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Case Details (Sorted by Age)

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VAERS ID:343599 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Unknown  Submitted:2009-04-06
Location:Foreign  Entered:2009-04-06
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Echography, 2009, cellulitis
CDC Split Type: B0568311A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Echography abnormal, Erythema, Induration, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: This case was reported by a physician and described the occurrence of arm cellulitis in a 6-year-old subject of unspecified gender who was vaccinated with INFANRIX-polio (GlaxoSmithKline). In 2009, the subject received unspecified dose of INFANRIX-polio (unknown route, unknown injection site). Lot number not provided. In 2009, within hours of vaccination with INFANRIX-polio, the subject experienced arm redness and the next morning, extended swelling with induration. The physician considered the events were disabling. An echography was performed and showed cellulitis image. At the time of reporting the outcome of the events was unspecified.

VAERS ID:343841 (history)  Vaccinated:2009-01-21
Age:6.0  Onset:2009-01-21, Days after vaccination: 0
Gender:Female  Submitted:2009-04-09, Days after onset: 77
Location:Foreign  Entered:2009-04-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0568890A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B55BA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Erysipeloid, Injection site inflammation, Injection site injury, Injection site pain, Injection site warmth, Skin plaque
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority (# ES-AGEMED-608215236) and described the occurrence of injection site injury in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 21 January 2009 the subject received unspecified dose of INFANRIX (intramuscular). On 21 January 2009, a few hours later after vaccination with INFANRIX, the subject experienced injection site injury, erysipeloid plaque, injection site warmth, inflammation and injection site pain. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. The regulatory authority reported that the events were probably related to vaccination with INFANRIX. No further information was expected as this was all the information that regulatory authorities had. Therefore this case has been closed.

VAERS ID:343955 (history)  Vaccinated:2009-03-04
Age:6.0  Onset:2009-03-04, Days after vaccination: 0
Gender:Male  Submitted:2009-04-10, Days after onset: 36
Location:Foreign  Entered:2009-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0568648A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site injury, Injection site pain, Injection site warmth, Skin plaque
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority (# ES-AGEMED-808217236) and described the occurrence of injection site injury in a 6-year-old male subject who was vaccinated with INFANRIX. On 4 March 2009, the subject received booster dose of INFANRIX (unknown route). Lot number not provided. On 4 March 2009, less than one day after vaccination with INFANRIX, the subject experienced injection site injury, skin plaque, injection site warmth and injection site pain. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 8 March 2009, the events were resolved. The regulatory authority reported that the events probably related to vaccination with INFANRIX. The Regulatory Authority had provided all the available information, no further information was expected. Therefore the case has been closed by regulatory authority.

VAERS ID:344136 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Female  Submitted:2009-04-14
Location:Foreign  Entered:2009-04-14
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: Anti-HBs antibody, 80UI/L; Blood test, normal; CSF culture, negative; Campylobacter like organism te, negative; Cytomegalovirus test, negative; electroneuromyography, see text; Epstein-Barr virus test, negative; HIV test, negative; Herpes s
CDC Split Type: B0569048A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNRA
Administered by: Other     Purchased by: Other
Symptoms: Anti-HBs antibody positive, Areflexia, Asthenia, Blood electrolytes normal, Blood product transfusion, Blood test normal, CSF culture negative, CSF glucose normal, CSF protein increased, CSF white blood cell count negative, Culture stool negative, Culture urine negative, Cytomegalovirus test negative, Demyelination, Electromyogram abnormal, Epstein-Barr virus test negative, Guillain-Barre syndrome, HIV test negative, Helicobacter pylori identification test negative, Herpes simplex serology negative, Hypotonia, Liver function test normal, Lumbar puncture abnormal, Mycoplasma serology, Nerve conduction studies abnormal, Neurological examination abnormal, Nuclear magnetic resonance imaging normal, Renal function test normal, Syphilis test negative
SMQs:, Rhabdomyolysis/myopathy (broad), Liver infections (narrow), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (broad)
Write-up: This case was reported in a literature article and described the occurrence of GUILLAIN BARRE Syndrome in a 6-year-old female subject who was vaccinated with Hep B (manufacturer unspecified). The subject had no history of fever, diarrhea, jaundice or upper respiratory infection. There was no bladder or bowel involvement. On an unspecified date, the subject received unspecified dose of Hep B (unknown route, unknown, injection site, lot number not provided). 15 days after vaccination with Hep B, the subject was hospitalized with progressive weakness. Vital signs and anthropometry were in normal limits. Neurological examination revealed reduced power (2/5) and hypotonia in all extremities. Deep tendon reflexes were absent. Laboratories studies showed hemogram, serum electrolytes, renal and liver function tests were normal. Lumbar puncture revealed no white blood cells, 123 mg/dl protein and 60 mg/dl glucose. CSF culture, urine and stool culture were normal. Serologic tests for Campylobacter Jejuni, HIV, HSV, Cytomegalovirus, VDRL test, Epstein-Barr virus and Mycoplasma were negative. Anti-HAV IgG level in serum was positive. HBsAg was non-reactive and anti-HBs titer was 80 UI/L. Nerve conduction and electromyography revealed demyelination damage. Spinal MRI was normal. On the basis of the clinical and laboratory findings, the subject was diagnosed with GUILLAIN BARRE Syndrome. The subject was treated with normal Immunoglobulins for 5 days. The subject was discharged 10 days after admission. Physical examination at the end of the first month showed a 4/5 of the muscle power. Aside from absent tendon reflexes in the lower limbs, physical examination was normal. At the time of reporting, the events were improved. The evidence about the relationship between Hep B vaccination and GUILLAIN BARRE Syndrome was still inadequate. No further information could be obtained; therefore the case has been closed.

VAERS ID:344226 (history)  Vaccinated:2009-02-09
Age:6.0  Onset:2009-02-10, Days after vaccination: 1
Gender:Female  Submitted:2009-04-15, Days after onset: 63
Location:Foreign  Entered:2009-04-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: CLARITHROMYCIN
Current Illness: FEVER AND COUGH (VIROSIS)
Preexisting Conditions:
Diagnostic Lab Data: Borrelia burgdorferi serology, 13Feb2009, negative; Cerebrospinal fluid protein, 02Mar2009, 1.2g/l; Electromyogram, 02Mar2009, see text; Epstein-Barr virus serology, 13Feb2009, negative; Herpes simplex serology, 13Feb2009, negative; Lumbar
CDC Split Type: B0569500A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMRL
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRL
Administered by: Other     Purchased by: Other
Symptoms: Areflexia, Borrelia burgdorferi serology negative, CSF cell count normal, CSF protein increased, Culture stool negative, Culture urine negative, Electromyogram abnormal, Epstein-Barr virus test negative, Facial palsy, Guillain-Barre syndrome, Herpes simplex serology negative, Immunology test, Injection site inflammation, Lumbar puncture abnormal, Myalgia, Paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a regulatory authority (# MA20090478, 09-1062 and MA20090480) and described the occurrence of Guillain Barre syndrome in a 6.5-year-old female subject who was vaccinated with INFANRIXTETRA (GlaxoSmithKline). Concurrent medical conditions included fever and cough (virosis). Concurrent medications included NAXY. On 9 February 2009, the subject received intramuscularly a booster dose of INFANRIXTETRA in right thigh (batch number not available). On 24 February 2009, 1 day after vaccination with INFANRIXTETRA, the subject experienced inflammation of right thigh. On 13 February 2008, a febrile cough was treated during 05 to 07 days with clarithromycin. Stool culture, urine culture, borrelia serology, Epstein-Barr virus serology and herpes simplex virus serology were negative. Cytomegalovirus was suspected. On 24 February 2009, the subject presented with inferior limb myalgia predominant on right side. On 28 February 2009, the subject experienced bilateral facial paralysis predominant on left side and paralysis predominant at inferior limbs. Then, soft palate paralysis occurred without deglutition disorder. On 02 March 2009, the subject was hospitalised. At clinical exam the subject presented areflexia at lower limbs level. Electromyogram revealed a latent period increased and mild slowdown of conduction''s latency suggestive of Guillain-Barre syndrome. Lumbar puncture showed absence of cell and normal immunofluorescence. Cerebrospinal fluid protein was at 1.2 g/l. Clinical course was favourable with TEGELINE treatment during 02 days since 02 March 2009. On 09 March 2009, the subject was completely recovered and was discharged from hospital after 07 days of hospitalization. The agency considered Guillain-Barre syndrome as possibly related to vaccination with INFANRIXTETRA, according to the foreign method of imputability.

VAERS ID:344945 (history)  Vaccinated:2008-06-10
Age:6.0  Onset:2008-09-24, Days after vaccination: 106
Gender:Female  Submitted:2009-04-27, Days after onset: 215
Location:Foreign  Entered:2009-04-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0061389A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TBE: TICK-BORNE ENCEPH (NO BRAND NAME)UNKNOWN MANUFACTURERVNR1G18F IMUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B028AG IMUN
Administered by: Other     Purchased by: Other
Symptoms: No reaction on previous exposure to drug, Type 1 diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)
Write-up: This case was reported by a regulatory authority (DE-PEI-PEI2009008401) and described the occurrence of juvenile type 1 diabetes mellitus in a 7-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Co-suspect vaccine included FSME immune junior (Baxter). Former vaccinations with tick-borne encephalitis vaccine on 05 June and 03 July 2007 and with TdPa vaccine on 22 January, 26 March, 09 July 2002 and 14 August 2003 were well tolerated. On 10 June 2008 the subject received booster dose of BOOSTRIX (intramuscular, unknown injection site), unspecified dose of FSME immun (intramuscular, unknown injection site). On 24 September 2008, 3 months after vaccination with BOOSTRIX and FSME immun, the subject experienced juvenile type 1 diabetes mellitus. This case was assessed as medically serious by GSK. At the time of reporting the event was unresolved. No further information will be available.

VAERS ID:345532 (history)  Vaccinated:2009-02-14
Age:6.0  Onset:2009-02-23, Days after vaccination: 9
Gender:Male  Submitted:2009-05-01, Days after onset: 66
Location:Foreign  Entered:2009-05-04, Days after submission: 3
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Rheumatic purpura
Diagnostic Lab Data: renal biopsy, 23Feb09, rheumatic purpura; diagnostic laboratory test, 17Mar09, creatininaemia: 45 umol/l; diagnostic laboratory test, 17Mar09, uremia 5.7 mmol/l; urine protein, 23Feb09, 1.14 g/l, proteinuria; urine protein, 17Mar09, 1.92 g/
CDC Split Type: WAES0904USA04338
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Azotaemia, Biopsy kidney abnormal, Condition aggravated, Henoch-Schonlein purpura, Hypercreatininaemia, Laboratory test abnormal, Proteinuria, Urine protein, quantitative
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Vasculitis (narrow), Chronic kidney disease (narrow), Hypersensitivity (narrow), Arthritis (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad)
Write-up: Information has been received from a health authority (reference numbers ES20090127 and 09121) concerning a 6 year old male with a history of rheumatic purpura associated with nephropathy treated with corticosteroids (by IV and per os) between April and August 2007 and recurred in January 2008 who on 13-JAN-2009 was vaccinated IM with his first dose of RECOMBIVAX HB (lot number and site not reported). On 14-FEB-2009 he was vaccinated IM with his second dose of RECOMBIVAX HB (lot number and site not reported). On 23-FEB-2009 the patient experienced recurrence of rheumatic purpura which was confirmed on renal biopsy and associated necrotic purpura, arthralgia and proteinuria at 1.14 g/L. On 17-MAR-2009 his outcome was stable without impairment of kidney function. He was found to have proteinuria at 1.92 g/L, creatininaemia at 45 u mol/L and uremia at 5.7 m mol/L. It is noteworthy that the patient had a history of rheumatic purpura associated with nephropathy treated with corticosteroids by intravenous and oral route (also reported os) between April and August 2007 which recurred in January 2008. Rheumatic purport was considered to be immediately life-threatening. The health authority assessed the causal relationship between the reported reaction and vaccination as "doubtful." Other business partner numbers included: E2009-03537. Additional information has been requested.

VAERS ID:345605 (history)  Vaccinated:2009-03-27
Age:6.0  Onset:0000-00-00
Gender:Female  Submitted:2009-05-04
Location:Foreign  Entered:2009-05-04
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: B0572634A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B063B6 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, Injection site inflammation, Injection site oedema, Injection site pruritus, Injection site warmth
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 (# ES-AGEMED-424923432) and described the occurrence of injection site induration in a 6year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 27 March 2009, the subject received unspecified dose of INFANRIX (intramuscular, right forearm). In March 2009, less than one week after vaccination with INFANRIX, the subject experienced injection site induration (20 cm of diameter) with edema, inflammation, pruritus and warmth at injection site. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with URBASON, POLARAMINE, PARACETAMOL and ice pack. At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX. The foreign Regulatory Authority has provided all the available information. They will send further information when they receive it. This case was considered closed.

VAERS ID:345741 (history)  Vaccinated:2009-04-15
Age:6.0  Onset:2009-04-18, Days after vaccination: 3
Gender:Female  Submitted:2009-05-05, Days after onset: 17
Location:Foreign  Entered:2009-05-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0572636A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B071CB IMUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority (#ES-AGEMED-917048235) and described the occurrence of induration in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included MMR (non-GSK) (Sanofi Pasteur; intramuscular; unknown injection site) given on 15 April 2009. On 15 April 2009, the subject received unspecified dose of INFANRIX (intramuscular, unknown injection site). On 18 April 2009, 3 days after vaccination with INFANRIX, the subject experienced induration around the arm to the chest muscle. The regulatory authority reported that the event was clinically significant (or requiring intervention). On 19 April 2009, the event was resolved. The regulatory authority reported that the event was probably related to vaccination with INFANRIX. No further information expected, this case has therefore been considered closed.

VAERS ID:345816 (history)  Vaccinated:2008-11-09
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2009-05-06
Location:Foreign  Entered:2009-05-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: TOURETTE''S SYNDROME
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0061424A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B028BF0UNLA
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Encephalitis, Grimacing, Tic, Tourette's disorder, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Congenital, familial and genetic disorders (narrow), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad)
Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2009008608) and described the occurrence of possible focal encephalitis in a 6-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 09 November 2008 the subject received the first dose of BOOSTRIX (0.5 ml, unknown). At an unspecified time post vaccination with BOOSTRIX, on an unknown date, the subject experienced possible focal encephalitis and Tourette''s syndrome with uncontrollable tics including movement, shaking and vocal tics, and grimacing. The events were confirmed by clinical examinations, anamnesis and electroacupuncture tests. This case was assessed as medically serious by GSK criteria. At the time of reporting, on 10 March 2009, the events were unresolved. The vaccination course with BOOSTRIX was discontinued. The reporter considered that suspected focal encephalitis may have been caused by vaccination with BOOSTRIX. The reporter to the foreign regulatory authority contained a covering letter from a public health agency. The public health agency reported that the subject''s concurrent medical conditions included Tourette''s syndrome. The public health agency stated not having received any report about encephalitis and that no results of cerebrospinal fluid (CSF) examinations have been provided. No further information will be available.

VAERS ID:346541 (history)  Vaccinated:2009-04-09
Age:6.0  Onset:2009-04-10, Days after vaccination: 1
Gender:Male  Submitted:2009-05-18, Days after onset: 38
Location:Foreign  Entered:2009-05-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 10Apr2009, 39deg C
CDC Split Type: B0574112A
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37034BD IMLA
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Convulsion, Injection site urticaria, Loss of consciousness, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (#98458) and described the occurrence of convulsion in a 6-year-old male subject who was vaccinated with BOOSTRIX, GlaxoSmithKline, (new strain) PRIORIX. On 9 April 2009, the subject received unspecified dose of BOOSTRIX (intramuscular, unknown injection site), unspecified dose of PRIORIX (unknown injection site). On 10 April 2009, 1 day after vaccination with BOOSTRIX and PRIORIX, the subject experienced convulsion like loss of consciousness and relaxing sphincter. No tonic-clonic jerks occurred. The subject experienced fever (39 deg C) and injection site urticaria for 3 days. This case was assessed as medically serious by GSK. The subject was treated with Paracetamol. On 12 April 2009, The events were resolved. The regulatory authority reported that the events were possibly related to vaccination with BOOSTRIX and PRIORIX.

VAERS ID:346749 (history)  Vaccinated:2009-01-26
Age:6.0  Onset:2009-01-26, Days after vaccination: 0
Gender:Female  Submitted:2009-05-20, Days after onset: 113
Location:Foreign  Entered:2009-05-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: B0574156A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B71AB IMUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Skin reaction
SMQs:, Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (ES-AGEMED-920948241) and described the occurrence of skin reactions in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline), MMR vaccine (non-GSK). On 26 January 2009, the subject received unspecified dose of INFANRIX (intramuscular, unknown injection site), unspecified dose of MMR vaccine (Non-GSK) (subcutaneous, unknown injection site). On 26 January 2009, less than one day after vaccination with INFANRIX and MMR vaccine (Non-GSK), the subject experienced generalised skin reaction all over the body. The regulatory authority reported that the event was clinically significant (or requiring intervention). The subject was treated with URBANSO and ATARAX. On 28 January 2009, the event was resolved. The regulatory authority reported that the event was possibly related to vaccination with INFANRIX and MMR vaccine (Non-GSK). No further information was expected as this was all the available information the regulatory authority had; they will send additional information if they receive it.

