Vaccine-related deaths reach 11 in Vietnam
An infant in southern Vietnam’s Lam Dong province has died after receiving Quinvaxem vaccine, bringing the total of such cases to 11 in the country since the begining of 2013, local press reported Friday.
A three-month-old boy died Wednesday, nearly 17 hours after being injected Quinvaxem vaccine. Local authorities are on their way to look into the cause of death, Tuoi Tre (Youth) online newspaper reported.
Former Deputy Minister of Health Trinh Quan Huan said that Quinvaxem is among the vaccines that caused the highest reaction rate, reports said.
Huan proposed that the government set aside more budget or to find more donors to replace Quinvaxem with a safer vaccine.
NIHE quoted Nguyen Nhat Cam, director of Vietnam’s capital Hanoi Center for Preventive Medicine, as saying Friday that Quinvaxem is a South Korean-imported vaccine that protects children out of five deadly infectious diseases including diphtheria, pertussis, tetanus, hepatitis B and Hib.
Since it was included in Vietnamese National expanded Program on Immunization in June, 2010, the death toll resulting from Quinvaxem among kids has risen to 33 as of early 2014.
In late December 2013, World Health Organization and United Nations Children’s Fund issued a joint announcement in Hanoi, saying there is no connection between the Quinvaxem vaccine and possible deaths among children after vaccinated.
However, recent deaths relating the vaccine triggered worries among Vietnamese parents about the links between the deaths or undesirable responses in some children and the “five in one” Quinvaxem vaccine.
Some refused to give vaccination for their children. Huynh Thai Phong, a reader, commented on VNExpress online newspaper on Friday that he wondered why Quinvaxem is still allowed to use after causing many deaths for kids.
An anonymous reader agreed with Phong, saying that he won’t bring his kids to the national expanded program on immunization and will use paid vaccine instead.
A reader named “Mai Nguyen” commented in a rage as she advised the government to stop the vaccine immediately, adding that vaccination is for prevention, not for death.
Nonetheless, officials seem to hold a different viewpoint over the quality of Quinvaxem vaccine amid worries of local people.
In December 2013, Nguyen Tran Hien, director of NIHE cum chief of the National Expanded Program on Immunization, said in a press conference that there is no vaccine with 100 percent safety and the quality of Vietnamese vaccine is good.
Hien also admitted that the proportion of Vietnamese vaccinated children declined recently due to the decrease in the confidence of Vietnamese parents.
Source: English News, 17th January 2014 – http://news.xinhuanet.com/english/health/2014-01/17/c_133053223.htm
Deaths resume with return of Quinvaxem vaccine to Vietnam
In two months since a ban slapped on the Dutch-made vaccine was lifted, at least two more children have died after getting shots, but health officials say the vaccine was not to blame.
They have defended Quinvaxem despite an Indian doctor’s accusation that the World Health Organization (WHO) was irresponsible for advising Vietnam to use it.
Tran My Ngoc, a five-month-old girl from the Mekong Delta province of Bac Lieu, became the latest victim on November 24, dying a few hours after being administered Quinvaxem.
She received the shot at a commune medical station with 17 other babies, and went into seizures on the way home, the family said.
Her eyes stopped moving, her mouth foamed, her body turned black and blue, and breathing became difficult.
She was rushed to the district general hospital, where she was given medicine and put on intravenous fluids, but sadly died.
The Ministry of Health, which sent experts to the province, said in a statement November 26 that the child had died of respiratory and cardiologic decline, “possibly due to anaphylactic shock after the vaccination. It is also unclear if the baby had other conditions that caused the death.”
The ministry denied that the vaccine was responsible, saying the same batch had been used for nearly 400,000 shots nationwide since October.
Earlier Bui Quoc Nam, director of the Bac Lieu Department of Health, had said doctors had diagnosed the cause of death as vaccination shock.
The department has sealed the batch of vaccines and taken samples for testing, and has suspended the use of Quinvaxem in the province. It paid the family compensation of VND40 million (US$1,900).
Deaths follow vaccine’s reintroduction
Some parents prefer to pay VND500,000 ($24) per shot for their children to get shots of Pentaxim, an acellular five-in-one shot made by French drug company Sanofi Pasteur with purified antigens that are supposed to be safer than the whole-cell preparations found in the whooping cough component of Quinvaxem.
Quinvaxem, a liquid injection vaccine which has been pre-qualified by the WHO, is distributed in Vietnam by the Berna Biotech Korea Corporation and given to babies from two months old, three times over two months, to immunize them against diphtheria, tetanus, whooping cough, hepatitis B, and Hib (Haemophilus influenza Type B).
It costs VND77,000 a dose and has been pushed in low-income countries since it was introduced globally in 2006 by the Netherlands-based biopharmaceutical company Crucell.
Quinvaxem was temporarily banned in May after nine infants died since November last year, but the ban was lifted in October on the recommendation of the WHO, which said tests found no problem with the vaccine.
After it was reintroduced, a three-month-old boy in the north-central province of Quang Tri died November 10, five days after he got his first Quinvaxem shot.
The family said he started crying uncontrollably sixteen hours after the vaccination and refused to be breastfed. He turned black and blue and was taken to Quang Tri General Hospital.
After his death, an autopsy found pneumonia to be the cause, and the Ministry of Health issued a statement denying allegations that Quinvaxem was to blame.
