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

Found 1,514 cases where Vaccine is HPV2 and Serious

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Case Details

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VAERS ID: 385818 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-08-06
Onset:2009-08-30
   Days after vaccination:24
Submitted: 2010-04-23
   Days after onset:236
Entered: 2010-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Eyelid ptosis, Meningitis, Nuclear magnetic resonance imaging abnormal, Pupils unequal
SMQs:, Noninfectious meningitis (narrow), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Paracetamol
Current Illness: Sialadenitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Nuclear magnetic resonance ima, 2009, negative; nuclear magnetic resonance ima, Meningitis
CDC Split Type: B0648745A

Write-up: This case was reported by a regulatory authority (# 115263) and described the occurrence of meningitis in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included sialadenitis in 2008. Concurrent medications included EFFERALGAN. On 6 August 2009, the subject received 1st dose CERVARIX (route and administration site unknown, lot number not provided). On 30 August 2009, 24 days after vaccination with CERVARIX, the subject experienced anisocoria. RMN was negative. On 11 September 2009, the subject received 2nd dose of CERVARIX (route and administration site unknown). On 25 January 2010, 4 months after vaccination with CERVARIX, the subject experienced palpebral ptosis and the RMN showed meningitis. The subject was hospitalised. At the time of reporting, the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX.


VAERS ID: 385821 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-04-23
Entered: 2010-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Neurological examination abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow), 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:
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: B0647877A

Write-up: This case was reported by the foreign regulatory authority (# GB-MHRA-ADR 20606872) and described the occurrence of abnormal neurological findings in a 17-year-old female subject who was vaccinated with CERVARIX. On an unspecified date the subject received an unspecified dose of CERVARIX. Approximately two weeks after vaccination with CERVARIX, the subject experienced bilateral weakness of arms and legs, numbness and guillain barre syndrome. At an unspecified time after vaccination, the subject also experienced abnormal neurological findings. The regulatory authority reported that the events were life threatening. At the time of reporting the events were unresolved. Patient developed weakness bilateral arms and legs and was treated as Guillain-Barre syndrome. Patient had cervical cancer vaccine 2 weeks prior to the onset of symptoms.


