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VAERS ID: 450629 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-01-01
Onset:0000-00-00
Submitted: 2012-02-27
Entered: 2012-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Foetal disorder, Maternal exposure before pregnancy, Premature delivery
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-07-01
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: A0964265C

Write-up: This retrospective pregnancy case was reported by a pharmacist and described the occurrence of twin-twin transfusion syndrome in a foetus subject of unspecified gender who was exposed to TWINRIX (GlaxoSmithKline) taken by the pregnant mother. On 25 November 2009 and in January 2010 (prior to pregnancy) the 32 year old mother of the subject received 1st dose and 2nd dose of TWINRIX. The mother took a trip in January 2010 and became pregnant in February 2010. The subject experienced maternal exposure before pregnancy. The mothers date of last menstrual period and estimated date of delivery were not reported. About 8 months following the mother''s 1st administration of TWINRIX and about 6 months following her administration of the 2nd dose of TWINRIX, the neonate experienced premature birth (twin birth - 23 weeks gestation). At the time of birth, a defect of twin-twin transfusion syndrome as noted. The pharmacist considered the events ere a congenital anomaly. The subject died in July 2010 from twin-twin transfusion syndrome. It was unknown whether an autopsy was performed. The linked twin report: A0964265B.


VAERS ID: 450673 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-27
Entered: 2012-02-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MER: MEASLES + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asphyxia, Death, Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1202USA03562

Write-up: Case was identified in lay press media article published in the News on 13-FEB-2012. This was one of a cluster of two cases and was linked to E2012-01039 (WAES # 1202USA03564), published in the same article, concerning the same batch and similar event. This case was not medically confirmed. A 15 year old male patient who was reportedly a healthy and happy school boy with no health problems before vaccination and no history or family history of epilepsy received a dose of measles and rubella vaccine (manufacturer unknown) (Lot#, dose and route not reported), on an unreported date in 1994. 10 days post vaccination a week before Christmas in 1994 the patient was found dead in his bed. An inquest in 1995 concluded that the patient died from asphyxiation due to a severe epileptic fit. Since the inquest and according to this press media article, a consultant paediatric neurologist concluded "on the balance of probabilities the patient''s seizure and death were caused by the vaccination". A second inquest has now been ordered. The article stated that the patient received the vaccine from the same batch as the patient in the linked case E2012-01039. It was reported that asphyxiation was related to the vaccination. Other business partner numbers include E2012-01038. Additional information has been requested.


VAERS ID: 450817 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-01-01
Onset:0000-00-00
Submitted: 2012-02-29
Entered: 2012-02-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningococcal sepsis, Multi-organ failure
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (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: B0784270A

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of multiple organ failure in a 4-month-old subject of unspecified gender who was vaccinated with INFANRIX HEXA (GlaxoSmithKline), SYNFLORIX and ROTARIX. In January 2011, on an unspecified date, the subject received unspecified dose of INFANRIX HEXA (unknown route, unknown injection site), unspecified dose of SYNFLORIX (unknown route, unknown injection site), unspecified dose of ROTARIX (unknown route, unknown injection site). Lot numbers were not provided. On an unspecified date, 3 days after vaccination with INFANRIX HEXA, ROTARIX and SYNFLORIX, the subject died from multiple organ failure and meningococcal septicemia (not confirmed). Additional information has been requested.


VAERS ID: 451279 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2012-01-10
Onset:2012-01-11
   Days after vaccination:1
Submitted: 2012-03-07
   Days after onset:56
Entered: 2012-03-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Diarrhoea, Endotracheal intubation, Fontanelle bulging, Frequent bowel movements, Mydriasis, Pallor, Pyrexia, Sepsis, Vomiting
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-01-26
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NELSONS POLLENA
Current Illness:
Preexisting Conditions: Cold; Cyanosis; Breathing difficult
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1203USA00356

Write-up: Information has been received from a municipal health office physician (local reference # PH-2012-03-001), concerning a 2 month old female patient with a history of cyanosis/difficulty of breathing when crying and colds 1 week prior to admission who on 10-JAN-2012 was vaccinated with first dose of ROTATEQ (lot number not reported). Concomitant therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, NELSONS POLLENA and possibly hepatitis B virus vaccine (lot number not reported, manufacturer unspecified) given approximately December 2011. On 11-JAN-2012 the patient experienced diarrhea which resolved on its own on 14-JAN-2012 after 3 days. The patient was described as having around 3 to 4 bouts of bowel movement per day. On 25-JAN-2012, the patient was admitted for fever and vomiting. Upon medical examination, patient was pale, with tense fontanel and dilated pupil at 4 mm. Diagnosis was sepsis to consider meningitis. Meningitis was not confirmed because there was no laboratory facility to confirm this in the admitting hospital. The patient was discharged intubated the following day, 26-JAN-2012, discharge diagnosis was sepsis to consider meningitis, rule out acquired prothrombin complex deficiency. Patient was also advised to transfer to a tertiary hospital. On 26-JAN-2012 the patient died. The reporting physician felt that diarrhea and death secondary to sepsis was related to therapy with ROTATEQ since the events occurred within 14 days from date of vaccine administration. It was noted by the municipal health office nurse that the patient had no congenital anomaly/birth defect, was breast fed and that there was no vaccine given at the same time ROTATEQ was given. No further information is available.


VAERS ID: 451486 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2012-02-24
Onset:2012-02-27
   Days after vaccination:3
Submitted: 2012-03-09
   Days after onset:11
Entered: 2012-03-12
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G1375 / 1 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 11G03A / 1 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Nonspecific reaction, Resuscitation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-02-27
   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: No medical history (including allergy); No concomitant therapy
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201202444

Write-up: Case received from the Health Authorities on 28 February 2012 under the reference number A201200064 (HA''s number HIB-337, 337-2). A 02-month-old female patient, with no medical history and no concomitant therapy, had received her 1st subcutaneous dose of ACTHIB (batch number G1375) in the left upper arm and her 1st subcutaneous dose of PREVENAR (other manufacturer, batch number 11G03A) in the right upper arm on 24 February 2012 at 02:37pm. The patient''s body temperature before vaccination was 36.8 degrees C. On 27 February 2012 at 09:00am, the patient did not experience any abnormal symptoms. On 27 February 2012 at 10:00am, she developed abnormal symptoms (not specified). She was taken to hospital by ambulance and the physicians began trying to resuscitate the patient. On 27 February 2012 at 0:09pm the patient''s death was confirmed. Physician''s comment: A causal relationship between the vaccines and the patient''s death is not assessable.


VAERS ID: 451701 (history)  
Form: Version 1.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-03-25
Onset:2011-06-05
   Days after vaccination:72
Submitted: 2012-03-12
   Days after onset:281
Entered: 2012-03-14
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA102AB / 2 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Exploratory operation, Hepatic mass, Hepatic neoplasm malignant non-resectable, Jaundice, Laboratory test, Laparotomy, Nausea, Palliative care, Pruritus generalised, Terminal state, Ultrasound abdomen abnormal, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Liver malignant tumours (narrow), Hypersensitivity (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: 2011-12-24
   Days after onset: 202
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 19 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 8/30/2011 subject reported by phone that she had started on 6/5/2011 with diffuse abdominal pain of moderate-to-severe intensity, nausea, vomits, generalized pruritus, and jaundice. Abdominal sonogram on 7/22/2011 showed a mass in the liver. Local hospital admission (7/23/2011) and testing led to referral to national hospital and exploratory laparotomy (8/8/2011), and discovery of liver tumor (5 cm diameter) in the portal vein bifurcation with infiltration of the extrahepatic bile duct. Tumor was unremovable. She was discharged 8/11/2011 with treatment against pruritus and referral to Oncology (appt 9/7/2011). On 12/22/2011 subject was in terminal phase, receiving palliative care at home; diagnosis was liver cancer.


VAERS ID: 451703 (history)  
Form: Version 1.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-02-16
Onset:2010-06-03
   Days after vaccination:1933
Submitted: 2012-03-12
   Days after onset:648
Entered: 2012-03-14
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS VX10787 / 3 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Chemotherapy, Colitis, Hysterectomy, Mass excision, Metastasis, Ovarian cancer stage III, Ovarian disorder, Pelvic discomfort, Pelvic pain, Stomach mass, Ultrasound ovary abnormal
SMQs:, Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Ovarian malignant tumours (narrow), Uterine and fallopian tube tumours of unspecified malignancy (broad), Noninfectious diarrhoea (broad), Non-haematological malignant tumours (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-23
   Days after onset: 507
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: Between June-August 2010, subject started with pain/discomfort in pelvic region. She consulted her local primary care center and was diagnosed and treated for colitis. After symptomology progressively worsened she was given a sonogram (8/25/2010) that showed "shadows on ovaries". Following readmission (8/30/2010), surgeons on 9/1/2010 removed a mass apparently started in the stomach; they told subject''s sister it was invasive cancer. Hospital admission and multiple chemotherapy courses took place in 9/2010 and 10/2010, then total hysterectomy (1/28/2011) and more chemo (5/2011). On 6/22/2011 she was admitted with diagnosis of ovarian cancer stage III C. Was taking Hyoscine, methadone, and bisacodyl as necessary.


VAERS ID: 452041 (history)  
Form: Version 1.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:1992-11-17
Onset:0000-00-00
Submitted: 2012-03-16
Entered: 2012-03-19
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Angiotensin converting enzyme, Arthropathy, Asthenia, Ataxia, Back pain, Borrelia test negative, Burning sensation, CSF oligoclonal band present, Cerebellar syndrome, Clumsiness, Condition aggravated, Death, Depression, Dysuria, Extrapyramidal disorder, Fatigue, Liver function test normal, Lumbar puncture abnormal, Micturition disorder, Motor dysfunction, Multiple sclerosis, Muscular weakness, Neck pain, Nervous system disorder, Nuclear magnetic resonance imaging brain abnormal, Pain in extremity, Paraesthesia, Paraparesis, Pollakiuria, Renal function test normal, Transaminases increased, Visual acuity reduced, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), 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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Multiple sclerosis
Preexisting Conditions: Balance disorder; Walking difficulty; Left half-body paresis and pyramidal syndrome in 1990. Left upper limb tremor; Fatigue and dysuria in January 1991. Motor activity disorder of the left-body in 1992 (demyelinating disease evoked). Family history of a grand-uncle suffering from Parkinson''s disease. The patient has three children born in 1978, 1979 and 1982.
Allergies:
Diagnostic Lab Data: Examination: Brain MRI; Exam Date: 1992 Exam Result; Result Text: ONE HYPERSIGNAL; Examination: BRAIN MRI; Exam Date: MAY-1993 Exam Result; Result Test: ONE PARA-VENTRICULAR HYPERSIGNAL; Examination: BRAIN MRI; Exam Date: OCT-1994 Exam Result; Result Text: ONE HYPERSIGNAL; Examination: COCHELO-VESTIBULAR EXAMINATION; Exam Date: 11-FEB-1992 Exam Result; Result Test: NORMAL; Examination: CONVERTING ENZYME; Exam Date: JAN-1995 Exam Result; Result Text: NORMAL; Examination: LUMBAR PUNCTURE; Exam Date: JAN-1995 Exam Result; Result Text: OLIGOCLONAL PROFILE; Examination: LYME''S DISEASE SEROLOGY; Exam Date: JAN-1995 Exam Result; Result Text: NEGATIVE; Examination: MEDULLARY MRI; Exam Date: 1994 Exam Result; Result Text: POSSIBILITY OF A FEW HYPERSIGNAL IN THE WHITE MATTER; Examination: MEDULLAR MRI; Exam Date: 15-DEC-1994 Exam Result; Result Text: SEVERAL INTER-MEDULLARY HYPERSIGNALS AT THE UPPER THORACIC JOINT AND LOWER AND MEDIUM THORACIC AREAS; Examination: MRI; Exam Date: NO HYPERSIGNALS; Examination: MRI; Exam Date: 25-APR-1995 Exam Result; Result Text: NO HYPERSIGNALS; Examination: SOMESTHESIC EVOKED POTENTIALS; Exam Date: APR-1992 Exam Result; Result Text: LESIONS OF THE LEMNICUS PATHWAY AT BRAIN AND MEDULLARY LEVELS; Examination: VISUAL EVOKED POTENTIALS; Exam Date: 10-FEB-1992 Exam Result; Result Text: INCREASED LATENCY IN FAVOUR OF A DEMYELINATING DISEASE; Examination: X-RAY (CERVIVAL COLUMN); Exam Date: JAN-1992 Exam Result; Result Text: DISKARTHROSIS (C4-C5 AND C5-C6); Exam Date: JAN-1992 Exam Result; Result Text: NORMAL
CDC Split Type: B0227195A

Write-up: Report number 1999028478-1 described the occurrence of multiple sclerosis aggravated in a 41-year-old female patient vaccinated with ENGERIX-B. This case was received from SB Legal Department. This case was also received from a physician. This case was also received from the agency (TO990485). Medical history included balance disorder, left half-body hemiparesis and walking difficulty in 1990, left upper limb tremor, fatigue and dysuria in January 1991. In March 1992, the patient was hospitalized in neurological unit. Pyramidal syndrome, bilateral Babinski''s sign and a moderate aggravation of the preexisting symptomatology were noticed (no cerebellar syndrome). Brain MRI showed only one hypersignal of the white matter. The spinal fluid was normal as well as the standard biological check-up. Somesthesic evoked potentials revealed lesions of the lemnicus pathway at brain and medullary levels. Cochleo-vestibular and auditory evoked potentials were normal. Visual evoked potentials were abnormal. At this time, a demyelinating disease was evoked and a treatment with SOLUMEDROL was started without an important improvement. The diagnosis of neuraxis was also evoked. On 08 September, 05 October and 17 November 1992, the patient was vaccinated with ENGERIX-B. Early 1993, urinary disorder (imperious micturition, pollakiuria) occurred treated with DITROPAN, DITROPAN had to be stopped (no date precision) because of unspecified side effects. In February 1993, an aggravation of the preexisting right lower limb motor deficit associated to pain occurred. The diagnosis of neuraxis was then again evoked. In April 1993, the patient was treated by an osteopath for neck and lumbar pain. She also developed at this period fatigue and right lower limb burning sensation (paresthesia). From 06 to 10 May 1993, the patient was hospitalized. Tetrapyramidal and cerebellar syndromes were noticed. Brain MRI showed only one para-ventricular hypersignal (not very specific). The diagnosis of multiple sclerosis was evoked and a new treatment with SOLUMEDROL was started (with an improvement). In June 1993, the patient was in incapacity for a week. On 28 September 1993, she received her ENGERIX B booster injection. In September 1994, the symptomatology still remained (no true worsening). In October 1994, she developed an unspecified deficit of the lower limbs. Hepatic and renal biological check-ups were normal. On 11 October 1994, MRI revealed one slight hypersignal. In November 1994, spasmodic paraparesis, ataxia and a mild cerebellar syndrome were noticed. A new study of the medullar MRI suspected the possibility of a few hypersignals in the white matter. On 15 December 1994, a new medullar MRI revealed several inter-medullary hypersignals at the level of the upper thoracic joint and the lower and medium thoracic areas. From 17 to 19 January 1995, the patient was hospitalized. A progressive progression of the pre-existing patient''s symptomatology was then noticed (no notion of flare-up). Cerebellar syndrome, tetrapyramidal syndrome spasmodism, right lower limb deficit and walking-induced fatigue were noted. Lumbar puncture showed an oligoclonal profile, but a new MRI did not retrieve any hypersignal. Lyme''s disease serology was negative. An unspecified corticotherapy was then initiated and an improvement occurred. On 25 April 1995, no hypersignal was revealed by a new MRI. At this period, a progressive aggravation of the symptomatology was noticed and RIVOTRIL, Aspirin, Methotrexate and regular corticotherapy courses with SOLUMEDROL were initiated. In December 1996, SOLUMEDROL was stopped due to suspected allergy (urticaria and lips edema). It is at this period that the diagnosis of multiple sclerosis was made for the first time. In February 1997, Methotrexate was stopped due to increased transaminases levels (no more precision) and LIORESAL was started. Left lower limbs and upper limb pain then occurred as well as hands clumsiness. At the same period, the SOLUMEDROL courses were reinitiated with a more delayed rhythm and without side effects. In 1997, vision had decreased to 8 for the right eye (it was at 12 both eyes in 1995). In December 1997, an aggravation of walking difficulty has progressively occurred. In July 1998, BETAFERON was started. In August 1998, a retraction of her articular shoulder capsular was noticed which necessitated infiltrations of an unspecified drug and kinesitherapy. In September 1998, the patient was given DETRUSITOL for urinary sphincterian disorder. In October 1998, the patient developed a severe reactional depression (non-event) for which she was hospitalized from 23 to 28 October 1998. LAROXYL was then started for her depression and XATRAL for her dysuria. An ataxia was noticed during this hospitalization. From 08 to 11 November 1998, she was hospitalized for an aggravation of her symptomatology (asthenia, left hand muscle weakness, feet paresthesia). The patient then received a bolus of an unspecified corticoid drug and an important improvement occurred. In January 1999, an important improvement of the patient''s neurological status due to BETAFERON, was noticed. Nevertheless, the prescription of an electric wheelchair was still necessary. The most recent information received on 02 August 1999 reports the outcome of the patient as not yet recovered. The reporter''s causality assessment is not specified. Causality assessment was reported by the agency as possibly related to ENGERIX-B. Local ID: ENG573. Case number 1999013940-1 has been identified as a duplicate record to this case (case number 1999028478-1) and all relevant information has been merged into this case. Case number 1999013940-1 will be logically deleted from the database and this case, (case number 1999028478-1), will stand as the case of record for this patient. Case number 1999031747-1 has been identified as a duplicate record to this case (case number 1999028478-1) and all relevant information has been merged into this case. Case number 1999031747-1 will be logically deleted from the database and this case, (case number 1999028478-1), will stand as the case of record for this patient. Follow-up received on 08 March 2012 from the agency (last information received on 28 February 2012). The agency reported that the subject received ENGERIX B adult by intravenous route. The subject''s death was reported (date and reason of death were unknown). It was unknown if an autopsy was performed. According to the agency, based on the method of assessment, the causal relationship between multiple sclerosis aggravated and vaccination with ENGERIX B adult was considered possible.


VAERS ID: 452195 (history)  
Form: Version 1.0  
Age: 1.3  
Sex: Female  
Location: Foreign  
Vaccinated:2009-03-09
Onset:2009-03-12
   Days after vaccination:3
Submitted: 2012-03-20
   Days after onset:1104
Entered: 2012-03-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adrenal haemorrhage, Autopsy, Blood culture positive, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood smear test normal, C-reactive protein increased, Complement factor normal, Crying, Diet refusal, Imaging procedure, Livedo reticularis, Meningococcal infection, Neisseria test positive, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging whole body, Pericardial effusion, Petechiae, Procalcitonin increased, Pyrexia, Red blood cell morphology normal, Respiratory arrest, Resuscitation, Sepsis, Skin warm
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Bronchiolitis
Preexisting Conditions: Gastrooesophageal reflux
Allergies:
Diagnostic Lab Data: Magnetic resonance imaging, whole body: pericardial effusion 4mm in diameter; Diagnostic laboratory test, Blood smear did not show Jolly bodies and imaging or autopsy revealed the presence of a spleen. Serum C-reactive protein, 9 mg/ml; serum procalcitonin, 80 ng/ml; blood culture, Group B Neisseria menigitidis; Complement assays, normal; serum immunoglobulin G test, normal; serum immunoglobulin A test, normal; serum immunoglobulin M test, normal
CDC Split Type: WAES1203USA01794

Write-up: Case retrieved from the literature on 07-MAR-2012. Case medically confirmed. A 15-month-old female patient was found to have severe Neisseria Menigitidis infection after she received a dose of MMR (Manufacturer unknown, batch number not reported) on 09-MAR-2009. On 12-MAR-2009 (also reported as 12-MAR-2012) she had a single fever spike and her mother gave her a paracetamol suppository. The same day, in the evening, the patient refused to eat and she slept with her mother. At 2:00 am, the patient''s cries woke her mother up. The patient''s body was hot but her temperature was not taken. She was given 30 mL of water and a further paracetamol suppository by her mother. She went back to sleep. She was found lying on her stomach in respiratory arrest when her mother woke up at 8:00 a.m. Firemen and then (emergency medical service) unsuccessfully tried to resuscitate her. She was taken to the hospital. On clinical examination, livedo was noted on her whole body, and petechiae and mottled patterns on her chest. Tests done on an intracardiac sample found CRP on 9 mg/mL and procalcitonin of 80 ng/mL. Whole- body MRI only showed a pericardial effusion of 4 mm. The autopsy revealed massive adrenal hemorrhage suggestive of sepsis. Blood culture was positive for group B Neisseria Menigitidis sensitive to amoxicillin. An immune deficiency was sought. Evaluation of complement and quantitative measurement of immunoglobulins (IgG, IgA and IgM) were normal. Blood smear did not show Jolly bodies and imaging or autopsy revealed the presence of a spleen. To be noted that the patient was born at 36 weeks and 6 days of amenorrhea. Her birth weight was 2.630 kg. She had a medical history of gastrooesophageal reflux (an episode) treated with domperidone and omeprazole, and recurrent bronchiolitis. Her vaccinations were up to date. Her psychomotor development was normal. Other business partner numbers included E2012-01702. Additional information has been requested.


VAERS ID: 452262 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-03-19
Onset:2012-03-19
   Days after vaccination:0
Submitted: 2012-03-21
   Days after onset:2
Entered: 2012-03-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 917690 / UNK UN / SYR
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1590AA / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1203USA02317

Write-up: Case of fatal outcome received from the Health Authorities on 19-MAR-2012 via the local site Sanofi Pasteur. The Health Authorities'' reference number was not yet provided. Case medically confirmed. A 5-month-old patient of unspecified sex had concomitantly received a dose of ROTATEQ (lot number: 671579/1590AA) via oral route and an injection of PREVENAR (batch number F73745/917690) on 19-MAR-2012 in the morning, and 4 hours later he was found dead. The expiry date of ROTATEQ was 31-MAY-2013, and the expiry date of PREVENAR was 31-MAY-2014. An autopsy was currently being performed. Other business partner number included: E2012-01867. A lot check has been initiated. No further information is available.


VAERS ID: 452558 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-03-20
Entered: 2012-03-28
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Bradycardia, Coma, Convulsion, Death, Encephalopathy, Hypotonia, Nystagmus, Pyrexia
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: PHHY2012ES023526

Write-up: Case number PHHY2012ES023526 is an initial literature report received on 14 Mar 2012: In this article the authors discussed about a study that was conducted to evaluate relevant new information about adverse drug reactions (ADR) reported in a foreign pediatric population over a six-year period from 2004 to 2009. The primary objective of their study was to determine the characteristics of suspected ADRs to pharmaceuticals used to treat the pediatric population on the basis of reports included in the (foreign pharmacovigilance database on adverse reactions) database during the period 2004-2009. This report refers to a 5-years-old male patient. He was vaccinated with rabies virus vaccine (manufacturer and batch number: unknown, therefore conservatively taken as RABIPUR INN) on undetermined date in between 2004 to 2009. After vaccination, he experienced convulsion, pyrexia, hypotonia, bradycardia, nystagmus, encephalopathy and coma in 2005 and he died. The events were assessed as suspected to the vaccine. No further information was provided.


VAERS ID: 452560 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-03-20
Entered: 2012-03-28
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Coma, Death, Encephalopathy, Hyporeflexia, Neuritis, Pyrexia, Stupor, Thinking abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: PHHY2012ES023535

Write-up: Case number PHHY2012ES023535 is an initial literature report received on 14 Mar 2012: In this article the authors discussed about a study that was conducted to evaluate relevant new information about adverse drug reactions (ADR) reported in the foreign pediatric population over a six-year period from 2004 to 2009. The primary objective of their study was to determine the characteristics of suspected ADRs to pharmaceuticals used to treat the pediatric population on the basis of reports included in the (foreign pharmacovigilance database on adverse reactions) database during the period 2004-2009. This report refers to a 7-years-old male patient. He was vaccinated with rabies virus vaccine (manufacturer and batch number: unknown, therefore conservatively taken as RABIPUR INN) on undetermined date in between 2004 to 2009. After vaccination he experienced pyrexia, vomiting, hyporeflexia, thinking abnormal, stupor, neuritis, encephalopathy and coma in 2005 and died. The events were assessed as suspected to the vaccination. No further information was provided.


VAERS ID: 453978 (history)  
Form: Version 1.0  
Age: 0.29  
Sex: Male  
Location: Foreign  
Vaccinated:2012-03-22
Onset:2012-03-25
   Days after vaccination:3
Submitted: 2012-04-19
   Days after onset:25
Entered: 2012-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / -

Administered by: Public       Purchased by: Public
Symptoms: Cardiopulmonary failure, Coagulation factor deficiency, Cyanosis, Delayed fontanelle closure, Diet refusal, Haematoma, Head deformity, Hepatic failure, Hyperfibrinogenaemia, Influenza virus test negative, Lumbar puncture, Meningitis, Meningococcal sepsis, Nail discolouration, Pyrexia, Rash generalised, Renal failure, Respiratory arrest, Resuscitation, Skin discolouration, Smallpox, Sputum test, Swelling, Tachycardia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-29
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Only green feces, pediatrician said "healthy, it is not necessary to postpone immunization".
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: HIB antibody concentration of immunization 02/09/2012 was not verified, nobody saw lumbar puncture laboratory analysis mentioned in discharge letter, so, there is no certainty if type A or type B, in discharge letter declared type A, but the same hospital hidden sputum report from E-54100 07/04/2011.
CDC Split Type:

Write-up: Became pimping, high temperature 38,9C then 39,8 C, refused to eat, threw out twice, the same evening appeared (mother said small pox- doctor said small petechial hematoma) that covered soon whole body, some of them were like large patches, tachycardia, cyanosis, hyperfibrinogenemia, deficit of external and internal way of coagulation, right wrist (mother said became black-doctor said three fingers and nails become colour violet), deformed head, large fontanelle tense, whole body swollen, cessation of breathing twice, applied reanimation twice, Dg: Insuffitientio cardiorespiratoria, Insuffitientio renalis, Insuffitientio hepatalis, Sepsis meningococcica fulminans (acuta), meningitis epidemica.


VAERS ID: 454335 (history)  
Form: Version 1.0  
Age: 1.27  
Sex: Male  
Location: Foreign  
Vaccinated:2011-10-26
Onset:2012-04-19
   Days after vaccination:176
Submitted: 2012-04-25
   Days after onset:6
Entered: 2012-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR - / UNK - / -

Administered by: Public       Purchased by: Public
Symptoms: Choking, Cyanosis, Death, Dehydration, Disseminated intravascular coagulation, Haematoma, Meningitis, Meningococcal sepsis, Neisseria test positive, Pyrexia, Respiratory arrest, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), 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: 2012-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: meningococcal bactery A 39, department for neuro- infective diseases,
CDC Split Type:

Write-up: At 14:30 high temperature, only ears at nape, Voltaren suppositories, temperature disappeared, he played, smiled, at 20:00 PM first vomit, at 23:00 PM become pimping, started to vomit several times every half of hour or every hour, at 04:00 AM at dawn black and brown spots appeared on his body, of different size, like hematoma, he dehydrated, missed air, he began to choke, his lips were blue, and he died, Dg: sepsis meningococicca A 39, DIC- disseminated intravascular coagulopathy, susp. meningitis.


