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

Found 498 cases where Vaccine is RV5 and Patient Died

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Case Details

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VAERS ID: 314113 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Michigan  
Vaccinated:2008-05-19
Onset:2008-05-29
   Days after vaccination:10
Submitted: 2008-05-29
   Days after onset:0
Entered: 2008-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B156BA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR U231AB,UF174AA / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C45891 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0212X / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-05-29
   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: CLOTRIMAZOLE 1 % EX CREA
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had immunizations on 5-19-08 and was found in bed on back today. 7/18/2008 Autopsy report received with COD: Sudden Unexplained Infant Death. Report states infant had some chest congestion x 2 days for which no medication used for tx. Infant had been acting normally with no other recent c/o. Infant had fed at 1 am and at 4 am parent noted infant was not breathing.


VAERS ID: 316231 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: North Carolina  
Vaccinated:2008-06-05
Onset:2008-06-08
   Days after vaccination:3
Submitted: 2008-06-13
   Days after onset:5
Entered: 2008-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B149AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF349AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C65049 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0281X / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Death, Upper respiratory tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-06-09
   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: Actigall, Ferrous Sulfate
Current Illness: Cholestatic Jaundice, URI sypmtoms 2 days later
Preexisting Conditions: see #7 please note hep B in NICU is unknown type or lot #
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: CBC 6/9/08 WBC 5.6. Lymphs 75.3% Hgb 8.9, Hct 27.4
CDC Split Type:

Write-up: Ex 29-week premature infant presented for routinue post NICU follow-up on 6/5/08 for 2mo. Relatively nml Pexam (hx of RDS,Apnea, R/o spesis, anemia, hyperbilirubinemia, cholestatic jaundice, murmur, bilat inguinal hernia) Of note only jaundice and murmur were present at time of discharge. Patient recieved 4 vaccines on 6/5/08. Patient presented with URI symptoms on 6/9/08 diagnoses with URI and sent home. The baby reportedly had a cardiac arrest later that evening and did not survive. ****please note submission of similar patient of similar event with ALTE diagnosis and hospitalization (survived). 6/27/08 Link w/317530 per direction of FDA. 9/24/08 ER record received for DOD 6/10/08. DX: Sudden Death. CPR unsuccessful. Infant last seen alive at 1800. EMS on scene at 22:35. Pt found cold, stiff and puple in color. CPR attempted but unsuccessful. Pt in rigor upon arrival in ED and prounounced. PMH: 28 wk premie. In NICU from DOB 3/29/08 until 4/29/08 with DX: Respiratory Distress syndrome. Apnea of Prematurity. R/O Sepsis x3. R/O NEC. Jaundice. Nutritional support. R/O IVH and PVL. Temperature Support. Infant on CPAP and NC O2. Had apnea, bradycardia and O2 desats. 3 episodes of sepsis w/u. Had physiologic jaundice requiring phototherapy. On parenteral feeds with intermittant enteral feeds. D/C on O2 and monitoring./pc 9/29/08 ME''s report received. Probable COD Acute Bronchopneumonia. DX: Acute bronchopnemonia, moderate. Cholestasis. Microscopic exam of the lungs reveals moderate acute bronchopneumonia present w/in the major and minor bronchi and alveolar spaces. Focal atelectasis. Liver shows diffuse cholestasis with bile plugs present. Slight chronic inflammation. Severe autolysis. 10/30/08 PCP records received which include d/c summary for 2+month NICU stay with D/C 6/4/08. Seen in f/u 6/5/08-cholestatic jaundice, anemia, ROP and scrotal masses (hydroceles) noted. Otherwise normal premie exam. Vax given. Seen again 6/9/08 for cough and congestion with Impression URI. RR 60. P ox 95%. Wet cough, wheeze and rhonchi noted (clear A/P/L). Nasal saline and suction as sympromatic care. To f/u in 1-2 days or to ER PRN.


VAERS ID: 316952 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Texas  
Vaccinated:2008-05-01
Onset:0000-00-00
Submitted: 2008-05-06
Entered: 2008-06-23
   Days after submission:48
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B142AA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF238AF / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08702B / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1231F / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms:
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-05-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZMAX
Current Illness: SINUSITUS
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: INFANT IN BED WITH PARENTS AT TIME OF DEATH. 6/30/08 Autopsy report states COD as SID, pt found unresponsive in bed w/parents.


