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From the 4/23/2021 release of VAERS data:

Found 68 cases where Vaccine is RVX and Patient Died

Table

   
AgeCountPercent
< 3 Years3145.59%
3-6 Years11.47%
Unknown3652.94%
TOTAL68100%



Case Details

This is page 1 out of 7

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VAERS ID: 581306 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-10
Entered: 2015-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1506USA004766

Write-up: This spontaneous report was received from a Licensed Practical Nurse who obtained the information from the web site where read an article which refers to two baby patients of unknown ages and genders. Concurrent conditions or pertinent medical history were not reported. On unknown date the patients were unsafe administer with a dose of hepatitis b vaccine (recombinant) (manufacturer unknown), rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) orally, and BCG (manufacturer unknown) (lot #, expiration date, route of administration (for hepatitis B vaccine (recombinant) and BCG)) and doses were not reported for either vaccines). On unspecified dates, the two babies died (due to an unspecified reason) after receiving those vaccines. It was unknown if autopsy was performed. The nurse also mentioned that the consumer was now scared about having her child vaccinated in other country, therefore, the nurse would like to know any comparative information between the vaccines produced in different countries as lot#s and ingredients used or if those vaccines were in question. The relatedness of the suspected vaccines with death was not reported. This is one of several reports from the same source. Additional information has been requested.


VAERS ID: 679107 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Wisconsin  
Vaccinated:2016-03-03
Onset:2016-03-04
   Days after vaccination:1
Submitted: 2017-01-23
   Days after onset:325
Entered: 2017-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LL / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 RL / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-07
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My son was put down for a nap about 12 or a bit after and he never woke up.


VAERS ID: 817274 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Georgia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Combined immunodeficiency syndrome (severe combined immunodeficiency disease)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: This case was reported in a literature article and described the occurrence of pneumonia in a infant subject who received Rotavirus vaccine for prophylaxis. Concurrent medical conditions included combined immunodeficiency syndrome (severe combined immunodeficiency disease). On an unknown date, unknown after receiving Rotavirus vaccine, the subject developed pneumonia. Serious criteria included death and GSK medically significant. The outcome of pneumonia was fatal. The reported cause of death was pneumonia. The investigator considered that there was a reasonable possibility that the pneumonia may have been caused by Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of pneumonia in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of the study that characterize adverse events (AE) after rotavirus (RV) in infants with immunocompromising conditions (IC) reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2006 to December 2015. The patient had severe combined immunodeficiency disease (SCID). No information on patient''s medical or family history or concomitant medication were provided. On an unspecified date, the patient received unspecified rotavirus virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient developed pneumonia. On an unspecified date, the patient died. The cause of death was pneumonia. It was unknown if an autopsy was performed. This case has been considered as serious due to death. The treatment was unknown. The author stated and concluded, "Adverse event (AE) after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to monoclonal antibodies MAB". This is 1 of the 11 valid cases reported in this literature article. The article corresponding to this case is not available for submission due to copyright restriction. Reported Cause(s) of Death: Pneumonia.


VAERS ID: 817275 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Georgia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Combined immunodeficiency syndrome (severe combined immunodeficiency disease)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a infant subject who received Rotavirus vaccine for prophylaxis. Concurrent medical conditions included combined immunodeficiency syndrome (severe combined immunodeficiency disease). On an unknown date, unknown after receiving Rotavirus vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the unknown cause of death may have been caused by Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of death not otherwise specified (NOS) in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of the study that characterize adverse events (AE) after rotavirus (RV) in infants with immunocompromising conditions (IC) reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2006 to December 2015. The patient had severe combined immunodeficiency disease (SCID). No information on patient''s medical or family history or concomitant medication were provided. On an unspecified date, the patient received unspecified rotavirus virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. This case has been considered as serious due to death. The author stated and concluded, "Adverse event (AE) after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to monoclonal antibodies MAB" This is 1 of the 11 valid cases reported in this literature article. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 817276 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Georgia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pneumonia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: HIV infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: This case was reported in a literature article and described the occurrence of respiratory failure in a infant subject who received Rotavirus vaccine for prophylaxis. Concurrent medical conditions included HIV infection. On an unknown date, unknown after receiving Rotavirus vaccine, the subject developed respiratory failure. Serious criteria included death and GSK medically significant. Additional event(s) included pneumonia with serious criteria of GSK medically significant. The outcome of respiratory failure was fatal. The outcome(s) of the additional event(s) included pneumonia (unknown). The reported cause of death was respiratory failure. The investigator considered that there was a reasonable possibility that the respiratory failure and pneumonia may have been caused by Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of pneumonia and respiratory failure in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of the study that characterize adverse events (AE) after rotavirus (RV) in infants with immunocompromising conditions (IC) reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2006 to December 2015. The patient had human immunodeficiency virus (HIV) infection. No information on patient''s medical or family history or concomitant medication were provided. On an unspecified date, the patient received unspecified rotavirus virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient developed pneumonia. On an unspecified date, the patient died. The cause of death was respiratory failure. It was unknown if an autopsy was performed. This case has been considered as serious due to death. The treatment was unknown. The author stated and concluded, "Adverse event (AE) after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to monoclonal antibodies MAB". This is 1 of the 11 valid cases reported in this literature article. The article corresponding to this case is not available for submission due to copyright restriction. Reported Cause(s) of Death: Respiratory failure.


