National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

Found 8,467 cases where Patient Died

Case Details

This is page 67 out of 85

Result pages: prev   1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85   next


VAERS ID: 530376 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-01-02
Submitted: 2014-05-07
   Days after onset:489
Entered: 2014-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SYR

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: 2013-05-13
   Days after onset: 130
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0990813A

Write-up: This case was reported by a consumer (subject''s relative) via a regulatory authority (ES-AGEMED-805461241) and described the occurrence of acute disseminated encephalomyelitis in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In 2012, the subject received unspecified dose of CERVARIX (unknown route, injection site and batch number). On 2 January 2013, less than one year after vaccination with CERVARIX, the subject experienced acute disseminated encephalomyelitis. The subject was hospitalised and the regulatory authority reported that the event was disabling. On 13 May 2013, the subject died die to acute disseminated encephalomyelitis. It was unknown whether an autopsy was performed. The regulatory authority reported that the event was unlikely to be related to vaccination with CERVARIX.


VAERS ID: 530519 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2014-04-28
Onset:0000-00-00
Submitted: 2014-05-08
Entered: 2014-05-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / UN

Administered by: Unknown       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: 2014-05-02
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: Heart failure; Diabetes; Lung infection; Liver carcinoma, patient recovered; Influenza vaccine
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014123296

Write-up: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 69 year-old patient of an unspecified gender received, on 28Apr2014, the first dose of PREVENAR 13 single dose. Relevant medical history included heart failure, diabetes, lung infection and liver cancer (patient recovered from liver cancer). Concomitant medications were unknown. On an unspecified date, two weeks prior to receiving PREVENAR 13, the patient received an unspecified trade name of flu vaccine. On an unspecified date, two days after PREVENAR 13, the patient experienced pneumonia. Therapeutic measures taken in response of the event was unknown. The patient passed away on 02May2014. It is unknown if autopsy was done.


VAERS ID: 530540 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-02-14
Onset:2012-08-16
   Days after vaccination:184
Submitted: 2014-05-09
   Days after onset:631
Entered: 2014-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. G01359 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Chills, Chromaturia, Death, Diarrhoea, Flank pain, Muscle spasms, Peritonitis, Pyrexia, Urine analysis abnormal, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal perforation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-08-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 08/08/2012, Body temperature, fever; 08/09/2012, Urine analysis, brown urine
CDC Split Type: WAES1405COL004779

Write-up: This spontaneous report as received from a foreign Regulatory Authority refers to a 73 year old female patient. The patient was vaccinated in the following scheme: on 22-NOV-2010, she was vaccinated with influenza virus vaccine (manufacturer unspecified), on 14-FEB-2012 with PNEUMOVAX 23 (LOT # G01359, expiration date unspecified, intramuscular, anatomical location: not provided), on 03-MAY-2012 with VAXIGRIP also reported as inactivated influenza trivalent types A and B (manufacturer unspecified), on 26-JUL-2012 with unspecified hepatitis B virus vaccine (unspecified manufacturer). On 08-AUG-2012, the patient experienced chills and fever that she related to the vaccine''s usual adverse events (verbatim), however she went to the emergency room on 09-AUG-2012 where she was hospitalized since she experienced pain at upper right side, vomit, abdominal swelling, diarrhea and color change in urine (brown color). On 12-AUG-2012 the patient experienced cramps in lower left limb while she was still hospitalized. The patient died on 16-AUG-2012 due to a generalized peritonitis. Relatedness between adverse events and suspect vaccines was not reported. Additional information is not expected.


VAERS ID: 530639 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-05-06
Entered: 2014-05-12
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Acidosis, Agitation, Autonomic nervous system imbalance, Autopsy, Blood creatinine increased, Blood glucose increased, Blood sodium increased, Blood urea increased, Bradycardia, Bronchopneumonia, Cardiac arrest, Death, Dehydration, Electroencephalogram, Hydrophobia, Hypercapnia, Hypotension, Hypothermia, Hypoxia, Intensive care, Lactic acidosis, Mechanical ventilation, Medical induction of coma, Mydriasis, Neutrophilia, Paralysis, Polyuria, Pupillary reflex impaired, Ultrasound Doppler abnormal, Urine output
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (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: Mechanical ventilation; Paraesthesia; Agitation; Vomiting; Hydrophobia; Haemofiltration
Preexisting Conditions: Tramadol
Allergies:
Diagnostic Lab Data: Blood creatinine, 79 ulol/l; Blood pressure, 171/90 mmHg; Blood urea, 7.9 mmol/L; Body temperature, 37.9 degrees C; Heart rate, 120 beats per minute
CDC Split Type: PHHY2014GB054160

Write-up: Case number PHHY2014GB054160 is an initial literature report received on 02 May 2014: The authors in this article discussed about a case report of diagnosis, management and post-mortem findings of rabies imported from one country to another. This report refers to a 58-years-old female patient who had a dog bite in the right forearm on an unknown date. On an unknown date, nine weeks after the dog bite, she attended her general practitioner (GP) and the local emergency department with painful paraesthesiae in her right hand and she given tramadol, thereafter she began to vomit, refused water and appeared fearful and agitated. The GP referred the patient to the local emergency department for further management (day 1) 7.9 mmol/L, creatinine 79 1/4mol/L and normal C-reactive protein. Saliva and skin biopsies from nuchal and bite sites subsequently tested positive for lyssavirus ribonucleic acid (RNA). Over the next few hours the patient The case was discussed with the Health Protection Agency; after an initial blood sample was taken. She received rabies vaccine (manufacturer and batch number: not reported, so conservatively coded as Rabies vaccine INN) and human rabies immunoglobulin and was transferred to an isolation room in the intensive care unit. On admission she demonstrated pronounced hydrophobia, she gagged and became agitated when water from the sponge dropped onto her bedclothes, or at sight of a cup of water. Initial examination showed dehydration, temperature of 37.9 degrees C, heart rate 120 beats per minute, blood pressure 171/90 mmHg, she was fully conscious. There was no abnormality on examination. Blood indices showed a mild neutrophilia, urea developed episodes of extreme agitation despite escalating doses of diazepam (2.5-7.5 mg intravenous, as frequently as every hour), when one episode became violent she was anaesthetized with standard dose of fentanyl, midazolam, propofol and rocuronium (the majority of elements of the Milwaukee Protocol were commenced). She received a drug-induced coma (which included propofol 200 mg/hr, fentanyl 200 mcg/hr and midazolam 20 mg/hr), neurotransmitter substrate replenishment and antiviral therapy (amantadine 200 mg bd). In addition she received nimodipine 60 mg, 4 hourly, sapropoetin 200 mg bd, vitamin C 500 mg and coenzyme Q10 100 mg bd. Continuous electroencephalogram (EEG) monitoring was adopted. On day 3, she became hypotensive and was commenced on noradrenaline (10-30 mcg/min to maintain a Mean Arterial Pressure (MAP) greater than 80 mmHg). Urine output was responsive, however stroke volume and cardiac output measurements by esophageal Doppler were not responsive, to fluid boluses. Ketamine sedation (45 mcg/hg/min) was introduced. Adrenaline was added to maintain MAP. By day 4, passive body warming was required for hypothermia. Ventilatory requirements increased. Escalating doses of ketamine (60 mcg/kg/min), fentanyl (300 mcg/hr) and propofol (70 mg/hr) were required to maintain sedation. Antibiotics were commenced following the suctioning of offensive sputum and evolving radiographic infiltrates. By day 5, progressive bilateral radiographic infiltrates accompanied worsening hypercapnia. Polyuria with an increasing serum Na was observed, and treated with esophageal Doppler-guided fluid optimization, nasogastric water and intravenous 5% dextrose. Glucose control was required. On day 6, paralysis (previously avoided due to risk of masking seizures) was achieved with atracurium (10-20 mg/hr) and nitric oxide introduced for intractable hypoxaemia. Escalation of adrenaline (to 80 mcg/min) was required for hypotension, cardiac output started to fall and remained unresponsive. Pupils were dilated and demonstrated sluggish reflex to light. Acidosis and multi-organ failure ensued and haemofiltration was commenced. On day 8, two episodes of bradycardia required atrophine. As nonadrenaline increased, hydrocortisone 50 mg qds and fludrocortisone 100 mcg od were started. On day 9, she developed a junctional rhythm with bradycardic episodes requiring further sedation to ablate the dysautonomia, atropine boluses, isoprenaline infusion and transvenous pacing. On day 10, she developed refractory, profound lactic acidosis. Management included 8.4% sodium bicarbonate along with continuous venovenous haemofiltration. Persistent hypotension was treated with more adrenaline (90 mcg/min) and noradrenaline (160 mcg/min) and addition of argipressin (0.01 u/min). Antimicrobial were escalated and suspected bowel ischaemia was treated supportively as she was unfit for imaging or surgery. The hypotension became refractory and temporary cessation of pacing demonstrated underlying asystole. Supportive treatment was withdrawn. She died on the eighth day. Autopsy results showed there was a terminal bronchopneumonia. The heart had mild interstitial T-cell inflammation and neuritis of vagus nerve branches, including a possible Negri body on Haematoxylin and eosin stain, but immunohistochemistry did not confirm this as rabies antigen. The tongue and parotid gland also had peri and endoneural inflammation and ganglionitis. The brain and meninges were grossly normal: there was no cerebral swelling. Histologically, there was mild encephalitis (T-cell infiltration, perivascular cuffing and microgliosis), most prominent in temporal lobes. Neuronal rabies infection with abundant Negri bodies (round/ oval eosinophilic inclusions in the perikaryon) was present in all parts of cerebrum and sub-tentorial brain tissue, most prominently in the temporal lobe and hippocampus. No hypoxic-ischaemic neuron damage was identified; only rare neurons were undergoing necrosis with sattelitosis. Post mortem samples showed RABV antigen and nuclei acid were widely distributed in central nervous system (CNS) and non-CNS tissues post mortem. All brain regions were strongly positive for RABV antigen using FAT; live virus was isolated from brain and cerebrospinal fluid tissue culture at first passage. Although viral RNA was detected in tongue, parotid salivary gland and a mouth swab taken post mortem, live virus was not recovered from these samples. Viral RNA was not detected in heart tissue. Profuse antigen was observed in the perikaryon and neuropil in all CNS regions, including all cranial nerve roots identified. Abundant antigen was observed in autonomic ganglia, muscle spindles and skeletal muscle fibers in the tongue. Limited amount of immunoglobulabelling was observed in nerve axons in the parotid gland. No labeling was observed in lingual epithelium or parotid acinary cells. The authors concluded that this case was treated with vaccine and immune globulin prior to institution of the recommended protocol, which may have resulted in delay in generation of the host immune response. As in other cases, it was recommended initially (prior to disease confirmation) as part of the standardized post exposure protocol. This patient had on serum antibody on presentation, and failed to develop detectable antibody levels in CSF by day 8, which supports previous evidence that lack of CSF antibody was a poor prognostic indicator. It was unknown whether the patient would have developed an effective immune response given sufficient time. We acknowledge that, in future suspected cases, post exposure prophylaxis should await results of diagnostic tests to give the protocol optimum chance. The acutal mode of this patient''s death appeared to have been profound dysautonomia. Despite anticipating it, we were ultimately unable to control it. Perhaps an earlier and even more aggressive approach to dampen this autonomic dysfunction may have changed the outcome. The authors further commented that in this case, the autopsy demonstrated the previously documented conundrum that death with brain involvement occurs despite minimal encephalitis and neuronal loss. The authors emphasized that management of disease is based on timely diagnosis to optimise supportive care. The prompt availability of the sequence and phylogenic analysis of the virus also aided clarification of the source as this was not initially clear. Much can be learnt from the promptness of confirmation of diagnosis in this case, as well as the efficient and daily coordination of information between specialist and referring hospitals, public health authorities and national experts which was crucial in this patient''s care and minimization of onward transmission. This highlights the benefit of discussion on a daily basis by relevant experts and fully encompasses the agenda for rare imported human infectious diseases.


VAERS ID: 530872 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-05-13
Entered: 2014-05-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014127684

Write-up: This is a spontaneous report from a contactable nurse. This report was forwarded to regulatory authority by GSK drug company. A 4-months-old female patient received PREVENAR 13 single dose, via an unspecified route of administration on an unspecified date and INFANRIX HEXA, via an unspecified route of administration on an unspecified date. The patient medical history and the patient''s concomitant medications were not reported. The patient died on an unspecified date. It was reported that the patient received combination vaccine at primary health care center then the mother took the baby home, feed the baby, then took the baby to sleep; 2 hours later the mother realized that the baby was not breathing. The mother called an ambulance and the health care team took the baby to the hospital, but the death of the baby was reported from the hospital. To determine the exact cause of the death, the baby was brought to the Forensic Medicine Institute.


VAERS ID: 531020 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-05-15
Entered: 2014-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / 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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0992150A

Write-up: This case was reported by a consumer via Pfizer and described the occurrence of death with unknown cause in a 4-month-old female subject who was vaccinated with INFANRIX-IPV/Hib (GlaxoSmithKline) and (non-GSK) PREVENAR. A physician or other health care professional has not verified this report. On an unspecified date, the subject received an unspecified dose of INFANRIX-IPV/Hib (administration site and route unknown, batch number not provided) and an unspecified dose of PREVENAR (unknown). 2 hours after vaccination with INFANRIX-IPV/Hib and PREVENAR, the subject died. The subject died from unknown cause of death. It was unknown whether an autopsy was performed.


VAERS ID: 531022 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-07-26
Onset:2012-08-08
   Days after vaccination:13
Submitted: 2014-05-15
   Days after onset:645
Entered: 2014-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC145AG / 1 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Chills, Chromaturia, Death, Diarrhoea, Muscle spasms, Pain, Peritonitis, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal perforation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-08-16
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0992326A

Write-up: This case was reported by a consumer (subject''s son) and described the occurrence of generalized peritonitis in a 72-year-old female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline), seasonal influenza vaccine (non-GSK), PNEUMOVAX 23 (non-GSK) and VAXIGRIP (non-GSK). A physician or other health care professional has not verified this report. On 22 November 2010, the subject received unspecified dose of seasonal influenza vaccine, non-GSK (unknown route and site of injection). On 14 February 2012, the subject received unspecified dose of PNEUMOVAX 23 (unknown route and site of injection). On 3 May 2012, the subject received unspecified dose of VAXIGRIP (unknown route and site of injection). On 26 July 2012, the subject received 1st dose of ENGERIX B adult (unknown route and site of injection). The schedule dates for next administration of ENGERIX B adult were 26 August 2012 for 2nd dose, 26 September 2012 for 3rd dose and reinforcement on 26 July 2013. On 8 August 2012, 13 days after vaccination with ENGERIX B adult, 97 days after vaccination with VAXIGRIP, 6 months after vaccination with PNEUMOVAX 23, 21 months after vaccination with Seasonal influenza vaccine (non-GSK), the subject experienced chills, fever, pain in the upper side (unspecified), vomiting, swelling in the lower left part of the abdomen, diarrhea and brown urine. On 9 August 2012, the subject was taken to the emergency department. On 12 August 2012, the subject was still at the emergency department and she presented with leg cramps. On 16 August 2012, the subject died due to generalised peritonitis. It was unknown whether an autopsy was performed. The consumer considered that generalised peritonitis was probably related to vaccinations with ENGERIX B adult, seasonal influenza vaccine, PNEUMOVAX 23 and VAXIGRIP. No further information was available.


VAERS ID: 531068 (history)  
Form: Version 1.0  
Age: 0.51  
Sex: Female  
Location: Foreign  
Vaccinated:2014-03-24
Onset:0000-00-00
Submitted: 2014-05-15
Entered: 2014-05-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB842A / 3 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H75590 / 3 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activated partial thromboplastin time prolonged, Alanine aminotransferase increased, Ammonia increased, Antithrombin III decreased, Aspartate aminotransferase increased, Asthenia, Autopsy, Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, Blood creatinine, Blood creatinine increased, Blood fibrinogen, Blood lactate dehydrogenase increased, Blood urea increased, Blood uric acid increased, Breath sounds abnormal, Capillary nail refill test abnormal, Cardiac arrest, Cardiac failure, Chest X-ray abnormal, Cold sweat, Congestive cardiomyopathy, Cyanosis, Death, Diarrhoea, Echocardiogram abnormal, Eye movement disorder, Fatigue, Fontanelle depressed, Gastrointestinal infection, Granulocyte percentage, Haematocrit decreased, Haemoglobin decreased, Hepatomegaly, Lymphocyte percentage increased, N-terminal prohormone brain natriuretic peptide, Pallor, Platelet count increased, Protein total decreased, Prothrombin time shortened, Respiratory arrest, Resuscitation, Somnolence, Transaminases increased, Troponin T normal, Viral test negative, Vomiting, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (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), Pseudomembranous colitis (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), Cardiomyopathy (narrow), Ocular motility disorders (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-04-04
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: D-FLUORETTEN
Current Illness:
Preexisting Conditions: Cough; Common cold; 16-DEC-2013, INFANRIX HEXA, No adverse effect, Dose 1; 16-DEC-2013, PREVENAR-13, No adverse effect, Dose 1; 23-JAN-2014, INFANRIX HEXA, No adverse effect, Dose 2; 23-JAN-2014, PREVENAR-13, No adverse effect, Dose 2; Family history of cardiovascular disorder, A brother of the maternal grandfather died from heart failure at the age of 1 year; Family history of cardiovascular disorder, mother, grandfather, maternal great-grandmother; Familial risk factor, paternal great-grandfather had died from kidney failure; Familial risk factor, maternal uncle was reported to suffer from thrombocytopenia; Familial risk factor, uncle living in the same house as the patient''s family
Allergies:
Diagnostic Lab Data: 04-APR-2014, Activated partial thromboplastin, 107 seconds, time prolonged; 04-APR-2014, Activated partial thromboplastin, 32 seconds, time prolonged; 04-APR-2014, Alanine aminotransferase, 1126 IU/l; 04-APR-2014, Alanine aminotransferase increased, 752 IU/l; 04-APR-2014, Alanine aminotransferase increased, 945 IU/l; 04-APR-2014, Ammonia, 111 umol/l; 04-APR-2014, Antithrombin III, 54%; 04-APR-2014, Aspartate aminotransferase, 1633 IU/l; 04-APR-2014, Aspartate aminotransferase, 1353 IU/l; 04-APR-2014, Blood creatine phosphokinase, 9113 IU/l; 04-APR-2014, Blood creatine phosphokinase MB, 0.0001356 g/l; 04-APR-2014, Blood creatinine, 64 umol/l; 04-APR-2014, Blood creatinine, 61 umol/l; Blood creatinine, 0.60 mg/dl; 04-APR-2014, Blood fibrinogen, 1.1 g/l; 04-APR-2014, Blood lactate dehydrogenase, 1649 IU/l; 04-APR-2014, Blood lactate dehydrogenase, 1295 IU/l; 04-APR-2014, Blood urea, 53 mg/dl; 04-APR-2014, Blood uric acid, 838 umol/l; 04-APR-2014, Chest X-ray, cardiomegaly; 04-APR-2014, Echocardiogram, heart insufficiency; 04-APR-2014, Granulocyte count, 17%; 04-APR-2014, Haematocrit, 0.30; 04-APR-2014, Haemoglobin, 9.3 g/dl; 04-APR-2014, Lymphocyte count, 65.2%; 04-APR-2014, N-terminal prohormone brain natriuretic peptide, 0.0001526 g/l; 04-APR-2014, Physical examination, hepatomegaly; 04-APR-2014, Platelet count, 595x10 9/l; 04-APR-2014, Platelet count, 152x10 9/l; 04-APR-2014, Protein total, 36 g/l; 04-APR-2014, Prothrombin time, 13%; 04-APR-2014, Prothrombin time, 35%; 04-APR-2014, Transaminases, increased; 04-APR-2014, Troponin T, 0.000225 g/l; 04-APR-2014, Troponin T, 0.000643 g/l; 04-APR-2014, White blood cell count, 25.5x10 9/l
CDC Split Type: 2014128650

