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Case Details (Sorted by Age)

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VAERS ID:223695 (history)  Vaccinated:2004-06-09
Age:6.0  Onset:2004-06-09, Days after vaccination: 0
Gender:Male  Submitted:2004-07-06, Days after onset: 27
Location:Foreign  Entered:2004-07-07, 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: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Diagnostic Lab Data: ESR: not given; WBC: increased;
CDC Split Type: B0337536A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14613C9 IM 
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Laboratory test abnormal, Red blood cell sedimentation rate increased, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by the regulatory authority and described the occurrence of cellulitis in a 6 year old male subject who had received DTAP (Infanrix) injection for prophylaxis. On 06/09/04 the pt received Infanrix (IM). The same day, after vaccination, the subject developed cellulitis on thigh and feet as well as pain and redness at the injection site. He was hospitalized. Lab test was performed and showed a mild increasing of ESR and WBC. The pt was treated with ampicillin + sulbactam. As of 06/29/04, at the time of reporting, he had not yet recovered. The events were unresolved. The regulatory authority reported that the events were possibly related to vaccination with Infanrix. Additional information has been requested but will unlikely be available.

VAERS ID:223782 (history)  Vaccinated:2003-01-01
Age:6.0  Onset:2003-01-01, Days after vaccination: 0
Gender:Male  Submitted:2004-07-06, Days after onset: 551
Location:Foreign  Entered:2004-07-09, 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: UNK
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: WAES0406USA02766
Vaccination
Manufacturer
Lot
Dose
Route
Site
MM: MEASLES + MUMPS (MM-VAX)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Hypersensitivity
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a manufacturer (reference number MA2004-0285) via a health professional concerning an approximately 6 year old male pt who in January 2003, was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (lot # not provided). In January 2003, several hours after vaccination, the pt experienced acute dyspnea during the night. The injection site was "inconspicuous". The ER physician expressed suspicion of an allergic reaction due to the vaccine. The pt recovered on an unspecified date. It was reported that dyspnea was considered to be an other important medical event (OMIC). No further information available. Other business partner numbers include E2004-02087

VAERS ID:226771 (history)  Vaccinated:2004-08-08
Age:6.0  Onset:2004-08-08, Days after vaccination: 0
Gender:Male  Submitted:2004-09-13, Days after onset: 36
Location:Foreign  Entered:2004-09-20, 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: UNK
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: Cardiac monitoring: results not reported; Electromyography: results awaited; Diagnostic lab test: viral check-up=results awaited; Cerebrospinal fluid albumin test: dissociation;
CDC Split Type: WAES0409USA00346
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: CSF test abnormal, Difficulty in walking, Facial palsy, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a health authority concerning a 6 year old male with no personal or family history who on 8/8/04 was vaccinated with a dose of MMR (1.0 ml), SC. Subsequently, seven days later, on 8/15/04, the patient presented with a left facial paralysis (no bilateral facial paralysis) followed by paresthesia of the lower limbs, and walking deficiency. It was noted that assisted breathing was not necessary. The patient was hospitalized with continuous cardiac monitoring. CSF showed albuminocytologic dissociation. Electromyogram and viral check up results were pending. The patient was treated with human immunoglobulin. The patient was considered to be not recovered at the time of the report. It was noted that the patient had no previous reaction to vaccine. No further information is available. Follow up 03/03/05: Patient has recovered from the adverse events.

VAERS ID:229543 (history)  Vaccinated:2004-08-08
Age:6.0  Onset:2004-09-06, Days after vaccination: 29
Gender:Male  Submitted:2004-11-18, Days after onset: 73
Location:Foreign  Entered:2004-11-22, Days after submission: 4
Life Threatening? Yes
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: NONE
Diagnostic Lab Data: UNK
CDC Split Type: WAES0411USA02474
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Encephalitis, Meningitis
SMQs:, Noninfectious encephalitis (narrow), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health authority concerning a 6 year old male with no relevant medical history reported who on 8/8/04 was vaccinated SC with a dose of MMR. On 8/8/04, the patient was concomitantly vaccinated IM with a dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid. On 9/6/04, the patient developed encephalomyelitis and meningitis. The patient was hospitalized on an unspecified date. The patient was treated with acyclovir and corticosteroids. Subsequently, the patient recovered without sequelae in September 2004. Encephalomyelitis and meningitis were considered to be immediately life-threatening. Other business partner numbers include E200403926 and 888396339. Additional information is not expected.

VAERS ID:229830 (history)  Vaccinated:2003-06-05
Age:6.0  Onset:2003-06-05, Days after vaccination: 0
Gender:Male  Submitted:2004-11-30, Days after onset: 544
Location:Foreign  Entered:2004-11-30
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: B0358414A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  SC 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Diarrhoea, Injection site pain, Injection site swelling, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a foreign regulatory authority and described the occurrence of severe abdominal pain in a 5 year old boy receiving diphtheria, tetanus and acellular pertussis, Infanrix injection for prophylaxis. On 6/5/03, the subject received a dose of Infanrix (SC). The same day, after vaccination, the boy developed severe abdominal pain, pain and swelling at the injection site. On 6/6/03, he also developed severe diarrhea and vomiting. The subject was hospitalized. On 7/5/03 he had completely recovered. The regulatory authority reported that the events were possibly related to vaccination with Infanrix. Further information has been requested.

VAERS ID:231890 (history)  Vaccinated:2004-11-24
Age:6.0  Onset:2004-11-25, Days after vaccination: 1
Gender:Male  Submitted:2005-01-03, Days after onset: 39
Location:Foreign  Entered:2005-01-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0412USA03179
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)AVENTIS PASTEURY0286 IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site inflammation
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a health authority concerning a 5 year old male who was vaccinated IM with a dose of a MMR on an unspecified date. On 11/24/04, the patient was vaccinated IM with a dose of concomitant suspect therapy diphtheria toxoid (+) pertussis acellular 2 component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (batch # Y0286). On 11/25/04, the patient developed injection site inflammation. The patient was treated with amoxicillin (+) clavulanate potassium, promethazine hydrochloride and ibuprofen. On an unspecified date, the patient recovered from injection site inflammation. No further information is available. The case was closed. The reporter did not specify the site of the injection site inflammation, however, diphtheria toxoid (+) pertussis acellular 2 component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid vaccine was reported as suspect. Injection site inflammation was considered to be an other important medical event (OMIC). Other business partner numbers included E200404759 and 033030.

VAERS ID:231891 (history)  Vaccinated:2004-11-23
Age:6.0  Onset:2004-11-23, Days after vaccination: 0
Gender:Male  Submitted:2005-01-03, Days after onset: 41
Location:Foreign  Entered:2005-01-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0412USA03180
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)AVENTIS PASTEURY0286 IM 
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEURY0286 IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site inflammation
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a health authority concerning a 6 year old male who was vaccinated with a dose of MMR on an unspecified date. On 11/23/04, the patient was vaccinated IM with concomitant suspect therapy diphtheria toxoid (+) pertussis acellular 2 component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (batch # Y0286). On 11/23/04 the patient developed injection site inflammation. The patient was treated with antihistamines, antibiotics and acetaminophen. On an unspecified date, the patient recovered from the injection site inflammation. No further information is available. The case was closed. The site of the patient''s reaction was not reported, however, diphtheria toxoid (+) pertussis acellular 2 component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid was reported as suspect therapy. The patient''s injection site inflammation was considered to be an other important medical event (OMIC). Other business partner numbers included E200404757 and 033029.

VAERS ID:232214 (history)  Vaccinated:2004-12-01
Age:6.0  Onset:2004-12-01, Days after vaccination: 0
Gender:Female  Submitted:2005-01-12, Days after onset: 42
Location:Foreign  Entered:2005-01-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Vestibular disorder; Deafness
Diagnostic Lab Data: NONE
CDC Split Type: GBWYE312404JAN05
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypoacusis, Vestibular disorder
SMQs:, Hearing impairment (narrow), Vestibular disorders (narrow)
Write-up: Case reversioned to include medical history. Follow up information received on 11Jan05 amending date of birth and adding further information regarding medical history and outcome has also been incorporated into the narrative. This case was considered medically important. Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 6 year old female pt was experienced loss of nearly all residual hearing. The pt received a dose in Dec04. The pt''s concurrent illness includes vestibular disorder (wide vestibular aquaduct requiring cochlea implant) with a past history of deafness (loss of nearly

VAERS ID:232261 (history)  Vaccinated:2001-11-06
Age:6.0  Onset:2001-11-06, Days after vaccination: 0
Gender:Male  Submitted:2002-10-10, Days after onset: 337
Location:Foreign  Entered:2005-01-14, Days after submission: 827
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluticasone; Calpol; Salmeterol; Salbutamol
Current Illness:
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type: PJP200100431
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)EVANS VACCINES760847 IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Lymphadenopathy, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: A report was received from a foreign regulatory authority concerning a 6 year old male patient who experienced an injection site reaction and enlarged lymph nodes, which were considered to be serious as they were medically significant (OMIC), after receiving the Fluvirin vaccine on 11/6/01. Relevant medical history includes asthma, for which the patient was receiving concomitant medications Fluticasone, Salmeterol, Salbutamol, and Paracetamol. On 11/6/01, the patient experienced redness, swelling, itchiness and some hardness over the circumference of the arm around the injection site and over two thirds of the upper arm extending onto the top of the shoulder and into the axilla, after receiving the Fluvirin vaccine. The patient also experienced enlarged lymph nodes. Therapeutic measures taken as a result of these events included paracetamol and antihistamines. At time of report, the patient was recovering. There was insufficient information to determine the reporter''s causality assessment.

VAERS ID:232617 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Female  Submitted:2005-01-12
Location:Foreign  Entered:2005-01-21, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Cochlea implant
Diagnostic Lab Data: UNK
CDC Split Type: WAES0501USA00634
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hearing impaired
SMQs:, Hearing impairment (narrow)
Write-up: Information has been received from a health professional concerning a 6 year old female with a history of cochlea implant who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced complete loss of residual hearing. At the time of the report, it was not known if the patient had recovered. The patient''s hearing loss was considered to be disabling. Other business partner numbers include E200500045. Additional information has been requested.

VAERS ID:232905 (history)  Vaccinated:2004-11-01
Age:6.0  Onset:2004-11-06, Days after vaccination: 5
Gender:Male  Submitted:2005-01-24, Days after onset: 79
Location:Foreign  Entered:2005-01-26, 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:
Preexisting Conditions: UNK
Diagnostic Lab Data: Stool culture positive for enterovirus; CSF negative for virus.
CDC Split Type: WAES0411CAN00196
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective, Laboratory test abnormal, Meningitis aseptic, Rash, Viral infection
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Noninfectious meningitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning a 6.5 year old male who on 11/1/04 was vaccinated IM with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. On 11/6/04 the patient experienced chicken pox rash (with several papules on face and trunk) and aspetic meningitis and was hospitalized. The patient had a cerebrospinal fluid culture which was negative for virus and a stool culture which was positive for enterovirus. Subsequently, the patient recovered from chicken pox rash and aseptic meningitis. The physician reported that the child''s pediatrician felt that the enterovirus was most likely the reason for aseptic meningitis. The physician felt that chicken pox rash and aseptic meningitis were related to therapy with varicella virus vaccine live. No further information is available.

VAERS ID:233347 (history)  Vaccinated:2003-12-01
Age:6.0  Onset:2003-12-01, Days after vaccination: 0
Gender:Male  Submitted:2005-02-02, Days after onset: 429
Location:Foreign  Entered:2005-02-02
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: Body temperature increased 40C.
CDC Split Type: B0366205A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Hyperthermia, Injection site inflammation
SMQs:, Accidents and injuries (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This report was received from the regulatory authorities (ref 611375244) and describes the occurrence of inflammation (injection site) in a 5 year old male subject receiving diphtheria tetanus acellular pertussis vaccine (Infanrix) for prophylaxis. In Dec03, the subject received a dose of Infanrix. After vaccination, the subject developed inflammation with more than 5cm in diameter and showed a body temp of 40C (hyperthermia). The event resolved. The reporting Authorities considered the events to be possibly related to the vaccination with Infanrix and assessed the case as medically serious. The case has been closed.

VAERS ID:233428 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2005-02-04
Location:Foreign  Entered:2005-02-07, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 28 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Culture urine (results: Pneumococcus positive) was done on an unspecified date.
CDC Split Type: ESWYE376927JAN05
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES 0IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective, Pleural effusion, Pleurisy, Pneumonia
SMQs:, Lack of efficacy/effect (narrow), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Further information was received providing patient details, product details, event details and adding the event of pachypleuritis. Initial information regarding Prevnar was received from a health care professional regarding a 6 year old male patient who experienced pneumococcal pneumonia, pleural effusion, drug ineffective and residual pachypleuritis. The patient received the first dose in 2001. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered in 2001. Dose regimen was 1 dose (IM). Concomitant medications were not reported. The patient experienced pneumococcal pneumonia, pleural effusion, drug ineffective and residual pachypleuritis in January 2005 and was hospitalized for 28 days. The patient is recovered of the events but he has still pachypleuritis. No additional information was available at the time of this report.

VAERS ID:233763 (history)  Vaccinated:2004-10-12
Age:6.0  Onset:2004-10-31, Days after vaccination: 19
Gender:Female  Submitted:2005-02-11, Days after onset: 103
Location:Foreign  Entered:2005-02-14, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: E200500529
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Nephrotic syndrome
SMQs:, Chronic kidney disease (broad), Proteinuria (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was initially reported by a foreign health authority on 2/8/05. This case concerns a 6 year old female patient. The patient received influenza vaccine, batch number not reported, on 10/12/04. On 10/31/04, 19 days post vaccination, the patient developed nephrotic syndrome, for which she was hospitalized. No details of treatment were provided. The patient recovered on 11/14/04. The report comments that this presented a risk to kidney function. The reporter considered this reaction to be serious as it involved hospitalization, and persistent or significant disability or incapacity. The agency also considered this reaction to be serious (OMIC). No further information is expected, case is closed.

VAERS ID:233870 (history)  Vaccinated:2004-09-16
Age:6.0  Onset:2004-09-20, Days after vaccination: 4
Gender:Female  Submitted:2005-02-15, Days after onset: 148
Location:Foreign  Entered:2005-02-16, 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:
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: E200500492
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER37760A91IM 
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEURW03814SC 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.HT765902SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial case was reported on 7Feb05 by health authority. It was reported that a 6 year old girl was vaccinated with poliomyelitis vaccine (Imovax Polio, dose 4, SC, batch W0381), measles, mumps and rubella vaccine (MMRII, dose 2, SC batch HT76590) and diphtheria tetanus acellular pertussis vaccine (Boostrix, dose 1, IM, batch 37760A9 on 16Sep04 at 15:15. On 20Sep04 the pt developed urticaria and was hospitalized on 21Sep04. The pt recovered. Further information is expected.