VAERS ID: 454769 (history)  
Form: Version 1.0  
Age: 0.21  
Sex: Male  
Location: Foreign  
Vaccinated:2012-04-16
Onset:2012-04-17
   Days after vaccination:1
Submitted: 2012-04-27
   Days after onset:10
Entered: 2012-05-01
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RA / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F62144 / UNK LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cold sweat, Death, Hypotonia, Nonspecific reaction
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-04-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Low birth weight baby 5lb 13oz; Breech presentation leading to a caesarean section; Jaundice; Failure to thrive, had resolved
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012099556

Write-up: This is a spontaneous report received from the contactable foreign agency. Regulatory authority report number 2012-011173. The report was received by the agency from a contactable physician. A 10 week old male infant received PREVENAR 13 in the left deltoid, and INFANRIX HEXA in the right deltoid, both at unspecified dose on 16Apr2012 at approximately 3:30pm. The subject was a low birth weight baby (5lb 13oz) and was a breech baby leading to a cesarean section. The infant was reported as having mild jaundice at birth and initially failed to thrive, weight dropped to 2.2kg on breast milk in the first week, then when switched to bottle, increased to 2.4kg. At the time of the six week check up, three weeks prior to vaccination, on 22Mar2012, the infant weighed 4.4kg. There was no relevant family medical history. According to the reporter, the infant was healthy. No concomitant medications were reported. The reporter stated that twelve hours after receiving PREVENAR 13 and INFANRIX HEXA, the parents noticed that the infant was clammy and floppy. An ambulance was called. According to the reporter, the infant "arrested" at 8.00am the next morning and died. The reporter also indicated that he had received some information verbally on the initial post mortem results that nothing was found. The event causality with regards to PREVENAR 13 and INFANRIX HEXA was reported as unclassified. The Lot number for the PREVENAR 13 vaccine was F62144. Additional information indicated that there were no other adverse event reports globally for Lot number F62144.


VAERS ID: 454878 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-05-02
Entered: 2012-05-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activated partial thromboplastin time prolonged, Activated partial thromboplastin time shortened, Adrenal insufficiency, Aspartate aminotransferase increased, Blood chloride normal, Blood corticotrophin normal, Blood cortisol increased, Blood creatinine increased, Blood culture positive, Blood fibrinogen decreased, Blood fibrinogen increased, Blood glucose increased, Blood lactate dehydrogenase increased, Blood potassium increased, Blood sodium decreased, Blood urea increased, C-reactive protein normal, Clonic convulsion, Death, Disseminated intravascular coagulation, Electrolyte imbalance, Fibrin D dimer, Hyperkalaemia, Intensive care, Metabolic acidosis, Multi-organ failure, Pallor, Platelet count decreased, Platelet count increased, Pneumococcal infection, Prothrombin time prolonged, Pyrexia, Renal failure, Septic shock, Vaccination failure, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Atrioventricular septal defect; Heart disease congenital; Dextrocardia; Asplenia syndrome; Pulmonary artery atresia; Anomalous pulmonary venous connection; Heterotaxia
Preexisting Conditions: Cardiac operation; Meconium stain; Umbilical cord abnormality
Allergies:
Diagnostic Lab Data: Diagnostic procedure, 0 point, DIC score; Diagnostic procedure, 7 point, DIC score; Ultrasound, atrioventricular septal defect, single atrium, right ventricular type single atrium, dextrocardia; APTT, 16.8 sec.; APTT, 160 or more sec.; APTT, 420 or more sec.; APTT, 64 sec.; WBC count, 16500/microL; WBC count, 28300/microL; arterial blood O2 saturation, 98%; platelet count, 24.9 10000/microL; platelet count, 7.5 10000/microL; serum C-reactive protein, 0.58 mg/dL; serum c-reactive protein, 0.48 mg/dL; serum LDH, 385 IU/L; serum LDH, 2632 IU/L; serum aspartate aminotransferase, 56 IU/L; serum aspartate aminotransferase, 577 IU/L; serum aspartate aminotransferase, 23 IU/L; serum aspartate aminotransferase, 151 IU/L; serum blood urea nitrogen, 14.9 mg/dL; serum blood urea nitrogen, 27.2 mg/dL; serum chloride, 104 mEq/L; serum chloride, 98 mEq/L; serum creatinine, 0.54 mg/dL; serum creatinine, 1.49 mg/dL; serum potassium, 6.4 mEq/L; serum potassium, 7.3 mEq/L; serum sodium, 138 mEq/L; serum sodium, 133 mEq/L; total serum cortisol, 136 microg/dL; plasma fibrinogen test, 547 mg/dL; plasma fibrinogen test, 50 mg/dL; plasma D-dimer test, 2.9 mg/dL; blood culture, Pneumococcus (serotype 6B); plasma D-dimer test, 369.4 mg/dL; plasma adrenocorticotropic hormone test, 19.6 picog/mL
CDC Split Type: WAES1204USA04283

Write-up: Initial information has been received from a physician, author of a literature article, concerning a 38 month old female patient with atrioventricular septal defect, heart disease congenital single atrium, right ventricular type single atrium, dextrocardia, pulmonary artery atresia, anomalous pulmonary venous connection, heterotaxia and history of cardiac operation who on an unknown date, was vaccinated with PNEUMOVAX 23 (dose, route, site of administration and lot number not reported). Literature summary: We encountered two cases of asplenia syndrome that rapidly resulted in fatal pneumococcal sepsis. Both patients had been under outpatient management after operation of complicated heart malformation and the courses of heart disorder were favorable. One patient (this case) developed pneumococcal infection despite that she had been inoculated PNEUMOVAX 23 14 months prior to the infection. Both patients presented to the emergency outpatient department with chief complaint of pyrexia but they fell in dangerous acute condition while CRP elevation was mild, suggesting that CRP could not be an indicator for treatment. In both cases, marked electrolyte abnormality was observed and in case 2 (this case), administration of corticosteroid was required for correction of hyperkalaemia, high blood glucose and metabolic acidosis and presence of adrenal insufficiency was considered. In asplenia syndrome, while the number of patients who receive long-term management after operation for heart disorder had been increasing, patients with asplenia syndrome could develop fatal infection even after inoculation of vaccine and drug resistant Streptococcus pneumoniae infection had been increasing, therefore intravenous injection of antimicrobial drug should be initiated even after inoculation of vaccine. Initial information has been received from auctorial physicians concerning a 3 year 2 month old female patient. At 40 weeks and 3 day of gestation, the patient was delivered by caesarean section because of the presence of ptosis of umbilical cord and meconium stain with birth weight of 3400 g. After birth, the patient was diagnosed as having atrioventricular septal defect, single atrium, right ventricular type single atrium, dextrocardia, pulmonary artery atresia, total anomalous pulmonary venous connection (Ia type) and asplenia syndrome by ultrasonographic examination at the reporters'' hospital. At age 1 year and 11 months, Fontan operation was completed. After operation, percutaneous oxygen saturation was 98% and general condition was stable. The patient was orally taking amoxicillin (AMPC) since infant period as prophylaxis. At age 2 years, the patient was inoculated with PNEUMOVAX 23 (injection route, site, dose and lot number not reported). Until age 2 years and 6 months, the patient received amoxicillin and the therapy was completed. On the day of hospital admission (at age 3 years and 2 months), ill complexion appeared and ambulance was called. In ambulance, pyrexia was observed and generalised clonic convulsion appeared, and convulsion continued for more than 30 minutes until arrival to the reporters'' hospital. When admitted to the hospital DIC and renal (adrenal) failure with septic shock were diagnosed. The patient was admitted to the intensive care unit and treated with 24 hour-ceftriaxone, PAPM/BP (panipenem/betamipron) and corticosteroid, but died of sepsis shock, DIC and multi-organ failure. There was no information on autopsy. During the course: Pneumococcus (serotype 6B) was detected by blood culture performed at the time of admission to the emergency outpatient department of the reporter''s hospital. Blood test results at the time of admission to the emergency outpatient department of the reporter''s hospital. (immediately after pyrexia): WBC 16500/uL, CRP 0.58 mg/dL, Plt 24.9x10^4/uL, BUN 14.9 mg/dL, Cr 0.54 mg/dL, Na 138 mEq/L, K 6.4 mEg/L, Cl 104 mEq/L, AST 56 IU/L, ALT 23 IU/L, LDH 385 IU/L, PT 16.8 seconds, APTT 64.0 seconds, Fib 547 mg/dL and D-dimer 2.9 mg/dL. Blood test results 6 hours after pyrexia: WBC 28300/uL, CRP 0.48 mg/dL, Plt 7.5x10^4/uL, BUN 27.2 mg/dL, Cr 1.49 mg/dL, Na 133 mEq/L, K 7.3 mEq/L, CI 98 mEq/L, AST 577 IU/L, ALT 151 IU/L, LDH 2632 IU/L, PT greater than 160 seconds, APTT greater than 420 seconds, Fib 50 mg/dL, and D-dimer 369.4 mg/dL. An elevation of CRP was mild but DIC scores (ISTH: International Society on Thrombosis & Haemostasis) at immediately after pyrexia and 6 hours after pyrexia were 0 point and 7 points, respectively, which revealed rapid progression to DIC within 6 hours after onset. In addition, adrenal insufficiency was suspected from abnormalities such as serum electrolytes, blood glucose level and severe metabolic acidosis, and corticosteroid was administered during the course and then, acidosis was temporarily improved, therefore, adrenal insufficiency was suspected. Examination of adrenal cortical hormone performed after hospital admission showed ACTH within normal range (19.6pg/mL but cortisol was abnormally high at 1360ug/dL. Reporter''s comment: The patient was infected with serotype pneumococcus which was contained in the pneumococcal vaccine. The patient might not have been able to obtain sufficient antibody or may have had a complication of immunodeficiency such a IL-1 receptor associated kinase 4 (IRAK4) deficiency. The auctorial physicians felt that pyrexia, generalised clonic convulsion, septic shock, DIC, multi-organ failure and vaccination failure were definitely related to pneumococcal vaccine. The physicians considered that septic shock, DIC, multi-organ failure were serious due to hospitalization and death. Upon internal review, renal failure and generalized clonic convulsion were determined to be other important medical events. Additional information has been requested.


VAERS ID: 454879 (history)  
Form: Version 1.0  
Age: 0.32  
Sex: Female  
Location: Foreign  
Vaccinated:2012-04-19
Onset:2012-04-19
   Days after vaccination:0
Submitted: 2012-05-02
   Days after onset:13
Entered: 2012-05-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA752C / 2 LG / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F82154 / 2 LG / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AR0LA436C / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Death, Pyrexia, Resuscitation, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2012-04-22
   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:
Preexisting Conditions: Hypoglycaemia, status post; Feeding problem in newborn, status post; Sight disability, unclease sight disability; 25-FEB-2012, Respiratory syncytial virus bronchiolitis, not continuing; 25-FEB-2012, Acute respiratory insufficiency, partial respiratory insufficiency, not continuing; Hypotonia, severe hypotonia of trunk muscles
Allergies:
Diagnostic Lab Data: 19-APR-2012, pyrexia, 38.5 centigrade; 21-APR-2012, pyrexia, 40 centigrade; 22-APR-2012, pyrexia, 39.9 centigrade; EEG (during hospitalization from 25Feb2012 to 09Mar2012): no abnormal finding. Diagnostic testing of metabolism (during hospitalization from 25Feb2012 to 09Mar2012): no abnormal finding. VEP (during hospitalization from 25Feb2012 to 09Mar2012): "pathologic", no further details reported. Pyrexia (20Apr2012): between 38 degrees C and 40 degrees C
CDC Split Type: 2012104389

Write-up: This is a spontaneous report received from the contactable foreign Health Authority. Regulatory Authority report number DE-PEI-PEI2012012761. A 3-month-old female patient was vaccinated with the second doses of PREVENAR 13 (batch: F82154) in thigh at 0.5 ml single dose; INFANRIX IPV+HIB (batch: A20CA752C) in thigh at 1 DF single; and, oral ROTARIX (batch: AR0LA436C) at 1 DF single, on 19Apr2012. Previous vaccinations with INFANRIX IPV+HIB; PREVENAR 13; and, ROTARIX administered on 19Mar2012 had been well tolerated. The child is a twin born in the 37 week of gestation. Medical history included hypoglycaemia, neonatal feeding problems, sight disability, acute respiratory syncytial virus bronchiolitis with partial respiratory insufficiency requiring hospitalization of 25Feb2012, and severe hypotonia of thorax and abdomen. The patient was hospitalized from 25Feb2012 to 09 Mar2012 to perform an extended screening for metabolic disorders. EEG as well as VEP examinations were performed of which only the VEP revealed pathological findings. On 19Apr2012, after vaccination, the patient developed fever (38.5 C) without showing further symptoms. On 20Apr2012 the fever persisted (between 38 C and 40 C) thus the mother administered a suppositorium (Paracetamol 75 mg). On 21Apr2012 the child still had fever. As the fever was high at 7 o''clock p.m. (40 C) the mother administered a further suppositorium (Paracetamol 75 mg). Besides pyrexia the child appeared to be well. On 22Apr2012 at 1 o''clock a.m. the child cried to be fed and again had fever (39.9 C). At 5:17 in the morning the child was found lifeless. An emergency physician was called who arrived eight minutes later and started cardiopulmonary resuscitation which was continued until 6:53. It was reported that the patient died due to sudden infant death syndrome (SIDS) on 22Apr2012. The deceased child''s sister who received the same vaccinations at the same time did not show any signs and symptoms of disease. Both two and a half year-old brothers, also twins, of the deceased child suffered from fever since 18Apr2012. On 23Apr2012, one of the brothers was diagnosed with streptococcal sore throat. A smear was taken which was tested positive for streptococci and was treated with Cefaclor. At the time of this report, it was unknown whether an autopsy will be performed. The public prosecutor will decide whether to request an autopsy.


VAERS ID: 454905 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2012-04-25
Onset:2012-04-25
   Days after vaccination:0
Submitted: 2012-05-02
   Days after onset:7
Entered: 2012-05-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
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: 2012-04-25
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012103908

Write-up: This is a spontaneous report from a non-contactable consumer through a Pfizer sales representative. A 4-months-old female patient received PREVENAR 13, via an unspecified route of administration, at 0.5 ml single dose; SABIN VACCINE, and PENTAVAC; on 25Apr2012. Patients medical history and concomitant medications were not reported. On 25Apr2012 the patient died.


VAERS ID: 455370 (history)  
Form: Version 1.0  
Age: 1.4  
Sex: Male  
Location: Foreign  
Vaccinated:2012-04-26
Onset:2012-05-01
   Days after vaccination:5
Submitted: 2012-05-10
   Days after onset:9
Entered: 2012-05-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0717AA / 1 AR / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acidosis, Blood lactic acid, Blood pH decreased, Brain hypoxia, CSF test abnormal, Cardiac arrest, Cerebral ischaemia, Chest X-ray normal, Computerised tomogram head abnormal, Convulsion, Death, Echography normal, Electrocardiogram normal, Enterovirus test positive, Herpes simplex serology positive, Human herpes virus 6 serology positive, Hypoperfusion, Hypoxic-ischaemic encephalopathy, Lactic acidosis, Loss of consciousness, Mouth haemorrhage, Polymerase chain reaction, Restlessness, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lactic acidosis (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), 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), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2012-05-04
   Days after onset: 3
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: Unknown
Current Illness:
Preexisting Conditions: Fever; Upper respiratory tract infection
Allergies:
Diagnostic Lab Data: Head computed axial tomography, 01May12, showed outcomes of anoxic damage; chest X-ray, 01May12, normal; electrocardiogram, 01May12, normal; arterial blood pH, 01May12, 6.82, abnormal; body temp, 01May12, 37.7 degrees C; serum L-lactate test, 01May12, 10, increased; serum L-lactate test, 01May12, 3.1; arterial blood PH, 02May12, 7.16; enterovius PCR, 04May12, positive; serum Herpes simplex virus IgG antibody, 04May12, Herpes virus 6 serology: Positive
CDC Split Type: WAES1205USA01055

Write-up: Case reported by Health Authority (case n. 165454) through agency (local case n. IT210/12). Initial case received on 03-MAY-2012. Case medically confirmed. A 17 month old male patient was vaccinated on 26-APR-2012 with the first dose of MMR II, (batch n. G014794, lot n. 671487/0717AA), I.M. in the deltoid. On 01-MAY-2012, 5 days post-vaccination, at 17:58 he was hospitalized due to a cardiac arrest. The case history during the hospitalization evidenced that the child, since birth, was hospitalized 5 times mainly due to fever and infections of the upper respiratory tract. The fifth hospitalization on 16-NOV-2011, was following the 3rd dose of INFANRIX HEXA, (on 15-NOV-2011) due to fever and convulsions. On the early morning of 01-MAY-2012 at 04:30 a.m., the child presented with fever (37.7 degrees C) that the parents treated with paracetamol. Until 12:00 p.m. the child was restless but ate normally and slept afterwards. At 16:30 p.m. the parents found the child unconscious in bed with traces of blood in the mouth and on the pillow. The father resuscitated him and called the emergency unit that took the child to the hospital. At 17:58 p.m. he was admitted in the pediatric emergency room where he was resuscitated presenting with severe hypoperfusion acidosis and brain hypoxia; suspicion of convulsive crisis during sleep, no signs of brain hemorrhage. Labwork and investigations were performed (see lab comments screen) that evidenced: normal RX (x-ray) thorax; normal electrocardiogram (ECG); normal echography; abnormal brain computerized tomography (CT) scan (outcomes of anoxic damage) and lactic acidosis. The diagnosis of emergency admission was cardiac arrest, cerebral ischaemia, and lactic acidosis. The outcome was not recovered/not resolved. Additional information received from Health Authority (HA) on 04-MAY-2012: Cerebrospinal fluid (CSF) analysis by polymerase chain reaction (PCR) and blood tested positive for enterovirus and negative for human herpes virus 6. The patient died on 04-MAY-2012. The case was closed. A lot check has been initiated. Other business partner numbers included: E2012-02892. No further information is available.


VAERS ID: 455721 (history)  
Form: Version 1.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-04-30
Onset:2012-04-30
   Days after vaccination:0
Submitted: 2012-05-16
   Days after onset:16
Entered: 2012-05-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR E0480 / UNK UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. G005304 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Condition aggravated, Death, Ileus, Nuclear magnetic resonance imaging, Resuscitation, Sepsis
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DECORTIN; Pantoprazole
Current Illness:
Preexisting Conditions: Crohn''s disease since years, ileo-coecal resection in 2000, multiple intestinal fistulae and persistent abdominal pain. Treatment with DECORTIN 30 mg daily and pantoprazol 40 mg.
Allergies:
Diagnostic Lab Data:
CDC Split Type: E201203025

Write-up: This case with fatal outcome was received from a healthcare professional via another company (Novartis Vaccines, reference no. S2012DE03337) on 10-May-2012. The case is medically confirmed. A 44-year-old male patient received a dose of IPV MERIEUX (lot-no. E0480-2) IM and dose 1 of PNEUMOVAX 23, lot-no. G005304) IM at 10 a.m. on 30-Apr-2012. Approximately four hours later, at 2 p.m. the patient presented with acute abdominal pain. At 5 p.m. the patient went to his GP who suspected an ileus, the patient was admitted in hospital. An MRI was performed but results were not reported. During the night, the patient''s condition obviously aggravated and he died after unsuccessful cardio-pulmonary resuscitation. At the time of the report the cause of death was not reported. It was not yet decided whether an autopsy will be performed. The reporting physician suspected the pre-existing Crohn''s disease with fistulae to have contributed to the patient''s death (suspicion of sepsis). Medical history included Crohn''s disease for years (ileo-coecal resection in 2000) with multiple intestinal fistulae and persisting abdominal pain. Concomitantly, the patient was on long-term treatment with oral DECORTIN 30 mg/day and pantoprazol (40 mg/day).


VAERS ID: 455934 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-10-06
Onset:0000-00-00
Submitted: 2012-05-17
Entered: 2012-05-21
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
JEV1: JAPANESE ENCEPHALITIS (IXIARO) / INTERCELL AG - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature, Brain injury, Death, Dizziness, Encephalitis viral, General physical health deterioration, Influenza like illness, Speech disorder
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Doxycycline; yellow fever vaccine; rabies vaccine; Pre-travel vaccines (unspecified)
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSCRATCHP001070

Write-up: The following information was received from a nurse via distributor on 04 May 2012 (initial and follow up information received on the same day and reported in summary here). Reporter did not comment on causality. Part of the information has been published in a public newspaper on 26 Apr 2012, which was also supplied by the reporter. A 26 year old female received her first IXIARO vaccination (batch number JEV10G58A) on 22 Sep 2011, followed by a second dose on 06 Oct 2011 (day 14, rather than day 28), prior to a year long backpacking journey. Concomitant medication included yellow fever and rabies vaccinations, doxycycline for malaria prophylaxis, and other unspecified pre-travel vaccinations for travel to foreign countries. She had no relevant medical history and did not take other concomitant medication. After leaving foreign countries, and while in another foreign country, patient developed a temperature and flu-like symptoms, felt dizzy, and had difficulty speaking. Her health deteriorated and she was subsequently airlifted to a hospital. Viral encephalitis (not specified further) and associated brain damage were diagnosed. She died five days after arrival (approximately one week after symptom onset) on 05 Mar 2012 from viral encephalitis.


VAERS ID: 456118 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-04-28
Onset:2012-05-12
   Days after vaccination:14
Submitted: 2012-05-22
   Days after onset:10
Entered: 2012-05-24
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 3 UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Respiratory arrest, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-12
   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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012120756

Write-up: This is an initial spontaneous report from a contactable pediatrician via a Pfizer sales representative. A patient of unspecified age and gender received the third dose of PREVENAR subcutaneously on 28Apr2012, the third dose of ACT-HIB subcutaneously on 28Apr2012, and the second dose of DPT subcutaneously on 28Apr2012. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 12May2012, 2 weeks after the vaccination, the patient''s mother found the patient in respiratory arrest, and the patient was transported by ambulance. Shortly thereafter, the patient was transferred to another hospital and was pronounced dead on 12May2012. An autopsy was performed on an unknown date showing no abnormalities and diagnosis the cause of death as suspected sudden infant death syndrome (SIDS). This was in consideration of the fact that the patient was sleeping on the stomach. The reporting pediatrician classified the event, suspected SIDS, as serious due to the patient''s death and assessed the event as unrelated to PREVENAR.


VAERS ID: 456319 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-12-09
Onset:2012-01-01
   Days after vaccination:23
Submitted: 2012-05-25
   Days after onset:144
Entered: 2012-05-29
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: ADALAT CR; BLOPRESS; TANATRIL
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1205USA03874

Write-up: Initial information has been received from a physician concerning an 84 year old male patient, who on 09-DEC-2011, was vaccinated with PNEUMOVAX 23 0.5 ml, subcutaneously (injection site and lot number not reported). Concomitant therapy included ADALAT CR, TANATRIL and BLOPRESS. In January 2012, the patient developed interstitial pneumonia and admitted to another hospital. In January 2012, the patient died due to interstitial pneumonia. No information on autopsy was provided. Reporting physician''s comment: I do not know detailed information because the patient was admitted to another hospital after interstitial pneumonia developed. Reporting physician considered that interstitial pneumonia was serious due to hospitalization and death. Reporting physician felt that the relationship between interstitial pneumonia and pneumococcal vaccine was unknown. No further information is available.


VAERS ID: 456371 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2008-11-06
Onset:2008-12-11
   Days after vaccination:35
Submitted: 2012-05-25
   Days after onset:1260
Entered: 2012-05-29
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SYR
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SYR
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 1 - / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain neoplasm, Death, Hydrocephalus, Investigation abnormal
SMQs:, Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-04-07
   Days after onset: 116
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: Unknown
Current Illness: Familial risk factor
Preexisting Conditions: Torticollis
Allergies:
Diagnostic Lab Data: Ultrasound, 3 normal antenatal ultrasounds performed during pregnancy
CDC Split Type: WAES1011USA03505

Write-up: Case received from the health authorities on 15-SEP-2010 under the reference number 200900220. Case medically confirmed. A 3 month old male patient had received the first dose of ROTATEQ (batch number not reported), an injection of diphtheria toxoid, tetanus toxoid, pertussis vaccine (unspecified), hepatitis B virus vaccine (unspecified), poliovirus vaccine inactivated (unspecified), Hib conj vaccine (unspecified carrier) (batch number not reported, manufacturer unknown) and an injection of PREVENAR (batch number not reported, other manufacturer) on 06-NOV-2008 and, on 11-DEC-2008 he developed brain tumor. The patient had a personal medical history of torticollis and a family history of different organ neoplasia in his uncle, aunt, cousin and grandmother. The patient was hospitalized on 11-DEC-2008. Aetiological investigations were performed and revealed grade III glial brainstem tumor. The tumor was considered to be unresectable. Hydrocephalus was treated with external derivation. Palliative therapy was decided in December 2009, the patient was hospitalized on the day of his death. The patient died from brain tumor on 07-APR-2009. The investigator considered that brain tumor was not related. The sponsor considered that brain tumor was unlikely related to the study drug. Follow-up information received through the final clinical study report provided by the sponsor of the study, hospital on 11-MAY-2012 under the reference number 200900220: According to the sponsor, the event was possibly related to vaccination. Upon internal review, a corrective version was created on 23-MAY-2012 to correct a suspect vaccine. In the information received on 11-MAY-2012 it was specified that the patient had received on 06-NOV-2008 a dose of INFANRIXQUINTA (batch number not reported, other manufacturer) instead of a dose of diphtheria toxoid, tetanus toxoid, pertussis vaccine (unspecified), hepatitis B virus vaccine (unspecified), poliovirus vaccine inactivated (unspecified), Hib conj vaccine (unspecified carrier) (batch number not reported, manufacturer unknown) as previously reported. Other business partner numbers include E2010-07349. No further information is available.


VAERS ID: 456530 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-05-29
Entered: 2012-05-31
   Days after submission:2
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: 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: 2012119054

Write-up: This is a spontaneous report from a contactable consumer (responsible for the vaccination center), via consumer service. The reporter informed that a 5-month-old patient of unspecified gender, weight and height received a dose of PREVENAR 13, intramuscularly on unknown date. The reporter did not provide information on patient''s medical history. It was not reported if the patient was taking concomitant medications. Twenty-four hours after receiving the vaccine, the infant died. It was not reported if an autopsy was performed.


VAERS ID: 456608 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-08-18
Onset:2011-09-01
   Days after vaccination:14
Submitted: 2012-05-31
   Days after onset:273
Entered: 2012-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA143BA / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Completed suicide, Death, Musculoskeletal stiffness
SMQs:, Suicide/self-injury (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-09-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Carbocisteine; Fexofenadine hydrochloride; Pranlukast
Current Illness: Allergic rhinitis; Congenital heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0804493A

Write-up: This case was reported by a physician and described the occurrence of suicide in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included allergic rhinitis and congenital heart disease. Concurrent medications included MUCODYNE, ALLEGRA and ONON. On 18 August 2011, the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, left deltoid). On an unspecified date, as the subject had muscle stiffness, Kakkonto 2.5g twice a day for 3 days and LOXONIN for 6 doses were prescribed. On 1 September 2011, 14 days after vaccination with CERVARIX, the subject committed suicide. The subject died on 1 September 2011 from accomplished suicide. It was unknown whether an autopsy was performed.


