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Found 596268 cases in entire database

Case Details (Sorted by Age)

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VAERS ID:202349 (history)  Vaccinated:2003-03-27
Age:4.0  Onset:2003-03-27, Days after vaccination: 0
Gender:Female  Submitted:2003-04-28, Days after onset: 31
Location:Foreign  Entered:2003-04-30, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: B0297457A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS1456469 IM 
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERSR6YE PO 
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALS519A43A IM 
Administered by: Other     Purchased by: Other
Symptoms: Coma, Disorientation, Heart rate decreased, Listless, Pallor, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of feeling vague, pallor, listless, vomiting, weak pulse, unresponsive to stimuli in a 4 year old female who received MMR vaccine, strain not specified injection as routine immunization. Co-suspect medication included Infanrix, Poliomyelitis vaccine live oral. After the second injection, the patient became very pale, vague, listless, vomited, became unresponsive, peripheral pulse weak, effectively rested and was given oxygen therapy for 40 minutes. The events resolved.

VAERS ID:202520 (history)  Vaccinated:0000-00-00
Age:4.0  Onset:2003-03-21
Gender:Male  Submitted:2003-04-30, Days after onset: 39
Location:Foreign  Entered:2003-05-05, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: UNK
CDC Split Type: WAES0304USA02442
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abnormal behaviour, Aggression
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (narrow)
Write-up: Information has been received from a health authority concerning a 4 year old male with no relevant history reported, who was vaccinated on an unknown date with a dose of MMR II. It was reported that following vaccination, on 3/21/03, the pt became aggressive. He was reported to be "hitting out and very naughty." It was also reported that the pt had not recovered. The pt became aggressive was considered to be an other important medical event (OMIC). No further info is expected. Case to be considered as closed.

VAERS ID:203524 (history)  Vaccinated:2003-04-03
Age:4.0  Onset:2003-04-04, Days after vaccination: 1
Gender:Male  Submitted:2003-05-20, Days after onset: 45
Location:Foreign  Entered:2003-05-22, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0299441A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14549A9 IM 
Administered by: Other     Purchased by: Other
Symptoms: Ecchymosis, Pain, Rash, Skin disorder
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (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 ecchymosis, pain, localized skin reaction, rash in a 4 year old male who took Infanrix for the treatment of routine immunization. Time to onset for the events was the next day and at the time of reporting the pt was recovering. This case was considered serious (OMIC).

VAERS ID:203581 (history)  Vaccinated:2003-04-03
Age:4.0  Onset:2003-04-05, Days after vaccination: 2
Gender:Female  Submitted:2003-05-21, Days after onset: 45
Location:Foreign  Entered:2003-05-23, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0300011A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS211A9   
Administered by: Other     Purchased by: Other
Symptoms: Meningitis
SMQs:, Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This report was received from a foreign authority and describes the occurrence of a serous meningitis in a 4 year old girl receiving hepatitis A hepatitis B vaccine for prophylaxis. On 4/3/03, a dose of Twinrix (lot #HAB211A9) was given. On 4/5/03, 2 days after vaccination, the girl developed a serous meningitis. As of 4/8/03, at the time of this report to the authorities, she had not yet recovered. The reporter did not assess a causal relationship. This case was considered serious by GSK physician (OMIC). Additional information has been requested. Follow up on 09/17/2003: "No additional information could be obtained and this case has therefore been closed."

VAERS ID:203788 (history)  Vaccinated:2002-06-03
Age:4.0  Onset:2002-06-03, Days after vaccination: 0
Gender:Female  Submitted:2003-05-14, Days after onset: 345
Location:Foreign  Entered:2003-05-28, Days after submission: 14
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: UNK
CDC Split Type: A0372358A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS538A2 IMLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site induration, Injection site oedema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: The medical history, concurrent conditions and concurrent medications were not provided. On 06/03/2002, the vaccinee received an injection of Infanrix. The number of previous injections of Infanrix was not reported. Sometime after the injection, she developed an injection site reaction characterized by a "baseball size" area of swelling that was hot and hard. The outcomes of these events were not reported. The reporter considered these events to be related to Infanrix administration.

VAERS ID:205255 (history)  Vaccinated:2002-11-01
Age:4.0  Onset:2002-11-02, Days after vaccination: 1
Gender:Male  Submitted:2003-06-20, Days after onset: 229
Location:Foreign  Entered:2003-06-23, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: Blood test-no sign of infection.
CDC Split Type: B0301625A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS1454969 IM 
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALS1454969 IM 
Administered by: Other     Purchased by: Other
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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 erythema in a 4 year old male pt who received Infanrix injection for routine immunization. Overwhelming erythema of upper limb and shoulder. Blood tests showed no evidence of infection. On 11/1/02 the pt received Infanrix (IM). Approximately 1 day after receiving Infanrix-Hib, on 11/2/02, the pt experienced erythema. The pt was hospitalized.

VAERS ID:205259 (history)  Vaccinated:2003-05-12
Age:4.0  Onset:0000-00-00
Gender:Female  Submitted:2003-06-19
Location:Foreign  Entered:2003-06-23, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0301978A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DPP: DIPHTHERIA TOXOID + PERTUSSIS + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER14564F9 IM 
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALS553A41R IM 
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER5127AJ PO 
Administered by: Other     Purchased by: Other
Symptoms: Erythema multiforme, Rash
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 4 year old female pt who had Priorix (MMR, new strain) injection for routine immunization. Concurrent medications included Poliomyelitis vaccine and Diphtheria, tetanus and pertussis vaccine. On 5/12/03 the pt received Priorix IM. At an unknown time after Priorix, the pt experienced possible erythema multiforme with a non-specific viral rash and target lesions of the feet. The regulatory authority reported that the events were clinically significant (OMIC) (or requiring intervention). The outcome of the events is unknown.

VAERS ID:205280 (history)  Vaccinated:0000-00-00
Age:4.0  Onset:0000-00-00
Gender:Male  Submitted:2003-06-19
Location:Foreign  Entered:2003-06-24, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: UNK
CDC Split Type: WAES0306USA01949
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0782H   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Autism
SMQs:
Write-up: Information has been received from a health authority concerning a 4 year old male patient, with no relevant medical history reported, who was vaccinated with a dose of MMR (second generation) (lot # 627695/0782H; batch # HH50280). According to the patient''s parents the patient had severe autism which began two weeks (reported elsewhere as two years) after the patient received MMR (second generation). Further information has been requested. Case to remain open. Autism was considered to be an important medical event (OMIC). Follow up information received on 08/22/2003: "Follow up information on 08/11/2003 reported by the Health Authority clarified that the onset of the adverse reaction was 2 weeks, not 2 years after the MMRII vaccination. Case is closed. Autism was considered to be an important medical event. Other business partner numbers include E2003-00992."

VAERS ID:205794 (history)  Vaccinated:2003-06-09
Age:4.0  Onset:0000-00-00
Gender:Male  Submitted:2003-07-01
Location:Foreign  Entered:2003-07-03, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0303072A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14564F93IM 
Administered by: Other     Purchased by: Other
Symptoms: Oedema peripheral, Skin disorder
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a nurse and described the occurrence of swelling arm in a 4 year old male pt who had Infanrix injection. On previous exposure, Infanrix was well tolerated, but the child has developed previous site reactions to DTP vaccinations. On 6/9/03 the pt received a fourth dose of Infanrix IM. Within 24 hours of receiving Infanrix, the pt experienced swelling arm and skin induration. The events improved. The events were considered medically serious (OMIC) by a physician.

VAERS ID:208474 (history)  Vaccinated:2003-07-25
Age:4.0  Onset:2003-07-25, Days after vaccination: 0
Gender:Male  Submitted:2003-08-27, Days after onset: 33
Location:Foreign  Entered:2003-08-28, 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: NONE
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0307449A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Contusion, Injection site erythema
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of injection site redness in a 4 year old male patient who had received Infanrix injection. No concurrent medication. On 7/25/03 the patient received Infanrix (IM) at 0.5ml. On the say day, the patient experienced injection site redness which affected half of the upper arm, followed by bruising appearance. The regulatory authority reported that the events were clinically significant (or requiring intervention) (OMIC). The events resolved.

VAERS ID:208761 (history)  Vaccinated:2003-08-18
Age:4.0  Onset:2003-08-18, Days after vaccination: 0
Gender:Female  Submitted:2003-08-29, Days after onset: 11
Location:Foreign  Entered:2003-09-04, Days after submission: 6
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: B0307651A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER  PO 
Administered by: Other     Purchased by: Other
Symptoms: Conjunctivitis, Erythema multiforme, Eye oedema, Headache, Pyrexia, Rash erythematous, Skin ulcer, Stevens-Johnson syndrome
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Conjunctival disorders (narrow), Ocular infections (broad), 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 possible Stevens Johnson Syndrome in a 4 year old female patient who had received Priorix injection. Co-suspect medication included Infanrix and Oral Polio vaccine. On 8/18/03 the patient received Priorix (IM). Approximately 12 hours after receiving Priorix the patient experienced possible Stevens Johnson Syndrome, possible erythema multiforme, puffy eyes, headache, erythemic rash, mucosal lesions, conjunctivitis and fever. The outcome of the events is unknown. The patient has no history of allergic reactions. The case was considered serious (OMIC).

VAERS ID:209111 (history)  Vaccinated:2003-08-20
Age:4.0  Onset:2003-08-23, Days after vaccination: 3
Gender:Unknown  Submitted:2003-09-08, Days after onset: 16
Location:Foreign  Entered:2003-09-11, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: UNK
CDC Split Type: WAES0309USA00170
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.HS46040   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dermatitis contact, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health professional concerning an approximately 4 year old child who on 8/20/03 was vaccinated with the first dose of MMR (second generation) (batch # HS 46040). It was reported that 3 days later everywhere except from the patient''s face came out in what looked like dermatitis, skin was peeling/exfoliation. The outcome of the reaction was not reported. File to be completed. The patient''s dermatitis and skin peeling/exfoliation was considered to be an other important medical event. Further information is requested. Follow up on 10/01/2003: "Upon follow up, it was reported that "on possible vaccine relationship. The reporter did not consider the reaction to be serious. No treatment was given. It was confirmed on 09/18/2003 that the date of recovery of symptoms was 09/10/2003." The case is closed. The patient''s dermatitis and skin peeling/exfoliation was considered to be an other important medical event (OMIC). Other company numbers E2003-02033. Additional information is not expected." Follow up on 09/17/2003: "It was reported that 3 days later everywhere exept from the patient''s face came out in what looked like dermatitis, skin was peeling/exfoliation". The outcome of the reaction was not reported. File to be completed. The patient''s dermatitis and skin peeling/exfoliation was considered to be an other important medical event. (OMIC). Other company numbers E2003-02033. Futher information requested."

VAERS ID:209113 (history)  Vaccinated:2003-08-21
Age:4.0  Onset:2003-08-21, Days after vaccination: 0
Gender:Male  Submitted:2003-09-08, Days after onset: 18
Location:Foreign  Entered:2003-09-11, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: Body temp: 37.5 deg 8/24/03-high
CDC Split Type: WAES0308CHN00017
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dermatitis, Pyrexia, Rash, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from an agency officer concerning a 4 year old Asian male who at 4 PM on 8/21/03 was vaccinated IM with a 0.5 ml dose of MMR (second generation). At 6 PM on 8/21/03, the boy developed skin rash. On 8/23/03, the boy was placed on therapy with ascorbic acid, chlorpheniramine maleate and clarithromycin for the treatment of skin rash. On 8/24/03, the boy was hospitalized with the diagnosis of exfoliative dermatitis. Subsequently, the dermatitis extended to whole body skin. Especially the exduation appeared on the subaxillary and inguinal region. The skin around mouth appeared epidermolysis and whole auricular skin was vesicular. At that time, his body temperature increased to 37.5. The reporter felt that exfoliative dermattis was probably related to vaccination with MMR (second generation). As of the time of reporting the boy''s exfoliative dermatitis was recovering. Additional information has been requested. Follow up information received on 09/30/2003: "Follow up information has been received on 09/18/2003. On 09/08/2003, the boy recovered from exfoliative dermatitis and was discharged from the hospital. Additional information is not expected."

VAERS ID:209149 (history)  Vaccinated:2003-01-15
Age:4.0  Onset:2003-01-17, Days after vaccination: 2
Gender:Female  Submitted:2003-09-09, Days after onset: 234
Location:Foreign  Entered:2003-09-12, 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:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0308335A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14569A9 IM 
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site rash, Injection site warmth, Pruritus, 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 describes the occurrence of cellulitic type skin reaction in a 4 year old female pt who had administered Infanrix injection for routine immunization. On 1/15/03 the pt received Infanrix IM at 0.5ml. Approximately two days after discontinuing Infanrix, on 1/17/03, the pt experienced cellulitic type skin reaction, injection site rash, large red swelling of top of arm following injection and redness and warming of injection site. The event of cellulitic type skin reaction was considered to be potentially medically serious (OMIC). The pt was treated with Erythromycin ethyl succinate and Chlorpheniramine maleate. The events resolved. The reporter noted large red swelling of top of arm from injection site, hot to touch, looked cellulitic. Redness resolved, but then itchy urticarial rash in same area. The reporter did not consider the reaction to be serious.

