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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: 686928 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
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: FR2015GSK186242

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 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? A young child died of this vaccination.


VAERS ID: 686933 (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: FR2015GSK186313

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 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? My doctor had no opinion, not enough hindsight and I have head that a child had died following this vaccine. Then my opinion had been forged against it.


VAERS ID: 686934 (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: FR2015GSK186312

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 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 child died following this vaccine.


VAERS ID: 686966 (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: FR2015GSK186314

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a infant 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? Little useful and death of an infant due to the vaccine.


VAERS ID: 705619 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-07-06
Onset:2017-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER N1D891V / 1 LG / UN
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-07-07
   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: Prophylactic vaccination
Preexisting Conditions: Comments: Relevant comorbidities including immunity status was reported as unknown.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131707GBR010906

Write-up: Initial unsolicited report received from health care professional on 14-Jul-2017. This case is related to case SW50157l (same reporter). This case involves nine-month-old female patient who was vaccinated with primary dose of PEDIACEL (Batch number: N1D891V, expiration date, dose and route was not reported) in thigh on an unspecified date. The patient''s medical history and concomitant medications were not reported. Relevant comorbidities including immunity status was reported as unknown. On 07 Jul 2017, within 24 hours of receiving PEDIACEL the patient died (cause of death was not reported). The information about autopsy was not reported. The reporter felt the causality between the reaction and the drug. Follow-up report received from health care professional on 18-Jul-2017. It was reported that two-month-old (also reported as 9-week-old) was vaccinated with PEDIACEL as well as primary dose of ROTAVIX and MENINGITIS B and PREVENAR (batch number, expiry date, dose, route and site of administration was not reported for last three vaccines) on 06-Jul-2017. On 06-Jul-2017, on the same day after vaccination, the patient experienced low grade fever at home and was put to bed. It was also reported that patient was fit and well during the vaccination and left the clinic shortly after vaccination. List of documents held by sender: none. Sender''s Comments: Follow-up information received on 18-Jul-2017, changes the previous medical assessment. In this case a 9 weeks old female experienced low grade fever on the same day of vaccination and died within 24 hours of receiving PEDIACEL. The patient was concomitantly vaccinated with ROTAVIX, Meningitis B and PREVENAR vaccines (other manufacturer). No information is provided on conditions at the time of death, sleeping position, patient''s medical history especially any congenital anomaly or prematurity, previous vaccination history, autopsy and results of investigations, etc. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Moreover, as multiple vaccines were administered concomitantly, the role of each component cannot be assessed separately. GB-SA-SW50157L. Reported Cause(s) of Death: Death.


VAERS ID: 710764 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-08-09
Onset:2017-08-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER N3A29 / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER 159VPN027I / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER AROLB594AA / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Ascites, Autopsy, Bradycardia, Cardio-respiratory arrest, Choking, Cyanosis central, Death, Dyspnoea, Fontanelle depressed, Generalised tonic-clonic seizure, Hypertrophic cardiomyopathy, Pericardial effusion, Respiratory symptom, Resuscitation, Tachypnoea
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-10
   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: PENTAVALENT VACCINE; PNEUMOCOCCAL 10 VALENT; ORAL ROTAVIRUS VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2017SA159426

