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

Found 1,511 cases where Vaccine is HPV2 and Serious

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Case Details

This is page 5 out of 152

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VAERS ID: 367212 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-10-03
Onset:2009-03-17
   Days after vaccination:165
Submitted: 2009-11-13
   Days after onset:241
Entered: 2009-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acute myeloid leukaemia
SMQs:, Haematological malignant tumours (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: Benzydamine hydrochloride
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0601547A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20514963) described the occurrence of acute myeloid leukemia in a 17-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included CERVARIX given on 26 November 2008. Concurrent medications included DIFFLAM. On 3 October 2008 the subject received an unspecified dose of CERVARIX (.5 ml, intramuscular). On 17 March 2009, approximately 165 days after the vaccination with CERVARIX, the subject experienced acute myeloid leukemia. The regulatory authority reported that the event was life threatening. At the time of reporting the event was improved. Verbatim Text: Coincidental occurrence of leukemia post HPV vaccination. Last administration of CERVARIX was on 26/11/2008.


VAERS ID: 367765 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-10-06
Onset:2009-10-07
   Days after vaccination:1
Submitted: 2009-11-16
   Days after onset:40
Entered: 2009-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA042AH / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Injection site erythema, Injection site oedema, Pruritus, Rash morbilliform
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic to mildew; Allergy to olives; Allergy to parietaria
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0603729A

Write-up: This case was reported by a physician and described the occurrence of morbilliform exanthema in a 10-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included allergic to mildew, allergy to olives and allergy to parietaria. On 6 October 2009, the subject received 1st dose of CERVARIX (intramuscular, right arm). On 7 October 2009, 12 hours after vaccination with CERVARIX, the subject experienced edema and erythema at injection site (right arm). In October 2009, 30 hours after vaccination with CERVARIX, the subject experienced morbilliform exanthema, itching and dyspnea. The physician considered the events were life threatening. At the time of reporting the events were resolved with sequelae. The physician considered the events were possibly related to vaccination with CERVARIX.


VAERS ID: 368528 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-03-18
Onset:2009-03-19
   Days after vaccination:1
Submitted: 2009-11-18
   Days after onset:244
Entered: 2009-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA057AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache, Lumbar puncture normal, Neurological examination normal, Nuclear magnetic resonance imaging brain normal, Photophobia
SMQs:, Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (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: Microgynon (Ethinyloestradiol + Levonorgestrel)
Current Illness: Unknown
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data: Lumbar puncture, normal; MRI brain, normal
CDC Split Type: B0603413A

Write-up: This case was reported by a foreign agency (Agency # GB-MHRA-ADR-20522503) and described the occurrence of severe headaches in a 19-year-old female subject who was vaccinated with CERVARIX, GlaxoSmithKline. The subject''s medical history included asthma. Concurrent medications included MICROGYNON. On 18 March 2009, the subject received a single dose of CERVARIX (intramuscular, batch number: AHPVA057AA). On 19 March 2009, 1 day after the vaccination with CERVARIX, the subject experienced headache and photophobia. The subject was hospitalised. Relevant test results included a lumbar puncture and a brain MRI which were both normal. The Neurological review was reported as normal. Approximately 20 days later, the headache had improved but had not yet resolved. At the time of reporting the events were unresolved. Verbatim Text: Severe headache, admitted to hospital as associated photophobia. Medically significant: 20 days later headache lessened but continues with headache. Neurological review normal.


VAERS ID: 368686 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-16
Onset:2009-09-16
   Days after vaccination:0
Submitted: 2009-11-19
   Days after onset:64
Entered: 2009-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Injected limb mobility decreased, Muscular weakness, Musculoskeletal stiffness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (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: B0603050A

Write-up: This case was reported by the regulatory authority (Regulatory Agency # GB-MHRA-ADR 20520909) and described the occurrence of muscle pain in a 53-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 16 September 2009 the subject received an unspecified dose of CERVARIX (.5 ml, intramuscular). On the same day, after vaccination with CERVARIX, the subject experienced severe muscle pain, muscle weakness of the upper limb and stiffness of the right arm. The mobility of the injected limb had decreased, as the subject was unable to lift her right arm. The regulatory authority reported that the events were disabling. The events continued for over 3 weeks. The subject was seen by her doctor because of severity of her symptoms. The subject''s doctor advised that the symptoms would pass, but advised the subject to stop cervical vaccination course (2 doses were remaining). At the time of reporting the events were improved. Verbatim Text: Severe muscle ache/weakness/stiffness of right arm post injection. Reduced mobility, patient unable to lift right arm. Continued for $g3 weeks. Patient has been seen by her doctor because of severity of her symptoms. Doctor advised symptoms would pass, but advised patient to stop cervical vaccination course (2 doses remaining).