Write-up: This is a spontaneous report received from the foreign Health Authority. Regulatory Authority report number DE-PEI-PEI2014031744. A 6-month-old female patient received third dose of PREVENAR 13 (Lot# H75590), intramuscular in left thigh, on 24Mar2014, at 0.5ml single and third dose of INFANRIX HEXA (Lot# A21CB842A), intramuscular in right thigh, on 24Mar2014, at 1DF. Concomitant medication included cholesterol, colecalciferol, D-FLUORETTEN, at 500 IU 1x/day, for an unspecified indication. The patient previously received first dose of PREVENAR 13 on 16Dec2013 at 0.5ml single; first dose of INFANRIX HEXA on 16Dec2013 at 1DF; second dose of PREVENAR 13 on 23Jan2014 at 0.5ml single; second dose of INFANRIX HEXA on 23Jan2014 at 1DF. All previous vaccinations were well tolerated. Relevant medical history included cough and common cold (not ongoing). Patient''s mother had normal pregnancy and delivery. Well-baby examinations without pathological findings. Family history of heart disease with cardiac arrhythmia, heart insufficiency as well as a big heart (mother, grandfather, maternal great grandmother). A brother of the maternal grandfather died from heart failure at the age of 1 year. The paternal great grandfather had died from kidney failure and a maternal uncle was reported to suffer from thrombocytopenia. The infant''s uncle living in the same house as the patient''s family was currently suffering from a gastroenteritis. On 04Apr2014, the patient was hospitalized because of increased transaminases. Prior to hospital admittance, the infant had been weak and tired for 5 days, vomited twice and had watery stools. In addition, the parents had noticed a groaning breathing as well as cold sweat. On 03Apr2014, the resident attending paediatrician suspected a gastrointestinal infection. On 04Apr2014, when she again presented at the private practice, the infant had become weaker, but she did not vomit any longer. A blood sample revealed severely increased transaminases. Immediately, the infant was referred to hospital. An ambulance was called. On the way to the hospital, the infant fell asleep several times and could hardly be woken. In the emergency room, when an infusion was inserted the infant rolled her eyes. Subsequently, 5mg Diazepam was administered rectally and the resuscitation team was called. When the resuscitation team arrived, the infant did no longer breathe spontaneously. Cardiopulmonary resuscitation was initiated and continued for two hours without success. A jugular central venous catheter was placed. With difficult placement of an arterial entry the operative insertion of femoral artery was planned. During the preparation there was another cardiac arrest, therefore another cardiopulmonary reanimation had to be performed and the operation was interrupted. The parents were consulted and it was decided to end the therapy. The infant died on 04Apr2014 at 23:22 in the presence of her parents. At the time of hospitalization the patient was examined with the following results: fontanel slightly sunken in, skin color pale rosy, capillary refill time 3 sec., cardiac sounds pure and regular, eupnoeic, freely ventilated, lip-cyanosis, abdomen: hepatomegaly. Significant findings: Clinical examination: hepatomegaly: Chest X-ray; cardiomegaly, reduced transparency of the lungs; Echocardiography after resuscitation: heart insufficiency of the left ventricle compatible with a dilated cardiomyopathy. No pericardial effusion. No pulmonary hypertension. Laboratory parameters on 04Apr2014 were: PTT: 32 sec, 107 sec; GPT: 1126 IU/l; ALT: 945 IU/l, 752 IU/l; ammonia: 111 umol/l, antithrombin 3: 54%; Aspartate aminotransferase: 1633 IU/l, 1353 IU/l; Creatine kinase: 9113 IU/l; CK MB: 135.60 ug/l; creatinine: 61 umol/l, 64 umol/l; creatinine: 0.60 mg/dl; fibrinogen: 1.1 g/l; LDH: 1649 IU/l; LDH: 1295 IU/l; urea: 53 mg/dl; uric acid: 838 umol/l; segmented granulocytes: 17%; hematocrit: 0.30 l/l; hemoglobin: 9.3 g/dl; lymphocytes: 65.2%; NT-proBNP: 152600 g/l; thrombocytes: 595 x 10 9/l; thrombocytes: 152 x 10 9/l; protein: 36 g/l; Quick: 35%; hs Troponin T: 225 pg/ml; Troponin T: 643 ng/l; leukocytes: 25.5 x 10 9/l. All tests for causative viruses were negative. An autopsy was performed on 07Apr2014. Preliminary results: dilated heart with severe fibrosis of the inner wall compatible with the diagnosis of cardiomyopathy. No follow-up attempts needed, follow-up automatically provided by regulatory authority. This case is being treated according to the foreign IfSG (Protection against Infection Act).


VAERS ID: 531072 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2012-11-28
Onset:2012-11-28
   Days after vaccination:0
Submitted: 2014-05-15
   Days after onset:532
Entered: 2014-05-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Pneumococcal infection, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-02-04
   Days after onset: 433
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: Congenital heart disease; Congential abnormality NOS; Sickle Cell disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014130296

Write-up: This is a spontaneous report from a contactable healthcare professional via an Agency. A 16-month-old female patient received the first dose of PREVENAR 13 of unspecified dose from batch F87972 on 28Nov2012 when she was 2.1 month old. The patient''s second and third doses were received on 06Feb2013 from batch F61157 when she was 4.4 month old and 09Dec2013 from G33996 when she was 14.4 month old respectively. The patient''s relevant medical history included congenital heart abnormality, congenital absence of spleen and homozygous sickle cell disease which was diagnosed at the time of organ donation. On 30Jan2014, the patient experienced a pneumococcal infection, serotype 14 which was reported as a vaccination failure. The specimen was taken from EDTA blood on 30Jan2104. It was noted that the patient got ill very quickly. Unfortunately, on 04Feb2014, she passed away. At post mortem, it was found out that she did not have a spleen. No further information was provided at the time of this report. No follow-up attempts possible. No further information is expected.


VAERS ID: 531508 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Female  
Location: Foreign  
Vaccinated:2014-01-16
Onset:0000-00-00
Submitted: 2014-05-21
Entered: 2014-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H019432 / 1 UN / UN

Administered by: Public       Purchased by: Other
Symptoms: Death, Intussusception, Respiratory tract infection
SMQs:, Gastrointestinal obstruction (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-02-25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1405MEX008810

Write-up: This spontaneous report as received from a health care professional via CENSIA (Institution that coordinates child vaccination) refers to a 9 months old female patient. Patient''s medical history was unknown. On 16-JAN-2014, the patient was vaccinated with ROTATEQ (Lot # H019432, Expiration date: July 2014) (Strength: 0.5 millilitre(ml), Frequency: single, route of administration: unknown) in a public Hospital. No concomitant medication reported. On 22-FEB-2014, the patient was admitted in the hospital due to Respiratory tract infection and Intussusception (death and hospitalization). The outcome of respiratory tract infection and intussusception was reported as fatal. The patient died on 25-FEB-2014. This case has been related to 1405MEX008648, 1405MEX008653, 1405MEX008915, 1405MEX008650, 1405MEX008657, 1405MEX008837, 1405MEX008700, and 2014PVMX0167.


VAERS ID: 531609 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-03-19
Onset:2014-03-19
   Days after vaccination:0
Submitted: 2014-05-21
   Days after onset:63
Entered: 2014-05-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-19
   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: Hypertension
Allergies:
Diagnostic Lab Data: Tabularized lab data is appended
CDC Split Type: 2014042543

Write-up: This medically confirmed health authority report (initial receipt 07-May-2014) concerns a 77-year-old male patient. The patient had a medical history of hypertension. On 19-Mar-2014 at 09:00 am, the patient received subcutaneous influenza vaccine injection (manufacturer and batch number not provided). On 19-Mar-2014 at 15:15, the patient experienced sudden cardiac arrest. Resuscitation was attempted. The patient was taken to the hospital via ambulance. His treatment included CP (cardiopulmonary resuscitation), intubation, adrenaline 10 x 1 mg and adrenaline infusion. An ECG-VT (electrocardiogram - ventricular tachycardia) echo was performed which showed global left ventricular dysfunction. On 19-Mar-2014 at 18:22 pm, the patient died. Reporter''s comments: The health authority assessed the causality as possible. The reported Preferred Term was ''ventricular dysfunction''. .


VAERS ID: 531620 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:2011-10-19
Onset:2011-10-19
   Days after vaccination:0
Submitted: 2014-05-21
   Days after onset:945
Entered: 2014-05-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER ASPNA086 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain lower, Acid base balance abnormal, Acidosis, Capillary nail refill test abnormal, Cardio-respiratory arrest, Cardiogenic shock, Cardiomegaly, Chest X-ray abnormal, Crying, Crystal urine present, Death, Decreased appetite, Dehydration, Dyspnoea, Gram stain negative, Haematocrit decreased, Haemoglobin decreased, Hypokalaemia, Immunomodulatory therapy, Irritability, Lymphocyte percentage, Medical induction of coma, Monocyte percentage increased, Mucosal dryness, Myocarditis infectious, Neutrophil percentage decreased, Nitrite urine absent, Pallor, Platelet count normal, Protein urine present, Pyrexia, Syncope, Urine abnormality, Urine analysis abnormal, Urine ketone body present, Urine leukocyte esterase, Vasoconstriction, White blood cell count normal, pH body fluid decreased, pH urine normal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute renal failure (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Agranulocytosis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-04-14
   Days after onset: 178
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: 18-JUL-2011, First dose PREVENAR 13
Allergies:
Diagnostic Lab Data: 21-OCT-2011, Haematocrit, 27.8; 21-OCT-2011, Haemoglobin, 9.68; 21-OCT-2001, Heart rate, 155; 21-OCT-2011, Lymphocyte count, 37.7%; 21-OCT-2011, Monocyte count, 10.3%; 21-OCT-2011, Neutrophil count, 51%; 21-OCT-2011, pH body fluid, 6.5; 21-OCT-2011, Platelet count, 333,000; 21-OCT-2011, Respiratory rate, 36; 21-OCT-2011, Urine analysis, cloudy yellow; 21-OCT-2011, White blood cell count, 13300; 21-OCT-2011, Protein urine present, 200; 21-OCT-2011, X-ray, cardiomegaly; Cardiac frequency (21Oct2011): 155/min; Respiratory frequency (21Oct2011): 36/min; Urine analysis (21Oct2011): cloudy yellow, density 1030, pH 6.5, esterase and negative nitrite, protein 200, ketone corps 20, abundant crystals, urine gram negative, dehydration; Thorax Rx (21Oct2011): broad pedicle cardiomegaly
CDC Split Type: 2014119361

Write-up: This is a spontaneous report from a non-contactable consumer. A 5-month-old male patient of an unspecified ethnicity received single dose of PREVENAR 13 and SYNFLORIX, both on the same day, on 19Oct2011, via an unspecified route of administration. Relevant medical history and concomitant medications were unknown. The patient''s family lawyer informed that a male patient of 5 months of age received the first dose of PREVENAR 13 on 18Jul2011; the second dose had to be applied two months after that but due to administrative reasons, the second dose was applied on 19Oct2011 but with the vaccine SYNFLORIX identified with lot ASPNA086. After dose application of PREVENAR 13 the patient experienced unspecified adverse events related with the vaccine which aggravated after the dose application with the vaccine SYNFLORIX. After dose application of SYNFLORIX, the patient experienced decay, inappetence and shortness to breath. On 20Oct2011, the patient was in medical control, it was reported that the symptoms were normal due to SYNFLORIX and it was ordered as treatment to change the milk, take a bath and to administer DOLEX. The same day the patient experienced a fainting that required urgency aid. On 21Oct2011, the patient experienced inappetence and irritability for 12 hours, fever, crying, cardiac frequency at 155/min, respiratory frequency at 36/min, dry mucous and generalized paleness, abdomen partially depressible, apparently painful throbbing in right iliac fossa, delayed capillary refill at 3 seconds. Relevant laboratory data included leucocytes 13300, neutrophils 51%, lymphocytes 37.7%, monocyte 10.3%, Haemoglobin (HB) 9.68, Haematocrit (HTO) 27.8, platelets 333,000, urine analysis cloudy yellow, density 1030, pH 6.5, esterase and negative nitrite, protein 200, ketone bodies 20, abundant crystals, urine gram negative, dehydration. It was performed a thorax Rx which showed cardiomegaly. The same day, the patient experienced cardiogenic shock probably due to acute infectious myocarditis, severe vasoconstriction, acid-base disorder, was acidotic and hypokalemic. It was reported that "Immunomodulation was ordered in response to human gammaglobulin". The patient was hospitalized. On 21Oct2011, the patient experienced a cardio-respiratory arrest and it was reported that a coma was induced because the patient was not recovering about symptoms. The patient died on 14Apr2012, reported as due to symptoms generated by dose application of SYNFLORIX. Follow-up (15May2014): New information reported from consumer includes: suspect drug details, reaction data, case seriousness changed from non-serious to serious and patient''s clinical course.


VAERS ID: 533087 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-05-30
Submitted: 2014-06-05
   Days after onset:6
Entered: 2014-06-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drug ineffective, Meningitis, Meningitis pneumococcal
SMQs:, Lack of efficacy/effect (narrow), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-05-30
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014150633

Write-up: This is a spontaneous report from a contactable physician (pediatrician) via a Pfizer sales representative. A 5-month-old patient of an unspecified gender and ethnicity received the third dose of PREVENAR 13 (lot number unknown) injection subcutaneously on an unspecified date at 0.5 ml, single dose. No information on previous doses was reported. Relevant medical history, concomitant medications and lab data were not reported. The patient experienced drug ineffective and meningitis pneumococcal on 30May2014. The patient died of meningitis pneumococcal on 30May2014. The reporting physician classified the event, meningitis pneumococcal as serious (fatal). Information on causality assessment was unavailable as of this report. It was not reported if an autopsy was performed.


VAERS ID: 533126 (history)  
Form: Version 1.0  
Age: 0.11  
Sex: Female  
Location: Foreign  
Vaccinated:2013-01-08
Onset:2013-04-25
   Days after vaccination:107
Submitted: 2014-06-06
   Days after onset:407
Entered: 2014-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER 201111A067 / 1 AR / ID
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS YHBVC065AA / 1 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Axillary mass, Bovine tuberculosis, Crying, Death, Injection site induration, Seborrhoeic keratosis
SMQs:, Extravasation events (injections, infusions and implants) (broad), Depression (excl suicide and self injury) (broad), Opportunistic infections (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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B1000584A

Write-up: This case was reported by the foreign regulatory authority and described the occurrence of disseminated BCG infection in a 6-month-old female subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline), BCG (non-gsk). On 8 January 2013, the subject received 1st dose of ENGERIX B pediatric (.5 ml, intramuscular, unknown deltoid), 1st dose of BCG (Non-GSK) (.1 ml, intracutaneous, unknown deltoid). On an unspecified time after vaccination with BCG (Non-GSK) and ENGERIX B pediatric, the subject experienced injection site induration (2.6-5). On 25 April 2013, 107 days after vaccination with BCG (Non-GSK) and ENGERIX B pediatric, the subject experienced a prominent axillary mass (hard texture upon palpation, clear border) with crying on pressure and a visible seborrheic keratosis. The subject was diagnosed with a disseminated BCG infection. The subject was hospitalised and the regulatory authority reported that the events were clinically significant (or requiring intervention). The subject died from unknown cause of death. It was unknown whether an autopsy was performed. This report was received as part of a line-listing of several hundred reports, each containing minimal information. No further information is expected.


VAERS ID: 533302 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2013-10-09
Onset:2013-10-13
   Days after vaccination:4
Submitted: 2014-06-06
   Days after onset:236
Entered: 2014-06-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1428 / 1 UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 12K03A / 1 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood pressure immeasurable, Blood test abnormal, Cardiac arrest, Cardio-respiratory arrest, Coma, Death, Decreased activity, Decreased appetite, Leukaemia, Multi-organ failure, Mydriasis, Purpura, Resuscitation, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Haematological malignant tumours (narrow), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-13
   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: Unknown
Allergies:
Diagnostic Lab Data: 09-OCT-2013, Blood pressure, undetectable; 09-OCT-2013, Body temperature, 37.1 Centigrade; OCT-2013, White blood cell count, 457400/mm3; Blood test analysis (Oct2013): suggested multi-organ failure
CDC Split Type: 2014152323

Write-up: This is a spontaneous report from a contactable physician. This is a report received from the Ministry of Health. Regulatory authority report number V14000112. A 2-month-old female patient of an unspecified ethnicity received the first dose of PREVENAR (Lot Number: 12K03A), subcutaneous on 09Oct2013 at a single dose, and the first dose of ACTHIB (Lot Number: J1428) subcutaneous on 09Oct2013 at a single dose. The patient''s medical history and concomitant medications were not reported. No remarks of concern for vaccination such as allergy were reported. The patient''s birth weight was 3044 g. Body temperature prior to the vaccinations was 37.1 degrees Centigrade on 09Oct2013. The infant developed the fatal event "suspected infant leukaemia" and died on 13Oct2013. The clinical course was as followed: On 12Oct2013, there was a decrease in activity and poor intake of milk-feeding was seen. At 22:00 PM, the patient fell asleep after feeding milk. In the following morning at 5:00 AM on 13Oct2013, the patient was found in cardiopulmonary arrest. At 5:47 AM, the patient was brought to a hospital. Epinephrine, atropine, and sodium bicarbonate were administered and the patient was resuscitated. Although cardiac arrest occurred several times, heart rate was maintained by administration of DOA (dopamine) and DOB (dobutamine), and the patient was brought to the reporter''s hospital. Upon arrival, blood pressure was almost undetectable, pupils dilated, no spontaneous respiration was noted. The patient was in profound coma. Purpura was noted throughout her body (due to massage for resuscitation), and liver was around 8 cm in size. Blood test analysis showed findings that suggested multi-organ failure. It was particularly worth noting that white blood cell count was 457400/mm3 in single cell. Therefore, leukemia was suspected. No response for resuscitation was seen afterwards and the patient died on 13Oct2013. No information was provided whether autopsy was performed or not. The reporting physician classified the event "suspected infant leukemia" as serious for being fatal. The causality of the event, suspected infant leukemia, and PREVENAR was "unevaluable". The other possible causal factor was reported as "suspected infant leukemia". The reporting physician commented as follows: "Cause of death had not been identified, but infant leukemia was being suspected based on blood test and physiological findings. Further investigation was being conducted."


VAERS ID: 533510 (history)  
Form: Version 1.0  
Age: 0.53  
Sex: Male  
Location: Foreign  
Vaccinated:2011-09-20
Onset:2011-11-22
   Days after vaccination:63
Submitted: 2014-06-09
   Days after onset:929
Entered: 2014-06-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB143A / 2 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E70837 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apgar score normal, Death, Epstein-Barr virus infection, Histiocytosis haematophagic, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-05
   Days after onset: 225
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: Apgar score, 10
CDC Split Type: 2014153627

Write-up: This is a spontaneous report received from the foreign Regulatory Authority. Regulatory Authority report number 253199. A pediatrician (contactable through Regulatory Authority only) referred that a 8-month-old male patient received on 17May2011 the first dose and on 20Sep2011 the second dose of PREVENAR 13 (first dose: lot n. E57639, second dose: lot n. E70837) at 0.5ml, single dose and of INFANRIX HEXA (first dose: lot n. A21CAP80A, second dose: lot n. A21CB143A) both intramuscular. The patient was born at full health with APGAR score 10 at birth, grew in perfect shape and normal development. Concomitant medications were not reported. The patient experienced non-familiar histiocytosis haematophagic in conjunction with a probable infection by EBV on 22Nov2011 showing first fever. The diagnosis was stated after a month of careful medical investigation under hospitalization. At first, the physician suggested that it was inherited disorder, but later it was not possible to identify the genes responsible; inheritance has been excluded due to the absence of the disease in their family trees of the two parents. The patient died on 05Jul2012 and it was reported that the vaccine may have contributed. It was not reported if an autopsy was performed.


