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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: 546972 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Unknown  
Vaccinated:2011-04-25
Onset:2011-04-25
   Days after vaccination:0
Submitted: 2014-10-06
   Days after onset:1260
Entered: 2014-10-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test normal, Eye irritation, Headache, Mydriasis, Nausea, Visual impairment, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

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: No other medications
Current Illness: Seasonal allergy; Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: A201105703

Write-up: This case was reported by a physician and described the occurrence of vomiting in a 15-year-old female subject who was vaccinated with CERVARIX. On 25 April 2011 the subject received unspecified dose of CERVARIX (.5 ml, intramuscular). On 25 April 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced vomiting, headache and mydriasis. At the time of reporting the events were unresolved. The physician considered the events were related to vaccination with CERVARIX. Follow-up information received on 17 May 2011: Concurrent medical conditions included asthma and seasonal allergy. Lot number was provided. The vaccine was administered in right deltoid. On 25 April 2011, less than one day after vaccination with CERVARIX, the subject experienced vomiting, and mydriasis. On 26 April 2011, one day after vaccination with CERVARIX, the subject experienced headache, queasy, vision disturbance and irritation when opening the eyes. A blood test was performed and showed no abnormality. On 28 April 2011, the events were improved. On 6 May 2011, the headache and queasy recurred. Follow-up information received on 18 May 2011: Previous vaccination included 1st dose of CERVARIX (GlaxoSmithKline, intramuscular, unknown injection site) given on 25 March 2011. This case has been linked to case B0718792A because it was a duplicate. All future correspondence will be submitted to B0716098A. Follow-up information received on 26 May 2011: The subject was treated with unknown (Infusion) and unknown (Unknown medication).


VAERS ID: 596167 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Unknown  
Vaccinated:2012-12-26
Onset:0000-00-00
Submitted: 2015-09-18
Entered: 2015-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA164AA / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Biopsy skin abnormal, Blood catecholamines increased, Complex regional pain syndrome, Orthostatic intolerance, Pain, Pain in extremity, Palpitations, Plethysmography, Postural orthostatic tachycardia syndrome, Schellong test, Temperature difference of extremities, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (broad), Cardiomyopathy (broad), Skin tumours of unspecified malignancy (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

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: No other medications
Current Illness: Unknown
Preexisting Conditions: 05/14/2012, CERVARIX, dose 1 - AHPVA162AA; 06/16/2012, CERVARIX, dose 2 - AHPVA162AA
Allergies:
Diagnostic Lab Data: The subject underwent the following tests: Schellong test (maximum change decreased systolic blood pressure: 1 mmHg; increased heart rate/minute: 48), measurement of catecholamine plasma levels (Noradrenaline at supine position: 0.22 ng/mL, Increasing rate of noradrenaline: 100%), evaluation of skin temperature (2nd finger: 33.2, 1st toe: 24.1, room temperature 23-25 deg C) and digital plethysmogram (2nd finger: decreased height of waves, 1st toe: decreased height of waves). In addition to this, a punch biopsy of the skin of the first toe was performed and no pathological findings were identified. Upon light microscopic examination, three small nerve fascicles were identified in one skin sample and some of these nerve fascicles were near apocrine glands (where sudomotor autonomic unmyelinated nerves were thought to be present, according to the authors). Upon electron microscopic examinations, one fascicle was found to consist of a small number of myelinated nerve fibers (most of them <5 um in diameter) and a large number of unmyelinated nerve fibers.
CDC Split Type: US2014GSK041878