VAERS ID:234045 (history)  Vaccinated:2003-06-13
Age:6.0  Onset:2003-06-14, Days after vaccination: 1
Gender:Female  Submitted:2005-02-18, Days after onset: 615
Location:Foreign  Entered:2005-02-18
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: Alanine aminotransferase 56 u/l; Alpha 1 globulin 6.1%; Alpha 2 globulin 18.3%; Body temp 37.1 C and 39C; Echocardiography normal; ESR 84mm/h; Lymphocytes 16%; Neutrophils 70%; Protein 5g/dl; White blood cells 18.66mm3.
CDC Split Type: B0371409A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14540B9 IM 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Albuminuria, Conjunctivitis, Cyanosis, Hyperaemia, Hypokinesia, Kawasaki's disease, Laboratory test abnormal, Lymphoedema, Pyrexia, Rash, Skin exfoliation, Swelling, Tongue black hairy, Tongue oedema, Tonsillitis
SMQs:, Acute renal failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Oropharyngeal infections (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vasculitis (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a foreign authority and described the occurrence of a possible Kawasaki disease in a 5 year old female subject who received diphtheria, tetanus, acellular pertussis injection for prophylaxis. On 6/13/03, the child received a dose of Infanrix (IM, batch # 14540B9). One day following vaccination, on 6/14/03 in the evening, she suffered from severe abdominal pain. On 6/15/03, the mother removed some ticks from the child''s skin and in the evening she noticed peri-auricular, bilateral swelling and the subject was admitted to the emergency room some hours later. A diagnosis of pharyngotonsillitis with lymphoadenomegaly was made. The subject''s fever was 37.1 C. The subject was treated with paracetamol, amoxicillin and clavulanic acid. On 6/16/03, the subject''s treatment was switched to macladin. In the afternoon fever was 39C and redness appeared on conjunctivas, palms of the hands and plants of the feet. On 6/17/03, the child''s fever was still high, the subject presented polymorphous cutaneous rash, dark bluish nails, hyperemic eyes, cleavage on buccal cavity, furred and cherry red tongue with swelling and reduced movement of right arm, leg, and foot. On 6/18/03, in the afternoon the physician prescribed blood tests, performed on the 6/19/03. On 6/20/03, fever started to resolve. On 6/26/03, signs and symptoms slowly improved but proteinuria and hyperaeremic conjunctiva were still present. On 6/28/03, conjunctival hyperemia resolved but proteinuria persisted and desquamation of hands and feet appeared. On 7/1/03, blood tests were normal. About one year later, a diagnosis of suspected Kawasaki disease was made. An echocardiography was made with normal results. The regulatory authority reported that the event was possibly related to vaccination with Infanrix.

VAERS ID:234886 (history)  Vaccinated:2004-11-29
Age:6.0  Onset:2004-12-07, Days after vaccination: 8
Gender:Female  Submitted:2005-03-11, Days after onset: 94
Location:Foreign  Entered:2005-03-14, Days after submission: 3
Life Threatening? Yes
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: NONE
Diagnostic Lab Data: 1/17/05: Islet cell antibodies positive, C-peptid decreased, HbA1 8.1%, blood glucose 201 mg%.
CDC Split Type: E200500880
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEURW13070IMGM
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dehydration, Diabetes mellitus, Dry skin, Fatigue, Hyperglycaemia, Immune system disorder, Laboratory test abnormal, Polydipsia, Polyuria, Somnolence
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Tubulointerstitial diseases (broad), Hypoglycaemia (broad)
Write-up: Case initially received on 3/3/05. Case reported by HA. It was reported that a 5.5 year old girl was vaccinated with her first dose of inactivated polio vaccine into the buttock on 11/29/04. At the end of the first week of December 2004, she showed tiredness, polydipsia, and polyuria, duration and outcome not reported. On 12/25/04,. she became somnolent, was desiccated and had a keotacidotic fetor ex ore, skin and mucosa was dry. Blood glucose level was 489mg%. Insulin therapy was started, the child was not hospitalized because of Christmas holiday. The situation was considered to be life-threatening. She recovered from the acute symptoms within an unspecified time. In January 2005, exact dates not reported, she was hospitalized (no report available), diagnostics revealed immune allergic islet-cell antibody positive insulin dependent Diabetes mellitus. Laboratory findings see lab comments. Viral infection was ruled out (not specified). To be noted that this vaccination was the first vaccination the child ever got. The reporter stated that IPV vaccine (especially vero cells and high allergenic antibiotics like streptomycin/neomycin) might have acted as ANA inducer. No further information is expected. File closed.

VAERS ID:235419 (history)  Vaccinated:2005-02-16
Age:6.0  Onset:2005-02-17, Days after vaccination: 1
Gender:Male  Submitted:2005-03-25, Days after onset: 36
Location:Foreign  Entered:2005-03-25
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: B0375722A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14613C9 IM 
Administered by: Other     Purchased by: Other
Symptoms: Injection site inflammation, Injection site reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a foreign regulatory authority and described the occurrence of phlegmon in a 6 year old male subject who had received diphtheria tetanus acellular pertussis vaccine injection for prophylaxis. On 2/16/05 the patient received Infanrix (IM). On 2/17/05, 1 day after vaccination, the patient developed phlegmon from shoulder to elbow (right) and a reaction at the injection site. This case was assessed as medically serious (OMIC). The patient was treated with antibiotics and corticosteroid. The events resolved on 2/20/05. The regulatory authority reported that the events were possibly related to vaccination with Infanrix.

VAERS ID:236657 (history)  Vaccinated:2003-09-09
Age:6.0  Onset:2003-09-26, Days after vaccination: 17
Gender:Unknown  Submitted:2005-04-26, Days after onset: 578
Location:Foreign  Entered:2005-04-26
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: ALT:84 and 1439; Hepatitis A IgM positive.
CDC Split Type: B0378803A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS780A9   
Administered by: Other     Purchased by: Other
Symptoms: Drug ineffective, Hepatitis A, Jaundice, Laboratory test abnormal, Liver function test abnormal, Viral infection
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Liver infections (narrow), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This report was received from an epidemiologist describes the occurrence of hepatitis A in a 6 year old subject who received hepatitis A vaccine for prophylaxis during a vaccination campaign. As the first cases of hepatitis were registered on 8/28/03, immunization was provided for outbreak control. This started on 9/9/03 and on 9/10/03, and Havrix was given to among 370 children and teens. Blood sample was not taken before immunization and the cold chain was not broken. Fourteen of vaccinees developed hepatitis A. The subject was in contact with a positive hepatitis A person before vaccination. On 9/9/03, a dose of Havrix was given. On 9/26/03, 17 days after vaccination, the subject developed acute hepatitis A with icteric form and moderate intensity. Lab test was performed and showed ALT 84 and 1439 and the result for anti-HAV IgM was positive. The event resolved spontaneously within a reasonable delay. The lot of vaccine was tested and revealed to meet the standard requirement.

VAERS ID:237038 (history)  Vaccinated:2005-03-22
Age:6.0  Onset:2005-03-24, Days after vaccination: 2
Gender:Male  Submitted:2005-05-05, Days after onset: 41
Location:Foreign  Entered:2005-05-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0377355A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14A0014AB IM 
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, 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 and described the occurrence of injection site reaction in a 5 year old male receiving diphtheria tetanus acellular pertussis vaccine injection for prophylaxis. No adverse reaction were observed with the previous vaccinations. On 3/22/05, the patient received Infanrix (IM). On the same day, in the evening, the subject showed pain, redness, and swelling at the injection site. On 3/23/08, the phenomena involved the whole thigh, from the knee to groin, while the color of the affected area switched from red to purplish and then to blackish. The pediatrician was consulted and antibiotics (unspecified) and topical anti-inflammatory drugs (unspecified) were prescribed. In the afternoon, the subject''s mother decided to go to the emergency ward. After administering betamethasone, the subject was hospitalized for 24 hours. The outcome of the event is unknown. The regulatory authority reported that the event was possibly related to vaccination with Infanrix. No further information will be available; this case has therefore been closed.

VAERS ID:237200 (history)  Vaccinated:2005-05-02
Age:6.0  Onset:2005-05-03, Days after vaccination: 1
Gender:Unknown  Submitted:2005-05-06, Days after onset: 3
Location:Foreign  Entered:2005-05-10, 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: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0505CAN00021
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Feeling hot, Oedema, Pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: Information has been received from a pharmacist concerning a 6 year old female pt who on 02-MAY-2005 was vaccinated with Pneumovax 23 (lot number not reported) IM. On 03-May-2005 the pt experienced arm was very swollen, hot, painful and was hospitalized. The pharmacist reported that it was not known if this was "the first dose ever". No further information is available.

VAERS ID:239055 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Female  Submitted:2005-06-03
Location:Foreign  Entered:2005-06-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: UNK
Preexisting Conditions: No history of allergies. No problems with previous vaccinations. The patient had received a typhoid vaccination in the past. She had also received Havrix in 2001 with no problems. The patient had experienced a urinary tract infection prior to vaccination. She had been treated with antibiotics - the course was completed two days prior to the vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: B0382427A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS    
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Agitation, Erythema, Face oedema, Hypersensitivity, Rash macular
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a nurse and described the occurrence of allergic reaction ina 6 year old female subject who was vaccinated with hepatitis A vaccine, polysaccharide typhoid vaccine for prophylaxis. Concurrent medical conditions included urinary tract infection. The subject received no concurrent medications. On an unspecified date, the subject received an unspecified dose of Havrix (in the left arm), and unspecified dose of Typherix (1 injection, unknown arm) on the same day. The subject became distressed and the nurse calmed her down. The nurse noted within minutes of vaccination with Havrix and Typherix, the subject developed red blotches on her wrist. The nurse also noted red patches on the subjects arm and tummy. On the left arm, where the child received the Havrix vaccination, she developed red blotches which spread over onto her shoulder and back. The subjects face became red and she developed swollen lips. The subject was treated with adrenaline and within 10 minutes the subject recovered. The subject was seen in casualty where she was given the all clear. The healthcare professional considered the events were clinically significant (or requiring intervention) (OMIC).

VAERS ID:239842 (history)  Vaccinated:2005-05-09
Age:6.0  Onset:2005-05-10, Days after vaccination: 1
Gender:Female  Submitted:2005-06-14, Days after onset: 35
Location:Foreign  Entered:2005-06-14
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: B0384117A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14A004ABB   
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Asthenia, Convulsion, Headache, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by foreign authorities and described the occurrence of convulsion in a 6 year old female subject who was vaccinated with absorbed diphtheria, tetanus, and acellular pertussis vaccine for prophylaxis. Concurrent vaccination included live attenuated MMR given on 5/9/05. There was no reactions to previous vaccination. On 5/9/05, the subject received a dose of Infanrix. On 5/10/05, 1 day after vaccination with Infanrix, the subject developed convulsion, fainting, asthenia, abdominal pain, headache and pallor. Convulsion and fainting lasted a few seconds. There were no further findings at the pediatrician visit the next day. This case was assessed as medically serious (OMIC). At the time of reporting, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with Infanrix.

VAERS ID:241545 (history)  Vaccinated:2005-04-04
Age:6.0  Onset:2005-04-06, Days after vaccination: 2
Gender:Female  Submitted:2005-07-20, Days after onset: 105
Location:Foreign  Entered:2005-07-20
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: B0387819A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Hallucination, Pruritus
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by foreign authorities and described the occurrence of hallucinations in a 6 year old female subject who was vaccinated with hepatitis B vaccine for prophylaxis. On 4/4/05 the subject received a dose of Engerix B. On 4/6/05, 36 hours after vaccination with Engerix B, the subject developed redness and got warm in the face, itched herself in the neck and she experienced that she saw bees buzzing around her head and was panic-stricken. The visual hallucinations disappeared but during the four following days, reappeared. The subject also developed an intensive and bothering pruritus. The girl was examined by an eye specialist who excluded ocular genesis and optic neuritis. This case was assessed as medically serious (OMIC). At the time of reporting the events were unresolved. The regulatory authority reported that the events were possibly related to vaccination with Engerix B. Further information has been requested.

VAERS ID:243799 (history)  Vaccinated:2005-08-01
Age:6.0  Onset:2005-08-01, Days after vaccination: 0
Gender:Male  Submitted:2005-08-31, Days after onset: 30
Location:Foreign  Entered:2005-09-06, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: WAES0508MEX00005
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.HW07760 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 6 yr old male who on approx 01Aug05 was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no concomitant medication. On approx 01Aug05, 10 minutes after the vaccine administration, the pt experienced tonic convulsions, which began as lipotimia and finished with hypotension 80-70/44. Subsequently, the pt recovered from tonic convulsion. The physical exam performed just after the tonic convulsion stopped was normal. Another physical exam performed a week later was also normal. The reporter felt that tonic convulsion was related to therapy with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The event was considered as an OME (OMIC). Additional information is not expected.

VAERS ID:244521 (history)  Vaccinated:2005-09-12
Age:6.0  Onset:2005-09-12, Days after vaccination: 0
Gender:Male  Submitted:2005-09-23, Days after onset: 11
Location:Foreign  Entered:2005-09-23
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: B0394688A
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  SC 
TD: TD ADSORBED (DITANRIX)SMITHKLINE BEECHAM  IM 
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), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of syncope in a 6 year old male subject who was vaccinated with absorbed diphtheria, tetanus vaccine (Ditanrix) for prophylaxis, Concurrent vaccination included live attenuated measles, mumps (strain not specified), rubella vaccine,subcutaneous given on Sept 12 2005. On Sept 12 2005 the subject received unspecified dose of Ditanrix (intramuscular). The same day after vaccination with Ditanrix, the subject developed syncope. The subject was hospitalized and underwent cardiopulmonary resuscitation. On Sept 12 2005, the event was resolved. The regulatory authority reported that the event was possibly related to vaccination with Ditanrix.

VAERS ID:244584 (history)  Vaccinated:2005-08-01
Age:6.0  Onset:2005-08-04, Days after vaccination: 3
Gender:Female  Submitted:2005-09-23, Days after onset: 50
Location:Foreign  Entered:2005-09-27, Days after submission: 4
Life Threatening? No
Died? Yes
   Date died: 2005-08-15
   Days after onset: 11
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: NONE
Diagnostic Lab Data: UNK
CDC Split Type: WAES0509USA02665
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 1  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Infarction, Myocarditis, Pyrexia, Viral infection
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health professional concerning a 6 year old female with no relevant medical history and no safety problems following previous vaccinations who in approximately August 2005, was vaccinated with a second dose of MMR (batch number not reported). Subsequently, eight to ten days post vaccination, she presented with a fever. Three days after onset of the fever, she suffered from abdominal pain which required medical consultation. Fourteen days after vaccination, she experienced an infarction right-left which occurred within the framework of acute myocarditis (documented through clinical examination and echography). She was hospitalized. The child died fifteen days after vaccination. No autopsy was performed. According to the reporter, the symptomatology evoked a viral like post infection myocarditis. The file is to be completed. Other business partner numbers included E200503659. Additional information has been requested.

