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From the 11/26/2021 release of VAERS data:

Found 1,511 cases where Vaccine is HPV2 and Serious

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Case Details

This is page 4 out of 152

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VAERS ID: 365491 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-22
Onset:2009-09-22
   Days after vaccination:0
Submitted: 2009-11-05
   Days after onset:44
Entered: 2009-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA049AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Complex regional pain syndrome, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No other medication documented
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0599844A

Write-up: This case was reported by the foreign regulatory authority (Regulatory Agency #GB-MHRA-ADR 205131B3) and described the occurrence of reflex sympathetic dystrophy of the upper limb in a 14-year-old female patient who was vaccinated with CERVARIX. On 22 September 2009 the patient received a dose of CERVARIX (intramuscular). On 22 September 2009, approximately 20 minutes after vaccination with CERVARIX, the patient experienced hand swelling and on the same day as vaccination with CERVARIX experienced reflex sympathetic dystrophy of the upper limb. The regulatory authority reported that the events were disabling. At the time of reporting the events were unresolved. Parents have requested that the programme is suspended for the present time. Slight lt hand swelling 20 mins after immunisation. Attended accident and emergency, returned to GP four days later, referred back to A&E. Receiving physiotherapy and hyrdotherapy treatment at present. Parents have requested that programme is suspended for the present time.


VAERS ID: 365925 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-09-26
Onset:2008-10-07
   Days after vaccination:11
Submitted: 2009-11-06
   Days after onset:395
Entered: 2009-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA011BJ / UNK UN / IM

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.
Allergies:
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.


VAERS ID: 365930 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-30
Onset:2009-09-30
   Days after vaccination:0
Submitted: 2009-11-06
   Days after onset:37
Entered: 2009-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS VA055AG / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0600124A

Write-up: This case was reported by a foreign agency (agency # GB-MHRA-ADR 20513736) and described the occurrence of anaphylaxis in a 12-year-old female patient who was vaccinated with CERVARIX. On 30 September 2009 the patient received a dose of CERVARIX (0.5 mL, intramuscular). On 30 September 2009, on the same day as vaccination with CERVARIX, the patient experienced anaphylaxis. The agency reported that the event was life threatening. On 30 September 2009, the event was resolved quickly after treatment with Adrenaline. Verbatim Text: Anaphylaxis. Recovered quickly after the adrenaline.


VAERS ID: 365936 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-24
Onset:2009-09-25
   Days after vaccination:1
Submitted: 2009-11-06
   Days after onset:42
Entered: 2009-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood product transfusion, Gait disturbance, Guillain-Barre syndrome, Paraesthesia, Paralysis
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune 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? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Cough
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0601391A

Write-up: This case was reported by a regulatory authority (# NL-LRB-92275) and described the occurrence of Guillain-Barre Syndrome in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included cough. No concomitant medication. On 24 September 2009 the subject received 3rd dose of CERVARIX (intramuscular) lot number unknown. On 25 September 2009, 1 day after vaccination with CERVARIX, the subject experienced paresthesia (in feet and calf). On 28 September 2009 the subject had unspecified paralysis (she fell with her bike and she could not put her foot on the pedal). On 04 October 2009 she had abnormal gait. The general practitioner referred her to the physiotherapist. The subject was referred to the pediatrician and neurologist who diagnosed Guillain-Barre Syndrome. The subject was hospitalized. The subject was treated with normal immunoglobulin (Immunoglobulin). At the time of reporting the outcome of the events were unspecified. The regulatory authority reported that Guillain Barre Syndrome was unlikely to be related to vaccination with CERVARIX. No further information was available as this was all the information that regulatory authorities had.


VAERS ID: 365938 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-06-30
Onset:2009-07-16
   Days after vaccination:16
Submitted: 2009-11-06
   Days after onset:113
Entered: 2009-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Typhoid fever
SMQs:

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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0602071A

Write-up: This female subject was enrolled in a post-marketing surveillance open study 108160. On 29 January 2009, 03 March 2009 and 30 June 2009, she received the 1st, 2nd and 3rd dose of CERVARIX (IM deltoid) On 16 July 2009, 16 days after the 3rd dose of CERVARIX, this 25-year-old subject developed typhoid fever. The subject was hospitalised. The event resolved on 27 July 2009. The investigator considered that there was no reasonable possibility that the typhoid fever may have been caused by CERVARIX.


VAERS ID: 366154 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-23
Onset:2009-10-23
   Days after vaccination:0
Submitted: 2009-11-09
   Days after onset:17
Entered: 2009-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Feeling cold, Injection site pain, Postmenopausal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)

Life Threatening? Yes
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:
Current Illness: Unknown
Preexisting Conditions: Menopausal
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0601901A

Write-up: This case was reported by a healthcare professional (subject) via a sales representative and described the occurrence of post menopausal bleeding in an adult female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included menopausal 4 years ago. On 23 October 2009 the subject received unspecified dose of CERVARIX (unknown route). Lot number not provided. On 23 October 2009, less than one day after vaccination with CERVARIX, the subject experienced cold feeling, injection site pain and joint pain. These events lasted one day. On 24 October 2009, the events were resolved. On 24 October 2009, one day after vaccination with CERVARIX, the subject experienced post menopausal bleeding. The healthcare professional considered the events were life threatening. The subject was treated with BRUFEN. On 30 October 2009, the post menopausal bleeding was resolved. The healthcare professional considered the events were almost certainly related to vaccination with CERVARIX.