Write-up: Initial unsolicited report received from healthcare professional via partner company on 23 Aug 2017 and transmitted to Sanofi on 25 Aug 2017. This case involves a two months old female patient who was vaccinated with a dose of IPV (VERO) (INACTIVATED POLIOMYELITIS VACCINE) (Batch number: N3A29, expiry date, dose, site of administration were not reported and route of administration was unknown) on 09 Aug 2017. The patient''s medical history was unknown. Patient received DIPHTHERIA, TETANUS, PERTUSSIS, HAEMOPHILUS INFLUENZAE, AND HEPATITIS B VACCINES (PENTAVALENT VACCINE) (batch number: 279X6013E), PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL 10 VALENT) (batch number: 159VPN027I) and dose of ROTAVIRUS VACCINE (ORAL ROTAVIRUS VACCINE) (batch number: AROLB594AA) as concomitant medication on 09-Aug-17. On 10-Aug-2017 one day following vaccination patient went to health care unit because infant choked at home. The infant arrived in good general condition, stayed under observation at the health care unit for 2 hours and was discharged in good condition. 10-Aug-2017 at 23:20 PM, one day following vaccination the child was brought to hospital with tachypnea, dyspnea (RR 72 irpm) with severe respiratory signs, central cyanosis, afebrile. On 10-Aug-2017 at 23:40 PM, one day following vaccination, the child presented generalized clonic tonic seizures, bradycardia and cardiorespiratory arrest. CPR and relevant medications were performed without success, and patient was died at 12:40 AM (11 Aug 2017). Patient investigations includes: Oxygen saturation (O2 sats): 80%, Regular heart rate with normal heart sounds. Flat abdomen, weak peristalsis, depressible, without mass or painful compression, anterior fontanelle depressed. Patient was treated with macro nebulization with Fenoterol, METHYLPREDNISOLONE (IV METHYLPREDINISOLONE) 3mg. On 10 Aug 2017 patient recovered from choking and outcome of other events was not reported. Autopsy report was pending. On 11 Aug 2017 at 00:40 hrs., 2 days following vaccination, the patient died due to hypertrophic cardiomyopathy, pericardial (non-inflammatory) effusion and c-ascites (Reported as causes of death). Upon internal review the case was also considered as serious because of important medical event: choking. List of documents held by sender: none.; Sender''s Comments: This case was reported for an infant male patient who died approximately 2 days after vaccination. It was reported that the infant choked at home on the next day of vaccinations and was discharged after 2 hours of observation in good condition. At 23:20 hours on the same day, the patient was brought to the hospital with complaints of tachypnea, dyspnea with severe respiratory signs, central cyanosis, afebrile and saturated oxygen level of 80%. Physical examination showed regular heart rate with normal heart sounds, flat abdomen, weak peristalsis, depressible, without mass or painful compression and anterior fontanelle depressed. As a result patient was treated with macronebulization with Fenoterol and IV methylpredinisolone however at 23:40 hours patient presented with generalized clonic tonic seizures , bradycardia and cardiorespiratory arrest. A cardiopulmonary resuscitation was performed without success and the patient died at 00:40 hours. The cause of death was reported as hypertrophic cardiomyopathy, pericardial (non-inflammatory) effusion and C-Ascites. As hypertrophic cardiomyopathy is a congenital condition it could have manifested the reported events resulting in death. Further information on medical history including birth history, immune status at the time of vaccination, previous vaccination and tolerance, autopsy and results of investigations, etc. are needed to further assess the case. In addition, since, multiple vaccines (Poliomielites inactivated, Pentavalent vaccine, oral Rotavirus vaccine and Pneumococcal 10 valent) were administered concomitantly, the role of each component cannot be assessed separately.; Reported Cause(s) of Death: C-Ascites; cardiorespiratory arrest; Hypertrophic cardiomyopathy; Pericardial (non-inflammatory) effusion; Autopsy-determined Cause(s) of Death: C-Ascites; cardiorespiratory arrest; Hypertrophic cardiomyopathy; Pericardial (non-inflammatory) effusion.


VAERS ID: 711924 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IL0095075131709ISR000844

Write-up: This spontaneous report was received from a patient''s mother via company representative and refers to a female patient of 3.5 months old. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) (dose, strength, route, lot number and expiry date were not reported) for prophylaxis. Other suspect therapies included unspecified vaccines received on unspecified dates (reported as vaccinated with all the vaccines including rotavirus vaccine, live, oral, pentavalent (manufacturer unknown)). On an unspecified date, the patient died at the age of 3.5 months. Information about the cause of death and autopsy was unknown. The company representative was not certain and she estimated that the event occurred a year or two years ago. The reporter didn''t assess the causal relationship of death to rotavirus vaccine, live, oral, pentavalent (Manufacturer unknown) and other vaccines. Upon internal review, the event death was considered to be medically significant.