VAERS ID:347174 (history)  Vaccinated:2009-01-26
Age:6.0  Onset:2009-01-26, Days after vaccination: 0
Gender:Female  Submitted:2009-05-22, Days after onset: 115
Location:Foreign  Entered:2009-05-26, 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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0905USA01974
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Skin reaction
SMQs:, Hypersensitivity (narrow)
Write-up: Information has been received from an agency concerning a 6 year old female who on 26-JAN-2009, was vaccinated SC with MMR II. Concomitant therapy included INFANRIX. On 26-JAN-2009, the patient suffered a systemic reaction that consisted of a generalized skin reaction all over her body. On 28-JAN-2009, after treatment at a primary care center with methylprednisolone and ATARAX for 48 hours, the patient recovered. Generalized skin reaction was considered an other important medical event. Other business partners numbers include: E2009-04072. No further information is available.

VAERS ID:347220 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Unknown  Submitted:2009-05-26
Location:Foreign  Entered:2009-05-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0061700A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Facial paresis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: This case was reported by a physician and described the occurrence of facial nerve paresis in a 6-year-old subject of unspecified gender who was vaccinated with (ENGERIX B pediatric, GlaxoSmithKline). In 1999 the subject received 1st dose of ENGERIX B pediatric (unknown route and application site). In 1999, 1 day after vaccination with ENGERIX B pediatric, the subject experienced facial nerve paresis at the left side. This case was assessed as medically serious by GSK. After two to three weeks the event was resolved. Follow-up information has been requested.

VAERS ID:347939 (history)  Vaccinated:2009-05-08
Age:6.0  Onset:2009-05-08, Days after vaccination: 0
Gender:Female  Submitted:2009-05-28, Days after onset: 20
Location:Foreign  Entered:2009-05-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0575404A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B078AA IMUN
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALSA69CB687A SCUN
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a regulatory authority (ES-AGEMED-915447133) and described the occurrence of syncope convulsive in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline), (new strain) PRIORIX. On 8 May 2009, the subject received unspecified dose of INFANRIX (intramuscular, unknown injection site), unspecified dose of PRIORIX (subcutaneous, unknown injection site)0. On 8 May 2009, less than one day after vaccination with INFANRIX and PRIORIX, the subject experienced syncope convulsive and loss of consciousness. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX and PRIORIX. No further information is expected, the foreign Medicines Agency has provided us with all the available information for the time being. The case is closed.

VAERS ID:348130 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Female  Submitted:2009-05-29
Location:Foreign  Entered:2009-05-29
Life Threatening? Yes
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Dog bite right upper arm (grade III)
Diagnostic Lab Data:
CDC Split Type: MA20091313
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABIPUR)NOVARTIS VACCINES AND DIAGNOSTICS 3IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: CSF test abnormal, Death, Myalgia, Oedema, Pyrexia, Quadriparesis, Rabies, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad)
Write-up: We received the following literature report: A six-year-old girl presented with sudden onset of quadriparesis for one day, preceded by fever, myalgia, and vomiting for four days. There was also a history of a dog bite in her right upper arm (grade III bite) three weeks back. The child was given the PCEC vaccine as per schedule in the deltoid and received a total of four doses before the development of any symptoms. In that case also RIG was not given though it was indicated. The patient was treated conservatively, but the clinical features and the progression of disease was similar to the first case, except for the presence of myoedema, a striking feature of rabies. In spite of good supportive measures, she expired on the 12th day of disease onset. Results of laboratory investigations on the 11th day of the illness were also quite similar to the first case. The CSF test was strongly positive for rabies antigen and immune complexes. Neutralizing antibodies to rabies virus were detected in both serum and CSF by the Rapid Fluorescent Focus Inhibition Test (RFFIT). Seriousness criteria: fatal, life-threatening, hospitalisation. Causality: not related. Rabies is an infectious disease and not due to vaccination. Paralytic rabies is not expected after vaccination with RABIPUR. No change in benefit-nsk-ratio. No measures necessary.

VAERS ID:348949 (history)  Vaccinated:2009-05-04
Age:6.0  Onset:2009-05-05, Days after vaccination: 1
Gender:Male  Submitted:2009-06-11, Days after onset: 37
Location:Foreign  Entered:2009-06-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0576888A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B078AA UNRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority ( # ES-AGEMED-82504332) and described the occurrence of induration erythema in a 6-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 4 May 2009, the subject received unspecified dose of INFANRIX (unknown route of administration). On 5 May 2009, 1 day after vaccination with INFANRIX, the subject experienced a 15cm induration erythema with injection site warmth, redness and inflammation. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 11 May 2009, the events were resolved. The regulatory authority reported that the events were probably related to vaccination with INFANRIX. No further information is expected; this case has therefore been closed.

VAERS ID:349960 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Unknown  Submitted:2009-06-23
Location:Foreign  Entered:2009-06-24, 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: Medical history and concomitant medications were not reported. The patient was noncompromised and had previously received a 4-dose series of PENTACEL.
Diagnostic Lab Data: Positive culture from a normally sterile site.
CDC Split Type: 200902632
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR 3UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Culture positive, Haemophilus infection, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Initial report received on 15 June 2009 from a literature article search. The uniform use in foreign country of a single Hib vaccine in combination with DTaP, and IPV (DTaP.IPV/Hib) facilitates ongoing assessment of vaccine effectiveness, including any effects of recently added concurrent vaccinations and increasing time since vaccination. Surveillance at 12 pediatric centers in 2004-2007 indicates that vaccine failures remain rare and case totals approach an irreducible minimum, with no age shift. In foreign country, recommended childhood vaccines are supplied free of charge to providers and children by the provincial governments. Since 1998, all provinces have supplied the same vaccine to prevent Hib infections, a PRP-T conjugate given in combination with DTaP, and IPV (DTaP.IPV/Hib, PENTACEL, Sanofi Pasteur Vaccines). The standard schedule recommends doses at 2, 4, 6, and 18 months of age. The uniformity of Hib vaccination during this time affords an unusual opportunity to observe the ongoing effectiveness of the combination vaccine, including any influences of coadministered vaccines (eg, pneumococcal conjugate) recently added to the infant immunization schedule or any indication of waning immunity with increasing time since immunization. The program has actively monitored Hib admissions at 10-12 hospitals since 1994. The 12 current centers account for over 90% of foreign country''s tertiary care pediatric beds and admit over 75,000 children annually. Retrospective surveillance identified a preimmunization era (1985) annual total of 485 Hib cases, roughly half of the national total reported for children. By 1994, Hib admissions at centers totaled only 24, as a result of diverse programs with several conjugate vaccines. During 1998-2003, when all provinces used the same DTaP.IPV/PRP-T vaccine, we reported annual case totals ranging from 3 to 16 (period average 8.8 cases). Most cases involved unimmunized or incompletely immunized children. The number of vaccine failures after 3 or 4 doses was remarkably uniform at 1-3 per year, with one-third occurring in immunocompromised children. During 2004-2007, provincial program uniformity remained and program surveillance continued as previously described. Case-finding involved reviews of laboratory data and discharge diagnoses. Cases had a positive culture from a normally sterile site. Immunization history was obtained for each case, mainly from provider records. Cases were categorized as local (from the metropolitan area served by a center) or referred (from beyond the metro area). The incidence rate was calculated for local cases, using the 2004 census data for metropolitan area populations, age 0-16 years. A second incidence rate was calculated for local cases that occurred despite age-appropriate primary Hib vaccination. The center was excluded from incidence calculations for lack of a defined primary catchment area. Of the 25 cases reported, 11 were incompletely immunized infants <12 months of age, 4 were unimmunized children ($g/=2 years of age), and 10 had completed age-appropriate primary immunization and represented vaccine failures. One failure in 2007 followed PROHIBIT (Connaught Laboratories) vaccination in 1992, in a 17-year-old with respiratory compromise. The remaining breakthrough cases had received PRP-T vaccine. Only 7 cases were local, arising from a population of 1,486,507 children 0-16 years old. Three of the 7 cases were failures after PRP-T vaccination. Thus, the overall incidence rate for Hib infection in 2004-2007 was 0.10 per 100,000 (95% confidence interval [CI]: 0.04-0.22) and the overall rate of PRP-T vaccine failure was 0.05 per 100,000 (95% CI: 0.01-0.15). This case is for a 6 year old noncompromised patient, who had previously received a four dose series of PENTACEL (lot number not reported) and developed Invasive Haemophilus Influenzae Type b in 2005. The other cases of HIB infections following age appropriate immunization are discussed in 2009-02596,

VAERS ID:349961 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Unknown  Submitted:2009-06-23
Location:Foreign  Entered:2009-06-24, 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: Medical history and concomitant medications were not reported. The patient was noncompromised and had previously received a 4-dose series of PENTACEL.
Diagnostic Lab Data: Positive culture from a normally sterile site.
CDC Split Type: 200902633
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR 3UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Culture positive, Haemophilus infection, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Initial report received on 15 June 2009 from a literature article search. The uniform use in foreign country of a single Hib vaccine in combination with DTaP.IPV/Hib facilitates ongoing assessment of vaccine effectiveness, including any effects of recently added concurrent vaccinations and increasing time since vaccination. Surveillance at 12 pediatric centers in 2004-2007 indicates that vaccine failures remain rare and case totals approach an irreducible minimum, with no age shift. In this country, recommended childhood vaccines are supplied free of charge to providers and children by the provincial governments. Since 1998, all provinces have supplied the same vaccine to prevent Hib infections, a PRP-T conjugate given in combination with DTaP.IPV/Hib, (PENTACEL, Sanofi Pasteur Vaccines, foreign). The standard schedule recommends doses at 2, 4, 6, and 18 months of age. The uniformity of Hib vaccination during this time in this foreign country affords an unusual opportunity to observe the ongoing effectiveness of the combination vaccine, including any influences of coadministered vaccines (eg, pneumococcal conjugate) recently added to the infant immunization schedule or any indication of waning immunity with increasing time since immunization. The foreign program has actively monitored Hib admissions at 10-12 hospitals since 1994. The 12 current program centers account for over 90% of this countries tertiary care pediatric beds and admit over 75,000 children annually. Retrospective surveillance identified a preimmunization era (1985) annual total of 485 Hib cases, roughly half of the national total reported for children. By 1994, Hib admissions at program centers totaled only 24, as a result of diverse programs with several conjugate vaccines. During 1988-2003, when all provinces used the same DTaP.IPV/PRP-T vaccine, we reported annual case totals ranging from 3 to 16 (period average 8.8 cases). Most cases involved unimmunized or incompletely immunized children. The number of vaccine failures after 3 or 4 doses was unremarkably uniform at 1-3 per year, with one-third occurring in immunocompromised children. Patients and During 2004-2007, provincial program uniformity remained and program surveillance continued as previously described. Case-finding involved reviews of laboratory data and discharge diagnoses. Cases had a positive culture from a normally sterile site. Immunization history was obtained for each case, mainly from provider records. Cases were categorized as local (from the metropolitan area served by a center) or referred (from beyond the metro area). The incidence rate was calculated for local case, using the 2004 census data for metropolitan area populations, age 0-16 years. A second incidence rate was calculated for local cases that occurred despite age-appropriate primary Hib vaccination. The center in the foreign city was excluded from incidence calculations for lack of a defined primary catchment area. Of the 25 cases reported, 11 were incompletely immunized infants <12 months of age, 4 were unimmunized children ($g/=2 years of age), and 10 had completed age-appropriate primary immunization and represented vaccine failures. One failure in 2007 followed PRP-D (ProHIBit, Connaught Laboratories) vaccination 1992, in a 17-year-old with respiratory compromise. The remaining breakthrough cases had received PRP-T vaccine. On 7 cases were local, arising from a population of 1,486,507 children 0-16 years old. Three of the 7 cases were failures after PRP-T vaccination. Thus, the overall incidence rate for Hib infection in 2004-2007 was 0.10 per 100,000 (95% confidence interval [CI]: 0.04-0.22) and the overall rate of PRP-T vaccine failure was 0.05 per 100,000 (95% CI: 0.01-0.15). This case is for a 6 year old noncompromised patient, who had previously received a four dose series of PENTACEL (lot number not reported) and developed Invasive Haemophilus Influenzae Type b in 2004. The other cases of HIB infections following a

VAERS ID:349962 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Unknown  Submitted:2009-06-23
Location:Foreign  Entered:2009-06-24, 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: Medical history and concomitant medications were not reported. The patient was immunocompromised and had previously received a 4-dose series of PENTACEL.
Diagnostic Lab Data: Positive culture from a normally sterile site.
CDC Split Type: 200902634
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR 3UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Culture positive, Haemophilus infection, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Initial report received on 15 June 2009 from a literature article search. The uniform use in foreign country of a single Hib vaccine in combination with DTaP.IPV/Hib facilitates ongoing assessment of vaccine effectiveness, including any effects of recently added concurrent vaccinations and increasing time since vaccination. Surveillance at 12 pediatric centers in 2004-2007 indicates that vaccine failures remain rare and case totals approach an irreducible minimum, with no age shift. In this country, recommended childhood vaccines are supplied free of charge to providers and children by the provincial governments. Since 1998, all provinces have supplied the same vaccine to prevent Hib infections, a PRP-T conjugate given in combination with DTaP.IPV/Hib, (PENTACEL, Sanofi Pasteur Vaccines, foreign). The standard schedule recommends doses at 2, 4, 6, and 18 months of age. The uniformity of Hib vaccination during this time in this country affords an unusual opportunity to observe the ongoing effectiveness of the combination vaccine, including any influences of coadministered vaccines (eg, pneumococcal conjugate) recently added to the infant immunization schedule or any indication of waning immunity with increasing time since immunization. The foreign program has actively monitored Hib admissions at 10-12 hospitals since 1994. The 12 current program centers account for over 90% of this countries tertiary care pediatric beds and admit over 75,000 children annually. Retrospective surveillance identified a preimmunization era (1985) annual total of 485 Hib cases, roughly half of the national total reported for children. By 1994, Hib admissions at program centers totaled only 24, as a result of diverse programs with several conjugate vaccines. During 1998-2003, when all provinces used the same DTaP.IPV/PRP-T vaccine, we reported annual case totals ranging from 3 to 16 (period average 8.8 cases). Most cases involved unimmunized or incompletely immunized children. The number of vaccine failures after 3 or 4 doses was remarkably uniform at 1-3 per year, with one-third occurring in immunocompromised children. Patients and During 2004-2007, provincial program uniformity remained and program surveillance continued as previously described. Case-finding involved reviews of laboratory data and discharge diagnoses. Cases had a positive culture from a normally sterile site. Immunization history was obtained for each case, mainly from provider records. Cases were categorized as local (from the metropolitan area served by a center) or referred (from beyond the metro area). The incidence rate was calculated for local cases, using the 2004 census data for metropolitan area populations, age 0-16 years. A second incidence rate was calculated for local cases that occurred despite age-appropriate primary Hib vaccination. The center in this foreign city was excluded from incidence calculations for lack of a defined primary catchment area. Of the 25 cases reported, 11 were incompletely immunized infants <12 months of age, 4 were unimmunized children ($g/=2 years of age), and 10 had completed age-appropriate primary immunization and represented vaccine failures. One failure in 2007 followed ProHIBit (Connaught Laboratories) vaccination in 1992, in a 17-year-old with respiratory compromise. The remaining breakthrough cases had received PRP-T vaccine. Only 7 cases were local, arising from a population of 1,486,507 children 0-16 years old. Three of the 7 cases were failures after PRP-T vaccination. Thus, the overall incidence rate for Hib infection in 2004-2007 was 0.10 per 100,000 (95% confidence interval [CI]: 0.04-0.22) and the overall rate of PRP-T vaccine failure was 0.05 per 100,000 (95% CI: 0.01-0.15). This case is for a 6 year old immunocompromised patient, who had previously received a four dose series of PENTACEL (lot number not reported) and developed Invasive Haemophilus Influenzae Type b in 2004. The other cases of HIB infections following age appr

VAERS ID:350732 (history)  Vaccinated:2008-11-14
Age:6.0  Onset:2008-11-14, Days after vaccination: 0
Gender:Male  Submitted:2009-06-19, Days after onset: 216
Location:Foreign  Entered:2009-06-25, 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:
Preexisting Conditions: Pregnant: NA
Diagnostic Lab Data:
CDC Split Type: 200814352
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Report received from a nurse of a surgery via Wyeth Pharmaceuticals on 17-Nov-2008. A 6-year-old boy (DOB: unknown) received ENZIRA (lot-number and dose unknown) on 11-Oct-2008 for influenza immunisation. He was given also a dose on 14-Nov-2008. It was last year that he had the 2 vaccines for the first time. He has been fine since having the vaccine. No seriousness criterion mentioned. The company considered this event to be unassessable/unclassifiable. Information derived from this AE report does not change the current safety profile of ENZIRA (Fluvax).

