MedAlerts Home
  Read the MedAlerts Blog Subscribe to the MedAlerts Blog 

Found 459176 cases in entire database

Case Details (Sorted by Age)

This is page 2479 out of 4592

Result pages: prev   2380 2381 2382 2383 2384 2385 2386 2387 2388 2389 2390 2391 2392 2393 2394 2395 2396 2397 2398 2399 2400 2401 2402 2403 2404 2405 2406 2407 2408 2409 2410 2411 2412 2413 2414 2415 2416 2417 2418 2419 2420 2421 2422 2423 2424 2425 2426 2427 2428 2429 2430 2431 2432 2433 2434 2435 2436 2437 2438 2439 2440 2441 2442 2443 2444 2445 2446 2447 2448 2449 2450 2451 2452 2453 2454 2455 2456 2457 2458 2459 2460 2461 2462 2463 2464 2465 2466 2467 2468 2469 2470 2471 2472 2473 2474 2475 2476 2477 2478 2479 2480 2481 2482 2483 2484 2485 2486 2487 2488 2489 2490 2491 2492 2493 2494 2495 2496 2497 2498 2499 2500 2501 2502 2503 2504 2505 2506 2507 2508 2509 2510 2511 2512 2513 2514 2515 2516 2517 2518 2519 2520 2521 2522 2523 2524 2525 2526 2527 2528 2529 2530 2531 2532 2533 2534 2535 2536 2537 2538 2539 2540 2541 2542 2543 2544 2545 2546 2547 2548 2549 2550 2551 2552 2553 2554 2555 2556 2557 2558 2559 2560 2561 2562 2563 2564 2565 2566 2567 2568 2569 2570 2571 2572 2573 2574 2575 2576 2577 2578   next


VAERS ID:437115 (history)  Vaccinated:2011-09-26
Age:14.0  Onset:2011-09-26, Days after vaccination: 0
Gender:Female  Submitted:2011-10-06, Days after onset: 10
Location:Foreign  Entered:2011-10-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0751789A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148AB0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Cold sweat, Hypoaesthesia, Hypotension, Immediate post-injection reaction, Pallor, Shock
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of shock symptom in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Subject''s body temperature before vaccination was 36.4 Deg.C. On 26 September 2011, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left upper arm). On 26 September 2011, immediately after vaccination with CERVARIX, the subject experienced cold sweat, facial pallor and shock symptom. Numbness was observed in the upper arm and hypotension was also noted. The physician considered the events were clinically significant (or requiring intervention). The patient was administered oxygen and drip infusion; and was placed under observation. On 26 September 2011, the events were resolved.

VAERS ID:437139 (history)  Vaccinated:2011-09-25
Age:14.0  Onset:2011-09-25, Days after vaccination: 0
Gender:Female  Submitted:2011-10-06, Days after onset: 11
Location:Foreign  Entered:2011-10-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Loss of consciousness; Heat illness
Diagnostic Lab Data: blood pressure measurement, 25Sep11, 90 mmHg, Systolic (At 12:05 before inoculation); blood pressure measurement, 25Sep11, 64 mmHg, Diastolic (At 12:05 before inoculation); blood pressure measurement, 25Sep11, 118 mmHg, Systolic (Approximately 1 minute later); blood pressure measurement, 25Sep11, 70 mmHg, Diastolic (Approximately 1 minute later); blood pressure measurement, 25Sep11, 98 mmHg, Systolic (2 minutes later); blood pressure measurement, 25Sep11, 58 mmHg, Diastolic (2 minutes later); blood pressure measurement, 25Sep11, 54 mmHg, Diastolic (At 12:55); blood pressure measurement, 25Sep11, 108 mmHg, Systolic (At 12:55); body temp, 25Sep11, 36.4 degrees C, At 12:05 before inoculation; total heartbeat count, 25Sep11, 70 /min, At 12:05 b
CDC 'Split Type': WAES1110USA00022
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1336Z0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arrhythmia, Condition aggravated, Immediate post-injection reaction, Loss of consciousness, Mental impairment, Pallor, Pulse pressure decreased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 14 year and 3 month old female patient with a history of consciousness loss attack following influenza vaccine (November 2008) and consciousness loss attack at the time of heat illness (September 2010) who on 25-SEP-2011 (12:05) was vaccinated with the first dose of GARDASIL (lot number 1336Z, batch number 9QN01R), 0.5 mL, intramuscularly into left upper arm. No other vaccine was injected at the same time. No information on concomitant medications had been provided. On 25-SEP-2011, before inoculation of the vaccine, her body temperature was 36.4 degrees C, blood pressure 90/64 and pulse was 70/regular, (12:05), the physician asked the patient "would you like to lie down for injection?" and the patient commented "this time seems fine", therefore the patient received the vaccine in a sitting position. Immediately after injection the vaccine (approximately 30 seconds), when the patient turned to her mother, the patient collapsed forward from the chair. She had loss of consciousness and arrhythmia. Pulse pressure was weak and she was immediately placed in a recumbent position with both legs up. Approximately 1 minute later, her consciousness returned, blood pressure was 118/70, pulse was 70/regular and she had facial pallor. Thereafter, her condition was stabilized and she stayed in a sitting position, however, 2 minutes later, she returned to a recumbent position due to severe dullness. Blood pressure was 98/58 and pulse was 60/regular. Starting medium (1) (SOLITA-T No.1) 200 mL was administered via intravenous drip infusion. At 12:55, blood pressure was 108/54 and pulse was 70/regular. She had no problem holding standing position and went home. During the course, there was no measurement of blood glucose, ammonia and ethanol levels. The reporting physician considered that loss of consciousness was serious as other important medical event. The reporting physician considered that loss of consciousness was serious as other important medical event. The reporting physician felt that loss of consciousness was definitely related to GARDASIL and there was no other factor. No further information is available.

VAERS ID:437396 (history)  Vaccinated:2011-09-27
Age:14.0  Onset:2011-09-27, Days after vaccination: 0
Gender:Female  Submitted:2011-10-07, Days after onset: 10
Location:Foreign  Entered:2011-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0751777A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA147AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 27 September 2011, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left upper arm). On 27 September 2011, less than one day after vaccination with CERVARIX, the subject experienced loss of consciousness for a moment and vasovagal reaction. She immediately recovered consciousness. There were no abnormalities in blood pressure and so forth. Thereafter she did not have any symptom of sequela and left the reporter''s hospital with a smile 20 minutes later. The physician considered the events were clinically significant (or requiring intervention). On 27 September 2011, the events were resolved. The physician considered the events were unrelated to vaccination with CERVARIX.

VAERS ID:437403 (history)  Vaccinated:2011-09-24
Age:14.0  Onset:2011-09-24, Days after vaccination: 0
Gender:Female  Submitted:2011-10-07, Days after onset: 13
Location:Foreign  Entered:2011-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0752106A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMAR
Administered by: Other     Purchased by: Other
Symptoms: Pallor, Visual acuity reduced
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of reduction of visual acuity in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 24 September 2011, the subject received an unspecified dose of CERVARIX (.5 ml, intramuscular, unknown arm, batch number not provided). On 24 September 2011, less than one day after vaccination with CERVARIX, the subject experienced reduction of visual acuity and facial pallor. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting, the events were resolved.

VAERS ID:437406 (history)  Vaccinated:2011-09-22
Age:14.0  Onset:2011-09-22, Days after vaccination: 0
Gender:Female  Submitted:2011-10-07, Days after onset: 15
Location:Foreign  Entered:2011-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 22Sep2011, 80/50mmHg; Body temperature, 22Sep2011, 36.4deg. C.
CDC 'Split Type': B0751766A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Feeling abnormal, Neurogenic shock, Pallor, Pulse pressure decreased
SMQs:, Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of neurogenic shock in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s body temperature before inoculation was 36.4 deg. C. On 22 September 2011, the subject received unspecified dose of Cervarix (intramuscular, unknown injection site, batch number not provided). On 22 September 2011, 2 minutes after vaccination with CERVARIX, the subject experienced poor feeling, facial pallor, weak pulse and her blood pressure was 80/50 mmHg. It was suspected that she had neurogenic shock. The subject was treated with drip infusion and stronger neo-minophagen C 40 mL. Blood pressure gradually increased as well as pulse. The physician considered the events were clinically significant (or requiring intervention). On 22 September 2011, the events were resolved.

VAERS ID:437407 (history)  Vaccinated:2011-09-26
Age:14.0  Onset:2011-09-26, Days after vaccination: 0
Gender:Female  Submitted:2011-10-07, Days after onset: 11
Location:Foreign  Entered:2011-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, Sep2011, No abnormality
CDC 'Split Type': B0751769A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Decreased appetite, Muscular weakness, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This case was reported by a physician and described the occurrence of weakness of limbs in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 26 September 2011, the subject received unspecified dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). On 26 September 2011, less than one day after vaccination with CERVARIX, the subject experienced weakness of limbs, anorexia and fever. The subject was hospitalised. From 26 September 2011 until 29 September 2011? the subject was treated with fluid replacement and stayed in bed. A blood test was performed and no abnormality was found. On 29 September 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:437416 (history)  Vaccinated:2011-09-24
Age:14.0  Onset:2011-09-24, Days after vaccination: 0
Gender:Female  Submitted:2011-10-07, Days after onset: 13
Location:Foreign  Entered:2011-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0751697A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 24 September 2011, the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, unknown site of injection, batch number not provided). On 24 September 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced loss of consciousness. The physician considered the event was clinically significant (or requiring intervention). On 24 September 2011, the event was resolved. The physician considered the event was related to vaccination with CERVARIX.

VAERS ID:437419 (history)  Vaccinated:2011-08-11
Age:14.0  Onset:2011-08-14, Days after vaccination: 3
Gender:Female  Submitted:2011-10-07, Days after onset: 54
Location:Foreign  Entered:2011-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchial Asthma
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 12Aug2011, 37Deg.C; Body temperature, 14Aug2011, 38Deg.C
CDC 'Split Type': B0747964A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA138BA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthma, Condition aggravated, Cough, Malaise, Nasopharyngitis, Pyrexia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: This case was reported by a physician and described the occurrence of cough in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 11 August 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, unknown site of injection, batch number not provided). On 14 August 2011, 3 days after vaccination with CERVARIX, the subject experienced cough and fever. The physician considered the events were clinically significant (or requiring intervention). On 24 August 2011, the events were resolved. Follow-up information received on 29 September 2011: Concurrent medical condition details included bronchial asthma. Date of birth, batch number and site of injection were added. The reporter considered the events as clinically significant (or intervention required). On 11 August 2011 in the evening, the subject experience malaise and mild cough. On 12 August 2011, the subject experienced pyrexia (around 37 Deg. C.) On 14 August 2011, body temperature rose of 38 Deg. C. and the subject visited the reporting physician''s hospital. The subject was told that she had probably caught a cold in the reporting physician''s hospital on the date of the vaccination. On 14 August 2011 in the evening, the cough was aggravated. On 17 August 2011, the subject saw her primary care doctor. It was diagnosed that asthma was probably induced by the vaccination of CERVARIX. The subject was treated with Zithramac (250 mg at 1 tablet x3/day), Predonine (5 mg at 3 tablets x2/day, 2 tablets x2/day and 1 tablet x2/day) Calonal (200 mg). The subject became afebrile. The cough persisted for 2 weeks. No dyspnoea was observed. On 24 August 2011, all the symptoms disappeared. Although the vaccination with CERVARIX and the cough attack had a temporal relationship, it was unknown that the cough attack was due to the asthma from the beginning. The pyrexia developed at the same time as the inoculation of CERVARIX and might have induced the asthma. The direct causal relationship between CERVARIX and the asthma was unknown.

VAERS ID:437421 (history)  Vaccinated:2011-08-26
Age:14.0  Onset:2011-08-27, Days after vaccination: 1
Gender:Female  Submitted:2011-10-07, Days after onset: 41
Location:Foreign  Entered:2011-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 27Aug2011, 39 Deg.C
CDC 'Split Type': B0744600A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143AA0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Pneumonia mycoplasmal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of mycoplasmal pneumonia in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received 1st dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). At an unspecified time after vaccination with CERVARIX, the subject experienced fever. At the time of reporting, the outcome of the event was unspecified. Follow-up information received on 9 September 2011 by a physician: Subject details were added. The vaccination date was 26 August 2011. The event fever started on 27 August 2011. The reporter considered the event was related to vaccination with CERVARIX. Follow-up information received on 29 September 2011: Batch number and site of injection were added. Value for fever was 39 Deg. C. On 28 August 2011, the subject visited the department of pediatrics. It was turned out that the pyrexia was due to mycoplasmal pneumonia. The healthcare professional considered the event was clinically significant (or requiring intervention).

VAERS ID:437582 (history)  Vaccinated:2011-09-24
Age:14.0  Onset:2011-09-24, Days after vaccination: 0
Gender:Female  Submitted:2011-10-07, Days after onset: 13
Location:Foreign  Entered:2011-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0752106A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMAR
Administered by: Other     Purchased by: Other
Symptoms: Pallor, Visual acuity reduced
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of reduction of visual acuity in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 24 September 2011, the subject received an unspecified dose of CERVARIX (.5 ml, intramuscular, unknown arm, batch number not provided). On 24 September 2011, less than one day after vaccination with CERVARIX, the subject experienced reduction of visual acuity and facial pallor. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting, the events were resolved.

VAERS ID:437604 (history)  Vaccinated:2011-09-27
Age:14.0  Onset:2011-09-27, Days after vaccination: 0
Gender:Female  Submitted:2011-10-07, Days after onset: 10
Location:Foreign  Entered:2011-10-11, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Blood pressure measurement, 27Sep11, 110 mmHg, Systolic (At 09:20); Blood pressure measurement, 27Sep11, 60 mmHg, Diastolic (At 09:20); Blood pressure measurement, 27Sep11, 110 mmHg, Systolic; Blood pressure measurement, 27Sep11, 60 mmHg, Diastolic; Body temp, 27Sep11, 36.2 degrees C, Before vaccination; Pulse oximetry, 27Sep11, 97, Before vaccination; Pulse oximetry, 27Sep11, 98, At 09:20; Total heartbeat count, 27Sep11, 87 /min
CDC 'Split Type': WAES1110USA00025
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1336Z0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bed rest, Convulsion, Fall, Gaze palsy, Head injury, Immediate post-injection reaction, Loss of consciousness, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 14 year old and 0 month old female patient who had no history of allergy, underlying diseases, growth problem, vaccination within the past 1 month and other diseases. On 27-SEP-2011 (08:45) the patient was vaccinated with the first dose of GARDASIL, 0.5 mL intramuscularly into left upper arm (lot number: 1336Z, batch number: 9QN01R) at sitting position. No other vaccine was injected at the same time. No information on concomitant medications had been provided. On 27-SEP-2011, the patient did not seem to be particularly nervous or afraid before vaccination. Her body temperature before vaccination was 36.2 degrees C and pulse oximetry oxygen saturation (SpO2) was 97. At 08:45 am, immediately after inoculation of the vaccine, the patient developed syncope, convulsion and rolling of the eyes. Immediately after inoculation, she fell backward and hit her back of head to the desk. Her consciousness gradually returned in about 20 seconds. She recovered from syncope and convulsion. She had bedrest for 45 minutes. At 09:20, blood pressure was 110/60 and heart rate was unknown (also reported as 87/min). SpO2 was 98. She went home at 09:30. During the course, the value of blood sugar, ammonia and ethanol was unknown. The reporting physician felt that the cause of syncope was vasovagal reflex. The reporting physician considered that syncope and convulsion were non-serious. Upon internal review, convulsion was determined to be serious as an other important medical event. The reporting physician felt that the causal relationship of syncope and convulsion to GARDASIL was unknown and there was no other factor. No further information is available.

VAERS ID:437666 (history)  Vaccinated:2011-09-12
Age:14.0  Onset:2011-09-12, Days after vaccination: 0
Gender:Female  Submitted:2011-10-10, Days after onset: 28
Location:Foreign  Entered:2011-10-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0752516A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA147AA IMRA
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 12 September 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, right upper arm). On 12 September 2011, less than one day after vaccination with CERVARIX, the subject experienced loss of consciousness. The physician considered the event was clinically significant (or requiring intervention). On 12 September 2011, the event was resolved. The physician considered the event was related to vaccination with CERVARIX.

VAERS ID:437670 (history)  Vaccinated:0000-00-00
Age:14.0  Onset:2011-09-01
Gender:Female  Submitted:2011-10-10, Days after onset: 39
Location:Foreign  Entered:2011-10-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disorder
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0752512A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Local swelling, Pyrexia
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a pharmacist and described the occurrence of fever in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included heart disorder. On an unspecified date, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, unknown injection site). In September 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced fever and neck swelling. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified.

VAERS ID:437787 (history)  Vaccinated:2011-09-30
Age:14.0  Onset:2011-09-30, Days after vaccination: 0
Gender:Female  Submitted:2011-10-11, Days after onset: 11
Location:Foreign  Entered:2011-10-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Loss of consciousness
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1110USA00734
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Epilepsy, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Initial information has been received from a physician concerning a 14 year old female patient with no concurrent conditions and a history of an episode of losing consciousness (according to the patient) who on 30-SEP-2011, was vaccinated with a dose of GARDASIL injection syringe, 0.5 ml once a day, intramuscularly (Lot number not reported). No information on concomitant medications had been provided. On 30-SEP-2011, after the injection of GARDASIL, the patient developed loss of consciousness and convulsion, and she was pulled back to consciousness in 10 seconds. Blood pressure and respiratory sound was confirmed in the timing of immediately after the event, 30 minutes and 1 hour later. Since the patient''s condition became stable, she was judged to be recovered and went home. The reporting physician felt that the relationship of loss of consciousness and convulsion to GARDASIL were unknown. The reporting physician considered that loss of consciousness and convulsion were non-serious. Upon internal review, the convulsion was determined to be serious as another important medical event. Comments: Regarding the loss of consciousness and convulsion, epileptic seizure was suspected. Therefore, the relationship between the events and the vaccine was unknown. The physician told the patient to have electroencephalography at pediatrics department at a later date. Additional information has been requested.

VAERS ID:437799 (history)  Vaccinated:2011-04-22
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2011-10-11
Location:Foreign  Entered:2011-10-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1110USA01068
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Anxiety, Arthralgia, Headache, Iridocyclitis, Ocular hyperaemia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Glaucoma (broad), Ocular infections (broad), Arthritis (broad)
Write-up: Case received from a physician on 03-OCT-2011 and medically confirmed. A 14-year-old female patient (almost 15 years old) with no personal or familial medical history had received the first dose of GARDASIL (batch number not reported) on 22-APR-2011. On unspecified time after vaccination, she presented with fever, headache and joint pain. On 09-MAY-2011, she saw an ophthalmologist due to red eye and was diagnosed with bilateral anterior uveitis. She was prescribed DEXAFREE and atropine. The patient was seen in outpatient pediatric care for a check-up. No etiology was found. A MRI (magnetic resonance imaging) was planned for which the generalist practitioner asked a search for demyelinating lesions. The patient was not recovered, and the uveitis reoccurred each time the treatment was stopped. No other dose of GARDASIL was administered. To be noted that the patient used to practice high-level basketball but completely stopped any sport since May 2011. Furthermore, the patient was very anxious at the time of reporting. Upon internal review the case was considered medically significant. Other business partner numbers include E2011-05910. No further information is available.

VAERS ID:437839 (history)  Vaccinated:2011-09-22
Age:14.0  Onset:2011-09-22, Days after vaccination: 0
Gender:Male  Submitted:2011-10-11, Days after onset: 19
Location:Foreign  Entered:2011-10-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No information reported.
Diagnostic Lab Data:
CDC 'Split Type': E201105879
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER498011 IMUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERC3620AK IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Dysphonia, Erythema, Oedema mouth, Paraesthesia
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Case received from Health Authority (case n. 148916) (local case n. IT394/11). Initial report received on 30-SEP-11. Case medically confirmed. A 14 year old male patient was vaccinated on 22-SEP-11 with one dose of TRIAXIS (batch n. C3620AK) i.m. and concomitantly with one dose of MENJUGATE (Mfr. Novartis, batch n. 498011) i.m.. On the same day, 5 minutes post-vaccination, he presented with a lipothymic episode without loss of consciousness and feeling of throat tingling, the patient was placed in the Trendelenburg position, also referred edema of the oral cavity, facial redness and hoarse voice. Arterial blood pressure 120/80. He was treated with adrenalin 1 vial i.m. and hydrocortisone 250 mg. i.m. Due to the persistence of the symptoms he was taken to the ER were he was held for monitoring from 9:45 am to 1:13 pm. Upon arrival he was in good general condition, objective exam all within normal limits; during admission the patient remained asymptomatic. Diagnosis upon discharge: lipothymic episode following vaccination, possible vasovagal or anaphylactic reaction. The outcome is recovered on 22-SEP-11. Upon medical review the Company judged relevant to code the adverse event "hoarse voice" which was mentioned in the narrative but not coded by HA. The case is closed.

