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VAERS ID: 489802 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2011-11-18
Submitted: 2013-04-19
   Days after onset:517
Entered: 2013-04-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cardiac failure congestive, Chronic myeloid leukaemia, Nausea, Right ventricular failure
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Pulmonary hypertension (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), 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: TASIGNA
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011JP102270

Write-up: Case number PHHY2011JP102270 is a combined spontaneous report initially received from physician on 18 Nov 2011 and 21 Nov 2011 and a follow up report received from the physician on 02 Oct 2012 with a follow up report from physician received on 26 Nov 2012 and a follow up literature report received on 09 Apr 2013. This report refers to a 79-year-old female patient. The patient received TASIGNA for the treatment of chronic myeloid leukemia from 10 Jun 2011 at a dose of 600 mg daily orally. On 18 Nov 2011, 162 days after starting TASIGNA therapy, the patient who did not have bad cardiopulmonary function so much, experienced cardiac failure congestive and right heart failure. TASIGNA dosage was reduced to 400 mg daily orally on an unknown date. About 1 month later, the patient recovered. Seriousness of cardiac failure congestive and right heart failure was reported as non-serious. Outcome of cardiac failure congestive and right heart failure was reported as recovery on an unspecified date in Dec 2011. On an unspecified date, after starting treatment with suspect drug, the patient experienced nausea. The event outcome was reported as resolved. The author concluded that nilotinib can be administered to patients on hemodialysis with renal failure at any stage. Causality of cardiac failure congestive and right heart failure was reported as not related to TASIGNA. The physician commented that the "patient had received an Influenza vaccine injection (manufacturer unknown, batch no: unk) on an unspecified date, which possibly had an effect". As of this report, treatment with TASIGNA was ongoing with no problems at all. Follow up report received from the physician on 02 Oct 2012: The action taken with the drug, outcome, seriousness, causality, treatment received and the physician''s comment were updated. Follow up report from physician received on 26 Nov 2012: Updated patient''s initials, TASIGNA therapy details and start date of the events. Follow up literature report received on 09 Apr 2013: The case PHHY2012JP068351 was identified as duplicate of the case PHHY2011JP102270. All the information from the case PHHY2012JP068351 was merged with this case PHHY2011JP102270 and the case PHHY2012JP068351 will be deactivated. The merged information is report type, TASIGNA dosage, suspect drug, event, outcome were updated.


VAERS ID: 490002 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2013-04-11
Onset:2013-04-12
   Days after vaccination:1
Submitted: 2013-04-24
   Days after onset:12
Entered: 2013-04-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LG / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR J0225 / 1 LG / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient did not have any underlying disease or medication taken.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201304997

Write-up: Initial report was received on 12 April 2013 from an unidentified "hospital staff" member through the local affiliate. A four-month-old male patient with no underlying disease or medications taken had received on 11 April 2013 at 11 A.M. a primary one, intramuscular thigh dose of IMOVAX POLIO, batch number J0225 (side of administration unknown) and a primary 2 (0.5 ml/ 1 dose) intramuscular thigh dose of DTaP (manufacturer, batch number and side of administration unknown) and on 12 April 2013, was found dead. The patient was not hospitalized. No further information was available at the time of the report. Documents held by sender: none.


VAERS ID: 490427 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-04-08
Submitted: 2013-04-29
   Days after onset:21
Entered: 2013-04-30
   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: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-04-08
   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: 2013129828

Write-up: This is a spontaneous report from a contactable physician. A 2-months-old patient of an unspecified gender received a dose of PREVENAR 13, via an unspecified route of administration on an unspecified date for immunisation. Patient''s medical history and concomitant medications were not reported. On 08Apr2013, the patient died. At the time of reporting, it was not reported if an autopsy was performed.


VAERS ID: 490874 (history)  
Form: Version 1.0  
Age: 1.76  
Sex: Female  
Location: Foreign  
Vaccinated:2013-03-08
Onset:2013-04-05
   Days after vaccination:28
Submitted: 2013-05-02
   Days after onset:27
Entered: 2013-05-06
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB486A / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G36572 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Febrile convulsion
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-04-05
   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: JUL-2012, Febrile convulsion; OCT-2012, Febrile convulsion
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013133791

Write-up: This is a spontaneous report from a contactable physician. This is a report received from the foreign Regulatory Authority. Regulatory authority report number DE-PEI-PEI2013022811. A 22-month-old female patient, received at the age of 21 months, a single dose of PREVENAR 13 (lot no.: G36572) intramuscularly and a single dose of INFANRIX HEXA (lot no.: A21CB486A) intramuscularly, both on 08Mar2013. Patient''s medical history included: two episodes of febrile convulsion in Jul2012 and Oct2012. Concomitant medications were not reported. On 05Apr2013, 29 days after vaccination, the patient died. At the time of reporting it was unknown if an autopsy was performed.


VAERS ID: 490877 (history)  
Form: Version 1.0  
Age: 0.39  
Sex: Male  
Location: Foreign  
Vaccinated:2013-04-17
Onset:2013-04-28
   Days after vaccination:11
Submitted: 2013-05-03
   Days after onset:5
Entered: 2013-05-06
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR - / UNK UN / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-04-28
   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: 2013135829

Write-up: This is a report from a Non-Pfizer sponsored interventional study source. A 5 month-old male patient received, at the age of 4 months, PREVENAR 13, MENJUGATE and PEDIACEL, all received intramuscularly at 0.5ml single doses on 17Apr2013. The subject had no medical history and was receiving no concomitant medications. There were no relevant tests/laboratory data. On 28Apr2013, the baby died at home due to suspected sudden infant death syndrome. The death was not expected as the baby appeared to be well at the last study visit and outreach midwives were planning to stop visiting the baby. It was not reported if an autopsy was performed. The neonatal outreach midwives who visited the baby had no details of causality at this time. The investigator considered the relationship between PREVENAR 13, MENJUGATE and PEDIACEL and the event to be not assessable. The case is managed as if the investigator''s assessment was that a reasonable possibility exists that the event was related to the study product, as a cautionary measure and for reporting purposes. This is a preliminary report for notification of a fatal event.


VAERS ID: 491244 (history)  
Form: Version 1.0  
Age: 1.6  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-05-08
Entered: 2013-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Death, Epstein-Barr virus infection, Epstein-Barr virus test positive, Febrile convulsion, Gene mutation identification test positive, Hepatosplenomegaly, Histiocytosis haematophagic, Multi-organ failure, Polymerase chain reaction, Pyrexia, Stem cell transplant, Thrombocytopenia
SMQs:, Liver related investigations, signs and symptoms (narrow), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Sepsis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Acrocyanosis; Apneic period; Consciousness disturbed; Hypotension; Paracentesis; Respiratory infection; X-linked Lymphoproliferative syndro
Preexisting Conditions: Adenotomy; Mastoidectomy; Premature birth; Splenomegaly; Suppurative otitis
Allergies:
Diagnostic Lab Data: Gene mutation identification t, see text; Laboratory test, HLH criteria; Polymerase chain reaction, active EBV infec; Serology test active EBV infec
CDC Split Type: B0889564A

Write-up: This case was reported in a literature article and described the occurrence of multiple organ failure in a 19-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), PREVENAR. The subject''s medical history included at the age of 6 weeks, disturbances of consciousness with apnoeic pauses appeared. The sonographical examination of his heart did not prove any structural abnormality, the electroencephalogram examination of his brain resulted in a normal finding. Until the age of 19 months, the boy was approximately 10 times treated with antibiotics because of repeated respiratory infections and more than 20 times, he went through a paracentesis because of a suppurative otitis. At the age of 13 months, the subject underwent an adenotomy, and one month later, a both sided mastoidectomy was performed. At the age of one year, a splenomegaly was detected. Later, the spleen size returned to normal, and the boy was not examined in detail at the time. Concurrent medical conditions included x-linked lymphoproliferative syndrome (XLP). On an unspecified date, the subject received unspecified dose of INFANRIX (unknown route and injection site; lot number not provided), unspecified dose of PREVENAR (unknown route and injection site; lot number not provided). Several hours of vaccination with INFANRIX and PREVENAR, the subject experienced a pyrexial reaction. After a momentary decrease, the temperature increased again and the subject experienced febrile convulsions. A progressive hepatosplenomegaly, anaemia, thrombocytopenia, and the laboratory markers gradually reached the satisfaction of hemophagocytic lymphohistiocytosis criteria. Based on serological and polymerase chain reaction tests, active Epstein Barr virus infection was proved. A diagnosis of Epstein Barr virus -associated with hemophagocytic lymphohistiocytosis was determined, and the subject was treated with combined cytotoxic treatment based on the hemophagocytic lymphohistiocytosis 2004 protocol. The subject''s situation partially improved (temperature decrease, splenomegaly retrogression, cytopenia improvement); however, the Epstein Barr virus infection remained very active. The subject was hospitalised and the author considered the events were clinically significant (or requiring intervention). Due to the persistent activity of the disease, an allogene hematopoietic stem cell transplantation (HSCT) was indicated from an unrelated donor. A molecular genetic examination excluded the SH2D1A affection, and a permanent suspicion of x-linked lymphoproliferative syndrome resulted in the baculoviral IAP repeat-containing protein 4 (BIRC4) gene examination. A mutation in the gene confirmed the x-linked lymphoproliferative syndrome -2 diagnoses, and resulted in the reduction of originally planned intensity of a preparative mode with the exclusion of busulphanu (Fludara, Melfalan, Campath). The subject was treated with cytotoxic agent and rituximab administered on a one-time basis. In spite of treatment modification, at 13 days after the graft transfer, the subject died from multiple organ failure based on the combination of preparative mode toxicity and the hemophagocytic lymphohistiocytosis activity. It was unknown whether an autopsy was performed. Summary: X-linked lymphoproliferative disease is a rare primary immunodeficiency with incidence 1-3 subjects in a million boys. The condition is caused by a defect in SH2D1A (XLP-1) or (XLP-2) gene. Most of the clinical symptoms overlap in both of the variants of the disease (fulminant infectious mononucleosis, hemophagocytic lymphohistiocytosis, impairment of immunoglobulin production) other signs are typical only for the particular disease variant (malignant lymphoma in XLP-1, hemorrhagic colitis in XLP-1). The only casual therapy is hematopoietic stem cell transplantation. In so far, 7 subjects have been diagnosed with XLP-1 and one subject with XLP-2. The subjects were born between 1961 and 2005. The disease manifested with medical 4.5 years of age (range 19 months to 16 years). Two subject died due to fulminant HLH, one subject died during HSCT. One subject underwent successful HSCT, whereas other 4 living subjects have not been transplanted. Median age of the living subjects is 22 years (range 17-27). In the text the authors summarize the current opinion of the pathophysiology, diagnostic and treatment of XLP. The course of the disease in the subjects treated is presented.


VAERS ID: 491237 (history)  
Form: Version 1.0  
Age: 0.22  
Sex: Male  
Location: Foreign  
Vaccinated:2013-04-19
Onset:2013-04-23
   Days after vaccination:4
Submitted: 2013-05-07
   Days after onset:14
Entered: 2013-05-09
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB591A / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G59985 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adenovirus infection, Adenovirus test positive, Biopsy liver, Blood test, Death, Hepatic failure, Polymerase chain reaction, Pulmonary haemorrhage, Stool analysis
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-04-27
   Days after onset: 4
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: PCR (unspecified date): confirmed adenovirus infection; Adenovirus test (24Apr2013): positive; blood/stool test (unspecified date): results not provided
CDC Split Type: 2013138333

Write-up: This is a spontaneous report from the foreign Health Authority, Regulatory Authority report number: DE-PEI-PEI2013024002, from a physician. A 12-weeks-old male patient received first dose of PREVENAR 13 (Batch# G59985), via an unspecified route of administration on 19Apr2013 at 0.5 ml single; and first dose of INFANRIX HEXA (Batch# A21CB591A), via an unspecified route of administration, on 19Apr2013, at 0.5 ml single. The patient medical history and concomitant medications were not reported. The patient experienced liver failure on 23Apr2013, lung hemorrhage on an unspecified date and the patient was diagnosed with adenovirus infection on 24Apr2013. Diagnosis was confirmed by PCR. Metabolic diseases were ruled out. Lab data included: adenovirus test positive (24Apr2013), blood/stool test performed on an unspecified date: results not provided, liver biopsy was performed on an unspecified date: results are pending. The patient died on 27Apr2013. The reported causes of death were lung hemorrhage with permanent liver failure. According to the reporting physician who was contacted by phone an autopsy was not performed. No follow-up attempts needed, follow-up automatically provided by agency.


VAERS ID: 491347 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-05-10
Entered: 2013-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Dysphagia, Dyspnoea, General physical health deterioration, Immunohistochemistry, Inappropriate schedule of drug administration, Laboratory test abnormal, Logorrhoea, Lyssavirus test positive, Musculoskeletal stiffness, Paraparesis, Psychomotor hyperactivity, Pyrexia, Rabies, Speech disorder, Urine flow decreased, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Medication errors (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Animal bite, Bitten by his 3-month old puppy on an unknown date. The puppy had been bitten in the head by a stray dog, a week before biting the boy. The puppy died a few days after biting the boy; Psychomotor hyperactivity; Dysphagia; Logorrhoea; Pyrexia; Vomiting; Urine output decreased; Musculoskeletal stiffness
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Immunohistochemisty, Positive, Rabies virus specific antigens were detected using direct rapid immune-histochemistry test (dRIT) and he was diagnosed with rabies
CDC Split Type: PHHY2013KE045377

Write-up: Case number PHHY2013KE045377 is an initial literature report received on 07 May 2013: The author in this article presented a case report from a rabies outbreak which was the first human rabies case report diagnosed using direct rapid immune-histochemistry (dRIT) test in a developing country. This report refers to a 2-year-old male patient. He was bitten by his 3-month old puppy on an unknown date. The puppy had been bitten in the head by a stray dog, a week before biting the boy. The puppy died a few days after biting the boy. On 07 Feb 2012, he was admitted at a district hospital with a 3-day history of verborrhea, hyperactivity, dysphagia, vomiting, fever and decreased urine flow. Despite a negative laboratory test, he was initially treated for cerebral malaria because it was a malaria endemic zone. Later the diagnosis was changed to meningitis after he developed stiff neck. On learning of the rabies outbreak in the region, he began post-exposure Rabies vaccine (manufacturer and batch number: not reported hence conservative taken as RABIPUR INN), administered on days 0 and 3 but without rabies immunoglobulin. His condition deteriorated on day 7 with bouts of vomiting. He was further administered a third dose of rabies vaccine (manufacturer and batch number: not reported, hence conservatively taken as RABIPUR INN) on day 12. He subsequently developed paraparesis and dyspnea before dying on day 13. Postmortem specimens were obtained from the brain stem, cerebrum and cerebellum. Rabies virus specific antigens were detected using direct rapid immune-histochemistry test (dRIT). The authors commented that although the patient did not have access to intensive care, he survived for two weeks in the hospital where as typical rabies cases would not survive more than a week without intensive care. The authors concluded that administration of rabies vaccine to the patient after illness was in conflict to existing WHO recommendations and confounded ante-mortem diagnostic testing. No further information was provided.


VAERS ID: 491366 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-05-09
Entered: 2013-05-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, 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:
CDC Split Type: 2013144003

Write-up: This is a spontaneous report from a contactable physician via a Pfizer Colleague. A 7 month old patient of an unspecified gender died due to pneumococcal meningitis on unknown date. The patient was up-to-date on PREVENAR 13 immunization: 2 doses had been received at 2 and 4 months. At the time of reporting, patient''s medical history and concomitant medications were not reported. The patient had been admitted on 23Apr2013, following 3 days of illness, with pneumococcal meningitis, and had succumbed to it. The reporter was following up with the microbiology lab to find out if the sample had been sent for pneumococcal serotyping, to determine if the disease was due to Streptococcus pneumonia serotype included in PREVENAR 13 vaccine or not. It was not reported if an autopsy was performed.


VAERS ID: 491427 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-04-24
Onset:2013-04-24
   Days after vaccination:0
Submitted: 2013-05-10
   Days after onset:16
Entered: 2013-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER 4511158 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bladder cancer, Chills, Death, Intensive care, Pyrexia, Urinary retention
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-04-25
   Days after onset: 1
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: Unknown
Preexisting Conditions: Bladder cancer, Papillary carcinoma of the bladder
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1305GRC000807

Write-up: A 73 year old male received ONCOTICE 1 dose, intravesically, on 24-APR-2013, for papillary carcinoma of the bladder. On 24-APR-2013 the patient presented with fever, rigors and acute urinary retention. He was admitted to another hospital (different than the one where ONCOTICE was administered), he was subsequently transferred to the intenstive care unit, where he expired on 25-APR-2013. Autopsy and/or cause of death report has been requested by the treating physician. No concomitant medications or other relevant medical history were reported. The reporting (treating) physician and the hospital pharmacist have requested a batch analysis for ONCOTICE to be performed immediately.


VAERS ID: 491747 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-05-15
Entered: 2013-05-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F92334 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Pneumococcal bacteraemia, Streptococcus test positive
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: First dose at the age of 2 months (lot no.: F89734), PREVNAR 13; Second dose at the age of 3 months (lot no.: F93512), PREVNAR 13
Allergies:
Diagnostic Lab Data: Blodd culture (unknown date): pneumonia serotype 10A
CDC Split Type: 2013146214

Write-up: This is a spontaneous report from a contactable physician. A 11-months-old female patient received PREVENAR 13. First dose of PREVENAR 13 was administered at the age of 2 months (lot no.: F89734), second dose was administered at the age of 3 months (lot no.: F93512) and third dose was administered at the age of 4 months (lot no.: F92334). Patient was not a former preterm and had no immunodeficiency and no chronic diseases. The patient''s concomitant medications were not reported. The patient experienced pneumococcal bateraemia without focus on an unspecified date with fatal outcome. Pathogen material was blood culture. Serotype was provided as 10A. The patient died on an unspecified date. No follow-up attempts possible. No further information expected.


VAERS ID: 491876 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-05-15
Entered: 2013-05-17
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F63697 / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: CSF test, Death, Meningitis, Streptococcus test positive
SMQs:, Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: First dose of PREVENAR 13 was administered at the age of 4 months (lot no.: F82154), PREVENAR-13; Second dose was administered at the age of 5 months (lot no.: F89734), PREVENAR-13
Allergies:
Diagnostic Lab Data: Liquor (unknown date): meningitis serotype 10A
CDC Split Type: 2013146123

Write-up: This is a spontaneous report from a contactable physician. A 12-months-old female patient received the third dose of PREVENAR 13 at the age of 6 months (lot no.: F63697). First dose of PREVENAR 13 was administered at the age of 4 months (lot no.: F82154) and the second dose was administered at the age of 5 months (lot no.: F89734). Patient was not a former preterm and had not immunodeficiency and no chronic diseases. The patient''s concomitant medications were not reported. The patient experienced meningitis on an unspecified date in 2013 with fatal outcome. Pathogen material was liquor. Serotype was provided as 10A. The patient died on an unspecified date. No follow-up attempts possible. No further information expected.


