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

Found 81 cases where Vaccine is RVX and Patient Died

Government Disclaimer on use of this data



Case Details

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VAERS ID: 642423 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-31
Entered: 2016-06-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
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: 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: IT2016GSK075415

Write-up: This case was reported by a non-health professional via call center representative and described the occurrence of sudden death in a 2-month-old female patient who received DTPa-HBV-IPV-HIB). Co-suspect products included Pneumococcal vaccine and Rotavirus vaccine. On an unknown date, the patient received DTPa-HBV-IPV-HIB at an unknown dose, Pneumococcal vaccine at an unknown dose and Rotavirus vaccine at an unknown dose. On an unknown date, 1 day after receiving DTPa-HBV-IPV-HIB, Pneumococcal vaccine and Rotavirus vaccine, the patient experienced sudden death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the sudden death was fatal. The reported cause of death was sudden death was fatal. The reported cause of death was sudden death. An autopsy was performed. The reporter considered the sudden death to be possibly related to DTPa-HBV-IPV-HIB, Pneumococcal vaccine and Rotavirus vaccine. Additional details were received as follows: The age at vaccination was not reported. This case was reported in an article of a newspaper. The patient was a newborn baby, found dead in the cradle after 1st vaccination cycle with DTPa-HBV-IPV-HIB, Pneumococcal vaccine and Rotavirus vaccine of an unknown brand. The rescuers at the hospital tried to resuscitate the patient but the patient was already died. It was reported that, the event was not medically confirmed at the time of reporting and the autopsy was ongoing but the results were not available.


VAERS ID: 644542 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Female  
Location: Foreign  
Vaccinated:2016-07-05
Onset:2016-07-06
   Days after vaccination:1
Submitted: 2016-07-20
   Days after onset:14
Entered: 2016-07-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER L8184 / 1 LL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER M5103 / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M52265 / 1 UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Autopsy, Death, Epistaxis, Floppy infant, Rhinorrhoea
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-07-06
   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:
Current Illness:
Preexisting Conditions: Premature baby was born Preterm at 29 weeks via Caesarean Section; Jaundice neonatal; Apnoea; Hypoglycaemia; BCG vac, Immunization, NO adverse event; Oral polio vaccine, Immunization, No adverse event
Allergies:
Diagnostic Lab Data: 05-JUL-2016, Body temperature, 36.4 degrees Centigrade; 05-JUL-2016, Head circumference, 35 cm; 05-JUL-2016, Respiratory rate, 22
CDC Split Type: 2016347440

Write-up: This is a spontaneous report from the Department of Health. A 5-week-old female patient of an unspecified ethnicity received first dose of PREVENAR 13 (lot M52265, exp. date 2017), via an unspecified route of administration at single dose, first dose of bivalent oral poliomyelitis vaccine from lot M5103 via an unspecified route of administration, first dose of HEXAXIM (lot L8184-1), intramuscular on left thigh, and rotavirus diarrhea vaccines, via an unspecified route of administration all on 05Jul2016. The patient was born Preterm at 29 weeks via Caesarean Section, her birth weight at delivery was recorded as 2.1 kilograms. She had to be admitted and nursed for a period of one week and four days in the Hospital for birth complications that included neonatal jaundice, apnoea and hypoglycaemia. The patient''s concomitant medications were not reported. Before discharge, she received this at birth BCG VAC and oral polio vaccine and experienced no adverse event. On 05Jul2016, before vaccination, the body temperature was 36.4 degrees Celsius, respiration was 22, head circumference was 35 cm, length: 43 cm. Baby looked well and reflexes were present, exclusively breast fed. According to the records from the hospital the baby was put on Nevirapine 1 mls daily, INH Prophylaxis 2 mls daily, Multivitamin syrup drops and Vitamin D daily. According to story from the mother, the baby was fine after immunisation even fed well. At 23h00 she breastfed her and put the baby to sleep, she again breastfed her at 03h00 and 04h00 am and left her sleeping on the bed. At about 06h45 (06Jul2016) she went to the bedroom to check on her baby again, only to realize that the baby was weak and floppy with whole body, she noticed slightly bleeding mixed with whitish stuff through both nostrils. The patient died on 06Jul2016. An autopsy was performed and results were not provided.