VAERS ID:437955 (history)  Vaccinated:2011-09-17
Age:14.0  Onset:2011-09-17, Days after vaccination: 0
Gender:Female  Submitted:2011-10-12, Days after onset: 25
Location:Foreign  Entered:2011-10-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ebastine
Current Illness: Fear; Pain
Preexisting Conditions: Allergic rhinitis; Urticaria
Diagnostic Lab Data: Blood pressure, 17Sep2011, 80/42mmHg; Blood pressure, 17Sep2011, 96/50mmHg; Pulse rate, 17Sep2011, 48beats/minute; Pulse rate, 17Sep2011, 72beats/minute
CDC 'Split Type': B0751784A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA147AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Blood pressure decreased, Fall, Fear, Loss of consciousness, Pain, Pallor, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 17 September 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, left deltoid). On 17 September 2011, less than one day after vaccination with CERVARIX, the subject experienced vasovagal reaction and syncope hypotensive. The physician considered the events were clinically significant (or requiring intervention). On 17 September 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX. Follow-up information received on 4 October 2011: Relevant medical history included allergic rhinitis and urticaria. Otherwise, the subject had no other family history or medical history such as cardiac disease, epilepsy, metabolic abnormality (such as diabetes mellitus), or allergy (such as vaccine-induced allergy, vaccine-component-induced allergy, food allergy, allergic rhinitis, eczema, or asthma, etc.). The subject had no past history of loss of consciousness. Concomitant medication included EBASTEL 10 mg tablets at 1 tablet/day. The subject was in a sitting position before the onset of the events. The subject had a painful/emotional stimulus before the onset of the event. It was unknown if the subject had a predisposing factor. The subject had the following triggering event: fear and pain. The subject had no sign or warning regarding the episode. The subject had no sweat or warmth feeling before the event. The events developed suddenly. Approximately 5 minutes later, the patient experienced vasovagal syncope/reaction, fell, pallor, lose consciousness for 5 or 10 minutes, weakness for 10 minutes, loss of posture, decreased blood pressure, fear and pain. The blood pressure was 80/42 mmHg and the pulse rate was 48 beats per minute. The subject was placed in the recumbent position, and in approximately 10 minutes, the consciousness was restored. The blood pressure was 96/50 mmHg and pulse rate was 72 beats per minute. The subject walked by herself and went home. Subject''s respiratory pattern was normal. There was no laboured respiration. The subject did not make any movement in association with the fall. The subject had no tongue biting. No treatment was provided. No symptoms developed after the patient recovered from loss of consciousness. The subject didn''t remember anything regarding loss of consciousness. The subject did not undergo special test. The events did not recur.

VAERS ID:437959 (history)  Vaccinated:2011-08-25
Age:14.0  Onset:2011-08-25, Days after vaccination: 0
Gender:Female  Submitted:2011-10-12, Days after onset: 48
Location:Foreign  Entered:2011-10-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Frusemide; Pranlukast; Losartan potassium
Current Illness: Cardiac Failure; Congenital Great Vessel Anomaly; Heart Valve Incompetence; Paralysed Diaphragm
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 25Aug2011, 37.4 Deg.C; C-reactive protein, 26Aug2011, 2.6; Stool culture, Aug2011, Pathogenic coli; White blood cells, 26Aug2011, 8000
CDC 'Split Type': B0743658A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143CA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal discomfort, Abdominal pain, C-reactive protein, Culture stool positive, Diarrhoea, Escherichia test positive, Gastroenteritis, Nausea, Pyrexia, White blood cell count normal
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a physician and described the occurrence of gastrointestinal upset in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 25 August 2011, the subject received unspecified dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). Less than one week after vaccination with CERVARIX, the subject experienced gastrointestinal upset. At the time of reporting, the outcome of the event was unspecified. Follow-up information received on 29 August 2011: Subject details were added. Concurrent medical conditions included cardiac failure, congenital great vessel anomaly, heart valve incompetence and paralysed diaphragm. Concurrent medications included FUROSEMIDE, ONON, NU-LOTAN. On 25 August 2011, less than one day after vaccination with CERVARIX, the subject experienced gastrointestinal upset. On 26 August 2011, results for C-reactive protein were 2.6 and for white blood cells were 8000. At the time of reporting, the outcome of the event was unspecified. Follow-up information received on 4 October 2011: The batch number and the site of injection were added. Concurrent medical conditions included congenital anomalous origin of the right pulmonary artery from the aorta with bicuspid valve. On 25 August 2011 at 08:10, the patient received the vaccine CERVARIX. on 25 August 2011, in the evening, the subject experienced abdominal pain, diarrhoea, queasy feeling and pyrexia of 37.4 Deg. C. The reporter considered the events as clinically significant (or intervention required). The subject was treated with SOLDEM (electrolyte solution) at 20 mL, PRIMPERAN at 2/3 ample, NICHIMALON at 2 tablets, TERPENONE at 2 capsules, and BIOFERMIN at 2 tablets were administered for 4 days. On 28 August 2011, the events improved. Pathogenic coli serotype 0166 was detected by stool culture. The patient was given a diagnosis of infectious gastroenteritis. On 28 August 2011, the events were resolved.

VAERS ID:438241 (history)  Vaccinated:0000-00-00
Age:14.0  Onset:0000-00-00
Gender:Male  Submitted:2011-10-13
Location:Foreign  Entered:2011-10-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: All baseline laboratory investigations were within normal ranges except for a mild decrease in the platelet count (144000/mm3), moderately elevated quantitative CRP value (7.89 mg/dl) and normal leucocytes count with monocytosis (19%). Erythrocyte sedimentation rate was in normal range (7mm/h). Contrast enhanced magnetic resonance imaging (MRI) and superficial high resolution sonographic (US) evaluations were performed. Precontrast MR images showed a mass deeply seated in the subcutaneous fat layer adjacent to the fascia. Lesion was mildly iso-hypointense on T1W images, apparently hyperintense on T2W images.
CDC 'Split Type': 201109497
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: C-reactive protein increased, Fat necrosis, Fluid retention, Incorrect route of drug administration, Inflammation, Laboratory test abnormal, Lesion excision, Monocyte percentage increased, Monocytosis, Necrosis, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Platelet count decreased, Red blood cell sedimentation rate normal, Ultrasound scan, Upper extremity mass, White blood cell count normal
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Literature case report retrieved on 04 October 2011 from a literature article search. A 14-year-old male patient had received an intramuscular dose of tetanus vaccine (manufacturer, batch number and anatomical site of injection were unknown) on an unspecified date. Approximately 6 months after, the patient was admitted to the hospital with the complaints of pain and palpable mass on the lateral aspect of his left upper arm. Physical examination revealed a painful semi-mobile mass 4x3cm in diameter on his left deltoid area. No enlargement in the regional lymph nodes was found. The patient had no other complaints. All baseline laboratory investigations were within normal ranges except for a mild decrease in the platelet count (144000/mm3), moderately elevated quantitative CRP value (7.89 mg/dl) and normal leucocytes count with monocytosis (19%). Erythrocyte sedimentation rate was in normal range (7mm/h). Contrast enhanced magnetic resonance imaging (MRI) and superficial high resolution sonographic (US) evaluations were performed. Precontrast MR images showed a mass deeply seated in the subcutaneous fat layer adjacent to the fascia. Lesion was mildly iso-hypointense on T1W images, apparently hyperintense on T2W images. The lesion was surgical excised. Histologic examination revealed a fluid collection in the center surrounded with hyalinized fat necrosis, a few lymphoid follicles with reactive germinal centers and perifollicular areas, and a predominantly mononuclear inflammatory infiltrate. Inflammatory cells mainly consisted of lymphocytes, histiocytes and plasma cells. Histopathological examination was reported as a local granulomatous reaction in response to the vaccine material, which consisted of coagulation and liquefaction necrosis. Follow-up information was provided on 05 October 2011 following contact with the corresponding author: According to the author, he was not able to clarify whether applied vaccine was TETAVAX or not. He also informed that the problem was wrong method of administration (fascial injection instead of intramuscular injection).

VAERS ID:438464 (history)  Vaccinated:2011-09-21
Age:14.0  Onset:2011-09-21, Days after vaccination: 0
Gender:Female  Submitted:2011-10-14, Days after onset: 23
Location:Foreign  Entered:2011-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 21Sep2011, 70/39mmHg
CDC 'Split Type': B0753669A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143DA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Depressed level of consciousness, Dizziness, Fall, Haematology test normal, Hypotension, Injection site discomfort, Nausea, Tinnitus
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of depressed level of consciousness in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 21 September 2011, at 17:00, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, left arm). On 21 September 2011, at 19:30, 150 minutes after vaccination with CERVARIX, the subject experienced depressed level of consciousness, hypotension, loss of posture, injection site discomfort, tinnitus, giddiness and feeling queasy. After inoculation, the subject experienced a strange feeling at the inoculation site and presented tinnitus, dizziness and queasy feeling. Although she had been sitting, the subject fell off the chair due to depressed consciousness. Ambulance was called and the subject was transferred to another hospital. Blood pressure at that time was 70/39 mmHg. Tests including haematological examination were performed, which could not reveal the cause of the symptoms. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with drip infusion. On 21 September 2011, the events were resolved. The reporter considered the relationship with vaccination with CERVARIX as unassessable.

VAERS ID:438497 (history)  Vaccinated:0000-00-00
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2011-10-13
Location:Foreign  Entered:2011-10-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0754294A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site atrophy, Injection site pain, Musculoskeletal pain, Pain in extremity, Skeletal injury
SMQs:, Rhabdomyolysis/myopathy (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a physician and described the occurrence of injection site atrophy in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). At an unspecified time after vaccination with CERVARIX, the subject experienced injection site atrophy, arm pain, shoulder blade pain, bone injury and injection site pain. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting, the outcome of the events was unspecified.

VAERS ID:438760 (history)  Vaccinated:2011-09-10
Age:14.0  Onset:2011-09-10, Days after vaccination: 0
Gender:Female  Submitted:2011-10-17, Days after onset: 37
Location:Foreign  Entered:2011-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 10Sep2011, 118/80mmHg; Blood pressure, 10Sep2011, 100/58mmHg; Pulse rate, 10Sep2011, 78beats/min; Pulse rate, 10Sep2011, 78beats/min
CDC 'Split Type': B0747976A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146DB0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Bed rest, Fall, Loss of consciousness, Muscle spasms, Syncope, Tonic convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician and described the occurrence of syncope in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 10 September 2011, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left arm). On 10 September 2011, 10 minutes after vaccination with CERVARIX, the subject experienced syncope. One minute later, she regained clear consciousness. The physician considered the event was clinically significant (or requiring intervention). On 10 September 2011, the event was resolved. Follow-up information received on 7 October 2011: The subject did not have medical history of loss of consciousness. On 10 September 2011, before the onset of the events, the subject had fear of pain caused by the injection. She did not have any sign or warning regarding the episode and she did not present sweat or warmth feeling before the event. On 10 September 2011, 10 minutes after vaccination with CERVARIX H1N1, the subject was in the sitting position when she suddenly fell with complete loss of consciousness for 1 minute. With the fall, the subject experienced tonic convulsion with cramp in hand for also 1 minute. She did not present pallor, cyanosis or flushing and any particular change in the respiratory pattern. She did not bite her tongue. Vital signs were measured: immediately after syncope, the blood pressure was 118/80 mmHg and pulse was 78 beats/minute. One minute later, the subject regained clear consciousness. After having bed rest for 20 minutes, the blood pressure was 100/58 mmHg and pulse was 78 beats/minute. She did not undergo any special test. The subject did not receive any medication. On 10 September 2011, the events resolved when the subject was in the supine position. She did not develop any symptoms after she recovered from loss of consciousness and she did not remember anything regarding this episode. The events did not recur.

VAERS ID:438769 (history)  Vaccinated:2011-09-30
Age:14.0  Onset:2011-09-30, Days after vaccination: 0
Gender:Female  Submitted:2011-10-17, Days after onset: 17
Location:Foreign  Entered:2011-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 30Sep2011, 35.5deg. C
CDC 'Split Type': B0755294A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148AB0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Nausea, Presyncope, Tinnitus
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of vasovagal reaction in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Subject''s body temperature before vaccination was 35.5 deg.C. On 30 September 2011, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left upper arm). On 30 September 2011, 3 to 5 minutes after vaccination with CERVARIX, the subject experienced vasovagal reaction with giddiness, queasy and tinnitus. The physician considered the events were clinically significant (or requiring intervention). No changes were observed in vital signs. The subject was placed under observation. On 30 September 2011, the events were resolved. The physician considered vasovagal reaction was related to vaccination with CERVARIX.

VAERS ID:438771 (history)  Vaccinated:2011-08-10
Age:14.0  Onset:2011-09-04, Days after vaccination: 25
Gender:Female  Submitted:2011-10-17, Days after onset: 43
Location:Foreign  Entered:2011-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0755295A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Genital haemorrhage, Metrorrhagia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: This case was reported by a physician and described the occurrence of metrorrhagia in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Before vaccination, the subject did not have menstrual irregularity. On 10 August 2011, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site and batch number). On 15 August 2011, her menstruation occurred. By the end of August, the subject experienced atypical genital bleeding which resolved in 2 to 3 days. On 04 September 2011, the subject experienced atypical genital bleeding. On 4 September 2011, 12 days after vaccination with CERVARIX, 25 days after vaccination with CERVARIX, the subject experienced metrorrhagia. The physician considered the events were clinically significant (or requiring intervention). On 12 September 2011, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site and batch number). From 24 September 2011, the event reoccurred. She experienced atypical bleeding. At the time of reporting, the events were improved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:438895 (history)  Vaccinated:2011-10-08
Age:14.0  Onset:2011-10-08, Days after vaccination: 0
Gender:Female  Submitted:2011-10-18, Days after onset: 10
Location:Foreign  Entered:2011-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, 08Oct2011, no aggravation o; Body temperature, 09Oct2011, 39Deg.C; Body temperature, 09Oct2011, 36Deg.C
CDC 'Split Type': B0755304A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test, Body temperature decreased, Convulsion, Headache, Iron deficiency anaemia, Loss of consciousness, Nausea, Pyrexia, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician and described the occurrence of iron deficiency anemia in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject had no past history of convulsion. On 8 October 2011, the subject received 2nd dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). On 8 October 2011, 2 hours after vaccination with CERVARIX, the subject experienced pyrexia and visited a nearby emergency designated hospital. Blood sampling revealed no aggravation of inflammatory reaction. Hypoferric anaemia was noted. On 9 October 2011, defervescence was observed. The subject complained of headache and queasy feeling. When she was going down the stairs at home, she sat on the step and presented with trembling-like convulsion for a minute. After the symptoms subsided, she regained her consciousness. She visited the reporting physician''s hospital. Her body temperature was 36.0 Deg.C at the visit to the hospital. In the evening, the body temperature elevated to 39.0 Deg.C. The subject was hospitalised. At the time of reporting, the events were resolved.

VAERS ID:438896 (history)  Vaccinated:2011-10-04
Age:14.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-18, Days after onset: 14
Location:Foreign  Entered:2011-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0755292A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146DB IMRA
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 4 October 2011, the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, right deltoid). On 4 October 2011, 10 minutes after vaccination with CERVARIX, the subject experienced loss of consciousness and syncope. The subject reported that inoculation with CERVARIX was not painful but she lost consciousness approximately 10 minutes later and immediately recovered from the event. The physician considered the events were clinically significant (or requiring intervention). On 4 October 2011, the events were resolved.

VAERS ID:438900 (history)  Vaccinated:2011-04-24
Age:14.0  Onset:2011-04-24, Days after vaccination: 0
Gender:Female  Submitted:2011-10-18, Days after onset: 177
Location:Foreign  Entered:2011-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0753137A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blindness, Blindness transient, Ophthalmological examination normal
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of temporary vision loss in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 24 April 2011 and 24 May 2011, the subject received 1st dose and 2nd dose of CERVARIX (administration site and route unknown, batch number not provided). On 24 April 2011, less than one day after vaccination with 1st dose of CERVARIX, the subject experienced temporary vision loss which was restored after some hours. On 31 May 2011, 7 days after vaccination with 2nd dose of CERVARIX, the subject experienced vision loss during 9 hours. The subject was hospitalised. The ophthalmological examination showed no abnormality. She was discharged. The subject was treated with DEXTROSE SALINE. At the time of reporting, the events were resolved. The physician considered the events were almost certainly related to vaccination with CERVARIX.

VAERS ID:439326 (history)  Vaccinated:2011-10-13
Age:14.0  Onset:2011-10-13, Days after vaccination: 0
Gender:Female  Submitted:2011-10-20, Days after onset: 7
Location:Foreign  Entered:2011-10-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 13Oct2011, 102/62mm Hg; Blood pressure, 13Oct2011, 90/40mm Hg
CDC 'Split Type': B0755656A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of CERVARIX (intramuscular, unknown route of administration and batch number). On 13 October 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced syncope. The physician considered the event was clinically significant (or requiring intervention). On 13 October 2011, the event was resolved. Follow-up information received on 14 October 2011: On an unspecified date, the subject received 1st dose of CERVARIX (.5 mL, intramuscular, unknown route of administration and batch number). The subject did not experience adverse event. On 13 October 2011, the subject received 2nd dose of CERVARIX (.5 ml, intramuscular, unknown injection site and batch number). On 13 October 2011, 3 minutes after vaccination with CERVARIX, the subject experienced facial pallor. She lost conscious while she was being transferred from one room to another one. Approximately 1 minutes later, as she was in a bed placed into supine position, she regained conscious. Her blood pressure was 90/40 mm Hg. The subject was treated with LACTEC G. After it, the subject''s blood pressure was 102/62 mm Hg. On 13 October 2011, the events were resolved. On 14 October 2011, the subject''s condition was confirmed by phone call: she had no more problem and was well.

VAERS ID:439653 (history)  Vaccinated:2011-04-01
Age:14.0  Onset:2011-04-01, Days after vaccination: 0
Gender:Female  Submitted:2011-10-21, Days after onset: 203
Location:Foreign  Entered:2011-10-24, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1110USA02353
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Case received from a healthcare professional (paediatrician) on 13-OCT-2011, under the reference number TMI-2011-482. Medically confirmed. A 14-year-old female patient had received the first dose of GARDASIL (batch number unknown) in April 2011. The vaccinating doctor was unknown by the reporter. The patient experienced an epileptic seizure during the vaccination. Medical history: No information reported. Afterwards, the patient experienced 3 other epileptic seizures. Epilepsy was confirmed medically. Patient was currently under treatment. She did not experience epileptic seizures since the treatment. Upon medical review, the company considered this case as serious (seriousness criterion: epilepsy) as other important medical event. Other business partner numbers included: E2011-06167. No further information is available.