VAERS ID:350294 (history)  Vaccinated:2009-05-26
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2009-06-26
Location:Foreign  Entered:2009-06-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0580402A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B078BD UNUN
Administered by: Other     Purchased by: Other
Symptoms: Lymphadenitis, Skin oedema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (# ES-AGEMED-425103432) and described the occurrence of lymphadenitis in a 6-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 26 May 2009, the subject received unspecified dose of INFANRIX (unknown route, right arm). In May 2009, less than one week after vaccination with INFANRIX, the subject experienced lymphadenitis, edema of skin and urticaria. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. The regulatory authority reported that the events were probably related to vaccination with INFANRIX. This was all the available information the regulatory authority had. If they receive additional details, they will send them in a proactive way. Therefore the case is considered closed.

VAERS ID:350295 (history)  Vaccinated:2009-05-07
Age:6.0  Onset:2009-05-08, Days after vaccination: 1
Gender:Female  Submitted:2009-06-26, Days after onset: 49
Location:Foreign  Entered:2009-06-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 08May2009, 38deg C
CDC Split Type: B0580450A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B055BA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site pain, Pyrexia, Reactogenicity event
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a foreign regulatory authority (# ES-AGEMED-325120432) and described the occurrence of reactogenicity event in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 7 May 2009 the subject received unspecified dose of INFANRIX (unknown). On 8 May 2009, 1 day after vaccination with INFANRIX, the subject experienced reactogenicity event, injection site induration, injection site pain, injection site redness and fever 38 deg C. The subject went to the emergency room where antibiotic with ZINNAT was prescribed. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 10 May 2009, the events were resolved. The regulatory authority reported that the events were probably related to vaccination with INFANRIX. No further information was available as this was all the information that regulatory authorities had.

VAERS ID:350386 (history)  Vaccinated:2009-05-01
Age:6.0  Onset:2009-05-07, Days after vaccination: 6
Gender:Male  Submitted:2009-06-29, Days after onset: 53
Location:Foreign  Entered:2009-06-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0580356A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B063BG UNLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Lip oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (# ES-AGEMED-925107332) and described the occurrence of lip edema in a 6-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). In May 2009, the subject received unspecified dose of INFANRIX (unknown route and injection site). On 7 May 2009, less than one month after vaccination with INFANRIX, the subject experienced lip edema and injection site pain. The subject was hospitalised. On 7 May 2009, the events were resolved. The regulatory authority reported that the events were probably related to vaccination with INFANRIX. Further information is not expected as the country regulatory authority has provided all the information available. This case has therefore been closed.

VAERS ID:350803 (history)  Vaccinated:2006-06-13
Age:6.0  Onset:2009-04-27, Days after vaccination: 1049
Gender:Female  Submitted:2009-07-06, Days after onset: 70
Location:Foreign  Entered:2009-07-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Acute Otitis Media; Bronchitis; Eczema; Rhino Pharyngitis; DTP (Revaxis) at 06-years-old; No known case of pertussis in neighbourhood
Diagnostic Lab Data: Body temperature, 2009, increased; Chest X-ray, 2009, normal; Lymphocyte count, 2009, 36.5percent; Monocyte count, 2009, 2.4percent; Neutrophil count, 2009, 59.9percent; Pertussis serology, 2009, see text; White blood cell count, 2009, 1080
CDC Split Type: B0574111A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B042HA4IMLA
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSAC20B042HA4IMLA
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERAC20B042HA4IMLA
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Chest X-ray normal, Cough, Lymphocyte percentage, Monocyte percentage, Neutrophil percentage, Pertussis, Pertussis identification test positive, Pyrexia, Vaccination failure, White blood cell count increased, Wrong drug administered
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: This case was reported by a paediatrician via a GSK sales representative and described the occurrence of pertussis in a 09-year-old female subject who was vaccinated wiwth INFANRIXQUINTA (GlaxoSmithKline). This case was linked to case B05274113A (same reporter). Vaccinal history included four doses of INFANRIXQUINTA (batches, routes and injection sites unknown) during infancy followed by REVAXIS at 06-year-old. In 2009, several years after vaccination with INFANRIXQUINTA, the subject developed cough and fever. Cough persisted during 3 weeks despite treatment with ORELOX and AUGMENTIN. Serology was performed and was positive for anti-pertussis toxin, anti-filamentous-haemagglutinin and anti-adenylate cyclase-hemolysin antibodies. Pertussis was diagnosed. Antibiotics were thus switched to ZECLAR and the symptoms resolved. This case was assessed as medically serious by GSK. Upon follow-up received on 24 June 2009 by the paediatrician: Current and/or past medical conditions included eczema, rhinopharyngitis, bronchitis and acute otitis media. There was no case of pertussis in the subject''s circle. The subject''s vaccinal history included four doses of PENTACOQ (non GSK vaccine and not INFANRIXQUINTA as previously reported) intramuscularly on 18 January 2000 (batch R0807-1), 22 February 2000 (batch R0806-1), 03 May 2000 (batch T00115-1) and 18 May 2001 (W00271). On 13 June 2006, she received a booster dose of INFANRIX TETRA (AC20B042HA but reported as AC2080.42HA, intramuscularly, injection site unknown), instead of REVAXIS as previously reported on initial (wrong drug administered). On 27 April 2009, 34 months after vaccination with INFANRIXTETRA, the first symptoms of a moderate pertussis occurred. She firstly developed dry irritant cough followed by whooping cough. Fever was also reported. Full blood count showed white blood cells at 10800/mm3 with 59.9 percent of neutrophils, 36.5 percent of lymphocytes and 2.4 percent of monocytes. Lung Xray was normal. Detection of germ by polymerase chain reaction was not perfor

VAERS ID:350948 (history)  Vaccinated:2008-03-26
Age:6.0  Onset:2008-03-27, Days after vaccination: 1
Gender:Male  Submitted:2009-07-07, Days after onset: 467
Location:Foreign  Entered:2009-07-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0581384A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B068AD UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Injection site induration, Local reaction, Localised oedema, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a regulatory authority (# ES-AGEMED-125143232) and described the occurrence of injection site induration in a 6-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 26 March 2008 the subject received unspecified dose of INFANRIX (unknown). On 27 March 2008, 24 hours after vaccination with INFANRIX, the subject experienced local reaction with edema, injection site induration and strong and painful erythema in arm and forearm. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX. No further information was available as this was all the information that regulatory authorities had.

VAERS ID:351190 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Female  Submitted:2009-07-13
Location:Foreign  Entered:2009-07-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Examinations: Throat swab showed pertussis infection.
CDC Split Type: D0062239A
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cough, Culture throat positive, Pertussis
SMQs:, Anaphylactic reaction (broad)
Write-up: This case was reported by a physician, via a sales representative, and described the occurrence of pertussis in a 6-year-old female subject who was vaccinated with INFANRIX HEXA (GlaxoSmithKline) and BOOSTRIX (GlaxoSmithKline). On unspecified dates the subject received unspecified doses of INFANRIX HEXA (unknown route and application site) and 1st dose of BOOSTRIX (unknown route and application site). At an unspecified time after vaccination with INFANRIX HEXA and BOOSTRIX, the subject experienced cough. Throat swab showed pertussis infection. This case was assessed as medically serious by GSK. At the time of reporting, on 10 July 2009, the outcome of the events were was unspecified. Further information was requested. Please see also suffix case D0062240A for additional report regarding the same reporter.

VAERS ID:351202 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Female  Submitted:2009-07-13
Location:Foreign  Entered:2009-07-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Examinations: Throat swab showed pertussis infection.
CDC Split Type: D0062240A
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cough, Culture throat positive, Pertussis, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow)
Write-up: This case was reported by a physician, via a sales representative, and described the occurrence of pertussis in a 6-year-old female subject who was vaccinated with combined INFANRIX HEXA, (GlaxoSmithKline) and BOOSTRIX, (GlaxoSmithKline). On unspecified dates the subject received unspecified doses of INFANRIX HEXA (unknown route and application site) and 1st dose of BOOSTRIX (unknown route and application site). At an unspecified time after vaccination with INFANRIX HEXA and BOOSTRIX, the subject experienced cough. Throat swab showed pertussis infection (vaccination failure). This case was assessed as medically serious by GSK. At the time of reporting, on 10 July 2009, the outcome of the events were was unspecified. Further information was requested. Please see main case D0062239A for additional report regarding the same reporter.

VAERS ID:351875 (history)  Vaccinated:2009-07-10
Age:6.0  Onset:2009-07-10, Days after vaccination: 0
Gender:Female  Submitted:2009-07-17, Days after onset: 7
Location:Foreign  Entered:2009-07-20, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Previous vaccinations (not otherwise specified) were generally well tolerated. At the time of vaccination the patient''s sister suffered from angina tonsillaris.
Diagnostic Lab Data: on 10-Jul-09: pulmonary auscultation without pathological findings
CDC Split Type: E200905829
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2968A UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Pallor, Pulmonary function test normal, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Case received from a health care professional in country on 10-Jul-2009. It was reported by a paediatrician that a 6-year-old female patient was vaccinated with a booster dose of COVAXIS (lot # C2968AA, injection route and site not reported) on 10-Jul-2009. About 30 minutes p.v. the patient became pale and asthenic and fainted. She was responsive. Skin and pulmonary examination (auscultation) were without pathological findings. Under elevation of legs and intake of fluids (H2O) the patient recovered within a few minutes. For observation and investigation she was hospitalised the same day. Previous vaccinations (not otherwise specified) were generally well tolerated. At the time of vaccination the patient''s sister suffered from angina tonsillaris. The reporter pointed out that no signs of illness were seen be the patient before vaccination.

VAERS ID:352102 (history)  Vaccinated:2009-05-25
Age:6.0  Onset:2009-05-26, Days after vaccination: 1
Gender:Male  Submitted:2009-07-22, Days after onset: 57
Location:Foreign  Entered:2009-07-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: RHINITIS
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0062270A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, 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 hospital physician via a foreign regulatory authority (DE-PEI-PEI2009014916) and described the occurrence of hard swelling at injection site in a 6-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included rhinitis without fever. On 25 May 2009 the subject received a booster dose of BOOSTRIX (0.5 ml, intramuscular, left deltoid). This was the first dose of BOOSTRIX which the subject has received. Approximately one day post vaccination with BOOSTRIX, on 26 May 2009, the subject experienced hard swelling at injection site at the left arm deltoid of more than 10 cm, injection site redness, injection site pain and decreased mobility of left arm. the subject was hospitalised for an unknown period of time. At the time of reporting the outcome of the events was unspecified. No further information will be available.

VAERS ID:352665 (history)  Vaccinated:2005-01-21
Age:6.0  Onset:0000-00-00
Gender:Female  Submitted:2009-07-28
Location:Foreign  Entered:2009-07-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0907USA04323
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPIPV: DTP + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypotonic-hyporesponsive episode, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (narrow)
Write-up: Case upgraded by company. It was reported that a 6-year-old girl who on 21-JAN-2005 was vaccinated against MMR II (batch number, route and site of administration and number in series not reported) and TETRAVAC (batch number, route and site of administration and number in series not reported). She experienced following reactions after vaccination on unspecified date( cessation and duration not reported) : hypotonic-hyporesponsive episode and slight temperature. The outcome is not reported. Hypotonic-hyporesponsive episode and slight temperature were considered other medical important events. Other business partner number include E200906176. No further information is available. Case is closed.

VAERS ID:352920 (history)  Vaccinated:2008-08-16
Age:6.0  Onset:0000-00-00
Gender:Female  Submitted:2009-07-31
Location:Foreign  Entered:2009-07-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0907USA05426
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactoid reaction, Malaise, Vaccination site reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)
Write-up: Website listing 2008. It was reported that a 6 years old girl with no medical history reported was vaccinated with a dose of MMR II (lot number, batch number, route and site of administration and number in series not reported) on 16-AUG-2008. She experienced following reactions after vaccination on an unspecified date (cessation and duration not reported): anaphylactic type of reaction, malaise and vaccination site reaction. The outcome was not reported. Upon internal review, anaphylactic reaction was determined to be an other important medical event. Other business partner numbers included: E2009-06265. No further information is available. The case is closed.

VAERS ID:353039 (history)  Vaccinated:2009-03-24
Age:6.0  Onset:2009-03-25, Days after vaccination: 1
Gender:Female  Submitted:2009-08-03, Days after onset: 131
Location:Foreign  Entered:2009-08-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0586130A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA69CB560A IMUN
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALSAC14B068AF IMUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Inflammation, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: This case was reported by a regulatory authority (# ES-AGEMED-007193345) and described the occurrence of inflammation in a 6-year-old female subject who was vaccinated with PRIORIX (GlaxoSmithKline), (INFANRIX). On 24 March 2009, the subject received unspecified dose of PRIORIX (intramuscular, unknown injection site), unspecified dose of INFANRIX (intramuscular, unknown injection site). On 25 March 2009, 1 day after vaccination with INFANRIX and PRIORIX, the subject experienced inflammation, edema and erythema. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with urbason and (POLARAMINE). On 27 March 2009, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with PRIORIX and INFANRIX. No further information could be obtained from the Regulatory Authority; they will send additional information in a proactive way. Therefore the case has been closed.

VAERS ID:353078 (history)  Vaccinated:2009-03-24
Age:6.0  Onset:2009-03-25, Days after vaccination: 1
Gender:Male  Submitted:2009-08-03, Days after onset: 131
Location:Foreign  Entered:2009-08-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0907USA05571
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEUR  IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dependent rubor, Dyspnoea, Inflammation, Injection site warmth, 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 country Health Authority (Ref. # ES-AGEMED-807191245), concerning a 6 year old male who on 24-MAR-2009 was vaccinated intramuscularly with a dose of MMR II (batch number and site of administration not reported). Concomitant therapy included a dose of DAPTACEL (batch number and site of administration not reported) given intramuscularly. It was reported that on 25-MAR-2009 the patient experienced dyspnea, inflammation, dependent rubor, oedema and injection site warmth. It was unknown which vaccine is responsible for adverse reactions, although the reporter''s suspicion fall on MMR II. The patient attended in the emergency room later on he was referred to the hospital. The patient recovered from the events on 26-MAR-2009. It was reported that the patient was hospital admitted due to adverse event, admission and discharge dates have not been reported. Case is closed. Other business partner numbers included: E2009-06222. No further information is available.

VAERS ID:353167 (history)  Vaccinated:2009-03-24
Age:6.0  Onset:2009-03-24, Days after vaccination: 0
Gender:Female  Submitted:2009-08-04, Days after onset: 133
Location:Foreign  Entered:2009-08-05, 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: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0907USA05424
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Inflammation, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Information has been received from the health Authorities (reference number ES-AGEMED-007193345) concerning a 6 year old female who on 24-MAR-2009 was vaccinated with a dose of MMR II intramuscular (lot number and site not reported). Other suspect therapy included DTP MERIEUX intramuscular. On 25-MAR-2009 the patient presented with inflammation, erythema and oedema. The patient received treatment while in the emergency room with URBASON and POLARAMINE. The patient recovered on 27-MAR-2009. Case reported as serious by the HA with other medically important condition as criteria. Other business partner numbers included E200906223. Case was closed. No further information is available.

VAERS ID:353322 (history)  Vaccinated:2009-03-24
Age:6.0  Onset:2009-03-25, Days after vaccination: 1
Gender:Unknown  Submitted:2009-08-06, Days after onset: 134
Location:Foreign  Entered:2009-08-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0586275A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B068AF IMUN
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALSA69CB560A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dependent rubor, Dyspnoea, Inflammation, Injection site warmth, 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: This case was reported by a regulatory authority (ES-AGEMED-807191245) and described the occurrence of dependent rubor in a 6-year-old subject of unspecified gender who was vaccinated with PRIORIX (GlaxoSmithKline), INFANRIX (GlaxoSmithKline). On 24 March 2009, the subject received unspecified dose of PRIORIX (intramuscular, unknown injection site), unspecified dose of INFANRIX (intramuscular, unknown injection site). On 25 March 2009, 1 day after vaccination with INFANRIX and PRIORIX, the subject experienced dependent rubor, inflammation, injection site warmth, edema and dyspnoea. It was unknown which of the two vaccines was the one that caused the adverse drug reactions. Although the suspicion fell over the MMR vaccine. The subject was treated in the emergency room and later was derivate to the hospital. The subject was hospitalised. On 26 March 2009, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with PRIORIX and INFANRIX.

