vials) (concentration and lot number were not reported). Concomitant medication was not reported. The patient reported that the planned date for the third dose (also reported as second dose) was 17-DEC-2013 and after the vaccination a surgery was planned (surgery not specified). The outcome of the planned surgery was unknown. Causality was not reported. Upon internal review, the surgery was medically significant. Additional information is not expected.


VAERS ID: 507857 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-18
Onset:2013-09-18
   Days after vaccination:0
Submitted: 2013-10-14
   Days after onset:26
Entered: 2013-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019633 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Nausea, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310IRL004963

Write-up: This case was received from the health authority on 03-Oct-2013. Ref 2013-018323. This case is part of a cluster of 5 cases after human papilloma virus vaccination (same batch number, same period of vaccination, all received from the health authority) and is linked with cases E2013-07663, E2013-07664, E2013-07668, E2013-07670. It is unknown whether the initial reporter was the same for the five cases. This case is medically confirmed as it was reported by a physician. A 12-year-old female patient, with no relevant medical history, received on 18-Sep-2013 an injection of GARDASIL (batch and lot # H019633, exp date 31-MAY-2015) 0.5 ml intramuscularly (dose in series not reported) and 20 minutes later, on 18-Sep-2013, the patient experienced an itchy rash on her face and neck and was nauseous. The reactions persisted for 3 hours. The reporter described it as an acute hypersensitivity reaction. The patient''s vitals were stable and she had no bronchospasm. Corrective treatment included PIRITON 4 mg orally. The patient had no concomitant treatment. At the time of reporting the patient had made a complete recovery. The health authority considered this case to be serious as an other medically important condition because it required intervention.


VAERS ID: 507860 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-18
Onset:2013-09-18
   Days after vaccination:0
Submitted: 2013-10-14
   Days after onset:26
Entered: 2013-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019633 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Immediate post-injection reaction, Rash, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310IRL004961

Write-up: This case was received from the health authority on 03-Oct-2013. Ref 2013-0183219. This case is part of a cluster of 5 cases after HPV vaccination (same batch number, same period of vaccination, all received from the health authority) and is linked with cases E2013-07661, E2013-07663, E2013-07668, E2013-07670. It is unknown whether the initial reporter was the same for the five cases. This case is medically confirmed as it was reported by a physician. A 12-year-old female patient, with no relevant medical history, received on 18-Sep-2013 an injection of GARDASIL (batch/lot n. H019633, 31-MAY-2015) 0.5 mL intramuscularly (dose in series not reported) and immediately after the vaccination, on 18-Sep-2013, the patient experienced an itchy rash on her face and neck. The reaction persisted for 2.5 hours. The reporter described it as an acute hypersensitivity reaction. The reporter described it as an acute hypersensitivity reaction. The patient''s vitals were stable and she had no bronchospasm. Corrective treatment included PIRITON 4mg orally. The patient had no concomitant treatment. At the time reporting the patient had made a complete recovery. The regulatory authority considered this case to be serious as an other medically important condition because it required intervention.


VAERS ID: 507869 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-16
Onset:2013-09-16
   Days after vaccination:0
Submitted: 2013-10-14
   Days after onset:28
Entered: 2013-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H010590 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest discomfort, Drug hypersensitivity, Dyspnoea, Erythema, Muscle tightness, Oropharyngeal pain, Pallor, Tremor
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVEMIR; NOVORAPID
Current Illness: Immunisation; Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR004950

Write-up: This case was received from the health authority on 03-Oct-2013. GB-MHRA-ADR 22255597. This case is medically confirmed. A 12-year-old female patient was vaccinated on 16-Sep-2013 with a dose of GARDASIL (batch/lot n. H010590, expiration date 28-FEB-2015) 0.5 mL intramuscularly (dose in series and site of administration not reported). Five minutes post vaccination, on 16-Sep-2013, she complained of shakiness, she was unable to breathe, her chest was tight and she was pale. The reactions recovered 10 minutes later. Then, 30 minutes after the injection, she complained of a sore throat, cherry red neck and was tight around the neck. Her colour was good, she had no stridor and was alert. She was taken to her GP by her mum. The GP suggested a probable allergic drug reaction. No corrective treatment was given as the symptoms resolved. Concomitant medication included LEVEMIR and NOVORAPID both for diabetes. At the time of reporting the patient had fully recovered. The regulatory authority considered this case to be serious as an other medically important condition.


VAERS ID: 507870 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-08-03
Onset:2009-08-04
   Days after vaccination:1
Submitted: 2013-10-15
   Days after onset:1533
Entered: 2013-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Blood creatinine increased, Blood urine present, Chemotherapy, Glomerulonephritis, Plasmapheresis, Proteinuria, Renal impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 11/2010, Blood creatinine, $g450
CDC Split Type: WAES1310DNK006102

Write-up: Case of adverse event received from non health care professional via Health Authorities on 08-Oct-2013 under the reference number 22252552 and 13-5895. The primary reporter was a lawyer from patient insurance company (PIC). A 13 year old female patient had received the third dose of GARDASIL (batch number unknown) via not reported route of administration in not reported site of administration on 03-Aug-2009 and later on, 04-Aug-2009, she developed pain in back (around the kidney region), blood in urine, excretion of too much protein and chronic disease (Glomerulonephritis). HA received information from PIC on 17-Sep-2013, patient insurance number 13-5895, which was the patient''s initial notification to the PIC. PIC has not taken a decision on the case. Adverse reactions: Pain in the back (around the kidneys), chronic kidney disease (glomerulonephritis) which manifests in occasional compromised renal function with blood in the urine and excretion of too much protein. Vaccination: The first GARDASIL dose given on 15-Jan-2009, batch number is unknown to the patient''s physician, it has not been noted in the journal. Second GARDASIL vaccination is given on 26-Mar-2009 with batch number NJ38950. Third GARDASIL vaccine is given on 03-Aug-2009, batch number unknown to the patient''s physician, it has not been noted in the journal. Event around the adverse reactions: The patient was hospitalized from 22-Nov-2010 to 07-Dec-2010. The patient was hospitalized when her creatinine level was over 450. Patient was during her hospitalization treated with antibiotics, chemotherapy, plasmapheresis (seven times in 14 days), adrenal hormone and blood pressure lowering drugs to treat to kidneys. When the patient was discharged from the hospital she continued with blood pressure lowering drugs and adrenal hormone. The patient''s disease is currently stable but the disease is chronic and will under certain conditions (not specified) break out again at any time. Over the past three years, the patient has generally had high protein excretion, and blood in the urine for many times. The patient has recently stopped the blood pressure lowering medication. The patient has always been well and healthy. At the time of reporting, the patient had not recovered.


VAERS ID: 507873 (history)  
Form: Version 1.0  
Age: 32.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-02-15
Onset:2013-04-01
   Days after vaccination:45
Submitted: 2013-10-15
   Days after onset:197
Entered: 2013-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0542AE / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Disturbance in attention, Fatigue, Haemorrhagic disorder, Headache, Memory impairment, Menstrual disorder, Pain, Pain in extremity, Palpitations, Pernicious anaemia, Sensory disturbance, Weight decreased
SMQs:, Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TOPIMAX
Current Illness: Immunisation; Human papilloma virus immunisation; Epilepsy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: This patient has been at the neurological outpatient clinic, and diagnostic center.
CDC Split Type: WAES1309DNK000911

Write-up: Case received from a health care professional via Health Authority in a foreign country on 20-Aug-2013 under reference number 22208215. Case medically confirmed. A 32 year old female patient had received an injection of GARDASIL (dose 1, batch number, intramuscular, site not reported) on 15-Feb-2013 and later on 01-Apr-2013 she developed MEMORY DIFFICULTIES, HEADACHE, DIFFICULTY CONCENTRATING, MENSTRUAL DISTURBANCE, TIREDNESS, PAIN IN ENTIRE BODY. HA coded drug end date as 18-Apr-2013, which presumably is the vaccination date of GARDASIL dose 2 because it is also reported by the HA that vaccination number 3 is not given. The patient''s medical history not reported. At the time of reporting, the outcome was not recovered. Follow up received from the foreign Health Authority on 10-OCT-2013: ADVERSE EVENTS: Memory problems, headache, tiredness, pain in the whole body, concentration difficulties, and menstruation disorders. The adverse events have not disappeared and the third HPV vaccine is not given. FOLLOW UP received on 26 SEP 2013 reported by the patient: ADVERSE EVENT: Pernicious anemia, bleeding disorders, weight loss, palpitation, sensory disturbances and pain in arms and legs. The patient has received the following treatment for the adverse event: B12 injection (pernicious anemia). She has been examined at the neurological outpatient clinic and diagnostic center. The patient was vaccinated with GARDASIL on 15 FEB 2013 (Batch No. H019462) and SILGARD on 18 APR 2013 (J000396). She has chosen not to receive the second vaccine because of the adverse events.


VAERS ID: 507878 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-05-09
Onset:2013-05-20
   Days after vaccination:742
Submitted: 2013-10-15
   Days after onset:148
Entered: 2013-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Borrelia test negative, CSF test normal, Sudden hearing loss
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 01/28/2011, GARDASIL, Drug Indication: Immunisation, batch number NN02290; 05/21/2010, GARDASIL, Drug Indication: Immunisation, batch number NL45420
Allergies:
Diagnostic Lab Data: A negative borrelia test including a cerebrospinal fluid test was performed on an unspecified date.
CDC Split Type: WAES1310DNK006354

Write-up: Case received from health care professional via Health Authority in a foreign country on 04-Oct-2013 under the reference numbers 22256262 and EFO7020. The primary reporter was a physician. Case is medically confirmed. A 15 year old female patient (weight:52 kg; height: 160 cm), had received the third dose of GARDASIL (batch number NN02290) via intramuscular route of administration in not reported site of administration on 09-May-2011 and later on 20-May-2013 she developed sudden deafness on the right ear. The Health Authority was in contact with the physician on 26-Sep-2013. A negative borrelia test including a cerebrospinal fluid test was performed on an unspecified date. The patient had no other medications. The patient had a history of vaccination with the first and second dose of GARDASIL (batch number NL45420 and NN02290) respectively) via intramuscular route of administration and not reported site of administration on 21-May-2010 and 28-Jan-2011. At the time of reporting, the patient had not recovered.


VAERS ID: 507886 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-18
Onset:2013-09-18
   Days after vaccination:0
Submitted: 2013-10-15
   Days after onset:27
Entered: 2013-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019633 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Nausea, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310IRL004995

Write-up: This case was received from the health authority on 03-Oct-2013. REF 2013-018321. This case is part of a cluster of 5 cases after GARDASIL (same batch number, same period of vaccination, all received from the IMB) and is linked with cases E2013-07661, E2013-07664, E2013-07668, E2013-07670. It is unknown whether the initial reporter was the same for the five cases. This case is medically confirmed as it was reported by a physician. A 12-year-old female patient, with no relevant medical history, received on 18-Sep-2013 an injection of GARDASIL, batch and lot n. H019633) 0.5 mL intramuscularly (dose in series not reported) and 30 minutes later, on 18-Sep-2013, the patient experienced a rash on her face and neck and was nauseous. The reactions persisted for 3 hours. The reporter described it as an acute hypersensitivity reaction. The patient''s vitals were stable and she had no bronchospasm. Corrective treatment included PIRITON (chlorphenamine) 4 mg orally. The patient had no concomitant treatment. At the time of reporting the patient had made a complete recovery. The IMB considered this case to be serious as an other medically important condition because it required intervention.


VAERS ID: 507914 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-01-19
Onset:2009-03-21
   Days after vaccination:61
Submitted: 2013-10-15
   Days after onset:1669
Entered: 2013-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1941U / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Arrhythmia, Atrial septal defect, Atrial septal defect repair, Blood pressure decreased, Bone pain, Cardiac murmur, Cardiovascular disorder, Computerised tomogram abnormal, Concussion, Contusion, Cyanosis, Dizziness, Dizziness postural, Dysaesthesia, Echocardiogram abnormal, Electrocardiogram PQ interval, Electrocardiogram QT interval normal, Electrocardiogram abnormal, Electrocardiogram ambulatory normal, Electrocardiogram normal, Electroencephalogram abnormal, Epistaxis, Erythema, Excoriation, Fall, Fatigue, Fundoscopy normal, Headache, Heart rate decreased, Hyperventilation, Local swelling, Loss of consciousness, Nasal inflammation, Nasopharyngitis, Nausea, Nuclear magnetic resonance imaging brain normal, Orthostatic hypotension, Paraesthesia, Periorbital contusion, Presyncope, Syncope, Tenderness, Tilt table test normal, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (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), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Osteonecrosis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: 10/23/2008, GARDASIL
Allergies:
Diagnostic Lab Data: 01-OCT-2010: EEG (electroencephalography): widespread dominant activity of 8-10 Hz sometimes activity above 13 Hz and 5-7 Hz activity diffuse amplitude up to 4 uV, no hemisphere difference. No focal or paroxysmal. Hyperventilation and photo stimulation: Nothing further. Sleep Stage I: normal pattern. Electrocardiogram Regular heart rate of 56, no abnormality; On an unknown date, Computerised tomogram (CT) scan: No suspected breach of maxillary/infraorbitalis; On an unknown date, Computerised tomogram (CT) scan: Nothing abnormal and sinus abnormal; On an unknown date Systolic blood pressure, 95; On an unknown date, Tilt table test: normal; On 26-JAN-2010: Pulse decreased 68; On 02-FEB-2010; Holter monitoring: normal; On 01-OCT-2010, Electroencephalogram: No abnormality; On 23-FEB-2010: Transesophageal echocardiography: Normal; ASD closure; On 01-JUN-2010, Echocardiography: Well fitting ASD occlusion no residual effect; On 21-MAY-2010, Ophthalmoscopy normal; On approximately June 2010 Echocardiography: Normal; On 16-DEC-2009, Electrocardiogram atrial septum defect; On 26-JAN-2010, Pulse decreased 68 (no units provided); On 07-JAN-2011, Tilt table test: Terminated without positive test, Pulse normal; On 15-FEB-2011, Nuclear magnetic resonance imaging brain (MRI) Brain no abnormality; On 16-FEB-2011, Electrocardiogram event monitoring ECG mild sinus rhythm; On 28-JUL-2011, Electroencephalogram (EEG) normal; On 19-DEC-2011, Electrocardiogram: Normal. PQ-distance and QT; 11/23/2009, Blood pressure, 119/73, Stand up for 4 min; 11/23/2009, Blood pressure, 113/65, Stand up for 3 min; 11/23/2009, Blood pressure, 117/65, Stand up for 2 min; 11/23/2009, Blood pressure, 104/67, Stand up for 1 min; 11/23/2009, Blood pressure, 96/58, Stand up for 2 min; 11/23/2009, Blood pressure, 109/70, Stand up for 1 min; 11/23/2009, Blood pressure, 108/65, (sitting); 01/26/2010, Blood pressure, 107/73; 02/15/2011, Blood pressure systolic, 95; 11/23/2009, Heart rate, 81, (sitting); 11/23/2009, Heart rate, 79, Stand up for 1 min; 11/23/2009, Heart rate, 76, Stand up for 2 min; 11/23/2009, Heart rate, 78, Stand up for 1 min; 11/23/2009, Heart rate, 70, Stand up for 2 min; 11/23/2009, Heart rate, 71, Stand up for 3 min; 11/23/2009, Heart rate, 65, Stand up for 4 min; 01/26/2010, Heart rate, 78; 05/21/2011, Intraocular pressure test, right eye, 13 mmHg; 05/21/2011, Intraocular pressure test, left eye, 12 mmHg; 01/26/2010, Respiratory rate, 16, Normal
CDC Split Type: WAES1310DNK004977

Write-up: Case received from healthcare professional via Health Authority on 01-Oct-2013 and 02-Oct-2013 under the reference number 22256170. The primary reporter is a physician. Case is medically confirmed. A 13-year old female patient had received the second and third dose of GARDASIL (batch number NJ01850, Lot # 1941U, exp date 12-DEC-2010 and NK05560 Lot # 0773X, exp 16-JUN-2011, respectively) via intramuscular route of administration and not reported site of administration on 19-Jan-2009 and 09-Jun-2009 and later on 21-Mar 2009 she developed several times vision disturbance/blackened for the eyes, syncope, presyncope, headache and on one occasion she fell down the stairs, bruise on right cheek and forehead, right cheek red and swollen, mild indirect tenderness at the clenching and skin abrasion on her left leg, easy nausea and amnesia and on 08-Aug-2009 she experienced dizzy. On 23-Nov-2009 she was diagnosed with orthostatic hypotension on 16-Dec-2009 diagnosed with atrial septum defect (corresponding to the fossa ovalis), on 26-Jan-2010 diagnosed with suspected hyperventilation and on 20-May-2010 diagnosed with nasal mucosa seen inflamed bilateral. On an unspecified date in the end of Aug-/beginning of Sep-2010 the patient experienced commotio-cerebri symptoms and big bulge in the neck and on 11-May-2011 the patient developed tired and on unspecified dates cold and slightly cyanotic fingers. The HA has received additional information from the reporting physician on 02-Oct-2013. The reporting physician has a suspicion that the patient''s orthostatic hypotension may be due to the patient''s treatment with GARDASIL. Summary from epicrisis 21-Mar-2009. The girl experienced blackened for the eyes and the patient fainted and fell down the stairs. She was unconscious, probably around 1 minute. She is now bruised on the right cheek, forehead skin abrasion on her right leg. Has amnesia for the event. No dizziness or vomiting. Mild headache localized to the right side. Easy nausea. Right cheek is red and swollen, mild indirect tenderness at the clenching. CT shows no suspected breach of either maxillary or infraorbitalis. Treatment: None. Note medical record 30-Jul-2009: Persistent sore facial skeleton after the accident. CT scan showed nothing abnormal. Note medical record 01-Sep-2009: Superficial lesion of the head without any specification. In March lipothymia where the patient fell and hit the right half of the face. The patient has no functional face problems, but still sense mild dysesthesia on the right cheek and pressure tenderness around the ulnar infraorbitalis dexter. No difficulty swallowing. Sinus scan normal conditions in both jaw caves. Cranium/Face: Symmetric conditions. No conture leaps at orbital ridges. Os zygomaticus symmetric and stable on the two sides. Is sore over the right ulnar infraorbitalis. The skin quite unremarkable. No swelling or subcutaneous accumulations. Eyes: Free eye movements in all planes. Normal pupils. Anterior mouth and neck normal. Improvement may be seen up to a year after this. Wait and see how the situation develops. There can be no treatment. Medical record 01-Sep-2009: The mother reports that the patient on 08-Aug-2009 has been malaise and dizzy and she has the same symptoms today. Medical record 02-Sep-2009: Again "attack" of dizziness and malaise, not fainting. 23-Nov-2009, Outpatient Clinic, Hospital. 14 year old girl referral from a GP due to dizziness. The patient was over the past half year had attacks of dizziness, where it blackened for the eyes and she became malaise. The dizziness comes primarily when the patient must concentrate and if she is stressed. The patient has no palpitations, no sweating, no nausea. There has been no loss of consciousness or convulsions. The patient has sometimes headaches associated with the dizziness attacks, but not always, and may also have a headache when there is no dizziness. The headache does not affect the patient''s everyday life, and it is only because the doctor asked about it, it was mentioned. No further complaints. Physical examination: Healthy girl. Totally normal movement. Blood pressure 131/67, pulse 63. The patient stands up: After 1 minutes: Blood pressure 96/58, pulse 78, at 2 minutes: Blood pressure 117/65, pulse 76, at 3 minutes: Blood pressure 119/73, pulse 79, at 4 minutes: Blood pressure 104/67, pulse 81. The patient becomes dizzy and unwell and must sit down. After sitting a few minutes, the blood pressure 109/70 and pulse 65. Stands up: After 1 minute: Blood pressure 113/65, pulse 71, after 2 minutes: Blood pressure 108/65, pulse 70. Heart sound: Regular. Systolic murmur grade 2-3. Possible mitral ejection sound? Pulmonary: normal air exchange, no murmur. Abdomen: Soft, not tender. No hepatosplenomegaly. Conclusion and plan: The history and blood pressure measurement indicates most that the patient has a degree of orthostatic hypotension, which can be reproduced in the outpatient clinic. The patient is advised to stand up slowly and sit down if she gets dizzy and take her head between her legs. Medical records 16-Dec-2009 Outpatient Clinic (Section H), Hospital Observation on suspicion of cardiac vascular disorder. Cardiac murmur has been heard, why patient referred for echocardiographic examination. Echocardiography shows a atrial septum defect (ASD) corresponding to foramen ovale with left-right flow and no volume load and slightly increased anti degree flow rate on the right side. No other accompanying malformations. Conclusion and plan: It is about a atrial septum defect corresponding to the fossa ovalis, that explain the murmur and there are undoubtedly treatment indication and probably it will be possible to make this of an interventional cardiac catheterization. If it is not possible, indication for an operative closure. 26-Jan-2010 Section H Hospital diagnose short-term loss of consciousness / syncope. The patient has briefly been dizzy and unwell and cold, perhaps slightly cyanotic fingers. Current situation: Was this morning slightly dizzy. Got improved fast. After a few hours she started feel dizzy and mild pressure upwards in the head, no headaches or vision disturbance, besides she gradually began to see black dots for eyes. There are plans for surgery date in week 8. Ambulance arrived and she was somewhat weak and dizzy. Blood pressure 107/73 and also the normal saturation of 100. The pulse is initially 78 and drops to 68, normal respiratory rate of 16. There has been no vomiting or disease with diarrhea, or similar. General condition: Good, completely unaffected (1 - S hours after the attack began). Normal nice colours. Normal tonus and strength of arms. Hear: earlier systolic murmur grade 2-3. Regular=heart rate = Peripheral pulse. No pulmonary abnormality. Neurology: can stand on one leg, but get dizzy in connection with the change from lying to standing up. Conclusion and plan: Initially does not sound like a cardiac-triggered problem. Looks more like hyperventilation. There is no indication for blood tests or other, and the patient goes home. Epicrisis 02-Feb-2010, Section H: results of Holter monitoring is now available which shows only sinus rhythm, including those times when palpitations and dizziness are described. There is thus no reason for any further and we await the convening of catheter-based closure of ASD. Discharge epicrisis 25-Feb-2012. The patient has been hospitalized 23-25Feb 2010 at the paediatric ward Hospital. Due to TEE (transoesophageal echocardiography) and catheter-based ASD closure. Uncomplicated procedure. Amplatzer ASD occluder has been inserted. Subsequently, the echo is completely normal. Discharged with MAGNYL 125 mg daily until the outpatient control in 3 months. Outpatient epicrisis 05-Mar-2010, Cardiology ward B, Hospital: The mother calling. The patient has after ASD occlusion developed severe headache and a few times nosebleeds. They gave PANODIL (other mfr) as a basis for headaches and supplements sometimes with IPREN (other mfr). The patient was before catheter occlusion informed that headache could be a problem, but usually transient. 04-Mar-2010: The mother calling again. The headache is now gone, but problems remain with nosebleeds. Epicrisis 20-May-2010 (Ear, Nose, Throat physician): The nasal mucosa is seen inflamed bilateral, septum centred. There is a fairly strong hurled vein on the right side of the transition between mucosa and skin. Similarly, on the left side. The area on the right side is lapis brushed. BACTROBAN (other mfr) on the basis of the strong irritation of the mucous membrane. Get time for lapis treatment on the left side in 6 weeks if there is bleeding. 21-May-2010 epicrisis, ophthalmologist: Episodes of flickering for the eyes. Eye pressure right 13.0mmHg left 12.0mmHg. Position sitting, motility and pupils normal examination, normal examination. Field of vision, examination normal. Slit lamp examination, clear media. No intraocular, ophthalmoscopy examination: normal, well defined papillae''s and age-related vascular and centre without pathology. No treatment. Control after need. Outpatient epicrisis 01-Jun-2010, Cardiology ward B, Hospital: The patient had after the catheter-based ASD occlusion some problems with headaches and nosebleeds, but this has now disappeared. She is now generally well and actively participate in any physical activity. The patient has repeatedly complained that during football games she can feel half-sided visual field failure. She was therefore examined by an eye specialist, found normal conditions. Echocardiography: Showing a well-fitting ASD occlusion no residual defect. There is no further enlargement of the right-side cavities. All valves function normally. Left sided arcus without ductus or coarctation. Conclusion: ASD is completely closed. The patient''s specific symptoms cannot be seen in the context of ASD occlusion, there is no evidence of peripheral embolic phenomena. MAGNYL treatment may cease in 3 months. Outpatient epicrisis 01-Sep-2010, Hospital: The patient had the last week a fainting episode when she was in the room, did not realize what was happening until she regained consciousness on the floor. There should be renewed ECHO and ECG. The patient is operated for ASD, successful outcome. Have made Holter monitoring that has been normal. We must consider whether there is a basis for tilt table test (which was previously found to be a tendency to orthostatic hypotension). Outpatient epicrisis 06-Sep-2010, H-ward, hospital: Short term loss of consciousness / syncope. Seen because of lipothymia. Had a week ago a fainting situation. Has amnesia of the event itself. May be the usual orthostatic problems. She had distinct commotio cerebri symptoms after the event and big bulge in the neck, but is completely recovered. Echocardiography shows completely normal. Conclusion and plan: The patient has no doubt, as previously noted, orthostatic problems, but have now had a slightly unexplained fainting reaction and ordered therefore EEG examination. Epicrisis 01-Oct-2010, N-ward, Hospital: EEG (electroencephalography): widespread dominant activity of 8-10 Hz sometimes activity above 13 Hz and 5-7 Hz activity diffuse amplitude up to 4 uV, no hemisphere difference. No focal or paroxysmal. Hyperventilation and photo stimulation: Nothing further. Sleep Stage I: normal pattern. ECG: Regular heart rate of 56. Conclusion: No abnormality. 08-Oct-2010: The patient has lately had 3 occasions of darkening for the eyes, but no actual fainting. EEG examination a week ago is normal. Outpatient epicrisis: 16-Nov-2010 hospital. Meetings with patient for readout of R test. The patient has had one episode with darkening of the eyes during a basketball game, where she got a friend to activate the button. R-test was not activated adequately why there is no data, no automatic recordings has been seen at that time. R-test attached again. Outpatient epicrisis 25-Nov-2010, B- patient ward, Hospital: patient meeting to readout R test. There has been no symptoms during the week. R-test attached again. Epicrisis 08-Dec-2010, B-ward, Hospital: R-test readout, no symptoms during the period. There is not much on the automatic recordings. Therefore instated with new R-testing device. Epicrisis 17-Dec-2010, B-ward, hospital: In the period there was an attack where the R test unfortunately was not attached. R-test has not worked during the period. Epicrisis 22-Dec-2010, B-ward, Hospital: No attack during the period. Epicrisis 07-Jan-2011, B-ward, Hospital: Studies: Tilt table test. During the test, the patient describes symptoms of tingling in the left arm and hand and left eye flicker tendency spread to both eyes. Throughout the session normal pressure and pulse. Terminated without positive test. Conclusion and plan: Completion. Informs the patient and the mother that they in the light of numerous examinations have not found anything cardiopulmonary suspicious, it is probably orthostatic hypotension, cannot either exclude an event of vasovagal problematic, but there in the light of current findings and examinations there is no indication for any further action, and the patient''s investigations are considered as terminated at the cardiology ward. Epicrisis 19-Jan-2011, H-ward, Hospital: the patient did the day before yesterday faint. Epicrisis 24-Jan-2011, H-ward, Hospital: The patient is annoyed that there is no explanation for her fainting. Epicrisis 01-Feb-2011, H-ward, Hospital: The patient experienced yesterday another fainting. Epicrisis 08-Feb-2011, B-ward, Hospital: R test attached. The patient has fainted 3 times since 14-Jan-2011. Also had a presyncope on 07-Feb-2011. She gets no warning. Epicrisis 15-Feb-2011, H-ward, Hospital: MRI of the cerebrum: No abnormality. Epicrisis 16-Feb-2011, B-ward, Hospital: R test is readout and removed. Event button was activated 2 times in the morning of 16-Feb-2011, when she has a typical attack. Epicrisis 18-Feb-2011, B-ward, Hospital: There has been response to R-test from 08-16Feb2011. It has been activated 2 times on the morning of 16-Feb-2011 at 06.40 and 06:52. Both times right after syncope, when she also was dizzy in the head. There is both times measured a sinus rhythm with 68-70 in frequency per minute. That is mild sinus arrhythmia. There is also recorded ECG during the attack, which also shows normal sinus rhythm. The other ECG printouts from monitoring period show the same sinus rhythm. Conclusion: Immediately the R-test does not give a reason to believe that the patient''s syncope is arrhythmia triggered. A tilt-table test was performed on 07-Jan-2011 when the patient had the same symptoms as during the R-test, but which neither showed pulse or blood pressure decrease. Immediately there is still no good explanation for the patient''s syncope tendencies. On the other hand, we can assume that the reason for the syncopes are harmless. Preliminary there is no indication for further investigation with regards to treatment. Epicrisis 04-Mar-2011, H-ward, Hospital: R test normal. Neither the mother nor the patient believes that further follow-up in this place is needed. It turns out that there are some school related problems that might influence the patient''s situation. At the same time there is the event of orthostatic hypotension, the patient must take adequate measures. Epicrisis 12-May-2011, H-ward, Hospital: contacted by the mother. The patient has continued fainting, the latest yesterday. She had in the evening a fainting attack, and was subsequently very tired. The mother has repeatedly noted that fainting attacks often happens in the evening. Renewed EEG will be performed. Epicrisis 28-Jul-2011, H-ward, Hospital: Answers to EEG: EEG is normal. The patient has not during the summer holiday fainted without notice, but probably tendency to orthostatic events in the hot south. Epicrisis 19-Dec-2011, B-ward, Hospital: The patient is bothered by the almost daily presyncope events, particularly in relation to postural change, and she has at the boarding school had a few episodes of lipothymia. She can stop attacks by lying down or have her head between her legs. No chest pain. No arrhythmia sensation. No family history of ischemic or structural heart disease, and there is no sudden death in the family. ECG taken today with normal PQ-distance and QT. There is no pre- or post-excitatory potentials. Conclusion and plan: Anamnestic, there are strong indications that the patient''s primary problems are a mixture of orthostatic hypotension and vasovagal syncope mixed, probably of neurovascular type. Have a low blood pressure and is before measured at 95 systolic. The patient started treatment tablet GUTRON (other mfr) 2.5 mg 3 times daily for the next 14 days and thereafter a potential dose increase. Epicrisis 01-Feb-2012, B-ward, Hospital: Syncope: 1, had forgotten pills a few days, otherwise no attack. Presyncope: None. No more discharge summaries attached. The patient was previously healthy, and was vaccinated with the first dose of GARDASIL (batch number NJ01850, Lot # 1941U, Exp date 12-DEC-2010) via intramuscular route of administration and not reported site of administration on 23-Oct-2008. At the time of reporting, the outcome was recovered with sequelae for syncope, presyncope, visual disturbance and orthostatic hypertension, recovered for ASD, commotio-cerebri symptoms, amnesia, headache, fell down stairs, nasal mucosa inflamed and big bulge in the neck, recovering for nausea and not reported outcome for all other events. According to the reporter, the reaction orthostatic hypertension was related to vaccination.