VAERS ID: 645849 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Male  
Location: Foreign  
Vaccinated:2016-04-29
Onset:2016-04-30
   Days after vaccination:1
Submitted: 2016-07-21
   Days after onset:82
Entered: 2016-07-25
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER L7413 / 1 LL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER M5103 / 1 MO / PO
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L21066 / 1 UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-30
   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: Premature birth around the gestational age of 28 weeks; 26-MAR-2016, Oral polio vaccine, Immunization, No adverse event Oral; 26-MAR-2016, BCG vac, Immunization, No adverse event intramuscular injection
Allergies:
Diagnostic Lab Data: Apgar score, Ratings were recorded as 7/10 and 9/10; His birth body length and head circumference were documented to be 34 centimeters and 28 centimeters respectively
CDC Split Type: 2016347259

Write-up: This is a spontaneous report from the Department of Health. A 6-week-old male patient of an unspecified ethnicity received, on 29Apr2016, the first dose of PREVENAR 13 (Lot. L 21066, Expiration date: Apr2018) single dose; first dose of bivalent oral poliomyelitis vaccine (Lot. M 5103, Expiration date: Jan2017); first dose of intramuscular HEXAXIM (Lot. L 7413, Expiration date: May2017); and rotavirus diarrhea vaccines (Lot. M 5103, Expiration date: Nov2017). The patient was born preterm. Concomitant medications were not reported. The patient previously received on 26Mar2016, oral polio vaccine and BCG vaccine. The patient did not experience any adverse event after the vaccinations. The patient died on 30Apr2016. An autopsy was performed (autopsy results not available). Patient''s clinical course was the following: the deceased child was a male who was delivered prematurely through caesarean section around the gestational age of 28 weeks. The indication for the operation was breech delivery as well as fetal distress. His birth weight was recorded to be 1.09 kilograms. Apgar ratings were recorded as 7/10 and 9/10. His birth body length and head circumference were documented to be 34 centimeters and 28 centimeters respectively. The child had to be on admission in the neonatal ICU of that hospital for several weeks afterwards. He did not have any history of allergy and had no history of recurrent illnesses. He was discharged from the hospital on 25Apr2016 on excellent clinical grounds with an improved body weight of 1.8 kilograms. He also had no past or current medical history of note. He was not HIV positive and was not on any chronic medications of note. Expected Date of Delivery (EDD) was 15Jun2016 but mother had to give birth some 12 weeks earlier. Details regarding the mother was the following: she had her first child in 2005. This was a male child who was also born preterm. He is alive and well and never had any reactions with any of the administered Expanded Programme of immunization (EPI) vaccinations. The mother had another pregnancy in 2010, which unfortunately, spontaneously aborted at 4 weeks. She could not attribute this miscarriage to any cogent cause. The child received "At Birth" vaccinations of oral polio vaccine and BCG VAC intramuscular injection at the Hospital just before his discharge, on 26Mar2016. There were no allergic reactions squeal after administrations of these two vaccines. The child was brought to the clinic around 09:30 on 29Apr2016 for his six weeks schedule of vaccinations. The vaccines normally administered for this age, according to the National EPI vaccination schedule include the first dose of the PREVENAR 13, first dose of bivalent oral poliomyelitis vaccine, as well as the first dose of the HEXAXIM that was administered intramuscularly on the left thigh. As at the time of presentation at the clinic for his six weeks vaccinations, he was not on any medications and had no illness of note, according to the mother. According to the records that were made available for the investigating team, the child was well and fit when he was brought in by his mother to the clinic. There were no history of fever and there was no recording of any pyrexia. Other vitals were described as normal. The vaccinations on that day were administered by the attending EPI nurse herself. He was eventually taken home by mother on satisfactory clinical grounds. No other child who received vaccines of same batch numbers as those administered to the child has ever come back with any complaint. According to the mother, the child, whilst at home was well and fine within the first few hours post vaccination. There was no vomiting and there were no abnormal respirations such as grunting nor chest wheezes. He remained so until when he was checked to be fed around the early hours of Saturday, 30Apr2016. It was at this time that the mother noticed the child had ceased breathing. She observed that he was lifeless with no chest movements. The mother and the accompanying grandmother rushed the child straight to the clinic. The child was unfortunately declared as a "Death on Arrival" (DOA) case by the two attending health care practitioners. Cause of death was unknown. Findings of the post mortem report were not provided at time of this report.


VAERS ID: 653975 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2016-08-23
Onset:2016-08-23
   Days after vaccination:0
Submitted: 2016-09-19
   Days after onset:27
Entered: 2016-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK UN / UN
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Pyrexia, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-08-27
   Days after onset: 4
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:
CDC Split Type: GBSA2016SA171723

