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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

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VAERS ID: 380985 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-19
Onset:0000-00-00
Submitted: 2010-02-22
Entered: 2010-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Hypoaesthesia, Lip swelling, Loss of consciousness, Obstructive airways disorder, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (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: Nil recorded.
Allergies:
Diagnostic Lab Data: unk
CDC Split Type: B0633079A

Write-up: This case was reported by a foreign regulatory authority (# GB-MHRA-ADR 20568767) and described the occurrence of loss of consciousness in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 19 November 2009 the subject received a single dose of CERVARIX (.5 ml, intramuscular). At an unspecified time after vaccination with CERVARIX, the subject experienced suspected anaphylaxis, numb, swollen lips, had restricted airway and collapsed. The subject was transferred to Accident and Emergency via ambulance. The regulatory authority reported that the events were life threatening. At the time of reporting the events were unresolved. Verbatim Text: Suspected anaphylaxis. Collapse, restricted airway, numb, swollen lips, 999 called, transferred to Accident and Emergency via ambulance.


VAERS ID: 380986 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-28
Onset:2009-09-28
   Days after vaccination:0
Submitted: 2010-02-22
   Days after onset:147
Entered: 2010-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA049AA / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Post viral fatigue syndrome
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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0633088A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20568756) and described the occurrence of post viral fatigue in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 28 September 2009 the subject received a single dose of CERVARIX (subcutaneous, batch number: AHPVA049AA). On the same day, at an unspecified time after vaccination with CERVARIX, the subject experienced post viral fatigue. The regulatory authority reported that the event was disabling. At the time of reporting the event was unresolved.


VAERS ID: 381205 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-01-13
Onset:2010-01-13
   Days after vaccination:0
Submitted: 2010-02-24
   Days after onset:42
Entered: 2010-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA056AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test normal, Malaise
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: Cervix disorder; surgery; Multiple medical history.
Allergies:
Diagnostic Lab Data: Blood test, results all
CDC Split Type: B0633879A

Write-up: This case was reported by a health professional via the foreign authority (# GB-MERA-ADR 20568914) and described the occurrence of unwell in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included cervix disorder and surgery. On 13 January 2010, the subject received a single dose of CERVARIX (0.5 mL, intramuscular). On 13 January 2010, the same day as the after vaccination with CERVARIX, the subject was unwell and had possibly developed a urinary tract infection. The subject was hospitalised. Blood results were performed and the results were normal. At the time of reporting the event was resolved. Patient admitted with possible urinary tract infection post injection as unwell in the evening. All blood results normal in hospital.


VAERS ID: 381432 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-02-26
Entered: 2010-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chills, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0579626A

Write-up: This case was reported by a sales representative and described the occurrence of breath difficulty in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date, the subject received 2nd dose of CERVARIX (intramuscular, unknown injection site), lot number not provided. Five minutes after vaccination with CERVARIX, the subject experienced breath difficulty with chills and fever. The subject was hospitalised for 1 day. The subject was treated with hydrocortisone. At the time of reporting the events were resolved. Additional information has been requested but could not be obtained. This case has therefore been closed.


VAERS ID: 381869 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-01-18
Onset:2010-01-18
   Days after vaccination:0
Submitted: 2010-03-04
   Days after onset:45
Entered: 2010-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA060AF / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Blood immunoglobulin E increased, Body temperature increased, Epstein-Barr virus test negative, Immediate post-injection reaction, Pyrexia, Rash, Viral test negative
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

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: Body temperature, 39.5deg.C; Immunoglobulin E, 21Jan2010, 190.53KIU/L
CDC Split Type: B0636937A

Write-up: This case was reported by a regulatory authority (# 112316) and described the occurrence of asthenia in a 11-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 18 January 2010, the subject received 1st dose of CERVARIX (unknown route and injection site). On 18 January 2010, immediately after vaccination with CERVARIX, the subject experienced asthenia and rash on skin. On the same day, 3 hours later, she had fever (39.5 deg.C). The subject was hospitalised. Relevant tests were performed and showed the following results : Immunoglobulin E (blood) : 190.53 KIU/L ; Viral Capsid Antigen : negative ; Epstein Barr Nuclear Antigen : negative. The subject was treated with CETIRIZINE. On 22 January 2010, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX. No further information is expected, the regulatory Authority has provided GSK with all the available information for the time being, if they ever get any further information they will send it to GSK.