VAERS ID:353525 (history)  Vaccinated:2009-05-25
Age:6.0  Onset:2009-05-25, Days after vaccination: 0
Gender:Male  Submitted:2009-08-07, Days after onset: 74
Location:Foreign  Entered:2009-08-10, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Blood pressure measurement, 86/80 mmHg; Serum C-reactive protein, normal; Complete blood cell count, normal
CDC Split Type: WAES0908USA00141
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1083U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: C-reactive protein normal, Dizziness, Full blood count normal, Injection site pain, Injection site swelling
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad)
Write-up: Case received from Health Authority on 29-JUL-2009 under HA reference no. PEI2009015494. It was reported that a 6-year-old male patient with no medical history reported was vaccinated with a first dose of PNEUMOVAX 23 (lot # 659402/1083U, batch # NH12830) I.M. into the left upper arm on 25-MAY-2009. This batch was imported and not released by Health authority for the country. On the same day, the patient experienced dizziness and injection site pain and swelling. He was hospitalized on an unknown date. Upon admission blood pressure was 86/80 mmHg. Serum C-reactive protein test (CRP) and full blood count values were within normal range. The patient was treated with NUROFEN and cooling. He recovered within three days and was discharged. Other business partner numbers include E2009-07161. No further information is available. File is closed.

VAERS ID:354912 (history)  Vaccinated:2009-03-01
Age:6.0  Onset:2009-07-15, Days after vaccination: 136
Gender:Female  Submitted:2009-08-20, Days after onset: 36
Location:Foreign  Entered:2009-08-21, 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: No concomitant therapy.
Current Illness:
Preexisting Conditions: No personal or family medical history. No previous adverse reaction to this vaccine or other drugs.
Diagnostic Lab Data: Quick test using nasal secretion: the diagnosis was influenza infection.
CDC Split Type: 200903583
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cough, Influenza, Influenza serology positive, No reaction on previous exposure to drug, Oropharyngeal pain, Pyrexia, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: Case received from a healthcare professional in a foreign country on 11 August 2009 under the local reference number BR2009-130. This case was linked with 2009-03587, 2009-03586, 2009-03585, 2009-03584, 2009-03579 and 2009-03581 (Flu vaccines, same country, same reporter, same diagnosis, suspected vaccination failure). 2009-03580 and 2009-03584 are part of a cluster. A 07-year-old female patient, with no personal and family medical history, had received her 1st intramuscular primary dose of INFLUENZA VACCINE (manufacturer and batch number unknown) in the arm on an unspecified date in March 2009. The patient had no previous adverse reaction to this vaccine or other drugs. She had no concomitant therapy. In mid-July 2009, the patient experienced fever, sore throat and cough. The same day, the patient was seen by a physician (the reporter) who performed a quick test using nasal secretion: the diagnosis was influenza infection. The patient received TAMIFLU and TRIFEDRIN syrup. Fever resolved in 1 day, sore throat in 2 days and cough in 4 days. She was not hospitalized. The patient completely recovered. This case was reported as non-serious. However, upon internal review, it has been upgraded to serious (medically important event).

VAERS ID:358193 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2009-09-23
Location:Foreign  Entered:2009-09-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Henoch-Schonlein purpura
Diagnostic Lab Data: blood pressure measurement, 100/60 mmHg; physical examination, no specific finding with the exception of typical eruptions of herpes zoster on the right lower leg; computed axial tomography, segmental thrombotic filling defect from the righ
CDC Split Type: WAES0909KOR00025
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activated partial thromboplastin time, Antinuclear antibody negative, Antiphospholipid antibodies negative, Antithrombin III, Arthralgia, Blister, Blood homocysteine, Blood pressure normal, Body temperature, Body temperature increased, C-reactive protein normal, Cardiolipin antibody negative, Computerised tomogram abnormal, Condition aggravated, Deep vein thrombosis, Echocardiogram normal, Erythema, Factor V Leiden mutation, Gait disturbance, Haemoglobin normal, Heart rate normal, Herpes simplex serology positive, Herpes zoster, Laboratory test abnormal, Liver function test normal, Platelet count normal, Protein C, Protein S normal, Protein total normal, Prothrombin time normal, Rash, Rash erythematous, Renal function test normal, Respiratory rate decreased, Respiratory rate increased, Skin lesion, Tenderness, Thrombophlebitis, Ultrasound scan normal, White blood cell count increased, White blood cell count normal
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Thrombophlebitis (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Arthritis (broad), Respiratory failure (narrow)
Write-up: Information has been received from a literature article concerning a 6 year old male with a history of Henoch-Schonlein purpura who was vaccinated with VARIVAX (Merck). A 6-year-old previously healthy boy was admitted to the hospital because of pain in the right hip and skin eruptions at the right tibial area. Pain and erythema in the right hip developed first. Three days later, skin eruptions with prickly pain appeared at the right tibial area. These skin lesions consisted of grouped vesicles on an erythematous base and were localised to the L5 dermatome, involving the right knee and shin. On presentation the body temperature was 36.7 celsius degree with a pulse rate of 116 beats/min, a respiratory rate of 24 breaths/min and a blood pressure of 100/60 mmHg. Physical examination revealed no specific findings with the exception of typical eruptions of herpes zoster on the right lower leg. The patient complained of gait disturbance due to aggravation of the right hip pain. However, his right and calf were not swollen; but severe tenderness at the right inguinal area was present. The result of the laboratory studies were as follows: white blood cell count 5,900mm^3, platelet count of 245,000/mm^3 and a hemoglobin 14.8 g/dL. The activated partial thromboplastin time and prothrombin time were normal (35 seconds, 10.6 seconds, respectively). The Antithrombin III test (38.7 mg/dL) was normal. The renal and liver function test and c-reactive protein were within normal range. The immunization record indicated that the patient had received a single dose of VARIVAX vaccine at one year of age. The patient had not developed chicken pox prior to or after the vaccination. The patient did not have a history of thromboembolic disease except for Henoch-Schonlein purpura five years previously. The inguinal pain was evaluated for a thrombophlebitis or thromboembolism by computed tomographic (CT) venography. The result showed a segmental thrombotic filling defect from the right iliac vein to the right common femoral vein. We evaluate

VAERS ID:360122 (history)  Vaccinated:2009-08-19
Age:6.0  Onset:2009-08-19, Days after vaccination: 0
Gender:Female  Submitted:2009-10-08, Days after onset: 50
Location:Foreign  Entered:2009-10-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 19Aug2009, 38deg C
CDC Split Type: B0596103A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B055CG UNUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Depressed level of consciousness, Hypotonia, Pyrexia, Somnolence
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a regulatory authority (103978) and described the occurrence of decreased responsiveness in a 5-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). MMRVAXPRO (non-gsk). On 19 August 2009 the subject received unspecified dose of INFANRIX (unknown), unspecified dose of MMRVAXPRO (unknown). On 19 August 2009, less than one day after vaccination with INFANRIX and MMRVAXPRO, the subject experienced decreased responsiveness, muscle hypotonia, somnolence and fever 38 deg C. This case was assessed as medically serious by GSK. The subject was treated with paracetamol. On 19 August 2009, the events were resolved.

VAERS ID:363722 (history)  Vaccinated:2009-02-24
Age:6.0  Onset:2009-02-24, Days after vaccination: 0
Gender:Female  Submitted:2009-10-29, Days after onset: 246
Location:Foreign  Entered:2009-10-29
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: B0599325A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Presyncope, Tonic convulsion
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a regulatory authority (ES-AGEMED-908760234) and described the occurrence of tonic convulsion in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 24 February 2009, the subject received unspecified dose of INFANRIX (intramuscular, unknown injection site), lot number not provided. On 24 February 2009, less than one day after vaccination with INFANRIX, the subject experienced tonic convulsion and presyncope for seconds. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, the presyncope was resolved with unspecified sequelae whereas the tonic convulsion was completely resolved. The regulatory authority reported that the events were probably related to vaccination with INFANRIX. No further information could be obtained as the foreign regulatory authority has provided all the available information. This case has therefore been closed.

VAERS ID:364514 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2009-11-02
Location:Foreign  Entered:2009-11-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Concurrent medical condition included "langerhans disease".
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0599690A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Liver function test abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow)
Write-up: This case was reported by a pharmacist and described the occurrence of increased liver function tests in a 6-year-old male subject who was vaccinated with Flu vaccine (unknown manufacturer). Concurrent medical conditions included langerhans disease. On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). At an unspecified time after vaccination with Flu vaccine, the subject experienced increased liver function tests. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. Verbatim text. On 23 October 2009, a pharmacist reported that a 6 year old male patient was administered a flu vaccine (manufacturer unspecified) on an unspecified date and subsequently developed increased liver function tests. No further information is available.

VAERS ID:367762 (history)  Vaccinated:2009-10-15
Age:6.0  Onset:2009-10-16, Days after vaccination: 1
Gender:Male  Submitted:2009-11-16, Days after onset: 31
Location:Foreign  Entered:2009-11-16
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: B0603696A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B83AD IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority (agency # ES-AGEMED-521655241) and described the occurrence of injection site induration in a 6-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 15 October 2009, the subject received unspecified dose of INFANRIX (intramuscular, unknown deltoid). On 16 October 2009, 1 day after vaccination with INFANRIX, the subject experienced injection site induration (15 cm). The regulatory authority reported that the event was clinically significant (or requiring intervention). At the time of reporting the event was unresolved. The regulatory authority reported that the event was probably related to vaccination with INFANRIX. No further information can be obtained; this case has therefore been closed.

VAERS ID:369549 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2009-11-23
Location:Foreign  Entered:2009-11-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Langerhans disease
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MA20093888
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IJUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Liver function test abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow)
Write-up: Initial case report received from a regulatory agency in a foreign country on 09 NOV 2009. A 6-year-old male patient was vaccinated with influenza virus vaccine ( unknown manufacturer, batch no. unknown) in 2009. On an unspecified date after vaccination, the child showed increased liver function liver tests. At the time of report the outcome was unknown.

VAERS ID:370580 (history)  Vaccinated:2009-10-01
Age:6.0  Onset:2009-10-02, Days after vaccination: 1
Gender:Unknown  Submitted:2009-11-27, Days after onset: 56
Location:Foreign  Entered:2009-11-30, 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:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 200905134
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC3106A4 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Headache, Injection site pain, 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)
Write-up: Case received from the Health Authorities on 24 November 2009 under the local reference number PL-URPL-OCR-20091028008. A 06-year-old patient (gender not specified), with no reported medical history, experienced injection site reaction on 02 October 2009, i.e. the following day after receiving an intramuscular dose of TRIPACEL, batch number "C3106A4", on 01 October 2009. On 02 October 2009, the patient developed injection site pain. Then, the patient presented with edema and redness covering the right shoulder joint, underarm and forearm. There was no fever. The patient recovered on an unspecified date. According to the HAs, this case was an important medical condition.

VAERS ID:370651 (history)  Vaccinated:2009-10-30
Age:6.0  Onset:2009-10-31, Days after vaccination: 1
Gender:Female  Submitted:2009-11-25, Days after onset: 25
Location:Foreign  Entered:2009-11-30, 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:
Preexisting Conditions: No personal or family medical history; No history of adverse reaction to a vaccine or a drug; No concomitant therapy
Diagnostic Lab Data: No complementary exams were done.
CDC Split Type: 200904998
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR 1IMAR
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Induration, Pyrexia, Skin warm
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Case received from a consumer (the patient''s mother who is biologist) on 13 November 2009 under the local reference number BR2009-783. A 06-year-old and 09-month-old female patient, with no personal or family medical history, had received her 2nd intramuscular booster dose of PERTACEL, batch number unknown, in the arm; concomitantly with her 2nd booster dose of TRIMOVAX, batch number unknown, in the opposite arm, on 30 October 2009. The patient had no history of adverse reaction to a vaccine or a drug, and no concomitant therapy. On 31 October 2009, i.e. the following day post-vaccination, the patient experienced extreme redness, extreme "hotness" and "hardness" of one arm (not specified) as well as fever. Fever lasted for 1 day. On 01 November 2009, the patient was hospitalized for some hours. She received IV KEFLEX. No complementary exams were done. From 01 November 2009, the patient received corrective therapies with KEFLEX and BACTROBAN. "Hardness" resolved after 5 days and both redness and "hotness" lasted for 1 week. The patient still had a"little spot on the site" at the time of the report, however the reported considered the outcome was recovered.

VAERS ID:374864 (history)  Vaccinated:2009-11-19
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2009-12-23
Location:Foreign  Entered:2009-12-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Unk
CDC Split Type: B0619189A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B090FB IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site phlebitis, Reactogenicity event
SMQs:, Thrombophlebitis (broad)
Write-up: This case was reported by a regulatory authority (# ES-AGEMED-225973332) and described the occurrence of reactogenicity event in a 6-year-old male subject who was vaccinated with INFANRIX. On 19 November 2009 the subject received unspecified dose of INFANRIX (intramuscular, unknown injection site). In November 2009, less than one month after vaccination with INFANRIX, the subject experienced reactogenicity event and injection site phlebitis. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX. Please note that no further information is expected, the Foreign Medicines Agency had sent all the available information for the time being, if they ever get any further they will send it to us. This case was considered closed.

VAERS ID:375308 (history)  Vaccinated:2009-10-19
Age:6.0  Onset:2009-10-19, Days after vaccination: 0
Gender:Male  Submitted:2009-12-29, Days after onset: 71
Location:Foreign  Entered:2009-12-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Elbow swelling; Erythema elbow; Itching; Redness on shoulder; Shoulder swelling; Swelling of upper arm; Upper arm red
Diagnostic Lab Data: RAST, Oct2009, negative
CDC Split Type: D0065648A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA452AC4IMUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature normal, Injection site erythema, Injection site swelling, Neurological examination normal, Radioallergosorbent test negative, Reaction to previous exposure to any vaccine
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 (# DE-PEI-PEI2009024171) and described the occurrence of upper arm redness and swelling in a 6-year-old male subject who was vaccinated with INFLUSPLIT (GlaxoSmithKline). The subject''s medical history included no known serious medical conditions. Previous vaccinations with INFLUSPLIT (GlaxoSmithKline) in 2005, INFLEXAL (Baxter) (non-GSK) in 2006 and INFLEXAL (Baxter) (non-GSK) in 2007 were well tolerated. Post previous vaccination with MUTAGRIP (Sanofi Pasteur) (non-GSK), given on 18 November 2008, the subject experienced severe injection site reaction with erythema and swelling involving upper arm, elbow and shoulder and itching. These events have been more severe than the events experienced now. The subject had not been hospitalised for these events. All other vaccinations, including tetanus + diphtheria vaccine (Td vaccine, unknown manufacturer), last dose given in July 2009, have been well tolerated. On 19 October 2009 the subject received a dose of INFLUSPLIT (0.5 ml, intramuscular, left deltoid). This was the fifth annual vaccination with a seasonal influenza vaccine. Approximately one hour post vaccination with INFLUSPLIT, on 19 October 2009, the subject experienced redness and swelling of left upper arm. The subject was hospitalised for two days. On admission to hospital the subject was in good general and nutritional condition. All examinations on admission, including internal, otorhinolaryngologic and neurologic examinations, were normal. Body temperature was 36.4 degC. Radioallergosorbent test (RAST) for food allergens including egg white, milk protein, codfish, wheat flour, peanut and soybean, was negative. During hospitalisation redness and swelling of the vaccinated left upper arm increased further over night. The subject was treated with antihistamine and cool packs. During whole time of monitoring at hospital the subject was in stable condition. The subject did not experience anaphylactic reaction. In the afternoon of the next day, on 20 October 200

VAERS ID:378725 (history)  Vaccinated:2009-11-16
Age:6.0  Onset:2009-11-20, Days after vaccination: 4
Gender:Male  Submitted:2010-01-29, Days after onset: 70
Location:Foreign  Entered:2010-01-29
Life Threatening? No
Died? Yes
   Date died: 2009-12-21
   Days after onset: 31
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Nil
Preexisting Conditions: Nil
Diagnostic Lab Data: 50 bacteria and viral/ parasites test with the autopsy shows parvovirus-related hemophagocystic diseases
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER 0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Autopsy, Bacterial test positive, Blood product transfusion, Death, Liver function test abnormal, Parasitic test positive, Parvovirus infection, Platelet count increased, Pyrexia, Rash, Serum ferritin increased, Viral test positive, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: rashes starting from extremities follow with fever up to 39C 4 days later and elevation of WBC/ Platelets/ liver functions/ ferritin/ Antibiotic and antiviral/ IVIG given together with NSAIS''s

VAERS ID:381532 (history)  Vaccinated:2009-11-05
Age:6.0  Onset:2009-11-05, Days after vaccination: 0
Gender:Male  Submitted:2010-02-26, Days after onset: 113
Location:Foreign  Entered:2010-03-01, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1002USA03389
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B090FB IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0150Y IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Hypotension, Pallor, Somnolence, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a Health Authorities (ES-AGEMED-807068242) via healthcare professional concerning a 6 year old male who on 05-NOV-2009 was vaccinated with a dose of MMR II (lot # 663663/0150Y, batch # NK 47500, IM, site of administration not reported). Concomitant therapy included a dose of INFANRIX (GSK, batch # AC14B090FB, IM, site of administration not reported). On the same day of vaccination, 05-NOV-2009, the patient was presented a hypotensive episode, cutaneous pallor, tendency to sleep, diarrhea and emesis. It was reported that the patient was hospitalized (admission and discharge dates not reported). The patient recovered from adverse events. Cessation dates were not reported, but it was mentioned that the evolution was favorable. Case reported as serious by HA with hospital admission as criteria. Other business partner numbers included E2010-01079.