VAERS ID: 507916 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-15
Entered: 2013-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019078 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Dizziness, Dysphagia, Dyspnoea, Hypoaesthesia, Nausea, Paraesthesia
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), 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 (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
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: Blood pressure: not reported; Heart rate: 140 bpm, 112 bpm and 130 bpm.
CDC Split Type: WAES1310GBR006530

Write-up: This case was received from the health authority on 04-Oct-2013. GB-MHRA-ADR 22258057. This case is medically confirmed. A 12 year female patient, with no medical history reported, received on an unreported date, an injection of GARDASIL, (batch and lot number H019078) 0.5 mL intramuscularly in the left arm, dose in series not reported. It was reported the patient experienced anaphylactic reaction described as follow: ten minutes after immunization, she left the medical office and then she went back to class with no problems at this time. One hour later she returned to the health care professionals, feeling nauseous, tingling in her fingers, and her left arm felt numb. She began complaining of dizziness, and she lay on the floor. She was also complaining of difficulty in swallowing and breathing and tingling on her face. No rashes or swelling present. Two hours fifteen minutes post-immunisation, a first dose of adrenaline was given and paramedics called. A second dose of adrenaline was given. Paramedics arrived. They recorded her blood pressure, saturations and heart rate: 104, 112 bpm and 130 bpm when paramedics arrived, then they stabilised her. At the time of reporting, the patient was recovering. The MHRA considered that case serious due to life threatening. Upon internal review the Company decided to code tingling in fingers and left arm felt numb which were mentioned in the narratives but not coded by the HA.


VAERS ID: 507918 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-19
Onset:2013-10-01
   Days after vaccination:12
Submitted: 2013-10-15
   Days after onset:14
Entered: 2013-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H022294 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blindness transient, Dizziness, Headache, Migraine, Rash, Vision blurred
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: WAES1310SWE006529

Write-up: Case of adverse event received from health care professional via company representative on 03-Oct-2013. Additional information was received on 10-Oct-2013. The primary reporter (on both reported occasions) was a school nurse. A 11 year old female patient with no medical history reported, had received the first dose of GARDASIL, (batch and lot number H022294) via not reported route of administration in not reported site of administration on 19-Sep-2013 and later on 27-Sep-2013 she experienced rash (on right shoulder down to the chest, but also on back and arm). She visited a doctor for the rash, the doctor believed the rashes were caused by some kind of bite. In the evening of 01-Oct-2013, upon standing up, she developed headache, dizziness and temporary vision loss and/or blurred vision (unclear which or both). The symptoms continued the next day and on 02-Oct-2010 the patient visited the core hospital. They believed the rash was due to bites (as the previous visited doctor) and they suspect migraine. According to the reporter, none of the visited doctor''s were aware of the patient''s GARDASIL vaccination. She was better on 03-Oct-2013. The nurse was wondering if symptoms were due to vaccination hence she contacted company representative for more information. On 10-Oct-2013, the outcome for all events were reported as recovered.


VAERS ID: 507976 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-08-29
Onset:2012-09-26
   Days after vaccination:28
Submitted: 2013-10-16
   Days after onset:385
Entered: 2013-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H003811 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Chest pain, Dizziness, Dyspnoea, Fatigue, Headache, Musculoskeletal pain, Pyrexia, Renal pain, Systemic lupus erythematosus
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MERCILON; ERCOQUIN
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1302DNK003426

Write-up: Case received from a physician via the Health Authority on 23-Jan-2013 under the reference numbers DK-DKMA-ADR 21995878 and EFO4038. Case medically confirmed and assessed as non-serious. A 21-year-old female patient (weight and height not reported) with no relevant medical history reported, had received the first dose of GARDASIL (batch and lot number H003811) via not reported route and site of administration on 29-Aug-2011. 28 days later, on 26-Sep-2011, the patient developed thorax pain, shoulder pain, dyspnea and fatigue. Investigations performed (date not reported) showed systemic lupus erythematosis (SLE). Therefore the patient was examined in order to determine whether the events were symptoms of SLE. However, SLE was excluded by cardiologist and pulmonologist. There were no findings. No other medications were reported. At the time of reporting, the patient had not yet recovered. No causality assessment was provided. No further information expected. Follow up information received from patient insurance company via Health Authority on 04-Oct-2013. HA received follow up information on 17-Sep-2013: Case received from the patient insurance J. no. 13-6097 in terms of the patient''s own report. Note that the patient insurance company has not made a decision on the matter yet. Note from the HA: In the initial report, the reporting physician reporting that GARDASIL was given in 2011 and that the reactions started in 2011, but in the report from the patient to the patient insurance company 2012 was reported. HA has therefore been in contact with the reporting physician that confirms that the correct year is 2012. The second dose was given 08-Nov-2012 (batch and lot number H016967) the third dose has not been given. Patient''s description of the reactions: Around 12-Sep-2012, after the first HPV vaccination, she developed fever and pain in the area around the kidneys and was on sick leave. Thereafter the pain spread to the chest and to the back in the area around the lungs. In the same time feeling of chronic fatigue. After the second vaccination the pain became worse and addition of dizziness and headache. The patient was hospitalised on hospital rheumatology department. The patient has still problems. The patient had no longer fever, but constant pain in the area around the kidney''s, chest region and back around the lungs. Constant feeling of chronic fatigue, daily dizziness and periodic headache. The patient is treated with tramadol actiavis 50 mg 2 times daily, klorzoxazone "DAK" 250 mg and PANODIL 500 mg 6 times daily. The patient is on 100% sick leave due to the reaction. Fatigue has been changed to chronic fatigue, renal pain, back pain dizziness and headache has been added by the HA. MERCILON and ERCOQUIN has been added as concomitant medications.


VAERS ID: 507979 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-18
Onset:2013-09-18
   Days after vaccination:0
Submitted: 2013-10-16
   Days after onset:28
Entered: 2013-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019633 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Rash, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Psoriasis; Eczema
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310IRL004965

Write-up: This case was received from the health authority on 03-Oct-2013. IMB-REF 2013-018320. This case is part of a cluster of 5 cases after human papilloma virus vaccination (same batch number, same period of vaccination, all received from the IMB) and is linked was cases E2013-07661, E2013-07663, E2013-07664, E2013-07668. It is unknown whether the initial reporter was the same for the five cases. This case is medically confirmed as it was reported by a physician. A 12-year-old female patient received on 18-Sep-2013 an injection of GARDASIL (batch and lot #. H019633, Exp date 31-MAY-2015) 0.5 mL intramuscularly (dose in series not reported) and 10 minutes after the vaccination, on 18-Sep-2013, the patient experienced an itchy rash on her face and neck. The reporter described it as an acute hypersensitivity reaction. The patient''s vitals were stable and she had no bronchospasm. Corrective treatment included PIRITON 4 mg orally. The patient''s medical history included psoriasis and eczema as concurrent conditions. The patient had no concomitant treatment. At the time of reporting the reactions were persisting. The IMB considered this case to be serious as an other medically important condition because it required intervention.


VAERS ID: 507982 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-08-25
Onset:2010-11-18
   Days after vaccination:450
Submitted: 2013-10-16
   Days after onset:1062
Entered: 2013-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Epilepsy, Petit mal epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1310DNK006554

Write-up: Case of adverse event received from a non-health professional via Health Authorities in a foreign country on 04-Oct-2013 under the reference number EFO6969 and 22254006. The primary reporter was the patient''s mother. A 13 year old female patient (weight: 65 kg; height: 174 cm) had received probably second dose (not specified in the HA report) of GARDASIL (batch number not reported) via not reported route of administration in not reported site of administration on 24-Feb-2009 and later on, 02-May-2009, she developed absence attacks. The patient had probably received the third dose (not specified in the HA report) of GARDASIL (batch number not reported) via not reported route of administration in not reported site of administration on 25-Aug-2009 and later on 18-Nov-2010, she developed epileptic seizure. According to the HA report the absence attacks started between the second and the third dose of GARDASIL vaccine. She was not then treated for the absence attacks. on 18-Nov-2010 she experienced her first epileptic seizure and was hospitalized. She experienced additional epileptic seizures, one on 26-Dec-201 and another on 03-Jan-2013, and was hospitalized. On her last hospitalization (03-Jan-2013), the patient received medication/treatment for her seizures. She has no other medications. The health authority has requested medically confirmation as well as vaccination dates and batch numbers for all three GARDASIL vaccinations. Patient has no other health problems in general. At the time of reporting, the patient had not recovered. Company comment: The company also coded D3 as suspected vaccine due to the epileptic seizures occurring post-vaccination. Corrective version was created on 11-Oct-2013: Latency for epileptic seizure was added (D3).


VAERS ID: 508419 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-09-25
Submitted: 2013-10-17
   Days after onset:22
Entered: 2013-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash erythematous, Rash generalised, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin
Current Illness: Immunisation
Preexisting Conditions: Sinusitis; Dermatitis contact
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR006857

Write-up: This case was received from the health authority on 08-Oct-2013. GB-MHRA-ADR 22261135. This case is not medically confirmed as it was reported by a consumer. A 12 year female patient (weight: 31.29 kg) received on an unreported date an injection of GARDASIL (batch number not reported) intramuscularly, dose in series and site of administration not reported. She was also concomitantly treated with amoxicillin for sinus infection on an unreported date. On 24-Sep-2013, the patient experienced hives. The rash started appearing on the back of her hands around. It then started to spread quite rapidly to the rest of her body and became increasingly itchy on 25-Sep-2013 (coded as severe by the agency). By the time she had got home, around an hour and a half later on 25-Sep-2013, her rash was bright red and covered her from head to toe. She couldn''t stop herself from scratching and has got a doctor appointment. She was prescribed loratadine 5ml twice a day but the rash was worse, as did the itching, on the following day. Health professional suggested that she took PIRITON which can be taken every four hours so that there wasn''t such a gap between doses. The rash was very bad according to the patient''s daughter who wasn''t sure if it was an allergic reaction to the vaccine or Measles. The patient''s medical history included adhesive plaster sensitivity described as allergy to plasters and sinus infection which occurred the week before the vaccination. At the time of reporting the patient has not recovered from the adverse events. The agency considered that case serious due to be medically significant.


VAERS ID: 508450 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-28
Onset:2013-09-30
   Days after vaccination:2
Submitted: 2013-10-17
   Days after onset:17
Entered: 2013-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Blood count normal, Blood electrolytes normal, Blood glucose normal, C-reactive protein normal, Dizziness, Electrocardiogram normal, Fall, Head injury, Headache, Loss of consciousness, Malaise, Nausea, Wound
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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; Drug hypersensitivity
Preexisting Conditions: GARDASIL, Dose 2, No adverse event; GARDASIL, Dose 1, No adverse event
Allergies:
Diagnostic Lab Data: 30-SEP-2013: Blood glucose, blood count, blood electrolytes NOS, C-reactive protein, blood pressure and ECG, all normal.
CDC Split Type: WAES1310FRA006633

Write-up: Case received from the Health Authorities on 10-Oct-2013 under the reference number SE20130619. A 16-year-old female patient with a history of allergy to CLAMOXYL had received the third dose of GARDASIL (batch number not reported) on 28-Sep-2013 in the morning. On 28 and 29 September, she was doing well. On 30-Sep, when getting up at 6 am, the patient experienced headache, abdominal pain and nausea. As she went to the toilet, she experienced a malaise with dizziness and then lost consciousness. She fell and experienced a wound of the lip. She then fell a second time in the same context and this time was found to have occipital injury. She was admitted to the Emergency Unit Care. Blood glucose, blood count, blood electrolytes, C-reactive protein, blood pressure and ECG were normal. Physical examination was normal too. The emergency physician wondered about the causality of GARDASIL. To be noted that the patient had no usual treatment. She had received the first and second doses of GARDASIL uneventfully. At the time of reporting, the patient was recovering. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 I1) according to the foreign method of assessment. Upon medical review the company judged relevant to code the adverse events headache, abdominal pain and nausea which were mentioned by the Health Authorities in the narrative but not coded.


VAERS ID: 508467 (history)  
Form: Version 1.0  
Age: 26.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-10-12
Onset:2012-10-17
   Days after vaccination:5
Submitted: 2013-10-17
   Days after onset:365
Entered: 2013-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H011751 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Blood test, Nuclear magnetic resonance imaging, Urine analysis
SMQs:, Retroperitoneal fibrosis (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: WAES1310DNK006598

Write-up: Case of adverse event received from health care professional via Health Authority on 09-Oct-2013 under the reference number 22257346 and EFO7030. The primary reporter was a physician. Case is medically confirmed. A 26 year-old female patient (weight: 60 kg; height: 165 cm) with no medical history reported, had received the first dose of GARDASIL, (batch/lot number H011751) via intramuscular route of administration in not reported site of administration on 12-Oct-2012 and later on, 17-Oct-2012, she developed lower back pain on the left side. Treatment refractory. She was thoroughly investigated with blood tests, urine tests and MRI-scan (results and lab dates not reported). She has no other vaccines or medications. At the time of reporting, the patient had not recovered.


VAERS ID: 508477 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-08
Onset:2013-03-09
   Days after vaccination:1
Submitted: 2013-10-17
   Days after onset:221
Entered: 2013-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H01899 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Amenorrhoea, Anti-VGKC antibody positive, Asthenia, Convulsion, Electroencephalogram normal, Encephalitis, Hypermetabolism, Hypometabolism, Immunoglobulin therapy, Lumbar puncture normal, Muscle spasms, Musculoskeletal stiffness, Myalgia, Neurological symptom, Opisthotonus, Pain, Positron emission tomogram abnormal, Scan normal, Speech disorder, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dystonia (narrow), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Fertility disorders (broad), Generalised convulsive seizures following immunisation (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? No
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; Menstruation normal
Preexisting Conditions: Hep B vaccine, No adverse event; MMR vaccine, No adverse event; DTaP vaccine, No adverse event
Allergies:
Diagnostic Lab Data: June 2013: Lumbar puncture normal. EEG normal including during episodes. Scan normal. PET/CT scan: hypermetabolism in bilateral fronto-opercular area; hypermetabolism in striatum; hypometabolism in posterior cingulum. Anti-VGKC antibody negative right after second cure. Anti-VCKB antibody, 260 IU/l
CDC Split Type: WAES1310FRA006590

Write-up: Case received from the Health Authorities on 10-Oct-2013 under the reference number MA20131901. This case was first reported to the Health Authorities by the patient''s mother. The symptomatology was confirmed by the neurologist who was following the patient. A 15-year-old female patient had received the first dose of GARDASIL (batch number H01899) via intramuscular route on 08-Mar-2013. She had no relevant medical history. Up to then her vaccinations (DTaP/IPV, MMR and HepB) had been uneventful. She had regular menstruation since 12 years old. On 09-Mar-2013, i.e. one day after vaccination, she spontaneously experienced a first spasmophilia-like fit with tremor and opisthotonus attitude. The fit lasted approximately for 5 minutes, and the patient subsequently complained from muscle pain. In the following days and weeks, the fits increasingly repeated following the same symptomatology, occurring up to 2 to 3 fits a day, and became protracted, lasting up to 10 minutes, despite a treatment with magnesium. On 01-Apr-2013 the patient was hospitalized. She presented then with severe asthenia. As the whole work-up was negative she was discharged. Added to the previously described seizures the patient also experienced two further types of fits: episodes of painful stiffness affecting electively the lower limbs and the shoulders with blockage and impossibility to walk. Those flare-ups could last up to half an hour. Regressive episodes with modification of speech: "the teenager spoke like a young child." These episodes were transient and uncontrollable although occurring consciously. In June-2013, the patient was hospitalized again in neurological service in order to widen the work-up. Lumbar puncture and EEG were normal in June 2013, including the EEG performed during the episodes. CT scan were normal. Search for antibodies showed slow positivity of anti-VGKC antibodies (potassium channels) at 260 IU/l. Except for that, the whole antibodies search was normal. PET/CT scan for the whole body was performed and showed marked hypermetabolism in bilateral fronto-opercular area, associated with a more moderate hypermetabolism in right striatum, and moderate hypometabolism in posterior cingulum. The remainder of brain metabolism seemed preserved, particularly in the limbic regions. Considering the positivity of anti-VGKC antibodies and the pictures found by PET scan, the whole picture could suggest encephalitis and it was then decided to perform immunoglobulin cures and to give TEGRETOL as corrective treatment. The first immunoglobulin cure was performed at the end of June 2013 and led to a clear regression of the symptoms. In the beginning of July a few episodes occurred again. A second immunoglobulin cure was performed and leg again to a regression of the symptoms with a few episodes less frequent and asthenia. Search for anti-VGKC antibodies was negative but performed right after immunoglobulin cure. They should be rechecked in Oct-2013. To be also noted an amenorrhea persisting since Apr-2013 (15 years old) whereas the patient was menstruated in a regular way since the age of 12. The Health Authorities report concluded to persisting complex neurological symptomatology occurring the day after a vaccination with the first dose of GARDASIL. The neurologist was called and the symptomatology was medically confirmed. The following arguments were compatible with a somatic origin: positivity of anti-VGKC antibodies (to be confirmed in a sample to be perform at distance from immunoglobulin cure), signs of hypermetabolism found by brain PET scan, regression of the symptoms under immunoglobulin cure. Furthermore, the child psychiatrists consulted ruled out a psychopathological-type pathology. However, questions arouse concerning atypical clinical symptomatology and concerning the assessment of GARDASIL considering the chronology (occurrence one day after receiving the first dose). The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S2 I1) according to the method of assessment. Upon medical review the company judged relevant to code the adverse events suspicion of encephalitis, speech disorder, walking difficulty and asthenia, which were mentioned by the Health Authorities in the narrative but not coded. At the time of reporting, the patient had not recovered.


VAERS ID: 508566 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-02
Onset:2013-09-02
   Days after vaccination:0
Submitted: 2013-10-17
   Days after onset:45
Entered: 2013-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypotonia, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RHINOCORT; VENTOLIN
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR007134

Write-up: This case was received from the health authority on 08-Oct-2013. GB-MHRA-ADR 22261134. This case is medically confirmed. A 13 year old female patient, with no medical history reported, received on 02-Sep-2013 an injection of GARDASIL (batch number J005923) 0.5 mL intramuscularly, dose in series and site of administration not reported. She was also concomitantly treated by inhalation with RHINOCORT and VENTOLIN. Three to four minutes post vaccination, the patient became floppy but not unconscious with arm and head shakes. An ambulance was called and the patient had no concerning features from their assessment but was taken to hospital to be seen by a doctor. Within 30 minutes of the incident, the patient walked normally out to the ambulance and is back in school this afternoon. At the time of reporting the patient had fully recovered. The regulatory authority considered that case serious due to patient''s hospitalization.


VAERS ID: 508755 (history)  
Form: Version 1.0  
Age: 33.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-10
Onset:2013-10-01
   Days after vaccination:52
Submitted: 2013-10-18
   Days after onset:17
Entered: 2013-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Biopsy cervix abnormal, Cervical dysplasia, Smear cervix normal
SMQs:, Reproductive premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Uterine and fallopian tube malignant tumours (broad), Uterine and fallopian tube tumours of unspecified malignancy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Smear cervix normal
Allergies:
Diagnostic Lab Data: 10/01/2013, Biopsy, CIN grade III type 16 N/A; Smear cervix, Normal
CDC Split Type: WAES1310ISR006929

Write-up: This spontaneous report as received from a 33 year old female nurse refers to herself. Prior to vaccination the patient had repeating normal pap smears. On 10-AUG-2013 the patient was vaccinated with the first dose of GARDASIL (lot#, expiration date, dose and route unspecified). On approximately 01-OCT-2013 the patient was diagnosed with (Cervical Intraepithelial Neoplasia) CIN grade III type 16 on biopsy. The patient was placed on treatment (unspecified). GARDASIL second dose was not administered yet. The event outcome was unknown. Upon internal review CIN grade III type 16 was considered to be medically significant. Additional information has been requested.