VAERS ID:439916 (history)  Vaccinated:2011-09-26
Age:14.0  Onset:2011-09-26, Days after vaccination: 0
Gender:Female  Submitted:2011-10-25, Days after onset: 29
Location:Foreign  Entered:2011-10-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Phenytoin
Current Illness: Unknown
Preexisting Conditions: Encephalitis herpes
Diagnostic Lab Data: Nerve conduction studies, NORMAL; Nuclear magnetic resonance ima, NORMAL; Unknown date: Phenytoin blood concentration: 20.1
CDC 'Split Type': B0757208A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA123BC0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Anticonvulsant drug level increased, Asterixis, Gait disturbance, Injection site joint pain, Muscular weakness, Nerve conduction studies normal, Nuclear magnetic resonance imaging brain normal
SMQs:, Rhabdomyolysis/myopathy (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad)
Write-up: This case was reported by a physician and described the occurrence of muscle weakness in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included encephalitis herpes. Concurrent medications included PHENYTOIN. On 26 September 2011, around 10:00, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, right upper arm). On 26 September 2011, from around 14:00, 4 hours after vaccination with CERVARIX, the subject experienced asterixis and complained of not being able to put her strength in the lumbar region along with right shoulder pain. On 28 September 2011, 2 days after vaccination with CERVARIX, the event gradually intensified and the subject had difficulty walking without support. On 03 October 2011, 7 days after vaccination with CERVARIX, since it became difficult for the subject to be even in a sitting position, she was admitted to the reporting physician''s hospital. There were no abnormalities in Head Magnetic Resonance Imaging (MRI) and nerve conduction velocity. Phenytoin blood concentration was 20.1. The dose of Phenytoin was decreased and she was placed under observation. The event was gradually improving. The subject was hospitalised. At the time of reporting the events were improved. The physician reported that the relationship between the events and vaccination with CERVARIX was unassessable and considered the events as related to Phenytoin poisoning.

VAERS ID:439926 (history)  Vaccinated:0000-00-00
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2011-10-25
Location:Foreign  Entered:2011-10-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0757526A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Pneumothorax
SMQs:
Write-up: This case was reported by a physician and described the occurrence of pneumothorax in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site, batch number not provided). On an unspecified date, 1 month after vaccination with CERVARIX, the subject experienced pneumothorax. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified.

VAERS ID:440236 (history)  Vaccinated:2011-09-09
Age:14.0  Onset:2011-09-12, Days after vaccination: 3
Gender:Female  Submitted:2011-10-26, Days after onset: 44
Location:Foreign  Entered:2011-10-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Lymphadenitis
Diagnostic Lab Data: Body temperature, 18Sep2011, over 38deg. C.
CDC 'Split Type': B0757533A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Biopsy lymph gland, Histiocytic necrotising lymphadenitis, Local swelling, Lymph node pain, Lymphadenopathy, Pyrexia
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a physician and described the occurrence of histiocytic necrotizing lymphadenitis in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included lymphadenitis. Concurrent vaccination included ENCEVAC (non-GSK, subcutaneous, unknown injection site, batch number not provided) given on an unspecified date. On 9 September 2011, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site, batch number not provided). On 12 September 2011, 3 days after vaccination with CERVARIX, swollen lymph nodes were observed in the left cervical region, accompanied with severe pain. On 18 September 2011, 9 days after vaccination with CERVARIX, pyrexia of over 38 degrees centigrade developed. Subsequently, swelling was noticed on the left and right clavicles. On 29 September 2011, the subject was hospitalised. Lymph gland biopsy was performed and she was treated with PREDONINE. Two days after the hospitalisation, pyrexia improved. On 7 October 2011, the subject was discharged from the hospital. At the time of reporting the events were resolved.

VAERS ID:440240 (history)  Vaccinated:2011-10-15
Age:14.0  Onset:2011-10-15, Days after vaccination: 0
Gender:Female  Submitted:2011-10-26, Days after onset: 11
Location:Foreign  Entered:2011-10-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0757210A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA147AA0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Clonic convulsion, Cold sweat, Depressed level of consciousness, Foaming at mouth, Loss of consciousness, Muscle spasms, Paralysis, Seizure like phenomena, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician and described the occurrence of clonic convulsion in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 15 October 2011, around 11:40, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, right upper arm). On 15 October 2011, around 11:50, 5 to 6 minutes after vaccination with CERVARIX, the subject presented with depressed level of consciousness and lost consciousness transiently. Cramps of the limbs developed. Clonic seizure-like stamping of the four extremities was observed. The subject mildly foamed at her mouth and experienced paralysis of the limbs. Mild cold sweat was observed. Four to five minutes after the seizure, the symptoms gradually improved. Twenty minutes after the seizure, the subject smiled. Thirty minutes after the seizure, the subject was able to walk. Subsequently, the symptoms resolved. After arriving home, the subject vomited once. The subject rested at home on Saturday and Sunday. The physician considered the events were clinically significant (or requiring intervention). On 15 October 2011, the events were resolved. On Monday 17 October 2011, the subject attended school as usual. On 18 October 2011, the subject attended school as usual and had appetite, no symptoms were observed. On Friday 21 October 2011, the subject was scheduled to undergo a neurosurgical examination. The subject had no history of epilepsy. However, according to the subject''s parent who accompanied her, said that she received the inoculation under considerable anxiety, insecurity and tension.

VAERS ID:440241 (history)  Vaccinated:2011-10-12
Age:14.0  Onset:2011-10-12, Days after vaccination: 0
Gender:Female  Submitted:2011-10-26, Days after onset: 14
Location:Foreign  Entered:2011-10-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Nasopharyngitis
Diagnostic Lab Data: Blood pressure, 12Oct2011, 90/70mmHg; Blood pressure, 12Oct2011, 90/70mmHg; Systolic blood pressure, 12Oct2011, 70mmHg
CDC 'Split Type': B0757206A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148AB0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Bed rest, Blood pressure decreased, Feeling abnormal, Pallor, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a consumer and described the occurrence of vasovagal reaction in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject''s medical history included nasopharyngitis. On 12 October 2011, at 16:20, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, left upper arm). On 12 October 2011, at 16:29, 9 minutes after vaccination with CERVARIX, the subject experienced vasovagal reaction, presented with feelings of weakness, decreased blood pressure (maximum blood pressure of 70 mmHg) and facial pallor. She was made to have a bed rest and placed under observation. On 12 October 2011, at 16:40, the patient had better complexion with blood pressure at 90/70 mmHg. At 17:20, blood pressure was 90/70 mmHg, and poor feeling was not noted. The subject had left for home. On 12 October 2011, the events were resolved. The event was reported by the consumer as clinically significant (or requiring intervention). The consumer reported the events were related to the vaccination with CERVARIX.

VAERS ID:440246 (history)  Vaccinated:2011-10-01
Age:14.0  Onset:2011-10-01, Days after vaccination: 0
Gender:Female  Submitted:2011-10-26, Days after onset: 25
Location:Foreign  Entered:2011-10-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 01Oct2011, 103/58mmHg; Heart rate, 01Oct2011, 48bpm
CDC 'Split Type': B0753649A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMAR
Administered by: Other     Purchased by: Other
Symptoms: Depressed level of consciousness, Feeling abnormal, Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of facial pallor in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 1 October 2011, the subject received unspecified dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). On 1 October 2011, less than one day after vaccination with CERVARIX, the subject experienced facial pallor and feels poorly. On 1 October 2011, the events were resolved. Additional information received on 20 October 2011: On 20 October 2011, this case was upgraded from non-serious case to serious SAE. On 01 October 2011, CERVARIX was inoculated in unspecified deltoid muscle. On 01 October, at an unspecified time after vaccination with CERVARIX, the subject experienced loss of consciousness and depressed level of consciousness. The subject presented with facial pallor and poor feeling, and laid down for approximately 10 minutes. Subsequently, the patient went home without assistance. The subject had a blood pressure at 103/58 mmHg and a heart rate at 48 bpm. On 01 October 2011, the events were resolved. The physician considered the events were clinically significant (or requiring intervention).

VAERS ID:440402 (history)  Vaccinated:2011-08-25
Age:14.0  Onset:2011-09-20, Days after vaccination: 26
Gender:Female  Submitted:2011-10-27, Days after onset: 37
Location:Foreign  Entered:2011-10-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0753088A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA138BA0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Guillain-Barre syndrome, Hypoaesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: This case was reported by a physician and describes the occurrence of limb numbness in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 25 August 2011, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, unknown injection site). On 20 September 2011, 26 days after vaccination with CERVARIX, the subject experienced limb numbness. At the time of reporting the event was unresolved. The physician considered the event was related to vaccination with CERVARIX. Additional information received on 21 October 2011: On 21 October 2011, this case was upgraded from non-serious to serious case. On 20 September 2011, 26 days after vaccination with CERVARIX, the subject experienced Guillain-Barre syndrome. At the time of reporting the event was improved. The patient had a consultation with neurologist of another hospital, who had an opinion that it was hard to say her condition would be Guillain-Barre syndrome. Also the neurologist had a point of view that it was hard to determine whether the symptoms in this case were adverse events. the reporting physician was unable to assess that the symptoms were not adverse events due to the prophylactic inoculation, and thus the physician had a conflict whether additional inoculation of CERVARIX should be given or not for which it was discontinued.

VAERS ID:440290 (history)  Vaccinated:2008-09-03
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2011-10-26
Location:Foreign  Entered:2011-10-28, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: STALLERGENES
Current Illness: Drug hypersensitivity; Allergenic desensitisation procedure; Asthma exercise induced
Preexisting Conditions: Pneumonia
Diagnostic Lab Data: Body weight measurement, 38 kg, had lost 14 kg within 8 months
CDC 'Split Type': WAES1110USA03365
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Amenorrhoea, Asthenia, Condition aggravated, Cough, Decreased appetite, Gastrooesophageal reflux disease, Hypomenorrhoea, Pneumonia, Stress, Weight decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Fertility disorders (broad)
Write-up: Case received from the Health Authorities on 19-OCT-2011 under the reference number TO20111763. Case medically confirmed. A 14-year-old female patient had received the three doses of GARDASIL (lot # not reported) via intramuscular route on 21-JUL-2008, 03-SEP-2008 and 31-JAN-2009. The patient had a medical history of allergy to BETULAC, asthma exercise induced. She had been undergoing a desensitization to her allergy since 2006 with STALLERGENES which were stopped on 03-JUL-2009. On an unspecified onset of time after the administration of the second dose of GARDASIL, the patient observed a hypomenorrhea. After receiving the third dose of GARDASIL, she developed amenorrhea. She started to lose weight and appetite, and became asthenic. In May 2009, the patient experienced an episode of pneumonia and a cough which lasted for 2 months. (To be noted that pneumonia was reported as medical history and consequently was not coded as an adverse event.) In September 2009, the patient was hospitalized due to a severe loss of weight and significant abdominal pain. She weighed 38 kg and had lost 14 kg within 8 months. Laboratory tests were not available. Anorexy, which was a non-drug etiology, was suggested but not ruled out. The patient went to see different specialists, i.e. generalist practitioner, endocrinologist, paediatrician, ostheopath and sophrologist. At the time of reporting, the patient had a normal diet but had no regained weight. Amenorrhea persisted as well as asthenia and stress. Furthermore, she also developed gastrooesophageal reflux disease. Upon medical review, the company judged relevant to code the adverse events hypomenorrhea, weight loss, suspicion of anorexia, abdominal pain, asthenia, stress and gastrooesophageal reflux disease which were mentioned by the CA in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 11) according to the foreign method of assessment. No further information is available. Other business partner numbers included E2011-06360.

VAERS ID:440682 (history)  Vaccinated:2011-09-17
Age:14.0  Onset:2011-10-04, Days after vaccination: 17
Gender:Female  Submitted:2011-10-28, Days after onset: 24
Location:Foreign  Entered:2011-10-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0756743A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA093BB0IMUN
Administered by: Other     Purchased by: Other
Symptoms: CSF test normal, Coma, Intensive care
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)
Write-up: This case was reported by a physician via a regulatory authority (# ES-AGEMED-129374332) and described the occurrence of coma in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). No known family medical history. On 17 September 2011, the subject received 1st dose of CERVARIX (intramuscular, administration site unknown). On 4 October 2011, 17 days after vaccination with CERVARIX, the subject experienced coma. The subject was hospitalised in the Intensive Care Unit. The cephalorraquid liquid test was without abnormality sequelae. At the time of reporting, the event was resolved without sequelae and she was discharged from hospital. The regulatory authority reported that the event was possibly related to vaccination with CERVARIX. Further information has been expected.

VAERS ID:440654 (history)  Vaccinated:2011-09-27
Age:14.0  Onset:2011-09-27, Days after vaccination: 0
Gender:Female  Submitted:2011-10-28, Days after onset: 31
Location:Foreign  Entered:2011-10-31, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1110USA01770
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NM100903IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Incorrect dose administered, No adverse event
SMQs:
Write-up: This misuse case with no associated adverse event was reported by a doctor on 27-SEP-2011, 06631. This case is medically confirmed. A 14 year old female patient who had previously completed a course of GARDASIL in March 2010, received a fourth dose of GARDASIL, (Lot number: NM10090; Batch number: NN33040) on 27-SEP-2011. No adverse event was reported. Follow up received on 05-OCT-2011. The reporter stated that the patient had not experienced any adverse event following the off license administration. Follow up received from the agency, ref no 2011-007242 on 19-OCT-2011. This case has been upgraded to serious. The patient was vaccinated with a single dose of GARDASIL 0.5 ml intramuscularly on 27-SEP-2011 (Batch number NN30040 is not a valid lot number for GARDASIL). This was an error as the patient had already received three doses of the vaccine last season (2010-2011) (also reported as "the course was completed in March 2010"). The patient''s mother thought that the patient needed to be vaccinated again. The patient had experienced no adverse reaction at the time of reporting and the patient had been well since vaccination. The agency considered the event of medication error to be serious due to other medically important condition which required intervention. Other business partner numbers include E2011-05901. No further information is available.

VAERS ID:440871 (history)  Vaccinated:2011-10-13
Age:14.0  Onset:2011-10-13, Days after vaccination: 0
Gender:Female  Submitted:2011-10-31, Days after onset: 18
Location:Foreign  Entered:2011-10-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 13Oct2011, 123/73mmHg; Pulse rate, 13Oct2011, 54bpm
CDC 'Split Type': B0755665A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Depressed level of consciousness, Fall, Injection site pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of syncope in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 13 October 2011, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, left deltoid). On 13 October 2011, less than one day after vaccination with CERVARIX, the subject experienced syncope. The pharmacist considered the event was clinically significant (or requiring intervention). On 13 October 2011, the event was resolved. The pharmacist considered the event was related to vaccination with CERVARIX. Follow up information received on 19 October 2011: The subject was in sitting position. Activity: the subject was in the postvaccination state. The subject had a painful/emotional stimulus before the onset of the event. Predisposing factor was unknown. Triggering event was pain at the time of vaccination. The subject did not have a sign or warning regarding the episode. The subject did not have sweat or warmth feeling before the event. The event developed suddenly. The subject fell down from a chair. Complexion: No abnormalities. The subject''s respiratory pattern showed no abnormalities. The subject had no movement. The subject did not have tongue biting. The subject did not lose consciousness completely. The subject did not receive any medical treatment. Vital signs: Blood pressures were 123/73 mmHg and pulse rate was 54 beats/minue. No symptom developed after the subject recovered from loss of consciousness. The subject did not remember anything regarding loss of consciousness. The subject had no family history or medical history. The subject had no past history or medical history. The subject had no past history of loss of consciousness. The subject did not under go any special test. The event did not recur. The subject did not receive any medication.

VAERS ID:440874 (history)  Vaccinated:2009-04-16
Age:14.0  Onset:2009-06-01, Days after vaccination: 46
Gender:Male  Submitted:2011-10-31, Days after onset: 882
Location:Foreign  Entered:2011-10-31
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Scoliosis
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0757856A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB611AB1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Balance disorder, CSF test abnormal, Decubitus ulcer, Myelitis, Neurogenic bladder, Neurological symptom, Paraparesis, Paresis, Sensory disturbance, Syncope, Vaccination complication
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a lawyer and described the occurrence of myelitis in a 15-year-old male subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). This case was medically confirmed. Concurrent medical conditions included scoliosis. On 6 March 2009, the subject received 1st dose of ENGERIX B adult (1 ml, unknown route of administration). On 16 April 2009, the subject received 2nd dose of ENGERIX B adult (1 ml, unknown route of administration). In June 2009 (Spring - Summer 2009), at an unspecified time after vaccination with ENGERIX B adult, the subject experienced fainting and loss of balance. Due to persistence of that symptoms patient was admitted to the hospital. During the 2nd hospitalization (21Sep - 21Oct2009), after cerebrospinal fluid test, the diagnosis of spastic paresis of lower extremities probably after history of inflammation of the spinal cord was given. The subject was directed to Rehabilitation. On 20 October 2009, the subject received 3rd dose of ENGERIX B adult (1 ml, unknown route of administration). After that vaccination the increasing intensity of neurological symptoms was noticed. Paresis of lower extremities and trunk was diagnosed. From January 2010, the subject started to experienced sensibility disturbances and neurogenic bladder. From March 2010, the subject started to experienced pressure ulcers. The reporter considered the events were disabling. Despite of many hospitalizations the improvement of health state was not achieved. Subject has still not experienced sensibility recovery and recovery of sphincters function, additionally recovery process has been complicated with occurrence of pressure ulcers. Finally, it was concluded that the cause of subject''s health problems are postvaccinal complications (events almost certainly related to ENGERIX-B vaccine). At the time of reporting, myelitis was resolved with the following sequelae: paresis of lower limbs and neurogenic bladder, the rest of the events were unresolved.

VAERS ID:441278 (history)  Vaccinated:2011-10-20
Age:14.0  Onset:2011-10-20, Days after vaccination: 0
Gender:Female  Submitted:2011-11-03, Days after onset: 14
Location:Foreign  Entered:2011-11-03
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0758982A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148AB0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Fall, Pallor, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of shock in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Before vaccination, the subject''s body temperature was 36.1 deg C. On 20 October 2011, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, left deltoid). On 20 October 2011, 10 minutes after vaccination with CERVARIX, the subject experienced shock, facial pallor and fall. Blood pressure was 72 mmHg. The physician considered the events were life threatening. The subject was treated with BOSMIN and SOLUCORTEF. At the time of reporting the events were improved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:441279 (history)  Vaccinated:2011-09-03
Age:14.0  Onset:2011-09-03, Days after vaccination: 0
Gender:Female  Submitted:2011-11-03, Days after onset: 61
Location:Foreign  Entered:2011-11-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 03Sep2011, 98/56mmHg; Blood pressure, 03Sep2011, 68mmHg; Heart rate, 03Sep2011, 60 bpm; Oxygen saturation, 03Sep2011, 98%
CDC 'Split Type': B0758989A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Cold sweat, Depressed level of consciousness, Fall, Fear, Feeling abnormal, Pallor, Presyncope, Pulse pressure decreased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of vasovagal reaction in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject had no family history and no past medical history such as cardiac disease, epilepsy, metabolic abnormality, or allergy. The subject had no past history of loss of consciousness. The subject had no concomitant medications. No obesity was observed. Before vaccination, the subject''s body temperature was 35.8 deg C. On 3 September 2011, at 13:00, the subject received 1st dose of CERVARIX (0.5ml, intramuscular, left deltoid). On 3 September 2011, at 13:10, 10 minutes after vaccination with CERVARIX, the subject experienced vasovagal reaction, syncope, cold sweat, ill complexion, fuzzy head, depressed level of consciousness, decreased blood pressure, weak pulse and fall. The subject did not present cough or rash. The physician considered the events were clinically significant (or requiring intervention). Relevant test results included: Blood pressure: 68 mmHg; SpO2: 98%; Pulse: 60 bpm; The level of consciousness was I-1 by Coma Scale (CS). The subject was treated with SOLITA-T 200 mL. The complexion gradually became normal with BP at 98/56 mmHg. On 3 September 2011, at 13:50, the events were resolved and the subject was sent home. The physician considered the events were related to vaccination with CERVARIX. The subject was in sitting position, in post-vaccination state around 10 minutes after the inoculation. The subject had no predisposing factor. The triggering event was fear. The subject had no sign or warning regarding the episode and no sweat or warmth feeling before the event. The event developed gradually. The subject presented with ill complexion and fall (collapsed). There was no cyanosis. The subject experienced depressed level of consciousness for around 30 minutes. The subject''s respiratory pattern and movement were normal. The subject had no particular movement and no tongue biting. The subject did not lose consciousness completely. The event resolved while the patient was in the supine position. The event resolved while the patient was in the supine position. No symptom developed after the patient recovered from loss of consciousness. The subject did not remember anything regarding loss of consciousness. No special test was performed. After the second vaccination with CERVARIX, the event recurred. On 5 October 2011, the events were resolved.