VAERS ID:209669 (history)  Vaccinated:2003-08-05
Age:4.0  Onset:2003-08-05, Days after vaccination: 0
Gender:Female  Submitted:2003-09-25, Days after onset: 51
Location:Foreign  Entered:2003-09-26, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: B0308926A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, 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 report describes the occurrence of an injection site inflamation in a 4 year old girl receiving DTaP vaccine (Infanrix) for prophylaxis. On 05-aug-03, a dose of Infanrix (0.5 ml IM) was given. The same day, after vaccination, the girl developed an inflammation at the injection site and fever (38.5 C). On observation, an erythema (7 cm) was noted. On 11-aug-03, she had completely recovered. The reporting physician considered the events to be definitely related to the vaccine and assessed the case as medically serious (OMIC). No further details will be available and this case has been therefore closed.

VAERS ID:209670 (history)  Vaccinated:2003-07-24
Age:4.0  Onset:2003-07-24, Days after vaccination: 0
Gender:Male  Submitted:2003-09-25, Days after onset: 63
Location:Foreign  Entered:2003-09-26, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0308927A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site inflammation
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This report describes the occurence of an injection site inflammation in a 4 year old boy receiving diptheria tetanus acellular pertussis (Infanrix) for prophylaxis. On 24-jul-03, a dose of Infanrix (0.5 ml IM) was given. The same day after vaccination, the boy developed an inflammation at the injection site: he had a local erythema (6 cm) on the deltoid. He went to the emergency room where he was first treated with ibuprofen and 48 hours after, amoxicillin/clavulanate (every 8 hours) was added to the treatment. On 27-jul-03, he had completely recovered. The reporting physician considered the event to be definitely related to Infanrix and assessed the case medically serious (OMIC). No further details will be available and this case has therefore been closed.

VAERS ID:209859 (history)  Vaccinated:2003-08-06
Age:4.0  Onset:2003-08-06, Days after vaccination: 0
Gender:Male  Submitted:2003-09-30, Days after onset: 55
Location:Foreign  Entered:2003-10-01, Days after submission: 1
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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0309284A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14570B9 IM 
Administered by: Other     Purchased by: Other
Symptoms: Oedema, Pain, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: This case was reported by a regulatory authority and describes the occurrence of swollen left upper arm in a 4 year old male patient who had Infanrix injection for routine immunization. On August 6, 2003 the patient received Infanrix (intramuscular). On the same day after Infanrix, the patient experienced swollen left upper arm. The patient was hospitalized and the reporter reported that the event was clinically significant (or requiring intervention). The patient was treated with antibiotics. The outcome of the event is unknown. Reaction text: Swelling of left arm. Hard area from elbow to shoulder inclusive. Pain, tender to touch, needing admission to hospital, IV antibiotics.

VAERS ID:210438 (history)  Vaccinated:2003-07-28
Age:4.0  Onset:2003-08-04, Days after vaccination: 7
Gender:Male  Submitted:2003-10-14, Days after onset: 71
Location:Foreign  Entered:2003-10-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: Stool culture: NAD
CDC Split Type: B0310813A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14570A9151 IM 
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALS553A4A IM 
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea haemorrhagic
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of bloody diarrhea in a 4 year old male patient who had Priorix injection for routine immunization. Co-suspect medication included Infanrix. On 7/28/03, the patient received Priorix (IM) and Infanrix (IM). Seven days after Priorix and Infanrix, on 8/4/03, the patient experienced bloody diarrhea. Subsequent stool culture - nothing abnormal detected. The event resolved on 8/5/03. This case was considered serious according to the regulatory authority. (OMIC)

VAERS ID:210554 (history)  Vaccinated:0000-00-00
Age:4.0  Onset:1997-05-16
Gender:Unknown  Submitted:2003-10-10, Days after onset: 2338
Location:Foreign  Entered:2003-10-17, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Cerebrospinal fluid culture: CSF showed Nontypeable H. infleuznae (strain 70097); serum Hib PRP antibody 2.81 ug/ml
CDC Split Type: WAES0310USA00872
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC. 0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Laboratory test abnormal, Meningism
SMQs:, Noninfectious meningitis (narrow)
Write-up: Information has been received from a literature article, concerning a 4 year old child with no risk factors who was vaccinated with a first dose of Hib conj vaccine. The child was diagnosed with meningitis. On 5/16/97, Nontypeable H. influenzae was isolated from the CSF (strain 70097). The anti-PRP was 2.81 ug/ml. Upon internal review, meningitis was considered to be an other important medical event (OMIC). The literature also indicated that seven other children were vaccinated with a dose of Hib conj vaccine and developed an adverse event (WAES0310USA00808, WAES0310USA00873, WAES0310USA00874, WAES0310USA00875, WAES0310USA00876, WAES0310USA00877, and WAES0310USA00878). Additional info was requested. Follow up 3/15/05: Patient''s outcome is unknown.

VAERS ID:210557 (history)  Vaccinated:0000-00-00
Age:4.0  Onset:1999-01-08
Gender:Unknown  Submitted:2003-10-10, Days after onset: 1735
Location:Foreign  Entered:2003-10-17, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: HIV test positive
Preexisting Conditions: HIV test positive
Diagnostic Lab Data: Blood showed HIB (stain 2999); Serum HIB PRP antibody 2.29 ug/ml
CDC Split Type: WAES0310USA00875
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC. 0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective, Laboratory test abnormal, Pneumonia, Sepsis
SMQs:, Agranulocytosis (broad), Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received concerning a 4 year old child who is HIV positive who was vaccinated with a first dose of HIB conjugate vaccine. The patient was diagnosed with pneumonia. On 1/8/99, the strain of HIB was isolated in the patient''s blood (strain 2999). The anti-PRP was 2.29ug/ml. This patient had not developed AIDS, her CD4+ T-cell count was normal, and her viral load was undetectable; no immunoglobulin abnormalities were reported. The HIB strain 2999 (isolated from a case of true vaccine failure) exhibited an intermediate genetic distance (0.38) between the major HIB clone and the nonencapsulated strains. The HIB strain 2999 was distant from the other vaccine failure isolates (genetic distance, 0.75), although its cap pattern was identical to that of another HIB prevaccination control isolated in 1995. Upon internal review, pneumonia was considered to be an other important medical event (OMIC). The literature also indicated that seven other children were vaccinated with a dose of HIB conjugate vaccine and developed an adverse event. Additional information has been requested. Follow up 3/15/05: Patient''s outcome is unknown.

VAERS ID:210761 (history)  Vaccinated:2003-04-15
Age:4.0  Onset:2003-04-21, Days after vaccination: 6
Gender:Male  Submitted:2003-10-20, Days after onset: 182
Location:Foreign  Entered:2003-10-22, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: Temp 39.3
CDC Split Type: B0311356A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14549B9 IM 
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site rash, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (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 pruritic rash at injection site in a 4 year old male pt who had received Infanrix injection for routine immunization. No relevant medical history was reported. On 4/15/2003 the pt received Infanrix (IM) at .5ml. Approximately six days after receiving Infanrix, on 4/21/03, the pt experienced a severe, red, fiery, pruritic rash surrounding the injection site, covering half of the upper arm and fever (39.3 deg C). The reporter did not consider the reaction to be serious but considered it to be medically significant (OMIC). The events improved.

VAERS ID:211699 (history)  Vaccinated:2003-09-26
Age:4.0  Onset:2003-09-28, Days after vaccination: 2
Gender:Male  Submitted:2003-11-04, Days after onset: 37
Location:Foreign  Entered:2003-11-05, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0312513A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS1456909 IM 
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 4 year old male pt who had received Infanrix injection for routine immunization. Co-suspect medication included Poliomyelitis vaccine. On 9/26/03 the pt received Infanrix (IM) at 1 ml. Two days after receiving Infanrix, on 9/28/03, the pt experienced henoch-schonlein purpura. The regulatory authority reported that the event was clinically significant (OMIC) (or requiring intervention). The event resolved after 7 days. The pt was previously fit.

VAERS ID:212280 (history)  Vaccinated:2003-10-31
Age:4.0  Onset:2003-10-31, Days after vaccination: 0
Gender:Male  Submitted:2003-11-12, Days after onset: 12
Location:Foreign  Entered:2003-11-14, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0313615A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14580A9 IM 
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a nurse and described the occurrence of injection site induration in a 4 year old male pt who had received Infanrix for prophylaxis. At an unknown time after receiving Infanrix, the pt experienced injection site induration and erythema which extended from shoulder to elbow. The outcome of the events is unknown. The reporter considered this case as clinically significant (OMIC) or requiring intervention. A 15-day follow up report received 12/08/2003 adds: The nurse noted that they have withdrawn the batch (14580A9) from use. On 10/31/2003 the pt experienced severe localized reaction following Infanrix injection. Erythema and swelling covering entire deltoid area. The pt was treated with Promethazine and Paracetamol. The events resolved.

VAERS ID:214008 (history)  Vaccinated:2003-11-25
Age:4.0  Onset:2003-11-25, Days after vaccination: 0
Gender:Female  Submitted:2003-12-15, Days after onset: 20
Location:Foreign  Entered:2003-12-16, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Salbutamol sulphate; Beclomethasone dipropion
Current Illness: Asthma
Preexisting Conditions: Asthma
Diagnostic Lab Data: UNK
CDC Split Type: B0317087A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS1456909 IM 
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURERS127FA PO 
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Muscular weakness, Pallor, Rash, Rash macular
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (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 pallor in a 4 year old female subject who had received Infanrix injection for routine immunization. Concurrent medical conditions included asthma. The patient''s asthma is well controlled but increases when pollen levels are high. Co-suspect medication included Polio sabin. Concurrent medications included Ventolin and Becotide. On 11/25/03 the subject received Infanrix (IM). Within minutes of receiving Infanrix, on 11/25/03, the subject went pale and wobbly at the knees. She was laid down. She developed a blotchy red rash on the face which was treated with adrenaline IM. The events resolved on 11/25/03 and the child made a good recovery. The reporter considered the reaction to be serious for the following reason: life-threatening.

VAERS ID:215916 (history)  Vaccinated:2004-01-19
Age:4.0  Onset:2004-01-19, Days after vaccination: 0
Gender:Male  Submitted:2004-02-03, Days after onset: 15
Location:Foreign  Entered:2004-02-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0320760A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14523A9 IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.HS32610 IM 
Administered by: Other     Purchased by: Other
Symptoms: Neck pain, Screaming
SMQs:, Hostility/aggression (broad), Arthritis (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of screaming in a 4 year old male patient who had received Infanrix injection. Co-suspect medication included Polio vaccine. Concurrent medications included MMR II vaccine. On previous exposure, Infanrix was well tolerated. On 1/19/04 the patient received Infanrix (IM) at 0.5ml. Approximately 2 hours after receiving Infanrix, on 1/19/04, the patient experienced screaming and neck pain. The patient was hospitalized. The outcome of the events is unknown. Information from Annual Follow-up report states this report was received from a regulatory authority. No further information is available.

VAERS ID:215917 (history)  Vaccinated:2003-03-14
Age:4.0  Onset:2003-09-01, Days after vaccination: 171
Gender:Female  Submitted:2004-02-03, Days after onset: 155
Location:Foreign  Entered:2004-02-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: IgA 2.57mg/dl
CDC Split Type: D0042796A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS200070VH IMLL
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALS200070VH IMLL
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER200070VH IMLL
Administered by: Other     Purchased by: Other
Symptoms: Cough, Drug ineffective, Gastrointestinal disorder, Infection, Laboratory test abnormal, Pharyngitis, Pyrexia, Rhinitis
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician via representative and described the occurrence of pertussis in a 4 year old female subject who was vaccinated with Infanrix-IPV+Hib for prophylaxis. Within the family, atopy was reported. The subject''s mother suffered from pollinosis. The subject''s parents were non-smokers and had no pets. There were no concurrent medications. On 2/22/99 the subject received the first dose of Infanrix-IPV+HIb vaccine IM into the right thigh on 3/31/99 the second dose IM into the left thigh on 5/6/99 the third dose, IM into the right thigh and on 3/14/00 a booster, IM into the left thigh. Initially, it was reported that an unknown time after vaccination the subject developed mitigated pertussis via another child who had not been vaccinated. Later, the subject''s grandmother got massive pertussis and infected the child a second time. This time the infection was more severe. According to follow-up info, the subject experienced pertussis on 9/1/03. After disappearing of acute pertussis symptoms, she developed tickling cough at nights and recurrent feverish airway infection. In September 2003, a radioallergosorbent test was performed and showed no pathologic result. In October 2003, the subject developed purulent angina tonsillaris. She was hospitalized for an unknown time. She had no medications at the time of hospitalization. In hospital, the tickling cough at nights and the recurrent airway infection was treated with inhaled cromoglicine acid; Salbutamol, Atrovent, ambroxolhydrochloride, nasal spray, and Sedotussin. In hospital, the subject devleoped gastrointestinal infection, which was treated with Vomex, Perenterol, and Kaoprompt H. As additional treatment, the subject received massages. All lab results were normal. The IgA level was at 2.57mg/dl. A standard pulmonary function test of six minutes under physical stress was negative, so an exercise-induced asthma could be ruled out. Via pulse oxymetry an exercise-included hypoxaemia could be ruled out. The exercise tolerance test was normal. B

VAERS ID:216289 (history)  Vaccinated:2004-01-19
Age:4.0  Onset:2004-01-19, Days after vaccination: 0
Gender:Male  Submitted:2004-02-06, Days after onset: 18
Location:Foreign  Entered:2004-02-11, Days after submission: 5
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:
CDC Split Type: WAES0401USA02237
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14523A IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0655M IM 
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURERS127FK PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Agitation, Crying, Erythema, Headache, Myalgia, Neck pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a health authority concerning a 4 year old male pt who on 1/19/04 at 10 am was vaccinated with his "preschool booster doses" of MMR II (643492/0655M; HS32610) given IM, Infanrix (14523A) given IM and poliovirus vaccine live oral (S127FK). Within 2 hrs of his vaccinations, at approximately 11:30 am, the pt was screaming with a bright, red face and was hysterical due to pain in his neck. There was no fever or rash. The immunization sites were reportedly "fine." The pt screamed for about 2 hrs. The reaction was treated with 7.5ml of paracetamol (180mg) to ease the pain. "The pt was admitted to the hospital during the day and went home in the afternoon." The reporter stated that there was a possibility of a pulled muscle. It was reported that the pt recovered on the same day. Further info was requested. Case to remain open. In follow up information on 11JUN2004 it was reported that the patient developed a headache and screaming within one hour of vaccination. The raction was reportedly mild. No further treatment given. No additional information expected. Case is closed. Other business partner numbers include E2004-00275. Follow up on 06/29/04 states: "In follow up information on 06/11/04 it was reported that the pt developed a headache and screaming within 1 hour of vaccination. The reaction was reportedly mild. No further treatment given. No additional information expected. Case is closed."