VAERS ID: 491996 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-16
Onset:2012-10-16
   Days after vaccination:0
Submitted: 2013-05-17
   Days after onset:213
Entered: 2013-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA757AA / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Dyspnoea exertional, Feeling abnormal, Hyporeflexia, Multi-organ failure, Nausea, Pneumonia, Sepsis, Shock
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-24
   Days after onset: 39
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: Blood pressure, 22Nov2012, 101/67; Heart rate, 22Nov2012, 83; Physical examination, 22Nov2012, see text
CDC Split Type: B0892467A

Write-up: This case was reported by a physician via a regulatory authority (ES-AGEMED-337279340) and described the occurrence of sepsis shock in a 82-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 16 October 2012, the subject received unspecified dose of FLUARIX (unknown route and injection site). On 16 October 2012, less than one day after vaccination with FLUARIX, the subject experienced hyporexia, nausea and dizziness, unstable feeling and dyspnea during exertion. On 22 November 2012, during a physical exploration subject''s blood pressure was 101/67, heart rate: 83, he had no edema, his heart activity was rhythmic, without murmur, only some basal crackling modified by cough were seen, anodyne abdomen, no hepato-jugular reflux and no jugular swelling. On 24 November 2012, 39 days after vaccination with FLUARIX, the subject suddenly presented septic shock with multiorganic failure secondary to pneumonia. The regulatory authority reported that the events were unlikely to be related to vaccination with FLUARIX. On 24 November 2012, the subject died from sepsis. It was unknown whether an autopsy was performed.


VAERS ID: 492265 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-05-05
Submitted: 2013-05-20
   Days after onset:15
Entered: 2013-05-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest X-ray abnormal, Cough, Death, Extracorporeal membrane oxygenation, Intensive care, Pneumonia pneumococcal, Pyrexia, Streptococcus test, Streptococcus test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-05-10
   Days after onset: 5
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: 2 doses of PREVENAR and 2 dose of PREVENAR-13, Therapy regimen changed; First doses of PREVENAR; Second doses of PREVENAR
Allergies:
Diagnostic Lab Data: Unspecified sample test at hospital: (09May2013): streptococcus serotype 19a; Streptococcus serotype identification by CDC (09May2013): unknown; Chest X ray (09May2013): pneumonia
CDC Split Type: 2013148485

Write-up: This is a spontaneous report from a contactable physician and his OPD nurse via a company representative. A 3-year-old male patient received the second doses of PREVENAR 13 intramuscularly on an unspecified date. Batch/lot number and expiration date were reported as unknown. The patient previously received 2 doses of PREVENAR and one dose of PREVENAR-13, all on an unspecified date. The patient experienced fever and cough on 05May2013 and sent to ER on 05May2013 with unspecified medications treatment. On the routine OPD follow-up visit on 09May2013, the chest X ray showed pneumonia and the patient was hospitalized on 09May2013 evening. The condition of the patient was getting worse and he was transferred to ICU with extracorporeal membrane oxygenation support at that night. On 10May-2013, the patient was expired. The patient performed unspecified sample for examination at hospital and was sent to the central disease control agency (CDC) as well. The sample examination in the hospital was confirmed as Streptococcus pneumoniae infection, serotype 19A. The result from CDC was unknown at the time of reporting. The physician initially judged the cause of death is Streptococcus pneumoniae infection, serotype 19A. It was not reported if an autopsy was performed. The physician refused to provide causality assessment, discharged summary and any further information. No follow-up attempts possible. No further information expected.


VAERS ID: 492374 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2013-03-07
Onset:2013-03-07
   Days after vaccination:0
Submitted: 2013-05-22
   Days after onset:75
Entered: 2013-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA916C / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Aspiration, Death, Dyspnoea, Feeding disorder of infancy or early childhood, Irritability, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-03-10
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Down Syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0893336A

Write-up: This case was reported by a physician (hospital) and described the occurrence of possible aspiration in a 2-month-old male subject who was vaccinated with INFANRIX-IPV/Hib (GlaxoSmithKline). Concurrent medical conditions included possible down syndrome. On 7 March 2013, the subject received 1st dose of INFANRIX-IPV/Hib (0.5 ml, intramuscular, unknown injection site). On 7 March 2013, less than one day after vaccination with INFANRIX-IPV/Hib, the subject experienced mild fever (subject''s body temperature not provided). On 8 March 2013, fever was resolved. On 9 March 2013, 2 days after vaccination with INFANRIX-IPV/Hib, the subject experienced difficulty breathing, difficulty drinking and irritability. On 10 March 2013, the subject was brought to hospital. According to the reporter, the subject was already dead when arrived at the hospital. Based on the chronological investigation, the Department of Health considered the death was not related to vaccination with INFANRIX-IPV/Hib. According to the report, the death was probably due to aspiration of breast milk. It was unspecified if the other events were considered as related to vaccination with INFANRIX-IPV/Hib. The subject died on 10 March 2013 from possible aspiration. It was unknown whether an autopsy was performed.


VAERS ID: 492411 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-05-22
Entered: 2013-05-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F92334 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Pneumococcal bacteraemia, Streptococcus test positive
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: Dose 1-PREVENAR-13; Dose 2, PREVENAR-13
Allergies:
Diagnostic Lab Data: Blood culture (unknown date): pneumococcal bacteremia without focus, serotype 10A
CDC Split Type: 2013156171

Write-up: This is a spontaneous report from a contactable physician. A 11-month-old female patient received the third dose of PREVENAR 13 at the age of 4 months (Lot no. F92334). First dose of PREVENAR 13 was administered at the age of 2 months (Lot no. F89734) and the second dose was administered at the age of 3 months (Lot no. F93512). Patient was not a former preterm and had no immunodeficiency and no chronic diseases. The patient''s concomitant medications were not reported. The patient experienced pneumococcal bacteremia without focus on an unspecified date in 2013 with fatal outcome. Pathogen material was blood culture. Serotype was provided as 10A. The patient died on an unspecified date. No follow-up attempts possible. No further information expected.


VAERS ID: 492482 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-04-22
Onset:2013-04-24
   Days after vaccination:2
Submitted: 2013-05-22
   Days after onset:28
Entered: 2013-05-24
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MER: MEASLES + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER MR197 / 1 UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 12F04A / 4 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Death, Pyrexia, Rhinorrhoea, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (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), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-04-26
   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: 22-APR-2013, Body temperature, 36.9 Centigrade; 24-APR-2013, Body temperature, 39.0 Centigrade; 25-APR-2013, Body temperature, 38.7 Centigrade
CDC Split Type: 2013153382

Write-up: This is a spontaneous report from a contactable pediatrician. This is a report received from the Ministry of Health. Regulatory authority report number V13000173. A 12-month-old male patient received the fourth dose of PREVENAR (Lot Number: 12F04A) subcutaneous on 22Apr2013 at1 14:10 at a single dose, the first dose of MEARUBIK (Lot Number: MR197), subcutaneous on 22Apr2013 at 14:10 at a single dose. The patient''s medical history was not reported. The patient''s concomitant medications were not reported. The patient''s body temperature before the vaccination was 36.9 degrees Centigrade. Vaccination was done by the reporting pediatrician. In the evening of 24Apr2013, he experienced the event, vomiting once. At 23:00 on 24Apr2013, he developed pyrexia at 39.0 degrees Centigrade. Unspecified antipyretics were given. On 25Apr2013 at 09:15 A.M. the patient visited the reporter''s hospital on an outpatient basis. Body temperature was 38.7 degrees Centigrade. His general condition was not bad after breakfast and he had no vomiting. On 25Apr2013, he developed nasal discharge. Therapeutic measures were taken in response to the event, nasal discharge included ASVERIN, MUCODYNE and PARACETA (suppository). On 26Apr2013, the police station informed the reporting physician that the patient was found in the state of cardio-respiratory arrest in the morning and subsequently, he was transferred to a hospital and pronounced dead. The event, cardio-respiratory arrest, was serious due to death. The clinical outcome of the event, vomiting, was recovered on 25Apr2013. The clinical outcome of the events, pyrexia and nasal discharge, was unknown. The cause of death was unknown. It was unknown whether autopsy was performed. According to the reporting pediatrician''s opinion, a causal relationship between the events and the vaccinations could not be judged on the basis of insufficient information about clinical course following his visit to the reporter''s hospital on 25Apr2013 and about clinical findings given by the hospital on 26Apr2013. No follow-up attempts possible. No further information expected.


VAERS ID: 492810 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-05-29
Entered: 2013-05-30
   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: 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: Therapy regimen changed
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013159394

Write-up: This is a spontaneous report from a contactable physician via a sales representative. This physician reported similar events for seven patients. This is the first of seven reports. The case is valid. The six additional cases are invalid. A patient of unspecified age, ethnicity and gender (not an adult, reported as child) was vaccinated with the second dose of PREVENAR 13 on an unspecified date at 0.5 ml single for immunisation. Relevant medical history and concomitant medications were not provided. Past product history included immunisation with 3 doses of PREVENAR and one dose of PREVENAR 13, dates for each vaccination unknown. On an unspecified date the patient died from an unspecified cause attributed to streptococcus pneumoniae serotype 3. Relevant laboratory data was unknown.


VAERS ID: 492878 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2010-01-20
Onset:2010-02-04
   Days after vaccination:15
Submitted: 2013-05-30
   Days after onset:1210
Entered: 2013-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LG / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Acute lymphocytic leukaemia, Contusion, Death, Petechiae, Rash macular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-12-14
   Days after onset: 678
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: B0895429A

Write-up: This case was reported by a consumer via a regulatory authority (# FI-FIMEA-20130565) and described the occurrence of death with unknown causes in a 26-month-old male subject who was vaccinated with INFANRIX-IPV/HIB (GlaxoSmithKline) and Rotavirus vaccine (manufacturer unspecified). The subject had no distress before the leukemia and had not experienced previous vaccine reactions. On 20 January 2010, the subject received an unspecified dose of INFANRIX-IPV/HIB (intramuscular, unknown thigh, batch number not provided) and an unspecified dose of Rotavirus vaccine (oral, batch number not provided). On 4 February 2010, 15 days after vaccination with INFANRIX-IPV/HIB and Rotavirus vaccine, the subject experienced acute lymphocytic leukemia with pink blotches, contusion and petechiae. The subject died on 14 December 2011, 23 months after vaccination with INFANRIX-IPV/HIB and Rotavirus vaccine, from death with unknown causes. It was unknown whether an autopsy was performed.


VAERS ID: 493031 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-06-03
Entered: 2013-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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: Predonine
Current Illness: Unknown
Preexisting Conditions: Hospitalisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1306JPN000127

Write-up: Initial information has been received from a pharmacist concerning a patient of unknown age who on an unspecified date was placed on therapy with PNEUMOVAX NP, (lot number, expiry date was not reported) injection drug. Other concomitant medications included predonine. On an unspecified date, the patient was inoculated with pneumococcal vaccine before leaving the hospital. On an unspecified date (three days after being inoculated with the pneumococcal vaccine), the patient developed pneumonia. On an unspecified date, although the patient was placed on therapy with antibiotic and other therapeutic method, the patient was still dead. The cause of death was pneumonia and it was unclear whether autopsy was carried out. Reporter comment: felt that the pneumonia was definitely not related to PNEUMOVAX NP, but a few months later, the patient''s family said the pneumonia was caused by PNEUMOVAX NP inoculated. It was still unclear whether Pneumococcus was the pathogenic bacteria or not. The reporting pharmacist felt that the pneumonia was definitely not related to PNEUMOVAX NP. The reporting pharmacist considered that the pneumonia was serious due to death. Additional information is not expected.


VAERS ID: 493115 (history)  
Form: Version 1.0  
Age: 1.8  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-06-03
Entered: 2013-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Endocrine disorder, Immune system disorder, Parvovirus infection, X-linked chromosomal disorder
SMQs:, Congenital, familial and genetic disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic diarrhea; Obstructive lung disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0895548A

Write-up: This case was reported in a literature article and described the occurrence of human bocavirus infection in a 21-month-old male subject who was vaccinated with Rotavirus vaccine (manufacturer unspecified). His older brother died at the age of 20 months suffering from BCGitis and severe CMV infection suggesting a severe primary immunodeficiency syndrome. Concurrent medical conditions included chronic diarrhea and obstructive lung disease. Immunological dysregulation, endocrine dysfunction and enteropathy compatible with IPEX syndrome were found. Therefore the subject was listed for stem cell transplantation. FOXP3 gene showed no IPEX associated mutations, but in sequencing IL2RG, a mutation in Exon 2 associated with x-linked IPEX-LIKE SCID was found. The pulmonary condition of the subject deteriorated and the subject was hospitalised where he was mechanically ventilated. After common respiratory infections were excluded, chronic human bocavirus infection was identified by multiplex-PCR as the primary causative pulmonary agent causing his respiratory failure. Human bocavirus infection was found in decreasing quantity in respiratory material, blood and stool specimen. Chronic rotavirus shedding was notified in repetitive stool specimen. Since the subject received an unspecified dose of rotavirus vaccine on an unspecified date, vaccine-acquired chronic infection was suspected and confirmed by the typing of a vaccine virus specific gene variant. The subject died from human bocavirus infection. This literature article showed that human bocavirus infection could lead to lethal respiratory infections in immunocompromised children.


VAERS ID: 493133 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2013-05-25
Onset:2013-05-25
   Days after vaccination:0
Submitted: 2013-06-03
   Days after onset:9
Entered: 2013-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Aspiration, Death, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-05-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A1025127A

Write-up: This case was reported in a local media television and press and described the occurrence of aspiration in a 2-month-old female subject who was vaccinated with ROTARIX liquid formulation (GlaxoSmithKline), SYNFLORIX (unspecified), DTPW-HBV-HIB vaccine (non-gsk), poliomyelitis vaccine live oral (non-gsk) and PANADOL for fever. On 25 May 2013 the subject received unspecified dose of ROTARIX liquid formulation (oral), unspecified dose of Pneumococcal vaccine-unspecified (intramuscular, unknown), unspecified dose of DTPW-HBV-HIB vaccine (Non-GSK) (intramuscular, unknown), unspecified dose of Poliomyelitis vaccine live oral (Non-GSK) (oral). On 25 May 2013, with hours after vaccination with DTPW-HBV-HIB vaccine (Non-GSK), Pneumococcal vaccine-unspecified, Poliomyelitis vaccine live oral (Non-GSK) and ROTARIX liquid formulation, the subject experienced fever. On 25 May 2013 the patient started Paracetamol (oral) (single dose) for fever. On 26 May 2013, hours after starting Paracetamol and 24 hours after vaccinations the subject experienced aspiration. The subject died on 26 May 2013 from aspiration. As reported by the media, a 2-month old female subject was vaccinated with four vaccines as part of local UMV scheme. She received oral polio, ROTARIX, Pneumococcal vaccine-unspecified and DTPW-HBV-HIB vaccine (Non-GSK) on 25 May 2013. The subject received PANADOL drops for fever after vaccinations. The mother was feeding her and the subject went to sleep. The mother reported that the next day after the vaccinations the subject was found dead. The subject died 24 hours after she received the vaccinations. It was presumed she may have died due to aspiration because she was feeding and went to sleep. Investigation was reportedly in progress, autopsy will be performed. Local authority considered the event (death) related to aspiration, but an evaluation was ongoing, pending final result with autopsy information.


VAERS ID: 493202 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: Foreign  
Vaccinated:2013-05-23
Onset:2013-05-23
   Days after vaccination:0
Submitted: 2013-06-03
   Days after onset:11
Entered: 2013-06-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR H8087 / 1 AR / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asphyxia, Cardiac arrest, Death, Decreased activity, Decreased appetite, Electrocardiogram, Endotracheal intubation, Pallor, Pupillary light reflex tests abnormal, Resuscitation, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Glaucoma (narrow), Cardiomyopathy (broad), Retinal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-05-23
   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:
Current Illness:
Preexisting Conditions: The patient was full-term spontaneous delivered. Birth weight = 3500g. The patient is the 3rd child of the family. She had a sister (about 10 years old) and a brother. Both of the parents are peasants.
Allergies:
Diagnostic Lab Data: Physical exam: T=35.5 degrees, HR=0/min, RR=0/min; equal size and shape of the bilateral pupils, round, diameter=4mm, no light reflex; pale complexion.
CDC Split Type: 201306422

Write-up: Case received from a Healthcare Professional through the local affiliate on 23 May 2013. A 9-week-old female patient, with no relevant medical history, had received intramuscularly her first primary dose of ACTHIB (batch number H8087-1) in the arm on 23 May 2013 around 09:00 a.m. The patient had been vaccinated with Hepatitis B vaccine and BCG vaccine (not co-administered with ACTHIB, details not available). There was no concomitant treatments or vaccines. The patient was full-term spontaneous delivered (birth weight - 3500g). She was the 3rd child of the family. She had a sister (about 10 years old) and a brother. Before the vaccination, the nurse did not find any abnormal symptoms or signs in the physical exam. On 23 May 2013, around 3:00 p.m., the patient was less active and took less breast milk than usual when she was fed. The patient was put on the bed and fell asleep. At about 7pm, the patient had no response when the parents tried to wake her up. The patient was sent to the emergency room at 7:50pm. On admission, physical exam showed body temperature at 35.5 degrees, HR=0/min, RR=0/min; equal size and shape of the bilateral pupils, round, diameter=4mm, no light reflex; pale complexion. Sputum aspiration, oxygen inhalation, electrocardiogram surveillance, blood oxygen saturation surveillance, chest wall compression, endotracheal intubation were performed as corrective actions. Adrenalin was prescribed: 7:5 pm 1:10000 adrenalin 1ml im, 7:56pm 1:10000 adrenaline 0.5ml endotracheal injection, 7:58pm 1:10000 adrenalin 1ml im, 8:0 pm 1:10000 adrenalin 1 im; 8:2 pm 1:10000 adrenalin 1ml iv; 8:2 pm 1:10000 adrenalin 1ml iv. The physician formally announced the patient''s death at 8:25pm with the diagnosis of cardiac arrest and asphyxia. The cadaver was frozen on the night of 23 May 2013. The autopsy has not been performed by 24 may 2013.


VAERS ID: 493755 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2013-02-25
Onset:2013-02-26
   Days after vaccination:1
Submitted: 2013-06-07
   Days after onset:100
Entered: 2013-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB448A / 1 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F92985 / 1 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0592AE / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-26
   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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On 26-FEB-2013 ultrasound showed possible intussusception possible volvulus.
CDC Split Type: WAES1306AUS000832

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail concerning an 8 week old male patient. On 25-FEB-2013 the patient was vaccinated with the first dose of ROTATEQ (manufacturer unknown) (batch/Lot # 0592AE, dose not reported) oral. Other suspect therapies included the first dose of PREVNAR 13 (batch# F92985, dose not reported) intramuscularly and the first dose of INFANRIX HEXA (batch# A21CB448A, dose not reported) intramuscularly. The patient saw general practitioner (GP) on 26-FEB-2013 incidentally for discussion regarding circumcision, and his mother asked GP to have a look as not himself at 20:21. It was presented to emergency department (ED): shocked; ultrasound showed possible intussusception possible volvulus. Patient was given fluid resuscitated. It was planned to be flown to hospital when the patient had an unexpected cardiac arrest approximately 0120 and did not survive. The patient passed away on 26-FEB-2013. Cardiac arrest and intussusception were considered as possible related to ROTATEQ (manufacturer unknown). Upon internal review, cardiac arrest was determined as medically significant. The original reporting source was the state/territory health department. Additional information is not expected.