VAERS ID: 533795 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2014-05-20
Onset:2014-05-31
   Days after vaccination:11
Submitted: 2014-06-12
   Days after onset:12
Entered: 2014-06-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1712 / UNK UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 13H02A / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Nasopharyngitis, Pharyngeal erythema, Pyrexia, Upper-airway cough syndrome, Urine analysis normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-06-02
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: On 02 June 2014, the urinalysis test revealed no abnormalities; Body temperature, 31MAY2014, 38.9 Degree C
CDC Split Type: 2014SA076636

Write-up: Initial report received from healthcare professional on 09 June 2014. A 02-month-old male patient had received a subcutaneous 0.5 ml dose of ACTHIB (Lot number: J1217, expiry date, dose number and site of vaccination not reported) and a dose of PREVENAR 13 (lot number: 13H02A, dose, expiry date, route and site of vaccination not reported) on 20 May 2014). Patient''s medical history and concomitant medications were not reported. It was reported that the patient was found to have pyrexia in the morning of 31 May 2014. On the same day, at 15:00, he was taken to the reporting clinic. At 15:52, he had pyrexia of 38.9 degrees C, but he suckled well, had a good complexion, and was vibrant. Redness of the pharynx was observed and common cold was suspected. In the morning of 01-Jun-2014, the pyrexia went down. On 02-Jun-2014, at 9:40 am, he was taken to the reporting clinic for the second consultation. The findings of redness and postnasal drips in the pharynx were observed, but he suckled well and had energy. On 02 June 2014, urinalysis test revealed no abnormalities. As a corrective treatment the patient has been taking MUCODYNE syrup. On 31 May 2014, MUCODYNE syrup was prescribed for 2 days and on 02 June 2014 same was prescribed for 4 days. In the morning of 04-Jun-2014, the police station made a phone call to the reporting clinic and reported that patient''s death was confirmed around 18:00 hours at 02-Jun-2014 and a legal autopsy was performed, but the cause of death was unknown. Reporting pediatrician''s seriousness assessment: Serious (death). Reporting pediatrician''s causality assessment: Unknown. Documents held by sender: None.


VAERS ID: 533797 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2014-06-05
Onset:2014-06-06
   Days after vaccination:1
Submitted: 2014-06-12
   Days after onset:6
Entered: 2014-06-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 13J03A / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-06-06
   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: Down''s syndrome; Heart disorder; Patent ductus arteriosus
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014158897

Write-up: This is a spontaneous report from a contactable pediatrician via a Pfizer sales representative. A 2-month-old female patient of an unspecified ethnicity received PREVENAR 13 (Lot Number: 13J03A; Expiration date: 31Aug2016) subcutaneous at around 11am on 05Jun2014 at 0.5 ml single dose and ACTHIB subcutaneous around at 11am on 05Jun2014 at 0.5 ml single dose. Medical history included Down''s syndrome, heart disorder and patent ductus arteriosus. Patient''s weigh at birth was 2360 g, while her weight at the event onset was 3745g. The patient''s concomitant medications were not reported. The patient died in the middle of the night on 06Jun2014. It was not reported if an autopsy was performed. The reporting pediatrician classified the event, death as serious (death). The reporting pediatrician commented that the causal relationship between the event, death and PREVENAR 13 as well as ACTHIB was unknown.


VAERS ID: 534376 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2014-06-09
Onset:2014-06-09
   Days after vaccination:0
Submitted: 2014-06-18
   Days after onset:9
Entered: 2014-06-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H82163 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-06-11
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014162268

Write-up: The initial case was missing the following minimum criteria: unidentifiable reporter. Upon receipt of follow up information on 12Jun2014, this case now contains all required information to be considered valid. This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 2-month-old female patient received, on 09Jun2014, PREVENAR 13 (Lot. H82163) EUHIB (manufacturer: LG Life Sciences). Relevant medical history and concomitant medications were unknown. The parents of the baby stated that fever appeared after that she received pneumonia vaccine on 09Jun2014 at a local hospital. Then, the patient was transferred to a hospital due to dyspnea symptom, around 5:30 at dawn on 11June2014. The patient was treated but she died.


VAERS ID: 534885 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-05-20
Onset:0000-00-00
Submitted: 2014-06-25
Entered: 2014-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Multi-organ failure, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-06-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UnBetamethasone valerate; Amoxicillin(+) clavulanic acid; Cholecalciferol; Lansoprazole; Polyethylene glycol; Prednisolone
Current Illness: Unknown
Preexisting Conditions: Lower respiratory tract infection; Cataract; Temporal arteritis; Musculoskeletal chest pain; Chest pain; Cataract operation; Biopsy artery, Biopsy of the temporal artery
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1406GBR010752

Write-up: Information has been received from Sanofi Pasteur (MFR. Control No: E2014-05480) on 20-JUN-2014. This case was received from the health authority on 17-Jun-2014. GB-MHRA-ADR 22571754. This case is medically confirmed. A 80 year old male patient received an injection of ZOSTAVAX (batch number not reported), route and site not reported, on 20-May-2014. On 20-May-2014, the patient developed a fever and died on 10-Jun-2014. The patient had a medical history of biopsy of the temporal artery, cataract extraction, unspecified chest pain, anterior chest wall pain, giant cell arteritis, left cataract and lower respiratory tract infection. The patient was taking as concomitant medications betamethasone valerate from 21-Mar-2014 to 18-Apr-2014, co-amoxiclav from 11-Apr-2014 to 18-Apr-2014, colecalciferol from 02-Apr-2014 to 02-May-2014, lansoprazole from 11-Feb-2014 to 30-May-2014, macrogol from 21-Mar-2014 to 22-Mar-2014, and prednisolone 02-May-2014 to 03-May-2014 and 11-Mar-2014 to 12-Mar-2014 and 11-Apr-2014 to 12-Apr-2014, all for unknown indications. The reporter stated that the fever and death could be related to vaccine. The patient had the vaccine and the family reported he developed a fever shortly after. Unfortunately he was admitted to hospital seven days after vaccination and subsequently died of multi-organ failure. The reporter stated he reported it in view of the fact that the vaccine is relatively new. The reported causes of death were death unexplained, fever and multi-organ failure. The events were considered to be serious due to death and hospitalisation.


VAERS ID: 535577 (history)  
Form: Version 1.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-04-06
Onset:2012-01-21
   Days after vaccination:290
Submitted: 2014-07-01
   Days after onset:891
Entered: 2014-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA076EB / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Back pain, Biopsy cervix abnormal, Blood test, Cervical dysplasia, Cytology abnormal, Death, Exposure during pregnancy, Fatigue, Malaise, Metastasis, Papilloma viral infection, Smear cervix normal
SMQs:, Retroperitoneal fibrosis (broad), Reproductive premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Uterine and fallopian tube malignant tumours (broad), Uterine and fallopian tube tumours of unspecified malignancy (broad), Non-haematological malignant tumours (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-21
   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: Unknown
Preexisting Conditions: Cervical uterine dysplasia
Allergies:
Diagnostic Lab Data: Blood test, Dec2011, Not provided; Cervical biopsy, 21Mar2011, See text; Cervical cytology, 11Mar2011, Positive for hig; Cytology, 17Jan2011, Low grade sqamou; Cytology, 20Oct2011, See text; Laboratory test, Jan2014, Metastasis of un; On 21 March 2011, the cervical biopsy was performed which showed low grade squamous intraepithelial lesion with morphological changes related to Human Papilloma virus, Uterine cervical dysplasia; On 29 October 2011, cytology showed no malignant cells and cervical smear without dysplastic lesion
CDC Split Type: B1006932A

Write-up: This retrospective pregnancy case was reported by a consumer via a regulatory authority (# ES-AGEMED-205169340) and described the occurrence of metastasis in a 29-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 17 January 2011, cytology was performed which showed low grade squamous lesion (mild dysplasia). On 11 March 2011, a test to detect the papillomavirus in the cervical secretion was performed and the result was positive to high grade Human Papilloma virus (unknown the serotype of HPV) and a biopsy was recommended. On 21 March 2011, the cervical biopsy was performed which showed Low Grade Squamous Intraepithelial Lesion with morphological changes related to Human Papilloma virus (uterine cervical dysplasia). On 6 April 2011, the subject received 1st dose of CERVARIX, (.5 ml, intramuscular, unknown site of injection). In April 2011, less than a month after vaccination with CERVARIX, the subject experienced malaise, asthenia, fatigue and back pain. On 14 June 2011, the subject received 2nd dose of CERVARIX, (.5 ml, intramuscular, unknown site of injection). On 20 October 2011, the subject received 3rd dose of CERVARIX, (.5 mol, intramuscular, unknown site of injection). On the same day, after the administration of the 3rd dose of the vaccine, a new cytology was performed. On 2 November 2011, the results showed no malignant cells and cervical smear without dysplastic lesion. On 14 November 2011, the subject visited the gynaecologist where it was confirmed that the subject was pregnant from 1 month. The subject was pregnant at the time of 3rd vaccination with CERVARIX, leading to vaccine exposure during pregnancy. She went to the physician every week since November. The subject took paracetamol. No more tests were performed to determine the subject''s bad health conditions. In December 2011, the gynaecologist requested a new blood test due to the pregnancy. The pain was more intense. When the subject went to pick up the test results, the gynaecologist told that the subject had to go to the hospital. On 2 January 2012, the subject was hospitalized. On 21 January 2012, (19 days later) the subject died (while she was pregnant). During those 19, days several test were performed and the physicians told the family that she had metastasis of an unknown cause. It was unknown whether an autopsy was performed or not. The regulatory authority considered that metastasis, malaise, asthenia, fatigue and back pain were unlikely related to vaccination with CERVARIX.


VAERS ID: 535581 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2014-04-16
Onset:2014-04-17
   Days after vaccination:1
Submitted: 2014-06-30
   Days after onset:74
Entered: 2014-07-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER 4K05C / 2 UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1671 / 2 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 13E03A / 2 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac massage, Cardio-respiratory arrest, Death, Pallor, Peripheral coldness, Resuscitation
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), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-04-17
   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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: 16-APR-2014, Body temperature, 36.8 Centigrade
CDC Split Type: 2014173735

Write-up: This is a spontaneous report received from a contactable prescribed pediatrician and a contactable treatment pediatrician through Ministry of Health, Labor and Welfare (MHLW) under the regulatory authority report number of V14000161. A 4-month-old male patient of an unspecified ethnicity (birth weight: 3360 g) received the 2nd dose of PREVENAR 13 (Lot # 13E03A), via subcutaneous route, on 18Apr2014; the 2nd dose of ACT-HIB (Lot # J1671), via subcutaneous route, on 16Apr2014, and the first dose of DIPHTHERIA TOX/PERTUSSIS VACC/POLIOMYELITIS VACCINE INACT/TETANUS TOX (Lot # 4K05C), vis subcutaneous route, on 16Apr2014. Body temperature before vaccination was 36.8 degrees C. The patient did not have underlying disease, complication, medical history, allergy, history of adverse drug reaction and concomitant drugs. The patient did not receive any vaccination in the past 1 month. The patient experienced cardio-respiratory arrest at 05:47 am on 17Apr2014. Clinical course was as follows. On 17Apr2014: The patient slept in a supine position after being breast-feeding at 03:00 am. As the patient was sleeping in a prone position when the mother of the patient noticed, the mother put the patient in a supine position (the patient just became to do roll-over recently). Thereafter the mother fell asleep. The patient was sleeping in a prone position again when the mother noticed. Thus the mother tried to change the patient''s position, and then she realized that the patient''s lip turned to pale and legs were cold. An ambulance was called and cardiac massage was performed. The patient presented with cardio-respiratory arrest when he arrived at the reporter''s hospital. The patient did not response to resuscitation and death of the patient was confirmed. The pediatrician classified the event as serious (death) and assessed the causality as unevaluable while mentioning a possibility of asphyxiation due to prone position.


VAERS ID: 535769 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:1989-10-10
Onset:0000-00-00
Submitted: 2014-07-02
Entered: 2014-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Ataxia, Communication disorder, Death, Dystonia, Hypotonia, Mental disorder due to a general medical condition, Posture abnormal, Quadriplegia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-24
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: WAES1407ITA000649

Write-up: Information has been received from a business partner Sanofi Pasteur MSD (SPM) (manufacturer control number E2014-05730) on 01-JUL-2014. Case retrieved from the lay press on 27-JUN-14 through SPMSD. Case not medically confirmed. A female patient received the first dose of DT vaccine (Mfr. Unknown, batch n. not reported), the first dose of Hep B vaccine (Mfr. Unknown, batch n. not reported) and the first dose of polio vaccine (Other Mfr. batch n. not reported) on 10-OCT-1989 when she was less than 1 year old with repeated administrations in the following months and years until 1997. In the days following vaccination she presented with diffuse hypotonia and could not hold her head up. She died on 24-OCT-2007 due to an "encephalitic syndrome with hypotonic-dystonic-ataxic tetraparesis and communication-relation deficit post-vaccination". The case is a legal proceeding against a foreign state. The case is closed.


VAERS ID: 535942 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Foreign  
Vaccinated:2014-06-27
Onset:2014-06-29
   Days after vaccination:2
Submitted: 2014-07-07
   Days after onset:8
Entered: 2014-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA823AA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Bacterial infection, Death, Pneumonia, Pyrexia, Sudden infant death syndrome, Use of accessory respiratory muscles, Viral infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-06-29
   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: Unknown
Preexisting Conditions: Fever; Immunodeficiency; Infection; Nasal congestion; Use of accessory respiratory muscle
Allergies:
Diagnostic Lab Data:
CDC Split Type: B1010980A

Write-up: This case was reported by a physician and described the occurrence of sudden infant death syndrome in a 10-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), ACTHIB (non-gsk). On 23 May 2014, the subject visited clinic for pyrexia. Since the subject had the symptom of retractive breathing, the subject was suspected to have pneumonia and referred to hospital. Based on the diagnostic test results, the symptom was reportedly not associated with pneumonia but was associated with viral or bacterial infection due to immunodeficiency. No particularly serious symptoms were noted. On 10 June 2014, the subject visited clinic for nasal stuffiness and no other particularly unusual symptoms were noted. On 20 June 2014, the subject received unspecified dose of ACTHIB (subcutaneous). On 27 June 2014, the subject received 1st dose of ROTARIX (1.5 ml, oral). The subject had no particularly unusual symptoms. On 29 June 2014, 2 days after vaccination with ROTARIX, 9 days after vaccination with ACTHIB, the subject was found dead by his parents. He was not breathing. The subject was transferred to hospital, but was confirmed to be dead. The police contacted to the vaccinating physician to inform the aforementioned details. The notice of death alone was received from the police, and thus the details of the circumstances were unknown. The subject died on 29 June 2014 from sudden infant death syndrome. On 30 June 2014, at 13:30, forensic autopsy was performed at the department of legal medicine at university. Autopsy findings: The cause of death: Sudden infant death syndrome was suspected. No findings of invagination of intestine. The causal relationship of the event to ROTARIX was unknown but could not be completely be denied, because the subject had been vaccinated with ROTARIX alone. Although child abuse and other possibilities were also taken into consideration, no particular evidence was obtained. Child abuse was considered unlikely because the subject had been the youngest of the four siblings and the parents had actively committed themselves to vaccination.


VAERS ID: 536104 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Male  
Location: Foreign  
Vaccinated:2014-06-23
Onset:2014-06-24
   Days after vaccination:1
Submitted: 2014-07-04
   Days after onset:10
Entered: 2014-07-08
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER K0333 / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H88976 / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cardiac arrest, Death, Electrocardiogram abnormal
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? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-06-24
   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: 24-JUN-2014, Electrocardiogram, asystole
CDC Split Type: 2014181110

Write-up: This is a spontaneous report received from the foriegn Health Authority (PEI=contactable), Regulatory Authority report number DE-PEI-PEI2014044197. A 3-month-old male patient of an unspecified ethnicity received PREVENAR 13 (Lot # H88976), via an unspecified route of administration at 0.5 ml, single and HEXYON (Lot # K0333-3R), via an unspecified route of administration, both on 23Jun2014. The patient medical history and concomitant medications were not reported. The patient previously took PREVENAR-13 and HEXYON on 12May2014 was well tolerated. On 24Jun2014, the patient exprienced cardiac arrest (life threatening) and died. Diagnosis was confirmed by ECG (asystole) on 24Jun2014. Death cause was reported as cardiac arrest. An autopsy was performed. Results are currently pending. No follow-up attempts needed, follow-up automatically provided by PEI.


VAERS ID: 536362 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2014-02-17
Onset:2014-03-17
   Days after vaccination:28
Submitted: 2014-07-11
   Days after onset:116
Entered: 2014-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB754A / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H91632 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J010122 / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Base excess increased, Blood bicarbonate decreased, Blood glucose increased, Blood lactic acid increased, Blood potassium increased, Body temperature decreased, Breath holding, Breath sounds abnormal, Death, Electroencephalogram abnormal, Endotracheal intubation, Hyperhidrosis, Hyperkalaemia, Intensive care, Microbiology test normal, Nasopharyngitis, Neurone-specific enolase, Ophthalmological examination abnormal, PCO2 increased, PO2, Pallor, Protein S, Pupils unequal, Resuscitation, Retinal haemorrhage, Ultrasound scan normal, pH body fluid increased
SMQs:, Angioedema (broad), Lactic acidosis (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Optic nerve disorders (broad), Corneal disorders (broad), Retinal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-17
   Days after onset: 0
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: No other medications
Current Illness: Immunisation; Hypertrophy, birth weight was 4380 g
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 03/13/2014, Base excess, 34.9 mmol/l; 03/13/2014, Blood bicarbonate, 6.9 mmol/l; 03/13/2014, Blood glucose, 109 mg/dL; 03/13/2014, Blood lactic acid, 172 mg/dL; 03/13/2014, Blood potassium, 7.72 mmol/l; 03/13/2014, Blood potassium, hyperkalemia of 8 mmol/l; 03/14/2014, Blood potassium, under 5 mmol/l; 03/13/2014, Body temperature, 32.3 degrees C; 03/13/2014, Electroencephalogram, burst suppression pattern; 03/13/2014, Heart rate, 107 bpm; 03/13/2014, Microbiology test, Normal; 03/13/2014, Neurone-specific enolase, 47.2 ug/l, Increased; 03/14/2014, Ophthalmological examination, mild venous congestion, bleeding of retina vessels; 03/13/2014, Oxygen saturation, 98%; 03/13/2014, PCO2, 91 mmHg; 03/13/2014, PO2, 94.5 mmHg; 03/13/2014, Protein S, 10.33 ug/l, Increased; 03/13/2014, Ultrasound scan, Normal; 03/13/2014, pH body fluid, 8.49; 03/13/2014, pH body fluid, normalized, 6 hours after admission
CDC Split Type: WAES1407DEU004820

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control number E2014-05867) on 09-JUL-2014. Case of fatal outcome was received from the Health Authorities on 04-Jul-2014 (reference no. PEI2014045467). Case is medically confirmed. A 3-month-old patient with a medical history of hypertrophy (birth weight 4380 g) received the first dose of ROTATEQ (lot-no. J010122, expiry: 31-MAR-2015) orally, the first dose of PREVENAR 13 (Pfizer, lot-no. H91632) IM in to the left thigh and the first dose of INFANRIX HEXA (GSK, lot-no. A21CB754A) IM into the right thigh on 17-Feb-2014. On 13-Mar-2014, the patient''s mother noticed stertorous breathing, no aspiration was observed. As she suspected a "common cold" the mother laid the baby in the prone position on the couch, looking after him every few minutes. At around 3 p.m. she found him breathless and sweaty. Non-professional resuscitation was started. Reanimation was continued by the emergency physician. 2 intraosseous accesses were applied for volume and adrenaline administration. Recapillarisation time was 2-3 seconds at that time. Resuscitation and intubation was successful and the baby was referred to the Intensive Care Unit of a hospital. On admission, the patient was pale, recapillarisation time was 3-4 seconds. The fontanel was within level and soft. Pupils showed anisocoria (left


