MedAlerts Home
  Read the MedAlerts Blog Subscribe to the MedAlerts Blog 

Found 533901 cases in entire database

Case Details (Sorted by Age)

This is page 2479 out of 5340

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:170580 (history)  Vaccinated:1994-09-01
Age:8.0  Onset:1994-09-01, Days after vaccination: 0
Gender:Male  Submitted:2001-06-01, Days after onset: 2465
Location:Foreign  Entered:2001-06-06, Days after submission: 5
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: NONE
Diagnostic Lab Data:
CDC Split Type: U2001007581
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)SMITHKLINE BEECHAM  IM 
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)CONNAUGHT LABORATORIESX0195 IM 
Administered by: 0     Purchased by: 0
Symptoms: Chromatopsia, Coma, Eye movement disorder, Loss of consciousness, Nausea, Oculogyration, Visual disturbance
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), Dyskinesia (narrow), Dystonia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: "An 8 year old boy was immunized with Typhoid and Hep-A vaccine, date unknown. Two hours later, the child reported to his mother that he could see pink and green spots. He was in the back of the car at the time and when the mother turned and looked, the child appeared to have rolling eyes. The child then, possibly, lost consciousness. The mother took the child to see the PCP the same day. By the time she saw the doctor, the child had recovered and was left feeling nauseous for the rest of the day. The child recovered fully from this event. The incident occurred approx. 4 years ago and the child has not experienced any similar episodes in subsequent years. He has since received Hep-A vaccine, BCG vaccine and diphtheria-tetanus vaccine with no problems. Case is closed."

VAERS ID:174550 (history)  Vaccinated:1997-07-04
Age:8.0  Onset:1997-07-18, Days after vaccination: 14
Gender:Female  Submitted:2001-08-20, Days after onset: 1494
Location:Foreign  Entered:2001-08-22, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Gamma Glutamyl Transferase-increased; SGOT and SGPT-increased
CDC Split Type: 20010197331
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM2204C92IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Cushing's syndrome, Gamma-glutamyltransferase increased, Hepatic enzyme increased, Pyrexia, Rheumatoid arthritis
SMQs:, Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (narrow)
Write-up: The 1st and 2nd Engerix-B pediatric were well tolerated. On 7/4/97, the pt received the 3rd Engerix-B pediatric and approx. 14 days, post vax, she developed Still''s disease and a fever over 40C and was hospitalized on 07/29/1997. Still''s disease was diagnosed The vaccinee was treated with cortisone and methotrexate disodium (MTX) and developed medication induced Cushing''s syndrome. The hepatic enzymes were increased. ON 08/23/1997, the vaccinee was discharged from the hospital. The mother of the pt consulted a non-medical practitioner who stopped the treatment medication. All events resolved. On follow up the physician reported that the patient was hospitalized again six times between 08/1997 and 06/1999. The physician now reported the outcome of Still''s disease, an unknown. Most recent information received on 11/21/2001 reported that fever and Cushing''s syndrome resolved. The outcome of Still''s disease was unknown. The reporter considered that fever and Still''s disease were possibly related and Cushing''s syndrome was not related to treatment with E-B pediatric. Information received on 8/16/01, reports that the pt recovered. The mother of the pt considered that all events were due to treatment with Engerix-B pediatric. The lot used for the vaccination has been checked and no deviation in manufacturing process or qulaility tests have been found.

VAERS ID:175286 (history)  Vaccinated:2001-07-12
Age:8.0  Onset:2001-08-03, Days after vaccination: 22
Gender:Male  Submitted:2001-08-24, Days after onset: 21
Location:Foreign  Entered:2001-09-14, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Spinal Tap 08/03/01 - 98 cells / microL. CSF glucose 08/03/01 - 78 mg / dl - corresponding serum level 120 mg / dL. Cerebrospinal fluid protein test 08/03/01 - 35 mg / dL. F/U CSF-showed "elevated cell count and protein, but no germs"; F/U
CDC Split Type: WAES01081848
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1550J IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Laboratory test abnormal, Malaise, Meningitis aseptic
SMQs:, Noninfectious meningitis (narrow)
Write-up: Information has been received from a health professional concerning a 8 year old male who on 06/12/2001 was vaccinated IM with a dose of MMRII (lot # 633825/1550J; batch HL61377). On 08/03/01, this patient became ill and was hospitalized. A lumbar puncture was performed and a diagnosis of aseptic meningitis was made. The boy was treated with certriaxone and his condition rapidly improved. It was reported that the boy will be discharged when "fully recovered in the following days". It was not known if the boy had received a previous dose of MMR vaccine. It was noted that the situation was not considered to be life threatening. The reporters assessment was unassessible. FOLLOW-UP information received on 11/27/2001 from a business partner indicated that on 11/12/2001 that the lab test was available. FOLLOW-UP rerceived on 11/22/2001 indicated that according to the laboratory physician some of the lab results were reported in error. the physician confirmed that no CSF antibodies had been examined and that a technical data error had occurred. Additional information expected Other business partner numbers include I-MMR 01-013, GE 10815 and PEI 4616-2001

VAERS ID:177590 (history)  Vaccinated:2001-08-28
Age:8.0  Onset:2001-09-17, Days after vaccination: 20
Gender:Male  Submitted:2001-11-06, Days after onset: 50
Location:Foreign  Entered:2001-11-12, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: allergic asthma
Diagnostic Lab Data: 9/18/01:echodoppler-?hypogonadism; PE-inflammatory oedema of the scrotum; surgical exam-ruled out testicular torsion; testicular ultrasound-bilateral thickening of superficial envelopes: CBC and metabolic marker test-nml
CDC Split Type: WAES01101387
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 1IM 
Administered by: Other     Purchased by: Other
Symptoms: Hypogonadism male, Oedema, Orchitis, Pain, Testicular disorder
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Fertility disorders (narrow)
Write-up: On 9/17/01, the pt developed bilateral testicular pain which resulted in hospitalization on 9/18/01. It was reported that "there were no other signs associated." Upon clinical exam of the pt, there was an inflammatory oedema of the scrotum, and the testes were sensitive. During hospitalization, it was reported that the local inflammation progressively decreased with unspecified anti-inflammatory drugs. Although "few" pains were still persisting, the pt was discharged from the hospital on 9/20/01. He was treated with ibuprofen 200mg for 7 days, and it was reported that he recovered on 9/24/01. It was noted that the diagnosis was "a probable orchitis" from an undetermined etiology. No further info is available.

VAERS ID:182945 (history)  Vaccinated:1994-11-17
Age:8.0  Onset:1995-03-01, Days after vaccination: 104
Gender:Male  Submitted:2002-03-26, Days after onset: 2582
Location:Foreign  Entered:2002-03-29, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0203USA01604
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 1IM 
Administered by: 0     Purchased by: 0
Symptoms: Crohn's disease, Granuloma skin, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Gastrointestinal premalignant disorders (narrow), Ischaemic colitis (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a health authority concerning an 8 year old male pt who on 11/17/94 was vaccinated IM, with 0.5 ml of a booster dose of MMRII. In 3/95, the pt was admitted to the hospital with facial swelling and orofacial granulomatosis was dx''d and treated with steroids. Erythromycin was given on 1/27/95, amoxicillin trihydrate + clavulanate potassium (Augmentin) on 3/15/95 and it was noted that the pt was also taking baclofen (date unknown). It was also noted that in 6/99, the pt was dx''d with Crohn''s disease. No additional information provided. The case is closed.

VAERS ID:190967 (history)  Vaccinated:1995-10-14
Age:8.0  Onset:0000-00-00
Gender:Male  Submitted:2002-10-01
Location:Foreign  Entered:2002-10-03, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: At an unspecified time, clinical examination was normal as were laboratory findings including creatinine kinase, aldolase, erythrocyte sedimentation rate and electromyogra. On 3/23/99, in view of the mother''s disease, a left deltoid muscula
CDC Split Type: B0269743A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Fibrosis tendinous, Muscle disorder, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (narrow)
Write-up: Report number B0269743A describes the occurrence of macrophagic myofascitis in a 8 year old male pt vaccinated with Engerix B for hep B prophylaxis and Infanrix polio for diphtheria, tetanus, pertussis and poliomyelitis prophylaxis. This case was reported in the literature. Drug histories included four injections of tetracoq vaccine from 9/4/87 to 9/17/88, and one injection of MMR vaccine on 7/2/88. Family history: his mother experienced myalgia and a diagnosis of macrophagic myofascitis was made after a muscular biopsy (vaccinated by Genhevac 2 years before for hep B prophylaxis). On 4/23/93, the child received one injection of DTPolio vaccine. On 4/26 and 5/24/95, he received one injection of Engerix B at a dose of 10g. In September 1995, he experienced the first adverse event (not specified). On 10/14/95, he received the third injection of Engerix B, at a dose of 10g. At an unspecified time, the child developed arthralgia. In December 1995, the pt experienced asthenia and myalgia. In 1997, the pt experienced mild chronic myalgia, asthenia and muscular deficienty. On 4/30 and 9/2/98, the child received one injection of Infanrix polio and one injection of MMR vaccine respectively. At an unspecified time, clinical examination was normal as were laboratory findings including creatinine kinase, aldolase, erythrocyte sedimentation rate and electromyogra. On 3/23/99, in view of the mother''s disease, a left deltoid muscular biopsy was carried out and the diagnosis of macrophagic myofascitis was made. The most recent info received on 9/19/02 reports the outcome of the pt as not yet recovered.

VAERS ID:193011 (history)  Vaccinated:2002-10-16
Age:8.0  Onset:2002-10-18, Days after vaccination: 2
Gender:Female  Submitted:2002-11-27, Days after onset: 40
Location:Foreign  Entered:2002-11-11, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Asthma NOS, status asthmaticus
Diagnostic Lab Data: Oxygen saturation 92%, respiratory rate 60 breaths/minute, x-ray NOS chest confirmed right middle lobe pneumonia
CDC Split Type: HQ4789924OCT2002
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLU-IMUNE)LEDERLE LABORATORIES 0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Condition aggravated, Cough, Dyspnoea, Heart rate increased, Pneumonia, Respiratory rate increased, Rhinitis, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Follow-up info received on 11/20/02 from the study investigator corrected the dates of vax, event onset, and outcome. An investigator reported that an 8 year old female received her first dose of influenza virus vaccine, *trivalent, types A & B, live cold adapted (nasal solution / liquid formulation) (CAIV-T) on 10/16/02*, as part of the Clinical Research and Development Study, which has a distinct title. The pt''s medical history consisted of asthma including status asthmaticus. Over the past year, the pt''s asthma had been improving and led to the discontinuation of her asthma prophylaxis therapy. On *10/18/02*, two days after vaccine administration, the child developed cough and coryza, followed by dyspnea the next day. Her oxygen saturation dropped to 92% and two days later, she was hospitalized. Physical examination revealed diminished breath sounds with wheezing, respirations at 60 breaths/minute and her heart rate was 160 beats/minute. Chest x-ray confirmed right middle lobe pneumonia. Her diagnosis was pneumonia associated with an exacerbation of asthma. Treatment included oxygen therapy, inhalation with bronchodilators, systemic steroids and antibiotics. The pt recovered from the events on *10/24/02*. The investigator considered the events *(each unexpected as per the investigator''s brochure)* "probably" related to study vaccine administration. The medical monitor considered the events "possibly" related to study vaccine administration.

VAERS ID:193061 (history)  Vaccinated:2001-08-09
Age:8.0  Onset:2002-08-01, Days after vaccination: 357
Gender:Male  Submitted:2002-11-11, Days after onset: 102
Location:Foreign  Entered:2002-11-13, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: Temperature 40-41C
CDC Split Type: D0039720A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Blister, Diarrhoea, Lymphadenopathy, Pancreatitis, Pyrexia, Rash, Splenomegaly, Vomiting
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: A physician reported the occurrence of pancreatitis in an 8 year old male who was vaccinated with Hepatitis B vaccine for prophylaxis. A pharmacist, who is also the mother of the subject, first reported this case. On 8/9/01 the subject received a dose of Hepatitis B vaccine (Engerix-B). On 8/25/01, the subject developed pancreatitis, swollen lymph nodes, swollen spleen, swollen kidney, fever (about 40-41 C), diarrhea (for about 3 wks), vomiting (for 3 days) and exsiccation. Treatment with antibiotics included first cefadroxil for about three days and was followed by asithromycin. Infectious mononucleosis was suspected. Antibiotic treatment was discontinued after leukocytosis occurring on 9/3/01. Additionally, the subject developed a blistering skin rash at hands and feet, which was infected with Streptococoacea and Staphylococcacea. The subject was hospitalized on 09/4/2001. Admission examination showed dry lips and tongue, white furred tongue, severe sweling of cervical lymph nodes, reddened acoustic ducts, white film on tonsils, abdomen soft, pressure pain in liver region, spleen palpable, no meningism. On the fourth day in teh hospital the subject experienced severe epigastric pain. Pancreatitis was diagnosed. The subject received completely parenteral feeding for five days. From 9/8/01 until 9/10/01 the subject additionally developed eoagulopathy. Treatment included fresh frozen plasma. Despite negative serology for HBV IgM, infectious mononucleosis was still suspected. Alternatively, CMV infection was suspected by differential diagnosis, but no serology has been performed. The subject was released on 9/20/01. On 9/24/01 the subject was rehospitalized for blistering skin rash at hands and feet, which was infected with Streptococcea and Staphylococcacea, and perleche. Treatment included flucloxacilline sodium, benzyl penicillins, potassium permanganate and povidone-iodine. The subject was released again on 9/29/01 in good health. Tonsillitis, enteritis, fever, pancreatitis and coagulopathy due to suspected mon

VAERS ID:208403 (history)  Vaccinated:2003-01-31
Age:8.0  Onset:2003-01-31, Days after vaccination: 0
Gender:Male  Submitted:2003-08-26, Days after onset: 206
Location:Foreign  Entered:2003-08-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0041705A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS5317C9   
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER134011H   
Administered by: Other     Purchased by: Other
Symptoms: Circulatory collapse
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow)
Write-up: A physician reported the occurrence of circulatory collapse in an 8 year old male who was vaccinated with hepatitis B vaccine for prophylaxis. This report was received from the regulatory authority. Co-suspect medication included MMR vaccine. On 1/31/03, the subject received the second dose of hepatitis B vaccine, lot number ENG5317C9. On the same day post vaccination the subject developed circulatory collapse. The event resolved after about 20 minutes. The subject was hospitalized. The event did not reoccur after the third vaccination with hepatitis B vaccine in July 2003 (negative rechallenge).

VAERS ID:209554 (history)  Vaccinated:1996-04-01
Age:8.0  Onset:2003-07-14, Days after vaccination: 2660
Gender:Male  Submitted:2003-09-19, Days after onset: 67
Location:Foreign  Entered:2003-09-24, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0309USA01303
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.MA04450   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective, Infection, Parotitis
SMQs:, Lack of efficacy/effect (narrow), Oropharyngeal infections (narrow)
Write-up: Information has been received from a health authority concerning an 8 year old male who on 4/1/96 and 2/12/99 was vaccinated with a first (batch reported as MA04450-invalid lot, reported as suspected to be batch HA04450) and second IM 0.5ml dose (batch reported as H645670-invalid lot, reported as suspected to be batch HG45670) of MMR respectively. On 7/14/03, the patient experienced vaccination failure and developed suspected mumps with bilateral parotiditis. Subsequently, the patient recovered by 7/25/03. The reporter considered the reaction to be serious, reasons not stated. Mumps, bilateral parotiditis, and vaccine failure were considered to be other important medical events (OMIC). Additional information is not expected. Case to be considered as closed.

VAERS ID:211952 (history)  Vaccinated:2003-10-21
Age:8.0  Onset:2003-10-22, Days after vaccination: 1
Gender:Female  Submitted:2003-11-03, Days after onset: 12
Location:Foreign  Entered:2003-11-10, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: WBC increased; Body temperature increased.
CDC Split Type: WAES0310CHN00028
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site swelling, Pyrexia, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Initial information has been received from an agency officer concerning an 8 year old Asian girl who on 10/21/03 was vaccinated with pneumococcal 23v polysaccharide vaccine, 0.5ml, IM and influenza virus vaccine (unspecified). The girl experienced fever and white blood cell count increase after vaccination. Follow up information has been received on 10/28/03. In the morning of 10/22/03, the girl developed fever with 38 of body temperature, injection site swelling and white blood cell count with 14x10[9] of white blood cell count after vaccination. In the afternoon of 10/22/03, the girl''s body temperature was 40 with 25x10[9] of white blood cell count. Subsequently, the girl was hospitalized because of fever and was recovering from injection site swelling. It is unknown whether the girl recovered from white blood cell count increased. The physician at a hospital thought her fever and white blood cell count increased were related to pneumococcal 23v polysaccharide vaccine. No further information is available.

VAERS ID:214858 (history)  Vaccinated:2003-12-29
Age:8.0  Onset:2003-12-29, Days after vaccination: 0
Gender:Male  Submitted:2004-05-07, Days after onset: 129
Location:Foreign  Entered:2004-01-14, Days after submission: 113
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: PPD
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: E200400053
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (NO BRAND NAME)AVENTIS PASTEURW0648 IM 
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEURW0648 IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site reaction, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: It was reported on 1/9/04 through health authorities that an eight year old boy was administered a DT-IPV vaccine on 12/29/03 at 10 hrs. He also had an intra-dermal tuberculin test on the same day at 10 hrs. To be noted that the boy was from foreign origin, just arrived; no info on his past vaccinal status was available. The same day, the boy presented with urticaria on the back and the thorax and with a local plaque at the injection site of the DT-IPV vaccine; he had no fever. He was seen at the emergency dept and was treated with anti-histamines. He recovered without sequelae (symptoms duration not reported). Further info had been requested. Follow up (on 05May2004) Despite several requests, no further data was obtained. Case is closed. Follow up on 5May2004: despite several requests, no further data was obtained. Case is closed.