In Hanoi, at least 37 babies have been admitted to hospital since October after being given Quinvaxem. They had high fevers, seizures, and rashes on their body. Hundreds of other similar cases have been reported nationwide, according to local media.
Thankfully, none of those cases have ended in death.
Of 47,000 kids who got the vaccine in Hanoi, 113 developed complications. But Nguyen Tran Hien, director of the National Extended Vaccination Program, said the rate of complications was acceptable based on WHO standards.
Vaccine Father Slams Official Report on Babies’ Deaths
The father of one of 17 infants who died after receiving hepatitis B vaccine on Friday dismissed as “total rubbish” claims by Chinese officials that the deaths were unrelated to the inoculation.
Nine of the babies’ deaths had nothing to do with the vaccines, the official news agency Xinhua quoted disease control and prevention official Yu Jingjin as saying on Friday.
Autopsies had yet to be carried out on the remaining eight infants, but a “preliminary analysis” also showed no link between the deaths and the vaccines, Yu said.
Shanxi-based Yang Wenlong, whose own child was among those who died, said the official account of the babies’ deaths was groundless.
“They are talking absolute rubbish, and no one in China will believe it unless they are idiots,” Yang said.
“I for one don’t believe their results.”
He said Yu’s account had been roundly criticized by Chinese netizens, who are deeply suspicious of the government following a series of product safety and public health scandals in recent years.
“If you look at [chat site] QQ and online, you will see how many people are cursing him,” Yang said. “I think they are afraid of affecting people’s uptake of the vaccine.”
“But I think that what they’ve done here will have the opposite effect to the one they intended.”
Child deaths
The deaths were reported following inoculation with a hepatitis B vaccine, made by Shenzhen-based BioKangtai, between Dec. 13 and Dec. 31.
BioKangtai said in a statement last month that it has “rigorously” followed safety rules but that company is also testing the batches concerned.
On popular social media sites, many commentators agreed with Yang, however.
“Seventeen lives have been lost, and you still talk about your vaccine being viable?” wrote user @sz1961sy. “We call on relevant experts to carry out some research in the hospitals with a view to protecting young lives.”
Parent activist Zhao Lianhai, whose child was made ill by melamine in the 2008 tainted milk formula scandal, said there had been well-documented cases of tainted vaccines before in China.
“This has been going on for years now,” Zhao said. “We have met with the parents of children affected by tainted vaccines, but they have never won any sort of redress.”
He called for an investigation into the source of the problem. “There should be an investigation in all areas [of vaccine production, storage and administration],” he said. “This cannot be tolerated.”
“Is it with the vaccines themselves, or with the hospital?” he said.
“Some companies in China have common interests with certain government departments,” Zhao said. “This is pretty much an open secret nowadays.”
“If problems occur, they use their relationships [with government] or money to get around it.”
Poor regulation
China’s pharmaceutical industry is highly lucrative but poorly regulated, resulting in a string of fatalities blamed on counterfeit or shoddy medications in recent years.
An investigative report in the China Economic Observer newspaper in 2010 said that improperly stored vaccines administered by Shanxi health officials for encephalitis, hepatitis B, and rabies between 2006 and 2008 had killed four children and sickened more than 70 others, with tainted vaccines being used as late as March 2009.
Top investigative reporter Wang Keqin, who exposed the vaccine scandal among others, was forced out of his job at the newspaper in February 2013.
Parents who complain about mishaps linked to health and safety issues say they are frequently themselves targeted for official harassment and punishment.
In 2011, authorities in Beijing sentenced parent activist Yang Yukui to five months’ “re-education through labor” on charges of “provoking disputes and causing trouble” after he complained that his son had been in and out of the hospital since being given a bacille Calmette-Guerin (BCG) tuberculosis vaccination shortly after birth.
Source: Radio Free Asia, 3rd January 2014 – http://www.rfa.org/english/news/china/vaccine-01032014164833.html
Baby Haylee Marie Dies 5 Hours After Hep B Shot
Haylee Marie passed away aged 10 months old, five hours after a shot for Hepatitis B. The government pathologist ruled it as SIDS (which is not a diagnosis, it just means ‘the baby died suddenly and we don’t know why’) but the family didn’t believe that their healthy baby could just suddenly drop dead a few hours after vaccinations and it just be a ‘coincidence’ so they had an independent pathologist examine her, who ruled she died as a result of an allergic reaction to the vaccine.
Court orders Rs 3 lakh for parents of child who died after vaccination
Meant to immunize an infant from fatal diseases, vaccines took away the life of a 42-day-old boy. Eleven years after the tragedy, the state consumer commission held an hospital and the doctor guilty of negligence, and awarded a compensation of 3 lakh to the child’s parents.
K Dhanasekaran of Manali had admitted his wife in Dr Durga Nursing Home, Avadi, where she delivered a boy on January 26, 2003. The next day, she underwent a sterilisation operation and was discharged on January 30. As part of post-natal care, she took the infant to the hospital for vaccination. However, after the boy was administered Diptheria-Pertussis-Tetanus (DPT) and Oral Polio Vaccination (OPV), he died.
The same year, Dhanasekaran moved District Consumer Disputes Redressal Forum claiming the hospital had used expired medicines. The hospital doctor denied the claim and said the vaccine had been given after “observing necessary formalities.” The boy died “unexpectedly due to sudden development,” it said.