VAERS ID: 508765 (history)  
Form: Version 1.0  
Age: 29.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-01-15
Submitted: 2013-10-18
   Days after onset:641
Entered: 2013-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Hysterectomy, Lymphadenectomy, Lymphadenopathy, Positron emission tomogram abnormal, Smear cervix normal, Uterine cancer, Vaginal discharge, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Uterine and fallopian tube malignant tumours (narrow), Uterine and fallopian tube tumours of unspecified malignancy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: Familial risk factor, patient''s grandmother; Familial risk factor, Patient''s father
Allergies:
Diagnostic Lab Data: Physical examination (2012): Patient was in a general good condition, the examination showed a sprained cervix and the tumor was located in the cervix canal surrounded by cervix tissue that appeared to be normal. The size of the tumor was 5 centimetres (cm). Rectal examination (2012): Right parametrium with a lump up to 1 cm was palpable characteristic to the tumor distrubution of the pelvis. Positron Emission Tomography-Computed Tomography (PET CT) (2012): Imaged lymphadenopathy from both sides of the pelvis reaching the level of L4-L5, 1.5 cm lymph node under the aorta bifurcation, peri-sacral and peri-aortic lymph nodes up to 2 cm. PET.CT (unknown date following treatment and before surgery): reduction in the above findings but they were not eliminated. Abdominal exploratory test: identifies normal intestine and peritoneum, pelvis lymph nodes in different sizes up to 2 cm, about 4 cm lymph nodes at the common iliac bifurcation on the left under the branching of the cervix, 1 cm peri-aortal lymph nodes. Human papilloma virus test, Normal; 09/2011, Smear cervix, Normal
CDC Split Type: WAES1310ISR008137

Write-up: Information has been received from a gynecologist concerning a single 29 year old usually healthy female with no children with a familial history of colon cancer (patient''s father) and stomach cancer (patient''s grandmother) who was vaccinated with a dose of GARDASIL (lot#, expiration date and route not reported) on an unknown date. The patient was vaccinated with GARDASIL when there was no history of sexual activity. On an unknown date in September 2011 the patient experienced transparent vaginal discharge and had PAP smear which was normal. Several weeks later the patient experienced vaginal bleeding and after an investigation was diagnosed with uterine cervix adenocarcinoma on 15-JAN-2012. Under physical examination the patient was in a general good condition, the examination showed a sprained cervix and the tumor was located in the cervix canal surrounded by cervix tissue that appeared to be normal. The size of the tumor was 5 centimeters (cm). On rectal examination right parametrium with a lump up to 1 cm was palpable characteristic to the tumor distribution to the pelvis. Positron Emission Tomography-Computed Tomography (PET C.T) imaged lymphadenopathy from both sides of the pelvis reaching the level of L4-L5, 1.5 cm lymph node under the aorta bifurcation, peri-sacral and periaortic lymph nodes up to 2 cm. The patient received three treatments of Carboplatin and TAXOL. Following treatment and before surgery PET C.T imaged a reduction in the above findings but they were not eliminated. Human Papilloma Virus (HPV) was found to be normal under laboratory examination. The patient underwent lymph nodes removal, ovary preservation and lifting due to a planned radiation therapy. It was determined to keep the uterine in order to avoid intestine loops entering the pelvis. Therefore the patient did have a hysterectomy at that point. The findings during surgery were cervix with an intracervical tumor in a sprained right parametrium. Abdominal exploratory identifies normal intestine and peritoneum, pelvis lymph nodes in different sizes up to 2 cm, about 4 cm lymph nodes at the common iliac bifurcation on the left under the branching of the cervix, 1 cm peri-aortal lymph nodes. The outcome of the events were unknown. Causality was not reported. Upon internal review uterine cervix adenocarcinoma and hysterectomy were considered as medically significant. Additional information has been requested.


VAERS ID: 508781 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2013-04-24
Onset:0000-00-00
Submitted: 2013-10-20
Entered: 2013-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Adverse event, Computerised tomogram normal, Gait disturbance, Impaired work ability, Nuclear magnetic resonance imaging normal, Pain, Ultrasound scan normal
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: 2013, Computerised tomogram, Normal; 2013, Nuclear magnetic resonance imaging, Normal; 2013, Ultrasound scan, Normal
CDC Split Type: WAES1310KOR008108

Write-up: This spontaneous report was received from a guardian of the patient via a company representative concerning a female patient of unknown age. On 24-APR-2013, the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. Approximately on an unknown date in 2013 (reported as subsequently), the patient experienced an adverse event (unspecified), so she visited several hospitals and computed tomography (CT), magnetic resonance imaging (MRI) and ultrasound were performed but there was no abnormal result found. Symptomatic treatments were done but the pain was getting severe. At the time of report, the patient reported it was hard to walk due to the pain and also there was impact to her work. The outcome of all the events was unknown. The relatedness for the events was unknown for GARDASIL. Additional information is not expected.


VAERS ID: 508784 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-10
Onset:2013-09-11
   Days after vaccination:1
Submitted: 2013-10-20
   Days after onset:39
Entered: 2013-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H013135 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema nodosum, Fatigue, Oropharyngeal pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Lymphadenopathy; Hiatus hernia
Allergies:
Diagnostic Lab Data: 09/19/2013, Physical examination, no swollen glands nor organomegaly N/A
CDC Split Type: WAES1310IRL008301

Write-up: This case was received from the health authority on 10-Oct-2013. REF 2013-018389. This case is medically confirmed as it was reported from a physician. A 17 year old female patient received on 10-Sep-2013 a first dose of GARDASIL (batch number H013135), 0.5 mL intramuscularly, site of administration not reported. Twenty four hours post vaccination, on 11-Sep-2013, the patient experienced erythema nodosum on her skin and on her right thigh, a sore throat for 5 days and fatigue for 6 days (sore throat and fatigue coded as not recovered by the regulatory authority). The patient had a medical history included hiatus hernia and lymphadenopathy (swollen glands in her neck), but none was palpated on 19-Sep-2013 and no organomegaly was noted on 19-Sep-2013 either. The corrective treatment included paracetamol and DISPRIN for sore throat. At the time of reporting, the patient has not recovered from all the adverse events. The regulatory authority considered that case serious due to be medically significant.


VAERS ID: 508799 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-21
Entered: 2013-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Adverse event, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK008116

Write-up: Cluster case of adverse event received from consumer via other company (Merck) and company representative on 09-Oct-2013 under the reference number 1-8925713306. The primary reporter was the mother of a patient. This is a cluster case of hundreds of females, reported to suffer from various adverse events after vaccination with GARDASIL. No details were provided on these cases so it was not possible to identify if they were previously reported. This cluster case is linked to the case E2013-06782, concerning the daughter of the reporter, developing similar symptoms. A number of female patients (reported as hundreds of girls and women) had received an injection of GARDASIL (batch number not reported) on unspecified dates and later on they developed feeling ill and unspecified adverse events, similar to the patient in the linked case (constant headache, dizziness, nausea, abdominal pains, muscle pains, temperature regulation problems, paraesthesias, numbness, the diagnosis POTS and fainting after feeling very dizzy and bad). According to the reporter, some patients have tried i.v. immunoglobulin as treatment (no details reported). At the tie of reporting, the outcome was not provided.


VAERS ID: 508815 (history)  
Form: Version 1.0  
Age: 52.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-07-07
Onset:2011-08-05
   Days after vaccination:29
Submitted: 2013-10-21
   Days after onset:808
Entered: 2013-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NK41800 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Balance disorder, Blood creatine phosphokinase increased, Pain in extremity, Sensory disturbance, Urinary incontinence
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Vestibular disorders (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: Folinic acid; VIBEDEN
Current Illness: Immunisation
Preexisting Conditions: Hypovitaminosis; 03/15/2011, GARDASIL, Immunisation; 01/12/2011, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Blood creatine phosphokinase, Transient increase
CDC Split Type: WAES1310DNK009226

Write-up: Case of adverse event received from health care professional via Health Authority on 17-Oct-2013 under the reference number DK-DKMA-ADR 22271247 and DK-DKMA-EFO7154. The primary reporter was a physician. Case is medically confirmed. A 52 year old female patient (weight: 89 kg ; height: 173 cm), had received the third dose of GARDASIL, (batch number NP16140) via intramuscular route of administration in not reported site of administration on 07-Jul-2011 and later on 05-Aug-2011 she developed urination involuntary, balance problems, pain in lower extremities and soles and sensory disturbance in lower extremities. The patient had concomitant treatment with VIBEDEN, (other mfr) started on 10-Mar-2011 and folinic acid (trade name not reported, other mfr) also started on 10-Mar-2011, for vitamin deficiency. The patient had no other vaccines. According to the reporter, the patient has been investigated for connective tissue disorder on a non-specified date. There has been a transient increase of creatine kinase (lab date not reported). The patient had previous been vaccinated with GARDASIL dose 1: on 12-Jan-2011 (batch number NL31810) and dose 2: on 15-Mar-2011 (batch number NN10280). Both doses were given intramuscular. The patient has a history of vitamin deficiency. At the time of reporting, the outcome was recovering.


VAERS ID: 508819 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-03-18
Onset:0000-00-00
Submitted: 2013-10-21
Entered: 2013-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome, Plasmapheresis
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DICILLIN
Current Illness: Wound infection staphylococcal; Immunisation
Preexisting Conditions: Arthropathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK010604

Write-up: Case received from patient via the Health Authorities in a foreign country on 16-Sep-2013 under the reference number 22239224 and EFO6830. Case not medically confirmed. A 15 year old female patient (weight 54 kg, height 182 cm) had received an injection of GARDASIL (dose not reported, batch number not reported site and route of administration not reported) on unspecified date in Mar-2010 and concomitant drug DICILLIN (other mfr) in Jun-2011 and later on, unspecified date in Jun-2011, she developed Guillain Barre Syndrome (cessation in Jan-2012). Patient was hospitalized because of the reaction on an non-specified date. Patient was treated with unspecified medication and plasmapheresis. Health authority has requested medical confirmation and information on vaccination dates and batch numbers from patient''s GP. At the time of reporting, the outcome was recovered. Medical history includes: Knee problems. Patient previously received a dose of GARDASIL vaccine (dose not reported, batch number not reported, site and route of administration not reported) on unspecified date in Nov-2009. Company note: it is unknown how many doses the patient received. HA reported 2 different vaccination dates. But no information on dose number in series or the total number of vaccinations have been reported. Follow up report received on 24-Sep-2013: It was reported that the case had been received on 18-Sep-2013 from the Patient Insurance company J. nr 13-6899 in terms of the patient''s initial report. It was noted that the Patient Insurance Association had not taken a decision on the matter yet. The patient''s mother had reported adverse reaction GBS to the Patient Insurance Association. Follow up information was received on 14-Oct-2013: Follow up was received HA on 26-Sep-2013 from the patient''s physician upon the request of HA: The physician can confirm, that the patient has experienced Guillain Barre Syndrome, but the physician does not know, if it is a case of an assumed adverse reaction to the treatment with GARDASIL. The matter is therefore still not medically confirmed according to the HA. The first GARDASIL vaccine was given on 29-Sep-2009, the second GARDASIL vaccine on 30-Nov-2009 and the third GARDASIL vaccine was given on 18-Mar-2010. HA has tried to obtain the batch numbers, but they cannot be informed. Upon medical review the company considered that the case has now become medically confirmed. Correction was made to the report, the indication for the concomitant drug DICILLIN was previously reported as wound infection staphylococcal which had not been captured in the database. Upon medical review the company decided to code wound infection staphylococcal as an adverse event (onset and outcome not reported).


VAERS ID: 508828 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-08-22
Submitted: 2013-10-22
   Days after onset:61
Entered: 2013-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK AR / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003184 / 1 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Anxiety, Dyspnoea, Malaise, Nausea, Sense of oppression, Vertigo
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: WAES1310FRA009272

Write-up: Case received from the Health Authorities in a foreign country on 14-Oct-2013 under the reference number MA20131891. An 11-year-old female patient had received intramuscularly the first dose of GARDASIL (batch-lot number J003184, expiration date 30-JUN-2015) in the deltoid and the booster dose of TETRAVAC (batch number J0313) in the opposite deltoid at 3pm on 22-Aug-2013. In the evening around 7-8pm, she was not feeling well, feeling anxious whereas usually rather "zen". She presented with nausea, vertigo, oppression in both chest and throat, dyspnea and abdominal pain. The on-call physician was called in and gave her VOGALENE. After a night of sleep, the symptoms had resolved. The Health Authorities assessed the causal relationship between the reported reactions on both vaccinations as doubtful according to the foreign method of assessment. The Health Authorities considered the case as serious due to the criterion ''other medically important condition''. Upon medical review the company judged relevant to code the adverse event anxiety, which was mentioned by the CA in the narrative but not coded.


VAERS ID: 508996 (history)  
Form: Version 1.0  
Age: 30.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-24
Onset:2013-07-28
   Days after vaccination:4
Submitted: 2013-10-22
   Days after onset:86
Entered: 2013-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Addison's disease, Arthralgia, Back pain, Cyanosis, Decreased appetite, Diarrhoea, Discomfort, Disturbance in attention, Emotional disorder, Fatigue, Feeling abnormal, Headache, Hyperhidrosis, Hypoaesthesia, Injection site pain, Insomnia, Muscle tightness, Muscular weakness, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, Neurological examination normal, Paraesthesia, Quality of life decreased, Sensory disturbance, Skin discolouration, Stress, Tic, Vision blurred, Visual impairment, Weight decreased
SMQs:, 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), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: 2007, Carcinoma in situ, The patient was recommended the vaccine by own physician due to carcinoma in situ in 2007; Colitis
Allergies:
Diagnostic Lab Data: Neurological normal test has been performed by the general practitioner, but the patient will be seen by a neurologist on 06-AUG-2013 for investigation.
CDC Split Type: WAES1308DNK003370

Write-up: Update: Duplicate identified, DK-DKMA-EFO6485 (ADR 22202251) has been merged with this master case. The case has been received from the patient''s physician; numbness/constant tingling in the left arm/leg, headache, visual disturbances on the left eye, stomach pain. The patient''s general feeling in the body is much changed - she is feeling comfortable with marked changes in emotion and feels that it worsens. She has also not tensions in the shoulder/neck, and when pressure is put on, the patient feels that the left arm is paralyzed. The patient has not been treated for the adverse event. The patient has not been hospitalized due to the adverse event. Added adverse events: Ache stomach, Headache, Neck stiffness and Visual disturbance. The patient''s initials have been changed. Follow-up received on 10-OCT-2013 from the patient insurance board in form of the patient''s own initial report to the patient insurance board, J. no 13-7626. Please note, the patient insurance board has not made a decision in the case yet. Description of the drug injury: Four days after the patient received the last injection with HPV vaccine (the last one was SILGARD Lot number 01946) is an invalid lot number for SILGARD, the two other was GARDASIL, Batch and lot # H017284 and Batch and Lot #J001201, Exp date 04-JUL-2015 she developed very strange sensory disturbances in the left arm. It appeared suddenly and affected that the left hand became clenched all the time. Further the nerve in the hand contracted constantly. It buzzed in the arm, as if there was water running under the skin. It only became worse in the following days and thereafter came more symptoms, such as chronic pain in the upper part of the back between the shoulder blades, pain on the middle of the backbone (that feeling has been there since early summer), headache, tiredness, sleeplessness (the patient could lie awake for 2-3 times a night, because her body works and the arm/legs sleeps), stretch marks on the arms, when she carries her daughter (it is deep furrows in the skin, which disappears again after 5 minutes), diarrhea, pain in the stomach, lack of appetite, which has resulted in weight loss, diffuse, feeling of being in a bubble, stress feeling, lack of sex drive; prolonged cycle (prior to HPV vaccine it was exactly 26 days between menstruation, now it is typically 32 days or more!), tics in the eye, leg and arms, increasing sweating and freezes more, blue fingers, swollen lymph nodes on the throat and in the groin and lump on the chest (which is going to be examined in mammography on 06-OCT-2013), muscle/joint pain in the whole body, lack of strength in the left upper arm (can no longer train with it, has lost much muscle mass and it hurts at the injection site), blurred vision and less able to focus and concentrate. The latest adverse event occurred yesterday with yellow dots in the palms, the physician suspects Addison disease (is going to be elucidated for this)! More and more strange symptoms constantly occur. The patient still has the above mentioned inconveniences due to the drug injury. The patient is on partial sick leave due to the drug injury (had to go home before time some days or meet later due to pain or various doctor visits/elucidation). Other remarks: As described the patient has for the last approx. 2 months only experienced more and more unpleasant adverse events, which makes it difficult for the patient to 1) manage her job, 2) be optimally well, 3) be good, spacious and happy. The patient sincerely hopes that it all will become better and that she can regain her old life back without pain and with a lot of happiness and surplus. The patient further mentions that she due to sensory disturbances has had a MRI scan of the brain performed - though, the neurologist has not yet sent the result to her own physician. In addition the patient awaits the date for the elucidation of the autoimmune disease, Addison disease as well the patient is going to have a mammography/ultrasound performed of the lump on the breast on 05-OCT-2013 and the dermatologist in connection with the "stretch marks" on her arm. Note: Please do not return cases received from the regulatory authority unless you have received new information regarding the case. Please note that the reference number for this case is: DK-DKMA-EFO6485. Also, please note that information should not be deleted from the case only appended (e.g. translation of narrative, patient characteristics).


VAERS ID: 508998 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-02-28
Onset:2013-07-06
   Days after vaccination:128
Submitted: 2013-10-23
   Days after onset:109
Entered: 2013-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019870 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Feeling hot, Headache, Memory impairment, Nausea, VIIth nerve paralysis, Vomiting
SMQs:, Acute pancreatitis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1310DNK009529

Write-up: Case of adverse event received from non-health care professional via Health Authorities on 14-Oct-2013 under the reference number EFO7063 and 22261035. The primary reporter was not specified. A 23 year old female patient (weight: 90 kg; height: 164 cm), with no other health problems in general, had received the first dose and the second dose of GARDASIL (batch number H018411 and H019870) via not reported route and site of administration on 10-Oct-2012 and 28-Feb-2013 and later on, 07-Jan-2013, she developed headache, nausea, vomiting and tiredness. On 08-Feb-2013 she experienced internal heat (fever, not specified). On 16-Mar-2013 she developed memory impairment and 06-Jul-2013 partial paralysis of the face (on the left side). Patient has not been treated for the adverse events. Patient has also received the third dose of GARDASIL (Batch number J004851) on 16-Jul-2013. HA has requested medically confirm from the patient''s doctor, on 11-Oct-2013, waiting for answer. At the time of reporting, the outcome of partial paralysis of the face was recovered and outcome of the other AE was not recovered. HA assess this case as serious with seriousness criteria hospitalization (dates unspecified, no more information provided).


VAERS ID: 509002 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-09
Onset:0000-00-00
Submitted: 2013-10-23
Entered: 2013-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Effusion, Gait disturbance, Groin pain, Lymphadenopathy, Nuclear magnetic resonance imaging abnormal, Therapeutic aspiration
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Osteonecrosis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: 2013, Nuclear magnetic resonance imaging, tiny effusion
CDC Split Type: WAES1310GBR009535

Write-up: This case was received from a health care professional on 14-Oct-2013. This case is medically confirmed. A 12 year old female patient, with no medical history reported, received on 09-Sep-2013 a first dose of human papillomavirus vaccine (manufacturer unknown, batch number not reported) in the deltoid, route of administration not reported. One week later, she attended the GP with 2 day history of painful left hip and limp. She was then seen and admitted to the local reporter''s hospital and ortopaedics discovered that patient had an effusion (onset date not reported), which was aspirated, then the MRI reported in tiny effusion. It was also noted that the patient had an enlarged lymph node in the left groin (onset date not reported), which seemed to be the focus of the pain. The patient was eventually discharged with physiotherapy and hydrotherapy. She should have received second dose but the patient''s mother has declined further vaccine at the moment. The patient has not recovered from limp and hip painful, she was recovering from effusion and the patient''s outcome for enlarged lymph node was not reported.


VAERS ID: 509005 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-25
Onset:2013-09-26
   Days after vaccination:1
Submitted: 2013-10-23
   Days after onset:27
Entered: 2013-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019633 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Rash pruritic, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310IRL009500

Write-up: This case was received from the health care authority on 16-Oct-2013. This case is not medically confirmed as it was reported by a consumer. A 13 year old female patient, with no medical history reported, received on 25-Sep-2013 a first dose of GARDASIL (batch number H019633), route and site of administration not reported. Within approximately 24 hours of vaccination, on 26-Sep-2013, the patient developed a rash that described as little spots (almost like chicken pox) first noticed on patient''s chest, then stomach, legs and on to her back. The spots were very itchy. Corrective treatment included ZYRTEC reported as ''ZIRTEX'', clarithromycin and EURAX Cream. At the time of reporting, the patient has not recovered. The agency considered that case serious due to be medically significant.


VAERS ID: 509008 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-30
Onset:2013-07-30
   Days after vaccination:0
Submitted: 2013-10-22
   Days after onset:84
Entered: 2013-10-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J000731 / 1 AR / SC

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Hypotension, Incorrect route of drug administration, Syncope, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: [therapy unspecified], No adverse event, vaccines
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308FRA000774

Write-up: Case received from a physician on 30-Jul-2013. Case medically confirmed. Case linked with case E2013-05777 (same report, similar adverse reaction). A 16-year-old female patient had received the first dose of GARDASIL (batch and lot number J000731, Exp date 20-JUN-2015) on 30-Jul-2013. Immediately post vaccination she experienced vasovagal syncope associated with tonic clonic movements. Blood pressure was taken and was low (value not reported). She did not hurt herself during syncope. She did not have any cutaneous allergic signs nor respiratory difficulties. To be noted that the patient was sitting during vaccination. She did not have any relevant medical history and previous vaccinations were uneventful. At the time of reporting, the patient had recovered. Follow-up information received on 15-Oct-2013: Upon medical review, the case was assessed as serious by the company upon the basis of the following information. This was a case of misuse. The patient had received the first dose of GARDASIL via subcutaneous route - instead of intramuscular as recommended - in the arm. Following the vaccination she experienced syncope and convulsive seizure. At the time of reporting, she had recovered.


VAERS ID: 509044 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-31
Onset:2013-08-27
   Days after vaccination:27
Submitted: 2013-10-23
   Days after onset:57
Entered: 2013-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003267 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cytomegalovirus test positive, Epstein-Barr virus antibody positive, Hepatic enzyme increased, Hepatitis A, Hepatitis B test negative, Hepatitis C test negative, Hepatitis acute, Hepatitis viral test negative, Injection site swelling, Local swelling
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Liver infections (narrow), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Examination and lab tests have been performed: Liver enzymes have decreased, but are still not normal, and there is negative Hepatitis A, B and C virus, EBV and CMV indicate previous infections. 06-SEP-2013: Hepatic enzyme decreased but still not normal. Hepatitis A virus test negative. Hepatitis B virus test negative. Hepatitis C virus test negative. CMV antibody positive indicates previous infection. EBV antibody positive indicates previous infection. Body temperature not febrile.
CDC Split Type: WAES1310SWE010008

Write-up: Case of adverse event received from health care professional via Health Authority on 17-Oct-2013 under the reference number DK-DKMA-ADR 22262405 and DK-DKMA-EFO7080. The primary reporter was a physician. Case is medically confirmed. A 22 year old female patient, had received the second dose of GARDASIL (batch/lot number J003267, expiration date 30-JUN-2015) via intramuscular route of administration in not reported site of administration on 31-Jul-2013 and later on 27-Aug-2013 she developed elevated liver enzymes, possible viral infection and diffuse swelling of the right upper arm and mild swelling of the left upper arm. The patient has informed that on the 27-Aug-1013 a swelling began of the right upper arm. The physician met the patient on 30-Aug-2013, with a swelling of the right upper arm without redness and warmth, and a mild swelling of the left upper arm was observed. The patient was sent to the hospital. Examination and lab tests have been performed: Print from the medical ward: Latest visit: 06-Sep-2013. Main diagnose: DB178, other acute viral hepatitis. Other diagnosis and surgeries: DZ038, observation because of suspected other disease or condition. DB159A, Hepatitis A without specification. Epicrisis: the patient arrives with parents, they are informed that the liver enzymes have decreased, but are still not normal, and there is negative Hepatitis A, B and C virus, EBV and CMV indicate previous infections. Patient has a general well-being, not febrile, and has not been febrile previously. Left arm has started to swell. Immediately the most possible cause could be a virus infection (evaluation). Plan: Control of liver enzymes in the following week. If the patient is well she can receive a telephone call answer, otherwise renewed clinical control here. The patient had no other medications. The patient had a history of the primary dose of GARDASIL (batch/lot number J003267, expiration date 30-JUN-2015) via intramuscular route of administration in not reported site of administration on 18-Jun-2013. At the time of reporting, the outcome was recovering.


VAERS ID: 509294 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-02
Onset:2013-10-05
   Days after vaccination:3
Submitted: 2013-10-24
   Days after onset:19
Entered: 2013-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310MLT009773

Write-up: This spontaneous report as received from a physician refers to a 13 year old female patient. Approximately on 02-OCT-2013 ("three days before adverse event") the patient vaccinated with first dose of SILGARD (lot#, expiration date, dose, indication, route not reported). Approximately on 05-OCT-2013 ("approximately 2 weeks ago"), the patient was diagnosed with benign intracerebral hypertension after administration of SILGARD. Patient was hospitalized 3 days after the first dose of SILGARD. The outcome of the event was unknown. Additional information has been requested.