VAERS ID:244861 (history)  Vaccinated:2005-09-02
Age:6.0  Onset:2005-09-02, Days after vaccination: 0
Gender:Female  Submitted:2005-09-30, Days after onset: 28
Location:Foreign  Entered:2005-10-04, Days after submission: 4
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Otitis
Diagnostic Lab Data: UNK
CDC Split Type: WAES0509USA03992
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.Y95872SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypersensitivity, Injection site erythema, Injection site inflammation, Injection site pain, Injection site rash, Movement disorder, Oedema, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health professional concerning a 6 yr old female with recurrent otitis and no known drug allergies who on 02Sep05 was vaccinated in the right deltoid with a SC second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (batch Y9587). The pt had no adverse reaction to previous vaccinations. The pharmacist reported on 05Sep05, that a few minutes after vaccination the pt presented with local redness, local red rash and pruritus. She was treated with mequitazine (Primalan) and betamethasone dipropionate (Diprosone). The physician reported on 06Sep05 that within one minute after administration the pt presented with a severe local inflammatory reaction at the injection site (oedema and redness, 6-7cm in diameter) with injected arm mobility decreased. The pt was given betamethasone per os and her oedema resolved within 15 minutes. Follow up information received on 27Sep05 indicated that immediately after receiving the booster dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (batch Y9587) the pt developed injection site pain and redness. One to two minutes post vaccination she also presented with an injection site oedema: injection site reactions were considered to be moderate. Pain resolved in 45 mins, redness and oedema lasted two hours. The pt was given betamethasone (Celestene), 2 x 90 drops, and was applied local dressing with alcohol. She was not hospitalized but watched over in the doctor''s office. The reporter made a diagnosis of an allergy. It was noted that the reporter did not described any further the injection site rash with pruritus or decreased limb mobility. Injections site pain, injections site redness, injection site oedema and allergy were considered to be immediately life threatening. Other business partner numbers include E200503455. Additional information is not expected. The case is closed.

VAERS ID:245887 (history)  Vaccinated:2005-09-30
Age:6.0  Onset:2005-09-30, Days after vaccination: 0
Gender:Male  Submitted:2005-10-21, Days after onset: 21
Location:Foreign  Entered:2005-10-21
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: B0397359A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAL14AO16AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of vagal syndrome in a 6 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix) for prophylaxis. On 30Sept05 the subject received unspecified dose of Infanrix (.5ml IM, left deltoid). On 30Sep05, less than one day after vaccination with Infanrix, the subject experienced vagal syndrome. This case was assessed as medically serious by manf (OMIC). On 30Sep05, the event was resolved. The regulatory authority reported that the event was possibly related to vaccination with Infanrix. No further information is needed, this case has therefore been closed.

VAERS ID:246184 (history)  Vaccinated:2005-10-10
Age:6.0  Onset:2005-10-10, Days after vaccination: 0
Gender:Male  Submitted:2005-10-26, Days after onset: 16
Location:Foreign  Entered:2005-10-26
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: B0397977A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B004AC   
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Asthma
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: This case was reported by the authorities and described the occurrence of an acute asthmatic attack in a 5 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine for prophylaxis. Concurrent vaccination included live attenuated measles, mumps, rubella vaccine; given on 10Oct05. On 10Oct05 the subject received a dose of Infanrix. The same day, 10 minutes after vaccination, the subject developed an acute asthmatic attack. The subject was hospitalized and treated with beclomethasone diproprionate, hydrocortisone, oxygen and salbutamol sulphate. At the time of reporting the event was resolved. The regulatory authority reported that the event was possibly related to vaccination with Infanrix. Further information has been requested.

VAERS ID:247852 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Female  Submitted:2005-11-16
Location:Foreign  Entered:2005-11-21, 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: Laparotomy, acute abdomen, surgery, ischemia, abdominal pain, vomiting, peptic ulcer disease.
Diagnostic Lab Data: Body temp High grade fever, blood culture negative for aerobic, non aerobic, fungal and tuberculosis, skin and or subcutaneous tissue culture negative for aerobic, non aerobic, fungal and tuberculosis.
CDC Split Type: WAES0511USA01681
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Fasciitis, Injection site vesicles, Necrosis, Oedema, Pain, Polyarteritis nodosa, Pyrexia, Vasculitis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: It was reported in a published article that a 6 year old female, who at the age of 5 years had a surgical laparotomy for sudden onset of an acute abdomen, a resection of necrotic ischemic terminal ileum, and three months after discharge was again admitted to the hospital with severe abdominal pain and vomiting and was diagnosed to have peptic ulcer disease and was treated with ranitidine who, in approximately Oct 2004, was vaccinated with a dose in the left arm of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Two days after receiving the vaccine the patients problem started. She developed painful swelling and a high grade fever followed by the development of blisters and vesicles around the site of injection. She was admitted to hospital and was treated as severe cellulitis of the upper arm with clindamycin and cefuroxime. She progressed to a full thickness tissue necrosis and underwent surgical debridement with transverse fasciotomy. All blood and tissue cultures were negative for aerobic, non aerobic, fungal and tuberculosis. The patient stayed in the hospital for 4 months and several courses of antibiotics were given with no response. She went through several attempts of skin grafting that were all unsuccessful. The patient was referred to a hospital in Feb 2005 with a diagnosis of necrotizing fascitis of the left arm. One month later, it was decided to treat the patients condition as a case of vasculitis possibly polyarteritis nodosa. She was treated with 3 days of IV methyl prednisolone followed by 0.5 mg/kg oral prednisolone and cyclosporin. The patient showed dramatic clinical response and had successful skin grafting. Additional information is not expected.

VAERS ID:248146 (history)  Vaccinated:2005-05-31
Age:6.0  Onset:2005-05-31, Days after vaccination: 0
Gender:Female  Submitted:2005-11-23, Days after onset: 176
Location:Foreign  Entered:2005-11-23
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: Dermographism
Diagnostic Lab Data: Body temperature 05/31/2005 38 deg C, Prick test 10/13/2005 neomycin negative, Ditanrix negative.
CDC Split Type: B0383928A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSUNK IMUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSUNK IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERUNK IMUN
Administered by: Other     Purchased by: Other
Symptoms: Angioneurotic oedema, Erythema, Eyelid oedema, Hypersensitivity, Injection site induration, Oedema, Pain, Pruritus, Pyrexia, Rash, Type III immune complex mediated reaction
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of injection site pruritus in a 6 year old female subject who was vaccinated with combined diphtheria, tetanus, acellular pertussis,inactivated poliomyelitis and haemophilus influenza b vaccine (Infanrix-IPV+Hib) for prophylaxis. Previous vaccinations were well tolerated. The subjects medical history included dermographism factitisa. On May 31 2005 the subject received 5th dose of Infanrix polio Hib (intramuscular, upper arm, no lot number available). On May 31 2005, 4 hours after vaccination, the subject experienced redness, pain, swelling and induration of the entire upper arm. After a few hours, the redness spread out to the face and she developed additionally swelling of lips and eyelids. On the following day, the exanthema had extended to trunk and legs. She had no pulmonary symptomatology and no circulatory complaints. She appeared otherwise in a good general status with a subfebrile temperature of 38 deg C. The subject was treated with hydrocortisone, dimethindene maleate (Fenistil), levocetirizine (Xyzal) and cooling. On June 9 2005 the events were resolved. On Oct 13 2005, she was investigated by an allergologist. On examination, she was in a good general status. Cardiopulmonary examination was inconspicuous with normal heart tones, no noises and symmetrical ventilation. ENT, skin and abdominal examination were normal. No enlarge lymph nodes were noticed. Skin prick test showed negative results for neomycin (3/8) and Ditanrix (3/8) and positive for Infanrix Polio. Inoculation antibodies were positive for IgG anti Tetanus Toxoid with 3700UL (<100), IgG anti Diphtheria Toxoid 980 U/L ($g100), IgG anti haemophilus influenza type B 0.77 mcg/ml (<0.15). Based on the skin prick test, a diagnosis of allergic reaction grade II with a Quincke''s oedema was made. A differential diagnosis of non IgE mediated allergy of the type of immune complexes (type III allergy, Arthus reaction) was also considered. It was recommended to have the next vaccination

VAERS ID:248230 (history)  Vaccinated:2005-10-24
Age:6.0  Onset:2005-10-31, Days after vaccination: 7
Gender:Male  Submitted:2005-11-28, Days after onset: 28
Location:Foreign  Entered:2005-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen, Vapoflu, Ammonium chloride + Orciprenaline + Clobutinol hydrochloride
Current Illness:
Preexisting Conditions: Chicken pox, hepatitis A
Diagnostic Lab Data:
CDC Split Type: B0400707A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB060AA   
Administered by: Other     Purchased by: Other
Symptoms: Blister, Erythema multiforme, Skin ulcer
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of erthyema multiforme in a 6 year old male subject who was vaccinated with hepatitis B vaccine for prophylaxis. The subject''s medical history included chicken pox at 5 years age and hepatitis A at 3 years age. Concurrent medications included Ibuprofen and Vapoflu. On October 24, 2005 the subject received 1st dose of Engerix B pediatric. On October 31, 2005 7 days after vaccination with Engerix B pediatric, the subject developed erythema multiforme, dermal lesions in the ankle and buttocks that evolved to blister lesions and disseminated to the legs and arms. Platelet count, urinary sediment test and blood test showed normal results. This case was assessed as medically serious (OMIC) by the manufacturer. At the time of reporting the outcome of the events were unspecified. The physician considered the events were possibly related to vaccination with Engerix B pediatric.

VAERS ID:248234 (history)  Vaccinated:2005-10-03
Age:6.0  Onset:2005-10-16, Days after vaccination: 13
Gender:Male  Submitted:2005-11-28, Days after onset: 43
Location:Foreign  Entered:2005-11-28
Life Threatening? Yes
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:
CDC Split Type: B0401034A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Neuritis, Pneumonia
SMQs:, Peripheral neuropathy (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of neuritis in a 6 year old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine, combined measles, mumps and rubella vaccine, live and attenuated for prophylaxia. On 10/03/2005 the subject received unspecified dose of Infanrix. On 10/13/2005 the subject received unspecified dose of Priorix. On 10/16/2005, 3 days after vaccination with Priorix, 13 days after vaccination with Infanrix, the subject experienced neuritis. The subject was hospitalised and the regulatory authority reported that the event was life threatening. The subject was treated with corticosteroid and immunoglobulin. A cerabrospinal fluid culture was performed showing hyperproteinorachia. Neurophysiologic studies agreed with suspected diagnose of neuritis. The subject also suffered from nosocomial pneumonia due to intubation that at the time of reporting was in resolution. On 10/27/2005, the event was resolved. The regulatory authority reported that the event was possibly related to vaccination with Infanrix and Priorix. No further information is expected as this is the only information that Spanish authorities has, so this case is now closed.

VAERS ID:249904 (history)  Vaccinated:2005-12-13
Age:6.0  Onset:2005-12-13, Days after vaccination: 0
Gender:Female  Submitted:2005-12-23, Days after onset: 10
Location:Foreign  Entered:2005-12-28, Days after submission: 5
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: B0404499A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B001AG IMLA
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER048805 SCRA
Administered by: Other     Purchased by: Other
Symptoms: Cyanosis, Hypotonia, Nausea, Pallor, Somnolence, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: This case was reported by foreign authorities and described the occurrence of lip cyanosis in a 5 year old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine, live attenuated MMR vaccine. On 12/13/05, the subject received a dose of Infanrix, and a dose of Morupar (SC, right arm). On 12/13/05, less than one day after vaccination with Infanrix and Morupar, the subject developed lip cyanosis, muscle hypotonia, pallor, somnolence, nausea and vomiting. The subject was hospitalized. The same day, the events were completely resolved. The regulatory authority reported that the events were possibly related to vaccination with Infanrix and Morupar.

VAERS ID:249986 (history)  Vaccinated:2005-05-20
Age:6.0  Onset:2005-05-20, Days after vaccination: 0
Gender:Female  Submitted:2006-01-03, Days after onset: 228
Location:Foreign  Entered:2006-01-03
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: B0405058A
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURERY9501 SCUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B005  UN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Hypotonia, Muscle disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported and described the occurrence of convulsions in a 5 year old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, absorbed (Boostrix), live attenuated measles, mumps (strain not specified), rubella vaccine (measles mumps rubella vaccine,) for prophylaxis. On May 20 2005 the subject received a dose of Boostrix and a dose of Measles, mumps, rubella vaccine. The same day, following vaccination, the subject developed convulsion, muscle hypotonia and floppiness. On May 21 2005, the subject was admitted to the neurologic department. The subject was treated with mannitol and phenobarbitone (Phenobarbital). At the time of reporting the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with Boostrix and Measles mumps rubella vaccine. Further information has been requested.

VAERS ID:250030 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:2005-08-31
Gender:Male  Submitted:2005-12-30, Days after onset: 121
Location:Foreign  Entered:2006-01-04, Days after submission: 5
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: Previous tetanus diphtheria vaccinations were well tolerated. Patient has a history of attention deficit hyperactivity disorder.
Diagnostic Lab Data:
CDC Split Type: E200505458
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER   UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Grand mal convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Case initially received on Dec 20 2005. It was reported that a 6 year old boy with a history of attention deficit hyperactivity disorder was vaccinated with a booster dose of tetanus diphtheria vaccine (man unknown) on an unspecified time. On Aug 31 2005 he developed his first grand mal. He recovered completely. The boy was hospitalised (no date given). EEG, ECG and glucose were normal. For ammoniac and leukocytes lab date see lab comments. File closed.

VAERS ID:251184 (history)  Vaccinated:2006-01-17
Age:6.0  Onset:2006-01-18, Days after vaccination: 1
Gender:Female  Submitted:2006-02-02, Days after onset: 15
Location:Foreign  Entered:2006-02-02
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:
CDC Split Type: B0408464A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14016AA IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Musculoskeletal stiffness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of syncope in a 6 year old female subject who was vaccinated with Diphtheria and tetanus toxoid and acellular pertussis vaccine (Infanrix), live attenuated measles, mumps (strain not specified), rubella vaccine (MMR II) for prophylaxis. On 1/17/2006, the subject received unspecified dose of Infanrix (intramuscular, unknown, lot number AC14A016AA) and unspecified dose of MMR II vaccine (intramuscular, unknown). On 01/18/2006, 1 day after vaccination with Infanrix and MMR II vaccine, the subject experienced syncope and muscle stiffness. The regulatory authority reported that the events were clinically significant (or requiring intervention) (OMIC). On 01/18/2006, the events were spontaneously resolved with any treatment. The regulatory authority reported that the events were possibly related to vaccination with Infanrix and MMR II vaccine.

