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

Found 81 cases where Vaccine is RVX and Patient Died

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Case Details

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VAERS ID: 493115 (history)  
Form: Version 1.0  
Age: 1.8  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-06-03
Entered: 2013-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Endocrine disorder, Immune system disorder, Parvovirus infection, X-linked chromosomal disorder
SMQs:, Congenital, familial and genetic disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic diarrhea; Obstructive lung disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0895548A

Write-up: This case was reported in a literature article and described the occurrence of human bocavirus infection in a 21-month-old male subject who was vaccinated with Rotavirus vaccine (manufacturer unspecified). His older brother died at the age of 20 months suffering from BCGitis and severe CMV infection suggesting a severe primary immunodeficiency syndrome. Concurrent medical conditions included chronic diarrhea and obstructive lung disease. Immunological dysregulation, endocrine dysfunction and enteropathy compatible with IPEX syndrome were found. Therefore the subject was listed for stem cell transplantation. FOXP3 gene showed no IPEX associated mutations, but in sequencing IL2RG, a mutation in Exon 2 associated with x-linked IPEX-LIKE SCID was found. The pulmonary condition of the subject deteriorated and the subject was hospitalised where he was mechanically ventilated. After common respiratory infections were excluded, chronic human bocavirus infection was identified by multiplex-PCR as the primary causative pulmonary agent causing his respiratory failure. Human bocavirus infection was found in decreasing quantity in respiratory material, blood and stool specimen. Chronic rotavirus shedding was notified in repetitive stool specimen. Since the subject received an unspecified dose of rotavirus vaccine on an unspecified date, vaccine-acquired chronic infection was suspected and confirmed by the typing of a vaccine virus specific gene variant. The subject died from human bocavirus infection. This literature article showed that human bocavirus infection could lead to lethal respiratory infections in immunocompromised children.


VAERS ID: 508058 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2013-08-30
Onset:2013-08-30
   Days after vaccination:0
Submitted: 2013-10-14
   Days after onset:45
Entered: 2013-10-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR J0110 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G79293 / UNK UN / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER AROLA767BB / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-08-30
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013289047

Write-up: This is a spontaneous report received from a healthcare professional via the contactable Regulatory Agency. Regulatory Authority report number ADR22261011. A 95 days old male patient received PREVENAR 13 (Lot# G79293) intramuscular at 0.5 ml single, on 30Aug2013; PEDIACEL (Lot# J0110-1) intramuscular at 0.5 ml single, on 30Aug2013 and Rotavirus vaccine (Lot# AROLA 767BB) oral at 1.5ml, on 30Aug2013. The patient medical history and concomitant medications were not reported. On 30Aug2013, the patient experienced death unexplained. Cause of death was unknown. It was unknown if any autopsy was performed. No follow up attempts possible. No further information expected.


VAERS ID: 543679 (history)  
Form: Version 1.0  
Age: 0.13  
Sex: Male  
Location: Foreign  
Vaccinated:2014-06-11
Onset:2014-06-11
   Days after vaccination:0
Submitted: 2014-09-12
   Days after onset:93
Entered: 2014-09-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER J0152 / 1 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 3C3001 / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER K5091 / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H91663 / 1 UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER A710AA / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Death neonatal, Dyspnoea, Endotracheal intubation, Eyelid oedema, Feeling cold, Irritability, Pupillary light reflex tests abnormal, Resuscitation, Strabismus
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Glaucoma (narrow), Cardiomyopathy (broad), Retinal disorders (narrow), Depression (excl suicide and self injury) (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Neonatal disorders (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-06-13
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: 11-JUN-2014, Body temperature, 38 Centigrade; 12-JUN-2014, Body temperature, 36.8 Centigrade; 12-JUN-2014, Body temperature, 36.5 Centigrade; 12-JUN-2014, Body temperature, 35-36.4 Centigrade; 12-JUN-2014, Heart rate, 200; 12-JUN-2014, Heart rate, 140; 12-JUN-2014, Heart rate 160 or more; 13-JUN-2014, Heart rate, 94; 12-JUN-2014, Oxygen saturation, 93%; 13-JUN-2014, Oxygen saturation, 69%; 13-JUN-2014, Oxygen saturation, 119%; 13-JUN-2014, Oxygen saturation, 72%; 11-JUN-2014, Respiratory rate, 54; 12-JUN-2014, Respiratory rate, 22; 12-JUN-2014, Respiratory rate, 48; 12-JUN-2014, Respiratory rate, between 20-25; 12-JUN-2014, Weight, 4.10 kg; Mobility (triage score): normal for age, score of 0; AVPU (triage score): of alert, score of 0; Trauma (triage score): no, score of 0; Vesvc Barloth Sinus (unspecified date): bilaterally; S1S2 M (unspecified date): negative
CDC Split Type: 2014249695

