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VAERS ID: 474770 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-09-15
Onset:2012-10-01
   Days after vaccination:16
Submitted: 2012-11-19
   Days after onset:49
Entered: 2012-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cerebral infarction, Death
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-01
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1211JPN006975

Write-up: Information has been received from a physician concerning a patient in 80''s who on approximately 15-SEP-2012 was vaccinated with PNEUMOVAX injection, 0.5 ml, once a day. Information on concomitant medication was not provided. On approximately 01-OCT-2012, the patient developed cerebral infarction and death. Physician''s comment: Regarding the causal relationship with PNEUMOVAX, related data was checked because of uncertainty. Definite conclusion cannot be made if asked whether there was definitely no causality, however, it was judged that it appears to be no causal relationship if have to choose, as there was reportedly no such difference between PNEUMOVAX injected group and non-injected group. The reporting physician considered that the cerebral infarction was definitely not related to PNEUMOVAX. Upon internal review, the cerebral infarction was determined to be related to PNEUMOVAX. Additional information is not expected.


VAERS ID: 475081 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-29
Onset:2012-10-31
   Days after vaccination:2
Submitted: 2012-11-21
   Days after onset:21
Entered: 2012-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER 127002 / UNK LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012DE105853

Write-up: Case number PHHY2012DE105853 is an initial spontaneous report received from a physician on 19 Nov 2012 and includes telephone contact with reporting physician as well as Authorities on 19 Nov 2012: This case refers to an adult male patient. Vaccination history included of BEGRIPAL (batch number: not reported) on an unspecified date in the last year (2011) and was well tolerated. He had no findings regarding medical and family history. The patient was healthy, no evidence for an infection at the time when BEGRIPAL was applied. He was vaccinated with BEGRIPAL (batch number: 127002) at a dose of 0.5ml in the left upper arm on 29 Oct 2012 at 08:15 am. The application of BEGRIPAL initially was well tolerated without any evidence for adverse reactions. The patient left the physician''s cabinet by himself. The patient was found dead on 31 Oct 2012. The physician assumed that the subject had a cardiac arrest (however, the cause of death was not reported). No other information was available at the time of this report.


VAERS ID: 475079 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-06-01
Onset:0000-00-00
Submitted: 2012-11-21
Entered: 2012-11-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningococcal infection, Purpura fulminans
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-31
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: PHHY2012FR105871

Write-up: Case number PHHY2012FR105871 is an initial spontaneous report received from a physician on 16 Nov 2012: This report refers to a 23-year-old male patient. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: unknown) on an undetermined date in Jun 2012. After vaccination the patient died on 31 Oct 2012 from fulminans purpura which was secondary to invasive meningococcal infection due to serogroup W135. No further information was provided.


VAERS ID: 475457 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2011-05-20
Onset:2011-10-14
   Days after vaccination:147
Submitted: 2012-11-27
   Days after onset:410
Entered: 2012-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RA / UN
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Anomaly of external ear congenital, Biopsy, Death neonatal, Foetal exposure timing unspecified, Limb malformation, Multiple congenital abnormalities, Oligohydramnios, Premature baby, Skeletal dysplasia, Skin exfoliation, Skin oedema
SMQs:, Severe cutaneous adverse reactions (broad), Angioedema (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic acid; Iron salt; Indomethacin; Ampicillin trihydrate; Dinoprost trometamol; Intravenous fluids; Oxytocin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Biopsy, 17Oct2011, see lab text; Fetal heart rate, 13Oct2011, 161 per minute; Fetal heart rate, 13Oct2011, 151 per minute; Sonogram, 14Oct2011, see lab text 14 October 2011: She had a sonogram performed which showed: alive baby, dimorphic with the following findings: A) cephalic baby with a cephalic circumference that remembers the image of a strawberry, with a extremely thin bone table, with a mean gestational age of 26 weeks and with an important skin edema above the skull. At central nervous system as a single finding is observed a decreased differentiation of wrinkles. B) Heart exam: atrial rhythm 156 per minute (min), ventricular rhythm 143 min, arrhythmic, it seems to have a disorder due to an atrioventricular node block. Structurally is a heart of 4 chambers with AV and VA concordance, outflow tracts without obstructions and normal aortic arch are observed. C) seems to have a narrow chest with a circumpherence of 12 cm with levocardia. Diaphragm intact. No pleural or pericardic effusion. D) Important ascytic with intestine with echogenic internal areas, liver with echogenic areas or points, at the examination of the venous ductus is noted a "a" negative wave. Spinal cord closed without defects at lumbar or sacral levels. Kidneys of normal aspect. In upper as well as in lower limbs important macromelia. In distal as well as in proximal segments rizomelia and mesomelia. Is not possible the analysis of hands and face due to an important oligohydramnios. Diagnostic impression: 1) considering the findings of narrow chest and macromelia, with a convex forehead and a not oval skull the most probable diagnosis is a thanatophoric dysplasia, 2) severe oligohydramnios, 3) growth of 26 weeks by cephalic circumpherence, 4) abdominal circumpherence and longitudinal femoral are not valid. 17 October 2011: Biopsy 11-9099. Specimen: placental remains. Diagnosis: decidua. 17 October 2011: Biopsy 11-9134. Specimen: fetus. Diagnosis female fetus of approximately 21 weeks of gestational age, multiple external malformations, 400g, 26 cm, of macerated aspect, slough skin with low set ears, ogival palate, short limbs.
CDC Split Type: A0933003B

Write-up: This female subject was enrolled in the study sponsored by the National Cancer Institute (NCI). On 20 May 2011, the subject received the 1st dose of CERVARIX and ENGERIX B in her right deltoid. The serious adverse event described below was not experienced by a study subject but her offspring. The study subject or mother was exposed to CERVARIX and ENGERIX B before conception. The mother took concomitant medications iron, folic acid, PROSTIN, oxytocin, iron, indomethacin, IV fluids, folic acid and ampicillin during her pregnancy. The mother had the following relevant medical conditions: SAE of therapeutic miscarriage (see case A0933003A for more details). On 14 October 2011, five months after the mother (subject) took the 1st dose of CERVARIX and the 1st dose of ENGERIX B, the subject''s fetus was diagnosed with multiple congenital malformations. The event was a congenital anomaly, clinically significant (or requiring intervention) and resulted in a fatal outcome. Due to the multiple congenital anomalies elective termination of pregnancy was decided on 17 October 2011. The investigator reported the multiple congenital malformations as possibly related to CERVARIX and ENGERIX B given the short time that elapsed between the last done of the vaccine and the last menstrual period (LMP). Investigator comments: Last menstrual period (LMP): 23 May 2011, total of seven pregnancies, five deliveries and one previous miscarriage. The subject (mother) used oral contraception before becoming pregnant. She only attended one prenatal care appointment. On 16 November 2011, the subject reported by phone that on 14 October 2011 she was hospitalized due to threatened preterm delivery (see serious adverse event number 60411). On 17 October 2011, when she was 21 weeks of gestational age she had induced a vaginal delivery and she gave birth to a preterm female newborn, weight 400 grams, length 23.5 centimeters, Apgar score unknown, who died some minutes after delivery. The medical chart will be reviewed as soon as possible. Diagnosis: prematurity. Investigator comments received on 22 November 2012: To follow up the serious adverse event 60446, with diagnosis of prematurity, on 21 November 2012 the medical chart was reviewed in a local hospital and the following was found: 13 October 20121: Referred from a primary care center to the emergency room (ER): gestational age: 20 weeks, with history of abundant vaginal bleeding. Physical examination: Normal BP, without fever, pelvic exam: 1 cm of dilation, vaginal bleeding (negative), hydrorrhea (positive), fetal heart rate: 161 per minute (min), fetal movements (positive). Diagnostic impression: threatened miscarriage. At the ER: delayed miscarriage. Pelvic exam: 1 cm of dilation, mild vaginal bleeding, fetal heart rate: 151 min. Plan: admission, ward routine, Indomethacin. Diagnosis of admission: delayed threatened miscarriage. 14 October 2011: She had a sonogram performed which showed: alive baby, dimorphic with the following findings: A) cephalic baby with a cephalic circumference that remembers the image of a strawberry, with a extremely this bone table, with a mean gestational age of weeks and with an important skin edema above the skull. At central nervous system as a single finding is observed a decreased differentiation of wrinkles. B) Heart exam: atrial rhythm 156 min, ventricular rhythm 143 min, arrhythmic, it seems to have a disorder due to an atrioventricular node block. Structurally is a heart of 4 chambers with AV and VA concordance, outflow tracts without obstructions and normal aortic arch are observed. C) seems to have a narrow chest with a circumference of 12 cm with levocardia. Diaphragm intact. No pleural or pericardic effusion. D) Important ascytis with intestine with echogenic internal areas, liver with echogenic areas or points, at the examination of the venous ductus is noted "a" negative wave. Spinal cord closed without defects at lumbar or sacral levels. Kidneys of normal aspect. In upper as well as in lower limbs important macromelia. In distal as well as in proximal segments rizomelia and mesomelia. Is not possible the analysis of hands and face due to an important oligohydramnios. Diagnostic impression: 1) considering the findings of narrow chest and macromelia, with a convex forehead and a not oval skull the most probable diagnosis is a thanatophoric dysplasia, 2) severe oligohydramnios, 3) growth of 26 weeks by cephalic circumference, 4) abdominal circumference and longitudinal femoral are not valid. Plan: the progress is explained to the patient, sterile clothe, lab tests. 15 October 2011: Is indicated: temperature measurement curve, ampicillin. 16 October 2011: Informed consent for therapeutic miscarriage is completed. Plan: PROSTIN gel, IV solution and oxytocin. 17 October 2011: She underwent dilation and curettage and biopsy. Pre and post surgical diagnosis: incomplete miscarriage. Plan: post surgical protocol, diclofenac, cephalothin, ampicillin, schedule for bilateral tubal occlusion by request of the patient, transfuse PRBC. On 18 October 2011, 19 October 2011 and 20 October 2011 hospitalized due to bilateral tubal occlusion. Diagnosis of discharge: delayed miscarriage, multiple fetal malformations, premature rupture of membranes, satisfied parity. Diagnosis: female fetus of approximately 21 weeks of gestational age, multiple external malformations, 400 grams (g), 26 centimeters (cm), of macerated aspect, slough skin with low set ears, ogival palate, short limbs. Given the information obtained the onset date and the diagnosis change. Considering that the diagnosis of the event changes to multiple malformations in the participant''s daughter and given the short time elapsed between the vaccination and the LMP we decided to change the relation with the vaccine as "possibly related". Diagnosis: multiple congenital multiple malformations in the participant''s daughter.


VAERS ID: 475412 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-11-15
Onset:2012-11-16
   Days after vaccination:1
Submitted: 2012-11-28
   Days after onset:12
Entered: 2012-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER J8336 / UNK UN / ID
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. G009997 / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-20
   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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1211ITA010964

Write-up: Case received from Health Authority (case n. 182595) through agency (local case n. IT614/12). Initial report received on 21-NOV-12. Case medically confirmed. An 87 year old male patient was vaccinated on 15-NOV-12 with one dose of INTANZA (batch n. J8336-1) i.d. and concomitantly with one dose of PNEUMOVAX (batch n. G009997) s.c.. On 16-NOV-12 he presented with febrile increase treated with TACHIPIRINA. On 17-NOV-12 and 18-NOV-12, the patient was afebrile. On 19-NOV-12 in the afternoon, there was a febrile increase with productive cough. He was treated with TACHIPIRINA and ceftriaxone i.m. On 20-NOV-12 at 6:15 am the patient died. The case is closed.


VAERS ID: 476070 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-11-29
Entered: 2012-12-03
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012295114

Write-up: This is a spontaneous report from a contactable physician. A 2-months-old patient received a dose of PREVENAR 13, via an unspecified route of administration on an unspecified date. The patient also received concomitantly rotavirus vaccine; and, diphtheria toxoid, haemophilus influenzae type b polysaccharide, pertussis vaccine, tetanus toxoid vaccine. Patient''s medical history was not reported. Two days after vaccinations, the patient died. At the time of reporting, the cause of death was unknown.


VAERS ID: 476286 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-03
Onset:2012-11-11
   Days after vaccination:39
Submitted: 2012-12-04
   Days after onset:23
Entered: 2012-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, General physical health deterioration, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012TW110879

Write-up: Case number PHHY2012TW110879, is an initial spontaneous report received from the consumer via press on 19 Nov 2012: This report refers to a 78-year old male patient. The patient had history of diabetes mellitus. The patient had vaccination (brand name and manufacturer unknown) two years ago and had no adverse event afterward. On 03 Oct 2012, he was vaccinated with seasonal influenza vaccine (batch number and manufacturer: unknown). On the same day, the patient experienced leg weakness. In the end of Oct 2012, the patient''s health condition deteriorated and was hospitalized. The patient died on 11 Nov 2012. The cause of death was not reported. The case is now under investigation of CDC (Centers of Disease Control). The causality of the events was not reported.


VAERS ID: 476406 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-03
Entered: 2012-12-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK AR / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Altered state of consciousness, Autopsy, Biopsy brain abnormal, Body temperature increased, Cardiac arrest, Coma scale normal, Dyspnoea, Endotracheal intubation, Rabies, Salivary hypersecretion, Suture insertion, Wound treatment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: 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:
Preexisting Conditions: Personal and family medical history: not reported.
Allergies:
Diagnostic Lab Data: On an unspecified date the patient presented oral temperature of 38.5 degrees Celsius and Glasgow Coma Scale score of 13.
CDC Split Type: 201211174

Write-up: Initial report collected from the literature in 22 November 2012. The following is the verbatim from the article: "A 60-year-old man was brought to the emergency department with facial injuries caused by a wolf attack as he was sitting in his garden. When the history of the case was taken, it was established that the wolf had bitten the patient''s face and that he had strangled it to death. On arrival he was conscious, oriented, and cooperative, and his vital findings were stable. Physical examination revealed an oblique laceration of the face, approximately 5 cm in length, full-thickness as far as the mucosa, starting from the right oral commissure and extending laterally, and with irregular edges. There was a 0.5-cm vermillion defect at the right lateral commissure and a 1-cm skin cut at the left lateral commissure. The facial artery was exposed, and was thrombosed proximally. Facial nerve and sensation examination was normal. The patient was administered tetanus vaccine, tetanus immunoglobulin, human diploid cell vaccine: HDCV 1.0 mL to the deltoid area, and human rabies immunoglobulin: HRIG 20 IU/kg around the wounds 2 hours after the attack. The lacerations were irrigated with saline and povidone-iodine solution for 15 minutes and sutured with the application of rabies immunoglobulin to the wound edges. The patient was given oral antibiotics (amoxicillin-clavulanate) and discharged. Vaccinations were performed for days 3 and 7 after discharge. Examination of the dead wolf''s brain tissue revealed Negri bodies. The patient''s vaccination program was continued. The patient was again vaccinated on day 14, but was brought back to the emergency department on day 25 with blurred consciousness. He had a Glasgow Coma Scale score (E3V4M6) of 13 and an oral temperature 38.5 degrees C, as well as increased salivation. Rabies was suspected. Respiratory difficulty developed 24 hours later. Endotracheal intubation was performed, and cardiac arrest occurred 4 hours later. Rabies was confirmed with autopsy and brain biopsy."


VAERS ID: 476682 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-06
Entered: 2012-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Aspiration tracheal, Death, Haemolytic uraemic syndrome, Human metapneumovirus test positive, Intensive care, Mycoplasma test positive, Pneumonia pneumococcal, Polymerase chain reaction, Septic shock
SMQs:, Haemolytic disorders (narrow), Toxic-septic shock conditions (narrow), Renovascular disorders (broad), Chronic kidney disease (broad), Infective pneumonia (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? No
Previous Vaccinations:
Other Medications: No other
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Mycoplasma pneumoniae and metapneumovirus were simultaneously detected by PCR in the nasopharyngeal and tracheal aspirates. Polymerase chain reaction, see relevant result
CDC Split Type: WAES1212HKG000581

Write-up: This literature marketed report refers to a young girl who died of Streptococcus pneumoniae 19A pneumonia, septic shock, and hemolytic uremic syndrome despite prior pneumococcal vaccination (manufacture unknown), appropriate antibiotics, and aggressive intensive care support. Serotype 19A was not covered by the 7- or 10-valent pneumococcal vaccines. Mycoplasma pneumoniae and metapneumovirus were simultaneously detected by PCR in the nasopharyngeal and tracheal aspirates. The pneumococcus was penicillin sensitive. Although infections with each of these pathogens alone were typically mild, this case highlighted that co-infection with the triple Han respiratory pathogens possibly contributed to the fatal outcome of this child. Additional information has been requested.


VAERS ID: 477609 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-11
Entered: 2012-12-11
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: WAES1212CAN002771

Write-up: This unconfirmed spontaneous report as received from a nurse, who obtained the information from the internet, refers to 47 patients of unknown age. The patients were vaccinated with GARDASIL on unknown dates. No other co-suspects and no concomitant medications were reported. The nurse mentioned 47 deaths as a result of patients getting GARDASIL. No treatment information was reported. The outcome of she mentioned 47 deaths as a result of patients getting GARDASIL was reported as fatal. No details for death are available. The relatedness for she mentioned 47 deaths as a result of patients getting GARDASIL is unknown for GARDASIL. Additional information is not expected.


VAERS ID: 477723 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2011-02-10
Onset:0000-00-00
Submitted: 2012-12-12
Entered: 2012-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212JPN003865

Write-up: Initial information has been received from a consumer or other non-health care professional concerning an elderly female patient who on 27-JAN-2011 and 10-FEB-2011, was vaccinated with PNEUMOVAX 23 NP injection (dose and indication was not reported). Information on concomitant medication was not provided. 27-JAN-2011, the patient was vaccinated with PNEUMOVAX 23 NP, 10-FEB-2011, the patient was vaccinated with PNEUMOVAX 23 NP by mistake. On an unspecified date, the patient''s condition got worse and the patient died. The reporter considered that the patient''s condition got worse and the patient died was serious due to death. The reporter did not judge the relationship between the patient''s condition got worse and the patient died and PNEUMOVAX 23 NP. Additional information has been requested.


VAERS ID: 477911 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-12
Entered: 2012-12-13
   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: Influenza, Influenza A virus test positive, Polymerase chain reaction
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Risk factors included the "presence of specific comorbidities (heart disease, lung disease, kidney disease, hemoglobinopathy, immunsuppression, diabetes, obesity, puerperium and smoking.)", and "specific symptoms (dyspnea, diarrhea, vomiting, chest pain, hemoptysis, pneumonia, and wheezing)".
Allergies:
Diagnostic Lab Data: The patients were diagnosed with influenza A/H1N1, with an exam performed by reverse transcription and PCR.
CDC Split Type: 201211651

Write-up: This case was received via a search of the scientific literature in a foreign country via local affiliate on 03 December 2012. The case is invalid, no patient identifiers. A cluster of 131 unknown patients received INFLUENZA VACCINE, manufacturer unknown, (lot number, route, site, side, dose in series reported as unknown) on unknown dates of administration and were diagnosed with influenza A/H1N1 with an exam performed by reverse transcription and polymerase chain reaction (PCR). Of these patients, seven died and 39 required hospitalization. No information was available on patients'' vaccination, only that patient had been vaccinated against influenza on an unknown date. Past medical history and treatments were reported as unknown. There was no information available about the patients and no additional information was provided. The patient''s outcome were reported as unknown, seven of which were fatal. The following is verbatim from the aforementioned article: Abstract "Objective: To evaluate pandemic influenza A (H1N1) 2009 in hospitalized patients in order to identify risk factors for hospitalization and, consequently, for the worsening of the disease. Methods: This retrospective observational study was conducted between March and December of 2010. The data were collected from the Ministry of Health National Case Registry Database. We included only patients (inpatients and outpatients) in whom H1N1 infection was confirmed (via laboratory testing) during the study period. The variables regarding demographic and clinical characteristics were statistically evaluated in order to compare the hospitalization rates in the presence or absence of these factors. Risk factors were identified by logistic regression analysis. Results: We included 4,740 patient with laboratory confirmation of H1N1 infection. Of these, 1,911 individuals were hospitalized, and 258 (13.5%) died. The risk factors for hospitalization were age (20-29 years), presence of specific comorbidities (heart disease, lung disease, kidney disease, hemoglobinopathy, immunosuppression, diabetes, obesity, puerperium, and smoking), a high number of comorbidities, and specific symptoms (dyspnea, diarrhea, vomiting, chest pain, hemoptysis, pneumonia, and wheezing). Higher levels of education and early use of oseltamivir were found to be protective factors. Hospitalization contributed to an increase in survival. Conclusions: Knowledge of the epidemiological characteristics that can be associated with hospitalization, disease severity, and mortality can be helpful in the adoption of preventive measures, as well as in the early diagnosis and treatment of disease, which might contribute to the reduction in the numbers of hospitalizations and deaths." Documents held by sender: None.