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of postural orthostatic tachycardia syndrome on a 15-year-old female patient who received CERVARIX (batch number AHPVA164AA, expiry date unknown). Previously administered products included CERVARIX (dose 1 - AHPVA162AA) and CERVARIX (dose 2 - AHPVA162AA). On 26th December 2012, the patient received the 3rd dose of CERVARIX. In December 2012, less than a month after receiving CERVARIX, the patient experienced postural orthostatic tachycardia syndrome (serious criteria hospitalization and disability), generalized aching and palpitation. On an unknown date, the outcome of the postural orthostatic tachycardia syndrome, generalized aching and palpitation were not recovered/not resolved. It was unknown if the reporter considered the postural orthostatic tachycardia syndrome, generalized aching and palpitation to be related to CERVARIX. Additional information: The case was reported by a physician (Neurology and rheumatology department) via the regulatory authority but it was confirmed the patient was vaccinated with all the 3 doses. The causal relationship to CERVARIX was unassessable. On 13 April 2015, after GSK internal review and requested clarification, it was confirmed the patient was not hospitalized and therefore hospitalization was removed as seriousness criteria. On 7 September 2015, this case has been identified as a duplicate of case JP2014JPN009776. Case JPN2014JPN009776 will be deleted and all future correspondence will be submitted to US2014GSK041878 which stands as the case of record. This case also reported in a literature article, this case corresponds to patient in the article: This case was reported in a literature article and it described a case of concurrent orthostatic dysregulation and complex regional pain syndrome I (according to the criteria of the Association) in a 15-year-old female subject who had received CERVARIX (GlaxoSmithKline). No information on the subject''s medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, the subject received at least dose of CERVARIX (dosage, administration route and site unknown; batch number not provided). On an unknown date between 21 June 2013 and 31 March 2014, an unknown period after the administration of the vaccine, the subject presented with limb pain, limb tremors and decrease temperature in toe. The authors reported that some of the subjects had been severely disabled by their conditions. The subject underwent the following tests: Schellong test (maximum change decreased systolic blood pressure: 1 mmHg; increased heart rate/minute: 48), measurement of catecholamine plasma levels (Noradrenaline at supine position: 0.22 ng/mL, Increasing rate of noradrenaline: 100%), evaluation of skin temperature (2nd finger: 33.2, 1st toe: 24.1, room temperature 23-25 degC) and digital plethysmogram (2nd finger: decreased height of waves, 1st toe: decreased height of waves). In addition to this, a punch biopsy of the skin of the first toe was performed and no pathological findings were identified. Upon light microscopic examination, three small nerve fascicles were identified in one skin sample and some of these nerve fascicles were near apocrine glands (where sudomotor autonomic unmyelinated nerves were thought to be present, according to the authors). Upon electron microscopic examinations, one fascicle was found to consist of a small number of myelinated nerve fibers (most of them less than 5 um in diameter) and a large number of unmyelinated nerve fibers. Treatment was unknown. At the time of reporting the outcome of the events was unspecified. The authors mentioned that a causal relationship between the human papillomavirus vaccine and the events described in the article could be possible. They argued that this possibility was reinforced by the unusual concurrence of complex regional pain syndrome and orthostatic dysregulation in some of the subjects, as well as the lack of preceding viral infections in the 4 subjects diagnosed with postural orthostatic tachycardia syndrome. The authors concluded that "The symptoms observed in this study can be explained by abnormal peripheral sympathetic responses. The most common previous diagnosis in the studied girls was psychosomatic disease. The social problems of the study participants remained unresolved in that the severely disabled girls stopped going to school". This case is 1 of the 22 valid cases reported in the same literature article.


VAERS ID: 698773 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Female  
Location: Missouri  
Vaccinated:2017-05-08
Onset:2017-05-14
   Days after vaccination:6
Submitted: 2017-06-08
   Days after onset:25
Entered: 2017-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / -
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR - / UNK UN / -

