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VAERS ID: 685998 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:1971-10-21
Onset:1971-10-21
   Days after vaccination:0
Submitted: 2017-03-16
   Days after onset:16583
Entered: 2017-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature increased, CSF test normal, Death, Febrile convulsion, Generalised tonic-clonic seizure, Loss of personal independence in daily activities, Mobility decreased, Motor developmental delay, Petit mal epilepsy, Seizure, Severe mental retardation
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1977-03-26
   Days after onset: 1983
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 197110; Test Name: body temperature; Result Unstructured Data: 38 Celsius temperature
CDC Split Type: DESA2017SA040729

Write-up: Initial unsolicited report received from literature via lawyer on 01 Mar 2017. This case was linked to 2017SA040606, 2017SA040624, 2017SA040635, 2017SA040892, 2017SA040642, 2017SA040652, 2017SA040699, 2017SA040743, 2017SA040758, 2017SA040771, 2017SA040781, 2017SA040802, 2017SA040817, 2017SA040831, 2017SA040815, 2017SA040811, 2017SA040577, 2017SA040585, 2017SA040608, 2017SA040615, 2017SA040621, 2017SA040625, 2017SA040639, 2017SA040655, 2017SA040662, 2017SA040669, 2017SA040700, 2017SA040706, 2017SA040710, 2017SA040717, 2017SA040838 (same literature). This case involves five-month-old male patient who was vaccinated with first dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) and dose of POLIOMYELITIS VACCINE (ORAL) (Batch number, expiration date, dose, route and site of administration was not reported) on 21 Oct 1971. The patient''s medical history and concomitant medications was not reported. The patients development was so far without pathological findings. On the night of 21/22 Oct 1971, following the vaccination, the patient experienced convulsion (lasting for two minutes) at a temperature of 38 degree Celsius. On 12 Nov 1971, 22 days post vaccination, the patient experienced second convulsion (lasting for 15-20 minutes). On an unspecified date, post vaccination, the patient experienced grand-mal seizures or small seizures of the astatic type despite anticonvulsive therapy. On an unspecified date in June 1975, the physician gave the statement that the patient had myoclonic-astatic petit-mal epilepsy was incurable, mentally severely retarded, also in motor development, cannot run freely, just sitting unsafe and not clean in bed (on an unspecified date post vaccination). It was also reported that, patient required constant care and maintenance (it was reported that "reduction in earning capacity 100%"). On 26-Mar-1977, the patient died. Cause of death was not reported. Lab data included CSF was without pathological findings. Corrective treatment was not reported (also reported that the patient had anticonvulsive therapy). On 21/22 Oct 1971, (duration 2 minutes), the patient was recovered from the event febrile convulsion. On 12 Nov 1971, (duration 15-20 minutes) the patient was recovered from convulsion. The outcome of other events was not reported. It was unknown whether autopsy was performed or not. This case was also considered as serious due to persistent or significant disability or incapacity. List of documents held by sender: none. Sender''s Comments: This case from the literature and reported recently included a patient was vaccinated with DPT and OPV vaccine (manufacturer unknown) on 21-Oct-1971 followed the same day (at night) by febrile convulsions for 2 minutes then convulsions again for 15-20 minutes. CSF was without pathological findings. Grand-mal or small seizures of the astatic type, after few years patient had Incurable myoclonic-astatic petit-mal epilepsy, mentally severely retarded, psychomotor development delay and patient died on 26-Mar-1977. There is temporal relationship with the event, but additional information regarding patient medical history, autopsy report, etiological work up, concomitant medication, autopsy report, details regarding seizure disorder and more investigation results to rule out the alternative cause are needed for complete assessment of the case. Based on available information no conclusion can be drawn. Reported Cause(s) of Death: patient died on 26-Mar-1977.


VAERS ID: 686200 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-17
Entered: 2017-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Injury
SMQs:, Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131703GBR007969

Write-up: This spontaneous report was received from an online news article. The article refers to an unspecified amount of patients (ages and genders not specified) who received ZOSTAVAX. Medical history and concomitant medications of the patients were not specified. The article stated the following: After several plaintiff''s filed lawsuits claiming the drugmaker''s shingles vaccine caused serious injury and death, attorneys say more cases are on the way. Plaintiffs have sued in state and federal courts alleging that ZOSTAVAX-used to prevent shingles, the painful complication of varicella-caused serious side effects, including death. A lawyer said that there are thousands of complaints yet to be filed with injuries running the gamut from contracting shingles as a result of the vaccine all the way to serious personal injuries such as blindness in one eye, individuals who have serious paralysis in their extremities, brain damage, all the way to death. The outcomes of blindness in one eye, serious paralysis in their extremities, brain damage and shingles were unknown. Upon internal review, death, blindness in one eye, serious paralysis in their extremities and brain damage were considered medically significant. Additional information is not expected as there were no contact details.


VAERS ID: 686265 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-01-20
Onset:2017-02-06
   Days after vaccination:17
Submitted: 2017-03-17
   Days after onset:38
Entered: 2017-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER M036073 / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Coma scale abnormal, Death, Electrocardiogram, Lividity, Muscle rigidity
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-06
   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: Idiopathic partial epilepsy; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IT0095075131703ITA003784

Write-up: Initial and follow up information was received from a physician via the Agency (#399881) on 07-MAR-2017, through the patient''s parents, concerning a 5 years old male patient, suffering from partial epilepsy; who, on 20-JAN-2017 at 10:40; underwent the administration of the first dose of M-M-RVAXPRO, powder and solvent for injectable solution, 1 dose unit, intramuscular, as needed for routine immunization, carried on the left shoulder. Concomitant therapy: On 20-JAN-2017, the patient received the intramuscular NIMENRIX injectable solution, 1 dose unit as a routine immunization. On 06-FEB-2017 at 08:00, the patient''s mother found her child already dead in the bed in a state of rigidity. The physician of the emergency care was called and he/she established his death. It was not performed autopsy and no death report was available. The lot number and expiry date of M-M-RVAXPRO were M036073 and 31-JUL-2018, respectively. The outcome of the adverse event was coded as "fatal". The frequency of administration of M-M-RVAXPRO was changed from "as needed" as "total" (discrepancy from initial version). The following additional information has been reported in the Follow-Up section of the Regulatory Form: The cause of death was not available. The patient''s parents had only the death certificate of the patient. The following information were included in the updated regulatory form: The patient concurrent condition consisted in partial cryptogenic epilepsy under treatment with DEPAKIN and TEGRETOL (both not coded by the Agency as concomitant therapies). The reporting physician felt that the serious case was related only to the treatment with M-M-RVAXPRO for the period of time occurred between the administration of M-M-RVAXPRO and the adverse event (AE). The lot number of NIMENRIX was A90CA234C and its expiry date was 30-SEP-2018. The following information were added in the report attached to the regulatory form, written by the emergency medical technician in the morning of body discovery, on 06-FEB-2017 at 08.35: Patient eyes were closed, with no verbal and no motor response. An electrocardiogram (ECG) was performed (results not provided) Glasgow Coma Scale was equal to 3. It was specified that patient mother found the patient in bed, with his face laid on the pillow; when rescuers arrived the patient was supine on the carpet, he had rigor mortis and hypostatic stains. The patient had no allergies and antiepileptic drugs as treatments were reported. Additional information is not expected because the reporter has no further information. Reported Cause(s) of Death: death.


VAERS ID: 686356 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-17
Entered: 2017-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Influenza virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unspecified date. Influenza virus test, confirmed influenza
CDC Split Type: ES2017GSK038017

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a elderly female subject who received Flu seasonal TIV Dresden. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the subject developed vaccination failure. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included influenza with serious criteria of death and hospitalization. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza (fatal). The reported cause of death was influenza. The investigator considered that there was a reasonable possibility that the vaccination failure and influenza may have been caused by Flu seasonal TIV Dresden. Relevant Tests: Lab tests performed on unspecified date Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was confirmed influenza. Additional information was provided. This case was reported in a literature article and described the occurrence of suspected vaccination failure in a female patient aged between 75 and 79-year who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown). The patient was a part of the cross-sectional study that aimed to determine the costs associated with laboratory-confirmed influenza-related hospitalization in patients aged equal to or more than 65 year and to assessed the effect of influenza immunisation in reducing costs due to hospitalisation. The study was performed in patients admitted to 20 hospitals from 7 regions during the 2013-14 and 2014-15 influenza seasons. No information on patient''s medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified seasonal influenza vaccine (administration route and site unknown; dosages unknown; batch number not provided). The patient received vaccination either in 2013-14 or 2014-15 influenza season. The patient received seasonal influenza vaccine equal to or more than 15 days prior to hospital admission. In this study, information on the influenza vaccination status was obtained from vaccination registers, hospital medical records, vaccination cards or primary healthcare records. On an unspecified date either in 2013-14 or 2014-15, at least 15 days after vaccination, the patient was hospitalised due to influenza infection. (In this study, the mean hospital and intensive care unit (ICU) stays were 1-138 days and 1-86 days respectively. Out of total 728 number of confirmed influenza hospitalisations, 483 admissions were due to influenza, 160 due to primary influenza pneumonia and 85 due to secondary influenza pneumonia). Subsequently, the influenza was confirmed by laboratory. On an unspecified date, the patient died due to influenza. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death/hospitalisation/suspected vaccination failure. Treatment was unknown. The authors did not comment on the relationship between the event of influenza infection and unspecified seasonal influenza vaccination. The authors stated "Although influenza vaccination of the elderly may not achieve significant savings in mean hospitalization costs, it can lessen the degree of severity and avoid complications. This study focused on the direct medical costs of laboratory confirmed influenza-related hospitalizations in patients aged equal to or more than 65 y. Future studies should include direct non-medical cost and indirect costs, including transportation, to accurately measure the annual social and economic burden and impact attributed to influenza infections". This is 1 of the 2 valid cases reported in the same literature article.


VAERS ID: 686359 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-17
Entered: 2017-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Influenza virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unspecified date. Influenza virus test, confirmed influenza
CDC Split Type: ES2017GSK038020

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a elderly male subject who received Flu seasonal TIV Dresden. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the subject developed vaccination failure. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included influenza with serious criteria of death and hospitalization. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included influenza (fatal). The reported cause of death was influenza. The investigator considered that there was a reasonable possibility that the vaccination failure and influenza may have been caused by Flu seasonal TIV Dresden. Relevant Tests: Lab tests performed on unspecified date. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was confirmed influenza unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of suspected vaccination failure in a male patient aged more than 90-year who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown). The patient was part of the cross-sectional study that aimed to determine the costs associated with laboratory-confirmed influenza-related hospitalization in patients aged equal to or more than 65 year and to assess the effect of influenza immunisation in reducing costs due to hospitalisation. The study was performed in patients admitted to 20 hospitals from 7 regions during the 2013-14 and 2014-15 influenza seasons. No information on patient''s medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified seasonal influenza vaccine (administration route and site unknown; dosages unknown; batch number not provided). The patient received vaccination either in 2013-2014 or 2014-2015 influenza season. The patient received seasonal influenza vaccine equal to or more than 15 days prior to hospital admission. In this study, information on the influenza vaccination status was obtained from vaccination registers, hospital medical records, vaccination cards or primary healthcare records. On an unspecified date either in 2013-2014 or 2014-2015, at least 15 days after vaccination, the patient was hospitalised due to influenza infection. (In this study, the mean hospital and intensive care unit (ICU) stays were 1-138 days and 1-86 days respectively. Out of total 728 number of confirmed influenza hospitalisations, 483 admissions were due to influenza, 160 due to primary influenza pneumonia and 85 due to secondary influenza pneumonia). Subsequently, the influenza was confirmed by laboratory. On an unspecified date, the patient died due to influenza. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death/hospitalization/suspected vaccination failure. Treatment was unknown. The authors did not comment on the relationship between the event of influenza infection and unspecified seasonal influenza vaccination. The authors stated "Although influenza vaccination of the elderly may not achieve significant savings in mean hospitalization costs, it can lessen the degree of severity and avoid complications. This study focused on the direct medical costs of laboratory confirmed influenza-related hospitalizations in patients aged equal to or more than 65 y. Future studies should include direct non-medical cost and indirect costs, including transportation, to accurately measure the annual social and economic burden and impact attributed to influenza infections in this country". This is 1 of the 2 valid cases reported in the same literature article.


VAERS ID: 686486 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-08
Entered: 2017-03-20
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Scleroderma
SMQs:, Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2010GSK000092

Write-up: This case was reported by a consumer via market research programs and described the occurrence of scleroderma in a male patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced scleroderma (serious criteria death and GSK medically significant). On an unknown date, the outcome of the scleroderma was fatal. The reported cause of death was scleroderma. It was unknown if the reporter considered the scleroderma to be related to Hepatitis B vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. Age at vaccination was not reported. The question and the reply for this case were: Why are you in favor of minimizing the number of vaccines? Because of problems some vaccines have caused, especially hepatitis B vaccine; some physicians do not keep silent the fact that hepatitis B vaccine is undoubtedly responsible for multiple sclerosis; one of my Uncles died of scleroderma and the professor who followed him had no doubt regarding what triggered the disease and one knows that in vaccines there is lead.


VAERS ID: 686531 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-08
Entered: 2017-03-20
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Multiple sclerosis
SMQs:, Optic nerve disorders (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2008GSK000072

Write-up: This case was reported by a consumer via market research programs and described the occurrence of multiple sclerosis in a female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced multiple sclerosis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the multiple sclerosis was fatal. The reported cause of death was multiple sclerosis. It was unknown if the reporter considered the multiple sclerosis to be related to Hepatitis B vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research Vaccinoscopie. The age at vaccination was not reported. The autopsy details were not reported. The question and the reply for this case were: You think vaccine against hepatitis B is useless or of little use, could you tell us why? I''m not for. Because I have a cousin who died from multiple sclerosis and she had this vaccine so I will never vaccinate my children. No further details were available.


VAERS ID: 686720 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-08
Entered: 2017-03-20
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2010GSK000118

Write-up: This case was reported by a consumer via market research programs and described the occurrence of pulmonary embolism in a patient who received Flu seasonal TIV Dresden. On an unknown date, the patient received Flu seasonal TIV Dresden at an unknown dose. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the patient experienced pulmonary embolism (serious criteria death and GSK medically significant). On an unknown date, the outcome of the pulmonary embolism was fatal. The reported cause of death was pulmonary embolism. It was unknown if the reporter considered the pulmonary embolism to be related to Flu seasonal TIV Dresden. Additional information was provided: This case is one of the multiple cases reported following the market research. Age at vaccination was not reported. The question and the reply for this case were: Could you tell us what you recall having seen/read/heard regarding vaccines during the last 12 months? Influenza vaccine led to fatal pulmonary embolism. Adjuvants included in vaccines are full of toxic products for the body.


VAERS ID: 686747 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-31
Entered: 2017-03-20
   Days after submission:47
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2011GSK000115

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in an unspecified number of patients who received Human papilloma type 16 + 18 vaccine + AS04D. On an unknown date, the patient received Human papilloma type 16 + 18 vaccine + AS04D at an unknown dose. On an unknown date, an unknown time after receiving Human papilloma type 16 + 18 vaccine + AS04D, 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 reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Human papilloma type 16 + 18 vaccine + AS04D. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not applicable. The question and the reply for this case were: which information have you retained regarding immunization against cervical cancer? I have mainly retained that people had problems following this vaccination and some of them died.


VAERS ID: 686450 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-21
Entered: 2017-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR UNKNOWN / UNK UN / UN
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER P0005001R / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Confusional state, Death, Headache, Meningitis meningococcal, Neck pain, Toxic shock syndrome, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Hypoglycaemia (broad), Sepsis (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: RUSA2017SA039341

Write-up: Initial unsolicited report received from a healthcare professional via the Health authority (reference no: 143345-1) on 07 March 2017. This case involves a 22-year-old male patient who was vaccinated with a dose of MENACTRA (batch number and expiry date, dose and dose in series, rout and site of administration were unknown), and also received drug SOLIRIS (batch number: P0005001R; expiry date, dose were unknown) via intravenous route on an unknown date. Patient''s medical history and concomitant medications were not reported. On an unknown date, after the administration of MENACTRA and SOLIRIS, the patient experienced meningococcal meningitis, toxic shock syndrome, headache, pain in the nape, confusion of consciousness. It was a case of Vaccination failure. Laboratory investigations and corrective treatment were not reported. On an unknown date, the patient died. It was not reported whether autopsy was performed. The reporter assessed the causal relationship as possible. List of documents held by sender: none.; Sender''s Comments: This case involves a 22-year-old male who reportedly experienced meningococcal meningitis with a fatal outcome an unspecified amount of time after receiving MENACTRA vaccine. Concomitant medication included SOLIRIS. As with any other vaccine, Menactra vaccine may not protect 100% of individuals. This case does not represent a confirmed vaccine failure based on the information provided so far; the specific serogroup involved was not reported. Furthermore, latency was not specified. Eculizumab is a complement inhibitor and therefore increases patient risk for meningococcal infections. Patients treated with eculizumab and without a history of prior vaccination are recommended to receive a meningococcal vaccine at least 2 weeks prior to receiving the first dose of SOLIRIS and be revaccinated according to current medical guidelines for vaccine use. In the current case; it is not specified whether vaccination occurred prior to initiating treatment with eculizumab. Additional information - such as previous vaccination history, start date of treatment with eculizumab, vaccination date, time to onset, diagnostic work-up, and the specific serogroup involved- is needed to complete the medical assessment of this case.; Reported Cause(s) of Death: Confusion of consciousness; Headache; Meningococcal meningitis; Pain in the nape; Toxic shock syndrome.


VAERS ID: 686473 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-08
Entered: 2017-03-21
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2013GSK000534

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, 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 reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Hepatitis B vaccine. Additional information was provided. This case is one of the multiple cases reported following the market research. Age at vaccination was not reported. The question and the reply for this case were: Why do you think vaccine against hepatitis B is of little use or useless? My best friend is dead after the mandatory vaccine in 6th class, her parents have accused of this vaccine and they have never been proven the contrary.


VAERS ID: 686506 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-21
Entered: 2017-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Off label use, Respiratory papilloma, Surgery
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: Laryngeal papillomatosis; Pulmonary disorder; Respiratory papillomatosis
Preexisting Conditions: Medical History/Concurrent Conditions: Laryngeal papillomatosis (diagnosed due to progressive dysphonia); Respiratory papillomatosis (diagnosed due to progressive dysphonia)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ES0095075131703ESP007027

Write-up: This spontaneous report has been received from a physician via a company medical advisor regarding a patient (gender and age not provided). The patient was diagnosed with respiratory (also reported as laryngeal) papillomatosis (HPV 6 and 11) when she was 2 and half years old due to progressive dysphonia. The patient had 43 surgeries between July 2005 and May 2013. The physician''s diagnose was juvenile recurrent respiratory (also reported as laryngeal) papillomatosis (HPV 6 and 11). In 2008, it was discovered that the patient had pulmonary involvement. On an unknown date the patient started therapies with GARDASIL (HPV vaccine) (solution for injection; dose, route and lot number not provided) for juvenile recurrent respiratory(also reported as laryngeal) papillomatosis (HPV 6 and 11) (off label use). Other suspect drug as adjuvant treatment included probenecid (manufacturer unknown), celecoxib, erlotinib hydrochloride and cidofovir (dose, frequency and lot number not provided) which were used for the same indication. The physician stated that the adjuvant treatment was usually reserved for the most serious cases with short intervals between surgeries (<4 months), wide extension (subglottis) and necessity of urgent surgeries. The patient did not improve during the time between surgeries and did not improve in the lesions severity. The physician stated that the patient had evolved disease in which the immunization intervals were not strictly followed. In 2014, the patient died due to worsening of the pulmonary evolution (onset date unspecified). It was unknown whether the autopsy was done. The physician stated that the juvenile recurrent respiratory papillomatosis was a rare disease with hospital and surgical dependency. The physician stated that there was not a curative treatment and the evolution was unpredictable. Upon internal review, the events of juvenile recurrent respiratory (also reported as laryngeal) papillomatosis (HPV 6,11) were determined to be medically significant due to required surgeries. This is one of several reports received from the same reporter. Additional information has been requested.; Sender''s Comments: ES-009507513-1703ESP007032: ES-009507513-1703ESP007041: ES-009507513-1703ESP007328:; Reported Cause(s) of Death: Worsening of the pulmonary evolution.


VAERS ID: 686519 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-21
Entered: 2017-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Malignant respiratory tract neoplasm, Off label use, Respiratory papilloma, Surgery
SMQs:, Non-haematological malignant tumours (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: Laryngeal papillomatosis
Preexisting Conditions: Medical History/Concurrent Conditions: Intubation difficult; Laryngeal papillomatosis; Respiratory papillomatosis; Tracheostomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ES0095075131703ESP007041

Write-up: This Spontaneous report has been received from two physicians via a company medical advisor regarding a female patient of unknown age. The patient was diagnosed with respiratory (also reported as laryngeal) papillomatosis (HPV 11) when she was 2 and half years old due to progressive dysphonia. In 1994, the patient had a tracheotomy performed, as it was impossible to intubate the patient. The patient had 40 surgeries between July 1993 and November 2011 and it was reported that she had had 45 interventions. The physician''s diagnose was juvenile recurrent respiratory (also reported as laryngeal) papillomatosis (HPV 11). On an unknown date, the patient started therapies with GARDASIL (solution for injection; dose, route and lot number not provided) for juvenile recurrent respiratory (also reported as laryngeal) papillomatosis (HPV 11) (off label use). Other suspect adjuvant therapies included celecoxib, acyclovir, lysozyme chloride, cidofovir, cimetidine and interferon (unspecified)(frequency,dose, route and lot number not provided) for the same indication. The physician stated that the adjuvant treatment was usually reserved for the most serious cases with short intervals between surgeries (<4 months), wide extension (subglottis) and necessity of urgent surgeries. The patient did not improve during the time between surgeries (reported as "interval of 2-4 months") and did not improve in the lesions severity. The physician stated that the patient had evolved disease in which the immunization intervals were not strictly followed. In 2013 , the patient died due to malignancy of the lung lesions. It was unknown whether the autopsy was done. The physician stated that the juvenile recurrent respiratory papillomatosis was a rare disease with hospital and surgical dependency. The physician stated that there was not a curative treatment and the evolution was unpredictable. Upon internal review, the events of juvenile recurrent respiratory (also reported as laryngeal) papillomatosis (HPV11) were determined to be medically significant due to required surgeries. This is one of several reports received from the same reporter. Additional information has been requested.; Sender''s Comments: ES-009507513-1703ESP007032: ES-009507513-1703ESP007027: ES-009507513-1703ESP007328:; Reported Cause(s) of Death: malignancy of the lung lesions.


