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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: 732232 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event
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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131712FRA012749

Write-up: Information has been downloaded from database (FR-GLAXOSMITHKLINE-FR2017GSK195603). This spontaneous report was received from a consumer refers to a 14 month old patient of unknown gender. On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(manufacturer unknown) orally for prophylaxis. Other suspect therapies included INFANRIX HEXA and PREVENAR 13. On an unknown date the patient experienced pneumocystis, encephalitis, post transfusion purpura, thrombocytopenia and necrosis. The outcome of pneumocystis, encephalitis, post transfusion purpura, thrombocytopenia and necrosis was reported as fatal. Causality assessment was not reported. The case was serious as all the events were considered as medically significant and these events led to death.


VAERS ID: 738695 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Death, Hypokinesia, Social avoidant behaviour
SMQs:, Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SESA2018SA045609

Write-up: Initial information regarding this unsolicited case downloaded from regulatory authority database without narrative (level 2A), was received on 15-Feb-2018 from Consumer or other Non-Health Professional via pharmaceutical company (GlaxoSmithKline) (Under reference number: SE-GLAXOSMITHKLINE-US2018GSK022450). The following narrative is based on the information retrieved from all other accessible data". This case involves a four-month-old patient (Gender was not reported), who was vaccinated with a dose of IPV oral drops, DTAP VACCINE SOLUTION FOR INJECTION, PNEUMOCOCCAL VACCINE, ROTAVIRUS VACCINE (Form oral drop) and HEPATITIS B VACCINE (Form: injection for solution} (batch number, expiry date, dose, dose series, route and site of administration was not reported for all vaccines) on an unknown date. Medical history and concomitant medication was not reported. On an unknown date, post vaccination the patient experienced withdrawn, moving less than before and no longer babbling or silent due to which patient died. Patient''s lab test and corrective treatment was not reported. It was unknown if autopsy was performed or not. There is causal relationship between Rotavirus vaccine, DTaP vaccine, Hepatitis B vaccine and events according to reporter and other pharmaceutical company. List of documents held by sender: none. Sender''s Comments: This is a poorly documented case concerning a 4 month old infant who died after vaccination with IPV, DTaP, PNEUMOCOCCUS, ROTAVIRUS and HEPATITIS vaccines. The date of vaccinations, the date of events, the date of death and the time interval between vaccination and the events is not reported. No information regarding medical history & tolerance to previous vaccinations was reported. Lab tests confirming the diagnosis were not reported. Autopsy confirmation is also not provided. Moreover, multiple vaccines were administered on unknown dates. Based upon reported information, the role of one vaccine cannot be assessed. Reported Cause(s) of Death: Movements reduced; Speech loss; Withdrawn.


VAERS ID: 740683 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Depressed level of consciousness, Diarrhoea, Multiple organ dysfunction syndrome, Norovirus test positive, Polymerase chain reaction positive, Rotavirus infection, Rotavirus test positive, Viral infection, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Down''s syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131803JPN001088J

Write-up: Information has been received from a physician concerning a 1-year-old male infant with Down''s syndrome who was orally vaccinated for the 2nd time with rotavirus vaccine, live, oral, pentavalent oral solution (manufacturer unknown) for prophylaxis against gastroenteritis due to rotavirus (lot number, vaccination date and dose not reported). No concomitant medication was reported. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent for the first time. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent for the second time. On an unknown date, the patient was brought to a hospital because vomiting, diarrhoea and depressed level of consciousness were confirmed. On an unknown date, norovirus and a minute amount of rotavirus were detected in a real time polymerase chain reaction (RT-PCR) test of stool (infection mixed with rotavirus and norovirus was developed). On an unknown date, multi-organ failure occurred, and multimodal therapy was performed. On an unknown date (the seventh day of the treatment), the patient died. The causes of death were multi-organ failure and infection mixed with rotavirus and norovirus. Autopsy information was not obtained. Reporter''s comment: Not provided. The reporting physician considered multi-organ failure and infection mixed with rotavirus and norovirus to be serious due to death. Upon internal review, multi-organ failure and infection mixed with rotavirus and norovirus were determined to be medically significant. The reporting physician did not assess the relationship of multi-organ failure, infection mixed with rotavirus and norovirus to rotavirus vaccine, live, oral, pentavalent.; Reported Cause(s) of Death: Multi-organ failure; Infection mixed with rotavirus and norovirus.