VAERS ID: 493834 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-06-10
Entered: 2013-06-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 4 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coma, Death, Infection
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Dose 1, PREVENAR-13; Dose 2, PREVENAR-13; Dose 3, PREVENAR-13
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013170694

Write-up: This is a spontaneous report from a contactable pediatrician through a Pfizer sales representative. A 18-month-old patient of an unspecified gender received the 4th dose of PREVENAR 13 intramuscular, on an unspecified date, at 0.5 ml single. In the past the patient had received three doses of PREVENAR 13 at unspecified dates. The patient medical history and concomitant medications were unknown. The patient experienced infection NOS on an unspecified date, hospitalized, fell into coma and finally expired (unspecified date). The exact cause of death was unknown. It was not reported if an autopsy was performed. The reporting physician had no more information as the child was not his patient.


VAERS ID: 493836 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-01-01
Onset:0000-00-00
Submitted: 2013-06-08
Entered: 2013-06-11
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, CSF culture positive, Meningitis, Streptococcus test positive
SMQs:, Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: First dose at the age of 4 months; Second dose at the age of 6 months, PREVENAR 13
Allergies:
Diagnostic Lab Data: Blood and liquor culture (unknown): miningitis, serotype 10A
CDC Split Type: 2013168324

Write-up: This is a spontaneous report from a contactable physician. A 12-months-old female patient who received 3 doses of PREVENAR 13. PREVENAR 13 was administered on unspecified dates at the age of 4 months (first dose, lot number unknown) in Nov2012, at the age of 5 months (second dose, lot number unknown) and at the age of 6 months (third dose, lot number unknown). Dose regimen was one single dose each time. Route of administration was not provided. Concomitant medication was not provided by reporter. At the age of 12 months, the patient experienced meningitis on an unspecified date in 2013. Meningitis was detected by blood and liquor culture. The serotype was 10 A. The outcome was fatal. No follow-up attempts possible. No further information expected.


VAERS ID: 494300 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-06-14
Entered: 2013-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Chills, Death, Dyspnoea, Influenza, Influenza A virus test positive, Myalgia, Pyrexia, Rhinitis
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: H1N1 influenza PCR, Positive
CDC Split Type: B0899558A

Write-up: This case was reported in a literature article and described the occurrence of death due to unknown causes in an elderly subject of unspecified gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced influenza A (H1N1). The subject was hospitalized. The H1N1 was confirmed by Reverse Transcription Polymerisation Chain Reaction. The subject died from death due to unknown causes. It was unknown whether an autopsy was performed. Two cases were identified in this study (see case B0899639A). Summary of the literature article: The objective of this study was to evaluate the 2009 Pandemic Influenza A (H1N1) in the elderly and identify the clinical characteristics, mortality and prognostic factors of the infection in these patients. This was an observational, retrospective study. Data were collected from the National Notifiable Diseases, from the foreign Ministry of Health. Only patients 60-year-old or more that had laboratory confirmed infections were included. The socio-demographic and clinical variables and outcomes were evaluated to compare mortality rates in the presence or absence of these factors. The main symptoms of the patients who died, in decreasing order of frequency, were dyspnea, coryza, fever, myalgia and chills. The age groups 60-69 years and 80 years had mortality rates higher than the average total of 16.1%. The highest mortality rate was observed in patients over the age of 80 years. Two patients of the seven patients in this age group died. Among the subjects included in the study, 38 (40.9%) patients had been previously vaccinated against seasonal influenza, two (5.3%) of which died. Comparing among the 15 patients who died, only 2 (13.3%) of these patients had been previously vaccinated. Therefore, 86.7% of the deaths occurred in unvaccinated elderly patients, suggesting that vaccination may reduce the number of influenza-associated deaths. The mortality rate observed in unvaccinated patients was 15% (6/40) and was significantly (p<0.05) higher than that observed among the vaccinated patients, which was 5.2% (2/38). Similarly, the hospitalization rate among unvaccinated patients, which was 62.5% (25/40), was significantly higher than that observed among those who received the influenza vaccine, which had a rate of 44.7% (17/38). With regard to hospitalization, 58.1% of the elderly were hospitalized as a result of the disease. Hospitalization was also significantly correlated with outcome (p=0.003), with an increased rate of death being observed in those that were hospitalized. The rate of oseltamivir treatment was 88.6% in this study. Early treatment within 2 days after the onset of symptoms was significantly associated with a lower risk of emergency admissions and death in hospitalized patients who contracted the 2009 Pandemic Influenza A (H1N1). The results agreed with other studies suggesting that oseltamivir treatment was beneficial. Authors'' results suggest benefits that elderly persons may receive from vaccination.


VAERS ID: 494302 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-06-14
Entered: 2013-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Chills, Death, Dyspnoea, Influenza, Influenza A virus test positive, Myalgia, Pyrexia, Rhinitis
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: H1N1 influenza PCR, Positive
CDC Split Type: B0899639A

Write-up: This case was reported in a literature article and described the occurrence of death due to unknown causes in an elderly subject of unspecified gender who was vaccinated with Influenza vaccine unspecified, (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced influenza A (H1N1). The subject was hospitalised. The H1N1 was confirmed by Reverse Transcription Polymerisation Chain Reaction. The subject died from death due to unknown causes. It was unknown whether an autopsy was performed. Two cases were identified in this study (see case B0899558A). Summary of the literature article: The objective of this study was to evaluate the 2009 Pandemic Influenza A (H1N1) in the elderly and identify the clinical characteristics, mortality and prognostic factors of the infection in these patients. This was an observational, retrospective study. Data were collected from the National Notifiable Diseases, from the foreign Ministry of Health. Only patients 60-year-old or more that had laboratory confirmed infections were included. The socio-demographic and clinical variables and outcomes were evaluated to compare mortality rates in the presence or absence of these factors. The main symptoms of the patients who died, in decreasing order of frequency, were dyspnea, coryza, fever, myalgia and chills. The age groups 60-69 years and 80 years had mortality rates higher than the average total of 16.1%. The highest mortality rate was observed in patients over the age of 80 years. Two patients of the seven patients in this age group died. Among the subjects included in the study, 38 (40.9%) patients had been previously vaccinated against seasonal influenza, two (5.3%) of which died. Comparing among the 15 patients who died, only 2 (13.3%) of these patients had been previously vaccinated. Therefore, 86.7% of the deaths occurred in unvaccinated elderly patients, suggesting that vaccination may reduce the number of influenza-associated deaths. The mortality rate observed in unvaccinated patients was 15% (6/40) and was significantly (p<0.05) higher than that observed among the vaccinated patients, which was 5.2% (2/38). Similarly, the hospitalization rate among unvaccinated patients, which was 62.5% (25/40), was significantly higher than that observed among those who received the influenza vaccine, which had a rate of 44.7% (17/38). With regard to hospitalization, 58.1% of the elderly were hospitalized as a result of the disease. Hospitalization was also significantly correlated with outcome (p=0.003), with an increased rate of death being observed in those that were hospitalized. The rate of oseltamivir treatment was 88.6% in this study. Early treatment within 2 days after the onset of symptoms was significantly associated with a lower risk of emergency admissions and death in hospitalized patients who contracted the 2009 Pandemic Influenza A (H1N1). The results agreed with other studies suggesting that oseltamivir treatment was beneficial. Authors results suggest benefits that elderly persons may receive from vaccination.


VAERS ID: 494492 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Male  
Location: Foreign  
Vaccinated:2013-05-28
Onset:2013-05-29
   Days after vaccination:1
Submitted: 2013-06-18
   Days after onset:20
Entered: 2013-06-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER K0003B / 2 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1037 / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Body temperature increased, Death, Endotracheal intubation, Nasopharyngitis, Respiratory arrest, Resuscitation
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-05-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Family and personal medical history: not reported.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201306902

Write-up: Case received from a healthcare professional via the Health Authority (HA''s number: V13000264) through the local affiliate on 10 June 2013. A 18-month-old male patient, with no reported medical history, had received his first booster dose of ACTHIB (batch number J1037, route and site of administration not reported) and his first booster dose of DTP (other manufacturer, batch number K0003B, route and site of administration not reported) on 28 May 2013. On 29 May 2013, i.e the day following the vaccination, he developed cold-like symptoms. At 19:00, his body temperature was 40 degrees C or higher. On 30 May 2013, at 12:00 am, he was still alive (the last time that this was confirmed). At 01:00 am, his mother noticed that he was not breathing. An ambulance was called and he was brought to the hospital. After tracheal intubation and establishment of intravenous access, resuscitation was performed, but was unsuccessful. At 2:02 am, the patient''s death was confirmed. An autopsy was to be performed by the local police. Physician''s comment: "Within 24 hours after vaccination, the patient developed cold-like symptoms and fever of 40 degrees C or higher. He died soon after the onset of these symptoms. The cause of death remains unclear. This case was serious (fatal) and the causal relation between the event and ACTHIB was not assessible."


VAERS ID: 494500 (history)  
Form: Version 1.0  
Age: 1.14  
Sex: Male  
Location: Foreign  
Vaccinated:2013-04-18
Onset:0000-00-00
Submitted: 2013-06-17
Entered: 2013-06-19
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS A69CD124A / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G49220 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial sepsis, Death, Streptococcal sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-05-19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013180058

Write-up: This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number DHH-N2013-61929. A 13 months old male patient received PREVENAR 13 0.5 ml single dose lot nr G49220, intramuscular on 18Apr2013, and also received PRIORIX lot nr A69CD124A, intramuscular on 18Apr2013. The patient medical history and the patient''s concomitant medications were not reported. The patient was hospitalized for unknown date and experienced bacterial streptococcus sepsis on 19May2013 with outcome fatal. It was not reported if an autopsy was performed. The reporter considered there was no relationship between the event and the immunisation. Follow-up attempts completed. No further information expected.


VAERS ID: 495150 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-10-26
Onset:2013-06-12
   Days after vaccination:960
Submitted: 2013-06-25
   Days after onset:13
Entered: 2013-06-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: CSF culture positive, Death, Intensive care, Meningitis pneumococcal, Musculoskeletal stiffness, Pyrexia, Sepsis, Streptococcus test positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-06-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 22-JAN-2010, PREVENAR, 1st dose; 22-FEB-2010, PREVENAR, 2nd dose; 26-APR-2010, PREVENAR, 3rd dose; Therapy regimen changed
Allergies:
Diagnostic Lab Data: Cerebrospinal fluid (CSF) culture (Jun2013): Streptococcus pneumoniae 24F serotype
CDC Split Type: 2013185761

Write-up: This is a spontaneous report from a contactable physician from a medical advisor. A currently 3-years-old female patient was vaccinated at approximately age of 1 year old with PREVENAR 13 intramuscularly on 26Oct2010 at 0.5 ml, single. The patient had previously received three doses of PREVENAR 7: 1st dose on 22Jan2010, 2nd dose on 22Feb2010 and 3rd dose on 26Apr2010. Concomitant medication was none. On 12Jun2013 the patient was admitted to the Intensive care unit (ICU) with high fever and intense neck stiffness and he was diagnosed pneumococcal meningitis. On 14Jun2013 the patient experienced sepsis and died due to sepsis. Cerebrospinal fluid (CSF) culture performed on Jun2013 showed the presence of Streptococcus Pneumoniae, serotype 24F. No follow up attempts possible. No further information expected.


VAERS ID: 495245 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-06-26
Entered: 2013-06-27
   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: Coma, Death
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013185956

Write-up: This is a spontaneous report from a contactable physician via Pfizer medical information team. A 3-month-old male infant received the first dose of PREVENAR 13 0.5 ml single dose, in 2012. Medical history and concomitant medications were not reported. Thirty hours following the vaccination, the infant went into a coma and died in 2012. The outcome of coma was not specified. Therapeutic measures taken as a result of the event were unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 495408 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-06-21
Onset:2013-06-22
   Days after vaccination:1
Submitted: 2013-06-27
   Days after onset:5
Entered: 2013-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC012AD / 2 LG / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Craniocerebral injury, Death, Kidney contusion
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-06-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0903026A

Write-up: This case was reported in a newspaper article and described the occurrence of craniocerebral injury in a 1-month-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included 1st dose of hepatitis vaccine not otherwise specified, (manufacturer unspecified) given in May 2013. On 21 June 2013, the subject received 2nd dose of hepatitis vaccine (unspecified) (unknown route, site of injection and batch number). According to national immunization calender, the hepatitis vaccine used is ENGERIX B. However, no information were reported in the article to confirm the vaccination with ENGERIX B. On 22 June 2013, 1 day after vaccination with hepatitis vaccine (unspecified), the subject died. An autopsy was performed and showed contusions (abdominal bruising in the kidney region) and craniocerebral injury. The case will be investigated by the local prosecution. Follow-up information receive from the subject''s general practitioner: On 21 June 2013, the subject received 2nd dose of ENGERIX B (intramuscular, unknown thigh and batch number provided). On 22 June 2013, the subject died from contusions and craniocerebral injury. The physician assessed an unrelated relationship between the subject''s death and vaccination with ENGERIX B. No further information will be available.


VAERS ID: 495540 (history)  
Form: Version 1.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2006-05-02
Onset:2012-09-25
   Days after vaccination:2338
Submitted: 2013-06-28
   Days after onset:276
Entered: 2013-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS VX17027 / 1 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Subject was enrolled in Vaccine Trial and received 3 doses of CERVARIX. Following closeout from CVT in 12/17/2010, patient continued in Extended Follow-up Study (since 8/1/2011). At study visit on 6/21/2013, parents-in-law of patient reported she passed away at home on 9/25/2012. Patient has hx of severe dilated cardiomyopathy starting in 2008, and suffered severe respiratory illnesses and a stroke in 2010 and 2011, respectively. Cause of death was believed to be related to her underlying heart condition and not related to vaccination.


VAERS ID: 495650 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2000-11-02
Onset:0000-00-00
Submitted: 2013-07-02
Entered: 2013-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Cough, Death, Hypoxia, Pulmonary fibrosis, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Interstitial lung disease (narrow), 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), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), 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: Prednisolone
Current Illness: Pulmonary fibrosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2001GB01438

Write-up: Case previously recorded as MA2001-0722. We received the following information from the regulatory agency: An 80 year old man was vaccinated for the first time with a virus influenza vaccine i.m. and PNEUMOVAX II vaccine i.m. on 02 NOV 2000. Activation of lung fibrosis with increasing SOBOE and progressive cough after flu and PNEUMOVAX II injections. Died from progressive CFA after 8 months. Required increased steroids (prednisolone increased from usual 10 mg daily to 30 mg). Oxygen saturation 60% on exercise. Died of respiratory failure with hypoxia. Cryptogenic pulmonary fibrosis had been stable for 3 years. Assessment: Seriousness criterion: death. Causality: unrelated. No. 434541. Following an internal review on 25 Jun 2013, it was found that the case PHHY2001GB01969 was identical to this case PHHY2001GB01438. Hence all the information of this case PHHY2001GB01438 was merged into the case PHHY2001GB01969 and this case PHHY2001GB01438 will be deactivated.


VAERS ID: 495670 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-10-23
Onset:0000-00-00
Submitted: 2013-07-02
Entered: 2013-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Dyspnoea, General physical health deterioration, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prednisolone; Azathioprine
Current Illness: Crohn''s disease; Idiopathic pulmonary fibrosis, As reported: alveolitis fibrosing
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2003GB00628

Write-up: Case previously recorded as SI2003-0083. A 53 year-old woman was vaccinated with an infuenza virus vaccine (manufact. unk.) on 23 OCT 2002. Patient had a history of crptogenic fibrosing alveolitis and Crohn''s disease since many years, treated with prednisolone and azathioprine. One-two weeks after receiving the flu jab the patient experienced aggravation with shortness of breath. Patient was admitted to hospital. Her condition continued to deteriorate. Patient died due to pulmonary embolus. The reporter considered the reaction to be serious for the following reasons: involved or prolonged in patient hospitalization; patient died due to reaction. No further information. Following an internal review received on 25 Jun 2013, it was identified that the case PHHY2003GB00628 was a duplicate of the case PHHY2003GB00609 and hence all the information of PHHY2003GB00628 was merged to PHHY2003GB00609 and PHHY2003GB00628 will be deactivated.


VAERS ID: 495672 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-10-23
Onset:0000-00-00
Submitted: 2013-07-02
Entered: 2013-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Dyspnoea, General physical health deterioration, Pulmonary embolism, Pulmonary fibrosis
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: Prednisolone; Azathioprine
Current Illness: Pulmonary fibrosis, alveolitis fibrosing; Crohn''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2003GB00609

Write-up: Case previously recorded as MA2003-0125. We received from the regulatory agency the following information: A 53-year-old woman was vaccinated with a virus influenza vaccine (batch-no. and manufacturer unknown) i.m. on 23 OCT 2002. She was suffering from cryptogenic fibrosing alveolitis and Crohn''s disease for many years. 1-2 weeks after receiving the flu jab the patient experienced aggravation of lung fibrosis with shortness of breath and was admitted to hospital. The patient''s condition continued to deteriorate. The patient died due to pulmonary embolus. Medical history: alveolitis fibrosing and Crohn''s disease. Assessment: Seriousness criteria: hospitalisation, fatal outcome. Causality: unrelated. No. 454191. Following an internal review received on 25 Jun 2013, it was identified that cases PHHY2003GB01709 and PHHY2003GB00628 were duplicates of the case PHHY2003GB00609 and hence all the information of PHHY2003GB01709 and PHHY2003GB00628 was merged to PHHY2003GB00609. PHHY2003GB01709 and PHHY2003GB00628 were deactivated. The suspect product was recoded from BEGRIVAC unknown to seasonal influenza vaccine (manufacturer and batch number unknown). Concomitant medications included prednisolone 10 mg and azathioprine 100 mg used for treating Crohn''s disease. It was reported that no autopsy was performed. It was mentioned that the case was assessed as unrelated to the vaccine since cryptogenic fibrosing alveolitis was a chronic and irreversible interstitial lung disease with a 5-year survival rate of 30 to 50 % after diagnosis.


VAERS ID: 495677 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-10-23
Onset:0000-00-00
Submitted: 2013-07-02
Entered: 2013-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Dyspnoea, General physical health deterioration, Pulmonary embolism, Pulmonary fibrosis
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Azathioprine; Prednisolone
Current Illness: Idiopathic pulmonary fibrosis; Crohn''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2003GB01709

Write-up: Case previously recorded as PJP-2003-00095. An ASPP (Anonymised Single Patient Print) was received from a regulatory authority on 10 March 2003 concerning a 53 year old female vaccinee who was hospitalised due to shortness of breath and aggravation of lung fibrosis, then died due to a pulmonary embolus 1 - 2 weeks after vaccination with virus influenza (brand unspecified) on 23 October 2002. The vaccinee had a history of cryptogenic fibrosing alveolitis and Crohn''s disease for many years. Concomitant medications taken included prednisolone and azathioprine. On an unspecified date, one to two weeks following influenza vaccination the vaccinee experienced aggravated lung fibrosis with shortness of breath. The vaccinee was admitted to hospital where her condition continued to deteriorate. The vaccinee died due to pulmonary embolus. No autopsy was performed. There was insufficient information to determine the reporter''s causality assessment. Following an internal review received on 25 Jun 2013, it was identified that the case PHHY2003GB01709 was a duplicate of the case PHHY2003GB00609 and hence all the information of PHHY2003GB01709 was merged to PHHY2003GB00609 and the case PHHY2003GB01709 will be deactivated.


