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From the 1/14/2022 release of VAERS data:

Found 979 cases where Vaccine is PNC and Patient Died

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Case Details

This is page 11 out of 98

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VAERS ID: 181512 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Male  
Location: Indiana  
Vaccinated:2002-01-17
Onset:2002-01-19
   Days after vaccination:2
Submitted: 2002-02-11
   Days after onset:23
Entered: 2002-02-20
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (TRIHIBIT) / SANOFI PASTEUR 3274C / 4 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR U03442 / 3 LA / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1094L / 1 RA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 488175 / 2 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1235L / 1 LA / SC

Administered by: Private       Purchased by: Public
Symptoms: Coma, Petechiae
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-01-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy-pending Autopsy states; few petechiae of heart, thymus and lungs; early stage of decompression; no evidence of injuries; cultures are neg for pathologic organisms; blood neg for volatiles, acetaminophen and CO; blood salicylate 11.2ug/ml; urine neg for drugs
CDC Split Type:

Write-up: Informed by mom on 2/8/02 that her child was found dead in bed on 1/19/02 about 33 hours after well child visit and immunizations. No previous by us, last immunizations at 6 months. Mom reports an autopsy is being done. Per coroner''s office no autopsy was done in this county. COD as per autopsy report is undetermined. Info rec''d 4/18/02 states; The decedent was an 18 month old white male who lived with his parents. He was pronounced nonviable by medics at 08:55 upon their arrival at the residence. The child was found by his father around 08:45 to be unresponsive and 911 was called. The child was last seen alive by his mother about 23:00 of the night before when she placed him in bed after returning from a birthday party. The child has a clinic visit on 1/17 when he had 5 immunization shots and treatment for dry skin rash. There was bottles of children liquid cold medicine scattered in the kitchen but according to the mother, the infant had not had any since the last time he was sick, about 2 1/2 weeks ago. COD: undetermined.


VAERS ID: 181780 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: California  
Vaccinated:2002-02-06
Onset:2002-02-06
   Days after vaccination:0
Submitted: 2002-02-21
   Days after onset:15
Entered: 2002-02-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. - / 1 - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardiac arrest, Cardio-respiratory arrest, Cerebrovascular disorder, Coma, Eosinophilia, Injection site inflammation, Injection site nodule, Injection site oedema, Small for dates baby, Strabismus, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Ocular motility disorders (narrow), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-02-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Low birth weight; Umbilical hernia and supernumerary digits on each hand was tied off and detached; Birthmark on buttocks-Mongolian spots
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: Healthy 2 month old black male received 4 vaccinations, IM, at about noon; fell asleep immediately, taken home, still apparently asleep. Found unresponsive with face down by mother at 18:00. Asystole at the scene. Full term with low birth weight of 4 lbs and 11 oz, NSVD to a 31 year old married G2 P2 with PNC; history of maternal alcohol and marijuana use with first trimester; no maternal disease. Autopsy shows severe eosinophilic infiltrate of muscle at the injection site. Weight at death 9 lbs and 4 oz. Per F/U 5/7/02: COD-SIDS Exam: left thigh injection site showing 2 hemorrhagic puncture defects extending vertically into the deep muscle surrounded by an extensive area of edema and severe acute inflammation composed mostly of eosinophils. Right thigh injection site showing a hemorrhagic puncture defect in the deep muscle and slight focal acute inflammation. Cerebrovascular congestion (mild) and heterotopic neuronal rest, large-cell type, cerebellar white matter; incidental finding. Hospital care facility report states: COD as cardiopulmonary arrest.