VAERS ID: 740965 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 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: ?
Symptoms: Autopsy, Death, Interstitial lung disease, Loss of consciousness, Lymphadenopathy, Splenomegaly, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPSA2018SA068930

Write-up: Initial unsolicited report received from the literature on 07-Mar-2018. This case is linked to Related case: 2018-JPN-002047_CLUSTER (case id: 2018SA068932) (same reporter). Verbatim of the article Introduction: In forensic autopsy of infants, causal relationship between vaccination and a death may rarely be suspected. Although it is actually difficult to assess their direct causal relationship in forensic medicine, at least submission of physical and laboratory findings are requested in such cases. In the present study, infantile autopsy cases that died following vaccination were extracted from cases within past 4 years retrospectively and reviewed their details. Subjects: After being approved by Institutional Review Board as a retrospective study, 45 cases of sudden deaths in infants younger than 3 years were extracted from autopsy cases in Department of Forensic Medicine of University School of Medicine between 2013 and 2017, excluding definite deaths by external causes such as abuse and death by fire. Autopsy findings, information provided by the Police and mother''s handbooks for health were used as data. Results: Causal relationship with vaccination was suspected in autopsies of 2 cases (#1 and #2), both of which were deaths at 3 months of age immediately after receiving Hib, pneumococcal, hepatitis B and rotavirus vaccines following quadruple vaccine (DPT-IPV). Case #1 was found unconscious on the next day of the vaccination, and #2 had mild flulike symptoms and found dead while sleeping 3 days later. In both cases, autopsy findings indicated severe interstitial pneumonia with neck and peritoneal lymph node swelling and splenomegaly. Discussion: For situations immediately before the deaths, neither of the 2 cases had any prominent symptoms after the vaccination without visiting hospital, and both were found to have acute deterioration while sleeping. Their situations were similar to those of general SIDS cases. Effect of vaccination was suspected because it was pointed out by their parents. The autopsy findings had typical infectious picture with lymph node swelling and splenomegaly. Some other cases of acute death also had similar findings. There may be other cases of death where effect of vaccination should be suspected to lead to death. Concurrent vaccination such as Hib and pneumococcal vaccine caused accidental deaths in 2011, and the concurrent vaccination was discontinued but resumed later. The overall condition published at that time was similar to that in the present cases and causal relationships should therefore need to be considered carefully. This case involves a three-months-old patient (gender unknown) who was vaccinated with ACTHIB, PNEUMOCOCCAL VACCINE, HEPATITIS B VACCINE, ROTAVIRUS VACCINE, and DPT-IPV (batch number, expiration date, dose, dose in series, route and site of administration were not reported). The patient''s medical history and Concomitant medication was not reported. On an unknown next day following the vaccination patient was found unconscious and found dead while sleeping 3 days later. On an unknown day, the autopsy was performed and autopsy findings indicated severe interstitial pneumonia with neck and peritoneal lymph node swelling and splenomegaly. For situations immediately before the deaths, patient had no prominent symptoms after the vaccination without visiting hospital, and found to have acute deterioration while sleeping. Their situations were similar to those of general SIDS cases. Laboratory investigations and corrective treatment were not reported. The outcome of all the events was fatal. It was also reported that the patient had not any prominent symptoms after the vaccination without visiting hospital, and were found to have acute deterioration while sleeping. Effect of vaccination was suspected because it was pointed out by the parents. In forensic autopsy of infants, causal relationship between vaccination and a death may rarely be suspected. Although it is actually difficult to assess their direct causal relationship in forensic medicine, at least submission of physical and laboratory findings is requested in such cases. List of documents held by sender: none. Sender''s Comments: This case concerns a literature article in which a 3 month old infant died in sleep 3 days after vaccination (ACT-HIB and pneumococcal, hepatitis B, DPT-IPV and rotavirus vaccines). The infant was found unconscious. Autopsy results indicated severe interstitial pneumonia with lymph node swelling and splenomegaly which indicate towards an underlying infection. However, the age and clinical details correspond closely with the general Sudden Infant Death Syndrome (SIDS) cases. Further information regarding patient medical history, details regarding whether it was a premature birth or not, recent infectious history especially upper respiratory, allergic history, past vaccination history and its tolerance are needed to further assess the case. Moreover, multiple vaccinations preceded the event. Based upon the reported information, the role of the vaccines cannot be assessed individually. Reported Cause(s) of Death: severe interstitial pneumonia; splenomegaly; Sudden Death; Autopsy-determined Cause(s) of Death: severe interstitial pneumonia; splenomegaly; Sudden Death.