Write-up: This is a spontaneous report from a contactable other HCP via the Department of Health. A 6-week-old male patient on 11Jun2014 received first dose of PREVENAR 13 (lot# H91663), via an unspecified route of administration, at single dose; second dose of OPV ("LEDERLE") (lot# K5091), via an unspecified route of administration, at unspecified dose and frequency; first dose of Rotavirus vaccine (lot# A710AA), via an unspecified route of administration, at unspecified dose and frequency; first dose of DTP/HEPB/IPV/HIB (lot# J0152), via an unspecified route of administration, at unspecified dose and frequency and first dose of Hepatitis B vaccine (lot# 3C3001/O), via an unspecified route of administration, at unspecified dose and frequency. Relevant medical history and concomitant medications were not reported. On 11Jun2014 half an hour after the injections patient''s breathing was 54 and temperature 38 Centigrade. Left eye had a slight squint and was puffy. The patient was complaining (Fussy/crying) when moving and had difficulty breathing. On 12Jun2014 at 05:55 PM, patient was carried in by his mother to the emergency room of a hospital with complaint of difficulty breathing following immunization, allergy that was noted as possibly due to immunization. The patient''s respiratory rate was 22 pm, heart rate 200 beats, oxygen saturation 93%, temperature 36.8 Centigrade, weight of 4.10 kg on 12Jun2014. Infant triage score noted as: mobility normal for age, score of 0; Respiratory rate between 20-25 thus score of 2; Heart rate of 160 or more, score of 3; Temperature 35-36.4 Centigrade, score of 0; AVPU of alert, score of 0; Trauma as no, score of 0. Nurse records and physician records: in addition to the above symptoms it was also noted that the left eye was twitching. The patient was noted to be well until 11Jun2014 post routine 6 week immunizations. The patient was sucking well (breastfeeding) and not vomiting. Healthy infant. On humidified oxygen, adrenaline. Not in respiratory distress. It was also reported: "Vesvc Barloth Sinus bilaterally, S1S2 M negative". Soft head. Immunizations noted as up to date. Condition noted as satisfactory. The patient was admitted to hospital on 12Jun2014 at 07:15 PM. On 12Jun2014 one of the physician''s noted the patient''s temperature at approximately 36.5 Centigrade, pulse of 140 and respiration of 48 at approximately 10:00 PM. On 13Jun2014 at 01:00 AM the mother complained that the patient was cold on one side. The mother was requested to wrap the patient up warmly and oxygen was still being administered. On 13Jun2014 at 01:30 AM the physician was called to have a look at the patient. Started resuscitation at 02:33 AM, pulse was 94; saturation 69%, afterwards resuscitation started. Physician intubated ETT 40 tube and injected adrenaline via ETT tube x 3 doses. Heartbeat initially improving but not maintaining. Patient had no pulse, no respiration and pupils reported as "N/A". Resuscitation was called off. Time of death noted as 02:55 AM. Medication received in hospital included: PANADO syrup, 60mg 12 hourly PO (orally), started on 12Jun2014; AMOXIL suspension, at 75mg 8 hourly PO, started on 12Jun2014. Death certificate noted the cause of death as due to natural causes on 13Jun2014. It was not reported if an autopsy was performed. Death was thought to be related to immunization.


VAERS ID: 551542 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-21
Entered: 2014-10-22
   Days after submission:1
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: 2014-10-21
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: IN2014GSK009371

Write-up: This case was reported in a literature article and described the occurrencce of death in an infant patient who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine at an unknown dose. In 2012, Unknown after receiving Rotavirus vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The patient died in 2012. The reported cause of death was death. It was not reported if the reporter considered the death to be related to Rotavirus vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of death in an infant of undetermined age and gender who had previously received an unspecified rotavirus vaccine (manufacturers unknown). The subject''s family proceeded. The subject had a family history that included parenteral consanguinity and recurrent pregnancy losses in the mother. A younger sibling was later diagnosed with RAG-1-deficient severe combined immunodeficiency syndrome with homozygous mutation (homozygosity $g10%). The authors expressed their belief that the subject had suffered from the same genetically condition during correspondence about the case. The subject''s sibling subsequently died of vaccine-associated paralytic poliomyelitis and disseminated bacille Calmette-Guerin infection. No further information on the subject''s medical history, concurrent medical conditions or concomitant medication was provided. On unspecified dates, the subject received an unspecified rotavirus vaccine (dosage, route and administration site unknown; batch number not provided). On an unspecified date in 2012, an unknown period after receiving the vaccine, the subject passed away. This case is serious as it resulted in death. Treatment was unknown. Outcome was fatal. It is unknown if an autopsy was performed. The authors did not comment on any causal relationship between this event and the vaccine received by the subject. The authors concluded that "by being vigilant, vaccine-associated diseases can be diagnosed early, the spread of disease could be prevented by immunization of exposed persons in the community and among contacts, and appropriate treatment can be given in a timely manner to minmize suffering and reduced morbidity and mortality". This case is 1 of the 2 valid cases reported in the same literature article (see case IN2014GSK009211).