VAERS ID: 182148 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Montana  
Vaccinated:2002-02-28
Onset:2002-03-01
   Days after vaccination:1
Submitted: 2002-03-01
   Days after onset:0
Entered: 2002-03-11
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 543A2 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0657L / UNK RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T1390 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 483169 / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Abnormal sleep-related event, Anaemia, Apnoea, Enterocolitis, Metabolic acidosis, Oedema, Petechiae
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synagis/Medimmune/GBZ163A/LL/02/27/02/1 previously
Current Illness: NONE
Preexisting Conditions: 30 week preemie; GERD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt with GERD, showed apnea on monitor. (30 week preemie) Reglan and ranitidine discontinued by mom, 2 weeks ago. Found lifeless at home. EMT''s in ambulance tried resuscitation and this was continued at the ER. No response. COD: undetermined, manner of death: undetermined Per F/U 5/22/01: Lungs show petechiae bilaterally and also in thymus. Also states; child was found unresponsive in bed shared with mother and another individual. Hospital course complicated by necrotizing enterocolitis, anemia, mild hyperbilirubinemia, periodic breathing (treated with caffeine), edema and mild metabolic acidosis. Discharged after birth on caffeine, ranitidine and Reglan. The cause of death could not be determined.


VAERS ID: 182418 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Unknown  
Vaccinated:2001-12-28
Onset:2002-01-10
   Days after vaccination:13
Submitted: 2002-03-14
   Days after onset:63
Entered: 2002-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 522A2 / 1 RL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5216A2 / 1 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 480938 / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T0790 / 1 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484134 / 1 LL / IM

Administered by: Other       Purchased by: Other
Symptoms: Abnormal sleep-related event, Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome, Thymus hypertrophy
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-01-09
   Days after onset: 1
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: NONE
CDC Split Type: HQ1250111MAR2002

Write-up: Information has been received from an investigator regarding a 2 month old male who received his 1st doses of Prevnar, Hib-Titer, Infanrix, IPV and Engerix-B vaccines on 12/28/01, as part of a post-marketing safety trial. On 1/10/02, at 02:00, the mother took the infant into her bed for breast-feeding and the infant remained in bed with her. At 06:00, the mother awoke to find the infant dead. The coroner reported the cause of death as SIDS. The investigator believes that SIDS (expected per package insert) was not related to vaccine administration. The medical monitor''s assessment of relatedness is unknown. This report of a serious labeled event is being submitted in a 15-day time frame, as requested by the FDA. Per F/U 4/1/02: Date of death is reported as 1/9/02 on autopsy report. COD was reported as SIDS (bed-sharing context). There was pulmonary congestion and edema and thymus weight 37 grams (enlarged). Follow up on 01/28/04: "Follow up information received on 01/14/04 provided a change in the event date. Information has been received from an investigator regarding a 2 month old male who received his first doses of Prevnar, Hib-Titer, Infanrix, IPV, and Engerix-B vaccines on 12/28/01 as part of a surveillance trial. On 01/09/02, at 03:00AM, the mother took the infant into her bed for breastfeeing and the infant remained in bed with her. At 6:00AM, the mother awoke to find the infant dead. The coroner reported the cause of death as Sudden Infant Death Syndrome. The investigator and the medical monitor agreed that SIDS (expected per package insert) was not related to vaccine administration. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by the FDA."


VAERS ID: 182420 (history)  
Form: Version 1.0  
Age: 0.75  
Sex: Female  
Location: Unknown  
Vaccinated:2001-08-22
Onset:2001-10-30
   Days after vaccination:69
Submitted: 2002-03-14
   Days after onset:135
Entered: 2002-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 506A2 / 3 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA563AC / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 478325 / 3 RL / IM

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Lymphadenopathy, Ovarian cyst, Polyp, Pulmonary congestion, Pulmonary haemorrhage, Pulmonary oedema, Sudden infant death syndrome
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-30
   Days after onset: 0
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: UNK
Allergies:
Diagnostic Lab Data: None
CDC Split Type: HQ1249511MAR2002