VAERS ID: 478117 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-14
Entered: 2012-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Areflexia, Autopsy, Bacterial test positive, Biopsy skin abnormal, Brain death, CSF glucose, CSF protein, CSF virus no organisms observed, CSF white blood cell count negative, Central nervous system inflammation, Coma, Condition aggravated, Conjunctival hyperaemia, Death, Decerebration, Echocardiogram abnormal, Encephalitis viral, Erythema multiforme, Gasping syndrome, Haemodynamic instability, Hyperaemia, Hypotonia, Immunoglobulin therapy, Immunology test abnormal, Kawasaki's disease, Keratitis, Laryngospasm, Lip swelling, Lyssavirus test positive, Mydriasis, Myocarditis, Neurological decompensation, Nuclear magnetic resonance imaging brain normal, Oropharyngeal spasm, Polymerase chain reaction, Posture abnormal, Priapism, Pupil fixed, Pyrexia, Rabies, Rash, Rash maculo-papular, Red blood cell sedimentation rate normal, Saliva analysis abnormal, Skin fissures, Somatosensory evoked potentials abnormal, Tremor, Viral test positive, White blood cell count normal
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Corneal disorders (narrow), Vasculitis (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Neonatal disorders (narrow), Skin tumours of unspecified malignancy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Rabies immune globulin, human; Acyclovir
Current Illness: Animal bite; Pain; Pyrexia; Hypoaesthesia; Insomnia; Erythema; Tremor, The next day, the child presented for medical assessment and was hospitalized; Exhibited bilateral arm-beating tremors with choreiform severe tremor and myoclonus of the face and all extremities; Oropharyngeal pain; Dysphagia; Pruritus; Myoclonus; Electroencephalogram, At that time, an electroencephalogram revealed a diffuse slowing of cerebral activity with rapid dysrhythmia but no epileptic activity; Arrhythmia; Hydrophobia; Rash macular; Agitation; Hallucination, visual; Priaprism; Drooling; Oropharyngeal spasm; Asphyxia; Wound
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy, Abnormal, Significant, The principal findings on autopsy revealed subacute encephalomyelitis with numerous Negri bodies found principally in the hippocampus, thalamus and brain stem; subacute, multifocal inflammation of the dorsal root ganglia of the spinal cord and of the autonomous ganglionic ramifications related to the myocardium, epicardium, esophagus gut, adrenal gland and retroperitoneum; and subacute myocarditis without coronary aneurysm; Biopsy skin, Abnormal, Significant, A non-purpuric maculopapular rash appeared over the face, neck and upper torso, and was confirmed by skin biopsy to be erythema multiforme; Echocardiogram, Abnormal, Significant, A possible right coronary aneurysm was identified by echocardiography; Immunology test, Abnormal, Significant, The skin biopsy was positive for rabies virus antigen by direct fluorescent antibody test; Visual evoked potentials, Abnormal, Significant, Revealed abnormal conduction in the left suprabulbar tract
CDC Split Type: PHHY2012CA113161

Write-up: Case number PHHY2012CA113161 is an initial literature report received on 31 Oct 2012: In this article the authors have presented a case of a nine-year-old boy who died from rabies encephalitis caused by a rabies virus variant associated with insectivorous bats. In late Sep 2000, a nine-year-old boy with no significant past medical history was bitten by a bat and complained of pain over the upper third of his left arm, associated with a fever of 38.2 degree Celsius. His pain was associated with numbness and progressed over the subsequent three days, radiating to the left wrist, left shoulder and lateral aspect of his neck. The pain was worse on palpation, with active movement and at night, causing insomnia. Three days after this event, the patient had showed his mother a small erythematous lesion on his left upper arm with a linear aspect at its center. Four days after the onset of symptoms, the patient developed uncontrolled tremors of his left arm, increasing with voluntary movements and stress. The next day, the child presented for medical assessment and was hospitalized. While his pain remained localized over the left arm, the tremor progressed to the right arm in the next 12 hours. He also started complaining of a sore throat and difficulty swallowing cold liquids. The subsequent night was complicated by an intense pruritus over the scalp, neck and torso, with minimal response to diphenhydramine. On day one after admission, still conscious and oriented, he exhibited bilateral arm-beating tremors with choreiform and myoclonic movements of the fingers, toes and calves. Deep tendon reflexes were symmetrical, and strength and sensory examinations were normal. At that time, an electroencephalogram revealed a diffuse slowing of cerebral activity with rapid dysrhythmia but no epileptic activity. An electromyogram of the left deltoid muscle and computed tomography of the head were normal. Later that day, the patient developed hydrophobia and aerophobia, and he became dysarthric. An evanescent macular rash was noted over the posterior aspect of the neck and back, associated with intense pruritis. He became agitated and experienced transient visual hallucinations. He had significant difficulty drinking but was still able to swallow his saliva. The following day, the patient developed severe tremor and myoclonus of the face and all extremities, priapism, drooling, pharyngeal spasm, and a feeling of suffocation. He was intubated, heavily sedated and transferred to a tertiary care facility with a presumptive diagnosis of rabies. Procedures to confirm diagnosis were undertaken, and he was vaccinated with a rabies virus vaccine (manufacturer and batch number: unknown, therefore conservatively taken as RABAVERT along with human rabies immune globulin and acyclovir on an undetermined date. He was given rabies immune globulin and rabies vaccine on the day that the diagnosis was suspected; an attempt at rabies post-exposure prophylaxis (RPEP) was considered worthwhile because the rarity of adverse effects associated with this treatment far outweighed the very poor prognosis associated with the disease. A few hours after RPEP administration, he developed a high fever, a bilateral nonexudative conjunctival hyperemia, swollen and fissured lips, and a polymorphous exanthem; moreover, a right coronary aneurysm was suspected on echocardiography. These clinical signs were considered suggestive of atypical Kawasaki disease, and consecutively, nonspecific immune globulins were administered. During the following 24 hours, extreme agitation and constant tremors required aggressive analgesia and sedation. On day three, high fever, intense keratoconjunctivitis and swollen "hyperemic lips" were noted; these signs remained present for the next six days. A non-purpuric maculopapular rash appeared over the face, neck and upper torso, and was confirmed by skin biopsy to be erythema multiforme. A possible right coronary aneurysm was identified by echocardiography, and the patient received intravenous immunoglobulin infusion for a Kawasaki-like syndrome. Over the ensuing two days, his neurological status progressively deteriorated. On day five, he developed decerebrate posturing as well as a marked pharyngolaryngeal spasm. The following day, his pupils became dilated and unequal, and he presented transient hemodynamic instability. On day seven, his pupils became fixed and dilated, priapism disappeared and gasping movements were noted. Sedation was gradually decreased as the patient lost bulbar reflexes and progressed to a profound flaccid coma. Evoked potentials revealed abnormal conduction in the left suprabulbar tract. On day nine, 14 days after the onset of his initial symptoms, the patient presented a clinical picture compatible with brain death, was extubated and died. A nuchal skin biopsy, cerebrospinal fluid (CSF), saliva and tears were sent to a Research Institute. The skin biopsy was positive for rabies virus antigen by direct fluorescent antibody test. All samples, except CSF, were positive for rabies virus by reverse-transcriptase polymerase chain reaction (RT-PCR) assay. Molecular analysis of rabies virus isolated from saliva revealed infection by a variant associated with silver-haired and eastern pipistrelle bats. Rabies virus grew from the saliva but not from the other samples. Immunofluorescence testing did not reveal rabies antigen on corneal impression smears, and rabies serology, sent to a Public Health Laboratory was negative. Cerebral magnetic resonance imaging revealed no abnormality. White blood cell count on admission was 6.7x10^9/L with a sedimentation rate of 4 mm/h; CSF white blood cell count was 5x10^6/L, CSF protein level was 0.56 g/L and CSF glucose concentration was 4.5 mmol/L. The principal findings on autopsy revealed subacute encephalomyelitis with numerous Negri bodies found principally in the hippocampus, thalamus and brain stem; subacute, multifocal inflammation of the dorsal root ganglia of the spinal cord and of the autonomous ganglionic ramifications related to the myocardium, epicardium, esophagus gut, adrenal gland and retroperitoneum; and subacute myocarditis without coronary aneurysm. A biopsy confirmed that the skin lesions were compatible with erythema multiforme, but no coronary aneurysm was found at autopsy. Although no diagnostic certainty was possible in this patient, several potential explanations for the rash were considered. The diagnosis was made seven days after the start of symptoms. While it was deemed possible that such a reaction could be drug-associated, this patient received neither antibiotics nor anticonvulsants, which might be associated with erythema multiforme and certain clinical features of Kawasaki disease. Furthermore, acyclovir, which this patient did receive, was not reported to cause such skin lesions. Secondly, infectious etiologies were considered. Numerous viral infections including herpes simplex and Epstein-Barr virus were known triggers of erythema multiforme. In addition, adenovirus, enterovirus and measles infections were known causes of Kawasaki-like syndrome and streptococcal and staphylococcal toxin-mediated illness could induce similar skin reactions. In this patient, viral and bacterial cultures were positive only for rabies virus, and the authors could find no case report associating rabies virus with erythema multiforme or Kawasaki-like disease. Finally, it remained possible that these lesions were secondary to a systemic reaction to RPEP.


VAERS ID: 478227 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-11-25
Onset:2012-12-01
   Days after vaccination:6
Submitted: 2012-12-17
   Days after onset:16
Entered: 2012-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Oedema peripheral, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-17
   Days after onset: 16
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: WAES1212NPL005349

Write-up: This spontaneous report as received from a physician via a business partner refers to a female patient of unknown age. The patient was vaccinated with the second dose of GARDASIL (lot number, dose, route, and strength were not reported). on 25-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. Following the vaccination on that evening, on 25-NOV-2012, the patient had little bit of swollen hand. She did not come to her class the next day, but a day after that, she had been moving around and attending her classes. But on 29-NOV-2012, her body was swollen and she died on 01-DEC-2012. The outcome of swollen hand and swollen body was unknown. The patient''s death was confirmed, her parents did not file any complain and the physician was told that it was not in relation with the vaccine administration. Based on the written field report the physician got from the local program coordinator, the death was not caused by vaccination. Additional information is not expected.


VAERS ID: 478756 (history)  
Form: Version 1.0  
Age: 0.39  
Sex: Female  
Location: Foreign  
Vaccinated:2012-11-30
Onset:0000-00-00
Submitted: 2012-12-18
Entered: 2012-12-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR H1232 / 1 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Computerised tomogram abnormal, Death, Pneumonia, Productive cough, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-02
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Body weight at birth 3674 g; Did the child have any abnormal findings at delivery?/No; Did the child have any abnormal findings after birth?/No; Has the child ever been indicated to have an abnormality in a medical checkup for infants?/No; Is there anything wrong with your child today?/No; Has your child been ill in the past 1 month?/Yes Name of disease: common cold was diagnosed on 04 October 2012 and the patient was treated; Was there any family member or friend of the child who had a disease, including measles (rubeola), rubella, varicella (chickenpox), and mumps, within the past 1 month?/No; Was there any family member or friend of the child who had a tuberculosis?/No; Was your child vaccinated in the past 1 month?/No; How many times has your child ever vaccinated? DPT: 0, Polio: 0; Has the child ever contracted a special disease (congenital abnormality, heart disease, renal disease, liver disease, neurologic disease, immunodeficiency, and other disease) from birth to now? And is your child attended by a physician?/No; Has the child ever had a seizure (convulsion)?/No; Has the child ever experienced rash or urticaria on the skin, or become ill as a reaction to medications or food?/No; Is there any close relative who was diagnosed with congenital immunodeficiency?/No; Has the child ever had serious reaction to a vaccine in the past?/No; Is there any close relative who had serious reaction to a vaccine in the past?/No; Has the child received blood transfusion or the injection of gamma globulin in the past 6 months?/No; Do you have any question about the vaccination of today?/No
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201211845

Write-up: Case received from the Health Authorities on 07 December 2012 under the reference number HIB-463. A 04-month-old female patient, with no concomitant therapies, had received her 1st primary dose of ACTHIB (batch number H1232) subcutaneously in her right upper arm on 30 November 2012 in the afternoon at the hospital. On 04 October 2012, the patient had been diagnosed with common cold and had been treated. On 16 November 2012, she had received DPT-IPV vaccination and had no abnormalities. The patient''s body temperature before the vaccination (DPT-IPV) was 36.6 degrees C. The patient''s body weight at birth was 3674 g. The patient did not have any abnormal findings at delivery or any abnormal findings after birth. She has never been indicated to have an abnormality in a medical checkup for infants. There was anything wrong with the patient at the time of reporting. There wasn''t any family member or friend of the patient who had a disease, including measles (rubeola), rubella, varicella (chickenpox), and mumps, within the past 1 month. There wasn''t any family member or friend of the patient who had tuberculosis. The patient was not vaccinated in the past 1 month. The patient has never been vaccinated with DPT or Polio vaccine. The patient has never contracted a special disease (congenital abnormality, heart disease, renal disease, liver disease, neurologic disease, immunodeficiency, and other disease) from birth to now. She has never had a seizure (convulsion) or experienced rash or urticaria on the skin, or become ill as a reaction to medications or food. There wasn''t any close relative who was diagnosed with congenital immunodeficiency. The patient has never had serious reaction to a vaccine in the past. There wasn''t any close relative who had serious reaction to a vaccine in the past. The patient did not receive blood transfusion or the injection of gamma globulin in the past 6 months. On 30 November 2012, the patient''s body temperature was 36.8 degrees C. She experienced sputum. No abnormal findings were observed (no rales). On 01 December 2012, it seemed the patient had no abnormalities (the reporter had not been informed directly of details). The physician who treated the patient on 02 December 2012 described as follows. On 02 December 2012, around 8:00 a.m., the patient was found in cardio-respiratory arrest in the supine position by her mother. Resuscitation by ambulance crew was of no avail. Around 9:30 a.m., the patient was transported to the nearby hospital. 10:18 a.m., the death was confirmed. CT scan revealed pneumonia. The cause of death was confirmed as pneumonia. The reporting physician''s comment: Causality between the event and the vaccinations was not assessable.


VAERS ID: 478907 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-11-09
Submitted: 2012-12-20
   Days after onset:41
Entered: 2012-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Foetal exposure during pregnancy, Hypoxia, Premature baby, Stillbirth, Trisomy 21
SMQs:, Asthma/bronchospasm (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHFR2012GB006492

Write-up: Case number PHFR2012GB006492, is an initial spontaneous report received from a consumer (patient''s father) via health authority (GB-MHRA-ADR 21929657-003) on 17 Dec 2012. This report refers to a stillbirth neonate. The baby''s mother had 4 prior pregnancies resulted in live births with no history of miscarriage or stillbirths in the family. Her pregnancy was normal all the way through, blood pressure and pulse was normal. The baby''s mother was vaccinated with Influenza vaccine (unknown manufacturer and batch number) parenteral and REPEVAX (batch number: unknown) on 01 Nov 2012. The mother had midwife appointment 3 days before vaccination, when the examinations done revealed normal baby movements and strong heartbeat. The mother''s blood pressure and pulse were also normal. The mother was advised by the mid-wife to receive whooping cough vaccination to protect unborn child and was advised that it was safe. Two days later, the mother received vaccination. After vaccination, things started to slow down and 5 days after the vaccinations baby''s movements stopped and the mother lost slight blood (See case: PHFR2012GB006478). On 06 Nov 2012, mother also noticed a decrease in baby''s movements. Over the next days, the baby''s movements had completely stopped but the mother was able to get a midwife appointment only three days later. At the midwife appointment, it was found that the baby had died. On 09 Nov 2012, the mother delivered a still born baby; he measured 47 cm and weighed 3.1 kg for the age 36.5 weeks. The reporter was in strong belief that the whooping cough vaccination caused the death of the child. The baby''s father had contacted the manufacturers of the vaccine to confirm that no clinical tests were carried out on pregnant women and was of opinion that he would not have allowed the vaccination if he had read the leaflet. He added that this was his wife''s fifth pregnancy, all 4 prior resulted in live births, there was no history of miscarriages or stillbirths in the family, and the only thing that has changed with all 5 pregnancies is the whooping cough vaccination. Post-mortem was not done, but the parents agreed for blood tests, testing on cord, placenta and also tissue. The test results revealed Down syndrome, but the parents believed very slightly as there were no visible signs, and added this as put "out of the blue since there was nothing in their blood that could cause a risk to this and that the placenta was in perfect condition and working order". The cause of death was reported as hypoxia. The parents were of belief that Down syndrome was not the cause of death.


VAERS ID: 479048 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-20
Entered: 2012-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS YHIBC593B / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-11
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: B0853253A

Write-up: This case was reported by a physician via a Sales Representative and described the occurrence of unknown cause of death in a 4-month-old male subject who was vaccinated with HIBERIX (GlaxoSmithKline). On 9 December 2012, the subject received an unspecified dose of HIBERIX (administration site and route unknown). On 11 December 2101, 2 days after vaccination with HIBERIX, the subject died. The subject died on 11 December 2012, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 479096 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-25
Onset:2012-10-27
   Days after vaccination:2
Submitted: 2012-12-21
   Days after onset:55
Entered: 2012-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA759A / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F33615 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Muscle rigidity, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0854222A

Write-up: This case was reported by another health professional via a regulatory authority (# NO-NOMAADVRE-FHI-2012-15225) and described the occurrence of sudden infant death in a 3-month-old male subject who was vaccinated with INFANRIX-POLIO-HIB (GlaxoSmithKline) and (non-gsk) PREVENAR 13. On 25 October 2012, the subject received 1st dose of INFANRIX-POLIO-HIB (parenteral, administration site unknown) and 1st dose of PREVENAR 13 (parenteral, unknown). On 27 October 2012, 2 days after vaccination with INFANRIX-POLIO-HIB and PREVENAR 13, the subject was found dead in his bed. Rigor mortis was present. The regulatory authority reported that the event was possibly related to vaccination with INFANRIX-POLIO-HIB and PREVENAR 13. The subject died on 27 October 2012 from sudden infant death. An autopsy was performed. Further information has been expected included autopsy report.


VAERS ID: 479323 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-26
Entered: 2012-12-26
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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212GBR009750

Write-up: This invalid case (multiple unknown patients) a hearsay report was received from a consumer on 12-DEC-2012. This case is not medically confirmed. Up to 200 girls received injections of GARDASIL (batch number not reported), route and site not reported, on an unreported date. The reporter stated that the girls were killed outright and that tens of thousands of others were injured. The outcome of the injured girls was not reported.


VAERS ID: 479866 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-17
Onset:2012-12-18
   Days after vaccination:1
Submitted: 2012-12-27
   Days after onset:9
Entered: 2012-12-31
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR H1024 / 3 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Death, Peripheral coldness, Respiratory arrest, Resuscitation, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-18
   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 (2450g), premature baby (36weeks); Family history not reported; The patient had developed pyrexia over 39 degrees C lasted 1 day on 18 October 2012 after receiving his 1st primary dose of ACTHIB (batch number not reported) on the same day (case 2012-12400). On 26 October 2012, the patient had received his 1st dose of PREVENAR, without abnormalities. On 15 November 2012, the patient had his 2nd dose of ACTHIB (batch number not reported), without abnormalities.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201212386

Write-up: Case received from a Healthcare Professional on 18 December 2012 then follow-up information received from the Health Authorities (reference number HIB-467) on 19 and 20 December 2012 though the local affiliate. This case is linked with case 2012-12400. A 04-month-old male patient, with a medical history of prematurity (36 weeks) and low birth weight at 2450g, had received his 3rd primary dose of ACTHIB (batch number H1024) subcutaneously in the right arm on 17 December 2012 in hospital. The body temperature before the vaccination was 36.6 degrees C. The patient had developed pyrexia over 39 degrees C lasted 1 day on 18 October 2012 after receiving his 1st primary dose of ACTHIB (batch number not reported) on the same day. On 26 October 2012, the patient had received his 1st dose of PREVENAR (other manufacturer), without abnormalities. On 15 November 2012, the patient had received his 2nd dose of ACTHIB (batch number not reported), without abnormalities. On 27 November 2012, the patient had received his 2nd dose of PREVENAR, without abnormalities. The patient had no abnormalities before the vaccination and 30 minutes after the vaccination. After vaccination, the patient went home. There was no abnormalities for the patient until the night of 17 December 2012. On 18 December 2012, at 1:00 the patient drank milk (180cc). At around 6:00 the patient was found not breathing. An ambulance was requested. The patient was taken to the reporting physician''s hospital. At around 06:30, on arrival, the patient was in cardio-respiratory arrest condition. The patient'' body had already been cold. The cardiopulmonary resuscitation was conducted for about one hour but the patient did not respond. At 07:37 the death was confirmed. The reporting physician''s comment: "Causality was unknown." The comment of the physician who vaccinated with ACTHIB to the patient" "Causality was unknown. Although it was considered the possibility of the relationship with ACTHIB was low, I would like to request a specialist''s judgment because the the death was confirmed within 24 hours after the vaccination." The reporting physician asked to perform an autopsy but it was refused.