VAERS ID:216187 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Male  Submitted:2004-02-03
Location:Foreign  Entered:2004-02-09, Days after submission: 6
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Antineoplastic (unspecified)
Current Illness:
Preexisting Conditions: Acute lymphobalstic leukaemia; T-cell count decreased; chemotherapy
Diagnostic Lab Data: Chest x-ray: day 5: diffuse bilateral infiltrate; blood pressure measurement; chest x-ray: prominent interstitial pattern bilaterally, particularly mid and lower lung fields; immunofluorescence antigen testing both lungs: parainfluenza virus type 3 detected; bronchial irrigation: pending: fungal, mycobacterial, legionella, mycoplasma pneumoniae cultures; bronchial irritation: negative direct staining for bacteria, fungi, P carinii, acid-fact bacilli, Legionella pneumophila; renal function study: normal; endotracheal tube culture: coagulase-negative staphylococci; blood pressure measurement: hypotension; autopsy; chest x-ray: bilateral, diffuse mixed interstitial and airspace, SC emphysema most evident in left axilla; WBC count 11.2 x 10 9/L
CDC Split Type: WAES0401CAN00086
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective, Heart rate increased, Hypotension, Hypoxia, Infection, Laboratory test abnormal, Pneumonia, Pyrexia, Rash papular, Respiratory disorder, Tachypnoea
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad)
Write-up: Information has been received from a physicians publishing article, January 2004 titled "Fever and Respiratory Distress in an 8 year old boy Receiving Therapy for Acute Lymphoblastic Leukemia," "Measles Vaccination" concerning an 8 year old male with acute lymphoblastic leukaemia, T-cell count decreased and chemotherapy was in remission by day 28 and had received his last dose IV chemotherapy therapy 2 weeks prior hospitalization, who in approximately 1988 was vaccinated with MMR II. The boy was previously a healthy boy. In 1995, the pt was hospitalized in a local hospital with a history of fever for a week and tachypnea and respiratory distress for 24 hrs. Therapy with ceftazidime and topical therapy was initiated on his upper lip for a cold sore. Blood culture and urine culture were negative. At day 5 of hospitalization, the pt experienced persistent high fever, hypoxemia and a deteriorating mental status. A chest x-ray demonstrated diffuse bilateral infiltrates. The pt was transferred to a hospital. On admission to the hospital, the pt had the following vital signs: body temp: 39.1 C, heart rate: 148 beats/min; oxygen sat 94% on room air, blood pressure: 90/50mmHg. The pt''s ears were red, with fluids. Examination demonstrated dry, slightly red and crusty conjunctivae and few scattered petechiea, several slightly raised, slightly red papules on skin on hand and back. No lymphadenopathy or hepatosplenomegaly were noted. Liver and renal function were normal. The pt also had the following test results: Hemoglobin: 106g/l, white blood cell count: 11.2 x 10 9/L, absolute neutrophil count: 8.6, platelets: 44 x 10 9/L, chest x-ray: prominent interstitial pattern bilaterally, particularly in the mid and lower lung fields. Therapy with piperacillin, gentamicin and high dose of trimethoprim/ sulfamethoxazole was initiated followed by IV acyclovir the next day. The following day a nasopharyngeal swab demonstrated a positive result for Parainfluenza virus type 3. The pt was still febrile (40 C) 2 days later. The pt need in oxygen increased. The pt had an absolute neutrophil count of 11,400/mm3. The pt was admitted to the ICU and received bilevel-positive airway pressure. A bronchoalveolar lavage demonstrated negative staining for bacteria, fungi, Pneumocystis carinii, acid-test bacilli and Legionella pneumophila. Result were pending on fungal, mycobacterial and legionella and Mycoplasma pneumonia cultures. Immunofluorescence antigen testing on both lungs was positive Parainfluenza virus type 3. Herpes simplex type 1 was present in a scraping of the lip, coagulase-negative staphylococci grew on an endotracheal tube culture and urine and buffy coat were negative for cytomegalovirus. The pt was intubated 2 days later because of increasing hypoxia. Therapy with amphotericin-B was initiated empirically because of persistent fever and furosemide for positive fluid balance, decreased urinary output and ''wet-looking" lungs. Diffuse air space and interstitial disease with pneumomediastinum and SC emphysema, most evident in the left axilla were noted on chest x-ray the next day. Therapy with dopamine was initiated to maintain good perfusion, therapy with acyclovir was discontinued and therapy with ganciclovir was initiated. A second bronchoalveolar lavage confirmed the findings of the first one. The pt stayed febrile and was difficult to ventilate over the course of the next several days. The pt became more and more hypotensive and developed lactic acidosis despite liquid ventilation with a perfluorocarbon emulsion containing oxygen. Decision was made to not pursue further aggressive treatment and therapy with dopamine was discontinued. The pt died 18 days after hospitalization. An autopsy was performed. "The cause of death was clearly the recent measles infection causing the giant cell pneumonia with diffuse damage to the lining epithelium of the respiratory tract from trracheal to alveolar levels." The authors also stated that the "believed tha

VAERS ID:216192 (history)  Vaccinated:2003-12-23
Age:8.0  Onset:2003-12-24, Days after vaccination: 1
Gender:Male  Submitted:2004-02-05, Days after onset: 43
Location:Foreign  Entered:2004-02-09, Days after submission: 4
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: CT scan and EEG: all normal
CDC Split Type: 200400414
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)AVENTIS PASTEURW0908 IMGM
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Asthenia, Circulatory collapse, Convulsion, Dizziness, Dyspnoea, Nausea
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: It was reported through an health care professional that a 7 year old male child presented with severe tonic-clonic seizures, weakness, stomach cramps, and nausea the day after the vaccination with Typhim VI performed on 12/23/03. The child felt dizzy and collapsed with a tonic-clonic seizures and a possibility of breathing difficulty. Resuscitation was done. CT scan and EEG were normal. The pt was not admitted to hospital and recovered on 12/24/03. It was reported that the vaccine was kept in vaccine fridge until the time of administration. This case is linked with case 2004-00415 concerning a female child (sister?) who received the same vaccine the day before and experienced also seizure, weakness, dizziness and stomach cramps 3 days after the injection and one day after the occurrence of the AE in the intended pt. File to be completed. Follow up on 02/17/04 states: "Follow up on 02/05/04. The female child who received the same vaccine is the sister of this boy. The mother who is the reporter an is also a doctor, said neither children has ever had a seizure before, this was the first time. The mother and father and elder brother also took the vaccine from the same vial (multidose) and they were okay. She has used Typhim vi severally without any reaction, so she believes something is wrong with the particular vial. The same children have taken typhim before, 3 years ago, and they had no reaction. The children are now fine, they recovered and none of them has had any more seizures since that time. The case is closed." Follow up 02/07/05:Follow up received on 02/02/04, the correct lot number is W0908 (exp 06/2005). Medical Assessment: In this case, it would have been relevant to know the results of investigations to search for another etioligy (infectious espisoe, metabolic disorders) to fully assess the case. To be noted that this patient had already received the same vaccine without any reaction.

VAERS ID:218727 (history)  Vaccinated:2002-05-30
Age:8.0  Onset:2002-05-30, Days after vaccination: 0
Gender:Male  Submitted:2004-04-07, Days after onset: 678
Location:Foreign  Entered:2004-04-08, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0325124A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER  PO 
Administered by: Other     Purchased by: Other
Symptoms: Bacterial infection, Dyspnoea, Medication error, Oesophagitis, Tetany
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific inflammation (narrow), Cardiomyopathy (broad)
Write-up: This case was reported by a physician and described the occurrence of tetanus in a 6 year old male subject who received Infanrix injection for routine immunization. Co-suspect medication included Priorix. Concurrent medications included Poliomyelitis (oral) and Meningitis C vaccine. On 5/30/02, the subject received a dose of Infanrix, Priorix, Meningitis C (IM) and Poliomyelitis (oral) vaccine. Forty eight hours after immunization, the patient experienced clinical tetanus. The subject had to be technically ventilated for four weeks. Subsequently, he had trouble with sub-glottic stenosis and was still receiving treatment. On 3/21/04, the events had improved but were still present and futher follow up will be done. The reporting physicist considered the events to be serious as it was life threatening and disabling for the patient as well as being clinically significant and requiring intervention and hospitalization (OMIC). He also considered that the event of tetanus to be associated with incomplete skin preparation prior to vaccine administration and commented that it was unlikely that the vaccines were related to the events.

VAERS ID:221368 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Female  Submitted:2004-05-17
Location:Foreign  Entered:2004-05-24, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Upper respiratory tract infection; Otitis Media; Head-face-neck syndrome; Hypogammaglobulinemia
Diagnostic Lab Data: B-lactamase production negative; CSF glucose 0.0 mmol./l and 2.5 mmol/l; WBC 20,000 WBCs/ul Neutrophil leukocytosis, 93% neutrophils, 41% neutrophils; Body temp 40 degrees C; Lymphocyte count 0.1%; Serum C-reactive protein 203 mg/l; Serum L-lactate test 19.5 mmol/l and 4.4 mmol/l; IgG4 diminished; IgG2 diminished; IgG1 diminished; Serum immunoglobulin A test: deficiency; Serum immunoglobulin G test; deficiency; CSF negative; CSF total protein test 47.8 mg/dl; CSF protein test: 267.7 mg/dl; Gram stain: numerous gram-negative bacilli; Urine bacteria screen negative; CSF: typed by reference lab as H. influenzae type F; Blood culture: typed by reference lab as H. influenzae type F
CDC Split Type: WAES0405USA00682
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Back pain, CSF test abnormal, Drug ineffective, Dyskinesia, Headache, Hypoglobulinaemia, Injury, Irritability, Laboratory test abnormal, Meningitis, Pyrexia, Sepsis, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad)
Write-up: It was reported, in the above stated article, an 8 year old girl with oro-facio-digital syndrome and a hypogammaglobulinemia and with a past medical history remarkable for frequent upper respiratory tract infections and otitis media had received all scheduled immunization including a full course of HIB conj vaccine. The girl was admitted to the hospital after falling from a swing 1 day earlier. Headache and backache were her chief complaints. She had fever of 40 degrees C, vomited several times, and her condition deteriorated within hours. Upon arrival, she appeared somewhat somnolent, but irritated with clinical signs of meningitis. Physical examination also received an oro-facio-digital syndrome with microcephaly, micrognathia, prominent incisors, small open mouth, large ears, hypoplastic thumbs with decreased motility and clinodactyly. Lab examination showed a neutrophil leukocytosis with 20,000 WBC''s/ul and C-reactive protein of 203 mg/l. The cerebrospinal fluid contained abundant white cells, with 93% neutrophils. Glucose level was 0.0 mmol/l, lactate was 19.5 mmol/l, and CSF protein was raised at 267.7 mg/dl. A Gram stain revealed numerous gram-negative bacilli. Bacterial antigen screening for Neisseria meningitides type B and ACW13.5, H. influenzae type B, Escherichia coli and Streptococcus pneumoniae was negative. The CSF and blood culture yieded H. influenzae susceptible to amipicillin, cefuroxime and cefotaxime. Meningitis and bacteremia were found in the blood and CSF. This strain was typed by the reference laboratory as H. influenzae type F. Treatment with cefotaxime, gentamicin, and dexamethasone was successful. Dexamethasone was administered 15 minutes before the first dose of antibiotics. After 72 hours, she became afebrile and the rest of the hospital stay was uneventful. Gentamicin was administered for 2 days, dexamethasone for 4 days, and cefotaxime for 14 days. The control CSF culture showed glucose 2.05 mmol/l, lactate 4.4 mmol/l, protein concentration 473.8 mg/dl and 159 WBCs/ul with 41% neutrophils. The CSF culture was negative. Because of the frequent and recurrent upper respiratory tract infections and the Hi meningitis despite regular vaccination, immunoglobulin levels were measured. A hypogammaglobulinemia with IgG and IgA deficiency and diminished IgG1, IgG2, and IgG4 subclasses and almost no B lymphocytes was found. The B-lactamase production was negative. To prevent further infections, a regular substitution of IV immunoglobulin was initiated during the hospital stay and was well tolerated. The girl now receives human immunoglobulin every 4 weeks. A genetic evaluation revealed a normal 46 XX karyotype. However, a genetic cause of the existing anomalies cannot be excluded. The girl''s mother underwent surgery because of a similar oro-facial-digital dysmorphology herself. An immunologic examination at the age of 35 revealed a mild IgG1 deficiency too. It was noted that the patient''s outcome was resolved. The authors indicated that 7 other patients received a dose of HIB conj vaccine and experienced an adverse event. A copy of the published article is attached as further documentation of the patient''s experience.

VAERS ID:222590 (history)  Vaccinated:1997-05-15
Age:8.0  Onset:2003-03-01, Days after vaccination: 2116
Gender:Female  Submitted:2004-09-22, Days after onset: 570
Location:Foreign  Entered:2004-06-11, Days after submission: 103
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: UNK
Diagnostic Lab Data: IgG in CSF 1:5120; Serum measles IgG antibody 1:25600; Body weight 27 kg.
CDC Split Type: WAES0406USA00262
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Delirium, Encephalitis, Laboratory test abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad)
Write-up: Information has been received from a health authority concerning an 8 year old female patient who on 5/15/97 was vaccinated with a dose of MMR (lot # not reported). During March 2003, the girl developed a panencephalitis and today is suffering from subacute sclerosing panencephalitis. It was reported that this event involved persistence or significant disability or incapacity. Laboratory evaluation indicated IgG against Measles 1:25600 and IgG in CSF 1:5120. The outcome was not recovered. Follow up information reported that the manufacturer of the MMR vaccine which was used was unknown. It was also reported that further information concerning the identification of the strains was requested. Further information was requested. Follow up information reported that, per hospital report, the pt had a history of being hospitalized from 10Apr95 until 18Apr95 with the diagnosis of infectious disease of the upper respiratory tract and dermatitis at thoracic region. Further information in the report noted the 2 month old pt was medicated with antibiotics, mucolytics, spasmycotics, also nasal drops and eye drop and she was monitored with an apnea monitor. It was also noted pt''s history: measles outbreak in the surroundings, the mother of the pt presented with florid measles, so there was an indication for the therapy with IV Immunoglobulins. A pediatric expert consultation on 11Apr95 diagnosed bronchiolitis. A telephone call with the attending practitioner of the pt revealed that he knew this report and he thought that the measles infection during infancy was the cause for the SSPE. The physician reported that he knew about a measles epidemic outbreak in the concerned district in the year 1995. The pt''s history revealed no immunosuppressive therapy and no immunodeficiency at any time. The follow up informatoin noted that at the age of 6 years the girl presented with the first symptoms, and in 2003 the symptoms aggravated. The attending physician of the pt confirmed the diagnosis of subacute sclerosing panencephalitis (SSPE) and the physician reported that he did not see a link between the vaccination and the onset of SSPE. Further attempts to get information about the outcome revealed that the health authorities did not have further details. The pt was not recovered. They only assumed that the girl still lived, because they think that the reporter should inform them about death. The health authority stated that there was no further information to expect so that the case had to be considered closed. Other business partner numbers inclued E200401702 and 20426.

VAERS ID:226158 (history)  Vaccinated:1996-11-14
Age:8.0  Onset:2004-01-23, Days after vaccination: 2626
Gender:Unknown  Submitted:2004-08-31, Days after onset: 220
Location:Foreign  Entered:2004-09-02, Days after submission: 2
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: The child had previously received Haemophilus influenzae type B vaccine, Act-HIB, batch L0066, on 1/16/96, route unknown, and Haemophilus influenzae type B vaccine, Act-HIB, batch M0096, on 10/17/96, route unknown.
Diagnostic Lab Data: On 1/23/04, the child, aged 8 years, experienced septic arthritis haemophilus, reported as a vaccination failure. This was confirmed by isolation from a blood sample.
CDC Split Type: E200402771
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)AVENTIS PASTEURM00962  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthritis, Bacterial infection, Drug ineffective, Sepsis
SMQs:, Agranulocytosis (broad), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (broad), Arthritis (narrow)
Write-up: A child, gender not specified, received Haemophilus influenzae type B vaccine, Act-HIB, batch M0096, on 11/14/96, route unknown. The child had previously received Haemophilus influenzae type B vaccine, Act-HIB, batch L0066, on 1/16/96, route unknown, and Haemophilus influenzae type B vaccine, Act-HIB, batch M0096, on 10/17/96, route unknown. On 1/23/04, the child, aged 8 years, experienced septic arthritis haemophilus, reported as a vaccination failure. This was confirmed by isolation from a blood sample. At the time of the report, (not specified), the child was said to have recovered. No further data are expected. Case is closed. (OMIC)

VAERS ID:226581 (history)  Vaccinated:2004-05-17
Age:8.0  Onset:2004-05-17, Days after vaccination: 0
Gender:Female  Submitted:2004-09-07, Days after onset: 113
Location:Foreign  Entered:2004-09-14, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Streptococcal infection
Diagnostic Lab Data: Streptolysin 1100; Arterial blood O2 saturation 98%; Serum antistreptolysin O antigen test 1600.
CDC Split Type: WAES0406USA01547
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0447N IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Bacterial infection, Dyspnoea, Laboratory test abnormal, Sepsis, Tonsillitis
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)
Write-up: Information has been received from a health authority concerning an 8 year old female with a streptococcal infection who on 5/17/04 was vaccinated with the second dose of MMR (lot # 646176/0447N). On the same day she presented with pharynodynia, dyspnea and asthenia. She was treated with BENTELAN and oxygen 98%. The duration of the event was not rpeorted. The outcome was recovered. Clarifications will be requested regarding the streptococcal infection as well as confirmation that the case is to be considered non-serious as reported. Additional information has been received. The case has been upgradded to serious. THe girl was admitted to the hospital on 5/17/04. She was discharged on a non reported date with the diagnosis of adverse reaction to MMR vaccine, chronic hypertrophic tonsillitis, and streptococcal sepsis Streptozyme test 1100, anti-streptolysine titer 1600. At the time of this report the outcome of adverse drug reaction, chronic hypertrophic tonsillitis and streptococcal sepsis were unknown. No further informatino is available. The case is closed. Additional information has been requested. Follow up 03/03/05: Patient has not recovered from the adverse events.

VAERS ID:228419 (history)  Vaccinated:2004-09-21
Age:8.0  Onset:2004-09-21, Days after vaccination: 0
Gender:Male  Submitted:2004-10-25, Days after onset: 34
Location:Foreign  Entered:2004-10-29, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: UNK
CDC Split Type: WAES0410USA02848
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.X95990SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypertonia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a health authority concerning an 8 year old male with no patient history who on 9/21/04 was vaccinated with a first dose of MMR (lot # X9599-1), SC. On 9/21/04, immediately after vaccination, he presented with lipothymic crisis with hypertonus. He was placed in the Trendelemburg position. The patient was admitted to the hospital. The outcome was not yet recovered. Other business partner''s numbers include: E200403532, IT500/04 and 55706. No further information is available. Follow up 03/03/05: Patient has not recovered from the adverse event(s). Per follow up report received 06/14/2005: Patient still has not recovered.

VAERS ID:229485 (history)  Vaccinated:2004-10-05
Age:8.0  Onset:2004-10-07, Days after vaccination: 2
Gender:Female  Submitted:2004-11-17, Days after onset: 41
Location:Foreign  Entered:2004-11-19, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MA20040640
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABIPUR)CHIRON CORPORATION34401141IM 
Administered by: Other     Purchased by: Other
Symptoms: Ascites, Pyrexia
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: We received the following information: An 8 year old female child, born on 6/24/96 was vaccinated with Rabipur IM (batch # 3440114?) IM into her thigh on 10/5/04. On 10/7/04, the child developed fever up to 40.4 C lasting for two days. On 10/10/04 she showed ascites for 3 days. The child was hospitalized. A previous vaccination with Rabipur was tolerated well.