VAERS ID:251595 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:2006-01-31
Gender:Female  Submitted:2006-02-13, Days after onset: 13
Location:Foreign  Entered:2006-02-17, Days after submission: 4
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: Hypothyroidism; Multiple allergies
Preexisting Conditions: Hypothyroidism; Multiple allergies
Diagnostic Lab Data: Upper extremity X ray 2//7/2006 Hydro aerial level, inflammation of soft tissues; blood chemistry, 07Feb06, normal; hematology, 07Feb06, leucocytosis; serum alanine aminotransferase, 07Feb06, normal; serum aspartate aminotransferase, 07Feb06, normal; hepatic function tests, 07Feb06, normal; abscess culture, 07Feb06, Streptoccocus milieir and Fusobacterium sp; gram stain, 07Feb06, gram positive coccus.
CDC Split Type: WAES0602MEX00001
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abscess drainage, Alanine aminotransferase normal, Aspartate aminotransferase normal, Bacterial infection, Culture, Erythema, Gram stain positive, Haematology test abnormal, Inflammation, Injection site abscess, Injection site erythema, Injection site inflammation, Injection site pain, Laboratory test normal, Leukocytosis, Liver function test normal, Pain, Purulent discharge, Pyrexia, Soft tissue inflammation, X-ray limb abnormal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Osteonecrosis (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)
Write-up: Information has been received from a physician concerning a 6 year old female with hypothyroidism and multiple allergies who in approximately 2000 was vaccine with measle virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Concomitant therapy included thyroid hormones. On 31-Jan-2006, after a re-vaccination, the patient experienced local inflammation characterized by local pain and erythema. On 04-Feb-2006 the patient experienced pyogen abscess on injection site (left shoulder), characterized by fever of 39-40 degree C for 4 days, and was hospitalized. On 07 Feb 2006 hematology test, blood chemistry, hepatic function test, TGO, TGP were determined to be normal, an upper extremity x ray film showed inflammation of soft tissues and hydroaerial level. Drainage was performed on 07 Feb 2006, and 100 ml of purulent material were obtained. A gram stain from this material showed gram positive coccus, the culture result is pending. Subsequently, the patient recovered from local inflammation on 07 Feb 2006 the patient started to be treated with Clindamicine 40 mg/Kg/day divided in 4 doses. Ketorolac 10 mg TID, and Omeprazole 10 mg/day. The reporter felt that local inflammation was related to therapy with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live and that the pyogen abscess on injection site was not. The patient is recovering from pyogen abscess as fever, pain and general condition is improved. Additional information has been requested. Follow-up information (14-Feb-2006): Culture from abscess drainage taken on 07 Feb 2006 was positive for Staphylococcus milieri (sensible to multiple antibiotics) and Fusobacterium sp. (sensible for Clindamicine). The patient has recovered from the pyogen abscess and was discharged form the hospital on 10-Feb-2006. She completed 10 days of treatment with clindamicine. It is the reporting physician''s opinion that the inflammation process in the injection site could have caused loss of integrity of the skin and, as a consequence, the pyogen abscess. In this opinion, the injection procedure was not related to the pyogen abscess. No additional information is expected.

VAERS ID:251654 (history)  Vaccinated:2005-05-03
Age:6.0  Onset:2005-05-31, Days after vaccination: 28
Gender:Male  Submitted:2006-02-20, Days after onset: 265
Location:Foreign  Entered:2006-02-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Throat pain
Preexisting Conditions:
Diagnostic Lab Data: Bone marrow biopsy 5/2005 normal, Platelet count 5/2005 4000 mm3.
CDC Split Type: B0411777A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSHAVB039AZ IMUN
Administered by: Other     Purchased by: Other
Symptoms: Platelet count decreased, Thrombocytopenic purpura
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of idiopathic thrombocytopenic purpura in a 6 year old male subject who was vaccinated with hepatitis A vaccine (Havrix) for prophylaxis. Concurrent medical conditions included throat pain. On 5/3/2005 the subject received unspecified dose of Havrix (intramuscular, unknown). On 5/31/2005, 28 days after vaccinations with Havrix, the subject experienced idiopathic thrombocytopenic purpura. This case was assessed as medically serious by manufacturer (OMIC). Relevant test results included platelets count (4000 mm#) and bone marrow biopsy with normal results. The subject was treated with methylprednisolone and normal immunoglobulin (immune globulin). At the time of reporting the events was unresolved. The regulatory authority reported that the event was probably related to vaccination with Havrix.

VAERS ID:251721 (history)  Vaccinated:2006-01-04
Age:6.0  Onset:2006-01-04, Days after vaccination: 0
Gender:Male  Submitted:2006-02-21, Days after onset: 48
Location:Foreign  Entered:2006-02-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: B0410504A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC19B009BA IMUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  SCRA
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea, Erythema, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by an authority and described the occurrence of dyspnea in a 5 year old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix) for prophylaxis. Previous and or concurrent vaccination included live attenuated measles, mumps (strain not specified), rubella vaccine (subcutaneous, right deltoid) given on 1/4/2006. On 1/4/2006, the subject received unspecified dose of Infanrix (intramuscular, unknown). On 1/4/2006, less than one day after vaccination with Infanrix, the subject experienced dyspnea, periorbital erythema and wheals (0.5 cm of diameter). The subject was hospitalised for 1 day. The subject was treated with adrenaline and salbutamol sulphate. On 1/5/2006, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with Infanrix.

VAERS ID:252365 (history)  Vaccinated:2006-02-13
Age:6.0  Onset:2006-02-13, Days after vaccination: 0
Gender:Male  Submitted:2006-03-06, Days after onset: 21
Location:Foreign  Entered:2006-03-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: B0414024A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B019CB IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema, Lymphadenitis
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of axillary lymphadenitis in a 5 year old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix) for prophylaxis. On 2/13/2006 the subject received unspecified dose of Infanrix intramuscular, unknown. On 2/13/2006, less than one day after vaccination with Infanrix, the subject experienced axillary lymphadenitis, injection site induration, injection site edema and redness ($g5cm). This case was assessed as medically serious by manufacturer (OMIC). the subject was treated with anti inflammatory. On 2/15/2006, the events were resolved. The regulatory authority reported that the event were possibly related to vaccination with Infanrix. No further information is needed, this case has therefore been closed.

VAERS ID:253568 (history)  Vaccinated:2005-09-28
Age:6.0  Onset:2005-09-28, Days after vaccination: 0
Gender:Female  Submitted:2006-03-30, Days after onset: 183
Location:Foreign  Entered:2006-04-03, Days after submission: 3
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: UNK
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: 28Sep05: Blood pressure measurement 85/60.
CDC Split Type: WAES0603USA03402
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS009BA IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.Y9597 SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Heart rate irregular, Hypotension, Rash, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a health authority concerning a 6 year old female with no previous medical history who on 28Sep05 was vaccinated SC with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Suspect vaccinations administered on that same day included an IM dose of diphtheria toxoid (+) pertussis acellular 3 component vaccine (+) tetanus toxoid (INFANRIX) (Batch AC14B009BA). It was reported that on 28Sep05, five minutes after vaccination, the pt presented with a lipothymic and a skin rash over the right forearm, behind the ear and on the left side of her neck which resolved after 5-10 mins. The pt''s heart beat was regular with the exception of rare decelerations and successive accelerations. Her blood pressure was 85/60. Emergencies was called and the pt was subsequently hospitalized. At the time of this report, the pt''s condition improved. The final outcome was not reported. Other business partner numbers include E200601425, 64324 and IT103/06. No further information is available. The case is closed.

VAERS ID:253692 (history)  Vaccinated:2006-03-26
Age:6.0  Onset:2006-03-26, Days after vaccination: 0
Gender:Female  Submitted:2006-04-04, Days after onset: 8
Location:Foreign  Entered:2006-04-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cranioencephalic trauma, subdural hematoma.
Preexisting Conditions: Food allergy
Diagnostic Lab Data:
CDC Split Type: B0417991A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS   UN
Administered by: Other     Purchased by: Other
Symptoms: Apnoea, Dizziness, Fall, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of a vagal reaction in a 6 year old female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis. Concurrent medical conditions included cranioencephalic trauma and subdural hematoma, at the age of 4 years. She was assessed by a neurologist who indicated follow up with periodic EEG, that had been normal normal according to the mother, epilepsy has been ruled out. Medical history included food allergy (NOS). On 3/26/2006 the subject received a 1st dose of Twinrix (unknown, lot number not provided). On 3/26/2006, 3 to 5 minutes after vaccination with Twinrix, the subject experienced lipothymia, fells from low height, hits her head and suffered from loss of consciousness and apnea for a short duration. The reporting physician considered the events to be a vagal reaction. The physician considered the events were clinically significant (or requiring intervention) (OMIC). The subject recovered spontaneously. A scanner and head radiography were performed, showing no trauma. After 4 hours, the patient was discharged. The vaccination cause has been discontinued. The reporting physician did not assess a causal relationship with the vaccine but considered the events could be associated with the subjects medical history.

VAERS ID:253743 (history)  Vaccinated:2005-09-28
Age:6.0  Onset:2005-09-28, Days after vaccination: 0
Gender:Female  Submitted:2006-04-05, Days after onset: 189
Location:Foreign  Entered:2006-04-05
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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: B0418486A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B009BA IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Bradycardia, Rash, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of syncope in a 6 year old female subject who was vaccinated with Diphtheria and tetanus toxoid and acellular pertussis vaccine (Infanrix), live attenuated measles, mumps strain not specified, rubella vaccine (MMR II vaccine). On 9/28/2005 the subject received unspecified dose of Infanrix intramuscular, right arm, and an unspecified dose of MMR II vaccine intramuscular, left. On 9/28/2005, 5 minutes after vaccination with Infanrix and MMR II vaccine, the subject experienced a syncope and later on the same day bradycardia and tachycardia as well as a localized rash on the right fore arm, left side of the neck and in the left retrosuricular area. The subject was hospitalized. Blood pressure was 85mmHg. At the time of reporting the events were improved but still present. The regulatory authority reported that the events were possibly related to vaccination of Infanrix and MMR II vaccine.

VAERS ID:253822 (history)  Vaccinated:2006-02-24
Age:6.0  Onset:2006-03-24, Days after vaccination: 28
Gender:Female  Submitted:2006-04-07, Days after onset: 13
Location:Foreign  Entered:2006-04-07
Life Threatening? Yes
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: B0419085A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B019CB IMUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER   UN
Administered by: Other     Purchased by: Other
Symptoms: Encephalitis, Rash scarlatiniform, Status epilepticus
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case reported by a regulatory authority and described the occurrence of possible encephalitis in a 5 year old female subject who was vaccinated with Diphtheria and tetanus toxoid and acellular pertussis vaccine (Infanrix), live attenuated measles, mumps (strain not specified, rubella vaccine (MMR vaccine). On 2/24/2006 the subject received unspecified dose of Infanrix intramuscular, unknown, unspecified dose of MMR vaccine. On 3/24/2006, 1 month after vaccination with Infanrix and MMR vaccine, the subject experienced scarlatiniform rash. On 3/30/2006 the subject developed a possible encephalitis with status epilepticus. The regulatory authority reported that the events were life threatening. The subject was treated with ampicillin trihydrate (Ampicilline). At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with Infanrix and MMR vaccine.

VAERS ID:254091 (history)  Vaccinated:2006-02-01
Age:6.0  Onset:2006-03-14, Days after vaccination: 41
Gender:Male  Submitted:2006-04-13, Days after onset: 29
Location:Foreign  Entered:2006-04-13
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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: B0419653A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B013BE IMUN
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALSA69CA349A  UN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Ecchymosis, Pain, Petechiae
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Arthritis (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of ecchymosis legs in a 5 year old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix) combined measles, mumps and rubella vaccine, live and attenuated (new strain) (Priorix) for prophylaxis. On 2/1/2006 the subject received unspecified dose of Infanrix (intramuscular, unknown) unspecified dose of Priorix (unknown). On 3/14/2006, 41 days after vaccination with Infanrix and Priorix, the subject experienced ecchymosis legs, ecchymosis buttocks, joint pain, leg pain and petechiae and legs and on buttocks. The subject was hospitalized. At the time of reporting the events were improved. The regulatory authority reported that the events were possibly related to vaccination with Infanrix and Priorix.

VAERS ID:254206 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2006-04-11
Location:Foreign  Entered:2006-04-18, Days after submission: 7
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Heart disease congenital, Pulmonary artery atresia.
Preexisting Conditions: Arterial bypass operation, Asplenia
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0603USA04702
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: It was reported in a published literature article title as stated above that a 6 year old male, with asplenia syndrome, single atrium, single ventricle, atrioventricularis communis,and pulmonary artery atresia and a history of arterial bypass operation (arteria subclavia pulmonary artery shunt), who as age 3 years and 8 months old was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown). Subsequently, at age 6 years and 7 months old the patient died. The cause of death was sudden death. The abstract of the article stated Pneumococcal vaccine was inoculated to 10 congenital asplenia syndrome CAS patients ranging from 1y 4m to 12y 10m and the antibody titers of Immunoglobin Ig and IgG2 subclass were measured 3-4 weeks after vaccination. The patients were divided into two groups, one group A consisted of 6 cases with age 3y 8m or older at inoculation, and the other group B consisted of 4 cases around 2y 1m. The antibody responses were compared between the two groups. As a result, the post vaccination antibody titre of IgG2 subclass containing anti pneumococcal capsular polysaccharide was significantly lower in group B than that of group A (p<0.05), while no difference was observed for IgG1 antibody. Physiological delay in IgG2 was suspected for the low response in group B. It is reported that post splenectomy sepsis develops within the first two years after surgery in more than 80% of children, and the splenectomy before the age of 2 is quite risky for infections. Congenital asplenia syndrome is supposed to be vulnerable to pneumococcal infection like splenectomized cases, and the prophylaxis for the infection should be accounted for them. Results indicate that pneumococcal vaccination under 2 years is ineffective as asplenia syndrome, and that other prophylactic procedures such as prophylactic antibiotics and or intravenous Ig administration should be considered for the asplenia syndrome patient under 2 years. The reporting physician did not assess the causal relationship between the patients sudde

VAERS ID:255137 (history)  Vaccinated:2006-04-13
Age:6.0  Onset:2006-04-13, Days after vaccination: 0
Gender:Male  Submitted:2006-05-01, Days after onset: 18
Location:Foreign  Entered:2006-05-08, 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:
Diagnostic Lab Data:
CDC Split Type: WAES0604USA03699
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALS  SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest pain, Eyelid oedema, Injection site pain, Neck pain, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health authority concerning a a6 year old male, with no reported medical history, who on 4/13/2006 was vaccinated with a subcutaneous first dose of varicella virus vaccine live (Batch NG0940/lot #). Concomitant vaccine administered on the same day included a second subcutaneous dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (PRIORIX) (Batch # A63CAGG2A). The injection site for each vaccine was not specified. On the same day, on 4/13/2006, at 4:30pm, the patient presented with an eyelid edema with itching, pain of the chest and nape of the neck, and in injection site, right deltoid, hive. Emergencies were called and he was admitted to the hospital. At the time of the report his condition had improved. The duration and final outcome were not reported. The case is closed. Other business partner numbers included E200602066, 64951 and IT17106.