VAERS ID: 536403 (history)  
Form: Version 1.0  
Age: 0.91  
Sex: Male  
Location: Foreign  
Vaccinated:2014-04-08
Onset:2014-04-21
   Days after vaccination:13
Submitted: 2014-07-10
   Days after onset:80
Entered: 2014-07-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR J0559 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial test, Death, Loss of consciousness, Polymerase chain reaction, Respiratory arrest, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-04-21
   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: Con Meds =Unknown; HepB vaccine, Route: Intramuscular, Site: Unknown, 12MAY2013, Dose #: Unknown; Mfg: Unknown, Lot # 130-0312; BCG vaccine, Route: Unknown, Site: Unknown, 14MAY2013, Dose #: Unknown, Mfg: Unknown, Lot # 171; BUBO-KOK, lot n
Current Illness:
Preexisting Conditions: Acute rhinitis, 03JUL2013; On 13 August 2013 there was no light form of ARI, length was not stated allergic illnesses (incl. reaction for medical preparations and foodstuffs). There were no cramps in anamnesis of the vaccinated, his parents, siblings, during high temperature or without. Patient has history of perinatal affection of CNS from 27-Jun-2013 to 12-Nov-2013, muscular torticollis? Background disease: chronic immune-endocrine insufficiency and anatomic immaturity of organs (fetopathy). No history of cramps in anamnesis of the vaccinated, his parents, siblings, during high temperature or without.
Allergies:
Diagnostic Lab Data: The patient underwent PCR and bacteriological check of section material on an unknown date; Body temperature, 36.5 degree C
CDC Split Type: 2014SA090514

Write-up: Initial case was received from a local HA (Health Authority) by company by mail as registered letter on 04 July 2014. A 11-month-old male patient whose medical history included had received 0.5 ml IMOVAX POLIO (lot number J0559-1, route ND, dose and anatomical site of administration not reported) on 08 April 2014. The patient received BUBO-KOK (lot number 0840413, dose and anatomical site of administration not reported) on an unspecified date. The patient''s temperature before vaccination was 36.5 degree Celsius. History and anamnesis: Patient had received an intramuscular HepB vaccination 0.5 ml (lot number: 130-0312, expiration date March 2016) on the second day of life 12-May-2013, an intracutaneous BCG vaccination 0.05 ml in 0.1 ml (lot number-171, expiration date August 2014) on the fourth day of life 14-May-2013. On 03 July 2013, the patient was diagnosed with acute rhinitis. On 13 August 2013, there was no light form of ARI, length was not stated allergic illnesses (incl. reaction for medical preparations and foodstuffs). There were no cramps in anamnesis of the vaccinated, his parents, siblings, during high temperature or without. The patient had no individual peculiarities (prematurity, birth injury, head injury, previous corticosteroids therapy, etc. and no previous illness. There were no unusual reactions on vaccination ever registered with vaccinated or his relatives. His concomitant medication was not reported. On 21 April 2014 at 08:13 it was reported that the call was registered at emergency medical station with the absence of breath and unconsciousness of a child. The ambulance left at 08:14, arrived at 08:16. At 08:20 biological death of a child before arrival of ambulance was registered. It was reported that there was sudden infant death syndrome on 21 April 2014. The co-existing diseases were absent. Date of discharge fare was lethal residual effects in case of death on 21 April 2014 at 08:20. Background disease included chronic immune-endocrine insufficiency and anatomic immaturity of organs (fetopathy). On the basis of medicolegal survey of the body of infant, results of lab tests (PCR and bacteriological check of section material), full information on child''s anamnesis, his health before vaccination the death of infant in post-vaccination period was not connected with injections of IMOVAX POLIO (IPV (VERO) and BUBO-KOK). No corrective treatment was reported. The list of documents held by sender: None.


VAERS ID: 536513 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-09
Entered: 2014-07-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cerebrovascular accident, Death
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and 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: PHHY2014IT083306

Write-up: Case number PHHY2014IT083306 is an initial spontaneous report received from the consumer via foreign internet site on 05 Jul 2014. This report refers to a patient of unknown age and gender. The patient''s medical history and concomitant medications were not reported. The patient was vaccinated with AGGRIPAL (batch number: unknown) on an unspecified date. Four days after vaccination patient died due to a cerebral stroke. The causality of the event was not reported.


VAERS ID: 536585 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2014-06-25
Onset:2014-06-29
   Days after vaccination:4
Submitted: 2014-07-14
   Days after onset:15
Entered: 2014-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CB045B / 1 UN / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H63249 / 1 UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-06-29
   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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B1012558A

Write-up: This case was reported by a healthcare professional via a regulatory authority (# NO-NOMAADVRE-FHI-2014-17985) and described the occurrence of sudden infant death syndrome in a 3-month-old male subject who was vaccinated with INFANRIX-IPV/HIB (GlaxoSmithKline) and PREVENAR 13 (non-GSK). At the time of vaccination, the subject was in a good general condition. On 25 June 2014, the subject received 1st doses of INFANRIX-IPV/HIB (.5 ml, parenteral, unknown injection site) and PREVENAR 13 (.5 ml, parenteral, unknown injection site). On 29 June 2014, 4 days after vaccination with INFANRIX-IPV/HIB and PREVENAR 13, the subject was found dead in bed (sudden infant death syndrome). The regulatory authority reported that the event was possibly related to vaccination with INFANRIX-IPV/HIB and PREVENAR 13. It was unknown whether an autopsy was performed.


VAERS ID: 536769 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-15
Entered: 2014-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1407IDN005640

Write-up: This spontaneous report as received from a physician via company representative refers to a 4 month old patient (gender unknown). Current conditions and medical history were not reported. On an unknown date the patient was vaccinated with ROTATEQ, oral (dose, dose schedule, lot number and expiration date were not reported), and poliovirus vaccine live oral together. Concomitant therapies were not reported. On an unknown date the patient has passed away. The cause and date of death were unknown. It was unknown if an autopsy was performed. Additional information has been requested.


VAERS ID: 536828 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2014-07-09
Onset:2014-07-10
   Days after vaccination:1
Submitted: 2014-07-14
   Days after onset:4
Entered: 2014-07-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-07-10
   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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA091890

Write-up: Initial report received from healthcare professional on 10 July 2014. A 03-month-old female patient, whose medical history and concomitant medications were not reported, had received 0.5 ml Intramuscular second dose of IMOVAX Polio (batch number was unknown and anatomical site of administration was not reported) and intramuscular first dose of DTP (batch number was unknown and anatomical site of administration was not reported) of other manufacturer on 09 July 2014 at about 03:00 PM. It was reported that on 10 July 2014, about 10 hours after receiving IMOVAX Polio and DTP vaccine, the patient died at home. The patient''s corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was fatal. Documents held by sender: none.


VAERS ID: 536863 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-16
Entered: 2014-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood immunoglobulin G abnormal, Brain herniation, Confusional state, Drug resistance, Fatigue, Headache, Immunoglobulins normal, Meningitis, Meningitis pneumococcal, Purpura, Pyrexia, Respiratory failure, Sepsis, Streptococcus test positive, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cefprozil
Current Illness: Prophylaxis; Staphylococcal bacteraemia; Immunodeficiency, deficiency causes IL-1R and TLR signaling failure, resulting in minimal clinical features despite invasive bacterial infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: IgG response to tested vaccine antigens was satisfactory; IgG to 6A reportedly cross-reacts with 6C, but this may not be protective; Immunoglobulin G4 related sclerosing disease, 3.4 g/l; Immunoglobulins, normal except IgG4
CDC Split Type: WAES1402CAN004674

Write-up: This literature marketed report as received from a physician refers to a 7 year old female patient with IRAK-4 deficiency and multiple occult staphylococcus aureus lymphadenitis. On an unknown date the patient was vaccinated with PNEUMOVAX 23. Other suspect therapies included PCV-13. On an unknown date, no bacterial infections occurred on prophylaxis for 6 years after initial presentation. IgG responses to pneumococcal saccharide were satisfactory but short-lived, requiring frequent boosting. At age 7, patient developed a morning headache and vomited once. Cefprozil was administered and redosed. Over 12 hours, she was fatigued without other symptoms. Low fever accompanied another emesis. Hours later she was confused, and purpuric rash appeared. Emergency physicians diagnosed sepsis/meningitis and started vancomycin-ceftriaxone. Respiratory failure and cerebellar herniation occurred <24 hours from first symptoms. Blood and CSF grew Streptococcus pneumonia type 6C resistant to second generation cephalosporins. The patient''s latest PCV-13 vaccinations was 6 weeks before death, which included serotype 6A. Immunoglobulins were normal except IgG4 was increased (3.4g/L). IgG response to tested vaccine antigens was satisfactory. IgG to 6A reportedly cross-reacts with 6C, but this may not be protective. Conclusions: Despite antibiotic prophylaxis and repeated vaccination, even older IRAK-4 deficient patients are high-risk for rapidly fatal infection due to emergent antibiotic resistance. These patients need early assessment at any age, bacterial culturing, alternative empiric antibiotic therapy and close observation when even vaguely unwell. Additional IVIG/SCIG prophylaxis warrants serious consideration. The outcome of drug ineffective (IgG responses to pneumococcal polysaccharide were satisfactory but short-lived, requiring frequent boosting) was unknown. Conclusions: Despite antibiotic prophylaxis and repeated vaccination, even older IRAK-4-deficient patients are high-risk for rapidly fatal infection due to emergent antibiotic resistance. These patients need early assessment at any age, bacterial culturing, alternative empiric antibiotic therapy and close observation when even vaguely unwell. Additional IVIG/SCIG prophylaxis warrants serious. Follow up information has been received from the Agency. It was reported that the patient experienced drug resistance and meningitis pneumococcal on an unknown date. The Agency considered the outcome of the events "drug resistance and meningitis pneumococcal" as fatal. It was unknown if autopsy was performed. Additional information has been requested.


VAERS ID: 537257 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-21
Entered: 2014-07-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pneumococcal infection
SMQs:, 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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014201383

Write-up: This is a spontaneous report from a contactable physician. A 5-year-old patient of an unspecified gender received PREVNAR, via an unspecified route of administration on an unspecified date at an unspecified dose. The patient''s medical history and concomitant medications were not reported. The patient had no identified risk factors. On an unknown date, the patient experienced fatal invasive pneumococcal disease, due to serotype 19a. The patient died on an unspecified date. It was not reported if an autopsy was performed. The physician, who was from a provincial Centre for Disease Control, prepared a report on invasive pneumococcal disease (IPD) on pediatric cases for a specific region. Enhanced surveillance was conducted for pediatric cases aged <17 years old to monitor the effectiveness of the pneumococcal conjugate vaccine program which began in this region in 2003. Among cases under 5 years old, 75% had serotyping results available (18/24), of which 17% (n=3) were due to serotypes covered by the 7-valent pneumococcal conjugate vaccine (PCV-7) and 28% (n=5) were due to the additional serotypes covered by the 13-valent vaccine (PCV-13). The remaining 10 cases (56%) were due to serotypes not covered by the conjugate vaccines. These cases with known serotype of children 59 months old or younger were reviewed for preventability by the vaccine as used in the provincial program with introduction of PCV-7 in 2003 and PCV-13 in 2010 without a catch-up program. There was only 1 fatal IPD pediatric case. Per the physician, this patient was fully immunized with PCV-7 and thus non-preventable in the provincial program without a catch-up component. No follow-up attempts possible. No further information expected.


VAERS ID: 537415 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Foreign  
Vaccinated:2013-01-08
Onset:2013-01-09
   Days after vaccination:1
Submitted: 2014-07-21
   Days after onset:557
Entered: 2014-07-23
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR H0449 / 1 LG / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asphyxia, Death, Irritability, Obstructive airways disorder
SMQs:, Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-09
   Days after onset: 242
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA093922

Write-up: This initial case belongs to the batch that have been forwarded to the company by the Health Authorities on 14-July-2014 in the format of line listing. HA reference number: 2334874. A 02-month-old male patient, whose medical history and concomitant therapies were not reported, had received 0.5 mL, first dose of IPV (VERO) (Sanofi Pasteur SA) (batch number H0449-1, by intramuscular route in thigh), on 08 January 2013. On 09 January 2013, the patient experienced delactation and mild irritability 4 hours after vaccination. Death on 7 AM of 9 September 2013. On 09 January 2013, the patient visited a physician. The patient was not hospitalized. The final diagnosis was reported as "others" and the other diagnosis as death from suffocation due to obstruction in respiratory tract. The patient''s outcome was reported as death. According to the Health Authority: the initial AE classification was to be determined and the AE final classification was Coincidental Event. The case was reported as a Serious Adverse Event by the Health Authorities. The case was not assessed as an AEFI cluster.


VAERS ID: 537858 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-06-27
Submitted: 2014-07-24
   Days after onset:27
Entered: 2014-07-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Intensive care, Laboratory test, Meningitis pneumococcal
SMQs:, 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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Mastoid sample (unspecified date): serotype identification was unknown.
CDC Split Type: 2014202502

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. An about 18-month-old male patient of an unspecified ethnicity received a complete vaccination schedule with three doses of PREVENAR 13, on unspecified dates, via unspecified routes of administration, at 0.5ml single. The patient''s medical history and concomitant medications were not reported. On 27Jun2014, the patient was admitted to hospital in ICU due to pneumococcal meningitis. It was noted that the patient had no cutaneous signs. A mastoid sample was taken: serotype identification was unknown. At the time of reporting, therapeutic measures taken in response to the event were unknown. The event outcome could be the patient''s death, to be confirmed. It was unknown if an autopsy was performed.


VAERS ID: 537884 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-25
Entered: 2014-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Biopsy, Cardiac failure, Death, Heart transplant, Heart transplant rejection, Immunosuppression, Pericardial excision, Post procedural complication, Tricuspid valve incompetence
SMQs:, Cardiac failure (narrow), Pulmonary hypertension (narrow), Cardiomyopathy (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: Cyclosporin; Azathioprine; Mycophenolate mofetil; Interleukin-2; Methylprednisolone; Prednisone; Tacrolimus; Gancyclovir
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B1016651A

Write-up: This case was reported in a literature article and described the occurrence of heart failure in a subject aged between 10 and 19 years old of unspecified gender who was vaccinated with influenza vaccine (manufacturer unspecified), HepB vaccine and unspecified Pneumococcal vaccine. The subject had undergone an orthotopic heart transplant between November 1992 and December 2008. This was the subject''s first heart transplant and only this organ was transplanted. Historical medication for this subject was not specified but the authors commented that the preoperative immunosuppressive protocol for subjects transplanted until June 1999 consisted of induction with cyclosporine 5 mg/kg and azathioprine 4 mg/kg per os (PO). The preoperative immunosuppressive protocol for subjects who underwent transplant after June 1999 included anti-interleuken-2 receptor monoclonal antibody, mycophenolate mofetil 1.5-2.0 g PO and cyclosporine 3-4 mg/kg PO (discontinued after January 2007). In addition to this, all the subjects received SOLUMEDROL 500 mg intravenous (IV) intraoperatively and the subjects transplanted after June 1999 also received methylprednisolone 500 mg IV during the procedure. Concurrent medication was not specified but the authors explained that the subjects were treated with immunosuppression and infection prophylaxis postoperatively. This postoperative immunosuppression treatment included cyclosporine (maintained around 400 ng/ml during the first year and then 250-300 ng/ml) and azathioprine (1.0-2.0 mg/kg/day to maintain white blood cell count (WBC) $g4,000/mm3) until June 1999. Between June 1999 and January 2007 the subjects received mycophenolate mofetil 1-3 g/day, anti-interleukin-2 receptor monoclonal antibody (to maintain a WBC of 4,000-6,000/L) and cyclosporine (trough levels maintained during the first year at 300-400 ng/mL and at 150-200 ng/mL thereafter). After January 2007 cyclosporine was substituted with methylprednisolone 125 mg (one injection every 8 h for 3 injections), prednisone (initially 1 mg/kg/day, decreasing to 0.25 mg/kg/day at 1 month, to 0.1 mg/kg/day at 6 months and discontinued after 1 year if possible) and FK 506 (trough levels of 10-15 ng/ml during the first year and 6-8 ng/ml afterwards). In addition to this some subjects received gancyclovir IV for 4 weeks before the transplant procedure. On unspecified dates, at an unspecified time before the heart transplant procedure the subject received an unspecified pneumococcal vaccine, an unspecified influenza vaccine and an unspecified hepatitis B vaccine (if the subject was negative for HBsAg and HBsAb) (administration site and routes unspecified, batch numbers not provided). Surveillance EMB was performed using a percutaneous right internal jugular approach on a scheduled basis, every week for 1 month, every month for 3 months, and at 6 months and 1 and 2 years. In the event of clinical suspicion of rejection, further biopsy was performed. On an unknown date, at least 6 months after the heart transplantation, the subject suffered from significant tricuspid regurgitation that required a pericardiectomy and subsequently developed heart failure. The subject died from heart failure. It was unknown whether an autopsy was performed. The author did not comment on any causal relationship with the vaccines. The author''s conclusion stated that in this study of subjects after heart transplantation, the incidence of moderate-to-severe tricuspid regurgitation was 10.4% and moderate-to-severe mitral regurgitation occurred less frequently than tricuspid regurgitation. The long term results of atrioventricular function after heart transplantation in adults were excellent regardless of anastomotic technique. Older donor age was the important factor associated with development of postoperative moderate-to-severe tricuspid regurgitation. This is 1 of the 5 valid cases reported in the same literature article.


VAERS ID: 537887 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-25
Entered: 2014-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Heart transplant, Tricuspid valve incompetence
SMQs:, Cardiac failure (broad), Pulmonary hypertension (narrow), Cardiomyopathy (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: Cyclosporin; Azathioprine; Mycophenolate mofetil; Interleukin-2; Methylprednisolone; Prednisone; Tacrolimus; Gancyclovir
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B1016653A

Write-up: This case was reported in a literature article and described the occurrence of death (cause undetermined) in a subject of at least 17 years old of unspecified gender who was vaccinated with influenza vaccine (unspecified, manufacturer unspecified), HepB and unspecified pneumococcal vaccine. The subject had undergone an orthotopic heart transplant between November 1992 and December 2008. This was the subject''s first heart transplant and only this organ was transplanted. Historical medication for this subject was not specified but the authors commented that the preoperative immunosuppressive protocol for subjects transplanted until June 1999 consisted of induction with cyclosporine 5 mg/kg and azathioprine 4 mg/kg per os (PO). The preoperative immunosuppressive protocol for subjects who underwent transplant after June 1999 included anti-interleukin-2 receptor monoclonal antibody, mycophenolate mofetil 1.5-2.0 g PO and cyclosporine 3-4 mg/kg PO (discontinued after January 2007). In addition to this, all the subjects received SOLUMEDROL 500 mg intravenous (IV) intraoperatively and the subjects transplanted after June 1999 also received methylprednisolone 500 mg IV during the procedure. Concurrent medication was not specified but the authors explained that the subjects were treated with immunosuppression and infection prophylaxis postoperatively. This postoperative immunosuppression treatment included cyclosporine (maintained around 400 ng/ml during the first year and then 250-300 ng/ml) and azathioprine (1.0-2.0 mg/kg/day to maintain white blood cell count (WBC) $g4,000/mm3) until June 1999. Between June 1999 and January 2007 the subjects received mycophenolate mofetil 1-3 g/day, anti-interleukin-2 receptor monoclonal antibody (to maintain a WBC of 4,000-6,000/?L) and cyclosporine (trough levels maintained during the first year at 300-400 ng/mL and at 150-200 ng/mL thereafter). After January 2007 cyclosporine was substituted with methylprednisolone 125 mg (one injection every 8 h for 3 injections), prednisone (initially 1 mg/kg/day, decreasing to 0.25 mg/kg/day at 1 month, to 0.1 mg/kg/day at 6 months and discontinued after 1 year if possible) and FK 506 (trough levels of 10-15 ng/ml during the first year and 6-8 ng/ml afterwards). In addition to this some subjects received gancyclovir IV for 4 weeks before the transplant procedure. On unspecified dates, at an unspecified time before the heart transplant procedure the subject received an unspecified pneumococcal vaccine, an unspecified influenza vaccine and an unspecified HepB vaccine (if the subject was negative for HBsAg and HBsAb) (administration site and routes unspecified, batch numbers not provided). Surveillance EMB was performed using a percutaneous right internal jugular approach on a scheduled basis, every week for 1 month, every month for 3 months, and at 6 months and 1 and 2 years. In the event of clinical suspicion of rejection, further biopsy was performed. On an unknown date, at least 6 months after the heart transplantation, the subject experienced significant tricuspid regurgitation and then died from unknown causes. It was unknown whether an autopsy was performed. The author did not comment on any causal relationship with the vaccines. The author''s conclusion stated that in this study of subjects after heart transplantation, the incidence of moderate-to-severe tricuspid regurgitation was 10.4% and moderate-to-severe mitral regurgitation occurred less frequently than tricuspid regurgitation. The long-term results of atrioventricular function after heart transplantation in adults were excellent regardless of anastomotic technique. Older donor age was the important factor associated with development of postoperative moderate-to-severe tricuspid regurgitation. This case is 1 of 5 valid cases reported in the same literature article.