VAERS ID:218696 (history)  Vaccinated:1998-06-09
Age:4.0  Onset:2002-08-28, Days after vaccination: 1541
Gender:Unknown  Submitted:2003-03-19, Days after onset: 203
Location:Foreign  Entered:2004-04-07, Days after submission: 384
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: NONE
Diagnostic Lab Data: Lab analysis isolated Haemophilus influenzae type B.
CDC Split Type: F200300524
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPHIB: DTP + HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective, Epiglottitis, Infection
SMQs:, Lack of efficacy/effect (narrow), Oropharyngeal infections (narrow)
Write-up: It was reported that a 4 year old child received a first dose of Haemophilus influenzae vaccine on 6/9/98, the second dose with Diphtheria-Tetanus-Pertussis-HIB vaccine on 7/27/98 and the third dose with Trivax-HIB vaccine on 9/15/98. It was reported that approximately four years after receiving the last dose the patient developed epiglottitis. Laboratory analysis isolated Haemophilus Influenzae type B. At the time of the reporting the outcome is unknown. No further information expected. Case to be considered as closed. Follow up on 3/17/03: The vaccine received on 7/27/98 was reported to be DTP HIB. No further information expected. Case is closed. Follow-up, on 17-Mar-03. The vaccine received on 27-Jul-90 was reported to be DTP Hib (manufacturer unknown). No furthr information expected. Case is closed.

VAERS ID:218730 (history)  Vaccinated:2004-03-06
Age:4.0  Onset:2004-03-11, Days after vaccination: 5
Gender:Male  Submitted:2004-04-07, Days after onset: 26
Location:Foreign  Entered:2004-04-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diarrhea; Food intolerance
Preexisting Conditions: The patient is intolerant to cow''s milk and develops diarrhea.
Diagnostic Lab Data: UNK
CDC Split Type: B0327869A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14588B9 IM 
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALS608A4 IM 
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURERS127HKL PO 
Administered by: Other     Purchased by: Other
Symptoms: Abasia, Convulsion, Somnolence, Speech disorder, Staring, Tremor, Urinary incontinence
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), 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 seizure in a 4 year old male patient who had received Infanrix injection for routine immunization. Concurrent medical conditions included diarrhea and food intolerance. Co-suspect medication included Oral polio vaccine and Priorix. On 3/6/04 the patient received Infanrix (IM) at 0.5ml, Oral polio vaccine and Priorix. Five days later, on 3/11/04, the patient developed symptoms of a fit (eyes open but glazed), shaking, no communication, incontinent of urine and sleepy. This lasted 5 minutes. The next morning, the patient could not walk on the right leg for 2 hours. The events resolved. The regulatory authority reported that the events were clinically significant (or requiring intervention) (OMIC).

VAERS ID:218763 (history)  Vaccinated:2004-02-14
Age:4.0  Onset:2004-02-14, Days after vaccination: 0
Gender:Male  Submitted:2004-04-08, Days after onset: 53
Location:Foreign  Entered:2004-04-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Body temp 37.5-39 C; segmented neutrophil 74.7%; serum C-reactive protein 4.16mg/dl
CDC Split Type: WAES0403TWN00009
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Oedema peripheral, Pyrexia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a pharmacist concerning a 4 year and seven month old male who on 2/14/04 was vaccinated with pneumococcal 23v polysaccharide vaccine, 0.5mL SC. On 2/14/04 the pt experienced swelling (left thigh) and fever (body temp 37.5-39 C) and was hospitalized. 2/22/04, the pt may be discharged. Subsequently, the pt recovered from swelling and fever. On 3/31/04, contacted with the pharmacist by phone. The pharmacist confirmed that the pt was discharged on 2/22/04. No further info is available.

VAERS ID:219279 (history)  Vaccinated:2001-05-01
Age:4.0  Onset:2004-02-24, Days after vaccination: 1029
Gender:Male  Submitted:2004-04-16, Days after onset: 51
Location:Foreign  Entered:2004-04-20, 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: UNK
Diagnostic Lab Data: Lumbar puncture (results: no organism isolated in culture) was done on an unspecified date. Polymerase chain reaction test negative.
CDC Split Type: HQWYE385307APR04
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES 1IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Meningitis
SMQs:, Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information regarding Prevnar was received from an independent epidemiological study regarding a 4 year old male patient, who having received a dose in May 2001, developed meningitis on 2/24/04. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered in May 2001. Dose regimen was 1 dose (IM). Concomitant medication were not reported. On 4/7/04, a pediatrician reported that a 4 year old male study participant, received a dose of Prevnar in May 2001. On 2/24/04, the child was hospitalized with meningitis. A lumbar puncture was preformed on an unspecified date, which determined that no organisms were present in the culture. The reporter stated that a polymerase chain reaction test will be performed to identify the meningitis origin. The child was discharged from the hospital on 3/3/04 and is completely recovered. The assessments of the investigator and medical monitor for meningitis and drug ineffective were unknown. No additional information was available at the time of this report. Follow up: A polymeratee chain test, performed on an unspecified date, was negative. The reporter stated that: "test is negative, so it is not a pneumococcal meningitis." The child was discharged from the hospital on 03MAR2004 and is "completely recovered". The investigator(s) considered menengitis not related to the study product. The medical monitor(s) assessment for meningitis was unknown. This report was received form Wyeth, Spain (reference number PRV/2051/04).

VAERS ID:219545 (history)  Vaccinated:2004-02-10
Age:4.0  Onset:2004-02-11, Days after vaccination: 1
Gender:Female  Submitted:2004-04-27, Days after onset: 75
Location:Foreign  Entered:2004-04-28, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0330881A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Injection site abscess
SMQs:
Write-up: This report was received from a foreign authority and describes the occurrence of sterile abscess at the injection site in a 4 year old girl receiving diphtheria tetanus acellular pertussis for prophylaxis. This report is one of a cluster of eleven reports received from the authority. On 2/10/04, a dose of Infanrix was given. On 2/11/04, 1 day after vaccination, the girl developed a sterile abscess at the injection. She was treated with ibuprofen (every 8 hours during 3 days) and local cold compress. On 2/16/04, she had completely recovered. The authorities considered the event to be possibly related to the vaccine and considered the case as clinically significant (or required intervention) (OMIC). No further details will be available and this case has therefore been closed.

VAERS ID:219884 (history)  Vaccinated:2004-04-21
Age:4.0  Onset:2004-04-22, Days after vaccination: 1
Gender:Male  Submitted:0000-00-00
Location:Foreign  Entered:2004-05-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD shot.
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: Negative
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)AVENTIS PASTEURC1679AA IMLL
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEURW0869 SCLL
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt''s mom states left thigh started to swell on 4/22/04 with redness and itchiness. Much better today 4/23/04 but still with redness and swollen. Antibiotics given to pt if redness and swelling still persistent.

VAERS ID:220352 (history)  Vaccinated:2004-05-05
Age:4.0  Onset:2004-05-05, Days after vaccination: 0
Gender:Male  Submitted:2004-05-14, Days after onset: 9
Location:Foreign  Entered:2004-05-17, 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:
Current Illness: UNK
Preexisting Conditions: The patient was fit and well before he received his vaccinations. He had had no reaction to his primary Infanrix vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: B0332157A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14604B9 IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0093N IM 
Administered by: Other     Purchased by: Other
Symptoms: Cold sweat, Dizziness, Nausea, Pallor, Pyrexia, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), 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 fainting in a 4 year old male pt who had received Infanrix injection for prophylaxis. Concurrent medications included MMRII (Batch HT37360, Lot # 0093N, expired 09/20, unknown year). The pt had not experienced a reaction to his primary Infanrix vaccination. The pt was fit and well before he received his vaccination. On 05/05/04 the pt received one single dose of Infanrix injection (IM). The pt was not distressed prior to the vaccinations, which took place mid-morning, and did not cry when vaccinated. Three to four minutes after receiving Infanrix, the patient felt dizzy then vomited and fainted. The patient also experienced dizziness, nausea, fever, vomiting, sensation of feeling clammy and pallor. The pt''s breathing remained stable and no treatment was given. The rise in temperature resolved quickly. The pt began to feel better after about 20 minutes and all events had resolved by 15:00. The reporter cmmented that the room where the vaccines were administered was warm which may have contributed to a faint. This case was assessed as medically serious by manufacturer (OMIC).

VAERS ID:220353 (history)  Vaccinated:2004-05-05
Age:4.0  Onset:2004-05-05, Days after vaccination: 0
Gender:Female  Submitted:2004-05-14, Days after onset: 9
Location:Foreign  Entered:2004-05-17, 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:
Current Illness: UNK
Preexisting Conditions: The patient was fit and well before she received her vaccination. She had had no reaction to her primary Infanrix vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: B0332156A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14604B9 IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0093N IM 
Administered by: Other     Purchased by: Other
Symptoms: Cold sweat, Dizziness, Nausea, Pallor, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), 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 fainting in a 4 year old female patient who had received Infanrix injection for prophylaxis. Concurrent medications included MMR II vaccine. The patient had not experienced a reaction to her primary Infanrix vaccination. The patient was fit and well before she received her vaccination. On 5/5/04, the patient received one single dose of Infanrix injection (IM). The patient was not distressed prior to the vaccinations and did not cry when vaccinated. Three to four minutes after receiving Infanrix, the patient fainted, experienced dizziness, nausea, fever, sensation of feeling clammy and pallor. The patient''s breathing remained stable and no treatment was given. The rise in temperature resolved quickly. The patient began to feel better after about 20 minutes. All events resolved the same day. This case was assessed as medically serious (OMIC).

VAERS ID:220418 (history)  Vaccinated:2004-05-03
Age:4.0  Onset:2004-05-03, Days after vaccination: 0
Gender:Female  Submitted:2004-09-10, Days after onset: 130
Location:Foreign  Entered:2004-05-18, Days after submission: 115
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: Pulse rate, 03May04, 60min.
CDC Split Type: B0331660A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Anaphylactic reaction, Anxiety, Pallor, Syncope vasovagal, Visual disturbance
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of stomach pain in a 5 year old female subject who received hepatitis A and hepatitis B (Twinrix) injection for prophylaxis. On 05/03/04, the subject received a first dose of Twinrix. The same day, 5 minutes following vaccination, she experienced stomach pain, pallor, anxiety and complained that she could not see properly. The symptoms disappeared before any medication was given. The symptoms were interpreted as vasovagal symptoms. Because of a small theoretical chance of anaphylaxis, it was decided that a second dose scheduled for the first part of June should be given at the hospital with access to an anestesiologist. This case was considered serious by manufacturer. In a follow up received from the authorities the event was assessed as possibly related to vaccination. The authorities considered the event to be an anaphylactic reaction while the initial reporter considered the event to be a vasovagal reaction. No additional information are requested and therefore this case has been closed.

VAERS ID:222446 (history)  Vaccinated:2004-03-30
Age:4.0  Onset:2004-04-01, Days after vaccination: 2
Gender:Male  Submitted:2004-06-07, Days after onset: 66
Location:Foreign  Entered:2004-06-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: No known medical history/concurrent illness.
Diagnostic Lab Data: UNK
CDC Split Type: B0328743A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14588A9 IMLA
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLL
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, 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 nurse and described the occurrence of possible cellulitis in a 4 year old male subject who had received Infanrix injection. Concurrent medications included MMR, new strain (IM) in the left thigh. On 3/30/04 the subject received Infanrix (IM) in the left deltoid. On 4/1/04 the subject''s mother brought her son into the surgery and he had developed swelling and redness around the left deltoid. His skin was inflamed around the injection site. The reporter considered possible cellulitis. The subject was treated with antibiotics including penicillin and flucloxacillin. The symptoms resolved within three to four days. The reporter considered the events were related to treatment with Infanrix. This case was assessed as medically serious (OMIC).