VAERS ID: 495781 (history)  
Form: Version 1.0  
Age: 1.01  
Sex: Female  
Location: Foreign  
Vaccinated:2011-12-05
Onset:0000-00-00
Submitted: 2013-07-02
Entered: 2013-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / 4 UN / SYR
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / SYR
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 4 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Apoptosis, Autopsy, Cardiac arrest, Coxsackie virus test negative, Culture throat positive, Death, Dehydration, Diarrhoea, Inflammation, Morbillivirus test positive, Muscle necrosis, Myocarditis, Pericardial drainage test normal, Pharyngitis, Pyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), 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), Pseudomembranous colitis (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, Dec 2011, 36Deg. C; Physical examination, Dec2011, Dehydrated
CDC Split Type: B0811004A

Write-up: This case was reported by a paediatrician and described the occurrence of fatal myocarditis in a 13-month-old female subject who was vaccinated with PRIORIX, HIBERIX (GlaxoSmithKline), PREVENAR 13 (non-GSK) and NEISVAC-C. On an unspecified date, the subject received unspecified dose of PRIORIX (unknown route of administration, unknown site of injection, batch number not provided). 8 days after vaccination with PRIORIX, the subject experienced fatal myocarditis. The subject died, the cause of death was fatal myocarditis. It was unknown whether an autopsy was performed. No further information was expected. Follow-up information received on 27 August 2012: Despite several attempts, no further information could be obtained. Therefore, this case has been closed. Follow-up information received on 28 June 2013 from a paediatrician via public health representative: The subject had no relevant medical history. On 5 December 2011, the subject received 4th dose of HIBERIX, 1st dose of PRIORIX, 4th dose of PREVENAR 13 and 1st dose of NEISVAC-C (unknown routes and injection sites, batch numbers not provided). In December 2011, 14 days after vaccination with HIBERIX, NEISVAC-C, PREVENAR 13 and PRIORIX, the subject experienced fever and pharyngitis. The subject was treated with antibiotics. 2 days later, the subject experienced vomiting and diarrhea. She was admitted to hospital. She was assessed to be moderately dehydrated and commenced on nasogastric tube fluids. The subject was afebrile (body temperature at 36 Deg. C). The physician considered the events were possible related to vaccination with HIBERIX, PRIORIX, PREVENAR 13 and NEISVAC-C. Approximately 2 hours after admission, the subject experienced cardiac arrest and died from myocarditis. An autopsy was performed and showed severe transmural chronic inflammation with associated myocyte necrosis and apoptosis. There was also noted to be inflammation in the epicardium. A throat swab at autopsy was vaccine strain measles (Genotype A) and Coxsackie A9 virus from a right tonsil swab. Pericardial fluid and myocardial samples were reportedly negative for measles virus (vaccine and wild type) and Coxsackie Ap virus. This case was identified as duplicate B0903851A. Case B0903851A was voided and all the future correspondence will be added int he present case which stands as case of record for this subject.


VAERS ID: 495927 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-06-09
Submitted: 2013-07-01
   Days after onset:22
Entered: 2013-07-05
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unspecified respiratory and heart problems.
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: 201307404

Write-up: Initial report received from the local affiliate on 25 June 2013. The information was collected in lay media by a Sanofi Pasteur spokesperson who sent it to the local affiliate on the same day. This case is not medically confirmed. A 77-year-old male patient (date of birth unknown) had received a dose of Influenza vaccine (manufacturer unknown) on an unspecified date and died on 09 June 2013 due to H1N1. The patient did not present with fever as a symptom, and was hospitalized for 10 days. Corrective treatments and complementary investigations were unknown. The patient had medical history of unspecified respiratory and heart problems. Family history was unknown. No additional information was provided. Additional information has been requested by the local affiliate. Documents held by sender: None.


VAERS ID: 495937 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-04-04
Onset:2010-07-05
   Days after vaccination:92
Submitted: 2013-07-01
   Days after onset:1092
Entered: 2013-07-05
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Chills, Cough, Death, Influenza A virus test positive, Myalgia, Pyrexia, Rhinitis
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-07-18
   Days after onset: 13
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: Medical history included asthmatic bronchitis.
Allergies:
Diagnostic Lab Data: Examination for detection of H1N1 was performed with positive results (date not reported).
CDC Split Type: 201307405

Write-up: Initial report received from a health care professional via the local affiliate on 25 June 2013. This case is medically confirmed. A 10-year-old patient (date of birth and gender unknown) had received a dose of Influenza Vaccine (manufacturer name and lot number unknown) on 04 April 2010 and on 05 July 2010 presented with fever, cough, coryza, chills, arthralgia and myalgia and was hospitalized that day. Examination for detection of H1N1 was performed with positive results. The patient was medicated with TAMIFLU, but died on 18 July 2010 due to H1N1. The patient had medical history of asthmatic bronchitis. Family history was unknown. No additional information was provided. Documents held by sender: None.


VAERS ID: 496315 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2002-10-23
Onset:0000-00-00
Submitted: 2013-07-09
Entered: 2013-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Dyspnoea, General physical health deterioration, Idiopathic pulmonary fibrosis, Pulmonary embolism, Pulmonary fibrosis
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: Prednisolone; Azathioprine
Current Illness: Unknown
Preexisting Conditions: Post inflammatory pulmonary fibrosis, regional enteritis of unspecified s
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0906066A

Write-up: This case was reported by the foreign regulatory authority and described the occurrence of alveolitis fibrosing in a 53-year-old female subject who was vaccinated with Influenza vaccine (unspecified). The subject''s medical history included post inflammatory pulmonary fibrosis and regional enteritis of unspecified site. Concurrent medications included Prednisolone and Azathioprine. On 23 October 2002 the subject received unspecified dose of Influenza vaccine (unspecified) (0.5 ml, intramuscular). In 2002, 1 to 2 weeks after vaccination with Influenza vaccine (unspecified), the subject experienced alveolitis fibrosing, pulmonary embolism and shortness of breath. The subject was hospitalised and the regulatory authority reported that the events were disabling and life threatening. The regulatory authority reported that the events were not related to vaccination with Influenza vaccine (unspecified). The subject died in 2002 from pulmonary embolism. It was unknown whether an autopsy was performed. Agency verbatim text: Case previously recorded as MA2003-0125. We received from the Agency the following information: A 53-year-old woman was vaccinated with a virus influenza vaccine (batch-no. and manufacturer unknown) i.m. on 23 OCT 2002. She was suffering from cryptogenic fibrosing alveolitis and Crohn''s disease for many years. 1-2 weeks after receiving the flu jab the patient experienced aggravation of lung fibrosis with shortness of breath and was admitted to hospital. The patient''s condition continued to deteriorate. The patient died due to pulmonary embolus. Medical history: alveolitis fibrosing and Crohn''s disease. Assessment: Seriousness criteria: hospitalisation, fatal outcome. Causality: unrelated. Agency-no. 454191. Following an internal review received on 25 Jun 2013, it was identified that cases PHHY2003GB01709 and PHHY2003GB00628 were duplicates of the case PHHY2003GB00609 and hence all the information of PHHY2003GB01709 and PHHY2003GB00628 was merged to PHHY2003GB00609. PHHY2003GB01709 and PHHY2003GB00628 were deactivated. The suspect product was recoded from BEGRIVAC unknown to seasonal influenza vaccine (manufacturer and batch number unknown). Concomitant medications included Prednisolone 10 mg and Azathioprine 100 mg used for treating Crohn''s disease. It was reported that no autopsy was performed. It was mentioned that the case was assessed as unrelated to the vaccine since cryptogenic fibrosing alveolitis was a chronic and irreversible interstitial lung disease with a 5-year survival rate of 30 to 50% after diagnosis.


VAERS ID: 496745 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-29
Onset:2012-10-30
   Days after vaccination:1
Submitted: 2013-07-11
   Days after onset:254
Entered: 2013-07-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 20122013A15 / UNK LA / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F29673 / 1 RA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood creatinine increased, Blood lactate dehydrogenase increased, Blood urea increased, Blood uric acid increased, Bronchitis, C-reactive protein increased, Cardiac arrest, Chest X-ray normal, Condition aggravated, Cough, Death, Dehydration, Electrolyte imbalance, Fatigue, General physical health deterioration, Glomerular filtration rate, Inflammatory marker increased, Renal failure, Renal failure acute, Resuscitation, Sepsis
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (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), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-23
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MARCUMAR
Current Illness:
Preexisting Conditions: Coronary artery disease; Myocardial infarction; Apoplectic fit, status post several insults; Hypertension arterial; Aortic aneurysm repair, Status post aortic aneurysm surgery in 1990; Influenza vaccine; PREVENAR; PNEUMOVAX
Allergies:
Diagnostic Lab Data: 05-NOV-2012, Blood lactate dehydrogenase, 326 IU/l; 07-NOV-2012, Blood lactate dehydrogenase, 258 IU/l; 12-NOV-2012, Blood lactate dehydrogenase, 271 IU/l; 29-OCT-2012, Blood urea, 106 mg/dl; 05-NOV-2012, Blood urea, 180 mg/dl; 07-NOV-2012, Blood urea, 179 mg/dl; 12-NOV-2012, Blood urea, 126 mg/dl; 05-NOV-2012, Blood uric acid, 9.9 mg/dl; 07-NOV-2012, Blood uric acid, 9.9 mg/dl; 12-NOV-2012, Blood uric acid, 7.9 mg/dl; C-reactive protein (05Nov2012): 114; C-reactive protein (07Nov2012): 132; C-reactive protein (12Nov2012): 136; Glomerular filtration rate (12Nov2012): 11.73; Creatinine (29Oct2012): 3.7; Creatinine (05Nov2012): 5.33; Creatinine (07Nov2012): 5.22; Creatinine (12Nov2012): 5.03
CDC Split Type: 2013200913

Write-up: This is a spontaneous report received from the foreign Health Authority. Regulatory Authority report number DE-PEI-PEI2013037811. A male 84-year-old patient was vaccinated on 29Oct2012 with the first dose of PREVENAR 13 (lot./batch no.: F29673), at 0.5 ml single dose into the right upper arm and with GRIPPEIMPFSTOFF RATIOPHARM (lot. 2012/2013 A15; batch A15), at 1 DF single into the left upper arm. Concomitant medication included MARCUMAR. Previous seasonal influenza vaccinations (administered yearly) had been well tolerated. Medical history included coronary artery disease, myocardial infarction, apoplectic fit, arterial hypertension, and aortic aneurysm repair in 1990. Previous vaccinations included influenza vaccine, PREVENAR and in 2005 PNEUMOVAX. On 30Oct2012, the patient experienced general physical health deterioration with tiredness. On 05Nov2012, a deterioration of the preexisting renal insufficiency was detected with elevated creatinine and urea values. In addition, inflammatory parameters (C-reactive protein) were increased. On 14Nov2012, the patient was admitted to hospital where he presented with nonproductive cough as well as increasing deterioration of the general condition with significantly elevated inflammatory and retention parameters. A chest X-ray did not reveal a infiltration of the lung. The patient was diagnosed with a bronchitis infection, exsiccosis and acute on chronic renal failure. Sepsis was suspected, but no pathogenic microorganisms were detected. Thus, it has to be assumed that the patient had been suffering from a systemic inflammatory response syndrome (SIRS). The patient was treated with intravenous fluids as well as ampicillin/sulbactam. Unfortunately, the antibiotic therapy had a bad response. On 23Nov2012 experienced Electrolyte Imbalance. Patient was hospitalized from 14Nov2012 to 23Nov2013. On 23Nov2012, the patient decided to discharge himself against medical advice. Before doing this, the patient experienced a cardiac arrest and required cardiorespiratory resuscitation. When the patient experienced a second cardiac arrest, no further CPR was performed, since the patient had decided in advance to refuse resuscitation and intensive care treatment. The patient died on 23Nov2012 at the clinic. According to the reporting physician, no autopsy was performed. Reporter''s comment as provided by Regulatory Authority: Most likely consistent with bronchitis infection accompanied by exsiccosis and consecutive acute on chronic renal failure. Antibiotic treatment did not take effect. Additional information provided by physician: Event''s outcome was reported as fatal. Exitus letalis due to malignant dysrhythmia in the context of septic infection and electrolyte imbalance. No follow-up attempts needed, follow-up automatically provided by agency.


VAERS ID: 497193 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-01-03
Onset:0000-00-00
Submitted: 2013-07-18
Entered: 2013-07-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Congenital absence of cranial vault, Congenital adrenal gland hypoplasia, Congenital diaphragmatic hernia, Death, Foetal exposure during pregnancy, Pulmonary hypoplasia
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-03-11
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: Maternal exposure timing unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307DNK009995

Write-up: Case was received by a physician via the Health Authorities on 08-Jul-2013 under the reference DK-DKMA-ADR 22166169. Case medically confirmed. This case is linked to case E2013-05277 (patient''s mother, same vaccine). A foetus had received the second dose of GARDASIL (batch number not reported) via transplacental route on 03-Jan-2013 as the mother of the patient had been vaccinated with GARDASIL. On an unspecified date the patient developed absence of cranial vault, congenital diaphragmatic hernia, congenital adrenal gland hypoplasia and pulmonary hypoplasia. Abortion was induced. The patient died on 11-Mar-2013. Autopsy was determined. It was reported that the mother was 19 gestation week at the time of the events but it was not specified whether it was at the time of vaccination, at the time of induced abortion or at the time of congenital anomalies diagnosis. The mother received D1 of GARDASIL on 06-Nov-2012, toleration not reported.


VAERS ID: 497348 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2003-01-17
Onset:0000-00-00
Submitted: 2013-07-19
Entered: 2013-07-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (INFANRIX PENTA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute pulmonary oedema, Cardiac arrest, Circulatory collapse, Death, Interstitial lung disease, Mental disorder due to a general medical condition, Myocarditis
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Interstitial lung disease (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-02-07
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: According to the pre-vaccination history taken by the vaccinating physician at the time of vaccination on 17-JAN-03, the patient was in excellent general condition, she never presented with febrile, inflammatory or allergic episodes, was not receiving any concomitant treatment, was never hospitalized. Birth weight 3040 gr. at birth, 5150 gr. on 08-JAN-03 at the pediatric check up. Family history was negative. According to the legal physician the patient''s mother was allergic to metals and affected by dermatitis, the paternal grandmother suffered from thyroid disease, a paternal cousin presented with skin erythema following vaccination, a paternal aunt was allergic to metals and maternal cousin was affected by psoriasis.
Allergies:
Diagnostic Lab Data:
CDC Split Type: E201305103

Write-up: Case retrieved from the lay press through agency (local case n. IT510/13) on 04-JUL-2013. Case not medically confirmed. A 4 month old female was vaccinated with one dose of DTAP-IPV-HIB-HEPB vaccine (Mfr. Unknown, batch n., route of administration and injection site not reported) on 17-JAN-2003. On 07-FEB-2003 the parents found her dead in the cradle. The case involved in a legal procedure (no medical or legal documentation is available) and the jury returned a verdict of monetary compensation for the parents on 02-Jul-2003. The outcome is fatal. The case is closed. Follow-up information received from the health care professional (vaccinating physician) through field force on 09-JUL-13. Case medically confirmed. The vaccinating physician who was made aware of the case at the time of the legal procedure against the Ministry of Health verbally communicate that the patient was vaccinated on17-JAN-03 with the first dose of INFANRIX PENTA (Mfr. GSK, batch n. not reported) and with the first dose of ACT HIB (batch n. not reported). The Company not obtained a clinical report written by the vaccination physician based on knowledge from evidence based medicine, on the report by the patient''s family legal physician and on the information from the patient''s vaccination chart. According to this report, the autopsy report dated 18-MAR-03 reports the diagnosis of bilateral lymphocytic interstitial pneumonia in multiple foci with associated acute pulmonary edema. Modest lymphocytic interstitial myocarditis. Total heart collapse due to cardiac arrest. The legal physician''s report mentions "encephalitic syndrome" which however is not mentioned in the autopsy report. According to the pre-vaccination history taken by the vaccinating physician at the time of vaccination on 17-JAN-03, the patient was in excellent general condition, she never presented with febrile, inflammatory or allergic episodes, was not receiving any concomitant treatment, was never hospitalized. Birth weight 3040 gr. at birth, 5150 gr. on 08-JAN-03 at the pediatric check up. Family history was negative. According to the legal physician the patient''s mother was allergic to metals and affected by dermatitis, the paternal grandmother suffered from thyroid disease, a paternal cousin presented with skin erythema following vaccination, a paternal aunt was allergic to metals and a maternal cousin was affected by psoriasis. The patient''s clinical history, confirmed by the vaccination chart, by the pediatrician as well as by the legal physician, shows that the patient responded well to external stimuli, maintained a good level of contact and attention, smiled. The parents felt she was growing rapidly and even more intensely than normal. The pediatric check-ups were all positive and the patient was vaccinated according to schedule. No further medical information is available in the report. The patient died on 07-FEB-2003.


VAERS ID: 497558 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-06-16
Submitted: 2013-07-18
   Days after onset:32
Entered: 2013-07-24
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cerebrovascular accident, Coma, Death, Influenza
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), 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: DIOVAN; EXELON Patch
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2013AR075728

Write-up: Case number PHHY2013AR075728, is an initial report received from a consumer (daughter of the patient) via patient oriented program on 15 Jul 2013. This report refers to an elderly male patient. The patient received DIOVAN tablets for pressure from 2 years ago (approximately) at a dose of 1 DF (80mg) daily, orally. Also, the patient received EXELON patch for Alzheimer principle from 1 year ago at a dose of 1 DF (4.6mg) daily, transdermal route. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number unknown) on unspecified date and had a very strong flu. On 16 Jun 2013 (five days after vaccination), patient experienced massive stroke; went into coma and was hospitalized. The patient died due to massive stroke and coma. It was unknown whether autopsy was done or not. Seriousness and outcome for strong flu were not reported. Causality for events was not reported.


VAERS ID: 497685 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-07-25
Entered: 2013-07-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza, Serology test, Tuberculosis
SMQs:, Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-07-17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Patient''s history was unknown.
Allergies:
Diagnostic Lab Data: Serology testing was performed. Results were not available.
CDC Split Type: 201307958

Write-up: Initial information was received on 18 July 2013 through the local affiliate from the lay media. A 59-year-old male patient received an injection of influenza vaccine, manufacturer and lot number unknown (route, site and side of vaccination were not reported) on an unknown date in 2013. According to the reporter, all persons had been vaccinated at the beginning of the year. An unspecified amount of time later, the patient had suspected influenza A/H1N1. The patient was hospitalized for four days. There was no confirmation regarding the cause of death, as there were two suspects that were under evaluation: influenza A/H1N1 and tuberculosis. Serologies were collected and sent to the laboratory, but resullts were not available. No additional information was provided. The patient''s outcome was reported as fatal on 17 July 2013. Documents held by sender: None.