VAERS ID:441288 (history)  Vaccinated:2011-09-16
Age:14.0  Onset:2011-09-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-03, Days after onset: 48
Location:Foreign  Entered:2011-11-03
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0758968A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146BA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Memory impairment
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad)
Write-up: This case was reported by a physician and described the occurrence of memory impairment in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 16 September 2011, the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, left arm). On 16 September 2011, approximately 1 hour after vaccination with CERVARIX, the subject experienced memory impairment (inability to remember her name). The physician considered the event was disabling. At the time of reporting the event was unresolved. The subject was visited another hospital.

VAERS ID:441300 (history)  Vaccinated:2011-09-26
Age:14.0  Onset:2011-09-26, Days after vaccination: 0
Gender:Female  Submitted:2011-11-03, Days after onset: 38
Location:Foreign  Entered:2011-11-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 26Sep2011, 120/70mmHg
CDC 'Split Type': B0751724A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Bed rest, Fall, Injection site pain, Pain, Pallor, Presyncope
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of vasovagal reaction in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 26 September 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, left deltoid). On 26 September 2011, less than one day after vaccination with CERVARIX, the subject experienced vagal reaction. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified. Follow-up information received on 11 October 2011: On 26 September 2011, less than one day after vaccination with CERVARIX, the subject experienced vasovagal reaction due to pain. The subject was treated with drip infusion of LACTEC. At the time of reporting the outcome of the pain was unspecified and the vasovagal reaction resolved on 26 September 2011. Follow-up information was received on 24 October 2011. On 26 September 2011, 5 minutes later after vaccination with CERVARIX, while the subject was sitting, she collapsed and fell on her back. Facial pallor was observed. The blood pressure was 120/70 mmHg. She recovered with bed rest and drip infusion. She left for home. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the injection site pain was unspecified and the other events resolved on 26 September 2011.

VAERS ID:441360 (history)  Vaccinated:2011-09-05
Age:14.0  Onset:2011-10-17, Days after vaccination: 42
Gender:Female  Submitted:2011-11-03, Days after onset: 17
Location:Foreign  Entered:2011-11-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Echocardiography, 22Oct11, normal; Diagnostic laboratory test, blood test normal; Diagnostic laboratory test, muscle enzyme normal; Serum C-reactive protein, normal; Hepatic function tests, liver enzyme normal; Erythrocyte sedimentation rate, 30, at 1 hour
CDC 'Split Type': WAES1110USA04443
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK107900UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Anxiety, Asthenia, Blood test normal, C-reactive protein normal, Chest discomfort, Crying, Decreased appetite, Dyspnoea, Echocardiogram normal, Feeling of body temperature change, Gait disturbance, Laboratory test normal, Liver function test normal, Malaise, Muscle enzyme, Muscle spasms, Nausea, Pain in extremity, Red blood cell sedimentation rate increased, Weight decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad)
Write-up: Case received from a physician on 27-OCT-2011 and medically confirmed. A 14 year old female patient (reporter''s daughter) with no relevant medical history was vaccinated with the first dose of GARDASIL (lot number NK10790, batch number NN45890) on 05-SEP-2011. On 17-OCT-2011, i.e. more than one month after vaccination, the parents had to pick the child up at school. She presented with difficulties in walking, nausea, feeling hot and cold, sensation of malaise and asthenia. Furthermore, she was not eating. Physical examination performed by the patient''s father was unremarkable. On 18-OCT-2011, the patient''s also developed anxiety, painful cramps of extremities and chest compression. She was given magnesium as corrective treatment. On 19-OCT-2011 she was still very anxious, cried for no apparent reason and still did not eat. Physical examination was still normal. The patient remained in bed during 4 days. The father eventually thought that there was perhaps nothing and sent her back to school on 20-OCT-2011. But he had to pick her up as she was not doing well at all. Although she was 14 years old, she slept with her parents in the night from 20 to 21-OCT-2011 because she was so anxious and asthenic. A complete work up was performed. The following investigations were normal: blood work up, liver enzymes, muscle enzymes and C reactive protein. Erythrocyte sedimentation rate was of 30 at 1st hour. On 21-OCT-2011 there was no improvement. The patient was still anxious, was still not eating and still presented with marked asthenia. She experienced again chest compression and dyspnoea. Cardiac ultrasound performed on 22-OCT-2011 in the morning showed normal. On 22-OCT-2011 she had lost 3 kg since the start of this episode as she had not eaten since 17-OCT-2011. On 25-OCT-2011 there were some improvements and on 26-OCT-2011 everything had gone back to normal. On 27-OCT-2011 the patient did not presented any symptom anymore. Asthenia, anxiety, loss of appetite, loss of weight, nausea, dyspnoea, chest compression, sensation of malaise, crying, feeling hot and cold, difficulty in walking and cramps of extremities with pain were considered to be other important medical events by the reporter. Other business numbers included: E2011-06595.

VAERS ID:441365 (history)  Vaccinated:2010-10-25
Age:14.0  Onset:2010-11-03, Days after vaccination: 9
Gender:Female  Submitted:2011-11-03, Days after onset: 365
Location:Foreign  Entered:2011-11-04, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 2010-11-06
   Days after onset: 3
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Computed axial tomography, 04Nov10, Numerous effusions; WBC count, 04Nov10, 500000; WBC count, 04Nov10, 426000; hemoglobin, 04Nov10, 9.5; hemoglobin, 04Nov10, 7; platelet count, 04Nov10, 51000; platelet count, 04Nov10, 45000; Glasgow coma scale, 04Nov10, 13; Glasgow coma scale, 04Nov10, 8
CDC 'Split Type': WAES1110USA04403
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Acute leukaemia, Cerebral haemorrhage, Coma scale abnormal, Computerised tomogram abnormal, Death, Effusion, Haemoglobin decreased, Headache, Hypertension, Hypokinesia, Hypotension, Intensive care, Mydriasis, Pain in extremity, Platelet count decreased, Purpura, Somnolence, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemorrhagic cerebrovascular conditions (narrow), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Malignant tumours (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Case received from a physician on 24-OCT-2011 and medically confirmed. A 15-year-old female patient received the second dose of GARDASIL (batch number not reported) via intramuscular route in the arm on 25-OCT-2010. On 03-NOV-2010, the patient was seen due to pain in calf and purpuric spots on both legs. The patient was not athletic and had been participating orienterring race the day before, and the physician thought it was a muscle strain. Blood count and differential white count was prescribed. On 04-NOV-2010, the patient experienced headaches and felt drowsy while being in classroom. Her mother picked her up and she remained at home. In the afternoon, her mother had difficulties waking her up. The patient was slow and had difficulties moving. EMU (Emergency Mobile Unit) was called and the patient was led to hospital on 04-NOV-2010. On admission diffuse hemorrhage cerebral and acute leukemia were discovered. White blood cells count was at 500 000. Hemoglobin was at 9, 5 and platelets at 51000. The patient was transferred to intensive care unit where her Glasgow coma scale quickly fell down from 13 to 8. Hemoglobin was at 7, platelets at 45000, white blood cells count at 426000. There was no adenopathy, no tumor. Liver and spleen were normal. CT scan showed numerous effusions. During the night, she experienced an episode of hypertension treated with EUPRESSYL and then hypotension and mydriasis. The patient died on 06-NOV-2010. To be noted that no clinical sign or symptom had been noticed prior to this episode. The patient used to be in good health and was not very often sick. She had received the first dose of GARDASIL via intramuscular route in the arm on 25-AUG-2010 which had been well tolerated. To be noted that the patient''s mother felt guilty and needed to "hold onto" something, including the vaccine. The hospital staff told her that there was no link between the vaccine and the events. Psychological follow-up was still ongoing. It was noteworthy that the general practitioner did not report any link with vaccination. Other business partner numbers included: E2011-06493. No further information is available.

VAERS ID:441687 (history)  Vaccinated:2011-10-19
Age:14.0  Onset:2011-10-19, Days after vaccination: 0
Gender:Female  Submitted:2011-11-04, Days after onset: 16
Location:Foreign  Entered:2011-11-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 19Oct2011, 96/50mmHg; Electrocardiogram, 19Oct2011, sinus bradycardia
CDC 'Split Type': B0759237A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148CB0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Bradycardia, Dysphoria, Electrocardiogram abnormal, Loss of consciousness, Presyncope, Sinus bradycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of vasovagal reaction in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 19 October 2011, at 16:00, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left arm). On 19 October 2011, at 16:05, 5 minutes after vaccination with CERVARIX, the subject sat on a chair and waited. However, she complained of dysphoria and tried to move to a different chair, but on the way, she suffered from loss of consciousness. Bradycardia and decreased blood pressure were noted. Therefore, the subject was placed on a stretcher in a recumbent position. An electrocardiogram (ECG) revealed sinus bradycardia. The blood pressure was recovered to 96/50 mmHg. Approximately 30 minutes later, the subjective symptoms also resolved, and the subject went home. The physician considered the events were clinically significant (or requiring intervention). On 19 October 2011, the events were resolved. The physician considered the events were unrelated to vaccination with CERVARIX.

VAERS ID:441713 (history)  Vaccinated:2011-08-26
Age:14.0  Onset:2011-09-01, Days after vaccination: 6
Gender:Female  Submitted:2011-11-07, Days after onset: 67
Location:Foreign  Entered:2011-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: CSF test, Oct2011, no abnormalities; nerve conduction studies, Oct2011, no abnormalities; nuclear magnetic resonance ima, 22Sep2011, no abnormalities
CDC 'Split Type': B0759900A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Brachial plexopathy, CSF test normal, Grip strength decreased, Guillain-Barre syndrome, Hemiparesis, Hypoaesthesia, Muscular weakness, Nerve conduction studies normal, Nuclear magnetic resonance imaging brain normal, Thoracic outlet syndrome
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)
Write-up: This case was reported by a physician and described the occurrence of Guillain Barre syndrome in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 26 August 2011, the subject received the 1st dose of CERVARIX (0.5 ml, intramuscular, left upper arm). Around 1 September 2011, 6 days after vaccination with CERVARIX, the subject experienced weakness and numbness in the right hand. The symptoms progressed gradually, and the subject began to have difficulty in writing. On 22 September 2011, the subject visited the department of orthopedics of another hospital. Head magnetic resonance imaging (MRI) revealed no abnormalities. On 26 September 2011, the subject visited the reporting physician''s hospital. Right hemiparesis was suspected, and the subject was referred to the department of neurology of the reporting physician''s hospital. From 04 October 2011 to October 2011, the subject was admitted to the hospital. Cerebrospinal fluid and peripheral nerve conduction studies revealed no abnormal findings. The patient was given the diagnosis that the main part of the lesions was in the brachial plexus of the right arm. Steroid pulse therapy was performed, for which the symptoms had improved. At the time of reporting, the patient was living as almost usual. At the time of reporting the events were resolved. The physician reported that relationship between the events and CERVARIX was unassessable and related to the suspected thoracic outlet syndrome.

VAERS ID:441714 (history)  Vaccinated:2011-08-27
Age:14.0  Onset:2011-08-27, Days after vaccination: 0
Gender:Female  Submitted:2011-11-07, Days after onset: 72
Location:Foreign  Entered:2011-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 27Aug2011, 94/54mmHg; hemoglobin, 27Aug2011, 12.5g/dL; pulse rate, 27Aug2011, 50bpm; red blood cell count, 27Aug2011, 433x10^4; white blood cells, 27Aug2011, 6700
CDC 'Split Type': B0747572A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143CA1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Altered state of consciousness, Anaemia, Blood pressure decreased, Cold sweat, Depressed level of consciousness, Haemoglobin normal, Hypotension, Nausea, Pallor, Red blood cell count normal, Vomiting, White blood cell count normal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of anemia in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 27 August 2011, the subject received 2nd dose of CERVARIX (.5 ml, intramuscular, injection site unknown, batch number not provided). On 27 August 2011, less than one day after vaccination with CERVARIX, the subject experienced facial pallor, cold sweat and decreased blood pressure. On 27 August 2011, the events were resolved. The physician considered the events were almost certainly related to vaccination with CERVARIX. Follow-up information received on 26 October 2011: The case was upgraded to serious. The batch number was provided. On 27 August 2011, less than one day after vaccination with CERVARIX, the subject experienced anemia, depressed level of consciousness, hypotension, vomiting and nausea. The physician considered the events were clinically significant (or requiring intervention). Blood pressure and pulse were 94/54 mmHg and 50 bpm. She was in twilight state, though not completely. White blood cell: 6700, red blood cell: 433x10^4 and hemoglobin: 12.5 g/dL. No eczema appeared. The subject was treated with SAXIZON and after 10 minutes, the symptoms improved. On 27 August 2011, vomiting, nausea and depressed level of consciousness were resolved. On 28 August 2011, hypotension and anemia were resolved. The physician considered facial pallor and cold sweat were related to vaccination with CERVARIX, anemia and hypotension were almost certainly related.

VAERS ID:441718 (history)  Vaccinated:2011-10-25
Age:14.0  Onset:2011-10-25, Days after vaccination: 0
Gender:Female  Submitted:2011-11-07, Days after onset: 13
Location:Foreign  Entered:2011-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0759235A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Bed rest, Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of vasovagal reaction in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 25 October 2011, at 15:30, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left arm). On 25 October 2011, at 15:45, 15 minutes after vaccination with CERVARIX, when the subject stood up to pay the bill before leaving, she had lost consciousness. The subject recovered in several seconds. After the subject was put on bed rest, the symptom had improved, and she went home. The physician considered the events were clinically significant (or requiring intervention). On 25 October 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:441751 (history)  Vaccinated:2008-10-28
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2011-11-07
Location:Foreign  Entered:2011-11-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1110USA04110
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cervical conisation, Cervical dysplasia, Cervix disorder
SMQs:, Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad)
Write-up: Information has been received from a physician (local reference number ISR-036-OCT11) concerning a 16 year old female patient with no sexual activity prior to vaccination who on 17-APR-2008 (also reported as approximately on 17-APR-2008) at the age of 14 years old, was vaccinated with a first dose of GARDASIL (lot number, dose and route not reported); on 01-JUL-2008 (also reported as approximately on 01-JUL-2008) was vaccinated with a second dose of GARDASIL (lot number, dose and route not reported) and on 28-OCT-2008 (also reported at approximately on 28-OCT-2008) was vaccinated with a third dose of GARDASIL (lot number, dose and route not reported). The physician reported that in 2010, the patient experienced a premalignant cervical lesion most likely Cervical Intraepithelial Neoplasm (CIN) grade III. Typing was unknown. On an unspecified date the patient underwent conization. Subsequently, the patient recovered from CIN grade III in 2010. Upon internal review CIN III was considered to be an other important medical event. Additional information is not expected.

VAERS ID:441763 (history)  Vaccinated:2011-08-27
Age:14.0  Onset:2011-08-27, Days after vaccination: 0
Gender:Female  Submitted:2011-11-08, Days after onset: 73
Location:Foreign  Entered:2011-11-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 27Aug2011, 96/63mmHg; Oxygen saturation, 27Aug2011, 76%
CDC 'Split Type': B0760610A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Fall, Immediate post-injection reaction, Presyncope
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of vasovagal reaction in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 27 August 2011, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left arm). On 27 August 2011, immediately after vaccination with CERVARIX, the subject experienced vasovagal reaction. Light-headed feeling was observed and the subject fell from the sitting position. She did not have any bruising in particular and was able to respond to calls. The oxygen saturation measured by pulse oximetry (SpO2) was 76 %, while the blood pressure (BP) was 96/63 mmHg. The subject was placed at bed rest. The physician considered the events were clinically significant (or requiring intervention). On 27 August 2011, the events were resolved around 45 minutes later. The subject became able to stand up by herself. Neither light-headed feeling nor queasy was observed and she left for home. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:441766 (history)  Vaccinated:2011-08-13
Age:14.0  Onset:2011-08-13, Days after vaccination: 0
Gender:Female  Submitted:2011-11-08, Days after onset: 87
Location:Foreign  Entered:2011-11-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Infection
Preexisting Conditions:
Diagnostic Lab Data: Diastolic blood pressure, 13Aug2011, 26mmHg; Diastolic blood pressure, 13Aug2011, 60mmHg; Diastolic blood pressure, 14Aug2011, normalmmHg; Systolic blood pressure, 13Aug2011, 68mmHg; Systolic blood pressure, 13Aug2011, 86mmHg; Systolic blood pressure, 14Aug2011, normalmmHg
CDC 'Split Type': B0740497A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Depressed level of consciousness, Fall, Hypoaesthesia, Insomnia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of depressed level of consciousness in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included infection. On 13 August 2011, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, left deltoid). On 13 August 2011, 3 minutes after vaccination with CERVARIX, the subject fell down and vomited while she was standing up from a chair. No complete loss of consciousness was reported but the subject experienced depressed level of consciousness. Subject''s blood pressure decreased to 68/26 mmHg. This case was assessed as medically serious by GSK. The subject was treated with SOLDEM, SOLUMEDROL and oxygen. One hour and half later, blood pressure increased to 86/60 mmHg and subject was sent at home with an improved level of consciousness. During the night, the subject complained of sleep difficulties due to lower extremities numbness. On 13 August 2011, the events were resolved. On 14 August 2011, her blood pressure was normal. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:442281 (history)  Vaccinated:1995-10-16
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2011-11-11
Location:Foreign  Entered:2011-11-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Early puberty; First pregnancy; Hypothyroidism; Influenza-like syndrome; Second pregnancy
Preexisting Conditions: Migraine
Diagnostic Lab Data: Cerebrospinal fluid protein, See Text; Nuclear magnetic resonance ima, 2000, See Text; Nuclear magnetic resonance ima, 2003, See Text; Nuclear magnetic resonance ima, Mar2005, See Text; Nuclear magnetic resonance ima, Jan2009, See Text; Nuclear magnetic resonance ima, Feb2009, See Text; 2000: Brain MRI: sus and sub tentorial and periventricular demyelinating lesions. There was enhanced contrast after gadolinium injection, suggestive of active multiple sclerosis. 2003: Brain MRI: enhanced contrast; March 2005: Brain MRI: increases in lesion load; January 2009: Brain MRI: enhanced contrast confirming the progress of multiple sclerosis; February 2009: Brain MRI: no evolutionary elements but confirmation of the persistence of multiple hypersign
CDC 'Split Type': B0760807A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS1760G60UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Asthenia, CSF oligoclonal band present, Central nervous system lesion, Depression, Diplopia, Fatigue, IIIrd nerve paralysis, Memory impairment, Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal, Nystagmus, Ophthalmoplegia, Pain, Paraesthesia, Pyramidal tract syndrome, Sensory disturbance, Speech disorder, Trigeminal nerve disorder, VIIth nerve paralysis
SMQs:, Peripheral neuropathy (narrow), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Ocular motility disorders (narrow)
Write-up: This case was reported by a GSK Legal Department and described the occurrence of multiple sclerosis in a 14-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject''s medical history included migraine. Migraine was also reported in her mother. Concurrent medical conditions included hypothyroidism and early puberty. Concomitant medications and other vaccinations, if any, were not specified. On 16 October 1995 and 16 November 1995, the subject received first dose (batch number 1760 G6) and second dose (batch number 1776 B6) of ENGERIX B (route and injection site unknown). In 1995 (unspecified date), the subject had first flare-up NOS. On 09 May 1996, the subject received third dose (batch number 1935 B6) of ENGERIX B (route and injection site unknown). At her entrance in high school (date not specified), the subject presented with severe fatigue and was less lively. She had diffuse pain and memory disorders especially. At the end of year, the subject had to stop school. In September 1999, the subject had a second flare-up with right facial anesthesia (coded sensory disorder) suggestive of regressive trigeminal impairment. Paralysis of eyes and face were reported. In March 2000, the subject had third flare-up with sudden diplopia, paralysis of left external oculomotor nerve, horizontal and rotary nystagmus in left side (in favour of lesion in brain stem) and anesthesia at thoraco-abdominal belt (coded sensory disorders). Brain MRI confirmed multiple sclerosis criteria which included sus and sub tentorial and periventricular demyelinating lesions. There was enhanced contrast after gadolinium injection, suggestive of active multiple sclerosis. Cerebrospinal fluid analysis after lumbar puncture showed an oligoclonal increase in gammaglobuline level. The subject was treated with SOLUMEDROL. In April 2000, the subject was diagnosed with multiple sclerosis. In May 2000, a treatment with BETAFERON was started. On 14 June 2000, the subject had a consultation where the physician validated the diagnosis of multiple sclerosis and treatment with interferon beta 1-b. In 2003, the subject had a flare-up (sensory disorder and regressive nystagmus). Brain MRI showed enhanced contrast. In 2004, she experienced three flare ups with paralysis and sensory disorders during her first pregnancy. On 26 January 2005, the subject delivered her first child. In March 2005, brain MRI showed an increase in lesion load. EDSS (Extended Disability Status Scale) was at zero. In February 2007, the subject presented with left hemibody sensory syndrome. EDSS score remained at zero. On 27 November 2007, due to second pregnancy, the treatment with interferon beta-1b was discontinued. On 03 March 2008, the subject presented with paresthesias in four limbs. On 09 July 2008, she delivered her second child, a premature male neonate with a weight of 2.200 kg and who presented with delayed growth. In August 2008, the subject presented with sensory syndrome of four limbs. She received two bolus of corticosteroids after which EDSS was at 0.5. On 01 September 2008, treatment with interferon beta-1b was resumed with the occurrence of influenza-like syndrome (adverse event secondary to interferon beta-1b). The subject presented with severe asthenia and depressive decompensation requiring a treatment with antidepressive drugs. Around the end of December 2008 or the beginning of January 2009, the subject presented with pyramidal syndrome in left hemibody. EDSS was at 3. In January 2009, brain MRI showed enhanced contrast and confirmed the progress of the multiple sclerosis. Beginning of February 2009, brain MRI showed no evolutionary elements but confirmed the persistence of multiple hypersignals in periventricular area. Corticotherapy was initiated following the MRI results. In April 2009, monthly perfusions at day care hospital of TYSABRI were started. On 29 July 2010, treatment with natalizumab was well tolerated with stabilization of the multipl

VAERS ID:442379 (history)  Vaccinated:2007-12-18
Age:14.0  Onset:0000-00-00
Gender:Male  Submitted:2011-11-10
Location:Foreign  Entered:2011-11-14, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201110786
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER06030440UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Adverse event
SMQs:
Write-up: This case report is part of a batch of several hundred reports associated with Rabies Vaccine, that was received on 27 October 2011 by sanofi pasteur affiliate, from the "Ministry of Health" (local case reference number BR-BT2011-4285). A male patient, whose medical history and concomitant therapies were not reported, had received his 1st dose of Rabies Vaccine (manufacturer not reported, batch number "0603044", route and anatomical site of administration not reported) on 18 December 2006. The suspect vaccine was reported as "RV", i.e. Rabies Vaccine/Vero. On an unspecified date post-vaccination, the patient experienced "other serious or unexpected adverse events". The patient''s symptoms lasted for 12 hours. He recovered without sequelae. The case was assessed as serious, i.e. significant medical condition, by the Ministry of Health. The patient was not hospitalized. The status of this case was "confirmed" (the Ministry of Health assessed the adverse events as related to the vaccine). There was no recommended "conduct". Documents held by sender: none.