VAERS ID: 817277 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Georgia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Diarrhoea, Human bocavirus infection, Rotavirus test positive
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: IPEX syndrome (Immune dysregulation, polyendocrinopathy, enteropathy, X-linked (IPEX) syndrome)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Stool analysis
CDC Split Type: USGLAXOSMITHKLINEUS2019GS

Write-up: This case was reported in a literature article and described the occurrence of human bocavirus infection in a infant subject who received Rotavirus vaccine for prophylaxis. Concurrent medical conditions included ipex syndrome (Immune dysregulation, polyendocrinopathy, enteropathy, X-linked (IPEX) syndrome). On an unknown date, unknown after receiving Rotavirus vaccine, the subject developed human bocavirus infection. Serious criteria included death and hospitalization. Additional event(s) included diarrhea with serious criteria of hospitalization. The outcome of human bocavirus infection was fatal. The outcome(s) of the additional event(s) included diarrhea (unknown). The reported cause of death was human bocavirus infection. The investigator considered that there was a reasonable possibility that the human bocavirus infection and diarrhea may have been caused by Rotavirus vaccine. Relevant Tests: Lab tests were performed on unspecified date between Feb 2006 to Dec 2015. Patient''s stool sample tested for detection of rotavirus. Patient was found positive for rotavirus vaccine strain. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Stool analysis result was see text. Additional information was provided. This case was reported in a literature article and described the occurrence diarrhea and human bocavirus infection of in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of the study that characterize adverse events (AE) after rotavirus (RV) in infants with immunocompromising conditions (IC) reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2006 to December 2015. The patient had Immune dysregulation, polyendocrinopathy, enteropathy, X-linked (IPEX) syndrome. No information on patient''s medical or family history or concomitant medication were provided. On an unspecified date, the patient received unspecified rotavirus virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient developed diarrhea and subsequently, hospitalised. Patient''s stool sample tested for detection of rotavirus. Patient was found positive for rotavirus vaccine strain. On an unspecified date, the patient died due to human bocavirus infection. It was unknown if an autopsy was performed. This case has been considered as serious due to death/hospitalisation. The treatment was unknown. The author stated and concluded, "Adverse event (AE) after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to monoclonal antibodies MAB" This is 1 of the 11 valid cases reported in this literature article. Lab Comments: Lab tests were performed on unspecified date between Feb 2006 to Dec 2015. Patient''s stool sample tested for detection of rotavirus. Patient was found positive for rotavirus vaccine strain.; Reported Cause(s) of Death: Human bocavirus infection.


VAERS ID: 885953 (history)  
Form: Version 2.0  
Age: 0.42  
Sex: Male  
Location: Texas  
Vaccinated:2020-05-27
Onset:2020-07-02
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2020-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR UU195AA / UNK RL / IM
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR UU195AA / UNK RL / IM
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR UU195AA / UNK RL / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER AT8661 / UNK RL / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER EY4P3 / UNK MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Autopsy, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-07-02
   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: none
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: Baby was completely healthy and died suddenly on July 2, 2020. ME finds cause of death Sudden Unexpected Death, Natural Causes. We need to be sure these vaccines had nothing to do with his death.