VAERS ID: 497896 (history)  
Form: Version 1.0  
Age: 0.51  
Sex: Female  
Location: Foreign  
Vaccinated:2013-04-29
Onset:2013-05-04
   Days after vaccination:5
Submitted: 2013-07-26
   Days after onset:83
Entered: 2013-07-29
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB591A / UNK LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Dose 1, INFANRIX HEXA, No adverse effect; Dose 2, INFANRIX HEXA, No adverse effect; Dose 1, PREVENAR-13, No adverse effect; Dose 2, PREVENAR-13, No adverse effect; NEISVAC-C, No adverse effect; Rotavirus vaccine, No adverse effect
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013213919

Write-up: This is a spontaneous report received from the Health Authority. Regulatory Authority report number DE-PEI-PEI2013041554. A 6-month-old female patient received the third dose of PREVENAR 13 (Batch no. G79394) intramuscular in the right thigh on 29Apr2013, at 0.5ml single, and INFANRIX HEXA (Lot/Batch no. A21CB591A) intramuscular in the left thigh, on 29Apr2013. Commitant medication was not reported. Patient past drug therapy included: first dose of diphtheria, tetanus and acellular pertussis, haemophilus influenzae b, hepatitis b vaccine, poliomyelitis vaccine inactivated on 27Dec2012 which had been tolerated, second dose of diphtheria, tetanus and acellular pertussis, haemophilus influenzae b, hepatitis b vaccine, poliomyelitis vaccine inactivated on 26Mar2013 which had been tolerated, first dose of pneumococcal 13-val conj vac on 27Dec2012 which had been tolerated and second dose of pneumococcal 13-val conj vac on 26Mar2013 which had been tolerated, NEISVAC-C on 21Feb2013 which had been tolerated, ROTARIX - on 21Feb2013 which had been tolerated, ROTARIX - on 05Apr2013 which had been tolerated. The patient was found dead by her mother on 04May2013. Death cause was reported by the reporting physician as presumption diagnosis of SIDS. An autopsy was performed. Follow-up information (including autopsy report) has been requested. This case is being treated according to the Agency (Protection against Infection Act). No follow-up attempts needed, follow-up automatically provided by agency.


VAERS ID: 498096 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2013-07-12
Onset:2013-07-13
   Days after vaccination:1
Submitted: 2013-07-30
   Days after onset:17
Entered: 2013-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1331 / 2 UN / SC
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER 12H04A / 2 UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA543BA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Blood test abnormal, Cardio-respiratory arrest, Cerebral ischaemia, Death, Hyperlactacidaemia, Metabolic acidosis, Pallor, Resuscitation, Tonic convulsion, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-07-14
   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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 13Jul2013, no increase; Blood test, 13Jul2013, metabolic acidosis
CDC Split Type: B0911474A

Write-up: This case was reported by a physician via a regulatory authority (# V13000472) and described the occurrence of cardiorespiratory arrest in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), (non-gsk) ACTHIB, pneumococcal vaccine (unknown manufacturer), DTaP-IPV (unknown manufacturer). Concurrent vaccination included ACTHIB (non-GSK manufacturer, subcutaneous); ROTARIX (GlaxoSmithKline; oral); pneumococcal vaccine (manufacturer unspecified, subcutaneous) all given on 7 June 2013. On 5 July 2013, the subject received unspecified dose of DTaP-IPV (subcutaneous, unknown injection site and batch number). On 12 July 2013, at 14:30, the subject received 2nd dose of ROTARIX (oral), 2nd dose of ACTHIB (subcutaneous, unknown injection site and batch number), 2nd dose of pneumococcal vaccine (subcutaneous, unknown injection site and batch number). On 13 July 2013, at 11:00, 1 day after vaccination with ACTHIB, pneumococcal vaccine and ROTARIX, 8 days after vaccination with DTaP-IPV, the subject experienced 4 episodes of vomiting. The subject visited a clinic, from which she was referred to another hospital. At the time of the visit to hospital, the subject had an ill complexion, and blood test showed marked metabolic acidosis and hyperlacticacidaemia. The subject was hospitalised. On 13 July 2013, at 22:00, the subject experienced generalised tonic convulsion. On 13 July 2013, at 22:10, the subject experienced a cardio-respiratory arrest. Resuscitation was performed. Return of spontaneous circulation was noted 30 minutes later. Thereafter, the subject was transferred to the reporter''s hospital. Severe cerebral ischaemia was noted, no increase of blood pressure was observed. The regulatory authority reported that the cardiorespiratory arrest was related to vaccination with ROTARIX. The causal relationship of vomiting, complexion ill, metabolic acidosis, hyperlacticacidaemia, tonic convulsion, and cerebral ischaemia to ROTARIX was not provided. Although occurring suddenly, the events were considered unlikely to be metabolic diseases based on blood test and others. Therefore, the events were strongly suspected to be related to the vaccinations. The subject died on 14 July 2013 from cardiorespiratory arrest. It was unknown whether an autopsy was performed.


VAERS ID: 498114 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2013-07-03
Onset:2013-07-06
   Days after vaccination:3
Submitted: 2013-07-30
   Days after onset:24
Entered: 2013-07-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1342 / 3 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 12H03A / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Brain oedema, Bronchial secretion retention, Cardio-respiratory arrest, Death, Endotracheal intubation, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-07-06
   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: No personal and family medical history; No history of adverse event to previous administration of vaccine or drug
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201308068

Write-up: Case received from the Health Authorities on 23 July 2013 under the reference number V13000478. A 06-month-old male patient, with no relevant personal and family medical history, had received his 3rd primary dose of ACTHIB (batch number J1342, route and site of administration not reported) and his 3rd primary dose of PREVENAR (other manufacturer, batch number 12H03A route and site of administration not reported) on 03 July 2013 at 14:00. His body temperature before vaccination was 36.7 degrees C. The patient''s weight at birth was 3668 g. He had no history of adverse event to previous administration of vaccine or drug. On 06 July 2013, around 3:00 a.m., the patient was found to be in cardiorespiratory arrest. At 5:28 a.m., emergency ambulance was requested. At hospital, the patient was confirmed to be in cardiorespiratory arrest. Cardiorespiratory resuscitation including tracheal intubation and epinephrine administration was performed, but there was no response. At 6:35 a.m., resuscitation was discotinued. Death was confirmed. Autopsy imaging revealed brain oedema and retention in the bronchi. Physician''s comment: "The causal relationship with the vaccines was not assessable. The event was possibly related to asphyxia."


VAERS ID: 498221 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2003-01-17
Onset:0000-00-00
Submitted: 2013-08-01
Entered: 2013-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (INFANRIX PENTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SYR
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Autopsy, Circadian rhythm sleep disorder, Death, Decreased appetite, Interstitial lung disease
SMQs:, Interstitial lung disease (narrow), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-02-07
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: B0906788A

Write-up: This case was reported in a newspaper article and described the occurrence of death due to interstitial pneumonia in a 4-month-old female subject who was vaccinated with INFANRIX PENTA (GlaxoSmithKline), ACT-HIB (non-gsk). On 17 January 2003 the subject received unspecified dose of DTPa-HBV-IPV-HIB (unknown route, unknown injection site). Lot number was not provided. Less than one month after vaccination with DTPa-HBV-IPV-HIB, the subject experienced symptoms such as joint pain, loss of appetite and sleep-wake schedule disorder. The subject was found dead in her cradle on 7 February 2003. The subject died on 7 February 2003 from interstitial pneumonia. An autopsy was performed. The parents filed a lawsuit at the Court and won the legal suit he filed against the Ministry of Health. The judge has recognized the causal relationship that a number of physicians, consultants of the family, and the judge''s consultant had established between the vaccination with hexavalent vaccine that was administered to the baby and her death which occurred in February. Follow up information received on 31 July 2013 from another manufacturer: According to a sales representative from Sanofi-Pasteur, the subject had been vaccinated with INFANRIX PENTA and ACT-HIB on 17 January 2003. This information was not officially confirmed.


VAERS ID: 498707 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-11-13
Onset:2012-11-13
   Days after vaccination:0
Submitted: 2013-08-07
   Days after onset:266
Entered: 2013-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA750AB / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: C-reactive protein increased, Chest X-ray normal, Chest discomfort, Cough, Death, Malaise, Pulmonary function test abnormal, Pyrexia, Rales
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-14
   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:
Current Illness: Unknown
Preexisting Conditions: Cardiac arrest, Chronic atrial fibrillation, Chronic obstructive pulmonary disease, Coronary artery disease, Heart failure, Low blood pressure, Surgery, Type II Diabetes
Allergies:
Diagnostic Lab Data: Body temperature, Nov2012, 39.4Deg. C; C-reactive protein, Nov2012, 67; Chest X-ray, Nov2012, no distinct pneu; Pulmonary function test, Nov2012, Rales on the left
CDC Split Type: B0913744A

Write-up: This case was reported by a nurse via a regulatory authority (# FI-FIMEA-20130911) and described the occurrence of death (cause undetermined) in a 80-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject''s medical history included cardiac arrest, chronic atrial fibrillation, chronic obstructive pulmonary disease, coronary artery disease, heart failure, low blood pressure, surgery and type II diabetes. On 13 November 2012, the subject received unspecified dose of FLUARIX (intramuscular, right upper deltoid). On 13 November 2012 (evening), within hours of vaccination with FLUARIX, the subject experienced chest discomfort, malaise and cough. Ague-type fever up to 39.4 Deg. C occurred in the night. The subject was hospitalised. Rales were heard on the left in the lungs on auscultation. No distinct pneumonia was seen in the lung x-ray. The subject was treated with ZINACEF. In the evening of 14 November 2012 the subject was found dead in his bed. It was unknown whether an autopsy was performed but requisition for medicolegal autopsy has been done.


VAERS ID: 498840 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-07
Entered: 2013-08-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza
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: Unknown
CDC Split Type: 201308186

Write-up: Initial case was received on 29 July 2013 from a non health care professional "lay media" via the local affiliate which involves a cluster of two elderly patients. Two unidentified elderly patients ages over 60 year, "came to death due to influenza virus infection after receiving influenza vaccine (manufacturer, lot number, route and site of administration not reported) in the same year." No further information was available at the time of the report. Outcome was fatal. Documents held by sender: none.


VAERS ID: 498864 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-04-30
Onset:2013-04-30
   Days after vaccination:0
Submitted: 2013-08-07
   Days after onset:99
Entered: 2013-08-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 090636201 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Condition aggravated, Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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: Known allergy; Other medical conditions; Acute myocardial infarction, unspecified
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013037172

Write-up: This health authority report (initial receipt 24-Jul-2013) concerns a 62 year old female patient with known allergy and other medical conditions. The patient had predisposing condition acute myocardial infarction unspecified. On 30-Apr-2013, the patient received influenza virus vaccine (batch 0906-36201) via intramuscular route at a dose of 0.5 ml. On 30-Apr-2013, within 12 hours post vaccination, the patient developed myocardial infarction which was severe. There was no improvement on dechallenge and no rechallenge was performed. The event outcome was fatal - unrelated to drug. Reporter''s comments: The reporter considered events serious as the patient died and unlikely in relation to the suspect drug. Cause(s) of death: Unknown cause of death.


VAERS ID: 498887 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-07
Entered: 2013-08-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Drug administered at inappropriate site, Inappropriate schedule of drug administration, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2013EG084610

Write-up: Case number PHHY2013EG084610 is an initial literature report from the health authority received on 06 Aug 2013. The authors presented a fatal case of vaccination failure of rabies vaccine. This report refers to a 09-year-old patient whose gender was not provided. The patient''s medical history was not reported. The patient received four doses of rabies vaccine (manufacturer unknown, so conservatively coded as RABIPUR INN, batch number: not reported) on an unknown date. It was reported that the first dose of rabies vaccine was administered in the gluteal muscle instead of the deltoid (inappropriate site) and the third dose was received on day 8 instead of 7 (inappropriate schedule). On an unknown date before receiving the fifth dose of rabies vaccine, the child developed rabies symptoms and died. It was reported that the vaccination failure was likely due to administration errors. The author reported that this was a fatal case of vaccination failure of rabies vaccine.


VAERS ID: 499330 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-13
Entered: 2013-08-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza, Influenza A virus test positive
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: The patient had a history of lung and liver disease.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201308319

Write-up: Initial report was received on 02 August 2013 from a non health care professional "lay media" via the local affiliate. A 62 year-old male patient (date of birth not reported) with a history of lung and liver disorder "came to death due to H1N1 virus infection, even after being vaccinated with Influenza vaccine (manufacturer, batch number, route, site and date of administration not reported). The patient had a positive serology to Influenza A/H1N1 virus. No further information was available at the time of the report. Outcome was fatal. Documents held by sender: none.


VAERS ID: 499537 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2013-08-04
Onset:2013-08-04
   Days after vaccination:0
Submitted: 2013-08-14
   Days after onset:10
Entered: 2013-08-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR J0444 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal X-ray, Abdominal distension, Death, Enteritis necroticans, Haematochezia, Intestinal obstruction, Resuscitation, White blood cell count increased, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (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:
Preexisting Conditions: The patient was the 2nd child in his family. No reported family medical history and no reported history of adverse event to a previous administration of vaccine/drug; No concomitant therapy
Allergies:
Diagnostic Lab Data: X-ray revealed incomplete intestinal obstruction, necrotic enteritis and abdominal distension. Blood analysis showed increased WBC level.
CDC Split Type: 201308313

Write-up: Received from a healthcare professional through the local affiliate on 04 August 2013. A 02-month-old male patient, who was the 2nd child in his family, with no reported family medical history and no reported history of adverse event to a previous administration of vaccine/drug, and no concomitant therapy, had received his 1st primary dose of IMOVAX POLIO, batch number J0444-1 or J0420-1 [to be confirmed], route and anatomical site of administration not reported, on 04 August 2013 at 08:20am. On 04 August 2013, at 10:00am, the patient was found with hematochezia while changing his diaper. He was sent to the hospital. X-ray revealed incomplete intestinal obstruction, necrotic enteritis and abdominal distension. Blood analysis showed increased WBC level. Due to the poor medical condition at the hospital, surgery was recommended in an higher level hospital. The patient''s vital signs decreased on the way to the new hospital. The physician performed cardio-pulmonary resuscitation when the patient arrived; but death occurred at around 1pm. Autopsy will be performed. Documents held by sender: none.


VAERS ID: 499584 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-14
Entered: 2013-08-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza, Influenza virus test positive
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: The patient had an unspecified chronic illness.
Allergies:
Diagnostic Lab Data: Positive serology to influenza virus.
CDC Split Type: 201308550

Write-up: Initial report was received from a non-healthcare professional (lay media) through the local affiliate on 08 August 2013. The reporter reported another case of death caused by influenza virus which was captured in case number 2013-08186. A patient (age, gender and date of birth not reported) with chronic illness received an injection of influenza vaccine (manufacturer, lot number, route, site and date of administration unknown) in 2013 and an unspecified amount of time later died due to influenza virus infection. The patient had a positive serology to influenza virus. No additional information was provided. Outcome was fatal. Documents held by sender: None.


VAERS ID: 500129 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-21
Entered: 2013-08-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aspiration, Autopsy, Death, Laboratory test normal, Lung infiltration, Pneumonia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-08-02
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Patient had pneumonia the week prior to death.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201308658

Write-up: Initial report was received on 12 August 2013 from lay media via the local affiliate. Verbatim from the report: "This is a spontaneous report of serious adverse events. We collected through lay media, the information about some children of the city that presented suspect of influenza A/H1N1, however, according to the City Hall data, 100% of the children were vaccinated against influenza. On 02/Aug/2013, a 10-month-old baby died after a respiratory arrest. The mayor reported that the patient had presented pneumonia a week before he died. On 02/Aug/2013, the parents took him to the hospital at noon, where tests were performed and did not detect any abnormalities. At 18 o''clock, the parents returned with the child to the emergency room, and he was presenting a respiratory crisis. According to the physician, the baby has arrived at the hospital with a respiratory arrest, with lungs infiltrated, although at noon lungs were clean, and died. The medical staff was not suspicious of influenza A/H1N1, because the patient did not present symptoms of infection, and the main suspect was bronchoaspiration. The result of the autopsy performed on the body of the baby should be released within 15 days. No additional information was provided." The reporter for this case is the same as for 2013-08659 and 2013-08660. Documents held by sender: none.


VAERS ID: 500147 (history)  
Form: Version 1.0  
Age: 8.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-08-06
Submitted: 2013-08-21
   Days after onset:15
Entered: 2013-08-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Dengue fever, Dyspnoea, Headache, Influenza, Lung infiltration, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201308659

Write-up: Initial report was received on 12 August 2013 from lay media via the local affiliate. "This is a spontaneous report of serious adverse events. We collected through lay media, the information about some children of the city that presented suspect of influenza A/H1N1, however, according to the City Hall data, 100% of the children were vaccinated against influenza. On 06/Aug/2013, a boy of eight years old went to the hospital with fever, headache, and body pain. After examination, physicians suspected of dengue, the patient was medicated and sent home. At noon, the child began to present difficulty breathing, and at 16 o''clock, when he returned to the hospital, he had critical situation. According to to the physician, the whole lung was infiltrated and they suspected of influenza A/H1N1. The patient did not resist and died. The result of the autopsy conducted on the body of the patient should be released in 15 days. No additional information was provided." This case is linked to cases 2013-08658 and 2013-08660. Documents held by sender: none.