In 2011, the forum said the hospital was not equipped with a storage system to preserve the medicines and did not have the necessary gadgets. It also did not have an ambulance. In its verdict, the forum fined the hospital 1 lakh.
Against the order, both Dhanasekaran and the hospital approached the State Consumer Disputes Redressal Commission. While the hospital sought to quash the order, Dhanasekaran asked for enhancing the compensation.
The court said the hospital should have “arrangements to get immediate and emergency services from other capable and speciality institutions” in case of an emergency. It also said Dr A Vijaya Varma, who was managing the affairs of the hospital, too was liable for paying compensation.
Source: Times of India, 5th April 2014 – http://timesofindia.indiatimes.com/city/chennai/Court-orders-Rs-3-lakh-for-parents-of-child-who-died-after-vaccination/articleshow/33255146.cms
Leaked Confidential Report on Infantrix Hexa Vaccine Deaths
B0683335A (Netherlands):
Meningitis viral, Convulsion, Yellow skin, Cyanosis, Dehydration, Diarrhoea, Somnolence, Crying, Vomiting. This case was reported by a regulatory authority (NL-College ter Beoordeling van
Geneesmiddelen # NL-LRB-111158) and described the occurrence of meningitis in a 2- month-old male subject who was vaccinated with combined diphtheria, tetanus-acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenza type b vaccine (Infanrix hexa, GlaxoSmithKline), pneumococcal vaccines (non-gsk) (Prevenar) for prophylaxis. The subject had no medical history and no concomitant medication.
On 13 September 2010, the subject received 1st dose of Infanrix hexa (unknown route, unknown injection site), 1st dose of Prevenar (unknown route, unknown injection site). 3 minutes after vaccination, the subject experienced crying and sleepiness on the same day.
On 18 September 2010, 5 days after vaccination, the subject was found in bed with eyes half-opened and a blue mouth. His skin was yellow/pale. He vomited pink, foaming milk. No fever was observed (37 degrees C). The boy
was hospitalized, diarrhea aggravated and dehydration was diagnosed. Blood test and spinal tap were performed.The boy had several afebrile convulsions and a MRI showed severe damage of the brain.
No further treatment was given.
On 25 September 2010, 12 days after vaccination, the subject died from viral meningitis.
The regulatory authority considered the events were unlikely
to be related with vaccination with Infanrix hexa and Prevenar.
Additional information has been requested but could not be obtained from regulatory authority (new regulatory number: NL-LRB-116469).It was unknown whether an autopsy was performed.
Company comment:
Case of death due to viral meningitis in a 2-month-old male subject 12 days after 1st combined vaccination with Infanrix hexa and Prevenar.
There was severe brain damage on MRI.
It is unknown whether an autopsy was performed.
B0700040A (Sweden):
Meningitis, Sepsis, Shock, Pneumococcal infection, Renal impairment, Hepatic function abnormal, Pyrexia, Diarrhea, Vomiting
This case was reported by a consumer and described the occurrence of meningitis in a 9-month-old female subject who was vaccinated with synflorix (GlaxoSmithKline) and combined diphtheria,tetanus-acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b vaccine. (Infanrix hexa,GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report.
Previous and/or concurrent vaccination included
Bacillus Calmette -Guerin vaccine (non-gsk) given on 28 October 2010; diphtheria and tetanus toxoids and acellular pertussis vaccine; GlaxoSmithKline given on 20 May 2010; hepatitis B vaccine recombinant; manufacturer unspecified given on 20 May 2010; synflorix; GlaxoSmithKline; given on 20 May 2010.
Concurrent medications included Paracetamol for her growing teeth.
On 17 August 2010, the subject received 2nd dose of Synflorix (administration site and route unknown, batch number not
provided). On 26 November 2010, 101 days after vaccination with Synflorix, the subject experienced fever, vomiting and diarrhea. This continued the whole day between 11 am to 6 pm. She suddenly got better and she was not vomiting and her fever went down.
She got fluid replacement and was able to urinate. On 27 November 2010, at 7 am, the subject was not breathing any longer.
At the hospital,they tried to save her during 40 minutes.
The subject died on 27 November 2010 from meningitis and sepsis. An autopsy was performed and showed abnormal renal function, hepatic function abnormal and possible pneumococcal infection. The body was in shock.
Company comment
:
Death of a 9 month-old female subject due to meningitis and sepsis 191 days after combined vaccination with Infanrix Hexa and Synflorix.