VAERS ID: 480127 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-31
Entered: 2013-01-03
   Days after submission:3
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: Anaemia, Anaemia haemolytic autoimmune, Aspiration, Blood bilirubin increased, Blood lactate dehydrogenase increased, Cardiogenic shock, Coombs direct test positive, Death, Decreased activity, Exchange blood transfusion, Growth retardation, Haematocrit decreased, Haemoglobin decreased, Haemolysis, Haptoglobin normal, Immunoglobulin therapy, Injury, Jaundice, Laboratory test abnormal, Ocular icterus, Osteoporosis, Red blood cell count decreased, Respiratory failure, Resuscitation, Sepsis, Yellow skin
SMQs:, Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Haematopoietic erythropenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Conjunctival disorders (narrow), Osteoporosis/osteopenia (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood bilirubin, 9.1 mg/dl; Blood lactate dehydrogenase, 430 IU/l; Haematocrit, 12.6%; Haemoglobin, 7.8 g/dl; Haemoglobin, 4.3 g/dl; Haemoglobin, 1.6 g/dl; Haptoglobin, 18 mg/dl; Red blood cell count, 150 x 10 4/ ul; Direct Coombs test: positive (unknown date before admission), C3b3d (+) on admission.
CDC Split Type: 2012328882

Write-up: This is a literature report. A 3-month-old male patient received PREVENAR, subcutaneously on an unspecified date at a single dose, and ACT-HIB, subcutaneously on an unspecified date at a single dose. The patient medical history was not reported. It was reported that the patient had no prior infections. The patient''s concomitant medications were not reported. Approximately one month after the patient received the vaccinations, the patient was diagnosed with autoimmune hemolytic anemia (AIHA) based on examination results including hemoglobin of 7.8 g/dL and direct Coombs test positive and was hospitalized. Due to inactivity and progression of anemia and jaundice, the patient was referred to a different hospital. The patient had conjuntiva bulbi coloring yellow and skin coloring yellow. The liver of 1 cm and the spleen of 2 cm were felt in the hypochondrium. Laboratory tests performed on an unspecified date included: hemoglobin (Hb): 4.3 g/dL, red blood cell count (RBC): 1,500,000/micro liter, hematocrit (Ht): 12.6%, (total bilirubin (T-Bil): 9.1 mg/dL, lactate dehydrogenase (LDH): 430 IU/L, and haptoglobin: <18 mg/dL. Direct Coombs test positive [C3b3d (+)]. At the initial onset of the autoimmune hemolytic anemia, the patient received erythrocyte transfusion and oral administration of prednisolone (PSL). Due to rapid progression of hemolysis, the patient had HbHt of 1.6 g/dL and developed cardiogenic shock on Day 2. After resuscitation, the patient''s condition became less severe following methylprednisolone (mPSL) pulse, exchange transfusion, massive administration of gamma-globulin, and administration of PSL at 6 mg/kg/day and concomitant cyclosporine A (CyA). On Day 98, the transfusion was discontinued and the dose of PSL was decreased. At the time of the first exacerbation: The disease in the patient was exacerbated on Day 130. Due to severe hemolysis, exchange transfusion was performed 14 times in total. The hemolysis became less severe after administration of rituximab (once weekly; 6 doses in total), continuous intravenous infusion of CyA, and dose increase of PSL. On Day 196, the transfusion was discontinued and the dose of PSL could be decreased. At the time of the second exacerbation: The disease in the patient was exacerbated on Day 229. Exchange transfusion was performed 22 times in total. Around Day 289 , when hemolysis seemed to become less intense, respiratory failure started to progress rapidly. And then patient died on Day 291. Sepsis, organ damage associated with iron deposition, and aspiration were suspected. While pediatric AIHA is said to have relatively good prognosis, some cases become fulminant and refractory. Since this patient was highly steroid-dependent and developed impairment in growth and development and osteoporosis related to a long-term use of steroids, drugs such as CyA and rituximab were also concomitantly administered. However, the patient poorly responded to any of the drugs used. In recent years, cases of pediatric AIHA related to vaccines have been reported. As far as we examined, however, there were no reports of pediatric AIHA caused by ACT-HIB or PREVENAR. It is not clear whether these vaccines were related to the fulminant and refractory AIHA in this patient. No information was provided whether an autopsy was performed or not.


VAERS ID: 480370 (history)  
Form: Version 1.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-11-28
Onset:2012-11-29
   Days after vaccination:1
Submitted: 2012-12-05
   Days after onset:6
Entered: 2013-01-04
   Days after submission:30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-29
   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: [therapy unspecified]
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212JPN000258

Write-up: Information has been received from a physician concerning a 93 years old female patient, who on 28-NOV-2012 was vaccinated with PNEUMOVAX 23 (dose and indication not reported). Concomitant medications are shown in THERAPY INFORMATION. On 28-NOV-2012, the patient was vaccinated with pneumococcal vaccine at the first time. On 29-NOV-2012, the patient died. The reporting physician considered that the death was serious due to death. The physician did not assess the casual relationship of the death to pneumococcal vaccine. Additional information has been requested.


VAERS ID: 480385 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2012-12-23
Onset:2012-12-23
   Days after vaccination:0
Submitted: 2013-01-04
   Days after onset:12
Entered: 2013-01-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR H0449 / 2 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cyanosis, Death, Pulmonary haemorrhage, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had no ongoing illness and no personal and family medical history.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201300088

Write-up: Case received from a healthcare professional through the local affiliate in a foreign country on 31 December 2012: A 03-month-old female patient, with no ongoing illness and no personal and family medical history, had received her second intramuscular injection of ACTHIB (lot number H0449-1) in the left thigh concomitantly with her first intramuscular injection of DTaP vaccine (manufacturer: Chengdu Institute of Biologica products Co, Ltd, batch number 20111255-1) in the arm on 23 December 2012. About one hour after vaccination, the parents found the patient with lips cyanosis and no response. The patient did not show any vital signs and was sent to hospital. Autopsy was performed on 27 December 2012: pulmonary hemorrhage was found by naked eye in the autopsy. Final autopsy report was still under investigation at the time of the report. List of documents held by sender: none.


VAERS ID: 480388 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-26
Onset:2012-12-27
   Days after vaccination:1
Submitted: 2013-01-04
   Days after onset:8
Entered: 2013-01-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / 3 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-27
   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: No personal medical history. No reported family medical history. No history of adverse event to a previous administration of vaccine/drug. No reported concomitant therapies.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201212587

Write-up: Case received from a healthcare professional through the local affiliate of a foreign country on 28 December 2012. A 07-month-old male patient, with no personal medical history, no reported family medical history and no history of adverse event to a previous administration of vaccine/drug, had received his 3rd primary dose of IMOVAX POLIO (batch number, route and anatomical site of administration not reported) on 26 December 2012. The patient had no reported concomitant therapies. On 26 December 2012, at around 09:30pm, the patient''s family noted that the patient''s body was cold. He was urgently transported to the hospital and hospitalized on 26 December 2012. The patient recovered with resuscitative maneuvers. However, he died on 27 December 2012 at 08:57pm. An autopsy was ongoing at the time of the report. Reporter''s comment: "The cause of death was unknown. Because it make no sense at all that the patient experienced anaphylaxis in terms of the onset time, it was unlikely that IMOVAX POLIO induced the patient''s death". Documents held by sender: none.


VAERS ID: 480643 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-11
Onset:0000-00-00
Submitted: 2013-01-07
Entered: 2013-01-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F92555 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Fontanelle bulging, Haemolytic uraemic syndrome, Meningitis, Nausea, Vomiting
SMQs:, Haemolytic disorders (narrow), Acute pancreatitis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Renovascular disorders (broad), Neonatal disorders (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood culture (15Nov2012) serotype 6C
CDC Split Type: 2013001101

Write-up: This is a spontaneous report from a healthcare professional via the Health protection agency. A 5 month old female patient received the first dose of PREVENAR 13 single dose from batch F92555 at 4 months on 11Oct2012. The patients relevant medical history and concomitant medications were not reported. On an unspecified date the patient experienced meningitis, hemolytic uremic syndrome, nausea, vomiting and bulging fontanelle. On 15Nov2012 serotype 6C was identified in a blood culture specimen. The patient died on 16Nov2012 and the cause of death at the time of this report was unknown. No follow up attempts possible. No further information expected.


VAERS ID: 481143 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2012-12-19
Onset:2012-12-29
   Days after vaccination:10
Submitted: 2013-01-10
   Days after onset:12
Entered: 2013-01-14
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 12D02A / 2 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Jaundice, developed at birth, but was recovering; BCG vaccine
Allergies:
Diagnostic Lab Data: 19-DEC-2012, Body temperature, 36.3 Centigrade
CDC Split Type: 2013007883

Write-up: This is a spontaneous report from a contactable pediatrician through Agency. Regulatory authority report number PREVENAR 645. A 4-month-old female patient received the second dose of PREVENAR; Lot Number: 12D02A), subcutaneous on 19Dec2012 at 10:30 at 0.5 ml single dose. Body temperature before vaccination was 36.3 degrees Centigrade. Medical history included jaundice which developed at birth but was resolving thereafter. It was further stated that the patient did not have any problems with growth. The patient''s concomitant medications were not reported. The patient previously received BCG vaccine on 16Nov2012. The patient died during the morning of 29Dec2012. The pediatrician classified the event as serious for death and assessed it as "unevaluable". The pediatrician commented that the details were unknown since I received inquiry from a police officer. The patient was found with bad condition at day-care center for children and her death was confirmed at the hospital where she was urgently sent to. It was not reported if an autopsy was performed. Follow-up (09Jan2013): This is a follow-up report obtained from the same contactable pediatrician through Agency. The institution requested the retraction of the report to Agency and Agency requested Pfizer to delete the case upon their request. No follow-up attempts possible. No further information expected.


VAERS ID: 481816 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-29
Onset:2012-10-30
   Days after vaccination:1
Submitted: 2013-01-17
   Days after onset:79
Entered: 2013-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA713BB / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-08
   Days after onset: 9
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: Atrial Fibrillation; Hypothyreosis-Hashimoto''s; Ischemic heart disease; Pacemaker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0860109A

Write-up: This case was reported by a physician via a regulatory authority (124709) and described the occurrence of death (cause undetermined) in a 92-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included atrial fibrillation, hypothyreosis-Hashimoto''s, ischemic heart disease and pacemaker. On 29 October 2012 the subject received unspecified dose of FLUARIX (intramuscular, unknown injection site). On 30 October 2012, 1 day after vaccination with FLUARIX, the subject was feeling unwell. The subject was hospitalised overnight under observation. She was discharged the following day. The discharge summary stated that the malaise was likely to be related to the vaccine and had no cardiac origin. According to her relatives, the subject was feeling unwell since the vaccination. In the evening of 7 November 2012, they spoke to her and everything was as usual. The subject was found dead on 8 November 2012 in the morning lying quietly in her bed. The cause of death was unknown. It was unknown whether an autopsy was performed. Since important medical information was missing in the report, the causality was assessed as unclassifiable. No further information can be obtained from regulatory authority. The case has therefore been closed.


VAERS ID: 482076 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Male  
Location: Foreign  
Vaccinated:2013-01-04
Onset:2013-01-04
   Days after vaccination:0
Submitted: 2013-01-18
   Days after onset:14
Entered: 2013-01-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 201112604 / 1 UN / SYR
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR H01261 / 1 UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Coma, Cyanosis, Death, Dyspnoea, Multi-organ failure, Respiratory failure, Systemic inflammatory response syndrome
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (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), Hypokalaemia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-01-05
   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: The patient had no ongoing illness and no relevant family history. He had no history of adverse event to previous administration of vaccine.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201300523

Write-up: Case received from a healthcare professional through the local affiliate on 08 January 2013: a 03-month-old male patient, with no ongoing illness, no personal and family medical history and no history of adverse event to previous administration of vaccine, had received his first injection of IPV (lot number H0126-1, site and route of administration not reported) concomitantly with his first injection of DTP vaccine (manufacturer: Wuhan Institute of Biological products Co, Ltd, batch number 20111260-4, site and route of administration not reported) on 04 January 2013 at 3 pm. The patient was found with dyspnea and cyanosis in the midnight and was sent to the emergency room. The patient died on 05 January 2013 at 4:30 pm. The reported diagnosis was respiratory failure, heart failure, systemic inflammatory reaction syndrome, multiple organ failure, "coma of unknown (Muggy syndrome ?)". Details of actions taken at hospital were not reported. It was not reported if an autopsy was performed. List of documents held by sender: none.


VAERS ID: 482080 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-01-08
Onset:2013-01-09
   Days after vaccination:1
Submitted: 2013-01-18
   Days after onset:9
Entered: 2013-01-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Respiratory arrest, Vital functions abnormal
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-01-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient''s personal and family history are not reported.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201300743

Write-up: Case received from a Healthcare Professional through the local affiliate on 09 January 2013: A two-month-old patient (gender and date of birth not reported) with a personal and family history not reported, had received his/her first dose of IMOVAX POLIO (batch number, route and site of administration not reported) at 10 am on 08 Jan 2013. The patient did not take any concomitant treatment. The mother of the patient fed him/her at 2 am on 9 Jan 2013 and did not see anything abnormal. The patient was found stop breathing about 5 am on 9 Jan 2013. The patient did not show any vital sign when he/she was sent to the hospital. Autopsy had been performed on the evening of 9 Jan 2013. Autopsy report was not available at the time of the report. List of documents held by sender: none.


VAERS ID: 482083 (history)  
Form: Version 1.0  
Age: 0.8  
Sex: Female  
Location: Foreign  
Vaccinated:2012-12-26
Onset:2012-12-27
   Days after vaccination:1
Submitted: 2013-01-18
   Days after onset:22
Entered: 2013-01-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-27
   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: Personal medical history of Down''s syndrome and abnormal cardiac function; No reported family medical history; No reported history of adverse event to a previous administration of vaccine/drug
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201300649

Write-up: Case received from a healthcare professional through the local affiliate on 08 January 2013. A 10-month-old female patient, with a personal medical history of Down''s syndrome and abnormal cardiac function, had received her dose of IMOVAX Polio (batch number, route and anatomical site of administration not reported), concomitantly with her dose of Hepatitis B vaccine (other manufacturer, batch number, route and anatomical site of administration not reported) on 26 December 2012. There was no reported family medical history and no reported history of adverse event to a previous administration of vaccine/drug. On 27 December 2012, i.e. the following day post-vaccination, the patient developed infectious gastroenteritis with vomiting and diarrhea. Her condition suddenly deteriorated and she died on 27 December 2012. No complementary investigations were reported. No corrective treatment was administered. No action was taken. According to the attending physician, there was no causal relationship between the event and the vaccination, in consideration of the following factors: the patient had a past history of Down''s syndrome with abnormal cardiac function, and there was an epidemic of infectious gastroenteritis prevailing at the time of the report. Documents held by sender: none.


VAERS ID: 482106 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-01-22
Entered: 2013-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1301ISR008834

Write-up: This spontaneous social media report refers to few patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (lot number, expiry date, dose, route unspecified). No concomitant medications were reported. Few fatal cases post vaccination were reported on an unknown date (query pending). Cause and other details of death were unknown. The relatedness for few fatal cases post vaccination was unknown for GARDASIL. Additional information has been requested.


VAERS ID: 482446 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-09-01
Onset:2012-12-01
   Days after vaccination:91
Submitted: 2013-01-24
   Days after onset:54
Entered: 2013-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Myelitis, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0078533A

Write-up: This case was reported by a consumer and described the occurrence of complete paralysis in an adult female subject of unspecified age who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). The reporting consumer was the husband of the subject. A physician or other health care professional has not verifired this report. On an unspecified date in September 2012 the subject received a dose of INFLUSPLIT SSW (0.5 ml, unknown). Approximately three months post vaccination with INFLUSPLIT SSW, on an unspecified date in December 2012, the subject experienced complete paralysis and myelitis. This case was assessed as medically serious by GSK criteria. At the time of reporting the outcome of the events was unspecified. The subject died on 00 January 2013 from cause of death. An autopsy was not performed. Follow-up information has been requested.


VAERS ID: 482742 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-12-07
Onset:2012-03-09
   Days after vaccination:93
Submitted: 2013-01-28
   Days after onset:325
Entered: 2013-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 66116279 / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Activated partial thromboplastin time normal, Alanine aminotransferase normal, Aspartate aminotransferase normal, Aspiration tracheal abnormal, Basophil count normal, Bladder catheterisation, Blood albumin, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood cholesterol normal, Blood creatine phosphokinase normal, Blood creatinine normal, Blood culture positive, Blood glucose normal, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood lactate dehydrogenase normal, Blood potassium normal, Blood sodium normal, Blood triglycerides normal, Blood urea normal, C-reactive protein increased, CSF cell count abnormal, CSF glucose, CSF protein, CSF protein normal, CSF white blood cell count negative, Cardiac arrest, Chest X-ray normal, Coma scale, Complement factor C3, Complement factor C4, Complement factor normal, Culture urine positive, Death, Delirium, Diet refusal, Dysarthria, Dysphagia, Dysphonia, Electromyogram abnormal, Electroneurography, Eosinophil percentage decreased, Eyelid function disorder, Gamma-glutamyltransferase normal, Globulin, Guillain-Barre syndrome, Haematocrit normal, Haemoglobin normal, Heart rate increased, High density lipoprotein normal, Hypertension, Immunoglobulin therapy, Intensive care, International normalised ratio normal, Keratitis, Klebsiella test positive, Laboratory test abnormal, Lipase increased, Loss of consciousness, Low density lipoprotein normal, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Mechanical ventilation, Monocyte count normal, Muscular weakness, Nasopharyngitis, Neutrophil percentage increased, Paraesthesia, Paralysis, Platelet count normal, Protein total normal, Prothrombin time normal, Pseudomonas test positive, Pupillary light reflex tests normal, Pyrexia, Red blood cell count normal, Red blood cell sedimentation rate increased, Red blood cells CSF positive, Red cell distribution width normal, Reflexes abnormal, Respiratory arrest, Respiratory failure, Sepsis, Speech disorder, Staphylococcus test positive, Tracheostomy, Urinary tract infection, White blood cell count normal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic leukopenia (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Demyelination (narrow), Corneal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Conjunctival disorders (narrow), Periorbital and eyelid disorders (narrow), Ocular infections (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PIRAMIL
Current Illness: Hypertension; Epididymitis; Prostatic adenoma
Preexisting Conditions: Surgery; Eyelid ptosis; Bladder catheterisation; Mechanical ventilation; 01/11/2012, Tracheostomy
Allergies:
Diagnostic Lab Data: Aspiration tracheal, Positive, Significant, Pseudomonas aeroginosa; Blood albumim, 26.9 g/dl, Low; Blood alkaline phophatase, 51 U/l, Low; Blood creatinine, 61 umol/l, Low; Blood culture, Positive, Significant, Pseudomonas aeuroginosa and coagulase negative Staphylococcus species; Blood pressure, 170/110, High; C-reactive protein, 56.6 mg/l, High; CSF cell count, Abnormal, Significant, RBC 50, WBC 2; CSF glucose, 3.7, Not Applicable; CSF protein, 0.6, Not Applicable; Culture urine, Positive, Significant, Klebsiella pneumoniae ESBL; Eosinophil count, 0.3%, Low; Heart rate, 90 per minute, High; Lipase, 19 g/dl; High; Lymphocye count, 7%, Low; Neutrophil count, 85.1%, High; Red blood cell sedimentation rate, 80 mm/3.6 ks, High
CDC Split Type: PHHY2013HR006498