VAERS ID: 500218 (history)  
Form: Version 1.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2007-10-01
Onset:2007-11-01
   Days after vaccination:31
Submitted: 2013-08-22
   Days after onset:2121
Entered: 2013-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal cavity drainage, Acute hepatitis B, Alanine aminotransferase increased, Amylase, Ascites, Aspartate aminotransferase increased, Bacterial test, Bilirubin conjugated increased, Biopsy kidney abnormal, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood creatinine increased, Blood glucose normal, Blood lactate dehydrogenase, Blood lactic acid, Blood product transfusion, Capillaritis, Child-Pugh-Turcotte score increased, Computerised tomogram abdomen abnormal, Condition aggravated, Culture, Cytomegalovirus test negative, Death, Dialysis, Encephalopathy, Epstein-Barr virus test negative, Fungal test, General physical health deterioration, Hepatitis A antibody positive, Hepatitis B DNA assay positive, Hepatitis B core antibody positive, Hepatitis B e antibody negative, Hepatitis B e antigen positive, Hepatitis B surface antibody positive, Hepatitis C RNA negative, Hepatitis C test negative, Hepatitis C virus test, Hepatitis acute, Hepatorenal syndrome, Herpes simplex serology negative, International normalised ratio increased, Intra-abdominal haematoma, Jaundice, Mycobacterium test, Nuclear magnetic resonance imaging normal, Perinephric effusion, Polymerase chain reaction, Prothrombin time prolonged, Renal tubular necrosis, Resuscitation, Scrotal oedema, Toxoplasma serology negative, Transplant rejection, Varicella virus test negative
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver-related coagulation and bleeding disturbances (narrow), Liver infections (narrow), Acute pancreatitis (narrow), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vasculitis (narrow), Renovascular disorders (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Mycophenolate mofetil; Cyclosporin; Methylprednisolone; Basiliximab
Current Illness: Chronic kidney disease
Preexisting Conditions: Hemodialysis; Kidney transplantation; Polycystic kidney
Allergies:
Diagnostic Lab Data: Alanine aminotransferase, Feb2009, 1023U/L; Alkaline phosphatase, Feb2009, 345U/L; Anti-HBc IgM antibody positive, Feb2009, Negative; Anti-HBc antibody, Mar2009, Positive; Anti-HBc antibody negative, Mar2009, Negative; Anti-HBc antibody positive, Feb2009, Positive; Anti-HBe antibody, Mar2009, Negative; Anti-HBe antibody negative, Feb2009, Negative; Anti-HBs antibody, Feb2009, More than 1000mI; Anti-HBs antibody, Mar2009, Positive (Less t; Anti-HBs antibody, Mar2009, Positive; Anti-HBsAag positive, Feb2009, 286.96mIU/ml; Anti-HBsAg positive, Mar2009, Positive; Aspartate aminotransferase, Feb2009, 530U/L; Bilirubin, Mar2009, 39.9MG/DL; Bilirubin direct, Mar2009, 24.4MG/DL; Bilirubin total, Feb2009, 6.23 mg/dl; Biopsy kidney, May2008, See text; Blood creatinine, May2008, 2mg/dl; Blood pressure, Feb2009, 150/80mm Hg; Child-Pugh-Turcotte score incr, Mar2009, Class C; Cytomegalovirus test, Feb2009, Negative; Epstein-Barr virus serology, Feb2009, Negative; HBV DNA detectable, Feb2009, 2.11x10E8IU/ml; HBV DNA detectable, Mar2009, More than 1.01x1; HBeAG, Feb2009, Negative; HBeAG, Mar2009, Positive; HCV viral load, Mar2009, RNA negative; HCV viral load, Mar2009, Negative; Heart rate, Feb2009, 86 beats/min; Hepatitis A IgM, Feb2009, Negative; Hepatitis A virus IgG antibody, Feb2009, Positive; Hepatitis C virus test, Feb2009, Negative; Hepatitis D virus test, Mar2009, Negative; Herpes simplex serology, Feb2009, Negative; International normalized ratio, Mar2009, INCREASED TO 2.2; Nuclear magnetic resonance ima, Feb2009, No pathological; Prothrombin time, Mar2009, to 25.4; Serum glucose abnormal, Mar2009, 96mg/dl; Toxoplasma serology, Feb2009, Negative; Varicella zoster serology nega, Feb2009, Negative; In May 2008, because of increase in serum creatinine levels (2.0 mg/dL), a graft biopsy was performed; the existing focal acute tubular necrosis and mild peritubular capillaritis were attributed to chronic active humoral rejection. In February 2009, a polymerase chain reaction amplification, full length sequencing was performed using newly designed primers, generating overlapping DNA fragments followed by population sequencing. Phylogenetic analysis determined the HBV genotype using a panel of reference sequences with maximum likelihood method as implemented in PAUP*. Identification of novel mutations was conducted by comparing the index patient''s sequence with reference sequence (accession number X02496). The patient was classified as HBV genotype D. Further phylogenetic analysis in full-length HBV genomic sequence from the fulminant patient revealed that he belongs to subgenotype D2. The consensus genotype D sequence was estimated using sequences sampled. Genotypic analysis in the S region revealed multipole mutations at various positions, among which the most interesting were at position 145 (G145R) and 160 (K160N). Mutations were also identified in the core, polymerase, pre-S, and the X region, whereas in the precore/core region a frameshift mutation (insertion) was identified between positions 1839 and 1839 (1838insA). We also estimated the synonymous (dS) and nonsynonymous (dN) ratios for 2 genomic fragments encoding for a single frame removing the overlapping reading frames. For X region, we estimated dS = 0.041 and dN = 0.007 and for C dS = 0.169 and dN = 0.055. The dN/dS ratio was <1 for both regions suggesting purifying selection against dN substitutions. The proportion of dS and dN substitutions was estimated for the sequence under study and the consensus genotype D sequence using the method as implemented in MEGA5. On March 2009, Abdominal computed tomography revealed free peritoneal fluid, which was drained. The ascitic fluid appeared clear with a polymorphonuclear count of 50/mm3. Biochemical evaluation revealed glucose levels of 90 mg/dL (serum glucose: 96 mg/dL); ascitic fluid lactic acid dehydrogenase (LDH) /serum LDH: 0.38: ascitic fluid amylases/serum amylase: 0.42. Cultures were sent for aerobic and anaerobic bacteria, fungi, and mycobacteria.
CDC Split Type: B0916668A

Write-up: This case was reported in a literature article and described the occurrence of fulminant hepatitis B in a 48-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject''s medical history included hemodialysis, kidney transplantation and polycystic kidney. Concurrent medical conditions included chronic kidney disease, encephalopathy and type 1 hepatorenal syndrome. Concurrent medication included normal immunoglobulin, Mycophenolate mofetil, CYCLOSPORINE, Methylprednisolone and Basiliximab. In October 2007, the subject received unspecified dose of ENGERIX B (40 mcg, unknown route, site of injection and batch number) following a renal transplantation from a donor who was HBsAg positive, HBeAg negative, and anti -HBe positive. In November 2007, 1 month after vaccination with ENGERIX B, the subject experienced lower abdominal hematoma and scrotal edema. In December 2007, 2 month after vaccination with ENGERIX B, the subject was admitted to hospital due to peripheral effusion, perineal collection and moderate distension of the collecting system (unspecified). In May 2008, 7 months after vaccination with ENGERIX B, the subject was re-admitted to hospital. A graft biopsy was performed; the existing focal acute tubular necrosis and mild peritubular capillaritis were attributed due to a chronic humoral graft rejection. The subject was treated with tacrolimus. In February 2009, 16 month after vaccination with ENGERIX B, the subject experienced jaundice and fulminant hepatitis. The subject was treated with BARACLUDE, mycophenolate mofetil and prednisolone. Tacrolimus was discontinued. In March 2009, 17 months after vaccination with ENGERIX B, the subject experienced an exacerbation of acute hepatitis. He was treated daily with plasma and was subjected to liver dialysis and was consider as a liver transplant candidate. The day after, his condition deteriorated with symptoms of type 2 hepatorena syndrome, encephalopathy Class C and ascites peritoneal fluid. The subject died from fulminant hepatitis B, symptoms of type 1 hepatorenal syndrome and encephalopathy Class C despite 45 minutes of cardiopulmonary resuscitation. It was unknown whether an autopsy was performed. It was highly probable that the subject was infected with a mixture of HBV strains, with the escape mutant prevailing owing to the presence of anti-HBs antibodies. This article described a rare case of fulminant hepatitis B in HBsAg-negative renal transplant recipient vaccinated against HBV who was engrafted by an HBsAg-positive donor. This case highlights the importance of careful evaluation of transplant recipients from HBsAg-positive donors for the existence of HBV escape mutants, as the employment of HBV vaccination and the administration of immune gammaglobulin does not prevent the transmission of such strains.


VAERS ID: 500640 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-01
Onset:2010-04-01
   Days after vaccination:31
Submitted: 2013-08-27
   Days after onset:1244
Entered: 2013-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Encephalitis autoimmune, General physical health deterioration, Headache, Immunoglobulin therapy, Intensive care, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308ISR009992

Write-up: This spontaneous report as received from a gynecologist refers to a 22 year old female patient with no history of sexual activity who was married with a young male with no history of sexual activity, both were not at risk group for HPV. In March 2010, the patient was possibly vaccinated with the first dose of GARDASIL (Lot # not reported, expiration date and route not specified). The physician reported that in April 2010, after one month of vaccination, following a day of hiking the patient complained to her husband at the evening about a headache and within a short time the patient lost consciousness. The patient was hospitalized at the intensive care unit under the diagnosis of autoimmune inflammation of the brain. Despite intensive treatments that included immunoglobulin therapy and wide and global consultations the patient''s condition deteriorated and the patient passed away after several days in April 2010. No post-mortem autopsy was performed. The physician felt that severe autoimmune inflammation of the brain was not related to vaccination with GARDASIL. The physician stated that hospital''s physicians did not relate the event to vaccination with GARDASIL and it was never raised as a cause. The reporter stated that the patient''s sister mentioned at one point that might be the patient was not vaccinated with GARDASIL after all and only had a prescription at that time. Additional information has been requested.


VAERS ID: 500726 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-27
Entered: 2013-08-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: 201308842

Write-up: Initial report was received on 16 August 2013 from the lay media via the local affiliate. Verbatim from the report: "The case was collected in lay media. This is a spontaneous reporting of serious adverse events. The reporter informed that a man of 83 years old was admitted to a private hospital in the city and died within the end of July/2013 due to H1N1 virus infection. According to the city Health Department, the man had been vaccinated. No additional information was provided." No further information was available at the time of the report. Documents held by sender: none.


VAERS ID: 500901 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-27
Entered: 2013-08-29
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E24611 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture, CSF test, Death, Meningitis pneumococcal, 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: Therapy regimen changed, The patient received 3 doses of PREVENAR 7 and one dose of PREVENAR 13.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013242333

Write-up: This is a spontaneous report from a contactable physician. A 5-years-old female patient received the first dose of PREVENAR 13 0.5ml single dose, via an unspecified route of administration on unspecified date at the age of 31 months (lot number E24611). The patient also received 3 doses of PREVENAR at the age of 2 months (first dose, lot number 28787), at the age of 3 months (second dose, lot number 28787), at the age of 4 months (third dose, lot number 31660) previously. The patient was not a premature baby, had no immune defect and no underlying disease. The patient''s concomitant medications were not reported. At the age of 5 years, the patient experienced pneumococcal meningitis and pneumococcal bacteremia without focus in 2013. The patient died on an unspecified date. It was not reported if an autopsy was performed. Pathogenic material were blood culture and liquor. The serotype was untypable. No follow-up attempts possible. No further information expected.


VAERS ID: 500930 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2013-07-26
Onset:2013-07-29
   Days after vaccination:3
Submitted: 2013-08-29
   Days after onset:31
Entered: 2013-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA767BB / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Cholelithiasis, Sudden death, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Cardiomyopathy (broad), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-07-29
   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: Paracetamol
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0916997A

Write-up: This case was reported by a foreign regulatory authority (# GB-MHRA-ADR 22217846) and described the occurrence of sudden infant death in a 3-month-old female subject who was vaccinated with ROTARIX. Concurrent medications included MENJUGATE (Non-GSK), PEDIACEL (Non-GSK) and paracetamol. On 26 July 2013 the subject received unspecified dose of ROTARIX (oral, batch number AROLA767BB). On 29 July 2013, 3 days after vaccination with ROTARIX, the subject experienced sudden infant death. The subject died on 29 July 2013 from sudden infant death. An autopsy was performed. A post mortem also revealed the baby had gallstones. Verbatim Text: Found deceased in cot - sudden unexpected death in infancy (SUDI). Cause so far unknown. Unlikely due to vaccine but needs reporting. Baby had gallstones on Post Mortem.


VAERS ID: 501327 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-05-16
Submitted: 2013-09-02
   Days after onset:109
Entered: 2013-09-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-05-16
   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: Animal bite; Face injury; Eyelid injury
Preexisting Conditions: Suture insertion
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2013EG095089

Write-up: Case number PHHY2013EG095089 is an initial literature report received on 28 Aug 2013. The author discussed about a death case after the administration of Rabies vaccine. This report refers to a 04-year-old male child. The patient''s history included animal bite on an unknown date and 10 hours after the bite, the child had a severe injury in face and eyelids which was sutured by 14 stitches. It was reported that the patient did not receive any antibiotic by mouth or by injection, but received tetanus vaccine, local eye treatment and wound care daily. The patient received 4 doses of rabies vaccine (unknown manufacturer, so conservatively considered as RABIPUR INN, batch number: not reported) on an unknown dates, with correct administration and dosage time. On 16 May 2013, after rabies vaccination the patient developed rabies symptoms and died. The author concluded that the death was due to vaccination failure of rabies vaccine.


VAERS ID: 501657 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-30
Entered: 2013-09-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza, Influenza virus test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-08-14
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: Patient had a history of diabetes and rheumatism. Family history was unknown.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201309161

Write-up: Initial report was received 23 August 2013 from an affiliate who received the report via a lay media report. A 75-year-old male, with a history of diabetes and rheumatism, had received an Influenza Vaccine (manufacturer, lot number, route, site and date of administration unknown). The patient died on 14 August 2013, victim of H3N2 influenza virus infection. Serologic testing was confirmed on 21 August 2013 by the agency. Additionally, the reporter informed that the man had been vaccinated against influenza and sought care at a health facility after developed flu symptoms for three days. Despite starting treatment with TAMIFLU, the man succumbed to complications (not specified). Hospitalization was reported as unknown and the patient''s family history was unknown. No additional information was provided. Additional information has been requested from the agency. Documents held by sender: None.


VAERS ID: 502058 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-08-30
Onset:2013-08-31
   Days after vaccination:1
Submitted: 2013-09-10
   Days after onset:10
Entered: 2013-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS YHBVC115AA / 2 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Blood cholesterol normal, Blood glucose normal, Blood triglycerides normal, Blood uric acid normal, Death, Nuclear magnetic resonance imaging brain normal, Rheumatoid factor negative
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-08-31
   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: Blood glucose, Normal; Cholesterol, Normal; Nuclear magnetic resonance ima, Normal; Rheumatoid factor, Normal; Triglycerides, Normal; Uric acid, Normal
CDC Split Type: B0921428A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of death (unspecified) in an adult male subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). Concurrent vaccination included 1st dose of ENGERIX B (GlaxoSmithKline, unknown route and injection site) given on 23 July 2013. On 30 August 2013, the subject received 2nd dose of ENGERIX B adult (unknown route and injection site). The subject died on 31 August 2013, 1 day after vaccination with ENGERIX B adult, from death unspecified. It was unknown whether an autopsy was performed. On an unspecified date, a Nuclear Magnetic Resonance Imaging of brain and neck was performed. Results were normal. Rheumatoid factor, uric acid, blood glucose, triglycerides and cholesterol were also normal. Further information was expected.


VAERS ID: 502329 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-05-05
Onset:2013-05-08
   Days after vaccination:3
Submitted: 2013-09-12
   Days after onset:127
Entered: 2013-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Death, Neurological decompensation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: 2013-05-08
   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: WAES1309COL004119

Write-up: This spontaneous report as received from a regulatory authority (AE13CO0200) refers to an 11 year old female patient. On 05-MAY-2013 the patient was vaccinated with her first and only dose of GARDASIL, 0.5 ml, intramuscular (site and lot number not provided). Three days after, on 08-MAY-2013, the patient experienced fever, seizures, neurological deterioration and death. The outcome of seizures, fever and neurological deterioration was reported as fatal. The cause of death was not reported. According to the investigation performed by the regulatory authority, the patient was healthy previous to the vaccination; the events were experienced only after the vaccination. No evidences of external issues as the cause of the events were found. As additional information, no samples of cerebrospinal fluid were taken (in order to discard meningitis). The causal relationship was not reported. Upon internal review, seizures was medically significant. Additional information has been requested.


VAERS ID: 502813 (history)  
Form: Version 1.0  
Age: 0.26  
Sex: Female  
Location: Foreign  
Vaccinated:2013-09-02
Onset:2013-09-02
   Days after vaccination:0
Submitted: 2013-09-16
   Days after onset:14
Entered: 2013-09-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20120430 / 1 AR / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR J0419 / 2 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Bed sharing, Death, Epistaxis, Mouth haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient was born from a spontaneous delivery. She did not have allergy history. The family medical history was not reported. No prior history of adverse event to a previous administration of vaccine/drug.
Allergies:
Diagnostic Lab Data: None; autopsy performed
CDC Split Type: 201309414

Write-up: Case received from a healthcare professional through the local affiliate on 05 September 2013. A 03-month-old female patient, born from a spontaneous delivery and with no allergy history, had received her 2nd primary dose of IMOVAX POLIO, batch number J0419-1, in the right thigh, concomitantly with her 1st primary intramuscular dose of DTaP vaccine (other manufacturer, batch number 20120430-2) in the arm, on 02 September 2013 at 09:00. The patient''s family medical history was not reported. There were no prior history of adverse event to a previous administration of vaccine/drug. There was no abnormality post-vaccination. On 02 September 2013, at 12:00, the patient drank 100 mL of milk. On 02 September 2013, at 15:00, she drank 125 mL of milk. On 02 September 2013, at 15:00, the patient fell asleep in her mother''s arms after drinking 100 mL of milk. She was then put to bed in the supine positive, her mother sleeping with her. On 02 September 2013, at 24:00, the mother found the patient dead; there was blood stains on her angle of mouth and nostrils. Feces were present in the diaper. On 04 September 2013, autopsy was performed (no results provided yet). Documents held by sender: none.


VAERS ID: 503532 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-20
Entered: 2013-09-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Rabies, Suture insertion
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-05-16
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: No medical history reported.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201309483

Write-up: Literature case retrieved from the literature on 09 September 2013, through the agency. A 4-year-old male patient, with no medical history reported, had received four doses of Rabies vaccine (manufacturer unknown, batch number and date of administration not reported) "by the correct administration and dosage time" (no details provided) after being bitten. "After 10 hours of the bite, the patient had severe injury in face and eyelids and was sutures by 14 stitches. He did not take any antibiotics by mouth or by injection, however he had received Tetanus vaccine (manufacturer unknown, batch number and date of administration not reported), local eye treatment and wound care daily." The patient developed symptoms of rabies and died on 16 May 2013. It was not reported if an autopsy was performed.


VAERS ID: 503710 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Foreign  
Vaccinated:2013-07-11
Onset:2013-07-21
   Days after vaccination:10
Submitted: 2013-09-23
   Days after onset:64
Entered: 2013-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LL / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK LL / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
PER: PERTUSSIS (NO BRAND NAME) / EMERGENT BIOSOLUTIONS - / UNK RL / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0505AE / UNK MO / PO
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK RA / -

Administered by: Public       Purchased by: Public
Symptoms: Acute disseminated encephalomyelitis, Brain stem syndrome, Cerebral atrophy, Convulsion, Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), 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: 2013-09-08
   Days after onset: 49
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 36 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: NONE AT THE MOMENT, AFTER VACCINATIONS NAPRONEX AND PARACETAMOL ONLY.
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: BRAIN STEM DYSFUNCTION - 36 HRS; CORTICAL-SUBCORTICAL ATROPHY - 14 DAYS; Acute disseminated encephalitis- 36 DAYS
CDC Split Type:

Write-up: FEVER, LETHARGIC, CONVULSIONS. TREATMENT: FEBRAX (NAPROXEN AND PARACETAMOL).


VAERS ID: 503811 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2012-05-02
Onset:0000-00-00
Submitted: 2013-09-23
Entered: 2013-09-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bronchitis, Condition aggravated, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Bronchitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013269569

Write-up: This is a spontaneous report from patient support program, received via a contactable nurse. A 3-month-old female patient received PREVENAR 13, intramuscular on 02May2012, at 0.5 ml single. Medical history included bronchitis. The patient''s concomitant medications were not reported. Laboratory tests and findings relevant to the event were reported as unknown. The patient passed away on 24Jun2012 due to bronchitis. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.


