This case was reported by a nurse via other manufacturer and described the

occurrence of unknown cause of death in a 15-month-old patient who received

PEDIARIX. Co-suspect products included PREVNAR 13 (batch number J11488, expiry
date November 2016) and HIB vaccine. On 18th November 2014, the patient
received PEDIARIX, PREVNAR 13 and HIB VACCINE. On 19th November 2014, 1 days
after receiving PEDIARIX, the patient experienced unknown cause of death (serious
criteria death and GSK medically significant). On an unknown date, the outcome of
the unknown cause of death was fatal. The patient died on 19th November 2014.
The reported cause of death was unknown cause of death. An autopsy was
performed. It was unknown if the reporter considered the unknown cause of death
to be related to PEDIARIX. Additional information was provided: No other
medications and medical conditions. The patient was healthy without a lot of clinic
visits. The patient passed away on 19 November 2014 at 9:50. An autopsy is
currently being done. An investigation was performed on PREVNAR 13. The results
showed no issues impacting the identity, strength, safety, purity or quality of the
product.

This spontaneous report as received from a nurse via company representative refers
to a 15 month old child patient (gender unspecified). The patient had no other
medications and had no medical conditions. On 18-NOV-2014 at 09:48 hours, the
patient was vaccinated with PEDVAXHIB, intramuscular in the left thigh. Other
suspect therapies included PREVNAR 13 vaccinated in the left thigh on 18-NOV-2014
at 09:48 hours and PEDIARIX vaccinated in the right thigh on 18-NOV-2014 at 09:48
hours. Reporter stated that the patient received PEDVAXHIB in the left thigh
approximately one inch from the PREVNAR 13. On 19-NOV-2014, around 09:50
hours (next day) the baby passed away. The patient was healthy without a lot of
clinic visits. Reporter did not know the cause of death because an autopsy was
currently being done. Action taken was not reported. The outcome of event was
reported as fatal as the patient died on 19-NOV-2014. The cause of death was
reported as unknown. Additional information has been requested.

PT RECEIVED PEDIARIX, HIB, AND PREVNAR ON 02/06/15. NO ADVERSE EVENT

REPORTED DURING THAT DAY. NO SYMPTOMS. PT WAS FOUND UNRESPONSIVE
AROUND 8AM ON 02/07/15. CAUSE OF DEATH HAS YET TO BE DETERMINED.
This spontaneous report was received from a physician concerning a 3 year old
patient (gender unknown), who on an unknown date was vaccinated with a varicella
containing vaccine which could be possible VARIVAX (Merck) or PROQUAD (Merck)
(vaccines, routes, doses, lot numbers and expiration dates were not provided).
Other suspect therapies or concomitant medication were not provided. The
physician reported, that she was told that a patient's younger relative developed
febrile seizure and on an unknown date died after getting the varicella containing
vaccine. The physician stated that she was not sure the brand name of the vaccine
(possibly VARIVAX (Merck) or PROQUAD (Merck)). The patient cause of death was

febrile seizure. It was unknown if an autopsy was performed. Upon internal review,
the event of febrile seizure was considered to be another important medical event.
This is one of several reports received from the same source. Additional information
is not expected because the physician did not have much information about the
patient and refused to continue with the AE reporting.