VAERS ID:255411 (history)  Vaccinated:2006-03-30
Age:6.0  Onset:2006-03-30, Days after vaccination: 0
Gender:Female  Submitted:2006-05-12, Days after onset: 42
Location:Foreign  Entered:2006-05-12
Life Threatening? Yes
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: B0423484A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B019CB IMUN
Administered by: Other     Purchased by: Other
Symptoms: Coma, Encephalitis, Hypoxia, Rash morbilliform
SMQs:, Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of encephalitis in a 5 year old female subject who was vaccinated with diphtheria and tetanus toxoid and acellular pertussis vaccine (Infanrix) for prophylaxis. On 3/30/2006 the subject received unspecified dose of Infanrix .5 ml, intramuscular, unknown. The same day, the subject experienced coma, encephalitis and morbilliform rash. The regulatory authority reported that the events were life threatening. The subject was treated with anti viral medication (Antiviral, not specified), and normal immunoglobulin (immunoglobulin, injection). The subject underwent intubation, assisted ventilation and parenteral nutrition. At the time of reporting the outcome of the events was unspecified.

VAERS ID:257101 (history)  Vaccinated:2006-05-13
Age:6.0  Onset:2006-05-13, Days after vaccination: 0
Gender:Male  Submitted:2006-05-31, Days after onset: 18
Location:Foreign  Entered:2006-05-31
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: B0425486A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC378015BD IMUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema multiforme, Pruritus
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of erythema multiforme in a 6 year old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine Infanrix for prophylaxis. On 5/13/2006 the subject received unspecified dose of Infanrix intramuscular, unknown, the lot number provided was however a lot number for Boostrix. On 5/13/2006, less than one day after vaccination with Infanrix, the subject experienced erythema multiforme and lower limb pruritus. This case was assessed as medically serious by manufacturer (OMIC). On 5/16/2006, the event was resolved. The regulatory authority reported that the events were possibly related to vaccination with Infanrix.

VAERS ID:257104 (history)  Vaccinated:2006-04-26
Age:6.0  Onset:2006-04-26, Days after vaccination: 0
Gender:Female  Submitted:2006-05-31, Days after onset: 35
Location:Foreign  Entered:2006-05-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: B0425488A
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SCUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS37B015ABC IMLA
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site reaction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of injection site cellulitis in a 5 year old female subject who was vaccianted with Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, absorbed (Boostrix) for prophylaxis. Previous and or concurrent vaccination included live attenuated measles mumps strain not specified, rubella vaccine subcutaneous unknown, given on 4/26/2006. On 4/26/2006 the subject received unspecified dose of Boostrix intramuscular, left deltoid. On 4/26/2006, less than one day after vaccination with Boostrix, the subject experienced edema, pain and redness at the injection site as well as fever. On 4/27/2006, the subject was hospitalised for 4 days due to injection site cellulitis. The subject was treated with antibiotics. At the time of reporting the events were improved. The regulatory authority reported that the events were possibly related to vaccination with Boostrix.

VAERS ID:258231 (history)  Vaccinated:2006-05-03
Age:6.0  Onset:2006-05-03, Days after vaccination: 0
Gender:Male  Submitted:2006-06-08, Days after onset: 36
Location:Foreign  Entered:2006-06-09, 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:
Diagnostic Lab Data:
CDC Split Type: B0425997A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B024BB IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Feeling cold, Hyperhidrosis, Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of vasovagal reaction in a 5 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix), live attenuated measles, mumps (strain not specified), rubella vaccine (MMR II vaccine) for prophylaxis. On 03May06 the subject received unspecified dose of Infanrix (.5ml IM, unk), unspecified dose of MMRII vaccine (.5ml, SC, unk). On 03May06, less than one day after vaccination with Infanrix and MMR II vaccine, the subject experienced a vasovagal reaction with loss of consciousness, cold sweat and pallor. This case was assessed as medically serious by manf (OMIC). On 03May06, the events resolved spontaneously. The regulatory authority reported that the events were possibly related to vaccination with Infanrix and MMR II vaccine.

VAERS ID:259567 (history)  Vaccinated:2006-03-16
Age:6.0  Onset:2006-03-18, Days after vaccination: 2
Gender:Male  Submitted:2006-07-14, Days after onset: 117
Location:Foreign  Entered:2006-07-14
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:
Current Illness:
Preexisting Conditions: Multiple bites of a stray rabid dog at lower and upper limbs
Diagnostic Lab Data:
CDC Split Type: MA20060492
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABIPUR)CHIRON CORPORATION11743IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Constipation, Cough, Loss of consciousness, Paralysis, Pyrexia, Urinary retention
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: A 6 year old male patient was bitten by a stray rabid dog into his lower and upper limbs on 3/2/06. The patient was started with a series of 1ml Rabipur (Batch # 1174), IM, into his musculus deltoideus on 3/2/06. Further vaccinations were given on 3/5/06, 3/9/06, and 3/16/06. The patient did not receive HRIG. On 3/16/06, the child developed fever, cough, paralysis of limbs and retention of stool and urine. He felt unconscious. The patient was hospitalized. Seriousness criteria: life-threatening, hospitalization, possible permanent damage. Causality: not related. The reported symptoms are not expected after vaccination with Rabipur. NO change in benefit-risk-ratio. No measures necessary. Addendum 7/10/06: We received the original documents. No further information available. No change in company and expectedness assessment.

VAERS ID:259762 (history)  Vaccinated:2005-03-31
Age:6.0  Onset:2005-03-31, Days after vaccination: 0
Gender:Male  Submitted:2006-07-19, Days after onset: 474
Location:Foreign  Entered:2006-07-19
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: B0431261A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14609C9 IM 
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERP1778A IM 
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), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of syncope in a 6 year old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine, live attenuated oral poliomyelitis vaccine for prophylaxis. On 3/31/05, the subject received unspecified dose of Infanrix (IM, unknown). unspecified dose of Polio vaccine (IM, unknown). On 3/31/05, less than one day after vaccination with Infanrix and Polio vaccine, the subject experienced syncope. The regulatory authority reported that the event was clinically significant (or requiring intervention) (OMIC). On 3/31/05, the event was resolved. The regulatory authority reported that the event was possibly related to vaccination with Infanrix and Polio vaccine. No additional information will be available and this case has been closed.

VAERS ID:261113 (history)  Vaccinated:2006-07-12
Age:6.0  Onset:2006-07-14, Days after vaccination: 2
Gender:Female  Submitted:2006-08-02, Days after onset: 19
Location:Foreign  Entered:2006-08-07, Days after submission: 5
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: NONE
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Physical examination 14Jul06 red throat and inflamed tonsil. Body temp fever 14Jul06 centigrade; body temp normal 17Jul06 centigrade.
CDC Split Type: WAES0607CHN00044
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0757R IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Inflammation, Pharyngolaryngeal pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician on 27Jul06 concerning a 6 yr old Asian female who on 12Jul06 was vaccinated with pneumococcal 23v polysaccharide vaccine, 0.5ml, IM (lot653141/0757R). There was no concomitant medication. On 14Jul06, the girl suffered from fever and afflicted throat. Physical examination revealed the girl was conscious with her throat red and tonsil inflamed. She was hospitalized at that time with diagnosis of fever of undetermined origin and acute pharyngitis. During hospitalization, she was placed on therapy with erythromycin estolate tablets, 0.1255g, PO thrice daily (from 14Jul06 to 16Jul06); vitamin C and vitamin B, PO twice daily (from 14Jul06 to 15Jul06). On 16Jul06, the girl had once been placed on therapy with antondin 1.2ml, IM; hexadecadrol 3mg, IV for treatment of fever. On 17Jul06, the girl recovered from fever (still reason unk) and acute pharyngitis then discharged from hospital. The reporter felt that fever of undetermined origin and acute pharyngitis were definitely related to pneumococcal 23v polysaccharide vaccine. Additional information is not expected.

VAERS ID:261198 (history)  Vaccinated:2006-07-19
Age:6.0  Onset:2006-07-19, Days after vaccination: 0
Gender:Male  Submitted:2006-08-07, Days after onset: 19
Location:Foreign  Entered:2006-08-07
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: Epilepsy
Preexisting Conditions: Prematurity
Diagnostic Lab Data:
CDC Split Type: B0433145A
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRL
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B009BA IMRL
Administered by: Other     Purchased by: Other
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of generalized seizure in a 6 year old male subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, absorbed (Boostrix) for prophylaxis. The subjects medical history included prematurity. Concurrent medical conditions included epilepsy. Concurrent vaccination included live attenuated MMR stain not specified, manufacturer unspec, IM Unk, given on 7/19/06. On 07/19/06 the subject received unspecified dose of Boostrix (IM, unk). On 7/19/06, less than one day after vaccination with Boostrix, the subject experienced a generalized seizure. The subject was hospitalized. An electroencephalogram and a brain nuclear magnetic resonance were performed, for which the results were unknown at the time of reporting. At the time of this report the outcome of the event was unspecified. The regulatory authority reported that the event was possibly related to vaccination with Boostrix.

VAERS ID:261227 (history)  Vaccinated:2005-10-20
Age:6.0  Onset:2005-10-26, Days after vaccination: 6
Gender:Male  Submitted:2006-08-04, Days after onset: 282
Location:Foreign  Entered:2006-08-08, Days after submission: 4
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:
CDC Split Type: WAES0607USA05539
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERY0286 IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERY0286 IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0538P SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Flank pain
SMQs:, Retroperitoneal fibrosis (broad)
Write-up: Information has bee received from a health authority concerning a 6 year old male who on 10/20/2005 was vaccinated SC with a dose of MMR II (lot 649233/0538P, batch NA03330). Secondary suspect vaccination given on the same day included an IM dose of diphtheria toxoid (+) pertussis acellular 2 component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid Tetravac (lot Y0286-1). On 10/26/2005 the pt experienced pain in flank and was hospitalized. Subsequently, the pt recovered without sequale. Other business partner numbers included E200603828. Additional information has been requested.

VAERS ID:261229 (history)  Vaccinated:2006-07-12
Age:6.0  Onset:2006-07-13, Days after vaccination: 1
Gender:Male  Submitted:2006-07-31, Days after onset: 18
Location:Foreign  Entered:2006-08-08, Days after submission: 8
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: Body temp 7/13/06 38 C, WBC count 7/14/06 17.2 10(9) L, body temp 7/14/06 39 C, Body temp 7/15/06 3708C, 7/16/06 38C, WBC count 7/17/06 18.1, body temp 7/19/06 normal.
CDC Split Type: WAES0607CHN00027
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0757R IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Nausea, Neck pain, Pyrexia, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician on 7/19/06 concerning a 6 year old male who on 7/12/06 was vaccinated with Pneumococcal 23v polysaccharide vaccine, 0.5ml, IM lot 653141/0757R. There was no concomitant medications. On 7/13/06, the boy complained injection site pain. At 23:00 o''clock that night, he developed fever with his body temperature 38. On 7/14/06 his body temp increased to 39 and white blood cell count 17.2. The boy went sent to clinic and was prescribed with cefaclor, 1 tablet, PO, thrice daily, unspecified antipyretic and unspecified traditional medicine. above treatment were treated from 7/14/06 to 7/17/06. On 7/15/06, the boy suffered from injection site swelling, injection site sclerosis and injection site pain which had spread to his elbow. Meanwhile, his body temperature was 37.8. In the morning of 7/16/06, his body temp was 38. He was placed on unspecified anti infective paste, external use and unspecified antipyretic therapy, oral. On 7/17/06, with his white blood cell counting 18.1, the boy was placed on therapy with antipyretic and anti allergic agent from 7/17/06 to 7/20/06. On 7/18/06, injection site swelling pain abated. But on 7/19/06, the boy complained injection site red, swelling, pain and injection site sclerosis again. Subsequently, he experienced nausea, vomiting and pain in neck. On the same day, he was hospitalized for further treatment. At the same time, he was placed on therapy with metronidazole, 100ml IV, levofloxacin, 200ml IV sulbactam cefoperazone and hexadecadrol (regimen unknown). At the time of reporting, the boy recovered from fever, injection site swelling, injection site sclerosis, injection site red, nausea, vomiting and pain in neck. Injection site pain was also recovering. the repro considered inject site pain, inject site swelling, inject site sclerosis, inject site red, fever, nausea, vomiting and pain in neck were definitely related to Pneumococcal 23v polysaccharide vaccine. Additional information was not expected.

VAERS ID:261570 (history)  Vaccinated:2002-06-29
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2006-08-11
Location:Foreign  Entered:2006-08-15, Days after submission: 4
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: UNK
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Blood culture, 5/28/06: streptococcus pneumonial serotype 18C isolated.
CDC Split Type: WAES0608AUS00054
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bacterial infection, Medication error, Sepsis
SMQs:, Agranulocytosis (broad), Medication errors (narrow)
Write-up: Information was obtained on request by the company from the agency via a public case detail form. The patient was 6 year old male who on 6/29/02 was vaccinated with pneumococcal 23v polysaccharide vaccine. Other suspect therapy included pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine, vaccinated on 7/17/02 and 11/26/03. Subsequently the patient experienced vaccination failure and pneumococcal infection and was hospitalized. Streptococcus pneumoniae serotype 18C, a vaccine preventable strain, was isolated on blood cultures collected on 5/28/06 manifesting as septicemia. Subsequently, the patient recovered from pneumococcal infection. The agency considered that vaccination failure and pneumococcal infection were certainly related to therapy with pneumococcal 23v polysaccharide vaccine and pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine. The original reporting source was not provided. Additional information is not expected.