Write-up: Case number PHHY2013HR006498 is an initial spontaneous report received from a consumer via health authority (HA reference number: 2012-01906) on 23 Jan 2013. This report refers to a 78-years-old male patient. His medical history included surgery on both eyelid due to eyelid ptosis and current conditions included arterial hypertension and inflammation of the left epididymis and prostate adenoma. His concomitant medications included RAMIPRIL 10 mg. He was vaccinated with FLUIMUN (batch number: 6/6 116279) on 07 Dec 2011. On 05 Jan 2012 around 4 pm he felt weakness in his legs and after that in his arms. He also had speech disturbance. He was taken to emergency room around 7 pm where it was concluded that the event was due to high pressure and he was sent home. The weakness got worse when he reached home. It was reported that on 06 Jan 2012, it was identified that he had Guillain Barre syndrome. He was hospitalized at the neurology ward due to the events. On the date of admission, at around 2 pm, he felt tingling in his legs and arms. It was difficult for him to get up from the table after lunch. During that day, by the evening the weakness got worse, with difficulties in speaking and swallowing. A few days previously he had had a cold. Physical status at admission was reported as follows: He was cardio-circulatory and respiratory compensated. He was hemodynamically stable. His blood pressure was 170/110 mmHg and pulse rate was 90/ minute. He was afebrile, rhythmic and had normal auscultatory findings on heart and lungs. His abdomen was soft and painless and there was no palpable organomegalles or pathological resistances. His peripheral arterial pulsations were normally palpitated, peristalsis was audible, extremities were symmetrical and there was no edema. Neurological status was reported as follows: He was conscious and Glasgow Coma Scale (GCS) was 15. There was no meningism. Speech was dysarthric and dysphonic. His right upper eyelid was disceetly lowered. Pupils were round and isochoric and had normal reactions to light. All extremities were brought to antigravity position limply falling on the surface. Own reflexes were not stimulated. Plantar reflex was bilaterally physiological. There was no signal of loss of feeling. Vascular status of the neck physically was with no special findings. It was reported that he had permanent urinary catheter placed. Results of tests were reported as follows: HDW was 27.8; Globulins was 45-1; CSF was clear and colorless. Pandy''s test was negative. Heart and lung X-ray performed revealed radiologically compensated heart, normal configuration of hila, lungs of normal airiness and no fresh infiltrates. Diaphragm was of normal position and form. Control heart and lung X-ray on 06 Jan 2012: Asymmetry of the imaging position. Lungs well ventilated with no pathological shadows. Tip of central venous catheter was in the shadow of the superior vena cava. Diaphragm and lateral phrenicocostal sinuses were of normal appearance. Laboratory test results were reported as follows: red blood cell count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width, platelet count, mean platelet volume, white blood cell count, glucose, urea, sodium, potassium, bilirubin total, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglycerides, protein total, lactate dehydrogenase, creatinine kinase, prothrombin time, international normalized ratio (INR), Complement factors C3 and C4, Immunoglobulin A, M and G, activated partial thromboplastin time (APTT) was reported as normal. Neutrophils was 85.1 percent, lymphocytes were 7 percent, eosinophil was 0.3 percent and monocytes and basophil were normal. Erythrocyte Sedimentation Rate (ESR) was 80, creatinine was 61, alkaline phosphatase was 51, lipase was 19, albumin was 26.9, C-reactive protein (CRP) was 56.6 mg/l, creatinine kinase was 79 U/l (normal value: 177U/l), Cerebrospinal fluid examination was as follows: RBC: 50, WBC: 2, protein: 0.6 and glucose: 3.7. Tracheal aspiration showed Pseudomonas aeuroginosa and urine culture yielded Klebsiella pneumoniae ESBL (extended spectrum beta lactamase). Hemoculture was positive for Pseudomonas aeuroginosa and coagulase negative Staphylococcus species. On 07 Jan 2012, in the morning hours he stopped breathing on his own, had respiratory insufficiency and was put on a ventilator. He was unconscious. The immunoglobulin (Ig) therapy was commenced immediately upon admission to hospital and lasted for 5 days. On 11 Jan 2012, tracheostomy was done. He was conscious on 17 Jan 2012 and the first indications appeared of a recovery of the facial musculature. Over the next few days the facial and neck musculature largely recovered. On 24 Jan 2012, the doctors decided to reinstitute lg therapy to which he did not respond (some muscle contractions on arms were noted, but there was no attempt to breathe on his own, and he continued to be paralyzed from the neck down). Even on 31 Jan 2012, there was no change in his condition. On 07 Feb 2012, he experienced urinary tract infection and sepsis. It was reported that he continued to be on ventilator and other machines by mid Feb 2012. Control heart and lung X-ray was performed on 20 Feb 2012 and the result was as follows: Lungs were well ventilated. Tip of the central venous catheter was in the projection of the superior vena cava. There was no differentiated pathological infiltrates. Diaphragm and lateral phrenicocostal sinuses were of normal appearance. Electromyography: ''in m. tibialis ant. dex.et sin.; m. ext. dig. brevis dex et sin; m. vastus lat. Dex.'' No willful or spontaneous activity was registered (eight days from the onset of neurological deficit). Neurography: for ''n. medianus sin.; n. ulnaris sin.; n. tibialis dex. et sin. muscle potential was not evoked''. For n. peroneus dex. extended terminal latency registered and low CMAP amplitude, from the proximal point of stimulation, muscle potential was not stimulated (condition block?). On an unknown date at the end of Feb 2012, he started to breathe on his own, managed to move his legs and arms and was sent to medical spa; since he had to wait for his turn to start therapy at the spa, he continued to lie in the neurosurgery ICU. Improvement occurred and he started to drink and take food by mouth, recovered his ability to swallow and speech returned to a certain degree but was made difficult by a cannula. On an unknown date in 2012, he had keratoconjunctivitis. It was reported that on 08 Mar 2012, after the visit everything was normal, but in the evening hours of the same day he got a fever, refused to eat and was delirious all night. On 09 Mar 2012, around noon he was still conscious, later he lost consciousness. He had a cardiac arrest and he finally died at 7 pm on 09 Mar 2012. The causality of the event was not assessed. No further information was provided.


VAERS ID: 482751 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2011-01-08
Submitted: 2013-01-25
   Days after onset:748
Entered: 2013-01-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Autopsy, Biopsy bone, Death, Influenza, Pneumonia legionella, Polycythaemia
SMQs:, Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Diabetes mellitus; Obesity; Pancytopenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2013HR006928

Write-up: Case number PHHY2013HR006928 is an initial spontaneous report received from a physician via health authority (reference number: 2011-00047) on 23 Jan 2013. This case refers to a 46-year-old male patient. His medical history included of diabetes mellitus since long period, obesity (weight: 150 kg) and was suffering from pancytopenia that was diagnosed after arrival at the hospital. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date. On 08 Jan 2011, a month after vaccination he developed swine flu. On the same day he developed severe clinical picture caused by the H1N1 virus. The patient was hospitalized in the clinic for infectious diseases, after admission to the hospital he was diagnosed with polycythemia which set suspicion on the hematological disease that could cause non development of protective antibodies. Within 24 days after hospitalization a severe clinical picture of acute respiratory distress syndrome (ARDS) was developed and the patient died from complications on 09 Jan 2011. It was also reported that he got over the legionnaire''s disease. Bone biopsy was taken during the autopsy for further diagnosis of causes of complications from influenza H1N1 virus. The final diagnosis was reported as inefficacy for the seasonal vaccine. The cause of death was reported as acute respiratory distress syndrome. The causality of the event inefficacy of the seasonal vaccine was reported as possibly related to seasonal influenza vaccine.


VAERS ID: 482925 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-01-29
Entered: 2013-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1301ROM010862

Write-up: Information has been received from the abstract of a literature article. Varicella is a common and extremely contagious disease of childhood. It has usually no major complications and healing is complete. Severe infections may be observed on immune-compromised patients and in adults. Bacterial infections, pneumonia, myocarditis or brain damage are among potentially fatal complications. The authors reported a special case with multiple and rare complications of varicella in a previously healthy 13 months boy, soon after vaccination against MMR and with abrupt evolution to death. Additional information has been requested.


VAERS ID: 483590 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-06
Entered: 2013-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Aortic stenosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0864334A

Write-up: This case was reported by a physician, via a GSK sales representative, and described the occurrence of death (cause undetermined) in a male subject in his 80s who was vaccinated with influenza virus vaccine (manufacturer unspecified). Concurrent medical conditions included heart disease with aortic stenosis. In 2010, the subject received a dose of seasonal influenza vaccine (unknown manufacturer, unknown batch number and unknown injection site). The same day, the subject died. The cause of death was undetermined. It was unknown whether an autopsy was performed. The reporting attending physician considered that the event was unrelated (chronological coincidence) to vaccination with seasonal influenza vaccine.


VAERS ID: 483693 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-05
Entered: 2013-02-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013042385

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 9-month-old male received two doses of PREVENAR 13 at 0.5 ml single dose, at the age of 2 and 4 months (lot numbers, route and site injection unknown). The patient''s medical history and concomitant treatment were not reported. On an unspecified date, the patient died from pneumococcal meningitis. The pneumococcal serotype was identified to be 19F.


VAERS ID: 483863 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-05-08
Onset:0000-00-00
Submitted: 2013-02-07
Entered: 2013-02-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4388AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aortic stenosis, Cardiac failure, Death, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Patient was reported as cardiac
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201301702

Write-up: This initial case report is part of a batch of reports associated with several products that was received on 30 January 2013 by the Sanofi Pasteur affiliate who received the report from the Ministry of Health. A male patient (age reported as 76 years), with a medical history of cardiac disorder (the patient was reported as "cardiac") and no reported concomitant therapies, had received his dose of FLUZONE, lot number U4388AA, (route and anatomical site of administration not reported) during a campaign on 08 May 2012. Three hours post-vaccination, the patient died. According to the death certificate, the patient had ventricular fibrillation, heart failure and aortic stenosis. The patient''s outcome was fatal (death). The case was assessed as serious by the Ministry of Health. The patient was hospitalized on unspecified dates. Documents held by sender: None.


VAERS ID: 483937 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Foreign  
Vaccinated:2012-05-28
Onset:0000-00-00
Submitted: 2013-02-08
Entered: 2013-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA44AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Enterocolitis, Intussusception, Peritonitis, Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0865631A

Write-up: This case was reported by other health professional (National Immunization Program) and described the occurrence of intussusception of intestine in a 6-month-old male subject who was vaccinated with live ROTARIX (GlaxoSmithKline). On 28 May 2012, the subject received 2nd dose of ROTARIX (oral). In 2012, at an unspecified time after vaccination with ROTARIX, the subject experienced intussusception of intestine, septic shock, peritonitis and enterocolitis. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). The subject died from enterocolitis, intussusception of intestine, peritonitis and septic shock. It was unknown whether an autopsy was performed. This report is one of 800 cases received as part of a line-listing, each containing minimal information. No further information is expected.


VAERS ID: 483939 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2012-05-15
Onset:0000-00-00
Submitted: 2013-02-08
Entered: 2013-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER 10PVZD085Z / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 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: B0865604A

Write-up: This case was reported by a healthcare professional (National Immunisation Program) and described the occurrence of death (nos) in a 2-month-old male subject who was vaccinated with live rotavirus vaccine (manufacturer unspecified, live attenuated oral poliomyelitis vaccine (oral polio vaccine) and dtpa-hib (non-GSK). On 15 May 2012 the subject received 1st dose of rotavirus vaccine (oral), 1st dose of oral polio vaccine (oral), 1st dose of DTPa-Hib (Non-GSK) (unknown route). Lot numbers not provided. At an unspecified time after vaccination with DTPa-Hib (Non-GSK), oral polio vaccine and rotavirus vaccine, the subject experienced death (nos). The subject was hospitalised and the healthcare professional reported that the event was clinically significant (or requiring intervention). The subject died from death due to unknown cause. It was unknown whether an autopsy was performed. This report is one of 800 cases received as part of a line-listing, each containing minimal information. No further information is expected.


VAERS ID: 483946 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Foreign  
Vaccinated:2012-01-23
Onset:2012-01-23
   Days after vaccination:0
Submitted: 2013-02-08
   Days after onset:382
Entered: 2013-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA291BA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal rigidity, Death, Gastroenteritis, Grunting, Haematochezia, Moaning, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (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: B0865586A

Write-up: This case was reported by a health professional (National Immunization Program) and described the occurrence of death (unknown cause) in a 2-month-old male subject who was vaccinated with live ROTARIX (GlaxoSmithKline). On 23 January 2012, the subject received 1st dose of ROTARIX (oral). On 23 January 2012, 2 hours after vaccination with ROTARIX, the subject experienced blood in stools, vomiting and hard abdomen. It evolved with grunting and moaning. A gastroenterocolitis was suspected. The subject was hospitalised and the regulatory authority reported that the events were clinically significant (or requiring intervention). No laboratory tests were performed. On 3rd day of hospitalization, the subject died from death (cause unknown). An autopsy was not performed. This report is one of 800 cases received as part of a line-listing, each containing minimal information. No further information was expected. Case was closed.


VAERS ID: 483954 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Foreign  
Vaccinated:2012-02-09
Onset:0000-00-00
Submitted: 2013-02-08
Entered: 2013-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER 109VZD030Z / 2 MO / PO
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER 19A / 2 MO / PO
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA360AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Hypotonic-hyporesponsive episode
SMQs:, Hypotonic-hyporesponsive episode (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0865633A

Write-up: This case was reported by a healthcare professional (National Immunisation Program) and described the occurrence of death (nos) in a 10-month-old male subject who was vaccinated with live attenuated oral poliomyelitis and dtpa-hib (non-GSK). On 9 February 2012 the subject received 2nd dose of ROTARIX, 2nd dose of oral polio vaccine, 2nd dose of DTPa-Hib (Non-GSK) (unknown route). At an unspecified time after vaccination with DTPa-Hib (Non-GSK), oral polio vaccine and ROTARIX, the subject experienced hypotonic-hyporesponsive episode. The subject was hospitalised and the healthcare professional reported that the event was clinically significant (or requiring intervention). The subject died from unknown cause of death. It was unknown whether an autopsy was performed. This report is one of 800 cases received as part of a line-listing, each containing minimal information. No further information us expected.


VAERS ID: 483955 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Female  
Location: Foreign  
Vaccinated:2012-02-02
Onset:0000-00-00
Submitted: 2013-02-08
Entered: 2013-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER 10PVZF031Z / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER G5364 / 1 MO / PO
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS ASPNA095BA / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA371BA / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, < 39.5deg. C
CDC Split Type: B0865632A

Write-up: This case was reported by other health professional (National Immunization Program) and described the occurrence of death due to unknown causes in a 3-month-old female subject who was vaccinated with live attenuated ROTARIX (GlaxoSmithKline), SYNFLORIX, poliomyelitis vaccine live oral (non-gsk) and dtpa-hib (non-gsk). On 2 February 2012, the subject received 1st dose of ROTARIX (oral), 1st dose of SYNFLORIX (unknown), 1st dose of poliomyelitis live oral (Non-GSK), 1st dose of DTPa-Hib (Non-GSK) (unknown). In 2012, less than one year after vaccination with DTPa-Hib (Non-GSK), poliomyelitis vaccine live oral (Non-GSK), ROTARIX and SYNFLORIX, the subject experienced fever (less than 39.5 deg. C) and hypersensitivity (systemic syndrome of premature reaction). The subject was hospitalised. The subject died due to unknown causes. It was unknown whether an autopsy was performed. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.


VAERS ID: 483986 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2012-02-23
Onset:2012-03-01
   Days after vaccination:7
Submitted: 2013-02-11
   Days after onset:347
Entered: 2013-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA350BA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Cardio-respiratory arrest, Death, Hypovolaemic shock, Intussusception, Multi-organ failure, X-ray abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Sepsis (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: Abdominal X-ray, Handles distenti
CDC Split Type: B0865673A

Write-up: This case was reported by a health professional and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 23 February 2012, the subject received 1st dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced intussusception, cardiorespiratory arrest, hypovolemic shock and multiple organ dysfunction. The subject was hospitalised and the regulatory authority reported that the events were clinically significant (or requiring intervention). An abdominal X-ray confirmed intussusception and showed handles distention. The subject died from cardiorespiratory arrest, hypovolemic shock, intussusception and multiple organ dysfunction. It was unknown whether an autopsy was performed. This report is one of 800 cases received as part of a line-listing, each containing minimal information. No further information was expected. Case was closed.


VAERS ID: 484050 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2013-01-30
Onset:2013-01-31
   Days after vaccination:1
Submitted: 2013-02-12
   Days after onset:12
Entered: 2013-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / SYR
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / SYR
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H012761 / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-01-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1302DEU003131

Write-up: Case of fatal outcome was received from a healthcare professional on 01-Feb-2013. Case is medically confirmed and poorly documented. A 9-week-old female patient received a first dose of live ROTATEQ (lot-no. H012761) orally, a first dose of INFANRIX HEXA (GSK, lot-no., injection route and site not reported) and a first dose of PREVENAR 13 (Pfizer, lot-no., injection route and site not reported) on 30-Jan-2013. One day later, on 31-Jan-2013, she experienced an unspecified "event" and was hospitalised. She died the same day. SIDS or aspiration was suspected. An autopsy will be carried out. The reporter did rather not see a causal relation to the vaccinations but reported this case because of the narrow timely relationship.


VAERS ID: 484135 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-07
Entered: 2013-02-12
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis pneumococcal, Meningoencephalitis bacterial, Nervous system disorder, Respiratory disorder, Streptococcus test positive
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-01-25
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: PREVENAR-13. drug reaction, first dose (at the age of 2 months); PREVENAR-13, drug reaction, second dose (at the age of 4 months)
Allergies:
Diagnostic Lab Data: Pneumococcal serotype (unspecified date): 20
CDC Split Type: 2013043921

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative and from a hospital physician. A female patient had received complete vaccination schedule with PREVENAR 13 at 0.5 ml single dose. The two first doses at the age of 2 and 4 months, the third dose at the age of 12 months (route and sites of injections and lot numbers unknown). The exact dates of injection were unknown but the reporter stated that the third dose had been administered more than three weeks before event onset. She had no relevant medical history, no risk factor for pneumococcal invasive disease, no recent infection. She was not taking concomitant medication and had not received any antibiotic drug, NSID or corticosteroid within the days previous to the event onset. In Jan2013, the patient was admitted to hospital with respiratory and neurological deficiencies. She died from pneumococcal meningoencephalitis on 25Jan2013 at the the age of 13 months. The pneumococcal serotype was identified locally to be 20. However it should be confirmed by national reference center for pneumococcus.


VAERS ID: 484349 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-05-09
Onset:0000-00-00
Submitted: 2013-02-12
Entered: 2013-02-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4387AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Erythema, Feeling hot, Gait disturbance, Pain, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient''s medical history and concomitant medications were not reported.
Allergies:
Diagnostic Lab Data: Laboratory data was not reported.
CDC Split Type: 201301795

Write-up: This initial case report is part of a batch of reports associated with several products that was received on 04 February 2013 by the Sanofi Pasteur affiliate who received the report the Ministry of Health. A female patient whose medical history and concomitant therapies were not reported, received a dose of FLUZONE; lot number U4387AA, (route and anatomical site of administration not reported) on 9 May 2012. On an unspecified date, post-vaccination, the patient experienced pain, redness, heating, generalized urticaria and difficulty in walking. The patient died on an unspecified date (outcome was fatal). The action regarding next vaccinations was reported as: ignored. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. Causality assessment by the PNI: Discarded (event assessed as coincidental with vaccination, ie, it would have occurred even if vaccination had not taken place). Documents held by sender: None.


VAERS ID: 484363 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Female  
Location: Foreign  
Vaccinated:2013-01-30
Onset:2013-01-31
   Days after vaccination:1
Submitted: 2013-02-12
   Days after onset:12
Entered: 2013-02-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR H0446 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Autopsy, Cyanosis, Diarrhoea, Laboratory test abnormal
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (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: Personal and family medical history: not reported. History of adverse event to previous administration of vaccine/drug: not reported.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201301429

Write-up: Case received from a Healthcare Professional through the local affiliate on 31 January 2013. A 2-month-old female patient, with no reported medical history and no concomitant therapies, had received her first intramuscular dose of IPV (batch number H0446-1, anatomical site of administration: not reported) on 30 January 2013 at 10 a.m. On 31 January 2013, around 2 a.m., the patient experienced diarrhoea for four times. She was found very weak when she was breastfed at 4 a.m. on 31 January 2013. The patient was found with lip cyanosis around 9 a.m. and had no vital signs when she was sent to the hospital around 10:30 a.m. on 31 January 2013. An autopsy was performed in the afternoon on 31 January 2013.


VAERS ID: 484364 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-12
Entered: 2013-02-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
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: Malnutrition; Physical abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013049367

Write-up: This is a spontaneous report from a non-contactable physician. A 2-months-old patient of an unspecified gender received a dose of PREVENAR 13, via an unspecified route of administration on an unspecified date at an unspecified dose. Medical history included malnutrition and physical abuse. The patient''s concomitant medications were not reported. The patient died on an unspecified date several days after vaccination. The patient''s cause of death was unknown at the time of reporting. Three cases where reported that occurred in malnourished children, some of them with adolescent parents and physical abuse signals. Case was initially associated with PREVENAR 13 as a probable cause of the SAE, and triggered investigation of Health Authority. Also a recommendation to move the first dose schedule from 2 months to 3 months of age. However this change caused a logistic issue, since some of the regions continued with the first dose at 2 months. The conclusion after a meeting was that there was no association between the death and PREVENAR 13. It will also continue following the original schedule for the first dose at 2 months. The National Immunization Program (NIP) authority will formally communicate the conclusions to all regions in the country.


