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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: 384357 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-12
Onset:2010-03-14
   Days after vaccination:2
Submitted: 2010-04-06
   Days after onset:22
Entered: 2010-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA060A1 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Condition aggravated, Headache, Lethargy, Nausea
SMQs:, Acute pancreatitis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
Current Illness: Unknown
Preexisting Conditions: Headache; Nil allergies or medications. usually well.
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: B0643943A

Write-up: This case was reported by the foreign regulatory authority (# GB-MHRA-ADR 20594365) and described the occurrence of headache in a 16-year-old female subject who was vaccinated with CERVARIX. The subject''s medical history included headache. On 12 March 2010 the subject received a 0.5 ml dose of CERVARIX (intramuscular). On 14 March 2010, at an unspecified time after vaccination with CERVARIX, the subject experienced headache (severe), lethargy and nausea. The regulatory authority reported that the events were disabling. At the time of reporting the outcome of the events was unspecified. Verbatim text: Patient experienced headaches (severe) with lethargy and nausea. Considered medically significant as patient was unable to attend school.


VAERS ID: 384486 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-03-03
Onset:2009-03-09
   Days after vaccination:6
Submitted: 2010-04-07
   Days after onset:394
Entered: 2010-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Dizziness, Headache, Malaise, Nausea, Vaccine positive rechallenge
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (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:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0580621A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20447192) and described the occurrence of dizziness in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Previous vaccination included 1st dose CERVARIX given on an unknown date. On 14 January 2008 the subject received 2nd dose CERVARIX to which they experienced the same adverse events (B0580621B). On 3 June 2009 the subject received 3rd dose of CERVARIX (.5 ml, intramuscular, batch AHPVA043BB). On 3 June 2009, less than one day after vaccination with CERVARIX, the subject experienced dizziness, headache to base of head, nausea, chest pain and feeling unwell. The regulatory authority reported that the events were disabling. At the time of reporting the events were improved. Unwell after second dose of CERVARIX and third. Dizziness, (severely), headache to base of head, nausea and chest pain. Medically significant: attended GP three days later. Follow-up information received on 29 September 2009: This case was reported by a the regulatory authority (# GB-MHRA-ADR 20452651) and described the occurrence of dizziness in a 13-year-old female subject who was vaccinated with CERVARIX. On 03 March 2009 and 3 June 2009 the subject received unspecified dose of CERVARIX (.5 ml, intramuscular). On 09 March 2009, 6 days after vaccination with CERVARIX, the subject experienced chest pain and 92 days after vaccination with CERVARIX the subject experienced dizziness, headache, nausea and feeling unwell. The regulatory authority reported that the events were disabling. At the time of reporting the events were improved. After the next vaccination with CERVARIX the events recurred. Patient felt unwell after the second and third dose. Dizzy - severely, headache base of head, nausea and chest pains - attended GP. This young girl is still unwell post vaccination, severe headache and dizziness - to see community paediatrician. Medically significant: attended GP. Follow up information received from the agency on 30 March 2010: The outcome of the events was resolved. The subject had received all "3 immunisations" as per schedule. Updated 26/03/2010- Nothing further to add. Had all 3 immunisations as per schedule. Now fully recovered.