VAERS ID: 503813 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Female  
Location: Foreign  
Vaccinated:2012-06-12
Onset:2013-01-15
   Days after vaccination:217
Submitted: 2013-09-23
   Days after onset:250
Entered: 2013-09-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-01-15
   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: 2013269535

Write-up: This is a spontaneous report from Health window patient support program, received via a contactable nurse. A 8-month-old female patient received a dose of PREVENAR 13, intramuscular on 12Jun2012, at 0.5 ml single dose. The patient medical history, concomitant medications and laboratory tests and relevant findings to the adverse event were reported as unknown. On 15Jan2013 the patient passed away, aspirated in her sleep at the day cay centre. The patient only received two doses of vaccine, the third dose was due at 9 months. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.


VAERS ID: 503814 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Female  
Location: Foreign  
Vaccinated:2012-12-03
Onset:2013-03-28
   Days after vaccination:115
Submitted: 2013-09-23
   Days after onset:179
Entered: 2013-09-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-03-28
   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: 2013269428

Write-up: This is a spontaneous report from Health window patient support program, received via a contactable nurse. A 5-month-old female patient received PREVENAR 13, intramuscular on 03Dec2012, at 0.5 ml single. The patient medical history, concomitant medication, lab tests and relevant findings to the adverse event were reported as unknown. The patient passed away on 28Mar2013 due to an unknown cause. It was unknown if an autopsy was performed.


VAERS ID: 504441 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-10-27
Onset:2012-01-17
   Days after vaccination:82
Submitted: 2013-09-25
   Days after onset:616
Entered: 2013-09-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Chills, Convulsion, Cough, Death, Pain in extremity, Pneumonia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: 06/2011 Pyrexia; Hypertension
Preexisting Conditions: Meningitis when the patient was child; Disability when the patient was child
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2013IT106423

Write-up: Case number PHHY2013IT106423, is an initial spontaneous report received from a consumer (lay press) on 20 Sep 2013. This case refers to a 53-year-old female patient. She was invalid due to meningitis when she was child. Since Jun 2011, she was suffering from mild fever every day and current condition included hypertension. On 27 Oct 2011, she was vaccinated with seasonal influenza vaccination (manufacturer and batch number: unknown) by her general practitioner even when she had fever. A few hours after the vaccination, she developed cough, shivering, severe pain at leg and increasing body temperature. The general practitioner suggested therapy with paracetamol. On 07 Nov 2011, she developed respiratory failure followed by seizure and pneumonia with multiple foci. She was hospitalized in resuscitation ward and then transferred to another structure. On 09 Jan 2012, she was re-hospitalized in resuscitation ward due to worsening of condition. On 17 Jan 2012, she died. The cause of death was not reported. It was unknown if an autopsy was performed. It is reported that, the forensic physician appointed by patient''s relatives assessed the relationship as suspected to the vaccination performed when the patient had fever.


VAERS ID: 506526 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-07
Entered: 2013-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: CD4 lymphocytes decreased, Death, Pneumococcal bacteraemia, Polymerase chain reaction, Respiratory tract infection bacterial, Streptococcal infection, Streptococcus test positive, Treatment noncompliance
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: No other medications
Current Illness: Immunisation; Hepatitis C
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown date: PCR: positive culture for S. pneumoniae; CD4 lymphocytes, 15 /mm3; Polymerase chain reaction, Positive culture for S. pneumoniae
CDC Split Type: WAES1309IRL014555

Write-up: Initial information was published in the scientific literature and identified on 18-SEP-2013. This case is medically confirmed. This case is invalid (no patient''s details provided). Abstract: Invasive pneumococcal disease (IPD) had an all-cause mortality of 5-35% in the developed world. Pneumococcal vaccination is recommended for at-risk groups, including those infected with human immunodeficiency virus (HIV) and those over 65 years of age. However, adherence to vaccination guidelines is low. We reviewed all cases of IPD in our tertiary referral hospital from 2006 to 2010. IPD was defined as the isolation of Streptococcus pneumoniae from a normally sterile site with a compatible clinical syndrome. Demographies, risk factors, susceptibilities, pneumococcal serotype, mortality, and vaccination status for each patient were analyzed. There were 127 IPD episodes in 122 patients. The overall case fatality rate was 21.2%. Seventy-two percent of the patients had two or more risk factors that should have prompted pneumococcal vaccination. However, the overall pneumococcal vaccination provision was only 9%: 64.6% of all typed isolated were contained in the pneumococcal polysaccharides vaccine 23 (PPV23), 48.8% in the 7-valent pneumococcal conjugate vaccine (PCV7), and 60.1% in PCV 13. All isolates were fully sensitive to penicillin and cefotaxime. Recurrent IPD was seen in 11% of the HIV-infected patients, highlighting a particular at-risk group. IPD has a high mortality rate. There is low vaccine provision in our study, although most IPD patients had risk factors that should have prompted vaccination. HIV-positive people are particularly at risk; vaccinating those with persisting CD4 counts less than 200 cells/mm3 and the use of "prime-boosts" strategies may decrease incidence in the future. Newer models of care such as a dedicated vaccine clinic as described in this study may help increase vaccine provision and uptake. Case report: It was reported that only one of the 27 patients who died had received on an unreported date an injection of pneumococcal polysaccharide 23 valent vaccine (MFR UNK, batch number not reported), dose number, route and site of administration not reported. Between 2006 and 2010, the patient was infected with S. pneumoniae serotype 9N, which is contained in pneumococcal polysaccharide 23 valent vaccine and it was reported that this patient, among the others who died, had a respiratory source of the pneumococcal bacteremia. At the time of presentation with the IPD episode, the patient had a CD4 count of 15/mm3 and was not on HAART due to non-adherence. The patient previously was HIV negative, hepatitis B negative and hepatitis C infected. The patient''s outcome was fatal. To be noted that is also noted in literature article: It was reported that only 11 (9%) of the 122 total number of patients had received pneumococcal vaccine (manufacturer unknown, batch number not reported), dose number, route and site of administration not reported, on unreported dates. These patients presented with IPV between 2006 and 2010 and had received vaccination prior to IPV. The patient''s outcomes were not reported. Additional information is not expected.


VAERS ID: 506585 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-08-30
Onset:0000-00-00
Submitted: 2013-10-07
Entered: 2013-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA143CA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Biopsy bone abnormal, Death, Imaging procedure, Osteosarcoma, Pain, Surgery, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Osteonecrosis (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Biopsy, 22Nov2011, osteosarcoma; Imaging procedure, 21Nov2011, osteosarcoma
CDC Split Type: B0927643A

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of osteosarcoma in a 14-year-old female patient subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject was previously healthy. Concurrent vaccination included 1st dose of CERVARIX (GlaxoSmithKline, intramuscular) given on 29 July 2011. On 30 August 2011, the subject received 2nd dose of CERVARIX (intramuscular, unknown injection site). In 2011, less than one year after vaccination with CERVARIX, the subject presented with marked swelling and pain. The following evening the pain subsided and the subject did not visit the hospital. In early October 2011, the subject was aware of the pain at the tumor site. On 21 November 2011, diagnostic imaging revealed osteosarcoma, which had developed within the past several months. On 22 November 2011, biopsy was performed. On 29 November 2011, diagnosis was confirmed. On 5 December 2011, the subject was admitted to hospital and was treated with cytotoxic agent (Unknown cancer therapy drug) and underwent a surgery. The physician considered the event was unrelated to vaccination with CERVARIX. It was considered that the causal relationship between the vaccine and the onset of osteosarcoma had not been medically confirmed. The subject died from osteosarcoma. It was unknown whether an autopsy was performed.


VAERS ID: 506610 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-11-10
Onset:2011-11-10
   Days after vaccination:0
Submitted: 2013-10-08
   Days after onset:697
Entered: 2013-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA666AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Bronchitis, Chills, Convulsion, Cough, Death, Pain in extremity, Pneumonia, Pyrexia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-17
   Days after onset: 68
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: Oxygen; Paracetamol; Ice
Current Illness: Disability; Hypertension; Low grade fever
Preexisting Conditions: Meningitis
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0927916A

Write-up: This case was reported by an article via another manufacturer via a regulatory authority (#218842) and described the occurrence of death-unknown cause in a 53-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject''s medical history included meningitis. Concurrent medical conditions included disability due to meningitis and hypertension. Since June 2011, the subject also presented with low grade fever (37.2-37.3 Deg. C) sometimes reaching up to 38 Deg. C. Concurrent medications included oxygen therapy, in the night at home, paracetamol and ice pack. On 10 November 2011, the subject received unspecified dose of FLUARIX (intramuscular, unknown injection site). On 10 November 2011, less than one day after vaccination with FLUARIX, the subject experienced respiratory failure, cough, fever, chills, leg pain, bronchitis, pneumonia and seizure. The subject was hospitalised in several departments. After her condition improved, she was transferred to a different structure until 9 January 2012 when she was hospitalised again. The subject died on 17 January 2012, cause of death was not reported. It was unknown whether an autopsy was performed. There were some inconsistency between the information received by the authority and information received from the article. Clarification has been requested. The fact that vaccine was administered when the subject presented with fever could have triggered a worsening of her condition leading to her death.


VAERS ID: 507034 (history)  
Form: Version 1.0  
Age: 1.6  
Sex: Male  
Location: Foreign  
Vaccinated:2013-05-28
Onset:2013-06-27
   Days after vaccination:30
Submitted: 2013-10-11
   Days after onset:106
Entered: 2013-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA885F / UNK UN / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-06-27
   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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0929326A

Write-up: This case was reported by a consumer (subject''s mother) regulatory authority (# ES-AGEMED-805154242) and described the occurrence of encephalitis in a 19-month-old male subject who was vaccinated with INFANRIX-POLIO-HIB (GlaxoSmithKline), MENINGITEC (non-gsk) and PREVENAR 13 (non-gsk). On 6 March 2013, the subject received unspecified dose of MENINGITEC (unknown route and injection site). On 28 May 2013, the subject received unspecified dose of INFANRIX-POLIO-HIB (unknown route and injection site) and unspecified dose of PREVENAR 13 (unknown route and injection site). On 27 June 2013, 30 days after vaccination with INFANRIX-POLIO-HIB and PREVENAR 13, 113 days after vaccination with MENINGITEC, the subject experienced encephalitis. The subject died on 27 June 2013 from acute encephalitis, An autopsy was performed. The regulatory authority reported that the event was possibly related to vaccination with INFANRIX-POLIO-HIB, MENINGITEC and PREVENAR 13.


VAERS ID: 507865 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-14
Entered: 2013-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood test abnormal, Death, Inflammation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood test, severe inflammation n/A
CDC Split Type: WAES1310HUN005078

Write-up: This spontaneous report was received from a physician refers to a 12 year old female patient with asthma. On an unknown date, the patient was vaccinated with a dose of MMRVAXPRO, (lot number, expiry date and route was unknown). Concomitant medications were not reported. The patient had been healthy for 5 months prior to vaccination without any complaint. She was also healthy on the day of vaccination. On an unknown date, 24 hours after vaccination the patient experienced fever (hospitalization) and inflammation (hospitalization). The pediatrician saw the patient on the 4th day after vaccination. Blood test was done which showed severe inflammation. On an unknown date, the patient was hospitalized. The patient received IV antibiotics. After short fever free period the given antibiotics were replaced by another one (not specified). Following this the patients body temperature rose again and finally she died 2 weeks after vaccination (date unknown). Blood tests and post mortem were done in the hospital (no results reported). The antibody level, the possible reactivation of the injected virus (not specified) was under investigation. The outcome of inflammation and fever was reported as fatal. The cause of death was reported an unknown. Additional information has been requested.


VAERS ID: 508000 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-12
Entered: 2013-10-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Complementary investigations were unknown.
CDC Split Type: 201307455

Write-up: Initial report received from scientific literature search on 19 June 2013. This case is invalid as individual patient identifiers are missing. Introduction: The aim of this study was to investigate the incidence of adverse effects and protective effects from influenza vaccine among elderly individuals who were vaccinated through the public healthcare system. Methods: A prospective cohort study was conducted between May and September 2008. A group of 341 patients was recruited, among whom 289 had been vaccinated through the public system (VSUS) and 52 had not been vaccinated (NV). The incidence of protective effects was observed by comparing the VSUS and NV groups. Results: It was observed that 22.5% of the vaccinated subjects exhibited at least one adverse effect. Comparing the VSUS and NV groups in relation to the incidence of flu symptoms presented during the winter, at least one symptom was observed in 47% and 28.8% (RR- 1.11, 1.02-1.22; p=0.0156), respectively. CONCLUSIONS: These findings demonstrate that the incidence of adverse effects was low. The high incidence of flu symptoms in the VSUS group, in comparison with NV, may be related to the profile of subjects who are in the habit of getting vaccinated against influenza. A cluster of 289 patients, whose medical history and concomitant medications were unknown, had received a dose of Influenza vaccine (Manufacturer and batch number unknown, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date, 11 patients presented local pain, 2 patients experienced local hyperemia, 3 patients experienced local induration, 20 patients presented fever, 34 patients presented malaise, 16 patients experienced muscle pain, 22 patients experienced headache, 1 patient experienced lymph node edema, 3 patients developed diarrhea, 4 patients developed vomiting, 25 patients experienced nasal discharge, 10 patients developed chest pain, 16 patients experienced cough, 2 patients developed ear pain, 8 patients developed arthralgia, 37 patients developed chills, 42 patients experienced sore throat and 7 patients experienced pain when moving eyes. Complementary investigations and corrective treatments were unknown. At the time of this report, the outcome was unknown. Follow-up information was received on 10 August 2013 from the health care professional via the local affiliate. Based upon new information received, it was determined this case meets seriousness criteria and has been upgraded from non-serious to serious. "The reporter informed that she could not find the documents where there was information about the patients. She informed that none of the patients was hospitalized at that time and all of them recovered. According to her, some patients died but due to other causes that were not breathing problems." No further information was available at the time of the report. Outcomes were reported as recovered (also reported as some patients died). Documents held by sender: None. Follow up information received from a healthcare professional on 30 September 2013. The reporter informed that she could not find the documents where there was information about the patients and, therefore, had no more information about this case. Thus, this case was considered closed (end of follow-up). No additional information was provided. This case is a summary case of 289 patients who received influenza vaccine and of which some patients had died. Document held by sender: none.


VAERS ID: 508058 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2013-08-30
Onset:2013-08-30
   Days after vaccination:0
Submitted: 2013-10-14
   Days after onset:45
Entered: 2013-10-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR J0110 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G79293 / UNK UN / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER AROLA767BB / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-08-30
   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: 2013289047

Write-up: This is a spontaneous report received from a healthcare professional via the contactable Regulatory Agency. Regulatory Authority report number ADR22261011. A 95 days old male patient received PREVENAR 13 (Lot# G79293) intramuscular at 0.5 ml single, on 30Aug2013; PEDIACEL (Lot# J0110-1) intramuscular at 0.5 ml single, on 30Aug2013 and Rotavirus vaccine (Lot# AROLA 767BB) oral at 1.5ml, on 30Aug2013. The patient medical history and concomitant medications were not reported. On 30Aug2013, the patient experienced death unexplained. Cause of death was unknown. It was unknown if any autopsy was performed. No follow up attempts possible. No further information expected.


VAERS ID: 507947 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-16
Entered: 2013-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Death, Gastrointestinal disorder, Granulomatosis with polyangiitis, Nervous system disorder, Renal disorder, Sinus disorder
SMQs:, Interstitial lung disease (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013038208

Write-up: This literature report (initial receipt 17-Sep-2013) concerns a 20 year old male. On an unspecified date, the patient received an influenza vaccination (non-CSL influenza vaccine, manufacturer and batch number not specified). On an unspecified date, the patient developed a relapse of AAV (Antineutrophil Cytoplasmic Antibody Vasculitis). The disease type was GPA (granulomatosis with polyangiitis). The ANCA type was cytoplasmic (c). Organs involved included kidney, brain, GI (gastrointestinal) tract and sinus. Treatment included MMP, prednisone (P) and plasma exchange (PE). The outcome was reported as fatal. Follow up (02-Oct-2013), non-CSL influenza vaccine (patient received influenza vaccine in 2004, CSL influenza vaccine was first registered in 2005). Cause of death is unknown.


VAERS ID: 508079 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-12
Entered: 2013-10-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza
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: Lab tests unknown
CDC Split Type: 2013SA097982

Write-up: Initial report received from a consumer (online newspaper) on 20 September 2013. This summary case concerns 07 elderly patients of unspecified age, who received Influenza vaccine (manufacturer unknown, batch number was unknown, route, dose number and anatomical site of administration were not reported) on an unspecified date in 2013. The patient''s concomitant medications and family history was unknown. On an unspecified date in 2013 after vaccination, the patients had fatal influenza virus infection. The information about laboratory investigations and corrective treatments was unknown. List of documents held by the sender none.


VAERS ID: 508080 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-12
Entered: 2013-10-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza
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: The patient had unspecified chronic disease.
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2013SA097998

Write-up: Initial report received from a consumer (online newspaper) on 30 September 2013. A patients of unspecified demographics, who received Influenza vaccine (manufacturer unknown, batch number was unknown, route, dose number and anatomical site of administration were not reported) on an unspecified date in 2013. The patient''s concomitant medications and family history was unknown. Patient had unspecified chronic disease. On an unspecified date in 2013 after vaccination, the patient had fatal influenza virus infection. The information about laboratory investigations and corrective treatments was unknown. List of documents held by the sender none.


VAERS ID: 508479 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-09-18
Onset:2013-09-20
   Days after vaccination:2
Submitted: 2013-10-17
   Days after onset:27
Entered: 2013-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. J0005500 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-09-20
   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: Immunisation; Uterine cancer; Hypertension; Diabetes mellitus; Breast cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR004973

Write-up: This case was received from the health authority on 07-Oct-2013. GB-MHRA-ADR 22255054. This case is medically confirmed as it was reported by a physician. A 70 year old female patient (weight: 88 kg) received on 18-Sep-2013 an injection of ZOSTAVAX (batch number J0005500) one dose intramuscularly, dose in series and site of administration not reported. On 20-SEP-2013, the patient died of suspected myocardial infarction. The patient''s medical history included breast cancer, diabetes, hypertension and uterine cancer. She was concomitantly treated with Bendroflumethiazide (bendrofluazide) 2.5 mg, bisoprolol, Co-codamol (codeine phosphate, paracetamol), letrozole, lymecycline, perindopril, pravastatin and TENSIPINE MR (nifedipine). The patient''s outcome was fatal. The MHRA considered that case serious due to be life threatening and due to patient''s death.


VAERS ID: 508750 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2013-10-11
Onset:2013-10-12
   Days after vaccination:1
Submitted: 2013-10-17
   Days after onset:5
Entered: 2013-10-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR J0146 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Peripheral coldness
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-12
   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: Unknown
CDC Split Type: 2013SA103524

Write-up: Initial report received from a healthcare professional on 12 October 2013. A 02-month-old female patient, whose medical history and concomitant medication were not reported, had received a first dose of IMOVAX POLIO (batch number J0146-1, site of administration was not reported) intramuscularly on 11 October 2013 at 9:30. No other vaccine was co-administered. On 12 October 2013, one day after vaccination, the vaccine was found cold at 5am. The patient was announced dead when she was sent to the hospital. Autopsy was refused by the patient''s parents. Laboratory investigations and corrective treatment were not reported. The outcome of event was fatal. Documents held by sender: none.