VAERS ID: 457040 (history)  
Form: Version 1.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-05-16
Onset:2012-05-18
   Days after vaccination:2
Submitted: 2012-06-08
   Days after onset:21
Entered: 2012-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 AR / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza like illness, Pneumonia, Rhinorrhoea, Sneezing
SMQs:, Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-28
   Days after onset: 10
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: B0805826A

Write-up: This case was reported by a consumer (subject''s granddaughter) and described the occurrence of pneumonia in a 100-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other healthcare professional has not verified this report. On 16 May 2012, the subject received 1st dose of FLUARIX (unknown route, unknown arm, batch number not provided). On 18 May 2012, 2 days after vaccination with FLUARIX, the subject experienced flu-like symptoms described as running nose and sneezing which according to the reporter evolved in pneumonia. No hospitalisation was required following the responsible physician''s recommendation. The subject died on 28 May 2012, cause of death was not reported. It was unknown whether an autopsy was performed. Follow-up information was not expected.


VAERS ID: 457157 (history)  
Form: Version 1.0  
Age: 0.29  
Sex: Female  
Location: Foreign  
Vaccinated:2012-05-29
Onset:2012-05-30
   Days after vaccination:1
Submitted: 2012-06-08
   Days after onset:9
Entered: 2012-06-11
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G1518 / 1 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dehydration
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown medical history; No concomitant therapy
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201205691

Write-up: Case received from a healthcare professional through the local affiliate on 30 May 2012 under the local reference number A201200154. A 03-month-old female patient, with an unknown medical history and no concomitant therapy, had received her 1st subcutaneous dose of ACT-HIB, batch number G1518, in the right upper arm, on 29 May 2012, at noon. The patient had previously received her 1st dose of ROTARIX (other manufacturer, batch number not reported) on an unspecified date in April 2012, her 2nd dose of ROTARIX (other manufacturer, batch number not reported) on an unspecified date in May 2012, her dose of PREVENAR (other manufacturer, batch number not reported) on 22 May 2012. On 30 May 2012, at around 06:00 am, the patient''s father found her dead. He called an ambulance. Due to the patient''s mother''s physical deconditioning, the patient did not receive hydration including breast feeding from 29 May 2012 16:00 to 30 May 2012 around 06:00 am. The police found a trace of the injection on the patient''s arm. The police informed the reporter of the patient''s death. After the police interview, the reporting physician informed the manufacturer of the adverse event (death). Physician''s comment: This case was serious (death) and the causality between the event and ACT-HIB was unknown. The patient did not receive hydration including breath feeding for 14 hours till the death time. Dehydration was also suspected of being related to the event. An autopsy would determine the cause of death. Documents held by sender: none.


VAERS ID: 457325 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-06-04
Onset:2012-06-05
   Days after vaccination:1
Submitted: 2012-06-07
   Days after onset:2
Entered: 2012-06-13
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-05
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012135142

Write-up: This is a spontaneous report from a contactable pediatrician via a Pfizer sales representative. A 4-month-old patient of unknown gender received a single dose of PREVENAR and ACT-HIB, which both were taken 0.5 ml subcutaneously on 04Jun2012 simultaneously. At questioning for immunization, there was no problem noted. The reporter was contacted by police on 05Jun2012 and informed that the patient died from an unspecified cause on 05Jun2012. The police asked the reporter if there was a bruise indicating abuse at questioning for immunization and requested checking the patient''s medical history. According to the police, the patient was transferred to another hospital. The details including a symptom leading to death was unknown. No information was provided whether an autopsy was performed. The reporter classified death as serious and assessed the event death as possibly related to PREVENAR.


VAERS ID: 457355 (history)  
Form: Version 1.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-05-10
Onset:2012-05-12
   Days after vaccination:2
Submitted: 2012-06-11
   Days after onset:30
Entered: 2012-06-13
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1203501 / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Blood gases, Cardio-respiratory arrest, Chest X-ray, Death, Decreased appetite, Dyspnoea, General physical health deterioration, Hyperhidrosis, Intensive care, Malaise, Productive cough, Pyrexia, Somnolence
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Interstitial lung disease (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), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-16
   Days after onset: 4
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: PHHY2012CO048429

Write-up: Case number PHHY2012CO048429 is an initial spontaneous report received from a hospital nurse and health authority through a Norvatis employee on 06 Jun 2012. This case refers to a 93-year-old female patient. The patient''s medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1203501, expiration date: Dec 2012) on 10 May 2012. On 12 May 2012, she experienced fever, cough with secretions, sweating, malaise, difficulty in breathing, loss of appetite. She received medical treatment, management of symptoms with acetaminophen, and respiratory therapy. The patient''s history was discussed with the caregivers (not specified). The patient was diagnosed with respiratory distress syndrome secondary to lymphangitic spread vs. post-vaccine reaction on 12 May 2012 by a physician. On 14 May 2012 physician referred the patient to the emergency room where chest radiography and arterial blood gases were performed. On 14 May 2012 the patient was admitted in ICU in bad general condition, with drowsiness, dyspnea, and fever. She was given treatment with normal saline solution, furosemide 5 mg every 12 hours, methylprednisolone, morphine, ranitidine, enoxaparin and 30% oxygen. On 16 May 2012 the patient experienced a cardiopulmonary arrest and died. The outcome of the events fever, difficulty breathing/dyspnea, loss of appetite, respiratory distress syndrome, bad general condition and drowsiness were reported as death. Agency consider that FLUVIRIN treatment was suspected to be related with events.


VAERS ID: 457411 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-07-01
Onset:0000-00-00
Submitted: 2012-06-12
Entered: 2012-06-14
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 36470 / 4 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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012138106

Write-up: This is a spontaneous report from a contactable physician. A 5-year-old male patient received PREVENAR, via an unspecified route of administration in Jun2007, Aug2007, Sep2007 and Jul2009. The patient medical history was not reported. The patient had no history of premature birth, immune defect or chronic underlying disease. The patient''s concomitant medications were not reported. On an unspecified date in 2012, the patient experienced pneumococcal meningitis and pneumococcal bacteraemia without focus and died on an unspecified date in 2012. Laboratory data included blood culture and cerebrospinal fluid with no serotyping. It was not reported if an autopsy was performed.


VAERS ID: 457419 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2003-03-01
Onset:0000-00-00
Submitted: 2012-06-13
Entered: 2012-06-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Chest pain, Chronic respiratory failure, Death
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-09-04
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: Unknown
Current Illness: Pneumoconiosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1206USA01313

Write-up: Initial information has been received from a wife of a male patient (elderly) who around in March 2003 was vaccinated with a dose of PNEUMOVAX 23, parenteral (indication, route, injection site and lot number not reported). The patient was under treatment for pneumoconiosis. No information on concomitant medication was provided. Around in March 2003, the patient, who was receiving treatment for pneumoconiosis, was inoculated with the vaccine without any explanation. After a while, the patient experienced chest pain and was diagnosed as having chronic respiratory failure. From 08-MAR-2003 to 16-APR-2003, the patient was hospitalized. From 01-MAY-2003 to 05-JUN-2003, the patient was hospitalized. From 14-AUG-2003, the patient was hospitalized. On 04-SEP-2003, in early morning, the patient died of chronic respiratory failure. Thereafter, autopsy was performed (no information about the result). The reporter considered that chronic respiratory failure was serious due to hospitalization and death. The reporter did not assess the causal relationship between chronic respiratory failure and PNEUMOVAX 23. No further information is available.


VAERS ID: 457497 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-06-15
Entered: 2012-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Vaccination failure, Waterhouse-Friderichsen syndrome
SMQs:, Lack of efficacy/effect (narrow), Sepsis (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2012-06-06
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: PHHY2012DE051035

Write-up: Case number PHHY2012DE051035 is an initial combined spontaneous report received from a physician on 14 Jun 2012. This report refers to a 16-years-old female patient. Her medical history included no immunodeficiency. Her vaccination history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) through an unknown route and site of an unspecified date (3 to 4 years ago). On an unknown date, she developed meningococcal infection of serotype C. On 06 Jun 2012, she died due to Waterhouse-Friderichsen syndrome, a complication of the meningococcal C infection. Vaccination failure was suspected. The causality was not assessed. No further information was available.


VAERS ID: 457587 (history)  
Form: Version 1.0  
Age: 1.52  
Sex: Male  
Location: Foreign  
Vaccinated:2012-05-25
Onset:2012-06-02
   Days after vaccination:8
Submitted: 2012-06-14
   Days after onset:12
Entered: 2012-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F82152 / 2 AR / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Blood test, Bronchitis chronic, Cardiac arrest, Cardiac infection, Condition aggravated, Death, Myocardial infarction, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hospitalized a half year before this report, declared as cured, however still cough and sniveling; Chronic bronchitis; First dose, PREVENAR-13
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012137809

Write-up: This is a spontaneous report from newspapers and local television news and confirmed by a contactable physician, medical quality coordinator from health care organization. This physician reported that a 18-month-old male patient received PREVENAR 13, via intramuscular route in arm at 0.5 ml, single (lot number F82152, expiration date Jul2014), combined with a vaccination for PRIORIX on 25May2012. Medical history included chronic bronchitis (hospitalized a half year before this report, declared as cured, however still cough and sniveling) and respiratory syncytial virus infection (RSV infection). The patient''s concomitant medications were not reported. On 27 Jan2011, the subject had received the first dose of PREVENAR 13 via intramuscular route in arm. The second dose was administered on 25May2012 as a catch-up vaccination. At that time the child had superficial rattles and had no acute disease. Auscultation revealed no abnormalities. No serious symptoms were observed which could be consequence of the past RSV infection (according to the parents, this was the predestinating factor through which the vaccination could result in death). After vaccination, the patient experienced an aggravation of the chronic bronchitis and the infection transferred from the lungs to the heart, resulting in a myocardial infarction with fatal outcome. The patient died on 03Jun2012. An autopsy was planned and judicial inquiry is initiated. The general practitioner, who knew the child and had been treating him in the past, was consulted after the death and this physician could not make a link between the patient''s medical history of RSV infection, chronic respiratory illness and the vaccinations. The emergency physician who examined the child after the emergency call from the parents declared that the patient already deceased during his sleep, and did not consider a link between vaccination and death. The judicial physician who performed an external autopsy and took a blood sample, would have declared that the child had or went through an RSV infection (this information was received from others and the media). Further examination was planned (internal autopsy on 11Jun2012). The subject''s parents declared through the media that the child had high fever the evening before his death, which was treated with an analgesic (possibly paracetamol) with good response. The reporting physician could not confirm myocardial infarction but preferred the term sudden death awaiting further autopsy results. The reporting physician also declared there was no reason to assume there was a causal relationship between the patient''s death and the administration of the vaccine 9 days before the event. A copy of the publication of this case in the local newspaper, dated 09Jun2012, was provided. The article reported: "On Monday an additional autopsy will be performed to determine the cause of death of the toddler. The toddler of 18 months had a cardiac arrest at home last Sunday after a consultation. The police physician did not find foreign substances at the external autopsy and concluded that it was a natural death. The parents remain convinced that their son died because of the wrong vaccination." This case was also reported to the foreign regulatory authority.


VAERS ID: 457616 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-03-28
Submitted: 2012-06-18
   Days after onset:82
Entered: 2012-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-28
   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: Congenital heart defect
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0075986A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of primary AE in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline) and INFANRIX HEXA (GlaxoSmithKline). Co-suspect vaccinations included PREVENAR 13 (Pfizer Pharma). Concurrent medical conditions included severe congenital heart defect. On an unknown date in 2012 the subject received an unspecified dose of ROTARIX (oral), an unspecified dose of INFANRIX HEXA (0.5 ml, unknown) and an unspecified dose of PREVENAR 13 (0.5 ml, unknown). Approximately 14 days post vaccination with ROTARIX, INFANRIX HEXA and PREVENAR 13, on an unknown date in 2012, the subject experienced death - at present cause unknown. It was unknown whether an autopsy was performed. The reporting physician as well as all other treating physicians considered that the event was unlikely related to vaccination with ROTARIX, INFANRIX HEXA and PREVENAR 13 but nevertheless considered a temporal relationship between death and vaccination with ROTARIX, INFANRIX HEXA and PREVENAR 13. The case also reported to the foreign regulatory authority by the reporting physician. Follow-up information was received on 18 June 2012 by phone from the reporting physician. At the time of death the subject was about three and a half months old. The subject was vaccinated within the scope of early diagnosis examinations for children U4. On an unknown date in March 2012 the subject received an unspecified dose of ROTARIX (oral), an unspecified dose of INFANRIX HEXA (0.5 ml, unknown) and an unspecified dose of PREVENAR 13 (0.5 ml, unknown). Approximately 10 days post vaccination with ROTARIX, INFANRIX HEXA and PREVENAR 13, on 28 March 2012, the subject experienced death - at present cause unknown. An autopsy was performed. At the moment no written autopsy report was available. According to preliminary verbal information autopsy showed no cause of death up to now. Further examinations were still ongoing. Follow-up information has been requested.


VAERS ID: 457813 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2011-10-26
Submitted: 2012-06-20
   Days after onset:238
Entered: 2012-06-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alanine aminotransferase normal, Anuria, Aspartate aminotransferase increased, Blood alkaline phosphatase normal, Blood creatinine increased, Blood electrolytes abnormal, Blood fibrinogen increased, Blood lactic acid normal, Blood pH decreased, Blood potassium normal, Blood sodium normal, Blood urea, Brain death, CSF cell count abnormal, CSF glucose decreased, CSF protein increased, CSF test abnormal, Cardiac index decreased, Cardiac murmur, Cardiomegaly, Chest X-ray abnormal, Coagulation factor V level increased, Cough, Death, Diarrhoea, Drug ineffective, Endotracheal intubation, Feeding disorder of infancy or early childhood, Full blood count abnormal, Gamma-glutamyltransferase normal, Gaze palsy, Gram stain, Gram stain positive, Grand mal convulsion, Haematocrit decreased, Haemodialysis, Haemoglobin decreased, Haemolytic uraemic syndrome, Hypertension, Hypertonia, Intracranial pressure increased, Liver function test abnormal, Lumbar puncture abnormal, Lymphocyte count decreased, Meningeal disorder, Meningitis pneumococcal, Miosis, Monocyte count normal, Neurological examination abnormal, Neutrophil count decreased, Neutrophil percentage increased, PCO2 increased, Platelet count decreased, Protein total decreased, Prothrombin time ratio, Pyrexia, Red blood cells CSF positive, Renal failure, Skin warm, Status epilepticus, Streptococcus test positive, Tachycardia, Ultrasound scan normal, Vomiting, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Parkinson-like events (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Hypertension (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Renovascular disorders (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-10-31
   Days after onset: 5
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: Haemolytic anaemia on pyknocytosis; Cow''s milk intolerance
Allergies:
Diagnostic Lab Data: 26-OCT-2011, Factor V deficiency, 51%; 26-OCT-2011, Haematocrit, 28%; 26-OCT-2011, Haemoglobin, 9.1g; 26-OCT-2011, Prothrombin time ratio, 76%; 26-OCT-2011, White blood cell count, 1800/mm3; Pneumococcal stem: serotype 16F, cephalosporins non-resistant. Lab tests (Unknown date): lactic acid 1.5; pH 7.14; alkaline pool 19; PCO2 52.3, sodium 147; potassium 3.9; proteins 60; urea 9.9; creatinine 47. Complete blood count (Unknown): neutrophils count 980, lymphocytes count 720, monocytes count 110 and platelets count 61000. Liver function test (Unknown): aspartate aminotransferase 148 i.e. twice the upper normal limit UNL; alanine aminotransferase 29 i.e. 1.5 UNL, alkaline phosphatase 213; gamma glutamyltransferase 13. Coagulation profile (Unknown): prothrombin ratio 76%; factor V 51%; fibrinogen 8.5. Lumbar puncture test (Unknown): blurry fluid, 300 components of which neutrophils 61%, 780 red blood cells, hypoglycorachia 0.7 mmol/l, hyperproteinorachia 5.1 mmol/l, Cocci Gram positive on direct examination. Urinary antigen Test (Unknown): positive for pneumococcus. Trans-cranial Doppler (Unknown): pulsatility index 0.66 on the right side, 0.64 on the left. Cardiac ultrasound (Unknown): unrevealing. Chest X-ray (Unknown): well set tracheal catheter, bilateral alveolar opacities in systematized focus, cardiomegaly with cardiothoracic index 0.58.
CDC Split Type: 2012143064

Write-up: This is spontaneous report received from the Agency. Regulatory authority report number PC20120284. A 7-month-old female patient received second dose of PREVENAR, route of administration and dates not specified. Relevant medical history included birth at 35 weeks of gestation with twin pregnancy, neonatal hemolytic anemia on pyknocytosis and cow''s milk intolerance. No concomitant medicines were captured by the agency but it was noted that the infant received three injections of INFANRIX. The patient developed pneumococcal meningitis, haemolytic and uremic syndrome, intracranial hypertension, convulsive status epilepticus, hypertension, renal failure and ineffective drug which led to the infant''s death. On 26Oct2011, the patient was seen in consultation for fever (39C) persisting for three days, volume feeding reduction, vomiting, diarrhea and cough while her twin brother was presenting rhinopharyngitis. Clinical examination revealed: blood pressure 102/75, heart rate 177, temperature 38.3C and respiratory frequency 44/minute. Cardiovascular examination: warm extremities, perceived peripheral pulses and systolic murmur 2/6th. Neurological examination revealed meningeal disorders. The patient developed generalized tonic-clonic convulsive seizure which was treated with intra-rectal VALIUM 0.5 mg/kg administration. Fluid loading was performed (20 ml/kg) with administration of CLAFORAN 300 mg/kg/day and vancomycin (unspecified trade name) 15 mg/kg. Convulsive seizure resolved but tachycardia persisted. Additional fluid loading was performed (20 ml/kg) with administration of gentamicin (unspecified trade name) 3 mg/kg/day. A second episode of convulsive seizure occurred with clonic movements and gaze variability. Treatment with GARDENAL, loading dose of 20 mg/kg, allowed seizure to resolve. Intubation was performed after sedation. Neurological examination revealed pinpoint miosis, peripheral hypertonia, active, diffuse and symmetric deep tendon reflexes, fontanel was normal. Treatment with CELESTENE 0.15 mg/kg/6 hours and antibiotic therapy was started. Arterial hypertension, intracranial hypertension, hemolytic and uremic syndrome occurred, associated with oligoanuria and renal failure on laboratory test, requiring haemofiltration. Pneumococcal meningitis was diagnosed. Cefotaxime was continued alone (300 mg/kg/day). Laboratory work-up: lactic acid 1.5; pH 7.14; alkaline pool 19; PCO2 52.3. Full blood count: hemoglobin 9.1 g; hematocrit 28%; white blood cells count 1800/mm3 with neutrophils count 980, lymphocytes count 720, monocytes count 110 and platelets count 61000. Blood electrolytes: sodium 147; potassium 3.9; proteins 60; urea 9.9; creatinine 47. Liver function test: aspartate aminotransferase 148 i.e. twice the upper normal limit UNL; alanine aminotransferase 29 i.e. 1.5 UNL, alkaline phosphatase 213; gamma glutamyltransferase 13. Coagulation profile: prothrombin ratio 76%; factor V 51%; fibrinogen 8.5. Lumbar puncture: blurry fluid, 300 components of which neutrophils 61%, 780 red blood cells, hypoglycorachia 0.7 mmol/l, hyperproteinorachia 5.1 mmol/l, Cocci Gram positive on direct examination. Urinary antigen was positive for pneumococcus. Trans-cranial Doppler: pulsatility index 0.66 on the right side, 0.64 on the left. Cardiac ultrasound was unrevealing. Chest X-ray showed: well set tracheal catheter, bilateral alveolar opacities in systematized focus, cardiomegaly with cardiothoracic index 0.58. In the night from 28 to 29Oct2011, the infant became clinically brain dead. Death occurred in the night from 30 to 31Oct2011. Pneumococcal meningitis and ineffective drug led to the patient''s death. Hemolytic and uremic syndrome, intracranial hypertension, convulsive status epilepticus, arterial hypertension and renal failure could have lead to the patient''s death. Based on the Official Foreign Method of Causality Assessment, the suspected medicinal product was rated by the agency as possible. No follow-up attempts needed. No further information expected.


VAERS ID: 457815 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-06-05
Onset:2012-06-05
   Days after vaccination:0
Submitted: 2012-06-20
   Days after onset:15
Entered: 2012-06-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1638AA / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-05
   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: Haemangioma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1206USA02340

Write-up: Information has been received from a physician (local reference # KOR/2012/06/027) concerning a baby, who was vaccinated with ROTATEQ. Concomitant therapy included VAXEM HIB and PREVENAR. The baby had no specific disease, but had hemangioma on her right cheek. On 02-APR-2012, the baby was vaccinated with the first dose of ROTATEQ, and at the same time, she was also vaccinated with VAXEM HIB and PREVENAR. On 05-JUN-2012, the baby was vaccinated with the second dose of ROTATEQ (lot # 672247/1638AA, exp date 18-AUG-2012), and at the same time, she was also vaccinated with VAXEM HIB and PREVENAR. At that time, the baby had no adverse event and returned home. At 8 p.m. on the same day (6 hours after visiting the clinic), the baby died for unknown reason. The reporting physician mentioned that the causality with ROTATEQ was unknown. No further information is available.


VAERS ID: 457993 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-12-01
Onset:2009-04-18
   Days after vaccination:138
Submitted: 2012-06-22
   Days after onset:1161
Entered: 2012-06-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Antibody test negative, Aspiration tracheal abnormal, Atelectasis, Autoantibody negative, Autonomic nervous system imbalance, Autopsy, Bacterial test negative, Blood potassium increased, Blood triglycerides increased, Borrelia test negative, C-reactive protein increased, CSF glucose, CSF protein, CSF white blood cell count increased, Cardiac failure, Catatonia, Central nervous system lesion, Clonus, Computerised tomogram head abnormal, Condition aggravated, Convulsion, Cytolytic hepatitis, Cytomegalovirus test negative, Death, Dizziness, Electroencephalogram normal, Encephalitis, Encephalitis autoimmune, Endotracheal intubation, Gastrointestinal obstruction, Gliosis, HIV antibody negative, Hepatocellular injury, Hyperkalaemia, Hyperthermia, Hypertonia, Hypertriglyceridaemia, Immunosuppression, Inflammation, Intensive care, Major depression, Malaise, Mechanical ventilation, Meningitis, Multi-organ failure, Mutism, Nausea, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Pseudomonas infection, Pseudomonas test positive, Renal failure acute, Respiratory distress, Rhabdomyolysis, Septic shock, Sinusitis, Status epilepticus, Treatment failure, Treponema test negative, Varicella virus test negative, Viral test negative
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Cardiac failure (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Dyslipidaemia (narrow), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Parkinson-like events (narrow), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Lipodystrophy (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-10-20
   Days after onset: 550
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: TEMESTA
Current Illness: Obsessive-compulsive disorder; Trichotillomania; Major depression
Preexisting Conditions: Tonsillectomy
Allergies:
Diagnostic Lab Data: electroencephalography, 12May09, normal; brain radionuclear scan, ??Aug10, no cerebral thrombophlebitis, sinusitis; electroencephalography, 16Aug10, normal, no epileptic activity; magnetic resonance imaging, 16Aug10, normal; diagnostic laboratory test, 29Aug10, Aspiration tracheal P.aeroginosa; autopsy, 22Oct10, Result for brain autopsy: astrocytal gliosis; autopsy, 22Oct10, Result for brain: subacute inflammatory lesions; diagnostic laboratory test, Leptospirosis negative; diagnostic laboratory test, Syphilis test negative; diagnostic laboratory test, autoantibody test negative.; body temp, 13Aug10, 38.7 C; serum C-reactive protein, 13Aug10, 100 mg/l; serum creatine kinase, 13Aug10, 2400 IU/l; CSF glucose, ??Aug10, 1.78 g/l; CSF white cell count, ??Aug10, 20 /mm3, normal; cerebrospinal fluid total protein test, ??Aug10, 0.27 g/l; serum potassium, 08Oct10, hyperkaliemia; serum triglyceride, End Sep-Beg Oct-2010: hypertriglyceridemia; serum varicella zoster virus antibody, virus test negative; Cytomegalovirus culture, negative; serum HIV-1 p24 antibody test, negative; serum antiadrenal antibody test, workup negative; serum Borrelia burgdorferi antibody test, negative
CDC Split Type: WAES1206USA03351

Write-up: Case received from the Health Authorities on 15-JUN-2012 under the reference number T020101212 and medically confirmed. A 17-year-old female patient had received the three doses of GARDASIL (batch numbers not reported) in December 2008, January 2009 and April 2009. The route of vaccine administration reported as transdermal is to be clarified with HA. She had a medical history of obsessive-compulsive disorder, trichotillomania, major depressive disorder, and had undergone tonsillectomy in June 2010. It was reported that she was having a long-term treatment with SEROPRAM 10 mg per os. She was hospitalized since 06-AUG-2010 due to major depressive disorder and catatonia. During hospitalization, on an unspecified date between 06-AUG-2010 and 12-AUG-2010, she was given TEMESTA per os, 2 injections of TERCIAN 50 mg via intravenous route and one injection of RISPERDAL via intravenous route. On 13-AUG-2010 she was hospitalized with clinical features of hyperthermia at 38.7 C associated with mutism and generalized hypertonia with neurovegetative dysautonomia. Biological work-up on 13-AUG-2010 showed inflammatory syndrome with CRP at 100 mg/l and rhabdomyolysis with CPK at 2400 IU/l. On 16-AUG-2010 SEG and brain MRI were normal. The following non drug-induced aetiologies were ruled out: EEG did not enable to evidence any evident epileptic activity. Brain CT scan showed no cerebral thrombophlebitis but right maxillary sinusitis was present. Lumbar puncture showed CSF white cell count at 20/mm3, CSF glucose at 1.78 g/l and CSF protein at 0.27 g/l. Infectious work-up were negative for Cytomegalovirus, HIV, varicella, Lyme disease, Leptospirosis and syphilis. Autoimmune workup was negative. Further to lumbar puncture results a treatment with ZOVIRAX and RIVOTRIL was started and the patient was transferred to neurology department where she was given Dantrolene on 14-AUG-2010, ZOVIRAX was maintained. On 15-AUG-2010 at 4.00 am the patient experienced acute respiratory distress on right lung atelectasis. She was intubated, ventilated, sedated and treatments with ROCEPHIN and TAVANIC were initiated. These treatments failed. Dantrolene was also stopped then started again on 16-AUG-2010. On 26-AUG-2010 the patient was still intubated and sedated as the attempts of extubation failed. Neurovegatative dysautonomia was still present. On 29-AUG-2010 tracheal aspiration showed p.aeruginosa therefore the patient was put on TIENAM and AMIKLIN. On 02-SEP-2010 she experienced epilepticus status which regressed on PENTHOTAL, as well as GARDENAL and KEPPRA. Her hemodynamic status was stable. According to the physicians the only differential diagnosis was malignant catalonia, which was very rare. On 09-SEP-2010, the patient experienced clonism after each lifting of sedation despite treatment with TEMESTA, GARDENAL and KEPPRA. Autoimmune limbic encephalitis was treated with TEGELINE. On 21-SEP-2010, she experienced a convulsion treated by PRODILANTIN and PENTHOTAL. It was followed by ketogenic diet causing hepatic cytolysis, acute renal insufficiency, cardiac insufficiency and hypertriglyceridemia. On 04-OCT-2010, corticotherapy was initiated. On 08-OCT-2010, ketogenic diet was poorly tolerated, causing hepatocellular insufficiency, acute renal insufficiency, hyperkalemia and gastrointestinal obstruction. Continued hemofiltration enabled to improve prothrombin level and hepatic function. On 17-OCT-2010, the patient experienced a septic shock. On 19-OCT-2010, she was found to have multi-organ failure. The patient died on 20-OCT-2010. The patient''s parents sent a letter to the Health Authorities questioning a causal relationship between vaccination with GARDASIL and their daughter''s death linked with meningoencephalitis. The general practitioner was contacted. The patient had received the 3 doses of GARDASIL in December 2008, January 2009 and April 2009. On 18-APR-2009, the patient presented with malaise preceded by lipothymic sensations and nausea. Emergency medical assistance service was called and the patient received an injection of magnesium. There was no recurrence. The patient had no history of convulsion. EEG performed on 12-MAY-2009 was unremarkable. Citalopram 0.5 dosage form per day was introduced at the end of Feb. On 11-OCT-2010, the conclusion of hospital report (intensive care) was provided: Malignant epilepticus status. Encephalitis limbic autoimmune suggested. Early failure of ketogenic diet. Significant immune suppression induced by barbiturates and corticotherapy. Septic shock with pulmonary and digestive starting point. Acute respiratory distress. Multi-organ failure. Brain autopsy was suggested and accepted by the parents. Autopsy report on 22-OCT-2010: absence of spongiform encephalopathy. Quite diffuse astrocytic gliosis of the focal signal of the meningitis were noted. Elements suggesting meningoencephalitis. Lesions showed subacute inflammatory pathology mainly meningeal associated to tissue context. Time to onset of the event made it difficult to attribute a causal relationship to GARDASIL. On 08-JUN-2012, a discussion with the neurologist who had followed the patient was reported: Autoimmune encephalitis was the central problem, the other manifestations being complications. The neurologist affirmed that the symptomatology linked to the autoimmune encephalitis started before 06-AUG-2010, and this already for the symptomatologies at the end of July 2010 and beginning of August. It seemed at least possible that the symptoms which sneakily appeared over the previous months (and according to the parents starting on beginning of 2009) could be related to the autoimmune encephalitis. Upon medical review, the company judged relevant to code the adverse events respiratory distress, septic shock, renal insufficiency, cardiac insufficiency, hepatic cytolysis, right lung atelectasis, pseudomonas aeruginosa infection, status epilepticus, gastrointestinal obstruction, malaise, nausea and lipothymic sensations which were mentioned by the CA in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reactions and RISPERDAL and TERICAN as possible" (C2 S2 12) according to the foreign method of assessment. The Health Authorities assessed the causal relationship between the reported reactions and SEROPRAM and vaccination with GARDASIL as doubtful (C1 S1 11) according to the foreign method of assessment. Other business partner numbers include E2012-03912. No further information is available.