B0706503A (Thailand): Shock, Respiratory arrest, Cardiac arrest, Pyrexia, Somnolence, Hypotonia, Vomiting, Crying, Apnoea – Baby’s Brother Killed by Vaccines Too
This case was reported by a physician and described the occurrence of fatal shock in a 2-month-old female subject who was vaccinated with combined diphtheria,tetanus-acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (Infanrix hexa, GlaxoSmithKline)for prophylaxis. The subject was born by C-section. Apgar score was 10 at 0 and 5 min. Birth weight was 3.2 kg and experienced a normal growth and development. Medical condition included a possible genetic abnormality due to a family history of death after
vaccination (subject’s brother died 2 years ago after vaccination with DTwP). On 9 March 2011, the subject received unspecified dose of Infanrix hexa (.5 ml, unknown route of adminstration). The subject was normal before vaccination. On 10 March 2011, 24 hours after vaccination with Infanrix hexa, the subject experienced shock. She experienced low-grade fever, drowsiness and stopped breathing. The subject was floppy and had no heart rate. Cardiopulmonary resuscitation was performed during 3
hours but the subject did not respond to it. The physician considered the events were probably related to vaccination with Infanrix hexa. The subject died on 10 March 2011 from cardiorespiratory arrest. An autopsy was not performed. Follow-up received on 21 March 2011: The subject’s brother was 2 month-old when he died (11 years ago), after received DTwP which was EPI vaccine (no record available). After vaccination (no specific time available), the subject experienced vomiting (single ep
isode) and had colicky crying at home. On 10 March 2011, the subject was taken to the clinic due to fever and crying. After massive crying, the subject experienced apnea and no heart beat was detected after stimulation. Cardiopulmonary resuscitation was performed for 10 minutes and subject responded by crying. One hour later, the subject experienced apnea again and resuscitation was continued for 3 hours without any response.
Neither lab results nor autopsy results were available.
Company comment
: This case described a SUDI (Sudden Unexpected Death in Infancy)in a 2 month-old female subject 24 hours after vaccination with Infanrix
hexa. Autopsy or lab results were not provided. There is a notion of post-vaccine death in a sibling.
B0712016A (Italy): Hypotonia, Hyperhidrosis, Pyrexia – Contraindicated Baby Brain Damaged with Cerebral Palsy Given Further Shots that Kill Him
This case was reported by a regulatory authority (IT-Agenzia Italiana del Farmaco #137473) and described the occurrence of hypotonia nos in a 11-month-old male subject who was vaccinated with combined diphtheria, tetanus-acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b vaccine.
(Infanrix hexa, GlaxoSmithKline) and pneumococcal vaccines (non-gsk)(Prevenar13) for prophylaxis. The subject was born after 41 weeks + 3 days,normal pregnancy and spontaneous delivery. Concurrent medical conditions included severe respiratory distress at birth. He was reanimated and resigned from the prenatal intensive care on 20 May 2010. He was not able to feed spontaneously(dysphagia)so a nasogastric tube was inserted with pump infusion. According to the doctor, the subject had contraindication to the vaccine. He was hospitalised from 22 May 2010 to 25 May 2010 due to respiratory distress. From 14 to 21 July 2010 due to seizures. On 18 August 2010, diagnostic results showed cerebral palsy, gastroesophageal reflux, hypoxic-ischemic encephalopathy of grade 3, microcephaly, psychomotor retardation and spastic quadriplegia (mainly the upper limbs). Concurrent medications included Paracetamol (Tachipirina), Vitamin, Vigabatrin, Topiramate, Antibiotics (Antibiotic), Bronchodilator and Steroid. On 25 March 2011, the subject received 3rd dose of Infanrix hexa (intramuscular, right thigh) and 3rd dose of Prevenar 13 (intramuscular, left thigh). On 26 March 2011, 1 day after vaccination with Infanrix hexa and Prevenar 13, the subject experienced fever (38 to 38.5 deg.C).
On 27 March 2011, 2 days after vaccination with Infanrix hexa and Prevenar 13, the subject experienced hypotonia nos and crisis of sweating. The regulatory authority reported that the events were possibly related to vaccination with Infanrix hexa and Prevenar 13. The subject died on 28 March 2011, cause of death was not reported. It was unknown whether an autopsy was performed. Follow-up information receivedon 15 July 2011: As no additional information could be obtained, the case has been closed.
Company comment
: This case described death of an 11-month old male subject 48 hours after third combined vaccination with Infanrix hexa and Prevenar. The subject died in the context of severe hypoxic-ischemic encephalopathy (cerebral palsy leading to quadriplegia and microcephaly).
B0727175A (France): Death
This case was reported by the French regulatory authority (FR-Agence Françaiss de Sécurité Sanitaire des Produits de Santé # NT20110388) and described the occurrence of unexplained death in a 18-month-old femalesubject who was vaccinated with combined diphtheria, tetanus acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (Infanrix hexa,GlaxoSmithKline) for prophylaxis. The subject had no known and relevant medical history.
On 26 October 2010, the subject received an unspecified dose of Infanrix hexa (batch A21CA724A, intramuscular, injection site unknown). On 27 October 2010, 1 day after vaccination with Infanrix hexa, the subject was found dead after her nap. Autopsy did not identify any cause of death.Respiratory aspiration was assessed as not very probable. No other information was available. According to the French method of assessment, the AFSSaPS considered the causal relationship between vaccination with I
nfanrix hexa and unexplained death as dubious. Autopsy (2010): no identified cause of death.
Company comment
: This case described a SIDS in an 18 month-old female subject 1 day after vaccination with Infanrix hexa.
No cause was found after autopsy.
B0735723A (Australia): Death
This case was reported by a consumer and described the occurrence of death unspecified in a 6- week-old male subject who was vaccinated with combined diphtheria, tetanus-acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b vaccine. (Infanrix hexa,GlaxoSmithKline), live attenuated human rotavirus vaccine (Rotarix) and pneumococcal vaccines (non-gsk) (Prevenar 13) for prophylaxis. A physician or other health care professional has not verified this report. On 20 July 2011, the subject received unspecified dose of Infanrix hexa (administration site and route unknown), an unspecified dose of Rotarix (route unknown) and an unspecified dose of Prevenar 13 (unknown). On 21
July 2011, 14 hours after vaccination with Infanrix hexa, Prevenar 13 and Rotarix, the subject died for unknown reasons. The subject died on 21July 2011, cause of death was not reported. An autopsy was performed. Autopsy
results are not ye tavailable. Further information has been expected.