VAERS ID: 719785 (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: 2017-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Vaccination complication
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: BR0095075131710BRA001740

Write-up: This solicited social media report was received from an unspecified reporter, concerning to an article identified on an independent site, which refers to a 2 month old female patient, who was enrolled in an unspecified study. The patient''s pertinent medical history, concurrent conditions or concomitant medication were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), orally (strength, dose, route of administration, lot number and expiration date were unknown) for prophylaxis. Subsequently on an unknown date, the patient died due to complications of unspecified adverse effects caused by the rotavirus vaccine, live, oral, pentavalent (manufacturer unknown); it was unknown if an autopsy was performed. The reporter considered the unspecified adverse effects to be related to Rotavirus Vaccine, Live, Oral, Pentavalent (manufacturer unknown). Upon internal clarification, it was confirm that this case was not a solicited social media report; it was a spontaneous report received from the journalist who wrote the article (previously mentioned), in a local magazine. This is one of three reports received from the same reporter. Sender''s Comments: BR-009507513-1710BRA001810: BR-009507513-1710BRA001681: Reported Cause(s) of Death: Complications of the adverse effects caused by the Rotavirus Vaccine.


VAERS ID: 731556 (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: 2017-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / SYR
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: ?
Symptoms: Death, Encephalitis, Pneumocystis jirovecii pneumonia, Resuscitation, Thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2017544360

Write-up: This is a spontaneous report from non-contactable consumer received via a Pfizer colleague of legal division in form of a letter from a community of victims, or relatives of victims, of vaccination accidents, sent to the parliament and constitutional council. This document reported 17 vaccine "accidents" among them 7 included vaccination with PREVENAR 13. This is the 2nd of 7 reports. A 2-month and a half-old patient of unspecified gender received on an unknown date, as recommended by a paediatrician, PREVNAR 13 at single dose for immunization, INFANRIX HEXA at unknown dose for immunization, and Rotavirus vaccine (unspecified trade name) at unknown dose for immunization. Lot numbers, dose number, route and site of administration were unknown. The patient''s medical history and concomitant medications, if any, were not reported. On an unspecified date, 4 days after the injection, the patient presented with the first (unspecified) symptoms. The patient''s condition after vaccination was described as: pneumocystosis, post transfusion thrombocytopenic purpura and necrotizing encephalitis. The patient underwent intra cranial derivation and resuscitation. The patient died on an unknown date and due to unspecified reason at the age of 14 months. It was unkown if autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 731623 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Encephalitis, Pneumocystis jirovecii pneumonia, Post transfusion purpura, Resuscitation, Ventriculo-peritoneal shunt
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (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: FR0095075131712FRA010198

Write-up: This spontaneous report was received from patient''s association to State referring to a 2 month old patient of unknown gender. The patient''s medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), orally, at the age of 2 months and a half, following the recommendation from the pediatrician for prophylaxis (dose, lot# and expiry date were unknown). Other suspect therapies included INFANRIX HEXA and PREVENAR 13 for prophylaxis (dose, route of administration, lot # and expiry date were unknown). On an unknown date (reported as 4 days after the injection), the patient experienced pneumocystosis, post transfusional thrombocytopenic purpura, necrotic encephalitis and resuscitation with intracranial shunt. On an unknown date, at the age of 14 months old, the patient died. It was unknown if an autopsy was performed. The causality assessment between the suspect vaccines and the aforementioned events was not reported. Upon internal review, pneumocystis jirovecii pneumonia, post transfusion purpura, encephalitis and resuscitation were determined to be medically significant events. Reported Cause(s) of Death: necrotic encephalitis; Pneumocystosis; resuscitation with intracranial shunt; post transfusional thrombocytopenic purpura.


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