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| VAERS ID: | 156326 | Vaccination Date: | 2000-07-05 | | Age: | 0.2 | Onset Date: | 2000-07-05 Days later: 0 | | Gender: | Male | Submitted: | 2000-07-10 | | State: | California | Entered: | 2000-07-11 | |
| Life Threatening Illness? Yes |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? Yes |
| Hospitalized? Yes, 5 days | | Extended hospital stay? No |
| Current Illness: Mild upper respiratory symptoms | | Diagnostic Lab Data: CXR-nml; CBC-nml | | Previous Vaccinations: | | Other Medications: NONE | | Preexisting Conditions: premature, anemia of prematurity | | CDC 'Split Type': HQ8250207JUL2000 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | DTAP | LEDERLE LABORATORIES | 466023 | 0 | IM | LL | | HIBV | MERCK & CO. INC. | 0287K | 0 | IM | RL | | IPV | AVENTIS PASTEUR | R0578 | 0 | SC | LL | | PNC | LEDERLE LABORATORIES | 471220 | 0 | IM | RL | |
| Administered by: Private Purchased by: Private | | Symptoms: Apnoea, Cardiac arrest, Cyanosis, Gastrooesophageal reflux disease | | Write-up: A physician reported that a 2 month old male who was born premature at 30.5 weeks gestation, received Prevnar, Acel-Imune, Pedivax-Hib (Merck) and IPV (Aventis Pasteur SA) vaccines on 7/5/00, and 2 hours, post vax, the infant developed a cyanotic episode while feeding. He developed 4 cyanotic episodes ranging in duration from 30 seconds to 3 minutes. After the 2nd episode, his parents called 911 and his father performed cardiopulmonary resuscitation for 1 1/2 minutes. He was hospitalized for monitoring and remained stable for 12 hours. F/U rec'd 11/17/00, it was reported the infant was hospitalized for 5 days. He was treated for GE reflux, No further events have ensued. The pt is doing very well, now 6 mo of age. He has now rec'd subsequent doses of all 4 vaccines without any reactions. No further information is anticipated for this report. This case is closed. From follow-up received on 5/1/01, it was reported, "pt recovered, brief hospitalization for cyanotic/apneic event possibly due to GE reflux, possible reaction to vaccines given at 2 months (incorrect age). Now pt is 11 months old and healthy". From F/U, it was stated that while in the hospital, the pt experienced 3 more episodes of apnea, which were described as "near-miss SIDS". The physician stated the adverse experience was apnea. The cyanosis noted in the original report was actually a symptom of apnea. The physician noted the pt would likely have died had he not been monitored, or the events had not been witnessed. A consulting pediatrician in the hospital thought the pt had possible "GE Reflux", which may have contributed to the symptoms; however, the reporting physician did not feel this was the case. The pt was hospitalized for 5 days and released. A CXR and CBC were normal. By 7/10/00, the pt completely recovered from the experience and had no further episodes of apnea. The physician did not believe the pt's experiences were related to the vaccinations. The pt's symptoms were considered life-threatening. F/U The pt rec'd subsequent doses of all 4 |
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| VAERS ID: | 158751 | Vaccination Date: | 2000-07-27 | | Age: | 0.8 | Onset Date: | 2000-07-28 Days later: 1 | | Gender: | Male | Submitted: | 2000-07-31 | | State: | Wisconsin | Entered: | 2000-08-14 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2000-07-28) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: Sinusitis | | Diagnostic Lab Data: | | Previous Vaccinations: | | Other Medications: | | Preexisting Conditions: Walker-Warburg syndrome | | CDC 'Split Type': | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | PNC | LEDERLE LABORATORIES | 475228 | 1 | IM | LL | |
| Administered by: Private Purchased by: Private | | Symptoms: Cardio-respiratory arrest, Unevaluable event | | Write-up: Death. Doubt any relationship other than temporal. Cause of death given as cardio-pulmonary arrest. . |
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| VAERS ID: | 159003 | Vaccination Date: | 2000-08-04 | | Age: | 0.3 | Onset Date: | 2000-08-05 Days later: 1 | | Gender: | Male | Submitted: | 2000-08-08 | | State: | Unknown | Entered: | 2000-08-21 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2000-08-05) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: preliminary autopsy report-SIDS | | Previous Vaccinations: | | Other Medications: Tylenol infant | | Preexisting Conditions: mother has hx of smoking during pregnancy | | CDC 'Split Type': | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | DTAP | LEDERLE LABORATORIES | 467674 | | IM | | | HBHEPB | MERCK & CO. INC. | 0293K | | IM | | | IPV | PASTEUR MERIEUX INST. | R12512 | | | | | PNC | LEDERLE LABORATORIES | 469692 | | IM | | |