Company comment
:This case reported a SUDI in a 6-week old male subject 14 hours after combined vaccination with Infanrix hexa, Prevenar and Rotarix.
An autopsy was performed but results are not available.
D0071496A (Germany): Death
This case was reported by a health professional via a regulatory authority (DE-Paul-Ehrlich-Institut # DE-PEI-PEI2011016343) and described death ofa 3-month-old female subject who was vaccinated with combined diphtheria,tetanus-acellularpertussis, hepatitis B,inactivated poliomyelitis and Haemophilus influenzae type b vaccine (Infanrix hexa, GlaxoSmithKline) and pneumococcal vaccines (non-gsk,Prevenar 13) for prophylaxis.
Previous vaccinations with Infanrix hexa and Prevenar13 (on 14 April 2011) have been well tolerated. On 16 May 2011 the subject received the second dose of Infanrix hexa (intramuscular, unknown thigh) together with the second dose of Prevenar 13 (intramuscular, unknown thigh).
At this time the subject had suffered from a mild intestinal infection.
In the morning of the following day, on 17 May 2011,the subject was found dead .An autopsy was performed and a preliminary autopsy report was provided. According to the autopsy protocol very early in the morning of 17 May 2011 the subject had been found “cold and lifeless” by her parents. On
05:02 an emergency physician had been called. Cardiopulmonary resuscitation by the parents and later by the emergency personal failed and death was testified.
Policemen were involved at 06:20. Interrogation of the subject’s parents revealed that the subject and her four siblings had always been healthy.
Follow-up information was received from the institut of legal medicine Halle (Saale) on 04August 2011: The final autopsy report was provided.
The causes and mode of death could not be clarified. The infant had been suffering from an acute unilateral otitis media at the time of death
(smear from the left middle ear: proof of Haemophilus influenzae; smear from the right middle ear: no proof of microorganisms). Within the
scope of additional examinations no alcohol (alcohol concentration 0.00 %) or other pharmacologic could be detected. There was neither evidence of an
allergic reaction.(total IgE 5.65 kU/l, reference <20kU/l) nor of a gastrointestinal infection. Nor was there any evidence of a postvaccinal disorder.”According to the autopsy report, the onset date of the subject’s otitis media was “very recent”, but it could not be clarified whether it had been prior to or following the vaccination. Although no evidence of a
relation of the event to the vaccination was found during the autopsy the close temporal relation might be seen as an indication that the subject’s death was possibly related to the vaccination with Infanrix hexa and Prevenar 13. Company comment: This case described a SUDI in a 13 month-old female subject 1day after 2nd combined vaccination with Infanrix hexa and Prevenar .A recent acute haemophilus influenzae otitis media was diagnosed on autopsy.
D0072663A (Germany): Death -Poor 9 week old recieved so many vaccines, fluoride and radiation This case was reported by a German regulatory authority (DE-PaulEhrlich Institut #DE-PEI-PEI2011029271) and described the occurrence of unexplained death in a 9-week-old male subject who was
vaccinated with combined diphtheria, tetanus-acellular pertussis, hepatitis B,inactivated poliomyelitis and Haemophilus influenza type b vaccine (Infanrix hexa, GlaxoSmithKline) for prophylaxis.Co-suspect
vaccinations included 13 valent pneumococcal conjugate vaccine (non-GSK)
(Prevenar 13, Pfizer Pharma).
Pregnancy and birth had been normal. The subject’s medical history
included neonatal jaundice.The subject was developing normal. Family history included no allergies.
Concurrent medical conditions included suspicion of congenital hip dysplasia. Hip ultrasonography, performed on 09 August 2011, showed type IIa left and type I right. Follow-up hip ultrasonography,performed on 05 September 2011, showed type Iboth sides. At the time of vaccination, on 05 September 2011,the subject was well.The subject showed small white plaques in oral mucus (oropharyngeal plaques) left but most likely no oral candidiasis.
Previous vaccination with Rotavirus vaccine (non-GSK) (RotaTeq; Sanofi Pasteur MSD),given orally at 2 ml on 09 August 2011, was well tolerated.
Concurrent medications included colecalciferol + sodium fluoride (D-Fluoretten) and paracetamol (Ben-u-ron).
On 05 September 2011 the subject received the first dose
of Infanrix hexa (0.5 ml,intramuscular, unknown thigh lateral) and the first dose of Prevenar 13 (.5 ml,intramuscular, unknown thigh lateral). Approximately two days post vaccination with Infanrix hexa and Prevenar 13, on 07 September 2011, the subject died. The cause of death was unknown (death unexplained).
The event had also been reported as life threatening. An autopsy was performed on 07 September 2011 at an institute for forensic pathology
At the time of reporting, on 08 September 2011, examinations had not been finished and no autopsy results have been reported.