VAERS ID: 509338 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-25
Onset:2013-09-25
   Days after vaccination:0
Submitted: 2013-10-24
   Days after onset:29
Entered: 2013-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR010512

Write-up: This case was received from the health authority on 18-Oct-2013. GB-MHRA-ADR 22274912. This case is medically confirmed. A 12 year old female patient, with no medical history reported, received on 25-Sep-2013 an injection of GARDASIL, (batch number not reported) intramuscularly, dose in series and site of administration not reported. The same day on 25-Sep-2013, within a couple of hours post vaccination, the patient experienced rash all over the body, particularly on the legs. The patient received a corrective treatment with PIRITON (chlorphenamine) that day on 25-Sep-2013 by first aiders at school and rash subsided. At the time of reporting, the patient has not received an other dose of HPV as it may result in worse reaction. The patient has recovered on 25-Sep-2013. The MHRA considered that case serious due to be medically significant.


VAERS ID: 509482 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-08
Onset:2013-10-08
   Days after vaccination:0
Submitted: 2013-10-24
   Days after onset:16
Entered: 2013-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019078 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cyanosis, Depressed level of consciousness, Dizziness, Dyspnoea, Heart rate decreased, Hyporesponsive to stimuli, Muscle twitching, Presyncope
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: Heart rate, 60; Heart rate, 120
CDC Split Type: WAES1310GBR010862

Write-up: This case was received from the health authority on 17-Oct-2013. GB-MHRA-ADR 22275422. This case is medically confirmed. A 12 year old female, with no medical history reported, received on 08-Oct-2013 an injection of GARDASIL, (batch number H019078) 0.5 mL intramuscularly, dose in series and site of administration not reported. Approximately 30 seconds after vaccination, on 08-Oct-2013, the patient appeared less responsive and said she was dizzy and looked as if she was to faint and therefore laid on side, however, she became less conscious. The patient received a corrective treatment with a dose of Epipen (adrenaline) 5 minutes after vaccination but the patient continued to be unresponsive. It was also reported the patient was cyanosed to fingers and lips, experienced twitching movements, breathing laboured and her pulse rate had slowed from 120 to 60 on unreported dates and the patient was taken to Emergency (no patient''s hospitalization was reported). The health care professional was unsure if it was an anaphylactic reaction and the patient was not known to be epileptic. On 08-Oct-2013, the patient had recovered from consciousness decreased, dizziness, felt faint and hyporesponsive to stimuli. The patient''s outcome for other adverse events was unknown. The severity of each AE was unknown. The MHRA considered that case serious due to be medically significant and life threatening.


VAERS ID: 509485 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-27
Onset:0000-00-00
Submitted: 2013-10-25
Entered: 2013-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H013135 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Butterfly rash, Dizziness, Pallor, Rash macular
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1310IRL010809

Write-up: This case was received from the health authority on 15-Oct-2013. REF 2013-018416. This case is medically confirmed as it was reported by a physician. A 13-year-old female patient, with no reported medical history, received on 27-Sep-2013 a first 0.5 mL dose of GARDASIL, (batch n. H013135) intramuscularly (site of administration not reported) and 45 minutes post-vaccination (date not reported) she experienced a confluent blanching macular rash on her upper chest and anterior shoulders. The patient also experienced dizziness, malar flush and pallor on an unreported date. Corrective treatment included PIRITON. The patient was referred to hospital for observation. At the time of reporting the patient had not recovered. The IMB considered the case to be serious as an other medically important condition because it required intervention.


VAERS ID: 509487 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-10-09
Onset:2013-01-23
   Days after vaccination:837
Submitted: 2013-10-24
   Days after onset:273
Entered: 2013-10-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Autoimmune hepatitis, Biopsy liver abnormal, Feeling abnormal, General physical health deterioration, Infection susceptibility increased, Influenza like illness, Jaundice, Liver disorder, Malaise, Pain
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions: HPV vaccine (unspecified): Malaise
Allergies:
Diagnostic Lab Data: Biopsy, autoimmune liver disease
CDC Split Type: WAES1310GBR010526

Write-up: This case was received from the health authority in the foreign country on 15-Oct-2013. GB-MHRA-ADR 22262806. This case is not medically confirmed as it was reported by a consumer. A 16-year-old female patient was vaccinated on 09-Oct-2010 with a third dose of human papilloma virus vaccine (manufacturer unknown, batch n. not reported), route, dose, site of administration not reported. on an unreported date, the patient was unwell, she began getting more and more infections as time went on, her immune system was not handling normal colds making it feel more like the flu, she was feeling strange, was admitted to hospital with jaundice and was diagnosed with autoimmune liver disease, had joint ache causing more and more pain and on 23-Jan-2013 her health deteriorated. On an unreported date a biopsy was performed and showed autoimmune liver disease. Concomitant treatment included cetrizine dihydrochloride, DIFFERIN, lymecycline, mercaptopurine, MICROGYNON, paracetamol, prednisolone, SERETIDE and VENTOLIN. The patient''s medical history included asthma. She had received the first dose of human papilloma virus vaccine on 18-Jan-2013 and on 23-Jan-2010 she felt unwell for a few weeks. She had received a second dose of human papilloma virus vaccine on 08-Jun-2010 and on an unreported date she felt unwell again for a few weeks. On 29-Sep-2013 the patient recovered with sequelae from health deterioration and feeling unwell. The outcome was unknown for the other reactions. The MHRA considered this case to be serious due to hospitalisation.


VAERS ID: 509519 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-25
Entered: 2013-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Cervix carcinoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310RUS011669

Write-up: This spontaneous report as received from a social media website refers to a 14 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (dose, strength, route and site of administration not reported) for cervical cancer. On an unknown date the patient died. The reason of death was not reported. Additional information is not expected.


VAERS ID: 509959 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-27
Onset:0000-00-00
Submitted: 2013-10-28
Entered: 2013-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H013135 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash, Rash pustular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Hypothyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310IRL011821

Write-up: This case was received from the health authority on 21-Oct-2013. IMB REF 2013-018536. This case is medically confirmed as it was reported by a physician. A 18 year old female patient received on 27-Sep-2013 an injection of GARDASIL (batch and lot number H013135) 0.5 mL intramuscularly, site of administration not reported. Three to four days later, the patient developed a rash with pustules on her arms, abdomen, legs and back. The patient''s medical history included hypothyroidism treated by herbal drops for some weeks at the time of reaction onset. At the time of reporting, the patient has not recovered. The IMB considered that case serious due to be medically significant.


VAERS ID: 509960 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-28
Entered: 2013-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cervical conisation, Cervical dysplasia, Human papilloma virus test positive, Smear cervix abnormal
SMQs:, Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 2007, GARDASIL; 2007, GARDASIL
Allergies:
Diagnostic Lab Data: Human papilloma virus test, HPV 16 positive, HPV 18 negative; Smear cervix, PAP IVa
CDC Split Type: WAES1310DEU011868

Write-up: Case received from a health care professional on 21-Oct-2013. Case is medically confirmed. A 14-year-old female patient received the complete vaccination series with three doses of GARDASIL (lot. no not reported) on unspecified dates in 2007. 6 years after the vaccinations at the age of 20, the patient developed severe cervical dysplasia. Cervical smear revealed PAP IVa. HPV test was positive for high risk type 16 and negative for type 18. The patient underwent cervical conisation. At the time of reporting, the patient had recovered within an unspecified timeframe. Upon medical review the case was assessed as serious by the company.


VAERS ID: 510016 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-29
Entered: 2013-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cervical conisation, Cervix carcinoma stage 0, Human papilloma virus test positive
SMQs:, Uterine and fallopian tube malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Sexually active
Allergies:
Diagnostic Lab Data: On an unknown date, Papanicolaou smear test revealed PAP IV. HPV high risk test was positive (not otherwise specified).
CDC Split Type: WAES1310DEU012125

Write-up: Case received from a health care professional in a foreign country on 21-Oct-2013. Case is medically confirmed. Poorly documented case. A female patient of unknown age had received the third dose of GARDASIL (lot-no. not reported) on an unspecified date in 2007. On an unspecified date, at the age of 22 years, Papanicolaou smear test revealed PAP IV. HPV high risk test was positive (not otherwise specified). Patient underwent cervical conisation. At the time of reporting, the outcome was not reported. Previous doses of GARDASIL (D1-D2) were given on unspecified dates. Toleration was not reported. Patient had been sexually active prior to the vaccinations. Upon medical review the case was assessed as serious by the company.


VAERS ID: 510017 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-28
Entered: 2013-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Acne, Anal fissure, Arthralgia, Blood iron decreased, Blood test abnormal, Confusional state, Cough, Dizziness, Dyslexia, Dyspraxia, Fatigue, Feeling abnormal, Haemorrhoids, Lymphadenopathy, Memory impairment, Menorrhagia, Myalgia, Nasal congestion, Nasopharyngitis, Nausea, Oropharyngeal pain, Pain, Peripheral coldness, Sinus headache, Suicidal ideation, Temperature regulation disorder, Thrombosis, Vision blurred, Weight increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Suicide/self-injury (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood iron low levels.
CDC Split Type: WAES1310GBR011839

Write-up: This case was received from the health authority on 17-Oct-2013. GB-MHRA-ADR 22271078. This case is not medically confirmed as it was reported by a consumer. A female patient (age not reported), with no medical history reported, received in 2009 an injection of GARDASIL (batch number not reported), dose in series, route and site of administration not reported. On an unreported date the patient experienced acne and low iron levels were found in blood tests and the patient was awaiting some more blood tests at the time of reporting. The same year after vaccination, in 2009, the patient experienced anal fissure, blocked nose, menstruation clots, overheating, confusion, always getting colds, pain in hip, cold hands and feet, dizzy, extreme fatigue, foggy feeling in head, forgetfulness, cluster aches, haemorrhoids, life weariness, muscle pain, nausea, sinus pain, sore throat, swollen glands, tiredness, weight gain, memory impairment. She noticed it was life changing as it interfered with life and education and that she seemed to be getting worse. In 2010, the patient also experienced dyslexia and dyspraxia, and in 2012, the patient presented with blurry vision and coughing all the time. The consumer noticed that the GP was not informed about the suspected side effects as they presumed that GARDASIL was free from these types of side effects (causality not clearly reported). All these reported adverse events were coded by the regulatory authority. At the time of reporting, the patient was recovering from menorrhagia. The patient''s outcome for iron blood level was unknown. The patient has not recovered from all the other adverse events. The regulatory authority considered that case serious due to be medically significant.


VAERS ID: 510018 (history)  
Form: Version 1.0  
Age: 10.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-03
Onset:2013-09-10
   Days after vaccination:7
Submitted: 2013-10-28
   Days after onset:48
Entered: 2013-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H006967 / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Fatigue, Headache, Muscle twitching, Panic attack, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Dyskinesia (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310SWE011841

Write-up: Case received from a consumer via Health Authorities on 21-Oct-2013 under the reference number SE_KRMPAWWW-138139142800. The primary reporter was a relative to the patient. HA considered the report as serious, due to other important medical event: sick-leave. A 10-year-old female patient had received an injection of GARDASIL (batch/lot number H006967) on 03-Sep-2013 and later on 10-Sep-2013 she developed exfoliation of soles of feet, dyspnoea, headache and muscle twitches. Later on unspecified date she experienced panic attack and tiredness. It was reported that girl experienced starting of the symptoms about a week after vaccination with exfoliation of the soles of her feet, dyspnoea, headache and muscle twitches. The girl also had panic attacks a few evenings, and she was "completely exhausted during one day, tired and with headache", about 3-4 weeks post vaccination. The patient had received ALVEDON (other mfr, 500 mg film-coated tablet, dates not rep). It was not specified whether this was for treatment of adverse events or concomitant medication. The patient had no relevant medical history. At the time of reporting, the outcome was reported as recovered with sequelae.


VAERS ID: 510021 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-05-26
Onset:2012-06-01
   Days after vaccination:6
Submitted: 2013-10-29
   Days after onset:515
Entered: 2013-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain lower, Computerised tomogram normal, Dysmenorrhoea, Nausea, Nuclear magnetic resonance imaging normal, Ultrasound abdomen normal, Ultrasound scan normal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Echography (05-SEP-2013): no abnormality; Various examinations, such as abdominal echography, CT and MRI (unspecified date): no abnormality
CDC Split Type: WAES1310JPN012437

Write-up: Initial information has been received from a physician concerning a 15-year-old female patient. On 26-MAY-2012, the patient received the second vaccination of GARDASIL IM injection drug 0.5 ml (injection site not reported). No concomitant medication was reported. On 21-MAR-2012, the patient received the first vaccination of GARDASIL. No specific problem occurred in the patient after the vaccination. On 26-MAY-2012, as mentioned above, the patient received the second vaccination of GARDASIL. Around June 2012, feeling queasy and lower abdominal pain developed in the patient. In June 2012, the patient had hard period pain than ever, for which she stayed away from school for 2 days. Around 31-AUG-2012, queasy feeling and lower abdominal became severe, and she often stayed away from school. On 05-SEP-2012, the patient visited an obstetrics and gynecology department, where echography revealed no abnormality. The symptoms did not improve thereafter. The patient had examinations at departments of internal medicine and psychosomatic medicine, but the cause of the symptoms was not found. On an unspecified date, no abnormality was found in various examinations such as abdominal echography, CT, and MRI. On 28-AUG-2013, the queasy feeling and lower abdominal pain improved. She finally became able to go to school after more than 6 months. At the time of this report, the outcome of the period pains was unknown. Reporter''s comment: The symptoms seem to be different from co-called "CRPC (complex regional pain syndrome)", and cannot comment on these. The reporting physician assessed that the queasy feeling and lower abdominal pain were related to GARDASIL, and did not assess the causal relationship between the period pains and the vaccine. The reporting physician assessed the queasy feeling and lower abdominal pain as serious (other important medical events) and did not assess the seriousness of the period pains. Additional information has been requested.


VAERS ID: 510074 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-01-02
Onset:2012-01-15
   Days after vaccination:13
Submitted: 2013-10-28
   Days after onset:651
Entered: 2013-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NM02340 / 1 UN / IM
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Allergy test positive, Blood immunoglobulin E increased, Blood test, Condition aggravated, Disturbance in attention, Dizziness, Eczema, Electrocardiogram abnormal, Epstein-Barr virus test negative, Fatigue, Headache, Loss of consciousness, Malaise, Myalgia, Nausea, Nuclear magnetic resonance imaging brain normal, Parasite tissue specimen test negative, Red blood cell count normal, Seasonal allergy, Skin test, Sleep study normal, Syncope, Thyroid function test normal, White blood cell count normal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Conjunctival disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Seasonal allergy; Dermatitis atopic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: The patient has been examined and have had blood tests or similar. She is currently under investigation at a hospital. Lab data received to HA from the doctor 27-Sep-2013: No abnormality apart from allergy tests: IgE 0.55, grass allergy test 0.45. Reporting from hospital doctor: MRI of the cerebrum nothing abnormal. Polysomnography performed 26-Jun-2013 showed a total sleep time with 3 sleeping periods, these is localized early afternoon, early evening and late night, with the patient in the last period fell asleep around 03 in the morning. Each of the sleep periods are with normal NREM/REM subtlety. There were no motor or respiratory episodes and ECG showed sinus rhythm, no paroxystic activity during any of these. Subsequently MSLT (Multiple Sleep Latency test) showed normal sleep latency, and there was a single episode of REM sleep in test 3, all in all normal MSLT. Thyroid numbers, red and white blood cell normal, IGE elevation checked by prick test, which was negative. Examination for intestinal parasites negative. Examined by a psychiatrist who has not found evidence of psychiatric disorder. EBV negative.
CDC Split Type: WAES1307DNK004414

Write-up: Case received from a consumer or other non health care professional via the Health Authorities in a foreign country on 04-Jul-2013 under the references DK-DKMA-ADR 22156768 and DK-DKMA EFO6162. Case not medically confirmed. A 12-year-old female patient, had received the second injection of GARDASIL (batch number not reported) via not reported route and site of administration on an unspecified date. On 08-Mar-2012, the patient developed chronic nausea, chronic headache and severe tiredness. The patient was hospitalised. The patient received D3 of GARDASIL on 24-Sep-2012. At the time of reporting, the patient had not recovered. The patient received D1 of GARDASIL on 02-Jan-2012, toleration not reported. Follow up report received from the Health Authorities in a foreign country on 01-Aug-2013: The Health Authorities tried to obtain medical confirmation of the report. The patient''s physician provided the patient''s initials and the administration date (08-Mar-2012) of the second dose of GARDASIL. The physician could not confirm whether the patient had developed the reported events and could not provide an causality assessment. The report therefore remained as not medically confirmed. Follow-up information was received from health care professionals via the Health Authorities in a foreign country on 21-Oct-2013 and 22-Oct-2013. The reference number DK-DKMA-EFO7182 and DK-DKMA-ADR 22275018 were added (case reported by physician, information has been merged by HA). The case is now medically confirmed. The patient''s initials were updated. The patient has a history of dermatitis atopic and hay fever, which are both continuing. The patient received the first dose of GARDASIL (batch number NN30600, lot # NM02340, exp date 31-DEC-2012 i.m.) on 02-Jan-2012 (previously reported in history). As the patient experienced the first adverse events after this first dose, it is now considered as suspect product. The second dose of GARDASIL (given on 08-Mar-2012) had batch number NP26930, Lot # NK47540, exp date 31-MAY-2012 and the third dose (given on 24-Sep-2012) had batch number H01175; both given i.m. PRIORIX (other mfr) was administered on 02-Jan-2012 and was reported as concomitant medication. It was reported that the patient fainted three times after HPV vaccination and she experienced dizziness, muscle pain and aggravation of hay fever and child eczema, with onset 07-Jan-2012. She experienced malaise and concentration impaired, with onset 15-Jan-2012. She developed black outs with onset 08-Mar-2012. The onset of tiredness was changed to 15-Jan-2012 (previously reported: 08-Mar-2012). After the HPV vaccination the patient has been tired and fainted three times. The patient was tired and could not attend school. Her hay fever and child eczema was aggravated. She experienced headache, dizziness and muscle pain. According to the physician the above mentioned adverse events caused invalidity or severe function impairment. The girls also experienced two blackouts after the second vaccination with GARDASIL. With the increased development of tiredness, indisposition and malaise as well as headache and concentration impairment, the girl was not able to follow school, despite good intelligence. The patient has been examined and have had blood tests or similar. She is currently under investigation at a hospital. Lab data received to HA from the doctor 27-Sep-2013: No abnormality apart from allergy tests: IgE 0.55, grass allergy test 0.45. Reporting from hospital doctor: MRI of the cerebrum nothing abnormal. Polysomnography performed 26-Jun-2013 showed a total sleep time with 3 sleeping periods, these is localized early afternoon, early evening and late night, with the patient in the last period fell asleep around 03 in the morning. Each of the sleep periods are with normal NREM/REM subtlety. There were no motor or respiratory episodes and ECG showed sinus rhythm, no paroxystic activity during any of these. Subsequently MSLT (Multiple Sleep Latency test) showed normal sleep latency, and there was a single episode of REM sleep in test 3, all in all normal MSLT. Thyroid numbers, red and white blood cell normal, IGE elevation checked by prick test, which was negative. Examination for intestinal parasites negative. Examined by a psychiatrist who has not found evidence of psychiatric disorder. EBV negative. The outcome was reported as not recovered, except for concentration impaired and blackouts where outcome was unknown.


VAERS ID: 510261 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-09
Onset:2013-09-13
   Days after vaccination:4
Submitted: 2013-10-29
   Days after onset:46
Entered: 2013-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019078 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Joint dislocation, Weight bearing difficulty
SMQs:, Accidents and injuries (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Coeliac disease
Preexisting Conditions: Anisometropia
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR011849

Write-up: This case was received from the health authority on 22-Oct-2013. GB-MHRA-ADR 22280257. This case is medically confirmed. A 12 year old female patient (weight: 28 kg), with a medical history of anisometropia and a continuing coeliac disease, received on 09-Sep-2013 an injection of GARDASIL (batch/lot number H019078, expiration date 30-JUN-2015), 0.5 mL intramuscularly, dose in series and site of administration not reported. On 13-Sep-2013, the patient experienced increasing pain in left hip, internal/external rotation and was unable to be fully bear weight. The patient was admitted to hospital and orthopaedics. At the time of reporting, the patient has not recovered from all the adverse events. The MHRA considered that case serious due to the patient''s disability and to patient''s hospitalization.


VAERS ID: 510268 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-04-20
Onset:0000-00-00
Submitted: 2013-10-30
Entered: 2013-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram abnormal, Myasthenia gravis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: Computerised tomogram, Inspection myasthenia gravis and diagnosis
CDC Split Type: WAES1310JPN012866

Write-up: Information has been received from a physician concerning a 13-year-old female patient with no underlying disease or medical history. On 20-APR-2013, the patient received the first vaccination of GARDASIL IM, 0.5 ml (injection site and lot number not reported). On 21-JUN-2013, the patient received the second vaccination with GARDASIL IM 0.5 ml (injection site and lot number not reported). On an unspecified date in 2013, myasthenia gravis developed in the patient after the vaccination. On an unspecified date, the patient underwent examinations at a hospital. On 24-SEP-2013, the patient was referred to the university hospital A. On an unspecified date, myasthenia gravis was diagnosed from the results of examinations such as CT. On 16-OCT-2013, the patient was transferred to the pediatric department. On 18-OCT-2013, the patient was admitted to the pediatric department. On 19-OCT-2013, treatment with an oral steroid drug was started, but her clinical course did not change. At the time of this report of 25-OCT-2013, the patient had not recovered from the myasthenia gravis. Reporter''s comment: The causal relationship between the myasthenia gravis and GARDASIL was unknown. The reporting physician assessed the myasthenia gravis as serious (hospitalization). Upon interval review, myasthenia gravis was considered to be an other important medical event. Additional information has been requested.


VAERS ID: 510271 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-24
Onset:0000-00-00
Submitted: 2013-10-30
Entered: 2013-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: CSF test abnormal, Decreased appetite, Headache, Laboratory test normal
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RISUMIC; DEPAKINE; BRUFEN
Current Illness: Migraine
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Laboratory test, Decrease in cerebrospinal fluid; Laboratory test, no abnormality
CDC Split Type: WAES1309JPN012548

Write-up: Follow-up information has been received from physician concerning a 14-year-old female patient. The patient had underlying disease of migraine and had been receiving treatment for it at hospital A. The patient visited a hospital B for vaccination of GARDSIL. On 09-NOV-2012, the patient had the second injection of GARDASIL intramuscular (IM) drug 0.5 ml (injection site unknown). Concomitant medications included RISUMIC tablet (orally, dosage is uncertain during a day), DEPAKENE (orally, dose is uncertain during a day) for migraine and BRUFEN (orally, dosage is uncertain during a day) for migraine. On 08-SEP-2012, the patient received the first injection of GARDASIL. On 09-NOV-2012, as mentioned before, the patient received the second injection of GARDASIL. Around February 2013, the patient received the third injection of GARDASIL. On an unspecified date, no abnormality was found in examinations. The patient was referred to a hospital C. On an unspecified date, the hospital C referred the patient to the brain surgery department of a hospital D, where a prophylactic against headache was prescribed for 2 weeks. On an unspecified date, the patient visited the hospital, where examinations revealed that the cause of the headache was decrease in cerebrospinal fluid. The patient was again referred and admitted to a hospital E. At the time of the report of 22-OCT-2013, the patient had not recovered from the headache. The outcome of the appetite lost was unknown. At the time of this report of 23-OCT-2013, the patient had already been discharged from the hospital E and had been attending class. A physician of the hospital D contacted a physician of the hospital E and confirmed that the patient had already recovered from all the events (outcome date unknown). Examinations (date unknown): Decrease in cerebrospinal fluid was found. Comment from a physician of hospital B: The patient was complaining of the event at the same time that kind of vaccine news had widely been reported, and also the patient had migraine since before. Therefore, I don''t think there was causality between the vaccine and the event. Comment from the physician of hospital D: The decrease in cerebrospinal fluid is unrelated to the GARDASIL. Comment from a physician of hospital C: Casual relationship of the headache to the vaccine is unknown. The physician of the hospital B assessed the relationship between the headache and the GARDASIL as unrelated and the physician of the hospital C assessed the relationship as unknown. Subsequently, the physician of the hospital D made a comprehensive assessment from all the information that there was no causal relationship between the headache and the GARDASIL. The physicians of the hospital B, C, and D did not assess the causal relationship betweeen the appetite lost and the GARDASIL. The physician of the hospital D comprehensively assessed based on all the information that the decrease in cerebrospinal fluid was definitely not related to the GARDASIL. The physician of the hospital B assessed the headache as serious (other important medical event), while the physicians of the hosptial C and D did not assess the seriousness. None of physicians of the hospital B, C, and D assessed seriousness of the appetite lost. The physician of the hospital D assessed the decrease in cerebrospinal fluid as serious (hospitalization). No additional information was available.