VAERS ID: 484370 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-12
Entered: 2013-02-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Malnutrition; Physical abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013052599

Write-up: This is a spontaneous report from a non-contactable physician. A 2-months-old patient of an unspecified gender received a dose of PREVENAR 13, via an unspecified route of administration on an unspecified date at an unspecified dose. Medical history included malnutrition and physical abuse. The patient''s concomitant medications were not reported. The patient died on an unspecified date several days after vaccination. The patient''s cause of death was unknown at the time of reporting. Three cases where reported that occurred in malnourished children, some of them with adolescent parents and physical abuse signals. Case was initially associated with PREVENAR 13 as a probable cause of the SAE, and triggered investigation of Health Authority. Also a recommendation to move the first dose schedule from 2 months to 3 months of age. However this change caused a logistic issue, since some of the regions continued with the first dose at 2 months. The conclusion after a meeting was that there was no association between the death and PREVENAR 13. It will also continue following the original schedule for the first dose at 2 months. The National Immunization Program (NIP) authority will formally communicate the conclusions to all regions in the country.


VAERS ID: 484374 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-05-18
Onset:0000-00-00
Submitted: 2013-02-12
Entered: 2013-02-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4387AA / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure congestive, Death, Pneumonia aspiration, Sepsis
SMQs:, Cardiac failure (narrow), Cardiomyopathy (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:
Current Illness:
Preexisting Conditions: Not reported.
Allergies:
Diagnostic Lab Data: Not reported.
CDC Split Type: 201301787

Write-up: This initial case report is part of a batch of reports associated with several products that was received on 04 February 2013 by the Sanofi Pasteur affiliate who received the report from the Ministry of Health. A female patient (whose medical history and concomitant therapies were not reported, had received her 1st dose of FLUZONE, lot number U4387AA, (route and anatomical site of administration not reported) on 18 May 2012. On an unspecified date, post-vaccination, the patient developed congestive heart failure, aspirative pneumonia, septicemia and subsequently died. The outcome was fatal (date of death was not reported). The action regarding next vaccinations is reported as: ignored. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The causality assessment by the PNI: Discarded (event assessed as coincidental with vaccination, ie, it would have occurred even if vaccination had not taken place). Documents held by sender: None.


VAERS ID: 484647 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-14
Entered: 2013-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient underwent splenectomy due to haematological disease (not specified) on an unspecified date.
Allergies:
Diagnostic Lab Data: Not reported.
CDC Split Type: 201302289

Write-up: Case retrieved from a literature on 04 February 2013. A patient (age, gender and initials not reported), with a medical history of splenectomy due to hematological disease on an unspecified date, had received a dose of Haemophilus influenza type B vaccine (manufacturer unknown, batch number, route and site of administration not reported) and a dose of Pneumococcal vaccine (manufacturer unknown, batch number, route and site of administration not reported) preoperatively (exact date not reported). It was not reported if the patient had received concomitant therapies. One month after the surgery, the patient died due to sepsis. It was not reported if laboratory tests were performed. Aetiological agent was not reported.


VAERS ID: 484849 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-15
Entered: 2013-02-19
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: 2013056779

Write-up: This is a spontaneous report from a contactable physician. A 2-months-old patient of an unspecified gender received a dose of PREVENAR 13, via an unspecified route of administration on an unspecified date at an unspecified dose. Patient''s medical history and concomitant medications were not reported. The patient died in Jan2013, 24 hours after receiving PREVENAR 13 and other vaccines. This is the second of two reports regarding two 2-months-old infants that died after vaccination with PREVENAR 13. One of them died on Dec2012, the other on Jan2013. An autopsy has been performed to one of them and reported electrolyte disturbances, autopsy was not performed in the other infant. Based on the reported information, it was not possible to associate the information on autopsy to the individual patient.


VAERS ID: 484861 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-15
Entered: 2013-02-19
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: 2013056777

Write-up: This is a spontaneous report from a contactable physician. A 2-months-old patient of an unspecified gender received a dose of PREVENAR 13, via an unspecified route of administration on an unspecified date at an unspecified dose. Patient''s medical history and concomitant medications were not reported. The patient died in Dec2012, 24 hours after receiving PREVENAR 13 and other vaccines. This is the first of two reports regarding two-months-old infants that died after vaccination with PREVENAR 13. One of them died on Dec2012, the other on Jan2013. An autopsy has been performed to one of them and reported electrolyte disturbances, autopsy was not performed in the other infant. Based on the reported information, it was not possible to associate the information on autopsy to the individual patient.


VAERS ID: 484887 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-14
Entered: 2013-02-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, C-reactive protein increased, Chronic obstructive pulmonary disease, Condition aggravated, Death, Dyspnoea, Mechanical ventilation, Myalgia, Sputum culture positive, Streptococcus test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Chronic obstructive lung disease; diagnosed 20 years ago; exacerbated 3-4 times a year due to streptococcal pneumonia; (PNEUMO 23), Immunization, the patient had received 1 dose of Pneumo 23, 2 years ago
Allergies:
Diagnostic Lab Data: Sputum culture (??Feb2013): streptococcus pneumonia reproduced; C-Reactive Protein (??Feb2013): increased
CDC Split Type: 2013056195

Write-up: This is a spontaneous report from a contactable physician. A 60-year-old female patient received PREVENAR via an unspecified route of administration on an unspecified date in Feb2013 (reported as 2 - 3 days prior to 08Feb2013). Relevant medical history included ongoing chronic obstructive pulmonary disease stage 3 which was diagnosed 20 years ago and the patient had experienced exacerbated chronic obstructive lung disease 3 - 4 times a year due to streptococcal pneumonia. Relevant concomitant medications were not reported. Past drug/vaccine history included "Pneumo 23" (as reported) which was received 2 years ago. The day after administration of PREVENAR, the patient experienced generalized muscle pain and generalized joint pain and then the patient went to see a physician due to dyspnea. Two days later, she was hospitalized due to exacerbated chronic obstructive lung disease. A sputum culture revealed growth of streptococcus pneumoniae. First the patient was treated with levofloxacin then with both a macrolide and a third generation cephalosporin. The patient was placed on mechanical ventilation in a different hospital due to shortness of breath on 07Feb2013. C-Reactive Protein (CRP) levels increased since the onset of the events dyspnea, generalized muscle pain, generalized joint pain, and exacerbated chronic obstructive lung disease. The patient died on 08Feb2013 at around 1600 to 1700 hours. It was not reported if an autopsy was performed. Another physician (pulmonologist) from a different hospital indicated that the cause of death could possible have been influenza pneumonia.


VAERS ID: 485198 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-21
Entered: 2013-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1302KOR009332

Write-up: Information has been received froM a physician, author of the published literature article. The authors analyzed surveillance data from 1994 to 2011 identified by the Adverse Events Following Immunization (AEFI) rapid response team to describe the epidemiology of sudden death in the first 2 years of life following immunization. Since 1994, the AEFI rapid response team is dispatched within 24 hours to launch an in-depth epidemiologic investigation and causality assessment when any case of death temporally associated with immunization is reported to the AEFI surveillance system. Because the passive surveillance system is subject to underreporting, the authors supplemented the data by including cases identified from the Vaccine Injury compensation Program (VICP) (they excluded duplicate reports). While sudden deaths in childhood have been reported most in infancy (age <1 year), the authors included young children in the second year of life, in accordance with guidance of the Brighton Collaboration Unexplained Sudden Death Working Group. For each sudden death case, the authors reviewed the demographic information, interval from immunization to presentation, vaccine(s) used, findings from postmortem examination, and examination of the death scene. The authors first classified the sudden death cases into categories according to the presence of identified cause of death. The cases with identified cause of death were further categorized into the following groups: congenital abnormality; accidental injury; infectious diseases; and malignancy. The authors then categorized the cases with no identified cause of death as follows: Sudden unexpected death in children (SUDC) (deaths in the second year of life); and sudden unexpected death in infancy (SUDI) (deaths in the first year of life). Any SUDI case meeting Brighton Collaboration case definition (BCCD) of unexplained sudden death levels I or II were classified as possible sudden infant death syndrome (SIDS) (deaths in the first year of life which remain unexplained after autopsy). Of 45 cases of sudden death, the authors identified 23 cases with cause of death, and 22 cases without explanation of death. The 23 cases with identified explanation of death were classified as follows: 13 infectious diseases; seven accidental injuries; two congenital abnormalities; and one malignancy case. All of five cases that were classified as asphyxia were confirmed from review of investigation data that included postmortem autopsy and death scene examination reports. The authors classified 22 cases with no identified explanation of deaths in two age groups: two SUDC cases; and 20 SUDI cases. The SUDI cases included six BCCD I cases and three BCCD II cases, which were then classified as possible SIDS cases. Hepatitis B (HepB) was found to be the most frequent vaccine with temporal association with death (n = 11), followed by acellular diphtheria-tetanus-pertussis vaccine (DTaP) (n =4), Bacillus Calmette-Guerin (n = 2), Japanese encephalitis vaccine (n = 2), Haemophilus influenza vaccine (Hib; n = 2), and H1N1 (n = 2). Combination of DTaP and IPV (inactivated polio vaccine) was found to be the most frequently identified vaccine (n = 10), followed by DTaP+OPV (live attenuated polio vaccine; n = 5), and Hib+PCV (pneumococcal conjugate vaccine; n = 2). Of 31 cases with identified interval between immunization and the time of death, the most frequent interval was 6-24 h (n = 16), followed by 24-72 h (11 = 8) and 0-6 h (n = 5). The interval between immunization and time of death was not identified in 14 cases. Two cases of HepB and one case each of DTaP, DTaP+IPV and DTaP+OPV were found to have an interval between 0 and 6 h. This report concerns about two infant patients (age and gender unknown) who on an unspecified date were vaccinated with a dose of Influenza Virus Vaccine (Hib) (manufacturer unknown) and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (both lot and dose number not reported, route of administration not reported). On an unspecified date the patients experienced Sudden infant death syndrome. Additional information has been requested. This report is linked to MARRS case 1302KOR007184, same literature article.


VAERS ID: 485459 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-22
Onset:0000-00-00
Submitted: 2013-02-22
Entered: 2013-02-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 098617901 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Death, Respiratory failure
SMQs:, Anaphylactic reaction (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 encephalitis (narrow), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-04
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: 2013034788

Write-up: This legal report (initial receipt 12-Feb-2013) concerns a male patient, age not specified. On 22-Oct-2010, the patient received ENZIRA (batch number: 17901). On 04-Jan-2011, the patient died. His death certificate listed the cause of death as respiratory failure and acute disseminated encephalomyelitis. The medical officer who examined the claim stated that the vaccine received did not contain the swine flu strain. No further information was provided.


VAERS ID: 485462 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-22
Entered: 2013-02-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201303138

Write-up: Case retrieved from the literature on 13 February 2013. This case is linked with the reference case 2013-03135. The following is verbatim from the aforementioned article abstract: "BACKGROUND: Because the peak age for incidence of sudden deaths in infancy temporally coincides with the age of infant primary immunization, some have raised the question as to whether immunization is a risk factor for sudden death in infancy. Recent occurrence of two sudden deaths in infants has renewed concerns about the causal association between immunization and sudden deaths in infants. METHODS: We carried out a retrospective review of data from the foreign Centers for Disease Control and Prevention Adverse Events Following Immunization Surveillance System and Vaccine Compensation programs. RESULTS: From 1994 to 2011, a total of 45 cases of sudden deaths in the first 2 years of life following immunization were reported. The causes of death were classified as follows: infectious diseases (n = 13); accidental injuries (n = 7); congenital abnormalities (n = 2); and malignancy (n = 1). Of 20 sudden deaths in infancy, nine deaths met Brighton Collaboration case definition level I and II, and therefore were classified as possible sudden infant death syndrome cases. Hepatitis B vaccine (n = 13) was the most frequent vaccine with temporal association with sudden deaths in the first 2 years of life. CONCLUSION: Few sudden deaths in the first 2 years of life following immunization have been reported, despite the use of universal immunization. The majority of deaths in infancy did not meet case definition for sudden infant death syndrome. Encouraging investigators to perform thorough investigation, including postmortem autopsy and death scene examination, may promote data comparability and provide guidance on decision-making in the vaccine-safety monitoring and response system." A retrospective review of data from 1994 to 2011 was carried out from the foreign Centers for Disease Control and Prevention Adverse Events Following Immunization Surveillance System and Vaccine Compensation programs to describe the epidemiology of sudden death in the first 2 years of life following immunization. For each sudden death case, the demographic information, interval from immunization to presentation, vaccine(s) used, findings from postmortem examination, and examination of the death scene were reviewed. The present case described an infant patient (age, gender, medical history, risk factors and concomitant therapy not reported), who had received a dose of IPV vaccine (manufacturer unknown, batch number, route and site of administration not reported) and a dose of Diphtheria Tetanus and acellular Pertussis vaccine (as no DTaP from Sanofi Pasteur is marketed, interpreted as other manufacturer, batch number, route and site of administration not reported) on an unspecified date. On an unspecified date after vaccination, the patient experienced sudden unexpected death in the first year of life. This case met the Brighton Collaboration Case Definition (BCCD) level III.


VAERS ID: 485464 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-22
Entered: 2013-02-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201303139

Write-up: Case retrieved from the literature on 13 February 2013. This case is linked with reference case 2013-03135. The following is verbatim from article abstract: "BACKGROUND: Because the peak age for incidence of sudden deaths in infancy temporally coincides with the age of infant primary immunization, some have raised the question as to whether immunization is a risk factor for sudden death in infancy. Recent occurrence of two sudden deaths in infants has renewed concerns about the causal association between immunization and sudden deaths in infants. METHODS: We carried out a retrospective review of data from the Centers for Disease Control and Prevention Adverse Events Following Immunization Surveillance System and Vaccine Compensation programs. RESULTS: From 1994 to 2011, a total of 45 cases of sudden deaths in the first 2 years of life following immunization were reported. The causes of death were classified as follows: infectious diseases (n = 13); accidental injuries (n=7); congenital abnormalities (n = 2); and malignancy (n= 1). Of 20 sudden deaths in infancy, nine deaths met Brighton Collaboration case definition level I and II, and therefore were classified as possible sudden infant death syndrome cases. Hepatitis B vaccine (n = 13) was the most frequent vaccine with temporal association with sudden deaths in the first 2 years of life. CONCLUSION: Few sudden deaths in the first 2 years of life following immunization have been reported, despite the use of universal immunization. The majority of deaths in infancy did not meet case definition for sudden infant death syndrome. Encouraging investigators to perform thorough investigation, including postmortem autopsy and death scene examination, may promote data comparability and provide guidance on decision-making in the vaccine-safety monitoring and response system". A retrospective review of data from 1994 to 2011 was carried out from the Centers for Disease Control and Prevention Adverse Events Following Immunization Surveillance System and Vaccine Compensation programs to describe the epidemiology of sudden death in the first 2 years of life following immunization. For each sudden death case, the demographic information, interval from immunization to presentation, vaccine (s) used, findings from postmortem examination, and examination of the death scene were reviewed. The present case described an infant patient (age, gender, medical history, risk factors and concomitant therapy not reported), who had received a dose of IPV vaccine (manufacturer unknown, batch number, route and site of administration not reported) and a dose of Diphtheria Tetanus and acellular Pertussis vaccine (as no DTaP from Sanofi Pasteur is marketed here, interpreted as other manufacturer, batch number, route and site of administration not reported) on an unspecified date. On an unspecified date after vaccination, the patient experienced sudden unexpected death in the first year of life. This case met the Brighton Collaboration Case Definition (BCCD) level III.


VAERS ID: 485581 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-25
Entered: 2013-02-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201301346

Write-up: Case retrieved from the literature on 13 February 2013. This case is linked with the reference case 2013-03135. The following is verbatim from the aforementioned article abstract: "BACKGROUND: Because the peak age for incidence of sudden death in infancy temporally coincides with the age of infant primary immunization, some have raised the question as to whether immunization is a risk factor for sudden death in infancy. Recent occurrence of two sudden deaths in infants has renewed concerns about the causal association between immunization and sudden deaths in infants. METHODS: We carried out a retrospective review of data. Results: From 1994 to 2011, a total of 45 cases of sudden deaths in the first 2 years of life following immunization were reported. The causes of death were classified as follows: infectious diseases (n = 13); accidental injuries (n =7); congenital abnormalities (n = 2); and malignancy (n = 1). Of 20 sudden deaths in infancy, nine deaths met Brighton Collaboration case definition level I and II, and therefore were classified as possible sudden infant death syndrome cases. Hepatitis B vaccine (n = 13) was the most frequent vaccine with temporal association with sudden deaths in the first 2 years of life. CONCLUSION: Few sudden deaths in the first 2 years of life following immunization have been reported, despite the use of universal immunization. The majority of deaths in infancy did not meet case definition for sudden infant death syndrome. Encouraging investigations to perform thorough investigation, including postmortem autopsy and death scene examination, may promote data comparability and provide guidance on decision-making in the vaccine-safety monitoring and response system." A retrospective review of data from 1994 to 2011 was carried out to describe the epidemiology of sudden death in the first 2 years of life following immunization. For each sudden death case, the demographic information, interval from immunization to presentation, vaccine(s) used, findings from postmortem examination, and examination of the death scene were reviewed. The present case described an infant patient (age, gender, medical history, risk factors and concomitant therapy not reported), who had received a dose of Haemophilus influenza type B vaccine (manufacturer unknown, batch number, route and site of administration not reported) and a dose of Pneumococcal conjugate vaccine (other manufacturer, batch number, route and site of administration not reported) on an unspecified date. On an unspecified date after vaccination, the patient experienced sudden unexpected death in the first year of life. This case met the Brighton Collaboration Case Definition (BCCD) level III.


VAERS ID: 485601 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-25
Entered: 2013-02-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201303137

Write-up: Case retrieved from the literature on 13 February 2013. This case is linked with the reference case: 2013-03135. The following is verbatim from the article abstract: BACKGROUND: Because the peak age for incidence of sudden deaths in infant temporally coincides with the age of infant primary immunization, some have raised the question as to whether immunization is a risk factor for sudden death in infancy. Recent occurrence of two sudden deaths in infants has renewed concerns about the causal association between immunization and sudden deaths in infants. METHODS: We carried out a retrospective review of data. RESULTS: From 1994 to 2011, a total of 45 cases of sudden deaths in the first 2 years of life following immunization were reported. The causes of death were classified as follows: infectious diseases (n = 13); accidental injuries (n =7); congenital abnormalities (n = 2); and malignancy (n = 1). Of 20 sudden deaths in infancy, nine deaths met Brighton Collaboration case definition level I and II, and therefore were classified as possible sudden infant death syndrome cases. Hepatitis B vaccine (n = 13) was the most frequent vaccine with temporal association with sudden deaths in the first 2 years of life. CONCLUSION: Few sudden deaths in the first 2 years of life following immunization have been reported, despite the use of universal immunization. The majority of deaths in infancy did not meet case definition for sudden infant death syndrome. Encouraging investigators to perform thorough investigation, including postmortem autopsy and death scene examination, may promote data comparability and provide guidance on decision-making in the vaccine-safety monitoring and response system. The present case described an infant patient (age, gender, medical history and risks factors not reported), who had received a dose of IPV vaccine (manufacturer unknown, batch number, route and site of administration not reported) and a dose of Diphtheria Tetanus and acellular Pertussis vaccine (as no DTaP from Sanofi Pasteur is marketed, interpreted as other manufacturer, batch number, route and site of administration not reported) on an unspecified date. On an unspecified date after vaccination, the patient experienced sudden unexpected death in the first year of life. This case met Brighton Collaboration Case Definition (BCCD) level I or II and was classified by the Author as possible sudden infant death syndrome (death in the first year of life which remained unexplained after autopsy). List of documents held by sender; none.


VAERS ID: 485603 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-25
Entered: 2013-02-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201303145

Write-up: This case is linked with the reference case 2013-03135. The following is verbatim from the article abstract: "BACKGROUND: Because the peak age for incidence of sudden deaths in infancy temporally coincides with the age of infant primary immunization, some have raised the question as to whether immunization is a risk factor for sudden death in infancy. Recent occurrence of two sudden deaths in infants has renewed concerns about the causal association between immunization and sudden deaths in infants. METHODS: We carried out a retrospective review of data. RESULTS: From 1994 to 2011, a total of 45 cases of sudden deaths in the first 2 years of life following immunization were reported. The causes of death were classified as follows: infectious diseases (n = 13); accidental injuries (n =7); congenital abnormalities (n = 2); and malignancy (n = 1). Of 20 sudden deaths in infancy, nine deaths met Brighton Collaboration case definition level I and II, and therefore were classified as possible sudden infant death syndrome cases. Hepatitis B vaccine (n = 13) was the most frequent vaccine with temporal association with sudden deaths in the first 2 years of life. CONCLUSION: Few sudden deaths in the first 2 years of life following immunization have been reported, despite the use of universal immunization. The majority of deaths in infancy did not meet case definition for sudden infant death syndrome. Encouraging investigators to perform thorough investigation, including postmortem autopsy and death scene examination, may promote data comparability and provide guidance on decision-making in the vaccine-safety monitoring and response system. A retrospective review of data from 1994 to 2011 was carried out to describe the epidemiology of sudden death in the first 2 years of life following immunization. For each sudden death case, the demographic information, interval from immunization to presentation, vaccine(s) used, findings from post-mortem examination, and examination of the death scene were reviewed. The present case described an infant patient (age, gender, medical history, risk factors and concomitant therapy not reported), who had received a dose of Haemophilus influenza B vaccine (manufacturer unknown, batch number, route and site of administration not reported) and a dose of Pneumococcal conjugate vaccine (other manufacturer, batch number, route and site of administration not reported) on an unspecified date. On an unspecified date after vaccination, the patient experienced sudden unexpected death in the first year of life. This case met the Brighton Collaboration Case Definition (BCCD) level III.