This case was reported in a literature article and described the occurrence of
vomiting in a 7-year-old male patient who received Influenza vaccine. On an
unknown date, the patient received Influenza vaccine (unknown). On an unknown
date, 3 days after receiving Influenza vaccine, the patient experienced vomiting,
appetite lost and influenza A virus infection. On an unknown date, the outcome of
the vomiting, appetite lost and influenza A virus infection were unknown. The
reported cause of death was Reye's syndrome. An autopsy was performed. The
autopsy determined cause of death was hepatic steatosis, kidney tubule disorder,
cerebral edema, influenza A virus infection and salicylate intoxication. It was
unknown if the reporter considered the vomiting, appetite lost and influenza A virus
infection to be related to Influenza vaccine. Additional information received: This
case was reported in a literature article and it described the occurrence of vomiting
in a 7-year-old male patient who had received unspecified influenza A vaccination
(manufacturer unknown). No information on the patient's medical or family history
or concurrent condition was provided. On an unspecified date, the patient received
unspecified influenza A vaccine (administration route and site unspecified; dosages
unknown; batch numbers not provided). On an unspecified date, 3 days after
receiving vaccination the patient developed profound vomiting and loss of appetite.
The patient's mother had given him PEPTO-BISMOL and Gatorade as treatment and
sent the patient to bed. The patient was found unresponsive less than 12 hours
later and pronounced dead 4 minutes after arrival at the hospital. Autopsy findings
included diffuse mixed micro and macro vesicular steatosis of the liver, micro
vesicular steatosis in the renal tubule cells, and cerebral edema. A postmortem
nasopharyngeal swab screening was positive for influenza A. Toxicology was positive
for salicylate. The outcomes of the events were unspecified. The authors did not
comment on causality relationship between the vaccine and the event. The authors
concluded that "Reye's syndrome is a rare severe neurologic disorder consisting of a
biphasic illness characterized by a viral infection followed by an acute onset of noninflammatory encephalopathy and hepatic failure, with rapid progression to death if
not properly treated. It most commonly affects children younger than 16 years of
age who are treated with aspirin during certain viral infections, including varicella
and influenza. The exact cause is unknown, but it is thought to result from
mitochondrial impairment resulting from the actions of salicylate and its
metabolites, hydroxyhippurate and gentisate. This impairment appears to be
intensified during viral illnesses".

A spontaneous health professional report from a regulatory authority in an article,

concerns a 19 year old female. The patient's medical history included cold sweat,
nausea, dizziness, and difficulty reading numbers on the day prior to death.

Concomitant medications included quadrivalent human papilloma virus vaccine and

meningococcal conjugate. Patient received Nasal FLUMIST QUADRIVALENT on an
unknown date. The patient died 10 days after these vaccinations from unknown
causes. Despite an extensive post-mortem examination including autopsy and
microscopic, neuropathological, toxicological, and chemical evaluation, the
immediate cause of death could not be ascertained. Autopsy revealed no obvious
cause of death. The reporter assessed the death to be serious by the criterion of
death.

A report from VAERS concerns a three year old male patient. The patient was born
prematurely between gestational weeks 32 and 33 and suffered from atrial septal
defect. The patient received nasal FLUMIST and 10 days later experienced hypoxicischemic brain injury. The patient died of the hypoxic-ischemic brain injury on an
unknown date. It was unknown if autopsy was performed. The reporter assessed the
event as serious due to death. Based on the information in this report, and awaiting
the reporter's assessment, the company physician considered the event to be at
least possibly related to FLUMIST.
It is a spontaneous report to the VAERS program concerning a child patient with
unknown gender and age. The patient's medical history, concurrent diseases, and
concomitant medications were not reported. On an unknown date, the patient
received nasal FLUMIST. Two days after vaccination, the patient had a seizure, and
the patient died. The cause of death was seizure. Interval after vaccination
unknown. According to the reporter the seizure was considered to be serious with
the serious criteria of death.
A spontaneous health professional report from a regulatory authority in an article.
Vaccine Adverse Event Reporting System (VAERS), July 2013-April 2014, concerns a
7 year old female. The patient's medical history included subacute sclerosing
panencephalitis (SSPE). No concomitant diseases and concomitant medications
were reported for consumer. Patient received Nasal FLUMIST QUADRIVALENT on an
unknown date, and 64 days later she required hospitalization for 16 days for
changes in mental status and progression of SSPE. The patient died from an
unknown cause on an unspecified date. The report did not describe whether an
autopsy was performed. The reporter assessed the death to be serious by the
criterion of death.

Died 2 days after receiving routine 4 month vaccines. Reportedly, developed upper
respiratory congestion, limpness, was taken to the ED, went into respiratory arrest
and died. The mom states the death was linked to "pneumococcal vaccine in her
lungs and blood".