Administered by: Public       Purchased by: Public
Symptoms: Abscess, Cerebral disorder, Cough, Deafness unilateral, Ear pain, Headache, Hypotension, Mastoiditis, Oral fungal infection, Oropharyngeal pain, Pain, Pneumococcal infection, Productive cough, Pyrexia, Sepsis, Sinus pain, Sneezing, Thrombosis
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Hearing impairment (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Albuterol inhaler, dulera inhaler, cetrizine. My stepson received the meningitis vaccine, I got sick 6 days later, hospitalized on the 24th of May with bacterial meningitis.
Current Illness: No
Preexisting Conditions: Allergies
Allergies:
Diagnostic Lab Data: Blood clots in brain, Acute mastoiditis of left side, Hearing loss in left ear, Low blood pressure, Acute brain disorder, Abscess in head, pneumococcal infection of spinal fluid, Disorder of Intracranial venous sinus, severe headache, Infection in blood stream, Low blood pressure, oral yeast infection.
CDC Split Type:

Write-up: Sneezing, sore throat, headache, body aches, phlegmy cough, earache, sinus pain, fever.


VAERS ID: 742722 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Texas  
Vaccinated:2013-08-13
Onset:2013-08-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS PH43F / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anxiety, Arthralgia, Autonomic nervous system imbalance, Bartonella test positive, Blood test, Borrelia test positive, Depression, Disturbance in attention, Dizziness, Dysmenorrhoea, Eye swelling, Fatigue, Feeling abnormal, Headache, Hypersomnia, Hypotension, Immunology test, Lyme disease, Menorrhagia, Muscular weakness, Myalgia, Mycoplasma test positive, Nausea, Panic attack, Photophobia, Pneumonia mycoplasmal, Postural orthostatic tachycardia syndrome, Seizure, Syncope, Tilt table test positive, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: diagnosed with Lyme disease in August 2016 (Western Blot CDC positive) diagnosed with Bartonella August 2016; diagnosed with mycoplasma pneumonia; diagnosed with Dysautonomia/POTS in September 2015
Allergies: allergic to penicillin, ciprofloxacin
Diagnostic Lab Data: Western Blot lab test which revealed Lyme disease, bartonella, and mycoplasma pneumonia. Tilt table test=dysautonomia/POTS. Numerous blood tests.
CDC Split Type:

Write-up: Extreme fatigue, headaches, nausea, muscle weakness, low blood pressure, dizziness, blurry vision, seizures, heavy menstrual periods with severe cramps, sleeping 14-16 hours and still feeling tired, muscle pain, joint pain, dysautonomia/POTS, fainting, brain fog, problems concentrating, depression, anxiety, panic attacks, sensitivity to light, swelling in eyes. All of these symptoms have been evident since first HPV vaccine.


VAERS ID: 811125 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131904USA009137

Write-up: This spontaneous report as received from a consumer regarding unspecified female patients of unknown age. The information on medication history, concurrent conditions, concomitant medicaitons, drug allergies and reactions were unknown. On unknown dates, the patients were vaccinated with GARDASIL (dose, units, frequency, batch and lot# number, expiry date were unknown) for prophylaxis. Other suspect therapy include CERVARIX. On unknown dates, 879 patients experienced disability (from an unspecified adverse event), 99 patients died, 5352 patients did not recover (from an unspecified adverse event), 500 patients had abnormal papsmear, 202 patients experienced cervical dysplasia, 57 patients experienced cervix carcinoma, 502 patients had adverse event which was life threatening, 9545 patients had to visit emergency room (from an unspecified adverse event), 2717 patients were hospitalized and 218 patients extended the hospital stay (from an unspecified adverse event), 3625 experienced serious adverse events (from an unspecified medically significant adverse event), 25636 experienced non serious adverse events. The outcome of "disability (from an unspecified adverse event)", abnormal papsmear, cervical dysplasia, cervix carcinoma, "adverse event which was life threatening", "visit emergency room (from an unspecified adverse event)", "hospitalized and extended the hospital stay (from an unspecified adverse event)", unspecified medically significant adverse event and non serious adverse event was unknown. Causality assessment was unknown. Upon internal review, the events cervix carcinoma was determined to be medically significant. This is one of the multiple reports from the same reporter.