The German regulatory authority (DE-Paul-Ehrlich-Institut) has requested further information .Quality test result was received on 11 October 2011. A complete review of the batch records has been performed by Qualit yAssurance and Production. No deviation that could impact the quality of the product has been highlighted during th eGlaxoSmithKline Biologicals investigation.
Company Comment:
Since 12 September 2011 ,five cases linked to batch A21CB094A were reported to GSK (D0072663A, D0072852A, D0072638A, D0072908A, D0072920A). All five were serious reports and two had a fatal outcome).
D0072852A (Germany): Circulatory collapse, Sepsis, Shock, Crying, Pallor
This case was reported by a regulatory authority (DE-Paul-Ehrlich-Institut # DE-PEI-PEI2011030856) and described the occurrence of circulatory failure in a 5-month-old male subject who was vaccinated with combined diphtheria, tetanus-acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (Infanrix hexa, GlaxoSmithKline) for prophylaxis.Co-suspect vaccination included 13-valent pneumococcal vaccine (non-GSK) (Prevenar 13, Pfizer). First vaccination with both vaccines on 23 August 2011 was well tolerated. Information about anamnesis was provided by a hospital report from intensive care treatment after birth The mother had been pregnant for the first time. The mother had former surgerybecause of false lung vein opening and received permanent treatment with bisoprolol.The subject was delivered prematurely in 31+4 weeks of gestation, by section from breech presentation after pathologic CTG. There was no premature rupture of the amnion andamniotic fluid was clear. The subject had an APGAR of 6/10/10, a weight of 1490 g, lengthof 39 cm, head circumference of 32.6 cm, navel artery pH was 7.16.After birth the subject had neonatal respiratory distress syndrome grade I with continuous positive airway pressure for 24 hours.The subject developed possible meconium ileus due to microcolon, transient intestinal transportation disorder, cholestatic hepatosis after parenteral nutrition, with increased transaminases (alanine aminotransferase 131 U/l, aspartate aminotransferase 100 U/l,creatine kinase 342 U/l, total bilirubin 3 mg/dl, direct bilirubin 2.75 mg/dl). Additional diagnoses after birth included neonatal anemia and iron deficiency, asymmetry from lying, small hemangioma right gluteal and dystrophic growth and weight increase. On the sixth day of life, the subject’s condition worsened and he was transferred to an intensive care unit for neonates. Intravenous antibiotics were given for seven days.
The subject had abdominal distension since birth and not yet passed meconium. Acute abdomen was suspected on the seventh day of life. The subject was transferred to a pediatric chirurgic unit for further intervention, but after conservative treatment the symptoms resolved.
Test results were normal for ions, blood gases, immune reactive trypsin (tested on 06 Mayand 06 June 2011), sonogram of head, abdomen and hip (Graf classification Ib) and hearing screening.
Cytomegalovirus (CMV) and toxoplasmosis IgM and IgG antibodies were negative. Initially increased Tyroid stimulating hormone normalised on control. Bile acid was increased (74.6 mcmol/l), pancreatic kinase was decreased (68 mcg/g). Eye examination showed vascularisation limit zone III at both sides.
The subject was discharged after 39 days in good condition and received rachitis prophylaxis and iron substitution.
On 20 September 2011 the subject received 2nd dose of Infanrix hexa (unknown route and application site), 2nd dose of Prevenar (unknown route and application site). On 20 September 2011 in the evening, less than one day after vaccination with Infanrix hexa and Prevenar, the subject had been crying and turned grey while lying in bed. The vaccinating physician was consulted and admitted the nfant to hospital, where thesubject died on 21 September 2011, from circulatory depression or possible sepsis. Different lot numbers were reported on follow-up. Approximately 20 hours after vaccination with Infanrix hexa and Prevenar 13, the subject experienced shock with circulatory failure. An emergency physician was called and the subject was hospitalized on emergency to an intensive care unit. Approximately 10 hours after onset of symptoms the subject died despite intensive care. According to follow-up information received on 07 October 2011 via the
German regulatory authority (PEI), the lot number A21CB094A was documented in vaccination certificate, while there was no documentation for the mentioned lot numbers A21CB105A and A21CB115A.
Quality test result was received on 11 October 2011. A complete review of the batch records has been performed by Quality Assurance and Production. No deviation that could
impact the quality of the product has been highlighted during the GlaxoSmithKline Biologicals investigation. An autopsy was performed. A duplicate case was reported bya physician, via a sales representative and no further details about the reported event were provided.
Since 12 September 2011, five cases linked to batch A21CB 094A were reported to GSK (D0072663A, D0072852A, D0072638A, D0072908A, D0072920A). All five were serious reports and two had a fatal outcome.
Baby Dies Less Than 48 Hours after First Shots
As a 56-year-old grandmother I must offer my thought’s on your April 29 opinion reagrding vaccines (“Anti-vaccines movement puts children at risk”).
First off I carry the lifetime scar of one of the first polio vaccines of the ’60s. I also vaccinated all my children.
Nowadays they mix too many vaccines in a deadly cocktail in their hurry to get things done.
I held my two-month-old granddaughter while the nurse injected her with with a mixture of four vaccines. In less then 48 hours our precious baby was dead. They said SIDS was to blame, but I have my doubts. I even questioned the “mixing” of so many shots and was assured it was okay.
I am all for vaccines, but I say get back to the way they were administered when everything was not rushed and carelessly done.