VAERS ID: 686520 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Male  
Location: Foreign  
Vaccinated:2017-02-13
Onset:2017-02-15
   Days after vaccination:2
Submitted: 2017-03-21
   Days after onset:33
Entered: 2017-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cardiomegaly, Death, Pyrexia, Resuscitation
SMQs:, Cardiac failure (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Routine childhood immunisation
Preexisting Conditions: Medical History/Concurrent Conditions: Eczema; Inflammation localised (Toenail)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NL0095075131703NLD007665

Write-up: SUMMARY: SPECIFIC HISTORY This moderately documented serious (Death) spontaneous report from a community health service concerns a male aged 14 months, with fever (not measured; latency 2 days) and death nos (latency 3 days) following administration of NEISVAC-C and MMRVAXPRO for routine childhood immunisation. The patient recovered from the fever after 3 hours. The next morning the patient was found lifeless in his bed. Concomitant medication was not reported. PAST MEDICAL HISTORY / COMEDICATION / FAMILY HISTORY The medical history indicates that the patient had an inflammation of the toenail (approximately one year before the reported events) and also had eczema, which was treated with cetomacrogol. The patient has no known past drug therapy. Medical history of the mother: The mother had an abnormal PAP test before she became pregnant. She had surgery, and in November 2014 the tests were normal. In April 2015 she became pregnant. She also was atopic, had hay fever and asthma. No familial cardiac problems. PHYSICAL FINDINGS AND INVESTIGATIONS On the day of vaccination the patient made a healthy impression. There were no abnormalities during the consult. An investigation for the cause of death is still in progress. Parents told the reporter that for now, an enlarged right heart was found and that they found something in the lungs. TREATMENT AND CLINICAL COURSE Two days after vaccination, the patient developed fever during the afternoon (unknown temperature). The fever was treated with paracetamol suppository, the patient recovered from the fever after three hours. In the evening the patient ate and played as usual. The patient didn''t felt warm anymore. The parents had no reasons to check for him after he was laid to bed. The next morning he was found lifeless in his bed. The mother tried to resuscitate him. The forensic doctor concluded that the patient was already dead for several hours when the mother found him. CAUSALITY ASSESSMENT Causality for the fever and vaccination NEISVAC-C was considered possible because of the latency time. Causality for the fever and vaccination MMRVAXPRO was considered unlikely because of the latency. Causality for the death NOS and vaccination NEISVAC-C and MMRVAXPRO was considered not assessable because of lack of data. CONCLUDING SUMMARY / KEY WORDS Male, 14 months, NEISVAC-C, MMRVAXPRO, fever, death NOS. NARRATIVE INCLUDE CLINICAL: Patient death cause description: Unknown. Patient reaction [1].primary source reaction: Fever. Patient reaction [1].serious: No. Patient reaction [1].seriousness death: No. Patient reaction [1].seriousness life threatening: No. Patient reaction [1].seriousness hospitalization: No. Patient reaction [1].seriousness disabling: No. Patient reaction [1].seriousness congenital anomali: No. Patient reaction [1].seriousness other: No. Patient reaction [1].reaction treatment: YES. Patient reaction [1].reaction treatment info: Paracetamol suppository. Other side effects, the little child was found lifeless in his bed in the morning of day 3 after vaccination. During the afternoon of day 2 the child had fever, good response to paracetamol. During the evening no more fever, ate well and played as normal. During the late evening and night his parents did not went to check on him. They were not used to do so and had no worries when bringing him to bed. Patient reaction [2].serious: No. Patient reaction [2].seriousness death: Yes. Patient reaction [2].seriousness life threatening: No. Patient reaction [2].seriousness hospitalization: No. Patient reaction [2].seriousness disabling: No. Patient reaction [2].seriousness congenital anomali: No. Patient reaction [2].seriousness other: No. Patient reaction [2].reaction treatment: No. Patient drug [1].medicinal product: First injection BM. Patient drug [2].medicinal product: First injection MenC. Other side effects, the little child was found lifeless in his bed in the morning of day 3 after vaccination. During the afternoon of day 2 the child had fever, good response to paracetamol. During the evening no more fever, ate well and played as normal. During the late evening and night his parents did not went to check on him. They were not used to do so and had no worries when bringing him to bed. RVP National Vaccination Program (NVP). Second RVP Vaccine site of administration: Left Arm intramuscular. NVP Vaccine used previously: No. NPV- vaccine site of administration: right arm subcutaneous. What happened after vaccination: The child got fever 2 days after vaccination (15FEB2017) in the afternoon. He responded to Paracetamol, then good intake and play. In the morning of the third day post vaccination, he was found lifeless in his bed. May the (parents or guardians of the) vaccinee be approached? Yes. Fever - Maximum temperature measurement: Not measured. Fever - temperature measurement Date: 15-FEB-2017. Other side effects: Extra information: General Practitioner has applied the standard procedure to investigate the cause of death (NODO procedure) via hospital. Are there possible other causes or circumstances that may have caused or deteriorated the event? Unknown, the standard procedure to investigate the cause of death (NODO procedure) is still ongoing. During consultation 13-FEB-2017 apparently perfectly healthy boy. 14-MAR-2017, 11.30 telephone contact with the reporter: Vaccination given by fellow colleague, around 13:15 to 13:30 hours. No particularities around the vaccination. Short reporting of consultation that there were no particularities and child could walk by himself. The day after vaccination no particularities, did not have a cold. The second day after vaccination temperature increased, therefore paracetamol. After afternoon nap everything was normal, he ate normal amount and played actively. He did not feel warm anymore ($g 6 hours after paracetamol administration). Next morning he was found lifeless in bed, unknown in which position. The mother started immediately CPR. Forensic doctor reported that at that time the child was already deceased for several hours. The Child Practice Center physician informed that the outcome of the analysis may be expected this week. The doctor has so far only heard that there would be an enlarged right heart and that there may have been something found in the lungs. In previous controls at the Child Practice Center no particularities, weight always about two standard deviations above average. When infant the child had an inflamed toenail (January 2016); eczema which was treated with cetomacrogol. Mother history with increased PAP score, for which she has been operated and in November 2014 controls were good. In April 2015 the mother was pregnant of this child. Mother history: atopy, asthma, hay fever. Familial no particularities, no cardiac problems. The parents are doing relatively well under the circumstances, They are motivated to carry on for the older brother. They are aware of the reporting to regulatory authority, know that in case of questions they can be contacted by regulatory authority. They have given permission to the Child Practice Center physician to ask for the batch number data. The Child Practice Center physician will ask parents to request the pediatrician of the NODOK procedure to forward the autopsy results to the Child Practice Center physician. In case additional information will be available, the Child Practice Center physician will inform regulatory authority. Sender''s Comments: Brand name of reported MMR vaccine is not specified. MMRVAXPRO is the most plausible vaccine that is used in the Childhood Immunization Programme at reported date of administration. Brand name of reported Meningococcal C vaccine is not specified. NEISVAC-C is the most plausible vaccine that is used in the Childhood Immunization Programme at reported date of administration. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 686716 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-09
Entered: 2017-03-21
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2014GSK055462

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in an unspecified number of female patients who received Human papilloma type 16 + 18 vaccine + AS04D. On an unknown date, the patient received Human papilloma type 16 + 18 vaccine + AS04D at an unknown dose. On an unknown date, an unknown time after receiving Human papilloma type 16 + 18 vaccine + AS04D, 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 reported causes of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Human papilloma type 16 + 18 vaccine + AS04D. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The autopsy details were not reported. The question and the reply for this case were: Which information have you retained regarding immunization against cervical cancer? Protection only at 20%, not even 50%. Some girls died after the vaccination and others developed other diseases.


VAERS ID: 686831 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-14
Entered: 2017-03-21
   Days after submission:34
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2013GSK000649

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, 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 reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Hepatitis B vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. Age at vaccination was not reported. The question and the reply for this case were: Why are you in favor of minimizing the number of vaccines? Worries in the family with vaccine for hepatitis B (death of my mother).


VAERS ID: 686881 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-14
Entered: 2017-03-21
   Days after submission:34
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Immediate post-injection reaction
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2014GSK055533

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in multiple female patients who received Human papilloma type 16 + 18 vaccine + AS04D. On an unknown date, the patient received Human papilloma type 16 + 18 vaccine + AS04D, 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 reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Human papilloma type 16 + 18 vaccine + AS04D. Additional information was provided: This case is one of the multiple cases reported following the market research. Age at vaccination was not reported. The question and the reply for this case were: Which information have you retained regarding immunization against cervical cancer? That several teen girls have died immediately after this vaccination while they had no problems before.


VAERS ID: 686688 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-06
Entered: 2017-03-22
   Days after submission:43
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2015GSK186243

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a child female patient who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, an unknown time after receiving Rotavirus vaccine, 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 reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Rotavirus vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The autopsy details were not reported. The question and the reply for this case were: Which information have you retained regarding immunization against rotavirus gastroenteritis? The information comes from one of my best friends who lost her baby after vaccinating her daughter.


VAERS ID: 686825 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-10
Entered: 2017-03-22
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2015GSK186316

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a child patient who received ROTARIX. On an unknown date, the patient received ROTARIX (oral). On an unknown date, an unknown time after receiving ROTARIX, 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 reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to ROTARIX. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The question and the reply for this case were: which information have you retained regarding immunization against rotavirus gastroenteritis? My first child had had this vaccine which had greatly limited the effects of gastroenteritis. It was then quite natural for me to do it for my second child. He made the first vaccine and shortly after I read on the newspaper the death of two children following this vaccine. So I have talked about this with my pediatrician before the second vaccine and he advised me not to do it because there was not enough hindsight and above all, the symptoms after the vaccine that caused the death of these poor children were hardly detectable by the parents. So I did not take the risk of doing the second vaccine. This case was linked with FR2015GSK186315 and FR2015GSK186320, as reported by the same reporter.


VAERS ID: 686869 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-07
Entered: 2017-03-22
   Days after submission:42
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2015GSK186250

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in multiple children patients who received Rotavirus vaccine. On an unknown date, the patient Rotavirus vaccine (oral). On an unknown date, an unknown time after receiving Rotavirus vaccine, 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 reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Rotavirus vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. Age at vaccination was not reported. The question and the reply for this case were: Which information have you retained regarding immunization against rotavirus gastroenteritis? Children deaths.


VAERS ID: 686895 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-05
Entered: 2017-03-22
   Days after submission:44
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2014GSK055456

Write-up: This case was reported by a consumer via market research programs and described the occurrence of amyotrophic lateral sclerosis in a female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced amyotrophic lateral sclerosis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the amyotrophic lateral sclerosis was fatal. The reported cause of death was amyotrophic lateral sclerosis. It was unknown if the reporter considered the amyotrophic lateral sclerosis to be related to Hepatitis B vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The autopsy details were not reported. The question and the reply for this case were: Why do you think vaccine against hepatitis B is of little use or useless? My half sister died of amyotrophic lateral sclerosis. If the link between amyotrophic lateral sclerosis and this vaccine is not demonstrated, the opposite is not demonstrated too.


VAERS ID: 686901 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-10
Entered: 2017-03-22
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2015GSK186240

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in an unspecified number of children who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, an unknown time after receiving Rotavirus vaccine, 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 reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Rotavirus vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The question and the reply for this case were: which information have you retained regarding immunization against rotavirus gastroenteritis? Deaths of children following vaccination. Vaccine not reimbursed and expensive.


VAERS ID: 686921 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-12
Entered: 2017-03-22
   Days after submission:37
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), 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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2015GSK186205

Write-up: This case was reported by a consumer via market research programs and described the occurrence of vaccination failure in a female patient who received Flu seasonal TIV Dresden. On an unknown date, the patient received the 1st dose of Flu seasonal TIV Dresden. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu seasonal TIV Dresden. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The question and the reply for this case were: in the case of a future pregnancy, if a healthcare professional recommend you to vaccinate against seasonal influenza during your pregnancy to protect your baby, would you do it? If not, why? My grandmother died because of the flu when it was the first time she got vaccinated. The patient died on an unknown date. This case was considered as suspected vaccination failure as the details regarding time to onset for the event and lab test confirmation were unknown at the time of reporting. MAH Comment: Suspected reasonable causal relationship based on the event vaccination failure is upgraded from ''Unknown'' to ''Yes'' as the event is listed with Flu seasonal TIV vaccine Dresden vaccine and for the event Influenza is downgraded from ''Unknown'' to ''No'' as there is not enough evidence to establish a causal relationship with the Flu seasonal TIV vaccine Dresden vaccine.


VAERS ID: 686926 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-10
Entered: 2017-03-22
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2015GSK186297

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a child male patient who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, an unknown time after receiving Rotavirus vaccine, 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 reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Rotavirus vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The question and the reply for this case were: which information have you retained regarding immunization against rotavirus gastroenteritis? Oral vaccine. Well tolerated by my son. Never has gastroenteritis thanks to the vaccine. There was an accident this year with a death of a child.


VAERS ID: 686927 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-09
Entered: 2017-03-22
   Days after submission:40
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2015GSK186311

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown case of death in a neonate patient who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, an unknown time after receiving Rotavirus vaccine, 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 reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Rotavirus vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The question and the reply for this case were: which information have you retained regarding immunization against rotavirus gastroenteritis? A newborn died following this vaccines.


VAERS ID: 686928 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-06
Entered: 2017-03-22
   Days after submission:43
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2015GSK186242

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a child patient who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, an unknown time after receiving Rotavirus vaccine, 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 reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Rotavirus vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The autopsy details were not reported. The question and the reply for this case were: Which information have you retained regarding immunization against rotavirus gastroenteritis? A young child died of this vaccination.


VAERS ID: 686933 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-09
Entered: 2017-03-22
   Days after submission:40
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2015GSK186313

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a child patient who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, an unknown time after receiving Rotavirus vaccine, 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 reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Rotavirus vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The question and the reply for this case were: which information have you retained regarding immunization against rotavirus gastroenteritis? My doctor had no opinion, not enough hindsight and I have head that a child had died following this vaccine. Then my opinion had been forged against it.


VAERS ID: 686934 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-09
Entered: 2017-03-22
   Days after submission:40
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2015GSK186312

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a child patient who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, an unknown time after receiving Rotavirus vaccine, 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 reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Rotavirus vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The question and the reply for this case were: which information have you retained regarding immunization against rotavirus gastroenteritis. A child died following this vaccine.


VAERS ID: 686936 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-27
Entered: 2017-03-22
   Days after submission:53
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2016GSK196312

Write-up: This case was reported by a consumer via market research programs and described the occurrence of death in a female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to Hepatitis B vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. Age at vaccination was not reported. The autopsy details were not reported. The question and the reply for this case were: Why do you think vaccine against hepatitis B is of little use or useless. I have an aunt who made the vaccine and yet she died.


VAERS ID: 686966 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-09
Entered: 2017-03-22
   Days after submission:40
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2015GSK186314

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a infant patient who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, an unknown time after receiving Rotavirus vaccine, 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 reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Rotavirus vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The question and the reply for this case were: which information have you retained regarding immunization against rotavirus gastroenteritis? Little useful and death of an infant due to the vaccine.


VAERS ID: 686974 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-08
Entered: 2017-03-22
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2016GSK196338

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a male patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, 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 reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Hepatitis B vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The question and the reply for this case were: For what reason(s) would you reduce the number of vaccines? Severe history in dad''s family following hepatitis B vaccine. Death of the grandfather. We have some apprehension to get our daughter vaccinated.


VAERS ID: 688490 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-03-16
Onset:2011-03-17
   Days after vaccination:1
Submitted: 2017-03-23
   Days after onset:2198
Entered: 2017-03-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLUA589AB / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-17
   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: oxycodone; alendronate; furosemide; acetylsalicylic acid; cholecalciferol
Current Illness: Nephropathy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ2017GSK040393

Write-up: This case was reported by a regulatory authority and described the occurrence of dyspnea in a 83-year-old female patient who received Influenza vaccine (batch number AFLUA589AB, expiry date unknown). Concurrent medical conditions included renal disease. Concomitant products included alendronate, furosemide, acetylsalicylic acid, Cholecalciferol and oxycodone. On 16th March 2011, the patient received Influenza vaccine (intramuscular) .5 ml. On 17th March 2011, 1 days after receiving Influenza vaccine, the patient experienced dyspnea (serious criteria death). On an unknown date, the outcome of the dyspnea was fatal. The patient died on 17th March 2011. The reported cause of death was dyspnea. The reporter considered the dyspnea to be possibly related to Influenza vaccine. Additional details were provided as follows: The case was received via regulatory authority in the form of line listing from 1st January 2007 to 31st December 2016. The primary reporter was not provided; therefore no further information would be available. The patient had pre existing renal disease and had no known allergy. The age at vaccination was not provided. The patient had other medical conditions and also received nutritional supplements. This was 1 of the 12 cases reported by the same reporter. No further information was provided.


VAERS ID: 688495 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-02-25
Onset:2011-03-04
   Days after vaccination:7
Submitted: 2017-03-24
   Days after onset:2211
Entered: 2017-03-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA589AD / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Death, Pneumonia, Sepsis
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-04
   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: No other medications
Current Illness: Chronic obstructive pulmonary disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ2017GSK040394

Write-up: This case was reported by a regulatory authority and described the occurrence of pneumonia in a 75-year-old male patient who received FLUARIX (batch number AFLUA589AD, expiry date unknown). Concurrent medical conditions included chronic obstructive pulmonary disease. On 25th February 2011, the patient received FLUARIX (subcutaneous) .5 ml. On 4th March 2011, 7 days after receiving FLUARIX, the patient experienced pneumonia (serious criteria death and GSK medically significant) and sepsis (serious criteria GSK medically significant). On an unknown date, the outcome of the pneumonia was fatal and the outcome of the sepsis was unknown. The patient died on 4th March 2011. The reported cause of death was pneumonia. The reporter considered the pneumonia and sepsis to be unlikely related to FLUARIX. Additional details were provided as follows: This case was received via regulatory authority in the form of line listing involving GSK Influenza vaccine for the period of 1st January 2007 to 31st December 2016. The primary reporter was not provided. The age at vaccination was not reported. The patient''s pre-existing renal disease, pre-existing hepatic disease, recent surgery, transfusion, X-ray with contrast media, known allergy, familial, other chemicals and nutritional supplements were unknown. The events lasted for less than a week. The outcome was provided as died (unrelated to drug). The cause of death was not specified that due to which event the patient has died. Autopsy results were unknown. No follow up would be available. This is one of the 12 linked cases reported by the same reporter.


VAERS ID: 688340 (history)  
Form: Version 1.0  
Age: 1.33  
Sex: Male  
Location: Foreign  
Vaccinated:2016-03-31
Onset:2016-04-01
   Days after vaccination:1
Submitted: 2017-03-28
   Days after onset:361
Entered: 2017-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR K5040 / UNK UN / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. K025856 / UNK UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L75637 / UNK UN / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-01
   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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ0095075131703NZL009284

Write-up: Information was obtained on a request by the Company from the agency (HA#120274) via a Case Line Listing concerning a 16 months old male patient. It was unknown if the patient had any pre existing renal disease, pre existing hepatic disease, recent surgery, transfusion, Xray with contrast media, allergy, familial factors and other medical conditions. It was unknown if the patient was receiving any nutritional supplements and other chemicals. The patient''s concomitant medications were not reported. On 31-MAR-2016, the patient was subcutaneously vaccinated with a 0.5 ml dose of M-M-R II lot # K025856 (expiration date was not provided) for immunization against measles-mumps-rubella. Other suspect vaccines included a 0.5 ml dose of ACTHIB lot# K5040 (expiration date was not reported) and pneumococcal 13v conj vaccine (crm197) lot# L75637 (expiration date was not reported) both administered intramuscularly on 31-MAR-2016 for immunization against other single bacterial diseases. On 01-APR-2016, the patient experienced sudden death (the agency considered this event as severe and serious). The time between administration of the vaccines and the onset of the event was within 24 hours. The cause of death was not reported. The outcome of sudden death was reported as fatal. The cause of death was not reported. The relatedness between the event of sudden death and M-M-R II and ACTHIB and pneumococcal 13v conj vaccine (crm197) was not provided by the Agency. The original reporting source was not provided. Additional information is not expected as no further information can be obtained from the local regulatory authority.


VAERS ID: 688574 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-03-15
Onset:2011-03-17
   Days after vaccination:2
Submitted: 2017-03-28
   Days after onset:2203
Entered: 2017-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA589AD / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-03-17
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ2017GSK040395

Write-up: This case was reported by a regulatory authority and described the occurrence of sudden death in a 64-year-old female patient who received FLUARIX (batch number AFLUA589AD, expiry date unknown). On 15th March 2011, the patient received FLUARIX (subcutaneous) . 5 ml. On 17th March 2011, 2 days after receiving FLUARIX, the patient experienced sudden death (serious criteria death and GSK medically significant). On 17th March 2011, the outcome of the sudden death was fatal. The patient died on 17th March 2011. The reported cause of death was sudden death. It was unknown if the reporter considered the sudden death to be related to FLUARIX. Additional information as provided as follows: This case was received via regulatory authority in the form of line listing involving GSK Influenza vaccine covering 1st January 2017 to 31st December 2016. The primary reporter was not provided, therefore no further information would be available. The patients had other medical conditions however no further information was provided. The patient medical conditions including pre-existing renal disease, pre-existing hepatic disease, recent surgery, transfusion and X-ray with contrast media, known allergy, familial, other chemicals and nutritional supplements were unknown. The events lasted for less than a week. Autopsy results were unknown. No further details was provided. This is one of the 12 linked cases reported by the same reporter.


VAERS ID: 688643 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2017-03-01
Submitted: 2017-03-28
   Days after onset:26
Entered: 2017-03-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Death, Meningitis, Neisseria test positive, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious meningitis (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-03-22
   Days after onset: 20
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 03/2017, Neisseria test positive, type B strain
CDC Split Type: ES2017GSK041998

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of meningitis in a 9-month-old male patient who received BEXSERO. Co-suspect products included BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO and the 2nd dose of BEXSERO. In March 2017, not applicable after receiving BEXSERO and less than a year after receiving BEXSERO, the patient experienced cardiac arrest (serious criteria GSK medically significant). On 19th March 2017, the patient experienced meningitis (serious criteria death, hospitalization and GSK medically significant) and vaccination failure (serious criteria GSK medically significant). On 22nd March 2017, the outcome of the meningitis was fatal. On an unknown date, the outcome of the vaccination failure and cardiac arrest were unknown. The patient died on 22nd March 2017. The reported cause of death was meningitis. It was unknown if the reporter considered the meningitis and vaccination failure to be related to BEXSERO and BEXSERO. It was unknown if the reporter considered cardiac arrest to be related to BEXSERO. Additional details were provided as follows: The patient''s age at vaccination was not reported. On 19th March 2017, less than a year after receiving 1st dose of BEXSERO and 2nd dose of BEXSERO, the patient experienced meningitis and vaccination failure. On 19th March 2017, the patient was hospitalized. The patient was transferred to another hospital, where he died on 22nd March 2017. The patient was diagnosed with meningitis. The meningitis strain was reported as type B. The reporter did not provided more information and informed that had no way to get further information. The case was considered as suspected vaccination failure because the exact time to onset of the event was unknown.


VAERS ID: 688733 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-29
Entered: 2017-03-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FJ0095075131703FJI011425

Write-up: This spontaneous media report received from an unspecified reporter was obtained during a review of a website, and refers to a 14 year old female patient. The patients concurrent conditions, medical history or concomitant medications were not reported. On an unspecified date, the patient was vaccinated with an unspecified dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) as prevention of cervical cancer (dose, route, anatomical location, lot number and expiration date were not reported). It was reported that on an unspecified date, the same day she received the vaccine, the patient died at school. Within the media report it was stated that it turns out that this vaccine, supposedly protecting against cervical cancer, could be the main killer of women. Firstly, there was no research showing that it really works Second: the vaccine had been on the market since 2006, but no one has tested it on children under the age of 16. Third: It was issued that the medical records should be kept for as long as 10 years, unless it exists at all. Fourth: lack of complete monitoring system for vaccinated children Fifth: the age of the vaccinated was reduced to the age of 12 and then to the age of 8. Sixth: girls of this age do not have developed sexual organs, so they are damaged during their development. This had been proven. Seventh: the boys were also started vaccinating, allegedly as viral carriers. The problem was that the virus also moves in the saliva and already the newborn baby can be infected with the kisses. Vaccination of an infected child accelerates the development of cancer. Eighth: 95% of the virus dies spontaneously within 6 months. The original work on HPV Gardasil / Silgard, summarizes: "Although HPV was found in cervical cancer, this was not a valid reason to confirm. Thus, other cofactors were essential for the progression of HPV cervical cancer." Long term use of hormonal contraceptives had a very high probability of this change, smoking and concomitant human immunodeficiency virus (HIV) infection have been identified as factors that significantly affect the onset of cancer. Concomitant Chlamydia trachomatis (CT) and herpes simplex virus type 2 (HSV-2), immunosuppression, and even some dietary deficiencies are likely to be responsible for cancer. Also genetic and host immune factors and viral agents such as viral variants and viral integration that may be important but not identified. Already after the first year of GARDASIL sales in 2006, more than 1,600 reports of complications were reported (1703FJI013081), of which 371 were reported as serious (1703FJI013082), and 42 cases were vaccination in pregnant women (1703FJI013083), of which 18 had miscarriage or fetal malformations (1703FJI013084). The Vaccination Information Center noted: 5 deaths of girls (1703FJI013085), 31 reports identified as life-threatening (1703FJI013086) and 1385 cases required acute medical intervention (1703FJI013087). In total, 2207 adverse effects were reported (1703FJI013088). The journal reported that GARDASIL may be more dangerous than it could have been. Comparison with MENACTRA (for meningitis) showed that: At least 2 times more need for home visits in children vaccinated with GARDASIL, four times more reports of fatalities were reported, 6 times more reports of syncope and 7 times more reports. A professor more bluntly defined about such mindless vaccinations to girls, not just boys: "It is not justified to vaccinate the whole population without the number of cases that can be reduced to a fraction of a cent." Correspondingly, cervical screening had virtually eliminated cervical cancer mortality. There were no complications such as those occurring after vaccination. The reporter stated that it should be strongly emphasized that vaccinations do not eliminate cytological tests. There are over 120 types of this virus. However, the authors of a book written specifically for the Internal Medicine Archives write: "Although the HPV virus has not yet grown, but by the use of molecular methods, different genotypes of the virus have been identified " and further: "As many as 120 of these genotypes have been identified but not always corresponding to serotypes. " In other words, despite over 40 years of research, the virus was uncovered. The government of a country had "suspended" the program of vaccinating girls after 4 deaths (1703FJI013089). "The HPV vaccine was associated with serious adverse events with a high level of reported complication (1703FJI013090). Death and devastating illness have been confirmed (1703FJI013091). " Only in the period from 2010 to 2012 were Human papillomas, type 611,16,18 HPV4, as many as 1253 complications (1703FJI013092). The causal relationship between the death and therapy with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) was not reported. Upon internal review, death was considered to be medically significant. This is one of several cases from the same reporter. Additional information has been requested.; Sender''s Comments: FJ-009507513-1703FJI013081: FJ-009507513-1703FJI013082: FJ-009507513-1703FJI013083: FJ-009507513-1703FJI013084: FJ-009507513-1703FJI013085: FJ-009507513-1703FJI013086: FJ-009507513-1703FJI013087: FJ-009507513-1703FJI013088: FJ-009507513-1703FJI013089: FJ-009507513-1703FJI013090: FJ-009507513-1703FJI013091: FJ-009507513-1703FJI013092:; Reported Cause(s) of Death: died at the school.