VAERS ID: 366696 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-06
Onset:2009-10-06
   Days after vaccination:0
Submitted: 2009-11-11
   Days after onset:36
Entered: 2009-11-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA014EA / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood count normal, C-reactive protein increased, Chills, Diarrhoea, Dyspnoea, Headache, Nausea, No reaction on previous exposure to drug, Pyrexia, Retching, Tremor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (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? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood count, 06Oct2009, normal; C-reactive protein increased, 06Oct2009, 34mg/dl
CDC Split Type: D0063163A

Write-up: This case was reported by a physician and described the occurrence of dyspnea in a 17-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Previous vaccination with the first dose of CERVARIX (GlaxoSmithKline), given on an unspecified date, was well tolerated. on 06 October 2009, the subject received the second dose of CERVARIX (0.5 ml, unknown). Approximately two hours post vaccination with CERVARIX, on 06 October 2009, the subject experienced shaking chills, headache, retching, nausea, diarrhea, fever and dyspnea. The subject experienced no reaction at injection site. The subject was hospitalized by the parents overnight. Blood count was normal. C-reactive protein (CRP) was increased (34 mg/dl). On the next day, on 07 October 2009, all events were resolved. Follow-up information was received on 05 November 2009 from the reporting physician. The subject has no underlying or concurrent medical conditions or other risk factors. The subject received no concomitant medication. Previous vaccination with CERVARIX was well tolerated. On 06 October 2009 the subject received the second dose of CERVARIX (0.5 ml, intramuscular, left deltoid). Approximately two hours post vaccination with CERVARIX, on 06 October 2009 at around 18:00, the subject experienced dyspnea, vomiting, diarrhea, headache and fever. The subject was treated with ibuprofen (Ibu). After about six hours, on 07 October 2009 at around 00:00 (midnight), all events were resolved. The vaccination course with CERVARIX was discontinued. The reporting physician considered that the events were probably related to vaccination with CERVARIX. No further information will be available.


VAERS ID: 366697 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-11
Onset:2009-09-11
   Days after vaccination:0
Submitted: 2009-11-11
   Days after onset:61
Entered: 2009-11-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Mental disorder, Nausea, Schizophrenia, Suicidal ideation, Vomiting
SMQs:, Acute pancreatitis (broad), Suicide/self-injury (narrow), Dementia (broad), Psychosis and psychotic disorders (narrow), 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? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0601840A

Write-up: This case was reported by a consumer and described the occurrence of schizophrenia disorder in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). On 11 September 2009, the subject received 2nd dose of CERVARIX (unknown route of administration, lot number not provided). On 11 September 2009, less than one day after vaccination with CERVARIX, the subject experienced nausea, vomiting, severe psychiatric disorder and schizophrenia disorder including recurrent thoughts of death and suicide (with a formal reporting recording the police office and the hospital on 18 September 2009). The subject was hospitalised. At the time of reporting the outcome of the events was unspecified.


VAERS ID: 366912 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-28
Onset:2009-09-28
   Days after vaccination:0
Submitted: 2009-11-12
   Days after onset:45
Entered: 2009-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA058BF / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypersensitivity, Panic reaction, Paraesthesia oral, Rash macular, Respiratory rate increased, Throat irritation
SMQs:, Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Current Illness: Unknown
Preexisting Conditions: Allergic reaction
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0601161A

Write-up: This case was reported by the regulatory authority (Regulatory Agency# GB-MHRA-ADR 20514478) and described the occurrence of systemic allergic reaction in a 15-year-old female subject who was vaccinated with (CERVARIX, GlaxoSmithKline). The subject''s medical history included an allergic reaction. The subject had not had any reactions since she was 4 years and 6 months old. On 28 September 2009, the subject received a single dose of CERVARIX (intramuscular, Batch number AHPVA058BF). On 28 September 2009, within 5 minutes after the vaccination with CERVARIX, the subject developed a blotchy face, tingling in mouth, throat and tongue. She then panicked and had rapid breathing. The regulatory authority reported that the events were life threatening. An ambulance was called, and the young person was asked to lie down, and was calmed with breathing exercises. Adrenaline on stand by but not administered. At the time of reporting the events were improved. Verbatim Text: Young person had an unknown allergy, but had not had any reaction since she was 4 yrs and 6 months old. Within 5 minutes of vaccination, the young person developed blotchy face, tingling in mouth, throat and tongue. She then panicked and had rapid breathing. Ambulance called, young person asked to lie down, and calmed with breathing exercises. Adrenaline on stand by but not administered.


VAERS ID: 367192 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-17
Onset:2009-09-17
   Days after vaccination:0
Submitted: 2009-11-13
   Days after onset:57
Entered: 2009-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPV043BB / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cyanosis, Dizziness, Hypoventilation, Immediate post-injection reaction, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness: Unknown
Preexisting Conditions: PANIC ATTACK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0602195A

Write-up: This case was reported by the foreign regulatory authority (Regulatory Agency #20518357) and described the occurrence of fainting in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included panic attacks. Concurrent medications included PARACETAMOL. On 17 September 2009 the subject received the first dose of CERVARIX (intramuscular, batch: AHPV043BB09/2). On 17 September 2009, immediately after vaccination with CERVARIX, the subject felt faint. This spontaneously resolved, however, the subject stopped responding again. On an unknown date, the subject experienced shallow breathing, cyanotic lips & nose and was unresponsive to verbal stimuli. The subject was treated with adrenaline at 0.5 mg and started to respond. The regulatory authority reported that the subject was hospitalised. At the time of reporting the events were improved. Patient felt faint immediately after immunisation then spontaneous recovery, then stopped responding again. Patient experienced shallow breathing, cyanosis lips and nose. After adrenaline 0.5 mg was given the patient started responding. The patient then was transferred to hospital. This was the patients first dose of vaccine.


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