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

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

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

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


VAERS ID: 387747 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-25
Onset:2010-03-25
   Days after vaccination:0
Submitted: 2010-05-18
   Days after onset:54
Entered: 2010-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Blood culture negative, CSF culture positive, Death, Fontanelle bulging, Gram stain positive, Pneumonia pneumococcal, Pyrexia, Streptococcus test positive, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood culture, 2010, Negative; CSF culture, 2010, see text
CDC Split Type: B0652265A

Write-up: This case was reported by a physician and described the occurrence of cause unknown, death in a 3-year-old female subject who was vaccinated with meningococcal polysaccharide vaccine group C (manufacturer unspecified), DTP-HIB (A or W not known), poliomyelitis vaccine unspecified and rotavirus vaccine. On 25 March 2010, the subject received unspecified dose of Meningococcal polysaccharide vaccine group C (unknown route of administration, lot number not provided), unspecified dose of DTP-HIB (A or W not known) (unknown route of administration, lot number not provided), unspecified dose of Poliomyelitis vaccine (unknown route of administration, lot number not provided), unspecified dose of Rotavirus vaccine (unknown route of administration, lot number not provided). The physician informed that the subject was not healthy at the time of vaccination, but she couldn''t provide details about the subject''s clinical condition. On 25 March 2010, 10 hours after vaccination with DTP-HIB (A or W not known), Meningococcal polysaccharide vaccine group C, Poliomyelitis vaccine and Rotavirus vaccine, the subject experienced fever (not specified), vomiting and bulging fontanel. The subject was hospitalised and evolved to death. Purulent CSF; CSF culture: streptococcus pneumoniae positive; Blood culture: negative; Blood gram: diplococcus gram positive. The subject died, cause of death is not specified. It was unknown whether an autopsy was performed. The physician couldn''t state if the event was related to the vaccines, because the case was still under investigation.


VAERS ID: 419067 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-01-20
Onset:2011-01-20
   Days after vaccination:0
Submitted: 2011-03-17
   Days after onset:55
Entered: 2011-03-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal faeces, Asthenia, Crying, Death, Diarrhoea, Diet refusal, Gastrointestinal disorder, Injection site pain, Poor sucking reflex, Pyrexia, Rhinorrhoea, Somnolence, Thermal burn, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Biliary system related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-22
   Days after onset: 2
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: 2011051309

Write-up: This is a spontaneous report of an adverse event involving PREVENAR. A non-contactable consumer reported that 14-week-old baby (gender unknown) was vaccinated with a dose of PREVENAR via intramuscular route of administration on 20Jan2011. The patient also received on the 20Jan2011 a dose of ROTAVIRUS orally, PENTAXIM intramuscularly and HEPATITIS B intramuscularly. The baby was injected with three (3) injections in all, two (2) on the right thigh and one (1) on the left thigh, the baby cried with pain. The mother carried the baby on her back and the baby slept when she left the clinic. On arrival at home, the baby was still sleeping and did not want to take his/her afternoon feed. The patient slept throughout the night. No fever, no vomiting and no diarrhoea were noted, but the patient was weak and sleepy and not feeding. The next morning around 0900, the mother bathed the baby to wake him/her up. The child passed a loose stool with offensive smell and vomited twice (2) with smelly vomitus with some pieces of flesh-like things, as if the baby was rotten inside. The baby became more weak could not cry nor suck from the breast. An ambulance was called, which arrived when the baby was already dead on 22Jan2011. Additional information was received based on police reports. The condition of the baby prior to immunisation was healthy. No previous immunisation reactions noted on the baby, no history of reaction in the family. The father of the baby stated that on arrival to the Doctor with the body of the baby, he asked them what was wrong. He (the doctor) did not examine the body of the baby; he just looked and wrote natural causes on the death certificate. He also stated that the baby was burnt around the mouth, and a black discharge coming out from the nostrils, this was noted when they fetched the baby''s body from mortuary for burial. Baby was buried on the 26Jan2011. The father of the baby wants the baby''s body to be exhumed for thorough examination for the cause of death. The nurse, that immunised the baby, mentioned that the baby had high temperature on the evening following immunisation and the following morning the baby was fine did not need to go to the clinic. The baby''s father is a Traditional Healer; it is assumed that a child was given something before or after clinic visit, although denied on inquiry. Other report from the program coordinator stated that the baby delivered normally at term with an Apgar of 9/10-10/10 was immunised at the clinic. The condition of the baby prior to immunisation according to the mother was good. The clinic has one minus 40 fridge. Vaccines are closely packed and there was no space in between vaccines for circulation of air. No expired vaccines were found. There is no vaccine stock out.