VAERS ID: 381968 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-05-13
Onset:2009-05-13
   Days after vaccination:0
Submitted: 2010-03-05
   Days after onset:296
Entered: 2010-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Injected limb mobility decreased, Injection site pain, Oedema, Oedema peripheral, Pain, Skin warm, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0574456A

Write-up: This case was reported by sales representative (subject) and described the occurrence of injected limb mobility decreased in a 45-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 13 May 2009, the subject received 1st dose of CERVARIX (unknown route of administration, right arm, lot number not provided). On 13 May 2009, 2 hours after vaccination with CERVARIX, the subject experienced injection site pain and could not move her arm anymore. The subject experienced a lot of vomiting during the night. The subject experienced swollen arm. The subject was treated with BRUFEN 600 mg but it did not help. The day after, it was still impossible for the subject to move her arm. On 14 May 2009, the subject was examined by her physician who did not consider that vomiting was linked to vaccination. On 14 May 2009, the subject had no vomiting. On 15 May 2009, the subject had less pain and her condition improved slightly. Further information has been requested. Follow up information received on 15 May 2009 from a physician (case upgraded to serious): On 13 May 2009, the subject received 1st dose of CERVARIX (intramuscular, right deltoid, lot number not provided). On 14 May 2009, the subject experienced extended local pain. She experienced edema, heat and pain. The subject was apyretic (no fever). On 15 May 2009, the subject had less pain and her condition improved slightly. The physician considered the events were disabling. The physician considered the events were probably related to vaccination with CERVARIX. Follow up information received on 25 May 2009 from the sales representative (subject): The subject''s condition clearly improved. The only remaining symptom was a slight restriction of the movement of the arm at the level of the shoulder and this restriction of the movement concerned only the movement of rotation of the arm backward. All other symptoms disappeared.