VAERS ID: 386073 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-04-12
Onset:2010-04-12
   Days after vaccination:0
Submitted: 2010-04-27
   Days after onset:15
Entered: 2010-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK AR / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdomen scan, Acid base balance normal, Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood creatinine normal, Blood electrolytes normal, Blood glucose normal, Blood immunoglobulin E increased, Blood lactic acid increased, Body temperature increased, C-reactive protein normal, Cardiac murmur, Chills, Dizziness, Dyspnoea, Echocardiogram abnormal, Electrocardiogram QT prolonged, Electrocardiogram abnormal, Fall, Haematocrit normal, Haemoglobin decreased, Headache, Injection site pain, Loss of consciousness, Lymphocyte percentage decreased, Nausea, Neurological examination normal, Neutrophil percentage decreased, Platelet count normal, Pyrexia, Sinus rhythm, Skin discolouration, Skin warm, Specific gravity urine normal, Tremor, Ultrasound abdomen abnormal, Urine analysis, White blood cell count increased, pH urine normal
SMQs:, Torsade de pointes/QT prolongation (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Lactic acidosis (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Retroperitoneal fibrosis (broad), Torsade de pointes, shock-associated conditions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hepatomegaly; renal cyst; upper respiratory tract infection
Preexisting Conditions: Arm pain after injection; Headache
Allergies:
Diagnostic Lab Data: Acid-base balance normal, 12Apr2010, normal; Alanine aminotransferase, 12Apr2010, normal; Aspartate aminotransferase, 12Apr2010, normal; Blood creatinine, 12Apr2010, normal; Blood electrolytes, 12Apr2010, normal; Blood glucose, 12Apr2010, normal; Blood lactic acid, Apr2010, 2mmol/l; Blood lactic acid, 12Apr2010, 3.4mmol/l; Body temperature, 12Apr2010, 38.7degC; C-reactive protein, 12Apr2010, normal; Hematocrit, 12Apr2010, 0.40; Hemoglobin, 12Apr2010, 8.4mmol/l; IgE, 12Apr2010, 209kU/l; Lymphocyte percentage, 12Apr2010, 3%; Platelet count, 12Apr2010, 254G/l; Segmented neutrophil percentag, 12Apr2010, 18%; Urine specific gravity, 12Apr2010, 1.015; White blood cell count, 12Apr2010, 12.2G/l; Urinalysis, performed on 12 April 2010: Specific weight: 1.015; pH: 8.0; otherwise normal. Abdominal sonography: Hepatomegaly; isolated renal cyst right; otherwise normal. Electrocardiogram (ECG) : Sinus rhythm; heart rate 81 - 87 /min; vertical type; p-time increased; QTc increased; other time and amplitudes age corresponding; no extrasystoles; no signs of hypertrophy. Signs of the enzymeallergosorbent test (EAST), possible long QT syndrome: therefore control ECG and echocardiogram. Control electrocardiogram (ECG) : Sinus rhythm; heart rate 68 - 78 /min; vertical type; PQ-time decreased; other time and amplitudes age corresponding; no extrasystoles; no signs of hypertrophy. ECG normal with normal QTc. Echocardiogram: Systolic murmur cannot be imaged unambiguously; multiple artefacts; second heart sound ends in T wave.
CDC Split Type: D0067318A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of generalized tremor in a 13-year-old female subject who was vaccinated with CERVARIX, (GlaxoSmithKline). At the time of the events the subject was healthy. Course of pregnancy, spontaneous birth, post natal adaptation and previous development have been normal. The subject''s medical history included arm pain after injection and headache for about 3 - 4 days post vaccination with the first dose of CERVARIX (GlaxoSmithKline) on 11 February 2010 in an unknown deltoid. Please see case D0067318B for further information. On 12 April 2010 at 14:00 the subject received the second dose of CERVARIX (0.5 ml, unknown, unknown deltoid). Approximately three hours post vaccination with CERVARIX, on 12 April 2010 at 16:00, the subject experienced generalized tremor like shaking chills, frontal headache, nausea and dyspnea. The subject was going to bed. On 12 April 2010 at around 17:00 the subject took one tablet of paracetamol for headache without success. Approximately two hours post vaccination with CERVARIX, on 12 April 2010 at 17:00, the subject experienced urge to vomit and went to the bathroom. In the bathroom the subject experienced loss of consciousness and fall. The subject woke up lying on the floor of the bathroom and has called for the mother for help. The subject showed severe tremor like shaking chills. An emergency physician was called who admitted the subject to a hospital. The subject was hospitalised for four days. On admission to hospital, approximately four hours post vaccination with CERVARIX, on 12 April 2010 at around 18:00, the subject was in stable general condition and good nutritional condition. The subject was slim and tall. The subject still complained about frontal headache (strength 8/10), still showed mild tremor and experienced nausea. The skin was warm from fever and showed some colored spots on the hands. At the injection site at the left upper arm the subject showed no irritation, no redness, no swelling and only slight pain. Internal and neurological examinations were normal. The subject was hospitalised for possible adverse reaction post vaccination with the second dose of CERVARIX. The subject experienced tremor, dyspnea, dizziness and fever up to 38.7 degC. These events might have been adverse events post vaccination with CERVARIX, but might also have been caused by underlying beginning upper respiratory tract infection which hardly showed any clinical relevant symptoms of infection. The subject was treated with NOVAMINUSULFON intravenously, followed by ibuprofen orally, SULTANOL inhaled and, for three days, parenteral electrolyte + glucose infusions. Headache, dizziness and subjective dyspnea improved. 24-hour cardiac monitoring was normal. Initially observed long-QT in electrocardiogram was not conformed by control ECG and echocardiogram. Secondary findings in abdominal sonography included hepatomegaly and isolated renal cyst right. Laboratory examination showed IgE of 209 kU/l. On 15 April 2010 the subject was discharged from hospital for ambulatory follow-up. No further information will be available.