VAERS ID:442633 (history)  Vaccinated:0000-00-00
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2011-11-15
Location:Foreign  Entered:2011-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 104/54mmHg; Blood pressure, 108/50mmHg; Oxygen saturation, 99%; Oxygen saturation, 98%; Pulse rate 61bpm; Pulse rate, 56 bpm; Pulse rate, 39bpm
CDC 'Split Type': B0761987A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Heart rate decreased, Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of loss of consciousness in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). Five minutes after vaccination with CERVARIX, the subject experienced loss of consciousness, pulse rate fell and ill complexion. The pulse rate fell to 39 bpm and blood pressure was 108/59 mmHg. The oxygen saturation measured by pulse oximetry (SpO2) was 99%. Facial pallor was observed. Eight minutes later, the pulse rate had recovered to 61 bpm and SpO2 was 98%. After another 4 minutes, the blood pressure was 104/54 mmHg while the pulse rate was at 56 bpm. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified.

VAERS ID:442634 (history)  Vaccinated:2011-11-04
Age:14.0  Onset:2011-11-04, Days after vaccination: 0
Gender:Female  Submitted:2011-11-15, Days after onset: 11
Location:Foreign  Entered:2011-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0761990A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148AB0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Feeling abnormal, Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician and described the occurrence of vagal reaction in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 4 November 2011, at 18:20, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, left upper arm). On 4 November 2011, at 18:21, 1 minute after vaccination with CERVARIX, the subject experienced vagal reaction, feeling poorly, loss of consciousness and convulsion. The subject regained consciousness immediately after she was laid on the bed. Drip infusion was administered and it was assessed that there was no other abnormality, so she was sent home. It was confirmed by phone on the next day that she recovered completely and there was no abnormality. The physician considered the events were clinically significant (or requiring intervention). On 4 November 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:442638 (history)  Vaccinated:2011-09-22
Age:14.0  Onset:2011-09-22, Days after vaccination: 0
Gender:Female  Submitted:2011-11-15, Days after onset: 54
Location:Foreign  Entered:2011-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Nervousness
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0756082A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMRA
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Loss of consciousness, Nausea, Pallor, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a pharmacist and described the occurrence of syncope in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, right deltoid, batch number not provided). On 22 September 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced syncope and vasovagal reaction. The pharmacist considered the events were clinically significant (or requiring intervention). On 22 September 2011, the events were resolved. Follow-up information received on 7 November 2011 by a physician: Subject details were added. No obesity was observed. The subject had no past history of loss of consciousness. No concomitant medication was reported. The vaccine CERVARIX was administered on 22 September 2011. Before the onset of the events, the subject was in a sitting position. The subject had no painful/emotional stimulus before the onset of the event. The subject had no predisposing factor. The subject had the following sign or warning regarding the episode: queasy feeling. The subject did not have sweat or warmth feeling before the event. The events occurred suddenly. The subject had no particular triggering event. However, since rumors were going around among her friends about the vaccination, which was said to be painful, she might have been more or less nervous. The subject had been extremely nervous before the vaccination. Her body was so tense that the reporting physician advised her to relax. On 22 September 2011, immediately after vaccination with CERVARIX, the subject experienced slightly pale, collapse, loss of consciousness for several seconds. She took rest for 30 minutes and went home. No problem in particular was reported thereafter. The reporting physician considered that the event was probably vasovagal reflex. Subject''s respiratory pattern was normal. The subject did not make a movement in association with the fall. The subject had no tongue biting. No treatment was provided. The subject recovered while she was in the supine position or the head-down position. No symptom occurred after the subject recovered from loss of consciousness. The subject did not remember anything regarding loss of consciousness. The events did not recur.

VAERS ID:443127 (history)  Vaccinated:2011-07-27
Age:14.0  Onset:2011-07-27, Days after vaccination: 0
Gender:Female  Submitted:2011-11-18, Days after onset: 114
Location:Foreign  Entered:2011-11-21, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Previous urticaria and swollen lips to foods, unsure which. Due for allergy testing.
Diagnostic Lab Data: UNK
CDC 'Split Type': B0762033A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA085AE1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a foreign regulatory authority (# GB-MHRA-ADR 21335085) and described the occurrence of generalized urticaria in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Previous vaccinations included the first dose of CERVARIX. On 27 July 2011 the subject received the second dose of CERVARIX (intramuscular, batch number AHPVA085AE). On 27 July 2011, the same day as vaccinated with CERVARIX, the subject experienced generalized urticaria and difficulty breathing. Possible anaphylaxis. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with anti-histamine. At the time of reporting the outcome of the events was unspecified. Verbatim Text: This was the second vaccine. Generalised urticaria noted on the day and given antihistamine. When attended ward for third injection mentioned difficulty in breathing. Possible anaphylaxis.

VAERS ID:443132 (history)  Vaccinated:2011-11-07
Age:14.0  Onset:2011-11-07, Days after vaccination: 0
Gender:Female  Submitted:2011-11-18, Days after onset: 11
Location:Foreign  Entered:2011-11-21, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0762675A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA133A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Pupillary disorder, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad)
Write-up: This case was reported by a physician via a regulatory authority (ES-AGEMED-217582335) and described the occurrence of blurred vision in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 7 November 2011, the subject received unspecified dose of CERVARIX (intramuscular, injection site unknown). On 7 November 2011, less than one day after vaccination with CERVARIX, the subject experienced blurred vision and intermediate pupil responsive. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, the outcome of the events was unspecified. No further information is expected, the regulatory authority has provided GSK with all the available information for the time being, if they ever get any further information they will send it to GSK.

VAERS ID:443264 (history)  Vaccinated:2011-11-12
Age:14.0  Onset:2011-11-12, Days after vaccination: 0
Gender:Female  Submitted:2011-11-22, Days after onset: 10
Location:Foreign  Entered:2011-11-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 12Nov2011, 84/-mmHg; Blood pressure, 12Nov2011, 96/60mmHg; Body temperature, 12Nov2011, 37.3deg.C
CDC 'Split Type': B0763542A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149BA1IMRA
Administered by: Other     Purchased by: Other
Symptoms: Depressed level of consciousness, Pallor, Presyncope, Pulse pressure decreased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of vasovagal reaction in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 12 November 2011, at 18:00, the subject received 2nd dose of CERVARIX (0.5 ml, intramuscular, right upper arm), in sitting position. On 12 November 2011, at 18:02, 2 minutes after vaccination with CERVARIX, the subject stood up while she was massaging the inoculation site. When the subject was moving, she suddenly began to have facial pallor and collapsed. The subject presented with decreased consciousness and weak pulse, and the blood pressure was 84 mmHg. There was no urticaria, no respiratory symptoms. Although the subject still had facial pallor, the consciousness started to be lucid. The subject was kept at rest on a bed and received treatment with oxygen (2L/min). On 12 November 2011, at 18:15, the subject had blood pressure of 94/60 mmHg, improved complexion and lucid consciousness with body temperature of 37.3 C?. After a 30-minute observation of the course, vital signs were examined and the subject went home. The physician considered the events were clinically significant (or requiring intervention). On 13 November 2011, the events were resolved. The physician considered the event vasovagal reflex was related to vaccination with CERVARIX.

VAERS ID:443270 (history)  Vaccinated:2011-07-25
Age:14.0  Onset:2011-07-25, Days after vaccination: 0
Gender:Female  Submitted:2011-11-22, Days after onset: 120
Location:Foreign  Entered:2011-11-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 25Jul2011, 104/50mm Hg; Blood pressure, 25Jul2011, 94/56mm Hg; Pulse rate, 25Jul2011, 71/min.
CDC 'Split Type': B0736147A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA138AC0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Eye irritation, Headache, Pallor, Photopsia, Presyncope
SMQs:, Anticholinergic syndrome (broad), Corneal disorders (broad), Retinal disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of vasovagal reaction in a 14-year-old subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 25 July 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, unknown injection site). On 25 July 2011, less than one day after vaccination with CERVARIX, the subject experienced pale lips, visual flashes and headache. On 25 July 2011, the events were resolved. The healthcare professional considered the events were related to vaccination with CERVARIX. Follow-up information received on 28 July 2011 from a physician. On 25 July 2011, at 17:45, the subject received 1st dose of CERVARIX (.5ml, intramuscular, unknown injection site). On 25 July 2011, 15 minutes after vaccination with CERVARIX, the subject experienced pale lips, irritated eyes, visual flashes and headache. After recumbency of 6 minutes, headache was improved and the pale lips was resolved. After about 30 minutes, the subject went back home. A vasovagal reflex was suspected. Follow up information received on 14 November 2011. The case has been upgraded to serious. The final diagnosis was vasovagal reaction. The reporter considered the events were clinically significant or required intervention.

VAERS ID:443821 (history)  Vaccinated:2011-08-20
Age:14.0  Onset:2011-08-20, Days after vaccination: 0
Gender:Female  Submitted:2011-11-28, Days after onset: 100
Location:Foreign  Entered:2011-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 20Aug2011, decreased
CDC 'Split Type': B0746868A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143CA IMAR
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Feeling abnormal, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of vasovagal reaction in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 20 August 2011, the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, unknown deltoid). On 20 August 2011, less than one day after vaccination with CERVARIX, the subject experienced feels poorly and decreased blood pressure. At the time of reporting, the events were improved. The physician considered the events were related to vaccination with CERVARIX. Additional information received on 18 November 2011. On 18 November 2011, this case was upgraded to serious adverse event. On 20 August 2011, five minutes after the patient had received inoculation of CERVARIX, the subject experienced feeling poorly and decreased blood pressure. One hour later, the symptoms had improved. The reporter considered the event as clinically significant/requiring intervention. It was reportedly assessed by the reporting physician that the events were caused by vasovagal reflex.

VAERS ID:443945 (history)  Vaccinated:2011-06-23
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2011-11-23
Location:Foreign  Entered:2011-11-28, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': D0073391A
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARILRIX)GLAXOSMITHKLINE BIOLOGICALSA70CB23A0SCLA
Administered by: Other     Purchased by: Other
Symptoms: Muscle spasms, Pyrexia, Retinal haemorrhage, Tremor
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Retinal disorders (narrow)
Write-up: This case was reported by a physician and described the occurrence of retinal bleeding in an approximately 15-year-old female subject who was vaccinated with VARILRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose of VARILRIX (unknown route and application site). At an unspecified time after vaccination with VARILRIX, the subject experienced retinal bleeding, spasmodic tremor (spasm, tremor) and fever. This case was assessed as medically serious by GSK. At the time of reporting, on 11 November 2011, the outcome of the events were unspecified. Follow-up information has been requested. Written follow-up information was received on 21 November 2011, from the physician. Former vaccination with HPV-vaccine was well tolerated. On 23 June 2011 the subject received 1st dose of VARILRIX (subcutaneous, left arm) and on 8 August 2011 the subject received 2nd dose of CERVARIX (intramuscular, left deltoid). At an unspecified date in 2011, after vaccination with CERVARIX and VARILRIX, the subject experienced retinal bleeding, spasmodic tremor and fever. Fever was unresolved after two days. The physician considered the events were disabling. At the time of reporting, on 15 November 2011 and spasmodic tremor was resolved and retinal bleeding was unresolved.

VAERS ID:443952 (history)  Vaccinated:2011-10-28
Age:14.0  Onset:2011-10-28, Days after vaccination: 0
Gender:Female  Submitted:2011-11-23, Days after onset: 26
Location:Foreign  Entered:2011-11-28, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 28Oct2011, 38.4deg.C
CDC 'Split Type': B0763562A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148BA1IMRA
Administered by: Other     Purchased by: Other
Symptoms: Depressed level of consciousness, Headache, Pyrexia, Vaccination complication, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of depressed level of consciousness in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 28 October 2011, at 18:00, the subject received the 2nd dose of CERVARIX (0.5 ml, intramuscular, right upper arm). On 28 October 2011, 30 minutes after vaccination with CERVARIX, the subject experienced depressed level of consciousness, fever, vomiting and headache. On 28 October 2011, shortly after 19:00, no abnormality was observed during 30 minutes after the subject had received the inoculation of CERVARIX. The subject came home and experienced headache and pyrexia of 38.4?C while having dinner. Vomiting was also observed. She was reportedly in twilight state and transported to another hospital where she was given a diagnosis of having an adverse reaction to the vaccine by a physician of the hospital. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting, the events headache and fever were resolved and the outcome of the events vomiting and depressed level of consciousness was unspecified. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:443781 (history)  Vaccinated:2011-10-08
Age:14.0  Onset:2011-10-09, Days after vaccination: 1
Gender:Female  Submitted:2011-11-28, Days after onset: 50
Location:Foreign  Entered:2011-11-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Food allergy; Drug hypersensitivity; Urticaria; Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: X-ray, 27Oct11, lung: normal; Body temp, 09Oct11, 38 degree C; Body temp, 09Oct11, 38.5 degree C
CDC 'Split Type': WAES1111USA02803
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bronchial disorder, Chest X-ray normal, Cough, Painful respiration, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Case received from the Health Authorities on 14-NOV-2011 under the reference number BX2011213. Case medically confirmed. A 14-year-old female patient had received the first dose of GARDASIL (batch number not reported) on 08-OCT-2011. The following day, i.e. on 09-OCT-2011, she experienced respiratory discomfort, cough and fever at 38 degree C to 38.5 degree C. The patient was seen by her treating physician. She was prescribed sulfamethoxazole trimethroprime, roxithromycin, ibuprofen and paracetamol to treat bronchopathy. The patient''s condition improved on 18-OCT-2011. She had a lung X-ray on 27-OCT-2011 which was normal. Her general condition improved on 27-OCT-2011. To be noted that the patient had a history of allergy to amoxicillin, transient food allergy and urticaria. At the time of reporting the patient was recovering. Upon medical review the company judged relevant to code the following adverse event: "Bronchopathy" (Med DRA LLT) which was mentioned by the CA in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reaction(s) and vaccination as doubtful (C1 S1 11) according to the method of assessment. Other business partner numbers included E2011-07146.

VAERS ID:444539 (history)  Vaccinated:2011-07-22
Age:14.0  Onset:2011-07-24, Days after vaccination: 2
Gender:Female  Submitted:2011-12-05, Days after onset: 134
Location:Foreign  Entered:2011-12-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pneumonia
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 24Jul2011, 38.7deg. C; Body temperature, 25Jul2011, 39.2deg. C; Body temperature, 28Jul2011, 37.8deg. C; Influenza serology, 25Jul2011, positive
CDC 'Split Type': B0736440A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA129CA2IMAR
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Influenza virus test positive, Pneumonia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: This case was reported by a pharmacist and a physician and described the occurrence of pneumonia in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 22 July 2011, the subject received 3rd dose of CERVARIX (.5 ml, intramuscular, unknown deltoid, batch number not provided). On 24 July 2011, 2 days after vaccination with CERVARIX, the subject experienced fever. At the time of reporting, the event was resolved. Follow-up information received on 10 August 2011: The batch number was added. On 24 July 2011, the body temperature was 38.7 Deg. C. On 25 July 2011, the body temperature was 39.2 Deg. c. The subject presented to an internal medicine department of another hospital. She was tested positive for influenza and received treatment with CALONAL and FLOMOX. On 28 July 2011, fever persisted with the body temperature at 37.8 Deg. w and the subject was prescribed with LOXONIN. At the time of reporting, the outcome of the events was unspecified. The reporter considered the event was unrelated to vaccination with CERVARIX. The fever was considered to be related to pneumonia.

VAERS ID:444746 (history)  Vaccinated:2008-11-13
Age:14.0  Onset:2008-11-13, Days after vaccination: 0
Gender:Female  Submitted:2011-12-06, Days after onset: 1118
Location:Foreign  Entered:2011-12-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: WBC count, 13Nov11, 6.3 g/l; blood glucose, 13Nov11, 3.9 mmol/l; blood glucose, 13Nov11, 9.2 mmol/l; hemoglobin, 13Nov11, 114 g/l
CDC 'Split Type': WAES1112USA00062
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0933U IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood glucose increased, Cardiopulmonary failure, Coma scale normal, Depressed level of consciousness, Dizziness, Fatigue, Feeling cold, General physical health deterioration, Haemoglobin normal, Headache, Hypoglycaemia, Laboratory test normal, Neurological examination normal, Pallor, Syncope, Tremor, White blood cell count normal
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Case received from the health authorities (which received it from a physician on 16-DEC-2008 under the reference number 2008-04837) via the local site Sanofi Pasteur MSD. Case medically confirmed. A 14 year old female patient on an empty stomach had received a 0.5 ml dose of GARDASIL (batch number NH46090, lot number: 0933U) via intramuscular route on 13-NOV-2008 at 9 am at school. After 20 minutes of a routine observation, the patient went back to her classroom and once there, she started to develop increasing dizziness. Forty five to sixty minutes after vaccination, she reported to the doctor who had vaccinated her the following events:" headache, severe dizziness, strong tremor, freezing and fatigue. The doctor noted that she was very pale. The clinical check-up showed that she was in cardiopulmonary compensation. The patient therefore layed down for about 60 minutes, conscious, covered with a blanket. She was given dextrose. After that, she went back to her classroom even though she as still feeling slightly dizzy. About 30 minutes later, which meant about 2 hours/2 hours and a half after vaccination, she suffered of a collapse, apparently without losing consciousness. When the rescue services arrived, they measured hypoglycemia (blood glucose in lower normal range) at 3.9 mmol/L the patient was taken to hospital by ambulance, due to clouded consciousness of unclear origin (according to the ambulance report), and she was admitted to the emergency unit. The diagnosis there was a suspected vasovagal syncope after HPV vaccination. Status: 14 year old female patient in reduce general condition. GCS at admission 14. No lymphadenopathy Hear: pure hear sounds, no murmurs lung: normal auscultation abdomen: soft pain-free, normal bowel sounds flanks not tender to percussion neurology: no meningism pupils of equal size and equal reaction. Normal eye following movement cranial nerves unremarkable. All tendon reflexes symmetrically elicitable. Sensorimotor function of the extremities normal. Could hold her arms up without them drooping. Babinski negative on both sides. Lab values on 13-NOV-2011: hemoglobin 114 g/l, leucocytes 6.3 g/l, glucose: 3.9 mmole/l 9.3 mmole/l. At the hospital, the case was assessed as follow: the patient was brought reduced general condition, her cardiopulmonary system was stable. Laboratory chemical test showed that the inflammatory signs were not elevated. In the course, her cardiovascular parameters were unremarkable. So the patient was discharged home. The symptoms were interpreted as vasovagal syncope after a GARDASIL vaccination, but whether it was a direct adverse drug reaction to the vaccine remained unclear. The health authorities assessed the causal relationship between the symptoms and the vaccination as probable. To be noted that the health authorities assessed the causal relationship between the collapse and the administration of GARDASIL as possible, since the patient''s blood glucose level was at the lower limit of normal. At the time of the reporting, the patient had recovered. Upon internal review, the company judged relevant to code "suspected vasovagal syncope" which was reported by HA in the SCC but not coded. Circulatory collapse, chills, dizziness, fatigue, feeling cold, headache, pallor and presyncope were considered to be an other important medical event by the agency. Other business partner numbers include # E2011-07552. No further information is available.