VAERS ID: 485604 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-25
Entered: 2013-02-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201303135

Write-up: Case retrieved from the literature on 13 February 2013. This case is the reference and is linked with 11 cases 2013-03137, 2013-03138, 2013-03139, 2013-03140, 2013-03141, 2031-03142, 2013-03143, 2013-03144, 2013-03145, 2013-03146, 2013-03276 (issued from the same article). The following is verbatim from the article abstract: "BACKGROUND: Because the peak age for incidence of sudden deaths in infancy temporally coincides with the age of infant primary immunization, some have raised the question as to whether immunization is a risk factor for sudden death in infancy. Recent occurrence of two sudden deaths in infants has renewed concerns about the causal association between immunization and sudden deaths in infants. METHODS: We carried out a retrospective review of data from the foreign Centers of Disease Control and Prevention Adverse Events Following Immunization Surveillance System and Vaccine Compensation programs. RESULTS: From 1994 to 2011, a total of 45 cases of sudden deaths in the first 2 years of life following immunization were reported. The causes of death were classified as follows: infectious diseases (n = 13); accidental injuries (n =7); congenital abnormalities (n = 2); and malignancy (n = 1). Of 20 sudden deaths in infancy, nine deaths met Brighton Collaboration case definition level I and II, and therefore were classified as possible sudden infant death syndrome cases. Hepatitis B vaccine (n = 13) was the most frequent vaccine with temporal association with sudden deaths in the first 2 years of life. CONCLUSION: Few sudden deaths in the first 2 years of life following immunization have been reported, despite the use of universal immunization. The majority of deaths in infancy did not meet case definition for sudden infant death syndrome. Encouraging investigators to perform thorough investigation, included postmortem autopsy and death scene examination, may promote data comparability and provide guidance on decision-making in the vaccine-safety monitoring and response system." The present case described in infant patient (age, gender, medical history and risks factors not reported), who had received a dose of IPV vaccine (manufacturer unknown, batch number, route and site of administration not reported) and a dose of Diphtheria Tetanus and acellular Pertussis vaccine (as no DTaP from Sanofi Pasteur is marketed, interpreted as other manufacturer, batch number, route and site of administration not reported) on an unspecified date. On an unspecified date after vaccination, the patient experienced sudden unexpected death in the first year of life. This case met the Brighton Collaboration Case Definition (BCCD) level I or II and was classified by the Author as possible Sudden Infant death syndrome (death in the first year of life which remained unexplained after autopsy). List of documents held by sender; none.


VAERS ID: 485691 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-26
Entered: 2013-02-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201303276

Write-up: Case retrieved from the literature on 13 February 2013. This case is linked with the reference case 2013-03135. The following is verbatim from the article abstract: "BACKGROUND: Because the peak age for incidence of sudden deaths in infancy temporally coincides with the age of infant primary immunization, some have raised the question as to whether immunization is a risk factor for sudden death in infancy. Recent occurrence of two sudden deaths in infants has renewed concerns about the causal association between immunization and sudden deaths in infants. METHODS: We carried out a retrospective review of data from the foreign Centers of Disease Control and Prevention Adverse Events Following Immunization Surveillance System and Vaccine Compensation programs. RESULTS: From 1994 to 2011, a total of 45 cases of sudden deaths in the first 2 years of life following immunization were reported. The causes of death were classified as follows: infectious diseases (n = 13); accidental injuries (n =7); congenital abnormalities (n = 2); and malignancy (n = 1). Of 20 sudden deaths in infancy, nine deaths met Brighton Collaboration case definition level I and II, and therefore were classified as possible sudden infant death syndrome cases. Hepatitis B vaccine (n = 13) was the most frequent vaccine with temporal association with sudden deaths in the first 2 years of life. CONCLUSION: Few sudden deaths in the first 2 years of life following immunization have been reported, despite the use of universal immunization. The majority of deaths in infancy did not meet case definition for sudden infant death syndrome. Encouraging investigators to perform thorough investigation, included postmortem autopsy and death scene examination, may promote data comparability and provide guidance on decision-making in the vaccine-safety monitoring and response system." The present case described an infant patient (age, gender, medical history, risk factors and concomitant therapy not reported), who had received a dose of Hib vaccine (manufacturer unknown, batch number, route and site of administration not reported) on an unspecified date. On an unspecified date after vaccination, the patient experienced sudden unexpected death in the first year of life. This case met the Brighton Collaboration Case Definition (BCCD) level III. List of documents held by sender: none.


VAERS ID: 485753 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-02-25
Entered: 2013-02-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis pneumococcal
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013067453

Write-up: This is a spontaneous report from a contactable pharmacist. A 4-year-old female patient received three doses of PREVENAR in 2008 to 2009. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient died from pneumococcal meningitis. The pneumococcal serotype was not provided.


VAERS ID: 486038 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-26
Onset:2013-02-04
   Days after vaccination:101
Submitted: 2013-03-01
   Days after onset:25
Entered: 2013-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA692DA / UNK UN / UN

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-02-09
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Multiple myeloma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: H1N1 Influenza PCR positive, 09Feb2013, positive
CDC Split Type: D0078940A

Write-up: This case was reported by a health professional, via local health authority, via a foreign regulatory authority (# DE-PEI-PEI2013009993) and described the occurrence of influenza A (H1N1) infection in a 75-year-old female subject who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). Concurrent medical conditions included multiple myeloma type IgA. On 26 October 2012 the subject received an unspecified dose of INFLUSPLIT SSW (unknown route and application site). On 4 February 2013, 101 days after vaccination with INFLUSPLIT SSW, the subject experienced influenza A (H1N1) infection. The subject was hospitalised for 6 days since 04 February 2013. The regulatory authority reported that the events were life threatening. Influenza A (H1N1) infection was confirmed by PCR. The subject died on 9 February 2013 from influenza a (h1n1) infection. It was unknown whether an autopsy was performed. Foreign regulatory authority has requested further information.


VAERS ID: 486168 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-03-05
Entered: 2013-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antibody test, Bacteraemia, Death, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Univentricular heart; Asplenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Antibody to the infecting serotype IgG(ug/ml): 0.57; Opsonization indice (OI) was not tested because of antibiotic use. Serotype 9V
CDC Split Type: WAES1302JPN009568

Write-up: Information has been received from a published literature article. Streptococcus pneumoniae is a leading human pathogen that causes a wide variety of diseases, ranging from otitis media to pneumonia, bacteremia, and meningitis in both children and adults. Vaccine-induced protective immunity is currently estimated by measuring the concentrations of serotype-specific immunoglobulin G (IgG) using enzyme-linked immunosorbent assay (ELISA) the opsonization index (OI) using a multiplex-opsonophagocytic assay (MOPA). The World Health Organization working group suggested a serotype-specific IgG of concentration of 0.35 mg/ml as a putative measure of protection at a population level against invasive disease in infants after immunization with pneumococcal conjugate vaccine. This working group also reported that antibody concentrations of 0.2-0.35 mg/ml measured with the ELISA using serum without serum absorption with 22F polysaccharide correlated best with an OI of 8, which in turn correlates best with protective efficacy. Serotype-specific protective immunity in pediatric patients with invasive pneumococcal disease (IPD) has not been fully investigated. To determine the protective immunity to the infecting serotype, the serotype-specific immunoglobulin G (IgG) levels and opsonization indices (OIs) were examined in 24 pediatric patients whose serum was collected within one month of an IPD episode between May 2008 and June 2011. The median age (range) of IPD patients was 17 (10-108) months and 63% were boys. Four patients (17%) had associated comorbid conditions including immune thrombocytopenia and splenectomy, meningoencephalocele, asplenia and single ventricle, and hydrocephalus (V-P shunt). In the 24 examined, the most common infecting serotype was 6B (9 isolates, 38%), followed by 19F (4 isolates, 17%), 19A (3 isolates, 13%), 6C and 14 (2 isolates each 8%) and one isolate each of 9V, 15B, 23F and 24F (4%). The median (range) period from the onset of IPD to the time of serum collection was two (0-23) days. Three patients received 23-valent pneumococcal polysaccharide vaccine (PPV23) due to pre-existing medical conditions. Before their episode of IPD, two patients infected with serotype 19F and one patient infected with serotype 9V received PPV23. Because PPV23 contains serotypes 19F and 9V, all three cases were considered PPV23 vaccine failure (VF). Case 3 (one of the three patients) was a 75 months male patient. Before IPD the patient was vaccinated with one dose of PPV23 at age of 24 months. The patient was diagnosed as bacteremia. The patient''s comorbid conditions were asplenia and single ventricle. The patient was infected with serotype 9V, and the serum was obtained 1 day after IPD. Antibody to the infecting serotype was IgG 0.57 ug/ml and OI was not tested because of antibiotic use. Category of IPD after PPV23 was vaccine failure. The patient outcome was death. Date of death and cause of death were unspecified. Three patients received PPV23 before PCV7 was licensed in 2009 because they were at increased risk for pneumococcal disease. Although the current guideline of the ACIP recommends that children aged 2-18 years with underlying medical conditions should receive PPV23 after completing all recommended doses of PCV13, pediatricians should be aware of the possible induction of nonfunctional IgG by PPV23 in high-risk children aged $g2 years. This is one of several reports received from the same literature. Additional information is not expected. 05MAR2013 This is a corrected report. The event of death was added.


VAERS ID: 486193 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Male  
Location: Foreign  
Vaccinated:2013-01-15
Onset:2013-01-17
   Days after vaccination:2
Submitted: 2013-03-05
   Days after onset:47
Entered: 2013-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA847B / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bordetella test negative, Citrobacter test positive, Death, Disseminated intravascular coagulation, Multi-organ failure, Myoglobinaemia, Myoglobinuria, Polymerase chain reaction, Respiratory syncytial virus test negative, Resuscitation, Rhabdomyolysis, Sudden infant death syndrome, Thrombocytopenia, Transaminases increased
SMQs:, Rhabdomyolysis/myopathy (narrow), Liver related investigations, signs and symptoms (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad), Neonatal disorders (narrow), Proteinuria (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-01-18
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Perianal Abscess Operation
Allergies:
Diagnostic Lab Data: Citrobacter freundii test posi, Jan2013, positive; Pertussis serology negative, Jan2013, PCR negative; Respiratory syncytial virus te, Jan2013, negative
CDC Split Type: D0078975A

Write-up: This case was reported by a physician via a foreign regulatory authority (# DE-PEI-PEI2013011701) and described the occurrence of sudden infant death syndrome (SIDS) in a 4-month-old male subject who was vaccinated with INFANRIX-IPV+HIB (GlaxoSmithKline). The subject''s medical history included perianal abscess operation in October 2012. At the time of vaccination the subject was in good general condition. The subject was sleeping frequently in prone position. Concomitant medication was not reported. The subject did not receive a concomitant dose of PREVENAR 13 (Pfizer Pharma) (non-GSK) by wish of the subject''s mother. On 15 January 2013 the subject received the first dose of INFANRIX-IPV+HIB (0.5 ml, unknown). Approximately two days post vaccination with INFANRIX-IPV+HIB, on 17 January 2013 during daytime, the subject was found lifeless in the baby stroller in prone position after an airing at wintery frosty temperatures. Primary cardiopulmonary resuscitation (CPR) was successful. The subject was hospitalised for two days. After about another 21 hours, on 18 January 2013, the subject died from sudden infant death syndrome (SIDS) and treatment refractory multiorgan failure. Symptoms of multiorgan failure included thrombocytopenia, disseminated intravascular coagulation, rhabdomyolysis, myoglobinemia, myoglobinuria and increased transaminases. Gastric juice aspirate was positive for Citrobacter freundii. Respiratory syncytial virus (RSV) quick test and pertussis polymerase chain reaction (PCR) were negative. The subject died from sudden infant death syndrome (SIDS), by definition death due to unknown cause. Nevertheless, the district attorney / public prosecutor did not order an autopsy. Therefore an autopsy was not performed. The reporting physician considered that death of the subject was temporally linked to vaccination with INFANRIX-IPV+HIB two days prior to onset of the events. No further information will be available.


VAERS ID: 486351 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2013-02-22
Onset:0000-00-00
Submitted: 2013-03-05
Entered: 2013-03-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS AC1CB487A / 1 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G43561 / 1 RL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-23
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: 2013073088

Write-up: This is a spontaneous report from a contactable physician received via company representative. The 3-month-old female patient was vaccinated on 22Feb2013 around 10:30 with first dose of PREVENAR 13 (lot# PAA012842/G43561, expiration date: Aug2014) single dose in right thigh in combination with INFANRIX HEXA (lot number AC1CB487A) single dose in left thigh. The patient died on 23Feb2013 around 17:13. Event was reported as: status post infant death of unknown origin on 23Feb2013 at 17:13. Event was reported as life-threatening with fatal outcome. The patient''s father was carrying his child in a wraparound garment for babies but as he wanted to swaddle the child, he was noticing that she was not alive anymore. The emergency doctor who was called was not able to resuscitate the patient. An aspiration could not be confirmed. The physician did not want to administer this lot of PREVENAERT 13 anymore and asked for compensation. Follow-up (01Mar2013): New information received from local product quality complaints group includes: There could not be found any further reports like this one affected lot number (G43561).


VAERS ID: 486423 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-03-05
Entered: 2013-03-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Blood immunoglobulin E, Blood immunoglobulin G, Blood immunoglobulin M, CSF test, Death, Decreased appetite, HIV test negative, Hepatitis B test negative, Hepatitis C test negative, Muscular weakness, Parasite urine test negative, Parasitic blood test negative, Polymerase chain reaction, Pyrexia, Yellow fever vaccine-associated viscerotropic disease
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Human immunodeficiency virus (HIV) and Hepatitis B/C tests were negative. Malaria test was positive. Results of lab tests performed on acute serum or plasma sample taken at onset of symptoms showed IgM (1:10) and IgG (1:100) were not available. Results of IgM level measured on convalescent serum sample (sample taken at 21-35 days after onset of symptoms) and cerebro-spinal fluid (CSF) were not available. Results of YF real-time reverse transcription-quantitative polymerase chain reaction (YF RT-qPCR) in CSF, serum, blood or plasma and urine were not available.Results of reciprocal neutralization titer (1:x) and total IgE were not available. The time between vaccination and sample collection for the analyses to be conducted at the the Institute was not available.
CDC Split Type: 201303430

Write-up: Case retrieved from the literature on 22 February 2013. A total of 22 cases were created corresponding to the cases classified as possible Yellow Fever (YF) vaccine reactions. This case is linked with the reference case 2013-03410. Abstract: "BACKGROUND Serious, but rare adverse events following immunization (AEFI) have been reported with yellow fever (YF) 17D vaccine, including severe allergic reactions, YF vaccine-associated neurologic disease (YEL-AND) and YF vaccine-associated viscerotropic disease (YEL-AVD). The frequency with which YEL-AND and YEL-AVD occur in YF endemic countries is mostly unknown. METHOD: From 2007 to 2010, eight countries - implemented large-scale YF preventive vaccination campaigns. Each country established vaccine pharmacovigilance systems that included standard case definitions, procedures to collect and transport biological specimens, and National Expert Committees to review data and classify cases. Staff in all countries received training and laboratory capacity expanded. RESULTS: In total, just over 38 million people were vaccinated against YF and 3116 AEFIs were reported of which 164 (5%) were classified as serious. Of these, 22 (13%) were classified as YF vaccine reactions, including 11 (50%) hypersensitivity reactions, six (27%) suspected YEL-AND, and five (23%) suspected YEL-AVD. The incidence per 100,000 vaccine does administered was 8.2 for all reported AEFIs, 0.43 for any serious AEFI, 0.058 for YF vaccine related AEFIs, 0.029 for hypersensitivity reactions, 0.016 for YELAND, and 0.013 for YEL-AVD. Our findings were limited by operational challenges, including difficulties in obtaining recommended biological specimens leading to incomplete laboratory evaluation, unknown case ascertainment, and variablelevels of staff training and experience. CONCLUSIONS: Despite limitations, active case-findings in the eight different countries did not find an incidence of YF vaccine associated AEFIs that was higher than previous reports. These data reinforce the safety profile of YF vaccine and support the continued use of attenuated YF vaccine during preventative mass vaccination campaigns in YF endemic areas." Study design and setting: "From 2007 to 2010, active surveillance of serious AEFIs was undertaken during preventative YF vaccination campaigns. All countries were included in the analysis except one country due to unavailability of the national database. Both the 17D-204 and 17DD YF substrain vaccines were 73 used." The present case described a 15-year-old male patient, with no reported medical history and concomitant therapy, who had received a dose of Yellow fever vaccine (manufacturer unknown. batch number, route and site of administration not reported) on an unspecified date. Four days post-vaccination, the patient developed abdominal pain, fever, muscle weakness and anorexia as primary symptoms. Six days post-vaccination, the patient had her first clinical evaluation. The diagnosis was yellow fever vaccine-associated viscerotropic disease (YEL-AVD) with viscerotropic reaction. Brighton viscerotropic disease case definition was not fulfilled. Human immunodeficiency virus (HIV) and Hepatitis B/C tests were negative. Malaria test was positive. Results of lab tests performed on acute serum or plasma sample taken at onset of symptoms showed IgM (1:10) and IgG (1:100). Results of IgM level measured on convalescent serum sample (sample taken at 21-35 days after onset of symptoms) and cerebro-spinal fluid (CSF) were not available. Results of YF real-time reverse transcription-quantitative polymerase chain reaction (YF RT-qPCR) in CSF, serum, blood or plasma and urine were not available.Results of reciprocal neutralization titer (1:x) and total IgE were not available. The time between vaccination and sample collection for the analyses to be conducted at the the Institute was not available. The patient died on an unspecified date. No autopsy was done.


VAERS ID: 486435 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-03-05
Entered: 2013-03-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Antibody test, Blood immunoglobulin E, Blood immunoglobulin G increased, Blood immunoglobulin M, Blood immunoglobulin M normal, CSF immunoglobulin, CSF test normal, Convulsion, Death, Flavivirus test positive, HIV test negative, Headache, Mental status changes, Neurological symptom, Parasitic blood test negative, Parasitic test, Polymerase chain reaction, Pyrexia, Treponema test negative, Treponema test positive, Yellow fever vaccine-associated neurotropic disease
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Not reported
Allergies:
Diagnostic Lab Data: Human immunodeficiency virus (HIV) test was positive. Result of malaria test was negative. Results of syphilis tests showed VDRL positive and TPHA (Treponema Pallidum Hemagglutination assay) test negative. Results of lab tests performed on acute serum or plasma sample taken at onset of symptoms showed IgM (1:10) negative (no detectable anti-YFV antibodies or genome) and IgG (1:100) strongly positive (strongly positive detection of anti-YFV antibodies more than 1:500). Results of IgM level measured on convalescent serum sample (sample taken at 21-35 days after onset of symptoms) were not available. In CSF, IgM (1:10) was negative and IgG (1:100) was positive. Results of YF real-time reverse transcription-quantitative polymerase chain reaction (YF RT-qPCR) in urine were not available; and in serum, blood or plasma and CSF were negative. Results of reciprocal neutralization titer (1:x) were not available. Results of total IgE was not available. The time between vaccination and sample collection for the analyses to be conducted at the Institute was 6 days.
CDC Split Type: 201303427

Write-up: Case retrieved from the literature on 22 February 2013. A total of 22 cases were created corresponding to the cases classified as possible Yellow Fever (YF) vaccine reactions. This case is linked with the reference case 2013-03410. Abstract: "BACKGROUND Serious, but rare adverse events following immunization (AEFI) have been reported with yellow fever (YF) 17D vaccine, including severe allergic reactions, YF vaccine-associated neurologic disease (YEL-AND) and YF vaccine-associated viscerotropic disease (YEL-AVD). The frequency with which YEL-AND and YEL-AVD occur in YF endemic countries is mostly unknown. METHOD: From 2007 to 2010, eight foreign countries implemented large-scale YF preventive vaccination campaigns. Each country established vaccine pharmacovigilance systems that included standard case definitions, procedures to collect and transport biological specimens, and National Expert Committee to review data and classify cases. Staff in all countries received training and laboratory capacity expanded. RESULTS: In total, just over 38 million people were vaccinated against YF and 3116 AEFIs were reported of which 164 (5%) were classified as serious. Of these, 22 (13%) were classified as YF vaccine reactions, including 11 (50%) hypersensitivity reactions, six (27%) suspected YEL-AND, and five (23%) suspected YEL-AVD. The incidence per 100,000 vaccine doses administered was 8.2 for all reported AEFIs, 0.43 for any serious AEFI, 0.058 for YF vaccine related AEFIs, 0.029 for hypersensitivity reactions, 0.016 for YELAND, and 0.013 for YEL-AVD. Our findings were limited by operational challenges, including difficulties in obtaining recommended biological specimens leading to incomplete laboratory evaluation, unknown case ascertainment, and variable levels of staff training and experience. CONCLUSIONS: Despite limitations, active case-finding in the eight different countries did not find an incidence of YF vaccine associated AEFIs that was higher than previous reports. These data reinforce the safety profile of YF vaccine and support the continued use of attenuated YF vaccine during preventive mass vaccination campaigns in YF endemic areas." Study design and setting: "From 2007 to 2010, active surveillance of serious AEFIs was undertaken during preventive YF vaccination campaigns in several countries. All countries were included in the analysis except one due to unavailability of the national database. Both the 17D-204 and 17DD YF substrain vaccines were 73 used." The present case described a 42-year-old female patient, with no reported medical history and concomitant therapy, who had received a dose of Yellow fever vaccine (manufacturer unknown, batch number, route and site of administration not reported) on an unspecified date. Two days post-vaccination, the patient developed fever, headache, generalized convulsions and altered mental status as primary symptoms. Six days post-vaccination, the patient had her first clinical evaluation. The diagnosis was yellow fever vaccine-associated neurotropic disease (YEL-AND) with neurologic reaction, Brighton encephalitis case definition was not fulfilled. Human immunodeficiency virus (HIV) test was positive. Result of malaria test was negative. Results of syphilis tests showed VDRL positive and TPHA (Treponema Pallidum Hemagglutination assay) test was negative. Results of lab tests performed on acute serum or plasma sample taken at onset of symptoms showed IgM (1:10) negative (no detectable anti-YFV antibodies or genome) and IgG (1:100) strongly positive (strongly positive detection of anti-YFV antibodies more than 1:500). Results of IgM level measured on convalescent serum sample (sample taken at 21-35 days after onset of symptoms) were not available. In CSF, IgM (1:10) was negative and IgG (1:100) was positive. Results of YF real-time reverse transcription-quantitative polymerase chain reaction (YF RT-qPCR) in urine were not available; and in serum, blood or plasma and CSF were negative. Results of reciprocal neutralization titer (1:x) were not available. Results of total IgE was not available. The time between vaccination and sample collection for the analyses to be conducted at the Institute was 6 days. The patient died on an unspecified date. No autopsy was done.