VAERS ID:236132 (history)  Vaccinated:2005-02-25
Age:8.0  Onset:2005-03-07, Days after vaccination: 10
Gender:Male  Submitted:2005-04-08, Days after onset: 31
Location:Foreign  Entered:2005-04-15, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Varicella exposure
Diagnostic Lab Data: UNK
CDC Split Type: WAES0504USA00539
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0520P   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Paralysis, Viral infection
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Information has been received from a health professional concerning an 8 year old male, with a history of varicella exposure (sister presented with varicella 2 days prior to vaccination), who on 2/25/05 was vaccinated (route unknown) with varicella virus vaccine live (lot # 649684/0520P; batch # HW08430). On 3/7/05, the patient experienced varicella and facial palsy and was hospitalized (dates unknown). Outcome unknown. Other business partner numbers include E200501280. Additional information is expected.

VAERS ID:239905 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Female  Submitted:2005-06-13
Location:Foreign  Entered:2005-06-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Skull fracture
Diagnostic Lab Data: + Streptococcus pneumoniae serotype 3 in blood; + Streptococcus pneumoniae serotype 3 in CSF.
CDC Split Type: WAES0506USA00930
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bacterial infection, CSF test abnormal, Drug ineffective, Meningitis, Pyrexia
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow)
Write-up: Information has been received from the authors of a published literature article concerning an approximately 8 year old female with a history of skull fracture who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine when she was 4 years old. Approximately 3 years later, the patient developed serotype 3 pneumococcal meningitis and was hospitalized. Streptococcus pneumoniae serotype 3 was detected in patient''s blood and cerebral spinal fluid. The patient received IV ceftriaxone and became afebrile after 3 days. Subsequently, the patient recovered from serotype 3 pneumococcal meningitis and was discharged from the hospital without complications. No further information is available. A copy of the published literature article is attached as further documentation of the patient''s experience. A copy of the translated article will be forwarded when available.

VAERS ID:240199 (history)  Vaccinated:2004-11-23
Age:8.0  Onset:2005-03-04, Days after vaccination: 101
Gender:Female  Submitted:2005-06-21, Days after onset: 108
Location:Foreign  Entered:2005-06-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: Vaccinal history included an injection dose of Pentacoq on 10/10/97.
Diagnostic Lab Data: Histological report: epithelioid granuloma with multinuclear giant cells and caseiform necrosis. Ziehl''s coloration: negative. Conclusion: epithelioid granulomatous and necrotizing inflammation, evoking a atypic mycobacterial surinfection.
CDC Split Type: B0384928A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  SCRA
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALS  SCRA
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  SCRA
Administered by: Other     Purchased by: Other
Symptoms: Bacterial infection, Injection site necrosis, Injection site nodule
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a foreign regulatory authority and described the occurrence of injection site granuloma with necrosis in a 8 year old female subject who was vaccinated with combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type B vaccine for prophylaxis. Vaccinal history included a first injection of Pentacoq on 10/10/97. On 11/23/04, the subject received the first injection dose of Infanrix Quinta, in the right arm, SC. On 12/23/04, the subject received the second dose of Infanrix Quinta, in the left arm, SC. On 3/4/05, three and two months after the first and second injection of Infanrix Quinta, injection site skin necrosis were discovered by the physician on each arm. At an unspecified date, the subject was hospitalized. On 3/31/05, two exeresis at both injection sites were performed. Histological reports (for both sides) showed epithelioid granuloma with multinuclear giant cells and caseiform necrosis. Ziehl''s coloration was negative. The reports concluded to epithelioid granulomatous and necrotizing inflammations, evoking atypic mycobacterial surinfections. The events were considered as resolved with sequelae. According to the agency, the events were probably related to Infanrix Quinta vaccine.

VAERS ID:241547 (history)  Vaccinated:2000-09-01
Age:8.0  Onset:2005-04-28, Days after vaccination: 1700
Gender:Male  Submitted:2005-07-20, Days after onset: 83
Location:Foreign  Entered:2005-07-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: 28Apr05: Alanine aminotransferase 3250iu/ml; alkaline phosphatase 2568 iu/ml; aspartate aminotransferase 3368.8 iu/ml; serum bilirubin direct 7.98mg%, serum bilirubin indirect 1.49mg%, serum bilirubin total 4.4mg%. 01May05: serum bilirubin
CDC Split Type: B0382819A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Anorexia, Aspartate aminotransferase increased, Asthenia, Blood alkaline phosphatase increased, Blood bilirubin increased, Jaundice, Pyrexia, Viral infection, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by a physician and described the occurrence of jaundice in a 13 year old male subject who was vaccinated with hepatitis A vaccine, hepatitis B vaccine for prophylaxis. During year 2000, the subject received 3 doses of Engerix B. On 9/20 and 3/00, the subject received second dose and first dose of Havrix 720. On 4/21/05, 5 years following vaccination, the subject developed jaundice, viral hepatitis, vomiting, loss of appetite, weakness, fever, and jaundice of eyes. The subject was hospitalized. The subject was treated with cefotaxime sodium. As of 5/13/05, the subject had partially recovered, as loss of appetite was still present and serum bilirubin was not within normal values.

VAERS ID:242212 (history)  Vaccinated:2005-07-13
Age:8.0  Onset:2005-07-20, Days after vaccination: 7
Gender:Female  Submitted:2005-08-04, Days after onset: 15
Location:Foreign  Entered:2005-08-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Renal insufficiency
Preexisting Conditions: At the time of reporting, the subject was in a waiting list for renal transplantation.
Diagnostic Lab Data: Cardiolipin IgG $g0; Cardiolipin IgM negative; Coagulation factor II Level normal; Coagulation factor V level 55%; Coagulation factor V level 53%; Coagulation factor VII level normal; Coagulation factor X level normal; Prothrombin ratio 1.5.
CDC Split Type: B0389548A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Coagulation factor decreased, Laboratory test abnormal, Prothrombin level increased
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage laboratory terms (broad)
Write-up: This case was reported by a physician and described the occurrence of decreased factor V in a 7.5 year old female subject who was vaccinated with hepatitis A vaccine for prophylaxis. Concurrent medical condition included renal insufficiency. At the time of reporting, the subject was in a waiting list for renal transplantation. Previously, prothrombin ratio tests were performed three times, and were normal (unknown dates of exam). On 7/13/05, the subject received an unspecified dose of Havrix at 720 unit (batch number not available). On 7/20/05, 7 days after vaccination with Havrix 720, during a regular examination before the transplantation, the prothrombin ratio was found to be increased to 1.5 and coagulation factor V decreased to 55%. There was no hepato-cellular insufficiency, nor cytolysis, nor cholestasis. No infectious etiology was found. The coagulation factors II, VII, and X were normal. On 7/25/05, the prothrombin ratio was at 1.5 and factor V at 53%. Still in July 2005, cardiolipin IgG was positive and cardiolipin IgM was negative. A hemostasis check up was planned for near future (1-2 months after the events). At the time of reporting, the outcome of the events and the causality relationship were unspecified. This case was assessed as medically serious (OMIC).

VAERS ID:242510 (history)  Vaccinated:2005-05-01
Age:8.0  Onset:2005-07-01, Days after vaccination: 61
Gender:Female  Submitted:2005-08-09, Days after onset: 39
Location:Foreign  Entered:2005-08-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0388516A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Drug ineffective, Hepatitis, Jaundice, Pyrexia, Vomiting
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Hepatitis, non-infectious (narrow), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by a physician and described the occurrence of hepatitis in a 8 year old female subject who was vaccinated with hepatitis A vaccine for prophylaxis. In May 2005, the subject received the first dose of Havrix. On an unspecified date after vaccination, the subject developed fever, pain in abdomen and vomiting. Two or three days after these events, she developed full blown jaundice. In the first week of July 2005, 2 months after vaccination with Havrix, the subject developed hepatitis. The subject was advised to take rest and multivitamins. This case was assessed as medically serious (OMIC). In the last week of July 2005, the subject''s condition had improved. At the time of reporting, she was absolutely fine.

VAERS ID:242811 (history)  Vaccinated:2005-07-15
Age:8.0  Onset:2005-07-15, Days after vaccination: 0
Gender:Female  Submitted:2005-08-11, Days after onset: 27
Location:Foreign  Entered:2005-08-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Benzydamine hydrochloride; Paracetamol; Phenoxymethylpenicillin
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: An ECG showed possible absence seizures but not labeled epilepsy. The subject was symptom free for 5 years.
CDC Split Type: B0389939A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAUB056GG IM 
Administered by: Other     Purchased by: Other
Symptoms: Dyskinesia, Heart rate irregular, Hypertonia, Nausea, Pallor, Petit mal epilepsy, Somnolence
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of jerkiness in an 8 year old female subject who was vaccinated with hepatitis A vaccine for prophylaxis. Concurrent medications included benzydamine hydrochloride, paracetamol and phenoxymethylpenicillin potassium. There were no previous allergies or reactions with any drug or immunization. An EEG showed possible absence seizures but not labeled epilepsy - symptom free for 5 years. On 7/15/05, the subject received an unspecified dose of Havrix Junior (0.5ml, IM) in the left arm. Sixty seconds later, the subject rolled head back. The subject experienced jerkiness, looked pale and had a thready pulse. The subject''s leg was stiff and extended. Checked ABC. Put into the recovery position. No drug treatment was needed. The subject was very sleepy afterwards, and had nausea. Took one hour to recover. The reporter did not consider the reaction to be serious; however, the regulatory authority considered the event to be serious and clinically significant (or requiring intervention) (OMIC).

VAERS ID:244920 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Female  Submitted:2005-10-04
Location:Foreign  Entered:2005-10-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0394812A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Psoriasis
SMQs:
Write-up: This case was reported by a physician and described the occurrence of psoriasis in 8 year old female subject who was vaccinated with Havrix for prophylaxis. On an unspecified date the subject received a second dos of Havrix. Four to five weeks after vaccination with Havrix, the subject developed psoriasis. This case was assessed as medically serious (OMIC) by the manufacturer. At the time of reporting the outcome of the event was unspecified. Further information has been requested.

VAERS ID:246643 (history)  Vaccinated:2005-08-03
Age:8.0  Onset:2005-08-05, Days after vaccination: 2
Gender:Female  Submitted:2005-11-02, Days after onset: 89
Location:Foreign  Entered:2005-11-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Imiglucerase
Current Illness: Gauchers disease
Preexisting Conditions:
Diagnostic Lab Data: Anti streptococcus Dnase B test 1370 iu/ml, Aspartate aminotransferase 615 IU/L, Body temperature 08/06/2005 39.8C, Anti hyaluronidase test 600 U.
CDC Split Type: D0047820A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB056AD IMUN
TBE: TICK-BORNE ENCEPH (NO BRAND NAME)UNKNOWN MANUFACTURER371204PE IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthritis, Aspartate aminotransferase increased, Headache, Joint swelling, Pain, Pyrexia
SMQs:, Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of arthritic signs in a 7 year old female subject who was vaccinated with hepatitis A vaccine and tick-borne encephalitis vaccine for prophylaxis. Concurrent medical conditions included Gaucher''s disease which was treated with Imiglucerase twice or three times per week. On 8/30/05, the subject received the second dose of Havrix (IM) together with the first dose of FSME immun (IM). On 8/5/05, 2 days after vaccination with FSME immun and Havrix, the subject developed fever and arthritis in the left elbow, the right knee, and the right ankle. On an unknown date, the subject was hospitalized. The following details on the symptoms were provided by the reporting physician: On 8/5/05, fever and headache occurred. One day later, on 8/6/05, the subject developed pain in the arms, especially in the left elbow. That day her temperature was 39.8 degrees C. Another two days later, on 8/8/05, her elbow joints were swollen. The following day, on 8/9/05 pain occurred at the right ankle and finally, on 8/16/05, her right knee was painful, too. Relevant test results included increased results of aspartate aminotransferase, anti-streptococcus DNase-B-test and anti-hyaluronidase. The subject was treated with prednisone and naproxen and the symptoms improved. Overall diagnosis was suspected juvenile idiopathic arthritis and suspected rheumatic fever. At the time of reporting, on 10/14/05, the events were resolved.

VAERS ID:249739 (history)  Vaccinated:2005-12-10
Age:8.0  Onset:2005-12-10, Days after vaccination: 0
Gender:Male  Submitted:2005-12-21, Days after onset: 11
Location:Foreign  Entered:2005-12-27, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES0512TWN00002
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning an 8 year old male who on Dec 10 2005 was vaccinated with Pneumococcal 23v polysaccharide vaccine. On Dec 10 2005 the patient experienced local erythema, the induration size as a palm about 9.5 x 7.2cm. On Dec 11 2005 the patient experienced fever and was hospitalized. Subsequently, the patient recovered from fever and discharged on Dec 14 2005. No further information is available.

VAERS ID:250096 (history)  Vaccinated:2005-12-17
Age:8.0  Onset:2005-12-17, Days after vaccination: 0
Gender:Male  Submitted:2005-12-30, Days after onset: 13
Location:Foreign  Entered:2006-01-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: WBC count 20DEc05 24480/ul;Serums C-reactive protein 20Dec05 19.7 mg/dl;WBC count 21Dec05 22060/ul;Serum C-reactive protein 21Dec05 21.8 mg/dl
CDC Split Type: WAES0512TWN00009
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Laboratory test abnormal, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad)
Write-up: Information has been received from a physician concerning an 8 year old male who on 17-Dec-2005 was vaccinated with pneumococcal 23v polysaccharide vaccine. On 17-Dec-2005 the patient experienced local erythema. On 18-Dec-2005 the patient experienced fever and was hospitalized on 20-Dec-2005. Subsequently, the patient recovered from local erythema and fever. No further information is available.

VAERS ID:254574 (history)  Vaccinated:2006-03-16
Age:8.0  Onset:2006-03-16, Days after vaccination: 0
Gender:Male  Submitted:2006-04-25, Days after onset: 39
Location:Foreign  Entered:2006-04-25
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:
Diagnostic Lab Data:
CDC Split Type: B0416226A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB178AH IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Hypotension, Pallor, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of dizziness in a 8 yr old male subject who was vaccinated with hep B vaccine (Engerix B) for prophylaxis. On 16Mar06 the subject received 1st dose of Engerix B (10mcg, IM, unk). On 15Mar06, 1 minute after vaccination with Engerix B, the subject experienced dizziness, vomiting, drop in blood pressure, and facial pallor. The physician considered the events were clinically significant (or requiring intervention) (OMIC). On 16Mar06, 5 mins later, the events were resolved. The physician considered the events were almost certainly related to vaccination with Engerix B. This case is associated with a product complaint.

VAERS ID:255280 (history)  Vaccinated:2006-02-18
Age:8.0  Onset:2006-02-23, Days after vaccination: 5
Gender:Female  Submitted:2006-05-10, Days after onset: 75
Location:Foreign  Entered:2006-05-10
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tegeline
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: CSF cell count 8/mm3 2006, Cerebrospinal fluid protein 1.16g/l 2006.
CDC Split Type: B0422509A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, CSF test abnormal, Dysphagia, Dysphonia, Eye disorder, Facial palsy, Guillain-Barre syndrome, Hypertension, Hypokinesia, Hyporeflexia, Keratitis, Micturition disorder, Muscular weakness, Myalgia, Nausea, Nervous system disorder, Paralysis, Speech disorder, Tachycardia, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Demyelination (narrow), Corneal disorders (narrow), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported and described the occurrence of Guillain Barr syndrome in a 8 year old female subject who was vaccinated with hepatitis B vaccine Engerix B for prophylaxis. Medical history of the subject was unknown. In April 1998, May 1998 and Dec 1998, the subject received the first, second and third injection of hepatitis B vaccine (HbVax DNA 5 mcg) unspecified batch references. On 2/18/2006, the subject received a 4th dose of Engerix B 20 mcg, intramuscular, unspecified batch reference. It was reported that the week preceding the first symptoms of myalgia, the subject developed a viral infection NOS. On 2/23/2006, 5 days after vaccination with Engerix B, the subject presented with asthenia and myalgia. On 2/28/2006, she presented with muscle weakness leading to functional disorder and was hospitalized. A treatment with human immunoglobulin Tegeline at 400 mg/kg/day during five days was initiated. At an unspecified date lumbar puncture was performed and showed proteinorachia at 1.16 g/l and eight elements/mm3. A Guillain Barre Syndrome was diagnosed. On 3/3/2006, despite treatment with Tegeline, she developed deglutition disorders, croaky voice and left side facial paralysis. From 3/3/2006 to 3/15/2006, she was transferred in intensive care unit. During this hospitalisation, she developed paralysis of four limbs and neurovegetative disorders including tachycardia and hypertension for which a treatment with clonidine hydrochloride (Catapressan) was initiated. She also had no nauseous reflex. On 3/7/2006, nauseous reflexes became normal. On 3/10/2006, speech disorders resolved and Motricity disorders improved. 3/15/2006 she was transferred in pediatric unit. 03/19/2006 she experienced left eye keratitis. ON 3/23/2006 micturition disorders improved. On 3/28/2006 upper limbs motor disorders improved. On 4/6/2006 lower limbs motor disorders improved. On 4/11/2006, she was discharged from hospital. She could walk and stand up with help. Motor deficit of lower limbs persisted, especially at distal level. There

VAERS ID:255768 (history)  Vaccinated:2006-03-22
Age:8.0  Onset:2006-03-22, Days after vaccination: 0
Gender:Male  Submitted:2006-05-15, Days after onset: 53
Location:Foreign  Entered:2006-05-18, 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: NONE
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES0605USA01959
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0339R IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Mouth haemorrhage, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a health authority (ADROIT506803) concerning an 8 year old male who on 3/22/2006 was vaccinated IM with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (batch NC04940, lot 650750/0339R). There was no concomitant medication. On 3/22/2006, approximately 4 hours post vaccination, the skin on the patients fingers began to peel and he also experienced cracked and bleeding lips. The patient received treatment with emollients and responded well to treatment. At the time of reporting the patient is recovering. Both the reporter and the health authority felt this was a serious reaction. The patients experience was considered an other important medical event (OMIC). Additional information is not available. The case is closed. Other business partner numbers include E200602301.