VAERS ID:381747 (history)  Vaccinated:2009-12-09
Age:6.0  Onset:2010-01-07, Days after vaccination: 29
Gender:Female  Submitted:2010-03-03, Days after onset: 55
Location:Foreign  Entered:2010-03-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: unknown
Preexisting Conditions:
Diagnostic Lab Data: unk
CDC Split Type: B0635684A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)GLAXOSMITHKLINE BIOLOGICALS  IMUN
FLU3: INFLUENZA (SEASONAL) (FLU-IMUNE)PFIZER/WYETH  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema nodosum
SMQs:, Hypersensitivity (narrow)
Write-up: This case was reported by the regulatory authority (GB-MHRA-FLU 00039539) and described the occurrence of erythema nodosum in a 6-year-old female subject who was vaccinated with PANDEMRIX H1N1 (GlaxoSmithKline), ENZIRA. Concurrent medications included Prednisolone and SALBUTAMOL. On 9 December 2009 the subject received a dose of PANDEMRIX H1N1 (0.25 ml, intramuscular) and a dose of Influenza vaccine (0.5ml, intramuscular). On 7 January 2010, 29 days after vaccination with ENZIRA and PANDEMRIX H1N1, the subject experienced erythema nodosum, marked on shins. The regulatory authority reported that the event was clinically significant (or requiring intervention). On 21 January 2010, the event was resolved. Clinical Erythema nodosum. Marked on shins. Clinically well. Recovery spontaneous.

VAERS ID:382526 (history)  Vaccinated:2009-05-19
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2010-03-12
Location:Foreign  Entered:2010-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: unk
CDC Split Type: B0578428A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B101AN IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERAC20B101AN IMUN
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis
SMQs:
Write-up: This case was reported by a regulatory authority (# 042360) and described the occurrence of cellulitis in a 6-year-old male subject who was vaccinated with INFANRIX-IPV, (GlaxoSmithKline). The subject''s medical history or concomitant medications was not available. On 19 May 2009, the subject received unspecified dose of INFNARIX-IPV (intramuscular, unknown injection site). In 2009, less than one month after vaccination with INFNARIX-IPV, the subject experienced cellulitis. The regulatory authority reported that the event was clinically significant (or requiring intervention). No treatment was given to the subject. At the time of reporting the outcome of the event was unspecified. Additional information has been requested but could not be obtained. This case has therefore been closed.

VAERS ID:382973 (history)  Vaccinated:2010-03-02
Age:6.0  Onset:2010-03-02, Days after vaccination: 0
Gender:Male  Submitted:2010-03-18, Days after onset: 15
Location:Foreign  Entered:2010-03-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0640170A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B128AC IMRA
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERAC20B128AC IMRA
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURERNL06780 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Injection site oedema, Pruritus, Skin discolouration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: This case was reported by a regulatory authority (# 113230) and described the occurrence of edema in a 6-year-old male subject who was vaccinated with INFANRIX-IPV (GlaxoSmithKline), (non-GSK) M-M-RVAXPRO. On 2 March 2010, the subject received unspecified dose of INFANRIX-IPV (.5 ml, intramuscular, unknown injection site), unspecified dose of M-M-RVAXPRO (.5 ml, intramuscular, unknown injection site). On 2 March 2010, less than one day after vaccination with INFANRIX-IPV and M-M-RVAXPRO, the subject experienced edema at the injection site (right arm). The subject was treated with cortisone and ice. On 6 March 2010, the subject experienced erythema and pruritus (right arm). On 8 March 2010, erythema, oedema and pruritus were resolved but a duschromia at the involved skin surface was still present. The regulatory authority reported that the events were clinically significant (or requiring intervention). The regulatory authority reported that the events were possibly related to vaccination with INFANRIX-IPV and M-M-RVAXPRO. Follow-up received 16 March 2010 : The injection site was the left arm but we do not know if the 2 vaccines were done in this arm or only one of those. On 2 March 2010, the subject received unspecified dose of INFANRIX-IPV (.5 ml, intramuscular, unknown injection site), unspecified dose of M-M-RVAXPRO (.5 ml, intramuscular, unknown injection site). On 2 March 2010, less than one day after vaccination with INFANRIX-IPV and M-M-RVAXPRO, the subject experienced edema at the injection site (left arm). The subject was treated with cortisone and ice. On 6 March 2010, the subject experienced erythema and pruritus (left arm). On 8 March 2010, erythema, oedema and pruritus were resolved but a duschromia at the involved skin surface was still present.

VAERS ID:382996 (history)  Vaccinated:2010-03-04
Age:6.0  Onset:2010-03-07, Days after vaccination: 3
Gender:Female  Submitted:2010-03-17, Days after onset: 9
Location:Foreign  Entered:2010-03-18, 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: Not reported
Diagnostic Lab Data: No data
CDC Split Type: 201001560
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURC3148A0IMRL
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALS 0SCAR
VARCEL: VARICELLA (VARILRIX)GLAXOSMITHKLINE BIOLOGICALS 1SCAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Skin warm, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Report received from a healthcare professional in foreign country on 10 March 2010. (No local reference number). A 6-year-old female patient, with no reported medical history, presented with moderate hotness, erythematous and tender patch of 10x10 cm on 07 March 2010, i.e. 3 days after receiving the 1st booster dose of TRIPACEL lot number C3148AC intra-muscularly in the antero-lateral aspect of the right thigh on 04 March 2010. On the same day, the patient had also received the 1st booster dose of PRIORIX from another manufacturer (SC route, in the deltoid) and the 2nd booster dose of VARILLEX from another manufacturer (SC route, in the deltoid). These vaccines were considered as not suspect by the reporting physician. The patient received corrective treatment with AUGMENTIN suspension and PANDERM ointment. The events lasted for 1 week and the outcome was reported as "ongoing" at the time of this report. This report was considered as serious by the reporting physician.

VAERS ID:383288 (history)  Vaccinated:2010-03-02
Age:6.0  Onset:2010-03-02, Days after vaccination: 0
Gender:Male  Submitted:2010-03-22, Days after onset: 19
Location:Foreign  Entered:2010-03-23, 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: Unknown
CDC Split Type: WAES1003USA02646
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B128AC IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0636Y IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Allergic oedema, Erythema, Oedema peripheral, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from an Health Authority (HA) (case n. 113230, local case n. IT119/10) concerning a 6 year old male who on 02-MAR-2010 was vaccinated IM with the second dose of MMR II (batch number NL06780,lot number 664898/0636Y, injection site not reported). Suspect therapy included the booster dose of INFANRIX (batch number AC20B128AC, IM, injection site not reported). On 02-MAR-2010 in the evening, he presented with edema extended over the entire left arm. He was treated with ice packs until 06-MAR-2010, on this date onset of erythema over the same area and itching. He was also treated with cortisone cream. The patient was evaluated on 08-MAR-2010 at this date the edema and the erythema had resolved leaving a peri-lesion halo. The final outcome was not reported. HA coded "allergic edema". The reporter considered this event as serious. the case is closed. Edema extended over the entire left arm, erythema and itching were considered to be an other important medical event. Other business partner numbers E2010-01574.

VAERS ID:383652 (history)  Vaccinated:2009-09-16
Age:6.0  Onset:2009-09-17, Days after vaccination: 1
Gender:Male  Submitted:2010-03-26, Days after onset: 190
Location:Foreign  Entered:2010-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 17Sep2009, 38.6deg. C
CDC Split Type: B0643009A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B123AI IMLA
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERAC20B123AI IMLA
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALSA69FB478A1SCRA
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Febrile convulsion, Pyrexia, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a regulatory authority (# FI-FIMEA-20091216) and described the occurrence of febrile convulsion in a 6-year-old male subject who was vaccinated with combined PRIORIX, and combined INFANRIX-POLIO. No basic illnesses, no previous convulsions or significant vaccination reactions. On 16 September 2009, the subject received 2nd dose of PRIORIX (subcutaneous, right upper arm), and an unspecified dose of INFANRIX-POLIO (intramuscular, left upper arm). On 17 September 2009, 1 day after vaccination with INFANRIX-POLIO and PRIORIX, the subject experienced febrile convulsion during 5 minutes, feeling sleepiness (after convulsion) and high fever (38.6 deg.C). The subject was hospitalised for 2 days (from 17 to 18 September 2009). At the time of reporting, the events were resolved.

VAERS ID:385711 (history)  Vaccinated:2004-09-20
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2010-04-21
Location:Foreign  Entered:2010-04-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None reported.
Diagnostic Lab Data: A test performed in a hair sample (date not reported) showed that the patient had a mercury level of 1.7 (units not reported).
CDC Split Type: E201001907
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Autism, Gene mutation identification test, Hair metal test abnormal
SMQs:
Write-up: Initial information received on 26-OCT-2009, this case is not medically confirmed. This case is linked with case E2010-01528, and is related to a general claim against a foreign Ministry of Health related to all products containing thiomersal. The claim contains 65 cases among which 41 are related to vaccines. Furthermore, this case is also linked with 2 cases related to patients who dropped their complaints. The claim is not against Sanofi Pasteur MSD, this latter is only a third party. Therefore some of the cases are poorly documented." Current case concerns a male patient born 15-APR-1998. The patient received 4 doses of a diphtheria-tetanus-pertussis and inactivated polio vaccine (manufacturer unknown, batch number, route and site of administration not reported) on 01-JUL-1998, 01-OCT-1998, 01-JAN-1999 and 18-APR-2000. The patient received 3 doses of a haemophilus influenza type B vaccine (manufacturer unknown, batch number, route and site of administration not reported) on 20-JUL-1998, second dose on 26-OCT-1998 and 26-APR-1999. The patient received a dose of MMR (manufacturer unknown, batch number, route and site of administration not reported) on 19-NOV-1999. According to the report, the patient received a dose of a meningococcal C vaccine (manufacturer unknown, batch number, route and site of administration not reported) on 07-FEB-2001. On 20-SEP-2004 the patient received a dose of an inactivated polio vaccine (manufacturer unknown, batch number, route and site of administration not reported). According to the report, the patient was diagnosed with autism on 2004, exact date not reported, and had a disability grade of 52%, evaluated on the 03-FEB-2004. A test performed in a hair sample (date not reported) showed that the patient had a mercury level of 1.7 (units not reported). According to the form received from the claimant, the following statements are included: hair test (mineralogram and others) and genetic test.

VAERS ID:386237 (history)  Vaccinated:1987-09-29
Age:6.0  Onset:1992-04-07, Days after vaccination: 1652
Gender:Female  Submitted:2010-04-28, Days after onset: 6595
Location:Foreign  Entered:2010-04-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: physical examination, 02Dec04, had a disability grade of 85%; hairy cell, had a hair mercury level of 1.2 (units not reported); urinalysis, a urine mercury levels of 1.9 and 7.9 (units not reported)
CDC Split Type: WAES1004USA03770
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTIPV: DT + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Allergy test, Autism spectrum disorder, Bacterial test, Blood count, Blood test, Disability, Fungal test, Hair metal test abnormal, Laboratory test, Urine analysis, Urine mercury abnormal
SMQs:
Write-up: Initial information received on 26-OCT-2009, this case is not medically confirmed. This case is linked with case E2010-01528, and is related to a general claim against the foreign Ministry of Health related to all products containing thiomersal. The claim contains 65 cases among which 41 are related to vaccines. Furthermore, this case is also linked with 2 cases related to patients who dropped their complaints. The claim is not against Sanofi Pasteur MSD, this latter is only a third party. Therefore some of the cases are poorly documented. Current case concerns a 6 year old female patient. The patient received a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid (manufacturer unknown, batch number, route and site of administration not reported) on 17-Mar-1986, a second dose on 02-SEP-1986 and third dose on 14-OCT-1986. According to the report, the patient received a dose of diphtheria toxoid (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid (manufacturer unknown, batch number, route and site of administration not reported) on 29-SEP-1987. It is reported that the patient received two doses of a hepatitis A virus vaccine inactivated (manufacturer unknown, batch number, route and site of administration not reported) on 31-OCT-2006 and 14-JUN-2007. The patient also received 4 dose of MMR II (manufacturer unknown, batch number, route and site of administration not reported) on 16-JUN-1987, 02-DEC-1999, 31-OCT-2006 and 14-JUN-2007. According to the report the patient was diagnosed with atypical autism on 07-APR-1992 and had a disability of 85%, evaluated on 02-DEC-2004. It was also reported that the patient has an otitis when she was two months old and acute bronchitis when she was one year old. A test performed in a hair sample and two test performed in urine sample (dates not reported) showed that the patient had a hair mercury level of 1,2 (units not reported) and a urine mercury levels of 1,9 and 7,9 (units not reported). According to the form received from the claimant, the following statements were included: urinary analysis, hair test (mineralogram and others), blood count, blood test, food allergies test, bacteria and yeast susceptibilities. No genetic test was performed. In the form the claimant, it was written" "Medical report: yes" but we hadn''t received it yet. Relevant test/laboratory data: a test performed in a hair sample and two tests performed in urine sample (dates not reported) showed that the patient had a hair mercury level on 1,2 (units not reported) and a urine mercury levels of 1,2 and 7,9 (units not reported). Other business partner number include E2010-01883.

VAERS ID:386855 (history)  Vaccinated:2010-03-17
Age:6.0  Onset:2010-03-17, Days after vaccination: 0
Gender:Male  Submitted:2010-05-03, Days after onset: 47
Location:Foreign  Entered:2010-05-06, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2010022625
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER090626501 SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Cyanosis, Hypotonia, Malaise, Pallor, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Report received from regulator on 27-APR-2010 (case number: 264472). A 6 year old male patient received FLUVAX (batch 090626501) 0.5 ml via subcutaneous injection on 17-MAR-2010. The patient''s medical history and concomitant medications were unknown. On 17-MAR-2010, the day of vaccination with the suspect drug, the patient experienced an anaphylactic reaction. His lips were blue, the patient was pale, slightly wheezy, had reduced muscle tone, felt sick. Blood pressure was 80/60 and heart rate was 110. The patient was treated with 0.2ml of adrenaline intramuscularly. The event outcome was recovered after 15 minutes on 17-MAR-2010. The reporter considered events possible the suspect drug. The case was reported as serious due to medical significance. The company considered events possible in relation to the suspect drug. Information derived from this AE report dose not change the current safety profile of the product.