VAERS ID:222638 (history)  Vaccinated:2004-03-24
Age:4.0  Onset:2004-03-25, Days after vaccination: 1
Gender:Male  Submitted:2004-06-14, Days after onset: 80
Location:Foreign  Entered:2004-06-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0335452A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, 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 injection site inflammation in a 4 year old male subject who had received diphtheria tetanus acellular pertussis injection for prophylaxis. Co-suspect medication included Priorix. On 3/24/04 the patient received Infanrix (IM) at 0.5ml and a dose of Priorix. On 3/25/04, 1 day after vaccination, this boy developed an injection site inflammation with a 5cm diameter induration in the left arm. It was not specified which of the both vaccines was administered in that arm. On 3/27/04, the events had resolved. The regulatory authority reported that the events were clinically significant (or requiring intervention) (OMIC). The regulatory authority reported that the events were possibly related to vaccination with Infanrix. No additional information will be available and this case has been closed.

VAERS ID:222639 (history)  Vaccinated:2004-04-22
Age:4.0  Onset:2004-04-23, Days after vaccination: 1
Gender:Female  Submitted:2004-06-14, Days after onset: 52
Location:Foreign  Entered:2004-06-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0335448A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, 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 injection site inflammation in a 4 year old female subject who had received diphtheria tetanus acellular injection for prophylaxis. On 4/22/04, the patient received Infanrix (IM) at 0.5ml. On 4/23/04, 1 day after vaccination, this girl developed an injection site inflammation with an induration (4cm in diameter) at the injection site. On 4/28/04, she had recovered. The regulatory authority reported that the events were clinically significant (or requiring intervention) (OMIC). The regulatory authority reported that the events were possibly related to vaccination with Infanrix. No additional information will be available and this case has been closed.

VAERS ID:222643 (history)  Vaccinated:2004-05-10
Age:4.0  Onset:2004-05-10, Days after vaccination: 0
Gender:Female  Submitted:2004-06-14, Days after onset: 35
Location:Foreign  Entered:2004-06-15, Days after submission: 1
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: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0334949A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, 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 foreign regulatory authority and described the occurrence of swelling arm in a 4 year old female patient who had received Infanrix injection for routine immunization. On 5/10/04 the patient received Infanrix (IM) at 1ml. On the same day, the left arm in which the patient had the injection became swollen, red, and indurated. There was no fever or tenderness. The patient was hospitalized and the reporter considered that the events were disabling and clinically significant (or requiring intervention) (OMIC). The patient was put on an IV drip. The events resolved after 3 days.

VAERS ID:222699 (history)  Vaccinated:2004-04-22
Age:4.0  Onset:2004-04-23, Days after vaccination: 1
Gender:Female  Submitted:2004-06-15, Days after onset: 53
Location:Foreign  Entered:2004-06-16, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0335447A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, 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 an injection site inflammation in a 4 year old female subject who had received diphtheria tetanus acellular pertussis injection for prophylaxis. On 4/22/04 the patient received Infanrix (IM) at 0.5ml. On 4/23/04, 1 day after vaccination, this girl developed injection site inflammation with an induration at the injection site (4cm in diameter). On 4/28/04, she had fully recovered. The regulatory authority reported that the events were clinically significant (or requiring intervention) (OMIC). The regulatory authority reported that the events were possibly related to vaccination with Infanrix. No additional information will be available and this case has been closed.

VAERS ID:222736 (history)  Vaccinated:2004-05-13
Age:4.0  Onset:2004-05-15, Days after vaccination: 2
Gender:Male  Submitted:2004-06-14, Days after onset: 30
Location:Foreign  Entered:2004-06-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0406USA00264
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0093N IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Contusion, Erythema, Injection site induration, Injection site warmth
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health professional concerning a 4 year old male who on 5/13/04 was vaccinated IM with a dose of MMR (site not reported) (lot # 645348/0093N). The child experienced injection site bruising, causing induration from the elbow to the shoulder, and described as hot and red commencing on 5/15/04. At the time of the report, the child had not recovered and the outcome was not known. He was treated with Brufen. The patient''s injection site bruising and injection site warmth and redness and injection site induration persisted. The reporter considered injection site bruising, injection site warmth, redness and injection site induration to be other important medical events (OMIC). Additional information has been requested.

VAERS ID:222879 (history)  Vaccinated:2004-01-30
Age:4.0  Onset:2004-02-02, Days after vaccination: 3
Gender:Male  Submitted:2004-06-18, Days after onset: 136
Location:Foreign  Entered:2004-06-21, 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:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0335532A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14580A9 IM 
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis
SMQs:
Write-up: This case was reported by a foreign regulatory authority and described the occurrence of cellulitis in a 4 year old male patient who had received Infanrix injection. Concurrent medications included Haemophilus influenzae type B vaccine. On 1/30/04 the patient received Infanrix (IM). Three days after receiving Infanrix, on 2/2/04, the patient experienced cellulitis. This case was assessed as medically serious (OMIC). The patient was treated with flucloxacillin sodium. The event resolved.

VAERS ID:223403 (history)  Vaccinated:2004-05-11
Age:4.0  Onset:2004-05-11, Days after vaccination: 0
Gender:Male  Submitted:2004-06-22, Days after onset: 42
Location:Foreign  Entered:2004-06-28, 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: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: NONE
CDC Split Type: WAES0406USA01747
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0057N SC 
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Oedema peripheral, Pyrexia
SMQs:, Cardiac failure (broad), Angioedema (broad), 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: Information has been received from an agency concerning a 4 year old male who on 5/11/04 was vaccinated with a dose of MMR (lot # 645149/0057N). Concomitant suspect therapy included diphtheria toxoid/tetanus toxoid and poliovirus vaccine. On the evening of vaccination, the patient was pyrexial. On 5/12/04 the patient developed severe swelling and erythema of his right upper arm from the neck and shoulder area to elbow and the arm girth virtually doubled. Subsequently, on 5/15/04, the patient recovered from pyrexial and injection site inflammation. The agency did not consider the events to be serious. However, the reporter to the agency stated that they considered the reaction to be serious for the following reason: medically significant due to event being excessive to the normal response (OMIC). Case to be considered as closed. No further information is available.

VAERS ID:223817 (history)  Vaccinated:2004-06-21
Age:4.0  Onset:2004-06-21, Days after vaccination: 0
Gender:Female  Submitted:2004-07-09, Days after onset: 18
Location:Foreign  Entered:2004-07-12, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: Heart rate: 60bpm; Heart rate: 80bpm;
CDC Split Type: B0337126A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14604139 IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER   UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURERHT34090 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Bradycardia, Heart rate increased, Pallor, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a foreign regulatory authority and described the occurrence of an anaphylactic reaction in a 4 year old female subject who had diphtheria, tetanus and acellular pertussis injection. Co-suspect medication included poliomyelitis vaccine. Concurrent medications included MMR vaccine (strain no specified). On 6/21/04 the subject received diphtheria, tetanus and acellular pertussis (IM) at 0.5ml, poliomyelitis vaccine and MMR vaccine. The same day, the subject was very pale and vomited and had bradycardia 60/min. The subject was given adrenaline 1/1000, 0.12ml IM and the condition improved. Her heart rate became 80/min and also her color improved. The subject was sent to hospital. She had an anaphylactic reaction. The events resolved. The reporter considered the reaction to be serious (OMIC): life-threatening/medically significant due to an anaphylactic reaction.

VAERS ID:223885 (history)  Vaccinated:2004-06-11
Age:4.0  Onset:2004-06-12, Days after vaccination: 1
Gender:Male  Submitted:2004-07-09, Days after onset: 27
Location:Foreign  Entered:2004-07-13, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Drug hypersensitivity; Cellulitis; Immunization
Diagnostic Lab Data: UNK
CDC Split Type: WAES0406USA02767
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Injection site reaction, Injection site vesicles, Similar reaction on previous exposure to drug
SMQs:
Write-up: Information has been received from a health authority concerning a 4 year old male patient, with a history of a drug hypersensitivity described as a cellulitis reaction to HIB vaccine on 8/6/03, who on 6/11/04 was vaccinated SC in the left arm with 0.5ml MMR. On 6/12/04, the patient developed injection site cellulitis and injection site blisters commencing on the left arm where the vaccine was given. At the time of this report, the patient was recovering. The reporter felt that injection site cellulitis and blisters were considered to be other important medical events (OMIC). No further information is available. The case is closed.

VAERS ID:223892 (history)  Vaccinated:2004-06-21
Age:4.0  Onset:2004-06-21, Days after vaccination: 0
Gender:Female  Submitted:2004-07-09, Days after onset: 18
Location:Foreign  Entered:2004-07-13, 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:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: E200402225
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14604139 IM 
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER    
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.HT34090 SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Bradycardia, Medication error, Pallor, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Medication errors (narrow)
Write-up: A 4 year old female patient received MMR, IM, batch HT34090, diphtheria tetanus and acellular pertussis vaccine, Infanrix batch 14604139, 0.5ml, IM and polio vaccine, route, manufacturer and batch not reported, all given on 6/21/04. It was reported that on 6/21/04 the child was very pale and vomiting and had bradycardia 60/min. She was given adrenaline 1/1000 0.12ml IM then condition improved. Heart rate became 80/min. Color also improved. She was sent to hospital. She had an anaphylactic reaction. Reporter considered condition serious as it was life-threatening and medically significant (OMIC). She recovered after treatment (time/date not specified). No further data expected; case is closed.

VAERS ID:224083 (history)  Vaccinated:2004-07-01
Age:4.0  Onset:2004-07-01, Days after vaccination: 0
Gender:Male  Submitted:2004-07-12, Days after onset: 11
Location:Foreign  Entered:2004-07-19, 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: NONE
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: NONE
CDC Split Type: WAES0407CHN00004
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site swelling, Lymphadenopathy
SMQs:, 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: Information has been received from a consumer concerning a 4 year old male (medical history unknown) who on 7/1/04 was vaccinated with pneumococcal 23v polysaccharide vaccine, 0.5ml, IM. There was no concomitant medication. On 7/1/04, the boy developed injection site swelling and enlargement of lymph nodes after the vaccination. On 7/3/04, the boy was hospitalized because of injection site swelling and enlargement of lymph nodes. On approximately 7/5/04, the boy recovered from his experiences and was discharged from the hospital. The reporter felt that injection site swelling and enlargement of lymph nodes were possibly related to therapy with pneumococcal 23v polysaccharide vaccine. Additional information is not expected.

VAERS ID:224183 (history)  Vaccinated:2004-06-23
Age:4.0  Onset:2004-06-23, Days after vaccination: 0
Gender:Male  Submitted:2004-07-16, Days after onset: 23
Location:Foreign  Entered:2004-07-21, 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: Fish allergy
Diagnostic Lab Data:
CDC Split Type: WAES0407USA00723
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: Information has been received from a health authority concerning a 4 year old male with an allergy to fish who on 6/23/04 was vaccinated IM instead of subcutaneously with a 0.5ml dose of MMR. On 6/23/04 the patient was also vaccinated IM with a 0.5ml dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid and a 0.135ml oral dose of poliovirus vaccine. On 6/24/04 the patient developed difficulty breathing and swelling arm (localization not reported). Subsequently, the patient was hospitalized. At the time of report the patient had not yet recovered. No further information is expected. The case is closed.

VAERS ID:224185 (history)  Vaccinated:2004-06-23
Age:4.0  Onset:2004-06-23, Days after vaccination: 0
Gender:Male  Submitted:2004-07-16, Days after onset: 23
Location:Foreign  Entered:2004-07-21, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0407USA01028
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER    
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypotension, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a health authority concerning a 4 year old male patient, with no reported other relevant history, who on 6/23/04 was vaccinated with a dose of MMR (lot # not reported). Secondary suspect therapy included vaccination on 6/23/04 with a dose of diphtheria toxoid (+) pertussis acellular 2-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (lot # not reported). On 6/23/04 the patient experienced hypotension and syncope. The patient was treated with adrenaline 0.3ml administered by GP. Subsequently, on an unspecified date, the patient recovered without sequelae from hypotension and syncope. Hypotension and syncope were reported to be other important medical events (OMIC). No further data expected. Case is closed.

VAERS ID:224488 (history)  Vaccinated:2004-05-11
Age:4.0  Onset:0000-00-00
Gender:Female  Submitted:2004-07-28
Location:Foreign  Entered:2004-07-29, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0340579A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, 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 inflammation in a 14 year old female subject who had received diphtheria tetanus acellular pertussis injection for prophylaxis. On 5/11/04 the patient received Infanrix (IM). Still in May 2004, after vaccination, this girl developed an injection site inflammation with redness and swelling and induration and covering an area of 7cmx8cm around the injection site. The regulatory authority reported that the event was clinically significant (or requiring intervention) (OMIC). In May 2004, the events resolved. The regulatory authority reported that the event was possibly related to vaccination with Infanrix.