VAERS ID: 369109 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-22
Onset:2009-09-22
   Days after vaccination:0
Submitted: 2009-11-20
   Days after onset:59
Entered: 2009-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA049AA / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Complex regional pain syndrome, Pain in extremity, Physiotherapy
SMQs:, Tendinopathies and ligament disorders (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: GAVISCON
Current Illness: Unknown
Preexisting Conditions: Gastritis; No other medical history known. Gastritis had improved therefore GAVISCON stopped 2 months prior to immunisation.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0605284A

Write-up: This case was reported by a foreign regulatory authority (GB-MHRA-ADR 20507243) and described the occurrence of a complex regional pain syndrome type I in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included gastritis. Concurrent medications included GAVISCON. On 22 September 2009, the subject received 1st dose (1 injection) of CERVARIX (intramuscular, batch details: AHPVA049AA). On 22 September 2009, moments after the vaccination with CERVARIX, the subject developed painful arm, then hand. Symptoms suggestive of complex regional pain syndrome type I. The regulatory authority reported that the event was disabling. The subject attended accident and emergency, returned to GP four days later, and then referred back to A&E. The subject was receiving physiotherapy and hydrotherapy treatment. At the time of reporting the events were resolved. Verbatim Text: Moments after injection of HPV vaccine-developed painful arm, then hand. Symptoms suggestive of complex regional pain syndrome. Occurred 3 weeks before the report was made. Attended accident and emergency, returned to GP four days later, referred back to A&E. Receiving physiotherapy and hydrotherapy treatment at present.


VAERS ID: 369119 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-09-04
Onset:2009-09-04
   Days after vaccination:0
Submitted: 2009-11-20
   Days after onset:77
Entered: 2009-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Adrenocortical insufficiency acute, Blood cortisol decreased, Blood test abnormal, Condition aggravated, Dizziness, Malaise, Nausea, Sensory loss
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (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: Hydrocortisone; fludrocortisone
Current Illness: Unknown
Preexisting Conditions: Also known as Addison''s disease. Concurrent medical condition - Congenital adrenal hyperplasia.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0603561A

Write-up: This case was reported by a consumer and described the occurrence of addisonian crisis in a 18-year-old female subject who was vaccinated with CERVARIX, GlaxoSmithKline. A physician or other health care professional has not verified this report. Concurrent medical conditions included congenital adrenal hyperplasia. Concurrent medications included Hydrocortisone, Fludrocortisone and Hydrocortisone. On 4 September 2009 the subject received dose of CERVARIX (injection, intramuscular). On 4 September 2009, within hours of vaccination with CERVARIX, the subject experienced nausea, dizziness, sensory loss, condition aggravated. The subject was hospitalized. On 07 September 2009, approximately 3 days after vaccination, the subject was diagnosed with addisonian crisis. Feeling unwell and low cortisol. At the time of reporting nausea, dizziness, sensory loss and condition aggravated were improved. Feeling unwell was unresolved and outcome for addisonian crisis and low cortisol were unknown. Verbatim text: A consumer reported on 11/11/2009 that 18 year old daughter received first dose of CERVARIX vaccine on 04/09/2009. The doctor was aware that her daughter had a pre-existing medical condition "Congenital adrenal hyperplasia (also known as Addison''s disease ) and had made a clinical decision to proceed with CERVARIX vaccination. Within a few hours after the first CERVARIX vaccination, her medical condition worsened whereby her daughter had "terrible nausea, extreme dizziness and loss of sense down left hand side of body''. Her symptoms had not improved and therefore on 07/09/2009, the patient was admitted to hospital which who was diagnosed for Addison''s crisis'' which normally arose from an infection. However on infection was diagnosed in this instance. Her daughter was discharged on 11/09/2009 but still felt unwell. Subsequently on 15/10/2009, her daughter was admitted to hospital for second ''Addison''s crisis'' with no diagnosed infection. Her daughter was discharged on 22/10/2009. On 04/11/2009, at an outpatients clinic visit, her daughter''s blood levels revealed low cortisol levels, although she was taking long term hydrocortisone 20mg day and Fludrocortisone 200mcg daily. Up till the time of reporting, her daughter''s condition had improved but still felt unwell. Another blood test was completed on 10/11/2009 and awaiting further results. No batch details of further information was available at the time of reporting.


VAERS ID: 369979 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2009-11-11
Submitted: 2009-11-24
   Days after onset:13
Entered: 2009-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA057BA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chest discomfort, Dyspnoea, Feeling cold, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (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: Colostomy
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0605783A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20525521) and described the occurrence of cold feeling in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The medical history included colostomy. On an unspecified date the subject received an unspecified dose of CERVARIX (.5ml, batch: AHPVA057BA). On 11 November 2009, at an unspecified time after vaccination with CERVARIX, the subject complained that her opposite arm began to swell. The subject also complained of an unexplained cold feeling, difficulty breathing and tightness in her chest. The regulatory authority reported that the events were life threatening. At the time of reporting the events were improved. Verbatim Text : Opposite arm began to swell and presented with a coldness that was unexplained, child complained of difficulty breathing and tightness in her chest.