VAERS ID: 510292 (history)  
Form: Version 1.0  
Age: 30.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-27
Onset:0000-00-00
Submitted: 2013-10-30
Entered: 2013-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J001201 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Addison's disease, Arthralgia, Asthenia, Back pain, Breast mass, Burning sensation, Confusional state, Cyanosis, Decreased appetite, Diarrhoea, Discomfort, Disturbance in attention, Fatigue, Feeling abnormal, Feeling cold, Headache, Hyperhidrosis, Hypoaesthesia, Impaired work ability, Insomnia, Joint contracture, Libido decreased, Lymphadenopathy, Memory impairment, Monoplegia, Muscle atrophy, Muscle contracture, Muscle spasms, Musculoskeletal chest pain, Musculoskeletal stiffness, Myalgia, Nuclear magnetic resonance imaging brain, Pain, Pain in extremity, Paraesthesia, Polymenorrhoea, Sensory disturbance, Skin discolouration, Skin striae, Skin wrinkling, Spinal pain, Stress, Tension, Tic, Vaccination site pain, Vision blurred, Visual impairment, Weight decreased
SMQs:, 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), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: 2007, Carcinoma in situ; Colitis; 01/25/2013, GARDASIL, Dose 1. Batch number H017284.
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK009982

Write-up: Case received from health care professional via Health Authorities on 04-Oct-2013 under the reference number 22255749. The primary reporter was a physician. A 30 year old female patient with a medical history of colitis, had received the second dose of GARDASIL (batch number J001201) via intramuscular route of administration in not reported site of administration on 27-Mar-2013 and an injection of SILGARD (other Mfr, batch number 01946) via not reported route in not reported site of administration on 27-Jul-2013. Later on, 28-Jul-2013, she developed burning sensation in lower back spine and left shoulder, feels that she forget, tingling feeling, continuously curved fingers, muscle cramps, muscle soreness and skin on the forearm folds. And on unspecified date patient experienced muscle pain, tenderness in the middle of thoracic, feels like growing pain and vaccination site tenderness. And 6 days post vaccination (not specified whether it was post GARDASIL or SILGARD vaccination) she developed periodic curled toes as well. Tingling feeling, muscle cramps, muscle pain and burning sensation, symptoms appears in left fingers/hand/arm, both legs and back, neck and shoulder. Patient forgets more than previously. Skin folds (on the left forearm). Four days after third dose HPV vaccination all fingers in the left hand was continuously curled. Tingling feeling in the left forearm began, it was worse during evening and night. Patient was sore at the vaccination site. On the sixth day post vaccination patient experienced tingling with periodic curled toes. Feels like growing pain over the knee and distal lower leg. After another few days burning sensation around the spine, lower back and neck as well as left shoulder. In addition patient had tenderness in the middle of thoracic. Patient feels that she forgets about things. Skin under her forearm folds when she lift things or a child. Patient was examined by a neurologist. Patient had received the first primary dose of GARDASIL (batch number H017284) via not reported route of administration in not reported site of administration on 25-Jan-2013. At the time of reporting, the patient had not recovered. Discrepancy: HA coded onset date of continuously curved fingers, tingling feeling in the left forearm and skin in the forearm folds as 28-Jul-2013 but it does not correspond with the narratives as per HA report. Company coded AE as mentioned by HA but not coded: Muscle pain (onset and outcome not reported), vaccination site tenderness (onset and outcome not reported) periodic curled toes (onset 6 days p-v and outcome not reported) and tenderness in the middle of thoracic (onset and outcome not reported). Follow-up information received from HA on 16-Oct-2013 under the reference numbers DK-DKMA-ADR 22202251 and DK-DKMA-EFO6485. The case is received from the patient''s physician: Numbness / constant tingling in the left arm / legs, headaches, visual disturbances on the left eye, stomach ache. The patient''s general feeling in the body is very changed - she is uncomfortable with the strong sensation changes and feelings, that they are getting worse. Has now also tension in the shoulder / neck, and when pressure is put on, the patient feels that left arm paralyzed. The patient has not been treated for the adverse reactions. The patient has not been hospitalized because of adverse reactions. Added adverse reactions: stomach ache, headache, neck stiffness and visual disturbance. Follow up: received HA on 10-Oct-2013 from the Patient Insurance Company (PIC) in terms of the patient''s own initial notification to the PIC J.no 13-7626. Note that PIC has not reached a decision in the matter yet. Description of drug injury: The patient experienced 4 days after her last injection of HPV vaccine (the last was SILGARD, the other 2 were GARDASIL) very strange sensory disturbances in the left arm. It came suddenly and she felt her left hand would fist continuously. Furthermore, her hand nerve was retract all the time. It buzzed in the arm, as if there was water that ran under the skin. It got worse the following days and then came several symptoms such as chronic pain in the upper back between the shoulder blades, pain in the middle of the spine (that feeling has been there since early summer), headache, tiredness, sleeplessness (she can lie awake for 2-3 hours a night because her body pains and the arm/leg are numb), stretch marks on her arms when carries her daughter (it is deep furrows in the skin that go away again after 5 minutes), diarrhea, stomach ache, appetite loss, resulting in weight loss, diffuse, feeling of being in a bubble, feeling of stress, no sexual desire, longer cycle (before she got the first HPV vaccine it was exactly 26 days between menstrual periods, now it is typically 32 days or more), tics in eyes, legs and arms, increased tendency to sweat and freezes more, blue fingers, swollen lymph nodes on the throat and in the groin and lump in breast (to be reviewed during mammography on the 06-Oct-2013) muscle-/joint pain in entire body, loss of strength in the left upper arm (can no longer train with it, has lost a lot of muscle mass and it hurts at the vaccination site), blurred vision and more difficult to focus and concentrate. Recent adverse reaction came yesterday with yellow spots on the palms, the physician suspects Addison''s disease (she will be investigated for this). There are constantly more and more strange symptoms. The patient still has the above mentioned adverse reactions because of the drug injury. The patient is partially on sick leave due to drug injury (she had to go home earlier some days or start later because of pain or various physician visits / investigations). Other comments: As described, she has the last well over two months gotten more and more unpleasant adverse effects, which makes it hard for her to 1) do her job, 2) be optimally healthy, 3) be great, spacious and happy. She sincerely hopes that it all gets better and that she can get her old life back without pain and with a lot of pleasure and profit. She can otherwise mention that due to her sensory disturbances have had an MRI scan of the brain (on a non-specified date), the neurologist has not yet an answer to her general practitioner. In addition, she is waiting for a date to be investigated for the autoimmune disease Addison''s, as well as to the mammography / ultrasound of the lump in the breast on the 05-Oct-2013 and dermatologist for the stretch marks on her arm. Added adverse reactions: Sensory disturbance, back pain, tiredness, sleeplessness, diarrhea, appetite impaired, weight loss, confusion, stress, sexual desire decreased, menstrual cycle prolonged, tics, sweating increased, feeling cold, swollen lymph nodes, breast lump, muscle pain, joint pain, injection site pain, skin colouring, Addison''s disease. The case has been upgraded to serious, since the patient states that she is under investigation for Addison''s diseases. The patient is 54 kg and 165 cm. The patient had also a medical history of carcinoma in situ, started on a non-specified date in 2007. The patient was advised to vaccination by own general practitioner because of the carcinoma in situ in 2007. The patient has in general no other health problems. At the time of reporting, outcome of suspected Addison''s disease was unknown and outcome of the other events was not recovered. Upon medical review the company judged relevant to code the following adverse events: Blue fingers, general feeling in the body is very changed and left arm paralyzed. HA changed vaccination date of SILGARD from 27-Jul-2013 to 24-Jul-2013. HA coded this but has not provided any information in narrative. Discrepancy in HA report, according to HA most of the AEs occurred four or five days post SILGARD vaccination (24-Jul-2013) but HA coded onset dates 27-Jul-2013, 28-Jul-2013 or Jul-2013.


VAERS ID: 510580 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-01
Onset:2013-10-01
   Days after vaccination:0
Submitted: 2013-10-30
   Days after onset:29
Entered: 2013-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1310CAN012453

Write-up: This spontaneous report was received from a consumer''s mother regarding her daughter, a female patient of unknown age who was reported "to be in grade 8 of her school", with no pertinent medical history reported. Approximately in October 2013 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (dose and route not reported). No other suspect therapies or concomitant medications were reported. Approximately in October 2013, after having received GARDASIL, the patient developed a rash and hives. The patient was currently receiving unspecified treatment for the adverse experience in the hospital''s emergency room. It was not specified whether the patient was being hospitalized for the adverse experience. The outcome for rash and hives was unknown at the time of the report. Additional information is not expected.


VAERS ID: 510625 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-07-01
Onset:2012-07-01
   Days after vaccination:0
Submitted: 2013-10-31
   Days after onset:487
Entered: 2013-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dermatitis acneiform, Mood altered
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310ESP012842

Write-up: Case received from the Health Authorities (reported to them by a pharmacist) on 22-OCT-2013 under the reference number: ES-AGEMED-937798340. Case medically confirmed. A 22 years-old female patient with no medical history reported had received the first dose of GARDASIL (batch number not reported) via intramuscular, site not reported, on JUL-2012 (exact date not reported) and later (latency not reported) the patient presented with acneiform dermatitis. According to the narratives the patient developed acneiform dermatitis after first dose of vaccination and the picture was worsening after following doses of vaccine (batch numbers, route, site, and administration dates not reported). After the last dose of vaccine the patient required treatment with tetraciclinas (active substance, product name and dosage not reported for 40 days (start and stop dates not reported) with no response. At the time of reporting the patient was being treated with isotretinoin (dosage, route and start dates not reported). The patient had mood affectation secondary to the magnitude problem. Upon medical review, the company judged relevant to code the "mood affectation secondary to the magnitude problem" which were mentioned by the CA in narrative but not coded. The outcome from this coded adverse event was not reported. Case reported as serious by the Health Authorities with other medically important condition as criteria. No further information reported.


VAERS ID: 510626 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-31
Entered: 2013-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bone marrow failure
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Myelodysplastic syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310HUN013826

Write-up: This spontaneous report as received from a physician via company representative refers to a young female patient of unspecified age. On an unknown date the patient was vaccinated with a first dose of SILGARD (Lot number, expiry date, route and dose were not reported), 1 dose. On an unknown date, within one week of vaccination the patient developed haematopoiesis decreased. The outcome of haematopoiesis decreased was unknown. Upon internal review the event haematopoiesis was considered medically significant. Additional information has been requested.


VAERS ID: 510662 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-21
Onset:2013-10-21
   Days after vaccination:0
Submitted: 2013-10-31
   Days after onset:10
Entered: 2013-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Local swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1310HUN013831

Write-up: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. Approximately on 21-OCT-2013 (reported as about 1 week prior to the report), the patient was vaccinated with a first dose of SILGARD (Lot number, expiry date, route and dose were not reported). Approximately on 21-OCT-2013, immediately after vaccination the patient experienced neck swelling. The patient was admitted to a hospital on an unknown date in October 2013. Later on the patient was transferred to another hospital where she was treated with steroids and antihistamine. A very slight improvement but not significant improvement was observed after the treatment therefore the patient was to another hospital on 28-OCT-2013. The outcome of neck swelling was unknown. Additional information has been requested.


VAERS ID: 510757 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-31
Entered: 2013-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Nervous system disorder, Pain, Quality of life decreased
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: HPV vaccine, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK014548

Write-up: Case of adverse event received from patient via company representative on 24-Oct-2013. The primary reporter was a patient. A female patient (age and gender not reported) via not reported route of administration in not reported site of administration on an unspecified date and later on (not reported date), she developed severe neurological disorder, quality of life decreased and excruciating pain every day. The patient has written to the company as she has developed severe adverse events post vaccination. She thinks that she might die prematurely because of the vaccine. No one has given her a clear diagnose and no one can tell her what the future holds for her. It was reported that she has been affected physically and in a way that is indescribable. The three HPV injection that she has received has ruined her life. Patient had previously received two doses of HPV vaccine on unspecified dates. No medical history reported. At the time of reporting, the patient had not recovered.


VAERS ID: 511111 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-17
Onset:2013-10-18
   Days after vaccination:1
Submitted: 2013-11-01
   Days after onset:14
Entered: 2013-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J000398 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dyskinesia, Electroencephalogram abnormal, Foaming at mouth, Muscle twitching, Nervous system disorder, Syncope, Unresponsive to stimuli, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (broad), Dyskinesia (narrow), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: Electroencephalography (EEG) (unknown date): relapsed of paroxysm of generalized nature
CDC Split Type: WAES1310CZE011267

Write-up: On 12-AUG-2013, the patient was vaccinated with the first dose of SILGARD (Lot # H017376 expiration date: April-2015 (dose and route were not reported). On 17-OCT-2013, the patient was vaccinated with the second dose of SILGARD (Lot # J000398 expiration date: July-2015) (dose and route were not reported). On an unknown date, the patient experienced unspecified neurologic problems after the administration of SILGARD. On unknown date, the patient needed intervention of a Neurologist. On 04-OCT-2013, reported as "2 weeks before this event" the patient had injury - car accident, she was not seriously injured, but she fainted, no further problem reported. On 18-OCT-2013, the patient experienced paroxysm-generalized nature. On 18-OCT-2013, in the morning the patient faint again, she did not respond, she had twitching legs, roaring and foaming at the mouth. This episode lasted for one minutes and all symptoms disappeared spontaneously. She was transferred to the hospital, she once vomited there. She had neurology examination during the hospitalization, electroencephalography (EEG) result-relapsed of paroxysm of generalized nature. On an unknown date, the patient started the administration of LAMICTAL. The parents of the patient described possible symptoms already in February 2013. The outcome of unspecified neurologic problems, injury fainted and paroxysm was unknown. Additional information is not requested.


VAERS ID: 511112 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-01
Entered: 2013-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005923 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Aura, Loss of consciousness, Muscle rigidity, Pallor, Skin discolouration, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR014391

Write-up: This case was received from the health authority on 23-Oct-2013. GB-MHRA-ADR 22280139. This case is medically confirmed. A 12 year old patient (gender not reported), with no medical history reported, received on an unreported date an injection of GARDASIL, (batch and lot number J005923, exp. 28-FEB-2016) 0.5mL intramuscularly, dose in series and site of administration not reported. Approximately 5 minutes post vaccination, the patient fainted. The patient experienced loss of consciousness for 2 to 3 minutes, after vaccination and on unreported dates, the patient also presented with pallor, blue, went rigid and made an unusual sound that often preceeds a seizure. Therefore, it was reported that a seizure was suggestive (seizure not coded as adverse event by the MHRA). On unreported dates, the patient has recovered for all the adverse events except for the skin discoloration''s outcome which was unknown. The MHRA considered that case serious due to be medically significant.


VAERS ID: 511162 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-05-13
Submitted: 2013-11-03
   Days after onset:174
Entered: 2013-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Guillain-Barre syndrome, Hypotonia, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: Examinations of 01-JUL-2013: Weakness/muscular weakness; Right upper limb: region, whole limb; Symptom, flaccid; Degree, CDC Split Type: WAES1307JPN001440

Write-up: This spontaneous report as received from a physician refers to a 14 year old female patient. On an unspecified date, the patient was vaccinated with GARDASIL intramuscularly (it was unknown how many times she had received the vaccination). No information on concomitant medication was provided. On 13-MAY-2013, Guillain-Barre syndrome-like symptoms developed in the patient. Around June 2013, the progression of the symptoms had stopped. Examinations of 01-JUL-2013: Weakness/muscular weakness; Right upper limb: region, whole limb; Symptom, flaccid; Degree,


VAERS ID: 511164 (history)  
Form: Version 1.0  
Age: 27.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-28
Onset:2013-10-29
   Days after vaccination:1
Submitted: 2013-11-04
   Days after onset:6
Entered: 2013-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Immune system disorder, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1310TWN013974

Write-up: This spontaneous report as received from a physician refers to a 27 year old female patient. On 24-APR-2013 the patient was vaccinated with the first dose of GARDASIL (lot # not reported), injection, dose 0.5 ml, intramuscularly. On 09-JUL-2013 the patient was vaccinated with the second dose of GARDASIL (lot # not reported), injection, dose 0.5 ml, intramuscularly and on 28-OCT-2013 the patient was vaccinated with the third dose of GARDASIL (lot # not reported), injection, dose: 0.5 ml, intramuscularly. There were no adverse events during the first and second doses. On 29-OCT-2013 the patient experienced skin rash. After the physician assessed, immune system disorder was suspected. The patient was transferred to the hospital (on an unknown date in October 2013) for the further treatment of skin rash. The outcome of skin rash was reported as recovering. The outcome of immune system disorder was not reported. The reporter considered skin rash to be related to GARDASIL, reported that the relationship between GARDASIL and skin rash was possible. The relationship between GARDASIL and immune disorder was not reported. Additional information has been requested.


VAERS ID: 511199 (history)  
Form: Version 1.0  
Age: 29.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-04
Entered: 2013-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Depressed mood, Dizziness, Hypotension, Presyncope, Reading disorder, Vision blurred
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), 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
Preexisting Conditions: GARDASIL, no adverse event
Allergies:
Diagnostic Lab Data: Blood pressuer systolic, 56
CDC Split Type: WAES1310ESP015410

Write-up: Case received from a health professional, a physician, through a company representative on 23-OCT-2013. A 29-year-old female patient, with no medical history reported, had received the second dose of GARDASIL (batch number not reported) route and site not reported, on an unspecified date, and at the moment of injection, the patient presented with hypotension, lipothymia (systolic BP of 56) which improved with postural measurements and she was sent to her home. Since that moment, (5 days ago), the patient felt low mood, dizziness, blurred vision was unable to focus near objects, this difficulted her in her work (she couldn''t read with normality). At the time of reporting the outcome was not reported. Upon medical review the company considered the case as serious with disability as criteria. No further information was reported.


VAERS ID: 511312 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-04
Entered: 2013-11-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Dyspnoea, Epiglottitis, Laryngeal papilloma, Odynophagia, Oropharyngeal pain, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: HPV vaccine (unspecified): Drug Reaction: Laryngeal papilloma
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR014500

Write-up: This case was received from the health authority in the foreign country on 23-Oct-2013 GB-MHRA-ADR 22280981. This case is medically confirmed as it was reported by a physician. A 12 year old female patient received on an unreported date a second dose of human papillomavirus vaccine (manufacturer unknown, batch number not reported) intramuscularly, site of administration not reported. Within 30 minutes of second dose of vaccine, the patient experienced tight throat and difficulty breathing. On unreported dates, the patient also experienced sore throat, painful swallowing, supraglottis and recurrent laryngeal papillomatosis which was, according to the reporter, likely to have been caused by one of the many serotypes of Human Papilloma virus (vaccine causality not clearly reported). The patient was given antihistamines and steroids in the emergency department before that ear, nose and throat review confirmed the supraglottis swelling. The sore throat and painful swallowing took more than 6 days to settle. The physician previously received a first dose of human papillomavirus vaccine (manufacturer unknown) and had laryngeal papillomatosis, on unreported dates (vaccine causality not clearly reported). The patient had recovered from sore throat, swallowing painful and supraglottis on unreported dates, and the patient''s outcome was unknown for the other adverse events. The MHRA considered that case serious due to be life threatening.


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: 511634 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-06
Entered: 2013-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1311ITA001482

Write-up: Case received from Health Care Professional on 30-OCT-2013 through SPMSD field force. Case medically confirmed. A 12 year old female patient was vaccinated on a not reported date with the third dose of GARDASIL (batch n. not reported). Two days post-vaccination she was admitted to the hospital and diagnosed with diabetes. Further information was requested.


VAERS ID: 511762 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-09
Onset:2013-09-09
   Days after vaccination:0
Submitted: 2013-11-06
   Days after onset:58
Entered: 2013-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H013137 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Flushing, Headache, Heart rate increased, Heart rate irregular, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: 09-Sep-2013 pulse was 144bpm, respiratory rate was 16, her BP 138/80, oxygen saturation was 99% a repeat pulse was 122bpm and BP was 160/82. After another 15 minutes her pulse was reduced to 100bpm. On sitting up the patient''s pulse increased to 112bpm.
CDC Split Type: WAES1311IRL001878

Write-up: This case was received from the health authority on 31-Oct-2013. REF 2013-018584. This case is medically confirmed. A 13 year old female patient with no medical history or concomitant medication received an injection of GARDASIL (batch number H013137), IM, site not reported, 0.5 mls, on 09-Sep-2013. On 09-Sep-2013, approximately 25 minutes post vaccination, the patient complained of a frontal headache and was feeling flushed. The reporter indicated that the patient''s pulse was 144bpm which is irregular. The patient''s respiratory rate was 16, her BP 138/80 and oxygen saturation was 99%. The patient had no respiratory distress. A few minutes later the patient also complained of dizziness. The patient lay down with her legs elevated. A repeat pulse was 122bpm and BP was 160/82. After another 15 minutes the dizziness and flushing had improved, her pulse was reduced to 100bpm. The patient sat up and was given one tablet of paracetamol for her headache. On sitting up the patient''s pulse increased to 112bpm. The patient was transferred to A&E for persistent tachycardia. If any corrective treatment was provided it was no specified. The reporter indicated that the patient was discharged from A&E that day. The duration of the events was two hours and the patient made a complete recovery. The events were considered to be medically important by the health authority.


VAERS ID: 511765 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-11
Onset:2013-03-12
   Days after vaccination:1
Submitted: 2013-11-06
   Days after onset:239
Entered: 2013-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H017285 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Application site reaction, Arthralgia, Blood gases normal, C-reactive protein normal, Cardiovascular disorder, Cyanosis, Fibrin degradation products normal, Haemoglobin normal, Local swelling, Pain, Pain in extremity, Platelet count normal, Sensation of heaviness, Skin discolouration, Ultrasound scan normal
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ethinyl estradiol (+) levonorgestrel
Current Illness: Immunisation
Preexisting Conditions: HPV vaccine (unspecified), Immunisation; HPV vaccine (unspecified), Immunisation
Allergies:
Diagnostic Lab Data: FDPs, CRP, hemoglobin, Thrombocyte, blood gases: without remark; Ultrasound test: without remark, nice flow
CDC Split Type: WAES1311SWE000215

Write-up: Case of adverse event received from health care professional via Health Authority on 29-Oct-2013 under the reference number 133537. The primary reporter was a general practitioner. Case is medically confirmed. A 14 year old female patient (weight and height not reported), had received the third dose of GARDASIL (batch and lot number H017285, exp. 31-MAR-2015, 0.5 ml) via intramuscular route of administration in not reported site of administration on 11-Mar-2013 and later on, the day after, on 12-Mar-2013 she developed pain, large application site reaction ($g5 cm diameter), left arm and fingers blue and swollen. On unspecified date the patient developed felt heavy in the arm. Sought emergency care after a week with continuous problems; sore in arm/wrist, discolouration and a slight feeling of pounding pain. Investigation showed chemical lab tests (date not reported) without remarks: D-dimer, CRP, Hb, TPC and blood gas. Ultrasound without remark, nice flow. The patient had received concomitant treatment with PRIONELLE coated tablet (other Mfr). According to the reporter, the judgment is a very severe local reaction by HPV-vaccination with some circulatory stasis (onset not reported) most likely - but so pronounced that she may come back if necessary if NSAIDs do not help. No further information specified. The patient had previously received the first and second dose of HPV-vaccine (brand/trade name not reported) via not reported route of administration on not reported site of administration on a non-specified date. No other history reported. At the time of reporting, the outcome was recovered without sequelae. According to the reporter, the reactions pain and large application site reaction ($g5 cm diameter) were possibly related to vaccination. The case was assessed as serious by the HA due to hospitalization (hospitalization dates not provided). Upon medical review the company judged relevant to code the following adverse events: circulatory stasis, left arm and fingers blue and swollen, felt heavy in the arm and vaccination site reaction which were mentioned by HA in the narrative, but not coded.


VAERS ID: 511899 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-07
Onset:2013-08-07
   Days after vaccination:0
Submitted: 2013-11-07
   Days after onset:92
Entered: 2013-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiovascular disorder, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 07-AUG-2013: Blood pressure 90/60.
CDC Split Type: WAES1311DEU002652

Write-up: Case received from a healthcare professional in a foreign country on 28-Oct-2013. Case is medically confirmed. A 14-year-old female patient received the first dose of GARDASIL (lot-no. not reported) IM into the left upper arm on 07-Aug-2013. After leaving the doctor, the patient developed circulatory problems and black out. The patient went back to the doctor and put her feet up. Blood pressure was 90/60. The patient had not eaten anything prior to vaccination. The patient recovered spontaneously on the same day. Upon internal review, the event black out was considered medically significant and the case was consequently upgraded. Additional information received on 06-Nov-2013: The patient received the second dose of GARDASIL on an unspecified date. The patient was lying during the administration. Vaccination was well tolerated.


VAERS ID: 512034 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: Foreign  
Vaccinated:2013-04-04
Onset:2013-04-21
   Days after vaccination:17
Submitted: 2013-11-08
   Days after onset:201
Entered: 2013-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Albumin urine present, Antinuclear antibody positive, Haematuria, IgA nephropathy, Red blood cells urine positive, Upper respiratory tract infection
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (narrow), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: Urine analysis: 22-Apr-2013: 20 erythrocyres in field; 22-APR-2013: Albumine ++ Antinuclear antibody: 22-APR-2013: slightly + in serum
CDC Split Type: WAES1311GRC002563

Write-up: Case received from a dermatologist on 01-Nov-2013 via the contractual partner under the reference number SPV13046. Case medically confirmed. Initial reporter: dermatologist. A 15-year-old male patient had received the second dose of GARDASIL (batch number not reported) via intramuscular route on 04-Apr-2013. 17 days post-vaccination, on 21-Apr-2013, he experienced macroscopic hematuria during 24 hours. After a consultation at the nephrologist on 22-Apr-2013, IgA nephropathy was diagnosed. Laboratory tests performed on 22-Apr-2013 showed: erythrocytes in urine sample: 20 in fields (normal range 0-5), albumine in urine sample:++ (normal range-), ANA in serum: slightly + (normal range-). The patient recovered on 22-Apr-2013. According to the reporter, relation to GARDASIL was considered as possible. Within the last 6 months, the patient underwent 3 follow-ups at the nephrologist. Urine samples were performed at every follow-up, but no abnormal findings were detected (no erythrocytes or albumin). To be noted that he had no concurrent medication. 15 days before the episode of macroscopic haematuria, he had experienced upper respiratory infection.