VAERS ID:386857 (history)  Vaccinated:2010-04-08
Age:6.0  Onset:2010-04-08, Days after vaccination: 0
Gender:Male  Submitted:2010-05-03, Days after onset: 25
Location:Foreign  Entered:2010-05-06, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Temperature, 39.3
CDC Split Type: 2010022621
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER27201 IJUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Headache, Myalgia, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Report received from the foreign Regulator on 27-APR-2010. A 6 year old male patient received FLUVAX on 08-APR-2010. The medical history and concomitant medications are unknown. On 08-APR-2010, on the day of receiving FLUVAX, the patient became febrile with a temperature of 39.3. He also developed headache, muscle pains, abdominal pain. He began vomiting 4 hours post-vaccination. He was admitted to hospital and treated with paracetamol, ibuprofen and ondansetron. The patient outcome is recovered on unknown date. The reporter considered event possible to the suspect drug, FLUVAX. This case was reported as serious because of hospitalisation. The company considered events possibly related to the suspect drug, FLUVAX given the time to onset of events. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:386880 (history)  Vaccinated:2010-03-15
Age:6.0  Onset:2010-03-15, Days after vaccination: 0
Gender:Female  Submitted:2010-04-30, Days after onset: 46
Location:Foreign  Entered:2010-05-06, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Pregnant: UNKNOWN
Diagnostic Lab Data:
CDC Split Type: 2010022694
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED090626502 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hallucination, Inappropriate schedule of drug administration, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Report received from the regulator on 26-APR-2010. A 6 year old female patient received FLUVAX (0.5mL via IM route) on 15-MAR-2010. The patient had other medical conditions (unknown). Concomitant medications are unknown. On 15-Mar-2010, the same day as receiving FLUVAX, the patient developed fever, hallucination and nausea (reported as not severe). Treatment unknown. The patient outcome was recovered without sequelae. The reporter considered the events possibly related to the suspect drug, FLUVAX. This case was reported as serious. It was considered to be a medically significant event. The company considered the events possibly related to the suspect drug, FLUVAX. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:387076 (history)  Vaccinated:1996-02-08
Age:6.0  Onset:2003-05-01, Days after vaccination: 2639
Gender:Female  Submitted:2010-05-10, Days after onset: 2566
Location:Foreign  Entered:2010-05-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Anxiety; Fever; Nausea; Pain in vertebral column; Vomiting
Preexisting Conditions:
Diagnostic Lab Data: Computerized tomography, May2003, see lab text; Immunology test, 2003, see lab text; Nuclear magnetic resonance ima, Sep2003, see lab text; May 2003: emergency hospitalisation, computerized tomogram evidenced chronic demyelinating disease of the central nervous system or multiple sclerosis. September 2003: nuclear magnetic resonance imaging (MRI) showed several T2 hyperintense demyelinating lesions. 2003: Complementary immunological investigations confirmed the diagnosis of chronic inflammatory disease of the central nervous system or multiple sclerosis.
CDC Split Type: B0650890A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Asthenia, Blindness unilateral, Bone pain, Central nervous system inflammation, Central nervous system lesion, Computerised tomogram abnormal, Condition aggravated, Demyelination, Dysgraphia, Gait disturbance, Immunology test abnormal, Motor dysfunction, Multiple sclerosis, Nausea, Nervous system disorder, Nuclear magnetic resonance imaging abnormal, Pain, Pyrexia, Sleep disorder, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Demyelination (narrow), Retinal disorders (broad), Osteonecrosis (broad), Hypersensitivity (broad)
Write-up: This case was reported by GSK Legal department and described the occurrence of multiple sclerosis in a 13-year-old female subject who was vaccinated with unspecified hepatitis B vaccine. Medical history of the subject was unspecified. Previous vaccination included ENGERIX B (GlaxoSmithKline), batch number not provided, unknown route and injection site given on 11 July 1995 and 16 August 1995. On 08 February 1996, the subject received a 3rd dose of hepatitis B vaccine (unknown manufacturer, batch number not provided, unknown route and injection site). In May 2003, seven years after the third vaccination, the subject presented with sudden writing disorder. The subject was hospitalized and a computerized tomography evidenced a chronic demyelinating disease of the central nervous system or a multiple sclerosis. In September 2003, the subject was hospitalized again due to left side vision loss. A nuclear magnetic resonance imaging showed several T2 hyperintense demyelinating lesions. Complementary immunological investigations performed few weeks later confirmed the diagnosis of chronic inflammatory disease of the central nervous system or multiple sclerosis. A treatment with AVONEX was initiated at an unknown dose (precise date not specified) and was badly tolerated: the subject developed fever, pain in vertebral column, nausea and vomiting (incidental events). In 2006, the subject''s condition aggravated with increased asthenia associated to motor discomfort. In 2007, efficacy of treatment with AVONEX was not sufficient and introduction of TYSABRI was initiated, despite anxiety related to possible safety problem. Since 2007, the subject had stopped to go to school in 2007. At an unspecified date, she experienced walking difficulties due to pain at walk and severe sleeping disorder. It was reported that each attempt to work was unsuccessful as she was not able to write or to hold the phone (coded cannot hold things (nos)). At the time of reporting, the outcome of the events was unspecified. Causality assessment was not provided.

VAERS ID:387247 (history)  Vaccinated:2010-04-12
Age:6.0  Onset:2010-04-12, Days after vaccination: 0
Gender:Female  Submitted:2010-05-11, Days after onset: 29
Location:Foreign  Entered:2010-05-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: PRADER WILLI syndrome
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2010022575
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER090626902 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Hypersomnia, Lethargy, Malaise, Pyrexia, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad)
Write-up: Report received from a nurse via a CSL representative on 23-APR-2010. A 7 year old female patient received FLUVAX on 12-APR-2010. The patient has a medical history of PRADER-WILLI Syndrome and can have interactions with other medications. Concomitant medications are unknown. On 12-APR-2010, 6 hours after FLUVAX vaccination, the patient developed a temperature of 40 degrees, slept for 16 hours and was not well for 24 hours. The patient was treated with PANADOL for the temperature. The patient outcome is recovered on 13-APR-2010. The company considered events possible to the suspect drug, FLUVAX. Follow up information received from doctor on 04-MAY-2010. The patient had not had previous therapy with FLUVAX. The patient received FLUVAX (batch 090626902, expiry 31-JAN-2011). The suspect drug was stored in cooled conditions (2-8 degrees celsius) and had remained in this temperature during storage at the reporting site. The event outcome was recovered on 13-APR-2010. The reporter did not consider the case to be serious. Information derived from this AE report does not change the current safety profile of the product. Follow up information received from the regulator on 03-MAY-2010. Body weight of the patient was 22 kg. One 0.5mL dose of FLUVAX was administered via intramuscular injection for prophylactic inoculation and vaccination. Additional serious adverse events of lethargy and excessive drowsiness. Fever up to 40 degrees was also serious. The reported considered the events serious due to incapacity / disability. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:387374 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:2010-04-07
Gender:Female  Submitted:2010-05-12, Days after onset: 35
Location:Foreign  Entered:2010-05-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2010022904
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER090626202 IJUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Delirium, Disability, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Report received from a foreign Regulator on 03-May-2010. A 6 year old female patient received a single dose of FLUVAX injection (batch: 090626202), date not specified. Medical and concomitant medication history were not specified. On 07-Apr-2010, the patient developed fever, rigors, delirium and vomiting. She was treated with PANADOL. The events caused incapacity/disability. The patient''s outcome is recovered. The reporter considers these events as possibly related to the suspect drug, FLUVAX. This case was reported as serious due to incapacity/disability. The company considers these events as possibly related to the suspect drug, FLUVAX. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:389115 (history)  Vaccinated:2010-03-27
Age:6.0  Onset:2010-03-27, Days after vaccination: 0
Gender:Female  Submitted:2010-05-20, Days after onset: 54
Location:Foreign  Entered:2010-05-24, 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:
Diagnostic Lab Data:
CDC Split Type: 2010023312
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED90626303 IJUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Delirium, Fatigue, Lethargy, Pyrexia, Sleep disorder, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Report received from the Regulator on 14-May-2010. A 6 year old female patient received a single 0.5mL dose of FLUVAX Injection (Influenza Vaccine batch: 90626303) on 27-Mar-2010. Medical and concomitant medication history was not specified. on 27-Mar-2010, 6 hours after receiving FLUVAX, the patient developed rigors, fever of 40 Celsius, vomited repeatedly became delirious "blithering and speaking jibberish". Patient slept fitfully, up and down all night and was tired and lethargic the next day. Treatments included PANADOL and NUROFEN given alternately every 2-4 hours. The patient was recovered by 29-Mar-2010. The reporter did not provide assessment of seriousness. The reporter assessed the causality as possible in relation to suspect drug, FLUVAX. The company considers these events as serious due to medical significance and possibly related to suspect drug, FLUVAX. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:389117 (history)  Vaccinated:2010-03-18
Age:6.0  Onset:2010-03-18, Days after vaccination: 0
Gender:Male  Submitted:2010-05-20, Days after onset: 63
Location:Foreign  Entered:2010-05-24, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2010023304
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED26303 IJUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Meningism, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow)
Write-up: Report received from the regulator on 14-MAY-2010. A 6 year old male patient received a FLUVAX injection (batch 26303) on 18-MAR-2010. The patient''s medical history and concomitant medications were unknown. On 18-MAR-2010, the day of vaccination with the suspect drug, the patient developed meningism, cerebral irritation and high fever of 41 degrees Celsius. The patient required hospitalisation. The event outcome was recovered on 19-MAR-2010. The reporter considered events possible to the suspect drug; FLUVAX. The case was reported as serious due to hospitalisation. The company considered the events serious and possible in relation to the FLUVAX. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:389288 (history)  Vaccinated:2010-04-27
Age:6.0  Onset:2010-04-27, Days after vaccination: 0
Gender:Female  Submitted:2010-05-24, Days after onset: 27
Location:Foreign  Entered:2010-05-25, 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: The patient''s concurrent illnesses include house dust allergy, asthma and seasonal allergy.
Preexisting Conditions:
Diagnostic Lab Data: None Provided.
CDC Split Type: JPWYEH15039910
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Conjunctival hyperaemia, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conjunctival disorders (narrow)
Write-up: Follow-up information upgraded this case to serious for the event of bulbar conjunctiva hyperaemia. Additional patient demographics, medical history, product details concomitant therapy and event details were provided. This case was considered medically important for bulbar conjunctiva hyperaemia. Information regarding PREVENAR was received from a healthcare professional regarding a 6-year-old female patient who experienced bulbar conjunctiva hyperaemia, injection site warmth, injection site redness, injection site swelling and pyrexia. The patient received a dose on 27-Apr-2010. On 27-Apr-2010, the patient received injection of PREVENAR. On that same day the patient experienced pyrexia, bulbar conjunctiva hyperaemia with redness, swelling (6 cm) and warmth at the injection site. On 30-Apr-2010, the patient received a consultation and was noted that pyrexia, hyperaemia and swelling at vaccination site were recovering and no other symptoms were noted. The physician noted that the "patient received the vaccination when his general condition was favorable, and then, bulbar conjunctiva hyperaemia and swelling occurred soon after that. Therefore, relationship between PREVENAR and the events was strongly suggested." No additional information was available at the time of this report.

VAERS ID:389460 (history)  Vaccinated:2010-04-07
Age:6.0  Onset:2010-04-11, Days after vaccination: 4
Gender:Female  Submitted:2010-05-26, Days after onset: 45
Location:Foreign  Entered:2010-05-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2010023307
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED090627101 IJUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature, Diet refusal, Hypersomnia, Hypotonia, Lethargy, Pallor, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (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), Generalised convulsive seizures following immunisation (broad)
Write-up: Report received from the foreign Regulator (case number: 267138) on 20-MAY-2010. A 6 year old female patient received one dose of FLUVAX (Batch number 090627101) on 07-APR-2010. Medical history and concomitant medications were unknown. On 11-APR-2010, four days after receiving FLUVAX, the patient was floppy (just wanted to lie down), vomiting for 2 - 3 days (large vomits), very pale, lethargic, sleeping a lot and not eating or drinking with temperatures. The patient saw a locum doctor and was treated with PANADOL, fluid and antibiotics (in case of urinary tract infection). The patient''s outcome was recovered on 16-APR-2010, 6 days later. The reporter considered the events possible to the suspect drug, FLUVAX. This case was considered serious due to medical significance. The company considered the events possibly related to the suspect drug, FLUVAX. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:389561 (history)  Vaccinated:2010-03-22
Age:6.0  Onset:2010-03-22, Days after vaccination: 0
Gender:Male  Submitted:2010-05-27, Days after onset: 66
Location:Foreign  Entered:2010-05-28, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2010023314
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED27002 IJUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hallucination, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Report received from the foreign Regulator (Case number: 267020) on 20-MAY-2010. A 6 year old male patient received one dose of FLUVAX (Batch number: 27002) on 22-MAR-2010. Medical history and concomitant medications were unknown. On 22-MAR-2010, the same day as receiving FLUVAX, six hours post vaccination the patient developed, hallucinations, high temperature and headaches lasting overnight. The patient was treated with PANADOL which was administered by his parents as required. He was settled by the following day. The patient''s outcome was recovered on 23-MAR-2010. The reporter considered the events possible to the suspect drug, FLUVAX. This case was considered serious due to medical significance. The company considered the events possibly related to the suspect drug, FLUVAX. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:389768 (history)  Vaccinated:2010-05-18
Age:6.0  Onset:2010-05-20, Days after vaccination: 2
Gender:Female  Submitted:2010-06-01, Days after onset: 12
Location:Foreign  Entered:2010-06-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0657951A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B109AC IMLG
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURERNK47500 IMAR
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority (ES-AGEMED-607408242) and described the occurrence of injection site induration in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included MMR vaccine (non-GSK, sanofi pasteur, intramuscular, unknown arm) given on 18 May 2010. On 18 May 2010, the subject received unspecified dose of INFANRIX (intramuscular, unknown thigh). On 20 May 2010, 2 days after vaccination with INFANRIX, the subject experienced injection site induration and injection site redness (17 x 20 cm) on the thigh. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 22 May 2010, the events were resolved. The regulatory authority reported that the events were probably related to vaccination with INFANRIX. The reporter added that there was no cold chain break. No further information was expected, the agency had provided us with all the available information for the time being, if they ever get any further they will send it to us.

VAERS ID:389848 (history)  Vaccinated:2006-06-18
Age:6.0  Onset:0000-00-00
Gender:Female  Submitted:2010-05-27
Location:Foreign  Entered:2010-06-02, 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:
Preexisting Conditions: Relevant medical history was not provided.
Diagnostic Lab Data: Antibody test (results: vaccine serotype levels not reactive) was done in 2009.
CDC Split Type: BRWYEH15264310
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH32939 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antibody test negative, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: This case was considered medically important. Information regarding PREVENAR was received from a healthcare professional regarding a 6-year-old female patient who experienced vaccine serotype levels not reactive and lack of efficacy. The patient received a dose on 18-Jun-2006. On an unspecified date on or around 2009, at 6 years of age, the patient''s laboratory test showed vaccine serotype levels not reactive. The patient''s father believed the vaccine to have lack of efficacy. No treatment was reported. The patient''s outcome was unknown. No additional information was available at the time of this report.

VAERS ID:389866 (history)  Vaccinated:2010-05-18
Age:6.0  Onset:2010-05-19, Days after vaccination: 1
Gender:Female  Submitted:2010-06-02, Days after onset: 14
Location:Foreign  Entered:2010-06-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0657983A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLG
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMAR
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority (# ES-AGEMED-407406242) and described the occurrence of vaccination site induration in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included MMRVAXPRO (non-GSK manufacturer; intramuscular; unknown arm) given on 18 May 2010. On 18 May 2010, the subject received unspecified dose of INFANRIX (intramuscular, unknown thigh). On 19 May 2010, 1 day after vaccination with INFANRIX, the subject experienced a local reaction in the thigh, consisting in redness (15X20 cm) and induration. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 21 May 2010, the events were resolved. The regulatory authority reported that the events were probably related to vaccination with INFANRIX.

VAERS ID:389950 (history)  Vaccinated:2010-03-30
Age:6.0  Onset:2010-03-31, Days after vaccination: 1
Gender:Male  Submitted:2010-06-03, Days after onset: 64
Location:Foreign  Entered:2010-06-03
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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0657401A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B148AH UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERAC20B148AH UNUN
Administered by: Other     Purchased by: Other
Symptoms: Oedema peripheral, Rash generalised
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of upper arm edema in a 6-year-old male subject who was vaccinated with INFANRIX-IPV (GlaxoSmithKline). On 30 March 2010, the subject received unspecified dose of PRIORIX (route and injection site unknown). On 31 March 2010, 1 day after vaccination with PRIORIX, the subject experienced upper arm edema. In 2010, at an unspecified time after vaccination with PRIORIX, the subject also developed a generalized rash. The subject was hospitalised for 3 days. The subject was treated with AUGMENTIN, cetirizine. At the time of reporting, the edema was resolved but the outcome of the generalized rash was unspecified. Correction made by NSC on 2 June 2010: Vaccine administered was INFANRIX IPV instead of PRIORIX and correct batch number was provided.

VAERS ID:391355 (history)  Vaccinated:2010-03-26
Age:6.0  Onset:2010-03-26, Days after vaccination: 0
Gender:Female  Submitted:2010-06-22, Days after onset: 88
Location:Foreign  Entered:2010-06-24, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2010024680
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED090929902 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Hallucination, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Report received from the Regulator (agency no. 089772) on 16-JUN-2010. A 6 year old female patient received a single 0.5 ml IM dose of FLUVAX (batch:0909-29902) on 26-Mar-2010. Medical history was unknown and concomitant medication history was not specified. The patient did not have any known allergies. On 26-Mar-2010, the same day as receiving suspect vaccine, patient developed hallucination (not severe), severe fever and severe rigors. Events were <12 hours in duration. Patient outcome was recovered, without sequelae. Definite improvement was reported for dechallenge and no rechallenge was performed. The reporter assessed the events as non-serious. The reporter assessed the causality as probable in relation to suspect, FLUVAX. The company considered these events as serious (medically significant) and possibly related to suspect, FLUVAX. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:391524 (history)  Vaccinated:2010-05-24
Age:6.0  Onset:2010-05-25, Days after vaccination: 1
Gender:Male  Submitted:2010-06-25, Days after onset: 31
Location:Foreign  Entered:2010-06-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0661911A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B078DC IMUN
Administered by: Other     Purchased by: Other
Symptoms: Vaccination site erythema, Vaccination site oedema, Vaccination site warmth
SMQs:
Write-up: This case was reported by a regulatory authority (# ES-AGEMED-122444341) and described the occurrence of vaccination site edema in a 6-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 24 May 2010, the subject received unspecified dose of INFANRIX (intramuscular, unknown injection site). On 25 May 2010, 1 day after vaccination with INFANRIX, the subject experienced vaccination site edema, vaccination site warmth and vaccination site erythema. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were improved. The regulatory authority reported that the events were probably related to vaccination with INFANRIX. No further information was expected, the agency has provided us with all the available information for the time being, if they ever get any further they will send it to us. The case has been closed.