VAERS ID:262508 (history)  Vaccinated:2006-08-01
Age:6.0  Onset:2006-08-01, Days after vaccination: 0
Gender:Female  Submitted:2006-08-31, Days after onset: 30
Location:Foreign  Entered:2006-09-01, 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:
Diagnostic Lab Data:
CDC Split Type: B0435768A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B01BF IMLA
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER   UN
Administered by: Other     Purchased by: Other
Symptoms: Injection site reaction, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by an authority and described the occurrence of syncope in a 6-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix) for prophylaxis. Concurrent vaccination included live attenuated measles, mumps (strain not specified), rubella vaccine (manufacturer unspecified unknown) given on 1 August 2006 the subject received unspecified dose of Infanrix (intramuscular, left deltoid). On 1 August 2006, less than one day after vaccination with Infanrix, the subject experienced a syncope and in injection site reaction. This case was assessed as medically serious. At the time of reporting the events were completely resolved. The authority reported that the events were possibly related to vaccination with Infanrix. (OMIC)

VAERS ID:262591 (history)  Vaccinated:2006-08-10
Age:6.0  Onset:2006-08-11, Days after vaccination: 1
Gender:Female  Submitted:2006-09-05, Days after onset: 25
Location:Foreign  Entered:2006-09-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: D0050769A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB166BA  UN
Administered by: Other     Purchased by: Other
Symptoms: Henoch-Schonlein purpura, Malaise, Nausea, Oedema peripheral, Petechiae
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vasculitis (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of Schonlein Henoch purpura in a 6 year old female subject who was vaccinated with hepatitis B vaccine Engerix B pediatric) for prophylaxis. Previous vaccination included hepatitis B vaccine (Engerix B ped) given on 8/12/05 and 9/27/05. On 8/10/06 the subject received 3rd dose of Engerix B ped (unk route and injection site). On day after vaccination with Engerix B ped, in the night from 11 to 12 Aug 2006, the subject experienced nausea, lasting the whole weekend and increasing washed out feeling. On 8/15/06 the subject developed petechiae and joint swelling at the feet and hands. The subject was hospitalised on 8/17/06 for 15 days. Schoenlein Henoch purpura was diagnosed. At the time of reporting nausea had resolved, but the outcome of the other events was unspecified. Follow up information has been requested.

VAERS ID:262989 (history)  Vaccinated:2005-08-25
Age:6.0  Onset:2005-09-10, Days after vaccination: 16
Gender:Male  Submitted:2006-09-11, Days after onset: 366
Location:Foreign  Entered:2006-09-13, 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: UNK
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Diagnostic lab test sample one present of fairly new infection 9/10/05, sample two no further rise in antibody levels, all other antibody test were negative, Monosticon negative, M group mycoplasma antibodies positive, WBC count 11.0, serum
CDC Split Type: WAES0602USA04404
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRA
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Blister, Dry mouth, Erythema, Laboratory test abnormal, Lymphadenopathy, Mucous membrane disorder, Musculoskeletal stiffness, Pain, Pharyngitis, Pyrexia, Red blood cell sedimentation rate decreased, Respiratory tract infection, Stevens-Johnson syndrome, Viral infection
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)
Write-up: Information has been received from a health authority concerning a 6 year old male with no reported medical history, who on 8/25/05 was vaccinated SC with a dose of MMR II. Secondary suspect vaccination included a dose of diphtheria toxoid+ pertussis acellular 2 component vaccine + poliovirus vaccine inactivated + tetanus toxoid (Tetravac) given IM. On 9/10/05, 16 days after the vaccinations, the pt developed Stevens Johnson syndrome and was hospitalized. The aetiological factor was thought to be a mycoplasma infection, because sample one suggested the presence of a fairly new infection. Sample two revealed no further rise in antibody levels. All other antibody test were negative. Subsequently, the pt recovered. Additional information received on 8/28/06 from the health authority reported that the MMR batch number was NA16550 and the DTaP/IPV (Tetravac) batch number was 40985. Follow up information was received on 8/31/06 from hospital records. The final evaluation indicated that the diagnosis was Stevens Johnson syndrome and mycoplasma infection. The MMR II vaccine was given in the left shoulder and the DTaP/IPV was given in the right shoulder. A basically healthy boy was referred from an emergency clinic to the hospital due to pharyngitis and painful swollen glands in the neck and underarms. The pt was hospitalized from 9/11/2005 until 9/19/2005. The onset of symptoms began on 9/10/05, loss of appetite and soreness in the underarms,neck and groin. The pt did not experience fever. A throat culture was taken in the referring unit and was negative; Monosticon was negative, the CRP was under 5, leukocytes were 11. When the boy arrived at the hospital he seemed to be in pain, no fever, swollen glands in the neck and thick green cover on the right tonsil. He also had swollen glands in the groin area. He had broken skin in the right armpit and erythema in the left armpit. Erythema also in the neck and groin areas. The skin at the corners of the mouth were broken and his lips were dry. A blood culture was taken and tre

VAERS ID:263091 (history)  Vaccinated:2006-09-09
Age:6.0  Onset:2006-09-09, Days after vaccination: 0
Gender:Female  Submitted:2006-09-15, Days after onset: 6
Location:Foreign  Entered:2006-09-15
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:
Diagnostic Lab Data:
CDC Split Type: B0437846A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS   UN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Eye movement disorder
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of tonic clonic convulsion in a 6 year old female subject who was vaccinated with hepatitis A vaccine Havrix 720, for prophylaxis. On 9/9/06 the subject received unspecified dose of Havrix 720 (unknown, lot number not provided). On 9/9/2006, 5 seconds after vaccination with Havrix 720, the subject experienced a generalized tonic clonic convulsion with eyes rolling that lasted for 8 seconds. The physician considered the events were life threatening.

VAERS ID:263128 (history)  Vaccinated:2006-08-29
Age:6.0  Onset:2006-08-30, Days after vaccination: 1
Gender:Female  Submitted:2006-09-13, Days after onset: 14
Location:Foreign  Entered:2006-09-18, 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: UNK
Current Illness:
Preexisting Conditions: Pneumonia
Diagnostic Lab Data:
CDC Split Type: WAES0609TWN00002
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.G2755 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Pyrexia, Urinary tract infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health professional concerning a 6 year old female with a history of pneumonia who on 29-Aug-2006 was vaccinated with pneumococcal 23v polysaccharide vaccine. On 30-AUG-2006 the patient experienced fever. On 31-AUG-2006 the patient experienced urinary tract infection. On 01-SEP-2006 the patient experienced cellulitis like reaction. Subsequently, the patient was hospitalized 01-Sep-2006, and she was recovered from urinary tract infection on 01-SEP-2006 and recovered from fever on 05-SEP-2006. The reporter felt that fever and cellulitis like were related to therapy with pneumococcal 23v polysaccharide vaccine and that the urinary tract infection was not. Additional information has been requested.

VAERS ID:263264 (history)  Vaccinated:2005-10-05
Age:6.0  Onset:2005-10-16, Days after vaccination: 11
Gender:Male  Submitted:2006-09-19, Days after onset: 338
Location:Foreign  Entered:2006-09-19
Life Threatening? Yes
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: B0438454A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS   LL
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER   UN
Administered by: Other     Purchased by: Other
Symptoms: Cardiomyopathy, Cerebrovascular accident, Coma, Myocarditis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of cardiomyopathy in a 6 year old male subject who was vaccinated with Diphtheria and tetanus toxoid and acellular pertussis vaccine (Infanrix), live attenuated MMR vaccine for prophylaxis. The subject had no relevant medical history. On 10/05/2005, the subject received unspecified dose of Infanrix (unk), unspecified dose of MMR vaccine (unknown), lots numbers not provided. On 10/16/2005, 11 days after vaccination with Infanrix and MMR vaccine, the subject was admitted at the intensive care unit in coma. Dilated myocardiopathy, myocarditis and acute cerebrovascular accident were diagnosed (bilateral cortical infarction with a probable embolic origin. Culture results were pending. The regulatory authority reported that the events were life threatening and clinically significant (or requiring intervention) (OMIC). On 11/14/05, the events were resolved with the following sequelae (Biopercular syndrome). The regulatory authority reported that the events were possibly related to vaccination with Infanrix and MMR vaccine. No additional information will be available and therefore the case has therefore been closed.

VAERS ID:263531 (history)  Vaccinated:2006-09-01
Age:6.0  Onset:2006-09-05, Days after vaccination: 4
Gender:Female  Submitted:2006-09-25, Days after onset: 20
Location:Foreign  Entered:2006-09-25
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: B0437977A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B024AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Henoch-Schonlein purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Vasculitis (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of Henoch Schonlein Purpura in a 6 year old female subject who was vaccinated with Dtap (Infanrix) for prophylaxis. On 9/1/06 the subject received unspecified dose of Infanrix IM, unk. On 9/5/06, 4 days after vaccination with Infanrix, The subject experienced Henoch Schonlein purpura. This case was assessed as medically serious by manufacturer (OMIC). Relevant test results included Immunoelectrophoresis, erythrocyte sedimentation rate, C reactive protein, pharangeal swab analysis, urine analysis, ultrasound of abdomen and kidney, immunoglobulin and complements (C3, C4). The results of the test were not provided. At the time of reporting the event was improved. The regulatory authority reported that the event was possibly related to vaccination with Infanrix.

VAERS ID:263565 (history)  Vaccinated:2006-09-03
Age:6.0  Onset:2006-09-03, Days after vaccination: 0
Gender:Male  Submitted:2006-09-22, Days after onset: 19
Location:Foreign  Entered:2006-09-26, Days after submission: 4
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:
Preexisting Conditions:
Diagnostic Lab Data: Lots of erythema spread around injection site which was swelling without ecchymosis, red throat and grade II enlargement in both tonsils attached with lots of pus, breath sound was hoarse 9/5/06, Body temp 9/3/06 39.4 C 9/4/06 38.8 C 9/5/06 39C 9/7/06 38.2C
CDC Split Type: WAES0609CHN00004
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Discomfort, Dysphonia, Erythema, Hypoaesthesia, Injection site erythema, Injection site oedema, Injection site pain, Pyrexia, Tonsillitis
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning a 6 year old male who at 15:00 of 9/3/06 was vaccinated with Pneumococcal 23v polysaccharide vaccine, 0.5ml, IM. there was no concomitant medication. At 19:00, the boy complained of discomfort and his body temperature was 39.4. he was treated with unspecified antipyretic by his parents. In the afternoon of 9/4/06, with his body temp measured as 38.8, the boy suffered from numbness of upper arm, pain in arm and red swelling arm. Since his symptoms did not alleviate, he was sent to clinic on 9/5/06. Meanwhile his body temp was 39 and he was hospitalized for further treatment. At time of reporting, the boys fever, discomfort, numbness of upper arm, pain in arm and red swelling are persisted. The reporter felt that fever, discomfort, numbness of upper arm, pain in arm red arm and swelling arm were definitely related to Pneumococcal 23v polysaccharide vaccine. Follow up information was received from the physician on 9/14/06 via detailed medical record. On 9/3/06, several hours after vaccination, the boy developed fever. Meanwhile, he did not experience sniveling, vomiting, diarrhea, pain in throat, headache, blood urine as well as twitching. On 9/5/06, the boy sought the doctor at clinic. Physical examination revealed injection site swelling, erythema spreading around without ecchymosis. The boy had a red throat. His both tonsils were in grade II enlargement cohering a sheet of pus. And his breath sound was hoarse. The responsible physician considered fever was caused by tonsillitis pyogenic. On the same day, the boy was hospitalized and placed on therapy with andrographolide, 80 mg, IV, QD, Benzylpenicillin sodium, 4800 thousands unit, IM, QD and metronidazole, 1/2 tablet, PO< tid. On 9/7/06, the boys body temp was measured as 38.2. On approx 9/10/06 the boy recovered from tonsillitis pyogenic, injection arm numbness, injection site pain as well as injection site red swelling and he was discharged from the hospital. The reporting physician felt that tonsillitis pyogenic injection arm numbness, injection site pain and injection site red swelling were definitely related to pneumococcal 23v polysaccharide vaccine. Additional information is not expected.

VAERS ID:268239 (history)  Vaccinated:2005-11-10
Age:6.0  Onset:0000-00-00
Gender:Unknown  Submitted:2006-12-04
Location:Foreign  Entered:2006-12-04
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: A0629499A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER3FV5323  UN
Administered by: Other     Purchased by: Other
Symptoms: Bronchospasm, Cough, Dyspnoea, Hypersensitivity, Respiratory disorder, Stridor
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of stridor in a 6 year old subject who was vaccinated with Fluviral for prophylaxis. On 11/10/05 the subject received unspecified dose of Fluviral unk. At an unspecified time on or before 11/14/05, after vaccination with Fluviral, the subject experienced stridor, allergic respiratory symptom, bronchospasm, cough and dyspnea. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the events were resolved.

VAERS ID:268255 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Female  Submitted:2006-12-04
Location:Foreign  Entered:2006-12-04
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: B0448949A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS   RA
Administered by: Other     Purchased by: Other
Symptoms: Coma, Fall, Headache, Loss of consciousness, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician (subject''s father) and described the occurrence of vasovagal malaise in a 6-year-old female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix pediatric) for prophylaxis. The subject had no relevant past medical history. Previously, all the vaccinations were well tolerated. She was not anxious. In 2006, the subject received a 1st dose of Twinrix pediatric (batch number not available), in a particular context: she was vaccinated the same day, after her brothers and sisters. Two minutes after vaccination, the subject presented with vasovagal malaise with loss of consciousness and fall. The events resolved quickly. Several days later, the subject developed decrease of responsiveness and headache. Electroencephalogram was normal. This case was assessed as medically serious. At the time or reporting (22 November 2006), the subject was in good health condition. The physician considered the events were probably related to vaccination with Twinrix pediatric. (OMIC)

VAERS ID:269435 (history)  Vaccinated:2006-07-19
Age:6.0  Onset:2006-07-20, Days after vaccination: 1
Gender:Female  Submitted:2006-12-20, Days after onset: 153
Location:Foreign  Entered:2006-12-20
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: B0449949A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blister, Cellulitis, Injection site erythema, Injection site inflammation, Injection site oedema, Injection site pain, Oedema
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of injection site inflammation in a 6-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix) for prophylaxis. On 19 July 2006 the subject received unspecified dose of Infanrix (intramuscular, right arm). On 20 July 2006, 1 day after vaccination with Infanrix, the subject experienced injection site inflammation and cellulitis with pain, redness, swelling, tumefaction and vesicles. The subject was hospitalized. The subject was treated with antibiotics (IV). At the time of reporting the events resolved. The regulatory authority reported that the events were almost certainly related to vaccination with Infanrix. No additional information will be available and this case has been closed.

VAERS ID:269436 (history)  Vaccinated:2006-11-06
Age:6.0  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? 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: B0449950A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14013BA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, Injection site inflammation, Injection site oedema, Type III immune complex mediated reaction
SMQs:, 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 arthus-type reaction in a 6-year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix) for prophylaxis. On 6 November 2006 the subject received unspecified dose of Infanrix (intramuscular, unknown). In November 2006, less than one month after vaccination with Infanrix, the subject experienced arthus-type reaction with injection site inflammation, induration, blush and tumefaction. The subject was hospitalized. At the time reporting the events were resolved. The regulatory authority reported that the events were almost certainly related to vaccination with Infanrix. No additional information will be available and this case has been closed.

VAERS ID:269955 (history)  Vaccinated:2006-11-09
Age:6.0  Onset:2006-11-11, Days after vaccination: 2
Gender:Female  Submitted:2007-01-02, Days after onset: 52
Location:Foreign  Entered:2007-01-02
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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: B0452006A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMRA
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Injection site inflammation
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of cellulitis in a 6 year old female subject who was vaccinated with Infanrix for prophylaxis. On 09 November 2006, the subject received unspecified dose of Infanrix (intramuscular, unknown injection site, lot number not provided). On 11 November 2006, 2 days after vaccination with Infanrix, the subject experienced cellulitis and inflammation at the injection site. 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 Infanrix. No further information is expected, the case had therefore been closed.