VAERS ID: 512431 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-14
Onset:2013-10-14
   Days after vaccination:0
Submitted: 2013-11-08
   Days after onset:25
Entered: 2013-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Fall, Malaise, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: Decreased appetite; Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DEU010192

Write-up: Case was received from a healthcare professional in a foreign country on 17-Oct-2013. Case is medically confirmed. A 17-year-old female patient with a medical history of anorexia received the first dose of GARDASIL (lot-no. not readable) IM into the right upper arm on 14-Oct-2013. A short time later, when leaving the doctor''s office, she developed dizziness and fell. A vasovagal syncope was suspected. The patient went to the next pharmacy and recovered after drinking a glass of water. Since then (not specified) the patient suffered from malaise and vomiting (especially at night) additionally to ongoing dizziness leading to hospitalisation (date not reported). The patient had recovered from vasovagal syncope and fall, but had not recovered from dizziness, malaise and vomiting. Follow-up information received from a pharmacist via the Drug Commission of Pharmacists (reference no. 181374) on 23-Oct-2013: The patient''s weight (55 kg) and height (160 cm) were provided. The patient collapsed approximately five minutes after vaccination. Follow-up information received from the Health Authorities in a foreign country on 04-Nov-2013 (reference no. PEI2013063815): Circulatory collapse was coded as an additional AE. The patient developed dizziness and circulatory collapse five minutes after vaccination and had not recovered from these two events at the time of reporting. The outcome of malaise and vomiting was not reported.


VAERS ID: 512468 (history)  
Form: Version 1.0  
Age: 33.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-11-04
Onset:2013-11-04
   Days after vaccination:0
Submitted: 2013-11-08
   Days after onset:4
Entered: 2013-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J000633 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Altered state of consciousness, Heart rate decreased, Pallor, Shock
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311CAN003150

Write-up: This spontaneous report as received from a pharmacist refers to a female patient of 33 years old. On 04-NOV-2013, the patient was vaccinated with the first dose of GARDASIL (lot # J000633, exp. date 16-AUG-2015) (dose and route were not reported) for prevention. Concomitant medications were not reported. On 04-NOV-2013 the patient experienced shock (pale, lost awareness and low pulse). The outcome of shock was recovered on 04-NOV-2013 at 01:00pm. The patient only received the first dose. The reporter considered shock to be not related to GARDASIL. Upon internal review shock was considered to be medically significant. Additional information has been requested.


VAERS ID: 512640 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-10
Onset:2013-05-10
   Days after vaccination:0
Submitted: 2013-11-11
   Days after onset:185
Entered: 2013-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cellulitis, Erythema, Induration, Pain
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1311COL003714

Write-up: This spontaneous report as received from a Regulatory Authority (Agency # AE13CO0242) refers to a 14 year old female patient. On 10-MAY-2013 the patient was vaccinated intramuscularly with the first dose of GARDASIL 0.5 ml dose (frequency reported as day1, 2 months after 1st dose, 6 months after 1st dose). On 10-MAY-2013 the patient experienced cellulitis, induration, local pain and erythema. She required hospitalization on 12-MAY-2013. The patient''s outcome was not reported. The relatedness between the vaccination with GARDASIL and the patient''s adverse events was not reported. Additional information has been requested.


VAERS ID: 512651 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-27
Onset:2013-07-03
   Days after vaccination:37
Submitted: 2013-11-11
   Days after onset:131
Entered: 2013-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cellulitis, Pyrexia, Systemic lupus erythematosus, Vasculitis
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Vasculitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1311COL003764

Write-up: This spontaneous report as received from a regulatory authority refers to a 17 year old female patient. On 27-MAY-2013, the patient was vaccinated (route not provided) with GARDASIL (lot number and expiry date not provided) dose 1, 0.5 ml, intramuscular. On 03-JUL-2013, 38 days after onset of therapy the patient experienced fever (hospitalization), systemic lupus erythematosus (hospitalization and medically significant upon internal review), vasculitis (hospitalization) and cellulitis (hospitalization) with one month of evolution. The patient was hospitalized on 03-JUL-2013. The outcome of vasculitis, cellulitis, fever and systemic lupus erythematosus was unknown. The action taken with GARDASIL was not provided. The reporter did not assess the relationship between the events and GARDASIL. The reporter assessed the event systemic lupus erythematosus to be medically significant. Additional information has been requested.


VAERS ID: 512693 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-09
Onset:2013-10-09
   Days after vaccination:0
Submitted: 2013-11-11
   Days after onset:33
Entered: 2013-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005627 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Headache, Nausea, Sensation of heaviness, Vision blurred
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311GBR003541

Write-up: This serious case was reported by the regulatory authority, via other health care professional, on 31-Oct-2013. GB-MHRA-ADR22290509. This case is medically confirmed. A female patient, 12-year old, had received an injection of GARDASIL, lot J005627, on 9-Oct-2013. Vaccine was administered IM, injection site and number in series were not reported. Following vaccination the patient experienced on the 9-Oct-2013 blurred vision, headache, felt faint, heaviness in limbs and nauseous. According to the report the AEs of faint, nauseous and arm felt heavy were reported as medically significant and their outcome was reported as unknown. The outcome for blurred vision and headache were reported as not recovered/not resolved. No patient history or concomitant medication was reported.


VAERS ID: 512710 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-10
Onset:2013-11-01
   Days after vaccination:236
Submitted: 2013-11-12
   Days after onset:11
Entered: 2013-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0788AA / 3 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Abdominal pain, Pain, Pain in extremity, Wheelchair user
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1311JPN003454

Write-up: Initial information has been received from a physician concerning a 14-year-old female patient. On an unspecified date more than 6 months before, she was vaccinated with a dose of GARDASIL IM (intramuscular) injection syringe (dose, injection site and lot number not reported). No concomitant medication was provided. On an unspecified date, she visited the hospital with a chief complaint of abdominal pain. On approximately November 2013 (more than 6 months since she received the vaccine), she experienced symptom of generalised aching. She was not able to walk due to the foot pain and moved in a wheelchair. At the time of November 2013, she was hospitalized in a medical hospital A. Transferring to another hospital was under consideration. The cause of the pain had not been identified by the detailed examination in medical hospital A. As of 07-NOV-2013, the outcome of the generalised aching, "not able to walk" and abdominal pain were unknown. Reporter''s comment: Not provided. The reporting physician did not assess the causal relationship with generalised aching, "not able to walk" and abdominal pain to GARDASIL. The reporting physician considered the generalised aching was serious due to hospitalization. The reporting physician did not assess the seriousness of abdominal pain and "not able to walk". Additional information has been requested.


VAERS ID: 512728 (history)  
Form: Version 1.0  
Age: 35.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-31
Onset:2013-11-06
   Days after vaccination:6
Submitted: 2013-11-12
   Days after onset:6
Entered: 2013-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Monoplegia
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311KOR003496

Write-up: This spontaneous report as received from a physician via company representative refers to a 35 year old female patient who on 31-OCT-2013, was vaccinated with a first dose of GARDASIL INJECTION (Lot number, expiry date, route and dose were not reported). On 06-NOV-2013, the patient experienced leg paralysis. The outcome of leg paralysis was reported as not recovered. The patient was planned to visit the clinic on 07-NOV-2013. Upon internal review, the event leg paralysis was considered as medically significant. Additional information is not expected.


VAERS ID: 512730 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-01
Onset:2013-07-08
   Days after vaccination:37
Submitted: 2013-11-12
   Days after onset:127
Entered: 2013-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Exposure during pregnancy, Uterine dilation and curettage, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1311COL003754

Write-up: This spontaneous prospective pregnancy report as received from the National Institute of Health in a foreign country refers to a 13 year old female patient. An inadvertent GARDASIL vaccination was performed on 20-MAY-2013. In June 2013, the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular. The patient had a LMP of 29-APR-2013 and EDD of 03-FEB-2014. The exposure was during the first trimester. The pregnancy outcome was spontaneous abortion. On 08-JUL-2013, the patient experienced vaginal bleeding (hospitalization) and curettage (hospitalization). At the time of the onset of the symptoms, the patient was on the 10 week of gestation, and subsequent curettage. The patient had an analysis unit on department and final classification as a matching case. The outcome of vaginal bleeding and curettage was unknown. The action taken with GARDASIL was not provided. The reporter did not assess the relationship between the vaginal bleeding and curettage and GARDASIL. Additional information has been requested.


VAERS ID: 512731 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-22
Onset:2013-08-23
   Days after vaccination:1
Submitted: 2013-11-12
   Days after onset:81
Entered: 2013-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dysaesthesia, Hyperhidrosis, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1311COL003698

Write-up: This spontaneous report as received from a regulatory authority (AE13CO02348) refers to a 14 year old female patient. On 22-AUG-2013 (also reported as 34 weeks ago) the patient was vaccinated with GARDASIL (lot number not provided), 0.5 ml, intramuscular. On 23-AUG-2013 the patient experienced dysesthesia, urticaria and sweating. The patient was hospitalized on the same day. The outcome of dysesthesia, urticaria and sweating was unknown. Additional information has been requested.


VAERS ID: 512733 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-08
Onset:2013-05-09
   Days after vaccination:1
Submitted: 2013-11-12
   Days after onset:187
Entered: 2013-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cellulitis, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1311COL003709

Write-up: This spontaneous report as received from a regulatory authority (#AE13CO0243) refers to a 13 year old female patient. No medical history provided. On 08-MAY-2013 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular for prevention of cervical cancer. No concomitant medications were provided. On 09-MAY-2013 the patient experienced cellulitis, local pain and fever. She required hospitalization on 23-MAY-2013. The outcome of local pain, fever and cellulitis is unknown. Unknown whether the patient received the second (after two months) and third dose (after six months) of GARDASIL. Additional information has been requested.


VAERS ID: 512735 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-12
Entered: 2013-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Lymphoma
SMQs:, Malignant lymphomas (narrow), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311SWE003112

Write-up: Case of adverse event received from health care professional via company representative in a foreign country on 04-Nov-2013. The primary reporter was a physician. Case is medically confirmed. A female patient (reported as 16 or 17 years old), with no reported medical history, had received an injection of GARDASIL (batch number not reported) via not reported route of administration in not reported site of administration on unspecified date and later on unspecified date (x years post vaccination) she developed lymphoma. According to the reporter, the patient is worried and relates GARDASIL to the lymphoma. Upon medical review the company judged relevant to consider the case serious. At the time of reporting, the outcome was not recovered. According to the reporter, the reaction lymphoma is not related to the vaccination.


VAERS ID: 512737 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-15
Onset:2013-06-18
   Days after vaccination:34
Submitted: 2013-11-12
   Days after onset:147
Entered: 2013-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Encephalopathy, Hypotonia, Paralysis
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: Familial risk factor
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311COL003734

Write-up: This spontaneous report as received from a regulatory authority (#AE13CO0245) refers to a 12 year old female patient with family history of epilepsy. On 15-MAY-2013 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular for prevention of cervical cancer. No concomitant medications were provided. On 18-JUN-2013 the patient experienced paralysis, encephalopathy and hypotonia. She required hospitalization on 23-JUN-2013. The outcome of hypotonia, encephalopathy and paralysis is unknown. Unknown whether the patient received the second (after two months) and third dose (after six months) of GARDASIL. The events of paralysis and encephalopathy were considered medically significant upon internal review. Additional information has been requested.


VAERS ID: 512739 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-12
Entered: 2013-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005626 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest discomfort, Dizziness, Feeling abnormal, Feeling hot, Malaise, Pallor, Paraesthesia, Pulse pressure decreased, Restlessness
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Drug hypersensitivity; Malformation venous; acetaminophen, Drug Reaction: Hypersensitivity; erythromycin, Drug Reaction: Hypersensitivity
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311GBR003166

Write-up: This case was received from health authority in a foreign country on 04-Nov-2013. GB-MHRA-ADR 22291742. The case is medically confirmed as it was reported by a health care professional. A 12 year old female patient (date of birth not reported), with medical history of venous malformation in right forearm and allergy to erythromycin (manufacturer unknown and paracetamol (manufacturer unknown), received an injection of GARDASIL (batch/lot number J005626, expiration date 29-FEB-2016) 1 dosage form by intramuscular route, dose in series and site of administration not reported on unspecified date and within a couple of minutes of having the vaccine, she felt hot and faint. She was taken to a safe area and continued to feel unwell, describing feeling hot, pins and needles throughout her arms and legs, feeling odd, her pulse was shallow, that her chest felt airy. These adverse effects continued for around 15 minutes, her symptoms became worse, pins and needles continued, she was pale in colour, restless and she was not showing any signs of recovery. A decision was made to call an ambulance. The child became unwell very quickly after having the vaccine. At the time of reporting, the patient was not recovered from unwell. The outcome for all other adverse effects was unknown. The MHRA considered that case serious due to be medically significant.


VAERS ID: 512744 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-11-01
Onset:2010-01-01
   Days after vaccination:61
Submitted: 2013-11-12
   Days after onset:1411
Entered: 2013-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hemiparesis, Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal, Sensory loss, White matter lesion
SMQs:, Peripheral neuropathy (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: Nuclear magnetic resonance imaging, Discrete T2 lesions
CDC Split Type: WAES1311GRC003181

Write-up: Case received from a health care professional in a foreign country on 04-Nov-2013 via a contractural partner under the reference number SPV13047. A 20-year-old female patient had received the third dose of GARDASIL (batch number not reported) via intramuscular route in Nov 2009. Two months post vaccination she developed mild hemiparesis of the right arm associated with sensory loss. MRI showed discrete T2 lesions in the left cerebral white matter. Multiple sclerosis was diagnosed by a neurologist. A treatment with interferon-beta 1a was started. The patient have been in remission for the last 3.5 years. It is noteworthy that the reporter assessed the relationship between the vaccine and the event as possible.


VAERS ID: 512759 (history)  
Form: Version 1.0  
Age: 10.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-06
Onset:2013-07-06
   Days after vaccination:0
Submitted: 2013-11-12
   Days after onset:129
Entered: 2013-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abscess, Erythema, Induration, Pain
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1311COL003727

Write-up: This spontaneous report as received from a regulatory authority refers to a 10 year old female patient with no reported medical history. On 03-MAY-2013 (reported as 27 weeks ago) the patient was vaccinated with GARDASIL (intramuscular, lot number unknown) dose 1, 0.5 ml. On 06-JUL-2013 the patient was vaccinated with GARDASIL (intramuscular, lot number unknown) dose 2, 0.5 ml. No other suspect therapy or concomitant medications was reported. On 06-JUL-2013, 46 days after onset of therapy the patient experienced abscess, erythema, local pain and induration. She required hospitalization on 27-Jul-2013. No treatment information was reported. The outcome of abscess, erythema, local pain and induration is unknown. The reporters relatedness of abscess, erythema, local pain and induration to GARDASIL is unknown. Additional information has been requested.


VAERS ID: 512831 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-12
Entered: 2013-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005923 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Feeling abnormal, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: BP: 117/78; Pulse rate: 78 BPM
CDC Split Type: WAES1311GBR004101

Write-up: This case was received from the health authority in a foreign country on 05-Nov-2013. GB-MHRA ADR 22297979. This case is medically confirmed as it was reported by health care professional. A 12 years old female patient, with no medical history reported, received an injection of GARDASIL (batch number J005923) 0.5 mL by intramuscular route, dose in series and site of administration not reported, on an unspecified date and a few minutes after receiving the injection, she experienced blurred vision and feeling wobbly in the legs and unstable when she stood. She did not lose consciousness or vomiting. Her blood pressure was stable. At the time of reporting, the patient has recovered from blurred vision and unstable feeling. The MHRA considered that case as serious due to be medically significant.


VAERS ID: 513032 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-07
Onset:2013-10-25
   Days after vaccination:79
Submitted: 2013-11-13
   Days after onset:19
Entered: 2013-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Generalised oedema, Idiopathic thrombocytopenic purpura, Lupus nephritis, Lymphadenopathy, Platelet count decreased, Proteinuria, Systemic lupus erythematosus
SMQs:, Acute renal failure (broad), Angioedema (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: 10/2010, Idiopathic thrombocytopenic purpura
Preexisting Conditions: 2012, Splenectomy
Allergies:
Diagnostic Lab Data: Platelet count (??-OCt-2010): decreased, diagnosed to have idiopathic thrombocytopenia purpura (ITP); Platelet count (21-AUG-2013): test showed dropped in platelets
CDC Split Type: WAES1308MYS011527

Write-up: This spontaneous report as received from a pediatrician, refers to a female patient (age to be confirmed). On an unknown date the patient was vaccinated with a dose of GARDASIL (Lot # not reported) (0.5 ml dose, intramuscular route). Concomitant therapy was not reported. On an unknown date the patient experienced cervical lymphadenopathy after vaccination. The outcome of cervical lymphadenopathy after vaccination was unknown. A prescription drug was not required to treat the adverse event. The relatedness between cervical lymphadenopathy and GARDASIL was unknown. The doctor did not have time to get further information. Follow up information has been received from the doctor who indicated that the patient was a 17 year old female non-pregnant patient with a previous history of splenectomy and few other medical conditions (unspecified). It was reported that this was the first dose of GARDASIL that the patient received. On an unspecified date, the patient also had idiopathic thrombocytopenia purpura (decreased platelet count). The patient had been referred to the hematologist for further treatment. The outcome of idiopathic thrombocytopenia purpura was unknown. The causal relationship was not reported. Upon internal review idiopathic thrombocytopenia purpura was considered to be medically significant. Follow up information was received from the physician (pediatrician). It was reported that the patient was diagnosed to have idiopathic thrombocytopenia purpura (ITP) in approximately October 2010 (also reported as three years ago). She was steroids and danazol. The patient historical condition included splenectomy in approximately 2012 (also reported as last year). On 08-JUL-2013 the patient was vaccinated intramuscularly with the first dose of GARDASIL 0.5ml dose. On 07-AUG-2013 the patient was vaccinated intramuscularly with the second dose of GARDASIL 0.5ml dose. Following GARDASIL dose II, in approximately 2013, she developed cervical lymphadenopathy and recurrence of decreased platelets. On 21-AUG-2013 lab diagnostic tests showed dropped in platelets and her lymph nodes swelled. The hematologist had advised not to give her the 3rd dose of GARDASIL (action taken reported as discontinued). There was a prescription drug required to treat the adverse events. The patient''s outcome was unknown at the time if this report. Upon internal review recurrence of decreased platelets (idiopathic thrombocytopenia purpura) was considered to be medically significant. The reporter felt that the adverse events were related to the vaccination with GARDASIL. Follow up information was received. Danazol and steroids were given as treatment of recurrence of decreased platelets (idiopathic thrombocytopenic purpura). Follow-up information has been received on 08-NOV-2013. The doctor informed a medical representative of the following information. 2 weeks ago (on approximately 25-OCT-2013), the patient presented with generalized oedema of the whole body (very puffy). Patient was hospitalized. Patient was found to have proteinuria (gross). The patient was diagnosed with lupus nephritis. Further diagnosis was systemic lupus erythematous (autoimmune disease) and present with thrombocytopenia, nephritis. Patient was on losartan(manufacturer unknown), LASIX, potassium chloride (manufacturer unknown) and CELLCEPT. Outcome of "systemic lupus erythematous (autoimmune disease) and present with thrombocytopenia, nephritis" was unknown. Upon internal review, systemic lupus erythematous was determined to be medically significant event. Additional information is not expected.


VAERS ID: 513042 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-02-01
Onset:2008-02-15
   Days after vaccination:14
Submitted: 2013-11-13
   Days after onset:2098
Entered: 2013-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NF58540 / 2 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Back pain, Leukopenia, Pain in extremity, Viral infection, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Itraconazole
Current Illness: Immunisation
Preexisting Conditions: 01/04/2008 - 01/20/2008 Historical Drug, Itraconazole; 11/19/2007, GARDASIL, Drug Indication, Immunisation
Allergies:
Diagnostic Lab Data: 02/18/2008 White blood cell count, 1.7; 02/28/2008 White blood cell count, 3.9; 03/11/2008 White blood cell count, 4.0; 08/13/2008 White blood cell count, 3.8; 09/29/2008 White blood cell count, 3.6; 02/24/2011 White blood cell count, Normal
CDC Split Type: WAES1309DEU001877

Write-up: Case received from a health care professional in a foreign country on 22-Aug-2013. Case is medically confirmed. A female patient (physician''s daughter) of unspecified age received a dose of GARDASIL (lot-no. not reported) on an unspecified date. Approximately 4 weeks later the patient developed pain in limbs and leucopenia. Duration and outcome were not reported. Follow up report received on 22-OCT-2013: The patient''s birthdate, weight (50 kg) and height (160 cm) was reported. The patient received a second dose of GARDASIL IM into the upper arm on 01-Feb-2008. 14 days later, on 15-Feb-2013, the patient developed leucopenia up to 1.7/nl, pain in joint and lumbar pain. Laboratory tests included leucocytes 3.6/nl (4.0-10.0) on 29-Sep-2008, 3.8/nl on 13-Aug-2013, 4.0/nl on 11-Mar-2008, 3.9/nl on 28-Feb-2008 and 1.7/nl on 18-Feb-2008. Laboratory values on 24-Feb-2011 were within normal range. The patient recovered after 2 weeks. According to the reporter, the events were probably related to the vaccination. D1 of GARDASIL (lot-no. NF58540) was given into the upper arm on 19-Nov-2007. Toleration was not reported. Follow-up information received from the Health Authorities in foreign country on 04-Nov-2013 (reference no. PEI2013063435). Case initially reported as non-serious was upgraded to serious by PEI (other medically important condition). Upon reporting form, the patient developed leucopenia in the scope of a viral infection. HA additionally coded viral infection, starting on 15-Feb-2008. Duration of viral infection was reported as two weeks. The patient had been treated with Itraconazole from 04-Jan-2008 to 20-Jan-2008 (indication not reported). HA considered Itraconazole as concomitant medication. Corrective version created on 07-Nov-2013 in order to add the duration of viral infection in the narrative and to code itraconazole as concomitant medication.


VAERS ID: 513043 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-13
Entered: 2013-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311ISR005118

Write-up: Information was received from a lawyer who reported that an article (unspecified) described a 15 year old who was vaccinated with GARDASIL. One month later, she had an epileptic fit, without there being any family history and as a total surprise. The girl was completely healthy before the vaccination. One of the doctors said it was a mistake to vaccinate her and definitely not before she is sexually active. Upon internal review, epileptic fit was considered to be medically significant. Additional information is not expected.


VAERS ID: 513044 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-13
Entered: 2013-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Convulsion, Headache, Malaise
SMQs:, 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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311ISR005115

Write-up: Information was received from a lawyer who reported that an article (unspecified) provided an example of a girl who was vaccinated with GARDASIL during her annual checkup. She got sick a week later. Her deterioration was rapid and severe with seizures, headaches, adn weakness. Upon internal review, seizures were considered to be medically significant. Additional information is not expected.


VAERS ID: 513081 (history)  
Form: Version 1.0  
Age: 25.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-08
Onset:2013-01-15
   Days after vaccination:7
Submitted: 2013-11-13
   Days after onset:302
Entered: 2013-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin positive, Ultrasound abdomen abnormal
SMQs:, Retroperitoneal fibrosis (broad), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 11/01/2012, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: 01/15/2013, Pregnancy test, Positive; 01/15/2013, Ultrasound scan, abortion spontaneous
CDC Split Type: WAES1311DNK004145

Write-up: Case of adverse event received from health care professional via Health Authorities on 05-Nov-2013 under the reference number DK-DKMA-ADR 22290795 and EFO7312. The primary reporter was a physician. This case is linked to E2013-09035 (same patient developed missed abortion after dose 3). A 25 year old female patient (weight: 48; height: 161), had received the second dose of GARDASIL (batch number not reported) via intramuscular route, site of not reported site on 08-Jan-2013 and later on, 15-Jan-2013, the ultrasound test showed that she had abortion spontaneous (coded by HA). Patient had received the first primary dose of GARDASIL on 01-Nov-2012. She then received the third dose of GARDASIL (batch number not reported) via intramuscular route of administration, site not reported on 07-May-2013, and later on, the patient had a positive pregnancy test on 06-Aug-2013 and the following ultrasound (date not specified) showed that she had missed abortion (HA coded LLT abortion missed). HA coded the second and the third dose as suspected products. Laboratory tests: U-HCG to confirm pregnancy on 15-Jan-2013 and 06/Aug/2013. Ultrasound performed at the gynecologist on 15-Jan-2013 and unspecified date in Aug-2013. No medical history reported. At the time of reporting, HA has coded outcome of all AE not recovered. HA reported onset age 26 years old (contradictory to date of birth and AE onset date).