VAERS ID:257078 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Male  Submitted:2006-05-26
Location:Foreign  Entered:2006-05-31, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Renal transplant, congenital nephrotic syndrome.
Diagnostic Lab Data: Chest X ray bilateral streaky shadowing, Electroencephalography rhythmic slow waves with intermittent focal sharp waves. JC virus PCR negative, measles virus strain wild type D8, computed axial tomography normal, magnetic resonance imaging progression in abn of right lentiform nucleus, changes in subthalmic nuclei, Rt cerebral peduncle, MRI altered signal in right basal ganglia, predominantly in the lentiform nucleus. Epstein Bar virus PCR Toxoplasma gondii PCR Cytomegalovirus PCR serum measles IgG antibody serum varicella zoster virus antibody herpes simplex virus culture and herpes simplex virus antigen test all negative.
CDC Split Type: WAES0605USA03372
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.   UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Bacterial infection, Balance disorder, Conjunctivitis, Convulsion, Depressed level of consciousness, Diarrhoea, Dysarthria, Dyskinesia, Dysphagia, Electroencephalogram abnormal, Encephalitis, Gait disturbance, Headache, Hemiparesis, Hypoxia, Immune system disorder, Laboratory test abnormal, Malaise, Myoclonus, Nephrotic syndrome, Neurological symptom, Ophthalmoplegia, Paraesthesia, Paralysis, Pharyngitis, Pyrexia, Rash maculo-papular, Renal disorder, Renal failure, Somnolence, Vasculitis, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Severe cutaneous adverse reactions (broad), Agranulocytosis (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (narrow), Parkinson-like events (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (broad), Vasculitis (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Proteinuria (broad), Respiratory failure (broad)
Write-up: It was reported in a published article, title as stated above that an 8 year old male with a history of renal transplant as a result of congential nephrotic syndrome was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (manufacturer unknown) at 10 months of age. On an unspecified date, he presented with headache and focal neurological signs (day 0). He had developed nephrotic syndrome in association with diffuse mesangial sclerosis at 7 months and at 18 months received a live related renal transplant. Post transplant induction therapy included anti lymphocyte globulin followed by maintenance cyclosporine, azathioprine and prednisolone. Seventy two days prior to neurological presentation, MMF was substituted for azathioprine to facilitate CsA withdrawal because of chronic allograft nephropathy. On day 44 he was treated with amoxicillin and clavulanic acid for pharyngitis. Five days later he was more unwell with fever, increasing drowsiness, diarrhea, bilateral conjunctivitis and a fleeting diffuse, maculopapular rash over his trunk, chest and arms. Chest X ray showed bilateral streaking shadowing for which he was treated with IV antibiotics. Six weeks later day 2, he presented with a weeks history of drowsiness, worsening right frontal headaches and unsteadiness. He was afebrile with a normal neurological examination. MMF was discontinued. On day 0, he was admitted with weakness of his left leg with associated paresthesia and myoclonic jerks. An initial computed tomography CT brain scan was normal and he was commenced empirically on cefotaxime, clarithromycin and acyclovir. By day 3, he had developed dysarthria, intermittent ophtalmophlegia and an evolving left hemiparesis with associated myoclonus. He suffered a generalized tonic clonic seizure and was commenced on phenytoin and sodium valproate. Electroencephalogram EEG showed rhythmic slow waves with intermittent focal sharp waves and magnetic resonance imaging MRI revealed altered signal in the right basal ganglia, predominantly in the lentiform nucleus. Laboratory indices of cerebrospinal fluid were unremarkable. Microscopy, bacterial culture, cryptococcal ag and CSF polymerase chain reaction PCR for herpes simplex virus, varicella zoster virus, entero viruses, cytomegalovirus, Epstein Bull virus, JC virus, Human herpes virus 6 and toxoplasma gondii were negative. By day 4, he required assisted ventilation for fluctuation conscious level and bulbar palsy. Repeat MRI showed marked progression in the abnormality of the right lentiform nucleus with new changes in the subthalmic nuclei, the right cerebral peduncle, the left basal ganglia and the medulla oblongata. Encephalitis, vasculitis or pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection were considered. On day +10, a single dose of IVIG was commenced in view of slight elevation of markers of streptococcal infection. Clinical improvement coincided with this. He showed no further neurological deterioration, but required a tracheostomy on +12 for continuing bulbar palsy. On day 17 serum from day 1 tested measles immunoglobulin IgM positive and IgG equivocal. Sequential samples collected prior to IVIG, confirmed recent seroconversion. There was evidence of ongoing infection with measles RNA detected in multiple samples, including serum form day 44 later genotype as wild type measles virus strain D8. No CSF was available for measles PCR testing. CsA was discontinued. Intravenous ribavirin (33 mg/kg loading dose then 16 mg/kg 6 hourly for 4 days followed by 8 mg/kg 8 hourly was administered for 3 weeks. Despite this, measles RNA remained detectable in multiple clinical samples. Retrospective testing showed him to be seronegative for measles when transplanted despite a single dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (manufacturer unknown). Over the next 12 months, he ste

VAERS ID:261221 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Female  Submitted:2006-08-03
Location:Foreign  Entered:2006-08-08, Days after submission: 5
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: Serum hep C antibody test 1998 negative. HIV antibody screen (EIA) 2003 negative. Serum alanine aminotransferase 2003 1820iu/l. Serum hep C antibody test 2003 positive. Plasma hep C RNA test 2003 genotype HCV 4a 3.3x10^5 copies/mL.
CDC Split Type: WAES0607USA05153
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.   UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Anorexia, Blood disorder, Fatigue, Haemolytic anaemia, Hepatitis C virus, Infection, Malaise, Viral infection
SMQs:, Liver related investigations, signs and symptoms (narrow), Haemolytic disorders (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Systemic lupus erythematosus (broad)
Write-up: It was reported in a published article, title as stated above that an 8 year old female was vaccinated at birth with a first dose of hepatitis B virus vaccine rHBsAg yeast, manufacturer unknown. The pt was diagnosed at six weeks of age with transfusion dependent thalassemia major. She was maintained on chelation therapy with desferoxamine. The pt as birth was negative for HCV and HIV. In spring of 2003, she developed fatigue, anorexia, and malaise ans was diagnosed with acute hepatitis C infection with peak alanine aminotransferase ALT of 1820 IU/L and a positive HCV antibody. Her previous blood test had shown consistently normal transaminases and the mode of exposure was presumably transfusion related (tracing putative donors implicated in the transmission of infection was unsuccessful). The pt improved spontaneously but continued to have elevation in ALT 2-2.6 times the upper limit of normal. A quantitative HCV RNA by polymerase chain reaction performed 16 weeks after the diagnosis of acute HCV infection showed persistent viremia (3.3 x 10^5 copies ml) and genotypes HCV 4a. After discussion with the parents, the pt was started on peginterferon alpha 2b (Peg Intron) with an initial 4 week induction period of 1.5 micrograms/kg weekly followed by a 20 week period of 1 microgram /kg weekly injections. The pt tolerated treatment well with no significant adverse effects or increase in transfusion requirements. Serum ALT became normal and viral RNA was undetectable at the end of treatment and after 24 weeks of follow up by qualitative PCR limit as detection 50 copies/ml). Upon internal review, the pt''s thalassemia major was considered to be an other important medical event (OMIC). Additional information is not expected. A copy of the published article is attached as further documentation of the pt''s experience.

VAERS ID:261865 (history)  Vaccinated:1997-10-24
Age:8.0  Onset:2006-05-01, Days after vaccination: 3111
Gender:Male  Submitted:2006-08-21, Days after onset: 112
Location:Foreign  Entered:2006-08-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Bordetalla pertussis antitoxin antibodies negative 5/13/06, anti adenly cyclase antibodies positive, bordetalla pertussis antitoxin antibodies positive 6/3/06, Anti Adenly cyclase antibodies positive.
CDC Split Type: WAES0608USA04275
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bacterial infection, Cough, Dyspnoea, Laboratory test abnormal
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Information has been received from a physician concerning an 8 year old male with no reported medical history who on 10/24/1997, 11/26/1997, 12/30/1997 and 9/2/1999 was vaccinated IM with a 0.5ml first, second, third and fourth dose of hepatitis B virus vaccine rHBsAg yeast thimerosal containing. Suspect vaccination on the same dates included a first batch N9744-1, second batch N1094-1, third batch N9822-1 and fourth batch R0804-1 IM dose of diphtheria toxoid + Hib conj vaccine tet toxoid + pertussis whole cell vaccine + poliovirus vaccine inactivated + tetanus toxoid Pentacoq. The pts vaccination history included a dose of diphtheria toxoid + polio virus vaccine inactivated + tetanus toxoid DT Polio at approx 6 years of age and and IM dose of diphtheria toxoid + poliovirus vaccine inactivated + tetanus toxoid Revaxis batch Y5283-1 on 9/14/2004. In May 2006, the pt presented with a severe cough and breathing difficulty. Two samples were performed and confirmed a diagnosis of pertussis. The first sample was negative and the second one was positive. The investigative report stated that the serological profile was compatible with an acute pertussis in the absence of a complete vaccination. Vaccination failure was noted. The pt was treated with josamycin during a forth night. He was not hospitalized. The pt recovered on an unspecified date. The physician also reported that the pts 13 year old asthmatic brother had a case of pertussis which was confirmed by two samples. The case is closed. The pts experience was determined to be an other important medical event (OMIC). Other business partner numbers included E200603242.

VAERS ID:263092 (history)  Vaccinated:2006-08-18
Age:8.0  Onset:2006-08-19, Days after vaccination: 1
Gender:Female  Submitted:2006-09-15, Days after onset: 27
Location:Foreign  Entered:2006-09-15
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:
Diagnostic Lab Data:
CDC Split Type: D0050870A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS   UN
Administered by: Other     Purchased by: Other
Symptoms: Blindness, Fall, Loss of consciousness, Nausea
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), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician (works medical officer and mother of the subject) via sales representative and described the occurrence of unconscious (duration unknown) in a 7 year old female subject who was vaccinated with Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, absorbed (Boostrix) injection for prophylaxis. On 8/18/06 the subject received a dose of Boostrix via unknown route into an unknown application site. On 8/19/06, 1 day after vaccination with Boostrix, the subject experienced unconsciousness (duration unknown) with falling down to ground, transient visual loss and nausea. A cut at the chin was sewed ambulatory. The treating pediatrician considered that this were no adverse events related to the vaccination with Boostrix according to the subjects mother. This case was assessed as medically serious by manufacturer criteria (OMIC). At the time of reporting the events were resolved. Follow up information has been requested.

VAERS ID:264190 (history)  Vaccinated:2006-09-11
Age:8.0  Onset:2006-09-23, Days after vaccination: 12
Gender:Male  Submitted:2006-10-04, Days after onset: 11
Location:Foreign  Entered:2006-10-10, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Epstein Barr virus antibodies 9/23/06 pending, Cytomegalovirus antigen pending, Platelet count 4 giga/l, serum hepatitis B surface AB neg, serum rubella IgM antibody 330, toxoplasma antibody screen neg, Platelet count on discharge 9/26/06 9
CDC Split Type: WAES0609USA08480
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.   UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Laboratory test abnormal, Periodontal disease, Petechiae, Platelet count decreased, Skin ulcer, Thrombocytopenic purpura
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Gingival disorders (narrow)
Write-up: Information has been received from a health professional concerning an 8 year old male who on 9/11/06 was vaccinated with a second dose of MMR II, administration route and site were not reported, (first dose administered in 2001 well tolerated). On 9/23/06 the pt was hospitalized with petechial lesions in the fundus oculi, petechiae in the mouth with a gingival lesion. Purpura was reported (thrombocytopic purpura). The pt was found with a platelet count at 4 Giga/l and a rubella IgM rate of 330 (IgG rate not communicated). Other relevant lab date included Toxoplasmosis neg, hepatitis NOS neg, CMV and EBV results pending. No infectious context, no etiology were found. The pt received treatment with human immunoglobulins (tegeline) on 9/23/06 and 9/25/06. He was discharged on 9/26/06 with platelets at 98 Giga/L. The outcome was unknown. Other business partner numbers included E200604954.

VAERS ID:267285 (history)  Vaccinated:2006-01-05
Age:8.0  Onset:2006-01-05, Days after vaccination: 0
Gender:Male  Submitted:2006-11-16, Days after onset: 315
Location:Foreign  Entered:2006-11-20, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: E200605729
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEURY1132  UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Infection, Injection site erythema, Injection site oedema, Oedema, Pain, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: It was reported that an 8 year old boy was vaccinated with poliomyelitis vaccine (IMOVAX, batch number Y1132, route and site of administration not reported) on 1/5/06. Eight hours after vaccination the boy had an elevated temp of 40C. He was red and slightly swollen at the injection site, and he had pain in his collar bone. he was seen by a physician the same evening, who could see a swelling on the collar bone. The boy was sent for X ray (results not rep). The day after 1/6/06 the boy had further pain in thigh and calf. The physician was contacted on 1/10/06. Analysis of blood showed infection related reaction. The boy was hospitalized for further examination and treatment. The boy was previously healthy. The outcome is not reported.

VAERS ID:268592 (history)  Vaccinated:2006-11-07
Age:8.0  Onset:2006-11-07, Days after vaccination: 0
Gender:Male  Submitted:2006-12-08, Days after onset: 31
Location:Foreign  Entered:2006-12-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: B0449154A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB068AE IMRA
Administered by: Other     Purchased by: Other
Symptoms: Bronchospasm, Dyspnoea, Hypoventilation, Pallor, Rhinitis, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of breathing difficulties in a 8-year-old male subject who was vaccinated with hepatitis A vaccine (Havrix) for prophylaxis. On 7 November 2006 the subject received 1st dose of Havrix (intramuscular, unknown). On 7 November 2006, 6 hours after vaccination with Havrix, the subject experienced shallow respiration and rhinitis. On 8 November 2006, he developed dyspnea, bronchospasm, tachypnea and pallor. The subject was hospitalized. On 9 November 2006, the events were resolved.

VAERS ID:268627 (history)  Vaccinated:2006-11-21
Age:8.0  Onset:0000-00-00
Gender:Unknown  Submitted:2006-12-06
Location:Foreign  Entered:2006-12-11, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Bronchitis asthmatic, respiratory disorder.
Diagnostic Lab Data:
CDC Split Type: WAES0612USA00269
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0879P IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a pediatrician concerning 4 children with bronchitis asthmatic or other respiratory disorders who was vaccinated IM, into the deltoid muscle, with a first dose of pneumococcal 23v polysaccharide vaccine (lot 650830/0879P). Subsequently the pts experienced severe swelling of the injected arm (circumference was doubled) spreading from the injection site down to the forearm. Under symptomatic therapy, the pts recovered. The reporting pediatrician considered the large arm swelling to be an other important medical event (OMIC). No further information is available. Other business partner numbers included E200606460.

VAERS ID:269439 (history)  Vaccinated:2006-11-24
Age:8.0  Onset:0000-00-00
Gender:Male  Submitted:2006-12-20
Location:Foreign  Entered:2006-12-20
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:
CDC Split Type: D0051809A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B024AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Circulatory collapse, Injection site oedema
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of circulatory collapse in an 8 year old male subject who was vaccinated with Boostrix for prophylaxis. On 24 November 2006 the subject received a dose of Boostrix (unspecified site on arm, intramuscular). Within an unspecified delay after vaccination the subject developed in extensive swelling of the vaccinated arm and circulatory collapse. According to the reporter the event was not life threatening. The duration of the swelling was approximately five days. Other wise there was no information on the outcome of the events. This case was assessed as medically serious by manufacturer (OMIC).

VAERS ID:269567 (history)  Vaccinated:2006-10-24
Age:8.0  Onset:2006-10-25, Days after vaccination: 1
Gender:Male  Submitted:2006-12-20, Days after onset: 56
Location:Foreign  Entered:2006-12-22, 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: E200606779
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)AVENTIS PASTEURC2291AC IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erysipelas, Febrile convulsion, Injection site erythema, Injection site oedema, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: It was reported that an 8 year old boy was vaccinated into the left deltoid muscle with a booster dose of Covaxis, lot C2291AC on 24-Oct-06. On 25/Oct/06 he experienced fever up to 39 deg C and fever convulsions. He developed injection site redness, swelling (11x10 cm) and warmth which was assumed to be erysipelas. The boy recovered under therapy with Penicillin within three days from fever, exact duration of convulsion and erysipelas was not reported (outcome recovered). The boy was not hospitalised. File closed. (OMIC)

VAERS ID:271971 (history)  Vaccinated:2004-02-04
Age:8.0  Onset:2004-02-04, Days after vaccination: 0
Gender:Female  Submitted:2007-02-08, Days after onset: 1100
Location:Foreign  Entered:2007-02-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0350787A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS   UN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Cyanosis, Diarrhoea, Fall, Fatigue, Musculoskeletal stiffness
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (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 (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of convulsion in a 8 year old female subject receiving Havrix for prophylaxis. On 4 February 2004, the subject received the 1st dose of Havrix at .5 ml. On the same day, a few seconds after vaccination, the subject experienced convulsions. She had stiffness, tug in the arm and body, fell to floor and had blue lips. The events lasted about 1 minute. She was also tired and had diarrhea. This case was assessed as medically serious. Despite several attempts to follow-up further information will be available, this case has therefore been closed.

VAERS ID:272803 (history)  Vaccinated:2007-01-18
Age:8.0  Onset:2007-01-20, Days after vaccination: 2
Gender:Male  Submitted:2007-02-21, Days after onset: 32
Location:Foreign  Entered:2007-02-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0052104A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)AVENTIS PASTEUR  IMLA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB138AJ IMRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site reaction
SMQs:
Write-up: This case was reported by a physician and described the occurrence of severe injection site reaction in an 8 year old male subject who was vaccinated with Engerix B for prophylaxis. Concomitant vaccination included Covaxis (0.5ml intramuscular,left deltoid), given contralaterally for prophylaxis on 18 January 2007. On 18 January 2007 the subject received the third dose of Engerix B Pediatric (0.5 ml, intramuscular, right deltoid. Approximately two days post vaccination with Engerix B pediatric, on 20 January 2007, the subject experienced severe injection site reaction. The subject was hospitalized for this event for unknown periods of time. The subject was treated locally with Antiphlogistic medication. After about three days, on 22 January 2007, the event was resolved. The reporting physician considered that the event was almost certainly related to vaccination with Engerix B pediatric. No further information will be available.

VAERS ID:273572 (history)  Vaccinated:2007-02-06
Age:8.0  Onset:2007-02-22, Days after vaccination: 16
Gender:Female  Submitted:2007-03-08, Days after onset: 14
Location:Foreign  Entered:2007-03-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0460414A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB117FCC  UN
Administered by: Other     Purchased by: Other
Symptoms: Cerebrovascular disorder, Facial palsy, Headache, Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: This case was reported by a physician (via a sales representative) and described the occurrence of ischemic cerebrovascular stroke in a 8-year-old female subject who was vaccinated with Havrix, for prophylaxis. Previous and/or current vaccination included meningococcal polysaccharide vaccine group C given on an unspecified date. On 6 February 2007 the subject received 1st dose of Havrix (unknown). On 22 February 2007, 16 days after vaccination with Havrix, the subject experienced ischemic cerebrovascular stroke, bell''s palsy and headache. The subject was hospitalized. At the time of reporting the outcome of the events was unspecified. The physician considered the events were unrelated to vaccination with Havrix.