VAERS ID: 458574 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Foreign  
Vaccinated:2012-06-05
Onset:2012-06-20
   Days after vaccination:15
Submitted: 2012-06-29
   Days after onset:9
Entered: 2012-07-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB259A / 2 LG / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F89734 / 2 LG / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012152041

Write-up: This is a spontaneous report from a contactable physician. A 4-month-old male patient received the second dose of PREVENAR 13 (lot # F89734), 0.5 ml single dose, and the second dose of INFANRIX HEXA (lot # A21CB259A), 1 DF single dose, on 05Jun2012. Both vaccines were administered intramuscularly in the thigh. Patient''s relevant medical history and concomitant medications were not reported. The patient was hospitalized under resuscitation conditions on 20Jun2012. It was also reported that between 05Jun2012 and 20Jun2012 no "negative information" regarding the patient was received by the physician. On 20Jun2012 the patient suddenly died and sudden infant death was suspected.


VAERS ID: 458755 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-06-05
Onset:2012-06-05
   Days after vaccination:0
Submitted: 2012-07-04
   Days after onset:29
Entered: 2012-07-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F52404 / 2 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asphyxia, Autopsy, Death, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-05
   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: At the 3-month-old, first dose, PREVENAR-13
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012156381

Write-up: This is a spontaneous from a contactable physician. A physician reported that a 5-month-old infant (gender unknown) received the second dose of PREVENAR 13 (lot# F52404) intramuscularly, on 05Jun2012. On the same day, the infant also received a dose of VAXEM-HIB and a dose of ROTATEQ. The patient had received the first dose of PREVENAR 13 previously when the infant was 3 months old It was reported that the patient had no relevant medical history and was taking no concomitant medications. On 05Jun2012, six hours after vaccination, the patient died. At the general hospital, it was presumed that the cause of death was not because of vaccine administrations but suffocation death due to dyspnea while rolling over. An autopsy was performed concluding that the infant had died due to suffocation. The reporting physician assessed the causal relationship as related, reporting also that there was no other etiological factor. The reporter refused to provided other additional information. No follow-up attempts possible. No further information expected.


VAERS ID: 458818 (history)  
Form: Version 1.0  
Age: 0.44  
Sex: Male  
Location: Foreign  
Vaccinated:2012-06-28
Onset:2012-06-29
   Days after vaccination:1
Submitted: 2012-07-06
   Days after onset:7
Entered: 2012-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA761B / 3 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0076208A

Write-up: This case was reported by a doctor''s assistant on behalf of a physician via a sales representative and described the occurrence of death - at present cause unknown - in a 5-month-old male subject who was vaccinated with INFANRIX-IPV+HIB (GlaxoSmithKline). Co-suspect vaccinations included PREVENAR 13 (Pfizer Pharma). On an unknown date in 2012 the subject received the third dose of INFANRIX-IPV+HIB (0.5 ml, unknown) and the third dose of PREVENAR 13 (0.5 ml, unknown). At an unspecified time post vaccination with INFANRIX-IPV+HIB and PREVENAR 13, on an unknown date in 2012, the subject experienced death - at present cause unknown. At present the cause of death was unknown. It was unknown whether an autopsy was performed. Follow-up information was received on the next day, on 04 July 2012, by the reporting physician, a paediatrician, via the sales representative. The subject was male. Co-suspect vaccinations included PREVENAR 13 (Pfizer Pharma) and ROTATEQ (Sanofi Pasteur). Previous vaccinations with the first two doses of INFANRIX-IPV+HIB (GlaxoSmithKline), PREVENAR 13 (Pfizer Pharma) and ROTATEQ (Sanofi Pasteur), given on 27 March 2012 and 25 April 2012, have been well tolerated. On 28 June 2012 the subject received the third dose of INFANRIX-IPV+HIB (0.5 ml, unknown), the third dose of PREVENAR 13 (0.5 ml, unknown) and the third dose of ROTATEQ (2ml, oral). Approximately one day post vaccination with INFANRIX-IPV+HIB, PREVENAR 13 and ROTATEQ, on 29 June 2012, the subject experienced death - at present cause unknown. At the time of death subject has been in a hospital. The reporting physician considered that death from an unknown cause was unlikely related to vaccination with INFANRIX-IPV+HIB, PREVENAR 13 and ROTATEQ. The case has also been reported to the local public health agency. Follow-up information has been requested.


VAERS ID: 459026 (history)  
Form: Version 1.0  
Age: 0.44  
Sex: Male  
Location: Foreign  
Vaccinated:2010-12-10
Onset:0000-00-00
Submitted: 2012-07-10
Entered: 2012-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Febrile convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (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)

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, Dec2010, High than 39deg.
CDC Split Type: B0812683A

Write-up: This case was reported by a healthcare professional (National Immunization Program) via another manufacturer (Fiocruz) and described the occurrence of febrile seizure in a 7-month-old male subject who was vaccinated with SYNFLORIX (GlaxoSmithKline). Concurrent vaccination included DTPA-HIB (non-GSK), ROTARIX (GSK, oral) and poliomyelitis vaccine live oral (non-GSK) given on 10 December 2010. On 10 December 2010, the subject received unspecified dose of SYNFLORIX (unknown route of administration, unspecified injection site, lot number not provided). Just after vaccination with SYNFLORIX, the subject experienced fever higher than 39 deg. C. The subject was treated with DIPIRONE, as self-medication. 6 days after vaccination, the subject experienced febrile seizures and was taken to hospital, where he arrived died. This report is one of cases received as part of a line-listing, each one containing minimal information. No further information can be obtained; this case has therefore been closed. Follow-up information was received on 26 June 2012: ROTARIX was also suspected.


VAERS ID: 459107 (history)  
Form: Version 1.0  
Age: 0.44  
Sex: Male  
Location: Foreign  
Vaccinated:2012-06-28
Onset:2012-06-28
   Days after vaccination:0
Submitted: 2012-07-11
   Days after onset:13
Entered: 2012-07-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / UN

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: 2012-06-28
   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: First dose; Second dose
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012159763

Write-up: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 5-months-old male patient received the third dose of PREVENAR 13, 0.5 ml single dose, via an unspecified route of administration on 28Jun2012 at 16:00. On the same day, he received concomitantly a dose of INFANRIX. The patient had received two previous doses of PREVENAR 13 on unknown dates. Patients medical history was not reported. On 28Jun2012 at 22:00, the patient was found dead at a hospital. The physician reported sudden infant death as suspected diagnosis. An autopsy will be performed.


VAERS ID: 459165 (history)  
Form: Version 1.0  
Age: 0.44  
Sex: Male  
Location: Foreign  
Vaccinated:2012-06-28
Onset:2012-06-29
   Days after vaccination:1
Submitted: 2012-07-12
   Days after onset:13
Entered: 2012-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA7618 / 3 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F72853 / 3 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1923AA / 3 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Fluid intake reduced, Initial insomnia, Irritability, Resuscitation, Secretion discharge, Vomiting, Yellow skin
SMQs:, Cholestasis and jaundice of hepatic origin (broad), Acute pancreatitis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 04/25/2012, PREVNAR 13, INFANRIX, ROTATEQ; 03/27/2012, PREVNAR 13, INFANRIX, ROTATEQ
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1207DEU000974

Write-up: Case of fatal outcome was received from a healthcare professional on 04-Jul-2012. Case is medically confirmed. A 5-month-old previous healthy male patient received a third dose of ROTATEQ (lot-no 1923AA) orally on 28-Jun-2012 at about 4pm. Concomitantly he received also the third dose of INFANRIX (GSK, lot-no A20CA7618) and the third dose of PREVENAR 13 (Wyeth, lot-no F72853). One day later, on 29-Jun-2012 in the afternoon, he was drinking less than normal, was tired and whiny and needed a longer time to fall asleep. The mother administered an antipyretic suppository. At 10pm he was breast-feeded and laid in bed afterwards. At 11pm the mother looked after him and detected some secretion at his mouth and on the bed, It was observed that the boy had a yellow skin and he was immediately transmitted to hospital. On the way he needed to be resuscitated and he vomited once. In hospital he was unsuccessfully resuscitated for about an hour. It is worth to notice that the patient was not found in a SIDS-typical position in his bed. He was found in a dorsal position, he wore a sleeveless body, no cover, one pillow in the bed, room ambient temperature was not too hot. At the time of reporting it was no clear whether an autopsy will be carried out. According to the reporter, the relation to vaccination was assessed as unlikely. Previous doses of ROTATEQ (lot-no. not readable for D1 and D2), INFANRIX (GSK, lot-no not readable for D1; A20CA7618 for D2) and PREVENAR 13 (Wyeth, lot-no. F2853 for D1 and D2) on 27-Mar-2012 (D1) and on 25-Apr-2012 (d2) were tolerated well.


VAERS ID: 459208 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-05-28
Onset:2012-05-30
   Days after vaccination:2
Submitted: 2012-07-12
   Days after onset:43
Entered: 2012-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB850AC / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Dialysis, Pulmonary oedema
SMQs:, Acute renal failure (narrow), Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-05
   Days after onset: 6
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: Ramipril; OLICARD; Frusemide; Amiodarone hydrochloride; Allopurinol; Famotidine; Colecalciferol; Nicoumalone; Digitoxin; Alprazolam; Erythropoietin; Ferric sodium gluconate; Carvedilol
Current Illness: Dialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0813833A

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of pulmonary edema in a 72-year-old male subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). Concurrent medical conditions included dialysis. Concurrent medications included RAMACE, Olicard, Furosemide, CORDARONE, MILURIT, Famotidine, ALPHA D3, SYNCUMAR, DIGIMERCK, FRONTIN, EPO, FERLIXIT and Carvedilol. Concurrent vaccination included ENGERIX B (GlaxoSmithKline) given on 23 March 2012 and 27 April 2012 without complication. On 28 May 2012 the subject received 3rd dose of ENGERIX B adult (unknown route, unknown injection site). On 30 May 2012, 2 days after vaccination with ENGERIX B adult, the subject experienced pulmonary edema after his dialysis. The subject was hospitalised at emergency ward. The subject died on 5 June 2012 from unknown cause of death. It was unknown whether an autopsy was performed. Additional information has been requested.


VAERS ID: 459502 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-05-23
Onset:2012-05-28
   Days after vaccination:5
Submitted: 2012-07-13
   Days after onset:46
Entered: 2012-07-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTIPV: DT + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER 143C / 6 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER G007672 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autoantibody negative, Biopsy heart normal, Brain herniation, Cardiac output, Cerebellar haemorrhage, Cerebellar infarction, Computerised tomogram head abnormal, Death, Echocardiogram abnormal, Epistaxis, Headache, Hyporesponsive to stimuli, Microbiology test normal, Platelet count normal, Pyrexia, Resuscitation, Syncope, Viral test negative, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 05/29/2012, Autoantibody test, negative, several; 05/29/2012, Biopsy heart, No myocarditis, no cardiomyopathy; 05/29/2012, Biopsy muscle, No anomalies; 05/28/2012, Computerised tomogram, intracranial hemorrhage; 05/28/2012, Echocardiogram, Abnormal; 05/28/2012, Platelet count, Normal; 05/29/2012, Viral test, Negative, No acute infections
CDC Split Type: WAES1207NLD000192

Write-up: Case received from the Health Authorities on 29-Jun-2012 under the reference number NL-LRB-139774. Medically confirmed. Initial source was a physician (also reported as a specialist doctor, pediatric intensive care). Case reported as serious by the agency (criterion: death). A 9-year-old female patient (weight 30 kg) had received the second dose of MMRVAXPRO (batch number G007672, administration site unknown) and the sixth dose of NVI (batch number 143C, administration site unknown) on 23-May-2012 in the Childhood Immunisation Programme. Concomitant medication was not reported. The day after the vaccinations, the patient developed fever, with 4 nose bleeds and headache at day 2 and 3. It was unknown if she had dizziness or diplopia, there was no rhinorroea. Nose bleeds were never experienced before. In the afternoon of day 4 she had somewhat recovered and went swimming. In the early morning of day 5 she got up from bed with suddenly severe headache and vomiting, and collapsed. She was resuscitated 5 times, transported to the regional hospital, which referred her to a university medical centre for extracorporeal membrane oxygenation (ECMO) therapy, for which anticoagulant therapy is required. At the centre, she had a massive infarction from the arteria basilaris was found by brain CT scanning, with signs of transtentorial herniation. There was decreasing response to stimuli. Further treatment was not done after the which the patient died. Medical history: The patient had no known medical history. She was said to be healthy with good endurance. She had no known past drug therapy. Physical findings and investigations: CT scan cerebrum 28-May-2012: massive hemorrhage and infarction in the right cerebellar region from the arteria basilaris was found by brain scanning, with signs of transtentional herniation and cerebellar edema. Postmortem investigations: the parents did not consent to autopsy, but agreed to less invasive diagnostics. A heart muscle biopsy was done to investigate cardiac anomalies (myocarditis/cardiomyopathy: pathology was normal and no signs of viral infection). Other areas of investigation: microbiology (no indication of acute viral infection), coagulation disorders (normal platelet, no indications of preexisting bleeding disorders), further brain pathology (CT scan brain not suitable to evaluate presence of vascular anomalies eg aneurisms). Treatment and clinical course: After the collapse incident she was resuscitated. Cardiac output was marginal due to diminished contractility and dilatation, however initially responsive to adrenalin. There were no signs for thombotic process elsewhere. Then ECMO treatment was started till it became clear that massive brain damage had occurred. Postmortem myocarditis and cardiomyopathy were excluded, there were no indication for an acute infection, no auto-immune disorder, no thrombocytopenia. Causality assessment and concluding summary: Causality for the eventually fatal intracranial hemorrhage and vaccinations was considered unlikely. This unique but tragic condition had not been reported earlier, and is most likely caused by another yet unknown mechanism. There is no biologic explanation, and the timing of events is inconsistent with known side effects of these vaccines. The following MedDRA LLT was coded by the agency: Intracrainial hemorrhage (5days). Patient outcome: fatal. No further information expected.


VAERS ID: 459549 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-07-17
Entered: 2012-07-18
   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, Dementia, Influenza, Laziness, Nasopharyngitis, Pain
SMQs:, Dementia (narrow), Noninfectious encephalopathy/delirium (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: The patient''s ongoing illness, medical history, risk factors and concomitant vaccines or medications were unknown.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201206866

Write-up: Initial spontaneous serious adverse event report was received from a consumer on 10 July 2012 via social media, under the Local reference number BR-BT2012-0412. The reporter for this case also reported another adverse event, which is captured in case number 2012-06867. A female (patient age and birth date not reported, also reported as grandmother) received an injection of INFLUENZA VACCINE, manufacturer unknown, lot number unknown, (route, site, side and dose in series not reported) on an unspecified date (reported as unknown). On an unspecified date, the patient presented with symptoms of cold, flu, pain, lazy. After six years, the patient died with dementia problems. The patient''s ongoing illness, medical history, risk factors and concomitant vaccines or medications were unknown. The patient''s height and weight were unknown. Laboratory and diagnostic tests were reported as unknown. Treatments were reported as unknown. No additional information was provided. The patient''s outcome was reported as fatal. Documents held by sender: None.


VAERS ID: 459561 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-07-17
Entered: 2012-07-18
   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, Fatigue, Influenza, Nasopharyngitis, Pain, Renal disorder
SMQs:, 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: The patient''s ongoing illness, medical history, risk factors and concomitant vaccines or medications were unknown.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201206867

Write-up: Initial spontaneous serious adverse event report was received from a consumer on 10 July 2012 via social media, under the Local reference number BR-BT2012-0413. The reporter for this case also reported another adverse event, which is captured in case number 2012-06866. A male (patient age and birth not reported, also reported as grandmother) received an injection of INFLUENZA VACCINE, manufacturer unknown, lot number unknown, (route, site, side and dose in series not reported) on an unspecified date (reported as unknown). On an unspecified date, the patient presented with symptoms of cold, flu, pain, lazy. After six years, although reported in very good health condition, the patient developed kidney problems and died. The patient''s ongoing illness, medical history, risk factors and concomitant vaccines or medications were unknown. The patient''s height and weight were unknown. Laboratory and diagnostic tests were reported as unknown. Treatments were reported as unknown. No additional information was provided. The patient''s outcome was reported as fatal. Documents held by sender: None.


VAERS ID: 460333 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-07-24
Entered: 2012-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
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: PREVENAR
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1207NZL004603