VAERS ID: 384940 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-06-03
Onset:2009-06-04
   Days after vaccination:1
Submitted: 2010-04-12
   Days after onset:312
Entered: 2010-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA019BB / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase normal, Angioscopy, Antinuclear antibody positive, Arthralgia, Arthritis, Arthritis reactive, Aspartate aminotransferase increased, Basophil count increased, Basophil percentage increased, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood calcium increased, Blood creatinine normal, Blood glucose normal, Blood immunoglobulin E, Blood immunoglobulin E increased, Blood magnesium decreased, Blood phosphorus decreased, Blood potassium normal, Blood sodium normal, Blood thyroid stimulating hormone normal, C-reactive protein increased, Connective tissue disorder, Eosinophil percentage, Eye swelling, Haematocrit normal, Haemoglobin normal, Lip swelling, Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte percentage increased, Musculoskeletal stiffness, Neutrophil count, Neutrophil percentage, Platelet count normal, Platelet distribution width, Platelet-large cell ratio, Procalcitonin, Rash rubelliform, Red blood cell count normal, Red cell distribution width normal, Thyroxine free normal, Tri-iodothyronine free, Ultrasound abdomen abnormal, White blood cell count normal, pH urine normal
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Systemic lupus erythematosus (narrow), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Biliary system related investigations, signs and symptoms (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conjunctival disorders (narrow), Ocular infections (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Thyroxine sodium
Current Illness: Herpes simplex; Thyroid cyst
Preexisting Conditions: Surgery
Allergies:
Diagnostic Lab Data: Alanine aminotransferase, Jun2009, 14U/l; Alanine aminotransferase,16 Jun2009, 29U/L; Alkaline phosphatase, 16Jun2009, 59,00U/L; Aspartate aminotransferase, Jun2009, 17U/l; Aspartate aminotransferase, 16Jun2009, 41U/L; Basophils, 16Jun2009, 0,09tys/ul; Basophils, 16Jun2009, 1,4%; Bilirubin, Jun2009, 18,9?mol/l; Blood pressure, Jun2009, 100/60mmHg; C-reactive protein, Jun2009, 1,44mg/dl; C-reactive protein, 16Jun2009, 7,00mg/dl; Calcium, 16Jun2009, 2,38mmol/l; Capillaroscopy, Jun2009, Normal; Creatinine, 16Jun2009, 0,86mg/dl; Eosinophils, Jun2009, 3%; Eosinophils, 16Jun2009, 4,30%; tys/ul; Eosinophils, 16Jun2009, 0,27tys/ul; Free T3, Jun2009, 2,44pg/ml; Free T4, Jun2009, 1,08ng/dl; Glucose normal, Jun2009, 4,7mmol/l; Glucose normal, 16Jun2009, 4,70mmol/l; Hematocrit, Jun2009, 39%; Hematocrit, 16Jun2009, 38.8%; Hemoglobin, Jun2009, 13,3g/dl; Hemoglobin, 16Jun2009, 13,1g/dl; IgE, Jun2009, 198IU/ml; IgE, Jun2009, 198IU/ml; IgE, 16Jun2009, 186,69IU/ml; Lymphocytes, Jun2009, 28%; Lymphocytes, 16Jun2009, 1,88tys/ul; Lymphocytes, 16Jun2009, 29,80%; MCH, Jun2009, 30pg; MCH, 16Jun2009, 30,00PG; MCHC, Jun2009, 34,2g/dl; MCHC, 16Jun2009, 33,80g/dl; MCV, Jun2009, 88Fi; MCV, 16Jun2009, 88,8Fl; Magnesium, 16Jun2009, 0,79mmol/l; Mean platelet volume, 16Jun2009, 9,1Fl; Monocytes, Jun2009, 9%; Monocytes, 16Jun2009, 0,61tys/ul; Monocytes, 16Jun2009, 9,7%; Neutrophils, 16Jun2009, 3,45tys/ul; Neutrophils, 16Jun2009, 54,80%; Nuclear antibody, Jun2009, Positive; Phosphorus, 16Jun2009, 1,2mmol/l; Platelet count, Jun2009, 146tys/ul; Platelet count, 16Jun2009, 344tys/ul; Platelet distribution width, 16Jun2009, 9,30Fl; Platelet-large cell ratio, 16Jun2009, 16,5%; Potassium, 16Jun2009, 4,4mmol/l; Procalcitonin, 16Jun2009, 0,31%; Red blood cell count, Jun2009, 4,4mln/ul; Red blood cell count, 16Jun2009, 4,37mln/ul; Red cell distribution width, 16Jun2009, See text; Sodium, 16Jun2009, 141mmol/l; Thyroid stimulating hormone, Jun2009, 1,249uIU/ml; Ultrasound abdomen, Jun2009, See text; White blood cells, Jun2009, 6,2tys/ul; White blood cells, 16Jun2009, 6,30tys/ul; pH urine, Jun2009,5
CDC Split Type: B0645907A

