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Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: A physician reported that a 2 month old female received Meningitec, haemophilus influenza type B, DTP and Poliomyelitis virus vaccines on 5/18/00 and the next day, the pt died. An autopsy was performed on 5/23/00. The pathologist reported that the baby was known to be co-sleeping with her parents, was appropriately grown and without metabolic inherited disease. Klebsiella was identified in the infant''s lungs; however, no evidence of bronchopneumonia was noted. There was focal necrosis at the injection site and evidence of myositis. No evidence of myelitis was found. The pathologist stated that "there was no way to implicate Meningitec and the death was probably someway due to the co-sleeping arrangement". Cause of death was unascertained. Sudden infant death syndrome, injection site necrosis and myositis are unexpected per the Investigator''s Brochure. | ||||||||||||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: This report describes the occurrence of cot death in a female infant pt receiving diphtheria, tetanus, pertussis and haemophilus influenza type B vaccine (DTP-HIB). She also had meningococcal GP C conjugate (Meningitec). On 5/18/00, the vaccinee received vaccinations and on 5/19/00, the vaccinee died in her cot. Histology of the site of the Meningitec injection revealed muscle necrosis. The most recent information was received on 1/9/01. No other details were given. No further information is expected. | ||||||||||||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: It was reported that a female infant received the vaccines on 7/6/00. On 7/9/00, the infant died. The probable cause of death was reported as sudden infant death syndrome. | ||||||||||||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: "It was reported that a less than 1 year old baby girl was concomitantly administered a Diphtheria-Tetanus-Pertussis, an Haemophilus influenza type B, a Meningococcal and a Poliomyelitis vaccine. The baby died 3 days later and the probable cause of death is Sudden Infant Death Syndrome. There is no Post Mortem performed. Further information is not expected, the case is closed." | ||||||||||||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: A regulatory authority reported that an 8 month old female received Hib-Titer mixed with Anatoxal Diteper (diphtheria and tetanus toxoids and pertussis), Polio Sabin Oral (poliovirus vaccine live oral) and Meningitec vaccine on 9/19/00. On 9/29/00 until 3/13/01, the child experienced encephalopathy that resulted in death. Necrosia and biochemical tests showed hyperglicinemia, so the authorities assessment was that there have been amino acid metabolism disorders. The death has not been related to any of the vaccines that the child received. Follow-up info received on 05/17/02. The reporting product is Meningitec. Correspondence and info concerning aMeningitec lot number was also received. | ||||||||||||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: Information has been received from a health professional concerning a 8 week old male who on 1/7/03 was vaccinated in the right thigh with a second dose of hepatitis B vaccine recombinant. Concomitant therapy that day included a first dose of diphtheria toxoid (+) haemophilus B conjugate vaccine (+) pertussis vaccine (+) tetanus toxoid, a first dose of meningococcal protein conjugate, and a first dose of poliovirus vaccine. The reporter indicated that following vaccination it was detected that the baby had a fever. On 1/7/03 the baby was hospitalized and died the same day. The suspected diagnosis was sepsis by streptococcus agalactiea. The report stated that the physician considers that there is no relationship between the vaccine administration and the adverse event. Additional information has been requested. | ||||||||||||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: The company was contacted by defective medicines unit requesting batch information and company pharmacovigilance data for batch W0198-1. This has been requested in connection with a report of a case of a child aged 11.5 months who received DTP-Hib, Act-HIBDTP batch W0198-1, Meningitis C vaccine and Oral Polio vaccine all given on 7/30/03. The child is reported to have had pneumonia and septicaemia and the outcome was fatal. Date of death was 8/3/03. Further info on the case report has been requested. FOllow up 10/27/03: The health authority report was received with further details about the case. The baby was female. 