| Administered by: Purchased by: | | Symptoms: Apnoea, Cardiac arrest, Coma, Cyanosis, Sudden infant death syndrome | | Write-up: Next day post vax, the pt was found blue and unresponsive. Efforts to resuscitate were unsuccessful. Autopsy states cause of death as sudden infant death syndrome. . |
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| VAERS ID: | 159916 | Vaccination Date: | 2000-09-11 | | Age: | 0.3 | Onset Date: | 2000-09-14 Days later: 3 | | Gender: | Female | Submitted: | 2000-09-14 | | State: | Texas | Entered: | 2000-09-20 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2000-09-14) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: | | Previous Vaccinations: | | Other Medications: | | Preexisting Conditions: | | CDC 'Split Type': | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | DTAP | CONNAUGHT LABORATORIES | U0317BB | 0 | IM | RL | | HBHEPB | MERCK & CO. INC. | 0555K | 0 | IM | LL | | IPV | CONNAUGHT LTD. | T0120 | 0 | SC | RL | | PNC | LEDERLE LABORATORIES | 471655 | 0 | IM | LL | |
| Administered by: Private Purchased by: Private | | Symptoms: Cardiac arrest, Cyanosis, Respiratory arrest | | Write-up: On 9/14/00, the baby was found blue and not breathing at 12:30 PM. Baby had been put to sleep at 10:30 am. Paramedics were unable to intubate due to rigor mortis. Taken to the ER and pronounced dead on arrival as pt was in asystole. . |
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| VAERS ID: | 159963 | Vaccination Date: | 2000-09-13 | | Age: | 0.8 | Onset Date: | 2000-09-20 Days later: 7 | | Gender: | Female | Submitted: | 2000-09-20 | | State: | Massachusetts | Entered: | 2000-09-21 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2000-09-20) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Autopsy pending; blood cultures-neg | | Previous Vaccinations: | | Other Medications: Tylenol | | Preexisting Conditions: Initial low blood sugar | | CDC 'Split Type': | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HEP | MERCK & CO. INC. | 0429K | 2 | IM | LL | | PNC | LEDERLE LABORATORIES | 473334 | 0 | IM | RL | |
| Administered by: Private Purchased by: Public | | Symptoms: Apnoea, Cardiac arrest | | Write-up: The pt was found pulseless and apneic in crib at 08:00 on 9/20/00. 1 |
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| VAERS ID: | 164642 | Vaccination Date: | 2000-10-18 | | Age: | 0.3 | Onset Date: | 2000-10-20 Days later: 2 | | Gender: | Female | Submitted: | 2001-01-04 | | State: | Arizona | Entered: | 2001-01-11 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2000-10-21) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? Yes |
| Hospitalized? Yes, 2 days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: Autopsy report-haven't received yet | | Previous Vaccinations: | | Other Medications: Milicon drops | | Preexisting Conditions: | | CDC 'Split Type': | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | DTAP | CONNAUGHT LABORATORIES | U0317AB | 1 | IM | LL | | HIBV | LEDERLE PRAXSIS | 471871 | 1 | IM | | | IPV | CONNAUGHT LTD. | T0161 | 1 | SC | LA | | PNC | LEDERLE LABORATORIES | 471226 | 1 | IM | RA | |
| Administered by: Private Purchased by: Other | | Symptoms: Anorexia, Apnoea, Cardiac arrest, Fatigue, Pneumonia | | Write-up: Within 48 hours post vax, the pt was found not breathing and had no heart rate. Following the vaccination she had been very tired and missed some feedings. When she was found not breathing, she was rushed to the hospital and within an hour of being found they were able to get a heart rate with resuscitation efforts. She remained intubated in the hospital but was brain dead and died on 10/21/00. Autopsy states cause of death as pneumonia. |
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| VAERS ID: | 165922 | Vaccination Date: | 2000-12-12 | | Age: | 1.0 | Onset Date: | 0000-00-00 Days later: | | Gender: | Male | Submitted: | 2001-02-13 | | State: | Florida | Entered: | 2001-02-16 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2000-12-13) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: Gastroenteritis | | Diagnostic Lab Data: | | Previous Vaccinations: | | Other Medications: Flovent, albuterol | | Preexisting Conditions: Chronic lung disease; prematurity | | CDC 'Split Type': | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HIBV | LEDERLE PRAXSIS | 581253 | 2 | IM | RL | | MMR | MERCK & CO. INC. | 0580K | 0 | SC | RL | | PNC | LEDERLE LABORATORIES | 475382 | 1 | IM | LL | | VARCEL | MERCK & CO. INC. | 1249K | 0 | SC | LL | |
| Administered by: Private Purchased by: Public | | Symptoms: Cardio-respiratory arrest, Encephalopathy | | Write-up: This infant died of cardiopulmonary arrest of unknown etiology; at this time autopsy is pending. Autopsy stated cause of death as acute encephalopathy. 3 |
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| VAERS ID: | 166170 | Vaccination Date: | 2000-08-07 | | Age: | 1.3 | Onset Date: | 2001-01-09 Days later: 155 | | Gender: | Male | Submitted: | 2001-02-22 | | State: | Unknown | Entered: | 2001-02-27 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2001-01-11) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? Yes, days | | Extended hospital stay? No |