VAERS ID: 386266 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-04-16
Onset:0000-00-00
Submitted: 2010-04-29
Entered: 2010-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA063DA / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure normal, Cyanosis, Depressed level of consciousness, Electrocardiogram normal, Heart rate normal, Urine analysis normal
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? 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: Blood pressure, 19Apr2010, ok; Electrocardiogram, 19Apr2010, ok; Pulse rate, 19Apr2010, ok; Urine analysis, 19Apr2010, ok
CDC Split Type: B0649165A

Write-up: This case was reported by a study nurse via a GSK employee (clinical study manager) and described the occurrence of cyanosis in a 26-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject was reported to be "fit and well". On 16 April 2010 the subject received an unspecified dose of CERVARIX (1 injection, intramuscular). At unspecified time after vaccination with CERVARIX, "during the night", the "subject''s boyfriend was unable to rouse her as she was cyanosed around her mouth". The patient was then admitted to hospital overnight and was discharged the following day and "felt fine". On 19 April 2010 tests performed for blood pressure, pulse, electrocardiogram and urine analysis "all came back ok". The nurse also reported that the pre-diagnosis from the hospital was that the patient may have "atypical epilepsy", but this was unconfirmed at the time of reporting. The study nurse was unsure if the patient was still taking the Cerazette contraception pill at the time of reporting. At the time of reporting the outcome of "atypical epilepsy was unspecified", the outcome of all other events was resolved. On 19/04/2010 a study nurse reported via a GSK employee, that as part of a crossover vaccine programme at the end of study, a 26 year-old female patient was administered a first dose of CERVARIX vaccine intramuscularly, on the afternoon of 16/04/2010. Post administration, the patient remained at the investigator''s site for half an hour and felt fine. Subsequently, during the night the patient''s boyfriend was unable to rouse her as she was cyanosed around her mouth. The patient was then admitted to hospital overnight but was observed only. The patient was discharged the following day and felt fine. On 19/04/2010 the patient went back to the investigator''s site and had the following tests performed: blood pressure, pulse, electrocardiogram and urine analysis tests. The test results all came back ''ok''. The study nurse also reported that the pre-diagnosis from the hospital was that the patient may have atypical epilepsy, but this was unconfirmed at the time of reporting. The study nurse also reported that the hospital advised that the patient should have a computerised tomography scan and magnetic resonance imaging scan done. Furthermore, the patient had no reportable medical history and was reported as ''fit and well''. The patient''s concomitant medication included the Cerazette contraception pill which she was taking last year however, the study nurse was unsure if the patient was still taking the pill at the time of reporting. No further information was available at the time of reporting.


VAERS ID: 386268 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-31
Onset:2010-03-31
   Days after vaccination:0
Submitted: 2010-04-29
   Days after onset:29
Entered: 2010-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blindness, Fatigue, Haematology test, Headache, Immediate post-injection reaction, Injection site erythema, Injection site warmth, Laboratory test, Neurological examination, Nuclear magnetic resonance imaging, Scan brain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to nuts; milk allergy; seasonal allergic rhinitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Brain computerized tomography, Apr2010, Unknown; Chemistry NOS, Apr2010, Unknown; Hematology test, Apr2010, Unknown; Neurological examination, Apr2010, Unknown; Nuclear magnetic resonance ima, Apr2010, Unknown
CDC Split Type: B0648966A