VAERS ID:275777 (history)  Vaccinated:2007-03-26
Age:8.0  Onset:2007-03-26, Days after vaccination: 0
Gender:Female  Submitted:2007-04-06, Days after onset: 11
Location:Foreign  Entered:2007-04-09, 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: Obstructive bronchitis
Preexisting Conditions: Infection
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0703USA05657
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.NE237900IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Conjunctival hyperaemia, Cyanosis, Dyspnoea, Hyperventilation, Laryngospasm, Paraesthesia, Petechiae, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conjunctival disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad)
Write-up: Information has been received from a physician concerning an 8 year old female with obstructive bronchitis and susceptability to infections and familiar atopy who on 26-MAR-2007 was vaccinated IM into the left deltoid with a first dose of Pneumovax 23 9batch #NE27390). Immediately post vaccination, the patient developed dyspnea, perioral lividity, tachypnea, hyperventilation, laryngospasm, conjunctival injection, facial paraesthesia and cervical petechiae. It was reported that the patient was calmed and treated with rebreathing and 100 mg Rectodelt. After 40 minutes, the patient recovered. Dyspnea, perioral lividity, tachypnea, hyperventilation, laryngospasm, conjunctival injection, facial paraesthesia and cervical petechiae were considered to be other important medical events. Other business partner numbers include: E200701940. Additional information is not expected. The file is closed.

VAERS ID:277355 (history)  Vaccinated:2007-03-10
Age:8.0  Onset:2007-03-20, Days after vaccination: 10
Gender:Female  Submitted:2007-04-24, Days after onset: 35
Location:Foreign  Entered:2007-04-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Ultrasound 03Apr07 regression of hematoma of the digestive walls, serum C-reactive protein 21Mar07 64 mg/L, serum lipase test 21Mar07 251 U/L, serum amylase test 21Mar07 242 U/L, serum lipase test 03Apr07 76 U/L, serum amylase test 03Apr07
CDC Split Type: WAES0704USA03086
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Blood amylase increased, C-reactive protein increased, Computerised tomogram abnormal, Haematoma, Henoch-Schonlein purpura, Lipase increased, Pancreatic disorder, Ultrasound abdomen abnormal
SMQs:, Acute pancreatitis (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vasculitis (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a health authority concerning an 8 year old female with no medical history who on 10-MAR-2007 was vaccinated with a 0.5 mL sc dose of MMR II. There was no concomitant medication. On 20-MAR-2007 the patient was hospitalized due to rheumatoid purpura with further complications; pancreatic impairment with abdominal pain was reported as well as parietal hematoma of the caecum and a small intestine loop, revealed by abdominal ultrasound and CT scan. Above mentioned complications justified corrective treatment with corticosteroids 2 mg/kg for 8 days, then progressively reduced. On 21-MAR-2007, laboratory tests found a lipase level of 251 U/L ie five times normal, amylase at 353 U/L ie 1.8 times times normal, C-reactive protein at 64 mg/l and normal hepatic work up. On 03-APR-2007, imaging showed regression of hematomae of the digestive walls and laboratory results showed regression of pancreatic enzymes, with lipase at 76 U/L, times normal, and amylase U/L with an upper limit os 131. The outcome was therefore favorable and the patient was discharged on 03-APR-2007 after 14 days of hospitalization, on tapered corticosteroids. Other business partner numbers include E2007-02388 and CN07000079. No further information is available. The case is closed.

VAERS ID:277893 (history)  Vaccinated:2007-02-06
Age:8.0  Onset:2007-02-06, Days after vaccination: 0
Gender:Female  Submitted:2007-05-02, Days after onset: 84
Location:Foreign  Entered:2007-05-04, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History of allergy to polio vaccine antigen.
Diagnostic Lab Data:
CDC Split Type: E200702503
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR  SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Urticaria, Wrong technique in drug usage process
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Case initially received by the Health Authorities under the reference TO070415-1. This is a case of misuse, ie wrong injection technique. Initial report on 19-Apr-07: A 8-year-old female patient with a history of allergy to polio vaccine antigen received a booster dose of Imovax Polio, (batch number not reported) via subcutaneous route in an unspecified site of administration on 06-Feb-07. The vaccine was administered by the Carre method, ie through six subcutaneous injections in order to have the usual dose. On the same day, she developed erythema and urticaria which led to hospitalization. The patient recovered on an unspecified date. The case is closed.

VAERS ID:281900 (history)  Vaccinated:2007-05-18
Age:8.0  Onset:2007-05-20, Days after vaccination: 2
Gender:Female  Submitted:2007-06-14, Days after onset: 25
Location:Foreign  Entered:2007-06-15, 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: WAES0706USA01156
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Encephalitis post immunisation
SMQs:, Noninfectious encephalitis (narrow)
Write-up: Information has been received from a health authority (case# PEI2007004763) concerning an 8-year-old female with no pertinent medical history who on 18-MAY-2007 was vaccinated intramuscularly in her left upper arm with a first dose of MMRII (batch# NE12400). On 20-MAY-2007 the patient experienced "encephalitis post vaccination". It is unknown if the patient sought medical treatment, however it is stated that the patient was not hospitalized. No symptoms were reported. At the time of the report the outcome is reported as not recovered. Other business partner numbers include: E2007-03566 Additional information is not expected.

VAERS ID:282190 (history)  Vaccinated:2007-05-11
Age:8.0  Onset:2007-05-11, Days after vaccination: 0
Gender:Female  Submitted:2007-06-18, Days after onset: 38
Location:Foreign  Entered:2007-06-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin trihydrate, Pholcodine linctus (Anhydrous citric acid + Pholcodine)
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Pulse rate 88
CDC Split Type: B0475326A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB132BA IM 
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  IM 
Administered by: Other     Purchased by: Other
Symptoms: Heart rate normal, Muscle spasms, Musculoskeletal stiffness, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of body spasm in an 8-year-old female subject who was vaccinated with Havrix, Typhim Vi for prophylaxis. Concurrent medications included Amoxicillin trihydrate and Pholocodine linctus. on 11 May 2007 the subject received unspecified dose of Havrix (0.5 ml, intramuscular), unspecified dose of Typhim Vi (0.5 ml, intramuscular). On 11 May 2007, immediately after vaccination with Havrix and Typhim Vi, the subject experienced body spasm, leg stiffness, body stiffness, arm stiffness and unresponsive to stimuli. This case was assessed as medically serious by GSK. On 11 May 2007, the events were resolved. Verbatim text: Immediate reaction - unresponsive - eyes open, stiffening legs/body/arms/hands pulling inward to body in spasm. Lasted 10-15 seconds. Colour good/pulse 88. Spontaneous recovery.

VAERS ID:282191 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Female  Submitted:2007-06-18
Location:Foreign  Entered:2007-06-18
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: B0474422A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of syncope in a 8-year-old female subject who was vaccinated with Havrix Junior, GlaxoSmithKline for prophylaxis. On an unspecified date, the subject received 1st dose of Havrix Junior (unknown route and injection site), lot number not provided. Immediately after vaccination with Havrix Junior, the subject experienced syncope for a few minutes. This case was assessed as medically serious by GSK. at the time of reporting the event was resolved. The physician considered the event was possibly related to vaccination with Havrix Junior.

VAERS ID:282743 (history)  Vaccinated:2007-05-11
Age:8.0  Onset:2007-05-11, Days after vaccination: 0
Gender:Female  Submitted:2007-06-22, Days after onset: 42
Location:Foreign  Entered:2007-06-25, 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: AMOXILLIN 27/MAR/2007 - 02/APR/2007, PHOLOCODEINE LINCTUS 27/MAR/2007
Current Illness:
Preexisting Conditions: Urinary tract infection
Diagnostic Lab Data:
CDC Split Type: E200703810
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB132BA IM 
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Immediate post-injection reaction, Muscle spasms, Musculoskeletal stiffness, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: This case was initially reported by the health authority, ref no: 20125961 on 11-Jun-07. This case concerns a 8 year old female patient. Details of the patient''s medical history have not been reported. The patient has also received amoxicillin for a urinary tract infection on 27-Mar-07 to 02-Apr-07 and also started pholcodeine linctus on 27-Mar-07. On 11-May-07, the patient received a Typhoid vaccine, Typhim Vi, batch number not reported. The patient also received a Havrix, batch number AHAVB132BA on the same day. On 11-May-07, immediately post immunisation, the patient was unresponsive with eyes open, had a stiffening in the legs, arms and body and was pulling inward in a spasm. The events lasted 10-15 seconds. The patient''s colour was good and post was 88 beats per minute. The patient recovered spontaneously. The reporter considered this to be a non serious reaction, however, the health authority considered this to be a serious reaction.

VAERS ID:295024 (history)  Vaccinated:2007-10-16
Age:8.0  Onset:2007-10-16, Days after vaccination: 0
Gender:Male  Submitted:2007-10-31, Days after onset: 15
Location:Foreign  Entered:2007-10-31
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure 16Oct2007 80/50mmHg; Pulse rate 16Oct2007 50pulse/min
CDC Split Type: B0493237A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Fall, Heart rate decreased, Loss of consciousness, Pallor, Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), 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), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of anaphylaxis in a 8-year-old male subject who was vaccinated with Twinrix for prophylaxis. No concurrent medication nor relevant medical history was known. Previous tolerance to vaccination was not reported. On 16 October 2007 the subject received 2nd dose of Twinrix (intramuscular, unknown, lot number not provided). At examination before vaccination the subject was well. On 16 October 2007, 10 minutes after vaccination with Twinrix, the subject fainted and fell backwards. He regained consciousness and was very drowzy. At examination at the time of the event he was pale, heart rate was measured at 50 pulse/min, blood pressure at 80/50 mmHg, he was alert and responded appropriately. He was treated with oxygen and transferred to hospital overnight. Twenty minutes after the events the subject was stable. There was no evidence of infection. The reporting physician reported the events as "cardiovascular event (anaphylaxis)". He considered the events were life threatening and clinically significant (or requiring intervention). At hospital the subject received 1 time hydrocortisone and was discharged the next day 12 hours later. The physician considered the events were possibly related to vaccination with Twinrix.

VAERS ID:299254 (history)  Vaccinated:2007-03-12
Age:8.0  Onset:2007-03-25, Days after vaccination: 13
Gender:Female  Submitted:2007-12-11, Days after onset: 261
Location:Foreign  Entered:2007-12-11
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: Febrile convulsion, Migraine
Diagnostic Lab Data: Body temperature Mar2007 36.7; C-reactive protein Mar2007 0.2; Calcium Mar2007 1.28; Chloride Mar2007 107; Glucose Mar2007 6.1; Hemoglobin Mar2007 139; Leukocyte count NOS Mar2007 4.2; Mean cell volume Mar2007 85; Potassium Mar2007 3.8; Res
CDC Split Type: B0498317A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB060BN IMLA
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURERA0213 IMRA
Administered by: Other     Purchased by: Other
Symptoms: Aura, Blood calcium decreased, Blood chloride normal, Blood glucose, Blood pH normal, Blood potassium normal, Blood sodium normal, Body temperature, C-reactive protein normal, Convulsion, Haemoglobin, Mean cell volume normal, Migraine, Platelet count increased, Platelet count normal, Respiratory rate, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of convulsion in a 8-year-old female subject who was vaccinated with Twinrix (GlaxoSmithKline) and Meningococcus vaccine Groups A + C). The subject''s family history included no epilepsy. The subject''s medical history included one febrile convulsion at the age of 3-4. During two years the subject has had migraine type headache with aura symptoms. Otherwise the subject had a normal growth and development. On 12 March 2007 the subject received unspecified dose of Twinrix (intramuscular, left arm), unspecified dose of Meningococcus vaccine Groups A + c (intramuscular, right arm). On 25 March 2007, 13 days after vaccination with Twinrix and Meningococcus vaccine Groups A + C, the subject experienced convulsive seizure which lasted 15 minutes according to the subject''s grandmother. The subject was well during the follow-up at the ward and she was discharged in good general condition. The subject had unspecified treatment from 25 March 2007 til 26 March 2007. Relevant test included C-reactive protein 0.2, leucocytes 4.2, hemoglobin 139, mean cell volume 85, thrombocyte 327, sodium 140, potassium 3.8, calcium 1.28, pH 7.38, chloride 107, glucose 6.1, body temperature 36.7 deg C and respiratory rate 108/63. On 01 April 2007 the subject experienced again a convulsive seizure which lasted for about 10 minutes. During the follow-up at the clinic the subject''s condition was well. She was discharged in good condition during the same day.

VAERS ID:300443 (history)  Vaccinated:2007-11-15
Age:8.0  Onset:2007-11-15, Days after vaccination: 0
Gender:Male  Submitted:2007-12-19, Days after onset: 34
Location:Foreign  Entered:2007-12-19
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: Not stated
Diagnostic Lab Data: UNK
CDC Split Type: B0500241A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB145B1 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic shock, Syncope, Vomiting projectile
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of anaphylactic shock in a 8-year-old male subject who was vaccinated with Havrix for prophylaxis. On 15 November 2007 the subject received unspecified dose of Havrix (intramuscular). On 15 November 2007, at an unspecified time after vaccination with Havrix, the subject experienced anaphylactic shock. The regulatory authority reported that the event was clinically significant (or requiring intervention). At the time of reporting the event was resolved. Verbatim Text: Collapse, projectile vomiting (anaphylactic shock).

VAERS ID:304735 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Male  Submitted:2008-02-11
Location:Foreign  Entered:2008-02-12, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: electrocardiogram normal; computed axial tomography normal; electrocardiogram high amplitudes; CSF VZV IgG Ab negative; cerebrospinal fluid analysis 29 leukocytes/mm3; 69% neutrophils, 10% lymphocytes; 21% monocytes; 115 mg/dl; globulin 35
CDC Split Type: WAES0801BRA00065
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abnormal behaviour, Affect lability, Amnesia, Apathy, Aphasia, Blood immunoglobulin G increased, CSF cell count, CSF lymphocyte count abnormal, CSF monocyte count, CSF neutrophil count increased, CSF protein increased, CSF test abnormal, CSF virus no organisms observed, CSF white blood cell count increased, Cognitive disorder, Complex partial seizures, Computerised tomogram normal, Death, Decerebration, Electrocardiogram abnormal, Globulins increased, Herpes simplex serology negative, Hypertonia, Lethargy, Muscle rigidity, Mutism, Myoclonus, Opisthotonus, Partial seizures with secondary generalisation, Pleocytosis, Respiratory disorder, Respiratory tract infection, Speech disorder, Subacute sclerosing panencephalitis, Tonic convulsion, Trismus
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Dystonia (narrow), Parkinson-like events (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Malignant lymphomas (broad), Respiratory failure (broad)
Write-up: Information has been received from a physician, author of a literature article, concerning an 8 year old healthy male who was vaccinated with MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) when he was ten months old and five years old. The boy presented at the neurology service with a two-month history of behavioural disturbances, mainly manifested by emotional lability and apathy associated with impairment of educational performance. This clinical picture was followed by complex partial seizures with secondary generalization, with normal interictal EEG and cranial computed tomography (CT). Despite having been treated with gamma-aminobutyric acid, the patient''s condition worsened progressively in the following two months, with amnesia, worsening of behavioural pattern, speech and cognitive impairment. He was hospitalized for further investigations. The patient did not have any prior history of measles infection, his immunization history was normal, including vaccination against measles. His developmental milestones were normal and there was no family background of neurological disorders. Carbamazepine was prescribed due to the onset of generalized myoclonic movements and tonic seizures. Recurrent seizures led to the prescription of valproic acid combined with clonazepam. Another EEG showed generalized periodic high-amplitude sharp waves. CSF analysis showed pleocytosis (29 leukocytes/mm3 with 69% neutrophils, 10% lymphocytes and 21% monocytes) and elevated protein (115 mg/dL) and globulin levels (35 mg/dL). The measles immunoglobulin C titer was over 1:200 on CSF analysis and it was greater than the serum titer (1:80). Polymerase chain reaction for herpes simplex virus (HSV) was negative as well as serum and CSF varicella zoster virus (VZV) serology. The patient became nonverbal and developed trism and an irregular respiratory pattern. Physical examination revealed a lethargic boy with increased muscular tone, diffuse rigidity, semi-opsthotonous position, mutism and decerebration. During his

VAERS ID:305154 (history)  Vaccinated:2008-01-30
Age:8.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-02-19, Days after onset: 20
Location:Foreign  Entered:2008-02-19
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: A0710316A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 2UNRL
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Nasopharyngitis, Rash, Urticaria, Viral infection
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a pharmacist and described the occurrence of injection site redness in a 8-year-old female subject who was vaccinated with Twinrix pediatric, GlaxoSmithKline for prophylaxis. On an unspecified date the subject received 3rd dose of Twinrix pediatric in an unknown arm. At an unspecified time after vaccination with Twinrix pediatric, the subject experienced injection site redness and swelling at the injection site. Four days later, she developed a rash on the other arm which got worse and extended to the whole body. It was also reported that the subject had a viral infection at the time the rash started. At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 13 February 2008, via pharmacist, who reported previous and/or concurrent vaccination included Twinrix Junior; GlaxoSmithKline; unknown; unknown given on June 2006 and July 2007. On 30 January 2008, the subject received 3rd dose of Twinrix pediatric (unknown, unknown arm). On 30 January 2008, the subject developed redness and swelling at the injection site. In approximately three days cold symptoms and hives developed. The cold symptoms improved, however the hives became worse. The hives were treated with over the counter antihistamines and diet. The pharmacist reported the previous Twinrix injections did not cause any problems. The pharmacist considered the events serious. At the time of reporting the events were unresolved. The pharmacist considered the events were probably related to vaccination with Twinrix pediatric.

VAERS ID:307018 (history)  Vaccinated:2007-11-06
Age:8.0  Onset:2007-11-12, Days after vaccination: 6
Gender:Female  Submitted:2008-03-13, Days after onset: 121
Location:Foreign  Entered:2008-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0056066A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB154CH0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Arthropathy, Joint crepitation, Joint swelling, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of joint crepitation in an 8-year-old female subject who was vaccinated with Havrix 720 Junior (GlaxoSmithKline). The case was additionally reported via a regulatory authority. On 6 November 2007 the subject received 1st dose of Havrix 720 Junior (intramuscular, right deltoid). Approximately one week after vaccination with Havrix 720 Junior, the subject experienced joint crepitation in all joints. Around 12 November 2007, 6 days after vaccination with Havrix 720 Junior, the subject experienced possible arthritis with reappearing swelling in the right shoulder joint with pain. At the time of reporting the subject showed no symptoms. The outcome of the events was unspecified. Laboratory parameters were normal. Borreliosis could be excluded. The physician considered possible arthritis with reappearing swelling in the right shoulder joint with pain were possibly related to vaccination with Havrix 720 Junior. Follow-up information was received on 10 March 2008: The subject had been treated with indomethacin (Indo-Pead) in late 2007. On 03 March 2008 the events recurred. The subject developed swelling and pain of her shoulder joint again. Additionally joint dysfunction occurred. Several other unspecified joints were also affected. In March 2008 the subject was hospitalised. At the time of reporting the events were unresolved. The physician considered the events were probably/certainly related to vaccination with Havrix 720 Junior.