VAERS ID: 537900 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-25
Entered: 2014-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Biopsy, Cardiac failure, Death, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative, Mitral valve incompetence, Pericarditis constrictive
SMQs:, Cardiac failure (narrow), Cardiomyopathy (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: Cyclosporine; Azathioprine; Mycophenolate mofetil; Interleukin-2; Methylprednisolone; Prednisone; Tacrolimus; Ganciclovir
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B1016657A

Write-up: This case was reported in a literature article and described the occurrence of heart failure in a subject aged of at least 17 years old of unspecified gender who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified), Hepatitis B vaccine and unspecified Pneumococcal vaccine. The subject had undergone an orthotopic heart transplant between November 1992 and December 2008. This was the subject''s first heart transplant and only this organ was transplanted. Historical medication for this subject was not specified but the authors commented that the preoperative immunosuppressive protocol for subjects transplanted until June 1999 consisted of induction with cyclosporine 5 mg/kg and azathioprine 4 mg/kg per os (PO). The preoperative immunosuppressive protocol for subjects who underwent transplant after June 1999 included anti-interleukin-2 receptor monoclonal antibody, mycophenolate mofetil 1.5-2.0 g PO and cyclosporine 3-4 mg/kg PO (discontinued after January 2007). In addition to this, all the subjects received SOLUMEDROL 500 mg intravenous (IV) intraoperatively and the subjects transplanted after June 1999 also received methylprednisolone 500 mg IV during the procedure. Concurrent medication was not specified but the authors explained that the subjects were treated with immunosuppression and infection prophylaxis postoperatively. This postoperative immunosuppression treatment included cyclosporine (maintained around 400 ng/ml during the first year and then 250-300 ng/ml) and azathioprine (1.0-2.0 mg/kg/day to maintain white blood cell count (WBC) $g4,000/mm3) until June 1999. Between June 1999 and January 2007 the subject received mycophenolate mofetil 1-3 g/day, anti-interleukin-2 receptor monoclonal antibody (to maintain a WBC of 4,000-6,000/?L) and cyclosporine (trough levels maintained during the first year at 300-400 ng/mL and at 150-200 ng/mL thereafter). After January 2007 cyclosporine ws substituted with methylprednisolone 125 mg (one injection every 8 h for 3 injections), prednisone (initially 1 mg/kg/day, decreasing to 0.25 mg/kg/day at 1 month, to 0.1 mg/kg/day at 6 months and discontinued after 1 year if possible) and FK 506 (trough levels of 10-15 ng/ml during the first year and 6-8 ng/ml afterwards). In addition to this some subjects received ganciclovir IV for 4 weeks before the transplant procedure. On unspecified dates, at an unspecified time before the heart transplant procedure the subject received an unspecified pneumococcal vaccine, an unspecified influenza vaccine and an unspecified hepatitis B vaccine (if the subject was negative for HBsAG and HBsAb) (administration site and routes unspecified, batch numbers not provided). Surveillance EMB was performed using a percutaneous right internal jugular approach on a scheduled basis, every week for 1 month, every month for 3 months, and at 6 months and 1 and 2 years. In the event of clinical suspicion of rejection, further biopsy was performed. On an unknown date, at least 6 months after the heart transplantation, the subject experienced a significant mitral regurgitation. Later on, the subject had a constrictive pericarditis that required a pericardectomy and subsequently developed heart failure and died. It was unknown whether an autopsy was performed. The author did not comment on any causal relationship with the vaccines. The author''s conclusion stated that in this study of subjects after heart transplantation, the incidence of moderate-to-severe tricuspid regurgitation was 10.4% and moderate-to-severe mitral regurgitation occurred less frequently than tricuspid regurgitation. The long-term results of atrioventricular function after heart transplantation in adults were excellent regardless of anastomotic technique. Older donor age was the important factor associated with development of postoperative moderate-to-severe tricuspid regurgitation. This case is 1 of the 5 valid cases reported in the same literature article.


VAERS ID: 538027 (history)  
Form: Version 1.0  
Age: 1.03  
Sex: Male  
Location: Foreign  
Vaccinated:2013-05-07
Onset:0000-00-00
Submitted: 2014-07-28
Entered: 2014-07-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Inappropriate schedule of drug administration, Meningitis pneumococcal, Otitis media, Pneumococcal sepsis, Tympanic membrane perforation
SMQs:, Accidents and injuries (broad), Hearing impairment (narrow), Medication errors (narrow), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-04-05
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: Premature birth, born in 33 2/7 week of pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014205131

Write-up: This is a spontaneous report from a contactable physician via a sales representative. An approximately 23-month-old male patient (an identical twin) received on 07May2013, when he was 12 months old, the third dose of PREVENAR 13 via an unspecified route of administration at 0.5 ml single. The first dose of PREVENAR 13 was administered on 03Jul2012 and the second dose on 08Nov2012. It was stated that the second dose was administered with delay (not exactly as per recommended scheme). Patient was a premature baby (born in 33 2/7 week of pregnancy, weight at birth: 1930 grams), and he had no immunodeficiency. The patient''s concomitant medications were not reported. On unspecified date the patient developed pneumococcal meningitis, pneumococcal sepsis and otitis media with perforation of tympanic membrane. The patient was hospitalized on 05Apr2014 and died six hours after admission on 05Apr2014. Patient died due to pneumococcal meningitis, pneumococcal sepsis and otitis media with perforation of tympanic membrane. No information regarding the serotype was available. It was not reported if an autopsy was performed.


VAERS ID: 538338 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-31
Entered: 2014-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood immunoglobulin A decreased, Blood immunoglobulin G decreased, Blood immunoglobulin M decreased, CD4 lymphocytes decreased, CD4/CD8 ratio decreased, Death, Monocyte count normal, Neutrophil count increased, Platelet count normal, Respiratory disorder, T-lymphocyte count decreased
SMQs:, Haematopoietic leukopenia (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Gene mutation; Hypogammaglobulinemia (IGA)
Preexisting Conditions: Bronchiectasis; Mycobacterium Kansasii infection; Pansinusitis; Pneumonia; Recurrent otitis media; Recurrent sinusitis; Wart on hand
Allergies:
Diagnostic Lab Data: Immunoglobulin A, Less than 7 mg/dL; Immunoglobulin A, Less than 5 mg/dL; Immunoglobulin G, 260 mg/dL; Immunoglobulin G, 886 mg/dL; Immunoglobulin M, 12 mg/dL; Immunoglobulin M, Less than 4 mg/dL; Monocytes, 252 cells/mL; Monocytes, 41 cells/mL; Neutrophils, 10970 cells/mL; Neutrophils, 3050 cells/mL; Platelet count, 256000 cells/mL; Platelet count, 162000 cells/mL; Vaccine titers (normal range) at 14-year-old: - Pneumococcal IgG (positive, $g1 mg/mL; normal, $g17/14 serotypes): Absent; 11/14 after booster - Tetanus IgG (IU/mL): 0.03; 0.02 after booster - Polysaccharide ribose phosphate, (ng/mL: 131; $g9,000 after booster; Lymphocytes (cells/mL): At 14-year-old: - CD3+: 770 - CD3+CD4+: 237 - CD3+CD8+: 494 - CD4+/CD8+ ratio: 0.48 - CD19+: 0 - CD16+/CD56+: 104; At 17-year-old: - CD3+: 871 - CD3+CD4+: 299 - CD3+CD8+: 547 - CD4+/CD8+ ratio: 0.52 - CD19+: 0 - CD16+/CD56+: 20
CDC Split Type: B1018590A

Write-up: This case was reported in a literature article and described the occurrence of progressive respiratory deterioration in a 22-year-old male subject who was vaccinated with Hib vaccine (unspecified, manufacturer unspecified), Tetanus vaccine (manufacturer unspecified), PREVENAR (non-GSK) and PNEUMOVAX (non-GSK). The subject''s medical history included recurrent otitis media and sinusitis at the age of 3, pneumonia and pansinusitis with absent tonsils at the age of 14, and warts on his hands and severe bronchiectasis due to Mycobacterium kansasii infection at the age of 16. Concurrent conditions included hypogammaglobulinemia and irregular development of vaccine titers. In addition to this, the subject and his mother had been diagnosed with a heterozygous mutation in GATA2. No mutations were found in the TACI, PNP, ADA, BTK or SH2D1A genes. Treatment for his conditions consisted of intravenous immunoglobulin started at 5 and discontinued at 10 years of age (historical medication). It had been restarted when the subject was 14 years old (concomitant medication). On unspecified dates, when the subject was 3 and 14-year-old he received an unspecified Hib vaccine (manufacturers, doses and routes unknown), he also received three doses of unspecified Tetanus vaccine when he was 3, 10 and 14 (manufacturers, doses and routes unknown). In addition to this the subject had repeated vaccination for PREVENAR (Wyeth Pharmaceuticals, doses and routes unknown) and PNEUMOVAX (Merck, doses and routes unknown) at the age of 14. On an unknown date, an unspecified time after receiving various doses of an unspecified Hib vaccine, an unspecified Tetanus vaccine, PREVENAR (Wyeth Pharmaceuticals) and PNEUMOVAX (Merck), the subject developed an unspecified progressive respiratory deterioration. The subject''s treatment was unknown. The subject died as a consequence of this deterioration. The outcome was death when the subject was 22-year-old. It was unknown whether an autopsy was performed. The authors did not comment on any causal relationship with the vaccine. The authors'' conclusion stated that "These subjects illustrated the broad spectrum of clinical presentation inherent in this disease. Subject 1 had an initially mild clinical presentation, with recurrent otitis media and sinusitis, but eventually had warts and mycobacterial infections despite normal proliferation to mitogens and antigens. Subject 2 had no history of recurrent infections despite her impaired lymphocyte proliferation to antigens. Thus these subjects, as in others, the same GATA2 mutation resulted in different phenotypes. This could have been due to differences in modifier genes, environmental exposures, and epigenetic factors. This report highlighted the importance of considering mutations in GATA2 in subjects with hypogammaglobulinemia, particularly in the setting of abnormal lymphocyte subsets and monocyte counts." This case is one of two valid cases reported in the same literature article. This case was linked to mother''s case (see case B1018631A).


VAERS ID: 538798 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2014-07-21
Onset:2014-07-21
   Days after vaccination:0
Submitted: 2014-08-04
   Days after onset:14
Entered: 2014-08-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1180 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-07-22
   Days after onset: 1
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: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA100260

Write-up: Initial report received from healthcare professional on 25 July 2014. A patient, whose gender, date of birth, medical history and concomitant medications were not reported, had received intramuscular first dose of ACT-HIB, batch number: J1180-1 (anatomical site of administration was not reported) on 21 July 2014. It was reported that on 21 July 2014, in the afternoon after receiving ACT-HIB vaccine, the patient was hospitalized. On 22 July 2014, the patient was dies. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was fatal. Documents held by sender: none.


VAERS ID: 539535 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-11-05
Onset:2013-04-03
   Days after vaccination:515
Submitted: 2014-07-31
   Days after onset:484
Entered: 2014-08-11
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Lumbar puncture abnormal, Meningitis pneumococcal
SMQs:, Guillain-Barre syndrome (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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: 03-APR-2013, Lumbar puncture, pneumococcal meningitis; Pneumococcal serotype identification (unspecified date): 19A
CDC Split Type: 2014210574

Write-up: This is a spontaneous report from a non contactable physician. Foreign national observatory of pneumococcal meningitis and bacteremia. This is the first of four cases. A 3-year-old had received three doses of PREVENAR 13: on 03Oct2009 (first dose), on 03Oct2010 (second dose) and on 05Nov2011 (third dose), all at 0.5 ml single. The patient''s medical history and concomitant treatment were not reported. On 03Apr2013, the patient underwent lumbar puncture and was diagnosed with pneumococcal meningitis due to serotype 19A. The patient died on an unknown date due to pneumococcal meningitis.


VAERS ID: 539627 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-08-12
Entered: 2014-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / 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: Asthenia; Cardiac disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1408ZAF006316

Write-up: This spontaneous report was received from a physician via a company representative refers to a 74 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot # and route of administration were not reported). On an unknown date (5 days after the patient was vaccinated with ZOSTAVAX) the patient died (on an unspecified date). Physician said it was by no means related to ZOSTAVAX, the patient was known as a cardiac patient and frail. The outcome of patient died was reported as fatal. The cause of death was unknown. The reporter considered patient''s death to be not related to ZOSTAVAX. Additional information has been requested.


VAERS ID: 539810 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-08-06
Entered: 2014-08-14
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Pneumococcal bacteraemia
SMQs:, Infective pneumonia (broad), Sepsis (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:
Current Illness:
Preexisting Conditions: Epilepsy; Development disturbance
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014214641

Write-up: A currently 4-years-old female patient received the third dose of PREVENAR 13 at 0.5 m, single dose at the age of 5 months (no lot number was reported). Concomitant medications were not provided by reporter. The patient was no premature baby and had no immunodeficiency. The patient had as chronic underlying diseases: malignant epilepsy, developmental retardation and microcepehaly. The patient previously received the first and second dose of PREVENAR 13 at the age of 1.9 months and at the age of 4 months respectively, at 0.5 ml, single dose each. In 2014, the patient experienced pneumococcal bacteraemia with focus pneumonia (serotype 24F) that was proven by blood culture. The outcome of the event was reported as fatal. The patient died on an unspecified date in 2014 it was reported if an autopsy was performed. No follow-up attempts possible. No further information expected.


VAERS ID: 542018 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-08-21
Onset:2014-08-24
   Days after vaccination:3
Submitted: 2014-09-02
   Days after onset:9
Entered: 2014-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Abscess, Death, Erythema, Local reaction, Subarachnoid haemorrhage
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-08-24
   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: 08/24/2014, Blood pressure, normal
CDC Split Type: WAES1409JPN000056

Write-up: Initial information has been received from a physician concerning a 90 year old female patient who on 21-AUG-2014 was injected with PNEUMOVAX NP injection drug subcutaneously, 0.5 ml once a day (lot number not reported). There was no concomitant medication reported. On 21-AUG-2014, the patient was vaccinated with pneumococcal vaccine. In August 2014, the patient developed some local adverse reaction such as abscess, but there was no generalized adverse reaction showed. On 24-AUG-2014, the patient developed subarachnoid haemorrhage, but her blood pressure was normal. Then the patient was transported to the other hospital. She died later. The cause of death was subarachnoid haemorrhage. There was no information about autopsy provided. At the time of this report, the outcome of redness was unknown. Comment from the reporter: it seemed there was no generalized adverse reaction, so in the reporter''s opinion the subarachnoid haemorrhage had no causal relationship with pneumococcal vaccine. The reporting physician considered that the subarachnoid haemorrhage was serious due to death. The reporting physician did not assess the seriousness of the redness. The reporting physician felt that the subarachnoid haemorrhage was not related to pneumococcal vaccine. Upon internal review, the relationship of subarachnoid haemorrhage to pneumococcal vaccine could not be ruled out. The reporting physician did not assess the relationship of redness to pneumococcal vaccine. No further information is available.


VAERS ID: 542202 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-03
Entered: 2014-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B1028476A

Write-up: This case was reported in a newspaper article and described the occurrence of death (cause undetermined) in a female subject of unspecified age who was vaccinated with an unspecified HPV vaccine (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of HPV vaccine (unknown route and injection site). At an unspecified time after vaccination with HPV vaccine, the subject died from undetermined cause. It was unknown whether an autopsy was performed. No further information could be obtained. Case was closed. This case was 1 of the 4 cases identified in the same article (see case B1029475A).


VAERS ID: 542203 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-03
Entered: 2014-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B1028477A

Write-up: This case was reported in a newspaper article and described the occurrence of death (cause undetermined) in a female subject of unspecified age who was vaccinated with an unspecified HPV vaccine (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of HPV vaccine (unknown route and injection site). At an unspecified time after vaccination with HPV vaccine, the subject died from undetermined cause. It was unknown whether an autopsy was performed. No further information could be obtained. Case was closed. This case was 1 of the 4 cases identified in the same article (see case B1029475A).


VAERS ID: 542210 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-03
Entered: 2014-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B1028475A

Write-up: This case was reported in a newspaper article and described the occurrence of death (cause undetermined) in a female subject of unspecified age who was vaccinated with an unspecified HPV vaccine (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of HPV vaccine (unknown route and injection site). At an unspecified time after vaccination with HPV vaccine, the subject died from undetermined cause. It was unknown whether an autopsy was performed. No further information could be obtained. Case was closed. This case was 1 of the 4 cases identified in the same article.


VAERS ID: 543025 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-08
Entered: 2014-09-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F14411 / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture, Death, Haemolytic uraemic syndrome, Microbiology test, Pneumococcal bacteraemia, Pneumonia pneumococcal, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemolytic disorders (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Renovascular disorders (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (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:
Current Illness:
Preexisting Conditions: Metabolic disorder
Allergies:
Diagnostic Lab Data: Blood culture, serotype 14; Microbiology test, serotype 14
CDC Split Type: 2014245574

Write-up: This is a spontaneous report from a contactable physician. A 3-year-old (39 months) female patient of an unspecified ethnicity received first dose of PREVENAR 13 (Lot/Batch# F14411), via an unspecified route of administration, on an unspecified date at 4 months, at single dose; second dose (Lot/Batch# F27003), via an unspecified route of administration, on an unspecified date at 6 months, at single dose; third dose (LotBatch# F(S?)49097), via an unspecified route of administration, on an unspecified date at 9 months, at single dose and fourth dose via an unspecified route of administration, on an unspecified date at 3 years (39 months), at single dose. Relevant medical history included glutanic acidemia type 1 from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date at the age of 39 months the patient experienced pneumococcal pneumonia, pneumococcal bacteremia, pneumococcal-associated hemolytic uremic syndrome and renal failure. The patient underwent lab tests and procedures which included blood culture and microbiology test with tracheal secretion performed on unspecified date: serotype 14 was diagnosed. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.


VAERS ID: 543034 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-08-27
Submitted: 2014-09-09
   Days after onset:13
Entered: 2014-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-08-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1409KOR003270

Write-up: This spontaneous report as received from a physician via a field sales representative refers to a 11 or 12 year old female patient. The physician read an on-line document, source unspecified which stated that on an unknown date the patient was vaccinated with a dose of GARDASIL (strength, dose, route and lot# unknown). On 27-AUG-2014 the patient died after receiving GARDASIL. The cause of death was not reported. Additional information has been requested.