VAERS ID: 513082 (history)  
Form: Version 1.0  
Age: 26.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-07
Onset:0000-00-00
Submitted: 2013-11-13
Entered: 2013-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion missed, Exposure during pregnancy, Human chorionic gonadotropin positive, Ultrasound antenatal screen abnormal
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Pregnancy~HPV (Gardasil)~2~25.00~Patient|Spontaneous abortion~HPV (Gardasil)~2~25.00~Patient
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Pregnancy; 01/08/2013, GARDASIL, Abortion spontaneous; 11/01/2012, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: 08/06/2013, Human chorionic gonadotropin, Positive; 08/2013, Ultrasound scan, missed abortion
CDC Split Type: WAES1311DNK004143

Write-up: Case of adverse event received from health care professional via Health Authorities on 05-Nov-2013 under the reference number DK-DKMA-ADR 22290795 and EFO7312. The primary reporter was a physician. This case is linked to E2013-08970 (same patient developed spontaneous abortion after dose 2). A 25 year old female patient (weight: 48; height: 161), had received the third dose of GARDASIL (batch number not reported) via intramuscular route, site of administration not reported on 07-May-2013, and later on, the patient had a positive pregnancy test on 06-Aug-2013 and the following ultrasound (date not specified) showed that she had missed abortion (HA coded LLT abortion missed). HA coded the second and the third dose as suspected products. Patient had received the first primary dose of GARDASIL on 01-Nov-2012. She had also received the second dose of GARDASIL (batch number not reported) via intramuscular route of administration, site not reported on 08-Jan-2013 and later on, 15-Jan-2013, the ultrasound test showed that she had abortion spontaneous (coded by HA). Laboratory tests: U-HCG to confirm pregnancy on 15-Jan-2013 and 06/Aug/2013. Ultrasound performed at the gynecologist on 15-Jan-2013 and unspecified date in Aug-2013. No medical history reported. At the time of reporting, HA has coded outcome of all AE not recovered. HA reported onset age 26 years old (contradictory to date of birth and AE onset date).


VAERS ID: 513090 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-03-24
Onset:2011-04-18
   Days after vaccination:390
Submitted: 2013-11-14
   Days after onset:941
Entered: 2013-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1334X / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Dizziness, Fatigue, Nausea, Neurological symptom
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? No
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: 11/23/2009, GARDASIL; 10/13/2009, GARDASIL
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311DNK004996

Write-up: Case of adverse event received from health care professional via Health Authority on 07-Nov-2013 under the reference number DK-DKMA-ADR 22280124 and DK-DKMA-EFO7220. The primary reporter was a physician. Case is medically confirmed. A 13 year old female patient (weight: 54 kg; height: 168 cm), had received the third dose of GARDASIL (batch number NL12890 and valid lot number 1334X) via intramuscular route of administration in not reported site of administration on 24-Mar-2010 and later on 18-Apr-2011, she developed diffuse neurological symptoms and on unspecified date in the spring of 2011 dizziness, nausea, tiredness and sudden total loss of energy. The patient had received no other vaccines or medications. The patient was examined at the children''s ward and at the neurological ward at hospital on a non-specified date (no results reported). The patient had previously received the primary and second dose of GARDASIL (batch number NK36120 and valid lot number NJ33240) via intramuscular route of administration in not reported site of administration on 13-Oct-2009 and 23-Nov-2009 respectively. No other medical history reported. At the time of reporting, the outcome was not recovered for diffuse neurological symptoms and unknown for dizziness, tiredness, nausea and sudden total loss of energy.


VAERS ID: 513091 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-11-04
Onset:2009-01-01
   Days after vaccination:58
Submitted: 2013-11-14
   Days after onset:1778
Entered: 2013-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Blood test, Chest pain, Computerised tomogram head, Dyspnoea, Headache, Myalgia, Neurological examination, Nuclear magnetic resonance imaging brain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311DNK005011

Write-up: Case of adverse event received from health care professional via Health Authority on 05-Nov-2013 under the reference number DK-DKMA-ADR 22271499 and DK-DKMA-EFO7164. The primary reporter was a physician. Case is medically confirmed. A 13 year old female patient (weight: 58 kg; height: 166 cm), with no medical history reported, had received the primary dose of GARDASIL (batch number not reported) via intramuscular route of administration in not reported site of administration on 04-Nov-2008 and later on a non-specified date in Jan-2009 she developed air hunger, headache, chest pain, muscle pain and joint pain. Blood tests, pediatric examination for asthma, neurological examination, CT-scan and MRI-scan of the cerebrum was performed on a non-specified date (lab results not reported). The patient had no other medications. The patient received the second and third dose of GARDASIL (batch number not reported) via intramuscular route of administration in not reported site of administration on 24-Mar-2009 and 04-Aug-2009 respectively. At the time of reporting, the outcome was recovering from all reported adverse events.


VAERS ID: 513143 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-21
Onset:2013-10-21
   Days after vaccination:0
Submitted: 2013-11-14
   Days after onset:24
Entered: 2013-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Dry throat, Syncope, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Ventricular septal defect; Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311GBR005024

Write-up: This case was received from the health authority on 06-Nov-2013. GB-MHRA-ADR 22301132. This case is medically confirmed. A 13 year old female patient received on 21-Oct-2013 an injection of GARDASIL (batch number not reported), dose in series, route and site of administration not reported. Five minutes post vaccination, the patient felt lightheaded, spinning sensation reported as "room spinning", her throat felt dry and she fainted. The patient''s medical history included a congenital ventricular septal defect as the patient was born with a hole in her heart. The patient was not under care of cardiologists at the time of reporting. At the time of reporting, the patient has not recovered from the adverse events. The regulatory authority considered that case serious due to be medically significant.


VAERS ID: 513144 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-14
Entered: 2013-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311ISR005788

Write-up: Information was received from a lawyer indicating that since 2000, approximately 21,000 people reported side effects due to the GARDASIL. Over 9000 cases ended in the hospital and 1,592 were considered severe. Additional information is not expected.


VAERS ID: 513145 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-14
Entered: 2013-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
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: WAES1311ISR005786

Write-up: Information was received from a lawyer who reported that since 2006, approximately 21,000 people reported side effects due to the Quadrivalent GARDASIL including 73 fatalities. Additional information is not expected.


VAERS ID: 513146 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-14
Entered: 2013-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Vaccination complication
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1311ISR005783

Write-up: Information was received from a lawyer who reported that since 2006, approximately 21,000 people reported side effects due to GARDASIL, 348 life endangering. Additional information is not expected.


VAERS ID: 513154 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-30
Onset:2013-09-30
   Days after vaccination:0
Submitted: 2013-11-14
   Days after onset:45
Entered: 2013-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005923 / 1 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Hypoacusis, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1311GBR005720

Write-up: Case received from healthcare professional on 07-Nov-2013. The primary reporter was other healthcare professional. This case is medically confirmed. A 12-year-old female patient, experienced blurred vision, reduced hearing and feeling of exhaustion, 5 minutes after she received an injection of the GARDASIL (dose 1, route and site not reported, lot J005923 exp. 28-FEB-2016), on 30-Sep-2013. While experiencing these AEs she was kept under supervision from the nurse, and after 1 hour the reduced hearing was reported as recovered. She was sent home where she slept all afternoon and was feeling exhausted. In the evening blurred vision outcome was reported as recovering. No patient relevant medical history and concomitant medication was reported. Upon internal review the Company considered this case as serious due to other medically significant event.


VAERS ID: 513266 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-08
Onset:2013-03-01
   Days after vaccination:113
Submitted: 2013-11-15
   Days after onset:259
Entered: 2013-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abnormal sensation in eye, Anti-transglutaminase antibody negative, Antiacetylcholine receptor antibody, Barotrauma, Blood 25-hydroxycholecalciferol decreased, Blood iron normal, Blood test normal, Blood zinc normal, Borrelia test, C-reactive protein normal, Chest X-ray abnormal, Chlamydia test positive, Computerised tomogram head normal, Computerised tomogram normal, Computerised tomogram thorax abnormal, Cough, Echocardiogram abnormal, Ehrlichia test, Electrocardiogram normal, Electroencephalogram normal, Electromyogram abnormal, Electroneurography, Erythema, Fatigue, Feeling cold, HIV test, Headache, Laryngoscopy normal, Lumbar puncture normal, Malaise, Mycoplasma test, Nuclear magnetic resonance imaging normal, Ophthalmological examination normal, Oropharyngeal pain, Pharyngoscopy, Photophobia, Post viral fatigue syndrome, Pyrexia, Red blood cell sedimentation rate normal, Serum ferritin normal, Spirometry normal, Streptococcus test, Vitamin B12 normal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Azithromycin; DOXYFERM; ERYMAX
Current Illness: Immunisation
Preexisting Conditions: 05/07/2012, GARDASIL, Immunisation; 03/14/2012, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: The patient was undergoing detailed investigation. Tests for CRP and blood status on 02-Apr-2013 and 10-Apr-2013 was without remarks. CRP on 17-Apr-2013 was also normal. Serology for Chlamydophila pneumonia was negative for IgM, but positive for IgG, as after previous infection. Lung X-ray 10-Apr-2013 without remark. Spirometry with reversible-test was performed on 17-Apr-2013 and showed no reversible obstructivity. ECG on 17-Apr-2013 without remarks. Echocardiography showed probable bicuspid aorta valve with minor insufficiency. Otherwise structurally normal heart with normal dimensions and normal function. Blood status and serology was tested (streptococcus, Borrelia, TBE, Mycoplasma, Chlamydia, Ehrlichiosis and HIV), TSH, T4, Iron, Ferritin, Cobalamin, ESR (Erythrocyte sedimentation rate) and Zinc without remark, but 25-OH-D-vitamin slightly low: 53. Transglutaminase without remark (enzyme level normal). EnEG (Electro neurography) without remarks. I-EMG (integrated electromyography) on the border of myopathy; EEG, LP, MR and CT brain and MR of back without remarks. Acetylcholine receptor antibodies without remarks. Lung X-ray and CT showed discrete thickening of bronchial wall. Fiberscope epipharynx and larynx normal. Eye examination on 25-Jun-2013 without remark. Nasal NO on 28-Jun-2013 without remark. CT sinuses without remarks. Phoniatric examination on 19-Aug-2013 without remark. MR muscles without remark.
CDC Split Type: WAES1311SWE005727

Write-up: Case received from health care professional via Health Authorities on 08-Nov-2013 under the reference number SE-Medical Products Agency-2013-000064. The primary reporter as a physician. A 13-year-old female patient had received the third dose of GARDASIL (batch number not reported) on 08-Nov-2012 and later on 01-Mar-2013 she developed myalgic encephalomyelitis. It was reported that the female got unwell in March 2013 with cough, feeling unwell, feeling cold. In early April she developed sore throat. Later on she got worse with more severe tiredness. She had dry cough during the day, but less cough during nights. She suffered from airplane ear on her right ear. She suffered from headache, but mostly from pressure over the eyes. She was light sensitive. She felt feverish, but had max 38 degrees in the evening, but it might have been higher during the nights. The patient had received treatment with (reported as concomitant treatment) of Azithromycin (other mfr) 22-May-2013 to 30-May-2013 (discontinued 1 day early due to skin redness), ERY-MAX (other mfr) treatment in July 2013 (specific dates not rep) and DOXYFERM (other MFR) for 10 days in July 2013. The patient was undergoing detailed investigation. Tests for CRP and blood status on 02-Apr-2013 and 10-Apr-2013 was without remarks. CRP on 17-Apr-2013 was also normal. Serology for Chlamydophila pneumonia was negative for IgM, but positive for IgG, as after previous infection. Lung X-ray 10-Apr-2013 without remark. Spirometry with reversible-test was performed on 17-Apr-2013 and showed no reversible obstructivity. ECG on 17-Apr-2013 without remarks. Echocardiography showed probable bicuspid aorta valve with minor insufficiency. Otherwise structurally normal heart with normal dimensions and normal function. Blood status and serology was tested (streptococcus, Borrelia, TBE, Mycoplasma, Chlamydia, Ehrlichiosis and HIV), TSH, T4, Iron, Ferritin, Cobalamin, ESR (Erythrocyte sedimentation rate) and Zinc without remark, but 25-OH-D-vitamin slightly low: 53. Transglutaminase without remark (enzyme level normal). EnEG (Electro neurography) without remarks. I-EMG (integrated electromyography) on the border of myopathy; EEG, LP, MR and CT brain and MR of back without remarks. Acetylcholine receptor antibodies without remarks. Lung X-ray and CT showed discrete thickening of bronchial wall. Fiberscope epipharynx and larynx normal. Eye examination on 25-Jun-2013 without remark. Nasal NO on 28-Jun-2013 without remark. CT sinuses without remarks. Phoniatric examination on 19-Aug-2013 without remark. MR muscles without remark. The patient sought alternative treatment, including acupuncture and homeopathy. She has been examined at a specialist clinic 24-Oct-2013. The patient had previously received two doses of GARDASIL, on 14-Mar-2012 and 07-May-2012 (batch number or route not rep). HA considered all three doses of GARDASIL as suspect. According to the reporter, the mother of the patient strongly suspected the reactions were related to the vaccination. HA considered the drug reaction relatedness as not assessable. Upon medical review the company judged relevant to code the following adverse events: cough, feeling unwell, feeling cold, airplane ear, head pressure over the eyes, light sensitivity and fever which were mentioned by the HA in the narrative, but not coded. Outcome for these AE was not reported. At the time of reporting, the outcome of myalgic encephalomyelitis was unknown.


VAERS ID: 513268 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-05-04
Onset:0000-00-00
Submitted: 2013-11-15
Entered: 2013-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NK44350 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoacusis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1311DNK005750

Write-up: Case of adverse event received from health care professional via Health Authorities on 05-Nov-2013 under the reference number DK-DKMA-ADR 22301659 and EFO7388. the primary reporter was a physician. A female patient, onset age not reported (weight: 62; height: 170) had received the first primary dose of GARDASIL (batch number NN02290, lot no. NK44350, exp. 31-MAY-2012) via intramuscular route of administration in not reported site of administration on 04-May-2011 and later on an unspecified date in 2012 she developed fainting and hearing decreased. Patient was examined by an ENT doctor. No medical history reported. Patient had no other vaccines or other medications. At the time of reporting, the patient had not recovered. Upon medical review the company upgraded the case to serious (due to hearing decreased).


VAERS ID: 513303 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-06
Onset:2013-08-13
   Days after vaccination:7
Submitted: 2013-11-15
   Days after onset:94
Entered: 2013-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1014AA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Complex regional pain syndrome, Gait disturbance, Injection site oedema, Injection site pain, Injection site swelling, Intermittent claudication, Temperature intolerance
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Familiar risk factor
Preexisting Conditions: Seasonal allergy; Dermatitis atopic
Allergies:
Diagnostic Lab Data: 08/06/2013, Body temperature, 36.7 degrees C
CDC Split Type: WAES1309JPN009987

Write-up: Follow-up information has been received from a physician via the agency concerning a 12 year-old female patient with no underlying disease or concomitant disease, a history of atopic dermatitis and pollinosis, and a family history of (slight) asthma (young sister) (so the patient also might have allergy). BCG induced-tuberculid (on young sister) was reported in the pre-vaccination interview sheet. On 06-AUG-2013, at 5:00 pm, the patient received the second dose of GARDASIL IM injection drug, 0.5 ml (injection site unknown, lot number: 9QN09R). There was no concomitant medication. On 11-JUN-2013, the patient received the first intramuscular injection of GARDASIL. On 06-AUG-2013, at 5:00 pm, patient received the second intramuscular injection of GARDASIL. The patient''s temperature prior to the vaccination was 36.7 degrees Celsius. No other medications were used on vaccination. On 13-AUG-2013, the patient developed oedema and pain on the right lateral thigh, difficulty in walking without any triggers such as bruise (those symptoms were considered to be complex regional pain syndrome). Since the patient reported that she had LOXONIN, the physician instructed her to take LOXONIN when the pain was unbearable and to visit the hospital if it did not work. On 26-SEP-2013, the patient visited the hospital. No change was observed in the patient''s condition. As the symptoms were not aggravated, the patient and her parents agreed that her condition was to be closely observed for a while. Around 03-OCT-2013, the patient visited the hospital. Although the pain improved transiently, it was worsened again when typhoon was coming. There was no problem with her perception, but the pain was aggravated by cold stimulation and was relieved by warming. As of 06-NOV-2013, the patient was treated with narcotics for severe pain. The outcome of complex regional pain syndrome/claudication (right thigh swelling and pain) was "not recovered/resolved". Reporter''s comments: Since the pain was aggravated by cold stimulation and relieved by heat stimulation, it was considered to be related to muscular/nervous system. The patient was considered to have developed complex regional pain syndrome due GARDASIL. The reporting physician considered the complex regional pain syndrome/claudication (right thigh swelling and pain) as serious due to other important medical event. The reporting physician felt that the complex regional pain syndrome/claudication (right thigh swelling and pain) was related to GARDASIL. The reporting physician considered that there was no other possible cause (such as other disease) of the complex regional pain syndrome/claudication (right thigh swelling and pain). No further information is available.


VAERS ID: 513441 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Male  
Location: Foreign  
Vaccinated:2012-11-07
Onset:2012-12-09
   Days after vaccination:32
Submitted: 2013-11-15
   Days after onset:341
Entered: 2013-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H011751 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autoimmune disorder, Caecum operation, Computerised tomogram, Decreased appetite, Dizziness, Dyspnoea, Fear, Gastrointestinal haemorrhage, Gastrointestinal infection, Gastrointestinal pain, Gastrointestinal surgery, Hyperventilation, Laboratory test, Nuclear magnetic resonance imaging, Oropharyngeal pain, Pain, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: WAES1311DNK005796

Write-up: Case of adverse event received from non-health professional via Health Authority in a foreign country on 07-Nov-2013 under the reference number DK-DKMA-ADR 22297562 and DK-DKMA-EFO7348. The primary reporter was an unspecified non-health professional. Case is not medically confirmed. A 13 year old male patient (weight: 62 kg; height: 186 cm), had received the second dose of GARDASIL (batch and lot number H011751) via intramuscular route of administration in not reported site of administration on 07-Nov-2012 and later on 09-Dec-2012, he developed hyperventilation, autoimmune syndrome, severe pain in lung, very difficult to draw breath, infection in stomach and intestines, dizziness, appetite loss, mortal fears, problems with pain from throat to stomach to intestines, vomiting and experienced a surgery (stomach/intestines). The patient struggled for half an hour to breathe. He had a mortal fear which he later had seen a psychologist for. He was very soon brought to surgery (onset 09-Dec-2012, coded by HA), where an infection in the stomach and intestines was seen and the caecum was removed. He had throughout the spring problems with pain from throat to stomach to intestines (spring is contradictory to onset date 09-Dec-2012, coded by HA), with appetite loss and vomiting, but is now recovering. The patient had received no other vaccines or medications. MRI and CT scan, various test of the intestinal flora was performed on a non-specified date (no results reported). The third dose of GARDASIL (batch and lot number H019870) was later received via intramuscular route of administration in not reported site of administration on 06-Mar-2013. The patient had previously no other health problems. The patient received the primary dose of GARDASIL (batch number H000245, Lot No. NN51680) via intramuscular route of administration in not reported site of administration on 06-Sep-2012. HA coded verbatim "infection in the stomach and intestines" with LLT Gastrointestinal haemorrhage Nos. At the time of reporting, the patient was recovering.


VAERS ID: 513443 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-09-04
Onset:2009-09-04
   Days after vaccination:0
Submitted: 2013-11-16
   Days after onset:1534
Entered: 2013-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0773X / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Back pain, Electronystagmogram, Immediate post-injection reaction, Inappropriate schedule of drug administration, Intervertebral discitis, Lumbar puncture, Nuclear magnetic resonance imaging brain, Optic neuritis, Visual evoked potentials
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (narrow), Demyelination (narrow), Ocular infections (broad), Hypersensitivity (narrow), Arthritis (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: Drug hypersensitivity; 04/27/2009, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311DNK005782

Write-up: Case of misuse with adverse events received from health care professional via Health Authority on 06-Nov-2013 under the reference number DK-DKMA-ADR 22271597 and DK-DKMA-EFO7168. The primary reporter was a physician. Case is medically confirmed. This is a case of misuse since drug dose administration interval between dose 2 and 3 was too long (hence inappropriate schedule of drug administration). A 13 year old female patient (weight: 63 kg; height: not reported), had received the second dose of GARDASIL (batch number NK05560, lot no. 0773X, exp. 16-JUN-2011) via intramuscular route of administration in not reported site of administration on 04-Sep-2009 and later on immediately post-vaccination (contradictory to onset date 10-Sep-2009, coded by HA) she developed joint pain / diffuse joint pain and abdominal pain and on a non-specified date in 2010 subjected to 3 years of back pain. The patient had also received the third dose of GARDASIL (batch and lot number H019870) via intramuscular route of administration in not reported site of administration on 04-Feb-2013 and later on 28-Jul-2013 she developed left-sided optic neuritis (contradictory to HA narrative which stated detection in Aug-2013) and on unspecified date in Aug-2013 spondylodiscitis / detected discit thoracic vertebra 10/11 / detected photobacterium nucleatum (as reported) in 1 out of 4 cobs, etiology not proven. No multiple sclerosis or neuromyelitis optica. Three months of antibiotic treatment was planned for the patient, initially intravenous, currently peroral metronidazole (brand name not reported, other mfr) until 23-Nov-2013. The patient had no other vaccines or medications. Examination/lab tests: MRI of totalcolumna and cerebrum, Visual Evoked Potential (EVP), Electronystagmogram (ENG) and lumbar puncture were performed on a non-specified date (results not reported). The patient had a medical history of penicillin allergy, unknown if continuing. The patient had previously received the primary dose of GARDASIL (batch number NJ50800, Lot no. 0773X, exp. 16-JUN-2011) via intramuscular route of administration in not reported site of administration on 27-Apr-2009. HA assessed the seriousness criteria as hospitalization. No further information was provided. At the time of reporting, the outcome was recovering for left-sided optic neuritis and spondylodiscitis and unknown for back pain, abdominal pain and drug administration interval too long and not recovered for joint pain / diffuse joint pain.


VAERS ID: 513445 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-28
Onset:0000-00-00
Submitted: 2013-11-15
Entered: 2013-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020168 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Malaise, Narcolepsy, Pain
SMQs:, Convulsions (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: 03/27/2013, GARDASIL, No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311SWE005776

Write-up: Case of advrese event received from health care professional via company representative in a foriegn country on 06-Nov-2013. The primary reporter was a nurse. Case is medically confirmed. A 14 year old female patient, had received the second dose of GARDASIL (batch and lot number H020168, exp. 31-MAY-2015) via not reported route of administration in not reported site of administration on 28-May-2013 and later on, the same day, in connection to the vaccination, she developed pain in entire body. She has been severaly sick entire summer (of 2013). She was hospitalized on a non-specified date where she was diagnosed with narcolepsy. The patient had (prior GARDASIL-vaccination) received PANDERMIX (GSK) via not reported route and site of administration on an non-specified date. According to the reporter, a nacrolepsy specialist has not seen a relatedness between the pandemic-flu vaccine and the narcolepsy since the time lapse between vaccination and the reaction has gone too far. The patient had previously received the primary dose of GARDASIL (batch lot number H016923) via not reported route and site of administration on 27-Mar-2013. No adverse reaction occurred. No other medical history reported. At the time of reporting, the outcome was not recovered for narcolepsy and not reported for severly sick and pain in entire body.


VAERS ID: 513743 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-10-26
Onset:2011-07-01
   Days after vaccination:613
Submitted: 2013-11-19
   Days after onset:872
Entered: 2013-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0773X / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Electroencephalogram normal, Hypotonia, Loss of consciousness, Nuclear magnetic resonance imaging normal, Staring
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 11/16/2007, MMR vaccine
Allergies:
Diagnostic Lab Data: The patient has been investigated at regional and national hospitals, and all investigations were normal. She had EEG and MR scanning.
CDC Split Type: WAES1311DNK007530

Write-up: Case received from health care professional via Health Authorities on 13-Nov-2013 under the reference number DK-DKMA-ADR 22288855. The primary reporter was a physician. A 15-year-old female patient had received the third dose of GARDASIL (batch number NK05560, lot number# 0773X, expiry date: 16-JUN-2011) on 26-Oct-2009 and later on unspecified date in July 2011 she developed attack with complete lack of tonus/flaccidity, generalised convulsion and she was not possible to contact/unconscious. It was reported that there was episode with flaccidity and lack of tonus as well as episode of generalised convulsion; both episodes are often without affected consciousness and last 5-10 minutes. The patient has also had other attacks with total lack of tonus and been impossible to contact, with her eyes staring in the distance. She has had one episode where she was flaccid throughout 12 minutes without consciousness where she wakes up, with memories, when arriving at the emergency room. The patient had been investigated at regional and national hospitals, and all investigations were normal. She had EEG and MR scanning. This has been assessed as psychosomatic events, but the visits with psychologist has not shown any psychopathology. The patient received the first two doses of GARDASIL on 24-Mar-2009 (batch number NJ17350, Lot number# 1941U, expiry date: 12-DEC-2010) and on 28-May-2009 (batch number NK05560, Lot number# 0773X, expiry date: 16-JUN-2011). The patient has previously received the MMR vaccine (mfr not rep) on 16-Nov-2007. At the time of reporting, the patient had not recovered.