VAERS ID:391581 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Female  Submitted:2010-06-25
Location:Foreign  Entered:2010-06-28, 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: anaphylaxis; milk allergy; egg allergy; meat allergy
Diagnostic Lab Data: Allergy test, milk egg and meat allergy; serum immunoglobulin E test, cow''s milk: 13.7 kU/l (Class III); serum immunoglobulin E test, Egg: 0.77 kU/l (Class II); serum immunoglobulin E test, 0.78 kU/l (Class II); serum immunoglobulin E test, 64 kU/l
CDC Split Type: WAES1006TUR00007
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Allergy test, Anaphylactic reaction, Blood immunoglobulin E increased, Sneezing, Stridor, Vaccine positive rechallenge, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a literature article, concerning a 6 year old female with a history of anaphylaxis after her first MMR vaccination when she was 1 year old, was vaccinated with MMR. She had a history of milk allergy, egg allergy and meat allergy confirmed by skin prick tests. She was admitted for her second dose of MMR vaccine. After infection of 10% dose of the full strength vaccine, she developed sneezing, wheezing and stridor within minutes. Subsequently the patient experienced anaphylactic reaction. Her IgE levels were as follows; cow''s milk: 13.7 kU/l (Class III), egg: 0.77 kU/l (Class II), meat: 0.78 kU/l (Class II) and total IgE: 64 kU/l. Subsequently, the patient recovered from anaphylactic reaction. She did not have hypotension or hypoxia. She was treated with intramuscular epinephrine, inhaled albuterol and oral methylprednisolone. Subsequently, the patient recovered completely from anaphylactic reaction over the next 2 hours. No further information is available. A copy of the published literature article is attached as further documentation of the patient''s experience.

VAERS ID:391852 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2010-06-30
Location:Foreign  Entered:2010-07-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: blood pressure measurement, 128/85 mmHg; physical examination, The remainder of the physical examination findings were normal; body temp, 37 C; serum varicella zoster virus antibody, sample from a vesicle had direct fluorescent antibody results that were positive for varicella virus; total heartbeat count, 91 beats/min; respiratory rate measurement, 28 breaths/min
CDC Split Type: WAES1006USA04278
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature normal, Dehydration, Diet refusal, Ear pain, Emotional distress, Facial palsy, Glossodynia, Herpes zoster oticus, Otorrhoea, Pruritus generalised, Purulent discharge, Rash, Rash erythematous, Rash vesicular, Superficial injury of eye, Tongue coated, Tongue ulceration, Varicella virus test positive
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Corneal disorders (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)
Write-up: It was reported in a published article, that a 6 year old boy was vaccinated with VARIVAX (Merck) when he was 12 month old. When he was 6 year old he was diagnosed with Ramsay-Hunt Syndrome and was hospitalized. The authors reported that a previously healthy 6 year old boy sustained a scratch over his right eye while playing outdoors. The next day, he complained of a right-sided earache and soreness of his tongue. By the following day, he had generalized pruritus and was pre-scribed prednisone. By day 3 of the illness, the patient was refusing solids and liquids. A rash developed on his face, and ulcers of his tongue became apparent. He was admitted to the hospital for diagnosis and rehydration. Physical examination revealed a nontoxic child in moderate distress with a temperature of 37 degreesC, a heart rate of 91 beats/min, a respiratory rate of 28 breaths/min, and blood pressure of 128/85 mmHg. Purulent drainage was noted from the patient''s right ear, and his tongue was coated in thick white material. A vesicular, erythematous rash extended from his right ear, across his cheek, to the right side of his mouth. The remainder of the physical examination findings were normal. The patient''s vaccinations were fully up to date and included receipt of a varicella vaccination at 12 months of age. A diagnostic test was performed. The patient was diagnosed with Ramsay-Hunt Syndrome. A swab sample from a vesicle had direct fluorescent antibody results that were positive for varicella virus. The virus was ultimately identified as Oka vaccine strain varicella zoster virus by real-time polymerase chain reaction genotyping. The patient was treated with intravenous acyclovir and 0.5 mg/kg of oral prednisone. Within 1 day after treatment, he began to show signs of significant improvement. Within 4 days after the initiation of treatment, the rash crusted over, the facial palsy resolved, and the patient was able to eat and drink normally, at which time treatment with prednisone was stopped. The patient was discharged from the hospital with a regimen of oral acyclovir, and a follow-up appointment for audiological examination was arranged. No further information is available.

VAERS ID:392604 (history)  Vaccinated:2010-04-09
Age:6.0  Onset:2010-04-09, Days after vaccination: 0
Gender:Male  Submitted:2010-07-09, Days after onset: 91
Location:Foreign  Entered:2010-07-12, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2010024996
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED090627401 IJUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Crying, Emotional distress, Hallucination, Headache
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad)
Write-up: Report received from the foreign Regulator on 29-JUN-2010 (case number: 267351). A 6 year old male patient received one dose of FLUVAX (batch number: 090627401) on 09-APR-2010. The patient''s medical history and concomitant medications were unknown. On 09-APR-2010, the same day as receiving FLUVAX, the patient experienced hallucinations that continued periodically overnight, a temperature of 41.5, severe headache and was upset/crying. He was treated with PANADOL and cool compressors. The patient was considered to be recovered on 10-APR-2010. The company assessed the events as serious due to medical significance and possibly related to suspect drug, FLUVAX. The reporter assessed the events as possibly related to the suspect drug, FLUVAX. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:392607 (history)  Vaccinated:2010-04-16
Age:6.0  Onset:2010-04-16, Days after vaccination: 0
Gender:Female  Submitted:2010-07-09, Days after onset: 84
Location:Foreign  Entered:2010-07-12, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2010025039
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED090628001 IJUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Delirium, Diarrhoea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Report received from the foreign regulator on 29-JUN-2010 (case number: 269793). A 6 year old female patient received 0.5ml of FLUVAX (batch 090628001) via injection on 16-APR-2010. The patient''s medical history and concomitant medications were unknown. On 16-APR-2010, the day of vaccination with the suspect drug, the patient developed a fever of 41 degrees, vomiting, diarrhoea and was delirious. The symptoms lasted on and off for 4 days. A locum doctor was called and advised to give paracetamol 4 hourly. The event outcome was recovered on 20-APR-2010. The reporter did not provide an assessment of seriousness. The reporter considered events possible in relation to the suspect drug, FLUVAX. The company considered events serious (due to medical significance) and possible in relation to FLUVAX. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:392614 (history)  Vaccinated:2010-04-16
Age:6.0  Onset:2010-04-16, Days after vaccination: 0
Gender:Male  Submitted:2010-07-09, Days after onset: 84
Location:Foreign  Entered:2010-07-12, 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:
Diagnostic Lab Data:
CDC Split Type: 2010025012
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED26801 IJUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abnormal behaviour, Delirium, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad)
Write-up: Report received from the foreign Regulator on 29-JUN-2010 (case number: 269222). A 6 year old male patient received one dose of FLUVAX (batch number: 26801) on 16-APR-2010. The patient''s medical history and concomitant medications were unknown. On 16-APR-2010, the same day as receiving FLUVAX, the patient experienced delirium, very high temperature and vomiting. He was also very subdued the next day. The patient was treated with NUROFEN. The patient''s outcome was unknown at the time of reporting. The reporter did not provide an assessment of seriousness. The reporter assessed the events as possibly related to the suspect drug, FLUVAX. The company assessed the events serious (due to medical significance) and possibly related to FLUVAX. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:392924 (history)  Vaccinated:2010-05-19
Age:6.0  Onset:2010-05-19, Days after vaccination: 0
Gender:Female  Submitted:2010-07-15, Days after onset: 57
Location:Foreign  Entered:2010-07-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0663357A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B908A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Local reaction, Skin discolouration
SMQs:, Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a regulatory authority (# ES-AGEMED-222454341) and described the occurrence of local reaction in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 19 May 2010, the subject received unspecified dose of INFANRIX (intramuscular, unknown injection site). On 19 May 2010, less than one day after vaccination with INFANRIX, the subject experienced local reaction. At the time of reporting, the subject had a brown coloration of the local reaction site. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were improved. The vaccination course with INFANRIX was discontinued. The regulatory authority reported that the events were probably related to vaccination with INFANRIX. No further information is expected as the regulatory authority has provided GSK with all the available information for the time being. If they ever get any further, they will send it to GSK. This case has therefore been closed.

VAERS ID:393960 (history)  Vaccinated:2010-06-09
Age:6.0  Onset:2010-06-26, Days after vaccination: 17
Gender:Female  Submitted:2010-07-30, Days after onset: 34
Location:Foreign  Entered:2010-07-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: viral gastroenteritis
Diagnostic Lab Data: Blood creatinine, 30Jun2010, normal; Protein urine, 30Jun2010, normal; Skin biopsy, 30Jun2010, see lab text; Streptococcus test, 30Jun2010, negative; 30 June 2010 : Skin biopsy in favour of a periarteritis nodosa.
CDC Split Type: B0667203A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Arthritis, Asthenia, Biopsy skin abnormal, Blood creatinine normal, Ecchymosis, Haematoma, Inflammation, Odynophagia, Oedema, Polyarteritis nodosa, Protein urine absent, Pyrexia, Rash maculo-papular, Skin lesion, Streptococcus test negative, Vasculitis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow), Arthritis (narrow)
Write-up: This case was reported by the regulatory authority (agency number TS20100269) and described the occurrence of periarteritis nodosa in a 6-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject''s medical history included viral gastroenteritis. On 01 June 2010, the subject was started on MOTILIUM, DEBRIDAT, SMECTA, SPASFON, for a viral gastroenteritis, during four to five days. On 09 June 2010, the subject received third dose of ENGERIX B (intramuscular, unknown batch and site of injection). On 26 June 2010, 17 days after vaccination with ENGERIX B, the subject experienced left wrist pain with hematoma treated with ADVIL, cream 15%. On 29 June 2010, she presented with right knee arthritis, asthenia, left wrist pain without fever. On 30 June 2010, the subject experienced odynophagia, arthralgia and joint inflammation on wrists, ankles and right knee; edematous ecchymotic lesions on fingers of both hand; multiple maculopapulars lesions predominant on articulations, legs, buttocks, forearm and fever. Cardio-pulmonary exam and blood creatinine were normal. They were no lymphadenopathy, organomegaly, hematuria or urine protein. Inflammatory syndrome and vasculitis were also reported by the reporter. The skin biopsy was in favor of a periarteritis nodosa. On an unspecified date the subject was hospitalised. At the time of reporting the events were improved. According to the method of assessment, the agency considered the relationship between the ENGERIX B and the events as dubious.

VAERS ID:396699 (history)  Vaccinated:2010-06-24
Age:6.0  Onset:2010-03-11, Days after vaccination: -105
Gender:Unknown  Submitted:2010-08-26, Days after onset: 167
Location:Foreign  Entered:2010-08-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No reported medical history and concomitant therapy
Diagnostic Lab Data: Not reported
CDC Split Type: 201004465
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURC3348AB IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site reaction
SMQs:
Write-up: Case received from the Health Authorities on 19 August 2010 under the reference number PLURPLOCR20100812011. A 06-year-old patient, with no reported medical history and concomitant therapy, had received an intramuscular dose of TRIPACEL (batch number C3348AB, site of administration not reported) on "24 June 2010". On "11 March 2010", the patient experienced very important injection site reaction (diameter more than 10cm); that persisted more than 3 days. The patient was hospitalized. The patient recovered on an unspecified date. Local reaction was not coded by the Health Authorities. List of documents held by sender: none.

VAERS ID:397304 (history)  Vaccinated:2010-05-25
Age:6.0  Onset:2010-05-25, Days after vaccination: 0
Gender:Female  Submitted:2010-08-27, Days after onset: 94
Location:Foreign  Entered:2010-09-03, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2010026139
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)CSL LIMITED090206001 IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Bradycardia, Cold sweat, Dizziness, Nausea, Pallor, Presyncope
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Report received from the Foreign Regulator on 19-AUG-2010 (case: 270021). A 6 year old female patient received one dose of PANVAX by intramuscular injection into the left deltoid (Batch number 090206001) on 25-MAY-2010. It is unknown if the patient had a relevant medical history or was taking concomitant therapy. On 25-MAY-2010 symptoms commenced 5 minutes post immunisation with PANVAX. The patient felt clammy and pale, was bradycardic (61 beats per minute), was dizzy, light headed and had abdominal pain and nausea. Symptoms were reported as slowly resolving after 25 minutes, however the symptoms had not resolved and the patient was sent to hospital for review. Heart rate increased to 87 beats per minutes on discharge. The patient was considered to have experienced a vasovagal episode within 5 minutes of vaccination with a bradycardic episode. The event resolved with a change in position. Treatment included the administration of oxygen and leg elevation. The patient was observed every 2 minutes. The patient outcome was reported as not recovered. The reporter considered events possible to the suspect drug PANVAX. This case was reported as serious due to medical significance. The company considered events possible to the suspect drug, PANVAX, due to the short time to onset of symptoms. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:397335 (history)  Vaccinated:2010-04-24
Age:6.0  Onset:2010-04-24, Days after vaccination: 0
Gender:Male  Submitted:2010-09-02, Days after onset: 131
Location:Foreign  Entered:2010-09-03, Days after submission: 1
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: Chronic disease (not specified). The patient had no previous history of seizure. Unknown previous history of adverse event to a vaccine or a drug. Unknown concomitant therapies.
Diagnostic Lab Data: Unknown
CDC Split Type: 201004668
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)SANOFI PASTEURUH039AB0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Grand mal convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Case received from Institute through sanofi pasteur on 25 August 2010 under the local reference number BR2010-269. A 06-year-old male patient, with a medical history of chronic disease (not specified) had received a first primary dose of H1N1; batch number UH039AD, route and anatomical site of administration unknown, on 24 April 2010. The patient had an unknown family medical history, an unknown previous history of adverse event to a vaccine or a drug and unknown concomitant therapies. On 24 April 2010, 3 minutes after immunization, the patient presented with a generalized tonic-clonic seizure. The patient was hospitalized. To be noted that the patient did not have any history of seizures. The patient evolved with ceasing to the symptoms without sequelae, even though the date of recovery was not specified. The patient was send to a neurologist for evaluation. The second dose of the vaccine was counter-indicated. Corrective treatment was unknown. The patient outcome was not reported. This case was assessed serious as a significant medical condition. Documents held by sender: none.

VAERS ID:397915 (history)  Vaccinated:2010-08-23
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2010-09-09
Location:Foreign  Entered:2010-09-10, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No relevant patient''s medical history.
Diagnostic Lab Data:
CDC Split Type: E201005114
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERC3547AD IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: C-reactive protein increased, Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Case received from a healthcare professional on 01-Sep-2010. Case medically confirmed. A 6-year-old previously healthy male patient had received a booster dose of COVAXIS (lot-no. C3547AD) IM into the left upper arm on 23-Aug-2010. Unspecified time later he developed a severe local allergic reaction with redness, swelling and warmth at the left upper arm leading to hospitalization for an unspecified time. He was found to have an increased CRP to 46.7 (N: <5, no unit reported). The patient recovered within an unspecified time. According to the reporter, the reaction was definitely related to vaccination. Case is closed.

VAERS ID:398112 (history)  Vaccinated:2010-07-20
Age:6.0  Onset:2010-07-20, Days after vaccination: 0
Gender:Female  Submitted:2010-09-13, Days after onset: 55
Location:Foreign  Entered:2010-09-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0673540A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B110AE IMUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURERVN12210 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site rash, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (# ES-AGEMED-609871337) and described the occurrence of injection site cellulitis in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline), NEISVAC-C. On 20 July 2010 the subject received unspecified dose of INFANRIX (intramuscular), unspecified dose of NEISVAC-C (intramuscular). On 20 July 2010, less than one day after vaccination with INFANRIX and NEISVAC-C, the subject experienced injection site edema and injection site redness. The next day she presented a considerable injection cellulitis and local reaction. She went several times to the emergency room because the reaction spread to the forearm and involved the flexure of elbow. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with AUGMENTIN, DALSY and ice. After 6 days cellulitis had disappeared, however she had mild edema and vaccination site eruption persisted. At the time of reporting the rest of the events improved. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX and NEISVAC-C. No further information was expected, the regulatory authorities has provided all the available information for the time being, if they get any further they will send it to us.