VAERS ID: 317385 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Texas  
Vaccinated:2008-04-14
Onset:2008-04-16
   Days after vaccination:2
Submitted: 2008-05-16
   Days after onset:30
Entered: 2008-06-25
   Days after submission:40
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B142AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF215AB / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C65043 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1621U / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Diarrhoea, Laboratory test, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-18
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 0~ ()~~0.00~In Patient|0~ ()~~0.00~In Sibling|0~ ()~~0.00~In Sibling
Other Medications:
Current Illness: WELL AT TIME OF VACCINE
Preexisting Conditions: NO
Allergies:
Diagnostic Lab Data: LABS 4/17
CDC Split Type:

Write-up: VOMITING AND DIARRHEA STARTED 4/16 IMPROVED ON 4/17. NO DEHYDRATION TOLERATED PEDIALYTE WELL. DIED AM OF 4/18 AFTER MOM FELL ASLEEP WHITE FEEDING CHILD. 7/2/08-records received-Undetermined causes, no convincing cause of death could be deteremined. The infant may have asphyxiated by various means, including suffoction or positional asphyxia or may have died of other reasons.


VAERS ID: 317877 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Kentucky  
Vaccinated:2008-06-09
Onset:2008-06-25
   Days after vaccination:16
Submitted: 2008-06-26
   Days after onset:1
Entered: 2008-06-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B143AA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF348AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 858845H / UNK LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 02124 / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-06-25
   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: Dwarfism-records received 8/29/08- dwarfism; remote SDH; history of c-section;
Allergies:
Diagnostic Lab Data: Dwarfism, Premature at 37 wks
CDC Split Type:

Write-up: Father called 6/25 to cancel appts for August/08 and states baby died of SIDS. 8/29/09 Autopsy report also states: apparently found unresponsive at home in car seat which had been placed in crib;no evidence of acute traumatic injury; post mortem studies all negative. 8/29 Autopsy states COD: no anatomic cause./


VAERS ID: 318120 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Illinois  
Vaccinated:2008-07-01
Onset:2008-07-01
   Days after vaccination:0
Submitted: 2008-07-02
   Days after onset:1
Entered: 2008-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B143AA / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR HF366AA / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C65930 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0501X / 2 MO / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-07-01
   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: TYLENOL after inj.
Current Illness: None
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received immunization at approx 10:15 am. Father found unresponsive @ approx 7:15 pm. 8/21/08-cause of death undetermined. pulmonary vascular congestion. petechiae of epicardium.


VAERS ID: 318702 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-07-10
Entered: 2008-07-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 2 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0501X / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: autopsy, results not yet available
CDC Split Type: WAES0807USA00755

Write-up: Information has been received from an office worker concerning a 4 month old patient who was vaccinated with oral ROTATEQ (lot # 660548/0501X), (therapy date and dose not reported). The baby died the same day ROTATEQ was given to the patient. Per office worker, they had a memo in their office not to give any further vaccines to patients because one 4 month old baby died after receiving ROTATEQ. The office is currently waiting for the autopsy report before they can resume giving vaccines in their office. Per office worker, the patient is not a patient in their office. The Director of Pharmacy from the pharmacy who dispensed ROTATEQ provided the name of the patient''s physician and lot # 0501X. Additional information was received from a pharmacist, indicating that this patient also received second dose of ACTHIB, PREVNAR and PEDIARIX on the same day that a second dose of ROTATEQ was given. It was reported that the patient sought unspecified medical attention, physician. The event was considered life threatening and disabling. A lot check has been requested. Additional information has been requested.


VAERS ID: 318749 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Unknown  
Vaccinated:2008-04-04
Onset:2008-07-02
   Days after vaccination:89
Submitted: 2008-07-11
   Days after onset:9
Entered: 2008-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LL / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Metabolic function test, Neurological examination
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-07-02
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVETIRACETAM; LANSOPRAZOLE
Current Illness: APNEA ; SEIZURE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: R0000398G