VAERS ID: 486439 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-03-05
Entered: 2013-03-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Antibody test, Blood immunoglobulin E, Blood immunoglobulin G, Blood immunoglobulin M, CSF test, Death, Face oedema, HIV test negative, Hypersensitivity, Nephritic syndrome, Oedema peripheral, Parasite urine test negative, Parasitic blood test negative, Polymerase chain reaction, Pyrexia, Yellow fever vaccine-associated viscerotropic disease
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Hypersensitivity (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Human immunodeficiency virus (HIV) and malaria tests were negative. No further tests were performed to evaluate other etiologies. Results of lab tests performed on acute serum or plasma sample taken at onset of symptoms showed IgM (1:10) and IgG (1:100) were not available. Results of IgM level measured on convalescent serum sample (sample taken at 21-35 days after onset of symptoms) and cerebro-spinal fluid (CSF) were not available. Results of YF real-time reverse transcription-quantitative polymerase chain reaction (YF RT-qPCR) in CSF, serum, blood or plasma, and urine were not available. Results of reciprocal neutralization titer (1:x) and total IgE were not available. The time between vaccination and sample collection for the analysis to be conducted at the Institute was not available.
CDC Split Type: 201303437

Write-up: Case retrieved from the literature on 22 February 2013. A total of 22 cases were created corresponding to the cases classified as possible Yellow Fever (YF) vaccine reactions. This case is linked with the reference case 2013-03410. "BACKGROUND Serious, but rare adverse events following immunization (AEFI) have been reported with yellow fever (YF) 17D vaccine, including severe allergic reactions, YF vaccine-associated neurologic disease (YEL-AND) and YF vaccine-associated viscerotropic disease (YEL-AVD). The frequency with which YEL-AND and YEL-AVD occur in YF endemic countries is mostly unknown. METHOD: From 2007 to 2010, eight countries - implemented large-scale YF preventive vaccination campaigns. Each country established vaccine pharmacovigilance systems that included standard case definitions, procedures to collect and transport biological specimens, and National Expert Committees to review data and classify cases. Staff in all countries received training and laboratory capacity expanded. RESULTS: In total, just over 38 million people were vaccinated against YF and 3116 AEFIs were reported of which 164 (5%) were classified as serious. Of these, 22 (13%) were classified as YF vaccine reactions, including 11 (50%) hypersensitivity reactions, six (27%) suspected YEL-AND, and five (23%) suspected YEL-AVD. The incidence per 100,000 vaccine doses administered was 8.2 for all reported AEFIs, 0.43 for any serious AEFI, 0.058 for vaccine related AEFIs, 0.029 for hypersensitivity reactions, 0.016 for YELAND, and 0.013 for YEL-AVD. Our findings were limited by operational challenges, including difficulties in obtaining recommended biological specimens leading to incomplete laboratory evaluation, unknown case ascertainment, and variable levels of staff training and experience. CONCLUSIONS: Despite limitations, active case-finding in the eight different countries did not find an incidence of YF vaccine associated AEFIs that was higher than previous reports. These data reinforce the safety profile of YF vaccine and support the continued use of attenuated YF vaccine during preventative mass vaccination campaigns in YF endemic areas." Study design and setting: "From 2007 to 2010, active surveillance of serious AEFIs was undertaken during preventative YF vaccination campaigns. All countries were included in the analysis but one due to unavailability of the national database. Both the 17D-204 and 17DD YF substrain vaccines were 73 used." The present case described a 05-year-old female patient, with no reported medical history and concomitant therapy, who had received a dose of Yellow fever vaccine (manufacturer unknown, batch number, route and site of administration not reported) on an unspecified date. Nine days post-vaccination, the patient developed fever, facial and lower extremities oedema as primary symptoms. Fifteen days post-vaccination, the patient had her first clinical evaluation. The diagnosis was yellow fever vaccine-associated viscerotropic disease (YEL-AVD) with viscerotropic reaction, nephritic syndrome and allergy. Brighton viscerotropic disease case definition was not fulfilled. Human immunodeficiency virus (HIV) and malaria tests were negative. No further tests were performed to evaluate other etiologies. Results of lab tests performed on acute serum or plasma sample taken at onset of symptoms showed IgM (1:10) and IgG (1:100). Results of IgM level measured on convalescent serum sample (sample taken at 21-35 days after onset of symptoms) and cerebro-spinal fluid (CSF) were not available. Results of YF real-time reverse transcription-quantitative polymerase chain reaction (YF RT-qPCR) in CSF, serum, blood or plasma, and urine were not available. Results of reciprocal neutralization titer (1:x) and total IgE were not available. The time between vaccination and sample collection for the analyses to be conducted at the Institute was not available. The patient died on an unspecified date. No autopsy was done.


VAERS ID: 486443 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-03-05
Entered: 2013-03-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood immunoglobulin E, Blood immunoglobulin G, Blood immunoglobulin M, CSF immunoglobulin, Death, Faeces discoloured, HIV test, Haemorrhagic disorder, Malaria antibody test, Polymerase chain reaction, Pyrexia, Vomiting, Yellow fever vaccine-associated viscerotropic disease
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Results of malaria test and Human immunodeficiency virus (HIV) were not available. Results of lab tests performed on acute serum or plasma sample taken at onset of symptoms (IgM and IgG) were not available. Results of IgM and IgG level measured on convalescent serum sample (sample taken at 21-35 days after onset of symptoms) and cerebro-spinal fluid (CSF) were not available. Results of YF real-time reverse transcription-quantitative polymerase chain reaction (YF RT-qPCR) were not available in serum, urine, blood or plasma or CSF. Results of reciprocal neutralization titer (1:x) were not available. Results of total IgE was not available.
CDC Split Type: 201303439

Write-up: Case retrieved from the literature on 22 February 2013. A total of 22 cases were created corresponding to the cases classified as possible Yellow Fever (YF) vaccine reactions. This case is linked with the reference case 2013-03410. Abstract: "BACKGROUND Serious, but rare adverse events following immunization (AEFI) have been reported with yellow fever (YF) 17D vaccine, including severe allergic reactions, YF vaccine-associated neurologic disease (YEL-AND) and YF vaccine-associated viscerotropic disease (YEL-AVD). The frequency with which YEL-AND and YEL-AVD occur in YF endemic countries is mostly unknown. METHOD: From 2007 to 2010, eight countries - implemented large-scale YF preventive vaccination campaigns. Each country established vaccine pharmacovigilance systems that included standard case definitions, procedures to collect and transport biological specimens, and National Expert Committees to review data and classify cases. Staff in all countries received training and laboratory capacity expanded. RESULTS: In total, just over 38 million people were vaccinated against YF and 3116 AEFIs were reported of which 164 (5%) were classified as serious. Of these, 22 (13%) were classified as YF vaccine reactions, including 11 (50%) hypersensitivity reactions, six (27%) suspected YEL-AND, and five (23%) suspected YEL-AVD. The incidence per 100,000 vaccine does administered was 8.2 for all reported AEFIs, 0.43 for any serious AEFI, 0.058 for YF vaccine related AEFIs, 0.029 for hypersensitivity reactions, 0.016 for YELAND, and 0.013 for YEL-AVD. Our findings were limited by operational challenges, including difficulties in obtaining recommended biological specimens leading to incomplete laboratory evaluation, unknown case ascertainment, and variablelevels of staff training and experience. CONCLUSIONS: Despite limitations, active case-findings in the eight different countries did not find an incidence of YF vaccine associated AEFIs that was higher than previous reports. These data reinforce the safety profile of YF vaccine and support the continued use of attenuated YF vaccine during preventative mass vaccination campaigns in YF endemic areas." Study design and setting: "From 2007 to 2010, active surveillance of serious AEFIs was undertaken during preventative YF vaccination campaigns. All countries were included in the analysis except one country due to unavailability of the national database. Both the 17D-204 and 17DD YF substrain vaccines were 73 used." The present case described a 40-year-old female patient, with no reported medical history and concomitant therapy, who had received a dose of Yellow fever vaccine (manufacturer unknown. batch number, route and site of administration not reported) on an unspecified date. Less than 1 day post-vaccination, the patient developed black stools, nausea, (black vomiting) and fever. The patient had her first clinical evaluation less than 1 day post-vaccination. The diagnosis was viscerotropic reaction and hemorrhagic syndrome. Brighton viscerotropic disease case definition was not fulfilled. No other etiologies were evaluated. Results of malaria test and Human immunodeficiency virus (HIV) were not available. Results of lab tests performed on acute serum or plasma sample taken at onset of symptoms (IgM and IgG) were not available. Results of IgM and IgG level measured on convalescent serum sample (sample taken at 21-35 days after onset of symptoms) and cerebro-spinal fluid (CSF) were not available. Results of YF real-time reverse transcription-quantitative polymerase chain reaction (YF RT-qPCR) in CSF, serum, blood or plasma and urine were not available.Results of reciprocal neutralization titer (1:x) were not available. Results of total IgE was not available. The time between vaccination and sample collection for the analyses to be conducted at the the Institute was not available. The patient died on an unspecified date. No autopsy was done.


VAERS ID: 486444 (history)  
Form: Version 1.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-03-05
Entered: 2013-03-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Blood immunoglobulin E, Blood immunoglobulin G, Blood immunoglobulin M, CSF immunoglobulin, Coma, Death, HIV test, Haemorrhage, Jaundice, Malaria antibody test positive, Polymerase chain reaction, Yellow fever vaccine-associated viscerotropic disease
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Result of human immunodeficiency virus (HIV) test was not available. Malaria test was positive. No additional tests were performed to evaluate other etiologies. Results of lab tests performed on acute serum or plasma sample taken at onset of symptoms showed IgM (1:10) and IgG (1:100) were not available. Results of IgM level measured on convalescent serum sample (sample taken at 21-35 days after onset of symptoms) and cerebro-spinal fluid (CSF) were not available. Results of YF real-time reverse transcription-quantitative polymerase chain reaction (YF RT-qPCR) in CSF, serum, blood or plasma, and urine were not available. Results of reciprocal neutralization titer (1:x) and total IgE were not available. The time between vaccination and sample collection for the analyses to be conducted at the Institute was not available.
CDC Split Type: 201303432

Write-up: Case retrieved from the literature on 22 February 2013. A total of 22 cases were created corresponding to the cases classified as possible Yellow Fever (YF) vaccine reactions. This case is linked with the reference case 2013-03410. "BACKGROUND Serious, but rare adverse events following immunization (AEFI) have been reported with yellow fever (YF) 17D vaccine, including severe allergic reactions, YF vaccine-associated neurologic disease (YEL-AND) and YF vaccine-associated viscerotropic disease (YEL-AVD). The frequency with which YEL-AND and YEL-AVD occur in YF endemic countries is mostly unknown. METHOD: From 2007 to 2010, eight countries - implemented large-scale YF preventive vaccination campaigns. Each country established vaccine pharmacovigilance systems that included standard case definitions, procedures to collect and transport biological specimens, and National Expert Committees to review data and classify cases. Staff in all countries received training and laboratory capacity expanded. RESULTS: In total, just over 38 million people were vaccinated against YF and 3116 AEFIs were reported of which 164 (5%) were classified as serious. Of these, 22 (13%) were classified as YF vaccine reactions, including 11 (50%) hypersensitivity reactions, six (27%) suspected YEL-AND, and five (23%) suspected YEL-AVD. The incidence per 100,000 vaccine doses administered was 8.2 for all reported AEFIs, 0.43 for any serious AEFI, 0.058 for vaccine related AEFIs, 0.029 for hypersensitivity reactions, 0.016 for YELAND, and 0.013 for YEL-AVD. Our findings were limited by operational challenges, including difficulties in obtaining recommended biological specimens leading to incomplete laboratory evaluation, unknown case ascertainment, and variable levels of staff training and experience. CONCLUSIONS: Despite limitations, active case-finding in the eight different countries did not find an incidence of YF vaccine associated AEFIs that was higher than previous reports. These data reinforce the safety profile of YF vaccine and support the continued use of attenuated YF vaccine during preventative mass vaccination campaigns in YF endemic areas." Study design and setting: "From 2007 to 2010, active surveillance of serious AEFIs was undertaken during preventative YF vaccination campaigns. All countries were included in the analysis but one due to unavailability of the national database. Both the 17D-204 and 17DD YF substrain vaccines were 73 used." The present case described a 34-year-old male patient, with no reported medical history and concomitant therapy, who had received a dose of Yellow fever vaccine (manufacturer unknown, batch number, route and site of administration not reported) on an unspecified date. Four days post-vaccination, the patient developed jaundice and bleeding as primary symptoms. Coma was also reported as primary symptom. Six days post-vaccination, the patient had her first clinical evaluation. The diagnosis was yellow fever vaccine-associated viscerotropic disease (YEL-AVD) with viscerotropic reaction; Brighton viscerotropic disease case definition was not fulfilled. Result of human immunodeficiency virus (HIV) test was not available. Malaria test was positive. No additional tests were performed to evaluate other etiologies. Results of lab tests performed on acute serum or plasma sample taken at onset of symptoms showed IgM (1:10) and IgG (1:100). Results of IgM level measured on convalescent serum sample (sample taken at 21-35 days after onset of symptoms) and cerebro-spinal fluid (CSF) were not available. Results of YF real-time reverse transcription-quantitative polymerase chain reaction (YF RT-qPCR) in CSF, serum, blood or plasma, and urine were not available. Results of reciprocal neutralization titer (1:x) and total IgE were not available. The time between vaccination and sample collection for the analyses to be conducted at the Institute was not available. The patient died on an unspecified date. Autopsy was done, but the autopsy samples obtained could not be analysed at the Institute due to problems with the international shipment.


VAERS ID: 486432 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-03-05
Entered: 2013-03-08
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaphylactic shock, Antibody test, Blood immunoglobulin E, Blood immunoglobulin G, Blood immunoglobulin M, CSF immunoglobulin, CSF test, Death, HIV test, Hypersensitivity, Loss of consciousness, Parasitic test, Polymerase chain reaction, Viral test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No reported
Allergies:
Diagnostic Lab Data: The diagnosis was hypersensitivity with anaphylactic shock; Brighton anaphylaxis case definition was not fulfilled. Result of human immunodeficiency virus (HIV) and malaria tests were not available. No further tests were performed to evaluate other etiologies. Results of lab tests performed on acute serum or plasma sample taken at onset of symptoms showed IgM (1:10) and IgG (1:100) were not available. Results of IgM level measured on convalescent serum sample (sample taken at 21-35 days after onset of symptoms) and cerebo-spinal fluid (CSF) were not available. Results of YF real-time reverse transcription-quantitative polymerase chain reaction (YF RT-qPCR) in CSF, blood or plasma, and urine were not available. Results of reciprocal neutralization titer (1:x) were not available. Result of total IgE was not available. The time between vaccination and sample collection for the analyses to be conducted at the Institute was not available.
CDC Split Type: 201303452

Write-up: Case retrieved from the literature on 22 February 2013. A total of 22 cases were created corresponding to the cases classified as possible Yellow Fever (YF) vaccine reactions. This case is linked with the reference case 2013-03410. "BACKGROUND Serious, but rare adverse events following immunization (AEFI) have been reported with yellow fever (YF) 17D vaccine, including severe allergic reactions, YF vaccine-associated neurologic disease (YEL-AND) and YF vaccine-associated viscerotropic disease (YEL-AVD). The frequency with which YEL-AND and YEL-AVD occur in YF endemic countries is mostly unknown. METHOD: From 2007 to 2010, eight countries - implemented large-scale YF preventive vaccination campaigns. Each country established vaccine pharmacovigilance systems that included standard case definitions, procedures to collect and transport biologic specimens, and National Expert Committed to review data and classify cases. Staff in all countries received training and laboratory capacity expanded. RESULTS: In total, just over 38 million people were vaccinated against YF and 3116 AEFIs were reported of which 164 (5%) were classified as serious. Of these, 22 (13%) were classified as YF vaccine reactions, including 11 (50%) hypersensitivity reactions, six (27%) suspected YEL-AND, and five (23%) suspected YEL-AVD. The incidence per 100,000 vaccine doses administered was 8.2 for all reported AEFIs, 0.43 for any serious AEFI, 0.058 for YF vaccine related AEFs, 0.029 for hypersensitivity reactions, 0.016 for YELAND, and 0.013 for YEL-AVD. Our findings were limited by operational challenges, including difficulties in obtaining recommended biological specimens leading to incomplete laboratory evaluation, unknown case ascertainment, and variable levels of staff training and experience. CONCLUSIONS: Despite limitations, active case-finding in the eight different countries did not find an incidence of YF vaccine associated AEFIs that was higher than previous reports. These data reinforce the safety profile or FY vaccine and support the continued use of attenuated YF vaccine during preventive mass vaccination campaigns in YF endemic areas." Study design and setting: "From 2007 to 2010, active surveillance of serious AEFIs was undertaken during preventive YF vaccination campaigns. All countries were included in the analysis except one due to unavailability of the national database. Both the 17D-204 and 17DD YF substrain vaccines were 73 used." The present case described a 57-year-old female patient, with no reported medical history and concomitant therapy, who had received a dose of Yellow fever vaccine (manufacturer unknown, batch number, route and site of administration not reported) on an unspecified date. Less than one day post-vaccination, the patient experienced loss of consciousness as primary symptoms. Less than one day post-vaccination, the patient had her first clinical evaluation. The diagnosis was hypersensitivity with anaphylactic shock; Brighton anaphylaxis case definition was not fulfilled. Result of human immunodeficiency virus (HIV) and malaria tests were not available. No further tests were performed to evaluate other etiologies. Results of lab tests performed on acute serum or plasma sample taken at onset of symptoms showed IgM (1:10) and IgG (1:100) were not available. Results of IgM level measured on convalescent serum sample (sample taken at 21-35 days after onset of symptoms) and cerebo-spinal fluid (CSF) were not available. Results of YF real-time reverse transcription-quantitative polymerase chain reaction (YF RT-qPCR) in CSF, blood or plasma, and urine were not available. Results of reciprocal neutralization titer (1:x) were not available. Result of total IgE was not available. The time between vaccination and sample collection for the analyses to be conducted at the Institute was not available. The patient died on an unspecified date. No autopsy was done. Upon internal review, the case was considered as serious due to other important medical condition.