VAERS ID:445370 (history)  Vaccinated:2011-09-28
Age:14.0  Onset:2011-09-28, Days after vaccination: 0
Gender:Female  Submitted:2011-12-13, Days after onset: 76
Location:Foreign  Entered:2011-12-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 28Sep2011, 110/70mmHg
CDC 'Split Type': B0763561A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA129CA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Fall, Loss of consciousness, Pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of syncope in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 28 September 2011, the subject received the 1st dose of CERVARIX (intramuscular, left upper arm). On 28 September 2011, less than one day after vaccination with CERVARIX, the subject experienced syncope. The physician considered the event was clinically significant (or requiring intervention). On 28 September 2011, the event was resolved. The physician considered the event was related to vaccination with CERVARIX. Additional information received on 06 December 2011: The subject had no past history of loss of consciousness. The subject was in the sitting position, immediately after the inoculation. The subject had painful/emotional stimulus before the onset of the event, pain was a triggering event. There was no sign or warning regarding the episode, no sweat or warmth feeling before the event. The event developed suddenly. The subject was just about falling forward, so she was supported. She lost consciousness for a few seconds (1-2 seconds). The subject''s respiratory pattern was normal, her movement was normal. There was no tongue biting. Blood pressure was 110/70 mmHg. The subject did not receive any medication and did not undergo any special test. The event improved while she remained in the sitting position. No symptom developed after the patient recovered from loss of consciousness and the subject remembered the event. The event did not recur.

VAERS ID:445723 (history)  Vaccinated:2011-08-19
Age:14.0  Onset:2011-08-19, Days after vaccination: 0
Gender:Female  Submitted:2011-12-16, Days after onset: 119
Location:Foreign  Entered:2011-12-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 19Aug2011, 104/60mmHg; Blood pressure, 19Aug2011, 90/54mmHg
CDC 'Split Type': B0744086A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143CA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Bed rest, Blood pressure decreased, Dizziness, Dizziness postural, Feeling abnormal, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of decreased blood pressure in a 14-year-old female subject who was vaccinate with CERVARIX (GlaxoSmithKline). On 19 August 2011, the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, left upper arm). On 19 August 2011, less than one day after vaccination with CERVARIX, the subject experienced decreased blood pressure, feels poorly and dizziness on standing up. On 19 August 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX. Additional information received on 20 September 2011. On 20 September 2011, this case was upgraded from non serious to serious adverse event. On 19 August 2011, after inoculation of CERVARIX, the subject complained of feeling poorly with lightheadedness while she was sitting. Blood pressure measurement was at 90/54 mmHg, and 30 minutes later, at 104/60 mmHg. The patient was recovered with 30-minute bed rest. The reporter considered that the event was probably a symptom of vasovagal reaction caused by the intramuscular inoculation of CERVARIX.

VAERS ID:445921 (history)  Vaccinated:2011-12-03
Age:14.0  Onset:2011-12-03, Days after vaccination: 0
Gender:Female  Submitted:2011-12-19, Days after onset: 16
Location:Foreign  Entered:2011-12-20, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Blood pressure measurement, 03Dec11, 87 mmHg, systolic; Blood pressure measurement, 03Dec11, 54 mmHg, diastolic; Blood pressure measurement, 03Dec11, 91 mmHg, systolic; Blood pressure measurement, 03Dec11, 68 mmHg, diastolic; Blood pressure measurement, 03Dec11, 95 mmHg, systolic; Blood pressure measurement, 03Dec11, 56 mmHg, diastolic; Blood pressure measurement, 03Dec11, 69 mmHg, diastolic; Blood pressure measurement, 03Dec11, 62 mmHg, diastolic; Blood pressure measurement, 03Dec11, 94 mmHg, systolic; Total heartbeat count, 03Dec11, 48 min; Total heartbeat count, 03Dec11, 53 min; Total heartbeat count, 03Dec11, 50 min; Total heartbeat count, 03Dec11, 49 min
CDC 'Split Type': WAES1112USA00858
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1336Z1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure decreased, Cold sweat, Cyanosis, Depressed level of consciousness, Nausea, Pallor, Shock
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 14 year old 7 month old female patient with no primary disease, concurrent conditions or past medical history, who on 03-DEC-2011 (AM 11:50) was intramuscularly vaccinated with the second 0.5 ml dose of GARDASIL into left upper arm (Lot number 1336Z batch # 9QN01R). No other vaccine was injected at the same time. No information on concomitant medication was provided. On 24-SEP-2011, the patient was vaccinated with the first injection of GARDASIL. No adverse reaction occurred. On 03-DEC-2011, the patient had a lack of sleep because of term-end examination, and also this day was right after end of her period. At 11:50, the patient was intramuscularly vaccinated with the second injection of GARDASIL (as stated above). At 12:00, after taking approximately 5-10 minutes of rest following vaccination, she complained of queasy and nausea, developed cold sweat, decreased consciousness level and cyanosis condition and had facial pallor and pale lips. She was immediately laid down on a bed and treated with emergency drip infusion of RINDERON added to lactate Ringer (500 cc). When the drip infusion was started, blood pressure was 87/54, pulse was 48 and pulsation was weak. At 12:08, 10 minutes after initiation of drip infusion, her consciousness gradually recovered. Blood pressure was 91/50 and pulse was 53. Her lips gradually recovered. At 12:26, 20 minutes after initiation of drip infusion, blood pressure was 95/62 and pulse was 50. At 12:30, blood pressure was 94/69 and heart rate was 49. At 12:40, 40 minutes after drip infusion, the needle was removed (330 cc was administered). At 12:50, 50 minutes after initiation of drip infusion, blood pressure was 100/86. The patient went home with her father who was there to accompany her. On 04-DEC-2011, shortly after 11:00, confirmation was obtained from the patient''s younger brother. The patient had gone out with her mother. She was recovering from the events (also reported as recovered). Comment: In the past, no adverse reaction occurred at the time of vaccination (Diphtheria/Tetanus vaccination) when she was a child and vaccination of the first injection of GARDASIL but adverse reaction occurred this time, which was surprising. Transporting the patient to a hospital was temporarily considered. Seriousness of the events was judged as serious and causal relationship was judged as related. Physician did not want to perform the third injection of this vaccination. The reporting physician felt that pallor facial, blood pressure decreased, shock like symptom and cyanosis were definitely related to GARDASIL. The reporting physician considered that pallor facial, blood pressure decreased and shock-like symptom were serious due to life threatening. A priority lot check has been initiated. Additional information has been requested.

VAERS ID:446101 (history)  Vaccinated:2011-07-23
Age:14.0  Onset:2011-07-23, Days after vaccination: 0
Gender:Female  Submitted:2011-12-22, Days after onset: 152
Location:Foreign  Entered:2011-12-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 23Jul2011, 90/45 mmHg; Blood pressure, 23Jul2011, 104/53mmHg; Pulse rate, 23Jul2011, 57 beats/minute; Pulse rate, 23Jul2011, 67 beats/minute
CDC 'Split Type': B0742363A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA138AC IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Depressed level of consciousness, Fall, Hypotonia, Injection site pain, Loss of consciousness, Pain, Pallor, Presyncope, Respiratory rate increased, Syncope, Vagus nerve disorder
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician and described the occurrence of decreased level of consciousness in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 23 July 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, unknown arm, batch number not provided). On 23 July 2011, less than one day after vaccination with CERVARIX, the subject experienced syncope. The physician considered the event was clinically significant (or requiring intervention). On 23 July 2011, the event was resolved. The physician considered the event was related to vaccination with CERVARIX. Follow-up information received on 12 September 2011: The vaccine was given into the left arm and batch number was provided. Follow-up information received on 13 December 2011: The subject had no family history or medical history such as cardiac disease, epilepsy, metabolic abnormality (such as diabetes mellitus), or allergy (such as vaccine-induced allergy, vaccine-component-induced allergy, food allergy, allergic rhinitis, eczema, or asthma, etc.). The subject had no past history of loss of consciousness. No concomitant medication was reported. Before the onset of the events, the subject was in a sitting position. The subject had no predisposing factor. She had no sign or warning regarding the episode. The subject did not have sweat or warmth feeling before the event. The events occurred suddenly. The subject had a painful/emotional stimulus before the onset of the event. On 23 July 2011, the subject also experienced pain during injection, pallor complexion, flaccidity, depressed level of consciousness, vasovagal reaction, fall, decreased blood pressure, loss of consciousness for a few seconds because of vagus nerve and slightly fast respiration. The subject regained consciousness without being particularly treated with medication. The subject had no tongue biting. No treatment was provided. The subject recovered while she was in the supine position. The blood pressure was 90/45 mmHg, and the pulse rate was 57 beats/minute. After recovery, the blood pressure was 104/53 mmHg and the pulse rate was 67 beats/minute. No symptom occurred after the subject recovered from loss of consciousness. The subject did not remember anything regarding loss of consciousness. The subject did not undergo special test. The events did not recur. The reporter considered the events were related to CERVARIX.

VAERS ID:446103 (history)  Vaccinated:2011-10-19
Age:14.0  Onset:2011-10-20, Days after vaccination: 1
Gender:Female  Submitted:2011-12-22, Days after onset: 63
Location:Foreign  Entered:2011-12-22
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Food allergy
Diagnostic Lab Data: UNK
CDC 'Split Type': B0765033A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148BA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad)
Write-up: This case was reported by a physician and described the occurrence of injected limb mobility decreased in a female subject of unspecified age who was vaccinated with CERVARIX. The subject''s medical history included food allergy. On 19 October 2011 the subject received unspecified dose of CERVARIX (.5 ml, intramuscular). On 19 October 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced injected limb mobility decreased. At the time of reporting the outcome of the event was unspecified. The physician considered the event was related to vaccination with CERVARIX. Follow-up information received on 14 December 2011: The case was upgraded to serious. On 20 October 2011, 1 day after vaccination with CERVARIX, the subject experienced injected limb mobility decreased and myalgia. The physician considered the events were disabling. The subject was treated with LOXONIN and electrotherapy at her regular orthopedic clinic on an irregular basis. At the time of reporting, the outcome of the events was unspecified.

VAERS ID:446607 (history)  Vaccinated:0000-00-00
Age:14.0  Onset:2009-04-01
Gender:Female  Submitted:2011-12-27, Days after onset: 1000
Location:Foreign  Entered:2012-01-03, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Pap test, Apr09, PAP II; Pap test, Dec09, PAP IIK; Pap test, Mar10, PAP IID; Pap test, Nov10, PAP II; Pap test, 11, abnormal results (no otherwise specified); Human papillomavirus DNA hybridization, 11, positive for HPV high risk; Pap test, May11, PAP IID; Pap test, Aug11, PAP IID
CDC 'Split Type': WAES1104USA02252
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Smear cervix abnormal
SMQs:, Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad)
Write-up: Case received from a health professional on 29-MAR-2011. Case medically confirmed. A 13 year old female virgin patient had received a complete immunization series with three doses of GARDASIL (lot # not reported, injection route and site not reported) on unspecified dates in 2007. At the age of 16 years, in year 2011, a PAP smear test revealed abnormal results (no otherwise specified). Hybrid capture test 2 was positive for HPV high risk. Further smear tests were planned for the next months. At the time of reporting, the patient''s outcome was not recovered. Follow-up on 21-OCT-2011. The reporter was contacted by letter. It was reported that no further smear test was carried out. At the time of reporting, the patient''s outcome was unknown. Follow-up was received on 19-DEC-2011. The case was also forwarded by HA on 19-DEC-2011 (reference number PEI2011041090). New event of PAP IIID was added. In APR-2009, when the patient was 14 years old, a smear test showed PAP class II. Further controls showed the following: December 2009 - PAP IIK (repetition for control/monitoring) ; Mar 2010 - PAP IIID; November 1010- PAP II; May 2011- PAP IIID; August 2011 - PAP IID. At the time of the report the outcome was not reported. The HA assessed the seriousness criteria to be medically significant. Other business partner numbers included E2011-02087. Case was closed.

VAERS ID:446636 (history)  Vaccinated:2011-09-28
Age:14.0  Onset:2011-09-28, Days after vaccination: 0
Gender:Female  Submitted:2011-12-27, Days after onset: 90
Location:Foreign  Entered:2012-01-03, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1112USA02124
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Abscess oral, Asthenia, Candidiasis, Confusional state, Decreased appetite, Fatigue, Headache, Loss of consciousness, Pyrexia, Rash, Syncope, Urinary tract infection, Visual impairment, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a blog on the internet told by the patient''s mother concerning her 14 year old daughter who at 15:45 in the afternoon of 28-SEP-2011 was vaccinated with a first dose of GARDASIL (lot# unspecified) without her mother''s consent or knowledge. By 16:00 in the afternoon of 28-SEP-2011, the patient was on the bus to come home. She already had a stomach ache and a headache. She decided to try and rest during the 45 minute drive home. She lost consciousness. Students noticed and tried to wake her up, but when they did she acted confused. They informed the bus driver, who promptly stopped the bus and called an ambulance. She was admitted to hospital barely 2 hours after her injection. She had no memory of how she got to the hospital other than she recalled waking up in the ambulance. The hospital staff said there was no link between her condition and the vaccine. They recommended consulting an allergist. The future brought fever, rash, fainting, fatigue, weakness, headaches, stomach pains and more consultations. She was now being treated for a urinary infection, abscesses in her mouth and oral candidose. Day after day she had to deal with them. She had no more appetite and had lost weight. This girl, who had been to an ophthalmologist every year since she was two years old and exhibited perfect vision, had now been told she would have to wear glasses because of her deteriorating vision. The doctor from a Health Agency told them there was no link between her symptoms and GARDASIL. Furthermore, the Health Agency said that the patient was sick and had all of those symptoms prior to vaccination. At the time of reporting, nearly two months after the first shot of GARDASIL, the patient still had headaches that would not go away, the outcomes of other adverse events were unknown. Additional information is not expected. The patient was admitted to hospital.

VAERS ID:446888 (history)  Vaccinated:1995-06-06
Age:14.0  Onset:1995-12-03, Days after vaccination: 180
Gender:Female  Submitted:2012-01-05, Days after onset: 5877
Location:Foreign  Entered:2012-01-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No relevant medical history
Diagnostic Lab Data: UNK
CDC 'Split Type': B0771771A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Appendicitis
SMQs:
Write-up: This case was reported by a foreign regulatory authority (RN20100525) and described the occurrence of appendicitis in a 15-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Previous vaccinations included first and second doses of ENGERIX B given on 10 November 1994 and 09 December 1994. Medical history was unspecified. On 06 June 1995, the subject received a third dose of ENGERIX B (intramuscular, batch and injection site unknown). On 03 December 1995, i.e. about six months after vaccination with ENGERIX B, the subject was hospitalized for appendicitis. Clinical course was favorable. At the time of reporting, appendicitis was resolved without sequelea. According to the agency, based on the method of assessment, the causal relationship between appendicitis and vaccination with ENGERIX B was considered unlikely.

VAERS ID:446933 (history)  Vaccinated:2011-02-07
Age:14.0  Onset:2011-02-07, Days after vaccination: 0
Gender:Female  Submitted:2012-01-05, Days after onset: 332
Location:Foreign  Entered:2012-01-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1201USA00127
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Angina pectoris, General physical health deterioration, Immediate post-injection reaction, Infection, Injection site pain, Injection site reaction, Myalgia, Sinusitis
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Hypersensitivity (narrow)
Write-up: Case received from the Health Authorities on 28-DEC-2011 under the reference number PB20111115. Case medically confirmed. Case reported to the Health Authorities by the patient''s mother. A 15-year-old female patient had received intramuscularly the first and second doses of GARDASIL (batch number and dose not reported) on 23-DEC-2010 and 07-FEB-2011. Immediately after the second dose, she experienced intermittent localized muscle pain in the left deltoid (vaccination side) with periods of interruption and resumption, independently from any sports activity. On an unspecified onset of time, she developed severe pain at the injection site that lasted 3 weeks. Besides, she was found with a reduced general condition. She experienced recurrent infections characterized by sinusitis and repeated angina''s since April 2011. She also had difficulties practicing sports. At the time of reporting, the patient had not recovered. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 11) according to the foreign method of assessment. The reduced general conditions, recurrent infection, pain at injections site and localised muscle pain were considered as other important medical events. Other business partner number included E2011-08504.

VAERS ID:447320 (history)  Vaccinated:2011-11-29
Age:14.0  Onset:2011-11-29, Days after vaccination: 0
Gender:Female  Submitted:2012-01-12, Days after onset: 44
Location:Foreign  Entered:2012-01-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1201USA00454
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NN08930 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dysphagia, Headache, Hypoaesthesia, Nervousness, Oedema peripheral, Throat irritation
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported from the Health Authorities (reported to them by a health care professional) on 02-JAN-2012 under the reference number ES-AGEMED-807851242. The case was medically confirmed. A 14 year old female patient received a dose of GARDASIL (Batch # G004222; Lot # NN08930) (site of administration not reported), via intramuscular on 29-NOV-2011 and on the same day, the patient presented with edema in hands, headache, itchy throat, numbness, nervousness and dysphagia. The patient received corrective treatment with URBASON injectable (exact route not reported, dose not reported) and POLARAMINE (route not reported, dose not reported) (start and stop dates not reported). The patient recovered from all adverse events on 02-DEC-2011, except from dysphagia, on 04-DEC-2011. The case was reported as serious by the Health Authorities with other medically important condition as criteria. Other business partner numbers include: E2012-00010. No further information is available.

VAERS ID:447557 (history)  Vaccinated:2011-08-01
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2012-01-18
Location:Foreign  Entered:2012-01-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Eye Disorder
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0775699A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Intraocular pressure increased, Surgery
SMQs:, Glaucoma (narrow)
Write-up: This case was reported by a pharmacist and described the occurrence if intraocular pressure increased in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included eye disorder. Concurrent vaccination included CERVARIX, 1st dose, given in July 2011. In August 2011, the subject received 2nd dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). At an unspecified time after vaccination with CERVARIX, the subject experienced intraocular pressure increased. The subject''s mother informed the reporting physician that because intraocular pressure kept increasing after the second inoculation, the patient underwent an operation. The name of the disease was unknown. The subject originally had a history of consulting the department of ophthalmology. The pharmacist considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified.