VAERS ID: 741214 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Death, Hypotonia, Interstitial lung disease, Lymphadenopathy, Splenomegaly
SMQs:, Peripheral neuropathy (broad), Interstitial lung disease (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Immune-mediated/autoimmune disorders (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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131803JPN000891J

Write-up: Initial information has been received from a physician concerning a 3-month-old infant who on an unspecified date was vaccinated with hepatitis B vaccine (product name unknown) (dose was not reported). Other suspect medications included diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine (SALK) (vaccinated date, dose unknown, indication: prophylaxis), pneumococcus vaccine (vaccinated date, dose unknown, indication: prophylaxis), live attenuated human rotavirus vaccine (vaccinated date, dose unknown, indication: prophylaxis) and adsorbed haemophilus type B vaccine (non-toxic) (vaccinated date, dose unknown, indication: prophylaxis). On an unspecified date, the patient was vaccinated with (non-toxic) Hib, pneumococcus vaccine, recombinant adsorbed hepatitis B vaccine (Yeast Origin), and live attenuated human rotavirus vaccine following diphtheria and DTaP-IPV. On an unspecified date, the patient died. The patient was found limply laying down on the following day of the vaccinations. The cause of death was not reported. Autopsy revealed severe interstitial pneumonia with dilated cervical/peritoneal lymph nodes and enlarged spleen. Reporter''s comment: The patient had no remarkable symptom and did not make hospital visits right before the death following the vaccination, and the condition suddenly changed while sleeping at home, which was corresponding to the typical condition of sudden infant death syndrome (SIDS). The influence by the vaccination was suspected as it was indicated by the patient''s parents. Upon internal review, death was considered to be serious due to other important medical event. The reporting physician felt that death was related to hepatitis B vaccine, and considered diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine, pneumococcus vaccine, live attenuated human rotavirus vaccine and adsorbed haemophilus type B vaccine as suspect drugs. This is one of the several reports received from the same source. Sender''s Comments: JP-MSD-1803JPN001079J: Reported Cause(s) of Death: Death.


VAERS ID: 741215 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: 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: Unknown       Purchased by: ?
Symptoms: Autopsy, Death, Interstitial lung disease, Nasopharyngitis, Splenomegaly
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131803JPN001079J