VAERS ID: 688735 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-29
Entered: 2017-03-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FJ0095075131703FJI013085

Write-up: This spontaneous media report received from an unspecified reporter was obtained during a review of a website and refers to 5 female patients of unspecified age. The patients concurrent conditions, medical history or concomitant medications were not reported. On an unspecified date, the patients were vaccinated with an unspecified dose of GARDASIL as prevention of cervical cancer (dose, route, anatomical location, lot number and expiration date were not reported). On an unknown date, it was reported that the patients died for unspecified reasons. Within the media report it was stated that it turns out that this vaccine, supposedly protecting against cervical cancer, could be the main killer of women. Firstly, there was no research showing that it really works. Second: the vaccine had been on the market since 2006, but no one has tested it on children under the age of 16. Third: It was issued that the medical records should be kept for as long as 10 years, unless it exists at all. Fourth: lack of complete monitoring system for vaccinated children. Fifth: the age of the vaccinated was reduced to the age of 12 and then to the age of 8. Sixth: girls of this age do not have developed sexual organs, so they are damaged during their development. This had been proven. Seventh: the boys were also started vaccinating, allegedly as viral carriers. The problem was that the virus also moves in the saliva and already the newborn baby can be infected with the kisses. Vaccination of an infected child accelerates the development of cancer. Eighth: 95% of the virus dies spontaneously within 6 months. The original work on HPV Gardasil / Silgard, summarizes: "Although HPV was found in cervical cancer, this was not a valid reason to confirm. Thus, other cofactors were essential for the progression of HPV cervical cancer." Long term use of hormonal contraceptives had a very high probability of this change, smoking and concomitant human immunodeficiency virus (HIV) infection have been identified as factors that significantly affect the onset of cancer. Concomitant Chlamydia trachomatis (CT) and herpes simplex virus type 2 (HSV-2), immunosuppression, and even some dietary deficiencies are likely to be responsible for cancer. Also genetic and host immune factors and viral agents such as viral variants and viral integration that may be important but not identified. Already after the first year of GARDASIL sales in 2006, more than 1,600 reports of complications were reported (1703FJI013081), of which 371 were reported as serious (1703FJI013082) and 42 cases were vaccination in pregnant women (1703FJI013083), of which 18 had miscarriage or fetal malformations (1703FJI013084). The Vaccination Information Center noted: 5 deaths of girls, 31 reports identified as life-threatening (1703FJI013086) and 1385 cases required acute medical intervention (1703FJI013087). In total, 2207 adverse effects were reported (1703FJI013088). The Journal of Medicine reported that GARDASIL may be more dangerous than it could have been. Comparison with MENACTRA (for meningitis) showed that: At least 2 times more need for home visits in children vaccinated with GARDASIL, four times more reports of fatalities were reported, 6 times more reports of syncope and 7 times more reports. A professor more bluntly defined about such mindless vaccinations to girls, not just boys: "It is not justified to vaccinate the whole population without the number of cases that can be reduced to a fraction of a cent." Correspondingly, cervical screening had virtually eliminated cervical cancer mortality. There were no complications such as those occurring after vaccination. The reporter stated that it should be strongly emphasized that vaccinations do not eliminate cytological tests. There are over 120 types of this virus. However, the authors of a book written specifically for the Internal Medicine Archives write: "Although the HPV virus has not yet grown, but by the use of molecular methods, different genotypes of the virus have been identified " and further: "As many as 120 of these genotypes have been identified but not always corresponding to serotypes. " In other words, despite over 40 years of research, the virus was uncovered. The government had "suspended" the program of vaccinating girls after 4 deaths (1703FJI013089). "The HPV vaccine was associated with serious adverse events with a high level of reported complication (1703FJI013090). Death and devastating illness have been confirmed (1703FJI013091). " Only in the period from 2010 to 2012 were Human papillomas, type 611,16,18 HPV4, as many as 1253 complications (1703FJI013092). Upon internal review, death was considered to be medically significant. The causal relationship between the events and therapy with GARDASIL was not reported. This is one of several cases from the same reporter. Additional information has been requested.; Sender''s Comments: FJ-009507513-1703FJI011425: FJ-009507513-1703FJI013081: FJ-009507513-1703FJI013082: FJ-009507513-1703FJI013083: FJ-009507513-1703FJI013084: FJ-009507513-1703FJI013086: FJ-009507513-1703FJI013087: FJ-009507513-1703FJI013088: FJ-009507513-1703FJI013089: FJ-009507513-1703FJI013090: FJ-009507513-1703FJI013091: FJ-009507513-1703FJI013092:; Reported Cause(s) of Death: death.


VAERS ID: 688737 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-29
Entered: 2017-03-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FJ0095075131703FJI013089

Write-up: This spontaneous media report received from an unspecified reporter was obtained during a review of a website and refers to 4 female patients of unspecified age. The patients concurrent conditions, medical history or concomitant medications were not reported. On an unspecified date, the patients were vaccinated with an unspecified dose of Quadrivalent Human Paplillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) as prevention of cervical cancer (dose, route, anatomical location, lot number and expiration date were not reported). It was reported that on an unspecified date, the patients died for unspecified reasons. Within the media report it was stated that it turns out that this vaccine, supposedly protecting against cervical cancer, could be the main killer of women. Firstly, there was no research showing that it really works. Second: the vaccine had been on the market since 2006, but no one has tested it on children under the age of 16. Third: It was issued that the medical records should be kept for as long as 10 years, unless it exists at all. Fourth: lack of complete monitoring system for vaccinated children Fifth: the age of the vaccinated was reduced to the age of 12 and then to the age of 8. Sixth: girls of this age do not have developed sexual organs, so they are damaged during their development. This had been proven. Seventh: the boys were also started vaccinating, allegedly as viral carriers. The problem was that the virus also moves in the saliva and already the newborn baby can be infected with the kisses. Vaccination of an infected child accelerates the development of cancer. Eighth: 95% of the virus dies spontaneously within 6 months. The original work on HPV Gardasil / Silgard, summarizes: "Although HPV was found in cervical cancer, this was not a valid reason to confirm. Thus, other cofactors were essential for the progression of HPV cervical cancer." Long term use of hormonal contraceptives had a very high probability of this change, smoking and concomitant human immunodeficiency virus (HIV) infection have been identified as factors that significantly affect the onset of cancer. Concomitant Chlamydia trachomatis (CT) and herpes simplex virus type 2 (HSV-2), immunosuppression, and even some dietary deficiencies are likely to be responsible for cancer. Also genetic and host immune factors and viral agents such as viral variants and viral integration that may be important but not identified. Already after the first year of GARDASIL sales in 2006, more than 1,600 reports of complications were reported (1703FJI013081), of which 371 were reported as serious (1703FJI013082) and 42 cases were vaccination in pregnant women (1703FJI013083), of which 18 had miscarriage or fetal malformations (1703FJI013084). The Vaccination Information Center noted: 5 deaths of girls (1703FJI013085), 31 reports identified as life-threatening (1703FJI013086) and 1385 cases required acute medical intervention (1703FJI013088). In total, 2207 adverse effects were reported (1703FJI013088). The Journal of Medicine reported that GARDASIL may be more dangerous than it could have been. Comparison with MENACTRA (for meningitis) showed that: At least 2 times more need for home visits in children vaccinated with GARDASIL, four times more reports of fatalities were reported, 6 times more reports of syncope and 7 times more reports. A professor more bluntly defined about such mindless vaccinations to girls, not just boys: "It is not justified to vaccinate the whole population without the number of cases that can be reduced to a fraction of a cent." Correspondingly, cervical screening had virtually eliminated cervical cancer mortality. There were no complications such as those occurring after vaccination. The reporter stated that it should be strongly emphasized that vaccinations do not eliminate cytological tests. There are over 120 types of this virus. However, the authors of a book written specifically for the Internal Medicine Archives write: "Although the HPV virus has not yet grown, but by the use of molecular methods, different genotypes of the virus have been identified " and further: "As many as 120 of these genotypes have been identified but not always corresponding to serotypes. " In other words, despite over 40 years of research, the virus was uncovered. The government had "suspended" the program of vaccinating girls after 4 deaths. "The HPV vaccine was associated with serious adverse events with a high level of reported complication (1703FJI013090). Death and devastating illness have been confirmed (1703FJI013091). " Only in the period from 2010 to 2012 were Human papillomas, type 611,16,18 HPV4, as many as 1253 complications (1703FJI013092). Upon internal review, death was considered to be medically significant. This is one of several cases from the same reporter. Additional information has been requested.; Sender''s Comments: FJ-009507513-1703FJI011425: FJ-009507513-1703FJI013081: FJ-009507513-1703FJI013082: FJ-009507513-1703FJI013083: FJ-009507513-1703FJI013084: FJ-009507513-1703FJI013085: FJ-009507513-1703FJI013086: FJ-009507513-1703FJI013087: FJ-009507513-1703FJI013088: FJ-009507513-1703FJI013090: FJ-009507513-1703FJI013091: FJ-009507513-1703FJI013092:; Reported Cause(s) of Death: death.


VAERS ID: 688858 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-29
Entered: 2017-03-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningococcal sepsis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Sepsis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-03-29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ES2017GSK042789

Write-up: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a male patient who received BEXSERO. Co-suspect products included BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO and the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO and BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal sepsis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningococcal sepsis was fatal. The patient died on 19th March 2017. The reported cause of death was meningococcal sepsis. The reporter considered the vaccination failure and meningococcal sepsis to be unrelated to BEXSERO and BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient died at an age of 15 months. The vaccination dates were unknown at the time of reporting. At the time of reporting, the strain causing the sepsis was unknown. Further information was expected. This case was considered as suspected vaccination failure since the time to onset of the event, confirmed lab serotypes and the vaccination schedule which the patient was following were unknown.


VAERS ID: 689107 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-03
Entered: 2017-04-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asphyxia, Choking, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Vaccine not specified (no brand name)~~0.00~Patient|~Vaccine not specified (no brand name)~~0.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNSA2017SA047998

Write-up: Initial unsolicited report received from the literature on 20-Mar-2017. The case is linked to case 2017SA047904 (same literature). The following is verbatim from the article: Background. The development of a Sabin strain-based inactivated poliovirus vaccine (Sabin-IPV) is imperative to protecting against vaccine-associated paralytic poliomyelitis in developing countries. Methods. In this double-blinded, parallel-group, noninferiority trial, eligible infants aged 60-90 days were randomly assigned in a ratio of 1:1 to receive either 3 doses of Sabin-IPV or Salk strain-based IPV (Salk-IPV) at 30-day intervals and a booster at the age of 18 months. Immunogenicity and safety were assessed on the basis of a protocol. Results. Of 1438 infants, 1200 eligible infants were recruited and received either Sabin-IPV or Salk-IPV. From the Sabin-IPV and Salk-IPV groups, 570 and 564 infants, respectively, completed the primary immunization and formed the per-protocol population. The seroconversion rates of the participants who received Sabin-IPV were 100%, 94.9%, and 99.0% (types I, II, and III, respectively), and those of the participants who received Salk-IPV were 94.7%, 91.3%, and 97.9% 1 month after the completion of primary immunization. An anamnestic response for poliovirus types I, II, and III was elicited by a booster in both groups. Except in the case of fever, other adverse events were similar between the 2 groups. Conclusions. The immune response induced by Sabin-IPV was not inferior to that established with Salk-IPV. This case involves an infant patient (age reported 60-90 days and gender was not reported) who was vaccinated with third primary injection of IPV (VERO) (Salk strain-based IPV or Salk-IPV) (Batch number, expiration date, dose and site of administration were not reported) via intramuscular route on an unspecified date. Patient''s medical history and concomitant medications were not reported. On an unknown date, 28 days following the vaccination, the patient experienced asphyxia which leads to sudden death at home. The patient was previously vaccinated with first and second primary injections of Salk-IPV via intramuscular route on unspecified dates at 30-day intervals. Laboratory investigations and corrective treatment were not reported. It was unknown if autopsy was performed or not. List of documents held by sender: none. Sender''s Comments: In this case reported from an unsponsored clinical study, one patient in the IPV (VERO) group died due to accidental choking 28 days after the third injection. The investigator assessed this event as not related to the vaccine. However few details were reported. Based on available information the role of vaccine appears unlikely. Reported Cause(s) of Death: asphyxia/accidental choking.


VAERS ID: 689110 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-03
Entered: 2017-04-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: RUPFIZERINC2017133853

Write-up: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A child patient of an unspecified age, gender, race and ethnicity received the third dose of PREVENAR 13 single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. Sender''s Comments: The limited information in this report precludes a full assessment of the case. However, per company guidance, "death cause unknown" is processed as "related" until sufficient information becomes available to confirm an unrelated cause of death. Case will be reassessed when follow-up information such medical history, concomitant medications and event term details especially death cause and autopsy results is received. Reported Cause(s) of Death: death.


VAERS ID: 689173 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-06-12
Onset:2015-06-18
   Days after vaccination:6
Submitted: 2017-03-31
   Days after onset:652
Entered: 2017-04-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER AC37B145DF / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Cough, Death, Dyspnoea, Exposure during pregnancy, Hypotension, Myalgia, Oropharyngeal pain, Pyrexia, Rhinitis
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-06-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR2016GSK197882

Write-up: This retrospective pregnancy case was reported by a consumer via licensee and described the occurrence of unknown cause of death in a 20-year-old female patient who received REFORTRIX (batch number AC37B145DF, expiry date unknown). Co-suspect products included Influenza vaccine (batch number 15017A ?, expiry date unknown). On 12th June 2015, the patient received REFORTRIX (intramuscular). On 15th May 2015, the patient received Influenza vaccine (intramuscular). The patient''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received REFORTRIX during the third trimester of pregnancy. On 18th June 2015, 6 days after receiving REFORTRIX and 34 days after receiving Influenza vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the patient experienced hypotension (serious criteria hospitalization), dyspnea (serious criteria hospitalization), throat pain (serious criteria hospitalization), dry cough (serious criteria hospitalization), fever (serious criteria hospitalization), myalgia (serious criteria hospitalization), arthralgia (serious criteria hospitalization), coryza (serious criteria hospitalization) and vaccine exposure during pregnancy. On 18th June 2015, the outcome of the hypotension, dyspnea, throat pain, dry cough, fever, myalgia, arthralgia and coryza were unknown. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was lost to follow up. The patient died on 18th June 2015. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, hypotension, dyspnea, throat pain, dry cough, fever, myalgia, arthralgia and coryza to be related to REFORTRIX. It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine. The reporter considered the hypotension, dyspnea, throat pain, dry cough, fever, myalgia, arthralgia and coryza to be related to Influenza vaccine. Additional information was provided as follows: The patient was 34 weeks pregnant. Less than week after receiving REFORTRIX and less than week after receiving Influenza vaccine, the patient experienced hypotension, dyspnea, throat pain, dry cough, fever, myalgia, arthralgia and coryza. On 16th June 2015, the patient was hospitalized. At night of 18th June 2015, the patient died. The physician suspected of influenza vaccine. The hospital sent the notification but tests were not performed to diagnose and the declaration of obit was failure. No further details were provided.


VAERS ID: 689336 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2013-06-03
Onset:2017-03-01
   Days after vaccination:1367
Submitted: 2017-04-04
   Days after onset:33
Entered: 2017-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER J40008 / 3 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G79394 / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Encephalitis
SMQs:, Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-03-01
   Days after onset: 0
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZERINC2017140778

Write-up: This is a spontaneous report from a contactable physician. A 5 year-old female patient of an unspecified race and ethnicity received for immunization via an unspecified route of administration four single doses of PREVENAR 13, the first dose (lot F72853) on 02Jul2012, the second dose (lot F93511) on 02Aug2012, the third dose (lot F32598) on 18Sep2012 and the fourth dose (lot G79394) on 03Jun2013. The patient medical history and concomitant medications were not reported. The patient was diagnosed with meningoencephalitis in hospital on an unspecified date in Mar2017, she received as treatment a third generation of cephalosporin immediately, but she died after a few hours. It was not reported if an autopsy was performed. Sender''s Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate. Reported Cause(s) of Death: Meningoencephalitis.


VAERS ID: 689508 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2017-03-27
Onset:2017-03-28
   Days after vaccination:1
Submitted: 2017-04-05
   Days after onset:8
Entered: 2017-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 1 MO / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Central nervous system infection, Convulsions local, Death, Electroencephalogram abnormal, General physical health deterioration, Hypotension, Hypoxia, Lumbar puncture, Mechanical ventilation, Muscle twitching, Oxygen saturation decreased, Ultrasound skull abnormal
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac disorder; Hospitalization
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac operation
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075131704AUS000512

Write-up: This spontaneous report was received from the patient''s parent referring to a 9 week old male patient. The patient''s pertinent medical history included complex cardiac history and recent cardiac surgery. The patient''s drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 27-MAR-2017, while being hospitalized, the patient was vaccinated with the first dose of ROTATEQ per oral, for prophylaxis (lot # and expiration date were not reported). Other suspect therapies included INFANRIX HEXA and PREVENAR 13, both first doses. On 28-MAR-2017, the patient developed localized seizures in left arm. It was stated that the patient''s left arm twitched 15 to 20 seconds continuously on and off. It was stated that a meningeal lumbar puncture (LP) was performed (no results reported) and that the patient had no fever. On the same day, a head ultrasound showed thickened meninges and abnormality in left caudate nucleus. An Electroencephalogram (EEG) showed multifocal epileptiform appearance. A magnetic resonance imaging (MRI) was planned but it was unknown if it was performed. On this day, the patient was treated with antiepileptic, antibiotics and antiviral therapies for a central nervous system (CNS) infection. On 31-MAR-2017, the patient became rapidly hypotensive and desaturated. It was stated that the patient received large dose of unspecified inotropes and vasopressors to maintain blood pressure and the patient was put on high-frequency oscillator ventilator. It was stated that the patient continued to deteriorate and after a discussion with his family, the decision was made to stop treatment. The patient was extubated at 19:15 and passed away shortly afterwards. The cause of the death was not reported. It was unknown if an autopsy was performed. The reporter considered the events to be possibly related to ROTATEQ, INFANRIX HEXA and PREVENAR 13. Upon internal review localized seizures, hypoxia, central nervous system infection and death were determined to be medically significant events. Additional information is not expected.


VAERS ID: 689530 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-04
Entered: 2017-04-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Left ventricular dysfunction; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU2017GSK046876

Write-up: This case was reported in a literature article and described the occurrence of cardiac arrest in a 77-year-old male subject who received Flu seasonal TIV Dresden. Concurrent medical conditions included left ventricular dysfunction and hypertension. On an unknown date, 9 hrs after receiving Flu seasonal TIV Dresden, the subject developed cardiac arrest. Serious criteria included death and GSK medically significant. The outcome of cardiac arrest was fatal. The reported cause of death was cardiac arrest. The investigator considered the cardiac arrest to be possibly related to Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of sudden cardiac arrest in a 77-year-old male patient who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown). The patient was a part of the report that summarized the national passive surveillance data for adverse events following immunisation (AEFI) reported to the Administration for 2014. The report focused on AEFI reported for vaccines administered during 2014 and trends in AEFI reporting over the 15-year period between 1 January 2000 and 31 December 2014. AEFI were notified to the Administration by state and territory health departments, health professionals, vaccine manufacturers and members of the public. All reports are assessed using internationally consistent criteria entered into the Adverse Drug Reactions System (ADRS) database. The patient had left ventricular dysfunction and a medical history of hypertension. No information on patient''s family history or concomitant medication was provided. On an unspecified date between 1 January 2014 and 31 December 2014, the patient received unspecified seasonal influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date in 2014, 9 hours later after vaccination, the patient had sudden cardiac arrest. Subsequently, the patient died from sudden cardiac arrest. It was unknown if an autopsy was performed. This case has been considered serious due to death. Treatment was unknown. The authors stated "All deaths were investigated by the Administration and no clear causal relationship with vaccination was found. The death NOS was temporally associated with the receipt of vaccine". The authors concluded that "The total number of reported AEFI in 2014 decreased compared with 2013. The majority of AEFIs reported to the Administration were mild transient events. The data reported here are consistent with an overall high level of safety for vaccines included in the schedule". This is 1 of the 5 valid cases reported in the same literature article.


VAERS ID: 689533 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-04
Entered: 2017-04-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Death
SMQs:, Noninfectious encephalitis (narrow), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Wound infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU2017GSK047446

Write-up: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 58-year-old male subject who received Flu seasonal TIV Dresden. Concurrent medical conditions included wound infection. On an unknown date, 5 days after receiving Flu seasonal TIV Dresden and DT vaccine (UNK), the subject developed acute disseminated encephalomyelitis. Serious criteria included death and GSK medically significant. The outcome of acute disseminated encephalomyelitis was fatal. The reported cause of death was acute disseminated encephalomyelitis. The investigator considered the acute disseminated encephalomyelitis to be possibly related to Flu seasonal TIV Dresden and DT vaccine (UNK). Additional information was provided. This case was reported in a literature article and described the occurrence of acute disseminated myeloencephalitis in a 58-year-old male patient who was vaccinated with unspecified DT vaccine and unspecified seasonal influenza vaccine (manufacturer unknown for both). The patient was a part of the report that summarized the national passive surveillance data for adverse events following immunisation (AEFI) reported to the Administration for 2014. The report focused on AEFI reported for vaccines administered during 2014 and trends in AEFI reporting over the 15-year period between 1 January 2000 and 31 December 2014. AEFI were notified to the Administration by state and territory health departments, health professionals, vaccine manufacturers and members of the public. All reports are assessed using internationally consistent criteria entered into the Adverse Drug Reactions System (ADRS) database. The patient had an infected leg wound prior to vaccination. No information on patient''s family history or concomitant medication or concurrent condition was provided. On an unspecified date between 1 January 2014 and 31 December 2014, the patient received unspecified DT vaccine and unspecified seasonal influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided for both). On an unspecified date in 2014, 5 days after vaccination, the patient developed the symptoms of acute disseminated myeloencephalitis, which progressed over 6 weeks leading to death. It was unknown if an autopsy was performed. This case has been considered serious due to death. Treatment was unknown. The authors stated "All deaths were investigated by the Administration and no clear causal relationship with vaccination was found. The death NOS was temporally associated with the receipt of vaccine". The authors concluded that "The total number of reported AEFI in 2014 decreased compared with 2013. The majority of AEFIs reported to the Administration were mild transient events. The data reported here are consistent with an overall high level of safety for vaccines included in the schedule". This is 1 of the 5 valid cases reported in the same literature article.


VAERS ID: 689709 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-05
Entered: 2017-04-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAPIPV: TDAP + IPV (FOREIGN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bordetella test positive, Death, Exposure during pregnancy, Pertussis
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests were performed on an unspecified date in 2014, the patient was diagnosed with laboratory confirmed pertussis.
CDC Split Type: GB2017GSK048296

Write-up: This retrospective pregnancy case was reported in a literature article and described the occurrence of pertussis in a infant. The mother received DTPa-IPV vaccine. The infant was exposed to DTPa-IPV vaccine during the third trimester of pregnancy. The pregnancy resulted in a live neonate with no apparent congenital anomaly. The infant was diagnosed with pertussis. Serious criteria included death and GSK medically significant. Additional even(s) included maternal exposure during pregnancy, third trimester. The outcome of pertussis was fatal. The outcome(s) of the additional event(s) included material exposure during pregnancy, third trimester (unknown). The reported cause of death was pertussis. The investigator considered that there was a reasonable possibility that the pertussis may have been caused by DTPa-IPV vaccine. Relevant Tests: Lab tests were performed on an unspecified date in 2014, the patient was diagnosed with laboratory confirmed pertussis. Additional information was provided. This retrospective pregnancy case was reported in a literature article and described the occurrence of pertussis infection in an infant aged less than 2 months of unspecified gender whose mother was vaccinated with unspecified DT3aP-IPV during pregnancy. The patient was a part of the study that updated the previously published estimates of vaccine effectiveness (VE) of the maternal program in this country, 3 years following its introduction, and provide the first estimates for the effectiveness of the maternal program on infant deaths and the comparative effectiveness of DT5aP-IPV and DT3aP-IPV on infant disease. No information on patient''s family or medical history or concurrent condition or concomitant medication was provided. On an unspecified date, in or after July 2014, the patient''s mother had received unspecified DT3aP-IPV vaccine (administration site and route; dosages unknown; batch number not provided) less than 10 days before delivery. Subsequently, the foetus was exposed to the vaccine. On an unspecified date in 2014, at the age of less than 2 months, an unknown period after vaccination, the patient was diagnosed with laboratory confirmed pertussis. [In this country, laboratory confirmation can either occur at the local hospital microbiology laboratory (culture); through the regional Public Health (PH) laboratory network (polymerase chain reaction available through the regional network since July 2017 for all age groups); or at the national reference laboratory (serological testing available since 2001 for all age groups)]. (In this study, all laboratory-confirmed cases are followed up with the patients general practitioner to collect additional clinical and epidemiological data including vaccination history and, for infants born after 1 October 2012, the maternal vaccination status). Subsequently, the patient died. It was unknown if an autopsy was performed. This case was considered serious due to death. Treatment was unknown. The authors did not comment on the relationship between pertussis infection and unspecified DT3aP-IPV vaccine. However the authors stated "maternal vaccination did not occur in the optimal period to confer protection to the infant". The authors concluded that "Our analysis suggests that similarly high levels of protection are conferred to infants whose mothers received vaccine at least 4 weeks and 1-4 weeks prior to delivery. The levels of protection decline significantly for the relatively low number of infants whose mothers received vaccine around the time of delivery, and any residual protection that may be conferred is likely to reflect the indirect protection from reduced maternal exposure. The 3-component vaccine is 5% lower than that of the 5-component vaccine, they are not significantly different. High levels of protection are conferred to infants who have received their first dose of the primary series. After the third infant dose, the numbers are small and there is no longer evidence of protection. However, importantly, the estimates are above 0%, which indicates that there is no evidence of greater risk of disease after primary immunization, in those infants whose mothers received vaccine during pregnancy. Although this provides some reassurance, given the low numbers, this question requires ongoing assessment to determine if this continues to be the case. It is important to note that some protective effect may be expected to last beyond the primary vaccination series in the child due to the mother being less likely to transmit. This may mask an interference effect on the direct protection in the child". This is 1 of the 2 valid cases from the same reported literature article.