VAERS ID:224489 (history)  Vaccinated:2004-05-21
Age:4.0  Onset:0000-00-00
Gender:Female  Submitted:2004-07-28
Location:Foreign  Entered:2004-07-29, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0340578A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, 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 injection site inflammation in a 4 year old female subject who had received diphtheria tetanus acellular pertussis injection for prophylaxis. On 5/21/04 the patient received Infanrix (IM). Still in May 2004, after vaccination, this girl developed an injection site inflammation with induration, redness, and blush covering a 5cm area around the injection site. The regulatory authority reported that the event was clinically significant (or requiring intervention) (OMIC). The events resolved after 3 days. The regulatory authority reported that the event was possibly related to vaccination with Infanrix.

VAERS ID:224490 (history)  Vaccinated:2004-04-14
Age:4.0  Onset:2004-04-14, Days after vaccination: 0
Gender:Female  Submitted:2004-07-28, Days after onset: 105
Location:Foreign  Entered:2004-07-29, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0340576A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, 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 injection site inflammation in a 4 year old female subject who had received diphtheria tetanus acellular pertussis injection for prophylaxis. On 4/14/04 the patient received Infanrix. On the same day, after vaccination, this girl developed an injection site inflammation and induration covering an area of 10cm around the injection site. The regulatory authority reported that the event was clinically significant (or requiring intervention) (OMIC). On 4/17/04, the event resolved. The regulatory authority reported that the event was possibly related to vaccination with Infanrix.

VAERS ID:224491 (history)  Vaccinated:2004-05-28
Age:4.0  Onset:2004-05-30, Days after vaccination: 2
Gender:Female  Submitted:2004-07-28, Days after onset: 59
Location:Foreign  Entered:2004-07-29, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0340574A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, 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 injection site inflammation in a 4 year old female subject who had received diphtheria tetanus acellular pertussis (Infanrix) injection for prophylaxis. On 5/28/04 the patient received Infanrix (IM). On 5/30/04, 2 days after vaccination, this girl developed an injection site inflammation and induration covering an area of 4cm around the injection site. The regulatory authority reported that the event was clinically significant (or requiring intervention) (OMIC). On 6/4/04, the events resolved. The regulatory authority reported that the event was possibly related to vaccination with Infanrix.

VAERS ID:224492 (history)  Vaccinated:2004-05-11
Age:4.0  Onset:2004-05-12, Days after vaccination: 1
Gender:Female  Submitted:2004-07-28, Days after onset: 77
Location:Foreign  Entered:2004-07-29, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0340573A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of injection site inflammation in a 4 year old female subject who had received diphtheria tetanus acellular pertussis (Infanrix) injection for prophylaxis. On 5/11/04, the patient received Infanrix (IM). On 5/12/04, 1 day after vaccination, this girl developed an injection site inflammation with redness, induration and warmth. The regulatory authority reported that the event was clinically significant (or requiring intervention) (OMIC). On 5/17/04, the events resolved. The regulatory authority reported that the event was possibly related to vaccination with Infanrix. Follow up on 07/30/04 states: "No new information."

VAERS ID:224493 (history)  Vaccinated:2004-06-16
Age:4.0  Onset:2004-06-16, Days after vaccination: 0
Gender:Female  Submitted:2004-07-28, Days after onset: 42
Location:Foreign  Entered:2004-07-29, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0340571A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, 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 injection site inflammation in a 4 year old female subject who had received diphtheria tetanus acellular pertussis (Infanrix) injection for prophylaxis. On 6/16/04 the patient received Infanrix. On the same day, after vaccination, this girl developed an injection site inflammation and induration (area of 10cm). The regulatory authority reported that the event was clinically significant (or requiring intervention) (OMIC). On 6/18/04, the event resolved. The regulatory authority reported that the event was possibly related to vaccination with Infanrix.

VAERS ID:224583 (history)  Vaccinated:2004-06-21
Age:4.0  Onset:2004-06-23, Days after vaccination: 2
Gender:Male  Submitted:2004-07-30, Days after onset: 37
Location:Foreign  Entered:2004-08-02, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0340960A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS1460489 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis
SMQs:
Write-up: This case was reported by a foreign regulatory authority and described the occurrence of cellulitis in a 4 year old male subject who was vaccinated with diphtheria, tetanus, and acellular pertussis (Infanrix) vaccine for routine immunization. There were no concurrent medications. On 6/21/04, the subject was given a dose of Infanrix (IM). Two days later, on 6/23/04, the subject experienced cellulitis which was treated with antibiotics. At an unknown date, the event improved. The regulatory authority considered the case to be serious as it involved persistent or significant disability or incapacity (OMIC). Follow up 02/14/05: Patient has recovered.

VAERS ID:224589 (history)  Vaccinated:2004-07-07
Age:4.0  Onset:2004-07-08, Days after vaccination: 1
Gender:Male  Submitted:2004-07-30, Days after onset: 22
Location:Foreign  Entered:2004-08-02, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0339908A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14604B9 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Delirium, Feeling abnormal, Feeling jittery, Joint range of motion decreased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a foreign regulatory authority and described the occurrence of feeling lifeless in a 4 year old male subject who received Infanrix injection for routine immunization. Concurrent medications included MMR (new strain). On 7/7/04, the subject received Infanrix (IM) in the left arm. One day later, on 7/8/04, the subject experienced lifeless feeling, jitteriness, delirium and was unable to lift his left arm for longer than 24 hours. The events were improved. Reporter gave no information on the seriousness of the reaction. This case was assessed as medically serious (OMIC). Follow up 02/14/05: All events alred described as improved. A request for the information above has now been made.

VAERS ID:224698 (history)  Vaccinated:2003-05-30
Age:4.0  Onset:2004-07-03, Days after vaccination: 400
Gender:Male  Submitted:2004-07-30, Days after onset: 27
Location:Foreign  Entered:2004-08-04, Days after submission: 5
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: NONE
Diagnostic Lab Data: NONE
CDC Split Type: WAES0407CHN00023
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective, Pneumonia
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning an approximately 4 year old boy who on 5/30/03 was vaccinated with pneumococcal 23v polysaccharide vaccine, 0.5ml, IM. There was no concomitant medication. On 7/3/04, the boy experienced bronchopneumonia and was hospitalized (detail unknown). On 7/10/04, the boy recovered from bronchopneumonia and was discharged from the hospital. Additional information is not expected.

VAERS ID:225434 (history)  Vaccinated:2004-05-11
Age:4.0  Onset:2004-05-12, Days after vaccination: 1
Gender:Male  Submitted:2004-08-13, Days after onset: 93
Location:Foreign  Entered:2004-08-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pimecrolimus; DIOMED DOUBLEBASE
Current Illness:
Preexisting Conditions: Atopic Dermatitis
Diagnostic Lab Data: UNK
CDC Split Type: B0341438A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14588B9 IMLA
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALSMJR60FA44A   
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER  PO 
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus, Rash
SMQs:, Anaphylactic reaction (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 foreign regulatory authority and described the occurrence of swollen left upper arm in a 4 year old male subject who was vaccinated with diphtheria, tetanus and acellular pertussis vaccine (Infanrix) and MMR vaccines for routine immunization. Concurrent medical conditions included atopic dermatitis. Co-suspect vaccination included Poliomyelitis vaccine oral. Concurrent medications included Elidel, and DIOMED DOUBLEBASE. On 5/11/04 the subject received a dose of Infanrix (IM) at 0.5ml and Priorix vaccines on the left arm. Twenty four hours after vaccinations, on 5/12/04, the subject experienced redness, swelling, itching and pain encompassing the whole of the left side of the upper arm. The subject required hospital admission owing to pain and swelling. Six days later, on 5/18/04, the events resolved. The reporter considered the reaction to be serious for the following reason: prolonged in-patient hospitalization/medically significant (OMIC).

VAERS ID:225816 (history)  Vaccinated:0000-00-00
Age:4.0  Onset:0000-00-00
Gender:Female  Submitted:2004-08-23
Location:Foreign  Entered:2004-08-25, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: NONE
CDC Split Type: HQWYE400518AUG04
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES 0IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Lung disorder
SMQs:
Write-up: This case was considered medically important (OMIC). Information regarding Prevnar was received from a cardiologist regarding a 4 year old female patient who experienced pleuroneuropathy. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose (IM). Concomitant medications were not reported. The patient developed pleuroneumopathy, described as a lung disease involving all organs near the lungs on an unspecified date. The child recovered. No additional information was available at the time of this report.

VAERS ID:226046 (history)  Vaccinated:2004-08-09
Age:4.0  Onset:2004-08-09, Days after vaccination: 0
Gender:Female  Submitted:2004-08-27, Days after onset: 18
Location:Foreign  Entered:2004-08-31, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: Allergen lab test shows that the patient is negative to all types of allergenic food and additives.
CDC Split Type: 200402870
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)AVENTIS PASTEURX0004 IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypersensitivity, Rash vesicular
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: It was reported through a health care professional from China that a 4 year old female child presented with allergic tetter appeared all over the body in the evening of 09AUG04, after the injection of ActHib (lot X0004-1) performed in the morning. The patient has no fever. Therapy and result: she received injection of hydrocortisone, Ca-Gluconate and Vitamin C on 11AUG04 and in the following 5 days, she took some local brand anti-anaphylaxis drugs and some embrocation and got recovered on 17AUG04. (OMIC) Follow up on 09/09/04 states: "Allergic tests have not been conducted with the components of vaccine. But it was reported that the pt is not allergic to egg protein (proved by lab test) and to all other allergic food and additives (also proved by lab test). This case is considered as "serious" by the reporter because the tetter appeared all over the pt''s body finally and the symptoms lasted almost 1 week. Further information regarding the pt''s history (adverse reaction with previous childhood vaccination) is expected. Follow up on 09/10/04 states: Allergic tests have not been conducted with the components of vaccine. But it was reported that the pt is not allergic to egg protein (proved by lab test) and to all other allergic food and additives (also proved by lab test). This case is considered as "serious" by the reporter because the tetter appeared all over the pt''s body finally and the symptom lasted almost one week. Further information regarding the pt''s history (adverse reaction with previous childhood vaccination....) is expected.

VAERS ID:227127 (history)  Vaccinated:2004-08-20
Age:4.0  Onset:2004-08-21, Days after vaccination: 1
Gender:Female  Submitted:2004-09-27, Days after onset: 37
Location:Foreign  Entered:2004-09-29, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0345825A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS1450489 IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0265N IM 
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURERASABD013EA PO 
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Circulatory collapse, Hypoventilation, Malaise, Pallor, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a foreign regulatory authority and described the occurrence of circulatory collapse in a 4 year old female patient who had received Infanrix injection for routine immunization. Co-suspect medication included Polio sabin vaccine. Concurrent medications included MMR II vaccine. On 8/20/04 the patient received Infanrix (IM) and OPV vaccine. One day after receiving Infanrix, on 8/21/04, the patient experienced circulatory collapse, shallow breathing and was grey. The patient was hospitalized and felt unwell for the next 5 days with a fever and aching joints. The events resolved on 9/26/04.

VAERS ID:227419 (history)  Vaccinated:0000-00-00
Age:4.0  Onset:2004-08-17
Gender:Unknown  Submitted:2004-10-05, Days after onset: 49
Location:Foreign  Entered:2004-10-07, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0346381A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis
SMQs:
Write-up: This case was reported by a foreign regulatory authority and described the occurrence of cellulitis in a 4 year old patient who had received DTPa injection for prophylaxis. Co-suspect medication included OPV vaccine. Concurrent medications included MMR II vaccine. The patient received DTPa vaccine. At an unknown time after receiving DTPa, on 8/17/04, the patient experienced cellulitis. The regulatory authority reported that the event was clincially significant (or requiring intervention). The patient was treated with oral antibiotics. The event was unresolved. Reported by the regulatory authority. A request for missing information has now been made. Per follow up report received on 08/19/2005: No further information is available.

VAERS ID:227785 (history)  Vaccinated:2004-08-20
Age:4.0  Onset:2004-08-20, Days after vaccination: 0
Gender:Female  Submitted:2004-10-07, Days after onset: 48
Location:Foreign  Entered:2004-10-15, Days after submission: 8
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: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0409USA02440
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS1450489 IM 
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERASABD013EA PO 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0265N IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Circulatory collapse, Hypoventilation, Pallor, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health authority concerning a 4 year old female patient, with no medical history reported, who on 8/20/04 was vaccinated, IM, MMR (lot # 645860/0265N). Concomitantly administered vaccines included diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (INFANRIX) (batch # 1450489) and poliovirus vaccine, oral administration (batch # ASABD013EA). On 8/21/04, the patient experienced shallow breathing, circulatory collapse, aching joints, fever, and appeared gray. The patient was admitted to the accident and emergency department, although hospitalization dates were not provided. The patient felt unwell for the next 5 days and had recovered on 8/26/04. No further information is available. Case is closed.