Write-up: It was reported in a meeting abstract. Initial information has been received from a physician concerning a 3-month-old infant who on an unspecified date was vaccinated with hepatitis b vaccine (product name unknown) (dose not reported). Other suspect medications included diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine (SALK) (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND. INACTIVATED POLIOVIRUS VACCINE (SALK)) (vaccinated date, dose unknown, indication: prophylaxis) , pneumococcus vaccine (PNEUMOCOCCUS VACCINE) (vaccinated date, dose unknown, indication: prophylaxis), live attenuated human rotavirus vaccine (LIVE ATTENUATED HUMAN ROTAVIRUS VACCINE) (vaccinated date, dose unknown, indication: prophylaxis) and adsorbed haemophilus type b vaccine (non-toxic) (ADSORBED HAEMOPHILUS TYPE B VACCINE (NON-TOXIC)) (vaccinated date, dose unknown, indication: prophylaxis). On an unspecified date, the patient was vaccinated with adsorbed haemophilus type b vaccine (non-toxic) (Hib), pneumococcus vaccine, recombinant adsorbed hepatitis B vaccine (Yeast Origin), and live attenuated human rotavirus vaccine following diphtheria and tetanus toxoids and acellular pertussis adsorbed and. inactivated poliovirus vaccine 4-component vaccine (DPT-IPV). On an unspecified date, the patient found dead while sleeping 3 days after mild symptoms of common cold were noted. The cause of death was not reported. Autopsy revealed severe interstitial pneumonia with dilated cervical/peritoneal lymph nodes and enlarged spleen. Reporter''s comment: The patient had no remarkable symptom and did not make hospital visits right before the death following the vaccination, and the condition suddenly changed while sleeping at home, which was corresponding to the typical condition of sudden infant death syndrome (SIDS). The influence by the vaccination was suspected as it was indicated by the patient''s parents. Upon internal review, death was considered to be serious due to other important medical event. The reporting physician felt that death was related to hepatitis b vaccine, and considered diphtheria and tetanus toxoids and acellular pertussis adsorbed and. inactivated poliovirus vaccine, pneumococcus vaccine, live attenuated human rotavirus vaccine and adsorbed haemophilus type b vaccine as suspect drugs. This is one of the several reports received from the same source.; Sender''s Comments: JP-MSD-1803JPN000891J:; Reported Cause(s) of Death: Death.


VAERS ID: 792408 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (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 MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Blood urine present, Contusion, Crying, Cyanosis, Decreased appetite, Dyspnoea, Irritability, Pallor, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), 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), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: COGLAXOSMITHKLINECO2018GS

Write-up: This case was reported by a consumer via local affiliate and described the occurrence of respiratory failure in a 2-month-old female patient who received Rotavirus vaccine for prophylaxis. Co-suspect products included Pneumococcal vaccine for prophylaxis, Polio vaccine for prophylaxis and DTPw-HBV/Hib for prophylaxis. On an unknown date, the patient received Rotavirus vaccine (oral), Pneumococcal vaccine, Polio vaccine and DTPw-HBV/Hib. On an unknown date, 1 day after receiving Rotavirus vaccine, Pneumococcal vaccine, Polio vaccine and DTPw-HBV/Hib, the patient experienced respiratory failure (serious criteria death and GSK medically significant), abnormal breathing (serious criteria life threatening), crying, blood in urine, pallor, bruising of leg, cyanosis, appetite lost and difficulty breathing. On an unknown date, the outcome of the respiratory failure was fatal and the outcome of the abnormal breathing, crying, blood in urine, pallor, bruising of leg, cyanosis, appetite lost and difficulty breathing were unknown. The reported cause of death was respiratory failure. An autopsy was performed. It was unknown if the reporter considered the respiratory failure, abnormal breathing, blood in urine, pallor, bruising of leg, cyanosis, appetite lost and difficulty breathing to be related to Rotavirus vaccine, Pneumococcal vaccine, Polio vaccine and DTPw-HBV/Hib. The reporter considered the crying to be related to Rotavirus vaccine, Pneumococcal vaccine, Polio vaccine and DTPw-HBV/Hib. Additional details were received as follows: This case was identified during media monitoring and was reported by a radio program. The patient�s mother was described the occurrence of fatal case, for the patient who received Polio vaccine, Pentavalent vaccine, Pneumococcal vaccine and Rotavirus vaccine, according to local schedule of 2 months. The reporter informed that 3 hours after application the patient started with irritable crying, loss of appetite. On the next day, the patient started with pallor and at night when the patient''s mother was to change the diaper and she saw blood in urine and decided to visit emergency service. In emergency service the patient started with fast abnormal breathing and after that the patient presented cyanosis and difficult breathe. Due this situation, the physician decided to supply 0.5 L of oxygen and was referred to another hospital with pediatrician. The patient''s mother arrived to vital emergency service and there the physician increased oxygen to 2 L and after to 3L, however the patient was not able to breath. Because of that, physician decided to sedate, intubate and place mechanical ventilation, but 4 hours after that the patient presented respiratory failure and baby died. The physician requested a necropsy, of which was not available at the moment of this report. During the interview was not mention a trade name of GSK, however taking into account the local health care system, Pneumococcal vaccine and rotavirus vaccine could be GSK products. Follow-up was not possible due to the reporter did not have access to contact information, however If the reporter would receive additional information they would reply. Reported Cause(s) of Death: respiratory failure.


