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From the 1/7/2022 release of VAERS data:

This is VAERS ID 365925

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Case Details

VAERS ID: 365925 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
   Days after vaccination:11
Submitted: 2009-11-06
   Days after onset:395
Entered: 2009-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Abdomen scan, Activated partial thromboplastin time prolonged, Antinuclear antibody positive, Antiphospholipid syndrome, Arthritis, Asthenia, Asthma, Body temperature normal, Brain scan normal, Butterfly rash, C-reactive protein normal, CSF culture negative, CSF glucose normal, CSF protein normal, CSF test normal, Cardiac murmur, Cardiovascular disorder, Chest pain, Circulating anticoagulant positive, Coagulation time prolonged, Complement factor C3 decreased, Complement factor C4 decreased, Complement factor abnormal, Cough, Cytomegalovirus antibody negative, DNA antibody positive, Decreased appetite, Echography normal, Endoscopy gastrointestinal normal, Epstein-Barr virus test, Erythema, Fibrin D dimer, Gastrointestinal disorder, HIV test negative, Haemoglobin normal, Headache, Hepatitis B antibody negative, Hepatitis C antibody negative, Herpes simplex serology negative, Hypochromic anaemia, Inappropriate schedule of drug administration, Inflammation, Kaolin cephalin clotting time prolonged, Liver function test normal, Lymphadenopathy, Lymphocyte count decreased, Lymphopenia, Mean cell haemoglobin concentration decreased, Mean cell volume decreased, Nausea, Neck pain, Neurological examination normal, Platelet count decreased, Protein urine present, Pyrexia, Rash erythematous, Red blood cell sedimentation rate increased, Renal function test normal, Rhinitis, Scan abnormal, Scintigraphy, Syphilis test, Syphilis test positive, Systemic lupus erythematosus, Tachycardia, Thrombocytopenia, Toxoplasma serology negative, Urine analysis abnormal, Vomiting, Weight decreased, White blood cell count decreased
SMQs:, Acute renal failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (narrow), Proteinuria (narrow), Tubulointerstitial diseases (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Dehydration (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Cyproterone + Et. Oestradiol (Ethinyloestradiol + Cyproterone acetate); SYMBICORT (Budesonide + Formoterol)
Current Illness: Unknown
Preexisting Conditions: Acaridae allergy; Asthma; Carpal tunnel syndrome; Migraine; Pollen allergy; Raynaud''s syndrome, Tibia fracture; Transtympanic drain; Bilateral carpal tunnel treated by bilateral infiltration; Diabetes and breast cancer in maternal grandmother.
Diagnostic Lab Data: Abdomen scan, Nov2008, see text; Activated partial thromboplast, 05Nov2008, 98; Antinuclear antibody, Nov2008, 1/2560; Blood pressure, 05Nov2008, 13/8; Body temperature, 05Nov2008, normal; C-reactive protein, 13Nov2008, normal; Cerebrospinal fluid glucose, Nov2008, 0.54g/l; Cerebrospinal fluid protein, Nov2008, 022g/l; circulating anticoagulant, 13Nov2008, positive; Complement factor, Nov2008, <35; Complement factor C3, Nov2008, 0.72; Complement factor C4, Nov2008, 0.08g/l; Cytomegalovirus antibody, 2008, see text; DNA antibody, Nov2008, 34IU/ml; Echography, Nov2008, see text; Endoscopy gastrointestinal, Nov2008, normal; Epstein-Barr virus serology, 2008, see text; Erythrocyte sedimentation rate, 14Oct2008, $g50mm; Erythrocyte sedimentation rate, 05Nov2008, 77mm; Erythrocyte sedimentation rate, Jan2009, 24mm; Erythrocyte sedimentation rate, 05Feb2009, 20mm; Fragment D dimer, Nov2008, 561mcg/l; HIV antigen, (p24) test, 05Nov2008, negative; HIV test, 05Nov2008, negative; heart rate, 10Nov2008, 100bpm; Hemoglobin, 05Nov2008, 11.3g/dl; Hemoglobin, 13Nov2008, 11.8g/dl; Hemoglobin, Jan2009, 10.4g/dl; Hemoglobin, 05Feb2009, 11g/dl; Hepatitis B antibody, 05Nov2008, negative; Hepatitis C antibody, 05Nov2008, negative; Herpes simplex serology, Nov2008, negative; Kaolin cephalin clotting time, 13Nov2008, prolonged; Liver function test, 13Nov2008, normal; Lymphocyte count, 05Nov2008, 900/mm3; Lymphocyte