Write-up: This case was reported by a sales representative and described the occurrence of vision loss in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included mild allergy to nuts, milk allergy and seasonal allergic rhinitis which not requiring regular treatment. The subject was healthy, did not take any other medication. On 31 March 2010, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, unknown injection site, lot number not provided). On 31 March 2010, immediately after vaccination with CERVARIX, the subject experienced mild fatigue, local injection site redness and warmth skin at the injection site. On 16 April 2010, the subject was in school, sitting, was not hungry or dehydrated and felt pain in one half of head and lost sight in one eye. Then, the subject experienced pain in the other half of head and loss of sight of the other eye and then fainted. The subject was hospitalised. RTG of the brain, haematology and chemistry, neurologic assessment, MR were performed but we did not have the results. At the time of reporting, the outcome of the events was unresolved.


VAERS ID: 386273 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-02-22
Onset:2010-02-22
   Days after vaccination:0
Submitted: 2010-04-29
   Days after onset:65
Entered: 2010-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA020CC / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Angioedema, Blood count normal, Blood gases normal, Cardiac monitoring normal, Dizziness, Headache, Laboratory test normal, Nausea, Oedema mouth, Reaction to previous exposure to any vaccine, Respiratory distress, Swelling face, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Dizziness; Fever post vaccination; Nausea
Allergies:
Diagnostic Lab Data: Blood count, normal; Blood gases, normal
CDC Split Type: D0067403A

Write-up: This case was reported by a regulatory authority (# DE-PEI-PEI2010006184) and described the occurrence of anaphylaxis in a 17-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included dizziness, fever and nausea after vaccination with tick-borne encephalitis vaccine on 24 July 1998. No allergies were known. First vaccination with CERVARIX on 25 January 2010 was well tolerated. On 22 February 2010 the subject received 2nd dose of CERVARIX (intramuscular, left deltoid). On 22 February 2010 at 14:30, less than one day after vaccination with CERVARIX, the subject experienced anaphylaxis. Two hours post vaccination the subject developed dizziness, headache, nausea and vomiting. Approximately 9 hours after vaccination the subject developed respiratory distress and swelling of face and mouth (Quincke''s edema). One to two hours later the subject was hospitalised. Clinical chemistry, blood count, blood gases, SO2 and cardio-respiratory monitoring were normal. The subject was treated with cortisone and clemastine and the events improved. At the time of reporting the events were resolved. No further information will be available.


VAERS ID: 386340 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-04-16
Onset:2010-04-17
   Days after vaccination:1
Submitted: 2010-04-30
   Days after onset:13
Entered: 2010-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA063DA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Confusional state, Cyanosis, Depressed level of consciousness, Loss of consciousness
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), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DESOGESTREL
Current Illness: Unknown
Preexisting Conditions: PELVIC INFLAMMATORY DISEASE; TONSILLECTOMY; No known drug allergies
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0649113A

Write-up: This case was reported by a foreign regulatory authority and described the occurrence of unconscious in a 26-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included pelvic inflammatory disease and tonsillectomy. Concurrent medications included CERAZETTE. On 16 April 2010 the subject received a single dose of CERVARIX (.5 ml, intramuscular, batch number: AHPVA063DA). The subject was admitted to hospital in early hours of the next day on 17 April 2010 after partner found the subject unconscious and was unable to rouse. upon admission the subject had a cyanosis of lips and when waking was confused. The subject was kept in for observation, no treatment was administered and no initial abnormalities were found in tests performed. Upon discharge, the subject stated that she still felt confused and when reporting incident to centre still complained of feeling slightly confused. The subject attended centre three days after initial administration for a doctor''s exam. No abnormalities found. At the time of reporting the events were unresolved. patient attended center to receive CERVARIX vaccine. Patient remained at centre 30 mins post dose with no problems and felt well at time of leaving centre. Patient was admitted to hospital in early hours of the next day after partner found patient unconscious and was unable to rouse. Upon admission patient had cyanosis of lips and when walking was confused. Patient was kept in for observation, no treatment was administered and no initial abnormalities were found in tests performed. Upon discharge patient stated still felt confused and when reporting incident to centre still complained of feeling slightly confused. Patient attended centre three days after initial administration for a doctor''s exam. no abnormalities found. Is now awaiting follow up with GP.