Write-up: PCV13 was approved for protection against pneumococcal disease in children aged 6 weeks to 5 years and adults aged 50 years. In randomized trials in adults aged 60-64 years (not previously vaccinated with PPV23) and 70 years (previously vaccinated with PPV23), PCV13 was non-inferior to PPV23 in opsonophagocytic assay (OPA) geometric mean titres (GMTs) for all 12 serotypes common to the two vaccines. More PCV13 than PPV23 recipients had 4-fold increases in serotype 6A OPA GMTs (serotype 6A is not included in PPV23), PCV13 recipients also had higher OPA GMTs and met superiority criteria for most serotypes. Adults aged 50-59 years had antibody responses to PCV13 that were non-inferior to those in adults aged 60-64 years for all included serotypes. PCV13 administered concomitantly with trivalent inactivated influenza vaccine in adults aged 50-59 or 65 years produced antibody responses that were non-inferior to those following sequential administration, except for influenza strain AJH3N2 and pneumococcal serotype 19F in those aged 65 years. Antibody responses were numerically higher with sequential administration, although the clinical significance of this is unknown. Adverse events within 14 days of vaccination were mostly of mild-to-moderate severity, with serious events occurring in 0.2-1.4% of PCV13 and 0.4-1.7% of PPV23 recipients. The first available vaccines against IPD were unconjugated vaccines consisting of pneumococcal capsular polysaccharide antigens. The most recent formulation is the PNEUMOVAX 23 (PPV23), which has been available and elsewhere since the 1980s. PPV23 protects against IPD in some adults, with a vaccine efficacy of 60% in observational studies in healthy elderly adults. However, PPV23 has a number of limitations. It induces poor vaccine responses in infants <2 years of age in at least a subset of elderly adults and in immunocompromised patients. Two recent meta-analyses of PPV23 effects in adult populations concluded that there was no convincing evidence of protection against all cause pneumonia, presumptive pneumococcal pneumonia or all-cause mortality. In a well designed trial, PPV23 failed to protect adults with HIV-1 infection against IPD. Finally, in children, 14-valent pneumococcal polysaccharide vaccine failed to significantly reduce nasopharyngeal carriage of S. pneumoniae, which would suggest that PPV23 is unlikely to be associated with indirect (herd) protection. The immunogenicity of PCV13 (antibody responses to vaccine antigens) had been evaluated in PPV23-naive adults aged 50-64 years (study 1), in adults aged 70 years who had received a single dose of PPV23 at least 5 years previously (study 2), and in PPV23-naive adults aged 60-64 years who received an initial dose of PCV13 or PPV23 (PCV13 recipients received PPV23 1 year later and PPV23 recipients received PCV13 1 year later) [study 3]. Further studies evaluated the immunogenicity of PCV13 the trivalent inactivated influenza vaccine (TIV) administered concomitantly versus after sequential administration (TIV followed 1 month later by PCV13) [studies 5 and 6]. Study 5 was discussed only in brief, as its design was the same as that of study 6, except that me age of the population enrolled differed (50-59 years in study 5 and 65 years in study 6) and the results of the two studies were generally consistent. Data for studies 1-3 and 5 were available from abstracts and/or the manufacturer''s prescribing information. Study 6 was fully published. Study 4 was a phase II immunogenicity study and is not discussed further in this review. The key inclusion criteria, primary study objectives and treatment groups after randomization in cited studies are shown. The studies were all randomized, multicentre trials with vaccines either administered in a double-blind (studies 5 and 6) or modified double-blind (studies 1, 2 and 3) fashion; in study 1, the cohort aged 50-59 years received open-label immunization with PCV13. In the modified double-blind condition, both investigators and participants were blinded to the vaccine, whereas staff administering the vaccine were not blinded. Participants in studies 1-3, 5 and 6 were healthy adults, or immunocompetent adults with chronic stable medical conditions, who were PPV23 vaccine-naive (studies 1, 3, 5 and 6) or vaccinated with PPV23 at least 5 years earlier (study 2). In all studies, the main serology endpoints were evaluated 1 month after vaccination. Endpoints based on immune responses to vaccine were chosen on the grounds that PPV23 induces a protective immune response against IPD; hence non-inferiority to PPV23 would be demonstrated for the immune responses to the 12 serotypes in common and 6A. The PPV23 vaccine contains 25ug of polysaccharide for each of the serotypes, whereas PCV13 contained 2.2ug, except for 6A which contained 4.4ug reflecting the higher immunogenicity of conjugate vaccines. Studies 1and 2 were non-inferiority trials in adults aged 60-64 years and 70 years. The coprimary endpoints were (i) the serotype-specific opsonophagocytic assay (OPA) geometric mean titres (GMTs) for 12 pneumococcal serotypes common to the two vaccines (non-inferiority was shown if the lower limit of the 95% Cl for the geometric mean ratio (GMR) [GMT PCV13:GMT PPV23]) was $g0.50); and (ii) the proportion of participants with a 4-fold increase in the OPA GMT for serotype 6A (superiority was shown if the lower bound of the 95% Cl for the between group difference in proportions was $g0). For the cohort aged 50-59 years in study 1, the primary objective was to demonstrate non-inferiority of the immune response in this age group to that in the 60-64 year age group for all 13 serotypes (non-inferiority required that the lower limit of the 95% Cl for the GMR [GMT age 50-59 years: GMT age 60-64 years] was $g0.5). Two-sided tests were used in the primary statistical analyses. In study 3, a key objective was to evaluate whether the immune response to PPV23 administered 1 year after an initial study dose of PCV 13 was non-inferior to an initial study dose of PPV23 for the 12 serotypes in common, as measured by serotype-specific OPA titres obtained 1 month after vaccination (non-inferiority required that the lower limit of the 95% Cl for the GMR [GMT PPV23 after PCV13: GMT PPV23 as initial dose] was $g0.5). Further objectives were to evaluate whether an initial dose of PCV13 was significantly more immunogenic than PCV13 administered 1 year after an initial dose of PPV23 for at least some of the 12 serotypes in common and whether PPV23 administered 1 year after PCV13 was significantly more immunogenic than an initial study dose of PPV23 for at least some of the 12 serotypes in common. In studies 5 and 6, the coprimary endpoints were (i) the proportion of participants with a 4-fold increase in haemagglutination inhibition assay (HIA) for the three specific TIV strains (non-inferiority was shown if the lower limit of the 95% Cl for the between-group difference in proportions was $g-10%); and (ii) enzyme-linked immunosorbent assay (ELISA) serotype-specific anticapsular polysaccharide IgG geometric mean concentrations (GMCs) for 13 pneumococcal serotypes (non-inferiority was shown if the lower limits of the 95% Cl for the GMC ratio [concomitant: sequential] was $g0.50). For influenza vaccines, the vaccine guidelines required that 30% of vaccines respond with a 4-fold increases in serotype-specific HIA titres to indicate that the vaccine provides a satisfactory protective effect against influenza and that 60% of vaccines achieve titres 40. These criteria were also applied in study 6. The FDA guidelines for efficacy of influenza, and vaccines relevant to study 5 indicate that appropriate endpoints could be the percentage of patients with an HIA titre of 1:40 and or the percentage of patients with an HIA titre <1: 10 who achieve a titre of 1:40, or have a 4-fold rise in titres, following vaccination. In PPV23-Naive Adults. In study 1, when evaluated 1 month after vaccination, PCV13 was non-inferior to PPV23 for all 12 serotypes common to the vaccines, based on the GMR (PCV13: PPV23) [coprimary endpoint]. PCV13 was associated with significantly greater immune responses than PPV23 for 8 of 12 serotypes common to the vaccines, as the lower limit of the 95% Cl for the GMR (PCV13: PPV23) was $g1 for each of these serotypes (prespecified superiority criterion). For serotype 6A (which is not included in the PPV23 vaccine), a higher proportion of PCV13 recipients had a 4-fold increase in the OPA GMT than PPV23 recipients (88.5% vs 49.3%; difference 39.2 [95% Cl 33.0, 45.1]). Furthermore, the OPA GMT for serotype 6A was higher in the PCV13 group than the PPV23 group, as the lower limit of the 95% Cl for the GMR (PCV13: PPV23) was $g2 (prespecified secondary endpoint). The immune response in PPV23-naive adults aged 50-59 years was non-inferior to that in adults aged 60-64 years, as the non-inferiority criterion was met for all 13 pneumococcal serotypes. Based on a superiority criterion of a lower limit of the 95% Cl for the GMR (age 50-59 years: age 60-64 years) of $g1, the immune response was greater in the participants aged 50-59 years than in participants aged 60-64 years for 9 of 13 serotypes. In adults aged 50-59 years and 60-64 years, OPA GMTs had declined by 1 year after vaccination, although, for each serotype, they remained numerically higher than baseline levels (statistical analyses not reported). In study 3, PCV13 did not diminish the response to subsequent PPV23, as immune responses for the 12 serotypes in common in participants who received PPV23 after PCV13 were non-inferior to those following a single dose of PPV23 (groups A and B). For six of the serotypes in common, the immune response was greater in participants who received PPV23 after PCV13 (superiority required a lower limit of the 95% Cl for the GMR of $g1.0). When PCV13 was administered 1 year after PPV23 versus initial vaccination with PCV13, the immune response was lower for all 12 serotypes common to the two vaccines (upper limit of the 95% Cl of the GMR of <1.0). Based on these results, if both PCV13 and PPV23 are to be used, PCV13 should be given first. In Adults Previously Vaccinated with PPV23. In study 2 in adult aged "2:70 years vaccinated with PPV23 at least 5 years previously, the immunogenicity of PCV13 was non-inferior to that of PPV23, as the non-interiority criterion was met for all 12 serotypes common to the two vaccines. For 10 of these 12 serotypes, PCV13 met the prespecified criterion for superiority over PPV23 (lower limit of the 95% Cl for the GMR of$g1). For serotype 6A, a higher proportion of PCV13 recipients had a 4-fold increase in the OPA GMT than PPV23 recipients (71.1% vs 27.3%; difference 43.8 [95% Cl 37.4, 49.9]). The OPA GMT for serotype 6A was also higher in the PCV13 group than the PPV23 group, with a lower limit of the 95% Cl for the GMR (PCV13:PPV23) of $g2 (prespecified secondary endpoint). As for the younger age group, in adults aged 70 years, OPA GMTs declined during the first year after vaccination, but remained numerically higher than baseline levels for each serotype (statistical analyses not reported). Administered with Trivalent Inactivated Influenza Vaccine. In study 6, in adults ages 65 years, the concomitant administration group was non-inferior to the sequential group in antibody response to two of three TIV antigens. For serotypes A/H1N1 and B, the concomitant administration group met the non-inferiority criterion, whereas for serotype A1H3N2, the lower limit of the 95% Cl was-10.4%, which just exceeded the prespecified limit of -10%. Both the concomitant and the sequential administration groups met EMA vaccine guideline criteria for all three TIV serotypes. For all pneumococcal serotypes except for 19F, concomitant administration of PCV13 with TIV was non-inferior to sequential administration, based on GMC ratios derived from ELISA estimates. [211 However, for all 13 serotypes, the GMC was numerically higher in the sequential administration group. In the absence of an established correlate of protection based on the GMC, the clinical significance of this was unknown. In study 5, which was conducted in adults aged 50-59 years, concomitant administration of PCV13 with TIV produced antibody responses that were non-inferior to sequential administration for each of the three TIV strains. Concomitant administration was also non-inferior to sequential administration in terms of IgG responses for all 13 serotypes (based on ELISA); in post hoc analyses, a non-inferiority criterion based on OPA GMC ratios was met for 8 of 13 serotypes. 2. Tolerability. The tolerability of PCV13 was evaluated in the immunogenicity studies described in section 1; the focus in this section is on adults aged 60-64 years (study 1) and years (study 2), as these include comparative data for the PPV23 vaccine. Data from study 6 comparing concomitant versus sequential administration of PCV13 and TTV in adults 265 years are also discussed. The tolerability of PCV13 in adults aged 50-59 years was not discussed specifically, as it was generally similar to that in the older age groups. All data were from the prescribing information or study 6, as these sources provide the most detail. Across six immunogenicity trials in adults aged 250 years, the most frequent treatment emergent adverse events occurring within 14 days of vaccination with PCV13 in $g5% of patients were pain at the injection site, fatigue, headache, muscle pain, joint pain, reduced appetite, injection site redness, injection site swelling, limitation of arm movement, chills and rash. Systemic adverse events of any grade of severity occurring within 14 days of vaccination in 21% of PCV13 or PPV23 recipients aged 60-64 years or 270 years are shown in figure. Events arising within 14 days of vaccination were generally similar between age groups and between the PCV 13 and PPV23 groups. However, PCV13 recipients aged 270 years had significantly (p <0.05) lower rates of new muscle pain, fatigue and rash than PPV23 recipients. The differences in rates were small, and statistical correction for multiple testing was not applied, so the clinical relevance of these between-group differences was uncertain. Local reactions of any severity occurring within 14 days of vaccination are shown. In PCV13 and PPV23 recipients across age groups, injection-site pain was the most frequent local reaction to vaccination, occurring in $g50% of vaccines. Limitation of arm movement, injection-site redness or swelling occurred in 10-31% of participants across treatment groups and were significantly (p <0.05) less common in PCV 13 than PPV23 recipients in the 70 years age group (statistical corrections for multiple tests were not applied. In adults aged 50 years, most adverse events were of mild-to-moderate severity. Serious adverse events within 1 month of initial vaccination occurred in 0.2-1.4% of PCV 13 recipients and 0.4-1.7% of PPV23 recipients. During the period 1-6 months following initial vaccination, serious adverse events occurred in 1.2-5.8% and 2.4-5.5% in the respective groups. One individual developed erythema multiforme 34 days after a second dose of PCV 13. Across trials, 12 of 5667 (0.21%) PCV13 recipients and 4 of 1391 (0.28%) PPV23 recipients died, with all deaths occurring within the period from day 3 to day 309 following vaccination. Two of 12 deaths in PCV13 recipients occurred within 30 days of vaccination (one from cardiac failure and one from peritonitis). Other causes of death (occurring $g30 days after vaccination with PCV13) were cardiac disorders and neoplasms (both associated with four deaths), and lex pulmonary infection and septic shock. In adults aged approximately 65 years, coadministration of PCV13 with TIV was associated with a higher rate of systemic adverse events than sequential administration of the vaccines (PCV13 given alone 1 month after the initial vaccination with TIV plus placebo). Systemic adverse events occurred in 60.1% of recipients within 14 days of concomitant vaccination with PCV13 and TIV (vs 48.5% after sequential administration; difference 11.6 [95% Cl5.4, 17.8]). 12IJ Specific adverse events that were more frequent with concomitant administration than with sequential administration were fatigue (37.4% vs 28.5%; difference 8.9 [95% Cl2.8, 14.9]), headache (32.6 vs 24.7; difference 7.9 [95% Cl 2.1, 13.8)), aggravated joint pain (15.7 vs 8.6; difference 7.1 [95% Cl 2.7, 11.4]), reduced appetite (16.9 vs 11.3; difference 5.6 [95% Cl 1.0, 10.2]), chills (13.8 vs 9.1; difference 4.7 [95% Cl 0.4, 9.0)) and new joint pain (16.2 vs 11.5; difference 4.7 [95% Cl 0.1, 9.2)) (statistical corrections for multiple tests were not applied). Concomitant and sequential administration of the PCV13 and TIV vaccines were associated with generally similar rates of local reactions; any local reaction occurred in 46.9% of recipients of concomitant administration (versus 46.6% with sequential administration; difference 0.3 [95% Cl -6.0, 6.7]). The majority of these reactions were mild. Two participants died as a result of serious adverse events (cardiac failure 3 days following vaccination in the concomitant administration group and by gastrointestinal haemorrhage 29 days after vaccination in the sequential administration group). One participant in the concomitant administration group withdrew from the study because of a serious adverse event occurring 10 days after vaccination (angina pectoris with ST-segment elevation). There were no reports of vaccine-related serious adverse events during the course of this study. Additional information has been requested.


VAERS ID: 460365 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-07-26
Entered: 2012-07-27
   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, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient''s past medical history was unknown.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201207093

Write-up: Initial report was received on 23 July 2012 via the local affiliate under local reference number BR-BT2012-0422 which was describe in a lay media journal. An unidentified patient (gender and date of birth not reported) had received an Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and unspecified amount of time later developed an influenza virus A/H1N1 and died. According to the reporter, the event was serious due to death and other medically important event "suspect vaccine failure". No further information was available at the time of the report. The patient''s outcome was fatal. Documents held by sender: none.


VAERS ID: 460782 (history)  
Form: Version 1.0  
Age: 0.22  
Sex: Female  
Location: Foreign  
Vaccinated:2009-07-13
Onset:2009-07-26
   Days after vaccination:13
Submitted: 2012-07-30
   Days after onset:1100
Entered: 2012-08-01
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS AZ1CA452A / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D63624 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-07-26
   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: Periventricular leukomalacia; Previous foramen ovale; Foramen ovale patent; Premature baby
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012180899

Write-up: This is a spontaneous report received from a general practitioner via the Regulatory Authority. Regulatory Authority report number 172079. A 2-month-old, female patient received a dose of PREVENAR (Lot Number D63624; Expiration Date 30Sep2012) intramuscularly on 13Jul2009 and a dose of INFANRIX HEXA (Lot Number AZ1CA452A) intramuscularly on 13Jul2009. Medical history included ongoing periventricular leukomalacia, ongoing atrial septal defect (previous foramen ovale), and premature baby. The patient''s concomitant medications were not reported. The patient experienced unknown cause of death on 26-Jul-2009. It was not reported if an autopsy was performed. The report was submitted by the general practitioner of the patient''s mother.


VAERS ID: 460960 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2012-07-26
Onset:2012-07-26
   Days after vaccination:0
Submitted: 2012-08-02
   Days after onset:7
Entered: 2012-08-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G1564 / 1 UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 11L01A / 1 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Mobility decreased, Pyrexia, Resuscitation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: De Lange''s syndrome
Allergies:
Diagnostic Lab Data: 26-JUL-2012, Body temperature, 37.4 Centigrade; 26-JUL-2012, Body temperature, 38 Centigrade
CDC Split Type: 2012183398

Write-up: This is a spontaneous report from two contactable pediatricians (primary pediatrician and another pediatrician in the same hospital). This is a report received from the Agency. A 2-month-old female patient received the first dose of PREVENAR (Lot Number: 11L01A), subcutaneously on 26Jul2012 at 15:30 at 0.5 ml single dose for an unspecified indication, and the first dose of ACT-HIB (Lot Number: G1564), subcutaneously on 26Jul2012 at 15:30 at 0.5 ml single dose for an unspecified indication. Medical history included De Lange''s syndrome. The patient''s concomitant medications were not reported. On 26Jul2012, at the time of vaccination, the patient''s body temperature was 37.4 degrees Centigrade (C). After receiving the vaccinations on 26Jul2012, the patient experienced temporal pyrexia of 38 degrees C. Seriousness and causality for the event, pyrexia, were not reported. The patient recovered from the pyrexia on an unknown date. In the morning on 27Jul2012 the patient was quiet. The patient''s state of calm was observed 30 to 40 minutes before the patient''s death. After 15:00 on 27Jul2012, the patient was discovered with no body motion and apnea. Resuscitation was provided but the patient showed no reaction. It was reported that the patient experienced sudden death not around 15:00 on 27Jul2012. The reporting pediatricians classified the event sudden death as unevaluable. No information was provided about whether an autopsy was performed. No follow-up attempts needed. No further information expected.


VAERS ID: 461378 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-08-06
Entered: 2012-08-08
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR G7173 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history and concomitant medications were not reported.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201207207

Write-up: Initial case received from Health Authorities through the local affiliate on 25 July 2012 under the reference number BY-2012-001. A patient (unspecified gender and age), with no reported medical history and concomitant therapy, had received IMOVAX POLIO, batch number G7173-5, route and anatomical site of administration not reported, on unspecified date. The patient died several hours post vaccination. HA refused to provide any additional information about this case until the end of investigation. Documents held by sender: none.


VAERS ID: 461449 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-08-07
Entered: 2012-08-09
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Vaccination failure
SMQs:, Lack of efficacy/effect (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: 2012032979

Write-up: This spontaneous consumer report (initial receipt: 02-AUG-2012) concerns a 65-year-old female patient. On an unknown date the patient received FLUVAX (batch number was not provided). It was reported that the patient died due to vaccination failure.


VAERS ID: 462459 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-08-10
Entered: 2012-08-20
   Days after submission:10
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, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201207585

Write-up: Initial report was received on 10 August 2012 from a health care professional via the local affiliate (local reference number BR-BT2012-0429) which involved a cluster of four unidentified patients. Four unidentified patients had received an Influenza vaccine (lot number unknown; manufacturer, route, site and date of administration not reported) and unspecified amount of time later, the patients presented with Influenza A/H1N1 and died. According to the reporter, they had four registered cases of death from influenza A/H1N1 in vaccinated patients. Concurrent illnesses, personal and family medical histories and corrective treatments were unknown. In addition to seriousness criteria of death, this case was also considered to as Other Medical Important - specify: suspected vaccine failure. Relationship was reported as unknown. No additional information was provided at the time of the report. Documents held by sender: None.


VAERS ID: 462460 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-08-17
Entered: 2012-08-20
   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: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-18
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 no comorbidities.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201207591

Write-up: Initial report was received from a lay media journal report via the local affiliate under local reference number BR-BT2012-0428. A 68 year-old female who did not have any comorbidities had received an Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and unspecified amount of time later presented with Influenza A/H1N1 and died on 18 July 2012. According to the reporter, the event was considered serious - other medically important event: suspected vaccine failure. No laboratory or diagnostic tests were reported. No further information was available at the time of the report. The patient''s outcome was fatal. Documents held by sender: None.


VAERS ID: 462461 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-10-01
Onset:0000-00-00
Submitted: 2012-08-17
Entered: 2012-08-20
   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: Unspecified major chronic conditions.
Allergies:
Diagnostic Lab Data: A number of cases were selected for swabbing from each outbreak according to different criteria: a random sample of influenza like illness (ILI), hospitalised patients or all ILI cases. Nasopharyngeal swabs were tested for detection of influenza virus by real time reverse transcription polymerase chain reaction (RT-PCR) and cell culture using a Madin-Darby canine kidney (MDCK) cell line. Isolates were sent to the National Reference Centre, National Center for Microbiology, for influenza genotyping.
CDC Split Type: E201205224

Write-up: Case of vaccination failure retrieved from a literature search performed on 07-AUG-2012. Case medically confirmed. In the 2011/2012 season, three influenza outbreaks were studied in nursing homes with high vaccination coverage. Attack rates ranged from 2.9% to 67%. Influenza A/18/2011 (H3N2) virus strain was isolated from the three outbreaks. According to the article, all three nursing homes had carried out an influenza vaccination campaign in OCT-2011 (trade name, batch number, route and site of administration not reported), reaching coverage from 82% to 97%. Problems concerning the vaccine lot, its conservation or administration were ruled out. A number of cases were selected for swabbing from each outbreak according to different criteria: a random sample of influenza like illness (ILI), hospitalised patients or all ILI cases. Nasopharyngeal swabs were tested for detection of influenza virus by real time reverse transcription polymerase chain reaction (RT-PCR) and cell culture using a Madin-Darby canine kidney (MDCK) cell line. Isolates were sent to the National Reference Centre, National Center for Microbiology, for influenza genotyping. The influenza outbreaks occurred between week 4 and week 8 of 2012, coinciding with the epidemic wave in the region. Influenza virus A (H3N2) was identified in all the three outbreaks, and the genotyped strains were characterised as A/18/2011 (H3N2), coinciding with the strain most frequently found in the non-institutionalised population during this season. The attack rates were much higher in nursing homes (range 2.9% to 67%) than those in the general population aged 65 and over (0.9%). The attack rates in vaccinated persons ranged between 2.6% and 66%. The attack rates did not differ significantly between vaccinated and non-vaccinated persons in any of the nursing homes. During the outbreak investigation 57 ILI patients were detected with vaccine failure, 13 of whom had laboratory-confirmed influenza. In vaccinated persons, the time between vaccination and onset of ILI symptoms ranged between 92 and 142 days. Overall, 5% of the ILI cases (3/63) in the three nursing homes required hospitalisation, and death occurred in 3% of those affected (2/63), all of them in vaccinated persons with previous major chronic conditions. The results may indicate insufficient vaccine effectiveness to contain the spread of the influenza virus in nursing homes during this season. A recent study has reported moderate vaccine effectiveness in the 2011/12 season and suggests a limited match between vaccine and circulating influenza viruses. Some limitations should be acknowledged in the study of these outbreaks. Information on ILI cases and vaccination status among nursing homes'' workers and frequent visitors was not systemically collected. The design and the size of the study were not adequate to obtain estimates of the vaccine effectiveness. However, the high attack rate in vaccinated persons and the number of vaccine failure suggest reduced vaccine protection in these nursing home. In conclusion, influenza vaccination should be complemented with other hygiene measures in institutionalised settings.


VAERS ID: 462467 (history)  
Form: Version 1.0  
Age: 1.6  
Sex: Male  
Location: Foreign  
Vaccinated:2011-03-15
Onset:0000-00-00
Submitted: 2012-08-17
Entered: 2012-08-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Incomplete course of vaccination, Meningitis pneumococcal, Streptococcus test positive
SMQs:, Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-08
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 Data (unknown date): confirmed pneumococcus of serotype 14
CDC Split Type: 2012198567

Write-up: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 18-month-old male patient received the first dose of PREVENAR at the age of 2 months via an unspecified route of administration on 14Jan2011 and the second dose of PREVENAR at the age of 4 months on 15Mar2011; both at single doses and for an unspecified indications. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient was vaccinated with two doses of PREVENAR. Then, the patient had to travel to another city with his mother and he did not receive any of the other shots in the series for reinforcement. On an unknown date, the patient was diagnosed with meningitis. He passed away on 08May2012. After that on an unknown date, it was confirmed that it was pneumococcus of serotype 14. It was not reported if an autopsy was performed.


VAERS ID: 462877 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-07-27
Onset:2012-08-01
   Days after vaccination:5
Submitted: 2012-08-22
   Days after onset:21
Entered: 2012-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B147AA / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0824010A

Write-up: This case was reported by a regulatory authority via another manufacturer and described the occurrence of death in a 2-month-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included hepatitis b vaccine (non-gsk) and another non-gsk vaccine (trade name unspecified) given on 27 July 2012. On 27 July 2012, the subject received unspecified dose of INFANRIX (unknown route of administration, unknown site of injection). Less than one month after vaccination with INFANRIX, the subject experienced sepsis. The subject was hospitalised. The subject died on 18 or 19 August 2012 from unknown cause. It was unknown whether an autopsy was performed. No further details were available at the time of reporting.


VAERS ID: 463931 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2012-07-13
Onset:2012-07-18
   Days after vaccination:5
Submitted: 2012-08-30
   Days after onset:43
Entered: 2012-09-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G1562 / 1 UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 11L02A / 1 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Circulatory collapse, Convulsion, Cyanosis, Death, Dehydration, Gaze palsy, Hypoglycaemia, Musculoskeletal stiffness, Pyrexia, Respiratory disorder
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: 13-JUL-2012, Body temperature, 37.4 Centigrade; 18-JUL-2012, Body temperature, 41.2 Centigrade
CDC Split Type: 2012208000

Write-up: This is a spontaneous report from a contactable physician through the Ministry of Health, Regulatory authority I.D. # of PREVENAR 572. A 6-month-old female infant received the first injection of PREVENAR (Lot number: 11L02A) and the first injection of immunisation, ACTHIB (Lot number: G1562) both subcutaneously at 2:30 p.m. on 13Jul2012. The patient''s medical history was not reported. Concomitant medications included the first injection of DPT subcutaneously on 05Jul2012. On 13Jul2012, her body temperature before the vaccination was 37.4 degrees C. On the morning of 18Jul2012, the patient''s general condition was favorable. However, the patient''s mother found that globe fixation and stiffness of hands were observed in the patient at around 9:30 a.m., for which the patient visited the reporting hospital on the same date. At the hospital pyrexia of body temperature at 41.2 degrees C, stiffness, convulsion and cyanosis were noted. The symptoms improved after oxygen and anticonvulsive drugs were administered. Thereafter, recurrence of convulsion and worsening of respiratory condition were observed, for which the patient was transported to the hospital. At 2:17 p.m. on the same date, the patient died. No information was provided whether autopsy was performed. The reporting physician classified the events as serious (death) and assessed them as unrelated to PREVENAR. The reporting physician commented that the cause of the death was considered to be circulatory failure due to hypertonic dehydration, hypoglycaemia and convulsive status. No information was provided whether autopsy was performed or not. No follow-up attempts needed. No further information expected.


VAERS ID: 464180 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-01-13
Onset:0000-00-00
Submitted: 2012-09-05
Entered: 2012-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Activated partial thromboplastin time normal, Alanine aminotransferase normal, Altered state of consciousness, Aspartate aminotransferase normal, Autopsy, Bacterial test negative, Basophil count, Benign prostatic hyperplasia, Blood albumin normal, Blood alkaline phosphatase increased, Blood chloride normal, Blood cholesterol increased, Blood creatinine normal, Blood fibrinogen increased, Blood glucose normal, Blood immunoglobulin G increased, Blood immunoglobulin M normal, Blood lactate dehydrogenase increased, Blood potassium normal, Blood sodium decreased, Blood urea increased, Blood uric acid normal, Body temperature decreased, C-reactive protein increased, CSF cell count increased, CSF culture negative, CSF glucose increased, CSF protein increased, Cerebral infarction, Computerised tomogram abdomen abnormal, Culture urine negative, Cytomegalovirus test, Death, Diverticulum intestinal, Dizziness, Electroencephalogram abnormal, Extensor plantar response, Fibrin D dimer, Gamma-glutamyltransferase increased, Glucose urine absent, Glycosylated haemoglobin normal, HIV test negative, Haematocrit normal, Haemoglobin normal, Hepatitis B surface antigen negative, Hepatitis C antibody positive, Herpes simplex serology positive, Hypoglycaemia, Hyporeflexia, Infection, Inflammation, Intestinal dilatation, Leukoencephalopathy, Lymphocyte count, Megacolon, Mumps antibody test negative, Muscular weakness, Neutrophil count increased, Nuclear magnetic resonance imaging brain abnormal, Occult blood negative, Platelet count normal, Protein total normal, Protein urine absent, Prothrombin time prolonged, Pupillary reflex impaired, Red blood cell count normal, Urine ketone body absent, Viral test negative, Vitamin B1, Vitamin B12 increased, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Liver infections (narrow), Acute pancreatitis (broad), Dyslipidaemia (narrow), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Biliary system related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Ischaemic colitis (broad), Demyelination (narrow), Vestibular disorders (broad), Lipodystrophy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-04
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMARYL
Current Illness: --/--/2011, Somnolence; Hypertension; Amblyopia; 06/--/2011, Aerophagia; --/--/1997, Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On 18-JAN-2012, MRI DWI (diffusion weighted image) revealed disseminated high signal area in the right deep cerebrum, which led to a suspicion of cerebral infarction. One week later Follow-up MRI showed a disappearance of DWI lesion. FLAIR (fluid attenuated inversion recovery) revealed leukoencephalopathy mainly in the right deep cerebral white matter and the anterior horn. Physical findings on hospital admission Consciousness clear. Chest region: Respiratory sound clear, no cardiac murmur; Abdominal region: Soft, decreased peristaltic sound, tympanitic sound overall, swelling of the left lower abdomen. No tenderness, no muscular defense, PLR (positive Likelihood Ratio) 1 1/4^-/sluggish 1 1/4%, pupil 2.5/3.5mm. round Neurological system: Evaluation difficult. Four limbs weakness. No rigidity, no spasms, no tremor. No convulsion. Generalized decrease of deep tendon reflex. No apparent asymmetry. Babbinski ind/ind Chaddock -/-. After hospital admission His consciousness status remained at III-200-300 and there was no pathological reflex either. Since inflammation and neutrophil predominant white blood cell increased were observed on blood test, some kind of infection was considered, however, the infectious focus such as brain abscess and pneumonia was unclear. Spinal fluid also showed only a mild elevation of protein and the cause was not clear. Because no abscess lesion could be pointed out on imaging and also deep white matter was dominant, viral encephalitis such as encephalitis herpes, PML (progressive multifocal leukoencephalopathy) and CJD 1 1/4^Creutzfeldt-Jakob disease 1 1/4% were also negative. From around hospital day 5 There was marked abdominal distention and marked dilatation of sigmoid colon and rectum on imaging were observed. There was no apparent abscess lesion, and trigger-unknown megacolon was considered. Abdominal CT (on February 7) A marked dilatation from the rectum to sigmoid colon was observed, and no apparent focus of obstruction was found. Diverticula of colon and prostatic hypertrophy were observed. There was no apparent swollen lymph node. Examinations Biochemical cytomegalovirus 1:32 (CF), HSV1IgG positive (EIA 63.0), HSV1IgM negative, HTLV-1 antibody negative, JCV virus quantitative less than 2*10E2, HIV negative. Blood culture Viable bacteria negative. Urine test Urine culture negative. Spinal fluid test Colorless clear, protein 126.5mg/dL, glucose 109mg/dL, cell count 6.3/1/4 L, mononuclear:fraction=5.7:0.7, ADA 14.4U/L, NSE 13.0ng/dL, culture negative, HSV-IgG positive 1 1/4^EIA0.60 1 1/4%, HSV-IgM negative, cytomegalovirus IgG+/-, mumpus virus IgG negative, JCV virus spinal fluid quantitative less than 2*10E2. Electroencephalography Hardly any alpha waive was observed, 2-3Hz 100vU ''range was observed, laterally+(Rt lazy) and no PSD. --/--/2012, Activated partial thromboplastin time, 37.2; --/--/2012, Alanine aminotransferase, 17 IU/L; --/--/2012 Aspartate aminotransferase, 23 IU/L; --/--/2012, Basophil count, 1.0; --/--/2012, Blood albumin, 3.8 g/dL; --/--/2012, Blood alkaline phosphatase, 281 IU/L; --/--/2012, Blood chloride, 98 mEq/L; --/--/2012, Blood cholesterol, 200; --/--/2012, Blood creatine, 0.91 mg/dL; --/--/2012, Blood fibrinogen, 513 md/dL; --/--/2012, Blood glucose, 174 mg/dL; --/--/2012, Blood lactate dehydrogenase, 195 IU/L; --/--/2012, Blood potassium, 4.7 mEq/L; --/--/2012, Blood pressure diastolic, 78 mmHg; --/--/2012, Blood pressure systolic 146 mmHg; --/--/2012, Blood sodium, 134 mEq/L; --/--/2012, Blood urea, 29 mg/dL; --/--/2012, Blood uric acid, 6.7 mg/dL; --/--/2012, Body temperature, 36.2 C; --/--/2012, C-reactive protein, 7.50 mg/dL; --/--/2012, Gamma-glutamyltransferase, 39 IU/L; --/--/2012, Glucose urine, Negative; --/--/2012, Glycosylated haemoglobin, 6.1%; --/--/2012, Haematocrit, 48.6%; --/--/2012, Haemoglobin, 16.6 g/dL; --/--/2012, Heart rate, 62 /min; --/--/2012, Hepatitis B surface antigen, Negative; --/--/2012, Hepatitis C antibody, Positive; --/--/2012, Lymphocyte count, 4; --/--/2012, Occult blood, +-; --/--/2012, Oxygen saturation, 96%; --/--/2012, Platelet count, 20.8 10000/1/4L; --/--/2012, Protein total, 8.0 g/dL; --/--/2012, Protein urine 1+; --/--/2012, Prothrombin time, 68.3 sec; --/--/2012, Red blood cell count, 515, 10000/1/4L; --/--/2012, Urine ketone body, Negative; --/--/2012, Vitamin B1, 84.1 ng/dL; --/--/2012, Vitamin B12, 2518 pg/mL; --/--/2012, White blood cell count, 15200 /ul
CDC Split Type: WAES1208JPN012555