VAERS ID: 543353 (history)  
Form: Version 1.0  
Age: 0.89  
Sex: Female  
Location: Foreign  
Vaccinated:2014-07-30
Onset:2014-07-31
   Days after vaccination:1
Submitted: 2014-09-10
   Days after onset:41
Entered: 2014-09-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (NO BRAND NAME) / UNKNOWN MANUFACTURER J5333 / UNK LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J11452 / UNK RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Decreased activity, Diarrhoea, General physical condition abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-08-02
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 07-AUG-2013, BCG, No adverse effect; 07-AUG-2013, OPV, No adverse effect; 18-SEP-2013, OPV, No adverse effect; 18-SEP-2013, Rotavirus vaccine, No adverse effect; 18-SEP-2013, DTP/HepB/Polio/Hib, No adverse effect
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014248150

Write-up: This is a spontaneous report from a contactable consumer received from the foreign department of health regarding an "Adverse Event Following Immunisation (AEFI) Case investigation. This is one of two reports for twins who were immunised. This is the first report for the twin who passed away. A 11-month-old female patient of an unspecified ethnicity received PREVENAR 13 (Lot# J11452, exp date Jun2016), intramuscular in right thigh, on 30Jul2014, at single dose and Measles virus vaccine (Lot# J5333, exp date Jun2015) intramuscular in left thigh, on 30Jul2014, at unspecified dose and frequency. Relevant medical history and concomitant medications were not reported. The patient previously received the following medications on 07Aug2013: BCG (batch no 111047) in right arm, OPV "Lederle" (batch no J5072) orally; on 18Sep2013; OPV "Lederle" (batch no H5510) orally, ROTARIX (batch no AROLA741AB) orally, DTaP/IPV/Hib (batch no. H5413) in left thigh, PREVENAR 13 (batch no. G99013) in right thigh; on 16Oct2013: DTaP/IPV/Hib (batch no. H8416) in left thigh; on 12Nov2013: DTaP-IPV-Hib (batch no. H8411) in left thigh, HepB (batch no. 2C191/O) in right thigh, PREVENAR 13 (batch no. G34367) in right thigh, ROTARIX (batch no. AROLA741AB) orally. The patient did not have any previous reaction after immunisation. Information was given prior to the immunisation. Her health status was assessed before immunisation. The patient experienced the following events: vomiting on 31Jul2014 with outcome of unknown, diarrhoea on 31Jul2014 with outcome of unknown, lack of activity (couldn''t play as usual) in Jul2014 with outcome of unknown, and died following immunisation on 02Aug2014. Course of the events was as follow: the patient and her twin were vaccinated together on 30Jul2014. The children developed vomiting and diarrhoea the next day (31Jul2014) of immunisation which was preceded by lack of activity (couldn''t play as usual). On 02Aug2014 night their condition worsened. The patient died on 02Aug2014. It was not reported if an autopsy was performed. The nurse was found to have used the correct techniques for vaccinating. She only vaccinated 2 children on 30Jul2014 and there were no complications or events reported. Two children on 31Jul2014 were also vaccinated by the same registered nurse without reporting any adverse events. There were no other adverse events following immunizations (AEFIs) reported from this clinic in the last 30 days. On 08Aug2014 she was busy with immunisation. She was using the vaccines from the batch used on 30Jul2014. The measles vaccine was good to use (the inner square was lighter than the outer ring). The fridge temperature was safe to use at 2 Centigrade and they never experienced power failure. The fridge temperature was monitored and recorded on a daily basis. The fridge was packed according to stated protocol. They do not have any out of stick vaccines.


VAERS ID: 543678 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Female  
Location: Foreign  
Vaccinated:2014-03-17
Onset:2014-03-18
   Days after vaccination:1
Submitted: 2014-09-12
   Days after onset:178
Entered: 2014-09-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER J5073 / 1 MO / PO
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H34701 / 1 RL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA810AA / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Incorrect storage of drug, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), 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: Unknown
Allergies:
Diagnostic Lab Data: 17-MAR-2014, Body temperature, 36.6 Centigrade; 17-MAR-2014, Weight, 4.8 kg
CDC Split Type: 2014249701

Write-up: This is a spontaneous report from a contactable nurse who reported the event to the surveillance officer. This report was then forwarded to a Pfizer colleague. A 7-week-old female patient of an unspecified ethnicity received first dose of PREVENAR 13 (Batch# H34701, Exp date Apr2016), via an unspecified route of administration in the right thigh, on 17Mar2014, at single dose; first dose of ROTARIX (Batch# AROLA810AA or AROLA812AC, Exp date Oct2015), oral, on 17Mar2014, at unspecified dose and frequency and first dose of OPV "Lederle" (Batch# J5073, Exp date Jan2014), oral, on 17Mar2014, at unspecified dose and frequency. The patient''s medical history and concomitant medications were not reported. The patient had no previous reaction after immunisation. A history of any allergies was obtained. Information was given prior to the immunisation. The health status of the child was assessed before the immunisation. The vital data recorded upon arrival at facility on 17Mar2014 included: temperature 36.6 C, weight 4.8 kg. No other AEFIs (adverse event following immunisation) were reported from this clinic in the 30 days before. The patient was taken to hospital in the early hours on 18Mar2014 with a history of lack of breathing apparently. The patient was not breathing on arrival at hospital, she was admitted on 18Mar2014. The baby was brought into the hospital casualty. She died on an unspecified date. Therapeutic measures were taken as a result of the event. It was unknown if an autopsy was performed. It was also reported that the vaccine fridge was checked and the following were identified: the temperature chart was charted up to date though the range was between 8-10, no indication of intervention for abnormal temperature. Inside the fridge there were three dial thermometers placed in boxes containing vaccines, two were at 10 degrees Celsius and one at 7 degrees Celsius. Bacillus Calmette-Guerin (BCG) diluents were kept in the fridge despite limited fridge space, this caused overstocking of the fridge and poor air circulation. 18 OPV vials from the campaign stock were found to be apparently still in use, new 20 dose vials x 20 vials were still sealed with the depot''s seal which is proof that they were not in use. The campaign stock had an expiry date of Jan2014 and VVM (vaccine vial monitor) at stage 4. Measles vials x 2 diluted were found in the fridge, one with date and time indicated 19Mar2014 and the other one was not marked with opening date and time. Reconstituted Bacillus Calmette-Guerin (BCG) vial also found in the fridge with no reconstitution date and time. In addition, it was also reported that the enrolled was working under direct supervision of the professional nurse allocated for vaccination on that day. All policy guidelines were available on file and on interviewing the nurses about the multidose vial policy, it was well known though not practiced since unmarked multi-dose vials were found in the fridge. No evidence of intervention when there are temperature fluctuations in the vaccine fridge as displayed on the fridge monitoring chart. Expired vaccines not removed from the fridge and not disposed of according to policy guidelines.


VAERS ID: 543679 (history)  
Form: Version 1.0  
Age: 0.13  
Sex: Male  
Location: Foreign  
Vaccinated:2014-06-11
Onset:2014-06-11
   Days after vaccination:0
Submitted: 2014-09-12
   Days after onset:93
Entered: 2014-09-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER J0152 / 1 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 3C3001 / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER K5091 / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H91663 / 1 UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER A710AA / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Death neonatal, Dyspnoea, Endotracheal intubation, Eyelid oedema, Feeling cold, Irritability, Pupillary light reflex tests abnormal, Resuscitation, Strabismus
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Glaucoma (narrow), Cardiomyopathy (broad), Retinal disorders (narrow), Depression (excl suicide and self injury) (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Neonatal disorders (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-06-13
   Days after onset: 2
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:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: 11-JUN-2014, Body temperature, 38 Centigrade; 12-JUN-2014, Body temperature, 36.8 Centigrade; 12-JUN-2014, Body temperature, 36.5 Centigrade; 12-JUN-2014, Body temperature, 35-36.4 Centigrade; 12-JUN-2014, Heart rate, 200; 12-JUN-2014, Heart rate, 140; 12-JUN-2014, Heart rate 160 or more; 13-JUN-2014, Heart rate, 94; 12-JUN-2014, Oxygen saturation, 93%; 13-JUN-2014, Oxygen saturation, 69%; 13-JUN-2014, Oxygen saturation, 119%; 13-JUN-2014, Oxygen saturation, 72%; 11-JUN-2014, Respiratory rate, 54; 12-JUN-2014, Respiratory rate, 22; 12-JUN-2014, Respiratory rate, 48; 12-JUN-2014, Respiratory rate, between 20-25; 12-JUN-2014, Weight, 4.10 kg; Mobility (triage score): normal for age, score of 0; AVPU (triage score): of alert, score of 0; Trauma (triage score): no, score of 0; Vesvc Barloth Sinus (unspecified date): bilaterally; S1S2 M (unspecified date): negative
CDC Split Type: 2014249695

Write-up: This is a spontaneous report from a contactable other HCP via the Department of Health. A 6-week-old male patient on 11Jun2014 received first dose of PREVENAR 13 (lot# H91663), via an unspecified route of administration, at single dose; second dose of OPV ("LEDERLE") (lot# K5091), via an unspecified route of administration, at unspecified dose and frequency; first dose of Rotavirus vaccine (lot# A710AA), via an unspecified route of administration, at unspecified dose and frequency; first dose of DTP/HEPB/IPV/HIB (lot# J0152), via an unspecified route of administration, at unspecified dose and frequency and first dose of Hepatitis B vaccine (lot# 3C3001/O), via an unspecified route of administration, at unspecified dose and frequency. Relevant medical history and concomitant medications were not reported. On 11Jun2014 half an hour after the injections patient''s breathing was 54 and temperature 38 Centigrade. Left eye had a slight squint and was puffy. The patient was complaining (Fussy/crying) when moving and had difficulty breathing. On 12Jun2014 at 05:55 PM, patient was carried in by his mother to the emergency room of a hospital with complaint of difficulty breathing following immunization, allergy that was noted as possibly due to immunization. The patient''s respiratory rate was 22 pm, heart rate 200 beats, oxygen saturation 93%, temperature 36.8 Centigrade, weight of 4.10 kg on 12Jun2014. Infant triage score noted as: mobility normal for age, score of 0; Respiratory rate between 20-25 thus score of 2; Heart rate of 160 or more, score of 3; Temperature 35-36.4 Centigrade, score of 0; AVPU of alert, score of 0; Trauma as no, score of 0. Nurse records and physician records: in addition to the above symptoms it was also noted that the left eye was twitching. The patient was noted to be well until 11Jun2014 post routine 6 week immunizations. The patient was sucking well (breastfeeding) and not vomiting. Healthy infant. On humidified oxygen, adrenaline. Not in respiratory distress. It was also reported: "Vesvc Barloth Sinus bilaterally, S1S2 M negative". Soft head. Immunizations noted as up to date. Condition noted as satisfactory. The patient was admitted to hospital on 12Jun2014 at 07:15 PM. On 12Jun2014 one of the physician''s noted the patient''s temperature at approximately 36.5 Centigrade, pulse of 140 and respiration of 48 at approximately 10:00 PM. On 13Jun2014 at 01:00 AM the mother complained that the patient was cold on one side. The mother was requested to wrap the patient up warmly and oxygen was still being administered. On 13Jun2014 at 01:30 AM the physician was called to have a look at the patient. Started resuscitation at 02:33 AM, pulse was 94; saturation 69%, afterwards resuscitation started. Physician intubated ETT 40 tube and injected adrenaline via ETT tube x 3 doses. Heartbeat initially improving but not maintaining. Patient had no pulse, no respiration and pupils reported as "N/A". Resuscitation was called off. Time of death noted as 02:55 AM. Medication received in hospital included: PANADO syrup, 60mg 12 hourly PO (orally), started on 12Jun2014; AMOXIL suspension, at 75mg 8 hourly PO, started on 12Jun2014. Death certificate noted the cause of death as due to natural causes on 13Jun2014. It was not reported if an autopsy was performed. Death was thought to be related to immunization.


VAERS ID: 543907 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-15
Entered: 2014-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Exposure during pregnancy, Malaise, Metastasis
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1409ESP006926

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (Sender''s case report number ES-1577272925-E2014-08202) on 12-SEP-2014. Case of fatal outcome received from a report of a meeting between healthcare professionals, lawyers and consumers regarding the HPV vaccine which took place and it held on 05-SEP-2014, and from newspapers received from the company GSK, on 08-SEP-2014. Case not medically confirmed. According to the meeting report, a consumer (patient''s mother of another child vaccinated by the HPV vaccine) reported that a female patient have received a dose of a human papillomavirus vaccine (product name not reported, manufacturer unknown) on an unspecified date and the consumer reported that the patient had told that after the vaccine administration "she felt ill"; and later, when she was 27 years-old she was pregnant and she died with metastasis (onset date of metastasis was not reported). It was not reported whether the patient received the vaccine when she was pregnant or before the pregnancy. The only information collected in the newspapers was that a female patient had died after receiving a human papillomavirus vaccine (product name not reported) on an unspecified date. Death date was not reported, neither if autopsy was performed or not. No further information was reported.


VAERS ID: 544024 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-12
Entered: 2014-09-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Endocardial fibroelastosis, Respiratory arrest, Respiratory disorder
SMQs:, Anaphylactic reaction (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (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: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Endocardial fibroelastosis
Allergies:
Diagnostic Lab Data: An autopsy was performed in the hospital, and revealed her underlying disease (endocardial fibroelastosis).
CDC Split Type: 2014SA123054

Write-up: Initial report received from healthcare professional on 08 Sep 2014. A 03-month-old female patient, whose concomitant medications were not reported, had received a 0.5 ml dose of ACTHIB (lot number, dose number, route and site of vaccination not reported), a dose of DTP/IPV vaccine (Other manufacturer, dose, lot number, dose number, route and site of vaccination not reported) and a dose of Pneumococcal Conjugate Vaccine (PCV) (Other manufacturer, dose, lot number, dose number, route and site of vaccination not reported), all three vaccines on an unspecified date. The patient had an underlying disease endocardial fibroelastosis. The patient''s concurrent condition, historical condition, past history of adverse reaction and allergies were reported as none. On an unspecified date, 4 days after the vaccination, she died of endocardial fibroelastosis. She had irregular respiration on the day, went into respiratory arrest 10 minutes later, and became motionless. She was transferred to another hospital. An autopsy was performed in the hospital, and revealed her underlying disease (endocardial fibroelastosis). Death. Reporting pediatrician''s seriousness assessment: Serious (death). Reporting pediatrician''s causality assessment: Not related. Reporting pediatrician''s comment: The underlying disease was considered as the direct cause of death. Documents held by sender: None.


VAERS ID: 544373 (history)  
Form: Version 1.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-10-20
Onset:0000-00-00
Submitted: 2014-09-19
Entered: 2014-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Metastasis, Pregnancy
SMQs:, Normal pregnancy conditions and outcomes (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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1409ESP009466

Write-up: Information has been received from a Sanofi Pasteur MSD (SPM) (manufacturer control # E2014-08202) on 12-SEP-2014. Case of fatal outcome received from a report written by a company representative (info added in 17-SEP-2014) of a meeting (info added on 17-SEP-2014), in this meeting were healthcare professionals, lawyers and consumers regarding the HPV vaccine which took place and it held on 05-SEP-2014 on 05-SEP-2014 (date corrected on 17-SEP-2014) and from newspapers received from the company GSK, on 08-SEP-2014. Case not medically confirmed. According to the meeting report, a consumer (patient''s mother of another child vaccinated by the HPV vaccine) reported that a female patient have received a dose of HPV vaccine (product name not reported, manufacturer unknown) on an unspecified date and the consumer reported that the patient had told that after the vaccine administration "she felt ill"; and later, when she was 27 years-old she was pregnant and she died with metastasis (onset date of metastasis was not reported). It was not reported whether the patient received the vaccine when she was pregnant or before the pregnancy. The only information collected in the newspapers was that a female patient had died after receiving an HPV vaccine (product name not reported) on an unspecified date. Death date was not reported, neither if autopsy was performed or not. No further information was reported. Information has been received from a Sanofi Pasteur MSD (SPM) (manufacturer control # E2014-08202) on 18-SEP-2014. A corrective version was created on 17-SEP-2014 in order to: Change the initial received date, from 08-SEP-2014 to 05-SEP-2014, in main screen was not possible change that date due to technical constraints; Add more information regarding the reporter and in the reporter screen (it has been added a company representative and other company for GSK). It has been added where the meeting took place. Follow-up information indicated that aware date of this report is 05-SEP-2014 instead of 08-SEP-2014. Therefore, the initial case # 1409ESP006926 is being deleted from our files and a new case 1409ESP009466 has been created with aware date of 05-SEP-2014 including all the information captured in 1409ESP006926.


VAERS ID: 544606 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-22
Entered: 2014-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Dyspnoea, Heart rate decreased, Incorrect storage of drug, Laryngeal inflammation, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-09-16
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: WAES1409SYR009176

Write-up: This spontaneous report as received from a social media and the medical society via a company representative refers to a up to 50 children under 1 year, of unknown gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with measles, mumps, and rubella virus vaccine, live (manufacturer unknown) or Measles, Mumps, Rubella and Varicella (Merck) (manufacturer unknown) (reported as spoiled or possibly sabotaged measles vaccine). Dose, route, lot number and expiration date were not reported. The company representative reported that saw an article. The suspect batch of doses received three days before use. A physician who helped administer the vaccines stated "Dosages may have been stored at improperly stored temperatures." A Medical Society was the source of the symptom description starting, the children began displaying symptoms within minutes including tightness of breath, slowed heart rate, weezing, and inflammation of the larynx (on an unknown date), 15 dead upon arrival all under 1 years of age at the facility, and that live saving efforts were performed on the children. Samples had been sent for an analysis. All the children died on Tuesday (16-SEP-2014)." The outcome of tightness of breath, inflammation of larynx, wheezing and slowed heart rate was unknown. The cause of death was not reported. This is one of two reports from the same source (other case # 1409SYR009831). Addional information has been requested.


VAERS ID: 544636 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2014-09-15
Onset:2014-09-17
   Days after vaccination:2
Submitted: 2014-09-22
   Days after onset:5
Entered: 2014-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN
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: 2014-09-17
   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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B1035288A

Write-up: This case was reported by a nurse and described the occurrence of unexplained death in a 10-week-old male subject who was vaccinated with INFANRIX HEXA (GlaxoSmithKline) and ROTARIX (GlaxoSmithKline). Concurrent vaccination included PREVENAR 13 (non-GSK) given on 15 September 2014. On 15 September 2014, the subject received unspecified dose of INFANRIX HEXA (unknown route and injection site) and unspecified dose of ROTARIX (oral). On 17 September 2014, 2 days after vaccination with INFANRIX HEXA and ROTARIX, the subject died of an unknown cause. It was unknown whether an autopsy was performed.


VAERS ID: 544909 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-22
Entered: 2014-09-24
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014255972

Write-up: This is a spontaneous report from a contactable physician. This physician reported similar events for two patients (two twins). This is the first of two reports. A 2-year-old male patient received PREVENAR 13, single dose, route of administration unknown, on an unspecified date. The patient''s medical history and the patient''s concomitant medications were not reported. It was referred that the patient had completed the scheme of vaccination with PREVENAR 13. The patient had experienced pneumonia with very poor prognosis on an unspecified date and he died due to this event on an unspecified date. Follow-up (17Sep2014): New information reported from the same contactable physician includes updated event outcome.


VAERS ID: 544955 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2014-04-01
Onset:2014-04-01
   Days after vaccination:0
Submitted: 2014-09-24
   Days after onset:176
Entered: 2014-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Aspiration, Crying, Decreased appetite, Sudden infant death syndrome
SMQs:, Depression (excl suicide and self injury) (broad), Neonatal 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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B1034776A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of sudden infant death syndrome in an infant male subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline). In April 2014, the subject received unspecified dose of ENGERIX B pediatric (intramuscular, unknown route and site of injection ), at birth. A few hours after vaccination with ENGERIX B pediatric, the subject was crying and did not want to eat well. The subject''s parents called the doctor in the midnight. The next day the subject was taken to the hospital and was found to be dead 2 hours ago. According to the physician the subject''s death was due to the wrong way of transition of the milk during feeding and that the events were unrelated to vaccination with ENGERIX B pediatric. The parents were not well educated and had difficulty knowing how to feed. It was unknown whether an autopsy was performed.