VAERS ID:227786 (history)  Vaccinated:2004-08-11
Age:4.0  Onset:2004-08-11, Days after vaccination: 0
Gender:Male  Submitted:2004-10-07, Days after onset: 57
Location:Foreign  Entered:2004-10-15, Days after submission: 8
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: Milk allergy;
Diagnostic Lab Data: UNK
CDC Split Type: WAES0409USA02439
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Eye movement disorder, Hypotonia, Loss of consciousness, Pharyngolaryngeal pain, Pruritus
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a health authority concerning a 4 year old male patient with a milk allergy who on 8/11/04 was vaccinated, IM, with MMR (batch # not reported). The patient was concomitantly vaccinated, IM, with diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (batch number not reported). On 8/11/04, the patient briefly lost consciousness, became floppy and his eyes rolled back. When the patient regained consciousness, he complained of an itchy top lip and a sore throat. The patient was seen by his physician but no treatment was necessary. It was unknown if the patient recovered. The reporting health professional considered loss of consciousness, floppy, eyes rolled, itchy top lip and a sore throat to be other important medical events (OMIC). No further information is available. Case is closed. Follow up 03/03/05: Patient''s recovery status is unknown.

VAERS ID:227787 (history)  Vaccinated:0000-00-00
Age:4.0  Onset:2004-08-17
Gender:Unknown  Submitted:2004-10-07, Days after onset: 51
Location:Foreign  Entered:2004-10-15, Days after submission: 8
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
Diagnostic Lab Data: UNK
CDC Split Type: WAES0409USA02438
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.    
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis
SMQs:
Write-up: Information has been received from a health authority concerning a 4 year old patient (sex not specified), with no medical history reported, who was vaccianted with a dose of MMR (lot number not reported). Concomitantly administered suspect vaccines included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (other manufacturer and lot number not reported) and oral poliovirus vaccine (manufacturer and lot number not reported). On 8/17/04, the patient developed cellulitis (site not specified) and was treated with oral antibiotics. At the time of this report, the patient''s cellulitis persisted. The health authority considered cellulitis to be an other important medical event (OMIC). No further information is available. Case is closed. Follow up 03/03/05: Patient has not recovered from the adverse event(s).

VAERS ID:228264 (history)  Vaccinated:2004-09-22
Age:4.0  Onset:2004-09-22, Days after vaccination: 0
Gender:Female  Submitted:2004-10-26, Days after onset: 34
Location:Foreign  Entered:2004-10-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sodium Picosulphate
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0348035A
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALS1460439 IM 
Administered by: Other     Purchased by: Other
Symptoms: Delirium, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a foreign regulatory authority and described the occurrence of delirium in a 4 year old female subject who had received MMR vaccine injection. Co-suspect medication included diphtheria, tetanus and acellular pertussis - date unknown. Concurrent medications included sodium picosulphate. On 9/22/04, the subject received Priorix (IM) at 0.5ml. Later that same day, the subject experienced delirium and high temperature. The patient was treated with Calpol. Four days later, on 9/26/04, the events resolved. This case was assessed as medically serious (OMIC).

VAERS ID:228266 (history)  Vaccinated:2004-09-24
Age:4.0  Onset:2004-09-25, Days after vaccination: 1
Gender:Female  Submitted:2004-10-26, Days after onset: 31
Location:Foreign  Entered:2004-10-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0348415A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14A012BA IMUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURERRV196802 SCUN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURERAOPVB099BA PO 
Administered by: Other     Purchased by: Other
Symptoms: Erythema multiforme
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 foreign regulatory authority and described the occurrence of erythema multiforme in a 4-year-old female patient who had received Infanrix injection for routine immunization. Co-suspect medication included OPV vaccine. Concurrent medications included MMR, new strain. On 9/24/04, the patient received Infanrix (IM) for prophylaxis. One day after receiving Infanrix, on 9/25/04, the patient experienced a leg rash (2cm) and target lesions which were raised and itchy. This was diagnosed as erythema multiforme. This case was assessed as medically serious (OMIC). The events were unresolved. Reported by the MHRA. MHRA contacted and asked to provide informaiton above. Additional correspondence from MHRA on March 8, 2005: No further information is available.

VAERS ID:228487 (history)  Vaccinated:2004-10-05
Age:4.0  Onset:2004-10-05, Days after vaccination: 0
Gender:Female  Submitted:2004-10-26, Days after onset: 21
Location:Foreign  Entered:2004-11-01, 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: UNK
Current Illness:
Preexisting Conditions: Eczema
Diagnostic Lab Data: UNK
CDC Split Type: WAES0410USA03094
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERX0517 IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure decreased, Hypotonia, Pallor
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a health authority concerning a 4 year old female with a history of eczema who on 10/5/04 was vaccinated IM with a dose of MMR (manufacturer and lot number unknown). On 10/5/04, the patient was concomitantly vaccinated IM with a dose of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (lot X0517-2). On 10/5/04, post vaccination, the patient experienced hypotonia, decreased blood pressure, and pallor. Subsequently, the patient recovered on 10/5/04. The reporter did not consider the events to be serious. The patient''s hypotonia, decreased blood pressure, and pallor were considered other medical events (OMIC). Other business partner numbers include E200403520 and ADROIT478981. Additional information is not expected. Case is closed.

VAERS ID:230086 (history)  Vaccinated:2004-10-28
Age:4.0  Onset:2004-10-28, Days after vaccination: 0
Gender:Male  Submitted:2004-12-01, Days after onset: 34
Location:Foreign  Entered:2004-12-07, 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: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0411USA03945
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)AVENTIS PASTEURX0517 IM 
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEURX0517 IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IM 
TTOX: TETANUS TOXOID (NO BRAND NAME)AVENTIS PASTEURX0517 IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypotonia, Pallor, Stupor, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: Information has been received from a health authority concerning a 4 year old male who on 10/28/04 was vaccinated IM with a dose of MMR (lot number not available) and vaccinated IM with 0.5ml of concomitant suspect therapy diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (batch X0517-2). On 10/28/04, 5 minutes after the vaccinations, the patient developed pallor and vomiting, and experienced a hypotonic-hyporesponsive episode. The patient was noted to have become limp and floppy and unresponsive. It was reported that all events resolved after 30 minutes. No further information is available. The patient''s hypotonic hyporesponsive episode, pallor and vomiting were considered other important medical events. Other business partner numbers include E200404198 and ADROIT 480632.

VAERS ID:231483 (history)  Vaccinated:2004-12-01
Age:4.0  Onset:2004-12-01, Days after vaccination: 0
Gender:Male  Submitted:2004-12-23, Days after onset: 22
Location:Foreign  Entered:2004-12-27, 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: Augmentin
Current Illness:
Preexisting Conditions: Ear infection
Diagnostic Lab Data: Prothrombin time (results: prolonged) was done in December 2004.
CDC Split Type: GRWYE291120DEC04
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Prothrombin level decreased, Purpura, Rash
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 4 year old male patient who experienced generalized rash, rash hemorrhagic in the neck and prothrombin time prolonged. The patient received a dose in 12/04. The patient has a past history of ear infection. The patient had been suffered from otitis several times in the past. Indication for Prevnar was immunization. Product was administered in December 2004. Dose regimen was 1 dose 1 time per day (IM). Additional suspect medication included Augmentin. Concomitant medications were not reported. The patient experienced generalized rash, rash hemorrhagic in the neck and prothrombin time prolonged in December 2004. The patient experienced generalized rash in the evening of the vaccination day. The pediatrician recommended the hospitalization of the patient. On the second day of the hospitalization. The patient experienced hemorrhagic rash in the neck area and decreased prothrombin time. The symptoms started resolving on the third day without any additional medication treatment and the patient finally left the hospital. The pediatrician also mentioned that the patient had suffered from otitis and had been under antibiotic treatment with Augmentin. On the day of the vaccination, the patient had received the last dose of Augmentin treatment. The pediatrician attributed the aforementioned symptoms mainly to Augmentin because the patient had suffered from otitis repeatedly in the past and had been under Augmentin for long. The treating physician recommended a follow up prothrombin time test. However, he did not have any contact with the patient and therefore he did not have any further documentation. No additional information was available at the time of this report.

VAERS ID:231904 (history)  Vaccinated:0000-00-00
Age:4.0  Onset:0000-00-00
Gender:Unknown  Submitted:2005-01-04
Location:Foreign  Entered:2005-01-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0363095A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Bronchospasm, Cough, Dysphonia, Laryngitis
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Parkinson-like events (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician via a manufacturer representative and described the occurrence of laryngitis in a 4 year old subject, who was vaccinated with Engerix B for hepatitis B prophylaxis. At an unspecified date in 2004, the subject received the first injection of Engerix B at 10mcg. Twelve hours later, the subject developed bronchospasms with hoarse cough. He was hospitalized for one day and diagnosed with laryngitis. He was treated with betamethasone. At the time of reporting, the outcome of the events was unknown. The hospital physician considered the events were unrelated to vaccination with Engerix B.

VAERS ID:232619 (history)  Vaccinated:2004-10-29
Age:4.0  Onset:2004-10-29, Days after vaccination: 0
Gender:Male  Submitted:2005-01-13, Days after onset: 76
Location:Foreign  Entered:2005-01-21, Days after submission: 8
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: Egg Allergy
Diagnostic Lab Data: Body weight measurement: 18kg.
CDC Split Type: WAES0411USA03888
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)AVENTIS PASTEURX05162 IM 
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEURX05162 IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.6458600265N IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Cold sweat, Grunting, Heart rate decreased, Hypoxia, Pallor, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a health authority concerning a 4 year old male with an egg allergy who on 29Oct04 was vaccinated IM with a 0.5ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (batch HT80610; lot 645860/0265N) (batch also reported as RT80610). Concomitant suspect vaccination given IM included a 0.5ml dose of diphtheria toxoid (+) pertussis acellular 5 component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (REPEVAX)(Batch X05162). On 29Oct04, the child experienced what was described as an anaphylactic reaction and was admitted to the hospital . The hospital felt that the pt had experienced a simple vasovagal episode which lasted fifteen minutes. It was described as a transient collapse, loss of consciousness, clammy, pale, and grunting. Within a few minutes after receiving the vaccines, the pt collapsed. The pt was immediately given IM epinephrine (Adrenaline). He regained consciousness but was pale, and clammy with grunting respirations. His pulse rate was 40, which was not palpable at the radial pulse, but audible with auscultation. The pt was laid supine with his legs up. He was given oxygen over 5-10 minute. The pt''s pulse rate returned to normal and his breathing was stabilized. It was reported that the child recovered on 29Oct04. Simple vasovagal episode was considered to be immediately life threatening and an other important medical event. Other business partner numbers include E200404222 and Adroit S002021. No further information is expected. The case is closed.

VAERS ID:233494 (history)  Vaccinated:1999-03-25
Age:4.0  Onset:1999-04-05, Days after vaccination: 11
Gender:Male  Submitted:2005-02-07, Days after onset: 2135
Location:Foreign  Entered:2005-02-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: E200500328
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS    
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEUR    
JEV: JAPANESE ENCEPHALITIS (JE-VAX)AVENTIS PASTEUR    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Difficulty in walking, Haematoma, Medication error, Muscle atrophy, Muscular weakness, Paraesthesia, Peroneal nerve palsy
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Medication errors (narrow), Hypoglycaemia (broad)
Write-up: Initial case was reported on 1/27/05 by health authority. It was reported that a 4 year old boy was vaccinated with Japanese Encephalitis vaccine, with poliomyelitis vaccine and Hepatitis A vaccine on 3/25/99. The second dose of JE-Vax was administered on 3/31/99. On 4/5/99, he got left-sided drop foot. On 4/8/99, the patient contacted orthopedic ambulatory because of hematoma on proximal crus on the left side. Hematoma was located a couple centimeters under tuberosity tibia. There was no sign of fracture in tibia or fibula. It was found that decreased muscular power with extension of left big toe and left ankle joint. Babinsky test was normal. Normal sensitivity. Natural patella reflexes bilateral. Achilles tendon reflex was normal bilateral. The x-ray did not show any sign of fracture. Later the patient was seen by another physician, who suspected peroneal nerve palsy and the patient had physiotherapeutic treatment for a couple of weeks with a good effect. The treatment was terminated because family had to start their traveling around the world for 7 months. JE-Vax vaccine was suspected, as higher dose was administered. The patient was examined after coming back from traveling around the world (no date specified). His walking problems increased after traveling. He was walking with clear left-sided drop foot. Clear decreased muscle power with dorsal extension of left big toe and left ankle joint. Because of atrophy of left femur, the physician was not convinced about injury of peroneural nerve. In April 1999, the patient''s mother asked for examination if patient''s condition could be caused by Borrelia infection, because he had few ticks. The results on 5/10/099 showed that Borrelia test was negative. During the past 5 years the condition of the patient was not significantly better: the left leg became slightly atrophic with decrease muscle power, especially after physical activity. His gait is affected and he has drop foot. The examination of the patient on 12/22/04 showed that his physical, mental and psychomot

VAERS ID:234792 (history)  Vaccinated:2004-12-15
Age:4.0  Onset:2004-12-15, Days after vaccination: 0
Gender:Female  Submitted:2005-03-04, Days after onset: 79
Location:Foreign  Entered:2005-03-10, 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: UNK
CDC Split Type: WAES0502USA03195
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)AVENTIS PASTEURX5172 IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0936N IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyskinesia, Medication error, Musculoskeletal stiffness, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Medication errors (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a health authority concerning a 4 year old female who on 15Dec04 at 12:10PM received measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) vaccination IM (lot number 647292/0936N). On the same day she was also vaccinated IM with a dose of diphtheria toxoid (+) pertussis acellular 5 component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (REPEVAX). After immunization the child appeared to faint, slumping forward after turning pale. She then became stiff and jerked her arms and legs. After lying down she quickly recovered. It was reported that the measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) vaccine had been delivered to the surgery the previous day (after 3PM). It was discovered the following day that the vaccine had not been stored in a fridge. The practice manager checked with the manufacturer that it was ok to use the vaccine. It was used at approx 12:10PM on 15Dec04.(OMIC) No further information is expected. The case is closed. Other company numbers include: 484935, E200500765.