Write-up: This case was reported by a physician and described the occurrence of diagnosed connective tissue disease in a 17-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included herpes simplex rash and thyroid cyst treated with LETROX after surgery. On 3 June 2009, the subject received 3rd dose of CERVARIX (intramuscular, injection site unknown). On 4 June 2009, 1 day after vaccination with CERVARIX, the subject experienced pain of shoulder joint, hands joints, knee and ankle joints, rubelliform rash on the trunk, face, upper and lower limbs. In addition, she developed morning stiffness in hands (palm) and knees and swelling of lips and eyes. She admitted to the diagnosis of systemic connective tissue diseases. The subject was hospitalised in good condition with no significant deviations from the norm in the physical examination. The physician considered the events were clinically significant (or requiring intervention). On June 2009, during hospitalization, relevant tests were performed and showed only IgE level increased: Blood pressure 100/60 mmHg; Hbs Ag negative; WBC 6.2 tys/ul; RBC 4.4 mln/ul; HGB 13.3 g/dl; HCT 39%; MCV 88 fl; MCH 30 pg; MCHC 34.2 g/dl; PLT 246 tys/ul; "pateczk" 1%; "segmen." 59%; eosinophils 3%; lymphocytes 28%; monocytes 9%; glucose 4.7 mmol/l; TSH 1,249 uIU/ml; fT3 2.44 pg/ml; fT4 1.08 ng/dl; bilirubin 18.9 umol/l; AIAT 14 U/l; AspAT 17 U/l; ASO 38 IU/ml; OB 12 mm; CRP 1.44 mg/dl; IgE calk. 198 IU/ml; urine pH 5.0; c.wl 1,025. Research in the direction of joint infection was negative. Nuclear antibody was positive in low level. The capillaroscopy was normal. Abdominal ultrasound did not reveal pathology. The clinical picture suggested reactive arthritis in the course of infection (limiting at this time). The subject was treated with ENCORTON. On 16 June 2009, when the subject was discharged in good condition, other relevant tests has been performed and showed: Leucocytes 6.30 tys/ul; erythrocytes 4.37 mln/ul; hemoglobin 13.10 g/dl; hematocrit 38.80%; MCV 88.80 Fl; MCH 33.00 PG; MCHC 33.80 g/dl; platelet 344,00 tys/ul; RDW-SD 41.70; RDW-CV 13.10%; PDW 9.30 Fl; MPV 9.1 Fl; P-LCR 16/50%; PCT 0.31%; neutrophils 3.45 tys/ul; lymphocytes 1.88 tys/ul; monocytes 0.61 tys/ul; eosinophils 0.27 tys/ul; basophils 0.09 tys/ul; neutrophils 54.80%; lymphocytes 29.80%; monocytes 9.70%; eosinophils 0.27 tys/ul; basophils 0.09 tys/ul; neutrophils 54.80%; lymphocytes 29.80%; monocytes 9.70%; eosinophils 4.30%; basophils 1.40%; OB 7.00 mm/h; Alat 29.00 U/L; Aspat 41.00 U/L; CRP 7.00 mg/l; phosphatase alkaline 59.00 U/L; phosphorus 1.20 mmol/l; glucose 4.70 mmol/l; IgE 186.69 IU/ml; creatinine 0.86 mg/dl; magnesium 0.79; potassium 4.40 mmol/l; sodium 141.00 mmol/l; calcium 2.38 mmol/l; Hbs antigen negative; mycoplasma IgM negative; mycoplasma IgG 13.44 DU (positive). At the time of reporting, joints inflammation, rash, stiffness of the palm and knee and ankle joints pain were resolved and the outcome of other events was unspecified. The physician considered joints inflammation, rash, stiffness of the palm and knee and ankle joints pain were possibly related to vaccination with CERVARIX.


VAERS ID: 385007 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-04-15
Onset:2009-04-16
   Days after vaccination:1
Submitted: 2010-04-13
   Days after onset:362
Entered: 2010-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Bacterial test positive, Blood test normal, Diplegia, Electrocardiogram normal, Headache, Malaise, Muscular weakness, Neurological examination normal, Nuclear magnetic resonance imaging normal, Paraesthesia, Sensory loss
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Infective pneumonia (broad), Opportunistic infections (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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Bacteria urine identified, bacteria; blood test, normal; Electrocardiogram, normal; Neurological examination, see text; Nuclear magnetic resonance ima, normal
CDC Split Type: B0580037A