VAERS ID: 432269 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2011-07-08
Submitted: 2011-08-26
   Days after onset:49
Entered: 2011-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Death, Gastrointestinal necrosis, Ileectomy, Ileostomy, Intussusception, Peritonitis, Rectal haemorrhage, Septic shock, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Toxic-septic shock conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-07-15
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0741808A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of fatal ileocolic intussusception in a 2-month-old male subject who was vaccinated with rotavirus vaccine (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of rotavirus vaccine (oral). On 8 July 2011, at an unspecified time after vaccination with rotavirus vaccine, the subject experienced vomiting, abdominal distension and rectal bleeding, which was diagnosed as ileocolic intussusception. On 11 July 2011, the subject had ileostomy with resection. After it, the subject experienced septic shock, peritonitis and intestinal necrosis. The subject died on 15 July 2011, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 433552 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: Foreign  
Vaccinated:2011-07-26
Onset:2011-07-27
   Days after vaccination:1
Submitted: 2011-09-07
   Days after onset:42
Entered: 2011-09-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR G5418 / 1 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 9C2911 / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER G5276 / 2 MO / PO
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH F12271 / 1 UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER AROLA245AA / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Bronchopneumonia, Death, Death neonatal, Hypotonia, Increased upper airway secretion, Lung consolidation, Petechiae, Premature baby, Pulmonary oedema, Renal fusion anomaly, Small for dates baby, Subarachnoid haemorrhage neonatal
SMQs:, Cardiac failure (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-07-27
   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: Prematurity, Born at 27 weeks and 6 days, Rh negative, normal vaginal delivery, Apgar: 9/10
Allergies:
Diagnostic Lab Data: 29May2011: Apgar score 9/10/10; 25Jun2011: KMC score 20/20; Developmental screening (26Jul2011): general appearance is premature. Skin and eyes, mouth and palate, sucking, genitalia, testes, hips, feet, limb movements, posture, neck, trunk, limbs tone, moro reflex-all reported as normal. Both parents and child born with normal hearing. Child responds to sound. Fixes (birth) and follows (6weeks). Child smiles at caregiver. Observation: caregiver interacts well with child. Caregiver is coping. According to the post mortem (significant findings noted only): Chief findings made by forensic officer on the body: small for age, no external injuries and consolidation of the lungs. The cause of death on the 27Jul2011 at 06g46: bronchopneumonia and prematurity was due to a natural manner. Old subarachnoid hemorrhages of the frontal and temporal lobes infero-medially and the cerebellum superiorly on the left with brown discolouration was probably from the birth process. Small amount of old, brown blood found in the ventricles. Trachea and bronchi contained a small amount of mucus. Visceral surfaces of the right and left lung showed multiple subpleural petechial haemorrhages, no adhesions. The lung tissue of both lungs showed a mottled lower lobe, consolidation of the lower lobe and moderate oedema. A single horse shoe kidney present which appears normal on section.
CDC Split Type: 2011205040