Write-up: Information has been rec''d from an investigator regarding a pt who rec''d her 3rd doses of Prevnar, Infanrix, and ActHIB vaccines on 8/22/01 as part of a post marketing safety surveillance trial. On 10/30/01, at 9 months of age the infant was found not breathing. Emergency services were called and she was seen in an ER where resuscitation efforts were unsuccessful. The results of an autopsy revealed that the cause of death was Sudden Infant Death Syndrome. The investigator believed that SIDS (expected per package insert) was not related to vaccine administration. The medical monitor''s assessment of relatedness is unknown. This report of a serious, labeled event is being submitted in a 15 day time frame as requested by the FDA. Per F/U 4/17/02: Autopsy states wholly liquified blood within the cardiovascular lumens, pulmonary congestion and a benign large tracheal polyp causing 50% occlusion of the tracheal lumen. The right ovary shows the presence of a cyst. There are enlarged lymph nodes.


VAERS ID: 182421 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Georgia  
Vaccinated:2002-03-11
Onset:2002-03-11
   Days after vaccination:0
Submitted: 2002-03-12
   Days after onset:1
Entered: 2002-03-14
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0540DA / 2 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 09332 / 2 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR U0179 / 2 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484132 / 1 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Petechiae, Sudden infant death syndrome
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-03-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: Pt received shots on 3/11/02. Pt expired, during sleep, on 3/11/02. COD as per autopsy report: SIDS Per F/U 5/16/02 fo autopsy report: There are florid thymic petechiae.


VAERS ID: 182510 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Unknown  
Vaccinated:2001-11-23
Onset:2002-01-24
   Days after vaccination:62
Submitted: 2002-04-02
   Days after onset:68
Entered: 2002-03-15
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 606A2 / 2 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 480938 / 2 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T13902 / 2 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484134 / 2 RL / IM

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Atelectasis, Cardiomegaly, Irritability, Oral intake reduced, Petechiae, Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome, Thymus hypertrophy
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Neonatal disorders (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-01-24
   Days after onset: 0
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: Past conditions; Ear infections NOS
Allergies:
Diagnostic Lab Data: Per F/U 4/1/02, the autopsy report states the date of death was 1/27/02 but then in also states it as 1/24/02. The lungs show patchy atelectasis. Serial section reveals congestion and some edema froth. Thymus is enlarged but otherwise normal. There are scattered visceral and parietal pleural petechiae and there are a few petechiae on the epicardium. The thyroid is mildly congested, otherwise normal. Liver and kidneys have moderate congestion. There is dilatation of right heart.
CDC Split Type: HQ1250911MAR2002

Write-up: An investigator reported that a 6 month old male received a 2nd dose of Prevnar vaccine on 11/23/01, as "Post marketing Evaluation of Prevnar Pneumococcal 7-Valent conjugate vaccine (CRM197 protein conjugate); Safety of Prevnar Administered Concurrently with Routine Infant Vaccinations at 2,4 ,6, and 12 to 15 Months of Age." Concomitant medication included Infanrix, Polio vaccine and Hib-Titer. The coroner''s office reported that the infant "hadn''t been feeling good" for 2-3 days, was not eating and fussy while at "sitter''s" house. Sitter said he ate very little. The infant was put down to sleep and 1/2 hours later, was fine. In another 1/2 hour, a blanket was found around the infant''s face and he was found not breathing but with a heartbeat. "911" was called, resuscitation was attempted and the infant was pronounced dead. The pathologist that handled the case, determined the cause of death as SIDS. The investigator noted that a MD at the hospital said he sent the final report to the coroner''s office; however, the coroner''s office said that the hospital would have the workup. The investigator is still attempting to track down the documentation. The investigator and the medical monitor agree that sudden infant death syndrome (expected per local package insert) as "not related" to study vaccine. Additional information received 03/29/02 from investigator. The infant was described as previously healthy, except for recent fussiness related to teething. He was dropped off at the babysitter''s residence at approximately 0700 on 01/24/02. He was not eating well.At 09:00 he took four ounces of Enfamil in the car seat. he was then put to bed in a portable crib and asleep at approximately 09:15. Two months ago he took antibiotics for an ear infection which has now cleared. At approximately 1000 he was checked and seemed to be fine, supine position.At 10:30-1100, he was found with the quilt over his face and unresponsive. 911 was called, He was in full cardiac arrest upon arrival of the paramedics. Coroners'' autopsy report confirmed cause of death as SIDS.