Write-up: This case was reported by a regulatory authority (# NL-LRB-88391) and described the occurrence of paralysis of legs in a 14-year-old female subject who was vaccinated with CERVARIX, (GlaxoSmithKline). None relevant medical history. None concomitant medication. On 15 April 2009 the subject received 2nd dose of CERVARIX (intramuscular), lot number incomplete. On 16 April 2009, 1 and a half day after vaccination with CERVARIX, the subject experienced paralysis leg, not feeling well and headache. First the subject had not feeling in her legs during volleyball training; thereafter she was unable to stand up. The subject was hospitalized. At the time of reporting the outcome of the events was unspecified. No further information was available as this was all the information that regulatory authorities had. In the follow up received on 16 September 2009 it was mentioned that on 18 March 2009 the subject received the 1st dose of CERVARIX vaccine. The subject was hospitalized from 16 April 2009 to 20 April 2009. The final diagnosis was loss of strength and tingling in legs. No GUILLAIN BARRE, no demyelinisation. Relevant test included normal electrocardiogram, normal magnetic resonance of spine and brain. Neurological examination showed no abnormalities in brain nerved, alert, motor examination revealed loss of strength in both legs, horizontal movements on bed was possible, normal tendon reflexes on both sides and sensibility which decreased up to half upper legs and decreased pain, no extra-pyramidal disturbance were presented. Also bacteria in urine identified for which no treatment was given. At the time of the reporting the events were resolved spontaneously. The authorities considered the events as probable coincidence. In the follow up received on 28 September it was mentioned that the previous final diagnosis was made by foreign health authority. The subject also presented paresthesia and muscle weakness lower limb at unspecified time. The regulatory authorities considered that the subject had paralysis of legs. At the time of the reporting all the events were resolved. After several attempts no further information could be obtained, therefore on 08 April 2010 this case has been closed.


VAERS ID: 385010 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-04-03
Onset:2009-12-28
   Days after vaccination:269
Submitted: 2010-04-13
   Days after onset:105
Entered: 2010-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA051AA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Postpartum haemorrhage, Retained products of conception
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Beclomethasone dipropion; Salbutamol sulphate
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0646662A

Write-up: This retrospective pregnancy case was reported by a healthcare professional and described the occurrence of postpartum haemorrhage in a 18-year-old female subject who was vaccinated with CERVARIX. Concurrent medical conditions included asthma. Concurrent vaccination included MMR, (strain not specified), (manufacturer unspecified; unknown route of administration; unknown injection site) given on 23 April 1997. The subject''s past medical history did not include any previous pregnancy. Concurrent medications included CLENIL MODULITE and salbutamol sulphate. On 3 April 2009, the subject received 1st dose of CERVARIX (unknown). Her last menstrual period was on 12 March 2009 and estimated date of delivery was on 20 December 2009. The subject was exposed to the vaccine during the first trimester of her pregnancy. On December 2009, after 39 weeks gestation, the subject gave birth to a female infant without apparent congenital abnormalities. The infant had a weight of 3.033 kg. On December 2009, 8 months after vaccination with CERVARIX and after delivery, the subject experienced postpartum hemorrhage and retained products of conception. On 28 December 2009, the subject was readmitted to a hospital because of it postpartum haemorrhage. On 29 December 2009, the subject was treated with a surgical procedure. At time of reporting, the outcome of the postpartum haemorrhage was unknown.


VAERS ID: 385216 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-18
Onset:2010-03-01
   Days after vaccination:103
Submitted: 2010-04-15
   Days after onset:44
Entered: 2010-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Gait disturbance, Headache, Malaise, Muscular weakness, Myoclonus, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: unk
CDC Split Type: B0646808A

Write-up: This case was reported by a regulatory authority (NL-LRB-105409) and described the occurrence of paresthesia of limbs in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject had no relevant medical history and was on no concomitant medication. On 18 November 2009 the subject received 3rd dose of CERVARIX (intramuscular, unknown, lot number not provided). In March 2010, 2.5 months after vaccination with CERVARIX, the subject experienced paresthesia of limbs, malaise, headache, back pain, myoclonus, muscle weakness lower limb and abnormal gait. The subject was hospitalised for 1 week for observation and neurological examinations. No clear cause could be found. Stress was probably involved. She was discharged with outpatient physiotherapy. As no improvement occurred, psychotherapy was also suggested. At the time of reporting the outcome of the events was unspecified. The abnormal gait was considered to be unlikely related to the vaccination with CERVARIX. No causality assessment was made for the other events. The regulatory Authority has provided GSK with all the available information at this time, any further information received by the regulatory authority will be forwarded to GSK.