Write-up: This is a spontaneous report received from the Department of Health via a Pfizer employee with additional reporters (nurse, physician) providing information. An 8-week-old male patient received the first dose of PREVENAR (batch number F12271) at 0.5mL, the first dose of PENTAXIM (batch number G5418) at 0.5mL, the first dose of HEPATITIS B VACCINE (batch number 9C291/1) at 0.5mL, the first dose of ROTAVIRUS VACCINE (batch number Arola245AA) at 1.5mls and the second dose of ORAL POLIO VACCINE (batch number G5276) 2 drops oral on 26Jul2011. Relevant past vaccine history included the first dose of BCG VACCINE (batch number 110018A) and the first dose of ORAL POLIO VACCINE (batch number G5276) on 11Jul2011. No concomitant medications were reported. The patient had no previous history of reaction after immunization; it is unknown if there was a history of any allergies in this child''s immunization. The health status of the child was assessed before immunization. There ere no other AEFI''s (adverse events following immunisation) reported from this clinic in the last 30 days (its day 1). Relevant medical history includes: the patient was born premature at 27 weeks and six days and was hospitalized from 29May2011 until 25Jul2011. The weight at birth was 1060g. The weight at discharge was 1540g, length of 41cm and head circumference of 30.5. Developmental screening on day of discharge from hospital (26Jul2011): general appearance is premature. Skin, eyes, mouth and palate, sucking, genitalia, testes, hips, feet, limb movements, posture, neck, trunk, limbs tone, Moro reflex - all reported as normal. Both parents and child were born with normal hearing. Child responds to sound. Fixes (birth) and follows (6weeks). Child smiles at caregiver. Observation: caregiver interacts well with child. Caregiver is coping. On 27Jul2011 at 0600 hours, the mother found the baby flabby/flaccid. The cause of death on 27Jul2011 at 0646 hours was bronchopneumonia, prematurity due to a natural manner. According to the post mortem (significant findings noted only): Chief findings made by forensic officer on the body: small for age, no external injuries and consolidation of the lungs. The cause of death on the 27Jul2011 at 06g46: bronchopneumonia and prematurity was due to a natural manner. Old subarachnoid hemorrhages of the frontal and temporal lobes infero-medially and the cerebellum superiorly on the left with brown discolouration was probably from the birth process. Small amount of old, brown blood found in the ventricles. Trachea and bronchi contained a small amount of mucus. Visceral surfaces of the right and left lung showed multiple subpleural petechial haemorrhages, no adhesions. The lung tissue of both lungs showed a mottled lower lobe, consolidation of the lower lobe and moderate oedema. A single horse shoe kidney present which appears normal on section. Conclusion of report: No evidence of adverse events following immunisation (AEFI) and the medical cause of death was reported as Pneumonia. The seriousness criteria for this event were fatal. The outcome of the event at the time of the report was fatal.


VAERS ID: 444240 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-12-01
Entered: 2011-12-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cyanosis, Death, Pyrexia, Rash generalised
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Preexisting Conditions: Nasopharyngitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011291526

Write-up: This is a spontaneous report from a consumer/non-healthcare professional (a local television news agency reported via the agency''s website). A 2.5-month-old female patient received a dose of PREVENAR 13 (Unknown), a dose of INFANRIX and a dose of ROTARIX in mid Oct2011. Relevant medical history included the patient had nasopharyngitis ongoing. Concomitant medications and past product history were not reported. Three days after the vaccinations the patient experienced high fever and was hospitalized. During the night the patient died. The cause of death was unknown. It was reported the whole body was covered with blue spots. The outcome of pyrexia and body covered with blue dots was unknown. It is unknown whether an autopsy was performed. An investigation is ongoing.


VAERS ID: 449427 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2011-12-01
Submitted: 2012-02-09
   Days after onset:70
Entered: 2012-02-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apathy, Asthenia, Autopsy, Brain death, Computerised tomogram abnormal, Computerised tomogram head, Crying, Multi-organ failure, Posture abnormal, Respiratory arrest, Rib fracture, Subarachnoid haemorrhage, X-ray abnormal
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (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), Dementia (broad), Dystonia (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Depression (excl suicide and self injury) (broad), Osteoporosis/osteopenia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-26
   Days after onset: 25
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: PREVENAR 13 Drug Reaction: Nasopharyngitis, Dose 1 at 2 months of age
Allergies:
Diagnostic Lab Data: CT scan (date unknown): revealed broken bones and subarachnoid haemorrhage; x-ray (date unknown): revealed broken bones and subarachnoid haemorrhage; Autopsy (Dec2011): results pending
CDC Split Type: 2012031281