VAERS ID: 386351 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-03-19
Onset:2009-03-20
   Days after vaccination:1
Submitted: 2010-04-30
   Days after onset:406
Entered: 2010-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA059BA / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Atrioventricular block, Blood pressure decreased, Cyanosis, Depressed level of consciousness, Hypotonia, Pallor, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0650554A

Write-up: This case was reported by a regulatory authority (# NL-LRB-105112) and described the occurrence of unconscious partial in a 14-year-old female subject who was vaccinated with CERVARIX, (GlaxoSmithKline). No concomitant medication or relevant medical history. On 19 March 2009, the subject received 1st dose of CERVARIX (intramuscular, administration site unknown). 1.1 day after vaccination with CERVARIX, the subject experienced fever. It was resolved after 1 week. 34 hours after vaccination with CERVARIX, the subject experienced unconscious partial, syncope, pallor, acrocyanosis and hypotonia nos. At an unspecified time after vaccination with CERVARIX, the subject experienced decreased blood pressure. Due to fainting several times, the subject was hospitalised for observation and was discharged after 1 day. During hospitalisation, orthostatic dysregulation with 1st-2nd AV block was diagnosed. She was under control of the cardiologist. At the time of reporting, the outcome of decreased blood pressure was unspecified. The other events were resolved. The regulatory authority reported that syncope was unlikely to be 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: 386727 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-09
Onset:2009-11-09
   Days after vaccination:0
Submitted: 2010-05-05
   Days after onset:176
Entered: 2010-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA056AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Groin pain, Headache, Lymphadenopathy, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Osteonecrosis (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0649854A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20610962) and described the occurrence of high temperature in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 9 November 2009 the subject received a single dose of CERVARIX (intramuscular, batch number: AHPVA056AA). On 9 November 2009, in the evening after vaccination with CERVARIX, the subject developed a high temperature, and painful groin. The patient attended her GP who referred them to the A & E department. The subject was hospitalised and diagnosed with "ingrown swollen lymph gland" in groin. Swelling resolved with antibiotics after approximately one week. Hospital advised against future HPV vaccinations. The subject continued to have headache and was generally unwell for five to six weeks. At the time of reporting the events were resolved. On evening of second HPV vaccination the patient developed a high temperature, and painful groin. Attended GP who referred them to the A & E department which diagnosed "ingrown swollen lymph gland" in groin. Swelling resolved with antibiotics after approximately one week. Hospital advised against future HPV vaccinations. The subject continued to have headache and was generally unwell for five to six weeks.


VAERS ID: 386981 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-02-02
Onset:2010-04-26
   Days after vaccination:83
Submitted: 2010-05-07
   Days after onset:11
Entered: 2010-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA056AA / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Drug exposure during pregnancy, Haemorrhage, Intra-uterine death
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Folic Acid
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0646079A

Write-up: This prospective pregnancy case was reported by a healthcare professional via Agency and described the occurrence of missed miscarriage in a 18-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included CERVARIX ;GlaxoSmithKline;unknown;unknown given on 27 August 2009 and 25 September 2009. Concurrent medications included Folic acid during pregnancy. On 2 February 2010, the subject received 3rd dose of CERVARIX (administration site and route unknown). Her last menstrual period was on 28 January 2010 and estimated date of delivery was on 4 November 2010. The subject was exposed to the vaccine before pregnancy. The pregnancy was ongoing. A follow-up was received on 4 May 2010. The case was upgraded to serious as the subject was hospitalised. On 26 April 2010, 83 days after vaccination with CERVARIX and after 12 weeks gestation, the subject experienced bleeding, stomach cramps and missed miscarriage.


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