Write-up: This case was reported in the following meeting abstract. Initial information has been received from a meeting abstract concerning an 80 year old male patient who on 13-JAN-2012 was vaccinated with PNEUMOVAX NP (indication, dose, injection route, injection site and lot number not reported). Concomitant medications included: AMARYL. The patient''s past medical history included type 2 diabetes mellitus for 15 years (treated with oral AMARYL), suspected aerophagia since June 2011, right amblyopia (congenital), hypertension, no operation history, no smoking history and no remarkable family history. As social history, the patient lived in urban area until age 62. There was an episode that he liked camping, living and sleeping out deep in the mountains. He immigrated with his family 18 years earlier. Daily conversation was possible but writing words was difficult. From summer in 2011, the patient began to have daytime somnolence, and the family often took him out for walk. On 13-JAN-2012, the patient was vaccinated with PNEUMOVAX NP. On 15-JAN-2012, since the patient had lightheadedness and consciousness disturbed, the family member suspected hypoglycaemia and the symptoms were improved after giving him juice. Hypoglycaemic attack was considered and glimepiride was discontinued but somnolent tendency gradually progressed. On 18-JAN-2012, cerebral infarction was suspected. MRI DWI (diffusion weighted image) revealed disseminated high signal area in the right deep cerebrum, which led to a suspicion of cerebral infarction and cilostazol was prescribed. One week later, the patient presented to the neurosurgery department again because of further progression of the symptoms. Follow-up MRI showed a disappearance of DWI lesion. FLAIR (fluid attenuated inversion recovery) revealed leukoencephalopathy mainly in the right deep cerebral white matter and the anterior horn. On 03-FEB-2012, because consciousness disturbed continued to progress, the patient was referred to the neurology department and hospitalized for detailed examination. After hospital admission, the course was observed together with imaging findings, but his consciousness status remained at III-200-300 and there was no pathological reflex either. Since inflammation and neutrophil predominant white blood cell increased were observed on blood test, some kind of infection was considered, however, the infectious focus such as brain abscess and pneumonia was unclear. Spinal fluid also showed only a mild elevation of protein and the cause was not clear. Because no abscess lesion could be pointed out on imaging and also deep white matter was dominant, viral encephalitis such as encephalitis herpes, PML (progressive multifocal leukoencephalopathy) and CJD 1 1/4^Creutzfeldt-Jakob disease 1 1/4% were also negative. From around hospital day 5. There was marked abdominal distention and marked dilatation of sigmoid colon and rectum on imaging were observed. There was no apparent abscess lesion, and trigger-unknown megacolon was considered. The course was observed with symptomatic treatment but the condition worsened. On 04-MAR-2012, at 19:22, the patient died. Physical findings on hospital admission. Consciousness clear, body temperature 36.2 degrees C, blood pressure 146/78, pulse rate 62/minute, SpO2 96% (room air). Chest region: Respiratory sound clear, no cardiac murmur. Abdominal region: Soft, decreased peristaltic sound, tympanitic sound overall, swelling of the left lower abdomen. No tenderness, no muscular defense, PLR (positive Likelihood Ratio) 1 1/4^-/sluggish 1 1/4%, pupil 2.5/3.5mm. round Neurological system: Evaluation difficult. Four limbs weakness. No rigidity, no spasms, no tremor. No convulsion. Generalized decrease of deep tendon reflex. No apparent asymmetry. Babbinski ind/ind Chaddock -/-. Examinations Blood count and coagulation WBC 15200, RBC 5,150,000, Hb 16.7, Ht 48.6, Plt 208,000, PT 68.3, APTT 37.2, Fib 513 Ddimer 1.0, FDP 4. Biochemical AST 23, ALT 17, LD 195, ALP 281, 3GT 39, CHE 200, TP 8.0, Alb 3.8, UN 29, Cr 0.91, UA 6.7, Na 134, K 4.7, Cl 98, CRP 7.50, HbA 1.6.1%, glu 174mg/dL vitamin B1 84.1ng/dL, vitamin B12 2518pg/mL, HBsAg(-), HCV-Ab 1 1/4^+1 1/4%, cytomegalovirus 1:32 (CF), HSV1IgG positive (EIA 63.0), HSV1IgM negative, HTLV-1 antibody negative, JCV virus quantitative less than 2*10E2, HIV negative. Blood culture Viable bacteria negative. Urine test Glucose (-), protein (1+), occ +/-, keton (-), urine culture negative. Spinal fluid test Colorless clear, protein 126.5mg/dL, glucose 109mg/dL, cell count 6.3/ 1/4 L, mononuclear:fraction=5.7:0.7, ADA 14.4U/L, NSE 13.0ng/dL, culture negative, HSV-IgG positive 1 1/4^EIA0.60 1 1/4%, HSV-IgM negative, cytomegalovirus IgG+/-, mumpus virus IgG negative, JCV virus spinal fluid quantitative less than 2*10E2. Abdominal CT (on 07-FEB-2012). A marked dilatation from the rectum to sigmoid colon was observed, and no apparent focus of obstruction was found. Diverticula of colon and prostatic hypertrophy were observed. There was no apparent swollen lymph node. Electroencephalography Hardly any alpha waive was observed, 2-3Hz 100vU orange was observed, laterally+(Rt lazy) and no PSD. Autopsy findings: Brain weight 1335g divided surface. The central nervous system, especially cortical-white matter border. The auctorial physicians considered that leukoencephalopathy was serious due to hospitalization and felt that the event was definitely related to pneumococcal vaccine. Additional information has been requested.


VAERS ID: 464194 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Female  
Location: Foreign  
Vaccinated:2012-08-10
Onset:2012-08-13
   Days after vaccination:3
Submitted: 2012-09-05
   Days after onset:23
Entered: 2012-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0720AA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death neonatal, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-08-13
   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: Cardiac pacemaker insertion; Cardiomyopathy; Arteriovenous malformation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1209FIN000813

Write-up: Serious case with fatal outcome reported on 03-Sep-2012 by Health Authority (HA ref. FI-FIMEA-20121040). The primary reporter is a physician. Case is medically confirmed. A 6 weeks old female patient (initials unknown, to be noted that the age of the patient is reported to be 0 years in AE template and 6 weeks in the case narrative) was vaccinated according to the vaccination calendar on 10-Aug-2012 with the ROTATEQ (batch number 0720AA, oral route, number in series not reported). The patient died suddenly on 13-Aug-2012, the reason for death is unknown at the time of the reporting. Patient''s medical history includes following information; during patient''s fetal period an anomalous AV derivation was detected. A pacemaker was placed when the patient was 3 days old. There was also suspicion of cardiomyopathy. The patient visited a cardiologist on 12-Jul-2012 for control and patient''s condition was good and function of pacemaker was normal. The HA has coded the case with medical term: "Sudden death". Additional information received from agency on 4-Sep-2012 as response to MA-holder follow up request. Agency don''t know if an autopsy had been or will be performed. The autopsy report will be provided to MA-holder from agency when available.


VAERS ID: 464524 (history)  
Form: Version 1.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-06-04
Submitted: 2012-09-07
   Days after onset:95
Entered: 2012-09-10
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood bilirubin, Blood culture negative, Blood product transfusion, Death, HIV test negative, Haemoglobin, Hepatitis B test negative, Hepatitis C test negative, Immunology test normal, International normalised ratio decreased, Platelet count decreased, Thrombotic thrombocytopenic purpura
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, arterial (narrow), Renovascular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-06
   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:
Allergies:
Diagnostic Lab Data: Hb, 94 g/l; INR, 1.1; Platelet, 10x10^9/l; T Bilirubin, 81 micromol/l
CDC Split Type: 2012033271

Write-up: This health authority report (initial receipt 29-Aug-2012) concerns a 28-year-old female patient. On an unspecified date the patient received influenza vaccine (manufacturer and batch no. not specified) 1 dose unspecified. On 04-Jun-2012 the patient developed thrombotic thrombocytopenic purpura (TTP). Laboratory results revealed platelet count of 10x10^9/l, haemoglobin (Hb) was 94 g/l, international normalized ratio (INR) was 1.1 and total (T) bilirubin was 81 micromol/l. A peripheral film revealed multiple fragmented cells consistent with TTP. A disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS-13 activity) was 1 ng/ml. Human immunodeficiency virus (HIV), hepatitis B and C, urine and blood cultures and immunology tests were all negative. She was treated with plasma exchange. On 06-Jun-2012 the patient died as a result of the event. Reporter''s comment: On 05-Aug-2012, the health authority considered the events as possible in relation to influenza vaccine.


VAERS ID: 464621 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2012-07-01
Onset:2012-07-27
   Days after vaccination:26
Submitted: 2012-09-10
   Days after onset:45
Entered: 2012-09-11
   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: Arthropathy, Autopsy, Computerised tomogram normal, Death, Sudden infant death syndrome, Toxicologic test normal
SMQs:, Neonatal disorders (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-27
   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: Toxicological investigations and unspecified CT scan (unknown date): no anomaly. Autopsy (unknown date): sudden death syndrome.
CDC Split Type: 2012218779

Write-up: This is a spontaneous report from a contactable physician via Medical Information team. A physician (reported about a 4-month-old female patient that received a dose of PREVENAR 13 at 0.5 ml single dose on an unspecified date in July 2012. The infant was born at full term, had none relevant medical history and was not taking concomitant medications. The reporter, a general practitioner, referred the patient to a paediatrician to get advice regarding a hip problem. The paediatrician administered a dose of PREVENAR 13 to the infant. At the time of this report, no vaccination details were available. On 27 Jul2012, the patient was found dead in her parent''s bed, lying on the stomach with the face in the sheets. It occurred about one hour after bottle feeding, whereas she had been led in the bed on the back surrounded with a lot of cushions. Toxicological investigations and unspecified CT scan did not find any anomaly. Patient''s cause of death determine by the autopsy was reported as sudden infant death syndrome. According to the reporter the vaccine dose was administered by paediatrician approximately eight days before patient''s death.


VAERS ID: 464985 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-08-23
Onset:2012-09-08
   Days after vaccination:16
Submitted: 2012-09-13
   Days after onset:5
Entered: 2012-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. G007396 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Cardiac arrest, Cardio-respiratory arrest, Condition aggravated, Death, Dyspnoea, Electroencephalogram abnormal, Endotracheal intubation, Headache, Hypoxic-ischaemic encephalopathy, Intensive care, Loss of consciousness, Nervous system disorder, Neurological decompensation, Nuclear magnetic resonance imaging abnormal, Resuscitation, Scan abnormal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-08
   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: WAES1209ESP005292

Write-up: Case received from a healthcare professional, a physician who is a member of the Advisory Board of Vaccination on 10-SEP-2012. A 13 year-old female patient, with a medical history of poorly controlled asthma, had received the second dose of a GARDASIL, batch number not reported, route and site not reported) date not reported. The patient was vaccinated according to the healthcare centre vaccination schedule. It was reported that 12 hours after vaccine administration (exact date not reported), the patient presented with severe asthma. The patient was taken to the hospital where she presented cardio-pulmonary arrest, the patient was transferred to the paediatrician ICU ward of another hospital, where she died. It was reported that the patient had received the first dose of GARDASIL (date of administration not reported), after vaccination the patient''s asthma aggravated. According to the reporter (he was not the physician who treated the patient directly) this case of death was not related to vaccine administration. No further information was reported. Additional information received on 11-SEP-2012, from a healthcare professional, an ICU ward physician who treated the patient: A 13-year-old female patient, born 03-JUL-1999, with a medical history of poorly controlled asthma and allergy to pollen, had received the second dose of GARDASIL, batch number not reported, route and site not reported) on 23-AUG-2012. Previous to vaccine administration and according to the family, the patient presented a mild dyspnea, which she frequently had. According to the reporter, 12 hours after vaccine administration, on 23-AUG-2012, the patient presented with a severe difficulty in breathing and headache. On 23-AUG-2012 at 20:20 hrs, the patient arrived at the healthcare center. The patient was unable to breathe, she vomited once (cessation date 23-AUG-2012) and then she lost consciousness. The patient was transferred to the hospital. She arrived 23 minutes later with asystolia. Cardiac arrest. Cardiopulmonary resuscitation was performed during 12 minutes. The patient was intubated, 3 doses of adrenaline were administered. 17 minutes after they were able to reanimate her. Bronchodilators, Ketamine and Bicarbonate were administered. The patient was transferred in a mobile paediatric intensive care unit to the hospital''s paediatric criteria care unit. MRI and scanners were performed. Neurological lesions were detected. The patient was diagnosed with severe neurological status deterioration and an almost flat encephalogram. On 08-SEP-2012 the patient died. Cause of death was ischemic encephalopathy. The family referred that after the patient had received the first dose of GARDASIL the patient had a mild-moderate asthmatic crisis. According to the reporter, who contacted the patient''s paediatrician, the patient received the first dose of GARDASIL on 27-JUL-2012, route and site not reported, batch number not reported. On 31-JUL-2012 the patient went to the healthcare center to report to her paediatrician that she had presented an asthmatic crisis (date not reported) after vaccination and she had been treated in the hospital. According to the physician who treated the patient in the ICU there is possible relationship between events and vaccination. Further information is expected. Additional information received on 12-SEP-2012, from the physician''s pediatrician: The patient received the first dose of GARDASIL (batch number G007396, route and site not reported) on 23-JUL-2012 (this date is different to the one reported by the ICU pediatrician but it is the one included in the clinical record of the patient at her healthcare centre). According to the pediatrician the patient went to the hospital on the 29-JUL-2012 due to a severe asthmatic crisis where she was treated and controlled. The reporter don''t know if the patient was admitted to hospital or treated at the emergency room. No further information on this episode was reported. On 31-JUL-2012 the patient attended his office to report the episode. At that time the patient was well. On 23-AUG-2012 the patient was administered the second dose of GARDASIL (batch number G007396, route and site not reported). According to the clinical record of the patient she had history of allergic asthma, not controlled because she did not follow the recommended treatment (prophylaxis with SYMBICORT), allergy to acaridae. The patient had frequent moderate exacerbations and previous episodes of bronchitis since year 2010, which is the date since the pediatrician had patient history. The patient had history of intrauterine growth retardation and short stature. According to the pediatrician opinion relationship of adverse events and vaccination is unknown. No further information is reported.


VAERS ID: 465842 (history)  
Form: Version 1.0  
Age: 0.98  
Sex: Female  
Location: Foreign  
Vaccinated:2002-05-31
Onset:2011-09-09
   Days after vaccination:3388
Submitted: 2012-09-20
   Days after onset:377
Entered: 2012-09-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acidosis, Antibody test positive, Blood culture positive, Body temperature increased, Brain death, Breath sounds abnormal, C-reactive protein increased, Cardioversion, Cyanosis, Death, Dyspnoea, Ear pain, Electroencephalogram, Endotracheal intubation complication, Haemophilus test positive, Hypoxia, Influenza virus test positive, Mechanical ventilation, Nervous system disorder, Nuclear magnetic resonance imaging abnormal, Oropharyngeal pain, Pneumonia haemophilus, Pulmonary oedema, Respiratory arrest, Respiratory disorder, Resuscitation, Rhonchi, Somnolence, Swelling, Syncope, Vaccination failure, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vasculitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient was born with benign hereditary chorea, with mild expression (mutation at Chrom 13, as well as the mother). As an infant, the patient had received 3 doses of Hib (HIB PRP-T RIVM, which is analogous to ACT-HIB) vaccinations, simultaneously given with DTP-IPV vaccine (whole cell pertussis) on 17-Sep-2001, 15-Oct-2001, 19-Nov-2001.
Allergies:
Diagnostic Lab Data: CRP 65 65 mg/l, blood culture 09-Sep-2011 Hib positive, after 1 day growth (in 2 bottles) of H. influenza type b bacteria. Serology 09-Sep-2011 antibody positive; anti-Hib antibodies 0,6 mcg/ml.
CDC Split Type: E201202941

Write-up: Case of fatal outcome received from the health authorities on 07-May-2012 under the reference number NL-LRB-137266. Case medically confirmed. Initial source was a physician (also reported as a specialist doctor). Additional data was also received from the mother of the patient. Case reported as serious by the Lareb (criterion: death). Upon internal review, the company added the following seriousness criteria: hospitalisation and other medically important event: vaccination failure, pulmonary oedema. A 10-year-old female patient (date of birth 08-Jun-2001) had received the fourth dose of ACT-HIB (batch number not reported) on 31-May-2002, simultaneously given with DTP-IPV (whole cell pertussis) vaccine. This vaccine was not coded by HA. On 09-Sep-11, the patient experienced pneumonia due to haemophilus influenza type b and died on 10-Sep-2011 after a short period of illness. It was reported that concomitant medication had not been used. The patient developed respiratory symptoms with ear pain and sore throat on 09-Sep-2011. That morning she still went to school. In the afternoon she was seen by the General Practitioner, who did a thorough physical examination but could not diagnose more than a possible viral upper respiratory tract infection. He advised paracetamol and xylometazoline. That evening her condition worsened, she was sleepy and dyspnoic, could only sit straight up. No coughs nor barking, temperature about 38 degrees. While the General Practitioner was coming again, the patient collapsed while walking, she was cyanotic and not breathing. General Practitioner started resuscitation which was taken over by ambulance personnel. Intubation was difficulty due to laryngeal swelling. It took about one hour to stabilize her. A ventricular tachycardia was treated by defibrillation. She was transported to the hospital. Upon arrival, there were signs of deep hypoxia, acidosis and loss of neurological functions. Patient was artificially ventilated, had symmetric breathing sounds with much rhonchi. Cap refill verified by EEG. After establishing brain death, treatment was stopped (after allowing time to discuss possibilities of organ donation). There was no autopsy done, only a post-mortem MRI confirming massive bacterial pneumonia with pulmonary oedema, no pericarditis. After termination of ventilation, the patient died. The cause of death was massive pneumonia and pulmonary oedema, caused by Haemophilus influenza type b infection (blood culture positive). The patient was born with benign hereditary chorea, with mild expression (mutation at Chrom 13, as well as the mother). As an infant, the patient had received 3 doses of Hib (HIB PRP-T RIVM, which is analogous to ACT-HIB) vaccinations, simultaneously given with DTP-IPV vaccine (whole cell pertussis) on 17-Sep-2001, 15-Oct-2001, 19-Nov-2001. Despite some developmental delay she visited a regular school, from the age of 8 years she was able to control involuntary movements. Fine motor functions were not affected; sometimes the patient was hyperkinetic. At the age of 5-6 years, she had a bacterial pneumonia, which well responded to intravenous antibiotics. The onset was as sudden and symptomless as the present case, with hardly coughing and increasing dyspnoea. At the age of 8 years she had recurrent urinary tract infections. Also from age 8 she was unexplained increased in body weight. Noteworthy: The Lareb reported in the narrative that "As an infant the patient received 4 Hib vaccinations administered in May-2002" but the vaccination dates for the 4 Hib (HIB PRP-T RIVM, which is analogous to ACT-HIB) vaccinations were reported in the narrative as 17-Sep-2001, 15-Oct-2001, 19-Nov-2001 and 31-May-2002. It was also reported that "as an infant the patient received 4 ACT-HIB vaccinations, simultaneously given with DTP-IPV (whole cell pertussis) vaccine" but DTP-IPV was not mentioned as a concomitant drug.


VAERS ID: 465843 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-05-28
Onset:2012-06-29
   Days after vaccination:32
Submitted: 2012-09-20
   Days after onset:83
Entered: 2012-09-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR J7051 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest X-ray abnormal, Chills, Cough, Dyspnoea, Influenza, Influenza A virus test positive, Lung consolidation, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: The patient has a history of chronic lung disease.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201208549

Write-up: Initial report was received on 11 September 2012 from a health care professional via the local affiliate, local reference number BR-BT2012-0435. A 79 year-old male patient with a history of chronic lung disease had received on 28 May 2012 VAXIGRIP, batch number J7051 (route and site of administration not reported). On 29 June 2012, the patient presented with flu symptoms of cough, fever, shivers and dyspnea. The patient was hospitalized on 29 June 2012 and a chest radiograph indicated the presence of consolidation. On 06 July 2012, a nasopharyngeal aspirate was completed and the PCR detected pandemic influenza A (H1N1). Treatments included oseltamivir. No further information was available at the time of the report. The patient outcome was fatal. The reporter for this case is the same as case 2012-07585 and 2012-07591. Documents held by sender: none.


VAERS ID: 465994 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-09-21
Entered: 2012-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Immunisation
Preexisting Conditions: Dementia; Immunodeficiency; Immunosuppressant drug therapy; Neoplasm malignant; Alcoholism; Tobacco user; Obesity; Hypercholesterolemia; Hypertension; Diabetes mellitus; Nephropathy; Liver disorder; Cor pulmonale chronic; Cerebrovascular accident; Coronary artery disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1209ESP008903

Write-up: Case retrieved from a literature, search performed on 05-SEP-2012. This case concerns several patients vaccinated with pneumococcal vaccine 23-valent MFR UNK (route and site not reported) who experienced community acquired pneumonia (CAP), acute myocardial infarction (AMI) and ischemic stroke; and several patients vaccinated with pneumococcal vaccine 23-valent MFR UNK (route and site not reported) who died from any cause. A large prospective cohort study, known as CAPAMIS was designed, with the major aim of evaluating the potential role of the PPV23 in cardiovascular prevention among the general population over 60 years. The CAPAMIS study was planned for 3-year follow-up. In this study, it was evaluated the clinical effectiveness of PPV23 in reducing the risk of hospitalisation for community acquired pneumonia (CAP), acute myocardial infarction (AMI) and ischaemic stroke in a first-time analysis at one-year follow-up. This is a closed population-based prospective cohort study including 27,204 individuals 60 years or older assigned to nine primary care centers. Cohort members were followed since the start of the study (December 1, 2008) until the occurrence of any event, change in pneumococcal vaccination status, disenrollment from the primary care center, death, or until the end of first 12-month follow-up) (November 30, 2009) The primary outcomes were hospitalisation for community acquired pneumonia, acute myocardial infarction, ischaemic stroke and death from any cause. The 27,204 cohort members were observed for a total of 26,444 person-years, of which 8,847 (33.5%) person years had received PPV23 in prior 5 years. Cohort members were classified as vaccinated against pneumococcal if they had received at least one dose of PPV23 in the last 60 months before the study start. Vaccinated group were significantly older, had more outpatient visits, had a much higher proportion of influenza vaccination and had more comorbidities than the unvaccinated group. Some vaccinated patients (n=898) presented with a medical history which included: Coronary artery disease, history of stroke, chronic pulmonary disease, chronic heart disease, chronic liver disease, chronic nephropathy, diabetes mellitus, hypertension, hypercholesterolemia, obesity, smoking habits, alcoholism, cancer, immunosuppressive medication, immunocompromised and dementia. In the unadjusted analysis, were observed 63 episodes of pneumonia in 8,824 vaccinated person-years (7.1 per 1000 person-years) compared with 144 events in 17,546 unvaccinated person-years (8.2 per 1000 person-years). For myocardial infarction, there were 41 episodes of myocardial infarction in 8,830 vaccinated person-years (4.6 per 1000 person-years) compared with 89 events in 17,565 unvaccinated person-years (5.1 per 1000 person years). For stroke, there were 30 events in 8,835 vaccinated person-years (3.4 per 1000 person-years) compared with 91 events in 17,559 unvaccinated person years (5.2 per 1000 person-years). For death, there were 231 patients in vaccinated persons compared with 609 unvaccinated persons. The unadjusted all cause mortally rates were 26.1 and 34.6 per 1000 person-years among vaccinated and unvaccinated subjects, respectively. In the multivariable analyses, despite vaccinated people had lower incidence rates than unvaccinated people, we found no evidence for an association between pneumococcal vaccination and risk of pneumonia or myocardial infarction, but vaccination emerged significantly associated with a reduced risk of ischaemic stroke. Although vaccinated subjected had lower all-cause mortality rates than unvaccinated subjects in the unadjusted analysis, vaccination was not associated with reduced risk of all-cause mortality in the multivariable analysis. In a separate analysis including only immunocompetent people, n = 24,278 persons, the results did not substantially vary. Among these subjects, with multivariable adjustment, pneumococcal vaccination did not emerge significantly effective against pneumonia, myocardial infarction or death from any cause, but it was associated with a significant reduction in the risk of ischaemic stroke. In the analyses including exclusively 25,471 subjects without history of coronary artery disease, we observed 30 episodes of myocardial infarction in 8,236 vaccinated person-years (3.6 per 1000 person-years) compared with 48 events in 16,510 unvaccinated person-years (2.9 per 1000 person-years). This means that pneumococcal vaccination was not associated with significant reductions in the risk of myocardial infarction in the unadjusted analysis neither in the multivariable. Among the 25,910 subjects without history of prior stroke, we observed 13 episodes of ischaemic stroke in 8,366 vaccinated person-years (1.6 per 1000 person year) compared with 60 events among 16,810 unvaccinated person-years (3.6 per 1000 person-years), which pointed to a significant reduction in the risk of ischaemic stroke among vaccinated subjects in the adjusted analysis. As main finding, data shows in marginally significant reduction in the risk of ischaemic stroke, suggesting a possible protective role of vaccination against some acute thrombotic events. This result seems to be robust considering that this significant protective effect remains when people with history of prior stroke are excluded from the analysis.


VAERS ID: 466665 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-09-27
Entered: 2012-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningitis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1209ESP011311

Write-up: Case medically confirmed. This case is linked to cases E2012-06174 and E2012-06175. Follow-up information was added to cases E2005-03512 and E2005-03513 because information regarding these cases was found in this literature. This study was conducted to evaluate relevant new information about adverse drug reaction for individuals aged 0-17 years reported to the Pharmacoviligance system from 2004 to 2009 were analyzed with respect to time, age, and sex, category adverse drug reactions [System Organ Class (SOC)], seriousness, suspected medicines [level 2 of the anatomical Therapeutic Chemical (ATC) Classification System] and type of reporter. During the 6 year period (2004-2009) FEDRA received a total of 60.342 spontaneous notifications. Of these, 7% (n=4.279) were identified as suspected ADPs in the paediatric population, with an average of 713 notifications per year. In 55% of theses, at least one vaccine was involved. More than one-third (37%) of these notifications described serious ADR''s (n=1590). The seriousness criteria were defined as fatal in 33 notifications (33% of these included a vaccine), life-threatening in 169 notifications (requiring admission and prolonged hospitalization in 552 cases, persistent disability/incapacity in 18 cases, congenital anomalies in 33 cases) and medically significant in 980 notifications. The current case was retrieved from a table describing suspected drugs and their therapeutic groups in relation with fatal suspected adverse drug reactions. It concerns a 2-year-old male child who received a Pneumococcal vaccine (Manufacturer unknown, route, site and batch number unknown) date of administration not reported. According to the article, on 2006, exact date not reported, after vaccine administration (latency not reported) the patient presented with meningitis and pyrexia. The patient died afterwards. No further information was reported.