count, 13Nov2008, 960/mm3; Mean cell hemoglobin concentra, 05Feb2009, 25.9pg; Mean corpuscular volume, 05Feb2009, 77.6fl; Platelet count, 14Oct2008, 85000/mm3; Platelet count, Nov2008, 77000/mm3; Platelet count, 05Nov2008, 99000/mm3; Platelet count, 13Nov2008, 100000/mm3; Protein urine 24 hours, Nov2008, 0.056g; Renal function test, 13Nov2008, normal; Scan, Nov2008, see text; Scan brain, Nov2008, see text; Scintigraphy, Nov2008, see text; syphilis test, Nov2008, see text; Systolic murmur, 10Nov2008, 2/6; Toxoplasma serology, 2008, negative; Urine analysis, 10Nov2008, see text; Weight loss2008, 5kg; White blood cell count, 05Nov2008, 3100/mm3; White blood cell count, 13Nov2008, 3340/mm3; 2008Cytomegalovirus and EBV serology: negative or old infection; 10 November 2008, Urine analysis: traces of ketones, protein at 0.3 g/l and presence of leukocytes; 13 November 2008, Cardiovascular abdomial and neurologic examinations: normal; November 2008, Complement factor CH50: <35 (Normal $g35); Echography heart: normal; Brain scan: no encephalic lesion and no cerebral thrombophlebitis; Thoraco-Abdomen-pelvis CT scan: infra centimetric cervical and bilateral axillary adenopathies; Respiratory function test: no ventilation disorder; Pulmonary ventilation perfusion scintigraphy: normal; Antinuclear antibody: positive at 1/2560; Anti SSA antibody:$g240 IU/l; Anticardiolipin antibody and anti beta2 glycoprotein antibody: positive IgM; Syphilis test: VDRL positive at 4, TPHA negative (<80); Lipidic, phosphocalcic, renal, and hepatic check up: normal; Anti-DNAnative antibody was 34 U/ml. other nuclear antigen autoantibodies were negative. CSF was clear, without flora at direct examination, CSF culture was negative for aerobic and anaerobic germs. CSF biochemistry was normal; PCR on herpesviridae family was negative.
CDC Split Type: B0574198A

Write-up: This case was reported by a foreign agency (AFSSAPS numbers NY20090284 and NY2919354) and described the occurrence of disseminated lupus erythematous in a 18-year-old female subject who was vaccinated with CERVARIX, GlaxoSmithKline. Concurrent medical conditions included bilateral carpal tunnel syndrome treated by bilateral infiltration, and Raynaud''s syndrome. In June 2008, on 01 August 2008 and 26 September 2008, the subject received 3 doses of CERVARIX (intramuscular, injection sites unknown) (batch AHPVA011BJ for 2nd and 3rd doses) (inappropriate schedule of vaccine administration). On 13 October 2008, first symptoms (nos) occurred. On 14 October 2008, lab tests results included platelet lower than 100000/mm3 and erythrocyte sedimentation rate upper than 50 mm. On 05 November 2008, the subject consulted in a specialized unit for a check up of asthenia, anorexia and weight loss of 5 kg in 3 weeks. Physical examination showed centrimetric posterior cervical and axillary adenopathies. The subject was apyretic and had an arterial blood pressure of 13/8. Lab tests included platelet count at 99000/mm3, haemoglobin at 11.3 g/dl, white blood cell at 3100/mm3, lymphocytes at 900, erythrocyte sedimentation tete at 77, kaolin cephalin clotting time 98. HIV serology, detection of P24 antigen, hepatitis B and C serologies were negative. On 13 November 2008, the subject was hospitalized because of suspicion of lupus associated with alteration of general health status. On admission, the subject presented with asthenia and butterfly rash. Cardiovascular, abdominal and neurological examinations were normal. Presence of sensitive laterocervical and bilateral occipital adenopathies were noted. Lab tests included platelet count at 100000/mm3, Haemoglobin at 11.8 g/dl, white blood cells at 3340/mm3, lymphocytes at 960, prolonged activated partial thromboplastin time and presence of circulating anticoagulant. Immunological check up revealed positive antinuclear antibody at 1/2560, anti SSR antibody (as reported) upper than 240 IU/l and positive IgM anticardiolipin and anti beta2 glycoproteinal antibodies. C3 complement was 0.72 (N: 0.75-01.51, Ca at 0.08 g/l (N: 0.1-0.34) and CH50 less than 35 (M: upper than 35). Cardiac