VAERS ID:270813 (history)  Vaccinated:2006-09-05
Age:6.0  Onset:2006-09-05, Days after vaccination: 0
Gender:Male  Submitted:2007-01-18, Days after onset: 135
Location:Foreign  Entered:2007-01-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0453662A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B028A IMLA
Administered by: Other     Purchased by: Other
Symptoms: Face oedema, Injection site oedema, Lip oedema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of urticarial eruption on face in a 6 year old male subject who was vaccinated with Infanrix for prophylaxis. On 5 September 2006, the subject received unspecified dose of Infanrix (intramuscular, unknown). On 5 September 2006, less than one day after vaccination with Infanrix, the subject experienced urticarial eruption on face and severe edema at injection site, face and lips. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with antihistamine and steroid (steroid unspecified). At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with Infanrix.

VAERS ID:271486 (history)  Vaccinated:2006-04-01
Age:6.0  Onset:2006-12-01, Days after vaccination: 244
Gender:Male  Submitted:2007-01-29, Days after onset: 59
Location:Foreign  Entered:2007-01-30, 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:
Current Illness: ASTHMA, RHINITIS
Preexisting Conditions: MENINGITIS VIRAL, MENINGITIS
Diagnostic Lab Data: CSF culture 00-Dec-2006 Streptococcus pneumoniae, 03-Jan-2007 no growth Culture throat 00-Dec-2006 positive for influenza type Streptococcal serology 28-Dec-2006 Streptococcus pneumonia serotype 6B in blood and CSF
CDC Split Type: HQWYE114102JAN07
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthma, Brain death, CSF test abnormal, Convulsion, Cough, Culture throat positive, Diabetes insipidus, Encephalocele, Headache, Inappropriate antidiuretic hormone secretion, Influenza, Meningitis pneumococcal, Meningitis viral, Mydriasis, Pupillary reflex impaired, Pyrexia, Rhinitis allergic, Rhinorrhoea, Sinusitis, Streptococcus serology positive, Vaccination failure, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Follow-up information was received that provided additional events, medical history, course of illness, treatment, event outcome and death date. This case was considered medically important for the events of influenza, sinusitis inappropriate antidiuretic hormone secretion and diabetes insipidus. Information regarding Prevnar was received from a pediatrician regarding an male patient who received the first dose in Apr-2006 at the age of 5 years. On 19-Dec-2006, at the age of 6 years, the child developed meningitis caused by Streptococcus pneumoniae serotype 63. On an unspecified date in Jan-2007, the patient died. In April-2006, the patient received a dose of Prevnar. On 19-Dec-2006, the child was hospitalized for headache, fever, rhinorrhea, mild cough and vomiting. The patient was initially diagnosed with paranasal sinusitis and allergic rhinitis. Treatment included Augmentin. Due to persistent fever, a throat culture was performed and was positive for influenza type B. On 25-Dec-2006, day 7 of hospitalization, the child experienced a sudden onset of severe headache and was transferred to the intensive care unit for conscious disturbance with pupil dilation and sluggish light reflex. On 28-Dec-2006, streptococcal serology of blood and cerebrospinal fluid samples revealed Streptococcus pneumoniae serotype 6B (vaccination failure) (meningitis pneumococcal). Treatment included vancomycin Claforan, erythromycin, acyclovir and Tamiflu, Mannitol, Decadron and Dilantin were used to treat seizure-like movement. On 03-Jan-2007. day 16 of hospitalization, a follow-up CSF culture showed no growth. On 04-Jan-2007, day 17 of hospitalization, the child was declared "brain" dead. On 06-Jan-2007, day 19 of hospitalization, a DNR was signed, and the parents agreed to have the patient decannulated. On 10-Jan-2007, the patient expired. The cause of death was not reported. Additional diagnoses included right maxillary sinusitis, craniopharyngeal canal with suspected encephalocele, diabetes insipidus and suspected syndrome of inappropriate antidiuretic hormone . See Relevant Tests/Laboratory Data: below. This report was received, reference number. No additional information was available at the time of this report.

VAERS ID:272056 (history)  Vaccinated:2007-01-08
Age:6.0  Onset:2007-01-08, Days after vaccination: 0
Gender:Male  Submitted:2007-02-09, Days after onset: 32
Location:Foreign  Entered:2007-02-09
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: B0456574A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B028AH IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased
SMQs:
Write-up: This case was reported by a regulatory authority and described the occurrence of decreased of injected limbs mobility in a 6 year old male subject who was vaccinated with Infanrix for prophylaxis. On 8 January 2007, the subject received unspecified dose of Infanrix (intramuscular, unknown injection site). On 8 January 2007, less than one day after vaccination with Infanrix, the subject experienced decrease of injected limb''s mobility. The subject was hospitalized. The subject was treated with Augmentin, Gentalyn and lasonil. At the time of reporting the event was unresolved. The regulatory authority reported that the event was possibly related to vaccination with Infanrix.

VAERS ID:272230 (history)  Vaccinated:2006-09-08
Age:6.0  Onset:2006-09-08, Days after vaccination: 0
Gender:Female  Submitted:2007-02-14, Days after onset: 159
Location:Foreign  Entered:2007-02-14
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: Electrocardiogram 08Sep2006 normal, Electroencephalogram 08Sep2006 normal
CDC Split Type: B0457452A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Electrocardiogram normal, Electroencephalogram normal, Hypotonia, Loss of consciousness, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of convulsion in a 6-year-old female subject who was vaccinated with Twinrix pediatric vaccine, Menjugate and Infanrix for prophylaxis. In 2002, when she was 18 months old, the subject received unspecified dose of Infanrix (unknown route and injection site), lot number not provided. In 2002, at an unspecified time after vaccination with Infanrix, the subject experienced loss of consciousness with general hypotonia and fever. On 8 September 2006, the subject received unspecified dose of Twinrix pediatric (10 ug/ml, intramuscular, unknown injection site), unspecified dose of Menjugate (intramuscular, unknown). The lot numbers were not provided. On 8 September 2006, less than one day after vaccination with Menjugate and Twinrix, the subject experienced convulsion. The subject was hospitalized. Electrocardiogram and Electroencephalogram performed were normal. On 8 September 2006, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with Twinrix pediatric and Menjugate.

VAERS ID:272378 (history)  Vaccinated:2007-02-01
Age:6.0  Onset:2007-02-01, Days after vaccination: 0
Gender:Male  Submitted:2007-02-15, Days after onset: 14
Location:Foreign  Entered:2007-02-15
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: Pulse rate 01Feb2007 80/min
CDC Split Type: B0457878A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B045AB IMUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic shock, Breast pain, Cough, Heart rate normal, Pallor, Pulse abnormal
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Lipodystrophy (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 6-year-old male subject who was vaccinated with Infanrix for prophylaxis. Concurrent vaccination included live attenuated MMR vaccine (non-manufacturer) given on 1 February 2007. On 1 February 2007 the subject received unspecified dose of Infanrix (intramuscular, left deltoid). On 1 February 2007, less than one day after vaccination with Infanrix, the subject experienced anaphylactic shock, decreased peripheral pulse, breast pain, dry cough and pallor. The subject was hospitalized. The subject was treated with adrenaline and betamethasone. Relevant test results after adrenaline treatment included heart rate 80/min. At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with Infanrix.

VAERS ID:272794 (history)  Vaccinated:2006-09-01
Age:6.0  Onset:2007-02-07, Days after vaccination: 159
Gender:Male  Submitted:2007-02-20, Days after onset: 13
Location:Foreign  Entered:2007-02-21, 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: NONE
Current Illness: Decreased immune responsiveness
Preexisting Conditions: Pneumonectomy
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA02893
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature, Immune system disorder, Inappropriate schedule of drug administration, Oedema peripheral, Pain in extremity, Tonsillitis
SMQs:, Cardiac failure (broad), Agranulocytosis (broad), Angioedema (broad), Oropharyngeal infections (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a consumer concerning a 6 year old male with "low immune system" and a history of lobectomy who in September 2006, was vaccinated with a first dose of Pneumovax 23 vaccine. On 7-FEB-2007, the patient was vaccinated with the second dose of Pneumovax 23 vaccine. It was reported that the second dose of Pneumovax 23 vaccine. It was reported that the patient was revaccinated as the first vaccination "did not take". On 07-FEB-2007, the patient experienced tonsillitis, swollen and painful arm from the shoulder to elbow, and had a temperature. The patient was taken to the hospital and was prescribed flucloxacillin and penicillin V for the arm and the suspected tonsillitis. The patient was admitted to the hospital due to his low immune system. At the time of the reporting, the patient had not recovered. Tonsillitis, swollen arm from the shoulder to the elbow, injection site reaction and temperature were considered other important medical events. Manufacturer numbers included E2007-00993 and 50531. Additional information is expected.

VAERS ID:272799 (history)  Vaccinated:2007-02-07
Age:6.0  Onset:2007-02-08, Days after vaccination: 1
Gender:Male  Submitted:2007-02-21, Days after onset: 13
Location:Foreign  Entered:2007-02-21
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: B0458266A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B037BE  RA
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, Injection site inflammation, Injection site oedema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of injection site inflammation in a 6-year-old male subject who was vaccinated with Infanrix for prophylaxis. This case is one out of 7 cases from the same reporter. On 7 February 2007, the subject received unspecified dose of Infanrix (unknown). On that day, 40 children were vaccinated. On 08 February 2007, one day after vaccination with Infanrix, the subject developed an injection site inflammation with induration and edema, as well as fever. This case was assessed as medically serious (clinically significant or required intervention) due to the fact that the events were very flashy. At the time of reporting, the outcome of the events was unspecified. The pharmacist considered the events were possibly related to vaccination with Infanrix. No further information could be obtained, this case has therefore been closed.

VAERS ID:272800 (history)  Vaccinated:2007-02-09
Age:6.0  Onset:2007-02-09, Days after vaccination: 0
Gender:Female  Submitted:2007-02-21, Days after onset: 12
Location:Foreign  Entered:2007-02-21
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: B0458282A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B037BE  RA
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, Injection site oedema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of injection site induration in a 6 year old female subject who was vaccinated with Infanrix for prophylaxis. This case id one out of 7 cases from the same reporter. On 9 February 2007, the subject received unspecified dose of Infanrix (unknown, unknown thigh). On that day, 100 children were vaccinated, 6 of them experienced some events. On 9 February 2007, the same day that she was vaccinated with Infanrix, the subject developed a massive edema with induration at the injection site from the gluteus to the groin, as well as fever. This case was assessed as medically serious (clinically significant or required intervention) due to the fact that the events were very flashy. At the time of reporting the outcome of the events were unspecified. The pharmacist considered the events were possibly related to vaccination with Infanrix. No further information is available, this case has therefore been closed.

VAERS ID:272801 (history)  Vaccinated:2007-02-09
Age:6.0  Onset:2007-02-09, Days after vaccination: 0
Gender:Female  Submitted:2007-02-21, Days after onset: 12
Location:Foreign  Entered:2007-02-21
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: B0458315A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B037BE  RA
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, Injection site oedema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of injection site induration in a 6 year old female subject who was vaccinated with Infanrix for prophylaxis. This case is one out of 7 cases from the same reporter. On 9 February 2007, the subject received unspecified dose of Infanrix (unknown, unknown thigh). On that day, 100 children were vaccinated, 6 of them experienced some events. On 9 February 2007, the same day that she was vaccinated with Infanrix, the subject developed a massive edema with induration at the injection site from the gluteus to the groin, as well as fever. This case was assessed as medically serious (clinically significant or required intervention) due to the fact that the events were very flashy. At the time of reporting the outcome of the events were unspecified. The pharmacist considered the events were possibly related to vaccination with Infanrix. No further information is available, this case has therefore been closed.

VAERS ID:272806 (history)  Vaccinated:2006-12-18
Age:6.0  Onset:2006-12-19, Days after vaccination: 1
Gender:Female  Submitted:2007-02-21, Days after onset: 64
Location:Foreign  Entered:2007-02-21
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: Body temperature 19Dec2006 38.6 deg C, body temperature 19Dec2006 39.9 deg C.
CDC Split Type: D0052327A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  IMRA
Administered by: Other     Purchased by: Other
Symptoms: Body temperature fluctuation, Chest pain, Cough, Headache, Hyperpyrexia, Pain in extremity, Pneumonia, Poor peripheral circulation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of pneumonia in 6-year-old female subject who was vaccinated with Influsplit SSW 2006/2007 for prophylaxis. The Regulatory Authority has received the case by an unknown phyisican. The subject has no underlying or concurrent medical conditions or other risk factor. the subject received no concomitant medication. Previous vaccination with Influsplit SSW 2006/2007 was well tolerated. On 18 December the subject received an unspecified dose of Influsplit SSW 2006/2007 (0.5 ml, intramuscular, unknown). Approximately one day post vaccination with Influsplit SSW 2006/2007, on 19 December 2006, the subject experienced hyperpyrexia (103.8 degrees F - 101.4 degrees F), severe headache, unstable circulation, and generalized pain in extremities. Approximately three days post vaccination with Influsplit SSW 2006/2007, on 21 December 2006, the subject experienced pneumonia with cough and thoracic pain left basal. This case was assessed as medically serious. The subject was treated with antipyretic and fluid therapy (unspecified) (Fluid). Since 21 December 2006 the subject received antibiotics for the treatment of pneumonia. After four days, on 22 December 2006, the events were resolved. No further information will be available.

VAERS ID:272906 (history)  Vaccinated:2007-02-09
Age:6.0  Onset:2007-02-09, Days after vaccination: 0
Gender:Male  Submitted:2007-02-22, Days after onset: 13
Location:Foreign  Entered:2007-02-22
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: B0458275A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B037BE  LA
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, Injection site oedema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of injection site induration in a 6 year old male subject who was vaccinated with Infanrix for prophylaxis. This case is one out of 7 cases from the same reporter. On 9 February 2007, the subject received unspecified dose of Infanrix (unknown, unknown thigh). On that day, 100 children were vaccinated, 6 of them experienced some events. On 09 February 2007, the same day that he was vaccinated with Infanrix, the subject developed a massive edema with induration at the injection site from the gluteus to the groin, as well as fever. This case was assessed as medically serious (clinically significant or required intervention) due to the fact that the events were very flashy. At the time of reporting the outcome of the events was unspecified. The pharmacist considered the events were possibly related to vaccination with Infanrix. No further information is available, this case has therefore been closed.