VAERS ID: 513745 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-06-18
Submitted: 2013-11-19
   Days after onset:154
Entered: 2013-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020323 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cyanosis, Gaze palsy, Headache, Hypoaesthesia, Injection site pain, Oligomenorrhoea, Pain, Pallor, Respiratory arrest, Screaming, Syncope, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Ocular motility disorders (narrow), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness:
Preexisting Conditions: 06/2010, Headache; 06/2010, Hot flush; 06/2010, Menarche, She has had her periods since she was 9
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311AUS006054

Write-up: Information was obtained on a request by the Company from the agency (# 326037) via a Public Case Detail concerning a 13 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL (lot # H020323; expiry: 25-JUN-2015) dose number 2 (dosing regimen unspecified). On 18-JUN-2013, the patient experienced syncope, oligomenorrhoea, vision blurred and headache. Patient''s mother stated that her daughter had a severe adverse reaction to her second dose of GARDASIL. Patient''s mother stated that the patient was screaming in pain with headache, followed by burred vision in one eye, loss of feeling in her legs and after at least 5 minutes she ceased respiration, her eyes rolled back in her head, her colour was pale and cyanosed and the nurse called the doctor, called for the crash cart, oxygen given, patient in recovery position and started her breathing again, legs raised, Panadol given, hospital advised possibility of ambulance arrival. Daughter too sick and in too much pain to drive to hospital so she observed her (she had been an RN (registered nurse) for years (mother) let registration lapse last year as now working in education). The patient still had severe headache and blurred vision afterwards and required oxygen. Patient''s mother stated that both her daughters had the second dose on the same day at the doctor''s surgery. They were twins. The twin that had the severe adverse reaction has since had only one menses which was very light. She has had her periods since she was 9 and they are regular up until this GARDASIL injection. She had also been having hot flushes and headaches. She still has pain in the injection site over 2 months later. Twin two has had headaches every day since her second dose of GARDASIL and has come out in tiny warts all over her body which she has been picking off. The outcome of vision blurred, headache, syncope, oligomenorrhoea, vision blurred and headache to be related to GARDASIL. The original reporting source was the nurse (patient''s mother). The agency considered the events vision blurred, headache, syncope and oligomenorrhoea to be life threatening. This case is linked to: 1311AUS007635 (siblings). Additional information is not expected.


VAERS ID: 513748 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-12
Onset:2012-12-01
   Days after vaccination:19
Submitted: 2013-11-19
   Days after onset:353
Entered: 2013-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019718 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiovascular disorder, Laboratory test normal, Limb injury, Masked facies, Skin discolouration, Systemic sclerosis, Weight decreased, Wound
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Parkinson-like events (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Laboratory test, Normal not provided
CDC Split Type: WAES1311DEU007734

Write-up: Case was received from a healthcare professional via company representative in a foreign country on 13-Nov-2013. Case is medically confirmed. A 15-year-old female patient (weight: 59.3 kg; height: 164.3 cm) received a first dose of GARDASIL (lot-no. H019718) IM on 12-Nov-2012. The first dose of GARDASIL was assessed as the suspect vaccine by the reporting physician. On an unspecified date in Dec-2012 she developed "damaged hands" (not specified), weight loss, rigid facial expressions and dark colouring of hands and feet. Systemic sclerosis with blood flow disorder of the acra and open wounds of the extremities was suspected. The patient was hospitalised from 12-Jun-2013 to 28-Jun-2013. Laboratory test showed no pathologic results. The patent was treated with nifedipine and triclosan. At the time of reporting the patient had not recovered. According to the reporter the causal relation between the events and the vaccine was unlikely. A second dose GARDASIL (lot-no. H019718) was given IM on 27-Dec-2012.


VAERS ID: 513755 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-19
Entered: 2013-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Thyroid cancer, Thyroid operation
SMQs:, Hypothyroidism (broad), Hyperthyroidism (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311KOR006219

Write-up: This spontaneous report as received via company representative from a female consumer of unknown age refers to herself. On an unknown date the patient was vaccinated with the first and the second dose of GARDASIL, injection (strength, route, lot number and expiration date not provided). The patient reported that she had thyroid cancer surgery and should be careful of iodine. The patient was planned to be vaccinated with the third dose of GARDASIL, so she asked whether GARDASIL contained an iodine. It was not reported when thyroid cancer occurred and when the patient had thyroid surgery. The outcome of thyroid cancer and thyroid cancer surgery was unknown. Upon internal review thyroid cancer and thyroid cancer surgery were considered to be medically significant. Additional information is not expected.


VAERS ID: 513762 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-24
Onset:2013-10-06
   Days after vaccination:135
Submitted: 2013-11-19
   Days after onset:44
Entered: 2013-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H013134 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Caesarean section, Exposure during pregnancy, Ultrasound antenatal screen normal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: 07/01/2013, Ultrasound foetal, Normal
CDC Split Type: WAES1309PRT012047

Write-up: Case of pregnancy follow-up received from the local Health Authorities on 24-Jun-2013 under the reference number L201306-57 via the local site Sanofi Pasteur MSD. The primary reporter was a nurse. Case medically confirmed. An 18-year-old female patient was exposed during pregnancy (gestation week: 21) to vaccination with a first dose of GARDASIL (batch number/valid lot # H013134) intramuscularly and to a dose of DT VAX adult (batch number H7173-7) intramuscularly on 24-May-2013. The patient experienced no adverse reaction. She had no known medical history and no known prior reactions to the vaccine or other drugs. No concomitant medication was reported. The patient went to the first maternal health medical visit on 12-Jun-2013 after been advised by the assistant physician. She did not want this pregnancy and did not know the date of the last menstrual period. According to the patient, she visited the hospital on 07-Jun-2013 where she was informed that she already had about 23 weeks of gestation and for this reason it could not be possible to perform a voluntary interruption of pregnancy. On the date of vaccination the patient did not report that she was pregnant, when questioned about this situation, the reason why the vaccine was administered. The patient was referred to a medical visit for high risk pregnancy. When the patient was seen during a medical visit on 10-Jul-2013 she had not experienced any adverse reaction. Foetal ultrasound was normal on 01-Jul-2013. The patient was sent to the high risk medical visit. The outcome was unknown. The Health Authorities assessed the causal relationship between the reported error and vaccination as unknown according to the global introspection. The reporter assessed the causal relationship between the reported error and vaccination as unknown according to an unknown assessment method. Follow-up information received on 13-Nov-2013 from the Health Authorities. The primary reporter was a physician: On 18-Sep-2013, the patient attended her medical visit. The delivery date was estimated to 23-Sep-2013. There was no changes in the gestational evolution, and no adverse event during the pregnancy. The patient had a Caesarean delivery on 06-Oct-2013. There was no complication during the delivery and no change in the placenta. The patient gave birth on 06-Oct-2013 to a living baby at 41 amenorrhea weeks. The baby weighed 4,400 kg at birth, was 52 cm high and his cephalic perimeter was 36 cm. Apgar score at 1st minute was 9 and 10 at 5 minutes. There was no malformations or anomalies diagnosed at birth, no resuscitation or admission in intensive care unit, nor any sign of prematurity. The patient did not show any neonatal disease requiring hospitalization and/or pharmacological therapy. At the time of reporting he was 30 days old and had been seen twice by the physician, presenting a balance growth. Upon internal review, the company considered the case as serious due to Caesarean section.


VAERS ID: 513890 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-10-26
Onset:0000-00-00
Submitted: 2013-11-20
Entered: 2013-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood smear test normal, Contusion, Full blood count normal, Gingival bleeding, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Immunoglobulins normal, Platelet count decreased, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Gingival disorders (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: 12/02/2011, Blood smear test, Normal; 12/02/2011, Full blood count, Normal, other cell lines except thrombocytes were normal; 12/02/2011, Immunglobulins, Normal; 12/02/2011, Platelet count, LOW; 02/05/2013, Platelet count
CDC Split Type: WAES1206USA01948

Write-up: Case received from physician via a company representative in a foreign country on 07-Jun-2012. Case medically confirmed. A 12-year-old female patient had received an injection of GARDASIL (dose 1, i.m., batch number unknown) on 26-Oct-2011. Previously the girl had received an injection of MMR vaccine (mfr unk, batch number A69CC748A) on 21-Sep-2011. Later on 02-Dec-2011 she developed Idiopathic thrombocytopenic purpura. The company judged the case serious due to ITP as an important medical event. At the time of reporting, the outcome was not provided. No assessment of causality was provided. Follow-up information received from Health Authority in a foreign country on 12-Jul-2012 with reference number DK-DKMA-ADR 21715034. FOLLOW-UP: The case was also received on 29-Jun-2012 by the Health Authority from a General Practitioner: The 26-Oct-2011 the patient received the first injection of GARDASIL. On 02-Dec-2011 the patient developed idiopathic thrombocytopenic purpura. Low platelets on 12. Still the patient is followed on the Pediatric Hematology Department. Note that GP has only reported GARDASIL (and not PRIORIX) as suspect drug to the Health Authority (where E2B transmission received from Sanofi Pasteur MSD indicates both PRIORIX and GARDASIL as suspect drugs)! SUMMARY: Severity criterion hospitalisation added. Outcome of idiopathic thrombocytopenic purpura changed from unknown to not recovered. The dose of GARDASIL (0.5 ml) added. Follow-up information received from Newsletter via the Health Authority in a foreign country on 06-Nov-2012. According to the reporter, the reaction was possible related to the vaccinations. Contradictory information received regarding dose. According to the newsletter the girl developed thrombocytopenia after dose 2, and not dose 1 as indicated in the initial report. No further information expected. Follow up information received from the Health Authority in a foreign country on 18-Nov-2012. They confirmed that the girl experienced the reactions after dose 1. No further information expected. Follow up information received from the health authority on 12-Nov-2013. HA received information from patient''s physician on 01-Oct-2013 by request of GSK. The adverse reactions requires extensive treatment. She has received Cyklokapron (other MFR) and IVIG infusion (intravenous immunoglobulin, other MFR, given on 15-Feb-2013 before vaccination) to treat the AEs. The patient was treated as medical center, haematology/oncology department, hospital. Patient had bruises and bleeding gums in addition to previous reported adverse event. Onset not reported and outcome unknown. Laboratory results: On 02-Dec-2011, thrombocyte count was 12, other cell lines were normal, normal peripheral smear and normal immunoglobulins. On 05-Feb-2013 thrombocyte count was 50 (IVIG given on 15-Feb-2013). Patient has not received other medications. Patient had received PRIORIX. The patient has no relevant medical history concerning viral infections and clinical conditions.


VAERS ID: 513898 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-14
Onset:2013-08-14
   Days after vaccination:0
Submitted: 2013-11-19
   Days after onset:97
Entered: 2013-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H018804 / 2 UN / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC37B088AF / 1 UN / SYR
VARCEL: VARICELLA (VARILRIX) / GLAXOSMITHKLINE BIOLOGICALS A70CC318A / 1 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Activities of daily living impaired, Asthenia, Gait disturbance, Headache, Influenza
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311AUS005756

Write-up: Information was obtained on a request by the Company from the agency (OPR No 325455) via a Public Case Detail concerning a 12 year old female patient. On 14-AUG-2013, the patient was vaccinated with the second dose of GARDASIL batch number reported as H018804 (dose and route were not reported). Other suspect therapies administered the same date, included BOOSTRIX dose 1, injection batch number reported as AC37B088AF (dose and route not reported) and VARILRIX (Rit) dose 1, injection, batch number reported as A70CC318A (dose and route not reported). No concomitant medications were reported. At the time of vaccination the patient reported to nurses being well. The teacher informed on 16-AUG-2013 that on 14-AUG-2013, after the nurses left the school the patient told her teacher that she had had the ''flu'' and was unwell before vaccination. The teacher took the patient to "sick bay" and phoned the mother and asked her to collect the patient as she was unwell. When they spoke to the mother the following day, the mother reported the symptoms as: cramps in stomach; headache and general weakness, "to the point of could hardly walk to the car", hence the mother contacted her general practitioner and was advised to take the patient to the hospital. The outcome of the event was reported as recovered (Date not reported). The agency considered the events to be related to GARDASIL. The original reporting source was State/Territory Health Dep. Additional information is not expected.


VAERS ID: 513903 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-04
Onset:2013-03-10
   Days after vaccination:65
Submitted: 2013-11-19
   Days after onset:254
Entered: 2013-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019870 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bedridden, Deafness unilateral, Dizziness, Meniere's disease, Nausea, Neuritis, Tension headache, Tinnitus
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline hydrochloride
Current Illness: Immunisation
Preexisting Conditions: 09/17/2012, GARDASIL
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311DNK007321

Write-up: Case of adverse event received from non-health professional via Health Authority on 13-Nov-2013 under the reference number DK-DKMA-ADR 22300296 and 13-7914. The primary reporter was a lawyer. Case was received HA from the patient insurance company, in terms of the patient''s own notification. Insurance company has not yet taken a decision. Case is not medically confirmed. A 23 year old female patient, had received the second dose of GARDASIL (batch/lot number H019870) via not reported route of administration in not reported site of administration on 04-Jan-2013 and later on 10-Mar-2013 she developed, the first attack where she for two days was, constantly dizzy, had nausea, tinnitus and ringing in ears and tension headaches. Then she lost most of her hearing in the right ear (coded hearing impaired by HA). Subsequently, she has had about 10 attacks of 20 min - 10 hours. The patient was concomitant treated with Sertraline (Mfr Unk). She was diagnosed in Jun-2013 with Morbus Meniere, and was treated but with minor effect. In Aug-2013 her otologist recommended her to do a patient''s complaint, as it could most likely be associated with the HPV-vaccinations, and that it was not Meniere she had, but a nerve inflammation of the ear (onset date 10-Mar-2013, coded by HA) as an adverse reaction to the HPV-vaccine. About once every 14 days the patient''s daily symptoms are worsened to such an extent that she is bedridden until they stop, which can take up to 2 days. The patient is recommended a hearing device as well as for drainage so a Meniett can be used, both an attempt to reduce her daily problems. No further information specified. The patient was treated with BETASERC (other Mfr, 16mg x 2 daily), balance training two times daily and stress course. The patient received the third dose of GARDASIL (batch/lot number J000587, expiration date 30-JUN-20015) via not reported route of administration in not reported site of administration on 06-May-2013. The patient had received the primary dose of GARDASIL (batch/lot number H011751) via not reported route and site of administration. No other medical history reported. At the time of reporting, the patient had not recovered.


VAERS ID: 513908 (history)  
Form: Version 1.0  
Age: 39.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-28
Onset:2013-08-14
   Days after vaccination:47
Submitted: 2013-11-19
   Days after onset:97
Entered: 2013-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Asthenia, Bladder scan, Blood pressure decreased, Blood test, Computerised tomogram, Disturbance in attention, Dizziness, Electrocardiogram, Fatigue, Headache, Hypoaesthesia, Irritability, Lumbar puncture, Memory impairment, Muscle fatigue, Nausea, Neurological examination, Neuropsychological test, Nuclear magnetic resonance imaging, Sensory disturbance, Speech disorder, Tremor, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: Human papilloma virus immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MRI and CT scan, blood tests, lumbar puncture tested for Lyme disease and other signs of infection, blood pressure, ECG, bladder scan, neurological assessment and neuropsychological tests.
CDC Split Type: WAES1311DNK006376

Write-up: Narrative: ADVERSE EVENT: Severe headaches, pain in joints and sensory disturbances/numbness in the right foot and hand, and the right side of the face. Right hand trembles. Reduced strength and general tiredness in the muscles on the right side. Declining blood pressure, dizziness and nausea, blurred vision on the right eye. Memory difficulty and transient speaking difficulty. Tired, irritable and concentration difficulty. Sensory disturbance seems at this time to be decreasing. The patient has not been treated for the adverse event. OTHER MEDICATION: No.


VAERS ID: 513915 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-06-20
Onset:2011-12-01
   Days after vaccination:164
Submitted: 2013-11-19
   Days after onset:719
Entered: 2013-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NJ37720 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Concussion, Dizziness, Fall, Fatigue, Head injury, Headache, Loss of consciousness, Memory impairment, Nausea, Presyncope, Syncope, Tilt table test normal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (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) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: Tilt table test POTS excluded
CDC Split Type: WAES1311DNK007306

Write-up: Case received from a health care professional via the Health Authorities on 11-Nov-2013 under the references DK-DKMA-ADR 22306084 and DK-DKMA-EFO7419. Case is medically confirmed. A 23-year-old female patient (weight 70 kg, height 176 cm) had received the first dose of GARDASIL (batch number NK38860, lot number NJ37720, expiration date 31-OCT-2011) via intramuscular route on 20-Jun-2011. The patient was hospitalized in Dec-2011 for observation due to symptoms after a fall with commoti cerebri, mild head trauma and brief loss of consciousness. On 15-Jul-2012, the patient developed syncope vasovagal, which recurred a few times a month. On 12-Sep-2012, the patient received the second dose of GARDASIL (batch/lot number H007797). On 15-Sep-2012, the patient developed pronounced tiredness, dizziness, near fainting, headache, nausea and memory problems. Postural Orthostatic Tachycardia Syndrome was excluded by tilt test (rise in heart rate of 20 bpm at orthostatic stress). She received D3 of GARDASIL (batch number H019870) on 22-Jan-2013. At the time of reporting, the patient had not recovered from pronounced tiredness, dizziness, near fainting, headache, and nausea. The outcome for memory problems, commoti cerebri, fall, mild head trauma and brief loss consciousness was reported as unknown. Noteworthy: The batch numbers of D2 and D3 of GARDASIL were reported as starting with HO, but H0 (zero) was coded.


VAERS ID: 513977 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-01-12
Onset:2009-06-01
   Days after vaccination:140
Submitted: 2013-11-20
   Days after onset:1633
Entered: 2013-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain lower, Balance disorder, Computerised tomogram head, Derealisation, Disturbance in attention, Dizziness, Dyspnoea, Erythema, Fall, Fatigue, Feeling abnormal, Gait disturbance, Hallucination, visual, Head injury, Headache, Hyperacusis, Influenza like illness, Injection site erythema, Injection site pruritus, Loss of libido, Pain threshold decreased, Palpitations, Photophobia, Reading disorder, Sensory disturbance, Sensory loss, Skin disorder, Tic, Vaccination site swelling
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
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: Attention deficit/hyperactivity disorder; Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310DNK010218

Write-up: Case of adverse event received from health care professional via Health Authority on 04-Oct-2013 under reference number 22251284 and EFO6945. The primary reporter was a physician. a 18 year-old female patient (unknown initials) with a medical history of personality disorder/ADHD (continuing; unknown), had received the second dose of GARDASIL (batch number unknown) via intramuscular route of administration in not reported site of administration on 12-Jan-2009 and later on, 01-Jun-2009, she developed sensory disturbance, concentration impaired, breathing problems, altered pain threshold, dizziness, sensitivity to light, sensitivity to sound, vaccination site itching and local redness at vaccination site. It is unknown whether the patient had other medications. Patient had received the third dose of GARDASIL (batch number unknown) via intramuscular route of administration in not reported site of administration on 11-Jun-2009. The patient has also a medical history of injection with the primary dose of GARDASIL (batch number unknown) via intramuscular route of administration in not reported site of administration on 27-Oct-2008. At the time of reporting, the patient had not recovered. Follow up received from patient via other company and the Health Authority on 13-Nov-2013. The reporter was a lawyer at the patient insurance company. The reference number is J.nr 13-8168. The report is based on the story from the patient. It was reported that the woman suffered from events also after the first dose of GARDASIL (administered on 27-Oct-2008), hence also the first dose is considered as suspect drug. As this report was considered serious by Health Authority, all the events are considered as serious events. It was reported that according to the patient she suffered from severe itching at the vaccination site, feeling absent, headache, influenza-like symptoms, nerve disturbance (no sensation in hands), chronic tiredness, redness in face, redness at vaccination site, lack of sexual drive, breathing difficulty, dizziness, lack of structural skill, visual hallucinations, feeling unreal, cramps/tics in abdomen, arm and lower abdomen. Palpitations (varying between fast and slow), altered pain threshold, bad balance, staggering when walking, cannot read and poor spelling skills, impure skin, she is sensitive to light, sound and pain. She developed swelling at the vaccination site. She falls often and has hit her head badly about 10 times since January 2013. She has been hospitalized and was examined by a neurologist at the hospital in January and Spring 2013 in connection to admittance to the acquired brain injury ward. She has severe pain in the back of her head and was scanned at the hospital in January 2013. Upon medical review the company judged relevant to code fall often, pain in back of head and swelling at the vaccination site, which were mentioned in narrative, but not coded by HA (date of onset not reported). The date of onset of the new reported events was 03-Nov-2008 for feeling absent, headache, influenza-like symptoms and nerve disturbance (no sensation in hands). The onset for chronic tiredness, redness in face, lack of sexual drive, visual hallucinations, cannot read and poor spelling skills, feeling unreal, cramps/tics in abdomen, arm and lower abdomen, palpitations, bad balance, staggering when walking and impure skin was at unspecified date in June 2009. At the time of reporting the outcome was not recovered.


VAERS ID: 513979 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-09-11
Onset:2013-09-18
   Days after vaccination:7
Submitted: 2013-11-20
   Days after onset:63
Entered: 2013-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bacterial test negative, CSF white blood cell count increased, Headache, Hypoaesthesia, Mental disorder, Viral infection
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 31 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 09/18/2013, Bacterial test, No bacterial growth; 09/2013, White blood cell count, 200; 09/18/2013, White blood cell count, 80; 10/18/2013, White blood cell count, 50
CDC Split Type: WAES1311HKG004189

Write-up: This spontaneous report as received from a physician via a company sales representative refers to a single, 21 year old patient. The patient had no family history of allergy, history of asthma or concurrent conditions. On 17-JUL-2013, the patient was vaccinated with dose 1 of GARDASIL (lot number and expiry date were not reported). No adverse event was experienced after the first dose of vaccine. The patient had received the second dose of GARDASIL (lot number and expiry date were not reported) on 11-SEP-2013 and came back. Concomitant medications were none. The patient encountered viral infection on an unknown date in 2013. One week after second dose of GARDASIL, on 18-SEP-2013 morning, the patient experienced severe headache, dottiness (for a short while) and whole body numbness. The patient was admitted to hospital on the same day. On 18-SEP-2013, Lumbar puncture sample indicated WBC was 80 (no unit provided), no bacterial growth was observed. The hospital suggested viral infection. Several days later on an unknown date in September 2013, WBC value was 200 (collected by lumbar puncture, no unit provided). One month after hospital admission, on 18-OCT-2013, the WBC value (collected by lumbar puncture, no unit provided) was 50 and patient was discharged from hospital on same day. No symptom or adverse experience was experienced by the patient after discharge. The outcome the events viral infection, severe headache and whole body numbness was reported as resolved (on an unknown date in 2013). The reporter considered all the events to be not related to GARDASIL. Additional information is not expected.


VAERS ID: 513982 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-02-17
Onset:2011-08-01
   Days after vaccination:165
Submitted: 2013-11-20
   Days after onset:842
Entered: 2013-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cognitive disorder, Dizziness, Fatigue, Headache, Heart rate increased, Labile blood pressure, Malaise, Nausea, Night sweats, Pollakiuria, Sensory disturbance, Tilt table test positive
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Hypersensitivity; Asthma
Preexisting Conditions: Polycystic ovaries; 06/2011, TICOVAC, Immunisation; 10/28/2010, GARDASIL, Immunisation; 05/30/2011, TICOVAC, Immunisation; 08/26/2010, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Examinations revealed no pathological findings; Tilt test and autonomic investigation gave no reliable diagnosis, but there was a striking blood pressure response to orthostatic stress; Tilt test showed elevated labile blood pressure and heart rate increased from 85 to 131; Tilt table test, POTS excluded
CDC Split Type: WAES1311DNK007517

Write-up: Case received from a health care professional via the Health Authorities on 11-Nov-2013 under the references DK-DKMA-ADR 22293785 and DK-DKMA-EFO7328. Case is medically confirmed. A 23-year-old female patient (weight: 56 kg, height: 160 cm), with a medical history of asthma bronchial, polycystic ovarian syndrome and allergy had received the third dose of GARDASIL (batch number not reported) via intramuscular route on 17-Feb-2011. Concomitant medication included third dose of TICOVAC (Baxter, batch number not reported) via intramuscular route on an unspecified date in Sep-2011 and a number of other vaccines (not further specified) in the same period. Previous doses of GARDASIL were given on 26-Aug-2010 (D1) and 28-Oct-2010 (D2), and of TICOVAC on 30-May-2011 (D1) and in Jun-2011 (D2). On 01-Aug-2011, the patient experienced headache, nausea and malaise. On an unspecified in Aug-2011, the patient developed dizziness, sensory disturbance in the face after physical exertion, tiredness, cognitive dysfunction, increased night sweats, rapid physical exhaustion and frequent urination. The patient suffered from chronic headaches since 2012. The patient was thoroughly neurologically investigated and was referred to headache clinic. Examinations revealed no pathological findings. Tilt test and autonomic investigation gave no reliable diagnosis, but there was a striking blood pressure response to orthostatic stress. Tilt test showed elevated labile blood pressure and heart rate increased from 85 to 131. Heart rate felt quickly again why the patient had not been diagnosed with POTS. At the time of reporting the patient had not recovered. Since it was an "insidious" onset on symptoms, the patient was in doubt about the causal relationship to the GARDASIL vaccination.


VAERS ID: 513989 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-02-04
Onset:2013-07-01
   Days after vaccination:147
Submitted: 2013-11-20
   Days after onset:142
Entered: 2013-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cerebellar ataxia, Dizziness,