0.5 ml Act-HIB DTP vaccine was given IM. Patient is also reported to have experienced malaise commencing on 7/31/03, the child became very unwell on 7/31/03. Patient became more unwell and was admitted with fever, increased respiratory distress, green nasal secretions and brown fluid leaking at peg (Gastric tube) site. Within two hours respiratory difficulties increased dramatically. Chest x-ray showed increased markings particularly at the left base. In spite of intubation, stabilization, adrenaline and further intensive care, the patient died. A post mortem was done, but the results are awaited. Outcome of the pneumonia was confirmed as the first probable cause of death, described as sudden death, with septicemia as second probable cause of death. To be noted that the patient received Prednisone since 7/30/03 orally (Abidec, Plesmet syrup and prednisone were administered via gastric tube. The milk in the gastric tube was changed on the same day as the vaccinations). Additional information: patient had low tone, absent gag reflex and possible tyrosine hydroxylase deficiency (date of diagnosis not reported). Further information is expected to confirm the circumstances following post mortem results. The case has also been received on 11/3/03 as a duplicate from the health authority. Follow up on 12/02/03: "Follow up on 11/17/03, no further information expected. Case to be considered as closed." | ||||||||||||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: Information has been received from a health professional concerning a 6 month old healthy male who was breastfeeding with no relevant history reported who on 10/25/05 was vaccinated with a 5mcg dose of hepatitis B virus vaccine (batch # NA23910). Concomitant therapy that day included a dose of diphtheria toxoid (+) HIB conjugate vaccine (tet toxoid) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (batch # A20CA094A) and a dose of meningococcal C conjugate vaccine (batch # 2498A). At this visit: weight = 7.380kg; height = 68cm; cranial perimeter = 43cm; skin, mucoses, ear, cardiopulmonary auscultation, abdomen, hip abduction, neurological exploration, and psychomotor development = normal. Family history: parents healthy; "youngs"; no blood relatives; rest of relatives without interest; pregnancy without incidences; delivery at 38+1/7 gestation weeks; newborn weight = 3.70kg; newborn height = 50.5cm; newborn cranial perimeter = 34cm; Apgar = 9-10; blood group B, rH +; metabolic screening performed on 4/29/05 = normal; hypoacusia screening performed on 5/10/05 = normal. On 10/25/05, during the afternoon the patient presented with a fever (not measured). He was treated with paracetamol. On 10/25/05 at 19:35, six hours after vaccination, the baby was carried to the primary care center when he arrived dead. A cardiopulmonary resuscitation was tried for 40 minutes without success. The preliminary performed by the forensic scientist was sudden infant death syndrome. Necropsy was performed on 10/26/05. It was noted that the patient did not have any adverse event with previous vaccinations at 2 and 4 months of age. Details information was not reported. Further information is expected. The case is incomplete. Other business partner numbers included E200504385. | ||||||||||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: This case was reported by regulatory authority and described the occurrence of bronchiolitis in a 8 week old female patient who was vaccainted with Dtap-IPV-HIB, meningococcal polysaccharide vaccine group C for prophylaxis. Concurrent medications included Paracetamol. On 30 May 2006 the patient received unspecified dose of Dtap-IPV-HIB (1 injection, intramuscular), and an unspecified dose of Meningococcal polysaccharide vaccine group C (1 injection, intramuscular). At an unspecified time after vaccination with Dtap-IPV-HIB, meningococcal polysaccharide vaccine group C, the patient experienced bronchiolitis and bronchopneumonia. However, 5 days prior to vaccination, the patient''s mother reported chesty. The patient''s GP examined the patient and stated that the patient was not unwell enough not to have vaccination. The patient died on 1 June 2006 from bronchiolitis and bronchopneumonia. An autopsy was performed. Reporter comments not sure if paracetamol was given to patient. | ||||||||||||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: Case initially received by the Health Authorities under the reference number LY0700424/1 and linked to the non-serious case E2007-03468 (same reporter, same product, patients of the same family). Initial report on 31-May-07: A 59-year-old female patient received a dose of Menomune (batch number not reported) via intramuscular route in an unspecified site of administration on 15-Feb-07 in view of a second trip out of the country. On 28-Mar-07, ie 42 days after vaccination and one week after her coming back to another country, she suddenly died without prodome and apparently without bronchospasm whereas she seemed to be very fit. The cause of death was unknown. No autopsy was performed. The patient has a medical history of sporadic asthma crisis experienced when she was 16 years old and also in 2003 when her father died. She was taking Savarine once a day as concomitant medication. The patient''s husband also received a dose of Menomune (batch number not reported) and, on an unspecified onset of time, he presented with a mild dysesthesia. No more information were available. The case is closed. | ||||||||||||||||||||||||||||||||
Link To This Search Result:
https://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=8&VAX[]=MEN&VAX[]=MENB&VAX[]=MENHIB&VAX[]=MNC&VAX[]=MNQ&VAX[]=MNQHIB&DIED=Yes&SUB_YEAR_HIGH=2015&SUB_MONTH_HIGH=09
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