VAERS ID: 381975 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-01-18
Onset:2010-01-21
   Days after vaccination:3
Submitted: 2010-03-05
   Days after onset:43
Entered: 2010-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVA018BE / 3 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Anti-thyroid antibody positive, Blood thyroid stimulating hormone normal, Condition aggravated, Disorientation, Drug level increased, Electroencephalogram abnormal, Epilepsy, Grand mal convulsion, Loss of consciousness, No reaction on previous exposure to drug, Sleep disorder, Somnolence, Thyroxine free normal, Tri-iodothyronine free normal
SMQs:, Torsade de pointes/QT prolongation (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), Dementia (broad), Convulsions (narrow), Drug abuse and dependence (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (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: Lamotrigine; valproic acid
Current Illness: Goiter grade I; grand mal epilepsy; lack of sleep; possible Hashimoto''s thyroiditis; primary generalized epilepsy; sleep disorder
Preexisting Conditions: Weight gain
Allergies:
Diagnostic Lab Data: Free T3, 23Feb2010, 3.23ng/l; Free T4, 23Feb2010, 11.6ng/l; Thyroid stimulating hormone, 23Feb2010, 3.44 mU/l; Blood examinations, performed on 23 February 2010: Blood lamotrigine level: 9.6 mg/l; Thyroid peroxidase antibody: 47 kU/l; Thyroglobulin antibody: 164 kU/l; Thyroid stimulating hormone receptor antibody: 0.6 U/l; EEG, performed on 12 January 2010: Well pronounced 9/s alpha basal activity. Plenty of generalised spikes and sharp waves with an emphasis towards frontal with slow following fluctuation, irregularly interspersed, sometime at about 3/s. No signs of focus. Overall image of primary generalised epilepsy. EEG, performed on 26 January 2010: Well pronounced 9/s alpha basal activity. Series of generalised high-voltage 3/s spike-wave complexes, in parts in abortive form.
CDC Split Type: D0066613A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of grand mal seizures in a 17-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date the subject received an unspecified dose of CERVARIX (0.5 ml, unknown). At an unspecified time post vaccination with CERVARIX, on an unspecified date, the subject experienced epileptic seizure. This case was assessed as medically serious by GSK criteria. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 28 February 2010 from the reporting physician. Concurrent medical conditions included grand mal epilepsy since February 2002. The subject experienced seizures very rarely (about three seizures per year) and up to now always experienced these seizures in the morning after waking up. The subject has never before experienced grand mal seizure in the evening. EEG, performed on 12 January 2010, showed image of primary generalised epilepsy. Furthermore, medical conditions included goiter grade 1 and possible Hashimoto''s thyroiditis, and the subject complained about sleep disorder / lack of sleep since a longer period of time. Previous medication for grand mal epilepsy included valproic acid (oral) at blood levels above 100 mg/l. The subject was free of grand mal seizures but experienced weight gain. After about three years without seizures treatment with valproic acid was discontinued end of 2006. Between 31 December 2007 and 30 January 2008 the subject experienced four recurrences of grand mal seizures. Therefore medication with lamotrigine at 100 mg - 0 - 175 mg was started early in 2008. The only recurrence of a grand mal seizure was experienced in February 2009 when the subject has forgotten to take the medication. Otherwise the subject has been free of grand mal seizures on treatment with lamotrigine. The subject received no further concomitant medication. Previous vaccinations with the first two doses of CERVARIX (GlaxoSmithKline), given on unknown dates, have been well tolerated. On 18 January 2010 the subject received the third dose of CERVARIX (0.5 ml, intramuscular, left deltoid). Approximately three days post vaccination with CERVARIX, on 21 January 2010 in the evening, the subject experienced grand mal seizure. On the next day, on 22 January 2010, the subject experienced two more grand mal seizures. The reporting physician considered that the event was life threatening. EEG, performed on 26 January 2010, showed series of generalised high-voltage 3/s spike-wave complexes, in parts in abortive form. The subject was treated with diazepam and the daily dose of lamotrigine was increased to 175 mg twice daily. After about two days, on 22 January 2010, the event was resolved. The subject received no further dose of CERVARIX. The reporting physician considered that the event was possibly to probably related to vaccination with CERVARIX. An examining neurologist considered that underlying sleep disorder / lack of sleep could have provoked the event. The reporting physician also provided the answers to a GSK questionnaire asking for additional information in cases of seizure: The convulsion was witnessed by the subject''s sister. The event was not preceded by an aura or headache. The symptoms were generalized. The patient did lose consciousness. Upon regaining consciousness the patient was disoriented and / or drowsy. The patient could recall the event. It was unknown whether or not the patient experienced urinary or faecal incontinence during convulsive seizure. There was no evidence that the symptoms may have resulted from withdrawal of alcohol or other psychotropic substances. Follow-up of the event was planned. The patient has no driving license. Medical history included seizures (including febrile seizures and epilepsy): Only very few seizures, well controlled by treatment with lamotrigine, never before seizures in this number over such a short period of time, never before seizures in the evening / at night. None of the following events was known in medical history: movement disorders, central nervous system including impairment of cerebral circulation, transient ischemic attack, psychiatric disorders, central nervous system tumor et cetera, head injury, cerebral palsy, neurological handicap or congenital abnormality, diabetes mellitus, renal failure, alcohol or drug abuse. The patient has not received medication which is known to reduce the seizure threshold. Neurological examinations including EEG, has been performed: results see above. There was no evidence of a neurological lesion or infection (encephalitis, meningitis) which might have been the cause of the seizure. It was unknown whether or not serum electrolytes have been determined. No further information will be available.


VAERS ID: 382056 (history)  
Form: Version 1.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-02-16
Onset:2010-02-23
   Days after vaccination:7
Submitted: 2010-03-08
   Days after onset:13
Entered: 2010-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA059CL / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase normal, Autoimmune disorder, Blood cholesterol normal, Blood creatinine normal, Blood glucose normal, Blood triglycerides normal, Body temperature increased, Coombs direct test negative, Coombs indirect test negative, Erythema, Haematocrit decreased, Hypokinesia, Inappropriate schedule of drug administration, Infection, Inflammation, Joint range of motion decreased, Joint swelling, Musculoskeletal stiffness, Pain in jaw, Platelet count normal, Polyarthritis, Pyrexia, Red blood cell sedimentation rate increased, White blood cell count decreased
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), 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:
Allergies:
Diagnostic Lab Data: Alanine aminotransferase, 02Mar2010, 64mg/dl; Aspartate aminotransferase, 02Mar2010, 29mg/dl; Body temperature, 02Mar2010, 37.5deg.C; Cholesterol, 03Mar2010, 181mg/dl; Creatinine, 02Mar2010, 0.9mg/dl; Direct Coombs test, 02Mar2010, Negatif; Erythrocyte sedimentation rate, 02Mar2010, 58mm/hr; Hematocrit, 02Mar2010, 31%; Indirect Coombs test, 02Mar2010, Negatif; Triglycerides, 03Mar2010, 115mg/dl; White blood cells, 02Mar2010, 4,600
CDC Split Type: B0636844A