I’d also like to ask you how an un-vaccinated child is responsible for an outbreak? I can see they would contract a disease but really fail to see that they are the responsibility for a disease.
Yes vaccines are a good thing and they have helped eliminate many diseases, but they can also be administered in the wrong way and can also be deadly.
Source: Trib.com, 3rd May 2014 – http://trib.com/opinion/letters/vasquez-vaccines-are-good-but-can-be-deadly-too/article_ef4ea830-2d8d-5eb9-abaa-47b7ae904560.html
Court orders Rs 3 lakh for parents of child who died after vaccination
Meant to immunize an infant from fatal diseases, vaccines took away the life of a 42-day-old boy. Eleven years after the tragedy, the state consumer commission held an hospital and the doctor guilty of negligence, and awarded a compensation of 3 lakh to the child’s parents.
K Dhanasekaran of Manali had admitted his wife in Dr Durga Nursing Home, Avadi, where she delivered a boy on January 26, 2003. The next day, she underwent a sterilisation operation and was discharged on January 30. As part of post-natal care, she took the infant to the hospital for vaccination. However, after the boy was administered Diptheria-Pertussis-Tetanus (DPT) and Oral Polio Vaccination (OPV), he died.
The same year, Dhanasekaran moved District Consumer Disputes Redressal Forum claiming the hospital had used expired medicines. The hospital doctor denied the claim and said the vaccine had been given after “observing necessary formalities.” The boy died “unexpectedly due to sudden development,” it said.
In 2011, the forum said the hospital was not equipped with a storage system to preserve the medicines and did not have the necessary gadgets. It also did not have an ambulance. In its verdict, the forum fined the hospital 1 lakh.
Against the order, both Dhanasekaran and the hospital approached the State Consumer Disputes Redressal Commission. While the hospital sought to quash the order, Dhanasekaran asked for enhancing the compensation.
The court said the hospital should have “arrangements to get immediate and emergency services from other capable and speciality institutions” in case of an emergency. It also said Dr A Vijaya Varma, who was managing the affairs of the hospital, too was liable for paying compensation.
Source: Times of India, 5th April 2014 – http://m.timesofindia.com/city/chennai/Court-orders-Rs-3-lakh-for-parents-of-child-who-died-after-vaccination/articleshow/33255146.cms
Fatal shots: TMC second in state for infant ‘deaths after vaccination’
The city witnessed two infant deaths in 2013 a few days after they took vaccination shots at state-run medical establishments. Both the infants were below one year. The BMC recorded three infant deaths last year, making them the highest in the state, followed by Thane.
In 2014, the TMC’s health department reported only one infant death so far. Investigations carried out by the district-wise Adverse Effects Following Immunisation (AEFI) committee, who look into the quality of vaccines, contamination and complications due to pre-existing conditions of a child, into the infant deaths have revealed that there was no problem with the vaccines that were administered to the kids. Neither were the doctors at fault while delivering the shots.
In Maharashtra, as many as 22 infants were reported dead in 2013 after being administered vaccine, while in 2012, 21 cases were reported. These figures do not include the deaths reported at private hospitals.
Pediatricians claimed that all the vaccines are safe. The only side effects that kids get are mild fever or redness in the area where the vaccine was administered.
”Death due to vaccine is a very rare case. We had a case wherein an infant died 15 days after the vaccination. There must have been many other factors like area where the child lives, no proper nutrition, etc,” said Dr R T Kendre, head of the TMC’s health department
Last year, the deaths were mainly after receiving the DPT, OPV and Hepatitis B vaccine and BCG and OPV vaccine. State immunization officer R M Kumbhar said that if a child gets side effects due to the vaccine then it can be treated.
”We organize workshops and training programmes for health workers who administer these vaccines. This is done to avoid any scope for error,” said Kumbhar.
Source: Times of India, 12th May 2014 – http://timesofindia.indiatimes.com/city/thane/Fatal-shots-TMC-second-in-state-for-infant-deaths-after-vaccination/articleshow/35031434.cms
7 Children Died After Measles Vaccination in Pakistan – See more at: http://www.newspakistan.pk/2014/06/02/7-children-died-measles-vaccination-pakistan/#sthash.F1dCJPX7.dpuf
Seven children died after a vaccination campaign in Khyber Pakhtunkhwa province. Four children in Charsadda and three in Peshiwar lost their lives after they were immunized with measles vaccine.
Two children die in Charsadda from measles vaccine
One month after being administered the measles vaccine, two children in Charsadda died on Sunday , Express News reported.
Faizan and Sabeen, who were both four years old, were injected with the measles vaccine on May 3 after which their condition became critical and they had been taken to the district hospital in Charsadda.
The two children died today.
An investigation committee has been formed to look into the matter.
Who’s at fault?
The government launched a 12-day measles campaign on May 19 and since then several cases of negative reactions to the vaccine are surfacing. Around 110 adverse reactions have been recorded by the health department so far.
According to investigations, 40% of the anti-measles vaccine staff is untrained and lack sufficient knowledge about the technicalities of administering measles vaccine.
But a medical specialist in Tehsil Headquarters Hospital Shabqadar earlier told The Express Tribune on the condition of anonymity that the deaths were caused by the vaccine and not due to untrained staff.
He claimed the medicine lost its efficacy due to prolonged outages in the hospitals.