VAERS ID: 370170 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2006-05-25
Onset:2008-02-05
   Days after vaccination:621
Submitted: 2009-11-25
   Days after onset:659
Entered: 2009-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure before pregnancy, Neonatal disorder
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Apgar score, 06Mar2007, 10
CDC Split Type: B0441365B

Write-up: This 26-year-old female subject was enrolled in a blinded study for the prophylaxis of cervical intraepithelial neoplasia (CINII). The subject received intramuscular investigational product single dose on 18 October 2005, 21 November 2005 and 25 May 2006, after negative urine pregnancy tests. Site of injection was the left deltoid. On 18 October 2005, 21 November 2005 and 25 May 2006, the subject received the 1st, 2nd and 3rd intramuscular injections of blinded study vaccine in the left deltoid. The subject had been randomized to receive the human papilloma virus (HPV)-16/18 virus-like particle (VLP) - AS04 vaccine. Lot number was not provided. The serious adverse event described below was not experienced by a study subject but by her offspring. The study subject or mother was exposed to vaccine before conception. On 6 March 2007, the subject gave birth to a female infant by normal vaginal delivery. The infant had an Apgar score of 10, a weight of 3600 grams and a height of 52 centimeters. On 05 February 2008, 20 months after the mother''s 3rd dose of Blinded vaccine, this 11-month-old infant developed invagination of intestine. The infant was hospitalised and the event was clinically significant (or requiring intervention). The infant was treated with intravenous fluid(s) and surgery. The event resolved on 10 February 2009. The investigator reported the invagination of intestine as possibly related to investigational product because of the time elapsed between the last vaccine dose and the mother''s last menstrual period. Investigator comments: On 17 November 2009, during the 48 months visit, the subject reported that her baby daughter initiated with abundant and constant vomiting associated with a strong abdominal pain on 05 February 2008. That same day (05 February 2008), she consulted the regional hospital''s emergency room. The infant was hospitalized for lab tests and she was administered intravenous solution for hydration. The infant was evaluated by the pediatrician on 06 February 2008 and she had a sonogram performed which reported: intestinal invagination, therefore she had an emergency surgery performed that same day at the regional hospital; she did not have complications. During the hospitalization, she remained 15 days at the intensive care unit with treatment (the mother does not remember the names) and lab tests. At 22 days post surgery, the infant initiated with a quantification of the breast feeding tolerance and soft diet. She did not present complications during the ablactation process and she evolved favorably. The infant was discharged on 04 march 2008 in good general health at the regional hospital and she was released from follow-up on 10 February 2009. The subject''s daughter is currently healthy and she is having an adequate physical and psychomotor development and she is attending healthy child follow-up appointments at the local primary care center; her mother denies her having sequelae or complications. This event is considered as possibly related to the vaccine because of the time elapsed between the last vaccine dose and the mother''s last menstrual period. The medical chart will be reviewed when possible. Diagnosis: Intestinal invagination in the subject''s daughter.


VAERS ID: 370602 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2009-01-09
Onset:0000-00-00
Submitted: 2009-11-30
Entered: 2009-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Premature baby
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal 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: Folic acid
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0563470B

Write-up: This prospective pregnancy case was reported by a nurse practitioner and described the occurrence of premature birth in male neonate exposed to CERVARIX transplacentally when his mother was being vaccinated with CERVARIX. The neonate was also exposed to Folic acid transplacentally, which the mother took concurrently. On 09 January 2009, the 17-year-old mother of the patient received a dose of CERVARIX (1 injection, intramuscular, left deltoid). The mother''s last menstrual period was on 21 December 2008 and estimated date of delivery was on 27 September 2009. The neonate was exposed to CERVARIX during the first trimester. On 21 August 2009, at 34 weeks gestation, the neonate was delivered by normal vaginal delivery and weighed 2.1 kg (head circumference 32 cm). The neonate was born pre-term at 34 weeks gestation and experienced a premature birth. No birth defects were noted. It was reported that "there was no details from the hospital regarding treatment following delivery" and that the neonate was in SCBU". The neonate was hospitalised. At the time of reporting the baby was "12 weeks old and healthy with no obvious problems". The reporting nurse practitioner did not provide a causal relationship between the event and the mother''s treatment with CERVARIX. Please see report B0563470A for details regarding the mother case.


VAERS ID: 370667 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-05
Onset:2009-11-07
   Days after vaccination:2
Submitted: 2009-11-30
   Days after onset:23
Entered: 2009-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA057CA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0607037A

Write-up: This case was reported by a foreign regulatory authority (Agency # GB-MHRA-ADR 20528079) and described the occurrence of epileptic fit in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 5 November 2009 the subject received an unspecified dose of CERVARIX (intramuscular, batch: AHPVA057CA). On 7 November 2009, 2 days after vaccination with the 2nd dose of CERVARIX, the subject experienced the first epileptic fit. The subject was hospitalised over night for observation. The subject had 2nd fits the next night and was due to be seen by consultant paediatrician in four months or sooner should a further fit occur. At the time of reporting the event was resolved. Agency Verbatim Text: Had 1st epileptic fit 2 days after receiving the 2nd dose of CERVARIX. Was admitted overnight for observation. Had 2nd fit the next night. Due to be seen by consultant paediatrician in four months or sooner should a further fit occur.


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