|
| VAERS ID: |
381727 (history) |
| Form: |
Version 1.0 |
| Age: |
26.0 |
| Sex: |
Female |
| Location: |
Maryland |
| Vaccinated: | 2009-03-01 |
| Onset: | 2009-03-10 |
| Days after vaccination: | 9 |
| Submitted: |
2010-03-03 |
| Days after onset: | 358 |
| Entered: |
2010-03-03 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS |
- / 3 |
LA / - |
Administered by: Private Purchased by: Private
Symptoms: Asthenia,
Back pain,
Blood arsenic increased,
Depression,
Dyspnoea,
Fatigue,
Headache,
Immediate post-injection reaction,
Lymphadenopathy,
Muscle twitching,
Nerve conduction studies,
Nuclear magnetic resonance imaging,
Palpitations,
Paraesthesia,
Protein total,
Rash,
Sensory disturbance,
Urticaria,
Ventricular extrasystoles
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Dyskinesia (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (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? No
Previous Vaccinations:
Other Medications: birth control
Current Illness: n/a
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood protein, arsenic in body, mri, nct,
CDC Split Type:
Write-up: I received the last of my Gardasil vaccine March of 2009. Immediately after I broke out in a rash/hives on my body. I started experiencing headaches on a regular basis, back pain, shortness of breath, pvcs, palpitations, racing heart and severe depression. November of 2009 I started experiencing tingling and zaps and gyrations in my legs, feet, arms, and hands as well as head. I have muscle twitches, weakness, fatigue, shortness of breath, back pain. And now swollen lymph nodes although I have no knowledge of having had a cold or virus. Labs revealed a high level of arsenic in my body, and proteins in my blood. |
|
| VAERS ID: |
383685 (history) |
| Form: |
Version 1.0 |
| Age: |
20.0 |
| Sex: |
Female |
| Location: |
New Jersey |
| Vaccinated: | 2005-04-28 |
| Onset: | 2010-01-12 |
| Days after vaccination: | 1720 |
| Submitted: |
2010-03-27 |
| Days after onset: | 73 |
| Entered: |
2010-03-27 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS |
- / 3 |
- / - |
Administered by: Other Purchased by: Other
Symptoms: Colposcopy,
Papilloma viral infection,
Smear cervix abnormal
SMQs:, Opportunistic infections (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? No
Previous Vaccinations:
Other Medications:
Current Illness: None - eventually developed lower, pelvic abdominal pain in June 2006-present (eventually found to be repeated kidney infections) and was able to get unblinded in March 2008 after a year of requests.
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Colposcopy was fine - will return for next pap smear in 6 months
CDC Split Type:
Write-up: Informed of abnormal pap smear and that I had contracted HPV (was sent to indp. lab for testing). The only time this would have been able to have occured is during 2007 (~2 years after vaccination). |
|
| VAERS ID: |
386047 (history) |
| Form: |
Version 1.0 |
| Age: |
26.0 |
| Sex: |
Female |
| Location: |
Louisiana |
| Vaccinated: | 2010-04-15 |
| Onset: | 2010-04-15 |
| Days after vaccination: | 0 |
| Submitted: |
2010-04-19 |
| Days after onset: | 4 |
| Entered: |
2010-04-27 |
| Days after submission: | 8 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AHPVA088BC / 1 |
LA / UN |
Administered by: Private Purchased by: Private
Symptoms: Dyspnoea,
Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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? No
Previous Vaccinations:
Other Medications: TRI-SPRINTEC
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: Pt called doctor''s office today. C/o "trouble breathing & wheezing on day of injections, that evening. Feels better today. |
|
| VAERS ID: |
389599 (history) |
| Form: |
Version 1.0 |
| Age: |
11.0 |
| Sex: |
Female |
| Location: |
Texas |
| Vaccinated: | 2010-05-26 |
| Onset: | 2010-05-27 |
| Days after vaccination: | 1 |
| Submitted: |
2010-05-28 |
| Days after onset: | 1 |