VAERS ID:234881 (history)  Vaccinated:2004-12-01
Age:4.0  Onset:2004-12-04, Days after vaccination: 3
Gender:Male  Submitted:2005-03-11, Days after onset: 97
Location:Foreign  Entered:2005-03-14, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Ear infection
Diagnostic Lab Data: Culture (results: positive for Streptococcus pneumoniae) was done in December 2004.
CDC Split Type: GRWYE470002MAR05
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)LEDERLE LABORATORIES  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bacterial infection, Laboratory test abnormal, Otitis media, Pyrexia, Tympanic membrane perforation
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (broad), Hearing impairment (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case is being reversioned to upgrade the seriousness criteria to medical important and to include changes in the codes. This case was considered medically important (OMIC). Information regarding Prevnar was received from a healthcare professional regarding a 4 year old male patient who experienced acute suppurative otitis media, fever, ear drum perforation, pneumococcal infection and drug ineffective. The patient received a dose in December 2004. The patient has a past history of ear infection (The patient suffered from otitis repeatedly.). Indication for Prevnar was immunization. Product was administered in December 2004. Dose regimen was 1 dose 1 time per day (IM). Concomitant medications were not reported. The patient experienced acute suppurative otitis media, fever, ear drum perforation, pneumococcal infection and drug ineffective on 12/4/04. The patient was treated with Augmentin and Amoxil for three weeks. Otitis duration was 10 days. The patient has a history of repeating otitis. Result of ear pus culture was positive Streptococcus pneumoniae. No additional information is anticipated. No additional information was available at the time of this report.

VAERS ID:234940 (history)  Vaccinated:2004-03-12
Age:4.0  Onset:2004-03-14, Days after vaccination: 2
Gender:Male  Submitted:2005-03-14, Days after onset: 365
Location:Foreign  Entered:2005-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cefixime
Current Illness: Ear infection
Preexisting Conditions:
Diagnostic Lab Data: Body temperature increased 43C
CDC Split Type: B0331596A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS762B9 IM 
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURW0160 IM 
Administered by: Other     Purchased by: Other
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This report was received from a foreign regulatory authorities and describes the occurrence of hyperpyrexia in a 4 year old boy receiving hepatitis A vaccine for prophylaxis. Concurrent medical condition included ear infection. Concurrent drugs included Typhim and Cefexime (treatment for ear infection). On 3/12/04, a dose of Havrix was given. On 3/14/04, 2 days after vaccination the boy developed hyperpyrexia which increased on 3/15/04 with a maximum value of 43 C (value confirmed. He was not hospitalized and did not receive any treatment. On 3/18/04, he had completely recovered. The reporter considered the event to be possibly related to the Havrix vaccine and considered the case as serious (OMIC). The case has been closed.

VAERS ID:235397 (history)  Vaccinated:2005-03-09
Age:4.0  Onset:2005-03-10, Days after vaccination: 1
Gender:Male  Submitted:2005-03-24, Days after onset: 14
Location:Foreign  Entered:2005-03-24
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: B0374893A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Injection site inflammation, Injection site oedema, Injection site reaction, 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: This case was reported by a regulatory authority and described the occurrence of swelling arm in a 4 year old male pt who had received DTaP (Infanrix) injection for routine immunization. On 09 March 2005 the pt received Infanrix (IM). One day after receiving Infanrix, on 10 March 2005, the pt experienced a local reaction; swelling; itching and inflammation of most of the upper arm. The reported considered that the events were clinically significant (OMIC) (or requiring intervention). The events improved.

VAERS ID:235466 (history)  Vaccinated:2005-03-07
Age:4.0  Onset:2005-03-08, Days after vaccination: 1
Gender:Female  Submitted:2005-03-24, Days after onset: 16
Location:Foreign  Entered:2005-03-28, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0503USA03305
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSX1141   
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.RV64010 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis
SMQs:
Write-up: Information has been received from a health authority concerning a 4 year old female with no reported medical history who on 3/7/05 was vaccinated with a dose of MMR (lot # RV64010), IM. Concomitant therapy that day included a dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (batch # X1141). On 3/8/05, the patient experienced cellulitis. At the time of the report the patient was not recovered. The reporter considered cellulitis to be an other important medical event (OMIC). Other business partner''s numbers include: E200501096 and ADROIT-B716587. No further information is available.

VAERS ID:236436 (history)  Vaccinated:2005-03-09
Age:4.0  Onset:2005-03-09, Days after vaccination: 0
Gender:Male  Submitted:2005-04-21, Days after onset: 42
Location:Foreign  Entered:2005-04-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No other relevant history.
Diagnostic Lab Data: Not available
CDC Split Type: 200500737
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)AVENTIS PASTEURY0354 IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: It was reported through an health care professional from a foreign country that a 3 year old boy presented with high fever and injection site inflammation (local area redness and swelling) after the first injection of Act-HIB performed on 3/9/05 (Batch # Y0354-1). The patient was hospitalized from 3/9/05 to 3/11/05. After anti-anaphylactic treatment, the serious reaction lessened.

VAERS ID:236658 (history)  Vaccinated:2003-09-09
Age:4.0  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: 36 and 759; Hepatitis A IgM positive.
CDC Split Type: B0378804A
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 4 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 36 and 759 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:237445 (history)  Vaccinated:2005-04-28
Age:4.0  Onset:2005-04-28, Days after vaccination: 0
Gender:Male  Submitted:2005-05-13, Days after onset: 15
Location:Foreign  Entered:2005-05-17, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness:
Preexisting Conditions: Immunization
Diagnostic Lab Data: Oxygen Saturation (blood, arterial) 95%, mean heart rate- increased to 115.
CDC Split Type: WAES0505USA01370
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B015BA IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0171P IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Heart rate increased, Hypoxia, Somnolence, Syncope vasovagal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a health authority (ADROIT489021) concerning a 4 year old male pt who on 28Apr05 was vaccinated IM with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 648655/0171P). Concomitant vaccination on the same day included a dose, also given IM, of diphtheria toxoid (+) pertussis acellular 3 component vaccine (+) tetanus toxoid (Infanrix) (Batch AC0B015BA). On 28Apr2005, following vaccination, the pt developed profuse vomiting, vasovagal attack, increased heart rate (to 115) and reduced oxygen saturation (95%). The pt was slow to recover (30 minutes) and was sleepy. The pt recovered the same day. It was also reported that the pt has had no reactions to previous immunizations. Additional information is not expected. Other business partner numbers include E200501819.

VAERS ID:237652 (history)  Vaccinated:2005-04-28
Age:4.0  Onset:2005-04-28, Days after vaccination: 0
Gender:Male  Submitted:2005-05-17, Days after onset: 19
Location:Foreign  Entered:2005-05-20, 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: UNK
Diagnostic Lab Data: pulse oximetry 95% ,reduced. Total heartbeat count 115, increased.
CDC Split Type: WAES0505USA01294
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B015BA IM 
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERAC20B015BA IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0171P IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Heart rate increased, Hypoxia, Somnolence, Syncope vasovagal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a health authority concerning a 4 year old male who on 28Apr05 was vaccinated IM with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot648655/0171P; batch NA05290). Suspect concomitant therapy included an IM dose of Diphtheria toxoid (+) pertussis acellular 3 component (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (INFANRIX-IPV) (batch AC20B015BA). On 28Apr05 following the vaccination, the pt developed profuse vomiting, a vasovagal attack, an increased heart rate to 115, a reduced oxygen saturation to 95% (the pt was slow to recover-30 minutes) and was sleepy. That same day, the pt recovered. It was noted that the pt has not had any reactions to previous immunizations. Profuse vomiting, vasovagal attack, increased heart rate, reduced oxygen saturation and sleepy were considered to be other important medical events (OMIC). Other business partner numbers included: E200501819 and ADROIT 489021. No further information is expected. The case is closed.

VAERS ID:239054 (history)  Vaccinated:2005-05-11
Age:4.0  Onset:2005-05-12, Days after vaccination: 1
Gender:Male  Submitted:2005-06-03, Days after onset: 22
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: Amoxicillin trihydrate
Current Illness: UNK
Preexisting Conditions: No known allergies.
Diagnostic Lab Data: UNK
CDC Split Type: B0382479A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B015CA IM 
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Joint swelling
SMQs:, Anaphylactic reaction (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a foreign regulatory authority a healthcare products regulatory agency and described the occurrence of swollen shoulder in a 4 year old male subject who was vaccinated with absorbed diphtheria, tetanus and acellular pertussis vaccine for prophylaxis. Concurrent medications included amoxicillin trihydrate. On 5/11/05, the subject received unspecified dose of Infanrix (IM). On 5/12/05, 1 day after vaccination with Infanrix, the subject''s left shoulder was twice the normal size and was red and warm to the touch. The reporter considered that the events were clinically significant (or requiring intervention) (OMIC). The subject was treated with erythromycin and cetirizine hydrochloride. On 5/16/05, the events were resolved. The reporter stated that the subject was given a new version of the vaccine. The subject had no known allergies.

VAERS ID:239573 (history)  Vaccinated:2005-04-28
Age:4.0  Onset:2005-04-30, Days after vaccination: 2
Gender:Male  Submitted:2005-06-06, Days after onset: 37
Location:Foreign  Entered:2005-06-10, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: UNK
CDC Split Type: WAES0506USA00346
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERX11411 IM 
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERX11411 IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.A69D228A IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Erythema, Feeling hot, Infection, Injection site erythema, Injection site swelling, Oedema peripheral
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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health authority concerning a 4 year old male with no medical history reported who on 4/28/05 was vaccinated with MMR (batch # A69DA228A), IM. Concomitant therapy that day included a dose of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (batch # X1141-1) (0.5ml), IM. On 4/30/05, 2 days after vaccination, the patient experienced erythema, edema peripheral, feeling hot and cellulitis. Redness and swelling was observed on the area of the left upper arm. The event was treated with flucloxacillin and phenoxymethyl penicillin (dosing details not reported). The event was considered to be an infection and not an allergic reaction. In the opinion of the reporter, the reaction was not considered to be serious. The health authority considered the reaction to be serious. All reactions resolved and the patient recovered on 5/6/05. This case is considered closed. Upon internal review, erythema, edema peripheral, feeling hot, and cellulitis were felt to be other important medical events (OMIC). Other business partner numbers include E200501996 and 489856. No further information is available.

VAERS ID:239900 (history)  Vaccinated:2005-05-17
Age:4.0  Onset:2005-05-18, Days after vaccination: 1
Gender:Male  Submitted:2005-06-13, Days after onset: 26
Location:Foreign  Entered:2005-06-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: UNK
CDC Split Type: WAES0506USA01153
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Injection site erythema, Injection site reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a health authority concerning a 4 year old male with no relevant history reported who on 17-MAY-2005 was vaccinated IM with a dose of MMR II. Concomitant suspect therapy, that same day, included DTP administered IM. On 18-MAY-2005, one day after the vaccinations, the pt developed significant redness and apparent cellulitis around the injection site on the left arm and was hospitalized. At the time of this report, the pt was recovering. Additional information is not expected. Case closed. Other business partner numbers include E200502212 and ADROIT490629.

VAERS ID:240310 (history)  Vaccinated:1995-06-20
Age:4.0  Onset:0000-00-00
Gender:Male  Submitted:2005-06-21
Location:Foreign  Entered:2005-06-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 200501076
Vaccination
Manufacturer
Lot
Dose
Route
Site
JEV: JAPANESE ENCEPHALITIS (JE-VAX)AVENTIS PASTEURBJEL0378   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Depressed level of consciousness, Encephalitis, Paralysis, Pyrexia, Speech disorder
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Case 200501076 is one of four cases that were received on 6/7/05. The reference numbers for the other cases are: 200501075, 200501077, and 200501078. From initial information received on 6/7/05 regarding an adverse event occurring in a foreign country, it was reported that a four year old male patient received a dose of JAPANESE ENCEPHALITIS VACCINE INACTIVATED, lot number BJEL0378, administered on 6/20/95. The route and site of administration were not reported. 15 days later, on 7/5/05, the patient developed acute disseminated encephalomyelitis with pyrexia, convulsion, consciousness disturbance, language disorder and tetanic paralysis. The patient did not recover from these events. (OMIC).