VAERS ID: 578280 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-15
Entered: 2015-05-15
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, Ill-defined disorder
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: WAES1505USA005092

Write-up: This spontaneous, unconfirmed report as received from a nurse via company representative refers to a unspecified number of children of unknown age and gender. On an unknown date the patients were vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) (dose and frequency were not reported, route of administration defaulted to oral). Other suspect therapies included hepatitis b vaccine (recombinant) (manufacturer unknown) and BCG live (manufacturer unknown) (dose, frequency and route of administration were not reported). Use of ROTATEQ, BCG, and RECOMBIVAX could not be ruled out. It could not be determined if the unspecified products were Merck products. The nurse stated that an unspecified media report announced that an unspecified number of children experienced illness and died on unspecified dates following the vaccination with unspecified hepatitis B, tuberculosis, and rotavirus products. The outcome of illness was unknown. The relatedness between the events and vaccination was not reported. Additional information has been requested.


VAERS ID: 578657 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-18
Entered: 2015-05-18
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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1505MEX005484

Write-up: This spontaneous unconfirmed report as received from a healthcare worker via company representatives, refers to 2 children of unknown age and gender. The healthcare worker was informed by the people in physician''s office that they heard from the news, (the exact source of this news report: TV versus newspaper versus internet, etc was not specified) that on an unknown date, after vaccination with unspecified tuberculosis vaccine (manufacturer unknown) (lot#, strength, dose, frequency and route were not reported), unspecified rotavirus vaccine (lot#, strength, dose, frequency and route were not reported), and hepatitis B vaccine (lot#, strength, dose, frequency and route were not reported) - the children died. The dates and causes of death were not specified. The relatedness between vaccination with rotavirus vaccine (manufacturer unknown), hepatitis B vaccine (manufacturer unknown) and tuberculosis vaccine (manufacturer unknown) and death was not reported. Additional information has been requested.


VAERS ID: 581257 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-06-04
Entered: 2015-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Intussusception
SMQs:, Gastrointestinal obstruction (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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1506DEU001956

Write-up: Information has been received from Sanofi Pasteur MSD (reference # DE-1577272925-E2015-06023) on 02-JUN-2015. Case of fatal outcome was received from a physician via a company representative on 30-May-2015. Case was medically confirmed. Poorly documented hearsay case from an exchange platform for paediatricians. An infant patient of unspecified gender and age received a dose of rotavirus live vaccine (manufacturer and lot-no. not reported) on an unspecified date. About four weeks later the patient developed intussusception and died.


VAERS ID: 588606 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2015-06-22
Onset:2015-06-23
   Days after vaccination:1
Submitted: 2015-07-24
   Days after onset:31
Entered: 2015-07-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER L7078 / 3 LL / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 3C39011 / 3 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L21066 / 2 RL / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER AROLA228BC / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Death, Decreased appetite
SMQs:, Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-06-23
   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: 14-MAR-2015 to Unknown, Baby premature, Child was delivered preterm with a birth weight of 890 g; 14-MAR-2015 to Unknown, Oxygen consumption, Spent 2 and a half months on continuous oxygen; 14-MAR-2015 to 14-MAR-2015, BCG, Immunisation, No adverse effect, at Birth, AROLA228BC; 14-MAR-2015 to 14-MAR-2015, Polio vaccine, Immunisation, No adverse event, at birth, batch number K5385; 27-APR-2015 to 27-APR-2015, Polio vaccine, Immunisation, No adverse event, 6 weeks immunization, batch number K5555; 27-APR-2015 to 27-APR-2015, Rotavirus vaccine, Immunisation, No adverse event, 6 weeks immunizations, batch number AROLA976AR; 27-APR-2015 to 27-APR-2015, PENTAXIM, Immunisation, No adverse event, 6 weeks immunization, batch number K8486; 27-APR-2015 to 27-APR-2015, Hepatitis B, Immunisation, No adverse event, 6 weeks, batch number 303301/0; 27-APR-2015 to 27-APR-2015, PREVENAR 13, Immunisation, No adverse event, 6 weeks immunization, lot X080620; 25-MAY-2015 to 25-MAY-2015, PENTAXIM, Immunisation, No adverse event, 10 weeks immunization, batch number K8485; 25-MAY-2015 to 25-MAY-2015, Hepatitis B, Immunisation, No adverse event, 10 weeks immunization, batch number 303301/0
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015244278