According to the specialist, the hospitals where the vaccines are being stored face almost 20 hours of outages. “The cold chain for all vaccines needs to be maintained; since the hospitals face outages the quality of medicine is affected,” he added.
Source: The Express Tribune, 1st June 2014 – http://tribune.com.pk/story/716156/two-children-die-in-charsadda-from-measles-vaccine/
No respite: Two more children die in reported reaction to measles vaccine
Two children, both aged four, reportedly died in Charsadda on Sunday after receiving the measles vaccine.
Local sources said Sohail, who lived in Majoki Prang village, was vaccinated last Friday and was admitted to District Headquarters Hospital after he fainted. The second child, Faizan, who was living in Peshawar, also fainted after receiving the vaccination from health workers at his residence.
In-charge of the Expanded Programme on Immunisation (EPI) in Charsadda, Dr Farhad denied the deaths were caused due to the vaccinations, saying these were ‘rumours’. He said Sohail was admitted to the hospital with a fever and it is believed that he passed away as he was suffering from measles. He added that Faizan died due to a fever and not from the vaccination.
Last week, two children – Mazhar and Umar – died in Shabqadar after reportedly having an adverse reaction to the vaccine, while three children were reported dead in Peshawar, including two-year-old Hilal of Mandra Khel area, two-year-old Rida of the same village and one-year-old Abul Samand, a resident of Faqir Kalay.
On May 29, Minister for Health Shahram Khan Tarakai formed an investigation team comprising local and foreign health experts to probe the deaths. However, he expressed confidence in the vaccine’s quality and said the deceased children might have had health issues prior to the vaccination.
On the same day, a report issued by the Khyber-Pakhtunkhwa Directorate of Health stated the instances of children fainting as well as dying due to the injections were occurring because untrained staff was administering the vaccine.
Source: The Express Tribune, 2 June 2014 – http://tribune.com.pk/story/716203/no-respite-two-more-children-die-in-reported-reaction-to-measles-vaccine/
A continuing dilemma: Five children faint in Mardan following measles vaccination
Around five children fainted in Mardan on Saturday after being injected with the measles vaccine, creating panic in the area.
According to local reports, the government’s measles vaccination drive was under way in Ghala Dher on the outskirts of Mardan where hundreds of children were vaccinated. However, five children fainted in the village and reported a fever which created panic and caused parents to be reluctant in allowing health teams to vaccinate their children.
Expanded Programme on Immunisation Mardan In charge Dr Niaz said he was not aware of the incident but presumed the children might have fainted due to the fear of the injection. “Fever is a common occurrence following the injection of the measles vaccine,” claimed Dr Niaz.
Parents refuse vaccine
On Friday, the measles drive came to an end in Hangu, Swabi and Shangla districts when parents refused to get their children vaccinated from the health teams, following several incidents of children fainting after receiving the shots.
Over 80 children fainted in Thal, Hangu, 70 fainted in Swabi and 15 in Shangla after they were administered the measles injection.
Thal resident Amanullah said there were rumours that the vaccine is expired and being administered by untrained staff which is why the adverse reactions are occurring.
A report issued by the K-P Directorate of Health on Thursday stated that the deaths of four children this past Wednesday was caused by untrained staff administering the vaccine.
He added that people fear the administering of the vaccine could lead to the death of their children and are no longer immunising them. “The government turns its back to every issue and to this as well, why should we put the lives of our children in danger,” he questioned.
Gul Muhammad Khan, a resident of Karbogha, said he would not let untrained people give the vaccine to his children. “Our children are fainting, complaining of headache, nausea and fever while the government and health officials claim everything is alright,” he said. Khan further said the disease may not kill the children but the injections would.
Hangu DHO Dr Azam Wazir claimed the children are fainting due to psychological stress. “We have vaccinated 0.13 million children in Hangu but now people have begun resisting because the vials of the medicine were made in India,” he further said.
Till May 29, five children had died across the province reportedly after the injection of the measles vaccine. Health Minister Shahram Khan Tarakai has formed an investigation committee comprising local and foreign health experts to probe the deaths.
Source: The Express Tribune, 1st June 2014 – http://tribune.com.pk/story/715929/a-continuing-dilemma-five-children-faint-in-mardan-following-measles-vaccination/
Report on measles deaths to be made public: minister
Khyber Pakhtunkhwa Senior Minister for Health Shahram Khan Tarakai has directed thorough, transparent and fair investigation into the death of three children during the ongoing anti-measles campaign in the province.
This he said while chairing a meeting of the fact finding committee of technical experts formed to probe the measles vaccine issue here on Friday, according to a handout.
He also directed the officials to furnish a factual and accurate report in the shortest possible time so that the actual causes behind the death of children could be ascertained.
The minister also directed the committee to thoroughly look into different aspects, including the pre-campaign preparations of health department, the vaccine being used in the campaign, human and technical errors in administering the vaccine and the medical treatment provided to the children after reaction of the vaccine, and thus come up with a solid and comprehensive report based on actual findings.
Mr Tarakai said that it was of prime importance not only for him but also for his government to ascertain the root causes behind the loss of three innocent lives because, if the children had died due to the reaction of measles vaccine then those responsible for it would be taken to task.
Source: Dawn, 31st May 2014 – http://www.dawn.com/news/1109721/report-on-measles-deaths-to-be-made-public-minister