VAERS ID: 689712 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-05
Entered: 2017-04-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAPIPV: TDAP + IPV (FOREIGN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bordetella test positive, Death, Foetal exposure during pregnancy, Pertussis
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests were performed on an unspecified date between July 2014 and 2015, the patient was diagnosed with laboratory confirmed pertussis.
CDC Split Type: GB2017GSK048394

Write-up: This retrospective pregnancy case was reported in a literature article and described the occurrence of pertussis in a infant. The mother received DTPa-IPV vaccine. The infant was exposed to DTPa-IPV vaccine during the third trimester of pregnancy. The pregnancy resulted in a live neonate with no apparent congenital anomaly. The infant was diagnosed with pertussis. Serious criteria included death and GSK medically significant. Additional event(s) included maternal exposure during pregnancy, third trimester. The outcome of pertussis was fatal. The outcome(s) of the additional event(s) included maternal exposure during pregnancy, third trimester (unknown). The reported cause of death was pertussis. The investigator considered that there was a reasonable possibility that the pertussis may have been caused by DTPa-IPV vaccine. Relevant Tests: Lab tests were performed on an unspecified date between July 2014 and 2015, the patient was diagnosed with laboratory confirmed pertussis. Additional information was provided. This retrospective pregnancy case was reported in a literature article and described the occurrence of pertussis infection in an infant aged less than 2 months of unspecified gender whose mother was vaccinated with unspecified diphtheria-tetanus-3-component acellular pertussis-inactivated polio vaccine (dT3aP-IPV) (PT: 8 ug; FHA: 8 ug; PRN: 2.5 ug) during pregnancy. The patient was a part of the study that updated the previously published estimates of vaccine effectiveness (VE) of the maternal program, 3 years following its introduction, and provide the first estimates for the effectiveness of the maternal program on infant deaths and the comparative effectiveness of diphtheria-tetanus-5-component acellular pertussis-inactivated polio vaccine (dT5aP-IPV) and dT3aP-IPV on infant disease. No information on patient''s family or medical history or concurrent condition or concomitant medication was provided. On an unspecified date, in or after July 2014, the patient''s mother had received unspecified dT3aP-IPV vaccine (administration site and route; dosages unknown; batch number not provided) less than 10 days before delivery. Subsequently, the foetus was exposed to the vaccine. On an unspecified date between July 2014 and 2015, at the age of less than 2 months, an unknown period after vaccination, the patient was diagnosed with laboratory confirmed pertussis. [Laboratory confirmation can either occur at the local hospital microbiology laboratory (culture); through the regional Public Health (PHE) laboratory network (polymerase chain reaction available through the regional network since July 2014 for all age groups); or at the national reference laboratory (serological testing available since 2001 for all age groups)]. (In this study, all laboratory-confirmed cases are followed up with the patients general practitioner to collect additional clinical and epidemiological data including vaccination history and, for infants born after 1 October 2012, the maternal vaccination status). Subsequently, in 2015, the patient died. It was unknown if an autopsy was performed. This case was considered serious due to death. Treatment was unknown. The authors did not comment on the relationship between pertussis infection and unspecified dT3aP-IPV vaccine. However the authors stated "maternal vaccination did not occur in the optimal period to confer protection to the infant". The authors concluded that "Our analysis suggests that similarly high levels of protection are conferred to infants whose mothers received vaccine at least 4 weeks and 1-4 weeks prior to delivery. The levels of protection decline significantly for the relatively low number of infants whose mothers received vaccine around the time of delivery, and any residual protection that may be conferred is likely to reflect the indirect protection from reduced maternal exposure. The 3-component vaccine is 5% lower than that of the 5-component vaccine, they are not significantly different. High levels of protection are conferred to infants who have received their first dose of the primary series. After the third infant dose, the numbers are small and there is no longer evidence of protection. However, importantly, the estimates are above 0%, which indicates that there is no evidence of greater risk of disease after primary immunization, in those infants whose mothers received vaccine during pregnancy. Although this provides some reassurance, given the low numbers, this question requires ongoing assessment to determine if this continues to be the case. It is important to note that some protective effect may be expected to last beyond the primary vaccination series in the child due to the mother being likely to transmit. This may mask an interference effect in the direct protection in the child." This is 1 of the 2 valid cases from the same literature article.


VAERS ID: 689791 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2016-11-21
Onset:2016-11-22
   Days after vaccination:1
Submitted: 2017-04-07
   Days after onset:135
Entered: 2017-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 RA / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR M74541M / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute respiratory failure, Autopsy, Circulatory collapse, Death, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20161122060000; Test Name: body temperature; Result Unstructured Data: 41 Celsius temperature
CDC Split Type: CNSA2017SA054517

Write-up: Initial unsolicited report received from a POV physician via company representative through the Health Authority on 29-Mar-2017. This case involves a four-month-old female patient who was vaccinated with one dose of 0.5 ml Imovax polio via intramuscular (batch number M74541M, expiration date was not reported) in the left arm on 21-Nov-2016 in the afternoon. Patient''s medical history was not reported. Patient''s concomitant medications included DTP (batch number and expiration date not reported) given intramuscularly in the right arm on 21-Nov-2016. On 22-Nov-2016 at about 06:00 AM, few hours following the vaccination, the patient had fever of 41 degrees Celsius. On the same date, few hours post vaccination, at noon the patient died. Death was caused by bronchial pneumonia (revealed in autopsy) The events acute respiratory and circulatory failure were also revealed from the autopsy. Other laboratory investigations was not reported. Patient''s received corrective treatment with AMINOPHENAZONE and RIBAVIRIN for fever. The outcome of the events was reported as fatal. The autopsy conclusion was reported as coincidence. List of documents held by sender: none. Sender''s Comments: This is a death case of 4 month old female who died next day after receiving IMOVAX POLIO and DTP. Reportedly the patient had fever next day and cause of death in autopsy was acute respiratory and circulatory failure due to bronchial pneumonia. As time to onset is too short for bronchial pneumonia to present, this could be preexisting which suggest alternative etiology. Based on available information and autopsy report the role of vaccine is unlikely. Reported Cause(s) of Death: Acute respiratory and circulatory failure; Acute respiratory and circulatory failure; bronchial pneumonia; Autopsy-determined Cause(s) of Death: Acute respiratory and circulatory failure; Acute respiratory and circulatory failure; bronchial pneumonia.


VAERS ID: 689871 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-03-30
Onset:2017-03-30
   Days after vaccination:0
Submitted: 2017-04-06
   Days after onset:7
Entered: 2017-04-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK AR / UN
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK AR / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Fatigue, Respiration abnormal, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NA2017GSK047070

Write-up: This case was reported by a non-health professional via other and described the occurrence of death in a 3-year-old female patient who received RABIPUR. Co-suspect products included Tetanus vaccine. On 30th March 2017, the patient received RABIPUR and Tetanus vaccine. On 30th March 2017, 2 hrs after receiving RABIPUR and Tetanus vaccine, the patient experienced death (serious criteria death and GSK medically significant). On 30th March 2017, the outcome of the death was fatal. The patient died on 30th March 2017. The reported cause of death was death. It was unknown if the reporter considered the death to be related to RABIPUR and Tetanus vaccine. Additional details were provided as follows: This was the report that was in the local newspaper. The patient''s aunt told the newspaper at the family home on Wednesday that that last week Thursday they left together for spending the weekend at her grandmother''s house. But, while walking along Street a dog attacked. The reporter did not expect the dog to bite the patient. The reporter picked her up, but it was too late because the dog''s teeth had left a scratch mark on the patient, although there was no blood. To play it safe, the reporter took the patient to the hospital for an injection. On their way to the hospital, the patient told to aunt that she would report the dog to her father, and that the dog was naughty. The reporter said that the patient was brave because when the dog attacked her, she was not afraid. When they got to the hospital, a doctor referred them to a nurse for the anti-rabies injection. The reporter asked the doctor if that was all, and he said yes, the patient just needed an injection. There were two nurses where the patient was to get her injection, and one, a student nurse, prepared the injections while the other nurse watched. The nurse administered two injections on the patient one on the left and another on the right arm. But after they walked for about 80 meters on their way home, the patient told that she was feeling tired. The reporter picked her up, and those were the last words she spoke to the aunt. The patient slept throughout until to reach home. When they got home, her cousin asked about the patient''s condition, and was told the child was feeling tired and slept. The reporter when looked at the patient, she realized that something was wrong because the patient''s breathing was not normal and she checked if her heart was beating, and immediately suggested that we must take her back to hospital. When they got to the hospital, the nurses were rude towards them. They told them they were too busy, and should wait. The reporter panicked, and told them that the patient was not well. While they were waiting, the reporter saw the doctor who had earlier referred them to the nurses, and called the doctor, who asked whether this was not the girl she had just examined. The doctor took one look at the patient and rushed her to the big room. The patient was immediately put on intravenous drip and given oxygen, but they could not save her. She died after 2 hours of administration of vaccine (at 12h 25). Health minister said they were investigating the patient''s death, while the ministry''s spokesperson, yesterday said they were waiting for test results on the vaccine. The patient was given anti-rabies vaccine and tetanus-toxoid injections on both arms. The Medical Regulatory Council took the vaccine, and was waiting for results. Inspector said they tested the dog, and it was negative for rabies, but had been put down. The reason for putting down the dog was to test the brains for rabies, and that could not do while it was alive", the paper stated. The regional police crime investigations coordinator, deputy commissioner said an inquest docket had been opened, and that police investigations were underway. The patient''s father, yesterday said he could not talk. It was really a hard time for him. The REP tried getting information from the hospital about batch/lot numbers for the vaccine. They told her that unfortunately they could not give it to her as they were busy with their own investigation.


VAERS ID: 690023 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-11
Entered: 2017-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131704GBR003037

Write-up: This spontaneous report as received from the author of the online article refers to unspecified 6 patients of unknown age and gender. There was no information about the patients'' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with GARDASIL (dose, route of administration, lot # and expiration date were not reported). On unknown dates, the patients died. The causes of patients'' deaths were not reported. The relatedness between the event and GARDASIL was not reported. Upon internal review, the event of patients'' death was considered to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected as follow up was not required.; Sender''s Comments: GB-009507513-1704GBR002599: GB-009507513-1704GBR003032: GB-009507513-1704GBR003034: GB-009507513-1704GBR003035: GB-009507513-1704GBR003036: GB-009507513-1704GBR003038: GB-009507513-1704GBR003039: GB-009507513-1704GBR003040: GB-009507513-1704GBR003060: GB-009507513-1704GBR003033:


VAERS ID: 690266 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-11
Entered: 2017-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Dehydration, Diarrhoea
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Dehydration (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IN2017GSK048999

Write-up: This case was reported by a physician via sales rep and described the occurrence of dehydration in a 4-month-old female patient who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, less than a year after receiving Rotavirus vaccine, the patient experienced dehydration (serious criteria death and hospitalization) and diarrhea (serious criteria hospitalization). On an unknown date, the outcome of the dehydration was fatal and the outcome of the diarrhea was unknown. The reported cause of death was dehydration. An autopsy was not performed. It was unknown if the reporter considered the dehydration and diarrhea to be related to Rotavirus vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had completed rotavirus vaccine schedule (date and brand unknown). The physician was not sure about the brand name of the rotavirus vaccine given to the child in the past. The patient was hospitalized due to severe diarrhoea and then could not survive due to severe dehydration. The physician did not related the death due to vaccine but he questions the efficacy of all Rotavirus vaccines. The post mortem and autopsy was not done.


VAERS ID: 690263 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2017-03-02
Onset:2017-03-02
   Days after vaccination:0
Submitted: 2017-04-12
   Days after onset:40
Entered: 2017-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER M8281V / UNK LG / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER M55231V / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N51781 / UNK RL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB500AA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Crying, Death, Epistaxis, Pulse absent, Unresponsive to stimuli
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-03-02
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZA2017GSK049850

Write-up: This case was reported by a other health professional via licensee and described the occurrence of unknown cause of death in a 6-week-old male patient who received ROTARIX liquid formulation (batch number AROLB500AA, expiry date May 2018). Co-suspect products included OPV (batch number M55231V, expiry date September 2017), HEXAXIM (batch number M8281V, expiry date June 2018) and PCV 13 vaccine (batch number N51781, expiry date October 2018). On 2nd March 2017, the patient received ROTARIX liquid formulation (oral), OPV, HEXAXIM and PCV 13 vaccine. On 2nd March 2017, less than a day after receiving ROTARIX liquid formulation and an unknown time after receiving OPV, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), unresponsive to stimuli (serious criteria GSK medically significant), crying uncontrollable, pulse absent and epistaxis. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the unresponsive to stimuli, crying uncontrollable, pulse absent and epistaxis were unknown. The patient died on 2nd March 2017. The reported cause of death was unknown cause of death. An autopsy was not performed. It was unknown if the reporter considered the unknown cause of death, unresponsive to stimuli, crying uncontrollable, pulse absent and epistaxis to be related to ROTARIX liquid formulation. Additional details were provided as follows: On 2nd March 2017, the patient was brought in by the mother at Clinic for his 6 weeks immunization. The patient received PCV 13 vaccine on the Right thigh. The patient''s father brought a letter to the clinic, stipulating his dissatisfaction about the treatment received at the facility and to report that his son has passed away, suspecting that it was due to Immunization. The nurse, who was trained in Expanded Program Immunization (EPI) and Integrated Management of Childhood Illness (IMCI), vaccinated the patient. The nurse stated that she did not remember the patient because they had a lot of clients that day and there was an inspection from National Office. The nurse, verbalized that routinely she would ask the mother to administer the Rotavirus whilst she was busy preparing for other vaccines. The cold chain was reported, the vaccines were stored in the fridge, which was in good working condition (800L and minus 40). The temperature chart was checked and the reading was 4.0 degrees Celsius. The vaccine fridge was well packed and clean. There was electricity interruption between the 28th February 2017 and the 01st March 2017 and the vaccines were moved to another clinic as contingency plan. That morning vaccines had to be fetched from the one clinic to the other clinic for the session. The antigens were not expired and record keeping was good. The home visit was done, and the patients mother reported that she arrived at the clinic around 08:00 am and was only seen after 14:00 pm, she was given a number 20 to wait in the waiting area and the patient was weighed at the reception and was told to wait again. After a while the nurse told her to come into the consultation room, she referred to the nurse as being rude and non-cooperative. The patient''s mother was then given Rotavirus vaccine by the nurse to administer to the child and then she noticed prefilled syringes on the table and was not inside the cooler box. The patient was injected in both thighs and she was then told to come back on 30th March 2017. Upon leaving the clinic, the patient''s mother came across another mother who had brought a 6 weeks old and she asked that mother whether her baby received one drop in the mouth but to her surprise the other baby was given 2 drops in the mouth. On the same day of vaccination, the patient''s mother verbalized that the patient was crying uncontrollably and she did not act on that because she thought that the reaction was because of the injections. The patient''s mother then prepared the feeds for the patient which was formula around 22:00, then the patient was slept after bottle fed. After 2 hours, the patient mother woke up to check on the patient but he was unresponsive, the pulse was not there and the mother noticed blood oozing out of the infants nostrils, she called a friend, who alerted the paramedics and the declared the patient dead. The postmortem was not done. The patient was buried in another Province the very same week. The challenges were reported as the patient''s father was very angry and there was inconsistencies in both the mother and the father''s statements.


VAERS ID: 690713 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2017-03-20
Onset:2017-03-21
   Days after vaccination:1
Submitted: 2017-04-14
   Days after onset:24
Entered: 2017-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC843A / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R93692 / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Adenovirus test, Autopsy, Blood culture negative, Blood fibrinogen increased, Body temperature decreased, Bordetella test negative, C-reactive protein increased, CSF culture negative, CSF glucose, CSF protein, CSF red blood cell count positive, CSF white blood cell count increased, Cardio-respiratory arrest, Chlamydia test negative, Coagulation test normal, Computerised tomogram abnormal, Computerised tomogram head normal, Culture stool negative, Cyanosis, Decreased appetite, Diarrhoea, Enterovirus test negative, Gastrooesophageal reflux disease, Haematochezia, Haemoglobin decreased, Human metapneumovirus test, Human rhinovirus test, Hypotonia, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Lymphocyte percentage increased, Mycoplasma test negative, Neutrophil percentage decreased, Pallor, Platelet count increased, Procalcitonin increased, Respiratory syncytial virus test negative, Resuscitation, Skeletal survey normal, Sudden infant death syndrome, Viral test negative, White blood cell count increased, Whole body scan
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Agranulocytosis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-03-22
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Enteral nutrition (complete enteral nutrition possible from Day13); Mechanical ventilation (until Day 6); Neonatal jaundice; Neonatal respiratory distress (transient neonatal respiratory distress requiring ventilation until Day 6); Phototherapy (from Day 3 to Day 7); Prematurity (birth at 31 weeks)
Allergies:
Diagnostic Lab Data: Test Date: 20170322; Test Name: Adenovirus serology NOS; Result Unstructured Data: Test Result: negative; Test Date: 20170322; Test Name: Blood culture; Result Unstructured Data: Test Result: 2 distinct cultures negative; Test Date: 201703; Test Name: Fibrinogen; Result Unstructured Data: Test Result: 5.1, Test Result Unit: g/l; Test Date: 201703; Test Name: Blood pressure; Result Unstructured Data: Test Result: 69/54, Test Result Unit: mmHg; Test Date: 20170322; Test Name: Body height; Result Unstructured Data: Test Result: 54; Test Date: 201703; Test Name: Body temperature; Result Unstructured Data: Test Result: 37.1, Test Result Unit: Centigrade; Test Date: 20170322; Test Name: Body temperature; Result Unstructured Data: Test Result: 33.7, Test Result Unit: Centigrade; Test Date: 20170322; Test Name: Body temperature; Result Unstructured Data: Test Result: 32, Test Result Unit: Centigrade; Test Date: 20170322; Test Name: Bordetella test; Result Unstructured Data: Test Result: negative; Test Date: 20170322; Test Name: Bordetella test; Result Unstructured Data: Test Result: negative; Test Date: 20170322; Test Name: Chlamydia test; Result Unstructured Data: Test Result: negative; Test Date: 201703; Test Name: Coagulation test; Result Unstructured Data: Test Result: normal; Test Date: 20170322; Test Name: Whole body CAT; Result Unstructured Data: Test Result: no pneumoperitoneum, no intraperitoneal effusion; Test Date: 20170322; Test Name: Brain CT; Result Unstructured Data: Test Result: neither intra nor peri-cerebral hemorrhagic lesion; Test Date: 201703; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 22, Test Result Unit: mg/l; Test Date: 20170322; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 19, Test Result Unit: mg/l; Test Name: CSF culture; Result Unstructured Data: Test Result: negative, no germ; Test Date: 20170322; Test Name: CSF glucose; Result Unstructured Data: Test Result: 1.9, Test Result Unit: mmol/l; Test Date: 20170322; Test Name: CSF protein; Result Unstructured Data: Test Result: 0.95, Test Result Unit: g/l; Test Date: 20170322; Test Name: CSF red blood cell count; Result Unstructured Data: Test Result: 3; Test Date: 20170322; Test Name: CSF white blood cell count; Result Unstructured Data: Test Result: 26; Test Date: 20170322; Test Name: Culture; Result Unstructured Data: Test Result: polymorph flora; Test Date: 20170322; Test Name: Stool culture; Result Unstructured Data: Test Result: negative; Test Date: 20170322; Test Name: Enterovirus test; Result Unstructured Data: Test Result: negative; Test Date: 201703; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 10, Test Result Unit: g/dl; Test Date: 20170322; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 7.9, Test Result Unit: g/dl; Test Date: 20161219; Test Name: Head circumference; Result Unstructured Data: Test Result: 28; Test Date: 201703; Test Name: Heart rate; Result Unstructured Data: Test Result: 168; Test Date: 20170322; Test Name: Human rhinovirus test; Result Unstructured Data: Test Result: negative; Test Date: 20170322; Test Name: Influenza A virus test; Result Unstructured Data: Test Result: negative; Test Date: 20170322; Test Name: Influenza B virus test; Result Unstructured Data: Test Result: negative; Test Date: 20170322; Test Name: Influenza serology; Result Unstructured Data: Test Result: negative; Test Date: 20170322; Test Name: Lumbar puncture; Result Unstructured Data: Test Result: clear and colorless cerebrospinal fluid; Test Date: 20170322; Test Name: Lymphocyte count; Test Result: 83 %; Test Date: 20170322; Test Name: Mycoplasma test; Result Unstructured Data: Test Result: negative; Test Date: 20170322; Test Name: Neutrophil count; Test Result: 14 %; Test Date: 201703; Test Name: Oxygen saturation; Test Result: 100 %; Test Date: 201703; Test Name: Physical examination; Result Unstructured Data: Test Result: good general condition; Test Date: 20170322; Test Name: Physical examination; Result Unstructured Data: Test Result: normal; Test Date: 20170322; Test Name: Physical examination; Result Unstructured Data: Test Result: no rash, soft abdomen,no sign suggestive of trauma; Test Date: 20170322; Test Name: Platelet count; Result Unstructured Data: Test Result: 496000; Test Date: 201703; Test Name: Platelet count; Result Unstructured Data: Test Result: 435, Test Result Unit: x10 9/l; Test Date: 20170322; Test Name: Procalcitonin; Result Unstructured Data: Test Result: 0.00029, Test Result Unit: ug/ml; Test Date: 20170322; Test Name: Respiratory syncytial virus serology; Result Unstructured Data: Test Result: negative; Test Date: 20170322; Test Name: X-ray of whole skeleton; Result Unstructured Data: Test Result: no traumatic bone injury; Test Date: 20170322; Test Name: Viral test; Result Unstructured Data: Test Result: negative; Test Date: 20170322; Test Name: Viral test; Result Unstructured Data: Test Result: negative; Test Date: 20170322; Test Name: Viral test; Result Unstructured Data: Test Result: negative; Test Date: 201703; Test Name: Weight; Test Result: 3870 g; Test Date: 20170322; Test Name: Weight; Test Result: 3798 g; Test Date: 20170322; Test Name: Weight; Test Date: 20170322; Test Name: Leukocyte count NOS; Result Unstructured Data: Test Result: 35500
CDC Split Type: FRPFIZERINC2017157577

Write-up: This is a spontaneous report received from the Agency, regulatory authority report number FR-AFSSAPS-PB20170386. A 03-month-old female patient of an unspecified race received the second dose of PREVENAR 13 (lot number R93692) at 0,5ml single dose and the second dose of INFANRIX HEXA (ACELLULAR), manufacturer GlaxoSmithKline, (lot number A21CC843A) at 1DF single dose both by unspecified route, on 20Mar2017 for immunization. The first dose of both vaccines were administered on 03Feb2017. Relevant medical history included prematurity with birth at 31 weeks post-last menstrual period by cesarean-section performed emergently for severe pre-eclampsia. At birth weight was 1290 g, height 39 cm and head circumference 28 cm. She then had transient neonatal respiratory distress requiring ventilation until day 6, neonatal jaundice requiring phototherapy from day 3 to day 7, and complete enteral nutrition possible from day 13. The outcome of prematurity was satisfactory with good general condition. No concomitant treatment was reported. On 22Mar2017, the patient was the subject of sudden infant death. On 20Mar2017, for 3-month visit at child the examination was normal. On that day, the mother reported one previous episode of blood traces in stools but nothing was observed during the examination. The mother was advised to consult the emergency room in case of recurrence. Second injection of vaccination with pneumococcal 13-valent conjugate vaccine and Diphtheria, Tetanus, acellular Pertussis, Hepatitis b, inactivated Poliomyelitis and conjugated Haemophilus influenzae type b vaccines was performed. On 21Mar2017, the mother noticed several diarrhea episodes for 2-3 days, with some reflux more important than usual. In the evening, the mother worried about a trickle of red blood in each stool. The mother visited the emergency room at 11:23 pm: the patient was in good general condition, with a weight of 3870 g, temperature at 37.1?C, heart rate at 168 beats per minute, blood pressure at 69/54mmHg, and saturation of 100%. No constipation, no abdominal discomfort, no vomiting, no malaise were found. Laboratory tests revealed hemoglobin 10 g/dl, platelet count 435x10^9/l, normal coagulation, fibrinogen 5.1 g/l, C-reactive protein 22 mg/l. It was advised to come again the following day to perform stool culture. The patient was discharged from the emergency room at 4:27 am. The mother reported to have given a bottle of milk but the patient drunk a little. Then the mother placed the baby on her back in the bed. She gave another bottle of milk at 06:00 am but the patient drunk just a little (not a full bottle). The patient was put in her bed. At 09:25 am, the patient was found lifeless on her bed, very pale, with mild cyanosed lips, and open mouth, in cardio-respiratory arrest. The body temperature seemed normal. The patient was hypotonic. The first aid techniques were performed. The emergency medical service was called: complete resuscitation was performed but cardiac activity did not recover. The temperature was 33.7?C. On admission to the hospital, the baby was "nice" with no sign of dehydration, weight of 3798 g, height of 54 cm, head circumference of 35 cm, temperature of 32?C. No rash, soft abdomen, no sign suggestive of trauma. Additional tests: complete blood count revealed leukocyte count at 35 500 with 83% of lymphocytes and 14% of neutrophils, hemoglobin at 7.9 g/dl, platelet count at 496 000; C-reactive protein at 19 mg/l, procalcitonin at 0.29 ug/l. 2 distinct blood cultures returned negative, lumbar puncture revealed clear and colorless cerebrospinal fluid with protein 0.95 g/l, glucose 1.9 mmol/l, 3 red blood cells, 26 leukocytes and, no germ. Cerebrospinal fluid culture and Enterovirus test returned negative. The tracheal flora was polymorph; Mycoplasma pneumoniae, Chlamydia pneumoniae, Bordetella pertussis and para-pertussis tests were negative. Viral serology returned negative for Influenza A and B, Para-influenza, Respiratory syncytial virus, Adenovirus, Bocavirus, Metapneumovirus, Coronavirus, and Rhinovirus. Stool culture was negative. Squeleton X-ray revealed no traumatic bone injury. Brain computed tomography scan revealed no intra or pericerebral hemorrhagic lesion, no midline shift. Full body computed tomography scan revealed gastric distension, no pneumoperitoneum, and no intraperitoneal effusion. Autopsy results were pending. Based on the Official Method of Causality Assessment, the causal relationship between pneumococcal 13-valent conjugate vaccine and Diphtheria, Tetanus, acellular Pertussis, Hepatitis b, inactivated Poliomyelitis and conjugated Haemophilus influenzae type b vaccines and the adverse event sudden infant death was assessed by the Agency as "doubtful". No FU attempts possible. No further information expected. Reported Cause(s) of Death: Sudden infant death syndrome.