VAERS ID:272907 (history)  Vaccinated:2007-02-08
Age:6.0  Onset:2007-02-09, Days after vaccination: 1
Gender:Male  Submitted:2007-02-22, Days after onset: 13
Location:Foreign  Entered:2007-02-22
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: B0458269A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B037BE  LA
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, Injection site oedema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of injection site induration in a 6-year-old male subject who was vaccinated with Infanrix for prophylaxis. This case is one out of 7 cases from the same reporter. On 8 February 2007, the subject received unspecified dose of Infanrix (unknown, unknown thigh). On that day, 100 children were vaccinated, 6 of them experienced some events. On 09 February 2007, one day after vaccination with Infanrix, the subject developed a massive edema with induration at the injection site from the gluteus to the groin, as well as fever. This case was assessed as medically serious (clinically significant or required intervention), due to the fact that the events were very flashy. At the time of reporting the outcome of the events was unspecified. The pharmacist considered the events were possibly related to vaccination with Infanrix. No further information is available, this case has therefore been closed.

VAERS ID:272908 (history)  Vaccinated:2007-02-09
Age:6.0  Onset:2007-02-09, Days after vaccination: 0
Gender:Male  Submitted:2007-02-22, Days after onset: 13
Location:Foreign  Entered:2007-02-22
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: B0458268A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B037BE  LA
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, Injection site oedema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of injection site induration in a 6-year-old male subject who was vaccinated with Infanrix for prophylaxis. This case is one out of 7 cases from the same reporter. On 8 February 2007, the subject received unspecified dose of Infanrix (unknown, unknown thigh). On that day, 100 children were vaccinated, 6 of them experienced some events. On 09 February 2007, the same day that he was vaccinated with Infanrix, the subject developed a massive edema with induration at the injection site from the gluteus to the groin, as well as fever. This case was assessed as medically serious (clinically significant or required intervention) due to the fact that the events were very flashy. At the time of the outcome was unspecified. The pharmacist considered the events were possibly related to vaccination with Infanrix. No further information is available, this case has therefore been closed.

VAERS ID:272909 (history)  Vaccinated:2007-02-07
Age:6.0  Onset:2007-02-09, Days after vaccination: 2
Gender:Male  Submitted:2007-02-22, Days after onset: 13
Location:Foreign  Entered:2007-02-22
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: B0458267A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B037BE  LA
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, Injection site oedema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of injection site induration in a 6-year-old male subject who was vaccinated with Infanrix for prophylaxis. This case is one out of 7 cases from the same reporter. On 8 February 2007, the subject received unspecified dose of Infanrix (unknown, unknown thigh). On that day, 100 children were vaccinated, 6 of them experienced some events. On 09 February 2007, the same day that he was vaccinated with Infanrix, the subject developed a massive edema with induration at the injection site from the gluteus to the groin, as well as fever. This case was assessed as medically serious (clinically significant or required intervention) due to the fact that the events were very flashy. At the time of the outcome was unspecified. The pharmacist considered the events were possibly related to vaccination with Infanrix. No further information is available, this case has therefore been closed

VAERS ID:273798 (history)  Vaccinated:2006-11-01
Age:6.0  Onset:2006-11-24, Days after vaccination: 23
Gender:Male  Submitted:2007-03-09, Days after onset: 105
Location:Foreign  Entered:2007-03-12, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0703USA00871
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis
SMQs:
Write-up: Information has been received from a health authority concerning a 6-year-old male who in November 2006, was vaccinated subcutaneously with MMR II. On 24-Nov-2006, the patient experienced cellulitis and was hospitalized. The event was considered "medically relevant." Subsequently on 07-DEC-2006, the patient recovered from cellulitis. Other business partner numbers included: E2007-01398.

VAERS ID:274061 (history)  Vaccinated:2007-02-14
Age:6.0  Onset:2007-02-14, Days after vaccination: 0
Gender:Male  Submitted:2007-03-16, Days after onset: 29
Location:Foreign  Entered:2007-03-16
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: B0461103A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B058DE IM 
Administered by: Other     Purchased by: Other
Symptoms: Injection site rash, Injection site reaction
SMQs:, Hypersensitivity (narrow)
Write-up: The case was reported by a regulatory authority and described the occurrence of injection site rash in a 6-year-old male subject who was vaccinated with Infanrix for prophylaxis. Previous and/or concurrent vaccination included MMR II (new strain) (manufacturer unspecified) given on an unspecified date. On 14 February 2007 the subject received unspecified dose of Infanrix (intramuscular). On 14 February 2007, less than one day after vaccination with Infanrix, the subject experienced injection site rash and injection site reaction. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved.

VAERS ID:274351 (history)  Vaccinated:2007-02-21
Age:6.0  Onset:2007-02-26, Days after vaccination: 5
Gender:Female  Submitted:2007-03-19, Days after onset: 20
Location:Foreign  Entered:2007-03-19
Life Threatening? Yes
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: B0461867A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMRA
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Cold compress therapy, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by regulatory authority and described the occurrence of cellulitis in a 6-year-old female subject who was vaccinated with Infanrix for prophylaxis. On 21 February 2007 the subject received unspecified dose of Infanrix (intramuscular, unknown gluteal). On 26 February 2007, 1 day after vaccination with Infanrix, the subject experienced cellulitis, injection site inflammation with pain, blush and induration of 6 cm. the subject required hospitalization due to cellulitis. The subject was treated anti-inflammatory and local cold application before being hospitalised. The regulatory authority reported that the events were life threatening. At the time of reporting the events were unresolved. The regulatory authority reported that the events were possibly related to vaccination with Infanrix. No further information is expected as this is the only information that the regulatory authority has, therefore this case has been closed.

VAERS ID:274441 (history)  Vaccinated:2006-09-20
Age:6.0  Onset:2007-02-07, Days after vaccination: 140
Gender:Male  Submitted:2007-03-20, Days after onset: 40
Location:Foreign  Entered:2007-03-21, 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: Diprobase, Oilatum emollient, acetaminophen, albuterol, Carbamazepine, fluticasone propionate (+) salmeterol XI, ibuprofen, lactulose, topiramate.
Current Illness: Decreased immune responsiveness; Asthma; Emphysema
Preexisting Conditions: Lung lobectomy; Infection
Diagnostic Lab Data: UNK
CDC Split Type: WAES0703USA02428
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1075P IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Injection site reaction, Joint injury, Oedema peripheral, Pain in extremity, Pyrexia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health professional concerning a 6 year old male patient with a low immune system, emphysema (with numerous hospitalizations for infections) and asthma and a history of lung lobectomy at 6 weeks old who on 20-SEP-2006 was vaccinated with his first dose of Pneumococcal 23v polysaccharide vaccine. On 07-FEB-2007 the patient was vaccinated IM in left arm with a booster dose of Pneumovax, lot #651522/1075P, batch NC66530 (it was reported that the first vaccination did not take and that an immunology work up showed that 6 out of the 7 serotypes were low). Concomitant therapy included Lactulose, fluticasone propionate (+) Salmeterol Xinafoate, mineral oil (DIPROBASE), albuterol, carbamazepine, topiramate, lanolin alcohols (+) mineral oil (IOLATUM EMOLLIENT), ibuprofen and acetaminophen. On 07-FEB-2007, the same day as the vaccination, the patient developed a swollen left arm from shoulder to elbow that was painful on movement, and also had a temperature. The patient was taken to the hospital and was prescribed Flucloxacillin and Penicillin for the arm and suspected tonsillitis. The patient was admitted to the hospital due to his low immune system. The hospital suspected that the patient had pulled his elbow whilst being injected, however the final description of the adverse event was an injection site reaction. The events were described as severe. On 10-FEB-2007 the patient recovered. The reporter felt that swollen arm, pyrexia and injection site reaction were very likely to be related to therapy with Pneumovax. Swollen arm, pyrexia, and injection site reaction were considered to be other important medical events. This was originally reported by a consumer. No further information is available. Other business partner numbers included E2007-00993.

VAERS ID:276200 (history)  Vaccinated:2007-02-09
Age:6.0  Onset:2007-02-09, Days after vaccination: 0
Gender:Male  Submitted:2007-04-12, Days after onset: 61
Location:Foreign  Entered:2007-04-12
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: B0465950A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site inflammation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of injection site inflammation in a 6-year-old male subject who was vaccinated with Infanrix for prophylaxis. On 9 February 2007 the subject received unspecified dose of Infanrix (intramuscular, unknown). The vaccine batch number was not provided. On 09 February 2007, the same day after vaccination with Infanrix, the subject experienced injection site inflammation and fever. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with Infanrix. No further information is expected as this is the only information that authorities had therefore this case has been closed.

VAERS ID:276201 (history)  Vaccinated:2007-02-09
Age:6.0  Onset:2007-02-09, Days after vaccination: 0
Gender:Male  Submitted:2007-04-12, Days after onset: 61
Location:Foreign  Entered:2007-04-12
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: B0465949A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site inflammation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of injection site inflammation in a 6-year-old male subject who was vaccinated with Infanrix for prophylaxis. On 9 February 2007 the subject received unspecified dose of Infanrix (intramuscular, unknown). The vaccine batch number was not provided. On 9 February 2007, 1 day after vaccination with Infanrix, the subject experienced injection site inflammation and fever. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with Infanrix. No further information is expected as this is the only information that authorities had therefore this case has been closed.

VAERS ID:276202 (history)  Vaccinated:2007-02-08
Age:6.0  Onset:2007-02-09, Days after vaccination: 1
Gender:Male  Submitted:2007-04-12, Days after onset: 61
Location:Foreign  Entered:2007-04-12
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: B0465947A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site inflammation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of injection site inflammation in a 6-year-old male subject who was vaccinated with Infanrix for prophylaxis. On 8 February 2007 the subject received unspecified dose of Infanrix (intramuscular, unknown). The vaccine batch number was not provided. On 9 February 2007, 1 day after vaccination with Infanrix, the subject experienced injection site inflammation and fever. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with Infanrix. No further information is expected as this is the only information that authorities had therefore this case has been closed.

VAERS ID:276298 (history)  Vaccinated:2007-02-09
Age:6.0  Onset:2007-02-09, Days after vaccination: 0
Gender:Female  Submitted:2007-04-13, Days after onset: 62
Location:Foreign  Entered:2007-04-13
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: Unknown
CDC Split Type: B0465995A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, Injection site inflammation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of injection site inflammation in a 6-year-old female subject who was vaccinated with Infanrix for prophylaxis. On 9 February 2007 the subject received unspecified dose of Infanrix (intramuscular, unknown). The vaccine batch number was not provided. On 9 February 2007, the same day after vaccination with Infanrix, the subject experienced injection site inflammation, serious induration and fever. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with Infanrix. No further information is expected at as this is the only information that the foreign authorities had therefore this case has been closed.

VAERS ID:276747 (history)  Vaccinated:2007-02-09
Age:6.0  Onset:2007-02-09, Days after vaccination: 0
Gender:Male  Submitted:2007-04-18, Days after onset: 67
Location:Foreign  Entered:2007-04-18
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: B0465944A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site inflammation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority (Foreign Regulatory Authority (clinical) # 721495232) and described the occurrence of injection site inflammation in a 6-year-old male subject who was vaccinated with Infanrix for prophylaxis. On 9 February 2007, the subject received unspecified dose of Infanrix (intramuscular, unknown injection site), lot number not provided. On 9 February 2007, less than one day after vaccination with Infanrix, the subject experienced injection site inflammation and fever. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with Infanrix. No further information is expected as this is the only information that the foreign regulatory authority has. This case has therefore been closed.

VAERS ID:276748 (history)  Vaccinated:2007-02-09
Age:6.0  Onset:2007-02-09, Days after vaccination: 0
Gender:Female  Submitted:2007-04-18, Days after onset: 67
Location:Foreign  Entered:2007-04-18
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: B0465961A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site inflammation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of injection site inflammation in a 6-year-old female subject who was vaccinated with Infanrix, for prophylaxis. On 9 February 2007, the subject received unspecified dose of Infanrix (intramuscular, unknown injection site), lot number not provided. On 9 February 2007, less than one day after vaccination with Infanrix, the subject experienced injection site inflammation and fever. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with Infanrix. No further information is expected as this is the only information that the foreign regulatory authority has. This case has therefore been closed.

VAERS ID:276749 (history)  Vaccinated:2007-02-09
Age:6.0  Onset:2007-02-09, Days after vaccination: 0
Gender:Female  Submitted:2007-04-18, Days after onset: 67
Location:Foreign  Entered:2007-04-18
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: B0465996A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site inflammation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of injection site inflammation in a 6-year-old female subject who was vaccinated with Infanrix for prophylaxis. On 9 February 2007, the subject received unspecified dose of Infanrix (intramuscular, unknown injection site), lot number not provided. On 9 February 2007, less than one day after vaccination with Infanrix, the subject experienced injection site inflammation and fever. The regulatory authority reported the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with Infanrix. No further information is expected as this is the only information that the foreign regulatory authority has. This case has therefore been closed.

VAERS ID:277641 (history)  Vaccinated:2007-04-12
Age:6.0  Onset:2007-04-18, Days after vaccination: 6
Gender:Female  Submitted:2007-04-30, Days after onset: 12
Location:Foreign  Entered:2007-04-30
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: D0053089A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37BC24CA  UN
Administered by: Other     Purchased by: Other
Symptoms: Electroencephalogram, Febrile convulsion
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of febrile convulsion seizure in 6-year-old female subject who was vaccinated with Boostrix, for prophylaxis. Previous vaccination included the first dose of Boostrix polio, given on 16 February 2007. On 12 April 2007 the subject received a dose of Boostrix (0.5 ml, unknown) as second dose. Approximately six days post vaccination with Boostrix, on 18 April 2007 at 12:15, the subject experienced febrile convulsion seizure, reported as febrile petit-mal state, for about 30 minutes. The subject was hospitalised for an unknown period of time. The event was confirmed by electroencephalogram (EEG). Epilepsy was excluded. The event was resolved on 18 April 2007. The vaccination course with Boostrix was discontinued. No further information will be available.

VAERS ID:278377 (history)  Vaccinated:2007-04-23
Age:6.0  Onset:2007-04-24, Days after vaccination: 1
Gender:Male  Submitted:2007-05-09, Days after onset: 15
Location:Foreign  Entered:2007-05-11, 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: None reported.
Diagnostic Lab Data:
CDC Split Type: E200702705
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURC2675A IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cold compress therapy, Erythema, Induration, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case initially received on 27-Apr-07. It was reported by a sales representative, that a physician observed an adverse effect after vaccination with COVAXIS. It was reported that a 6-year-old male patient was vaccinated into the right deltoid muscle with a booster dose of Covaxis (lot# C2675AA) on 23-Apr-07. On 24-Apr-07 he experienced redness, swelling and painful induration concerning the whole upper arm, including elbow and shoulder. Local cooling and Rivanol compresses were administered. On 04-May-07 we contacted the reporter by phone. On 26-Apr-07 symptoms had remarkably improved. The boy recovered completely, exact duration not reported ("few days"). FILE CLOSED.

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