VAERS ID: 385218 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-19
Onset:2010-03-19
   Days after vaccination:0
Submitted: 2010-04-15
   Days after onset:27
Entered: 2010-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA079CA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Insomnia, Mobility decreased, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Eosinophilic pneumonia (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? 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: body temperature, 20Mar2010, 37.6deg C.
CDC Split Type: B0645004A

Write-up: This case was reported by a physician and described the occurrence of myalgia in a 21-year-old female subject who was vaccinated with CERVARIX. On 19 March 2010 the subject received unspecified dose of CERVARIX (.5 ml, intramuscular). On 19 March 2010, less than one day after vaccination with CERVARIX, the subject experienced myalgia. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting the event was unresolved. The physician considered the event was related to vaccination with CERVARIX. Follow up information received on 7 April 2010: Lot number of vaccine was provided. On 19 March 2010, at 20:00, the patient experienced myalgia and was unable to fall asleep during the night due to the myalgia. On 20 March 2010, at 09:00, the patient presented to the reporting physician''s clinic. The patient''s body temperature was 37.6 deg C. No swelling and no paralysis were observed. Decreased mobility of the upper limbs was noted. The patient was unable to raise the arms. The physician considered the events were disabling. The subject was treated with CALONAL. On 22 March 2010, pyrexia resolved. On 23 March 2010, the patient became able to have her normal daily life. At the time of reporting the events were improved. The physician considered the events were almost certainly related to vaccination with CERVARIX.


VAERS ID: 385406 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-24
Onset:2010-03-25
   Days after vaccination:1
Submitted: 2010-04-19
   Days after onset:25
Entered: 2010-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA079CA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Cholecystitis, Computerised tomogram abnormal, Constipation, Echography abnormal
SMQs:, Acute pancreatitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Infectious biliary disorders (narrow), Gallbladder related disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Computerized tomography, 29Mar2010, Cholecystitis; Echography, 29Mar2010, Cholecystitis
CDC Split Type: B0647260A

Write-up: This case was reported by a physician and described the occurrence of cholecystitis in a 23-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 24 March 2010, the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, unknown injection site). On 25 March 2010, 1 day after vaccination with CERVARIX, the subject experienced a pain at stomach. On 26 March 2010, the pain continued. On 28 March 2010, she visited hospital, but she was said that it would be constipation. On 29 March 2010, CT and echography revealed cholecystitis. She was hospitalised until 07 April 2010. The physician considered the events were clinically significant (or requiring intervention). On 7 April 2010, the events were resolved.


VAERS ID: 385472 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-01-20
Onset:2010-01-23
   Days after vaccination:3
Submitted: 2010-04-20
   Days after onset:86
Entered: 2010-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA053CA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Cerebral palsy, Condition aggravated, Dyskinesia, Hypertonia, Muscular weakness, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Congenital, familial and genetic disorders (narrow), Dyskinesia (narrow), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Tendinopathies and ligament disorders (broad), Hypokalaemia (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:
Current Illness: Unknown
Preexisting Conditions: Movements Involuntary of limbs
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0647020A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20602918) and described the occurrence of arm pain in a 13-year-old female subject who was vaccinated with CERVARIX. The subject''s medical history included involuntary movements of limbs. On 20 January 2010 the subject received an unspecified dose of CERVARIX (intramuscular). On 23 January 2010, at an unspecified time after vaccination with CERVARIX, the subject experienced arm pain, arm weakness, increased muscle tone, involuntary muscle movement, cerebral palsy and condition aggravated. It was reported that the subject "complained of sore arm within 2 days which lasted a week". The regulatory authority reported that the events were disabling. At the time of reporting the events were improved. Patient experienced cerebral palsy. No immediate effect, complained of sore arm within 2 days which lasted a week. Patient complained of loss of power in right arm, increased muscle tone and intermittent involuntary movement of hand. Already suffers from this but the effect was increased. Seen by physiotherapist who knows young person with increased tone only in right arm.


VAERS ID: 385643 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-29
Onset:2010-03-29
   Days after vaccination:0
Submitted: 2010-04-21
   Days after onset:23
Entered: 2010-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Insomnia, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (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:
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: B0647593A

Write-up: This case was reported by a physician and described the occurrence of pain of whole injected arm in an adult female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 29 March 2010 the subject received unspecified dose of CERVARIX (unknown, lot number not provided). On 29 March 2010, less than one day after vaccination with CERVARIX, the subject experienced excruciating pain at the injection site and spreading to the whole arm, insomnia, and arm numbness. On 31 March 2010, she experienced injected limb mobility decreased. The physician considered the events were temporary disabling and clinically significant (or requiring intervention). On 2 April 2010, the events were resolved. The physician considered the events were almost certainly related to vaccination with CERVARIX.


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