VAERS ID: 691012 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-18
Entered: 2017-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Extra dose administered
SMQs:, Medication errors (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2017SA065887

Write-up: Initial unsolicited misuse case received from a consumer via e-mail to Vaccination Information Service on 10 Apr 2017. This case was considered INVALID as no event was reported (death outcome reported). This case was linked to 2017SA065881, 2017SA065895, 2017SA065906, 2017SA065876 same reporter. This case involves 11 year old female patient who was vaccinated with primary dose one, and primary dose two of YELLOW FEVER VACCINE (batch number, expiry date, dose, route and site of administration was not reported) on an unspecified dates. (Reported as second dose was received less than one month) The patient medical history, and previous therapies was not reported. Concomitant medications were not reported. On an unknown date, following the vaccination the patient was hospitalized. It was also a case of Extra dose administered (taking 2 doses of the vaccine of Yellow fever vaccine in less than 1 month (Product Use Issue Situation) The patient lab tests and corrective treatment was not reported. On an unknown year, in 19 Nov the patient died. It was unknown if autopsy was performed or not. Documents held by sender: none. Sender''s Comments: This case corresponds to a poorly documented and non-medically confirmed consumer report. Patient died after an unknown timeframe of receiving 2 doses of yellow fever vaccine for which the manufacturer was unknown in less than 1 month. The symptoms and circumstances of death were not reported. Additional details- such as medical history, concomitant vaccination and medications, vaccination details, the trade name of the specific vaccine administered, history of travel to any endemic region, clinical details surrounding the event, diagnostic work-up, cause of death and autopsy reports- are lacking to assess the vaccine causality. Reported Cause(s) of Death: patient died.


VAERS ID: 691013 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-03-15
Onset:2017-04-06
   Days after vaccination:22
Submitted: 2017-04-18
   Days after onset:12
Entered: 2017-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A2100835A / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R24648 / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROL8580AI / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-04-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2017160181

Write-up: This is a spontaneous report from a contactable physician received from the Health Authority. Regulatory authority report number DE-PEI-PEI2017031527. A 3-month-old male patient of an unspecified race/ethnicity received PREVENAR 13, intramuscular, on 15Mar2017, at 0.5 ml single, for immunisation; INFANRIX HEXA, intramuscular, on 15Mar2017, at 1 DF single, for immunisation and ROTARIX, oral, on 15Mar2017, at 1 single, for immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced suspected sudden child death on 06Apr2017. The patient died on 06Apr2017 due to sudden infant death syndrome (SIDS). An autopsy was performed and results were not available. No follow-up attempts needed, follow-up automatically provided by PEI.; Reported Cause(s) of Death: SIDS.


VAERS ID: 691015 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-18
Entered: 2017-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L65421 / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Death, Laboratory test abnormal, Lung abscess
SMQs:, Infective pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~Pneumo (Prevnar13)~~0.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial fistula
Allergies:
Diagnostic Lab Data: Test Name: Puncture site abscess; Result Unstructured Data: Test Result: serotype 16 F
CDC Split Type: DEPFIZERINC2017160742

Write-up: This is a spontaneous case report received from a contactable physician. A 12-month-old male patient of an unspecified race was vaccinated at an age of 2 months with the first dose of PREVENAR 13 (lot.no. M10951) and at age of 5 months with the second dose of the same vaccine from lot no. L65421) both at 0.5ml single dose for immunization. On a unspecified date the patient experienced lung abscess. It is unknown, if the patient recovered completely. The diagnosis was confirmed by abscess puncture fluid. Furthermore a serotyping with the result 16F was done. The patient was not a premature baby, she had an immune defect and suffered from a chronic disease (bronchial fistula). It was planned a bone marrow transplant but the patient died in the hospital. No follow-up attempts possible. No further information expected. Sender''s Comments: Reported event "lung abscess with serotype 16F" (non- PREVENAR 13 containing serotype) more likely represents coincidental bacterial infection, which considered not related to PREVENAR 13. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: Lung abscess; lung abscess with serotype 16F.


VAERS ID: 691352 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-11-02
Onset:2016-11-03
   Days after vaccination:1
Submitted: 2017-04-20
   Days after onset:168
Entered: 2017-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENHIB: MENINGOCOCCAL CONJUGATE + HIB (MENITORIX) / GLAXOSMITHKLINE BIOLOGICALS A76CA315A / 1 RA / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. L023496 / 1 LA / SYR

Administered by: Other       Purchased by: Unknown
Symptoms: Adenovirus test positive, Aspiration, Body temperature increased, Bradycardia, Cardiac arrest, Cerebral disorder, Death, Dyspnoea, Electroencephalogram abnormal, Endotracheal intubation, Enterovirus test positive, Generalised tonic-clonic seizure, Heart rate decreased, Hypoxia, Intensive care, Mechanical ventilation, Oxygen saturation decreased, Respiratory arrest, Resuscitation, Rhinitis, Seizure, Status epilepticus, Tachycardia, Tachypnoea, Tardive dyskinesia, Upper respiratory tract infection, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Dyskinesia (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-05
   Days after onset: 2
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: Family history of seizure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075131704AUS005669

Write-up: Information was obtained on a request by the Company from the Agency (Agency # 399125) via a Public Case Detail concerning a 12 month old male patient. The initial reporter was a healthcare professional. On 02-NOV-2016, the patient was vaccinated with M-M-R II (HSA) injection, dose 1, in left arm, lot # L023496 (route of administration and expiry date were not reported) and MENITORIX, dose 1, in right arm, batch # A76CA315A (route of administration and expiry date were not reported). Recent upper respiratory tract infection (URTI) symptoms. 03-NOV-2016 - grizzly in the morning. At approximately 13:00, child observed to be sitting up from a nap and was "smacking his lips". Generalised tonic-clonic seizure witnessed by family and ambulance crew. Total seizure time - 40 minutes. Large amounts of vomit/aspiration noted pre-hospital. Profoundly acidaemic. Bradycardia, probably related to hypoxia. Induction for intubation - arrest. Cardiopulmonary resuscitation (CPR) 1 hour, ceased at 15:20. Adrenaline. At 18:00 Pediatric Intensive Care Unit (PICU) admission. Positive for enterovirus and adenovirus. On 05-NOV-2016 - at 14:50 deceased. Coroners case. Public Health spoke with practice nurse who administered vaccines. Stated that the child presented well, mum did not mention any previous history of being unwell. Remained 15 minutes post vaccination, no adverse outcome noted. Treatment: brought in by ambulance to Hospital. Hospital Report: Child was normally fit and well, no medical problems, had mild coryzal symptoms for approximately 2 weeks, routine immunizations yesterday. No fevers observed by parents but ambulance crew noted temp: 38.5. 1 year old male with status epilepticus, requiring bag mask ventilation. Low sats 75-85% with airway soiling. "BMV", extreme work of breathing, tachypnoeic, tachycardiac. Occurring over 1-2 mins, patient tiring, respiratory rate dropped, oxygen sats dropped, heart rate (HR) decreased. Rapid sequence intubation (RSI) with thiopentone and suxamethonium. For induction and intubation. Hypoxic bradycardic arrest. CPR commenced, sats gradually improved with ventilation. 40 mins of CPR, cycling between intermittent return of spontaneous circulation (ROSC) followed by loss of cardiac output and recommencement of CPR. Patient re-intubated recovery of oxygen sats, given 10 mg rocuronium, 10 mcg fentanyl, bolus midazolarn. Transferred to hospital. Presented with prolonged seizure, prolonged CPR was required for asystolic arrest. Family history of seizure. Patient was ventilated and on muscle relaxants, midazolam, morphine, vecuronium, "VANC", cefotax, aciclovir. Background rhythm very low amplitude and attenuated. Largely appeared to represent pulse artefact. The recording was profoundly abnormal with no clear electroencephalogram (EEG) background rhythms. The findings suggested a profound cerebral insult. The Agency considered the event to be possibly related to M-M-R II and MENITORIX. Additional information is not expected, as no further information can be obtained from the local regulatory authority.


VAERS ID: 691521 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Female  
Location: Foreign  
Vaccinated:2016-06-27
Onset:2016-06-29
   Days after vaccination:2
Submitted: 2017-04-21
   Days after onset:296
Entered: 2017-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR L74901 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Asthenia, Blood count, Cardiac arrest, Condition aggravated, Crying, Culture, Cyanosis, Death, Diarrhoea, Dry skin, Dyspnoea, Eructation, Faeces discoloured, Gastroenteritis, Hypotonia, Lethargy, Mucosal discolouration, Pallor, Red blood cell sedimentation rate, Seizure, Skin turgor decreased, Tachypnoea, Term birth, Tongue discolouration, Tongue dry, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Normal pregnancy conditions and outcomes (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (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? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute bronchitis; Apgar score; Atopic dermatitis; Autonomic failure syndrome; Cough; Echocardiography; Foramen ovale patent; Respiratory insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20160703; Test Name: body temperature; Result Unstructured Data: 36.4 Celsius temperature; Test Name: body temperature; Result Unstructured Data: 36.9 Celsius temperature; Test Date: 20160703; Test Name: hemoglobin; Result Unstructured Data: 120 gram(s)/litre; Test Date: 20160703; Test Name: red blood cell count; Result Unstructured Data: 3750 billion(s)/litre; Test Date: 20160703; Test Name: White blood cell count; Result Unstructured Data: 10.2 billion(s)/litre; Test Date: 20160703; Test Name: hematocrit; Test Result: 38 %; Test Date: 20160704; Test Name: hemoglobin; Result Unstructured Data: 120 gram(s)/litre; Test Date: 20160704; Test Name: red blood cell count; Result Unstructured Data: 3750 billion(s)/litre; Test Date: 20160704; Test Name: White blood cell count; Result Unstructured Data: 10.2 billion(s)/litre; Test Date: 20160704; Test Name: hematocrit; Test Result: 38 %; Test Date: 20160704; Test Name: erythrocyte sedimentation rate; Result Unstructured Data: 45 millimeter(s)/hour; Test Date: 20160704; Test Name: band neutrophil count; Result Unstructured Data: 5; Test Date: 20160704; Test Name: lymphocytes; Result Unstructured Data: 22; Test Date: 20160704; Test Name: monocytes; Result Unstructured Data: 1; Test Date: 20160704; Test Name: hemoglobin; Result Unstructured Data: 132 gram(s)/litre; Test Date: 20160704; Test Name: red blood cell count; Result Unstructured Data: 4000 billion(s)/litre; Test Date: 20160704; Test Name: White blood cell count; Result Unstructured Data: 7.4 billion(s)/litre; Test Date: 20160704; Test Name: erythrocyte sedimentation rate; Result Unstructured Data: 5 millimeter(s)/hour; Test Date: 20160704; Test Name: band neutrophil count; Result Unstructured Data: 6; Test Date: 20160705; Test Name: hemoglobin; Result Unstructured Data: 132 gram(s)/litre; Test Date: 20160705; Test Name: red blood cell count; Result Unstructured Data: 4100 billion(s)/litre; Test Date: 20160705; Test Name: white blood cell count; Result Unstructured Data: 9.2 billion(s)/litre; Test Date: 20160705; Test Name: erythrocyte sedimentation rate; Result Unstructured Data: 34 millimeter(s)/hour; Test Date: 20160705; Test Name: platelet count; Result Unstructured Data: 229 billion(s)/litre; Test Date: 20160705; Test Name: hematocrit; Result Unstructured Data: 0.39; Test Date: 20160705; Test Name: eosinophils; Result Unstructured Data: 0; Test Date: 20160705; Test Name: band neutrophil count; Result Unstructured Data: 2; Test Date: 20160705; Test Name: lymphocytes; Result Unstructured Data: 22; Test Date: 20160705; Test Name: monocytes; Result Unstructured Data: 6
CDC Split Type: UASA2017SA065347

Write-up: Initial unsolicited report received from a healthcare professional via Health Authority (under reference number: 180-16) on 11-APR-2017. This case involves a seven-month-old female patient who was vaccinated with 0.5 ml first single injection of IMOVAX POLIO (batch number: L7490-1, expiry date: 31 Mar 2017 and site of administration was unknown) via intramuscular route on 27 Jun 2016. Medical history was reported as child was born from the first pregnancy, first in-term birth; in the first and third trimesters of the pregnancy, prenatal patronages were conducted. At birth, the child had apgar score 8.9, body weight 2230 gram, body length 44 centimeter, head circumference 30 centimeter, chest circumference 29 centimeter. The child was breastfed. At the age of I month: body weight 3 kg body length 49 cm, head circumference 34.5 cm chest circumference 31 centimeter, the child was examined by a pediatrician, neurologist, orthopedist, ophthalmologist and underwent analyses of blood, urine, and ultrasound examination. Diagnosis: pyramidal insufficiency syndrome, II group of health. At the age of two months: body weight 4 kilogram, body length: 53 centimeter, head circumference: 36.5 centimeter, Diagnosis: pyramidal insufficiency syndrome, II group of health. At the age of 3 months: body weight 5 kilogram, body length 56 centimeter, head circumference 38 centimeter, chest circumference 39 centimeter. Diagnosis: pyramidal insufficiency syndrome, II group of health. The girl was followed-up by a pediatrician until April 2016. At the age of four months, the parents with the child were registered in an outpatient clinic. On March 16, 2016, the parents contacted a pediatrician with complaints of cough. The child was examined: body weight 6300 gram, body length 57 cm, head circumference 38 centimeter, chest circumference 42 centimeter. The doctor established diagnosis of acute bronchitis, prescribed treatment, and gave a referral for admission to the children''s department of a hospital. Admission to the infectious department was offered to the parents, which they refused. On 27 March 2016, the child''s condition worsened, and she was admitted to the children''s department of the Central District Hospital, where treatment continued until 07 April 2016. Primary diagnosis- acute bronchitis, grade I moderate respiratory insufficiency; concomitant diagnosis -atopic dermatitis, acute course. The child received treatment. On April 01, 2016, the child was consulted by a cardiologist; diagnosisdysplastic cardiomyopathy, grade 0 cardiac insufficiency. Recommended: ECG (electrocardiogram) every 6 months, echocardiography once a year. At the age of 5 months: body weight 7100 grams, body length 60 centimeter, head circumference 40 centimeter, chest circumference 41.5 centimeter. On May 05, 2016, the parents contacted a pediatrician with complaints of cough in the child. Diagnosis- acute respiratory viral infection, outpatient treatment until 13 May 2016. At the age of 6 months: body weight 7600 g, body length 62 centimeter, head circumference 41 centimeter, chest circumference 43.5 centimeter. Diagnosis- dysplastic cardiomyopathy (patent foramen ovale). On 28 April 2016, echocardiography was performed and revealed a slight dilation of the cavities of the right atrium and right ventricle, patent foramen ovale- 5 mm. At the age of 7 months: body weight 8100 gram, body length 62.5 centimeter, head circumference 41 centimeter, chest circumference 43 centimeter. Diagnosis- dysplastic cardiomyopathy (patent foramen ovale). The parents deny any hereditary diseases. The epidemiological environment was safe. The child was examined by a physician before the vaccination conducted, and the informed consent to the vaccination was received. No contraindications to vaccination were identified. It''s known that vaccine was not used before. Allergic anamnesis was burdened. Patient received 0.5 ml first dose of DTP ADSORBED (batch number, expiry date, and site of administration was unknown) via intramuscular route on 27 June 2016 as a concomitant medication. On 29 June 2016, two days following vaccination the patient had repeated vomiting, pale skin, loose stool up to 10 times a day, general weakness, according to mother child was sick. On 01 July 2016 parents had contacted an acquaintance pediatrician regarding the child''s complains. The physician prescribed a treatment, to which the child reacted with vomiting (as the mother believes). The information about the contact with a physician was provided by the mother, although no documentary evidence of the contact with a pediatrician and the treatment prescribed was available. On July 02, 2016 three days following vaccination patient had loose stool 6 to7 times and general weakness. On 03 July 2016 four days following vaccination patient had, loose stool up to six times a day and general weakness. On 03 July 2016, the parents called in an ambulance with complaints of vomiting 4 to 5 times, lethargy, loose stool 4 to 5 times, convulsions (according to the parents), which resolved spontaneously. The ambulance team delivered the child to the department of anesthesiology and intensive care at 09:30 a.m. on grounds of convulsions. In the department of anesthesiology and intensive care, on 03 July 2016 at 09:40 AM., the child was examined by resuscitationist and a pediatrician. Patient complaining about of vomiting, loose stool, general lethargy and pale skin. On an unspecified date following vaccination patient''s condition was severe, with weak reaction to stimuli, weak crying, body weight was 8 kilogram, no skin rashes were observed pupils react light no meningeal signs were observed, muscle and tissue turgor were reduced, had tachypnoea, visible mucous membranes were dry, pale pink, the abdomen was bloated, gases pass, infrequent urination, loose stool 3 to 4 times since the morning and vomiting 10 to 15 times. Diagnosis: acute gastroenterocolitis, severe course with intoxication, Treatment was administered. The child had stayed in the department of anesthesiology and intensive care for 3 hours 30 minutes. On 03 July 2016, the child was conscious, active. Objectively: body temperature 36.4 degree Celsius, the skin and visible mucous membranes was pale-pink, vesicular breathing over the lungs, the respiration rate was 24 per minute, the tongue was moist, the abdomen was soft, non-responding to palpation, the peristalsis was satisfactory and stool was absent. For further treatment, on 03 July 2016, at 01:00 p.m., the child was transferred to the department of infectious diseases for the supervision of a pediatrician. On 04 July 2016, at 08:30 a.m. seven days following vaccination objectively the child''s condition was of moderate severity, the child was breastfed, sucks mother''s breasts actively, pronounced paratrophy, muscles and tissue turgor was decreased; the large fontanelle was not sunken. Periodically, vomiting with admixtures of bile was observed. No dyspnea was observed, no catarrhal signs were observed, the breathing was harsh, and no rales in the lungs were heard. The abdomen was moderately bloated, gases pass, loose stool 5-6 times with mucus. The child urinates into diapers at 04:45 p.m. the child was relatively calm, vomits occasionally, but sucks mother''s breasts actively. The child defecates during the day by small portions; stool was greenish, with mucus. On 05 July 2016, at 08:20 a.m., the child''s condition was worsened. According to the mother, the child became lethargic, sucked mother''s breasts reluctantly; of all liquids, the child drank only raisin compote, but did not lose weight. The condition was of moderate severity, the child was lethargic, no skin rashes were observed, and the skin was doughy. The large fontanelle was on the level of skull bones, not sunken. The tongue was moderately coated with white fur, no rales in the lungs are heard, heart tones are muffled and no meningeal signs were observed. Stool was 6-8 times during the night, in small amounts, greenish, with mucus. Diagnosis: acute gastroenterocolitis with pronounced intoxication syndrome of Proteus (107) etiology, paratrophy. The child had stayed in the department of infectious diseases for 49 hours. Due to the child''s paratrophy, intravenous administration of fluids was impossible. On 05 July 2016, at 12:50 p.m., the child was delivered from the children''s department of infectious diseases of the city hospital. The body weight of the child at admission was 8400 gram, body temperature 36.9 degree Celsius, respiration rate 40 per minute, heart rate 158 beats per minutes, oxygen saturation 93%. The child''s condition was assessed as severe due to the primary disease- acute gastroenterocolitis, grade 2 toxicosis, grade 2 exicosis and severe course. At examination: in the neurological status: the child responds to the examination with a moderate cry, was being exhausted quickly; spontaneous motor activity: motor activity was moderately reduced, passive limb movements are satisfactory. Meningeal signs (neck muscle stiffness, Kernig''s, Brudzinski''s, Lesage''s signs) are not observed. No focal neurological symptoms were observed. Reaction to stimuli (tactile and pain): loud cry, chaotic movements of limbs. Tendon reflexes were moderately reduced, muscle tone: moderate hypotonia. The eyes were open, pupils were D=S photoreaction was preserved, no oculomotor abnormalities were found. The large fontanelle was at bone level, does not transmit pulsation, 1.5x 1.0 centimeter in size. No separation of cranial sutures was observed. Neither convulsion nor convulsive readiness were observed. The skin was pale moderately dry, without rash; cyanosis of the lips and acrocyanosis were observed. On the upper limbs, signs of multiple injections were observed. Visible mucous membranes are pale-pink, clean and moderately dry. Turgor and elasticity of tissues was preserved. The child has hyper nutrition by paratrophy type. The subcutaneous adipose tissue was developed satisfactorily. Pale spot sign lasted up lo 3 seconds. No edema was observed. Injection sites do not bleed. Both halves of the chest was equally involved in breathing, dyspnoe was moderate. Chest excursion was adequate, breathing was mainly abdominal. At percussion, vesicular resonance heard over the lungs. At auscultation, breathing was vesicular, uniformly conducted on both sides; no rales were heard. Heart tones are rhythmic, muffled; tachycardia; pulse wave on "aa". Radiales was preserved. At percussion, the heart was within the age norm. The tongue was dry, without fur. The abdomen was soft, accessible to palpation in all areas; the anterior abdominal wall was not tense. The liver was +1.5-2 centimeter below the costal arch, the spleen was not enlarged. Peristaltic sounds at auscultation were languid. Stool was with mucus and green. Urination at the time of the examination: the child did not urinate. According to the mother, "constant burping after feeding" was present. The following diagnosis was established: acute intestinal infection, acute gastroenterocolitis, severe course, grade 2 toxicosis-exicosis. Treatment according to the intensive care algorithm was administered (antibacterial therapy, anti- inflammatory therapy, decongestant therapy, infusion therapy, eubiotics, and resuscitation measures). Respiratory support with humidified oxygen through the face mask was provided. On the background of tonic seizures, a cardiac monitor recorded cardiac arrest on 06 July 2016 at 07:55 a.m. resuscitation measures were initiated: 100% 02, manual mechanical ventilation using an Ambu bag, followed by intubation of the upper airways and trachea, diameter- 4.5 mm, chest compressions, 0.1% ATROPINE SULFATE (atropine) 0.1 mL, 0.18% (1:10000) epinephrine 0.1 mL, prednisolone 15 mg. For 15 minutes, heart rate was 0 bpm, spontaneous breathing was not restored. Repeated intravenous injection of atropine, epinephrine, prednisolone 15 mg, continued mechanical ventilation, chest compressions, After 30 minutes of resuscitation measures, cardiac function was not restored. Repeated injection of epinephrine, prednisolone, chest compressions and mechanical ventilation. After 40 minutes of resuscitation measures, cardiac function was not restored, pupils were dilated, photoreaction was absent, corneal, conjunctival reflexes were absent, the cardiac monitor recorded an isoline. On 06 July 2016 at 08:45a.m., biological death was established. On 03 July 2016 stool bacterial culture for the group of intestinal bacteria, proteus was isolated in the amount of 107. Hematology on 03 July, 2016: hemoglobin 120 g/L, RBC (red blood cell count): 3.75 x 1012/L, WBC (White blood cells count): 10.2 x 109/L, hematocrit 38%. On 04 July, 2016 Hematology: hemoglobin 120 g/L, RBC 3.75 x 1012/L, WBC 10.2 x109/L, hematocrit 38%, erythrocyte sedimentation rate (ESR) 45 mm/h, band neutrophils: 5, segmented neutrophils 72, lymphocytes 22, monocytes 1. On 04 July 2016 Hematology (repeated test): hemoglobin: 132 g/L, RBC: 4.0 x 1012/L, WBC 7.4 x 109/L, ESR: 5 mm/h, band neutrophils: 6, segmented neutrophils: 71, lymphocytes: 22, monocytes: 1. On 04 July 2016 Blood sugar: 3.2 mmol/L. On 04 July 2016 Stool test for helminth ova negative, analysis of the smear for enterobiasis: negative, coprogram: light-brown loose stool, neutral fat in small amounts, mucus in moderate amounts, WBC: 3-5 per HPF, detritus in moderate amounts. Stool analysis for cholera: negative three times. On 05 July 2016 Hematology: hemoglobin 132 g/L, RBC: 4.1 x 1012/L WBC 9.2 x 109/L, ESR 34mm/h, platelets 229 x 109/L, hematocrit 0.39, colar index 0.97, eosinophils 0, band neutrophils 2, segmented neutrophils 72, lymphocytes 22, monocytes 6. On 05 July 2016 to 06 July 2016 Bacterial culture for the group of intestinal bacteria; E. cloacae was isolated in the amount of 1 x 107. Results of histopathological examinatIon: vascular thrombosis with perivascular hemorrhages, hydropic degeneration; liver: pronounced dilation of Disses spaces, hyperemia, hydropic degeneration of hepatocytes; pancreas: hyperemia, perivascular hemorrhages, moderate lipomatosis of interlobar partitions; brain: perivascular edema stasis in the vessels, serous. meningoencephalitis; thymus: phase 3 accidental involution; intestine: catarrhal enterocolitis. On an unspecified date patient was recovered from weak reaction to stimuli, tachypnea, convulsions and outcome of other events was not reported. Upon internal review, the company decided to code the events cardiac arrest, childs condition was assessed as severe, child''s condition worsened, weak reaction to stimuli, muscle and tissue turgor is reduced, muscle and tissue turgor is decreased, muscle tone moderate hypotonia, tachypnoea, acute gastroenterocolitis, lethargy, child became sick, visible mucous membrane are dry, pale pink, abdomen was bloated, infrequent urination, greenish stool, skin was doughy, tongue white, exhausted, burping, tongue dry, mucous stool, dry skin, mucosal dryness, peristaltic sounds at auscultation are languid, acute intestinal infection, cyanosis of lip, motor activity retarded, tendon reflex decreased, liver enlargement, tonic seizures , nutritional condition abnormal, dyspnoea ,convulsions and weak crying which was mentioned in the narrative but was not coded by HA. List of documents held by sender: none. Sender''s Comments: A 7-month old female patient died due to infectious gastroenterocolitis 2 days following vaccination with IMOVAX POLIO and DTP (from other manufacturer). Reported information is suggestive of a severe bacterial infection. Based on available information, the role of the vaccines can be reasonably ruled out. Reported Cause(s) of Death: cardiac arrest; loose stool upto 10 times a day/Loose stool 6 to 7 times/ loose stool 4 to 5 times/loose stool/ 3 to 4 times/ Stool was 6 to 8 times/Child defecates during the day by small portions; Pale skin; Vomiting; General weakness; Autopsy-determined Cause(s) of Death: cardiac arrest; loose stool upto 10 times a day/Loose stool 6 to 7 times/ loose stool 4 to 5 times/loose stool/ 3 to 4 times/ Stool was 6 to 8 times/Child defecates during the day by small portions; Pale skin; Vomiting; General weakness.