VAERS ID: 466954 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-09-28
Entered: 2012-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Inappropriate schedule of drug administration, Meningitis pneumococcal, Pneumococcal bacteraemia, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Medication errors (narrow), 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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1209ESP011533

Write-up: Literature case retrieved from a literature search performed on 19-SEP-2012. Case medically confirmed. This case is linked to cases E2012-06173 and E2012-06175. Follow up information was added to cases E2005-03512 and E2005-03513 because information regarding these cases was found in this literature. This study was conducted to evaluate relevant new information about adverse drug reaction for individuals aged 0-17 years reported to the Pharmacovigilance system from 2004 to 2009 were analyzed with respect to time, age, and sex, category of adverse drug reactions [System Organ Class (SOC)], serious, suspected medicines [level 2 of the anatromical Therapeutic Chemical (ATC) Classification System] and type of reporter. During the 6 year period (2004-2009) FEDRA received a total of 60.342 spontaneous notifications. Of these, 7%(n=4.279) were identified as suspected ADRs in the paediatric population, with an average of 713 notifications per year. In 55% of these, at least one vaccine was involved. More than one-third (37%) of these notifications described serious ADR''s (n=1590). The seriousness criteria were defined as fatal in 33 notifications (33% of these included a vaccine), life-threatening in 169 notifications (requiring admission and prolonged hospitalization in 552 cases, persistent disability/incapacity in 18 cases, congenital anomalies in 33 cases) and medically significant in 980 notifications. The current case was retrieved from a table describing suspected drugs and their therapeutic groups in relation with fatal suspected adverse drug reactions. In concerns a 13 year-old male patient who received a Pneumococcal vaccine (Manufacturer unknown, route, site and batch number unknown) date of administration not reported. According to the article, on 2009, exact date not reported, after vaccine administration (latency not reported) the patient presented with pneumococcal bacteraemia, meningitis pneumococcal, vaccination failure, also inappropriate schedule of drug administration was reported. The patient died afterwards. No further information was reported.


VAERS ID: 466964 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-09-28
Entered: 2012-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningitis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Noninfectious meningitis (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1209ESP011536

Write-up: Literature case retrieved from a literature search performed on 19-SEP-2012. Case medically confirmed. This case is linked to cases E2012-06173 and E2012-06175. Follow up information was added to cases E2005-03512 and E2005-03513 because information regarding these cases was found in this literature. This study was conducted to evaluate relevant new information about adverse drug reaction for individuals aged 0-17 years reported to the Pharmacovigilance system from 2004 to 2009 were analyzed with respect to time, age, and sex, category of adverse drug reactions [System Organ Class (SOC)], serious, suspected medicines [level 2 of the anatromical Therapeutic Chemical (ATC) Classification System] and type of reporter. During the 6 year period (2004-2009) FEDRA received a total of 60.342 spontaneous notifications. Of these, 7%(n=4.279) were identified as suspected ADRs in the paediatric population, with an average of 713 notifications per year. In 55% of these, at least one vaccine was involved. More than one-third (37%) of these notifications described serious ADR''s (n=1590). The seriousness criteria were defined as fatal in 33 notifications (33% of these included a vaccine), life-threatening in 169 notifications (requiring admission and prolonged hospitalization in 552 cases, persistent disability/incapacity in 18 cases, congenital anomalies in 33 cases) and medically significant in 980 notifications. The current case was retrieved from a table describing suspected drugs and their therapeutic groups in relation with fatal suspected adverse drug reactions. In concerns a 13 year-old male patient who received a Pneumococcal vaccine (Manufacturer unknown, route, site and batch number unknown) date of administration not reported. According to the article, on 2009, exact date not reported, after vaccine administration (latency not reported) the patient presented with meningitis and vaccination failure. The patient died afterwards. No further information was reported.


VAERS ID: 466967 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Foreign  
Vaccinated:2005-08-15
Onset:0000-00-00
Submitted: 2012-09-28
Entered: 2012-10-01
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIE-VAX) / SANOFI PASTEUR Y0701 / 3 UN / UN
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial test negative, Bradycardia, CSF glucose normal, CSF mononuclear cell count increased, CSF protein decreased, CSF white blood cell count increased, Coma, Convulsion, Death, Encephalitis, Encephalopathy, Hyporeflexia, Hypotonia, Nervous system disorder, Nystagmus, Pyrexia, Vaccination complication
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2006-01-09
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: A dog bite in face and right hand at the beginning of August (on 6 Aug?). 2 doses of rabies vaccine were received on 08-Aug-2005.
Allergies:
Diagnostic Lab Data: Laboratory data: Spinal fluid: Leukocytes 24 with 95% of mononuclear cells; Glucose 71, Proteins 7 m; Serum tests negative for N Meningitidis and Haemophylus Gram Negative; Other: Results from CSF, saliva, skin biopsy and Magnetic Resonance Scan, all pending.
CDC Split Type: E200503513

Write-up: Initial information received on 07-SEP-05 through an e-mail from Health Authority concerning a 9 year old child from who was administered VERORAB (batch number not reported but only reference available: REV 06/2000 to be checked). After vaccination, the child developed an encephalitis associated to the vaccination, and was hospitalized in a hospital. . The outcome has not been reported. This is a case related to the case number E2005-03512. One of these cases might have happened 7 months ago. The other case''s patient is still at hospital. Further information is expected. Case is incomplete. Follow-up. Information received on 14-SEP-05 through an e-mail form HA. The patient is a 5 year old male (instead of a 9 year old one). He was admitted in the "Hospital" on 28-AUG-05, referred from the Hospital, with a clinical picture of coma Glasgow 3, and generalized hypotonia. His family told that, 21 days before, the child was bitten by a dog (face and right hand). Then, he was administered VERORAB (bar code 08492814-0) and anti-tetanic vaccine (MFR and batch number not reported) After the second dose of anti-rabies vaccine, he presented fever and convulsions, ending up in coma (48 hours before the admission at Hospital). Clinical examination at admission: Glasgow score: 3-4 without sedation with generalized hypotonia and hyporeflexia. He presents horizontal nystagmus beating to the right, episodes of bradycardia which reacting to Manitol + Flurosemide + Atropine bolus. (see lab comments). Further information is expected. Case is incomplete. Follow-up (2) received on 22-SEP05 through an e-mail from a physician. The patient was administered VERORAB (batch number Y0701-1). The clinical investigations on this case are still carrying on, while the child is still in coma with a generalized hypotonia. The stray dog who bit him was never captured. Further information is expected from hospital. Case is incomplete. Follow-up (3) received on 15-FEB-06 through a telephone call to the physician who treated the child at hospital. He told that the child stayed in hospital during five months until JAN-06 when he finally died. Case is incomplete. Follow-up (4) received on 20-FEB-06 through an e-mail from HA. The child died on 09-JAN-06 due to neurologic lesions. No more information is expected. Case is closed. Follow-up (5) received on 28-SEP06, the last information received concern the patient initials: and the vaccine administration: VERORAB route of administration was Intra-muscular, on 08-AUG-05 the patient received two dose of VERORAB and on 15-AUG-05 the patient received a third dose. No more information is expected. Case is closed. Follow-up information was found regarding this case in an article retrieved from a literature search performed on 19-SEP-2012. Case medical confirmed. This case is linked to cases from E2012-06173 to E2012-06175. Information regarding cases E2005-03512 and E2005-03513 was found in this article. This study was conducted to evaluate relevant new information about adverse drug reaction for individuals aged 0-17 years reported to the Pharmacovigilance system from 2004 to 2009 were analyzed with respect to time, age, and sex, category of adverse drug reactions [System Organ Class (SOC)], seriousness, suspected medicines [level 2 of the anatromical Therapeutic Chemical (ATC) Classification System] and type of reporter. During the 6 year period (2004-2009) FEDRA received a total of 60.342 spontaneous notifications. Of these, 7%(n=4.279) were identified as suspected ADRs in the paediatric population, with an average of 713 notifications per year. In 55% of these, at least one vaccine was involved. More than one-third (37%) of these notifications described serious ADR''s (n=1590). The seriousness criteria were defined as fatal in 33 notifications (33% of these included a vaccine), life-threatening in 169 notifications (requiring admission and prolonged hospitalization in 552 cases, persistent disability/incapacity in 18 cases, congenital anomalies in 33 cases) and medically significant in 980 notifications. The current case was retrieved from a table describing drugs and their therapeutic groups in relation with fatal suspected adverse drug reactions: According to the article a 5 year-old male patient who, on an unspecified date, had received an inactivated rabies vaccine whole virus (manufacturer, route, site and batch number not reported) presented in 2005, exact date not reported, convulsion, pyrexia, hypotonia, bradycardia, nystagmus, encephalopathy and coma. No further information was reported.


VAERS ID: 467539 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-06-27
Onset:2012-06-28
   Days after vaccination:1
Submitted: 2012-10-03
   Days after onset:97
Entered: 2012-10-04
   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, Dyspnoea, General physical health deterioration, Intensive care, Pyrexia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2012-06-30
   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? Yes
Previous Vaccinations:
Other Medications: Prednisolone
Current Illness:
Preexisting Conditions: Pulmonary fibrosis; Asbestosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012239950

Write-up: This is a spontaneous report from a contactable physician via a pfizer sales rep. A 64-year-old male patient was vaccinated with PREVENAR 13 intramuscular on 27 Jun2012 at 0.5 ml, single in adults more than 50 years. Concomitant medication included PREDNISOLONE orally at 20 mg, 1x/day for a non reported indication. Relevant medical history included pulmonary fibrosis and asbestosis (ongoing). On 28Jun2012 the patient was admitted to the intensive care unit since he experienced fever and shortness of breath. On an unspecified date the patient''s condition deteriorated to respiratory failure from which he died on 30Jun2012. It was not reported if an autopsy was performed. The treating physician did not believe that death was caused by PREVENAR 13 although he did not rule out anything when he was asked by the patient''s relatives. The family''s GP believed that death was caused by PREVENAR 13 as he was present with the relatives when the treating physician spoke to them.


VAERS ID: 467590 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2012-09-21
Onset:2012-09-22
   Days after vaccination:1
Submitted: 2012-10-03
   Days after onset:11
Entered: 2012-10-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cardiac failure, Cardiac procedure complication, Cardioversion, Death, Injection site erythema, Pallor, Pyrexia, Resuscitation, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No personal medical history, no underlying disease or any appreciable abnormality. No history of adverse event to previous administration of vaccine or drug. No reported family medical history.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201209089

Write-up: Initial information received from a Healthcare Professional on 24 September 2012 and follow-up information received from the Health Authorities on 27 September 2012 (HA''s number HIB-426. The local reference number is A201200292. This case is linked with the non-serious case 2012-09092. A 02-month-old female patient, with no personal medical history, no underlying disease or any appreciable abnormality, no history of adverse event to previous administration of vaccine or drug and no reported family medical history, had received her 1st primary dose of ActHIB (batch number H1007) subcutaneously in the right arm on 21 September 2012 around 02:00 to 03:00 pm. She had not received concomitant therapies. On 22 September 2012 early in the morning, about 20 hours post-vaccination, the patient''s mother noted that the patient was pale. The patient was transported to medical center by ambulance. Her heart rate was 200. She was diagnosed with ventricular tachycardia. Drugs (not specified) were administered and defibrillation was attempted but failed. The patient was taken to emergency department of general hospital. The physician examined her but she did not recover. Resuscitation attempts made for about 90 minutes failed and the patient died. On 23 September 2012, results of legal autopsy revealed that the patient had developed heart failure of uncertain cause. According to the patient''s mother, the patient also experienced fever and injection site redness on an unspecified date. The 1 year and 11 months old elder sister of the patient had received a dose of ActHIB (batch number not reported) on the same day, and developed fever at 38 degrees C for one day and injection site redness (see case 2012-09092). Reported physician''s comment: "The patient did not have underlying disease or any appreciable abnormality. The results of an autopsy revealed heart failure. It is probable that there is a casual relationship between the event and ActHIB administered recently." Relevant Test/Laboratory Data: not reported. Death occurred after


VAERS ID: 467779 (history)  
Form: Version 1.0  
Age: 0.7  
Sex: Female  
Location: Foreign  
Vaccinated:2012-09-01
Onset:2012-09-19
   Days after vaccination:18
Submitted: 2012-10-04
   Days after onset:15
Entered: 2012-10-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac massage, Death, Epistaxis, Respiratory arrest, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-20
   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: No reported medical history. No concomitant therapies. The patient had a medical history of mild pneumonia (date not reported)
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201209124

Write-up: Case received from a Healthcare Professional on 25 September 2012 under the reference number A201200295. A 07-month-old female patient, with a medical history of mild pneumonia (date not reported) and no concomitant therapies, had received a dose of IMOVAX (bath number, route and site of administration not reported) on 01 September 2012. On the night of 19 September 2012, the patient had been given a bath held in her father''s arms. She experienced nose bleeds, vomiting and she stopped breathing. She was taken to the medical center. During transport, her breathing stopped but the heart was still beating. Cardiac massage was performed but the patient died on 20 September 2012 at 10:37. There was a possibility the patient had developed asphyxia due to vomiting. Although the patient was found to have had mild pneumonia, causality between the event and IMOVAX could not be denied considering she had been administered this vaccine.


VAERS ID: 467780 (history)  
Form: Version 1.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-11-01
Onset:2010-01-15
   Days after vaccination:1536
Submitted: 2012-10-04
   Days after onset:992
Entered: 2012-10-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Biopsy stomach abnormal, Chemotherapy, Gastrectomy, Gastric cancer, Metastases to ovary, Radiotherapy
SMQs:, Acute pancreatitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-12
   Days after onset: 908
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: In 11/2009, subject reported onset of severe epigastralgia and was examined and biopsied on 01/15/2010. After receiving Dx of gastric cancer, had complete gastrectomy on 2/9/2010 and 45 day hospital stay. Was also hospitalized in 4/2010 for chemotherapy and radiotherapy, and discharged on 5/26/2010. Followed up with specialist, chemotherapy, and metoclopramide daily. Mother reported subject received Dx of ovarian metastasis in 4/2011, and additional chemotherapy was not successful.


VAERS ID: 469723 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-10-15
Entered: 2012-10-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Nonspecific reaction
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Meconium aspiration; Premature baby
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0997335A

Write-up: This case was reported in a newspaper article via website and described the occurrence of nonspecific reaction in a neonate male subject who was vaccinated with Hepatitis B (manufacturer unspecified). Concurrent medical conditions included meconium aspiration and premature baby. On an unspecified date in 2007 the subject received unspecified dose of Hepatitis B (unknown). Later, that same evening, of vaccination with Hepatitis B, the subject experienced nonspecific reaction. The subject was hospitalized due to being born two and a half weeks prematurely and suffered from meconium aspiration (MAS). On the seventh day of hospitalization the subject was to be released to go home following a hearing test and vaccination. That same evening, the subject had a reaction. Hospitalization was prolonged. Approximately 40 days later, the subject passed away in August 2007. he subject died, caused of death is not specified. It was unknown whether an autopsy was performed.


VAERS ID: 469972 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-10-15
Entered: 2012-10-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012KR090553

Write-up: Case number PHHY2012KR090553 is an initial literature report received on 10 Oct 2012. The author discussed a study which presented the retrospective review of data from the foreign Centers for Disease Control and Prevention adverse events following immunization surveillance system and vaccine compensation programs and assessed cases of sudden death in the first 2 years of life following immunization that were reported between 1994 and 2011 using standardized assessment by the Brighton collaboration. This report refers to a child whose age was not reported. The patient''s medical history and concomitant medications were not reported. The patient was vaccinated with pandemic influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, the patient experienced infectious disease and died. The literature stated that the event could be meningitis, encephalitis, bacterial sepsis, myocarditis, gastroenteritis or pneumonia. The author stated that although most of the cases identified in the study might be coincidental, continuing surveillance and thorough investigation were needed for more definitive assessment of the safety of immunization and its potential association to the infant mortality. The author concluded the article that the study data did not support the epidemiologic studies necessary to determine whether a causal association existed between immunization and adverse events following immunization (AEFI) and it did not provide important information in the causative role of vaccination and sudden death in the vaccinees in the first two years of life.


VAERS ID: 470046 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-10-15
Entered: 2012-10-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012KR090547

Write-up: Case number PHHY2012KR090547 is an initial literature report received on 10 Oct 2012. The author discussed a study which presented the retrospective review of data from the foreign centers for disease control and prevention adverse events following immunization surveillance system and vaccine compensation programs and assessed cases of sudden death in the first 2 years of life following immunization that were reported between 1994 and 2011 using standardized assessment by the Brighton collaboration. This report refers to a child whose age was not reported. The patient''s medical history and concomitant medications were not reported. The patient was vaccinated with H1N1 (manufacturer and batch number: not reported) on an unknown date. On an unknown date, the patient experienced accidental injury and died. The literature stated that the event could be asphyxia, subdural hematoma or an unspecified traumatic injury. The author stated that although most of the cases identified in the study might be coincidental, continuing surveillance and thorough investigation were needed for more definitive assessment of the safety of immunization and its potential association to the infant mortality. The author concluded the article that the study data did not support the epidemiologic studies necessary to determine whether a causal association existed between immunization and adverse events following immunization (AEFI) and it did not provide important information on the causative role of vaccination and sudden death in the vaccinees in the first two years of life.


VAERS ID: 469994 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-10-16
Entered: 2012-10-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

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: One of twins, Premature baby 26 to 32 weeks
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012256048

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 6-months-old male patient started to receive PREVENAR 13, via an unspecified route of administration on an unspecified date single dose for immunization. The patient''s concomitant medications were not reported. The patient died on an unspecified date at 6 months. It was not reported if an autopsy was performed. The reporting physician thinks it is related to PREVENAR 13. The baby was one of twins born at 26 weeks.


VAERS ID: 470717 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-10-13
Submitted: 2012-10-17
   Days after onset:4
Entered: 2012-10-22
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-13
   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: PHHY2012BR092128

Write-up: Case number PHHY2012BR092128 is an initial and spontaneous report received from a consumer on 15 Oct 2012. This report refers to a female patient who was less than 18-year-old. Her medical history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine ACWY (manufacturer and batch number: not reported, hence conservatively taken as MENVEO INN) on an unspecified date. According to the reporter, on 13 Oct 2012 the patient died. The cause of death was not reported. No other information was available.


VAERS ID: 470890 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-10
Onset:2012-10-11
   Days after vaccination:1
Submitted: 2012-10-22
   Days after onset:11
Entered: 2012-10-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Atrial thrombosis, Autopsy, Blood pressure fluctuation, Carotid artery stenosis, Coronary artery stenosis, Death, General physical health deterioration, Hepatic congestion, Pulmonary oedema, Respiratory distress
SMQs:, Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (broad), Cardiomyopathy (broad), Other ischaemic heart disease (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: 2012-10-12
   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: Chronic gastritis; Coronary arteriosclerosis; Diabetes mellitus Type 2; Generalized arteriosclerosis; Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 11Oct2012, fluctuating
CDC Split Type: D0077465A

Write-up: This case was reported by a physician via a regulatory authority (# DE-PEI-PEI2012052261) and described the occurrence of death - at present cause unknown - in an 80-year-old female subject who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). Concurrent medical conditions included arterial hypertension, chronic gastritis, diabetes mellitus type 2, severe coronary arteriosclerosis and generalized arteriosclerosis. It was unknown whether or not previous vaccinations with vaccines not further specified, including or not INFLUSPLIT SSW (GlaxoSmithKline), have been well tolerated. On 10 October 2012 the subject received a dose of INFLUSPLIT SSW (0.5 ml, subcutaneous, unknown). Approximately one day post vaccination with INFLUSPLIT SSW, on 11 October 2012, the subject experienced blood pressure fluctuation and respiratory distress. In the night between 11 October 2012 and 11 October 2012 the subject died (death - at present cause unknown). The subject was found dead at home sitting in an arm chair by the daughter in law. An autopsy was performed. Additional information was received by the foreign regulatory authority by phone from the reporting physician on 16 October 2012, 17 October 2012 and 18 October 2012. An autopsy was performed on 17 October 2012. Despite autopsy the cause of death remained unknown. The autopsy showed a pulmonary edema, signs of congestion of liver, thrombi in the left cardiac atrium, a generalized arteriosclerosis with high-grade stenosis of the coronary arteries and with high-grade stenosis of internal carotid artery on both sides. Examination of the brain and several histological examinations are planned, but not yet conducted. Therefore the final autopsy result was not yet available. Initially the physician had reported that the subject has experienced worsening of general condition post vaccination with INFLUSPLIT SSW. Later on worsening of general condition was specified and the physician more precisely reported that the subject experienced blood pressure fluctuation and respiratory distress. In additional information was received by the regulatory authority by phone on 18 October 2012 from a general practitioner, the family physician of the subject. This physician has specified that the seasonal trivalent Influenza vaccine used for vaccination on 10 October 2012 had been INFLUSPLIT SSW (GlaxoSmithKline). The foreign regulatory authority has requested further information. At the moment no further information was available.


VAERS ID: 471214 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-10-23
Entered: 2012-10-24
   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
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''s ongoing illness, medical history, risk factors and concomitant vaccines or medications were reported as unknown. History of adverse event to previous administration of vaccine or drug was reported as unknown. (According to the news, the patient was part of priority groups for vaccination, because of presented risk factors such as lung disease, obesity, diabetes or heart disease for example. It was not specified the risk factor of each patient).
Allergies:
Diagnostic Lab Data: Unknown.
CDC Split Type: 201209627

Write-up: Initial report was received from a consumer collected through lay media via the local affiliate on 15 October 2012, providing information of two vaccinated patients who died with suspect of influenza A/H1N1. The reporter for this case is also the same reporter (same vaccine, manufacturer unknown, and same adverse events) for case number 2012-09628. An unknown patient (gender, age, birth date not reported) received an injection of influenza vaccine, manufacturer unknown, (lot number unknown and route, site, side and dose in series not reported) on an unspecified unknown date. On an unknown date, the patient died with suspect of influenza A/H1N1. There was no information available about the patient, nor the details of vaccination, but according to the news, the patient was part of priority groups for vaccination, because of presented risk factors such as lung disease, obesity, diabetes or heart disease for example. It was not specified the risk factor for the patient. The patient''s ongoing illness, medical history, risk factors and concomitant vaccines or medications were reported as unknown. History of adverse event to previous administration of vaccine or drug was reported as unknown. Laboratory or diagnostic testing and corrective treatments were reported as unknown. It was unknown if the patient was hospitalized. No additional information was available at the time of the report. The patient''s outcome was reported as fatal. Documents held by sender: None.


VAERS ID: 471216 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-10-23
Entered: 2012-10-24
   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
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''s ongoing illness, medical history, risk factors and concomitant vaccines or medications were reported as unknown. History of adverse event to previous administration of vaccine or drug was reported as unknown. (According to the news, the patient was part of priority groups for vaccination, because of presented risk factors such as lung disease, obesity, diabetes or heart disease for example. It was not specified the risk factor of each patient).
Allergies:
Diagnostic Lab Data: Unknown.
CDC Split Type: 201209628

Write-up: Initial report was received from a consumer collected through lay media via the local affiliate on 15 October 2012, providing information of two vaccinated patients who dies with suspect of influenza A/H1N1. The reporter for this case is also the same reporter (same vaccine, manufacturer unknown, and same adverse events) for case number 2012-09627. An unknown patient (gender, age, birth date not reported) received an injection of influenza vaccine, manufacturer unknown, (lot number unknown and route, site, side and dose in series not reported) on an unspecified unknown date. On an unknown date, the patient died with suspect of influenza A/H1N1. There was no information available about the patient, nor the details of vaccination, but according to the news, the patient was part of priority groups for vaccination, because of presented risk factors such as lung disease, obesity, diabetes or heart disease for example. It was not specified the risk factor for the patient. The patient''s ongoing illness, medical history, risk factors and concomitant vaccines or medications were reported as unknown. History of adverse event to previous administration of vaccine or drug was reported as unknown. Laboratory or diagnostic testing and corrective treatments were reported as unknown. It was unknown if the patient was hospitalized. No additional information was available at the time of the report. The patient''s outcome was reported as fatal. Documents held by sender: None.


VAERS ID: 471789 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-10-26
Entered: 2012-10-26
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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1210HKG011628

Write-up: This spontaneous report as received from a consumer, who learnt from a radio channel of fatal cases after GARDASIL vaccination (121USA012211) and (2 fatal cases, this case) and (3 fatal cases, 1210USA012210). The reporter himself experienced serious adverse events (1210HKG011385). This report refers to three patients of unknown age. The patients were vaccinated with GARDASIL (date and route of administration not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients died. No details for death are available. The relatedness for death is unknown for GARDASIL. Additional information has been requested.


VAERS ID: 471832 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Male  
Location: Foreign  
Vaccinated:2012-04-16
Onset:2012-06-08
   Days after vaccination:53
Submitted: 2012-10-24
   Days after onset:138
Entered: 2012-10-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, HIV infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-06-08
   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: HIV infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012261605

Write-up: This is a spontaneous report from the non-clinical study program, from a contactable nurse. A 3-months male patient received PREVENAR 13, intramuscular at 7weeks, on 16Apr2012, single dose. The baby was enrolled on the program on 10May2012. At 12 weeks on 14May2012 received INFANRIX HEXA. Medical history included HIV infection. The patient''s concomitant medications were not reported. The patient died on 08Jun2012 due to the HIV infection. It was not reported if an autopsy was performed.


VAERS ID: 472392 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-04
Onset:2012-10-08
   Days after vaccination:4
Submitted: 2012-10-31
   Days after onset:23
Entered: 2012-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA741AA / UNK LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cardiopulmonary failure, Death, Treatment noncompliance
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-08
   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: Salbutamol sulphate; Beclomethasone dipropion; Amoxicillin trihydrate; Prednisolone
Current Illness: Unknown
Preexisting Conditions: Asthma; Exacerbation of asthma; Patient weight as of 22/11/2011: 41.5kg
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0839603A

Write-up: This case was reported by a physician, via the regulatory authority, and described the occurrence of cardiorespiratory failure in a 15-year-old male subject who was vaccinated with FLUARIX. The subject''s medical history included asthma. The subject was treated for an exacerbation of asthma on 19 September 2012 with amoxicillin and prednisolone. Concurrent medications included VENTOLIN and CLENIL MODULITE. It was reported that the subject had ''probable poor compliance with CLENIL inhaler''. On 4 October 2012 the subject received an unspecified dose of FLUARIX (1 injection, left arm, batch number AFLUA741AA). On 8 October 2012, 4 days after vaccination with FLUARIX, the subject experienced cardiorespiratory failure. The subject died on 08 October 2012 from acute cardiorespiratory failure. An autopsy was not performed. Agency Verbatim Text: Asthmatic patient died with acute cardio respiratory failure four days after receiving influenza vaccination (unexpected). Known asthmatic. Probable poor compliance with CLENIL inhaler. Was treated for exacerbation in September with a course of amoxicillin and prednisolone.