VAERS ID: 545363 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2014-06-25
Onset:2014-06-29
   Days after vaccination:4
Submitted: 2014-09-26
   Days after onset:89
Entered: 2014-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Bordetella test positive, Cyanosis, Death, Peripheral coldness
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-06-29
   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: Botdetella test-in 2014-Bordetella pertussis DNA detected from the epiglottis post mortem. 2014, Autopsy, Bordetella pertussis DNA detected; 2014, Bordetella test, Bordertella pertussis DNA detected
CDC Split Type: WAES1409AUS011109

Write-up: Information was obtained on a requests by the Company from a healthcare professional via the agency via a Public Case Detail and it refers to a 2 months old female patient. On 25-JUN-2014, the patient was vaccinated with the first dose of ROTATEQ oral liquid, 1 dose unspecified, lot# and expiration date was not reported, orally. On the same day, 25-JUN-2014, the patient was also vaccinated with the first dose of PREVENAR, one dose unspecified, lot# and expiration date not provided, intramuscularly and the first dose of INFANRIX HEXA, one dose unspecified, lot# and expiration date not provided, intramuscularly. On 29-JUN-2014 at 08:09 AM, the baby presented to hospital with mother-was cold and blue. The child died in the emergency department on 29-JUN-2014. Bordetella pertussis DNA was detected from the epiglottis on post mortem on unspecified date in 2014. The causality between vaccination with ROTATEQ and the event was assessed as possible. Additional information is not expected, no further information can be obtained from the local regulatory authority.


VAERS ID: 545371 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-26
Entered: 2014-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
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: 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: WAES1409NZL011935

Write-up: This information has been received from a regulatory authority (agency number 113290) and refers to a 15 week old male patient. The patient''s medical history included 6 weeks vaccination without any events. On an unknown date the patient was vaccinated with ROTATEQ (dose, strength, route of administration, dose number, lot# and expiration date were not reported). On an unknown date, two days after receiving ROTATEQ, the patient was vaccinated with PCV10 (dose, strength, route of administration, dose number, lot# and expiration date were not reported) and INFANRIX HEXA (dose, strength, route of administration, lot# and exp. date were not reported. It was reported that apparently the patient was well following vaccination on both occasions and was also otherwise well. On an unknown date, 3 days after receiving PCV10 and INFANRIX HEXA and 5 days after receiving ROTATEQ the patient died suddenly and unexpectedly. The cause of death was unknown. The patient''s outcome was also reported as unknown. The agency currently assessed the cause of death as unknown, and not causally related to the vaccines. Coroners report may be forwarded to the agency at some time. Additional information is not expected because no further information is available from the Agency.


VAERS ID: 545373 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Foreign  
Vaccinated:2013-02-15
Onset:2013-02-15
   Days after vaccination:0
Submitted: 2014-09-25
   Days after onset:586
Entered: 2014-09-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20110940 / 2 AR / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER G1588 / 2 AR / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER 201203017 / 3 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Death, Fatigue, Mental disorder, Multi-organ disorder, Pallor, Peripheral coldness, Pulse pressure decreased, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Body temperature, 15FEB2013, 39.5 degree C; Body temperature, 15FEB2013, Greater than or equal to 38.6 degree C
CDC Split Type: 2014SA130861

Write-up: This initial case belongs to the batch of ICSRs that have been forwarded to the company by the Health Authorities on 22-Sep-2014 in the format of line listing. HA reference number: 2369736 A 04-month-old male patient, whose medical history and concomitant therapies were not reported, had received 0.5 ml second dose of HIB [Sanofi Pasteur] (G1588-1, by intramuscular route in deltoid), 0.5 ml second dose of DTaP [Wuhan Bio] (20110940-1, by intramuscular route in deltoid), and 1 ml third dose of OPV [Tiantan Bio] (201203017-1, by oral route), all three vaccines on 15 Feb 2013. On 15 Feb 2013, the patient experienced fever 9 hours after vaccination with temperature 39.5 degree Celsius (greater than or equal to 38.6 degree Celsius) at maximum, accompanied with convulsion, cold hands, pale face, systemic fatigue, poor mental conditions and weak heart beat. On 15 Feb 2013, the patient visited a physician. The patient was not hospitalized. The final diagnosis was reported as others and other diagnosis was infant muggy syndrome. The patient''s outcome was reported as death. According to the Health Authority: the initial AE classification was to be determined (others) and the AE final classification was coincidental event. The case reported as a Serious Adverse Event by the Health Authorities. The case was not assessed as an AEFI cluster.


VAERS ID: 545377 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-09
Onset:2012-11-27
   Days after vaccination:49
Submitted: 2014-09-25
   Days after onset:666
Entered: 2014-09-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G16625 / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cerebral atrophy, Coma, Coma scale abnormal, Computerised tomogram head abnormal, Fundoscopy abnormal, Hypertonia, Hypotonia, Muscle spasms, Mydriasis, Nuclear magnetic resonance imaging brain abnormal, Retinal haemorrhage, Seizure, Status epilepticus, Subdural haematoma, Subdural haematoma evacuation, Ultrasound skull abnormal, Ventriculo-peritoneal shunt
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Glaucoma (narrow), Optic nerve disorders (broad), Retinal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 26-JUL-2012, Gastroenteritis, Three days before event onset; 26-JUL-2012, BCG vaccine; Inconsolable crying, Three days before event onset; 16-AUG-2012; INFANRIX HEXA
Allergies:
Diagnostic Lab Data: CT scan (unknown date): sub dural hematoma with bleeding in the left hemisphere leading to set up external derivation for drainage. Transcranial Doppler (unknown date): diastolic speed below 20 and symmetrical pulsatility index above 1.1. Eye fundus (Dec2012): bilateral abundant retinal hemorrhagic lesions and retro hyaloid hemorrhage. Repeat MRI (07Jan2013): increase of the subdural collection on the right side, cerebral atrophy and low bleeding in the left side. Repeat MRI (20Feb2013): found marked cortical sub cortical atrophy, with bilateral parietal and occipital ischemic sequels and bilateral sub dural hematoma predominant on the right side. MRI (25Nov2013): marked decreased of bilateral subdural effusion and bilateral cortical sub cortical atrophy, predominant on parietal occipital areas; 27-NOV-2012, Coma scale, 8
CDC Split Type: 2014259660

Write-up: This is a spontaneous report from a contactable court bailiff received via legal division. A 5-month-old male patient received the first dose of PREVENAR 13 on 16Aug2012 (lot F29657, Exp. Nov2014) when 2 months old and the second dose on 09Oct2012 (lot G16625) when 3 months old both at 0.5, single dose. The patient received also the second dose of INFANRIX HEXA on 09Oct2012 at 1DF, single. Concomitant medication included INFANRIX QUINTA administered on 20Sep2012 at 1 DF, single. The patient was born at 40 weeks and 6 days post LMP with birth weight 3320 g and Apgar score 10/10. In his health book the general practitioner had noted that at 4 months old he was well with a very good psychomotor development and at 5 months old he had lot of interactions, he catch things and physical examination was perfect. He had no relevant medical history apart from three days before event onset he had been suffering gastroenteritis with inconsolable crying. The patient had previously received a dose of BCG SSI vaccine on 26Jul2012 and the first dose of INFANRIX HEXA on 16Aug2012. On 27Nov2012, in the morning the patient experienced hypertonic attack and right mydriasis which spontaneously resolved with a post critic Glasgow Coma Score of 8. The patient went into a coma while he was with his child minder. The patient was hospitalized due to coma with convulsion. On admission he was found hypotonic with Glasgow Coma Score at 8 and right mydriasis. CT scan revealed sub dural hematoma with bleeding in the left hemisphere leading to set up external derivation for drainage. Transcranial Doppler found diastolic speed below 20 and symmetrical puslatility index above 1.1. On 28Nov2012 convulsion persisted despite treatment with GARDENAL and DILANTIN. PENTHOTAL was introduced. Status epilepticus needed 48 hours of barbituric treatment. In Dec2012, eye fundus found bilateral abundant retinal hemorrhagic lesions and retro hyaloid hemorrhage. Sub dural hematoma and retinal hemorrhagic lesions were considered suggestive of shaken baby syndrome. On 14Dec2012, as subdural hematoma persisted, subdural peritoneal shunt was surgically set up. On 21Dec2012 the patient was transferred to rehabilitation unit. On 20Dec2012 the patient was discharged on DEPAKINE and RIVOTRIL. On 07Jan2013, repeat MRI showed an increase of the subdural collection on the right side, cerebral atrophy and low bleeding on the left side. On 18Feb2013 convulsion had not recur. On 20Feb2013, repeat MRI found marked cortical sub cortical atrophy, with bilateral parietal and occipital ischemic sequels and bilateral sub dural hematoma predominant on the right side. In Sep2013, the patient experienced spasms leading to add SABRIL to sodium valproate. On 25Nov2013, MRI found marked decrease of bilateral subdural effusion and bilateral cortical sub cortical atrophy, predominant on parietal occipital areas. Shunts were still in place. Further vaccinations included a first dose of PRIORIX on 13May2013, the third dose of PREVENAR 13 and a dose of MENINGITEC on 27Jun2013, the second dose of INFANRIX HEXA and the second dose of PRIORIX on 18Oct2013. At the time of reporting, the patient had recovered from status epilepticus, coma and retinal hemorrhage, while he had recovered with sequel from subdural hematoma and he had weekly sessions of physiotherapy, psychomotor therapy, osteotherapy and orthoptic exercises. Shaken baby syndrome was ruled out by the parents as they have complete trust in their child minder and as a second hematoma occurred while their son was hospitalized. No follow-up attempt possible. No further information expected.


VAERS ID: 545931 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2014-08-05
Onset:2014-08-09
   Days after vaccination:4
Submitted: 2014-09-30
   Days after onset:52
Entered: 2014-10-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER A012B / 1 UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1787 / 2 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 13J05A / 2 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Endocardial fibroelastosis
SMQs:, Congenital, familial and genetic disorders (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-08-09
   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: 08-JUL-2014, PREVENAR-13, Dose 1; 08-JUL-2014, ACT-HIB, Dose 1; 08-JUL-2014, Rotavirus vaccine, Dose 2
Allergies:
Diagnostic Lab Data: 05-AUG-2014, Body temperature, 36.4 Centigrade
CDC Split Type: 2014265336

Write-up: This is a spontaneous report from a contactable physician received from Agency under the regulatory authority report number V14000341. A 3-month-old female patient received the 2nd dose of PREVENAR 13 (Lot# 13J05A, exp date 31Aug2016), subcutaneous, on 05Aug2014 at 02:00 PM, at 0.5ml single, the 2nd dose of ACT-HIB (Lot# J1787), subcutaneous, on 05Aug2014 at 02:00 PM, at 1DF single, and the 1st dose of QUATTROVAC (Lot# A012B), subcutaneous, on 05Aug2014 at 02:00 PM, at 1DF single. Relevant medical history and concomitant medications were not reported. Family medical history was reported as "not particular". The patient''s birth weight was 2796 g. Favorable weight increase had been observed since the birth and no cyanosis had been seen. The patient previously received first dose of PREVENAR 13 (Lot# 13J05A), first dose of ACT-HIB (Lot# J1775) and second dose of ROTARIX (Lot# AROLA858AA), on 08Jul2014. Body temperature prior to the vaccinations on 05Aug2014 was 36.4 degrees Centigrade. No particular symptom was noted. No abnormality was observed at the reporter''s clinic during post-vaccination observational time (around 30 minutes), thus the patient went home. Detailed information thereafter was unknown. The patient died on 09Aug2014 at 01:00 AM. Cause of death was reported as endocardial fibroelastosis. An autopsy was performed, no results available. Causality of the event was reported as "unevaluable".


VAERS ID: 547656 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-10
Entered: 2014-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1410JPN005289

Write-up: This spontaneous report as received from a consumer family refers to an elderly male patient. On an unknown date, the patent was vaccinated with a dose of PNEUMOVAX NP (dose and lot # not reported) subcutaneously. Concomitant medications were not reported. On an unknown date the, the patient who was vaccinated with PNEUMOVAX NP once every 5 years died of pneumonia. The case of death was pneumonia. No information on autopsy was provided. Reporter''s comment: A physician said pneumonia occurred due to different types of bacteria. There was also no use in taking X-ray of the chest. The reporter considered that the pneumonia was serious due to death. The reporter did not assess the relationship of pneumonia to PNEUMOVAX NP. Additional information is not expected.


VAERS ID: 547973 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2010-12-01
Submitted: 2014-10-14
   Days after onset:1412
Entered: 2014-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anti-aquaporin-4 antibody negative, Blood brain barrier defect, Blood test abnormal, CSF oligoclonal band present, Cardiac arrest, Central nervous system inflammation, Convulsion, Death, Dry mouth, Immunoglobulin therapy, Interleukin level increased, Monoparesis, Muscular weakness, Myelitis transverse, Neck pain, Necrosis, Neurogenic bladder, Neuromyelitis optica, Nuclear magnetic resonance imaging abnormal, Oral herpes, Paraplegia, Paresis, Plasmapheresis, Quadriparesis, Respiratory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (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), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (narrow), Cardiomyopathy (broad), Demyelination (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood-brain barrier disruption, oligoclonal band and highly elevated interleukin 6 were found in cerebrospinal fluid. Aquaporin 4 and MOG-Ab (Myelin Oligodendrocyte Glycoprotein (MOG)) were repeatedly tested negative.
CDC Split Type: DE2014GSK006175

Write-up: This case was reported in a literature article and described the occurrence of neuromyelitis optica in a 9-year-old male patient who received Influenza vaccine. In 2010, the patient received Influenza vaccine. In December 2010, less than a year after receiving Influenza vaccine, the patient experienced neuromyelitis optica (serious criteria GSK medically significant), transverse myelitis (serious criteria GSK medically significant), left leg paresis and possible infection. In 2013, the patient experienced midbrain inflammation (serious criteria GSK medically significant), dry mouth and neck pain. In July 2013, the patient experienced weakness of upper extremities, oral herpes infection and hand paresis. In September 2013, the patient experienced respiratory failure (serious criteria death and GSK medically significant), seizure (serious criteria death and GSK medically significant) and cardiac arrest (serious criteria death and GSK medically significant). On an unknown date, the patient experienced tetraparesis (serious criteria GSK medically significant), paraplegia (serious criteria GSK medically significant) and neurogenic bladder disorder. The patient was treated with Steroids, cyclophosphamide and Immunoglobulins. In September 2013, the outcome of the midbrain inflammation was unknown. On an unknown date, the outcome of the neuromyelitis optica, transverse myelitis, tetraparesis, paraplegia, left leg paresis, neurogenic bladder disorder, weakness of upper extremities, oral herpes infection, hand paresis, dry mouth, neck pain and possible infection were unknown and the outcome of the respiratory failure, seizure and cardiac arrest were fatal. The patient died in September 2013. The reported cause of death was respiratory failure, seizure and cardiac arrest. The reporter considered the neuromyelitis optica, transverse myelitis, tetraparesis, paraplegia, midbrain inflammation, respiratory failure, seizure, cardiac arrest, left leg paresis, neurogenic bladder disorder, weakness of upper extremities, oral herpes infection, hand paresis, dry mouth, neck pain and possible infection to be possibly related to Influenza vaccine. Additional information received: This case was reported in a literature article and described the occurrence of seronegative atypical neuromyelitis optica (NMO) in a 9-year-old boy following flu vaccination [route and dosage not stated and manufacturer unknown]. The patient''s medical history, concurrent medical conditions or concomitant medications were unknown. On an unspecified date the patient received flu vaccination [route and dosage not stated and manufacturer unknown]. In December 2010, following flu vaccination, the patient presented with paresis of his left leg. Longitudinal extensive transverse myelitis (LETM) with areas of beginning necrosis was diagnosed. Blood-brain barrier disruption, oligoclonal band and highly elevated interleukin 6 were found in cerebrospinal fluid (CSF). Clinically, the entire spinal cord was affected with tetraparesis and inverted breathing. The patient was treated with steroids, plasmapheresis, cyclophosphamide (CPM), and immunoglobulins. Paraplegia starting from Th9 and a neurogenic bladder disorder persisted. Antibodies to Aquaporin-4 (AQP4) and myelin oligodendrocyte glucoprotein (MOG), which are characteristic serological findings, were repeatedly tested negative. There was no evidence of optic neuritis during the follow-up period. In July 2013, the patient experienced a first relapse with weakness of the upper extremities following oral herpes infection. CSF, blood, and magnetic resonance images showed identical findings to the first episode. After treatment with steroids, plasmapheresis and CPM he showed no clinical improvement and lost his hand function. After 27 days, application of CPM again following oral herpes infection he experienced a second relapse with tetraparesis, sensibility loss starting at Th2, dry mouth, and neck pain. Lumbar puncture was no longer possible. The patient showed no improvement to steroids and plasmapheresis, but the inflammation progressed to the midbrain. In September 2013, the patient finally experienced respiratory failure, seizures and cardiac arrest. The authors considered NMO-spectrum disorder (high-risk NMO), possibly triggered by infection or vaccination without NMO and MOG-Ab nor optic nerve involvement. The clinical picture is characterized by a polyphasic course with late relapses and poor prognosis. This case demonstrates an unusual clinical course of LETM and should open discussion about the variable clinical picture of NMO in childhood.


VAERS ID: 549184 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-20
Entered: 2014-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1410JPN009435

Write-up: This spontaneous report as received from a physician concerning a female patient (age unknown) who on an unspecified date, was vaccinated with PNEUMOVAX NP injection subcutaneously (dose, expiration date and lot number were not reported). On an unspecified date, the patient developed pneumonia. On an unspecified date (several years ago), the patient died with pneumonia. No information on autopsy had been provided. The reporter stated that even though the patient was vaccinated with PNEUMOVAX NP, she died. The cause of death was pneumonia. Only pneumococcal pneumonia could be prevented by PNEUMOVAX NP. The reporting physician did not assess the relationship of pneumonia to PNEUMOVAX NP. Additional information has been requested.


VAERS ID: 549761 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-16
Entered: 2014-10-21
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Altered state of consciousness, Brain injury, Cerebral ischaemia, Computerised tomogram abnormal, Death, Fundoscopy abnormal, Grand mal convulsion, Intracranial pressure increased, Nervous system disorder, Papilloedema, Pyrexia, Scan with contrast abnormal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (narrow), Optic nerve disorders (narrow), Retinal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Features suggestive of raised intracranial pressure with papilloedema were noted on fundoscopic examination. Contrast-enhanced computed tomography of his head revealed diffused hypodense attenuation of bilateral cerebral hemispheres with effacement of the basal cisterns and sulcal spaces. His cerebellum showed normal attenuation and, due to this, it appeared hyperdense in comparison with the cerebral parenchyma.
CDC Split Type: IN2014GSK007481

Write-up: This case was reported in a literature article and described the occurrence of hypoxic ischemic brain injury in a 3-year-old male patient who received DTP (A or W not known). On an unknown date, the patient received DTP vaccine at an unknown dose. On an unknown date, 6 hrs after receiving DTP vaccine, the patient experienced hypoxic ischemic brain injury (serious criteria death and GSK medically significant), generalized tonic-clonic seizures (serious criteria death and GSK medically significant), altered sensorium (serious criteria GSK medically significant), raised intracranial pressure (serious criteria death and GSK medically significant), papilledema (serious criteria GSK medically significant) and fever. The patient was treated with medication unknown. On an unknown date, the outcome of the hypoxic ischemic brain injury, generalized tonic-clonic seizures and raised intracranial pressure were fatal and the outcome of the altered sensorium, papilledema and fever were unknown. The reported cause of death was generalized tonic-clonic seizure, intracranial pressure increased and cerebellar ischemia. It was not reported if the reporter considered the hypoxic ischemic brain injury, generalized tonic-clonic seizures, altered sensorium, raised intracranial pressure, papilledema and fever to be related to DTP vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a white cerebellum sign in a 3-year-old male subject who had received an unspecified DTP (manufacturer unknown). No information on the subject''s medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, the subject received an unspecified DTP vaccine (dosage, administration route and site unknown; batch numbers not provided). On an unknown date, within 6 hours of the administration of the vaccine, the subject presented to an emergency department with fever, generalized tonic-clonic seizures and altered sensorium. This case is serious as the outcome was fatal. Features suggestive of raised intracranial pressure with papilloedema were noted on fundoscopic examination. Contrast-enhanced computed tomography of his head revealed diffused hypodense attenuation of bilateral cerebral hemispheres with effacement of the basal cisterns and sulcal spaces. His cerebellum showed normal attenuation and, due to this, it appeared hyperdense in comparison with the cerebral parenchyma. Treatment was unknown. The outcome of the event was fatal. It is unknown if an autopsy was performed. The authors did not comment on any causal relationship between the vaccine received by the subject and the events. The authors concluded that "the white cerebellum sign was a pointer toward severe hypoxic ischemic brain injury. It has been described in conditions such as birth asphyxia, head injury, drowning, status epilepticus, hypothermia, meningoencephalitis and other causes of global hypoperfusion. The white cerebellum sign resulted from diffused cerebral oedema leading to loss of normal grey-white matter differentiation of the cerebral parenchyma. It has been postulated that there is a preferential blood flow to the posterior fossa structures in severe anoxia, thereby preserving the normal appearance of the cerebellum, making it look brighter on computed tomography evaluation. The white cerebellum sign suggested a poor prognosis indicative of irreversible brain damage. Knowledge of this sign is important from a diagnostic, therapeutic, and prognostic standpoint". The article corresponding to this case is not available for submission due to copyright restrictions.