VAERS ID: 267625 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2006-11-10
Submitted: 2006-11-21
   Days after onset:11
Entered: 2006-11-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hypoxia, Pallor, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRWYE589520NOV06

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 3 month old male pt who experienced sudden death. The pt received the first dose on 11/09/06. The pt had no medical history, particularly no history of either gastroesophageal reflux, or transient respiratory arrest, his birth was normal and he had no pertinent family history. Indication for Prevnar was immunisation. Product was administered on 11/9/06. Dose regimen was 1 dose (IM). Additional suspect medication included Tetravalent (diphtheria vaccine/haemophilus influenzae B/pertussis vaccine/tetanus vaccine) and Rotarix. Concomitant medications were not reported. The pt experienced sudden death on 11/10/06. The pt was fed by bottle at midday. In the afternoon while he slept on a double bed for an unspecified length of time (several minutes), he was found white and in respiratory arrest. After resuscitation by firemen, heart and respiratory rates reappeared. The pt was admitted in intensive care unit where heart and respiratory rates were artificially maintained by resuscitation. The investigations done for searching and infection were neg. Finally resuscitation was stopped on 11/12/06 and the pt died. Nuclear magnetic resonance imaging results normal was done on 11/10/06. Autopsy pending results was done on 11/12/06. The cause of death was reported as sudden death and an autopsy was performed, but results were not provided. No additional information was available at the time of this report.


VAERS ID: 307550 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2008-03-15
Onset:2008-03-15
   Days after vaccination:0
Submitted: 2008-03-20
   Days after onset:5
Entered: 2008-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS AT15B371AF / 2 UN / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER A41CA414A / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Pyrexia, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-03-16
   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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0512476B

Write-up: This case was reported by a physician and described the occurrence of sudden infant death syndrome in a 4-month-old female subject who was vaccinated with ROTARIX, GlaxoSmithKline, combined TRITANRIX HEP B for prophylaxis. The baby had no history of any disease or any medication. She had no history of allergy. Previous vaccination included TRITANRIX HEP B (GlaxoSmithKline; intramuscular; unknown) and ROTARIX (GlaxoSmithKline; oral) given at the age of 2 months. At previous vaccination with ROTARIX AND TRITANRIX HEP B the subject developed low fever and few episodes of diarrhea (for details see case B0512476A). On 15 March 2008, the subject received the 2nd dose of ROTARIX (oral), the 2nd dose of TRITANRIX HEP B (intramuscular, unknown). On 15 March 2008 (at the night time), less than one day after vaccination with the 2nd dose of ROTARIX and the 2nd dose of TRITANRIX HEP B, the subject experienced an episode of diarrhea and low fever. No other abnormal symptoms. On 16 March 2008 morning, after sleeping for 4 hours the parents found that their baby was dead. The subject died on 16 March 2008 from sudden infant death syndrome. On 17 March 2008, the doctor asked the baby''s parents for the autopsy but there was still no answer from the parents. Follow up information received on 18 March 2008: Autopsy was not done, the family refused and funeral will be finished on 19 March 2008.


VAERS ID: 350812 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2009-05-01
Onset:0000-00-00
Submitted: 2009-07-06
Entered: 2009-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Diarrhoea, Vomiting projectile
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diarrhea; Projectile Vomiting
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: B0581803A

Write-up: This case was reported by a nurse and described the occurrence of death in sleep in an infant female subject who was vaccinated with ROTAVIRUS vaccine (manufacturer unspecified). This is one of 2 cases reported that resulted in death (see case B0581670A). The subject''s involved came from the same home. Concurrent medical conditions included diarrhea and vomiting. On 1 may 2009 and 1 April 2009 the subject received 2nd dose and 1st dose of Rotavirus vaccine (Oral). In May 2009, less than one month after vaccination with the 2nd dose of ROTAVIRUS vaccine, the subject concurrent conditions (diarrhea more than 4 times a day and projectile vomiting) worsened. The subject was treated with fluid and oral rehydration salts but the subject pass away in her sleep. The health professional reported that the event was possibly related to vaccination with ROTAVIRUS vaccine. The subject died, cause of death is not specified. There was no postmortem done. The body was disposed off by the local council.


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