VAERS ID:309284 (history)  Vaccinated:1997-03-15
Age:8.0  Onset:2002-01-01, Days after vaccination: 1753
Gender:Female  Submitted:2008-04-10, Days after onset: 2290
Location:Foreign  Entered:2008-04-10
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Antinuclear antibody Dec2004 Positive; Biopsy muscle 11Jan2008 Abnormal; Erythrocyte sedimentation rate Dec2004 30/60 Immunochimic tests: Marcophagic myofascitis lesions; In December 2004: -Antinuclear antibody: Positive at 1/200 (fluoresce
CDC Split Type: B0515476A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Antibody test negative, Antinuclear antibody positive, Asthenia, Biopsy muscle abnormal, Disturbance in attention, Fibromyalgia, Immunology test abnormal, Myalgia, Myofascitis, Pain, Red blood cell sedimentation rate increased
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by the regulatory authority (MA20080317, 08-608) and described the occurrence of asthenia in a 14-year-old female subject who was vaccinated with ENGERIX B pediatric, (GlaxoSmithKline). Co suspect vaccine included Tetravac. On 18 July 1996, 27 October 1996 an 10 January 1997, the subject received an injection of Engerix B Pediatric (Intramuscular, unknown batch reference). On 15 March 1997, she received the fourth injection of Engerix B Pediatric (Intramuscular, unknown batch reference). In 2002, around five years later, the subject experienced asthenia, diffuse myalgia and then concentration disorders leading to difficulties at school. In unspecified date, pain worsened and analgesic drugs were inefficient. On 11 July 2002, she received a fifth of Engerix B Pediatric (Intramuscular, unknown batch reference) and an injection of Tetravac (intramuscular). In December 2004, biological tests evidence positive antinuclear antibody at 1/200 (fluorescence tests). The other antibodies tests were negative (NOS). Erythrocyte sedimentation rate was 30/60. A possible fibromyalgia was evoked. On 11 January 2008, muscle biopsy at the right side (vaccinated side) evidence signs of macrophagic myofascitis which was confirmed by immunochemistry tests. At the time of reporting, myalgia, asthenia and concentration disorders were unresolved. The outcome of antinuclear antibody positive, possible fibromyalgia and macrophagic myofascitis was unknown. The regulatory authority reported that the events were disabling. According to the AFSSaPS reporter, asthenia, myalgia and concentration disorder were dubiously related to Engerix B vaccine and Tetravac.

VAERS ID:309344 (history)  Vaccinated:2007-10-12
Age:8.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-11
Location:Foreign  Entered:2008-04-11
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: ATOPY, POLLINOSIS
Diagnostic Lab Data: UNK
CDC Split Type: D0056870A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA288AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Influenza, Otitis media, Tympanic membrane perforation
SMQs:, Accidents and injuries (broad), Hearing impairment (narrow)
Write-up: This case was reported by a physician and described the occurrence of influenza b virus infection in a 9-year-old male subject who was vaccinated with Influsplit SSW (GlaxoSmithKline). Concurrent medical conditions included atopy and pollinosis. On 12 October 2007 the subject received unspecified dose of Influsplit SSW (unknown route and application site). At an unspecified time after vaccination with Influsplit SSW, the subject experienced mitigated influenza b virus infection with left-sided perforated otitis media. This case was assessed as medically serious by GSK. At the time of reporting, on 2 April 2008, the events were unresolved.

VAERS ID:309522 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-15
Location:Foreign  Entered:2008-04-15
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: UNK
CDC Split Type: B0516258A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hallucination, Pyrexia, Throat irritation
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This case was reported by a consumer and described the occurrence of hallucination in a 8-year-old male subject who was vaccinated with Twinrix (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Twinrix (unknown). At an unspecified time after vaccination with Twinrix, the subject experienced hallucination, itchy throat and fever. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.

VAERS ID:310591 (history)  Vaccinated:2008-02-26
Age:8.0  Onset:2008-02-26, Days after vaccination: 0
Gender:Male  Submitted:2008-04-22, Days after onset: 55
Location:Foreign  Entered:2008-04-22
Life Threatening? Yes
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: 31 March 2008: Skin prick test to grass, tree, cat, peanut, hazelnuts, walnut, latex - Negative
CDC Split Type: B0514601A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Allergy test negative, Anaphylactic reaction, Pharyngolaryngeal pain, Rash generalised, Skin test, Sneezing
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of sneezing in a 8-year-old male subject who was vaccinated with meningococcal polysaccharide groups A, C, W and Y vaccine (ACWY vax, GlaxoSmithKline), HAVRIX and TYPHIM. On 26 February 2008 the subject received unspecified dose of ACWY vax (1 injection), unspecified dose of HAVRIX (1 injection) and unspecified dose of TYPHIM (1 injection). On 26 February 2008, approximately 10 minutes after vaccination with ACWY vax, HAVRIX and TYPHIM, the subject experienced sneezing and developed a sore throat and approximately an hour later developed rash all over body. At the time of reporting the events were resolved. Verbatim text received: On the 31st of March 2008 a doctor reported that a brother and sister were given HAVRIX junior, ACWY and TYPHIM at the same time, 10 minutes later the patients started sneezing, developed a sore throat and a hour later they both developed rash all over the body. The doctor stated that their symptoms had now resolved. Follow up information received on 16 April 2008: The subject did not have any previous reactions to vaccine or antibiotics. The subject did not experience eczema, food allergies, asthma or rhinitis. On 31 March 2008, skin prick test was performed to grass, tree, cat, peanut, hazelnuts, walnut, latex which was negative. The subject was diagnosed with anaphylactic reaction which was considered life threatening. The event resolved on 26 February 2008. The physician considered the event was possibly related to treatment with Mencevax ACWY, HAVRIX and TYPHIM. The subject received ENGERIX B successfully after testing.

VAERS ID:310864 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Female  Submitted:2008-04-24
Location:Foreign  Entered:2008-04-24
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 38degC
CDC Split Type: D0056996A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Inappropriate schedule of drug administration, Injection site erythema, Injection site necrosis, Injection site swelling, Pyrexia
SMQs:, 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 injection site necrosis in an 8-year-old female subject who was vaccinated with Boostrix (GlaxoSmithKline). On an unspecified date the subject received 1st dose of Boostrix (unknown route and application site). A few hours after vaccination with Boostrix, the subject experienced injection site necrosis with a diameter of approximately 1 cm, injection site redness, swelling at injection site and fever (38 degC). This case was assessed as medically serious by GSK. At the time of reporting, on 17 April 2008, the outcome of the events was unspecified.

VAERS ID:320050 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Male  Submitted:2008-07-21
Location:Foreign  Entered:2008-07-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hemiplegic migraine. Fever and upper respiratory tract symptoms several days prior to presentation.
Diagnostic Lab Data:
CDC Split Type: 200802303
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, CSF protein normal, CSF white blood cell count, Computerised tomogram normal, Electroencephalogram abnormal, Extensor plantar response, Headache, Hemiparesis, Influenza, Migraine with aura, Musculoskeletal stiffness, Pyrexia, Red blood cells CSF positive, Upper respiratory tract congestion
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Arthritis (broad)
Write-up: Initial literature report was published on 2008. Abstract: We identified neurological admissions temporally associated with influenza vaccine to determine the likelihood of causality using organization criteria. Although all cases were categorized as possibly related to the vaccine, most had a compelling alternative explanation. This observation suggests that the current criteria may not be sufficient in determining if an adverse event is truly vaccine related. This case involves an hospitalization of an 8-year-old male patient with history of hemiplegic migraine who experienced left-sided hemiparesis and right temporal headache 3 days after influenza vaccine (manufacturer unknown) was given in 2001. His symptoms resolved within 48 hours. Furthermore, he had fever and upper respiratory tract symptoms several days prior to presentation. Influenza B was detected by immunofluorescence microscopy in a nasal swap specimen 2 days after admission. CNS: no fever, right temporal headache, stiff neck, decreased power and upgoing plantar on left. WBC (cells/ul)= 3, RBC (cells/ul) = 3, protein (g/l) = 0.23. Serology was not done. CT was normal. EEG was slowing on the right. Final diagnosis was hemiplegic migraine / influenza B. The patient fully recovered. Cases 2008-02302 and 2008-02304 have been created to capture the other two events reported in this article.

VAERS ID:320604 (history)  Vaccinated:2008-07-01
Age:8.0  Onset:2008-07-01, Days after vaccination: 0
Gender:Male  Submitted:2008-07-28, Days after onset: 27
Location:Foreign  Entered:2008-07-28
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: UNK
CDC Split Type: D0058153A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: C-reactive protein increased, Fatigue, Headache, Pyrexia, Rash, Transaminases increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of increased transaminases in an 8-year-old male subject who was vaccinated with TWINRIX pediatric (GlaxoSmithKline). In July 2008 the subject received the first dose of TWINRIX pediatric. Three days after vaccination with TWINRIX pediatric, the subject''s transaminases and C-reactive protein were found increased. Additionally fever, exhaustion, headache and rash on trunk occurred. On an unspecified date within July 2008 transaminases and c-reactive protein were assessed again and were found decreased. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.

VAERS ID:323712 (history)  Vaccinated:2008-06-12
Age:8.0  Onset:2008-06-27, Days after vaccination: 15
Gender:Female  Submitted:2008-08-28, Days after onset: 62
Location:Foreign  Entered:2008-08-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA04643
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0684U1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Headache, Meningitis bacterial, Petechiae, Pharyngolaryngeal pain, Pyrexia, Rash papular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad)
Write-up: Information has been received from an agency concerning an 8 year old female who on 12-JUN-2008 was vaccinated with the second dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (rHA) (batch # NG52840) (Lot # 656987/0684U). On 27-JUN-2008 the patient presented with pharyngodinia, fever, headache and asthenia. On 28-JUN-2008 onset of papular cutaneous eruption and petechiae and on 29-JUN-2008 bacterial meningitis. She was admitted to the hospital and treated with ceftriaxone, vancomycin, acyclovir and DECADRON. The outcome is recovered on 14-JUL-2008. Other business partner numbers included: E2008-07876.

VAERS ID:324021 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Male  Submitted:2008-09-03
Location:Foreign  Entered:2008-09-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hemiplegic migraine
Preexisting Conditions:
Diagnostic Lab Data: CSF WBC, 3c/ul; Cerebrospinal fluid protein, 0.23g/l; Computerized tomogram, normal unit; Electroencephalogram, see text unit; Influenza serology, B+ unit; Red blood cells in cerebrospinal, 3c/ul
CDC Split Type: B0534611A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, CSF protein normal, CSF white blood cell count negative, Computerised tomogram normal, Electroencephalogram abnormal, Extensor plantar response, Headache, Hemiparesis, Influenza serology positive, Musculoskeletal stiffness, Pyrexia, Red blood cells CSF positive, Upper respiratory tract infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Arthritis (broad)
Write-up: This case was reported in a literature article and described the occurrence of hemiparesis in a 8-year-old male subject who was vaccinated with Influenza vaccine, manufacturer unspecified. The subject''s medical concurrent included hemiplegic migraine. On an unspecified date the subject received unspecified dose of Influenza vaccine (unknown). The subject experienced fever and upper respiratory tract infection symptoms several days before presentation. Three days after vaccination with Influenza vaccine, the subject experienced left sided hemiparesis, right temporal headache, stiff neck. The symptoms were resolved within 48 hours. The subject had also decreased power and upgoing plantar on left. Relevant test included: cerebrospinal fluid (white blood cell count 3 c/ul, red blood cell count 3 c/ul, protein 0.23 g/l), immunofluorescence microscopy in a nasal swab specimen 2 days after admission showed influenza B+, serology test was not done, computerized tomography which was normal, electroencephalogram which revealed slowing on right and magnetic resonance imaging which showed mild underlying edema. The subject was hospitalised. The author considered the events were possibly related to vaccination with Influenza vaccine because the onset of neurological manifestation occurred within a reasonable time from vaccine administration and could plausibly be explained by an underlying disease or another microbiologically confirmed infection.

VAERS ID:324392 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-05
Location:Foreign  Entered:2008-09-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Decreased Consciousness; Regression in Development; Seizure
Preexisting Conditions:
Diagnostic Lab Data: Blood culture, negative unit; CSF WBC, 7c/ul; CSF culture, negative unit; Cerebrospinal fluid protein, 0.26g/l; Computerized tomogram, atrophy unit; Electroencephalogram, abnormal unit; Nuclear magnetic resonance imaging, see text unit; Red
CDC Split Type: B0535542A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood culture negative, CSF cell count normal, CSF culture negative, CSF protein normal, CSF white blood cell count negative, Cerebral atrophy, Cerebrosclerosis, Clonic convulsion, Clonus, Computerised tomogram abnormal, Culture urine negative, Depressed level of consciousness, Electroencephalogram abnormal, Encephalopathy, Eye movement disorder, Hyperreflexia, Muscle spasticity, Nuclear magnetic resonance imaging abnormal, Pyrexia, Regressive behaviour
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad)
Write-up: This case was reported in a literature article and described the occurrence of acute encephalopathy in 8-year-old female subject who was vaccinated with FLUVIRAL (GlaxoSmithKline). Concurrent medical conditions included undiagnosed severe developmental regression and she had similar episode of decreased consciousness and seizure. In 2004 the subject received unspecified dose of FLUVIRAL (unknown). In 2004, 5 days after vaccination with FLUVIRAL, the subject experienced fever, decreased level of consciousness, gaze deviation to the right with clonic seizure, diffuse spasticity, clonus and hyperreflexia on right. The subject was hospitalized. Relevant test results included in cerebrospinal fluid: white blood cell 7 c/ul, red blood cell 0 and protein 0.26 g/l. Serology was not done. Bacterial culture and viral detection in blood, urine and cerebrospinal fluid were negative. Computerized tomography showed brain atrophy. Magnetic resonance imaging showed unchanged from previous with global brain atrophy and mesial temporal sclerosis. Electroencephalogram showed abnormal background, slower on left. Metabolic work up was negative. The subject was diagnosed with acute or chronic encephalopathy. The subject returned to abnormal baseline. The author considered the events were possibly related to vaccination with FLUVIRAL (Influenza vaccine) because the onset of neurological manifestation occurred within a reasonable time from vaccine administration.

VAERS ID:327379 (history)  Vaccinated:2003-10-21
Age:8.0  Onset:0000-00-00
Gender:Male  Submitted:2008-10-07
Location:Foreign  Entered:2008-10-07
Life Threatening? No
Died? Yes
   Date died: 2003-11-25
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Anti-Tetanus Serum, 21-OCT-2003 00:00/21-OCT-2003 00:00; Horse Rabies Antiserum (Rabies Antiserum), 21-OCT-2003 00:00/Unknown
Current Illness:
Preexisting Conditions: 21-OCT-2003 to Unknown, Dog bite
Diagnostic Lab Data:
CDC Split Type: MA20081998
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS 0IDUN
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Death, Hydrophobia, Inappropriate schedule of drug administration, Irritability, Phobia of flying, Pyrexia, Restlessness, Salivary hypersecretion
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad)
Write-up: On 23 SEP 2008 we received the following literature case: Recommended treatment for severe rabies exposure in unvaccinated individuals includes wound cleaning, administration of rabies immunoglobulins (RIG), and rabies vaccination. A survey of rabies treatment outcomes in the country was conducted. This was a case series involving 7,660 patients (4 months to 98 years of age) given purified equine RIG (pERIG) at the institute from July 2003 to August 2004 following Category II or III exposures. Data on local and systemic adverse reactions (AR) within 28 days and biting animal status were recorded; outcome data were obtained by telephone or home visit 6-29 months post-exposure. Follow-up data were collected for 6,464 patients (see case MA2008-1999). Of 151 patients with laboratory-confirmed rabies exposure, 143 were in good health 6-48 months later, seven could not be contacted, and one 4-year old girl died. Of 16 deaths in total, 14 were unrelated to rabies exposure or treatment. Two deaths were considered PEP failures: the 4-year-old girl, who had multiple deep lacerated wounds from a rabid dog of the nape, neck and shoulders requiring suturing on the day of exposure (see case MA2008-1997), and an 8-year-old boy who only received rabies PEP on the day of exposure. This extensive review of outcomes in persons with Category III exposure shows the recommended treatment schedule at institute using pERIG is well tolerated, while survival of 143 laboratory-confirmed rabies exposures confirms the intervention efficacy. Two PEP intervention failures demonstrate that sustained education and training is essential in rabies management. This case concerns a boy who only received treatment on the day he was bitten by a rabid dog, although this was not confirmed. With no subsequent vaccinations the boy died. On 21 OCT 2003 an 8-year-old boy was bitten by a pet dog and seen at institute the same day with a Category III single laceration of the right eyelid. He received pERIG (purified equine rabies immunoglobulins), partly infi

VAERS ID:330971 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Male  Submitted:2008-11-03
Location:Foreign  Entered:2008-10-31, 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: Unknown, Bitten by a dog
Diagnostic Lab Data:
CDC Split Type: MA20082453
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABIPUR)NOVARTIS VACCINES AND DIAGNOSTICS  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abnormal behaviour, Mental impairment, Psychotic behaviour, Social avoidant behaviour
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad)
Write-up: On 21 Oct 2008 we received the following information: An 8-year-old male child was bitten by a dog and received therefore a post exposure schedule with RABIPUR (batch no. unknown). Three months after the vaccination the child''s behaviour changed completely, no social interaction, psychotic behaviour and intellectual decline. His development was normal till 2.5 years. Company assessment: Seriousness criterion medically significant. Causality: insufficient data (the amount of data is not sufficient to finally assess this case). Expectedness assessment according to EU SPC/ US label: The reported symptoms are not expected after vaccination with RABIPUR. No change in benefit risk ratio. No measures necessary.

VAERS ID:339550 (history)  Vaccinated:2009-01-28
Age:8.0  Onset:2009-01-28, Days after vaccination: 0
Gender:Female  Submitted:2009-02-12, Days after onset: 15
Location:Foreign  Entered:2009-02-13, 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: WAES0902USA00902
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.NG28550 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Induration, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning an 8 (also reported as 9) year old female patient who on 28-JAN-2009 was vaccinated with a 0.5 mL dose of PNEUMOVAX 23 (Batch # NG28550) intramuscularly. It was reported that on 28-JAN-2009 the patient experienced fever, significant pain and indurations after vaccination. It was reported that the patient needed anti-inflammatory drug and hot fomentation. It was reported that the patient had recovered 3 days after vaccination. The reporting physician considered fever, pain and indurations to be other important medical event. This is one of several cases from the same source. No further information is available.