Write-up: This is a spontaneous report from lay media (a newspaper article). This is the second of four reports. This is one of the two serious reports. The two additional case are non-serious. This report is for the baby boy twin regarding the second administration of PREVENAR 13. This is a report based on information received by Pfizer from another facility. A 4-month-old male twin patient of an unspecified ethnicity received the second dose of PREVENAR 13 and the second dose of rotavirus vaccine on an unknown date. Past vaccine history included the first dose of PREVENAR 13 and a dose rotavirus vaccine on an unknown date at the age of 2 months. After being administered these vaccines, the patient experienced nasopharyngitis. The patient was conceived via in vitro fertilization (IVF) treatments. He was delivered via Caesarian section with a normal weight of more than 2 kg. Examinations after birth determined that the patient was completely healthy. The baby was not breastfed. Concomitant medications were not reported. One week after the second dose, at around 20:00 hours, the patient experienced multi-system failure. According to the father, he heard the baby crying. It was an unusual cry so he picked him up and saw that the baby was apathetic. Suddenly, he became very weak and his head dropped. The ambulance was called and the patient was rushed to the hospital. On the way to the hospital, the baby stopped breathing and respiration was performed in the ambulance. At the hospital, the parents were asked to bring the baby girl as well. CAT Scan (CT) and X-ray tests showed that the patient suffered from broken ribs and had an subarachnoid haemorrhage. On 26Dec2011, the baby was diagnosed with brain death. An autopsy was performed and the samples were sent out. The parents are now being investigated by the police in a suspicion of physical abuse in the twins. No follow-up attempts possible. No further information expected.


VAERS ID: 476070 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-11-29
Entered: 2012-12-03
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + 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: 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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012295114

Write-up: This is a spontaneous report from a contactable physician. A 2-months-old patient received a dose of PREVENAR 13, via an unspecified route of administration on an unspecified date. The patient also received concomitantly rotavirus vaccine; and, diphtheria toxoid, haemophilus influenzae type b polysaccharide, pertussis vaccine, tetanus toxoid vaccine. Patient''s medical history was not reported. Two days after vaccinations, the patient died. At the time of reporting, the cause of death was unknown.


VAERS ID: 483939 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2012-05-15
Onset:0000-00-00
Submitted: 2013-02-08
Entered: 2013-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER 10PVZD085Z / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0865604A

Write-up: This case was reported by a healthcare professional (National Immunisation Program) and described the occurrence of death (nos) in a 2-month-old male subject who was vaccinated with live rotavirus vaccine (manufacturer unspecified, live attenuated oral poliomyelitis vaccine (oral polio vaccine) and dtpa-hib (non-GSK). On 15 May 2012 the subject received 1st dose of rotavirus vaccine (oral), 1st dose of oral polio vaccine (oral), 1st dose of DTPa-Hib (Non-GSK) (unknown route). Lot numbers not provided. At an unspecified time after vaccination with DTPa-Hib (Non-GSK), oral polio vaccine and rotavirus vaccine, the subject experienced death (nos). The subject was hospitalised and the healthcare professional reported that the event was clinically significant (or requiring intervention). The subject died from death due to unknown cause. It was unknown whether an autopsy was performed. This report is one of 800 cases received as part of a line-listing, each containing minimal information. No further information is expected.


VAERS ID: 492878 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2010-01-20
Onset:2010-02-04
   Days after vaccination:15
Submitted: 2013-05-30
   Days after onset:1210
Entered: 2013-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LG / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Acute lymphocytic leukaemia, Contusion, Death, Petechiae, Rash macular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-14
   Days after onset: 678
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0895429A

Write-up: This case was reported by a consumer via a regulatory authority (# FI-FIMEA-20130565) and described the occurrence of death with unknown causes in a 26-month-old male subject who was vaccinated with INFANRIX-IPV/HIB (GlaxoSmithKline) and Rotavirus vaccine (manufacturer unspecified). The subject had no distress before the leukemia and had not experienced previous vaccine reactions. On 20 January 2010, the subject received an unspecified dose of INFANRIX-IPV/HIB (intramuscular, unknown thigh, batch number not provided) and an unspecified dose of Rotavirus vaccine (oral, batch number not provided). On 4 February 2010, 15 days after vaccination with INFANRIX-IPV/HIB and Rotavirus vaccine, the subject experienced acute lymphocytic leukemia with pink blotches, contusion and petechiae. The subject died on 14 December 2011, 23 months after vaccination with INFANRIX-IPV/HIB and Rotavirus vaccine, from death with unknown causes. It was unknown whether an autopsy was performed.


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