echography, oeso-gastro-duodenoscopy and ventilation perfusion scintigraphy were normal. Brain scan showed no encephalic lesion and no cerebral thrombophlebitis. Proteinorrhachia was 0.22 g/L and glycorrachia at 0.54 g/l. Respiratory function test showed no ventilatory disorder. Protein urine of 24 hours was normal. Thoraco abdominal Pelvis CT scan showed infra centimetric cervical and bilateral axillary adenopathies. Diagnosis of disseminated lupus erythematous and antiphospholipid syndrome was made. Corticotherapy was initiated. General health status improved and the subject was discharged from hospital on 22 November 2008. In January 2009, the subject consulted at emergency unit for hands arthritis. Lab test revealed hypochromic microcytic anemia with Haemoglobin at 10.4 g/dl and erythrocyte sedimentation rate at 24. On 05 February 2009, the subject was seen in specialized consultation. Physical examination showed face erythema and squamous erythematous eruption on back face of hands and fingers. There was no palpable superficial adenopathy. Lab tests included haemoglobin at 11 g/dl, mean cell haemoglobin concentration at 25.9 pg, mean corpuscular volume at 77.6 fl and erythrocyte sedimentation rate at 20. Treatment with hydroxychloroquine was initiated. At the time of reporting, outcome of the events was unknown. The AFSSAPS'' causality assessment for CERVARIX and lupus erythematous and antiphospholipid syndrome was dubious, according to the method imputability. Upon follow-up received from a physician, via a GSK sales representative, on 30 September 2009: On 13 October 2009, viral symptoms occurred. On 14 October 2009, platelet count was 85000/mm3 and biological lab tests showed an inflammatory syndrome. On 10 November 2008, diagnosis of lupus was made. The subject was treated with prednisone (Cortancyl) which resulted in weight gain and swelling. At the time of reporting, lupus was equilibrated under corticoids but the subject was depressive due to the diagnosis of lupus. The causality assessment of the reporter was unspecified. Upon follow-up received from the physician on 28 October 2009: Subject''s medical history included multiple surgeries for transtympanic drainage in childhood, tibia fracture, acaridas and pollen allergy, asthma for five years and migraine for several years. There was notion of alcohol or tobacco abuse. The subject had a family history of breast cancer and diabetes (maternal grand mother). Concurrent medication included cyproterone acetate + ethinylestradiol (Lumalia) and budesonide+formoterol fumarate dehydrate (SYMBICORT). There''s a discrepancy between information received on initial from the Afssaps (vaccination with first dose of CERVARIX in June 2008) and information on follow up from the physician (first dose of CERVARIX in August 2008). On 01 August 2008, CERVARIX (batch AHPVA011BJ) was injected in unspecified deltoid. On 26 September 2009, CERVARIX (batch AHPVA011BJ) was injected in left supraspinatus. On 07 October 2008, she presented with a rhinitis episode treated with unspecified symptomatic drug and maybe antibiotherapy (NOS). On 13 October 2008, the subject presented with adenopathy, anorexia, asthenia and febrile status. In October 2008, the subject complained of cervical rachis pain, treated with tetrazepam. On 14 October 2008, she consulted due to persistence of asthenia. Physical examination showed cervical adenopathies. Platelets was 100000/mm3, ESR upper than 50 mm first hour and CRP was normal. The reporter general practitioner sent the subject to a specialist in infectious disease for check up. Between 19 October 2008 and 8 November 2008, lab tests were performed. Serologies against toxoplasma, Eptein-Barr virus, herpes virus, HIV, hepatitis B and C and cytomegalovirus were negative or reflected an old infection. There was an anemia, a thrombocytopenia, a lymphopenia, an elevated erythrocyte sedimentation rate with normal C reactive protein. Coagulation check up showed a isolated prolonged activated partial thromboplastin time (3 times the normal) and presence of circulating