VAERS ID:339705 (history)  Vaccinated:2009-01-29
Age:8.0  Onset:0000-00-00
Gender:Male  Submitted:2009-02-16
Location:Foreign  Entered:2009-02-17, 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: WAES0902USA01391
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Neurological symptom
SMQs:
Write-up: Information has been received from a general practitioner concerning an 8 year old male patient who had received an injection of MMR II (lot # not reported) on 29-JAN-2009. He subsequently experienced reversible neurological deficit of both lower limbs. The outcome was not reported. Additional information has been requested. Other business partner numbers include E2009-01094.

VAERS ID:343046 (history)  Vaccinated:2006-06-20
Age:8.0  Onset:0000-00-00
Gender:Female  Submitted:2009-03-30
Location:Foreign  Entered:2009-03-31, 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:
Current Illness:
Preexisting Conditions: The patient received her primary dose IMOVAX POLIO (batch number X0329, 1 dosage form, parenteral) on 13-Jun-2006. No adverse effect was reported.
Diagnostic Lab Data:
CDC Split Type: E200902662
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURY10061UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Idiopathic thrombocytopenic purpura, Inappropriate schedule of drug administration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (narrow)
Write-up: Initial case was reported as serious on 20-Mar-2009 by Foreign Health Authority (ref. NO-NOMAADVRE-FHI-2009-7349 other ref. 09/564) to foreign agency. This is a case of misuse i.e. inappropriate schedule of administration. It was reported that a 9-years-old girl was vaccinated with IMOVAX POLIO (first primary, batch number X0329, parenteral route) on 13-Jun-2006, and on 20-Jun-2006 IMOVAX POLIO (second primary, batch number Y1006, parenteral route). HA reported ITP (Idiopathic Thrombocytopenic Purpura) with onset at the age of 11 years (no causality assessment reported). The HA has asked for more information from the primary reporter. The outcome is unknown. No further information is available. Case is closed.

VAERS ID:343846 (history)  Vaccinated:2009-03-19
Age:8.0  Onset:2009-03-19, Days after vaccination: 0
Gender:Female  Submitted:2009-04-09, Days after onset: 21
Location:Foreign  Entered:2009-04-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0567883A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B034AG IMLA
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Muscle rigidity
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), Parkinson-like events (narrow), 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 regulatory authority (#96667) and described the occurrence of loss of consciousness in a 8-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 19 March 2009, the subject received unspecified dose of BOOSTRIX (intramuscular, unknown injection site). On 19 March 2009, less than one day after vaccination with BOOSTRIX, the subject experienced loss of consciousness and muscular rigidity. The subject was hospitalised. At the time of reporting the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with BOOSTRIX.

VAERS ID:348412 (history)  Vaccinated:1997-01-10
Age:8.0  Onset:1997-04-05, Days after vaccination: 85
Gender:Female  Submitted:2009-06-03, Days after onset: 4441
Location:Foreign  Entered:2009-06-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Thin
Preexisting Conditions: Recurrent Bronchitis
Diagnostic Lab Data: Biopsy muscle, see lab text; Body temperature, 25Apr1997, 37.6degree cels; Creatine phosphokinase, 22 600; Electromyogram, see lab text; Electromyogram was in favour of muscular attack. Muscle biopsy showed dermatomyositis.
CDC Split Type: B0575688A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS2042C92UN 
Administered by: Other     Purchased by: Other
Symptoms: Biopsy muscle abnormal, Blood creatine phosphokinase increased, Dermatomyositis, Electromyogram abnormal, Erythema, Hypotonia, Muscular weakness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a foreign regulatory authority (NC20090228) and described the occurrence of dermatomyositis in a 8-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject''s medical history included recurrent bronchitis. The subject was thin. On 09 November 1995 and 14 December 1996, the subject received first and second dose of ENGERIX B (subcutaneous, respectively batches 1749 B9 and 2053 A9, injection sites unknown). On 10 January 1999, subject received a third dose of ENGERIX B (subcutaneous, injection site unknown, batch 2042 C9). 05 April 1997, 85 days after vaccination with ENGERIX B, the subject experienced muscle weakness. On 25 April 1997, the subject was hospitalised for muscle weakness. On that same date, physical examination evidenced muscle pain and muscle weakness, squamous erythema and muscular deficit, mainly proximal. Body temperature was at 37.6 degree Celsius. On unspecified date, complementary examinations evidenced creatine phosphokinase were at 22 600 (coded increased creatine phosphokinase). Electromyogram results were in favour of muscular attack. Dermatomyositis was diagnosed after muscle biopsy. On 23 January 2008, sclerodermatomyositis was diagnosed (coded dermatomyositis). The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, dermatomyositis was resolved with sequelae (NOS). The agency considered dermatomyositis as unlikely related to vaccination with ENGERIX B, according to the foreign method of imputability.

VAERS ID:350949 (history)  Vaccinated:2002-10-24
Age:8.0  Onset:2002-11-01, Days after vaccination: 8
Gender:Male  Submitted:2009-07-07, Days after onset: 2439
Location:Foreign  Entered:2009-07-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0581654A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Gait disturbance, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: This case was reported by a physician and described the occurrence of Guillain Barre Syndrome in a 8-year-old male subject who was vaccinated with INFANRIXTETRA (GlaxoSmithKline). Medical conditions and concurrent medications were unspecified. On 24 October 2002, the subject received an unspecified dose of INFANRIXTETRA (batch, route and injection site unknown). In November 2002, one month after vaccination with INFANRIXTETRA, the subject was hospitalized for Guillain Barre syndrome. At the time of reporting, the event was resolved. The causality assessment of the reporter was unspecified. Upon follow-up received on 02 July 2009 by the physician: Following Guillain Barre Syndrome, the subject presented with walking difficulty during one year. Since that time, no new flare up was observed. Etiology of Guillain Barre Syndrome was not found. Since October 2002, the subject did not receive any DTPa-IPV vaccine.

VAERS ID:351437 (history)  Vaccinated:2009-07-02
Age:8.0  Onset:2009-07-02, Days after vaccination: 0
Gender:Female  Submitted:2009-07-14, Days after onset: 12
Location:Foreign  Entered:2009-07-15, 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: Immunisation
Diagnostic Lab Data: Blood pressure measurement, 02Jul09, drop at 7; Sweat analysis, 02Jul09, "+++"
CDC Split Type: WAES0907USA00877
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1501X1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure decreased, Fatigue, Hyperhidrosis, Immediate post-injection reaction, No reaction on previous exposure to drug, Sweat test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a pharmacist concerning an 8 year old female patient with no personal nor family history of allergy who on 02-JUL-2009 was vaccinated with the second dose of MMR II (lot# 663665/1501X, batch# NK20190). 1 minute after vaccination, the patient experienced blood pressure drop at 7 (units not reported) and "sweating+++". She recovered in a few minutes, however she was tired for a few hours. Treatment with CELESTENE was prescribed for a few days. The reporter added that the cold chain was observed. It is noteworthy that patient had well tolerated the first dose of PRIORIX (other manufacturer) administered on an unspecified date. It was also reported that the patient''s brother experienced a similar event after receiving the second dose of vaccine on the same day (WAES#0907USA00875). The reporter felt that the events of hypotension, hyperhidrosis and tiredness were considered to be other important medical events. Other business partner numbers include: E2009-05652. No further information is available.

VAERS ID:353367 (history)  Vaccinated:2009-05-29
Age:8.0  Onset:2009-05-29, Days after vaccination: 0
Gender:Unknown  Submitted:2009-08-06, Days after onset: 69
Location:Foreign  Entered:2009-08-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0907POL00021
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0484X1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic shock, Convulsion, Loss of consciousness, Muscle spasms, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Dystonia (broad), 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: Information has been received from a physician via an Agency (Authority number: PL-URPL-OCR-20090716003; URPL paper id: N524/2009) concerning an 8 year old patient who on 29-MAY-2009 was vaccinated with MMR II (rHA; Batch number: NJ19760; Lot number: 660270/0484X). On 29-MAY-2009 the patient experienced seizure, anaphylactic shock, fainting (loses of consciousness for 1-2 minutes) and limbs spasm and was hospitalized on pediatric department. On admission the patient was in good general condition. Subsequently, the patient recovered from seizure, anaphylactic shock, fainting and limbs spasm. After few days the patient was examined by pediatrist. The pediatrist stated no deviation from normal condition. The reporter felt that seizure, anaphylactic shock, fainting and limbs spasm were related to therapy with MMR II. Additional information is not expected.

VAERS ID:354063 (history)  Vaccinated:2009-01-27
Age:8.0  Onset:2009-01-29, Days after vaccination: 2
Gender:Male  Submitted:2009-08-13, Days after onset: 195
Location:Foreign  Entered:2009-08-13
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: UNK
CDC Split Type: B0587913A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B098AE IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site discolouration, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a regulatory authority (# 042720) and described the occurrence of skin discoloration in a 8-year-old male subject who was vaccinated with INFANRIX-IPV (GlaxoSmithKline). Previous and/or concurrent vaccination included MMR; manufacturer unspecified; given in 2009; On 27 January 2009, the subject received unspecified dose of INFANRIX-IPV (intramuscular, unknown injection site). On 29 January 2009, 2 days after vaccination with INFANRIX-IPV, the subject experienced skin discoloration and swelling injection site. The regulatory authority reported that the evens were clinically significant (or requiring intervention). The subject was treated with antihistamine and Antibiotic. The events lasted 5 weeks. At the time of reporting the events were resolved.

VAERS ID:354915 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Male  Submitted:2009-08-20
Location:Foreign  Entered:2009-08-21, 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: Unknown
Diagnostic Lab Data: The diagnosis of Influenza infection was confirmed by a quick test using nasal secretion.
CDC Split Type: 200903587
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Influenza, Influenza like illness, Influenza serology positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Case received from a healthcare professional in a foreign country on 11 August 2009 under the local reference number BR2009-134. This case was linked with 2009-03579, 2009-03586, 2009-03584, 2009-03583, and 2009-03581 (Flu vaccines, same country, same reporter, same diagnosis, suspected vaccination failure). 2009-03580 and 2009-03584 are part of a cluster. An 08-year-old male patient, with an unknown personal and family medical history, had received his dose of INFLUENZA vaccine (manufacturer, batch number, route and site of administration unknown) on an unknown date. On an unknown date post-vaccination, the patient experienced flu-like symptoms. On 11 August 2009, the physician informed that the diagnosis was influenza infection, confirmed by a quick test using nasal secretion. No further information was available. The outcome was unknown at the time of the report. The seriousness of this case was unknown. However, upon internal review, it has been upgraded to serious (medically important event).

VAERS ID:360343 (history)  Vaccinated:2009-07-29
Age:8.0  Onset:2009-08-04, Days after vaccination: 6
Gender:Female  Submitted:2009-10-09, Days after onset: 66
Location:Foreign  Entered:2009-10-09
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Salbutamol Sulphate
Current Illness: Unknown
Preexisting Conditions: No medical history of allergies or vaccine reactions. Fully immunised. Two siblings received the same batch of vaccine and are well.
Diagnostic Lab Data: UNK
CDC Split Type: B0597183A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB248BW IMUN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Myelitis transverse
SMQs:, Demyelination (narrow)
Write-up: This case was reported by an agency and described the occurrence of transverse myelitis in an 8-year-old female subject who was vaccinated with HAVRIX, Salmonella typhi Vi capsular polysaccharide vaccine. Concurrent medications included VENTOLIN. On 29 July 2009 the subject received unspecified dose of HAVRIX (.5 ml, intramuscular), unspecified dose of Salmonella typhi vaccine (intramuscular). On 4 August 2009, 6 days after vaccination with HAVRIX and Salmonella typhi vaccine, the subject experienced transverse myelitis. The subject was hospitalised and the regulatory authority reported that the event was disabling and life threatening. At the time of reporting the event was improved.

VAERS ID:360949 (history)  Vaccinated:2009-10-01
Age:8.0  Onset:2009-10-01, Days after vaccination: 0
Gender:Female  Submitted:2009-10-14, Days after onset: 13
Location:Foreign  Entered:2009-10-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0910USA00982
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0301Y IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Epistaxis, Fall, Injury, Loss of consciousness, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Case reported by Health Authority (case#104132) through Foreign agency (local case#IT413/09). Initial case received on 03-OCT-2009. An 8 year old female with no previous medical history reported who was vaccinated IM on 01-OCT-2009 with one dose (number not reported) of MMR II (lot number: 664263/0301Y, batch number: NK47930). On the same day she presented with vagal crisis with fainting and epistaxis due to facial trauma from falling and loss of consciousness. She was hospitalized. The outcome was not reported. Other business partner included E2009-09257. No further information is available.

VAERS ID:377594 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Female  Submitted:2010-01-20
Location:Foreign  Entered:2010-01-20
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: Subject''s past vaccinal history included four doses of vaccines containing diphtheria, tetanus, pertussis, inactivated poliomyelitis and haemophilus influenzae type b components (Unknown manufacturers) during infancy.
Diagnostic Lab Data: UNK
CDC Split Type: B0625830A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Pertussis
SMQs:
Write-up: This case was reported by a physician and described the occurrence of pertussis in an 8-year-old female subject who was vaccinated with INFANRIXQUINTA (GlaxoSmithKline). Subject''s past vaccinal history included four doses of vaccines containing diphtheria, tetanus, pertussis, inactivated poliomyelitis and haemophilus influenzae type b components (Unknown manufacturers) during infancy. During the summer 2009, at the age of eight, the subject received a 5th dose of INFANRIX QUINTA (batch, route and injection site unknown) (inappropriate age at vaccine administration). In January 2010, she developed pertussis (NOS) (possible vaccination failure). At the time of reporting, pertussis was not resolved. This case was assessed as medically serious by GSK.

VAERS ID:382475 (history)  Vaccinated:2010-02-25
Age:8.0  Onset:0000-00-00
Gender:Female  Submitted:2010-03-11
Location:Foreign  Entered:2010-03-12, 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:
CDC Split Type: 2010022213
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER005030IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)
Write-up: Report received from a doctor via a regulator on 07-MAR-2010. An 8 year old female patient (date of birth: unknown) received her first dose of PANVAX H1N1 influenza vaccine (batch number: 00503) via intramuscular injection on 16-JAN-2010 and her second dose via intramuscular injection on 25-FEB-2010 (batch unknown). The medical history and concomitant medications are unknown. One week after each PANVAX injection, the patient developed a fever of 39.6 degrees celsius. The patient self medicated with Panadol. The fever was settled but the patient has developed lethargy now. The patient outcome is not yet recovered. The reporter considered the event serious and the patient did not require hospitalisation. This case was reported as serious because of medical significance. The company considered events possible to the suspect drug, PANVAX given the time to onset of events. Batch review results were received for 09D300503 on 23-FEB-2010. On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot were assessed as having no impact on product quality. All QC testing was satisfactory with no out of specification results reported. There are no outstanding issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:383084 (history)  Vaccinated:2009-10-30
Age:8.0  Onset:2010-02-28, Days after vaccination: 121
Gender:Male  Submitted:2010-03-19, Days after onset: 18
Location:Foreign  Entered:2010-03-19
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: The subject was not very often ill.
Diagnostic Lab Data: Pertussis serology, 03Mar2010, see text; On 03 March 2010, pertussis serology: highly positive anti-pertussis toxoid antibodies (+++), positive anti-adenylate cyclase antibodies (+) and highly positive anti-FHA antibodies (+++). The medical laboratory''s conclusion was diagnosis of bordetella pertussis, if absence of pertussis vaccination in the last three years.
CDC Split Type: B0639791A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Bordetella test positive, Cough, Pertussis, Wrong drug administered
SMQs:, Anaphylactic reaction (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of possible bordetella pertussis in a 8-year-old male subject who was vaccinated with INFANRIXTETRA (GlaxoSmithKline), INFANRIXQUINTA, and PENTAVAC (Sanofi-Pasteur). The subject was not very often ill. On 06 June 2002 and on 17 September 2002, the subject received two primary doses of INFANRIXQUINTA (batch number, route and injection site unknown). On 20 January 2003 and on 05 January 2004, the subject received two doses of PENTAVAC (batch number, route and injection site unknown). On 30 October 2009, the subject received a booster dose of INFANRIXTETRA (batch number, route and injection site unknown): wrong vaccine administered according to vaccination recommendations. It should have been a dT-IPV vaccine instead. On 28 February 2010, three months after the last vaccination (INFANRIXTETRA), the subject experienced cough which persisted. On 03 March 2010, a pertussis serology was performed and showed the following results: highly positive anti-pertussis toxoid antibodies (+++), positive anti-adenylate cyclase antibodies (+) and highly positive anti-FHA antibodies (+++). The medical laboratory''s conclusion was diagnosis of bordetella pertussis, if absence of pertussis vaccination in the last three years (possible vaccination failure). The subject was treated with ZECLAR. At the time of reporting, cough was improving. This case was assessed as medically serious by GSK.

VAERS ID:384708 (history)  Vaccinated:1973-03-09
Age:8.0  Onset:1981-01-19, Days after vaccination: 2873
Gender:Female  Submitted:2010-04-07, Days after onset: 10669
Location:Foreign  Entered:2010-04-08, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1004USA00258
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Autism
SMQs:
Write-up: Initial information received on 26-OCT-2009, this case is not medically confirmed. This case is linked with case E2010-01528 and is related to general claim against related to all products containing thiomersal. The claim contains 65 cases among which 41 are related to vaccines. Furthermore, this case is also linked to 2 cases related to patients who dropped their complaints. The claim is not against Sanofi Pasteur, this latter is only a third party. Therefore some of the cases are poorly documented. Current case concerns an 8 year old female patient (Plaintiff n. 8). The patient received three doses of a MMR II (manufacturer unknown, batch number, route and site of administration not reported) when she was 3, 4 and 5 months old respectively (exact dates not reported, in the form it is written 1973 in question marks). The patient also received one dose of a ATTENUVAX (manufacturer unknown, batch number, route and site of administration not reported) when she was 12 months old. According to the report, the patient was diagnosed with autism on 19-JAN-1981. Autism was considered to be an other important medical event. Other business partner numbers included E2010-01670. This is one of several reports received from the same source. No other information is available. Case is closed.

VAERS ID:385217 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Male  Submitted:2010-04-15
Location:Foreign  Entered:2010-04-15
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: UNK
CDC Split Type: B0646549A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Autism
SMQs:
Write-up: This case was reported by a pharmacist and described the occurrence of autism in a 8-year-old male subject who was vaccinated with ENGERIX B PEDIATRIC (GlaxoSmithKline). Medical history and concurrent medications were unspecified. On an unspecified date in 2005-2006, the subject received received an unspecified dose of ENGERIX B PEDIATRIC (route, injection site and batch unknown). At an unspecified time after vaccination with ENGERIX B PEDIATRIC, the subject was diagnosed with autism. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unresolved. The pharmacist considered the event was unlikely to be related to vaccination with ENGERIX B PEDIATRIC.