| Entered: |
2010-05-28 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HEPA: HEP A (VAQTA) / MERCK & CO. INC. |
0245Z / 1 |
RL / IM |
| HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS |
0331Z / 1 |
RA / IM |
| MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR |
U344BA / 1 |
LA / IM |
| TDAP: TDAP (ADACEL) / SANOFI PASTEUR |
U3051BA / 1 |
LA / IM |
| VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. |
1750Y / 2 |
RA / SC |
Administered by: Private Purchased by: Private
Symptoms: Injection site erythema,
Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (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? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: Localized induration and erythema on rt arm - HPV and VAR. Diameter of 2in. Warm compress 20min TID and IB. May last for 1wk. |
|
| VAERS ID: |
390263 (history) |
| Form: |
Version 1.0 |
| Age: |
23.0 |
| Sex: |
Female |
| Location: |
New York |
| Vaccinated: | 2009-12-09 |
| Onset: | 2009-12-20 |
| Days after vaccination: | 11 |
| Submitted: |
2010-06-08 |
| Days after onset: | 169 |
| Entered: |
2010-06-08 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS |
UNKNOOWN / 3 |
UN / IM |
Administered by: Other Purchased by: Other
Symptoms: Chest pain,
Muscle spasms,
Muscle twitching,
Myalgia,
Neutrophil count decreased,
Pain,
White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Dyskinesia (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: None known - please note this was administered at my prior office and I do not have the records. The 3rd dose was administered on the above date per patient but other dosing dates not now available
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Have started laboratory work-up. Abnormal WBCs (low WBCs and neutrophils) and plan to refer to hematology.
CDC Split Type:
Write-up: This is an estimate of the date. Patient took bus and developed cramps in calf muscles. Went to ER -- negative DVT. Pain then generalized. Now with generalized muscle achiness/pain (more in extremities), twitching, popping sensation in joints, now also shooting pains in chest. |
|
| VAERS ID: |
391384 (history) |
| Form: |
Version 1.0 |
| Age: |
19.0 |
| Sex: |
Female |
| Location: |
Ohio |
| Vaccinated: | 2010-03-25 |
| Onset: | 2010-05-01 |
| Days after vaccination: | 37 |
| Submitted: |
2010-06-24 |
| Days after onset: | 54 |
| Entered: |
2010-06-24 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS |
A4PVA085BC / 2 |
LA / UN |
Administered by: Private Purchased by: Private
Symptoms: Electromyogram abnormal,
Grip strength decreased,
Guillain-Barre syndrome,
Hypoaesthesia,
Immunoglobulin therapy,
Lumbar puncture abnormal,
Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (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, 4 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: EMG positive, spinal tap positive, other causes ruled out during hospitalization
CDC Split Type:
Write-up: Hand numbness then loss of grip strength then progressed to leg weakness gradual onset. EMG positive for Guillain Barre Syndrome and Hospitalized for IVIG on 06/16/2010. Resolution of symptoms at office visit on 06/23/2010. |
|
| VAERS ID: |
394405 (history) |
| Form: |
Version 1.0 |
| Age: |
11.0 |
| Sex: |
Female |
| Location: |
Florida |
| Vaccinated: | 2010-03-25 |
| Onset: | 2010-03-27 |
| Days after vaccination: | 2 |
| Submitted: |
2010-07-26 |
| Days after onset: | 121 |
| Entered: |
2010-08-05 |
| Days after submission: | 10 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AHPVA088BC / 1 |
AR / IM |
Administered by: Private Purchased by: Private
Symptoms: Arthralgia,
Blood urine present,
Diarrhoea,
Flushing,
Headache,
Lethargy,
Myalgia,
Nausea,
Pyrexia,
Vision blurred,
Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
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? No
Previous Vaccinations:
Other Medications: Concomitant medications were unknown.