VAERS ID:447690 (history)  Vaccinated:2011-12-12
Age:14.0  Onset:2011-12-13, Days after vaccination: 1
Gender:Female  Submitted:2012-01-20, Days after onset: 38
Location:Foreign  Entered:2012-01-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Electroencephalogram, 05Jan2012, not available
CDC 'Split Type': B0770197A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148BA IMRA
Administered by: Other     Purchased by: Other
Symptoms: Depressed level of consciousness, Electroencephalogram, Fall, Loss of consciousness, Malaise, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 12 December 2011, the subject received unspecified dose of CERVARIX (intramuscular, right upper arm). On 13 December 2011, 1 day after vaccination with CERVARIX, the subject experienced syncope. The physician considered the event was clinically significant (or requiring intervention). On 13 December 2011, the event was resolved. Follow-up information received on 22 December 2011: On 12 December 2011, at 04:30 PM the subject received unspecified dose of CERVARIX (0.5 mL, intramuscular, right deltoid). On 13 December 2011 at 10:00 AM, 18 hours after vaccination with CERVARIX, the subject experienced loss of consciousness and syncope. Subsequently the events resolved. It was unknown how long she lost consciousness. Follow-up information received on 12 January 2012: The subject had no past history of loss of consciousness, no presence of signs of alarm regarding the episode. The subject did not experience any emotional or painful stimulation, and no sweating or warmth feeling was observed before the onset of the events. On 13 December 2011, 18 hours after vaccination with CERVARIX, when the subject was sitting during she observed physical education class, she suddenly fell forward in sitting position and lost conscious for approximately 1 minute. She didn''t remember anything regarding the event. The same day, when she recovered from loss of consciousness, she experienced malaise which resolved the same day. On 13 December 2011, one day after vaccination with CERVARIX, the subject experienced depressed level of consciousness which resolved the same day. She did not bite her tongue. Subject''s vital signs were not measured. No treatment was given. Loss of consciousness didn''t reoccur. On 5 January 2012, an electroencephalogram was performed and the results were scheduled to be available on 13 January 2012.

VAERS ID:447914 (history)  Vaccinated:2008-10-07
Age:14.0  Onset:2008-10-10, Days after vaccination: 3
Gender:Female  Submitted:2012-01-24, Days after onset: 1201
Location:Foreign  Entered:2012-01-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Alanine aminotransferase, 10Nov2008, 208U/L; Alkaline phosphatase, 10Nov2008, 881U/L; Aspartate aminotransferase, 10Nov2008, 174U/L; Blood Eosinophils, 10Nov2008, 9.5%; Blood Monocytes, 10Nov2008, 6.5%; C-reactive protein, 10Nov2008, 73MG/L; Erythrocyte sedimentation rate, 10Nov2008, 90MM/H; Gamma-glutamyltranspeptidase, 12Nov2008, 796U/L; Hemoglobin, 10Nov2008, 116G/L; IgG, 12Nov2008, 18.38G/L; IgM, 12Nov2008, 1.95G/L; Lymphocytes, 10Nov2008, 10.0%; Plasma bilirubin, 10Nov2008, 37mcmol/L; Platelet count, 10Nov2008, 520E9/L; White blood cell count, 10Nov2008, 14.8E9/L; p-ANCA increased, 12Nov2008, 160TITTERI
CDC 'Split Type': R0000877B
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Alanine aminotransferase increased, Antineutrophil cytoplasmic antibody increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood immunoglobulin G decreased, Blood immunoglobulin M decreased, C-reactive protein increased, Cholangitis sclerosing, Colitis ulcerative, Colonoscopy abnormal, Eosinophil percentage increased, Gamma-glutamyltransferase increased, Haemoglobin increased, Infection, Lymphocyte percentage decreased, Monocyte percentage increased, Platelet count increased, Pyrexia, Red blood cell sedimentation rate increased, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (narrow), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal ulceration (narrow), Infectious biliary disorders (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Vasculitis (broad), Hypersensitivity (broad)
Write-up: This female subject was enrolled in a prophylactic study which is open or single blind according to communities. On 10 September 2008 and 07 October 2008, the subject received the 1st and 2nd dose of HPV (IM deltoid). On 10 October 2008, three days after the 2nd dose of HPV 16-18, this 14-year-old subject developed ulcerative colitis and primary sclerosing cholangitis. The subject was hospitalised. The subject was treated with mesalazine, prednisolone and ursodeoxycholic acid. The events were unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the ulcerative colitis and primary sclerosing cholangitis may have been caused by HPV 16-18. Investigator Comments: The subject had in the middle of October fever and abdominal pain, and was hospitalized for these on Nov 13 2008. Lab findings suggested an acute infection with hepatic afficion. Ulcerative colitis was identified in colonoscopy and the diagnosis: Colitis ulcerosa with primary sclerosing cholangitis was set (Colitis ulcerosa is considered a chronic disease not resolving). She was treated with ASACOL 800 mgx2, and Prednisolon 40 mg/day with decreasing doses (-5 mg/week). No family history or medical history or predisposing factors. The reason for considering the case as "possibly related to the investigational product" is suggestive time interval and/or lack of other major causes.

VAERS ID:448122 (history)  Vaccinated:2009-03-17
Age:14.0  Onset:2009-07-01, Days after vaccination: 106
Gender:Male  Submitted:2012-01-26, Days after onset: 939
Location:Foreign  Entered:2012-01-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: HbA1C, 31Aug2009, 8.9%; Serum glucose, 31Aug2009, 25.2MMOL
CDC 'Split Type': R0021006A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IMAR
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose increased, Glycosylated haemoglobin increased, Thirst, Type 1 diabetes mellitus, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad)
Write-up: This male subject was enrolled in the prophylactic study which is open or single blind according to communities. On 18 September 2008, 24 October 2008 and 17 March 2009, the subject received th e1st, 2nd and34d dose of control ENGERIX B (10 mcg, IM deltoid). In the course of July 2009 (exact day not available), four months after the 3rd dose of ENGERIX B, this 14-year-old subject developed type 1 diabetes mellitus. The subject was hospitalised. The subject was treated with intermediate/long-acting insulin and insulin. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the type 1 diabetes mellitus may have been caused by ENGERIX B. Relevant Risk Factors : His father and sister have IDDM, and he reports of being frequently thirsty during summer 2009. No other family history or medical history notes suggestive of predisposing factors. Investigator Comments : The subject was admitted to hospital because of high blood glucose levels in the end of August 2009 after loosing some weight during summer 2009. He had serum glucose of 25.2 and GHBA1c 8.9%, which defined the juvenile diabetes (IDDM) diagnosis. Levemir therapy (first 7+7 IU/day, thereafter 2 IU +3 IU/day) was started supplemented with Novorapid 0.5 IU/10g of dietary carbohydrates. His father and sister have IDDM, and he reports of being frequently thirsty during summer 2009. No other family history of medical history notes suggestive of predisposing factors. The reason for considering that case as "possibly related to the investigational product" is suggestive time interval and/or lack of other major causes.

VAERS ID:448130 (history)  Vaccinated:2009-04-28
Age:14.0  Onset:2010-05-02, Days after vaccination: 369
Gender:Male  Submitted:2012-01-26, Days after onset: 634
Location:Foreign  Entered:2012-01-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood Glucose, 24May2010, 24MMOL/L; Ketones, 24May2010, 0.6
CDC 'Split Type': R0021041A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose increased, Ketoacidosis, Polydipsia, Thirst, Type 1 diabetes mellitus, Urine ketone body present
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad)
Write-up: This male subject was enrolled in a study which is open or single blind according to communities. On 18 November 2008, 16 December 2008 and 28 April 2009, the subject received the 1st, 2nd and 3rd dose of control ENGERIX B (10 mcg, IM deltoid). On May 2010, 13 months after the 3rd dose of ENGERIX B, this 15-year-old subject experienced insulin-dependent diabetes mellitus. The subject was hospitalised. The subject was treated with intermediate/long-acting insulin and insulin aspart. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the insulin-dependent diabetes mellitus may have been caused by ENGERIX B. Relevant Risk Factors: A cousin both mother''s and father''s side has been diagnosed wit IDDM. Investigator Comments: The subject was admitted to hospital because of increased blood glucose: 24 and mild ketoacidosis 0.6 on May 24 2010. Earlier in May thirst and polydipsia were recorder. Insulin dependent diabetes mellitus (IDDM) diagnosis was set. LEVEMIR 11IU+4-6 IU with NOVORAPID 1 IU/10g carbohydrate treatment was started. A cousin on both mother''s and father''s side has been diagnosed with IDDM, otherwise in the medical history no predisposing factors recorded. The reason for considering the case as "possibly related to the investigational product" is suggestive time interval and/or lack of other major causes. Diabetes is a chronic illness and will not be recovered.

VAERS ID:448132 (history)  Vaccinated:2009-08-18
Age:14.0  Onset:2010-01-01, Days after vaccination: 136
Gender:Female  Submitted:2012-01-26, Days after onset: 755
Location:Foreign  Entered:2012-01-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Anti-islet cell antibody, 09Jan2010, 20; Blood glucose, 09Jan2010, 17.4; Hemoglobin glycosylated, 09Jan2010, 14/1; Platelet count, 09Jan2010, 193; White blood cell count, 09Jan0201, 11.6
CDC 'Split Type': R0021057A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anti-islet cell antibody positive, Blood glucose increased, Glycosylated haemoglobin increased, Platelet count normal, Polydipsia, Polyuria, Type 1 diabetes mellitus, White blood cell count increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad)
Write-up: This female subject was enrolled in a study which is open or single blind according to communities. On 19 February 2009, 18 March 2009 and 18 August 2009, the subject received the 1st, 2nd and 3rd dose of control ENGERIX B (10 mcg, IM deltoid). On January 2010, five months after the 3rd dose of ENGERIX B, this 14-year-old subject developed type 1 diabetes mellitus. The subject was hospitalised and the event was clinically significant (or requiring intervention). The subject was treated with intermediate/long-acting insulin and insulin. The event was unresolved at the time of reporting. The investigator considered that there was a reasonable possibility that the type 1 diabetes mellitus may have been caused by ENGERIX B. Investigator Comments; The subject was admitted to hospital because of polydipsia and polyuria during the previous two weeks. Blood glucose was 17.4 and the diagnosis of type 1 diabetes was made on Jan 09 2010. Treatment was set to LEVEMIR 11 IU and NOVORAPID 0.9 IU10 g carbohydrate. No predisposing family or medical history. The reason for considering the case as "possibly related to the investigational product" is suggestive time interval and/or lack of other major causes. "Diabetes is a chronic illness and will not be recovered".

VAERS ID:448133 (history)  Vaccinated:2008-11-26
Age:14.0  Onset:2008-12-01, Days after vaccination: 5
Gender:Female  Submitted:2012-01-26, Days after onset: 1151
Location:Foreign  Entered:2012-01-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Erythrocyte sedimentation rate, Dec2008, 25MM; Fecal calprotectin, Dec2008, 2077; Hemoglobin, Dec2008, 110G/L; Prealbumin, Dec2008, 0.20G/L; December 2008: Stool Blood: positive
CDC 'Split Type': R0020972A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 1IMAR
Administered by: Other     Purchased by: Other
Symptoms: Colitis ulcerative, Colonoscopy abnormal, Diarrhoea haemorrhagic, Faecal calprotectin, Haematochezia, Haemoglobin decreased, Occult blood positive, Prealbumin, Red blood cell sedimentation rate increased, Sigmoidoscopy abnormal
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific inflammation (broad), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)
Write-up: This female subject was enrolled in a study which is open or single blind according to communities. On 29 October 2008 and 26 November 2008, the subject received the 1st and 2nd dose of ENGERIX B (10 mcg, IM deltoid). In the course of December 2008 (exact day not available), one month after the 2nd dose of ENGERIX B, this 14-year-old subject experienced ulcerative colitis. The subject was hospitalised. The subject was treated with mesalazine, prednisolone and azathioprine. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the ulcerative colitis may have been caused by ENGERIX B. Investigator Comments: The subject was referred to hospital because of bloody diarrhoea on 18 December 2008. Laboratory findings (Dec2008): HB 110, ESR 25, pre-albumin 0.20, calprotectin 2077, blood in stools (+) were suggestive for colitis and in sigmoideoscopy on 19 December 2008 ulcerative findings that fitted Colitis ulcerosa were made, the diagnosis of which was confirmed on 19 January 2009 in colonoscopy. Asacol 800mgx3 and Prednisolon 20mgx3 treatment were started on 19 December 2008 and supplement wit Azamun 50mgx2 in 05 June 2009. No family history or relevant medical history suggestive of predisposing factors of chronic (not recovered) disease. The reason for considering the case "possibly related to the investigational product" is suggestive time interval and/or lack of other major causes. Information not available concerning other symptoms. Information not available concerning other lab tests performed (autoantibodies).

VAERS ID:448204 (history)  Vaccinated:2011-06-24
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2012-01-26
Location:Foreign  Entered:2012-01-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201200855
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERUP214AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This initial case report is part of a batch of several hundred reports associated with several products that was received on 17 January 2012 by Sanofi Pasteur affiliate in a foreign country, from the "foreign Ministry of Health" (local case reference number BR-BT2012-0016). A "14-year-11-month-29-day" old female patient, whose medical history and concomitant therapies were not reported, had received her dose of H1N1 Flu vaccine (manufactured by Sanofi Pasteur, batch number UP214AA, route and anatomical site of administration not reported) on 24 June 2011 during a campaign. On an unspecified date post-vaccination, the patient experienced "probably reflects vagal" and fainting. The patient recovered ("cure") without sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The case was "confirmed" as per the Ministry of Health, i.e. related to the vaccine. It was also reported that this case was "causality 1", i.e. "confirmed" corresponding to any clinical event that has linked plausible temporal association with administration of a vaccine and can not be explained by concurrent disease or administration of other drugs or chemicals. The Ministry of Health classified this case in category 1, i.e. Adverse Reaction Following Immunization (ARFI). Documents held by sender: none.

VAERS ID:448377 (history)  Vaccinated:2009-11-30
Age:14.0  Onset:2009-12-17, Days after vaccination: 17
Gender:Female  Submitted:2012-01-30, Days after onset: 774
Location:Foreign  Entered:2012-01-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': R0021004A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMAR
Administered by: Other     Purchased by: Other
Symptoms: Colitis ulcerative, Colonoscopy abnormal, Diarrhoea, Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)
Write-up: This female subject was enrolled in a study. On 28 October 2009 and 30 November 2009, the subject received the 1st and 2nd dose of CERVARIX (IM deltoid). On 17 December 2009, 17 days after the 2nd dose of CERVARIX, this 14-year-old subject developed ulcerative colitis. The subject was hospitalised. The subject was treated with prednisolone, mesalazine and pantoprazole. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the ulcerative colitis may have been caused by CERVARIX. Investigator Comments: The subject was admitted to hospital due to blood in loose stools, and was diagnosed in colonoscopy with Colitis ulcerosa on Dec 18, 2009. Prednisolone 50 mg/day treatment (to be gradually lowered to 20mg/day) was started together with ASACOL 1200 mg/day and Pantoprazole 20 mg/day (which was later increased to 40 mg/day and ended on 30Jul2010). Lab test two months after the disease onset/diagnosis are recorded only. No family history or medical history suggestive of predisposing factors is recorded. The reason considering the case as ''possible related to the investigational product'' is suggestive time interval and/or lack of other major causes.

VAERS ID:448380 (history)  Vaccinated:2009-04-27
Age:14.0  Onset:2010-03-01, Days after vaccination: 308
Gender:Female  Submitted:2012-01-30, Days after onset: 700
Location:Foreign  Entered:2012-01-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': R0021008A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Cataplexy, Hypersomnia, Influenza, Narcolepsy, Sleep study abnormal
SMQs:, Convulsions (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This female subject was enrolled in a prophylactic study which is open or single blind according to communities. On 17 November 2008, 15 December 2008 and 27 April 2009, the subject received the 1st, 2nd and 3rd dose of HPV (IM deltoid). In the course of March 2010 (exact day not available), same time as a dose of swine flu split dresden and 11 months after the 3rd dose of HPV 16-18, this 15-year-old subject experienced narcolepsy. The subject was hospitalised. The subject was treated with methylphenidate hydrochloride, medikinet, modafinil, clomipramine hydrochloride and sodium oxybate. The event was unresolved at the time of reporting. The investigator considered that there was a reasonable possibility that the narcolepsy may have been caused by HPV 16-18 and that the event was possibly due to the concomitant vaccination, swine flu split dresden (GlaxoSmithKline). Investigator Comments: The subject had had influenza infection in November 2009 and PANDEMRIX vaccination in March 2010, and at the same time symptoms (hypersomnia) suggestive of narcolepsy started. Sleep polygraphy (apnea/hypopnea index 0.3) was negative for apnea, cataplexy symptoms recorded, and the clinical diagnosis of narcolepsy was set on 05 June 2010. She received CONCERTA 36 mg/day and RITALIN 20 mg/day treatment. The latter was later replaced by MEDIKINET 20 mg x2. No family history or previous medical history suggestive predisposing factors for narcolepsy are recorded. The reason for considering the case as "possibly related to the investigational product" is suggestive time interval and/or lack of other major causes. Lab test results not available. Confirmed - a possibly multietiological disease.

VAERS ID:448394 (history)  Vaccinated:2011-12-26
Age:14.0  Onset:2012-01-07, Days after vaccination: 12
Gender:Female  Submitted:2012-01-30, Days after onset: 23
Location:Foreign  Entered:2012-01-31, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Body temp, 07Jan12, high fever continued for 4 days; Body temp, 08Jan12, 38 degrees C; Serum sodium, 08Jan12, 130 meq/L; Body temp, 09Jan12, 40 degrees C; Body temp, 10Jan12, 40 degrees C; Body temp, 11Jan12, 39.4 degrees C
CDC 'Split Type': WAES1201USA03302
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood sodium decreased, Conjunctival hyperaemia, Erythema multiforme, Eye discharge, Lip erosion, Pyrexia, Renal disorder, Stevens-Johnson syndrome
SMQs:, Severe cutaneous adverse reactions (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal ulceration (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hyponatraemia/SIADH (narrow), Conjunctival disorders (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 14 year old female patient who on 26-DEC-2011 was intramuscularly vaccinated with GARDASIL injection syringe, 0.5mL once a day, (injection site and lot number unknown). The patient had no primary disease, concurrent conditions or past medical history. No information on concomitant medications has been provided. On an unspecified date, the patient received GARDASIL at another hospital (as stated above). On 07-JAN-2012, the patient developed pyrexia (high fever continued for 4 days). On 08-JAN-2012, body temperature 38 degrees C. On 09-JAN-2012, body temperature 40 degrees C. On 10-JAN-2012, body temperature 40 degrees C. On 11-JAN-2012, body temperature 39.4 degrees C. On a specified date, the patient was urgently admitted to the reporting physician''s hospital because of Stevens-Johnson syndrome. At the time of the report, the patient was recovering but remained hospitalized. The outcome of Stevens-Johnson syndrome was "recovering". During the course: Dermatological findings were seen (erythema multiforme (more than 10% of body surface)). There was no information about skin biopsy. Mucosal findings were seen (conjunctival hyperaemia, eye discharge, lip erosion), and which spread from the eyes and the limbs to the whole body. Simple herpes viral infection was unknown, and there was no mycoplasma infection. Renal disorder was seen (Na 130). Physician''s comment: The causal relationship was unclear but the possibility was high because it was a single administration of GARDASIL. The reporting physician felt that Stevens-Johnson syndrome was definitely related to GARDASIL. The reporting physician considered that Stevens-Johnson syndrome was serious due to hospitalization. Additional information has been requested.

VAERS ID:448539 (history)  Vaccinated:2009-03-10
Age:14.0  Onset:2009-09-01, Days after vaccination: 175
Gender:Female  Submitted:2012-02-01, Days after onset: 883
Location:Foreign  Entered:2012-02-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': R0020973A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Face and mouth X-ray abnormal, Irritable bowel syndrome, Joint swelling, Juvenile arthritis, Laboratory test, Nuclear magnetic resonance imaging abnormal, Synovitis, Temporomandibular joint syndrome
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Osteonecrosis (broad), Arthritis (narrow), Noninfectious diarrhoea (broad)
Write-up: This female subject was enrolled in a prophylactic study which is open or single blind according to communities. On 10 September 2008, 27 October 2008 and 10 March 2009, the subject received the 1st, 2nd and 3rd dose of HPV-16-18 (IM deltoid). On an unspecified date in September 2009, six months after the 3rd dose of HPV 16-18, this 15-year-old subject developed juvenile rheumatoid arthritis. The event was clinically significant (or requiring intervention). The subject was treated with methotrexate, SOLOMET and triamcinolone hexacetonide. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the juvenile rheumatoid arthritis may have been caused by HPV 16-18. Relevant Risk Factors: Aunt with Crohn''s disease, mother with Coeliac. Investigator Comments: The subject has had swelling of the right ankle (without synovitis) since 2000. She was diagnosed with swelling of the right elbow, MRI being positive for synovitis on 9/2009. Synovitis in the ankle and foot and x-ray findings on deformations of mandibular joints were recorded on Jun 29, 2010 when juvenile RA diagnosis was set, knees affected in 2010, Borderline ASCA level and colonoscopic Colon irritable were not diagnostic for Crohn''s disease. TREXAN (highest 20mg per week) was started on Jun 29, 2010. Mother with Coeliac, aunt with Crohn''s disease, no medical history suggestive of predisposing factors of chronic (not recovered) disease. The reason for considering the case as "possibly related to the investigational product" is suggestive time interval and/or lack of other major causes. The disease juvenile rheumatoid arthritis is considered chronic disease, no enddate. The diagnosis was based on clinical and MRI/X-ray findings and the lab tests were not specific for the diagnosis. Methotrexate treatment for this slowly progressing disease was started 9 months after the diagnosis. No other information on specific treatment is available.