VAERS ID: 691877 (history)  
Form: Version 1.0  
Age: 0.83  
Sex: Female  
Location: Foreign  
Vaccinated:2017-02-06
Onset:2017-04-18
   Days after vaccination:71
Submitted: 2017-04-21
   Days after onset:3
Entered: 2017-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningococcal sepsis, Pyrexia, Rash, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-04-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ES2017GSK056460

Write-up: This case was reported by a physician via other and described the occurrence of meningococcal sepsis in a 13-month-old female patient who received BEXSERO. Co-suspect products included BEXSERO and BEXSERO. On 18th August 2016, the patient received the 1st dose of BEXSERO. On 9th November 2016, the patient received the 2nd dose of BEXSERO. On 6th February 2017, the patient received the 3rd dose of BEXSERO. In April 2017, less than a year after receiving BEXSERO, BEXSERO and BEXSERO, the patient experienced fever. On 18th April 2017, the patient experienced meningococcal sepsis (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant) and exanthema. On 18th April 2017, the outcome of the meningococcal sepsis was fatal. On an unknown date, the outcome of the vaccination failure, exanthema and fever were unknown. The patient died on 18th April 2017. The reported cause of death was meningococcal sepsis. The reporter considered the meningococcal sepsis, vaccination failure, exanthema and fever to be unrelated to BEXSERO, BEXSERO and BEXSERO. Additional details were provided as follows: The case was reported by the GSK physician of a Manufacturing site directly to the Safety Unit. The patient experienced fever approximately 4 to 5 days before reporting date for which the patient was taken to the emergency room. The patient was not hospitalized, she was discharged with observation recommendation. On the 18th April 2017 19:57 the patient had fulminant Sepsis meningococcal and at 19:58 the patient was presented exanthema, due to which, she was taken again to the emergency room. The patient received 3 doses of BEXSERO and experienced fulminant Sepsis meningococcal which led to suspected vaccination failure. She was referred to a bigger hospital in an Intensive Vigilance Unit ambulance, where she died on the 18th April 2017. The reporting physician did not consider the fatal outcome to be related to a lack of efficacy of BEXSERO and she considered that probably the patient was infected by a Meningococcus B strain not covered by BEXSERO or a strain more aggressive than normal. At the time of reporting the suspected cause of death was Meningococcus B infection, which was pending to be confirmed.


VAERS ID: 691783 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-25
Entered: 2017-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Unevaluable event
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131704DEU011328

Write-up: Information was received from an unspecified reporter (local famous writer or painter) via company representative concerning 11-14 year old female patients. The patients'' concurrent condition, medical history and concomitant therapy information was not provided. Information was reported in local online newspapers which had a article contained video in which local famous writer or painter talked about vaccination. During the speech "she" mentioned GARDASIL. The reporter called it not medicine but poison and said that about ten years ago (also reported as maybe this was not 10 years ago, maybe 20 years ago), in one country and later in another, there was huge vaccination campaign where parents brought their 11-14 year old girls to be vaccinated with GARDASIL (lot#, expiration date, strength, dose, frequency and route were not reported) for against cervical cancer. Subsequently on unknown dates, the vaccine caused massive infertility and in many cases death of these children, but this was whitewashed/covered up. The cause of death was unknown. It was unknown if autopsy was performed. The outcome of the infertility female was unknown. Upon internal review, death of these children was determined to be medically significant. This is one of two reports received from same reporter. Additional information is not expected because the reporter details were not provided.; Sender''s Comments: US-009507513-1704DEU012245:


VAERS ID: 691785 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-25
Entered: 2017-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Unevaluable event
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131704DEU012245

Write-up: Information was received from an unspecified reporter (local famous writer or painter) via company representative concerning 11-14 year old female patients. The patients'' concurrent condition, medical history and concomitant therapy information was not provided. Information was reported in local online newspapers which had a article contained video in which local famous writer or painter talked about vaccination. During the speech "she" mentioned GARDASIL. The reporter called it not medicine but poison and said that about ten years ago (also reported as maybe this was not 10 years ago, maybe 20 years ago), in one country and later in another, there was huge vaccination campaign where parents brought their 11-14 year old girls to be vaccinated with GARDASIL (lot#, expiration date, strength, dose, frequency and route were not reported) for against cervical cancer. Subsequently on unknown dates, the vaccine caused massive infertility and in many cases death of these children, but this was whitewashed/covered up. The cause of death was unknown. It was unknown if autopsy was performed. The outcome of the infertility female was unknown. Upon internal review, death of these children was determined to be medically significant. This is one of two reports received from same reporter. Additional information is not expected because the reporter details were not provided.; Sender''s Comments: US-009507513-1704DEU011328:


VAERS ID: 691838 (history)  
Form: Version 1.0  
Age: 102.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-25
Entered: 2017-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131704JPN002101J

Write-up: Initial information has been received from patient''s family referring to a 107-year-old female patient who was vaccinated subcutaneously with PNEUMOVAX NP for prophylaxis (inoculation date, dose and lot number not reported). There was no concomitant medication reported. On an unknown date (when the patient was 102 years old), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (described above). On an unknown date, though the patient was at home until she was 105 years old, care became difficult and the patient was moved to a facility for two years. On an unknown date (when the patient was 107 years old), the patient died. She did not get pneumonia a single time. No information on cause of death or autopsy was reported. Reporter''s comment: not provided. The reporter did not assess the relationship of death to pneumococcal vaccine, polyvalent (23-valent). Upon internal review, death was determined to be medically significant. Follow-up attempt was not made because the reporter did not wish to be contacted.; Reported Cause(s) of Death: Death.


VAERS ID: 691857 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-26
Onset:2014-11-26
   Days after vaccination:0
Submitted: 2017-04-25
   Days after onset:880
Entered: 2017-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 129301 / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Cardiac arrest, Cardiac ventriculogram normal, Death, Electrocardiogram, Hypophonesis, Lethargy, Loss of consciousness, Nausea, Pallor, Rales, Somnolence, Stupor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORAL; CARDURA; NORVASC; ZYLORIC; ATENOL; LASIX; gabapentin molteni; BUSCOPAN; FLUIFORT; acetylcysteine; TAULIZ; RATAC; EUBRON
Current Illness: Type 2 diabetes mellitus; Hypertensive cardiomyopathy; Obesity; Lymphoedema, Improved; Hemiparesis; Hypokinesia; Walking aid user; Hypertension
Preexisting Conditions: Haemorrhagic stroke, 15 years ago; FLUIBRON; Cerebrovascular accident, about 5 years ago; Respiratory disorder, at the visit (29-Oct-2014)
Allergies:
Diagnostic Lab Data: 23-10-2014: heart rate (64 beats per minute); 24-11-2014: heart rate (68 beats per minute); 10/23/2014, Blood pressure measurement, 120/76; 10/29/2014, Blood pressure measurement, 120/75, normal; 11/24/2014, Blood pressure measurement, 125/70; 10/29/2014, Electrocardiogram, Unknown, Ventriculogram at limits of normality, cardiac tones were rhythmic with IV tone. Rales at left pulmonary base were not many and modificable with cough. Hypophonesis at right pulmonary base; Oxygen saturation, 93%, normal, Done by spirometry; Oxygen saturation, 90%; Oxygen saturation, 90%; Sinus rhythm, 11; 10/29/2014, Sinus rhythm, 79 beats per minute; Spirometry, 93%; 10/29/2014, Spirometry, 93%, oxygen saturation of 93%
CDC Split Type: PHHY2014IT157148

Write-up: Case number PHHY2014IT157148 is a combined initial and follow up spontaneous report from a health care professional on 28 Nov 2014 and from the health care professional via health authority (reference number: 281956) received on 01 Dec 2014 with a follow up information received from the health authority via fax on 01 Dec 2014, with the follow-up information received from Quality Assurance Department (reference number: 340123) on 02 Dec 2014. This report refers to a 70-year-old female patient. Her medical history included hemorrhagic stroke 15 years ago, multifocal brain stroke and respiratory abnormality, unspecified. Her historical drug included FLUIBRON which was replaced with EUBRON. Her current conditions included right hemiparesis due to the previous stroke, Diabetes non insulin-dependent, hypertensive cardiopathy, obesity and lymphedema at lower limbs since few months and resolving at the time of report. She had scarce deambulation and she moved with walker. Her concomitant medications were METFORALMILLE, CARDURA, NORVASC, ZYLORIC, ATENOL, LASIX, Gabapentin Molteni, BUSCOPAN, EUBRON and TALUIZ. She had a cardiological examination on 29 Oct 2014 with electrocardiogram (ECG) at home and it was found that her arterial pressure was 120/75. On 23-Oct-2014 her arterial pressure was observed as 120/76 and on 24-Nov-2014 it was 125/70. Sinus rhythm was 79 beats per minute, ventriculogram at limits of normality and her cardiac tones were rhythmic with IV tone. There were rales at left pulmonary base, not many and modificable with cough. There was hypophonesis at right pulmonary base. It was reported that recent pneumological examination with spirometry at home was done and was found that her oxygen saturation was 93%. She was vaccinated with FLUAD (batch number: 142901, Expiry date: Feb-2015) on 26-Nov-2014 at 12:45. On the same date at 16:30, she developed somnolence, lethargy, skin pallor, arthralgia at arms and legs, nausea, stomach ache and back pain. At 20.00, she took PANTORC and under suggestion of her general practitioner took one posologic unit of BUSCOPAN. On 27-Nov-2014, patient experienced loss consciousness and torpor. She died on 27 Nov 2014 at 06:30. It was reported that paramedics diagnosed her with cardiocirculatory arrest. The health authority reported the events as serious. The causality of the events reported as suspected to be related to the administration of FLUAD. Based on the performed review on FLUAD batch number: 142901, there is no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that may be potentially related to the reported events. QA department confirmed that, the involved batches are compliant with internal procedures and with cGMP requirements. Reporters assessment: The other health professional considered the influenza vaccine and events as related. Follow up information received from the health authority via fax on 01 Dec 2014: Updated current conditions, historical drug, concomitant medications, laboratory tests, nausea added as event, narrative updated. Follow-up information received from the Quality Assurance Department (reference number: 340123) on 02 Dec 2014: Updated FLUAD batch review report. Regulatory follow-up received on 10-Apr-2017: No any new medically significant information received. Follow-up report received on 12-Apr-2017: Patients initials were updated. Multifocal brain stroke and respiratory abnormality, unspecified were updated as historical condition. Spirometric examination was done which showed the result of oxygen saturation of 93 percent. On 23-Oct-2014, arterial pressure was 120/76 and on 24-Nov-2014 it was 125/70. Frequency of concomitant medication METFORALMILLE updated as daily. Dose of PANTROC and FLUIFORT were updated. Action taken for FLUIFORT was updated from unknown to drug withdrawn as it was reported that it has been replaced by EUBRON. Start date of BUSCOPAN was updated. Lot no, of suspect product influenza vaccine was updated to 129301 from 142901. Expiry date was updated to Feb-2015. Gastric pain, Loss consciousness and torpor were added as an event. Start date, outcome, and seriousness were updated for the events Loss consciousness and torpor. The other health professional considered the events are related to influenza vaccine.


VAERS ID: 692170 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-02-01
Onset:2017-02-01
   Days after vaccination:0
Submitted: 2017-04-27
   Days after onset:84
Entered: 2017-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Crying, Death, Hypersomnia, Respiratory arrest, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRSA2017SA072857

Write-up: Significant correction has been performed on 24-APR-2017 to add a correct suspect product DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE. Initial unsolicited report received from a consumer via media on 16-Apr-2017. This case involves an infant female patient (onset age not specified) who was vaccinated with a first dose of DIPHTHERIA, TETANUS AND POLIOMYELITIS (INACTIVATED) VACCINE (Batch number, expiry date, frequency route and site of administration not reported) on an unspecified date in February 2017. The patient''s medical history and concomitant medications were not reported. On an unspecified date in February 2017, following the vaccination, the patient cried (it was reported that patient cried during at least 1 hour after the injection) and then fell asleep. The patient slept longer than usual, and vomited during her sleep and subsequently it was reported that the patient was breathing anymore. It was later reported that the patient died within 24 hours following the vaccination. Relevant laboratory investigations and corrective treatment was not reported. On an unspecified date in February 2017, the patient recovered from crying and the outcome of the events vomited during her sleep, fell asleep/slept longer than usual was unknown Autopsy was performed but did not identify the cause of death. According to the patient''s mother, it was the vaccine that was responsible of the death of the patient, that had never been sick before. List of documents held by the sender: None. Addendum: 24-APR-2017 Upon second medical examination of case at time of internal review the following has been modified in this case "Significant correction has been performed to add a correct suspect product DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE. Sender''s Comments: This case concerns an infant died after vaccination with DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (manufacturer unknown). Patient also experienced Crying, Vomiting and Somnolence. Time to onset is compatible with the role of vaccine. It was reported that patient was vomited during sleep before the patient died which could be alternative cause that may lead to aspiration of vomit and leads to respiratory arrest. In this case, autopsy was performed and did not reveal any significant findings (no abnormalities were observed). However, more details regarding, patient''s sleeping position, preexisting condition, concomitant medication and autopsy report are needed for complete assessment of the case. Based on the available information no conclusion can be drawn. Reported Cause(s) of Death: Death; Autopsy-determined Cause(s) of Death: Death.


VAERS ID: 692171 (history)  
Form: Version 1.0  
Age: 0.67  
Sex: Female  
Location: Foreign  
Vaccinated:2016-11-22
Onset:2017-04-09
   Days after vaccination:138
Submitted: 2017-04-27
   Days after onset:18
Entered: 2017-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 3 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Anaesthetic complication, Constipation, Crying, Death, Diarrhoea haemorrhagic, Flatulence, Intestinal operation, Intussusception, Loss of consciousness, Pyrexia, Tonic convulsion, Ultrasound abdomen abnormal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: 2017-04-17
   Days after onset: 8
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ML0095075131704MLI012621

Write-up: This spontaneous report was received from a physician referring to an 8 month old female patient who was enrolled in a Post Marketing Active Surveillance. The patient''s pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 19-SEP-2016, the patient was vaccinated with the first dose of ROTATEQ per oral, for prevention (lot # and expiration date were not reported). On 19-OCT-2016, the patient was vaccinated with the second dose of ROTATEQ per oral, for prevention (lot # and expiration date were not reported). On 22-NOV-2016, the patient was vaccinated with the third dose of ROTATEQ per oral, for prevention (lot # and expiration date were not reported). On 09-APR-2017, the patient experienced inconsolable crying, vomiting and bloody diarrhea (more than 3 stools). The patient consulted her physician and was prescribed with metronidazole, artemether and lumefabntrine as treatment. It was stated that the patient consulted another physician because no improvement of the signs was noted. On 12-APR-2017, the patient developed a fever and abdominal distension with stoppage of stools and gas. On 13-APR-2017, an ultrasound was performed and the results suggested intussusception. The patient was referred to the hospital and was admitted on 14-APR-2017. He had a surgery the same day. At the opening, the exploration found an ileo-caeco-colic intussusception without necrosis. A manual reduction was performed. It was reported that the reversal of anesthesia was difficult after surgery. On 15-APR-2017, the patient developed a high fever and despite wraps and antipyretic, the fever persisted. On 17-APR-2017, the patient presented tonic convulsions followed by a loss of consciousness, which led to death at 02:45. At the time of reporting the outcome of anaesthetic complication was unknown. The causality assessment between the events of tonic convulsions, loss of consciousness, anaesthetic complication and high fever and ROTATEQ was not provided. The reporter considered the intussusception to be not related to the ROTATEQ or to the study procedure. Upon internal review intussusception, tonic convulsions and loss of consciousness were determined to be medically significant events. Additional information is not expected as no follow-up is required. Reported Cause(s) of Death: Intussusception; The patient presented tonic convulsions followed by loss of consciousness, which led to death; The patient presented tonic convulsions followed by loss of consciousness, which led to death.


VAERS ID: 692267 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-27
Entered: 2017-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Left ventricular dysfunction
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2017SA072916

Write-up: Initial unsolicited report received from Literature on 19-Apr-2017. This case is linked with 2017SA072920 and 2017SA072926 (same reporter). The following is the verbatim from the article: Abstract: This report summarises passive surveillance data for adverse events following immunization (AEFI) for 2014 reported to the Administration for 2014 and describes reporting trends over the 15-year period 01-Jan-2000 to 31-Dec-2014. There were 3,087 AEFI records for vaccines administered in 2014; an annual AEFI reporting rate of 13.2 per 100,000 population. There was a decline of 5% in the overall AEFI reporting rate in 2014 compared with 2013. This decline in reported adverse events in 2014 compared with the previous year was mainly attributable to fewer reports following the human papillomavirus (HPV) vaccine as it was the second year of the extension of the National HPV Vaccination Program to males. AEFI reporting rates for most vaccines were lower in 2014 compared with 2013. The most commonly reported reactions were injection site reaction (27%), pyrexia (18%), rash (16%), vomiting (9%), headache (7%), and syncope (5%). The majority of AEFI reports described non-serious events while 7% (n=211) were classified as serious. There were 5 deaths reported with no clear causal relationship with vaccination found. This case involves a 77-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date dose in series, dose form, frequency not reported) on an unspecified date. The patient''s medical history included hypertension. Concurrent conditions included left ventricular dysfunction. Concomitant medications were not reported. On an unspecified date, nine hours following the vaccination, it was reported that the patient experienced sudden cardiac arrest and died later. Relevant laboratory investigations and corrective treatment were not reported. It was unknown if an autopsy was performed. All deaths were investigated by the Administration and no clear causal relationship with vaccination was found. List of documents held by the sender: None. Sender''s Comments: Patient died with sudden cardiac arrest 9 hours after vaccination. Time to onset is compatible, but patient had left ventricular dysfunction and hypertension which could be alternative explanation. However further information regarding patient''s medical condition, circumstances at the time of death, and detailed autopsy report would be needed for a complete assessment. Based on available information, contributory role of the vaccine cannot be assessed. Reported Cause(s) of Death: sudden cardiac arrest.


VAERS ID: 692268 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-27
Entered: 2017-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Death
SMQs:, Noninfectious encephalitis (narrow), Demyelination (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Wound infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2017SA072920

Write-up: Initial unsolicited report received from the literature on 19 Apr 2017. This case is linked to 2017SA072916 and 2017SA072926 (same reporter). Abstract: This report summarises passive surveillance data for adverse events following immunization (AEFI) for 2014 reported to the Administration for 2014 and describes reporting trends over the 15-year period 1 January 2000 to 31 December 2014. There were 3,087 AEFI records for vaccines administered in 2014; an annual AEFI reporting rate of 13.2 per 100,000 population. There was a decline of 5% in the overall AEFI reporting rate in 2014 compared with 2013. This decline in reported adverse events in 2014 compared with the previous year was mainly attributable to fewer reports following the human papillomavirus (HPV) vaccine as it was the 2nd year of the extension of the National HPV Vaccination Program to males. AEFI reporting rates for most vaccines were lower in 2014 compared with 2013. The most commonly reported reactions were injection site reaction (27%), pyrexia (18%), rash (16%), vomiting (9%), headache (7%), and syncope (5%). The majority of AEFI reports described non-serious events while 7% (n=211) were classified as serious. There were 5 deaths reported with no clear causal relationship with vaccination found. This case involves a 58-year-old male patient who was vaccinated with a of INFLUENZA VACCINE and DIPHTHERIA AND TETANUS TOXOIDS (DIPHTHERIA AND TETANUS) (batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient had an infected leg wound prior to vaccination. Concomitant medications were not reported. On an unspecified date, 5 days following the vaccination, the patient developed acute disseminated myeloencephalitis, which progressed over 6 weeks leading to death. Relevant laboratory test and corrective treatment was not reported. It was not reported, if the Autopsy was done or not as the Autopsy results were not reported. Documents held by sender: none. Sender''s Comments: Acute disseminated encephalomyelitisis reported in this case. Symptoms started 5 days after vaccination which is compatible with the role of the vaccine. Additional information regarding medical history, infectious history, any other co morbidities and other etiological work up are needed to further assess the case. In this case patient has history of infected leg wound prior vaccination which could have caused the ADEM. Based on available information the role of vaccine cannot be assessed. Reported Cause(s) of Death: Acute disseminated myeloencephalitis.


VAERS ID: 692350 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-04-27
Entered: 2017-04-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Death of brother; Comments: Family history: the patient''s brother died due to pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131704JPN002225J

Write-up: Initial information has been received from a patients younger brother concerning an 80-year-old male patient who on an unspecified date was vaccinated with PNEUMOVAX NP injection subcutaneously for prophylaxis (lot number and dose not reported). There was no concomitant medication reported. On an unspecified date (since 70-year-old), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) every five years. On an unspecified date (when 80-year-old), the patient died due to pneumonia. Information on autopsy was not reported. Reporters comment: not provided. The reporter considered pneumonia was serious due to death. Upon internal review, pneumonia was determined to be medically significant. The reporter did not assess the relationship of pneumonia to pneumococcal vaccine, polyvalent (23-valent). Follow-up attempt was not made because the reporter did not wish to be contacted.; Reported Cause(s) of Death: Pneumonia.


VAERS ID: 692638 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:2017-04-24
Onset:2017-04-25
   Days after vaccination:1
Submitted: 2017-04-28
   Days after onset:3
Entered: 2017-05-01
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER A035A / 2 LA / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR M1215 / 3 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 16D1A / 3 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Ammonia increased, Aspartate aminotransferase increased, Autopsy, Influenza A virus test positive, Pallor, Resuscitation, Sudden death, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-04-25
   Days after onset: 0
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2017JPN061562

Write-up: This case was reported by a physician via licensee and described the occurrence of sudden death in a 5-month-old male subject who received ROTARIX liquid formulation. Co-suspect products included ACTHIB (batch number M1215, expiry date unknown), PREVENAR 13 (batch number 16D01A, expiry date unknown) and QUATTROVAC (batch number A035A, expiry date unknown). Concomitant products included ROTARIX liquid formulation and Hep B vaccine (yeast-derived) On 28th February 2017, the subject received the 2nd dose of ROTARIX liquid formulation (oral). On 26th January 2017, the subject received the 1st dose of ACTHIB (subcutaneous). On 28th February 2017, the 2nd dose was an unknown dose. On 24th April 2017, the 3rd dose was 0.5 ml. On 26th January 2017, the subject received the 1st dose of PREVENAR 13 (subcutaneous). On 28th February 2017, the 2nd dose was an unknown dose. On 24th April 2017, the 3rd dose was 0.5 ml. On 28th February 2017, the subject received the 1st dose of QUATTROVAC (subcutaneous). On 24th April 2017, the 2nd dose was 0.5 ml. On 25th April 2017, 56 days after receiving ROTARIX liquid formulation, the subject experienced sudden death (serious criteria death and GSK medically significant), complexion ill and unresponsive to stimuli (serious criteria GSK medically significant). On an unknown date, the subject experienced influenza A virus test positive, AST high and ammonia increased. On 25th April 2017, the outcome of the sudden death was fatal. On an unknown date, the outcome of the complexion ill, unresponsive to stimuli, influenza A virus test positive, AST high and ammonia increased were unknown. The subject died on 25th April 2017. The reported cause of death was sudden death. An autopsy was performed. It was unknown if the reporter considered the sudden death, complexion ill, unresponsive to stimuli, influenza A virus test positive, AST high and ammonia increases to be related to ROTARIX liquid formulation. [Clinical course] On 26 January 2017, ACTHIB, PREVNAR, hepatitis B vaccine and ROTARIX were administered. On 28 February 2017, ACTHIB, PREVENAR and QUATTOROVAC were administered. On 24 April 2017, at 14:30, ACTHIB, PREVENAR and QUATTIRIVAC were administered. (The following was reported from the pediatrician of Hospital O and the police.) The subject was in good condition after he went home. On 25 April 2017, at midnight, the mother confirmed he was alive. At 2:00 a.m., the mother noticed his ill complexion and he showed no response to stimulation. At 2:05 a.m., the mother called and ambulance and he was admitted to the department of pediatrics of Hospital O. He showed no response to resuscitation. At 3:23 a.m., his death was noticed. According to the autopsy by the police, the estimated time of death was 1:00 a.m. He had no history of allergy. His elderly brother experienced erythema multiforme exudativum as an allergy. He was on no concurrent therapy. Information on primary disease, concurrent disease and medical history was unknown. [Reporter''s comment] Causality between sudden death and ACTHIB, PREVENAR and QUATTOROVAC and concurrent medications was unknown as of this report. Investigation of the cause of death had been ongoing at Hospital O including the possibility of so-called sudden infant death syndrome or presence of underlying disease. In the test results at Hospital O, influenza type A was positive, but he had no pyrexia at that time. The levels of aspartate aminotransferase and blood ammonia were also high. Whether the subject had inborn error of metabolism or not has been also been investigated at Hospital O. Causality between cause of death and the adverse events: Unknown.


