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This is VAERS ID 213168

Case Details

VAERS ID: 213168 (history)  
Form: Version 1.0  
Age: 1.42  
Sex: Male  
Location: California  
Vaccinated:2003-06-30
Onset:2003-07-14
   Days after vaccination:14
Submitted: 2003-11-24
   Days after onset:133
Entered: 2003-12-01
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 530A2 / 4 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0197 / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1236M / UNK - / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0975M / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain neoplasm malignant, Collapse of lung, Neuroblastoma, Pleural effusion, Pneumonia, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-09-01
   Days after onset: 49
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Chest x-rays: 7/28/03: at 21:48 hrs-show bilateral extensive pleural effusions and areas of pulmonary edema or pneumonia. 7/28/03 at 22:34 hrs-show bilateral pleural effusions and progressive diffuse pulmonary opacification, consistent with pulmonary edema, pulmonary hemorrhage, ARDS or severe diffuse pneumonia. Feeding tube is in the stomach. Tube is in the trachea. Broviac catheter is in the right atrium. 23:33 hrs-indicatiosn: respiratory failure. Status post drainage of bilateral pleural effusions with pigtail catheters. Continued diffuse pulmonary disease.
CDC Split Type: 200303028

Write-up: This subject is a 17 month old male, who was noted to have vomiting and an abdominal mass while enrolled in a Comparative post-marketing safety study of CPDT Vaccine Adsorbed administered with other recommended vaccines according to the standard of care, at 2, 4, and 6 months of age in infants and as a booster to toddlers, Protocol Number P3T08. The subject received four doses of Infanrix. The last dose prior to the event was given on 6/30/03. Other vaccines given on the same date were IPV, PRP-T, MMR and VZV. The subject developed vomiting and an abdominal mass was found, 14 days post-immunization. The subject underwent a tumor biopsy on 7/25/03, along with bone marrow aspirations and biopsies. The pt was diagnosed as a stage 4 Neuroblastoma and was started on the COG A3973 protocol. According to the protocol, the pt was due to have a stem cell harvest after two cycles of chemotherapy. The subject was to have a future autologous stem cell transplant if enough stem cells were harvested and other requirements of the protocol has been completed. There was unanimous agreement among the transplant committee that this subject was a candidate for a stem cell transplant assuming the subject remained on the COG protocol, and the subject met transplant criteria. The subject died on 9/1/03. The event of neuroblastoma, secondary brain/ spine cancer, anoxic brain damage, pneumonia, and pulmonary collapse was reported by the investigator as not related to the study vaccine. Autopsy is pending. A 15-day follow up report received 12/19/2003 adds no new info.


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