VAERS ID: 794129 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2018527724

Write-up: This is a literature report received from an Other Health Professional via the Regulatory Authority online database search. The regulatory authority report number is E2B_00570987. Literature citation was not provided. This information was initially reported to regulatory authority on 03Dec2015 an unknown Market Authorization Holder (AER# CA2015GSK171385). A patient of unspecified age and gender received PREVNAR 13 at single dose, diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid, ROTAVIRUS VACCINE, all on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the batch number has been requested. Follow-up attempts not possible. No further information expected. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 796873 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2017-09-27
Onset:2017-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. - / UNK - / OT
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / OT
HIBV: HIB (TETRACOQ) / SANOFI PASTEUR - / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / OT
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-09-28
   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:
CDC Split Type: JP0095075131901JPN001462J

Write-up: Information has been received from other medical expert concerning a 3-month-old male infant. The infant patient had no underlying disease. On 27-SEP-2017, the patient was immunized with recombinant sedimentation hepatitis B vaccination (derived from yeast) (product name unknown) for preventive measure (no dose was reported). Other concomitant medication included ACT HIB (date of starting the immunization: 27-SEP-2017, dose: unknown, indication: unknown) and PREVENAR 13 (date of starting the immunization: 27-SEP-2017, dose: unknown, indication: unknown), SQUAREKIDS (date of starting immunization: 27-SEP-2017, dose: unknown, indication: unknown), and LIVE ATTENUATED HUMAN ROTAVIRUS VACCINE(date of starting immunization: 27-SEP-2017, dose: unknown, indication: unknown). No other concomitant medication was reported. On 27-SEP-2017, the patient was immunized with recombinant sedimentation hepatitis B vaccination (derived from yeast), haemophilus influenzae type b conjugate vaccine (tetanus toxoid conjoined twins), sedimentation 13-valent pneumococcal combined vaccine (non-toxic variant diphtheria toxic conjoined twins), diphtheria toxoid, pertussis whole cell vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid, and LIVE ATTENUATED HUMAN ROTAVIRUS VACCINE (as described above). At the night of the day after the immunizations, the patient experienced vomiting and transferred to the hospital. On the way to the hospital, the patient was immediately changed the state. On 28-SEP-2017, the patient was confirmed to be dead. None of the cause of the death or information concerning whether autopsy was performed was reported. Reporter''s comment: not provided. The reporting other medical expert considered the vomiting was serious (death and medically significant). The reporting other medical expert considered the vomiting to be related to recombinant sedimentation hepatitis B vaccination (derived from yeast). The reporting medical expert considered haemophilus influenzae type b conjugate vaccine (tetanus toxoid conjoined twins), sedimentation 13-valent pneumococcal combined vaccine (non-toxic variant diphtheria toxic conjoined twins), and diphtheria toxoid, pertussis whole cell vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid were to be suspected medications. Reported Cause(s) of Death: Death.


VAERS ID: 819761 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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: Prophylactic vaccination
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131906DEU006907

Write-up: Information has been downloaded (DE-SA-2019SA150170) This spontaneous report was received from a physician concerning a neonate of unknown age and gender. The patient''s medical history, concomitant medications, concurrent conditions and past drug allergies/reactions were not reported. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), hib conj vaccine (tet toxoid), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 2-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (HEXYON) suspension for injection and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) all therapies for prophylactic vaccination (strengths, doses, routes of administration, anatomical sites of injection, lot numbers and expiry dates were not reported). On an unknown date, the patient died due to unspecified reason, within 24 hours after vaccination with hib conj vaccine (tet toxoid), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 2-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (HEXYON). However, no conclusion on the cause of death was reported, no autopsy results were available. The causal relationship between the patient dead and rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) were not provided. The causality assessment between the event and hib conj vaccine (tet toxoid), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 2-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (HEXYON) was reported as related by the physician.; Reported Cause(s) of Death: death NOS


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