VAERS ID:448850 (history)  Vaccinated:2011-09-13
Age:14.0  Onset:2011-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-02-03, Days after onset: 143
Location:Foreign  Entered:2012-02-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Paroxysmal Supraventricular Tachyca
Diagnostic Lab Data: Albumin, 19Jan2012, 4.74Units; Amylase, 19Jan2012, 35.4U/L; Antinuclear antibody, 19Jan2012, 0.38 INDICE; Basophils, 19Jan2012, 0.05M/UL; Bilirubin total, 19Jan2012, 0.56MG/DL; C-reactive protein, 19Jan2012, 0.04MG/DL; Calcium, 19Jan2012, 10.1MG/DL; Creatinine, 19Jan2012, 0.63MG/DL; ESR normal, 19Jan2012, 6MM; ESR normal, 19Jan2012, 11MM; Eosinophils, 19Jan2012, 0.17M/UL; Hemoglobin, 19Jan2012, 14.1G/DL; Lymphocyte count, 19Jan2012, 3.76M/UL; Monocytes, 19Jan2012, 0.29M/UL; Neutrophils, 19Jan2012, 3.65M/UL; Platelet count, 19Jan2012, 290x10E9/L; Potassium, 19Jan2012, 4.2MEQ/L; Red blood cell count, 19Jan2012, 5.16M/UL; Rheumatoid factor, 19Jan2012, 0UI/ML; Sodium, 19Jan2012, 143MEQ/L; Thyroid stimulating hormone, 19Jan2012, 3.21UUI/ML; Tota
CDC 'Split Type': B0778688A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Amylase decreased, Antinuclear antibody, Asthenia, Basophil count, Basophil count normal, Blood albumin normal, Blood bilirubin normal, Blood calcium normal, Blood creatinine normal, Blood potassium normal, Blood sodium normal, Blood thyroid stimulating hormone normal, Blood urea increased, C-reactive protein normal, Dermatitis, Eosinophil count increased, Haemoglobin normal, Lymphocyte count normal, Monocyte count normal, Nausea, Neutrophil count normal, Pericardial effusion, Pericarditis, Platelet count normal, Protein total normal, Pyrexia, Red blood cell count normal, Red blood cell sedimentation rate increased, Rheumatoid factor negative
SMQs:, Acute renal failure (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad)
Write-up: This case was reported by a physician via a regulatory authority (# ES-AGEMED-830002332) and described the occurrence of pericarditis in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included paroxysmal supraventricular tachycardia. On 13 September 2011 and 17 October 2011, the subject received 1st dose and 2nd dose of CERVARIX (administration site and route unknown, batch number not provided). On 20 September 2011, 7 days after vaccination with 1st dose of CERVARIX, the subject experienced abdominal pain. In the same month, she developed dermatitis. On 17 November 2011, 31 days after vaccination with 2nd dose of CERVARIX, the subject experienced pericarditis and pericardial effusion. On 20 November 2011, 34 days after vaccination with 2nd dose of CERVARIX, the subject experienced asthenia, nausea and fever. The subject was hospitalised. Albumin: 4.74 Units, Amylase: 35.4 U/L, Antinuclear antibody: 0.38 INDICE, Basophils: 0.05 M/UL, Bilirubin total: 0.56 MG/DL, Blood glucose: 66 MG/DL, C-reactive protein: 0.04 MG/DL, Calcium: 10.1 MG/DL, Creatinine: 0.63 MG/DL, ESR normal: 6 MM, ESR normal: 11 MM, Eosinophils: 0.17 M/UL, Hemoglobin: 14.1 G/dL, Lymphocyte count: 3.76 M/UL, Monocytes: 0.29 M/UL, Neutrophils: 3.65 M/UL, Platelet count: 290 x10E9/L, Potassium: 4.2 MEQ/L, Red blood cell count: 5.16 M/UL, Rheumatoid factor: 0 UI/ML, Sodium: 143 MEQ/L, Thyroid stimulating hormone: 3.21 UUI/ML, Total protein normal: 7.3 G/DL, Urea: 27 MG/DL. AT the time of reporting, abdominal pain was resolved, the other events were improved except dermatitis for which the outcome was unspecified.

VAERS ID:449029 (history)  Vaccinated:2011-12-26
Age:14.0  Onset:2011-12-26, Days after vaccination: 0
Gender:Female  Submitted:2012-02-03, Days after onset: 39
Location:Foreign  Entered:2012-02-06, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Electrocardiogram normal; Blood pressure measurement normal; Blood glucose normal.
CDC 'Split Type': WAES1201USA03721
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood glucose normal, Convulsion, Electrocardiogram normal, Immediate post-injection reaction, Incorrect route of drug administration, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Case of misuse GARDASIL administered by subcutaneous route instead of intramuscular route received from the Health Authorities (reported to them by another health care professional) on 23-JAN-2012 under the reference number: ES-AGEMED-328752344. Case medically confirmed. A 14 year old female patient had received the third dose of GARDASIL (batch # not reported) via subcutaneous on 26-DEC-2011 and on the same day, the patient developed syncope and convulsion. The patient was nervous when she went to the infirmary, according to her own words and the health care professional who saw the patient. Straight after administration the patient experienced syncope and she started with 2-3 convulsion which lasted a few seconds. The jaw tried to fit. The patient spontaneously recovered a few seconds later. The patient was evaluated by physicians. An electrocardiogram and a capillary blood glucose test were performed and the blood pressure was measured, all of them were unremarkable results. The patient was under observation for an hour. On 01-JAN-2012 the patient was evaluated by the physicians with normal results. Case reported as serious by the Health Authorities with other medically important condition as criteria. Other business partner numbers included: E2012-00456. No further information reported.

VAERS ID:448998 (history)  Vaccinated:2011-05-31
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2012-02-06
Location:Foreign  Entered:2012-02-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported.
Diagnostic Lab Data: Not reported.
CDC 'Split Type': 201111558
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER10092340UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (narrow)
Write-up: This case report is part of a batch of several hundred reports associated with Rabies Vaccine, that was received on 27 October 2011 by Sanofi Pasteur affiliate, from the "Ministry of Health" (local reference number BR-BT2012-4396). A male patient, whose medical history and concomitant therapies were not reported, received the 1st dose of Rabies vaccine (batch number 1009234, route and anatomical site of administration not reported) on 31 May 2011. On an unspecified date the patient presented hypersensitivity reaction 2 hours post vaccination. The duration of the adverse events was 3 hours. The patient was hospitalized for less than 24 hours. The patient had cured without sequelae on an unspecified date. The case status was "confirmed" (the Ministry of Health assessed the adverse events as related to the vaccine). The conduct was reported as "unknown". Documents held by sender: none. Follow-up case report is part of a batch of several hundred reports associated with several products that was received on 26 January 2012 by Sanofi Pasteur affiliate, from the "Ministry of Health" through the distributor: The patient was hospitalized on an unspecified date. The action with regards to the next vaccination was provided: "no conduct". The case was upgraded to serious due to hospitalization.

VAERS ID:449031 (history)  Vaccinated:2011-03-01
Age:14.0  Onset:2011-09-01, Days after vaccination: 184
Gender:Female  Submitted:2012-02-06, Days after onset: 158
Location:Foreign  Entered:2012-02-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Scoliosis; Congenital hip dislocation
Diagnostic Lab Data: Cardiac electrophysiology, 23Nov11, normal; Electroencephalography, 24Nov11, strictly normal with a normal somnolence and sleep for her age; Magnetic resonance imaging, 02Jan12, brain: did not find any patent anomaly; Blood pressure measurement, 10.5-10.6; Electrocardiogram; Carotid artery massage, did not show any hyper reflexivity; Electrocardiogram, normal; Ultrasound, Doppler tissue imaging screening: a mitral annulus normal; Ultrasound, Echodoppler; Holter monitoring, normal; Sleep study, 14, Epworth Sleepiness Scale; Electromyography, did not show any anomaly; Sleep study, 8-10 24H, Epworth Sleepiness Scale; Physical examinatin, normal; Blood LDH, 22Nov11, 609 IU/I; Serum beta-human chorionic gonadotropin, 22Nov11, <2 IU/I; Serum crea
CDC 'Split Type': WAES1111USA00812
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Affective disorder, Alanine aminotransferase normal, Amenorrhoea, Amnesia, Appetite disorder, Arthralgia, Arthropod bite, Aspartate aminotransferase normal, Asthenia, Back pain, Blood alkaline phosphatase normal, Blood bilirubin decreased, Blood cortisol normal, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased, Blood test normal, Borrelia test negative, Cardiac electrophysiologic study normal, Chest discomfort, Crying, Depression, Disturbance in attention, Dizziness, Dyspnoea, Dyspnoea exertional, Echocardiogram, Echocardiogram normal, Electrocardiogram ambulatory normal, Electrocardiogram normal, Electroencephalogram normal, Electromyogram normal, Electrophoresis normal, Epstein-Barr virus antibody positive, Family stress, Fatigue, Gamma-glutamyltransferase normal, General physical health deterioration, Heart rate decreased, Human chorionic gonadotropin decreased, Hyperhidrosis, Hypersensitivity, Hypersomnia, Joint lock, Laboratory test normal, Loss of consciousness, Malaise, Menstrual disorder, Movement disorder, Muscle spasms, Myalgia, Narcolepsy, Nervous system disorder, Nuclear magnetic resonance imaging brain normal, Pain in extremity, Pallor, Peripheral coldness, Postictal state, Red blood cell sedimentation rate increased, Sleep disorder, Sleep study abnormal, Social problem, Somnolence, Thyroid function test normal, Ultrasound Doppler normal, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Fertility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Information has been received from a physician on 20-OCT-2011. Case reported as serious (hospitalization and disability). Case medically confirmed. A 17-year-old female patient had received the third dose of GARDASIL (batch number not reported) on an unspecified date. One month after vaccination, the patient experienced myalgia, shortness of breath and had no more strength. At the time of reporting, the outcome was not provided. To be noted that the patient was followed by a cardiologist, and that according to the patient''s mother, the events were due to the vaccine. Follow-up information received on 24-JAN-2012: The patient was 14-year-old at the time of the events instead of 17 as previously reported. The patient had received the first dose of GARDASIL (batch number not reported) on 01-MAR-2011, the second dose (batch number NM23050) on 27-MAY-2011, and the third dose (batch number NM45890) on 29-AUG-2011. She had concomitantly received NEISVAC-C (other manufacturer, batch number VN914776) on 18-JUN-2011. Starting in the middle of September-2011, the patient was found severe asthenia, concentration impaired, appetite disorder, menstrual disorder and movements disorder. The patient also experienced narcolepsy accompanies by fine movements disorder. The disorders rapidly deteriorated. The patient was referred to a cardiologist dud to chest oppression and shortness of breath, and to a rheumatologist due to diffuse joint pain. She was subsequently hospitalized. Consultation at the cardiologist on 19-OCT-2011: The patient who used to practice high sporting activity up to the last summer presented since then severe asthenia with a need for prolonged sleep period furthermore, she also presented with malaises, some of them occurring just after practice sport with a sensation of slow heart beat which necessitated that she sat down, then followed by lipothymia without loss of consciousness. Other malaises occurred when she was in a sitting position, during the meal, or even lying down. It was difficult to assess whether she had lost consciousness. There was no familial history of heart disease, in particular no history of rhythmology anomaly which could have led to early serious events. Blood pressure was 10.5-6, hear sounds were regular, there was no sound or pathological add- on murmur. Distal pulse could be heard, there was no cervical murmur, lung auscultation was correct. Electrocardiogram showed sinusal rhythm 94/mm, PR interval 0-16, QRS axis superior to 40, supple repolarization, Q-T interval 0-28 for a theorical basis of 0-31. Carotid sinus massage did not show any hyper reflexivity. Echodoppler was reassuring with a good global and segmentary contractility and no stigma of pulmonary arterial hypertension, no shunt, no cavitary dilatation particularly left artrial. Doppler tissue imaging screening showed a mitral annulus normal. To be noted that the patient had experienced cutaneous hyper reactivity consequently to mosquito bites. The cardiologist suspected a possible tick bite which could lead to search for arguments suggestive of Lyme disease. 24h-ECG Holter monitoring was recommended. Consultation at hospital on 17-NOV-2011: The patient used to practice piano, dancing and sailing. During the last summer she had practiced sailing and cycling in a sport summer camp. To be note that the patient had started to have her periods from 9 years old to 11 years old. She now had her periods since the age of 13 under treatment with DUPHASTON which had recently been interrupted. On examination she presented with malaises with sensation for cardiac arrest. She presented with 4 malaises apparently with no prodrome, accompanied by hypersomnia (the patient slept for approximately 1 hour). When she was seen by her family and friends circle, she was found to have a sensation of white and cold hands and sweating. There was no notion of aura before these malaises, no loss of urine and no tonic-clonic movements. But the patient presented with p

VAERS ID:449133 (history)  Vaccinated:2012-01-10
Age:14.0  Onset:2012-01-12, Days after vaccination: 2
Gender:Female  Submitted:2012-02-07, Days after onset: 26
Location:Foreign  Entered:2012-02-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0778671A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVAQ82DC IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dystonia, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Dystonia (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (Agency # GB-MHRA-ADR 21461680) and described the occurrence of dystonia in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 10 January 2012 the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, Batch number AHPVA082DC, Expiry date unknown). On 12 January 2012, 2 days after vaccination with CERVARIX, the subject experienced dystonia and swollen tongue. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were improved. MHRA Verbatim Text: Medically significant: Dystonia and tongue swollen.

VAERS ID:449269 (history)  Vaccinated:2012-01-31
Age:14.0  Onset:2012-01-31, Days after vaccination: 0
Gender:Female  Submitted:2012-02-09, Days after onset: 9
Location:Foreign  Entered:2012-02-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Nuclear magnetic resonance ima, unknown
CDC 'Split Type': B0780033A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Immediate post-injection reaction, Loss of consciousness, Nuclear magnetic resonance imaging
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a pharmacist and described the occurrence of loss of consciousness in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). At an unspecified date the subject received the 1st and 2nd dose of CERVARIX (intramuscular, unknown sites of injection, batch numbers not provided). There were no problems after the first dose of vaccination with CERVARIX. At an unspecified time after the 2nd dose of vaccination with CERVARIX, the subject complained of feeling poorly a little. On 31 January 2012, the subject received the 3rd dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). On 31 January 2012, the subject lost consciousness immediately after the 3rd vaccination, but regained it as soon as she was spoken to. On 31 January 2012, less than one day after the 3rd vaccination with CERVARIX, the subject experienced headache. On 03 February 2012, the subject visited the reporting physician''s hospital and complained that headache had still persisted. She underwent magnetic resonance imaging (MRI) and CALONAL was administered. The pharmacist considered the events were clinically significant (or requiring intervention). On 31 January 2012, the event loss of consciousness had resolved. At the time of reporting the event headache was still unresolved and the outcome of the event feeling poorly was unspecified.

VAERS ID:449557 (history)  Vaccinated:2012-02-02
Age:14.0  Onset:2012-02-03, Days after vaccination: 1
Gender:Female  Submitted:2012-02-14, Days after onset: 11
Location:Foreign  Entered:2012-02-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 04Feb2012, 37.2deg. C.; White blood cell, 04Feb2012, 11200
CDC 'Split Type': B0780750A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Diarrhoea, Enterocolitis, Nausea, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a physician and described the occurrence of enterocolitis in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 2 February 2012, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site, batch number not provided). On 3 February 2012, at night, 1 day after vaccination with CERVARIX, the subject experienced enterocolitis with abdominal pain and diarrhea. On 4 February 2012, in the morning, 2 days after vaccination with CERVARIX, the subject experienced queasy feeling, vomiting and diarrhea. The subject''s body temperature was 37.2 degrees centigrade. The subject''s white blood cell count was 11200. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified.

VAERS ID:449560 (history)  Vaccinated:2011-11-15
Age:14.0  Onset:2012-01-08, Days after vaccination: 54
Gender:Female  Submitted:2012-02-14, Days after onset: 37
Location:Foreign  Entered:2012-02-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Platelet count, 4 x 10^9
CDC 'Split Type': B0780306A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA091DC1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a foreign regulatory authority (GB-MHRA-ADR 21473192) and described the occurrence of petechiae in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 29 September 2011 and 15 November 2011 the subject received the 1st (Batch number AHPVA087AD) and 2nd dose (Batch number AHPVA091DC) of CERVARIX. On 8 January 2012, 101 days after the 1st dose of CERVARIX and 54 days after the 2nd vaccination with CERVARIX, the subject experienced petechiae and idiopathic thrombocytopenic purpura. The patient had a platelet count of 4 x 10^9 (units unknown). The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. MHRA Verbatim Text: Presented with petechiae - Idiopathic thrombocytopenic purpura. Platelets 4 x 10^9. Ongoing problems.

VAERS ID:449893 (history)  Vaccinated:2011-01-19
Age:14.0  Onset:2011-01-19, Days after vaccination: 0
Gender:Female  Submitted:2012-02-20, Days after onset: 397
Location:Foreign  Entered:2012-02-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0782602A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Immediate post-injection reaction, Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a Ministry of Health via regulatory authority (# 11-03-1292A) and described the occurrence of syncope in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 19 January 2011 the subject received unspecified dose of CERVARIX (unknown route, unknown injection site). Lot number not provided. On 19 January 2011, immediately after vaccination with CERVARIX, the subject experienced syncope, giddiness and drowsiness. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX. This report was received from the foreign Regulatory Authority as part of a line-listing of several hundred reports, each containing minimal information. No further information is expected.

Result pages: prev   2380 2381 2382 2383 2384 2385 2386 2387 2388 2389 2390 2391 2392 2393 2394 2395 2396 2397 2398 2399 2400 2401 2402 2403 2404 2405 2406 2407 2408 2409 2410 2411 2412 2413 2414 2415 2416 2417 2418 2419 2420 2421 2422 2423 2424 2425 2426 2427 2428 2429 2430 2431 2432 2433 2434 2435 2436 2437 2438 2439 2440 2441 2442 2443 2444 2445 2446 2447 2448 2449 2450 2451 2452 2453 2454 2455 2456 2457 2458 2459 2460 2461 2462 2463 2464 2465 2466 2467 2468 2469 2470 2471 2472 2473 2474 2475 2476 2477 2478 2479 2480 2481 2482 2483 2484 2485 2486 2487 2488 2489 2490 2491 2492 2493 2494 2495 2496 2497 2498 2499 2500 2501 2502 2503 2504 2505 2506 2507 2508 2509 2510 2511 2512 2513 2514 2515 2516 2517 2518 2519 2520 2521 2522 2523 2524 2525 2526 2527 2528 2529 2530 2531 2532 2533 2534 2535 2536 2537 2538 2539 2540 2541 2542 2543 2544 2545 2546 2547 2548 2549 2550 2551 2552 2553 2554 2555 2556 2557 2558 2559 2560 2561 2562 2563 2564 2565 2566 2567 2568 2569 2570 2571 2572 2573 2574 2575 2576 2577 2578   next

New Search

Link To This Search Result:
http://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=2479&PERPAGE=100&ESORT=AGE


Copyright © 2014 National Vaccine Information Center. All rights reserved.
407-H Church Street, Vienna, Virginia 22180