| Current Illness: | | Diagnostic Lab Data: NONE | | Previous Vaccinations: | | Other Medications: UNK | | Preexisting Conditions: 2/20-bronchiolitis and given Albuterol; 1/4/01-croup; 1/7/01-inner ear infection and given Vantin | | CDC 'Split Type': HQ7324416FEB2001 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | DTAP | SMITHKLINE BEECHAM | 961A2 | 2 | | LL | | HEP | MERCK & CO. INC. | 1736J | 1 | | RL | | HIBV | LEDERLE LABORATORIES | 470140 | 2 | | RL | | PNC | LEDERLE LABORATORIES | 472542 | 0 | | LL | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Apnoea, Cardio-respiratory arrest, Coma, Hypoxia, Sepsis | | Write-up: Information has been received from an investigator concerning a 15 month old male who received his first injection of Prevnar, his second injection of Recombivax-HB, and his third injection of Hib-Titer and Infanrix vaccines on 08/07/00. The child was found in his crib one morning not breathing and in cardiac arrest. The child was taken to a local emergency room where a heartbeat was re-established following a long code. The child was placed on a ventilator, but was unresponsive to light and painful stimuli. The patient was removed from the ventilator and died due to "SIDS-LIKE SYNDROME" on 01/11/01. Both the investigator and the medical monitor agree that this event was not related to vaccine administration. NOTE: This report is being submitted in a 15-day time frame as requested by FDA. F/U received on 4/25/02 from the study investigator contained autopsy results. The reported cause of death has been changed from "Sids-like syndrome" to "cardiorespiratory failure (cardio-respiratory arrest) secondary to possible sepsis, etiology unknown" as found upon autopsy. The investigator considered the event not related to vaccine administration. |
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| VAERS ID: | 166796 | Vaccination Date: | 2001-01-25 | | Age: | 0.3 | Onset Date: | 2001-01-25 Days later: 0 | | Gender: | Female | Submitted: | 2001-01-31 | | State: | Colorado | Entered: | 2001-03-08 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2001-01-25) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: VSD, ASD, PDA with a bicuspid valve, severe bilirubinemia, paralyzed below the waist, extension deformities of knees, clubfeet. | | Diagnostic Lab Data: MANY | | Previous Vaccinations: | | Other Medications: Sulfatrim, vitamin D & E | | Preexisting Conditions: Meningomyelocele and clubfeet were dx'd prenatally. Baby born by C-section after 36 hours of labor and stayed in the hospital 3 weeks. She has a feeding tube in her nose which the parents use for gastric lavage. The hips are high and dislocated and the knees are dislocated. She has spina bifida of the lumbosacral region, horseshoe kidney, VSD, ASD, PDA with a bicuspid aortic valve, | | CDC 'Split Type': | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | DTAP | LEDERLE LABORATORIES | 473440 | 1 | IM | RL | | HEP | MERCK & CO. INC. | 1475K | 1 | IM | LL | | HIBV | LEDERLE PRAXSIS | 474703 | 1 | IM | RL | | PNC | LEDERLE LABORATORIES | 472046 | 1 | IM | LL | |
| Administered by: Private Purchased by: Private | | Symptoms: Cardiac arrest, Cardiac failure congestive | | Write-up: Pt seen for well check, 24 hours, after seeing cardiology. Appeared well for this pt. Had vaccines; no fever; become congested and heart stopped. |
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| VAERS ID: | 167376 | Vaccination Date: | 2001-02-20 | | Age: | 1.3 | Onset Date: | 2001-02-23 Days later: 3 | | Gender: | Female | Submitted: | 2001-03-15 | | State: | Virginia | Entered: | 2001-03-20 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2001-02-23) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: | | Previous Vaccinations: | | Other Medications: Albuterol, Zithromax. | | Preexisting Conditions: | | CDC 'Split Type': | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | MMR | MERCK & CO. INC. | 1308K | 0 | SC | | | PNC | LEDERLE LABORATORIES | 472355 | 1 | IM | | | VARCEL | MERCK & CO. INC. | 1466K | 0 | SC | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Bronchitis acute, Cardio-respiratory arrest, Contusion, Nasal congestion, Pulmonary oedema, Wheezing | | Write-up: Pt was seen for a well 15 month checkup on 2/20/01. She had mild wheezing and was afebrile. She was given MMR, Varivax and Prevnar #2. She was treated with albuterol syrup and Zithromax. She had a cardiopulmonary arrest on 2/23/01. Is there a correlation between mild wheezing, any of the vaccines, the medications used and sudden death? Pt had unexplained cardiopulmonary arrest and expired. Autopsy also states bruise right side of forehead, congestion, pulmonary edema. Cause of death given as acute bronchitis. |
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