Current Illness:
Preexisting Conditions: No concomitant vaccinations. Relevant medical history was unknown. The subject had not experienced adverse events following previous vaccinations.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0857520A
Write-up: This case was reported by a physician via sales representative and described the occurrence of muscle pain in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 25 March 2010 the subject received 1st dose of CERVARIX (.5 ml ,unknown, unknown arm). On 27 March 2010, 2 days after vaccination with CERVARIX, the subject experienced severe muscle pain, joint pain, vomiting, diarrhea, facial flushing, fever, nausea, blurred vision, lethargy, headache and blood in urine. On 10 April 2010, the muscle pain, joint pain, vomiting diarrhea, facial flushing, fever, nausea, blurred vision, lethargy, headache and blood in urine were resolved. Follow-up information received from healthcare professional (the subject''s mother) on 13 May 2010: CERVARIX was administered intramuscularly. The events resolved on 11 April 2010 (previously reported as 10 April 2010). The immunisation series with CERVARIX was discontinued. |
|
| VAERS ID: |
395151 (history) |
| Form: |
Version 1.0 |
| Age: |
23.0 |
| Sex: |
Female |
| Location: |
Arizona |
| Vaccinated: | 2010-08-03 |
| Onset: | 2010-08-04 |
| Days after vaccination: | 1 |
| Submitted: |
2010-08-13 |
| Days after onset: | 9 |
| Entered: |
2010-08-13 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS |
AHABB184AA / 2 |
LA / IM |
| HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AHPVA088BC / 1 |
RA / IM |
Administered by: Military Purchased by: Military
Symptoms: Rash,
Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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? No
Previous Vaccinations:
Other Medications: None known
Current Illness: None
Preexisting Conditions: Sulfa drugs; PCN''s; Hydrocodone
Allergies:
Diagnostic Lab Data: None
CDC Split Type:
Write-up: Pt broke out in a rash that itched and lasted 7 days. Initially on shoulders and progressed down her torso to legs over next two days. Pt was fine after one week. |
|
| VAERS ID: |
395593 (history) |
| Form: |
Version 1.0 |
| Age: |
12.0 |
| Sex: |
Female |
| Location: |
Florida |
| Vaccinated: | 2010-08-18 |
| Onset: | 2010-08-18 |
| Days after vaccination: | 0 |
| Submitted: |
2010-08-18 |
| Days after onset: | 0 |
| Entered: |
2010-08-18 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AHPVA088BC / 3 |
LA / IM |
Administered by: Private Purchased by: Private
Symptoms: Dyskinesia,
Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: none
CDC Split Type:
Write-up: fainting episode with 2-3 seconds jerking |
|
| VAERS ID: |
397710 (history) |
| Form: |
Version 1.0 |
| Age: |
24.0 |
| Sex: |
Female |
| Location: |
Indiana |
| Vaccinated: | 2010-08-27 |
| Onset: | 2010-08-27 |
| Days after vaccination: | 0 |
| Submitted: |
2010-09-08 |
| Days after onset: | 12 |
| Entered: |
2010-09-08 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS |
AHPVA113AA / 1 |
UN / UN |
Administered by: Other Purchased by: Other
Symptoms: Chills,
Dizziness,
Dyspnoea,
Myalgia,
Nausea,
Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)
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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: There were no concomitant vaccinations or medications. It was unknown whether the subject had experienced adverse events following previous vaccinations.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0878957A
Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of chills in a 24-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 27 August 2010 at 10:30 the subject received 1st dose of CERVARIX (1 ml, unknown route and site). On 27 August 2010, within 45 minutes after vaccination with CERVARIX, the subject experienced chills, nausea, vomiting, shortness of breath, dizziness, lightheadedness and muscular pain all over the body. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with ZOFRAN, TORADOL and Normal saline. At the time of reporting the events were resolved. The healthcare professional reported that the subject received 1st dose of CERVARIX at 10:30, and experienced all of the reported adverse events within 45 minutes of the dose. She was taken to a local Emergency Room (was not admitted to the actual hospital), received 2 doses of ZOFRAN IM, 1 dose of TORADOL IM (the mg dose of both is not known), and IV normal saline infusion (total amount not known). Admission to ER reported as 14:43, and discharge from ER at 17:00. At the time of discharge from ER the subject reported that all adverse events had resolved. |
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