Write-up: Initial unsolicited case received from SPMSD under the reference number- 2016009213. Case received from a physician by regulatory authority (Ref no. GB-MHRA-ADR 23635947) on 12-Sep-2016. A 2-month-old female infant patient received DTaP-IPV/Hib (manufacturer unknown, batch number Not known), recombinant Bexsero, (batch number unknown), Prevenar 13, (batch number unknown) administered via intramuscular route on 23-Aug-2016 and rotavirus vaccine, live (manufacturer unknown, batch number unknown) administered via oral route on 23-Aug-2016. The patient experienced Cot death on 27-Aug-2016 4 days Post Administration and Pyrexia on 23-Aug-2016 1 Days Post Administration. The patient developed a high temperature on day of administration. Sought medical attention from general practitioner who advised to give paracetamol. Temperature resolved. Baby found dead in cot with no apparent cause for death (has gone to post mortem). The patient''s outcome was reported as Fatal. The patient died on 27-Aug-2016. Sender''s Comments: Fever may occur folllowing diphtheria, tetanus, acellular pertussis, haemophilus influenza b, and polio vaccine and the time to onset is compatible. The baby death suddenly 4 days post vaccination. Coat death is not expected after the vaccine. The autopsy results, not reported, are necessary to assess the case. The case is poorly documented and not assessable. Reported Cause(s) of Death: Cot death.


VAERS ID: 677131 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-12-20
Entered: 2016-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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: AU2016GSK187789

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old subject who received DTPa-HBV-IPV+Hib vaccine. Co-suspect products included Pneumococcal 13 serotypes vaccine. On an unknown date, 1 day after receivng DTPa-HBV-IPV+Hib vaccine and 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 the unknown cause of death to be possibly related to DTPa-HBV-IPV+Hib vaccine and Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of death NOS in a 2-month-old child who was vaccinated with unspecified rotavirus vaccine, unspecified hexavalent vaccine and unspecified 13 valent pneumococcal conjugate vaccine (13vPCV) (manufacturer unknown for both). The patient was a part of the report that summarized national passive surveillance data for adverse events following immunisation (AEFI) reported to the Administration for 2013. The report focused on AEFI reported for vaccines administered during 2013 and trends in AEFI reporting over the 14-year period 1 January 2000 to 31 December 2013. AEFI were notified to the Administration by state and territory health departments, health professionals, vaccine manufacturers and members of the public. All reports are assessed using internationally consistent criteria entered into the Adverse Drug Reactions System (ADRS) database. No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 1 January 2013 and 31 December 2013, the patient received unspecified rotavirus vaccine, unspecified hexavalent vaccine (administration route and site unspecified; dosages unknown; batch number not provided) co-administered with 13vPCV. On an unspecified date, 1 day after vaccination, the patient died. It was not reported if the autopsy was performed. The cause of death was unknown. This case has been considered serious due to death. The authors commented that "All deaths were investigated by the Administration and no clear causal relationship with vaccination was found. The death NOS was temporally associated with the receipt of vaccine." The authors concluded that "The total number of reported AEFI in 2013 increased by 59% compared with 2012, due to an increasing trend in propensity to report. The higher reporting rates may also be in response to the activities undertaken by the Administration and the state and territory health departments to encourage and facilitate reporting of AEFI. Reporting rates for the majority of the vaccines were higher than 2012. Increases were most marked in the 7 to under 20 year age group following extension of HPV to boys and associated enhanced surveillance. The majority of AEFIs reported to the Administration were mild transient events. The data reported here are consistent with an overall high level of safety for vaccines included in the NIP schedule." This is 1 of the 9 valid cases reported in the same literature article.


VAERS ID: 686688 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-06
Entered: 2017-03-22
   Days after submission:43
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
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: FR2015GSK186243

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a child female patient who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Rotavirus vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The autopsy details were not reported. The question and the reply for this case were: Which information have you retained regarding immunization against rotavirus gastroenteritis? The information comes from one of my best friends who lost her baby after vaccinating her daughter.


VAERS ID: 686869 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-07
Entered: 2017-03-22
   Days after submission:42
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
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: FR2015GSK186250

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in multiple children patients who received Rotavirus vaccine. On an unknown date, the patient Rotavirus vaccine (oral). On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Rotavirus vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. Age at vaccination was not reported. The question and the reply for this case were: Which information have you retained regarding immunization against rotavirus gastroenteritis? Children deaths.


VAERS ID: 686901 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-10
Entered: 2017-03-22
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
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: FR2015GSK186240

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in an unspecified number of children who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Rotavirus vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The question and the reply for this case were: which information have you retained regarding immunization against rotavirus gastroenteritis? Deaths of children following vaccination. Vaccine not reimbursed and expensive.


VAERS ID: 686926 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-10
Entered: 2017-03-22
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
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: FR2015GSK186297

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a child male patient who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Rotavirus vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The question and the reply for this case were: which information have you retained regarding immunization against rotavirus gastroenteritis? Oral vaccine. Well tolerated by my son. Never has gastroenteritis thanks to the vaccine. There was an accident this year with a death of a child.


VAERS ID: 686927 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-09
Entered: 2017-03-22
   Days after submission:40
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
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: FR2015GSK186311

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown case of death in a neonate patient who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Rotavirus vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The question and the reply for this case were: which information have you retained regarding immunization against rotavirus gastroenteritis? A newborn died following this vaccines.


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