VAERS ID:240783 (history)  Vaccinated:2005-05-24
Age:4.0  Onset:0000-00-00
Gender:Female  Submitted:2005-06-28
Location:Foreign  Entered:2005-06-28
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: B0385192A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Injection site reaction
SMQs:
Write-up: This case was reported by a regulatory authority and described the occurrence of local reaction at injection site in a 4 year old female subject who was vaccinated with absorbed diphtheria, tetanus, and acellular pertussis vaccine for prophylaxis. On 5/24/05, the subject received 0.5ml of unspecified dose of Infanrix (IM). At an unspecified time after vaccination with Infanrix, the subject experienced local reaction at injection site. At the time of reporting the event was unresolved. The reporter considered the reaction to be serious for the following reason: medically significant - new vaccine (OMIC).

VAERS ID:240786 (history)  Vaccinated:2005-04-22
Age:4.0  Onset:2005-04-22, Days after vaccination: 0
Gender:Female  Submitted:2005-06-28, Days after onset: 67
Location:Foreign  Entered:2005-06-28
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: B0385545A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Injection site haemorrhage, Injection site inflammation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of injection site inflammation in a 4 yr old female subject who was vaccinated with adsorbed diphtheria, tetanus, and acellular pertussis vaccine (Infanrix) for prophylaxis. On 22Apr05 the subject received unspecified dose of Infanrix (.5ml). The same day after vaccination with Infanrix, the subject experienced injection site inflammation and hematoma. The regulatory authority reported that the events were clinically significant (OMIC). On 02May05, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with Infanrix. The case has been closed.

VAERS ID:240787 (history)  Vaccinated:2005-04-21
Age:4.0  Onset:2005-04-21, Days after vaccination: 0
Gender:Female  Submitted:2005-06-28, Days after onset: 68
Location:Foreign  Entered:2005-06-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ketotifen
Current Illness: UNK
Preexisting Conditions: Atopic dermatitis, hay fever
Diagnostic Lab Data: UNK
CDC Split Type: B0385546A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
Administered by: Other     Purchased by: Other
Symptoms: Injection site haemorrhage, Injection site inflammation, Vasculitis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Vasculitis (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of vasculitis in a 4 yr old female subject who was vaccinated with adsorbed diphtheria, tetanus, and acellular pertussis vaccine (Infanrix) for prophylaxis. The subject''s medical history included atopic dermatitis and hay fever. Concurrent medications included Ketotifen (Zasten). On 21Apr05 the subject received unspecified dose of Infanrix (.5ml IM, unk deltoid). The same day, 4 hours after vaccination with Infanrix, the subject experienced developed a local inflammation on the deltoid are that resolved on the following days. On 26Apr05, the subject developed an inflammation with vasculitis on the same area. Vasculitis turned into hematoma. The subject was treated with prednisolone steaglate. The regulatory authority reported that the events were clinically significant (OMIC). In May 2005, the subject had completely recovered. The regulatory authority reported that the events were possibly related to vaccination with Infanrix. The further details will be available and this case will be closed.

VAERS ID:240957 (history)  Vaccinated:2005-05-20
Age:4.0  Onset:0000-00-00
Gender:Male  Submitted:2005-06-28
Location:Foreign  Entered:2005-07-05, Days after submission: 7
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: Therapeutic procedure
Diagnostic Lab Data: UNK
CDC Split Type: WAES0506USA03351
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS    
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER    
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Erythema, Feeling hot, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health authority concerning a 4 year old male primed with whole cell pertussis, who on 20-MAY-2005 was vaccinated with MMR II. Suspect concomitant therapy included a booster dose of DTaP + IPV. Subsequently, the pt developed an adverse event which was described by the nurse as red, hot, and swollen arm. The nurse diagnosed the reaction as cellulitis. The pt was treated with Piroiton which did not seem to help. The pt was then brought to the surgery department and was prescribed treatment with unspecified antibiotics. The pt recovered after treatment. Cellulitis was considered to be an other important medical event (OMIC). Other business partner numbers include: E200502413 and ADROITE011755. No further information is expected. The case is closed.

VAERS ID:241147 (history)  Vaccinated:0000-00-00
Age:4.0  Onset:0000-00-00
Gender:Male  Submitted:2005-07-06
Location:Foreign  Entered:2005-07-11, Days after submission: 5
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: Haemoglobin decreased; asthma
Preexisting Conditions: Abnormal behavior; convulsion
Diagnostic Lab Data: Body temp febrile
CDC Split Type: WAES0506USA04359
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Pyrexia
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 authority concerning a 4 yr old male with decreased haemoglobin and asthma and a history of abnormal behavior (not specified) and convulsions who was vaccinated IM with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy included ferrous fumarate and albuterol. Following vaccination on an unspecified date the pt experienced localized, then spreading cellulitis, and a febrile reaction. This required hospitalization. The pt was initially treated with an antihistamine, chlopheniramine, and then flucloxacillin during hospitalization. The pt recovered after treatment on 31May05. Both the regulatory authority and the reporter considered these events to be serious, as the pt was hospitalized. Other business partner numbers include E200502496 and ADROIT 491765. Additional information is not expected.

VAERS ID:241904 (history)  Vaccinated:2005-07-18
Age:4.0  Onset:2005-07-18, Days after vaccination: 0
Gender:Female  Submitted:2005-07-28, Days after onset: 10
Location:Foreign  Entered:2005-07-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: Body temperature 39.5 C.
CDC Split Type: B0388477A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Chills, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of hyperpyrexia in a 4.5 year old female subject who was vaccinated with absorbed diphtheria, tetanus and acellular pertussis vaccine for prophylaxis. There was no reaction to previous vaccinations. On 7/18/05, the subject received second booster dose of Infanrix. The same day, following vaccination, the child developed hyperpyrexia (39.5 C), chills and generalized malaise. The subject was hospitalized. As of 7/27/05, at the time of this follow up report, the subject had completely recovered. The physician considered the events were almost certainly related to vaccination with Infanrix. Further information has been requested.

VAERS ID:242831 (history)  Vaccinated:2005-06-29
Age:4.0  Onset:2005-06-29, Days after vaccination: 0
Gender:Male  Submitted:2005-08-09, Days after onset: 41
Location:Foreign  Entered:2005-08-12, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Albuterol; Desloratadine
Current Illness:
Preexisting Conditions: Rash, Seasonal allergy
Diagnostic Lab Data: UNK
CDC Split Type: WAES0508USA01041
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis
SMQs:
Write-up: Information has been received from a health authority concerning a 4 year old male with seasonal allergies and a history of a rash, who on 6/29/05 was vaccinated IM with a dose of MMR. Concomitant therapy included desloratadine and albuterol. That same day, the patient developed cellulitis. The patient was hospitalized and was given IV antibiotics as corrective treatment. On 7/2/05, the patient recovered. Other business partner numbers include: E200502976 and ADROIT492849. No further information is expected. The case is closed.

VAERS ID:244170 (history)  Vaccinated:2004-02-11
Age:4.0  Onset:2004-02-22, Days after vaccination: 11
Gender:Female  Submitted:2005-09-15, Days after onset: 570
Location:Foreign  Entered:2005-09-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0393279A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER14588A9 IMRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
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 induration erythema in a 4 year old female subject who was vaccinated with adsorbed diphtheria, tetanus and acellular pertussis vaccine for prophylaxis. On 11Feb04 the subject received unspecified dose of Dtap (IM, right deltoid). On 12Feb04, 24 to 26 hrs after vaccination with Dtpa, the subject experienced redness, induration and swelling. The regulatory authority reported that the events were clinically significant (or requiring intervention) (OMIC). On 18Feb04, the events were resolved.

VAERS ID:244519 (history)  Vaccinated:2005-09-10
Age:4.0  Onset:2005-09-11, Days after vaccination: 1
Gender:Male  Submitted:2005-09-23, Days after onset: 12
Location:Foreign  Entered:2005-09-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0393712A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Contusion, Injection site swelling
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a physician and described the occurrence of injection site edema in a 4 year old male subject who was vaccinated with influenza vaccine for prophylaxis. Concurrent medication/vaccination are not known. On 9/10/05 the subject received unspecified dose of Fluarix. On 9/11/05, 1 day after vaccination with Fluarix, the subject visited site with edema and bruise at the injection site. On 9/11/05, the events worsened and the subject was hospitalized. At the time of reporting the events were improved. The subject was planned to be discharged on 9/14/05.

VAERS ID:244845 (history)  Vaccinated:0000-00-00
Age:4.0  Onset:0000-00-00
Gender:Female  Submitted:2005-10-03
Location:Foreign  Entered:2005-10-03
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: This case was linked to 5 other cases (same reporter: B0299670A, B0307654A, B0307666A, B0387553A, and B0387668A) describing the same event (injection site pseudolymphoma) and published in the literature.
Diagnostic Lab Data: Skin patch test positive. Biopsy of the nodule: pseudolymphoma. Morin coloration not performed. Patch test positive to aluminum.
CDC Split Type: B0395932A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS   RL
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALS   RL
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER   RL
Administered by: Other     Purchased by: Other
Symptoms: Eczema, Hypersensitivity, Injection site nodule, Laboratory test abnormal, Pseudo lymphoma
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)
Write-up: This case was reported by a physician and described the occurrence of injection site pseudolymphoma in a 4 yr old female subject who was vaccinated with combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and haemophilus influenzae type B vaccine (Infanrix quinta) for prophylaxis. This case was linked to 5 other cases (same reporter: B0299670A, B0307654A, B0307666A, B0387553A, and B0387668A) describing the same event (injection site pseudolymphoma) and published in the literature. Co suspect vaccination included pneumococcal vaccine in unk gluteal given on an unspecified date. At unspecified dates, the subject received unspecified dose number of Infanrixquinta (unk route, unk gluteal, batch number not available). At an unspecified date, the subject develo9ped eczema (before or after vaccination). In 2004, at an unspecified time after vaccination with Infanrixquinta, the subject developed two injection site pruriginous nodules in each gluteal. A biopsy was performed and was consistent with a histological diagnosis of pseudolymphoma. Patch test was positive to aluminum.l At the time of reporting, the events were unresolved (one year after beginning). This case was assessed as medically serious by manf (OMIC). The physician considered the nodules were probably related to vaccination with Infanrixquinta and Prevnar. Causality relationship was not assessed for eczema.

VAERS ID:244941 (history)  Vaccinated:0000-00-00
Age:4.0  Onset:2005-07-11
Gender:Female  Submitted:2005-10-04, Days after onset: 85
Location:Foreign  Entered:2005-10-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: blood culture streptococcus pneumoniae, no serotype identified, test results were white blood cell count 26.9 k/ul (4.5-10.5), neutrophil count 24.924 k/ul 92.4% ( 1.1-6.6) and chest x ray results suggestive of left basal bronchopneumonia.
CDC Split Type: HQWYE732829SEP05
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETHUNK2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Bacterial infection, Drug ineffective, Neutropenia, Peritonitis, Pneumonia, Sepsis, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer, the mother of a 4 year old female patient who received a third dose in Mar 2002. On Jul 11 2005, the child developed left basal pneumococcal pneumonia, pneumococcal bacteremia and abdominal pain. Relevant medical history was not provided. Indication for Prevenar was immunization. Product was administered in Mar 2002. Dose regimen was 0.5 ml 1 time per day (intramuscular). Concomitant medication were not reported. In Mar 2002, the patient received a third dose of Prevenar. On July 11 2005, the patient experienced abdominal pain and the reporter stated she was initially diagnosed with peritonitis. On the same day, a chest x ray, was performed which was suggestive of left basal bronchopneumonia. A diagnosis of pneumonia was made and the patient was hospitalizes. A hemoculture was performed on an unspecified date during her hospitalization which isolated streptococcus pneumoniae ( pneumococcal bacteremia). the serotype was not identified. After 12 days, the patient was discharged with a diagnosis of left basal pneumococcal pneumonia (drug ineffective). The patient recovered from the left basal pneumococcal pneumonia. The out come of the abdominal pain, pneumococcal bacteremia and drug infective was unknown. This report was received from a manufacturer. On Jul 11 2005 test results were white blood cell count 26.9 k/ul (4.5-10.5), neutrophil count 24.924 k/ul 92.4% ( 1.1-6.6) and chest x ray results suggestive of left basal bronchopneumonia. Additionally, a blood culture streptococcus pneumoniae, no serotype identified, was done on an unspecified date in Jul 2005. No additional information was available at the time of this report.

VAERS ID:245910 (history)  Vaccinated:2005-10-03
Age:4.0  Onset:2005-10-04, Days after vaccination: 1
Gender:Male  Submitted:2005-10-20, Days after onset: 16
Location:Foreign  Entered:2005-10-24, 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:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0510USA06946
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERX1321 UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERX1321 UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1001P UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Injection site reaction
SMQs:
Write-up: Information has been received from a health professional concerning a 4 year old male who on Oct 3 2005 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)(lot # NB41890, 650125/1001P). Concomitant vaccination that day included a dose of diphtheria toxoid (+) pertussis acellular 5 component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (REPEVAX) (Batch X1321). On Oct 4 2005, the day after vaccination, the patient developed local cellulitis. On Oct 5 2005 the patient was seen again and the area was extending. The patient was admitted to the pediatric unit and received treatment with intravenous antibiotics. At the time of reporting, the patient had recovered. It was noted that the patient had no previous reaction to vaccinations. Other business partner numbers include E200504012. Additional information has been requested.

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