VAERS ID: 811126 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131904USA009240

Write-up: This spontaneous report as received from a consumer regarding unspecified female patients of unknown age. The patients current condition include prophylaxis. The information on medication history, concurrent conditions, concomitant medicaitons, drug allergies and reactions were unknown. On unknown dates, the patients were vaccinated with GARDASIL (dose, units, frequency, batch and lot# number, expiry date were unknown) for prophylaxis. Other suspect therapy include CERVARIX. On unknown dates, 9 patients experienced disability (from an unspecified adverse event), 8 patients died, 124 patients did not recover (from an unspecified adverse event), 16 patients had adverse event which was life threatening, 354 patients had to visit emergency room (from an unspecified adverse event), 65 patients were hospitalized, 5 patients extended the hospital stay (from an unspecified adverse event), 80 patients experienced serious adverse events (from an unspecified medically significant adverse event), 1169 experienced non serious adverse events. The outcome of "disability (from an unspecified adverse event)","adverse event which was life threatening", "visit emergency room (from an unspecified adverse event)", "hospitalized and extended the hospital stay (from an unspecified adverse event)", unspecified medically significant adverse event and non serious adverse event was unknown. Causality assessment was unknown. This is one of the multiple reports from the same reporter.


VAERS ID: 327374 (history)  
Form: Version 1.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-09-16
Onset:2008-10-04
   Days after vaccination:18
Submitted: 2008-10-07
   Days after onset:3
Entered: 2008-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHVA006BA / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood follicle stimulating hormone normal, Blood luteinising hormone normal, Blood test normal, Inappropriate schedule of drug administration, Menstruation delayed
SMQs:, Fertility disorders (broad), Medication errors (narrow)

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: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: FSH, LH, BLOOD LEVELS WERE NORMAL.
CDC Split Type:

Write-up: I GOT THE CERVARIX FIRST SHOT ON SEPT 16, 2008. MY MENSES IS DELAYED FOR ABOUT A WEEK NOW. NEVER I HAD A LONGEST DELAY OF MENSES SUCH AS THIS.


VAERS ID: 361912 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-01-01
Onset:2009-04-26
   Days after vaccination:115
Submitted: 2009-10-20
   Days after onset:177
Entered: 2009-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Arthritis, Inflammation, Pyrexia, Rash, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MICROGYNON
Current Illness: Unknown
Preexisting Conditions: IDIOPATHIC THROMBOCYTOPENIA
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0597210A

Write-up: This case was reported by a foreign regulatory authority (GB-MHRA-ADR 20499409) and described the occurrence of fever in an 18-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included idiopathic thrombocytopenia. Concurrent medication included MICROGYNON for contraception. Previous vaccination included an unspecified dose of CERVARIX given in 2009. In 2009 the subject received an unspecified dose of CERVARIX (.5 ml, intramuscular). On 26 April 2009, at an unspecified time after vaccination with CERVARIX, the subject experienced fever, arthritis of the knees and wrists, arthralgia, raised inflammation markers and desquamation of the hands. The subject was hospitalised for supportive treatment. Investigations showed no other cause for the events. On 20 August 2009, the events were resolved. Verbatim Text : The patient experienced fever, arthritis (knees and wrists), raised inflammation markers, rash - desquamation (hands). Supportive treatment given an investigation in hospital showed no other cause found for symptoms. Follow-up information received on 13 October 2009 from the agency: On unknown dates in January 2009 and February 2009, the patient received CERVARIX (0.5 ml; intramuscular) for vaccination. The reported time to onset of events was 115 days. Verbatim Text : The patient experienced fever, arthritis (knees and wrists), arthralgia (neck and shoulders), raised inflammation markers, rash - desquamation (hands). Supportive treatment given an investigation in hospital showed no other cause found for symptoms.