Write-up: This is a spontaneous report from a consumer. A 3-months-old female patient of an unspecified ethnicity received the second dose of PREVENAR 13, (lot L21066, exp. date Jul2017), via an unspecified route of administration on 22Jun2015 at single dose in right thigh, third dose of PENTAXIM, (lot L7078, exp. date Aug2016), via an unspecified route of administration on 22Jun2015 in left thigh, third dose of Hepatitis B, (lot 3C3901/1, exp. date Sep2016), via an unspecified route of administration on 22Jun2015 in right thigh and second dose of rotavirus vaccine, oral on 22Jun2015. Medical history included premature baby on 14Mar2015 to an unknown date (Child was delivered preterm with a birth weight of 890 g), oxygen consumption from 14Mar2015 (Spent 2 and a half months on continuous oxygen). The patient''s concomitant medications were not reported. No history of allergies in this child was obtained. The parents denied any history of using any traditional medicine on the child at the time. There were no other AEFIs reported from this child in the last 30 days. The child lives with the parents, the baby has not a twin/triplet and with no disability present (including birth defects). The mother does not need additional support to care for this child. Baby head circumference at birth was 38 cm. The patient had previously received the following vaccines, at birth BCG (batch number 113047A) in the right arm, oral polio vaccine first dose (batch number K5385); on 27Apr2015 (6 weeks) oral polio vaccine second dose (batch number K5555), rotavirus vaccine first dose (batch number AROLA976AR) orally, DTP-Hib-IPV first dose (batch number K8486) in the left thigh, hepatitis B first dose (batch number 303301/0) in the right thigh, pneumococcal 13-val conj vac (first dose (lot X080620) in the right thigh; on 25May2015 (10 weeks) DTP-Hib-IPV second dose (batch number K8485) in the left thigh, hepatitis B second dose (batch number 303301/0) in the right thigh. The child has had no previous reaction after immunization. The health status of the child was assessed before immunization. On the day of Immunization the baby weighed 2.9 kg. The child was well and eligible for immunizations. The mother also reported that the child was well and that there are no allergies to immunizations. Then the child was immunized. The parents reported that the child was well after immunization until during the night. No fever, no vomiting or any rash was observed. At around midnight the child cried but slept well. No swelling was observed on the vaccine site. Mother stated that since the morning on the 23Jun2015 the child refused breast milk. According to the parents the child started not feeling well at about 11h00 on the 23Jun2015. There was no fever, no vomiting or any other except that the child had a weak cry and refused feeds. On the way to the clinic at around 14h00 the child passed away. On arrival there was not heartbeat and no pulse heard; skin anaemic. The patient died on 23Jun2015. An autopsy was performed and results were not provided.


VAERS ID: 629558 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-18
Entered: 2016-02-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 14J01A / UNK UN / SC
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2016092600

Write-up: This is a spontaneous report from a contactable physician (forensic specialist). A 3-month-old male patient of unspecified ethnicity received simultaneously PREVENAR 13 (Lot number 14J01A, expiration date 31Aug2017) at 0.5 ml single, ACT-HIB at 1 dosage form single, hepatitis B vaccine (manufacturer unknown) at 1 dosage form single, rotavirus vaccine (manufacturer unknown) at 1 dosage form single and diphtheria vaccine/pertussis vaccine/polio vaccine/tetanus vaccine (manufacturer unknown) at 1 dosage form single all subcutaneously except oral rotavirus vaccine on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, in the morning of the next day of vaccination, the patient suddenly died. As of 12Feb2016, the cause of death was not reported and a legally-ordered autopsy was supposed to be conducted hereafter. No follow-up attempts are possible. No further information is expected.


VAERS ID: 642422 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-05-24
Onset:2016-05-25
   Days after vaccination:1
Submitted: 2016-05-27
   Days after onset:2
Entered: 2016-06-01
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-05-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2016276050

Write-up: This is a spontaneous report from a contactable nurse and from a contactable healthcare assistants via a sales representative. A female patient of an unspecified age and ethnicity received PREVENAR 13 at single dose, rotavirus vaccine (unknown manufacturer) and acellular pertussis, diphtheria vaccine, haemophilus influenza b, hepatitis b vaccine, polio vaccine, tetanus vaccine (unknown manufacturer) all via an unspecified route of administration on 24May2016. the patient was a premature baby. Concomitant medications were not reported. the patient died on 25May0216. the event was described as: death of a premature baby the day after vaccination. It was not reported if an autopsy was performed.


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