VAERS ID:398764 (history)  Vaccinated:2010-07-27
Age:6.0  Onset:2010-07-28, Days after vaccination: 1
Gender:Male  Submitted:2010-09-17, Days after onset: 51
Location:Foreign  Entered:2010-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 28Jul2010, 40DegC; examination of cerebrospinal fluid 29.07.2010: leucocytes 2 per mcl, polynuclear cells 0 percent, mononuclear cells 100 percent, erythrocytes negative, glucosis 59 mg/dl, lactate 1.3 mmol/l, proteine 0.16 g/l; laboratory test 29.07.2010: phosphat 1.11 mmol/l, C-reactive proteine 79.4 mg/l, leucocytes 5.87x1E9/l, erythrocytes 5.4x1E12/l, MCV 78 fl, neutrophils 67.1 percent, lymphocytes 15.0 percent, TPZ (INR) 1.1, drained off fibrinogen 4.4 g/l, d-dimer 0.37 mg/l; laboratory test 30.07.2010: C-reactive proteine EDTA blood 24.9 mg/l, leucocytes 4.09x1E9/l, erythrocytes 5.2x1E12/l, thrombocytes 149x1E9/l, neutrophils 31.8 percent
CDC Split Type: D0068786A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B049AC0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Blood fibrinogen increased, Blood phosphorus decreased, Body temperature increased, C-reactive protein increased, CSF cell count normal, CSF glucose normal, CSF lactate normal, CSF protein normal, CSF white blood cell count negative, Conjunctivitis, Dehydration, Fatigue, Febrile infection, Fibrin D dimer increased, Headache, International normalised ratio, Lymphocyte percentage decreased, Mean cell volume decreased, Meningism, Musculoskeletal stiffness, Nausea, Neutrophil percentage decreased, Pallor, Platelet count decreased, Pyrexia, Red blood cell count normal, Urine ketone body present, Vomiting, White blood cell count decreased
SMQs:, Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: This case was reported by a physician and described the occurrence of fever in a 6-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 27 July 2010 the subject received 1st dose of BOOSTRIX (unknown route and application site). Less than one year after vaccination with BOOSTRIX, the subject experienced fever, headache and nausea. At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 14 September 2010 from the physician. There were no concurrent medical conditions or any other risk factors. The subject did not receive any concomitant medication. On 27 July 2010 the subject received a dose of BOOSTRIX (intramuscular, left upper arm). On 28 July 2010, 1 day after vaccination with BOOSTRIX, the subject experienced fever with a body temperature up to 40 degC and headache. These events were resolved on 30 July 2010. The subject also suffered from nausea, weakness, meningism and possible meningitis. The subject was monitored in hospital. The subject was treated with intravenous infusion/hydration. Examination included lumbar puncture. The physician considered the events were possibly related to vaccination with BOOSTRIX. At the time of reporting all events were resolved. The subject was hospitalized from 29 July 2010 to 30 July 2010. At hospital febrile infection and exsiccosis were diagnosed. Meningitis was suspected, but excluded according to test results of lumbar puncture. In the night after vaccination with BOOSTRIX the subject developed high fever with body temperatures up to 40 degC. The subject drank moderately. In the evening of the following day the subject experienced vomiting once, headache and stiff neck. The subject was hospitalized in stable general condition with pallor of skin, tiredness, meningism and mild red conjunctivitis. The subject had no lymph node swelling. Throat, nose and ear as well as neurological status were without pathological findings. At hospitalization the subject showed significant meningism and suffered from headache. Therefore lumbar puncture was performed. C-reactive protein was increased but focus for infection was not found. The subject was not treated with antibiotics because condition was stable. The subject was treated by intravenous fluid substitution due to triple increased ketone bodies in urine. General condition improved quickly under this treatment. Inflammation values also improved, the subject started to eat and drink. No further information will be available.

VAERS ID:398857 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Unknown  Submitted:2010-09-20
Location:Foreign  Entered:2010-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2010IN60858
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Fall, Head injury, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Initial report received from a physician on 13 Sep 2010: This patient was vaccinated with AGRIPPAL S1 (batch number unknown), on an unspecified date. Following vaccination, the patient developed convulsions and also suffered from head injury due to fall. However on checking with the physician, it was confirmed that it was just a vaso-vagal attack, i.e. a fainting spell and not a seizure. Outcome of the event was not reported.

VAERS ID:398992 (history)  Vaccinated:2010-08-13
Age:6.0  Onset:2010-08-14, Days after vaccination: 1
Gender:Unknown  Submitted:2010-09-20, Days after onset: 37
Location:Foreign  Entered:2010-09-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201004941
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC3106A IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site reaction, Lymph node pain, Lymphadenopathy, Oedema, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: Case received from the Health Authorities in a foreign country on 09 September 2010 under the local reference number PL-URPL-OCR-20100831001. A 06-year-old patient (gender not specified), with no reported medical history, had received an intramuscular dose of TRIPACEL, batch number C3106AL, in the left brachial muscle, on 13 August 2010. On 14 August 2010, i.e. the following day post-vaccination, the patient experienced a very strong reaction at the injection site (diameter $g 10 cm) beyond the nearest joint; painful and increased regional lymph nodes and fever at 37.2 degrees C. The patient developed inflammatory oedema on the whole arm from the elbow joint up to the shoulder joint involving a small part of the shoulder blade. The HAs coded "injection site reaction", "lymphadenopathy" and "body temperature increased". The patient recovered. This case was reported as serious, however no seriousness criterion was selected. Documents held by sender: none.

VAERS ID:399990 (history)  Vaccinated:2010-08-06
Age:6.0  Onset:2010-08-06, Days after vaccination: 0
Gender:Male  Submitted:2010-09-23, Days after onset: 48
Location:Foreign  Entered:2010-09-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0674936A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B110AE IMLA
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALSA69CC202A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Injection site erythema, Injection site oedema, Joint range of motion decreased, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a regulatory authority (# ES-AGEMED-609889337) and described the occurrence of joint range of motion decreased in a 6-year-old male subject who was vaccinated with INFANRIX, (GlaxoSmithKline). Previous and/or concurrent vaccination included combined PRIORIX (new strain) ;(GlaxoSmithKline); intramuscular; given on 6 August 2010. On 6 August 2010, the subject received unspecified dose of INFANRIX (intramuscular, left arm). On 6 August 2010, within minutes of vaccination with INFANRIX, the subject experienced nausea and dizziness. The events resolved the same day. On 8 August 2010, 2 days after vaccination with INFANRIX, the subject visited the emergency ward due to edema and erythema from shoulder to elbow of the left arm with joint range of motion decreased. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the erythema, edema and joint range of motion decreased were unresolved. The regulatory authority reported that the events were probably related to vaccination with INFANRIX. No further information is expected as the foreign regulatory authority has provided GSK with all the available information for the time being. If they ever get any further information, they will send it to GSK. This case has therefore been closed.

VAERS ID:401349 (history)  Vaccinated:2010-05-21
Age:6.0  Onset:2010-05-22, Days after vaccination: 1
Gender:Female  Submitted:2010-09-30, Days after onset: 131
Location:Foreign  Entered:2010-09-30
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: ADVERSE REACTION TO VACCINE
Diagnostic Lab Data: UNK
CDC Split Type: B0675588A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSAC20B126FA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Aphasia, Facial paresis, Obstructive airways disorder
SMQs:, Angioedema (broad), Asthma/bronchospasm (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: This case was reported by a regulatory authority (# OGY/40809-1/2010) and described the occurrence of facial paresis in a 6-year-old female subject who was vaccinated with combined INFANRIX-IPV (GlaxoSmithKline). The subject''s medical history included hyperreaction after BCG vaccination. On 21 May 2010, the subject received unspecified dose of INFANRIX-IPV (intramuscular, left arm). On 22 May 2010, 1 day after vaccination with INFANRIX-IPV, the subject could not speak and a facial paresis was diagnosed. The subject also experienced obstructive airways disorder NOS (reported as tubal obstruction, which ment: ''...air is not passing through the tube completely...''). This case was assessed as medically serious by GSK. The subject went to see a neurologist, and diagnosis of facial paresis was confirmed. The subject was treated with oro-facial massage and logotherapy. At the time of reporting, facial paresis was resolved, inability to speak was improving and obstructive airways disorder NOS was unresolved. No clarification could be obtained for the event of tubal obstruction.

VAERS ID:401794 (history)  Vaccinated:2010-09-09
Age:6.0  Onset:2010-09-10, Days after vaccination: 1
Gender:Male  Submitted:2010-10-04, Days after onset: 24
Location:Foreign  Entered:2010-10-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0068986A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B049AJ IMLA
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis
SMQs:
Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2010027719) and described the occurrence of phlegmon of left upper arm in a 6-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 09 September 2010 the subject received an unspecified dose of BOOSTRIX (0.5 ml, intramuscular, unspecified application site). Approximately one day post vaccination with BOOSTRIX, on 10 September 2010, the subject experienced phlegmon of left upper arm. The subject was hospitalised for an unknown period of time. The subject was treated with AMPICILLIN and OXACILLIN. The event was improved quickly and distinctly on three days of treatment with ampicillin trihydrate and oxacillin sodium. No further information will be available.

VAERS ID:402243 (history)  Vaccinated:2010-08-23
Age:6.0  Onset:2010-08-24, Days after vaccination: 1
Gender:Male  Submitted:2010-10-06, Days after onset: 43
Location:Foreign  Entered:2010-10-06
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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0676616A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSAC20B150AV UNLL
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, Injection site oedema, Injection site pain, Injection site reaction, Injection site warmth, Skin lesion
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 (# 124109) via a physician and described the occurrence of injection site warmth in a 6-year-old male subject who was vaccinated with INFANRIX-POLIO (GlaxoSmithKline). No relevant medical history or concomitant medication was reported. On 23 August 2010, the subject received unspecified dose of INFANRIX-POLIO (unknown route, left thigh). On 24 August 2010, 1 day after vaccination with INFANRIX-POLIO, the subject experienced hard edema, warm and pain at the left thigh and there was also a small lesion in left thigh like an insect sting but it was not on injection site. On 25 August 2010, the subject was hospitalised and discharged on 28 August 2010. The subject was treated with ampicillin + sulbactam for 4 days and AUGMENTIN 10 mL was recommended for 15 days. At the time of reporting, the events were improved. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX-POLIO. This case has been closed.

VAERS ID:402772 (history)  Vaccinated:2010-09-24
Age:6.0  Onset:2010-09-24, Days after vaccination: 0
Gender:Female  Submitted:2010-10-11, Days after onset: 17
Location:Foreign  Entered:2010-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 120/80mmHg; Heart rate, 120Bpm/min
CDC Split Type: B0677661A
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERD08717 UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B047DC UNRA
Administered by: Other     Purchased by: Other
Symptoms: Cyanosis, Gaze palsy, Muscle contractions involuntary, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician via a regulatory authority (124382) and described the occurrence of fainting in a 6-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), IMOVAX POLIO (non-gsk). On 24 September 2010, the subject received 4th dose of BOOSTRIX (route and injection site unknown) and 4th dose of IMOVAX POLIO (route and injection site unknown). On 24 September 2010, less than one day after vaccination with BOOSTRIX and IMOVAX POLIO, the subject experienced fainting, perioral cyanosis, retroversion of the eyeballs and involuntary muscle contractions. The subject was hospitalised. Relevant tests were performed and showed blood pressure 120/80 mmHG and heart rate 120 Bpm/min. On 24 September 2010, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with BOOSTRIX and IMOVAX POLIO.

VAERS ID:402996 (history)  Vaccinated:2010-09-08
Age:6.0  Onset:2010-09-08, Days after vaccination: 0
Gender:Unknown  Submitted:2010-10-08, Days after onset: 30
Location:Foreign  Entered:2010-10-12, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201005571
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURC3546A IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral, Pain of skin, Pyrexia, Respiratory tract infection, Skin tightness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Case received from the Health Authorities on 29 September 2010 under the reference number PL-URPL-OCR-20100917001 (affiliate''s number 2010-0311). A 06-year-old patient (gender not specified), with no reported medical history, had received the intramuscular dose of TRIPACEL, batch number C3546AA, on 08 September 2010. On 08 September 2010, post-vaccination, the patient experienced "edema and redness on the right arm from the elbow above the shoulder joint". The patient''s skin was tense, red and painful. The patient was hospitalized from 10 to 13 September 2010 due to persistent hand oedema, feverishness and suspected respiratory tract infection. The HAs coded "swelling arm", "pain in right arm" and "increased body temperature". The patient outcome was unknown at the time of the report. Documents held by sender: none.

VAERS ID:403080 (history)  Vaccinated:2010-09-10
Age:6.0  Onset:2010-09-11, Days after vaccination: 1
Gender:Female  Submitted:2010-10-12, Days after onset: 31
Location:Foreign  Entered:2010-10-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0678684A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B110AE IMAR
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site cellulitis
SMQs:
Write-up: This case was reported by a regulatory authority (agency # ES-AGEMED-789674439) and described the occurrence of injection site cellulitis in a 6-year-old female subject who was vaccinated with INFANRIX, GlaxoSmithKline. Previous and/or concurrent vaccination included MMR vaccine (non-gsk); Sanofi Pasteur MSD; given on 10 September 2010. On 10 September 2010, the subject received unspecified dose of INFANRIX (intramuscular, unknown arm). On 11 September 2010, 1 day after vaccination with INFANRIX, the subject experienced injection site cellulitis on the arm where INFANRIX was administered. The event lasted 5 days. The subject was hospitalised. On 15 September 2010, the event was resolved. The regulatory authority reported that the event was probably related to vaccination with INFANRIX. No further information is expected as the foreign regulatory authority has provided GSK with all the available information for the time being. If they ever get any further, they will send it to GSK. This case has therefore been closed.

VAERS ID:403475 (history)  Vaccinated:2010-09-04
Age:6.0  Onset:2010-09-05, Days after vaccination: 1
Gender:Female  Submitted:2010-10-14, Days after onset: 39
Location:Foreign  Entered:2010-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Vaccinal history of the subject during early childhood was correct.
Diagnostic Lab Data: Body temperature, 05Sep2010, 38.5deg Celsius
CDC Split Type: B0678190A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Drug dispensing error, Petechiae, Pyrexia, Rash, Wrong drug administered
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: This case was reported by the regulatory authority (MA20101688) and described the occurrence of petechiae over eyelids in a 6-year-old female subject who was vaccinated with INFANRIXQUINTA (GlaxoSmithKline). Vaccinal history of the subject in early childhood was correct. On 04 September 2010, the subject was supposed to receive a booster dose of DTP. Following a drug dispensing error, the subject received a booster dose of INFAXRIXQUINTA (batch number not provided, intramuscular, unknown deltoid) (wrong vaccine administered, medication error). On 05 September 2010, one day after vaccination with INFANRIXQUINTA, the physician was called because the subject presented with fever and a petechial like skin eruption located at palpebral level. No reaction at the injection site was observed. As the physician was unavailable, the subject consulted at hospital. On arrival, body temperature was at 38.5 degrees Celsius. At 07:00 PM, the subject was better and she was discharged from hospital at midnight. On 06 September 2010, the subject was healthy (information obtained by phone). The agency reported that the events were clinically significant (or requiring intervention): (consultation at hospital and medical surveillance for several hours required). The agency assessed the relationship of INFANRIXQUINTA with the events as probable, according to the method of assessment.

VAERS ID:407052 (history)  Vaccinated:2010-04-23
Age:6.0  Onset:2010-04-21, Days after vaccination: -2
Gender:Male  Submitted:2010-10-19, Days after onset: 181
Location:Foreign  Entered:2010-10-20, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 2010-04-30
   Days after onset: 9
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: Hydrocephaly
Diagnostic Lab Data: Not reported
CDC Split Type: 201005343
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURERUH001AH UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hydrocephalus, Intracranial pressure increased, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)
Write-up: This case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the "Ministry of Health" through foreign institute (local case reference number BR2010-650). A 06-year-old male patient, with a medical history of hydrocephaly, no reported concomitant therapy and "no other vaccine", had received his dose of H1N1 vaccine (batch number UH001AH, route and anatomical site of administration not reported) on 23 April 2010. Sanofi pasteur Inc. lot number is UH001AH and the corresponding lot number allocated at packaging by institute is 1003060. On 21 April 2010, i.e. 2 days pre-vaccination, the patient experienced fatal intracranial hypertensive syndrome and hydrocephalus. To be noted that the date of death was also reported to be 7 days post-vaccination. Unexpected sudden death was also mentioned. The patient was hospitalized on unspecified date. This case was considered as "severe". Documents held by sender: none.

VAERS ID:404943 (history)  Vaccinated:2010-10-05
Age:6.0  Onset:2010-10-07, Days after vaccination: 2
Gender:Female  Submitted:2010-10-22, Days after onset: 15
Location:Foreign  Entered:2010-10-22
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: B0679818A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B125EC IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site cellulitis, Injection site vesicles
SMQs:
Write-up: This case was reported by another health professional via a regulatory authority (# ES-AGEMED-920456247) and described the occurrence of injection site cellulitis in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 5 October 2010, the subject received unspecified dose of INFANRIX (.5 ml, intramuscular, injection site unknown). On 7 October 2010, 2 days after vaccination with INFANRIX, the subject experienced injection site cellulitis (10 cm of diameter) with blisters. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with antibiotics and corticosteroid. At the time of reporting, the outcome of the events was unspecified. No further information was expected.

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