VAERS ID: 473160 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Foreign  
Vaccinated:2012-08-09
Onset:2012-08-10
   Days after vaccination:1
Submitted: 2012-11-01
   Days after onset:83
Entered: 2012-11-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK UN / SYR
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, C-reactive protein normal, Coronary artery aneurysm, Death, Inflammation, Lower respiratory tract inflammation, Resuscitation, Sudden infant death syndrome, Tryptase, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (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: The patient''s weight at birth was 2,669 g. Patient''s medical history of Kawasaki disease.
Allergies:
Diagnostic Lab Data: At the autopsy, a mild inflammation was histologically observed in pulmonary parenchyma. However, no infiltration of inflammatory cells was observed in the upper respiratory tract. Blood test performed during autopsy on 10 August 2012: CRP, 0.60 mg/dL, Mild increase; Tryptase, 6.1 ug/L, Within the reference range
CDC Split Type: 201210093

Write-up: Initial report received from a healthcare professional via Agency (Case ID: #HIB-443) on 23 October 2012. A 07-month-old male patient with a medical history of Kawasaki disease had received a dose of ACTHIB (batch number, route of administration, site and side of injection were unknown) as well as a dose of PREVENAR (other manufacturer, batch number, route of administration, site and side of injection unknown) on 09 August 2012 at a clinic. The patient''s weight at birth was 2,669 g. During midnight (precisely, the date was changed to the next day or AM 0:30 on 10 August 2012) the parent noticed that the child did not respond on the bed. An ambulance was called and the patient was delivered to the hospital. The patient did not respond to resuscitation and death was confirmed. Thereafter, notification of abnormal death was submitted to a police station in the city by Hospital. For the police probe by the police station, autopsy was permitted and conducted at Department of Forensic Medicine, in order to investigate the cause of death. A permitted autopsy was performed and results of various examination was as follows: Coronary aneurysm sometimes observed as sequelae to Kawasaki disease diagnosed in the patient (Patient was on follow-up due to favorable outcome after hospitalized treatment), was confirmed not present. There was no finding that indicates suffocation. In addition, there was no finding suggesting anaphylaxis. No organic disease was observed. Furthermore, mild inflammation was histologically observed in pulmonary parenchyma. However, no infiltration of inflammatory cells was observed in the upper respiratory tract. The result of the blood test was as follows: CRP 0.60 mg/dL Mild increase Tryptase 6.1 ug/L Within the reference range. Thus, based on the result of the autopsy and various examinations, the cause of death was diagnosed as sudden infant death syndrome. Sudden infant death syndrome is, as defined by the agency''s guideline, syndrome in which infants younger than 1 year old, in principle, experience sudden death despite healthy condition and the cause of death cannot be identified from medical history. Furthermore, investigation of conditions surrounding death and autopsy cannot identify the cause of death. There was no finding that actively supports the relationship with the vaccination (anaphylaxis, etc.). Sudden infant death syndrome was a disease in which the cause is unknown. With regard to the causality to this vaccination, it was judged as "Not assessable." The time of death was, judging from findings of the dead body the situation surrounding the death, estimated to be PM 23:00 on 09 August 9, 2012. Permitted autopsy was conducted on 10 August 2012. Thereafter, various examinations were conducted and it took time before diagnosing as sudden infant death syndrome. Reporter''s case assessment: "This case was serious (death) and causality between the event and ACTHIB was not assessable."


VAERS ID: 473098 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-10-29
Entered: 2012-11-06
   Days after submission:8
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 disorder, Death, Pleural effusion
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012DE096951

Write-up: Case number PHHY2012DE096951, is an initial spontaneous report received from a consumer via e-mail on 25 Oct 2012. This report refers to a female patient of unknown age. The patient''s medical history and concomitant medications were not reported. She was vaccinated with influenza vaccine INN (batch number and manufacturer unknown) on an unknown date. Two weeks after vaccination the patient developed "problems" with her heart (details not provided). Subsequently the patient suffered from "water in the lungs" (details not provided). In 2011 the patient died. The cause of death was not reported. The causal relationship was not reported.


VAERS ID: 473105 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2009-11-27
Submitted: 2012-10-30
   Days after onset:1067
Entered: 2012-11-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012NL096317

Write-up: Case number PHHY2012NL096317 is an initial literature report received from a health care professional via foreign health authority (NL-LRB-102333) on 24 Oct 2012. The intent of the article was to describe an observational study conducted to describe the methods of processing, analyzing and performing signal detection on the reports of adverse events following immunization (AEFI) with respect to the two pandemic influenza vaccines, FOCETRIA and PANDEMRIX and to provide a summary of the results of the safety monitoring of both vaccines. This report refers to a 2-years-old male patient. The patient''s medical history and concomitant medications were not reported. He was vaccinated with pandemic influenza vaccine (manufacturer and batch number: not reported) 1x1 0.5 ml intramuscularly for immunization on an unknown date. On 27 Nov 2009, the patient died and the cause of death was not provided. The health authority assessed the causality as unlikely. But the authors commented that although a possible relationship could not be excluded, the causal relationship between administration of the vaccine and death was improbable on the basis of what was currently known about the report. The author concluded the article stating that no major safety issues occurred with respect to the type of reported AEFIs or with batches of either vaccine.


VAERS ID: 473187 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-05-29
Onset:2012-05-30
   Days after vaccination:1
Submitted: 2012-11-01
   Days after onset:155
Entered: 2012-11-06
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 1 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cardiac arrest, Cardio-respiratory arrest, Computerised tomogram normal, Death, Dehydration, Mechanical ventilation, Pallor, Resuscitation, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (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), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012271235

Write-up: This is a spontaneous report obtained from agency. A non-contactable physician reported that a female patient (below the age of 6-month-old) received subcutaneous PREVENAR suspension for injection at 0.5ml single on 22May2012 as the first inoculation. Co-suspect drug included subcutaneous ACT-HIB injection at 1 DF single on 29May2012 as the first inoculation and oral rotavirus vaccine syrup at 1 DF single on 27Mar2012, first inoculation and on 24Apr2012 as the second inoculation. On 30May2012, the patient experienced sudden infant death syndrome. The cause of death was unknown. Autopsy was performed. The causalities were unknown. Birth weight was 3150 kg. At the time of delivery, after the delivery and at the medical examination for infant, there was not any information including any abnormalities was obtained. At 11:00AM on 29May2012, the first inoculation of ACT-HIB was performed. The body temperature before the inoculation was 36.6 degrees C. After inoculation, there was not any allergic symptom found and the generalized status was favorable. She was 5 kg in weight. At 4:59AM on May2012, her father noticed that she had ill complexion and had no response and thus called an ambulance. At the same time, pressure under breastbone was started. At 5:05AM, an ambulance attendant confirmed that the patient''s cardiac arrest and the patient was transported while receiving pressure under breastbone and assisted ventilation. At 5:25AM, the patient arrived to the emergency center and bone marrow access was secured while pressure under breastbone and assisted ventilation were continued. In addition, adrenaline 0.05 mg was administered in the bone marrow. On arrival at the transporting hospital, the patient did not have common-cold symptom such as respiratory passage or pyrexia, and nothing abnormal was detected outer surface. At 6:19AM, the 11th administration of adrenaline 0.05 mg was given to the patient which was repeatedly given 0.05 mg was given to the patient every 4 minutes since 5:29AM. At 6:23AM, the return of heart beat was not confirmed. After completing the resuscitation, the patient''s death was confirmed. Because the mother''s poor physical condition, rehydration including breast feeding was not given to the patient from 4:00PM on 29May2012 until death. After death, whole body computer tomography (CT) did not show intracranial lesion or abdominal organ damage, and it was considered that the possibility of external injury was weak. According to the result of judicial autopsy, it was judged that the cause of death was sudden infant death syndrome; however, details were not obtained. Physician''s comment: The causality with ACT-HIB was unknown this time. Until death, the patient did not have any fluid replacement for 14 hours, which dehydration was considered as the cause. Anatomical consequence was waited. The physician who transported the patient to the hospital: It was difficult to identify the cause of death clinically. There were not any symptom of common cold such as respiratory passage or pyrexia, and there was nothing abnormal detected externally when the patient visited the hospital. In addition, whole body CT performed after death did not show any intracranial lesion or abdominal organ damage, and it was considered that the possibility of external injury was weak. Therefore, it was not completely said that there was not any causality with ACT-HIB which was given to the patient within 24 hours, which lead to this report. Specialist A: The patient was found with cardiopulmonary arrest on the next morning after receiving the first ACT-HIB, and this was the infant who could not be rescued in spite of receiving resuscitative maneuver at the emergency center. Although there was an anteroposterior relationship between the vaccination and death, it could not be said that there was a causality. A diagnosis of sudden infant death syndrome was made by autopsy. Moreover, it was difficult to say that the patient not taking breast feeding or bottle feeding at all due to the mother''s poor physical condition was the direct cause of the death. Specialist B: Because of the situation at the time the patient was found, and because the information whether the patient did have any oral intake after 4:00PM on 29May2012, it could not avoid thinking that the patient was suspicious with SIDS or there was the causality with the vaccination (ACT-HIB or heptavalent pneumococcal conjugate vaccine). The final decision would be made by whether the cause of death would be found by autopsy report, but according to the present report, the causality between the vaccination ACT-HIB or heptavalent pneumococcal conjugate vaccine) and the death could not be excluded. Specialist C: A female infant, below 6-month-old, 5 kg in weight. There was not any specific problem found at birth as well as growth afterward, and there was not any problem found on the first inoculation of rotavirus vaccination and the second PREVENAR vaccination. According to the clinical course, there was not any response that considered anaphylaxis after the injection, and pyrexia, respiratory passage or external abnormality were not found. Considering that intracranial lesion or abdominal organ damage was not noted by CT was performed after death, SIDS was the most suspicious. Because of the patient did not receive any fluid replacement for 14 hours and because of the fact that there was not other choice to give transfusion via bone marrow access at the emergency, it was also considered that extreme symptom of dehydration was also considered as the cause. It was considered that the above 2 points were strongly related to death; however, there was lack of data to deny the involvement of the vaccination completely.


VAERS ID: 473497 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-17
Onset:2012-10-17
   Days after vaccination:0
Submitted: 2012-11-07
   Days after onset:21
Entered: 2012-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0393AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Cardiac massage, Cardio-respiratory arrest, Chest pain, Death, Dizziness, Dyspnoea, Erythema, Hyperhidrosis, Hypertension, Loss of consciousness, Mechanical ventilation, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-17
   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: FLUZONE; tamsulosin hydrochloride
Current Illness: Immunisation
Preexisting Conditions: Obesity; Benign prostatic hyperplasia; Osteoarthritis; Influenza vaccine; Drug Indication: Immunisation, Drug Reaction: No adverse event
Allergies:
Diagnostic Lab Data: The patient presented a heart rate of 106 beats per minute, 94% oxygen saturation, and blood pressure of 250/140 mmHg. 10/17/2012, blood pressure; 10/17/2012, heart rate; 10/17/2012, Oxygen saturation, 94 %
CDC Split Type: WAES1211ESP002834

Write-up: Case received from the Health Authorities (reported to them by a physician) on 29-OCT-2012 under the reference number: ES-AGEMED-232525332 via the contractual partner ROVI under the reference number ES-ROVI-20120214. Case medically confirmed. A 69-year-old male patient with a medical history of arthrosis, hyperplasia of the prostate and obesity, had received a dose of a Influenza virus vaccine (Vacuna Antigripal Pasteur, batch number: J8351-1) via intramuscular and a dose of PNEUMOVAX, batch number: G007613) on 17-OCT-2012 and 15-20 minutes later, the patient presented with sweating, thoracic pain, dyspnea, and purplish erythema in the dorsal area with sensation of dizziness. The patient presented also hypertension and heart arrest on 17-OCT-2012 (latency not reported). The patient had a history of arthrosis, hyperplasia of the prostate and obesity treated with tamsolusin and unknown traditional non-steroidal anti-inlfammatory drug (NSAID). The patient received an unknown Influenza virus vaccine in 2011 having no adverse events associated. Fifteen to twenty minutes after the administration of the vaccine, the patient went to the clinic with sweating, pain in the thorax, dyspnea and purplish erythema in the dorsal area. The patient presented a heart rate of 106 beats per minute, 94% oxygen saturation, and blood pressure of 250/140 mmHg. The patient was given captopril sublingually and SEGURIL via intramuscular. The patient experienced loss of consciousness and cardiopulmonary arrest. Cardiopulmonary resuscitation maneuvers were performed, giving 3 ampoules of adrenaline and 80 mg of URBASON cardiac massage and manual ventilation with Ambu bag; with no response after twenty minutes. The patient died on 17-Oct-2012; the reported cause was cardiopulmonary arrest although the patient''s family did not want the autopsy to be performed. Upon internal review the company decided to code the event of ''erythema'' which was mentioned in the narrative by the Health Authorities but not coded. The health Authorities have assessed the casual relationship between the adverse events and the suspect vaccines, PNEUMOVAX and Pasteur Influenza vaccine, as conditional. The contractual partner ROVI assessed, due to internal procedures, the causal relationship between the adverse event and PNEUMOVAX as related. Case reported as serious by the Health Authorities with "death" as criteria. No further information reported.


VAERS ID: 473512 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-31
Onset:2012-10-31
   Days after vaccination:0
Submitted: 2012-11-06
   Days after onset:6
Entered: 2012-11-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Breath sounds abnormal, Death, Feeling cold, Snoring
SMQs:, Acute central respiratory depression (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-31
   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:
Preexisting Conditions: Cardiovascular disorder NOS treated with drugs NOS; Pulmonary oedema twice 2 years prior to this report
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012273372

Write-up: This is a spontaneous report from a contactable pharmacist. The pharmacist reported that his 86-years-old uncle received a dose of PREVENAR 13 at 0.5 ml single dose intramuscularly and a dose of VAXIGRIP at 0.5 ml single dose intramuscularly, both on 31Oct2012 (noon). Medical history included ongoing cardiovascular disorder treated with not specified drugs and two episodes of pulmonary oedema two years prior to this report. In the evening of 31Oct2012 the patient started feeling cold and when he slept he started snoring. Then, he developed abnormal breath sounds and he expired on 31Oct2012. The cause of death was unknown as no autopsy was performed.


VAERS ID: 473523 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-19
Onset:2012-10-20
   Days after vaccination:1
Submitted: 2012-11-06
   Days after onset:17
Entered: 2012-11-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER V088A / 2 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR H1043 / 2 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 12C03A / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac murmur, Death, Pharyngeal erythema, Pyrexia, Sudden infant death syndrome, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had a history of fetal alcohol syndrome, ventricular septal defect, pulmonary artery stenosis congenital, upper respiratory tract inflammation, intellectual disability, hospitalization for fever of unknown origin and other diseases. Family history included his 35-year-old mother had mental illness (integration disorder syndrome) and was receiving outpatient treatment for alcohol dependency. On 15 August 2012, the patient received the initial vaccinations with ACTHIB, PREVENAR and DPT simultaneously at the hospital. On 21 September 2012, the patient received BCG at the hospital. The patient''s temperature before vaccination on 19 October 2012 was 37.1 degrees C.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201210274

Write-up: Initial report was received from a healthcare professional via the Health Authorities (HA#:HIB-445) on 26 October 2012. A six-month-old male patient with cardiac disease and other primary diseases had received a dose two injection of ACT-HIB, lot number H1043, PREVENAR, Pfizer, lot number 12C03A, and DPT, Takeda, lot number V088A on 19 October 2012 after 2:00 PM. The patient''s temperature before vaccination was 37.1 degrees C. On 20 October 2012 at 12:15 PM, the patient''s mother noticed he had a fever of 39.7 degrees C. At 1:08 PM, he visited the hospital. His temperature was 39.9 degrees C, general appearance and sucking were good, throat was slightly red and there were no abnormal breath sounds. A 3/6 degree systolic murmur was heard at the second intercostal space of the left sternal border. No abnormalities were found in the abdomen. There was no hepatic enlargement. Neck stiffness was not found. There was no abnormality in the eardrums. He looked well. For treatment, MUCODYNE Granules 0.8 g for 2 days and AMHIBA 100 mg were administered. As he remained febrile, the reporting physician told the mother to take the patient to the emergency hospital. On 21 October 2012, at around 1:00 AM, the mother found the patient unresponsive and made contact with the infant home. As instructed, she called for an ambulance. At 1:30 AM, the patient was confirmed to be dead at the hospital. The patient had a history of fetal alcohol syndrome, ventricular septal defect, pulmonary artery stenosis congenital, upper respiratory tract inflammation, intellectual disability, hospitalization for fever of unknown origin and other diseases. Family history included his 35-year-old mother had mental illness (integration disorder syndrome) and was receiving outpatient treatment for alcohol dependency. Birth weight was 2,526 g. They are family on welfare. He was once taken temporarily in the custody of an infant home. On 15 August 2012, the patient received the initial vaccinations with ACT-HIB (lot number unknown), PREVENAR and DPT simultaneously at the hospital. On 21 September 2012, the patient received BCG at the hospital. Physician''s comment: Possible other diseases: Upper respiratory inflammation, primary diseases (fetal alcohol syndrome, ventricular septal defect). Case worker''s comment: The mother is now in highly unstable state, and the case worker involved is unable to talk with her to get information on the situation when the baby died. I heard autopsy was carried out at the hospital in the afternoon on 22 October 2012, and that the patient died of sudden infant death. Currently, the examination of tissue is conducted, and it will take about a month until official diagnosis is made. The patient''s outcome was fatal. Documents held by sender: None.


VAERS ID: 473733 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-01-21
Onset:2012-07-06
   Days after vaccination:532
Submitted: 2012-11-09
   Days after onset:126
Entered: 2012-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bacterial test positive, Blood culture positive, Death, Sepsis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-07-09
   Days after onset: 3
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: Ezetimibe; Spironolactone
Current Illness: Hypertension; Diabetes mellitus; Cardiac disorder
Preexisting Conditions: Implantation defibrillator insertion; Angina pectoris
Allergies:
Diagnostic Lab Data: Blood culture, Positive
CDC Split Type: WAES1211AUS002658

Write-up: Information was obtained on a request by the Company from the agency(local reference # AUS/12/2343) via a Public Case Detail concerning an approximately 41 years old male patient with chronic cardiac disease, Diabetes Mellitus, and hypertension. The patient''s medical history included angina and defibrillator implant. On 20-OCT-2005, the patient was vaccinated with dose 1 PNEUMOVAX23 (lot # and route not reported). On 21-JAN-2011, the patient was vaccinated with dose 2 PNEUMOVAX23 (lot # and route not reported). Concomitant medications included ezetimibe (10 mg) and spironolactone (12.5 mg). On 06-JUL-2012, the patient developed septicaemia with blood culture positive serotype and died after. Vaccination failure was also reported. Patient was hospitalized for treatment(unspecified). The outcome of septicaemia with blood culture positive serotype was reported as fatal. The patient died on 09-JUL-2012 outcome was reported as unrelated to death. For investigation(FI)- long term severe pulmonary hypertension and congestive cardiac failure (CCF) with increasing bilateral pedal oedema, septic shock and cardiomyopathy. Patient was not complaint with medication. Septicaemia with blood culture positive serotype was possibly related to PNEUMOVAX23. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 473745 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-11-08
Entered: 2012-11-09
   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: Acute respiratory failure, Cardiac arrest, Cardiomegaly, Chest X-ray abnormal, Cough, Death, Dyspnoea, Endotracheal intubation, Full blood count, Haemoptysis, Headache, Hypotension, Infection, Influenza, Influenza like illness, Kidney infection, Lung infection, Lung infiltration, Pain, Pneumonia, Pyrexia, Resuscitation, Rhinitis, Septic shock, Severe acute respiratory syndrome, Tuberculosis, Urinary tract infection, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-09-23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient was pregnant, six months gestational age at time of adverse event, and had a history of hypertension in her last pregnancy. The patient was reported as had a full vaccination schedule for diphtheria and tetanus (dT) and influenza vaccines. History of adverse event to previous administration of vaccine or drug was reported as unknown. The patient''s family history was reported as unknown.
Allergies:
Diagnostic Lab Data: 23 September 2012, reported worsening of radiographic images (not specified).
CDC Split Type: 201210247

Write-up: Initial report was received from a healthcare professional via the local affiliate on 31 October 2012. Other adverse events, regarding the patient''s children, are reported in case numbers 2012-09098 and 2012-09099. A 22-year-old female patient received a dose of INFLUENZA VACCINE, manufacturer and lot number unknown, (route, site and side, dose in series not reported) on an unknown date and she died on 23 September 2012. The patient was pregnant, six months gestational age at time of adverse event, and had a history of hypertension in her last pregnancy. The patient was reported as had a full vaccination schedule for diphtheria and tetanus (dT) and influenza vaccines. History of adverse event to previous administration of vaccine or drug was reported as unknown. The patient''s family history was reported as unknown. Symptoms of suspect of influenza A/H1N1 and fever started on 18 September 2012. The patient was admitted to the hospital on 21 September 2012 at 18:00pm, presenting with moderate cough, generalized pain, mild dyspnea and headache. She was hospitalized and started to receive antibiotics. On the next morning, 22 September 2012, the patient presented with hemoptysis, fever, dyspnea and hypotension. A complete blood count (results not reported) and chest X-ray were performed, which revealed presence of cardiomegaly and bilateral pulmonary infiltrates. The patient continued treatment of antibiotics, intravenous hydration and oxygen and she was transferred to a contact isolation room. On 23 September 2012, her condition remained serious, with an increase of the leukocytes (11,600 to 30,300) and worsening of radiographic images. At the end of the day, the patient was intubated to receive ventilator support. She had three cardiac arrests. Resuscitation was performed, but with no success. Her death was confirmed on 23 September 2012 at 21:40pm, with a death diagnosis suggestive of Severe Acute Respiratory Syndrome. According to news lay media, a health care professional who evaluated the patient who was treated at the emergency room on Thursday, 20 September 2012 with virus "virose", informed that the patient was treated and released from care that day. On Friday, 21 September 2012, she returned to the emergency unit with a worse health condition and was hospitalized. According to the the family, the patient presented with symptoms of flu-like illness, including coryza, dry cough, fever and body aches, between Tuesday, 18 September 2012 and Wednesday 19 September 2012. The patient was admitted and started treatment of antibiotics. She presented with an infectious condition, which indicated a clinical investigation with radiologic and laboratory testing, which revealed some changes compatible with pneumonia and tuberculosis. With the results of the exams, associated with the clinical diagnosis, it was concluded that the patient started an asymptomatic urinary tract infection that had reached her kidneys. There was a spread of the infection that reached her lungs and caused pneumonia (onset reported as unknown month in 2012), and later she also developed symptoms of tuberculosis. The patient''s condition advanced very fast. On Sunday, 23 September 2012, the patient died at approximately 22:00pm. The death was caused by acute respiratory failure and septic shock secondary to a serious infection. No additional information was provided at the time of the report. The patient''s outcome was reported as fatal on 23 September 2012. Documents held by sender: none.


VAERS ID: 474106 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-24
Onset:2012-10-25
   Days after vaccination:1
Submitted: 2012-11-13
   Days after onset:19
Entered: 2012-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA744AA / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-25
   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: Alendronate sodium; Tramadol hydrochloride; Enalapril maleate; Furosemide; Potassium chloride; Metoprolol succinate
Current Illness: Chronic obstructive pulmonary disea; Lung transplant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0843273A

Write-up: This case was reported by a physician via a regulatory authority (DK-DKMA-EFO3607) and described the occurrence of sudden death in a 61-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included chronic obstructive pulmonary disease and lung transplant. Concurrent medications included Alendronate sodium, DOLOL, CORODIL, FURIX, KALEORID and SELO-ZOK. On 24 October 2012, the subject received an unspecified dose of FLUARIX (subcutaneous, administration site unknown). On 25 October 2012, 1 day after vaccination with FLUARIX, the subject suddenly died. The subject died on 25 October 2012 from sudden death. It was unknown whether an autopsy was performed.


VAERS ID: 474221 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-17
Onset:2012-10-17
   Days after vaccination:0
Submitted: 2012-11-14
   Days after onset:28
Entered: 2012-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 22349421A / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Death, Lipase normal, Nausea, Pancreatitis acute, Renal failure, Respiratory failure, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? Yes
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: Coronary heart disease; Obstructive airways disorder; Hypertensive heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lipase, 27.67 ukat/L
CDC Split Type: 2012033879

Write-up: This medically confirmed report from foreign health authority (initial receipt 05-Nov-2012) concerns a 77-year-old female patient, who had a medical history of coronary heart disease, hypertensive heart disease and obstructive airways disorder. On 17-Oct-2012, the patient received one separate dose of AFLURIA (batch no. 22349421A) intramuscular. In the evening after the vaccination the patient developed nausea and vomiting. On 18-Oct-2012 the patient was hospitalized and diagnosed with acute pancreatitis (no lithiasis, no alcohol addiction, lipase 27.67ukat/L). In the further course she developed kidney failure along with respiratory and cardiac insufficiency. On an unspecific date the patient died. An autopsy was not performed. Reporter''s comment: The physician considered the adverse events as serious and not assessable to AFLURIA vaccination. Cause of death is unknown.


VAERS ID: 474376 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-11-15
Entered: 2012-11-16
   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: Not reported
CDC Split Type: 201210421

Write-up: Initial report received on 06 November 2012 from a healthcare professional via the local affiliate, local reference number BR-BT2012-0445. A 4 year old male patient with unknown medical/family history died on an unknown date by influenza A/H1N1 after receiving 2 days prior a vaccination with Influenza vaccine (manufacturer name, lot number unknown). It was unknown if the patient had been hospitalized. The local affiliate has requested additional information. Outcome was fatal. The reporter for this case is the same as case 2012-07585 and 2012-07591, and 2012-08549. Documents held by sender: none.


VAERS ID: 474460 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-11-07
Onset:2012-11-08
   Days after vaccination:1
Submitted: 2012-11-16
   Days after onset:8
Entered: 2012-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA753AA / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Death
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-08
   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: Tamsulosin HCl; Amlodipine
Current Illness: Benign prostate hypertrophy; Bladder carcinoma; Hypertension
Preexisting Conditions: Surgery
Allergies:
Diagnostic Lab Data: Body temperature, 07Nov2012, 38deg.C
CDC Split Type: B0845289A

Write-up: This case was reported by a regulatory authority (# 181257) and described the occurrence of death due to unknown causes in a 79-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject''s medical history included surgery in 2012 for bladder cancer. Concurrent medical conditions included benign prostate hypertrophy (since 10 years), bladder carcinoma with internal stomy not treated with chemotherapy and hypertension (since 15 years). Concurrent medications included OMNIC and Amlodipine. On 7 November 2012, at 7.30 pm, the subject received an unspecified dose of FLUARIX (route unknown, left deltoid). At 8.30 pm, his body temperature was 38 deg.C. On 8 November 2012, 9 hours after vaccination with FLUARIX, the subject died due to unknown causes. The regulatory authority reported that the event was possibly related to vaccination with FLUARIX. The subject died on 8 November 2012 at 4.30 am, cause of death was not reported. It was unknown whether an autopsy was performed.


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