This case was reported in a literature article and described the occurrence of
varicella in a 15-year-old female subject who received DTP (A or W not known)

vaccine. Previously administered products included DTP (A or W unknown) vaccine

with an associated reaction of no adverse event (1st dose), DTP (A or W not known)
vaccine with an associated reaction of no adverse event (2nd dose), DTP (A or W
not known) vaccine with an associated reaction of no adverse event (3rd dose) and
MMR vaccine with an associated reaction of no adverse event (2nd dose).
Concomitant products included MMR vaccine. On an unknown date, an unknown
time after receiving DTP (A or W not known) vaccine and Hib vaccine, the subject
developed severe - grade 3 varicella. Serious criteria included death and
hospitalization. Additional event(s) included fever, shortness of breath, face edema,
petechial rash, hypotension, pneumonia with serious criteria of GSK medically
significant, acute respiratory distress syndrome with serious criteria of GSK
medically significant, pancytopenia with serious criteria of GSK medically
significant, multi-organ failure with serious criteria of GSK medically significant,
iatrogenic infection, enterobacter cloacae infection with serious criteria of GSK
medically significant, respiratory tract infection with serious criteria of GSK
medically significant, urinary tract infection pseudomonal with serious criteria of
GSK medically significant, Stenotrophomonas sepsis with serious criteria of GSK
medically significant, thrombocytopenia, leukopenia with serious criteria of GSK
medically significant and lung consolidation. The subject was treated with acyclovir,
antibiotics unknown, antifungals for systemic use, ciprofloxacin, meropenem,
Sulfamethoxazole + Trimethoprim, Ticarcillin + Clavulanate and tigecycline. The
outcome of varicella was fatal. The outcome(s) of the additional event(s) included
fever (unknown), shortness of breath (unknown), face edema (unknown), petechial
rash (unknown), hypotension (unknown), pneumonia (unknown), acute respiratory
distress syndrome (unknown), pancytopenia (unknown), multi-organ failure
(unknown), iatrogenic infection (unknown), enterobacter cloacae infection
(unknown), respiratory tract infection (unknown), urinary tract infection
pseudomonal (unknown), Stenotrophomonas sepsis (unknown), thrombocytopenia
(unknown), leukopenia (unknown) and lung consolidation (unknown). The reported
cause of death was varicella. It was unknown if the investigator considered the
varicella, fever, shortness of breath, face edema, petechial rash, hypotension,
pneumonia, acute respiratory distress syndrome, pancytopenia, multi-organ failure,
iatrogenic infection, enterobacter cloacae infection, respiratory tract infection,
urinary tract infection pseudomonal, Stenotrophomonas sepsis, thrombocytopenia,
leukopenia and lung consolidation to be related to DTP (A or W not known) vaccine
and Hib vaccine. Diagnostic results (unless otherwise stated, normal values were
not provided): On 14th March 2009, Varicella virus test result was Positive absent.
On an unknown date, Aspiration bone marrow result was no evidence of leukaemia
absent. On an unknown date, Blood culture result was Negative absent. On an
unknown date, Blood culture result was Positive for Stenotrophomonas maltophilia
absent. On an unknown date, Body temperature result was 101.1 degree F. On an
unknown date, Chest X-ray result was Alveolar consolidation absent. On an
unknown date, Computerised tomogram result was no intracranial lesions absent.
On an unknown date, Electroencephalogram result was excluded subclinical
seizures absent. On an unknown date, Platelet count result was 30,000 /mcL. On an
unknown date, White blood cell count result was 1,400 /mcL. Additional information
received: This case was reported in a literature article and it described the

occurrence of a varicella infection in a 15-year-old female patient who had been

vaccinated with unspecified DTP

Admitted to hospital on 2/24/15 sepsis. Varicella verified on PCR with subsequent

progressive multi-organ failure. Autopsy: Cause of death 3/5/15 disseminated
varicella - final histology pending as of 4/6/15.