VAERS ID: 693080 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-02-23
Onset:2017-03-03
   Days after vaccination:8
Submitted: 2017-05-04
   Days after onset:61
Entered: 2017-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. M039219 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Drowning
SMQs:, Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-03-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131704DEU015209

Write-up: Information has been received from a health care profesional via the Agency (DE-PEI-PEI2017036489) on 27-APR-2017. Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Spontaneous case report: A female 12 year old patient, born on 12-MAY-2004, was vaccinated with the second dose of GARDASIL 9 (batch number M039219) for prophylactic vaccination, route of administration: intramuscular on 23-FEB-2017. Information on concomitant medication and past medical history were not provided. Previous vaccination with GARDASIL 9 administered on 08-AUG-2017 had been well tolerated. On 03-MAR-2017, the patient drowned during swim training. An autopsy was not performed. Follow up information has been requested.


VAERS ID: 693084 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-04-25
Onset:0000-00-00
Submitted: 2017-05-04
Entered: 2017-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Intensive care, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131704JPN002449J

Write-up: Initial information has been received from a physician concerning a 79-year-old female patient who on 25-APR-2017 was vaccinated with PNEUMOVAX NP for prophylaxis (route, dose and lot number not reported). There were no concomitant medications reported. On 25-APR-2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (described above). In April 2017, nearby general hospital contacted the reporter that the patient was hospitalized in intensive care unit (ICU) due to subarachnoid haemorrhage. At the time of this report, the outcome of subarachnoid haemorrhage was unknown. Reporter''s comment: not provided The reporting physician did not assess the causal relationship of subarachnoid haemorrhage to PNEUMOVAX NP. The reporting physician considered subarachnoid haemorrhage to be serious due to hospitalization. Upon internal review, subarachnoid haemorrhage was determined to be medically significant. Follow-up attempt was not made because the reporter did not wish to be contacted.


VAERS ID: 693113 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-04
Entered: 2017-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Unevaluable event
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MY0095075131705MYS000795

Write-up: This spontaneous report was received from a cardiologist and refers to multiple patients of unknown age and gender. No information about the patients'' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with ZOSTAVAX injection (lot#, expiration date, dose and route of administration were not reported). The reporter received news from the website where individuals claimed injury such as blindness in one eye, serious paralysis in their extremities, brain damage and death from taking ZOSTAVAX. The outcome of the events of blindness in one eye, serious paralysis in their extremities and brain damage was not reported. The reporter considered the events to be related to ZOSTAVAX. Upon internal review, the events of death, brain injury, peripheral paralysis and blindness unilateral were considered to be medically significant. Additional information is not expected as this is medical inquiry. Reported Cause(s) of Death: death.


VAERS ID: 693784 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2017-04-27
Onset:0000-00-00
Submitted: 2017-05-10
Entered: 2017-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
DTPHEP: DTP + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Autopsy, Death, Endotracheal intubation, General physical health deterioration, Hypothermia, Skin discolouration
SMQs:, Angioedema (broad), Acute central respiratory depression (narrow), Accidents and injuries (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Inguinal hernia (Operation was required one week before this report); Premature birth (Patient was born prematurely at the eighth month of pregnancy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TRPFIZERINC2017191403

Write-up: The initial case was missing the following minimum criteria: unspecified suspect drugs. Upon receipt of follow-up information on 02May2017, this case now contains all required information to be considered valid. This is a spontaneous report obtained from two physicians through a Pfizer sales representative. A 2 month-old male patient of an unspecified race and ethnicity received PREVENAR 13 single dose, and BCG vaccine, both on an unspecified date, for immunization. Relevant medical history included inguinal hernia (operation was required one week before this report). The patient was born prematurely at the eighth month of pregnancy (he was put on ventilatory support for 1 month after he was born). Concomitant medication included diphtheria vaccine, haemophilus influenza type b vaccine, hepatitis b vaccine, pertussis vaccine, tetanus vaccine (pentavalent vaccine), received on an unspecified date, for immunization. The patient received the vaccinations at primary health care center, one vaccine on left arm and 2 vaccines on legs. The patient was brought at home after injections and he worsened at 23:00, of the same day. Then the patient was brought at hospital with ambulance. One of the physician stated that the patient was intubated; the patient''s general condition was not well and the patient had hypothermia and apnea. The patient''s father stated that the patient became purple after vaccination at night. The patient was taken under treatment but the patient died next morning at 05:00. An Autopsy was performed but the date was unknown. At time of this report, the patient''s cause of death was unknown. Sender''s Comments: Per Company procedures, this report with "death of unknown cause" is assessed and processed as "possibly related" for Company Causality assessment until sufficient information becomes available to confirm an unrelated cause of death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety valuation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 693889 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-11
Entered: 2017-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pneumococcal infection, Pneumonia, Streptococcus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), 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: 2017-05-06
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Culture; Result Unstructured Data: Test Result: pneumococcal bacterium isolated
CDC Split Type: ITPFIZER INC2017202656

Write-up: This is a spontaneous report from a contactable physician through a sales representative. A 68-year-old female patient received a single dose of PREVENAR 13 either in 2011 and in 2016, as vaccination. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pneumonia, vaccination failure and pneumococcal infection, all serious for death. After a first suspect by meningococcal bacterium, pneumococcal bacterium has been instead isolated. This was a heavy clinically case: the patient died due to pneumonia (vaccination failure and pneumococcal infection) on 06May2017 and it was not reported if an autopsy was performed. It''s known that pneumococcal 13-val conj vaccine does not protect all individuals from the diseases caused by pneumococcal bacterias. However, the spectrum of antigens covered by the vaccine allows for high efficacy of prophylactic treatment.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative serotype results are needed for full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: pneumonia; Pneumococcal infection; Vaccination failure.


VAERS ID: 694318 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-11
Entered: 2017-05-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), 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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2012GSK000609

Write-up: This case was reported by a consumer via market research programs and described the occurrence of vaccination failure in a male patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Flu seasonal TIV Dresden at an unknown dose. On an unknown date, unknown after receiving Flu seasonal TIV Dresden, the patient experienced vaccination failure (serious criteria death and GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure and influenza were fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu seasonal TIV Dresden. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. This was the case of reporter''s grandfather. This case was considered as the suspected vaccination failure since the details of basic immunization, exact time to onset for the event and laboratory confirmation was not provided. The question and the reply for this case were: Why are you in favor of minimizing the number of vaccines? The consequences of a vaccine, like developing the pathology (the flu, my grandfather was vaccinated, contracted the flu and died of it, hepatitis B, my mother and my cousin contracted rheumatoid arthritis and multiple sclerosis following a recall .. my mother died of sudden death from polyarthritis at age 59). This case was linked with FR2012GSK000612 and FR2012GSK000614). MAH Comment: Suspected reasonable causal relationship based on the event vaccination failure is upgraded from ''Unknown'' to ''Yes'' as the event is listed for Flu seasonal TIV Dresden vaccine and downgraded for event influenza from ''Unknown'' to ''No'' as there is insufficient information provided for case assessment.


VAERS ID: 694364 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-11
Entered: 2017-05-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2013GSK000663

Write-up: This case was reported by a consumer via market research programs and described the occurrence of death in a female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to Hepatitis B vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The autopsy details were not reported. The question and the reply for this case were: why do you want to decrease the number of vaccines: Issues in my family following hepatitis B (death of my mother).


VAERS ID: 694365 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-11
Entered: 2017-05-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Multiple sclerosis
SMQs:, Optic nerve disorders (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2013GSK000666

Write-up: This case was reported by a consumer via market research programs and described the occurrence of death in a female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced death (serious criteria death and GSK medically significant) and multiple sclerosis (serious criteria GSK medically significant). On an unknown date, the outcome of the death was fatal and the outcome of the multiple sclerosis was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death and multiple sclerosis to be related to Hepatitis B vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination as not reported. The autopsy details were not reported. The question and the reply for this case were: why do you think Hepatitis B vaccine is not useful? Because risks of being contaminated are low. and my mother died following a multiple sclerosis so there is a doubt and I prefer to avoid the vaccination of my daughter. Myself I am not against Hepatitis B vaccine.


VAERS ID: 694371 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-11
Entered: 2017-05-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Multiple sclerosis, Polyarthritis, Rheumatoid arthritis
SMQs:, Systemic lupus erythematosus (broad), Optic nerve disorders (broad), Demyelination (narrow), Arthritis (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2012GSK000614

Write-up: This case was reported by a consumer via market research programs and described the occurrence of polyarthritis in a female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced polyarthritis (serious criteria death and GSK medically significant), rheumatoid arthritis (serious criteria GSK medically significant) and multiple sclerosis (serious criteria GSK medically significant). On an unknown date, the outcome of the polyarthritis was fatal and the outcome of the rheumatoid arthritis and multiple sclerosis were unknown. The reported cause of death was polyarthritis. It was unknown if the reporter considered the polyarthritis, rheumatoid arthritis and multiple sclerosis to be related to Hepatitis B vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. This was the case of reporter''s mother. The autopsy details were not reported. The question and the reply for this case were: Why are you in favor of minimizing the number of vaccines? The consequences of a vaccine, like developing the pathology (the flu = my grandfather was vaccinated, contracted the flu and died, hepatitis B = my mother and my cousin contracted rheumatoid arthritis and multiple sclerosis following a recall..my mother died of sudden death from polyarthritis at age 59). This case was linked with FR2012GSK000612 and FR2012GSK000609.


VAERS ID: 694374 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-11
Entered: 2017-05-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cervix carcinoma, Death, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Uterine and fallopian tube malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2012GSK000622

Write-up: This case was reported by a consumer via market research programs and described the occurrence of death in a female patient who received Human papilloma type 16 + 18 vaccine + AS04D. On an unknown date, the patient received Human papilloma type 16 + 18 vaccine + AS04D at an unknown dose. On an unknown date, unknown after receiving Human papilloma type 16 + 18 vaccine + AS04D, the patient experienced death (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant) and cervical cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the death was fatal and the outcome of the vaccination failure and cervical cancer were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death, vaccination failure and cervical cancer to be related to Human papilloma type 16 + 18 vaccine + AS04D. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. This case was considered as the suspected vaccination failure since the details of basic immunization schedule, exact time to onset for event and laboratory rest was not reported. The question and the reply for this case were: What information have you retained concerning this vaccination against cervical cancer? It''s important for young girls to be vaccinated but I know a young girl who was vaccinated and afterwards developed cervical cancer and died. Agency Comment: Suspected reasonable causal relationship based on the event vaccination failure is upgraded from ''Unknown'' to ''Yes'' as the event is listed for Human papilloma type 16 + 18 vaccine + AS04D and downgraded for event death and cervix carcinoma from ''Unknown'' to ''No'' as there is insufficient information provided for adequate case assessment.


VAERS ID: 694376 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-11
Entered: 2017-05-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2012GSK000606

Write-up: This case was reported by a consumer via market research programs and described the occurrence of death in a patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to Hepatitis B vaccine. Additional information was provided. This case is one of the multiple cases reported following the market research. The patient''s age at vaccination was not reported. The question and the reply for this case were: Why are you in favor of minimizing the number of vaccines? I have been working in pharmacy for thirty years, and I have seen pathologies occur after vaccine injections, so I am reluctant to vaccinate and I treat my son with homeopathic vaccines when I can. I had friends which after the second hepatitis B injection had multiple sclerosis, and two deaths after the injection, since the labs did not demonstrate categorically the non-cause-effect, I am very opposed to certain vaccines. This case was linked to FR2012GSK000605 and FR2012GSK000606, same reporter.


VAERS ID: 694378 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-11
Entered: 2017-05-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2012GSK000605

Write-up: This case was reported by a consumer via market research programs and described the occurrence of death in a patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to Hepatitis B vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The patient''s age at vaccination was not reported. The question and the reply for this case were: Why are you in favor or minimizing the number of vaccines? I have been working in pharmacy for thirty years, and I have seen pathologies occur after vaccine injections, so I am reluctant to vaccinate and I treat my son with homeopathic vaccines when I can. I had friends which after the second hepatitis B injection had multiple sclerosis, and two deaths after the injection, since the labs did not demonstrate categorically the non-cause-effect, I am very opposed to certain vaccines. This case was linked to FR2012GSK000604 and FR2012GSK000606, same reporter.


VAERS ID: 694354 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-15
Entered: 2017-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZA0095075131705ZAF007293

Write-up: This spontaneous report was received from a consumer concerning a few patients of unknown gender and age. The patients'' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with GARDASIL injection, (strength, dose, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patients developed pulmonary embolism. On an unknown date, the patients died. The cause of death was the pulmonary embolism. The causality between the event and the GARDASIL was not reported. Upon internal review, the event pulmonary embolism was determined to be medically significant. This is one of several reports received from the same source. Additional information has been requested. Sender''s Comments: ZA-009507513-1507ZAF012830. Reported Cause(s) of Death: pulmonary embolism.


VAERS ID: 694455 (history)  
Form: Version 1.0  
Age: 0.67  
Sex: Male  
Location: Foreign  
Vaccinated:2017-03-17
Onset:2017-03-18
   Days after vaccination:1
Submitted: 2017-05-15
   Days after onset:58
Entered: 2017-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Intensive care, Meningitis pneumococcal
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-03-21
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ES2017GSK070155

Write-up: This case was reported by a physician via sales rep and described the occurrence of pneumococcal meningitis in a 8-month-old male patient who received BEXSERO. On 17th March 2017, the patient received the 3rd dose of BEXSERO (intramuscular). On 18th March 2017, 1 days after receiving BEXSERO, the patient experienced pneumococcal meningitis (serious criteria death, hospitalization and GSK medically significant). On 21st March 2017, the outcome of the pneumococcal meningitis was fatal. The patient died on 21st March 2017. The reported cause of death was pneumococcal meningitis. The reporter considered the pneumococcal meningitis to be unrelated to BEXSERO. Additional details were provided as follows: On 18th March 2017, the patient was hospitalized due to pneumococcal meningitis and several hours later he was admitted to intensive care unit (ICU). The pneumococcal meningitis was on an advance phase. On 21st March 2017, the patient died. No information provided about BEXSERO batch number. No further information was available.


VAERS ID: 695153 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-05-10
Onset:2017-05-01
Submitted: 2017-05-19
   Days after onset:18
Entered: 2017-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / SYR

Administered by: Other       Purchased by: Unknown
Symptoms: Cerebral haemorrhage, Coma, Encephalitis, Encephalitis autoimmune, Head injury, Intensive care, Rabies
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Victim of child abuse
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BO0095075131705BOL008131

Write-up: This spontaneous report was received from a physician reporting on a 11-year-old female patient. No information concerning the patient''s concomitant therapy or medical history was provided. A history of chronic abuse was identified by the physician. On 10-MAY-2017, the patient was vaccinated with unspecified dose of GARDASIL subdermal injection (lot number and expiration date were not reported), as prophylaxis for Human Papilloma Virus (HPV) by medical prescription. On an unknown date approximately in May 2017, the patient was admitted into the Intensive Care Unit (ICU) for either the autoimmune encephalitis or encephalitis (in study). When evaluated by her pediatrician, the patient was diagnosed with human rabies. This diagnosis was confirmed by two epidemiologists. But later it was discarded. On an unknown date, the patient suffered trauma in her forehead as she was hit with a stone, which caused a cerebral hemorrhage on an unknown date in approximately May 2017. At the time of this report, the patient was in coma in the ICU. No relevant laboratory results or diagnostic tests were reported. The outcome of the autoimmune encephalitis and encephalitis in study was reported as unknown. The outcome of cerebral hemorrhage due to trauma and coma was reported as not recovered. The causality between the events and GARDASIL was reported as unknown. Upon internal review, the events of autoimmune encephalitis, encephalitis (in study), cerebral hemorrhage due to trauma and coma were considered to be medically significant. Additional information is not expected as no follow-up information is available.


VAERS ID: 695312 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-19
Entered: 2017-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / SYR

Administered by: Other       Purchased by: Unknown
Symptoms: Death, General physical health deterioration
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZA0095075131705USA009589

Write-up: This spontaneous report as received from a physician via information Centre refers to a female patient of unknown age. No medical history, concurrent conditions and concomitant medications were reported. On an unknown date, the patient was vaccinated GARDASIL (dosing regimen and frequency unknown) (lot number and expiry date unknown) for an unknown indication. It was reported that the patient''s health suddenly deteriorated after GARDASIL shots. On an unknown date, the patient died. The outcome of the event general physical health deterioration was unknown. The cause of death was unknown. Causality assessment for the events was not provided. Upon internal review, the event death was determined to be medically significant. This is one of the many reports from the same source. Additional information has been requested. Sender''s Comments: ZA-009507513-1705ZAF001234.


VAERS ID: 695316 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-18
Entered: 2017-05-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2017GSK072075

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a female subject who received HPV vaccine. On an unknown date, unknown time after receiving HPV vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to HPV vaccine. Additional information was provided. This case was reported in a literature article and described death not otherwise specified (NOS) in a female of unspecified age who was vaccinated with unspecified HPV vaccine (manufacturer unknown). The patient was reported by 1 of the participant in the study that aimed to explore reasons for being un-/under vaccinated. The patient had underlying unspecified medical conditions. No information on patient''s family history or concomitant medication was provided. On an unspecified date, the patient received unspecified HPV vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The batch of the vaccine administered was different than that used in the study. The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient died. The cause of death was unknown. It was not reported if an autopsy was performed. This case has been considered serious due to death. The authors did not comment on the relationship between the death NOS with unspecified HPV vaccine. The authors concluded "Among girls from diverse ethnic backgrounds, practical problems are likely to inhibit girls from completing the HPV vaccination course, whereas safety concerns, and perceiving that the HPV vaccination is not necessary can explain why girls remain unvaccinated. The findings of this study may be used to tailor interventions to increase informed participation among girls who are currently under vaccinated or unvaccinated".


VAERS ID: 695558 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-12-09
Onset:0000-00-00
Submitted: 2017-05-18
Entered: 2017-05-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Bacterial disease carrier, Death, Foetal exposure during pregnancy, Trisomy 21
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NO2017GSK073622

Write-up: This retrospective pregnancy case was reported by a physician via regulatory authority and described the occurrence of trisomy 21 in a female neonate exposed to Influenza vaccine unspecified in utero. The mother received the product. On 9th December 2016, the 35-year-old mother received Influenza vaccine unspecified. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The neonate was diagnosed with trisomy 21 (serious criteria death and congenital anomaly), streptococcal colonization (serious criteria death) and maternal vaccine exposure. On an unknown date, the outcome of the trisomy 21 and streptococcal colonization were fatal and the outcome of the maternal vaccine exposure was unknown. An autopsy was performed. The autopsy determined cause of death was trisomy 21 and streptococcal colonisation. It was unknown if the reporter considered the trisomy 21 and streptococcal colonization to be related to Influenza vaccine unspecified. See case NO2017033682 for details regarding the mother case. Initial information was received from physician via regulatory authority on 30-MAR-2017. Additional information will be requested. This is a preliminary report. Fetus - preliminary autopsy report - normal findings. Fetus - chromosomal analysis - trisomi 21. Fetus - streptococcal colonisation in placenta, vagina and throat. Final autopsy report will be requested.


VAERS ID: 695957 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2015-11-25
Submitted: 2017-05-15
   Days after onset:536
Entered: 2017-05-23
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cervical radiculopathy, 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:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700575

Write-up: This spontaneous case, initially received on 09-May-2017 was reported by other health professional (physician) via health authority (HA reference number: IT-MINISAL02-344293) and concerns a female patient of an unspecified age. Administration of Company suspect drug: On an unspecified date, the patient received Influenza vaccine, dose, batch number, expiry date, anatomical location and route of administration: not reported). Indication not reported. Adverse reactions/events and outcomes: On 25-Nov-2015, the patient experienced cervical spine polyradiculopathy. On an unknown date, the patient died. The cause of death was not reported. It was unknown whether autopsy was done or not. Action taken with the suspect vaccine was not applicable. Reporter''s Assessment: The reporter did not provide the causality of the event in relation to the INN Flu Vaccine Seasonal. Health Authority considered the event cervical spine polyradiculopathy as serious (death and hospitalization).


VAERS ID: 696078 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-19
Entered: 2017-05-23
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: CERVARIX, 1st dose received on unknown date
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZA2017GSK072229

Write-up: This case was reported by a consumer via other and described the occurrence of unknown cause of death in a female patient who received CERVARIX. Previously administered products included CERVARIX (1st dose received on unknown date). On an unknown date, the patient received the 2nd dose of CERVARIX. On an unknown date, unknown after receiving CERVARIX, 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 reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to CERVARIX. Additional details were provided as follows: The patient''s age at vaccination was not reported. The reporter had been notified via website by one of the patient of another potential serious case. The patient received two doses of CERVARIX and was passed away roughly two weeks ago. The reporter was not seen any media about this personally to date.


VAERS ID: 696080 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-02-17
Onset:0000-00-00
Submitted: 2017-05-23
Entered: 2017-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Intensive care, Interstitial lung disease
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-21
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU2017GSK074253

Write-up: This case was reported by a nurse via other manufacturer and described the occurrence of interstitial pneumonia in a 66-year-old female patient who received MENVEO. On 17th February 2017, the patient received the 1st dose of MENVEO. In February 2017, less than a week after receiving MENVEO, the patient experienced interstitial pneumonia (serious criteria death, hospitalization and GSK medically significant). On 21st February 2017, the outcome of the interstitial pneumonia was fatal. The patient died on 21st February 2017. The reported cause of death was interstitial pneumonia. The reporter considered the interstitial pneumonia to be possibly related to MENVEO. Additional details provided as follows: This case was report by a nurse via regulatory authority through a third company. The patient was included in a non GSK trail, in which MENVEO had to be given prior to eculizumab infusion commencing as their treatment in the trial. On 17th February 2017 at 7:45pm, the patient was vaccinated with MENVEO. On an unknown date, the patient was admitted into hospital with acute intestinal pneumonia. On 21st February 2017, the patient died after decline in intensive care unit (ICU). No further follow up would be conducted as this case was received via regulatory authority and no consent has been provided by the reporter as well.


VAERS ID: 695954 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2017-05-06
Submitted: 2017-05-24
   Days after onset:18
Entered: 2017-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Abdominal pain upper, Back pain, Coma, Death, Disturbance in attention, Dysuria, Encephalitis, Epistaxis, General physical health deterioration, Hyperaesthesia, Neurological symptom, Oral mucosal eruption, Pain, Sensory loss, Soft tissue injury, Tinnitus
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZA0095075131705ZAF010071

Write-up: Information has been received via GlaxoSmithKline from a female consumer concerning her daughter, a 12 year old female patient. The patient''s medical history, concurrent conditions and concomitant therapy were not provided. At the beginning of 2015, the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, dose and route not reported) for prophylaxis. On an unknown date, after the first dose of vaccination, the patient experienced ears ringing (tinnitus), unspecified throbbing. The patient was checked by a general practitioner (GP) and no issue was identified. Progressively then, on an unknown date, the patient experienced events: stomach pain, concentration issue, nose bleeds, rash around mouth and sensitive to touch. At the beginning of 2016, the patient received the second dose of CERVARIX (lot #, expiration date, dose and frequency not reported) (interchange of vaccine products and drug use for unapproved schedule). In September 2016, the patient got the third dose of CERVARIX (lot #, expiration date, dose and route unknown). On an unknown date in 2017 (reported as last week), the patient experienced sore back which was suspected as soft tissue injury playing netball. After suspected soft tissue injury, the patient was treated by physio for back pain. On 06-MAY-2017, the patient experienced sudden deterioration with difficulty urinating, neurological symptoms and coma and she could not feel. According to doctors in hospital, there might be (?) type of encephalitis. On 07-MAY-2017 at 18:00, the patient died. The cause of death was not provided. The reporter wanted to wait for autopsy (Friday unspecified date in May 2017) first. The outcome of the events except death was unknown. The causality between all of events and suspect vaccines was not provided. Upon internal review, death, coma and type of encephalitis were determined as medically significant. Additional information has been requested.


VAERS ID: 696116 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-22
Entered: 2017-05-24
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Scleroderma
SMQs:, Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO2017GSK074271

Write-up: This case was reported by a physician via local affiliate and described the occurrence of scleroderma in a female patient who received HPV vaccine. On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced scleroderma (serious criteria death and GSK medically significant). On an unknown date, the outcome of the scleroderma was fatal. The reported cause of death was scleroderma. The reporter considered the scleroderma to be possibly related to HPV vaccine. Additional details were reported as follows: This case was reported in a video, which was presumed that the video was of the year 2015, where the patient mentioned different cases, this video was sent by a physician to GlaxoSmithKline. The age at vaccination was not reported. The patient of unknown age, height and weight, was vaccinated with the HPV vaccine (unspecified name, date, anatomical vaccination site and dose). The patient presented with scleroderma after vaccination and died. The cause of death was associated to the vaccination. The physician who sent the video did not provide any analysis of the causality. The product information was not reported. Further information was not expected. This case is linked to cases CO2017GSK074274, CO2017GSK074273, CO2017GSK074272 and CO2017GSK074276 reported by the same reporter.


