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This is VAERS ID 506957

Case Details

VAERS ID: 506957 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: 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), Immune-mediated/autoimmune disorders (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, 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.


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