Write-up: This male subject was enrolled in the prophylactic open study 110870 (MenACWY-TT-057). On 4 April 2008, he received the 1st dose of HIB-MENCY-TT (IM L thigh) and of PEDIARIX (IM R thigh). The subject received concomitantly PREVNAR (IM) and ROTATEQ vaccines (po). Medical conditions at the time of the event included apnea and seizure. Concomitant medications included PREVACID and KEPPRA. On 02 July 2008, 89 days after the 1st dose of PEDIARIX, 89 days after the 1st dose of HIB-MENCY-TT, this five-month-old subject died. The event was disabling, life-threatening, clinically significant (or requiring intervention). The subject died on 02 July 2008, cause of death is unknown. An autopsy was performed. The investigator considered that there was a reasonable possibility that the death nos may have been caused by PEDIARIX and HIB-MENCY-TT. Investigator Comments: Site was Notified of report of death on 07-03-2008, records have been requested. All data pending. 07-07-2008. After PI review, cannot completely rule out vaccine related causality, but not probable. Subject on anticonvulsants and has underwent metabolic/neurologic work-up with no significant findings. Possibility of Munchausen by Proxy, but waiting on pending results of physician and ER notes, apnea monitor results and autopsy and toxicology report. 8/22/08 Autopsy states COD as sudden unexpected infant death. Report also states Anatomical diagnosis: same as COD & aspiration of vomitus, terminal/subterminal focal bilateral. Comments: infant had complicated history of seizures, aspiration & apnea which could not be substantiated during multiple hospitalizations & ER visits & Munchausen by proxy was questioned. Autopsy showed only relatively mild terminal aspiration of vomitus. 8/5/08 Reviewed ER medical records of 7/2/2008 submitted by FDA from manufacturer. Records reveal patient well known w/history of recurrent episodes of life-threatening events of possible apnea vs seizure over the prior 2 months w/cyanosis, choking & gagging. Was on apnea/bradycardia monitor at home. Found by parent vomiting & poorly responsive. Started CPR & ACLS by EMS. Arrived in ER in full arrest & unable to resuscitate.


VAERS ID: 320329 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Texas  
Vaccinated:2008-05-14
Onset:2008-05-15
   Days after vaccination:1
Submitted: 2008-07-18
   Days after onset:64
Entered: 2008-07-24
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B145AA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF330AA / 2 LA / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C65043 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1888U / 2 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Autopsy, Death, Life support, Myocarditis, Respiratory arrest, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-05-18
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None 8/1/08-records received-Congested for past several days. Cough symptoms for approximately 1 week secondary to seasonal allergies.
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy reports myocarditis as cause of death 8/6/08-records received-EEG:abnormal organic encephalopathy. CT brain-question of diffuse cerebral edema.
CDC Split Type:

Write-up: Pt found 5-15-08 @ 2110 by mother unresponsive, not breathing. He had been fed 4 oz and given TYLENOL for temp at 2040 hrs, then put in his crib, on abdomen with face turned to side, at 2100 she rushed him to ER at local hospital where CPR was performed and pt transferred via helicopter to another hospital. Pt on life support until 5-18-08 when it was stopped and he expired. 8/1/08-records received for DOS 5/16/08-5/18/08-presented in cardiopulmonary arrest, resuscitative efforts included CPR, intubation, mechanical ventilation. Hypothermic on presentation with rectal temperature of 91.6, hypoglycemia with blood sugar 16, metabolic acidosis. Prior to event C/O fussy all day running low grade fever, placed in crib on abdomen, found white, lump with face buried in cover. Drove child to hospital. PE: agonal respirations not compatible with life. Pupils nonreactive to light, fixed. No spontaneous movement of extremities. Deep tendon reflexes absent. 8/11/08-records received-Findings:Myocarditis. Inflammation and necrosis, myocardium. Interstitial edema, epiglottis. Tracheobronchitis, chronic. The inflammatory lesions observed in heart are consistent with either acute viral infection or post-viral syndrome.


VAERS ID: 321130 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Texas  
Vaccinated:2008-07-22
Onset:2008-07-24
   Days after vaccination:2
Submitted: 2008-08-01
   Days after onset:8
Entered: 2008-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B153AA / 2 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF263AB / 2 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C80884 / 2 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1928U / 2 MO / PO

Administered by: Private       Purchased by: Unknown
Symptoms:
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-07-24
   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:
Allergies:
Diagnostic Lab Data: Tox screens were neg.
CDC Split Type:

Write-up: Patient received shots 48 hours prior to death. 9/30/08 Autopsy states COD as sudden unexpected death of an infant. Manner of death undetermined. Report also states patient found unresponsive, face down on comforters, in bed surrounded by pillows.


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