VAERS ID: 362551 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-25
Onset:2009-09-28
   Days after vaccination:3
Submitted: 2009-10-23
   Days after onset:25
Entered: 2009-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Headache, Malaise, Peripheral coldness, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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: Mebeverine; Omeprazole
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0598292A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20507469) and described the occurrence of headache in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medications included Mebeverine and Omeprazole. On 25 September 2009 the subject received an unspecified dose of CERVARIX (subcutaneous). On 28 September 2009, 3 days after vaccination with CERVARIX, the subject experienced a severe headache, malaise, vomiting and cold extremities. The regulatory authority reported that the events were disabling. On 30 September 2009, the events were resolved. Verbatim Text : Patient experienced severe headache, vomiting and cold extremities. Medically significant due to severe headache, malaise. Settled after 2 days.


VAERS ID: 363051 (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: 2009-10-27
   Days after onset:29
Entered: 2009-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA043BB / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Circulatory collapse, Death, Malaise, Neoplasm malignant, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-09-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Propranolol hydrochloride; Lansoprazole; Sumatriptan succinate
Current Illness: Unknown
Preexisting Conditions: No known allergies. Was being treated for migraines with propranolol (unknown dose or presentation) but this has not been confirmed by patient''s GP or family.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0595286A

Write-up: This case was reported by a physician and described the occurrence of death nos in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On the morning of the 28 September 2009 the patient received unspecified dose of CERVARIX (1 injection). On 28 September, within 30 minutes after vaccination with CERVARIX, the patient experienced a possible anaphylactic reaction (not confirmed). The patient collapsed and had to be administered an adrenaline injection. The patient had to be resuscitated by the paramedics and was taken to accident and emergency where they made another attempt to resuscitate the patient. The attempt was not successful and the patient was declared dead on 28 September 2009. It was unknown whether an autopsy was performed. Verbatim text: On the 28th September 2009 a public health consultant reported that a 14 year old female patient was administered a dose of CERVARIX ( Batch: AHPVA043BB, expiry: 09/2010) at school, in the morning of the 28th September 2009 as part of a school immunization program. The consultant reported that within 30 minutes after the administration of the CERVARIX the patient experienced what they believed was an anaphylactic reaction (not confirmed). The patient collapsed and had to be administered an adrenaline injection, she had to be resuscitated by paramedics and was taken to accident and emergency where they made another attempt to resuscitate the patient but it was not successful and the patient was declared dead. There was no further information available at the time of reporting. Follow-up information received via regulatory authority on 30 September 2009: The patient was taking CERVARIX for the prevention of premalignant cervical lesions and cervical cancer. The patient had no known allergies. She was being treated for migraines with propranolol (unknown dose or presentation) but his has not been confirmed by patient''s GP or family. The patient received her first dose of CERVARIX (Batch Number: A1-IPVA043BB) at 10:45 on Monday 28th September 2009 and following complaining of being unwell, had collapsed at approximately 12:00. Paramedics performed CPR on the patient but could not revive her and following further unsuccessful resuscitation attempts at the local acute trust Emergency Care Department, was pronounced dead. The patient died on 28 September 2009 from anaphylaxis. Follow-up information received on 8 October 2009: On 28 September 2009 the subject experienced circulatory collapse. The cause of death was unknown. Follow-up information received on 9 October 2009: Concurrent medications included lansoprazole and sumatriptan succinate. On the morning of the 28 September 2009 the subject received an unspecified dose of CERVARIX (1 injection, intramuscular). The reporter stated that it was not possible to confirm whether the subject was actually administered a dose of sumatriptan succinate prior to vaccination with CERVARIX. The regulatory authority reported that the subject ''received the vaccination, collapsed approximately 60 minutes later, VF, then asystolic arrest. No external signs of anaphylaxis.'' The cause of death was reported to be anaphylaxis. Follow-up information received on 16 October 2009: On an unknown date the subject experienced a malignant neoplasm. The outcome of the malignant neoplasm was fatal. The cause of death was reported to be malignant neoplasm. Post mortem results were pending.


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