Write-up: This case was reported by a physician and described the occurrence of polyarthritis in a 39-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). No underlying disease or family history of autoimmune disease was known. On 16 February 2010, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site, lot number not provided). On 23 February 2010, 7 days after vaccination with CERVARIX, the subject experienced polyarthritis at both shoulders, wrist, knees and ankles, low grade fever (37.5 deg. C), morning stiffness, mild swelling and inflammated both shoulder, wrist, knees and ankles with limited range of motion on passive movement. The subject was treated at private clinic (unknown medication) before hospitalized on 2 March 2010. At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with CERVARIX. Follow-up received on 3 March 2010: There were no medical history and no concomitant drugs. On 2 March 2010, a physical examination was performed. The subject presented pain, swelling and redness at both shoulders, wrists, knees and ankles with limited range of motion, jaw pain. The hematocrite was 31 %. The white blood count was 4,600 (N94, L) Platelets were adequate. The direct and indirect Coomb''s test were negative. The erythrocyte sedimentation rate was 58 mm/hr. The creatinine was 0.9 mg/dl. The AST was 29 mg/dl and the ALT was 64 mg/dl. The diagnosis was polyarthritis. The differential diagnosis included autoimmune disease and systemic infection. The subject was treated with dexamethasone, diclofenac, paracetamol, ARCOXIA and DOXYCYCLIN. On 3 March 2010, the subject got better. He could walk. The pain was confined only at the fingers and jaws, however full range of motion can be performed. The subject did not presented fever yet. The fasting blood sugar was 86 mg/dl. The cholesterol was 181 mg/dl. The triglyceride value was 115 mg/dl. The subject was clinically improved


VAERS ID: 382068 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-12-01
Onset:2009-12-01
   Days after vaccination:0
Submitted: 2010-03-08
   Days after onset:97
Entered: 2010-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPV0053CA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Eyelid oedema, Swollen tongue, Tongue biting
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Convulsions (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Periorbital and eyelid disorders (narrow), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0636256A

Write-up: This case was reported by the regulatory authority (#GB-MHRA-ADR 20574574) and described the occurrence of swollen tongue in a 13-year-old female subject who was vaccinated with CERVARIX. The subject''s medical history included a penicillin allergy. On 1 December 2009 the subject received a 0.5ml dose of CERVARIX (intramuscular). On 1 December 2009, at an unspecified time after vaccination with CERVARIX the subject experienced eyelid swelling and a swollen tongue "so badly in her mouth she bit her own tongue several times". The subject had to sit upright and breathe through her nose. The regulatory authority reported that the events were disabling. On 2 December 2009, the events were resolved. Patient''s tongue became swollen, so badly in her mouth she bit her own tongue several times. Had to sit upright and nose breathe. Also had eyelid swelling.


VAERS ID: 382306 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2010-02-19
Onset:2010-02-19
   Days after vaccination:0
Submitted: 2010-03-10
   Days after onset:19
Entered: 2010-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Asthma, Condition aggravated, Cough, Hypersensitivity, Lip swelling, Myalgia, Pneumothorax, Urticaria, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), 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? 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: Pneumothorax
Preexisting Conditions: hypersensitivity
Allergies:
Diagnostic Lab Data: unk
CDC Split Type: B0637110A

Write-up: This case was reported by a consumer and described the occurrence of allergy in a subject of unspecified age and gender who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included pneumothorax. On 19 February 2010, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site, lot number not provided). At an unspecified time after vaccination with CERVARIX, the subject experienced allergy. At the time of reporting the outcome of the event was unspecified. Follow-up received on 4 March 2010: This case was upgraded to serious. This case was reported by a consumer and described the occurrence of pneumothorax in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included hypersensitivity. Concurrent medical conditions included pneumothorax. On 19 February 2010, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site). On 19 February 2010, 15-30 minutes after vaccination with CERVARIX, the subject experienced allergy, lip swelling, urticaria, vomiting, arthralgia, myalgia and asthma aggravated. THEODUR and HOKUNALIN were used for asthma but the symptoms did not improved and thereby the subject visited a hospital. The doctor diagnosed a pneumothorax. The cause was unknown. The subject was hospitalised due to bad cough. At the time of reporting the outcome of the events was unspecified.


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