VAERS ID:385939 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Female  Submitted:2010-04-26
Location:Foreign  Entered:2010-04-26
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 test, normal; borrelia burgdorferi serology, negative; immunohistochemistry, see text; skin biopsy, see text
CDC Split Type: B0648864A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  IJUN
Administered by: Other     Purchased by: Other
Symptoms: Acute lymphocytic leukaemia, Antibody test positive, Antinuclear antibody negative, B-cell lymphoma, Biopsy skin abnormal, Blood count normal, Blood test normal, Borrelia test negative, Chronic hepatitis, Histology abnormal, Immunology test abnormal, Injection site erythema, Injection site induration, Injection site inflammation, Injection site reaction, Laboratory test abnormal, Lymphocytic infiltration, Lymphoid tissue hyperplasia, Nodule, Pathology test, Plasma cells present, Skin lesion, Skin plaque, Skin warm
SMQs:, Hepatitis, non-infectious (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Extravasation events (injections, infusions and implants) (broad), Vasculitis (broad), Malignant tumours (narrow), Skin tumours of unspecified malignancy (broad), Hypersensitivity (broad), Malignant lymphomas (narrow)
Write-up: This case was reported in a literature article and described the occurrence of cutaneous lymphoid hyperplasia in a 8-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). At 8 year-old the subject received unspecified dose of hepatitis B vaccine. A 17-year-old girl was referred to the dermatology department for plaques and nodules of 9 year duration. While her medical history was unremarkable, 2 of these lesions had developed at the site of hepatitis B vaccine injections received 9 years before (on the arm and the buttock). They appeared rapidly after a common inflammatory reaction at the injection site, with progressive induration and erythema. Two similar lesions appeared a few years later on the thigh and the wrist, yet no injection had been made at these sites. The lesions gradually enlarged for 2 or 3 years and then became stable. Physical examination revealed a large erythematous, hot and indurate plaque on the left arm. She also had erythematous and indurated plaques on the left buttock and left thigh, and a smaller lesion on the right wrist. The general physical examination was otherwise normal. Histopathological examination of a skin biopsy showed nodular lymphoid infiltration, with periannexial distribution on the dermis component without lichenoid alteration of the basal membrane, and deep infiltration to the hypodermis. In the deep dermis, there were a few lymph follicles with formation of germinal centers. Immunohistochemical analysis showed the B-cell phenotype of proliferation (CD20/L26+) with an accompanying reactive T-cell (CD3+) infiltrate. Lymph follicle germinal centre cells were positive for BC16 and CD10 antibodies, with a high proliferation rate ( Ki67/MIB1+) only at this site. The follicular dendritic network stained by anti-CD23 antibody was well organized on a germinal centre. Disseminated Cutaneous Lymphoid Hyperplasia. The rare plasma cells (syndecan positive) showed a polyclonal expression of immunoglobulin and light chains. A search for inorganic deposits such as aluminum was performed using the Morin technique but was negative on a cutaneous biopsy involving the arm, an injection site. Blood counts and chemistry were normal. B. burgdorferi serology was negative as well as antinuclear antibodies. Given all these data, we diagnosed B-cell CLH. The subject was treatments with hydroxychloroquine and cyclins were successively prescribed but both were inefficient. Finally, 12 years after the onset the lesions, thalidomide treatment (100 mg/day for 1 month, then 50 mg/day because of poor tolerance) led to the progressive regression of the lesions. Indeed, 10 months later, the buttock lesion had disappeared, and the others were no longer erythematous and infiltrated. After 2 years, all the lesions had disappeared and the treatment was stopped. According to the author the causal role of hepatitis B vaccination was strongly suggested on the basis of the chronology and initial topography of the lesions at the injection sites. This case was assessed as medically serious by GSK.

VAERS ID:386238 (history)  Vaccinated:2001-01-05
Age:8.0  Onset:2001-12-21, Days after vaccination: 350
Gender:Male  Submitted:2010-04-28, Days after onset: 3049
Location:Foreign  Entered:2010-04-29, 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: Unknown
Diagnostic Lab Data: Diagnostic laboratory test, 0.51, Hair mercury level
CDC Split Type: WAES1004USA03810
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Allergy test, Antimicrobial susceptibility test, Aphasia, Autism, Bacterial test, Blood count, Blood test, Cytogenetic analysis, Disability, Hair metal test abnormal, Urine analysis
SMQs:, Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Initial information received on 26-OCT-2009, this case was not medically confirmed. This case was linked with case E2010-01528(WAES#1004USA03843) and was related to a general claim against the Ministry of Health related to all products containing thimerosal. The claim contains 65 cases among which 41 are related to vaccines. Furthermore, this case is also linked with 2 cases related to patients who dropped their complaints. The claim was not against Sanofi Pasteur MSD. this latter was only a third party. Therefore some of the cases are poorly documented. Current case concerns a male patient (plaintiff n 26) born on 2002. The patient received a dose of RECOMBIVAX HB (batch number, route and site of administration not reported) on 26-MAY-2005. The patient also received the following vaccines: -2 doses of RECOMBIVAX HB (manufacturer unknown, batch number, route and site of administration not reported) on 30-NOV-2004 and 30-DEC-2004. -4 dose of DTaP (manufacturer unknown, batch number, route and site of administration not reported on 09-DEC-1993, 07-FEB-1994, 11-APR-1994 and 11-MAR-1995. -1 dose of DTP (manufacturer unknown, route and site of administration not reported) on 02-JUL-1998. -2 doses of MMR II (manufacturer unknown, batch number, route and site of administration not reported) on 23-DEC-1994 and 05-JAN-2001. According to the report, the patient was diagnosed with autism on 21-DEC-2001, and had a disability grade of 48% which was evaluated on 22-NOV-2005. The patient was also diagnosed with dysphasia (date not reported). A test performed in a hair sample (dates not reported) showed that the patient had a mercury level of 0.51; normal range is below 0.40 (units not reported). According to the form received from the claimant, the following statements were included: Urinary analysis, Hair test (mineralogram and others), Blood count, Blood test, food allergies test, Genetic test, Bacteria and Yeast susceptibilities. In the form received from the claimant it was written "Medical report: Yes" but the company had not received it yet. Other business partner numbers included E 2010-01895. This is one of several reports received from the same source.

VAERS ID:386342 (history)  Vaccinated:2009-10-08
Age:8.0  Onset:2009-10-08, Days after vaccination: 0
Gender:Female  Submitted:2010-04-30, Days after onset: 204
Location:Foreign  Entered:2010-04-30
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: B0649341A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER139A5IMUN
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALSA69CB572A1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a regulatory authority (# NL-LRB-105401) and described the occurrence of syncope in a 8-year-old female subject who was vaccinated with (new strain) PRIORIX (GlaxoSmithKline), (A or W not known) DTP vaccine. No concomitant medication was reported. No relevant medical history was reported. On 8 October 2009, the subject received 2nd dose of PRIORIX (intramuscular, unknown injection site), 6th dose of DTP vaccine (intramuscular, unknown, unknown injection site). On 8 October 2009, 3 minutes after vaccination with DTP vaccine and PRIORIX, the subject experienced syncope. The regulatory authority reported that the event was clinically significant (or requiring intervention). On 8 October 2009, the event was resolved quickly. The regulatory authority reported that the event was probably related to vaccination with PRIORIX and DTP vaccine. No further information was expected, this case was therefore closed.

VAERS ID:386778 (history)  Vaccinated:2010-04-09
Age:8.0  Onset:2010-04-09, Days after vaccination: 0
Gender:Female  Submitted:2010-05-05, Days after onset: 26
Location:Foreign  Entered:2010-05-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: WBC count, 10.1/nl; serum C-reactive protein, 1.46 mg/dl
CDC Split Type: WAES1004USA04409
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0931U0UNUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA5831 UNUN
TDAP: TDAP (ADACEL)SANOFI PASTEURA5831 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: C-reactive protein normal, Cellulitis, Erythema, Expired drug administered, Inappropriate schedule of drug administration, Injection site swelling, Injection site warmth, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Case received from a health authority on 26-APR-2010 (HA reference number PEI2010011071). This is a case of misuse because of expired vaccine and used REPEVAX used. A physician reported that a 8-year-old female, patient was vaccinated with a first dose of RECOMBIVAX HB (lot # 656061/0931; batch # NJ50790) and concomitantly with a booster dose of REPEVAX (lot # A583-1, expiration date January 2009) on 09-APR-2010. One vaccine was administered into the right arm, the other into the left arm. The reporter considered RECOMBIVAX HB as probably given into the right arm, but was not sure. Two days post vaccination, the patient developed a phlegmon with redness, swelling and warmth at the right arm. On an unspecified date the patient was admitted to hospital. Laboratory test showed leukocytes with 10.1/nl and CRP with 1.46 mg/dl. At the time of reporting to health authority (13-APR-2010) the patient had not recovered. Health authority coded following AEs: phlegmon, redness, vaccination site swelling and vaccination site warmth. Other business partner''s numbers included: E2010-02733. No further information is available. The case is closed.

VAERS ID:387170 (history)  Vaccinated:2010-03-10
Age:8.0  Onset:2010-03-10, Days after vaccination: 0
Gender:Male  Submitted:2010-05-10, Days after onset: 60
Location:Foreign  Entered:2010-05-11, 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: No previous medical history reported.
Diagnostic Lab Data:
CDC Split Type: E201002905
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURB1158 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diplopia, Nausea, Neurological examination normal, Photophobia, Pyrexia, Vision blurred, Visual field tests normal, Visual impairment
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Ocular motility disorders (broad)
Write-up: Case reported by Health Authority (case n. 116103) through SPMSD (local case n. IT201/10). Initial report received on 30-APR-10. An 8 year old male was vaccinated on 10-MAR-10 with the booster dose of IMOVAX POLIO (batch n. B1158) i.m.. On the same day, about 10 minutes post-vaccination, he presented with blurred vision, diplopia, difficulty in reading and near vision disturbances, photophobia, nausea and onset of fever 40 degrees C in the evening. He was monitored for about 1 hour. On 17-MAR-10 the patient underwent neurological evaluation which was negative. On 19-MAR-10 he underwent visual field evaluation which resulted within normal limits. The duration and outcome of the event were not reported. HA coded diplopia, nausea, photophobia and fever. The case is closed.

VAERS ID:387363 (history)  Vaccinated:0000-00-00
Age:8.0  Onset:0000-00-00
Gender:Female  Submitted:2010-05-12
Location:Foreign  Entered:2010-05-13, 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:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1005USA00757
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antinuclear antibody negative, Biopsy skin abnormal, Borrelia test negative, Drug intolerance, Erythema, Immunohistochemistry, Induration, Injection site erythema, Injection site induration, Injection site inflammation, Laboratory test normal, Lymphadenopathy, Lymphocytic infiltration, Lymphoid tissue hyperplasia, Pseudolymphoma, Skin lesion, Skin plaque, Skin warm
SMQs:, Anaphylactic reaction (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Extravasation events (injections, infusions and implants) (broad), Skin tumours of unspecified malignancy (broad), Hypersensitivity (broad)
Write-up: Case received from literature on 03-MAY-2010. An 8 year old female patient with no relevant medical history had received injections of RECOMBIVAX (manufacturer unknown, batch number not reported) on unspecified dates and within an unspecified time to onset, she experienced two lesions on the arm and the buttock. They appeared rapidly after a common inflammatory reaction at the injection site, with progressive induration and erythema. Two similar lesions appeared a few years later on the thigh and the wrist, yet not injection had been made at these sites. The lesions gradually enlarged for 2 or 3 years and then became stable. When she was 17 years old, she was referred to a dermatology department for plaques and nodules of 9 years duration. Physical examination revealed a large erythematous, hot and indurate plaque on the left arm. She also had erythematous and indurated plaques on the left buttock and left thigh, and a smaller lesion on the right wrist. The general physical examination was otherwise normal. Occurrence of lesions far from the injection site of the vaccine suggested that it was not the only cause and that cutaneous lymphoid hyperplasia might occur in other localizations after a vaccination. Histopathological examination of a skin biopsy showed nodular lymphoid infiltration, with periannexial distribution on the dermis component without lichenoid alteration of the basal membrane, and deep infiltration to the hypodermis. In the deep dermis, there were a few lymph follicles with formation of germinal centers. Immunohistochemical analysis showed the B-cell phenotype of proliferation (CD20/L26+ with an accompanying reactive T-cell (CD3+) infiltrate). Lymph follical germinal centre cells were positive for BCL6 and CD10 antibodies, with a high proliferation rate (K167/MIB1+) only at this site. The follicular dendritic network stained by anti CD23 antibody as well organized on a germinal centre. The rare plasma cells (syndecan positive) showed a polyclonal expression of immunoglobulin "Kappa" and "lambda" light chains. A search for inorganic deposits such as aluminum was performed using the Morin technique but was negative on a cutaneous biopsy involving the arm, an injection site. Blood counts and chemistry were normal. B. burgdorferi serology was negative as well as antinuclear antibodies. Given all this data, the patient was diagnosed with B-cell cutaneous lymphoid Hyperplasia with secondary and initial topography of the lesions at the injection sites. Treatment with hydroxychloroquine and cyclins were successfully prescribed but both were inefficient. Finally, 12 years after the onset of the lesions, thalidomine treatment (200 mg/day for 1 month, then 50 mg/day because of poor tolerance) led to progressive regression of the lesions. Indeed, 10 months later, the buttock lesion had disappeared and the other were no longer erythematous and infiltrated. After 2 years, all the lesions had disappeared and the treatment was stopped. Pseudolymphoma and injection site inflammation were considered to be other important medical events. No further information is available.

VAERS ID:389409 (history)  Vaccinated:2010-03-30
Age:8.0  Onset:2010-04-25, Days after vaccination: 26
Gender:Female  Submitted:2010-05-25, Days after onset: 30
Location:Foreign  Entered:2010-05-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No personal history and unknown family medical history. No history of adverse reaction to a vaccine or a drug.
Diagnostic Lab Data: X-ray and tomography led to diagnosis of hip joint effusion
CDC Split Type: 201002886
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER007667 IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram abnormal, Injection site pain, Joint effusion, Pain, X-ray of pelvis and hip abnormal
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Osteonecrosis (broad), Arthritis (broad)
Write-up: Report received from a nurse and the patient''s mother via Vaccine Information Service of sanofi pasteur on 18 May 2010. Local reference number BR2010-141. A 8-year-old female patient, with no relevant medical history, experienced local pain and hip joint effusion on 25 and 28 April 2010, i.e. 26 and 29 days respectively, after receiving an intra-muscular dose of Influenza A/H1N1 vaccine lot number 007667, in the left thigh on 30 March 2010. On 25 April 2010, i.e. 26 days after vaccination, the patient complained about pain on the site of injection (left thigh) and the next day, i.e. on 26 April 2010, she was hospitalized for investigation. Several tests were performed. After X-Ray and tomography, she was diagnosed with hip joint effusion. She received corrective treatment with intravenous antibiotics (the mother did not know which antibiotic) and she was discharged 7 days later, i.e. on 3 May 2010 while she was recovering. At home, she had to continued antibiotics and received KEFLEX orally at unknown dosage for 6 days. She recovered. The mother of the patient stated that her daughter did not take any falls after the vaccination. She did not think that it could be an explanation for the adverse event.

VAERS ID:391262 (history)  Vaccinated:2010-01-09
Age:8.0  Onset:2010-01-12, Days after vaccination: 3
Gender:Male  Submitted:2010-06-18, Days after onset: 156
Location:Foreign  Entered:2010-06-23, Days after submission: 5
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:
CDC Split Type: 2010024540
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)CSL LIMITED  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema multiforme, Urticaria
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Report received from a foreign regulator on 10-JUN-2010 (case: 262770). An 8 year old male patient received PANVAX H1N1 influenza vaccine on 09-JAN-2010. Medical history and concomitant medications were unknown. On 12-JAN-2010, 3 days after receiving PANVAX, the patient developed moderate acute erythema multiforme and a urticarial rash (hive-like). The patient was treated with PHENERGAN and PREDNIX. The patient''s outcome was unknown at the time of reporting. The reporter considered the events possible to the suspect drug, PANVAX. This case was reported as serious due to medical significance. The company considered the events possibly related to the suspect drug, PANVAX. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:393968 (history)  Vaccinated:2010-06-14
Age:8.0  Onset:2010-06-14, Days after vaccination: 0
Gender:Male  Submitted:2010-07-30, Days after onset: 46
Location:Foreign  Entered:2010-07-30
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: B0661559A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSXHAVB228A1 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Angioedema, Eyelid oedema, Headache
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of angioedema in a 8-year-old male subject who was vaccinated with HAVRIX, (GlaxoSmithKline). On 14 June 2010, the subject received unspecified dose of HAVRIX (intramuscular, unknown injection site). On 14 June 2010, less than one day after vaccination with HAVRIX, the subject experienced angioedema. This case was assessed as medically serious by GSK. On 14 June 2010, the event was resolved. The physician considered the event was possibly related to vaccination with HAVRIX. Follow-up received on 21 July 2010: Two hours and thirty minutes after vaccination with HAVRIX pediatric, the subject complained about headache. During the examination, puffiness of eyelids was developed. The subject was treated with a single dose of BENADRYL and was put under observation for 3-4 hours. He was then sent back home with no complaint and no other signs and symptoms. As no further information could be obtained, this case has therefore been closed.

VAERS ID:394399 (history)  Vaccinated:2010-06-07
Age:8.0  Onset:2010-06-07, Days after vaccination: 0
Gender:Female  Submitted:2010-08-05, Days after onset: 59
Location:Foreign  Entered:2010-08-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: ECZEMA
Diagnostic Lab Data: UNK
CDC Split Type: B0667371A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERAHABB182AH IMUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURERA83CA088A IMUN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURERATYPB082BH IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inflammation, Pharyngeal inflammation, Pruritus, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by the foreign regulatory authority (# GB-MHRA-ADR 20668450) via a healthcare professional and described the occurrence of swelling of face in a 8-year-old female subject who was vaccinated with AMBIRIX (GlaxoSmithKline), ACWY vax and TYPHERIX. The subject''s medical history included eczema. On 7 June 2010 the subject received unspecified dose of AMBIRIX (intramuscular), unspecified dose of ACWY vax (intramuscular), unspecified dose of TYPHERIX (intramuscular). On 7 June 2010, 3 hours after vaccination with ACWY, AMBIRIX and TYPHERIX, the subject experienced throat inflamed. Later on the same day, on the 7 June 2010, the patient experienced swelling of face, itching and inflammation localized. The subject was hospitalised. On 7 June 2010, the events were resolved. Verbatim text: Facial swelling and itching. Throat inflamed about 3 hours post vaccine. Required treatment in Accident & Emergency.

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 © 2016 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166