VAERS ID: 508777 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-18
Entered: 2013-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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: 2012-01-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERETIDE; Tiotropium bromide; VENTOLIN
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR004980

Write-up: This case was received from the health authority on 07-Oct-2013. GB-MHRA-ADR 22261139. This case is not medically confirmed as it was reported by a consumer. A 56 year old male patient, with no medical history reported, received on an unreported date, an injection of PNEUMOVAX II (batch number not reported), dose in series, route and site of administration not reported. He was also concomitantly treated with SERETIDE, tiotropium bromide and VENTOLIN on unreported dates. The patient developed pneumonia shortly after having the vaccine (onset date not reported). The patient was treated at hospital and died from pneumonia on 14-Jan-2012. No more information was provided. The patient''s outcome was fatal. The regulatory authority considered this case as serious due to patient''s death.


VAERS ID: 508786 (history)  
Form: Version 1.0  
Age: 1.7  
Sex: Male  
Location: Foreign  
Vaccinated:2013-05-28
Onset:2013-06-27
   Days after vaccination:30
Submitted: 2013-10-18
   Days after onset:113
Entered: 2013-10-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA885F / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-06-27
   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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013295603

Write-up: This is a spontaneous report from a contactable consumer (the patient''s mother) through the Drug Agency with regulatory authority report number ES-AGEMED-805154242. The consumer was only contactable for the Drug Agency. A 19-month-old male patient of an unspecified ethnicity received PREVENAR 13, via an unspecified route of administration on 28May2013, INFANRIX IPV+HIB (Lot # A20CA885F), via an unspecified route of administration on 28May2013 and MENINGITEC (Lot # G55522), via an unspecified route of administration on 06Mar2013. The patient medical history and concomitant medications were not reported. The patient experienced encephalitis on 27Jun2013. The patient died on 27Jun2013 due to encephalitis. An autopsy was performed and determined that the encephalitis might be caused by the suspect product. No further information expected.


VAERS ID: 509519 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-25
Entered: 2013-10-25
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: 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: Cervix carcinoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310RUS011669

Write-up: This spontaneous report as received from a social media website refers to a 14 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (dose, strength, route and site of administration not reported) for cervical cancer. On an unknown date the patient died. The reason of death was not reported. Additional information is not expected.


VAERS ID: 510369 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-10-29
Entered: 2013-10-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Rabies
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: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013SA109315

Write-up: Initial report received from Literature case via healthcare professional on 24 October 2013. This case is invalid as individual patient identifiers were missing. Methods: Using the Morbidity and Mortality Weekly Report and PubMed, we identified 142 case reports of rabies from several countries. We systematically abstracted 126 selected data elements and compared clinical features and investigation results in dog- and bat-acquired cases of rabies. Results: Survivors and cases acquired from aerosolized viral exposure or tissue/organ transplant were excluded (n = 20). Of 122 cases, 49 (40.2%) were dog-acquired and 54 (44.3%) were bat-acquired. Bat-acquired cases of rabies were more often misdiagnosed and lacked a bite history. Encephalopathy, hydrophobia, and aerophobia were more common in dog-acquired rabies. Abnormal cranial nerve, motor, and sensory examinations, tremor, myoclonus, local sensory symptoms, symptoms at the exposure site, and local symptoms in the absence of a bite or scratch were more common in patients with bat-acquired rabies, as was increased cerebrospinal fluid protein (P = .031). Patients with paralytic rabies had longer survival times than those with encephalitic rabies, and also had shorter incubation periods if they had received post exposure prophylaxis. 19 patients whose gender, age at the time of event, medical history and concomitant medication were not reported had received a post exposure prophylaxis dose of rabies vaccine (manufacturer, trade name, lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. There was no difference in the proportion of patients with dog- or bat-acquired rabies who received PEP (16.3% vs. 7.9%; P = .111). Incubation and survival times were compared for patients who had received PEP versus those who had not. Among naturally acquired cases of rabies, the median incubation times were 50% shorter in patients who received PEP (31 days [IQR, 24.5-52.5 days]) than in those who had not received PEP (61.5 days [IQR, 34.5-98.3 days]; P = .002). Similarly, the median survival times were 60% shorter in patients who received PEP (9 days, [IQR, 8-14.5 days]) than in those who had not received PEP (15 days [IQR, 11-21 days]; P = .024). Differences in incubation periods or survival times were not observed among dog- or bat-acquired cases. Paralytic cases (n = 5 [44.4%]) were more likely than encephalitic cases (n = 7 [7.9%]) to have received PEP (P = .029). The median incubation time for paralytic cases was 4.2 times longer for those who had not received PEP (105 days [IQR, 48.3-192 days]) versus those who had (25 days [IQR, 19-29 days], P = .03). In encephalitic cases, the median survival time was 1.6 times longer in those who had not received PEP (14 days [IQR, 9.3-19 days]) versus those who had (9 days [IQR, 8-10 days], P = .035). The median survival time was 41% shorter for encephalitic (12 days [IQR, 9-17.8 days]) than paralytic rabies (22 days [IQR, 18-28 days]). Lab tests unknown. According to the literature article 19 patients who had received postexposure prophylaxis that included rabies vaccine, died of rabies with variable incubation period and survival time. This is a poorly documented case- patient medical history, time to event onset, and complementary investigation results confirming this diagnosis and its cause are needed to fully assess the case.


VAERS ID: 510375 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-02-25
Onset:2013-02-25
   Days after vaccination:0
Submitted: 2013-10-29
   Days after onset:245
Entered: 2013-10-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER AM014B / UNK LA / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR H1491 / 4 RA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaphylactic reaction, Cardiac arrest, Death, Dyspnoea, Electrocardiogram, Endotracheal intubation, Gastrooesophageal reflux disease, Mydriasis, Oxygen saturation immeasurable, Pallor, Peripheral coldness, Pulse absent, Respiratory arrest, Resuscitation, Therapeutic aspiration
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-25
   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: Unknown
Current Illness:
Preexisting Conditions: Bone dysplasia; Bradycardia; Spinal stenosis; Cervical cord compression; Nasal obstruction; Deafness; Pyloric stenosis; Ichthyosis; Spinal laminectomy, 05SEP2011; Spinal laminectomy on 05-SEP-2011 for hypoplasia of the first cervical vertebra, Spinal canal stenosis, and Cervical cord compression; Ramstedt''s operation, 20SEP2011 for hypertrophic pyloric stenosis; Underlying diseases: Chromosome abnormality (loss of Xp22), chondromysplasia punctate (XLP type and brachytelephalangic type), hypoplasia of the first cervical vertebra, spinal canal stenosis, cervical cord compression, rhinostenosis, bilateral deafness, hypertrophic pyloric stenosis, and ichthyosis. Surgical history: Spinal laminectomy on 05-Sep-20112 for hypoplasia of the first cervical vertebra, spinal canal stenosis, and cervical cord compression, Ramstedt operation on 20-Sep-2011 for hypertrophic pyloric stenosis; Allergic history: No appreciable allergy; Family history: No appreciable disease; Birth-weight: 2788 g
Allergies:
Diagnostic Lab Data: Body temperature, 46.8 Degree C
CDC Split Type: 2013SA109085

Write-up: Initial report received from Health Authority via healthcare professional on 23-Oct-2013 Health Authority Reference number: V13000732). A 19-month-old male patient had received 0.5 ml 4th dose of ACTHIB vaccine (Lot No.: H1491) in the right upper arm and 0.5 ml 4th dose of DTP vaccine (Lot No.: AM014B) in the left upper arm on 25 February 2013. The patient had medical history of underlying disease: Chromosome abnormality (loss of Xp22), chondrodysplasia punctate (XLP type and brachytelephalangic type), hypoplasia of the first cervical vertebra, spinal canal stenosis, cervical cord compression, rhino stenosis, bilateral deafness, hypertrophic pyloric stenosis, and itchthyosis The patient had surgical history of Spinal laminectomy on 05-Sep-2011 for hypoplasia of the first cervical vertebra, spinal canal stenosis, and cervical cord compression, Ramstedt operation on 20-Sep-2011 for hypertrophic pyloric stenosis and no appreciable allergy and family history of no appreciable disease. On 01-Dec-2011, the patient received simultaneous inoculation with the 1st doses of DTP and ACTHIB. On 12-Jan-2012, he received simultaneous inoculation with the 2nd doses of DTP and ACTHIB for primary immunization. On 09-Feb-2012, he received simultaneous inoculation with the 3rd doses of DTP and ACTHIB for primary immunization. On 25 February 2013 at around 15:00 hours, the patient experienced anaphylaxis and at around 15:30 hours, the patient experienced dilated pupils, facial pallor, and severe coldness in the peripheral extremities. The patient did not breathe spontaneously and his pulse pressure was impalpable. His Spo2 level was immeasurable by a pulse oximeter. It was confirmed that he was in cardiac or respiratory arrest. At 15:35, a resuscitative maneuver was started and an ambulance call was made at the same time. The patient had received cardiac massage and oxygen administration at a flow rate of 5L/min with bagging with an Ambu mask. Massive milk refluxed in the nasal cavities and mouth was aspirated by suction. Intubation was tried, but was difficult. At 15:45, the patient was put on an ECG monitor. Cardiac massage and bagging with an oxygen mask were ongoing. At the outpatient emergency department of the hospital, the resuscitative maneuver was ongoing. He was intubated, a route for intraosseous infusion was obtained, and he received BOSMIN. Heartbeat returned. After 21:00, the patient had died. The cause of death and information on whether an autopsy was performed were not provided. The patient''s body temperature before vaccination was 36.8 degree Celsius. Cause(s) of Death: Anaphylaxis.


VAERS ID: 510670 (history)  
Form: Version 1.0  
Age: 0.11  
Sex: Male  
Location: Foreign  
Vaccinated:2012-06-18
Onset:2012-06-18
   Days after vaccination:0
Submitted: 2013-10-31
   Days after onset:500
Entered: 2013-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Decreased appetite, Injection site mass, Injection site pain, Injection site swelling, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: B0937954A

Write-up: This case was reported by a healthcare professional in the frame of an immunization vaccines program monitored by Health Service and described the occurrence of death in a 1-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), PREVENAR (non-gsk). On 18 June 2012, the subject received unspecified dose of ROTARIX (oral, batch number not provided), unspecified dose of PREVENAR (unknown route, site of injection and batch number). On 18 June 2012, less than one day after vaccination with PREVENAR and ROTARIX, the subject experienced loss of appetite. In addition, the subject also experienced local reaction such as injection site pain and lump/swelling which were related to PREVENAR injection. In June 2012, less than one week after vaccination with PREVENAR and ROTARIX, the subject died from an unknown cause. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with paracetamol. This report is one of several cases received as part of a line listing, each containing minimal information. No further information is expected.


VAERS ID: 510678 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-10
Onset:2012-12-10
   Days after vaccination:0
Submitted: 2013-10-31
   Days after onset:324
Entered: 2013-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SYR
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Cough, Death, Nasopharyngitis
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-10
   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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0937670A

Write-up: This case was reported by a healthcare professional in the frame of an immunization vaccines program monitored by Health Service and described the occurrence of death (cause unknown) in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline) and PREVENAR (non-GSK). On 10 December 2012, the subject received an unspecified dose of ROTARIX (oral, batch number not provided) and an unspecified dose of PREVENAR (unknown route and injection site). On 10 December 2012, less than one day after vaccination with PREVENAR and ROTARIX, the subject experienced cough and catarrh. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Crystalline penicillin. The subject died, cause of death was not specified. An autopsy was requested, but it was unknown whether it was performed. This report is one of several cases received as part of a line listing, each containing minimal information. No further information is expected.


VAERS ID: 511856 (history)  
Form: Version 1.0  
Age: 0.27  
Sex: Female  
Location: Foreign  
Vaccinated:2013-08-23
Onset:2013-10-31
   Days after vaccination:69
Submitted: 2013-11-06
   Days after onset:6
Entered: 2013-11-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 UN / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 MO / PO
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Condition aggravated, Death, Respiratory distress, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013313973

Write-up: This is a report from a non-Pfizer sponsored interventional study. This is a report from an investigator initiated clinical research (IIR) study. A 5 month-old female subject received, at the age of 3 months, the third dose of PREVENAR 13 at 0.5 ml single dose intramuscularly on 23Aug2013. On 23Aug2013, the subject concomitantly received the third dose of DPT-Hib-HepB intramuscularly, and the third dose of polio vaccine orally. The subject had previously received two doses of PREVENAR 13, DPT-Hib-HepB and polio vaccine on 28Jun2013 and 26Jul2013. The subject had a relevant history of respiratory distress. On 31Oct2013, the subject developed respiratory distress and was hospitalized at the emergency unit of the pediatric service in the night of 31Oct2013. The event was described as follows: respiratory distress with intercostals retractions, "wing of nose beat" and vomiting; no fever nor diarrhea. The subject was treated with oxygen and unspecified antibiotics. It was reported that on an unknown date the subject died due to respiratory distress. The investigator assessment of the causal relationship of the respiratory distress with the PREVNAR 13 was provided as "unclear" at the time of this report. The case is managed as if the investigator''s assessment was that a reasonable possibility exists that the event was related to the study product, as a cautionary measure and for reporting purposes. This is a preliminary report for notification of a fatal/life threatening event.


VAERS ID: 511865 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2013-09-03
Onset:2013-09-07
   Days after vaccination:4
Submitted: 2013-11-05
   Days after onset:59
Entered: 2013-11-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature increased, Cough, Crying, Death, Diarrhoea, Faeces discoloured, Fluid intake reduced, Nasopharyngitis, Restlessness, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-12
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Milk allergy
Allergies:
Diagnostic Lab Data: 08-SEP-2013, Body temperature, 38 Centigrade
CDC Split Type: 2013312399

Write-up: This is a spontaneous report received from the foreign Health Authority (Regulatory Authority reference number: GREOF-20130360). A nurse (mother) reported that her 3 months and 26 days old, non-breastfeeding (due to milk allergy) male infant, born at 38 weeks via caesarean section (weight at birth 3850 kg), was vaccinated with MENJUGATE and PREVENAR-13, both on 03Sep2013 at 0.5 ml single dose. No concomitant medications were administered to the infant. Between 07Sep2013 and 08Sep2013 the infant presented catarrh and mild cough. As of 08Sep2013 he presented severe restlessness, sleep disorder (limited sleep), severe intermittent crying lasting 1 to 1.5 minutes each time, reduced milk intake to half, rectal temperature at 38 degrees Centigrade, stools watery and green-coloured. The infant was examined by a pediatrician on 11Sep2013 who could not diagnose something significant. On 12Sep2013 the infant went to sleep and never woke up.


VAERS ID: 511882 (history)  
Form: Version 1.0  
Age: 0.8  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-05
Entered: 2013-11-07
   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: Blood culture positive, Death, Meningitis pneumococcal
SMQs:, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood culture confirmed that baby died of strep pneumo meningitis (Unknown date)
CDC Split Type: 2013312160

Write-up: This is a spontaneous report from a contactable physician via a sales representative. A 9-month-old patient of an unspecified gender received PREVENAR 13, via an unspecified route of administration on unknown date. The patient medical history and concomitant medications were not reported. The patient developed streptococcus pneumoniae meningitis on an unspecified date that required hospitalization. The patient died on an unspecified date. Blood culture confirmed that baby died of streptococcus pneumoniae meningitis. It was not reported if an autopsy was performed. Follow-up attempts completed. No further information expected.


VAERS ID: 512765 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2013-10-28
Onset:2013-11-05
   Days after vaccination:8
Submitted: 2013-11-12
   Days after onset:7
Entered: 2013-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB680A / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H21317 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA769BD / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Echocardiogram normal, Resuscitation, Sudden infant death syndrome, Ultrasound skull normal
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-05
   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: D-fuoretten
Current Illness: Cold; Exophthalmos; Respiratory tract infection
Preexisting Conditions: Candidiasis
Allergies:
Diagnostic Lab Data: Echocardiography, normal; Ultrasound skull, normal
CDC Split Type: D0081774A

Write-up: This case was reported by physician via a regulatory authority (DE-PEI-PEI2013066145) and described the occurrence of suspected sudden infant death syndrome in a 10-week-old female subject who was vaccinated with INFANRIX HEXA (GlaxoSmithKline), ROTARIX (GlaxoSmithKline) and PREVENAR 13 (non-gsk). The subject''s medical history included candidiasis (soor mycosis, diagnosed on 10 September 2013; treated with miconazol ointment). Concurrent medical conditions included exophthalmus (diagnosed on 15-Oct-2013) and cold / mild respiratory tract infection (a few days prior to her death). Concurrent medications included D-fluretten. The subject had one older healthy sister. The mother''s partner refused the paternity of the second child. The patient''s mother did not get regular prenatal care. "No unusual adverse drug reactions were observed in other vaccines." According to the reporting physician (verbal communication to the authority), the subject had been a healthy child, no preterm birth, no malformations, no severe preceding medical conditions, no family history of SIDS. No signs of exposure to external force. On the day on vaccination, the child had been healthy. On 28 October 2013 the subject received the first doses of INFANRIX HEXA (intramuscular, right thigh), ROTARIX (oral) and PREVENAR 13 (intramuscular, left thigh). Eight days after vaccination with INFANRIX HEXA, PREVENAR 13 and ROTARIX, on 05 November 2013, the subject suddenly died in her mother''s arms "during a shopping tour". Sudden infant death syndrome was suspected. Cardiopulmonary resuscitation was performed. Post mortem brain sonography and echocardiography resulted normally. "An autopsy will be performed."


VAERS ID: 512796 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:2013-08-19
Onset:2013-08-19
   Days after vaccination:0
Submitted: 2013-11-11
   Days after onset:84
Entered: 2013-11-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest, Culture negative, Death, Hypoxia, Irritability, Laboratory test, Metabolic function test, Nuclear magnetic resonance imaging, Polymerase chain reaction, Syncope, Toxicologic test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (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: Vitiligo; Constipation
Allergies:
Diagnostic Lab Data: Culture (date unknown): Negative
CDC Split Type: 2013315917

Write-up: This is a spontaneous report from a physician via the contactable regulatory authority received under the reference number GB-MHRA-ADR 22297675. A 5 month old female patient of an unspecified ethnicity started to receive PREVENAR 13 intramuscularly on 19Aug2013 at single dose, Men C vaccine (trade name unspecified) intramuscularly on 19Aug2013 at single dose and PEDIACEL intramuscularly on 19Aug2013 at single dose. Medical history included vitiligo and constipation. No congenital abnormalities were found. Healthy term baby with no past medical history of note. No relevant family history. Concomitant medication included macrogol, potassium chloride, sodium bicarbonate, MOVICOL. The patient had immunisations at 2:30pm. The patient was irritable at 7:30pm. at 8:30pm the patient was apnoeic leading to cardiac arrest that recovered at 9:10pm. The patient died due to severe hypoxic injury. No clear cause for collapse was ever found. There was no evidence of sepsis. Negative cultures and polymerase chain reaction reported. In the reporters opinion the events were considered serious due to being medically significant and fatal. Medically significant details: Collapse later that evening and cardiac arrest - cause of cardiac arrest is still unknown despite magnetic resonance imaging/toxicology/septic screen/metabolic screen. The patient did not receive a post mortem examination. Unclear whether the vaccinations played any part whatsoever in the collapse. In the opinion of the regulatory authority the events were considered serious for an unspecified reason. No follow-up attempts possible. No further information expected.


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