anticoagulant. On 05 November 2008, during a consultation, the subject reported several episodes of vomiting (unknown time to onset). She was apyretic. There was an anorexia with loss of weight. Cervical and axillary adenopathies were present. Platelet was at 99000/mm3, with tendency to leukolymphopenia (3100 white blood cells and 900 lymphocytes). ESR was increased at 77 mm first hour with normal CRP. Activated partial thromboplastin was prolonged at 98 seconds (control at 31) with presence of circulating antibodies. The investigation were thus not in favor of an infectious etiology, but more likely of a systemic disease such as lupus. urinary analysis showed traces of ketones, protein at 0.3 g/l and presence of leukocytes. On 10 November 2008, during a consultation, physical examination showed a bad general health status with loss of weight around 5 kg in three weeks, cervical and axillary adenopathies and a butterfly rash. the subject reported a cough. Cardiac examination showed a tachycardia (heart rate at 100 bpm) and systolic murmur at 2/6. There was no arthritis, no hepatosplenomegaly. Neurological examinations was normal. The subject was therefore hospitalized on 13 November 2008 for further investigations. At admission, body temperature was 37?C and she prevented with nausea. There was no infection evidenced. Cardiovascular examination showed thoracic pain, no dyspnea, no murmur, regular heart rate and no argument in favour of a pulmonary embolism or phlebitis. D Dimer was at 561 mcg/L. Lipidic, phosphocalcic, renal and hepatic check up was normal. CRP was normal. Anti-SSA antibody was upper than 240 U/Ml. Anti-DNAnative antibody was 34 U/ml. Other nuclear antigen autoantibodies were negative. CSF was clear, without flora at direct examination. CSF culture was negative for aerobic germs. CSF biochemistry was normal. PCR on herpesviridae family was negative. Syphilis serology showed positive VDRL at 4 and negative TPHA (<80). During hospitalization, nausea, vomiting, headache and cervical rachis pain continued. Diagnosis of disseminated erythematous lupus with antiphospholopid syndrome was made. There was no organ damage. the subject was treated with prednisone percs (Cortancyl) 20 mg per day. General state improved and the subject was discharged on 22 November 2008. On discharge, treatment was metoclopramide hydrochloride (Primperan) if nausea, paracetamol if pain and desogestrel (Cerazette) one tablet daily and Cortancyl 20 mg daily. On 10 December 2008, during a consultation, fever, headache and digestive symptoms had resolved. At physical examination, there was no superficial adenopathy at palpation. Butterfly rash was still present. Between December 2008 and February 2009, she consulted for arthritis (both hands) with asthenia and Cortancyl was increased to 60 mg daily, without real improvement of arthritis. In mid-January 2009, lab test showed a microcytic hypochronic anemia (1.4 g/dl of haemoglobin), ESR at 24 mm first hour, negative CRP and normal renal, hepatic and blood electrolysis check up. On 05 February 2009, during a consultation, physical examination showed persistence of butterfly rash, an erythemato-squamous rash on back side of hands and fingers. There was no superficial adenopathy on palpation. Cardiac and respiratory examinations were normal. Haemoglobin was 11 g/dl and seric iron was at 0.15 mg/l. Cortancyl was progressively reduced. Iron supplement and hydroxychloroquine sulphate (Plaquenil) at 2 tablets daily were prescribed. But the subject did not take Plaquenil. On 12 March 2009, during a consultation, the subject was in good health status. There was no arthritis (no recurrence). Cutaneous signs had disappeared except erythema on face. The specialist planned a progressive increase of Cortancyl daily dose. The reporting physician considered fever, adenopathy, asthenia and anorexia as probably related to vaccination with CERVARIX. He also reported that the events were disabling. At the time of reporting, the subject''s condition was considered as improved.

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