VAERS ID: 549793 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-21
Entered: 2014-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Basophil percentage, Blood glucose normal, CSF glucose increased, CSF white blood cell count increased, Convulsion, Death, Encephalitis, Flow cytometry, Haemoglobin decreased, Headache, Herpes zoster meningoencephalitis, Leukaemoid reaction, Lymphocyte percentage decreased, Mean cell haemoglobin increased, Mean cell volume normal, Monocyte percentage increased, Neutrophil percentage increased, Platelet count normal, Polymerase chain reaction, Rash vesicular, Red blood cells CSF positive, White blood cell count normal
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (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: BACTRIM Adult; Acyclovir
Current Illness:
Preexisting Conditions: Varicella, during childhood with no identified exposure to the virus prior to the event; Myeloid leukaemia; Allogenic bone marrow transplantation therapy, He was reported to have done well after the transplant and that he had only suffered a chronic limited skin graft-versus-host disease that had not required continued immunosuppresants; MELPHALAN, Surgical preconditioning; FLUDARABINE, Surgical preconditioning; ALEMTUZUMAB, Surgical preconditioning; TACROLIMUS
Allergies:
Diagnostic Lab Data: Basophil count, 1 percent; Blood glucose, 154; CSF glucose, 159 mg/dL; CSF white blood cell count, 576/mm3; Haemoglobin, 13.2 g/ml; Lymphocyte percentage, 7 percent; Mean cell haemoglobin, 91 pg; Mean cell volume, 94.7 fL; Monocyte count, 21 and 24 percent; Monocyte percentage, 7 percent; Neutrophil percentage, 85 percent; Platelet count, 166/mcL; Polymerase chain reaction, more than 1.0 x 10E8 copies/ml; Polymerase chain reaction, 327000 copies/ml; Red blood cells CSF positive, 252/,mm3; White blood cell count, 10.4/mcL
CDC Split Type: CH2014GSK005479

Write-up: This case was reported in a literature article and described the occurrence of varicella-zoster virus meningoencephalitis in a 55-year-old male patient who received DTPa. Co-suspect products included Meningococcal vaccine unknown, 10PN-PD-Dit. Haemophilus influenzae type b vaccine. Hepatitis A vaccine, Hepatitis B vaccine and Polio Trivalent Inactivated. The patient''s past medical history included chickenpox (during childhood with no identified exposure to the virus prior to the event), leukemia myelogenous and allogenic bone marrow transplantation therapy (He was reported to have done well after then transplant and that he had only suffered a chronic limited skin graft-versus-host disease that had not required continued immunosuppressants). Previously administered products included melphalan, fludarabine, alemtuzumab and tacrolimus. Concomitant products included BACTRIM Adult and acyclovir. On an unknown date, the patient received DTPa vaccine at an unknown dose, Meningococcal vaccine at an unknown dose, Pneumococcal vaccine at an unknown dose, Haemophilus influenzae type b vaccine at an unknown dose, Hepatitis A vaccine at an unknown dose, Hepatitis B vaccine at an unknown dose and Inactivated polio vaccine at an unknown dose. On an unknown date, 244 days after receiving DTPa vaccine, Meningococcal vaccine, Pneumococcal vaccine, Haemophilus influenzae type b vaccine, Hepatitis A vaccine, Hepatitis B vaccine and Inactivated polio vaccine, the patient experienced varicella-zoster virus meningoencephalitis (serious criteria death and GSK medically significant), cerebrospinal leukemoid reaction (serious criteria death), seizures (serious criteria GSK medically significant), headache and vesicular skin rash. The patient was treated with antivirals for systemic use and medication unknown (Unspecified Treatment). On an unknown date, the outcome of the varicella-zoster virus meningoencephalitis and cerebrospinal leukemoid reaction were fatal and the outcome of the seizures, headache and vesicular skin rash were unknown. The reported cause of death was acute meningoencephalitis and leukemoid reaction. An autopsy was performed. It was not reported if the reporter considered the varicella-zoster virus meningoencephalitis, cerebrospinal leukemoid reaction, seizures, headache and vesicular skin rash to be related to DTPa vaccine, Meningococcal vaccine, Pneumococcal vaccine, Haemophilus influenzae type b vaccine, Hepatitis A vaccine, Hepatitis B vaccine and Inactivated polio vaccine. Additional details provided: This case was reported in a literature article and it described the occurrence of a varicella-zoster virus meningoencephalitis in a male subject who was at least 55 years old at the time of the event and had been vaccinated with unspecified DTP, meningococcal, pneumococcal, Haemophilus influenzae b, hepatitis A and B and inactivated poliovirus vaccines (manufacturers unknown). The subject had a medical history of chicken pox during childhood with no identified exposure to the virus prior to the event. He had not been vaccinated for measles or herpes zoster virus. He also had a previous history of acute myelogenous leukaemia with diploid cytogenetics that been treated with allogenic haematopoietic transplantation using a fully matched brother when he was 54 years old. He was reported to have done well after the transplant and that he had only suffered a chronic limited skin graft-versus-host disease that had not required continued immunosuppressants. The conditioning for the transplant had consisted of melphalan, fludarabine and alemtuzumab. In addition to that, tacrolimus had been used for graft-versus host disease prophylaxis. Concurrent medications at the time of the event included BACTRIM and acyclovir. No further information on his medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, 1 year after the allogeneic haematopoietic transplantation, the subject received unspecified DTP, meningococcal, pneumococcal, Haemophilus influenzae b, hepatitis A and B and inactivated poliovirus vaccines for (dosages, administration routes and sites unknown; batch numbers not provided). On an unknown date, 1 year and 8 months after the transplantation, the subject presented with headache, seizures and vesicular skin rash. This is a serious case as the outcome was fatal. Diffuse meningeal enhancement without focal lesions was revealed on magnetic resonance imaging. Cerebrospinal fluid analysis showed xanthochromic fluid with a red blood cell level of 252/cmm, white blood cell level of 576/cmm and glucose level of 159 mg/dL. Two cerebrospinal fluid cytology specimens contained monocytic cells that resembled blasts morphologically with delicate chromatin, moderate gray-blue cytoplasm with vacuoles and azurophilic granules, as well as the occasional mitosis. The corresponding flow cytometry showed 21% and 24% mature monocytes without immunophenotypic aberrancy. No myeloblasts or cells of the prior leukemic immunophenotype (CD341, CD1171, CD331, CD131, CD14-) were identified by flow cytometry. There was no nucleated red contamination. No cytogenetics studies were performed on the cerebrospinal fluid. Blood tests showed a blood glucose level of 154, a white blood count level of 10 400/mL (normal range 4.5-11), a haemoglobin of 13.2 g/mL (normal range 12-16), mean corpuscular volume of 94.7 fl (normal range of 82-100), mean corpuscular haemoglobin of 91 pg (normal range 27-34), platelets level of 166 000/mL (normal range 150-400) with a differential of 85% neutrophils, 7% lymphocytes, 7% monocytes and 1% basophils. Blood flow cytometry showed no blasts and 7% mature monocytes with no aberrancy. The morphologically immature cells seen in the cerebrospinal fluid were not present in his blood, which according to the authors, suggested that these cells originated in the cerebrospinal fluid. Cerebrospinal fluid and blood polymerase chain reaction for varicella-zoster virus revealed $g1.0 x 108 and 327 000 copies (Vira core) respectively. Treatment consisted of antiviral treatment and supportive care. The outcome of the event was fatal. Autopsy results indicated subacute/chronic meningoencephalitis with no acute leukaemia involving the central nervous system. The authors did not comment on any causal relationship between the vaccines received by the subject and the events. The authors concluded that "When considering acute myelogenous leukaemia relapse in the cerebrospinal fluid of an allogenic haematopoietic transplantation subject, flow cytometric and microbiology studies should be considered to rule out a reactive process. Disseminated varicella-zoster virus is the most frequent late infection of allogenic haematopoietic transplantation".


VAERS ID: 550098 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2014-08-08
Onset:2014-08-15
   Days after vaccination:7
Submitted: 2014-10-21
   Days after onset:67
Entered: 2014-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC163A / 1 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J13806 / 1 UN / SYR
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA900AC / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Autopsy, Computerised tomogram abdomen abnormal, Death, Dehydration, Diarrhoea, Drug administered to patient of inappropriate age, Fatigue, Haematochezia, Histology, Hypotonia, Intussusception, Loss of consciousness, Pyrexia, Vomiting, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-08-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BCG vaccine
Current Illness: Gastrointestinal malformation, a complete common mesentery; Increased appetite, The mother found her baby greedy and therefore gave her less dose of infantile milk than required; Peritoneal disorder, reported as mesenteric defect, which was discovered on 19 August 2014, at macroscopy test
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On 19Aug2014, at macroscopy intussusception found but also a mesenteric defect; Histology pending; 08/2014, Abdominal X-ray, showed fluid levels and dilated bowel loops; 08/19/2014, Autopsy, intussusception, abnormal; 08/2014, Computerised tomogram abdomen, visible intussusceptum or soft tissue, normal; 08/2014, Weight decreased, about 10 percent, depressed
CDC Split Type: FR2014GSK002297

Write-up: This case was reported by a physician via sales rep and described the occurrence of intussusception in a 3-month-old female patient who received ROTARIX. Co-suspect products included INFANRIX HEXA and PREVENAR. Concurrent medical conditions included increased appetite (the mother found her baby greedy and therefore gave her less dose of infantile milk than required) and peritoneal disorder (reported as mesenteric defect, which was discovered on 19 August 2014, at macroscopy test). Concomitant products included BCG vaccine. On 8th August 2014, the patient received 1st dose of ROTARIX (oral), the 1st dose of INFANRIX HEXA (injection) and the 1st dose of PREVENAR (injection). On 8th August 2014, an unknown time after receiving ROTARIX and INFANRIX HEXA, the patient experienced inappropriate age at vaccination. On 10th August 2014, the patient experienced fever and fatigue. On 15th August 2014, the patient experienced intussusception (serious criteria death and GSK medically significant), blood in stools (serious criteria GSK medically significant) and vomiting. In August 2014, the patient experienced dehydration (serious criteria death), loss of weight and diarrhea. On 17th August 2014, the patient experienced unconscious (serious criteria GSK medically significant) and hypotonia. On an unknown date, the outcome of the intussusception and dehydration were fatal and the outcome of the blood in stools, unconscious, fatigue, vomiting, hypotonia, loss of weight and diarrhea were not recovered/not resolved and the outcome of the fever was recovered/resolved and the outcome of the inappropriate age at vaccination was unknown. The patient died on 17th August 2014. The reported cause of death was dehydration and intussusception. An autopsy was performed. The report considered the intussusception, dehydration, blood in stools, unconscious, vomiting, hypotonia, loss of weight and diarrhea to be possibly related to ROTARIX. The reporter considered the fever and fatigue to be related to ROTARIX and INFANRIX HEXA. It was unknown if the reporter considered the inappropriate age at vaccination to be related to ROTARIX and INFANRIX HEXA. It was not reported if the reporter considered the intussusception, dehydration, blood in stools, unconscious, vomiting, hypotonia, loss of weight and diarrhea to be related to INFANRIX HEXA. Additional details: The patient''s age at vaccination was three and a half month which led to an inappropriate age at vaccination administration according to the vaccination schedule where the first doses of for these three vaccines should be given at two months old. Concomitant vaccine with BCG vaccine received at one and a half month old. On 17 August 2014, the patient presented again with blood in stools. She was looked after during the whole day by her 14-year-old cousin. At the end of the day, she was found unconscious in her bed. The emergency was called. On 19 August 2014, an autopsy was performed. At macroscopy, intussusception was found but also a mesenteric defect. Histology result was pending. It was concluded to a death by important dehydration. According to the physician, the parents seriously misjudged the status of their child. The physician assessed the causality between the intussusception and vaccination with ROTARIX as possible. Imputability for ROTARIX and intussusception C2S2I2. Imputability for ROTARIX and INFANRIX HEXA with fever and fatigue C2S2I2. Targeted follow-up information received on 14 October 2014 from a physician: The patient had no family history of intussusception or digestive abnormality and no personal history of digestive surgery. A complete common mesentery was confirmed as a concurrent gastrointestinal malformation to vaccination. The intussusception began on 15 August 2014. The plain abdominal radiography performed, showed fluid levels and dilated bowel loops and the abdominal scan showed a visible intussusceptum or soft tissue. No causality assessment was reported.


VAERS ID: 551230 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2014-07-22
Onset:2014-08-06
   Days after vaccination:15
Submitted: 2014-10-17
   Days after onset:72
Entered: 2014-10-22
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Death, Dyspnoea, Eyelid oedema, Heart disease congenital, Incorrect dose administered, Increased upper airway secretion, Intensive care, Mechanical ventilation, Off label use, Pyrexia, Transposition of the great vessels, Yellow skin
SMQs:, Torsade de pointes/QT prolongation (broad), Cholestasis and jaundice of hepatic origin (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-08-06
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PL2014GSK005526

Write-up: This case was reported by a consumer via call center representative and described the occurrence of heart defect in a male patient who received ENGERIX B pediatric for an unknown indication. Co-suspect products included ENGERIX B pediatric. Concurrent medical conditions included aorta-pulmonary arterial transposition (Outcome: death). On 22nd July 2014, the patient received the 1st dose of ENGERIX B pediatric and the 1st dose of ENGERIX B pediatric. In July 2014, Less than a week after receiving ENGERIX B pediatric and ENGERIX B pediatric, the patient experienced fever, breathing difficulties, mucus in respiratory tract and swollen eyelids. On 22nd July 2014, the patient experienced asystole (serious criteria GSK medically significant), yellow-brown skin, overdose and off label use. On 6th August 2014, the patient experienced heart defect (serious criteria death). On an unknown date, the outcome of the heart defect was fatal and the outcome of the asystole, yellow-brown skin, fever, breathing difficulties, mucus in respiratory tract, swollen eyelids, overdose and off label use were unknown. The patient died on 6th August 2014. The reported cause of death was heart disorder. It was unknown if the reporter considered the heart defect, asystole, yellow-brown skin, fever, breathing difficulties, mucus in respiratory tract, swollen eyelids, overdose and off label use to be related to ENGERIX B pediatric and ENGERIX B pediatric. Additional information was provided: The patient was born by the cesearean section on 22 July 2014. 30 min after the delivery, the patient was vaccinated with double dose of hepatitis B vaccine because of 4kg weight (overdose). The patient skin was yellow-brown. The patient experienced asystole. The rescue operation was assumed. The patient was transported to another hospital where a cardiologist took care of the patient. A transposition of the great arteries was diagnosed. The patient had fever. On day 3, the patient was connected to the respirator and was taken to the intensive care unit. The patient experienced breathing difficulties, mucus in respiratory tract and swollen eyelids. The patient died on 06 August 2014 (the patient was disconnected from the respirator). The cause of death was heart defect. The reporter considered that because of patient''s weight, he was administered the double vaccine dose.


VAERS ID: 551542 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-21
Entered: 2014-10-22
   Days after submission:1
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: 2014-10-21
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: IN2014GSK009371

Write-up: This case was reported in a literature article and described the occurrencce of death in an infant patient who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine at an unknown dose. In 2012, Unknown after receiving Rotavirus vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The patient died in 2012. The reported cause of death was death. It was not reported if the reporter considered the death to be related to Rotavirus vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of death in an infant of undetermined age and gender who had previously received an unspecified rotavirus vaccine (manufacturers unknown). The subject''s family proceeded. The subject had a family history that included parenteral consanguinity and recurrent pregnancy losses in the mother. A younger sibling was later diagnosed with RAG-1-deficient severe combined immunodeficiency syndrome with homozygous mutation (homozygosity $g10%). The authors expressed their belief that the subject had suffered from the same genetically condition during correspondence about the case. The subject''s sibling subsequently died of vaccine-associated paralytic poliomyelitis and disseminated bacille Calmette-Guerin infection. No further information on the subject''s medical history, concurrent medical conditions or concomitant medication was provided. On unspecified dates, the subject received an unspecified rotavirus vaccine (dosage, route and administration site unknown; batch number not provided). On an unspecified date in 2012, an unknown period after receiving the vaccine, the subject passed away. This case is serious as it resulted in death. Treatment was unknown. Outcome was fatal. It is unknown if an autopsy was performed. The authors did not comment on any causal relationship between this event and the vaccine received by the subject. The authors concluded that "by being vigilant, vaccine-associated diseases can be diagnosed early, the spread of disease could be prevented by immunization of exposed persons in the community and among contacts, and appropriate treatment can be given in a timely manner to minmize suffering and reduced morbidity and mortality". This case is 1 of the 2 valid cases reported in the same literature article (see case IN2014GSK009211).


VAERS ID: 551754 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011258

Write-up: Case 1 of 72. This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients.


VAERS ID: 551755 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011499

Write-up: Case 3 of 72. This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients.


VAERS ID: 551767 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-22
Entered: 2014-10-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cerebral haemorrhage, Death
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: 2014287098

Write-up: This is a spontaneous report from a contactable pharmacist who reported to the agency. This report was received via a Pfizer sales representative who was informed by phone call from the agency. A 76-year-old female patient of unspecified ethnicity received PREVENAR 13 on an unspecified date a single dose for immunization. The patient medical history and concomitant medications were not reported. The patient was brought to the hospital by an ambulance 6 days after vaccination with PREVENAR 13. In the hospital a major cerebral hemorrhage was diagnosed. After several additional bleeds the patient died on an unspecified date.


VAERS ID: 551768 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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 information
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1410CAN011501

Write-up: Case 5 of 72. This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information is not expected.


VAERS ID: 551776 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011508

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination. The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has no further information regarding the patients. Additional information is not expected.


VAERS ID: 551777 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011507

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination. The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information is not expected.


VAERS ID: 551778 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011498

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination. The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. The reporter has not further information regarding the patients.


VAERS ID: 551779 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011500

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination. The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information is not expected.


VAERS ID: 552237 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011509

Write-up: This spontaneous report as received from a nurse via company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information is not expected.


VAERS ID: 552238 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011502

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information is not expected.


VAERS ID: 552239 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011503

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information is not expected.


VAERS ID: 552240 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011504

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information is not expected.


VAERS ID: 552244 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011511

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information is not expected.


VAERS ID: 552245 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011505

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information is not expected.


VAERS ID: 552248 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011510

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-OCT-2014: The reporter has not further information regarding the patients. Additional information is not expected.


VAERS ID: 552296 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011506

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information is not expected.


VAERS ID: 552308 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011514

Write-up: Case 18 of 72. This spontaneous report as received from a nurse via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated on GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reproter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested.


VAERS ID: 552315 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011515

Write-up: Case 19 of 72. This spontaneous report a received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reproter has not further information regarding the patients. Additional information is not expected.


VAERS ID: 552317 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011513

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information is not expected.


VAERS ID: 552321 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011512

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information is not expected.


VAERS ID: 552482 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011516

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552483 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011517

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552484 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011518

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552485 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011520

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552486 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-23
Entered: 2014-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011519

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552513 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-24
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011528

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552517 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-24
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011530

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


Result pages: prev   1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85   next

New Search

Link To This Search Result:

https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=67&PERPAGE=100&DIED=Yes


Copyright © 2020 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166