VAERS ID: 696117 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-22
Entered: 2017-05-24
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO2017GSK074273

Write-up: This case was reported by a physician via other and described the occurrence of systemic lupus erythematous in a female patient who received HPV vaccine. On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced systemic lupus erythematosus (serious criteria death and GSK medically significant). On an unknown date, the outcome of the systemic lupus erythematosus was fatal. The reported cause of death was systemic lupus erythematosus. The reporter considered the systemic lupus erythematosus to be possibly related to HPV vaccine. The age at vaccination was not reported. This report was reported in a video, it was presumed that the video was of the year 2015, where the patient mentioned different cases, this video was sent by physician to GlaxoSmithKline. She mentioned about her case and informed about 3 other cases of death related to the use of this vaccine. This case of death was about a female patient who experienced lupus and died. The probable cause of death was due to lupus on an unspecified date. There was not more additional information about the death causes. The patient reported about other cases of girls around the country that presented the same events and she did especial emphasis in the cases and more than 760 cases around the Country and the world. The reporter said that the events were happened around the world. This case was linked to CO2017GSK074274, CO2017GSK074271, CO2017GSK074272 and CO2017GSK074276 reported by the same reporter.


VAERS ID: 696118 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-22
Entered: 2017-05-24
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Completed suicide, Schizophrenia
SMQs:, Suicide/self-injury (narrow), Psychosis and psychotic disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO2017GSK074274

Write-up: This case was reported by a physician via local affiliate and described the occurrence of schizophrenia in a female patient who received HPV vaccine. On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced schizophrenia (serious criteria death and GSK medically significant) and suicide (serious criteria death and GSK medically significant). On an unknown date, the outcome of the schizophrenia and suicide were fatal. The reported cause of death was schizophrenia and suicide. The reporter considered the schizophrenia to be possibly related to HPV vaccine. It was unknown if the reporter considered the suicide to be related to HPV vaccine. Additional details were reported as follows: This report was reported in a video, it was presumed that the video was of the year 2015, where a patient mentioned different cases, this video was sent by a physician to GlaxoSmithKline. The age at vaccination was not reported. The patient with unknown age, height and weight was vaccinated with the HPV vaccine (unspecified product, vaccination site and dose. After the vaccination the patient presented with schizophrenia and subsequently committed suicide on an unspecified date. It was unknown if an autopsy was performed. The physician who sent the video did not provide any analysis of the causality. The product information was not reported. There was no additional information about this case. No further information was expected. This case was linked to cases CO2017GSK074272, CO2017GSK074273, CO2017GSK074276 and CO2017GSK074271 reported by the same reporter.


VAERS ID: 696159 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-24
Entered: 2017-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Bacterial test negative, Death, Meningitis pneumococcal, Streptococcus test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Vaccine not specified (no brand name)~~0.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 201705; Test Name: Microbiology test; Result Unstructured Data: Test Result: absence of Meningococcus and presence of ''Streptoc; Comments: Microbiology test (May2017): absence of Meningococcus and presence of Streptococcus pneumoniae
CDC Split Type: ESPFIZER INC2017226166

Write-up: This is a spontaneous report from a contactable consumer received via Communication Department. A 2-year-old female patient of an unspecified ethnicity received PREVENAR 13 (lot number and expiration date unknown) via an unspecified route of administration at single dose on an unspecified date for prophylaxis. The patient medical history and concomitant medications were not reported. The patient previously received meningococcal B recombinant vaccine for prophylaxis. The patient experienced meningitis caused by pneumococcal bacteria in 2017. The patient underwent lab tests and procedures which included microbiology test in May2017 and the result was absence of Meningococcus and presence of Streptococcus pneumoniae. The patient died on 17May2017. An autopsy was performed and results were not provided. The narrative also included: An autopsy was going to be performed and the results were pending, as well as the anatomopathological studies. The child had completed the vaccination scheduled until the date of death, she even had received the meningococcal B vaccine. Follow-up attempts are not possible. No further information is expected.; Reported Cause(s) of Death: Pneumococcal meningitis


VAERS ID: 696321 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2017-05-15
Submitted: 2017-05-23
   Days after onset:8
Entered: 2017-05-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: CSF culture positive, Death, Petechiae, Pneumococcal sepsis, Streptococcus test positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: BEXSERO, 1st dose received on unknown date
Allergies:
Diagnostic Lab Data: 05/19/2017, CSF culture, pneumococcus, positive
CDC Split Type: ES2017GSK075763

Write-up: This case was reported by a non-health professional via sales rep and described the occurrence of pneumococcal septicemia in a 2-year-old female patient who received BEXSERO (batch number unk, expiry date unknown). Previously administered products included BEXSERO (1st dose received on unknown date). On an unknown date, the patient received the 2nd dose of BEXSERO (intramuscular). On 15th May 2017, unknown after receiving BEXSERO, the patient experienced pneumococcal septicemia (serious criteria death, hospitalization and GSK medically significant). On 16th May 2017, the patient experienced petechia. On 17th May 2017, the outcome of the pneumococcal septicemia was fatal. On an unknown date, the outcome of the petechia was unknown. The patient died on 17th May 2017. The reported cause of death was pneumococcal septicemia. An autopsy was performed. The reporter considered the pneumococcal septicemia and petechia to be unrelated to BEXSERO. Additional details provided as follows: The case was received from two digital newspapers. The age at vaccination was not reported. The patient had been vaccinated against meningitis B and she was up to date with the official vaccination schedule. On 15th May 2017, the patient started to have symptoms of sepsis. On 16th May 2017, she was taken to the pediatrician as the patient had extended petechiaes. The pediatrician decided to send her to the local hospital. The physician in the local hospital decided to send her to the Hospital. On 17th May 2017, the patient died where initially the cause of death was unclear if the sepsis was due to Meningococcus or due to Pneumococcus. On 19th May 2017, it was published that an analysis was performed by the Hospital Microbiology department, where it was confirmed the presence of pneumococcus and the absence of meningococcus in the spinal fluid extracted for post-mortem patient, so this discarded the suspect of a meningococcal infection. A follow up had been tried with the hospital and with patient''s pediatrician which was unsuccessfully.


VAERS ID: 696333 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2016-05-24
Onset:2016-05-25
   Days after vaccination:1
Submitted: 2017-05-25
   Days after onset:365
Entered: 2017-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC651A / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M90777 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA943AD / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Inborn error of lipid metabolism, Neurological examination normal, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Congenital, familial and genetic disorders (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-05-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Vaccine not specified (no brand name)~~0.00~Patient|~Vaccine not specified (no brand name)~~0.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apgar score (8/9, at birth); Head circumference (cranial circumference at birth: 31cm); Late preterm infant; Length at birth (length at birth: 43cm); Weight (weight at birth: 2095g)
Allergies:
Diagnostic Lab Data: Test Date: 20160524; Test Name: Physical examination; Result Unstructured Data: Test Result: normal; Comments: Physical examination (24May2016): normally perfused skin and mucous membranes, elastic skin with a very slight dryness of eczematous nature. Tones were valid, rhythmic, with no murmurs at cardiac auscultation and breath sounds appeared normal at respiratory auscultation. The abdomen appeared treatable, with hypochondriac organs within the limits. The central and peripheral neurological examination appeared normal. The fontanelle appeared normotensive with a transverse diameter of 0.5 cm.; Test Date: 20160427; Test Name: Psychiatric evaluation; Result Unstructured Data: Test Result: normal; Comments: Physical examination (24May2016): normally perfused skin and mucous membranes, elastic skin with a very slight dryness of eczematous nature. Tones were valid, rhythmic, with no murmurs at cardiac auscultation and breath sounds appeared normal at respiratory auscultation. The abdomen appeared treatable, with hypochondriac organs within the limits. The central and peripheral neurological examination appeared normal. The fontanelle appeared normotensive with a transverse diameter of 0.5 cm.; Test Date: 20160427; Test Name: Ultrasound scan; Result Unstructured Data: Test Result: normal; Comments: Physical examination (24May2016): normally perfused skin and mucous membranes, elastic skin with a very slight dryness of eczematous nature. Tones were valid, rhythmic, with no murmurs at cardiac auscultation and breath sounds appeared normal at respiratory auscultation. The abdomen appeared treatable, with hypochondriac organs within the limits. The central and peripheral neurological examination appeared normal. The fontanelle appeared normotensive with a transverse diameter of 0.5 cm.
CDC Split Type: ITPFIZER INC2016276050

Write-up: This is a spontaneous report from a contactable nurse and from a contactable healthcare assistants via a Pfizer sales representative based on information received from Regulatory Authority, Regulatory Authority report number 360836. A contactable pediatrician reported that an 11-week-old female patient received 1st dose of PREVENAR 13 (Lot.M90777, Exp date: 30Apr2018) intramuscular at right thigh at 0.5ml single dose for immunization, 1st dose of ROTARIX (Lot. AROLA943AD) orally at 1 DF, single for immunization and 1st dose of INFANRIX HEXA (Lot. A21CC651A) intramuscular at left thigh at 1 DF, single, all on 24May2016 10:30 AM for immunization. Medical history included premature baby. Concomitant medications include dietary supplement: BIMBOVIT at 10 gtt daily oral taken as prevention of vitamin deficiencies for preterm infants from the day of discharge. The infant was born preterm at 34 weeks of gestational age, with birth weight: 2095g, length: 43cm, head circumference: 31 cm, Apgar index 8/9. During first week of life she received treatment with ampicillin/sulbactam and amikacin for suspected chorioamnionitis. The infant was artificially fed. The infant was discharged from the Division of Neonatology on 15Mar2016 (with a weight of 2210g), was discharged on 15Mar2016 (weight 2210 g) after receiving ampicillin-sulbactam and amikacin for suspected chorioamnionitis. Subsequently, she was hosted with her mother in a community for the assistance to refugees. The infant was evaluated at the Emergency Department on 30Mar2016 for poor weight gain (2320g) due to difficult breastfeeding. On 08Apr2016 (at 39 weeks of corrected age) the infant had the first health check by a pediatrician that revealed a good growth (weight 2830g, height 48cm, head circumference 35.5) with mixed feeding (breast milk+ milk adapted formula "type 0"). During the visit the baby was in good general condition and objective examination of all organ systems was within the standard. No problem was reported by the mother. To prevent vitamin deficiencies in a preterm newborn, the infant was given Bimbovit 10 drops/day. On 27Apr2016, patient underwent a planned follow-up check for preterms that confirmed the good growth and the absence of any disease; transfontanellar ultrasound of the brain was normal, as well as the neuropsychiatric visit. In the morning of 24May2016, a health check between 2 and 3 months of age (according to the schedule) at the vaccination clinic of the Health District was performed. During visit the infant was in good general health, with a good growth for the corrected age (weight 4900 g, length 54.5 cm, head circumference 39 cm). The infant was fed with milk adapted formula type 1 (Neolatte 1) and the mother did not report issues concerning feeding or pathological alterations. Physical examination revealed normally perfused skin and mucous membranes, elastic skin with a very slight dryness of eczematous nature. At heart auscultation, tones were valid, rhythmic, with no murmurs at cardiac auscultation and breath sounds appeared normal at respiratory auscultation. The abdomen appeared treatable with hypochondriac organs within the limits, physiological globose, soft abdomen. Liver and spleen within limits. The central and peripheral neurological examination appeared normal. The fontanelle appeared normotensive with a transverse diameter of 0.5 cm. Considering the absence of clinical-anamnestic contraindications and after acquiring the consent of the mother, the Health Care assistant proceeded with the administration of the vaccines as recommended by Region for preterm infants. After vaccination the infant waited 15 minutes before going away without evidence of any reaction to vaccination. The patient experienced sudden death on 25May2016 that occurred likely after about 20 hours of vaccination carried out at a pediatric vaccination facility. An autopsy has been received. CLINICAL REPORT provided. MEDICO-LEGAL OPINION ON THE CAUSES OF DEATH: External examination: normal nutritional status, no apparent signs of traumatic injuries attributable to an outside influence. Of note, the leakage of a foamy, milk-colored fluid from the left nasal cavity. No evident signs of mechanical asphyxia, such as conjunctival petechial hemorrhages. REPORT OF THE NEONATOLOGY DIVISION OF HOSPITAL: Born by Cesarean section due to a non-reassuring CTG in a mother with fever. Vaginal swabs from the mother were positive for Ureaplasma parvum and Mycoplasma ominis, as well as for Candida albicans for which she was treated with antifungals and antibiotics. She had been admitted to hospital at 27 weeks due to threatened preterm delivery. Corticosteroid prophylaxis was administered on that occasion. The woman had neglected her pregnancy, collection of the history was difficult due to the language barrier. Incomplete antibiotic prophylaxis during labor. GA 34+3, weight at birth 2095g, length 43cm, cranial circumference 31cm. Apgar score 8/9. No resuscitation maneuvers were needed at birth. The infant was transferred to the Intensive Care Unit (ICU) in order to receive further treatment. First visit performed after the admission to Neonatal ICU showed: fairly good general conditions. Vigorous cry. Hyperchromic, erythrosis skin. Heart auscultation: good, rhythmic sounds, systolic murmur 1/6. Regular femoral pulses. Diffuse, harsh breathing, slightly polypnoic, with costodiaphragmatic re-entries. Normally transmitted VM. O2 demand 25% and adequate SatO2. Soft abdomen, liver and spleen within normal limits. Female external genitalia normally shaped. Tonus and reflexes appropriate for GA. REPORT OF THE EMERGENCY DEPARTMENT OF THE HOSPITAL. Admission on 30Mar2016: Weight loss (-50 g compared to last check) and poor reactivity in the newborn, weight increase curve not very clear, preserved diuresis and report of regular bowel habits. Her mother did not speak the language, incomplete history. Apyretic, good general conditions, pigmented skin, moist mucous membranes. Heart auscultation: good, rhythmic sounds, femoral pulses, present. Breath auscultation: diffuse, harsh breathing. Soft, meteoric abdomen. Liver and spleen within limits. Normally colored stools during the visit. Clear pharynx. Negative otoscopy. POST MORTEM DATA: The post-mortem examination on the body was carried out in the mortuary of the Hospital on 26May2016. The body of a newborn female, wearing only a diaper, in apparent good general conditions lies on the anatomical table. FORENSIC DATA: Post-mortem hypostasis scarcely detectable due to skin pigmentation, but its area seems to be larger in the dorsal regions. The cadaveric rigidity has nearly resolved in all districts. External examination: female subject with a normally developed pannicolus adiposus, and with regular somatic development in relation to age. Skin on the face: clear, thinned, with reddish eczematous lesions. Presence of whitish material in the left nostril. Yellow metal earrings at the earlobes. Lips: dark, dry. Tongue protrusion is observed. Multiple, small, blackish puncture lesions in head and forehead. Ecchymosis in left temporo-parietal region. Ecchymosis having form of 3 symmetrical arms in sternal area. No subconjunctival or subscleral petechiae. Sommer''s spot on the left. No lesions detected in examination of lips, oral cavity and gingival vestibules. Main size parameters: Total length: 56cm, Vertex-foot: 34cm, Upper limb: 21cm, Lower limb: 22cm, Foot length: 8.5cm, Trunk (neck-foot): 20cm, Hand length: 7cm, Cranial circumference: 39cm, Chin-vertex circumference: 44cm, Chest circumference: 39cm, Abdominal circumference: 41cm, Head height (chin-vertex): 17cm. CADAVERIC DISSECTION. Chest: A "Y" section of muscle portion of the chest and abdomen, with distal bifurcation towards the inguinal regions to preserve the umbilical region. Inspection: no fluid effusions in pleural cavity and abdomen. After sternal plate removal, lungs are hyperexpanded, dark colored and soft. Some limited area with dark colored, retracted appearance are observed. Right lung has 3 lobes, left lung has 2 lobes. Stomach and intestinal loops appear tense. Inside stomach: abundant, creamy, white-colored material. Complete evisceration is carried out. Thymus: normal size and appearance relative to the age. After opening the pericardial sac, the large vessels appear to be normally placed and normally rotated. Heart: normal shape and size. Dissection of the organ: normal morphology of the valve apparatus and a marked left ventricular hypertrophy. Lungs: pink and expanded; right lung weighs 90g, left lung 78g. Small and rare petechiae are observed mainly on the diaphragmatic aspect and in the interlobar fissures. Large and circumscribed subpleural areas of a darker color. When cutting, a fair amount of blood flows out of the section surfaces. Intestinal loops: free. Stomach: distended, it contains a very little amount of white, milk-like material. Spleen: normal size and morphology, weight 20g. Liver: regular size, dark color; with a fleshy texture at dissection. Kidneys: normal size and morphology, weigh 15g and 17g on the right and left, respectively. Regular morphology of corticomedullary architecture is observed at dissection. Encephalon: multiple, small ecchymoses in frontal and parietal areas are observed on the deep aspect of the scalp, at the level of the small signs of venipuncture described in the external examination. A large ecchymosis is observed in the left temporo-parietal area and another ecchymosis in the left occipital area. Anterior fontanelle: about 3.5?2.5cm. Posterior fontanelle: approx. 2?1cm. Vault: intact. Encephalon: regular morphology and volume, with markedly flattened gyri. No meningeal bleeding. Circle of Willis is complete, properly formed. The fresh dissection does not detect signs attributable to recent injuries or pre-existing disease. Tissues from various organs have been collected for histological examinations. HISTOLOGICAL EXAMINATIONS prepared at the Department of Pathological Anatomy of Hospital, stored in Histology Storage System under # 3981/16/i. Relevant findings: Lung: congestion, edema; Liver: diffuse vacuolation (hepatocytes with diffuse granular positivity after histochemical staining with Oil Red O (ORO) on cryostatic sections); Meninges: congestion. Diagnostic judgment: finding of diffuse liver vacuolation (positive to Oil Red O) strongly suspected of a lipid metabolism disease. No significant morphological alterations of other internal organs. MEDICO-LEGAL CONSIDERATION. Pst-mortem examination allowed to rule out any cause of a violent death: external examination has not detected the presence of signs attributable to traumatic events, though minimal, no traumatic lesions observed in the internal organs. Important diagnostic elements result from the histological examination indicating a lipid metabolism disease. Congenital defects in lipid metabolism are known to be a possible cause of sudden infant death. In conclusion, it was a natural death, in which the violent action of a third party did not play any role. CONCLUSIONS. The findings observed during the post-mortem examination carried out on the body of the infant indicate that the cause of death was a congenital lipid metabolism defect. It was a natural death that was not caused by a violent action of a third party. Investigational result were received: From Site: The batch records reviewed: no relevant comments or planned deviations that may have caused this type of complaint. This batch met all the criteria for the market and was Q.P. released. The cold chain temperature control data for the bulk stock received, the packed stock stored and during its journey to the markets distribution centre were all satisfactory, thus confirming suitable storage conditions maintained at all times with no impact to product quality, safety or efficacy. PCOM Lot History Report identified 0 other complaints for adverse events for this packed lot. The complaint is unconfirmed as no root cause has been identified and no trend has been identified by the Global Safety Team. From Site: This summarizes the technical evaluation conducted for the bulk conjugate batches and associated activated saccharide batches (as detailed above) in support of this reported Adverse Event. All investigations associated with these batches were reviewed from a manufacturing and technical perspective and all investigations were appropriately addressed and closed. Based on the review of the Batch Records, CoA and investigations associated with the batches, the release results are deemed satisfactory. These technical evaluations did not indicate any issues that would have contributed to this complaint. An evaluation of the reserve sample and complaint sample was not applicable under this Adverse Event as the Adverse Event was reported for the bulk drug product lot. From Site: This summarizes the technical evaluation conducted for the bulk conjugate batches and associated activated saccharide batches in support of this reported Adverse Event complaint. All investigations associated with these batches were reviewed from a manufacturing and technical perspective and all investigations were appropriately addressed and closed. Batch Records and testing results were reviewed prior to Product Release and were deemed satisfactory. Based on the review of associated investigations there is no requirement to repeat these reviews for the Drug Substance manufacture. An evaluation of the reserve sample and complaint sample was not applicable to this Drug Substance investigation and this will be carried out as part of the Drug Product investigation. No issues impacting the identity, strength, purity or quality of the product were identified during the technical evaluation therefore no regulatory notification is required. An evaluation of the complaint history for this interim Drug product lot confirms that this is the first Drug Substance adverse event-FDA 15 day reportable event received for investigation for this interim drug product Lot. Will continue to monitor adverse events for this interim Drug Substance Lot. No further action is required at this time. From Site: This is the 1st complaint received impacting Alpo Lot L28226K for the Class/Subclass; External Cause Investigation/Adverse Event Safety Request for Investigation. A trend was not identified. No evidence was found to indicate the complaint occurred as a result of activities conducted at Pfizer Pearl River therefore it was determined that a regulatory notification is not required. A reserve review was carried out and no defects were noted. Site will continue to monitor complaints for Aluminium phosphate Lot L28226K. No further action is required at this time. From Site: Formulation/Product transfer, all additions, mixes, thaws, etc., as applicable, were completed without deviation. All sterilization in place (SIP) cycles and/or autoclave sterilization cycles were acceptable for preparation of the batch equipment and components. Component preparations (such as washing, depyrogenation, and siliconization) were completed without deviation. All pre and post-use filter integrity testing was acceptable for solution and vent filters. In-process checks relevant to the problem code under evaluation (For AE/ADEs, all in-process checks) were acceptable. All environmental and personnel monitoring results were acceptable. No deviations related to environmental and personnel monitoring. Filling activities were completed without observation of atypical events. All finished product (and FPK) testing was acceptable. Inspection results: within specification 0.5% batch reject rate and 10% NMT). Finishing activities: completed per the Finishing Specification Sheet, Finishing Line template and applicable SOPs without deviation. No deviations relevant to the product complaint evaluation. AOL inspection(s) was/were acceptable. No defects relevant to the product complaint identified during the AQL inspection(s). Batch Reconciliation was acceptable (for AE/ADEs and product complaints with the problem code Mislabeled/Misbranded, Missing Label, Missing Items, and Packaging Count). No deviations, exceptions, non-conformances, atypical events, or work orders relevant to the product complaint. BPS Quality Assurance Batch Record Review indicates that the product was manufactured according to cGMP procedures. There were atypical observations (document for AE/ADEs) or relevant defects to the product complaint rejected during gross inspection by Capping. Microbiology Investigation Report (MIR) 884152 was initiated after a sample from the 1024 Gauntlet Left Hand Tub Ingress site following Batch 927404 yielded an out-of-level (OOL) result of 1 colony forming unit (CFU)/plate, which exceeded the action level of MT 0 CFU/plate per SOP 07-04-029, Environmental Monitoring Master Plan. The MIR concluded: based on the acceptable results of all other environmental monitoring data, confirmation that there were no Building Monitoring System alarms during the batch, all 3 follow-up monitoring samples resulted in acceptable results, sanitizations were completed before and after the filling of Batch 927404, and sterility testing for the batch resulted in no growth, there was no impact to the Safety, Identity, Strength, Purity, or Quality of the batch. All environmental monitoring results from Formulation Batch 927403 were under the alert and action levels. Per SOP 05-05-016, Syringe Transfer in the Capping/Sterilization Area, Capping operators perform a gross visual inspection of at least 50% of the filled syringes from each needle per tub during the capping processes. Capping personnel observed foreign matter on the rim of tub 410. Quality Assurance and Production Management were notified. Foreign material observed was determined to be intrinsic to the process. The tub was rejected. A 100% inspection of the five tubs filled before and after tub 410 was performed per SOP 05-04-034, Aseptic Processing Operation and Intervention; no foreign matter was found. Filling operators documented performance of an extra period check on Form 240-05-04-FOOl, Manufacturing Operational Period Checks for 240-104 (Syringe), to confirm that no foreign matter was observed on the machine deck, filling equipment, and stoppering equipment; no foreign matter was found. No follow up attempt needed. No further information expected. Follow-up (26May2016-30May2016): Additional information received from the Authority includes age at vaccination, lot of vaccines administered, route, clinical course. Follow-up (05Jul2016): New information received includes result of product quality complaints from Sites. Follow-up (15Jul2016): This follow-up report is being submitted to amend previously reported information: Expiration date of PREVENAR 13 (Lot. M90777) provided. Follow-up (20Jul2016): Follow-up attempts completed. No further information expected Follow-up (22May2017): New information included the clinical report received via the Vendor who provided the translation includes: clinical report; cause of death. Sender''s Comments: Based on investigational findings a possible contributory role of patients congenital lipid metabolism defects cannot be ruled out for patient sudden death and is probably not related to the suspect product The Company moreover considers the administration of concomitant vaccines an important confounder in the independent assessment of the causal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: congenital lipid metabolism defect.


VAERS ID: 696642 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-26
Entered: 2017-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MX0095075131705MEX013468

Write-up: This spontaneous report was received from a consumer via company representative social media regarding female patients of unknown age. On an unknown dates, the patients were vaccinated with GARDASIL 0.5 ml intramuscularly (lot and expiry date not reported). The sales representative read on the portal that a mother warned other mothers to avoid vaccinating their daughters with GARDASIL, because it indicated that some girls died. Causality of the event was not reported. The reporter considered the event to be serious as the patients died and to be medically significant. This is one of the three reports received from the same reporter. Additional information is not requested.


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