VAERS ID: 182511 (history)  
Form: Version 1.0  
Age: 0.7  
Sex: Male  
Location: Unknown  
Vaccinated:2001-11-08
Onset:2001-12-29
   Days after vaccination:51
Submitted: 2002-08-13
   Days after onset:226
Entered: 2002-03-15
   Days after submission:150
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 501A2 / 3 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 521142 / 3 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 479268 / 3 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484134 / 3 LL / IM

Administered by: Other       Purchased by: Other
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-29
   Days after onset: 0
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: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ1245111MAR2002

Write-up: An investigator reported that an 8 month old male received a 3rd dose of Prevnar as a post-marketing safety study. Concomitant vaccines included a 3rd dose of Infanrix, Recombivax-HB and Hib-Titer vaccines. On 12/29/01, the pt expired. The coroner''s office is investigating the death as SIDS; however, confirmation of dx is "still pending receipt of results from toxicology, pathology, etc". The investigator assessed SIDS (expected per local package insert) as "not related" to study vaccine.


VAERS ID: 182513 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Unknown  
Vaccinated:2001-10-05
Onset:2001-10-21
   Days after vaccination:16
Submitted: 2002-03-14
   Days after onset:144
Entered: 2002-03-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 506A2 / 1 LL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5205A2 / 2 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 479268 / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T05632 / 1 RA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 482373 / 1 RL / IM

Administered by: Other       Purchased by: Other
Symptoms: Petechiae, Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-21
   Days after onset: 0
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: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ1250311MAR2002

Write-up: Information has been received from an investigator regarding a 2 month old female who received her 1st doses of Prevnar, Hib-Titer, Infanrix, IPV and her 2nd dose of Engerix-B as part of a post-marketing safety study. On 10/21/01, at 3 months of age, the infant died. Autopsy results showed the cause of death to be SIDS. The investigator believed that SIDS (expected per package insert) was not related to study vaccine administration. The medical monitor''s assessment of relatedness in unknown. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by the FDA. Follow-up info received on 03/13/2002 indicated that the medical monitor agreed with the investigator''s assessment that the event was not related to vaccine administration. Per F/U 4/1/02 autopsy states: The pt has apparent healed rib fractures on the lateral aspect of left ribs 6,7 and 8 and rib 6 on the lateral right chest. The thymus has occasional petechial hemorrhages on both the anterior and posterior surfaces. Sectioning of the lungs reveals moderate congestion and edema.


VAERS ID: 182514 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Unknown  
Vaccinated:2001-11-15
Onset:2001-12-04
   Days after vaccination:19
Submitted: 2002-03-14
   Days after onset:100
Entered: 2002-03-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 506A2 / 1 RL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 529A2 / 1 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 480438 / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T07902 / 1 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 451553 / 1 LL / IM

Administered by: Other       Purchased by: Other
Symptoms: Bronchiolitis, Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
SMQs:, Cardiac failure (narrow), Interstitial lung disease (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ1247411MAR2002

Write-up: Information has been received from an investigator regarding a 2 month old female who received her 1st doses of Prevnar, Hib-Titer, Infanrix, Engerix-B and IPV vaccines on 11/15/01 as part of a post-marketing safety study. On 12/4/01, the infant was seen in an ER where CPR was attempted. Resuscitation was unsuccessful and the infant died. Autopsy results revealed the cause of death as SIDS. The investigator believed the SIDS (expected per package insert) was not related to vaccine administration. The medical monitor''s assessment of relatedness is unknown. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by the FDA. Follow-up info received on 03/12/2002 indicated that the medical monitor agrees with the investigator''s assessment that the evnet was not related to vaccine administration. F/U 4/1/02 autopsy states: Pulmonary congestion and edema with mild patchy chronic bronchiolar inflammation; generalized visceral congestion.


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