In the morning, I had leg cramps. Later in the afternoon, I had abdominal pain. By
8PM, I was in pre-term labor. I had extremely high blood pressure and rapid heart
rate upon entrance to the ER. I was in labor for at least 6 hours, giving birth to a
stillborn 16-weeks-gestation baby just after 2AM. Later determined to be
chorioamnionitis of the placenta and pneumonia in the baby, resulting in fetal
death. I had an ultrasound and doctor appointment 36 hours prior to the
miscarriage and everything appeared healthy with no signs of infection. The
vaccine was administered immediately after the ultrasound on 11/07/2014.

After flu shot developed autoimmune disease which kept her from eating and
eventually her airway which led to her death 3-25-15.

The infant received Pediarix, ActHIB, PCV13 and Rotarix on 5/4/2015 at 3:35pm. No
immediate issues post-vaccination in the clinic. The infant was found deceased the
next morning, 5/5/2015. The coroner reported onset of rigor mortis upon arrival to
pick infant up and approximate time of death 4-6 hours previously. The infant was
sent to the Medical Examiner for autotopsy. The parents reported the infant had
mild irritability/fussiness about 72 hours prior to death but no fever, diarrhea, oral
intolerance, flaccidity or seizures. No history of seizures. The autopsy was
essentially normal with no findings that would explain an acute death.

This spontaneous report was received from a pharmacist via company

representative concerning a patient of unknown age and gender. The patient's
medical history included an unspecified lymphoma and bone marrow transplant
(date was not provided). On an unknown date, the patient was vaccinated with
ZOSTAVAX, subcutaneously (anatomical location, dose, strength and lot number
were not provided). Co-suspect or concomitant therapies were not provided. On an
unknown date, after receiving ZOSTAVAX, the patient died of possible complications
of Epstein Barr Syndrome, it was unknown if an autopsy was performed. The patient
sought medical attention through an office visit. No product quality complaint was
involved. At the time of the report, the outcome of Epstein-Barr virus infection was
fatal. the causal relationship between Epstein-Barr virus infection/death and
vaccination with ZOSTAVAX was unknown. Additional information has been
requested.

This spontaneous report was received from a pharmacist via a company

representative refers to a 60 year old male patient. On an unknown date the patient
was vaccinated with ZOSTAVAX (lot # and expiry unknown). The company
representative read in the newspaper dated 14-MAY-2015, that was released on 13MAY-2015, that a patient passed away on 11-MAY-2015, because of "complications
due to a disseminated zoster virus". The representative stated that his wife
overheard some unspecified individuals discussing the patient's death and
mentioned that the patient had received one dose of ZOSTAVAX. Another company
representative reported that a pharmacist had reported to him that the same
patient had died after receiving the ZOSTAVAX. Causality of event was not reported.
Additional information has been requested.

This is a spontaneous report from a contactable licensed practitioner nurse. A 4month-old male patient received on 07Jul2015 at 09:50 am the second dose of
PREVNAR 13 (Lot/batch number: H65078, expiry date 30Jun2015, NDC number:
00005-1971-02) intramuscular on the right thigh at 0.5 ml single. Medical history
included failure to thrive on 21Apr2015 and ongoing. Concomitant medications
given on an unspecified date in 2015 included: second dose of ROTATEQ
(manufactured by Merck, lot number K001832) oral and second dose of PENTACEL
(manufactured by Sanofi, lot number C4679AA) administered intramuscular in left
thigh. The patient previously received on unknown date, the first dose of PREVNAR
13 and on 21Apr2015 ROTATEQ and PENTACEL. The patient had no illness at the
time of vaccination. The patient underwent on unknown date a hearing test and it
showed a bilateral abnormality. The patient was administered with a 7 days expired
PREVNAR 13. The patient did not receive any treatment after the vaccine was
administered and no emergency room or doctor visit was requested. The patient
passed away. The cause of death was not reported. Follow up (07Jul2015): New
information reported from a contactable nurse includes: patient's date of birth, date
and time of vaccination, site of vaccination and dose, medical history, lab data, past
vaccine history, causality assessment. Follow-up (12Aug2015): New information
reported from a contactable nurse includes onset date of the medical history and
siblings. Death added as event. Case upgraded to serious.