VAERS ID: 486738 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2011-10-03
Onset:0000-00-00
Submitted: 2013-03-12
Entered: 2013-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Brain oedema, Cardio-respiratory arrest, Death, Hepatic congestion, Hyperhidrosis, Hypotonia, Pallor, Peripheral coldness, Pulmonary congestion, Pulmonary haemorrhage, Pulmonary oedema, Renal haemorrhage, Renal tubular necrosis, Renal venous congestion, Spleen congestion, Sudden infant death syndrome, Toxicologic test abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Renovascular disorders (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Convulsion; Crying; Fever; Refusal to eat
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0873319A

Write-up: This case was reported by a physician and described the occurrence of sudden infant death in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), DTP-Hep B-Hib (non-gsk) and OPV. No family history of metabolic disorders/inborn errors of metabolism, of any cardiac problem, of epilepsy and convulsions, of non accidental injury in child and of non accidental injury in siblings. The subject had no known allergies, no episodes of cyanosis, stop breathing or apnea, no gastroesophageal reflux, no convulsions, no sleep disorder, no past surgery and no other medical conditions. Following last vaccinations (it was unknown which vaccines were administered), the subject experienced crying, fever (39.9 deg.C) and convulsions. He also refused to eat. It was unknown if there was a history of mistreatment prior to contact with social worker. 2 weeks before vaccination, the subject was not exposed to contagious disease, no infection, no loud breathing or snoring during sleep, no vomiting, no appetite change, no diarrhea or stool change, no dyspnea, no abnormal crying, no lethargy. He only had fever and excessive sweating during sleep. His twin brother had fever and convulsion that evolved favorably. Please see case B0873315A for details regarding this case. The 18-year-old subject''s mother didn''t smoke. During pregnancy, there was no maternal illness or complication, she didn''t smoke, she didn''t take any medication during pregnancy and breast feeding. She gave birth at 37 weeks of gestation of 2 boys (twins). Birth weight: 3.200kg, length: 51 cm. Apgar score: 8 at 1st minute, 9 at 5th minute and 10 at 10 minutes. There were no birth defects, no fetal distress. The subject was not breast fed. The evolution of the growth and weight since birth was normal. On 3 October 2011, the subject received 1st dose of ROTARIX (oral, batch number not provided), an unspecified dose of DTP-Hep B-Hib (unknown) and an unspecified dose of OPV (oral). His last meal was at 8 pm (milk). 12 hours after vaccination with DTP-Hep B-Hib, OPV and ROTARIX, the subject experienced cardiopulmonary arrest, flaccidity, pallor generalized, sweating and skin cold. The subject died from sudden infant death and post vaccinal reaction. The subject was found dead in his bed where he slept with his mother and brother. He was placed face up and was found also in this position. An autopsy was performed and showed cardiopulmonary arrest, brain edema, cardiac congestion, congestion of kidney, extensive intraparenchymal hemorrhage, hepatic congestion, lung congestion, pulmonary edema, pulmonary hemorrhage, renal hemorrhage, spleen congestion and tubular necrosis. The toxicology study showed the presence of phospine that could be contained in pesticides, not existing in the mentioned vaccines.


VAERS ID: 487036 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2013-03-04
Onset:2013-03-05
   Days after vaccination:1
Submitted: 2013-03-13
   Days after onset:7
Entered: 2013-03-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER 4K01B / 1 RA / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR H1496 / 2 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 12F01A / 2 RA / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA535AA / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: 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: 2013-03-05
   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: 04-MAR-2013, Body temperature, 37.0 Centigrade
CDC Split Type: 2013081150

Write-up: This is a spontaneous report received from a contactable pediatrician through the Ministry of Health, Labor and Welfare. Regulatory authority number PREVENAR 671. A 3-month-old male patient received the second dose of 0.5 ml of PREVENAR; Lot number 12F01A) on his right upper arm, the second dose of 0.5 ml of ACT-HIB (Lot number H1496) in his left upper arm and the first dose of 0.5 ml do TETRABIK (Lot number 4K01B) in his right upper arm, all by subcutaneous injections, and the second dose of 1.5 ml of oral ROTARIX (Lot number AROLA535AA) at 2:36 p.m. on 04Mar2013. Before the vaccinations, his body temperature was 37.0 degrees Celsius. After the vaccinations, he spent the day as usual with nothing out of the ordinary. Around 6:00 in the morning of 05Mar2013, his father noticed that he was not breathing, and he was taken to a hospital by an ambulance. His death was confirmed at 7:47 a.m. on that day. It was unknown if an autopsy was conducted. The reporting pediatrician classified this reported event, sudden death as serious and assessed the causality between the event and PREVENAR as unassessable. No follow-up attempts possible. No further information expected.


VAERS ID: 487041 (history)  
Form: Version 1.0  
Age: 0.55  
Sex: Female  
Location: Foreign  
Vaccinated:2013-02-22
Onset:2013-02-22
   Days after vaccination:0
Submitted: 2013-03-13
   Days after onset:18
Entered: 2013-03-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER K003A / UNK RA / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR H1400 / UNK LA / SC
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR 10084 / UNK LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 12E02A / UNK RA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-22
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013081152

Write-up: This is a spontaneous report from a non-contactable consumer. This is a report received from the Agency. Regulatory authority report number PREVENAR 674. A 6-month-old female patient received PREVENAR (Lot Number: 12E02A), subcutaneous on 22Feb2013 at 14:30 at a single dose on the upper right arm, DPT (Lot Number: K003A), subcutaneous on 22Feb2013 at 14:30 at a single dose on the upper right arm, ACT-HIB (Lot Number: H1400), subcutaneous 22Feb2013 at 14:30 at a single dose on the upper left arm, and IMOVAX POLIO (Lot Number: 10084), subcutaneous 22Feb2013 at 14:30 at a single dose on the upper left arm. The patient medical history was not reported. The patient''s concomitant medications were not reported. Around 15:30 on 22Feb2013, the patient came back home, played with something and then had milk. Around 16:30 on 22Feb2013, the patient fell asleep. After the immunizations, the patient seemed to be in good physical health. Around 19:30 on 22Feb2013, the patient''s father went and checked on the patient to take a bath and the patient was cold. The patient experienced sudden infant death syndrome at 19:30 on 22Feb2013. Immediately, the patient was transported by an ambulance to a hospital. Until the ambulance arrived to the patient''s home, she received cardiac massage. At 20:43 22Feb2013, the patient''s death was confirmed at the hospital. An autopsy was performed and the results were sudden infant death syndrome. Details of the autopsy results were not provided. No follow-up attempts possible. No further information expected.


VAERS ID: 487130 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2011-09-01
Onset:0000-00-00
Submitted: 2013-03-18
Entered: 2013-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Completed suicide
SMQs:, Suicide/self-injury (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: B0875158A

Write-up: This case was reported by a physician and described the occurrence of suicide in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). In September 2011, the subject received an unspecified dose of CERVARIX (intramuscular, unknown injection site, batch number not provided). At an unspecified time after vaccination with CERVARIX, the subject committed suicide. The suicide was accomplished. It was unknown whether an autopsy was performed. No further information could be obtained. Case was closed.


VAERS ID: 487213 (history)  
Form: Version 1.0  
Age: 0.55  
Sex: Female  
Location: Foreign  
Vaccinated:2013-02-22
Onset:2013-02-22
   Days after vaccination:0
Submitted: 2013-03-18
   Days after onset:23
Entered: 2013-03-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER K003A / 3 RA / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR H1400 / 3 LA / SC
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR J0084 / 1 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 12E02A / 3 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cardiac massage, Peripheral coldness, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No personal or family history reported
Allergies:
Diagnostic Lab Data: No data.
CDC Split Type: 201303937

Write-up: Initial report received from Health Authorities (reference number IMOVAX-11; reference HIB-493) via the patient''s family on 07 March 2013, on 08 March 2013, and on 11 March 2013 (from a healthcare professional). A 06-month-old female patient with no reported personal or family medical history had received a first primary subcutaneous dose of IMOVAX POLIO (Sanofi Pasteur, batch number J0084) in the left arm, concomitantly with a third primary subcutaneous dose of ACT-HIB vaccine (Sanofi Pasteur, batch number H1400) in the left arm, a third primary subcutaneous dose of PREVENAR (Pfizer, batch number 12E02A) in the right arm and a third primary subcutaneous dose of DPT (batch number K003A) in the right arm on 22 February 2013 around 02:30 p.m. The patient''s weight at birth was 2,124 g. Body temperature before the vaccination was not reported. The patient returned home at around 03:30 p.m. and played. Then, the mother fed the patient, and the patient went to sleep at 04:30 p.m. The patient''s physical condition after vaccination was good. At around 07:30 p.m., the father went to give the patient a bath and found the patient''s body was cold. The parents called an ambulance immediately, and the patient was taken to other hospital. Cardiac massage was performed until the ambulance arrived. The patient was confirmed to be dead at 08:43 p.m on 22 February 2013 at the hospital. The patient was not hospitalized, no complementary investigations were reported. According to the patient''s family, the autopsy''s finding was Sudden Infant Death Syndrom (SIDS). Autopsy''s results from an anatomist had not been obtained.


VAERS ID: 487216 (history)  
Form: Version 1.0  
Age: 0.7  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-03-17
Entered: 2013-03-19
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, CSF test, Meningitis pneumococcal, Pneumococcal bacteraemia, Streptococcus test positive
SMQs:, Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: First dose lot number: F 32598, Immunodeficiency; First dose lot number: F 32598, PREVENAR-13; Second dose. PREVENAR-13
Allergies:
Diagnostic Lab Data: Pathogen material were blood culture and liquor: serotype was 22 F.
CDC Split Type: 2013085608

Write-up: This is a spontaneous report from a contactable physician. A 8-months-old male patient received 3 doses of PREVENAR 13. The first dose of PREVENAR 13, single dose was administered on unspecified date at the age of 4 months (first dose, lot number: F 32598). Route of administration was not provided. Concomitant medication was not provided by reporter. Medical history included immunodeficiency from an unknown date and sister died of fulminate pneumococcal sepsis. The patient experienced pneumococcal meningitis and pneumococcal bacteremia on an unspecified date with fatal outcome. Pathogen material were blood culture and liquor. The serotype was 22 F. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.


VAERS ID: 487861 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-10-01
Onset:2012-10-01
   Days after vaccination:0
Submitted: 2013-03-26
   Days after onset:176
Entered: 2013-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA403AA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Aspiration, Death, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: UNK
CDC Split Type: B0877944A

Write-up: This case was reported by a physician and described the occurrence of death (cause undetermined) in a 4-month-old subject of unspecified gender who was vaccinated with ROTARIX liquid formulation (GlaxoSmithKline), DTPW-HBV-HIB and Oral polio vaccine. In October 2012 the subject received 2nd dose of ROTARIX liquid formulation (unknown route), 2nd dose of DTPW-HBV-HIB (unknown route, unknown lot number), 2nd dose of Oral polio vaccine (oral, unknown lot number). At unspecified time after vaccination with DTPW-HBV-HIB, Oral polio vaccine (oral, unknown lot number) and ROTARIX liquid formulation, the subject experienced fever, vomiting and bronchoaspiration. The physician considered the events were unlikely to be related to vaccination with ROTARIX liquid formulation, DTPW-HBV-HIB and of Oral polio vaccine. The subject died from unknown cause of death. The subject did not visit any medical center and was buried without autopsy. No autopsy result was available.


VAERS ID: 487849 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-01-05
Onset:2013-02-27
   Days after vaccination:53
Submitted: 2013-03-26
   Days after onset:26
Entered: 2013-03-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abortion, Exposure during pregnancy, Foetal death, Foetal disorder
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1303JPN010510

Write-up: Initial information has been received from a physician concerning a fetus patient. The patient''s mother on 05-JAN-2013 was vaccinated with the third injection of GARDASIL injection drug (injection site, dose and indication not reported). The information on concomitant medication was not reported. On 06-JUL-2012, the patient''s mother was vaccinated with the first injection. On 04-SEP-2012, the patient''s mother was vaccinated with the second injection. On 05-JAN-2013, the patient''s mother was vaccinated with the third injection. The patient''s mother was vaccinated at other health-care facility, after that visited the hospital. The last menses date was 03-JAN-2013. On 27-FEB-2013, the patient''s mother developed abortion. Gestational duration was 7 weeks. The cause of fetus''s death was an abortion by congenital anomaly. The reporting physician considered that the abortion was serious due to death and congenital anomaly. The reporting physician felt that the relationship between abortion and GARDASIL was unknown. Additional information has been requested.


VAERS ID: 487928 (history)  
Form: Version 1.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-10
Onset:0000-00-00
Submitted: 2013-03-27
Entered: 2013-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)) / GLAXOSMITHKLINE BIOLOGICALS A81CA097A / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Activities of daily living impaired, Asthenia, Autopsy, Cataplexy, Condition aggravated, Convulsion, Death, Depressed level of consciousness, Depression, Disturbance in attention, Dizziness, Dyspnoea, Epilepsy, Fatigue, General physical health deterioration, Hypersomnia, Hypoventilation, Hypoxia, Increased upper airway secretion, Motor dysfunction, Muscle disorder, Muscle twitching, Narcolepsy, Neck pain, Neuromyopathy, Oxygen saturation decreased, Panic attack, Poor quality sleep, Respiration abnormal, Respiratory disorder, Sleep disorder, Snoring, Somnolence, Tremor, Vertigo, Weight increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-01
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: Botulinum toxin; Cyanocobalamin; Lansoprazole; Fluticasone+salmeterol; Frusemide; Amoxicillin trihydrate
Current Illness: Adipositas; Airway infection; Alveolar hypoventilation; Ataxia; Disability; Dyspnea; Fatigue increased; Increased secretion in airways; Involuntary movement; Muscle atrophy; Paresis; Polyneuropathy; Reflux unspecified; Tremor; Wheelchair user
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy, 06Oct2012, No pathological; C-reactive protein, 21Oct2009, elevated; Oxygen saturation, 22Dec2009, Mild hypoxemia u
CDC Split Type: B0821742A

Write-up: This case was reported by a physician via a regulatory authority (# NO-NOMAADVRE-FHI-2012-14600) and described the occurrence of worsening of symmetrical polyneuropathy in a 32-year-old female subject who was vaccinated with PANDEMRIX H1N1 (GlaxoSmithKline) and with an unspecified Influenza vaccine (manufacturer unspecified). From birth she had a hereditary motoric neuropathy with ataxia. She had considerable paresis in both arms and legs (in legs almost paralysis) and used a wheelchair since adolescence. She had a weight of 140 kg. The last years she also had tremor and involuntary movements in neck/head and hands treated with botox injections. On 21 October 2009, the subject received unspecified dose of PANDEMRIX H1N1(parenteral, unknown site of injection). In 2009, the subject experienced dizziness. On an unspecified date, the subject experienced dyspnea, loss of strength, pain in neck (the pain aggravated), weight increased (she gained weight. Her appetite was normal) and reduced general condition she was out of form and her general physical condition was reduced. She had a minimum of physical activities, but had training with the physiotherapist. In January 2010, 3 months after vaccination with PANDEMRIX H1N1, the subject experienced excessive daytime sleepiness (tendency of falling asleep), concentration impaired, sleep disturbed. Her sleep was disturbed especially the last months. Often she woke up in the night, seldom sleeping a whole night continuously. She snored in the night. The subject was hospitalised. The months before she died, her respiratory function worsened and she was given some kind of a respiratory machine to use at home, but she found it difficult to use. Breathing worsened. The regulatory authority reported that the events were possibly related to vaccination with PANDEMRIX H1N1. The subject died on 1 October 2010 from unspecified cause. The report said that the conclusion in the post mortem report was that no significant pathologic changes was found at neuropathologic examination of the brain. They assumed that the death had a relation to her diagnosis familiar neuropathy, but this is an assumption, without concrete evidence. Follow-up information received on 7 September 2012: According to letter from the neurologist (private clinic), he had no information. It seemed that planned investigations had not been followed up by the subject. Neither had there been any new communication with the subject. Additional information from the neurologic polyclinic was received for the period of 4 August 2008 until 24 March 2012. Regarding the MFN2 gene sequencing, the findings was possibly without clinical importance. The subject received BOTOX treatment each third month from 16 September 2008 until 10 June 2009. At that time the subject reported minimal effect, and she also reported relatively moderate afflictions. Follow-up information received on 5 November 2012: A few days before 26 September 2012, the subject experienced seizure: subject''s consciousness was decreased for some seconds, then she recovered. Follow-up information received on 12 December 2012: On 22 December 2009, oxygen saturation test showed mild hypoxemia despite of oxygen given: 1l O2 at 9. Since autumn 2009, the subject experienced periods of depression. In 2010, panic attacks have been noted (precise onset date was unknown). On 19 July 2010, alveolar hypoventilation was diagnosis (onset date of the event was in 2010). On 6 October 2010, autopsy did not show any pathological findings in brain or elsewhere. Follow-up information received on 20 March 2013 from a drug insurance including report from physician: Medical condition included a non-specific progressing polyneuropathy with muscular atrophy. The subject''s sister had the same condition. No known genetic cause was found. The symptoms started in childhood. Concurrent medications included BOTOX, Vitamin B12, LANZO, SERETIDE, FURIX and IMACILLIN. In May 2008, she consulted a neurologist and stated that she had increasing fatigue and lack of energy. Since March 2009, she has been in need of additional personal assistance and claimed fatigue. At the same time she was transferred to 100% disability pension. She had constant tremor that has been treated with BOTOX injections. The last injection was in September or November 2009. On 21 October 2009, the subject received an unspecified dose of Influenza vaccine (unknown route and injection site, batch and manufacturer unspecified). At the same time treated with antibiotics due to likely airway infection (elevated C-reactive Protein). Less than one month after vaccination with Influenza vaccine, the subject felt tired, had increased vertigo, bad sleep, increasing secretion. The subject received the PANDEMRIX H1N1 on 10 November 2009. On 12 November 2009, the subject started treatment with vibramycin. In 2009, less than 3 months after vaccination with Influenza vaccine and less than 2 months after vaccination with PANDEMRIX H1N1, the subject experienced narcolepsy. In December 2009, 1 month after vaccination with PANDEMRIX H1N1 and 2 months after vaccination with Influenza vaccine, the subject could not walk and had further impaired motor function particularly in the left upper extremity. During 2008/2009, the subject experienced progressing dyspnea and secretion in the airways and she could not cough up, especially when lying. Evaluation revealed alveolar hypoventilation likely due to her muscle/nerve disease and adipositas. In 2009, the subject experienced narcolepsy that led to reduced general condition and possibly contributed to her death on 1 October 2010. In January 2010, the subject consulted a neurologist and she stated that after the last BOTOX injection she felt tired and unwell and had not regained her previous condition. She had concentration problems, slept more, and had increased pain in the neck and vertigo. The neurologist suggested further evaluation. On 22 September 2010, 10 months after PANDEMRIX H1N1 and 11 months after vaccination with Influenza vaccine, her General Practitioner noted that she was feeling severely fatigue, slept a lot and had increasing tremor. The subject became very tired when reading and watching TV and felt reduced strength in her arms. On 24 September 2010, 10 months after PANDEMRIX H1N1 and 11 months after vaccination with Influenza vaccine, the subject experienced an episode with twitching that was perceived as a first time epileptic episode. The following days, she had more similar episodes lasting few seconds without unconsciousness and with convulsions localised to the head and arms. She had also lively dreams and sometimes not sure what was dream or reality. She was referred to a neurologist for evaluation as the General Practitioner considered narcolepsy and cataplexy. In December 2009, the subject was treated with Bilevel Positive Airway Pressure and further adjustment of the treatment was done during hospitalisation. Other adjustment was planned to January 2010 but the patient refused it. In January 2010, she was also treated with SERETIDE. On 01 October 2010, the subject died at home. The autopsy did not reveal a specific cause of death and it was concluded that the death most likely was due to her neuromuscular disease. Evaluations/tests concerning narcolepsy and cataplexy were not performed before the subject died.


VAERS ID: 487990 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-03-25
Entered: 2013-03-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013094682

Write-up: This spontaneous report from a non-contactable physician. A patient of unspecified age and gender started to receive PREVENAR, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced death on an unspecified date. The action taken in response to the event for PREVENAR was not applicable. The patient died on an unspecified date. It was not reported if an autopsy was performed. The reporter mentioned that when the patient administered the vaccine, the patient got infected and died 3 days later, apparently because the vaccine had a live virus.


VAERS ID: 488007 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-02-07
Onset:2013-02-08
   Days after vaccination:1
Submitted: 2013-03-25
   Days after onset:44
Entered: 2013-03-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A2168423A / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G01327 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013092829

Write-up: This is a spontaneous report from a contactable physician received from agency, the foreign regulatory authority. Regulatory authority report number 2013-01122. A 6-weeks-old male patient received PREVENAR 13 lot G01327, intramuscular on 07Feb2013 at 14:30 at 0.5 ml single dose and INFANRIX HEXA lot A2168423A, intramuscular on 07Feb2013 at 14:30 at 0.5 ml single dose. After the immunization, the family went the same day on a long flight to an unspecified foreign country. On 08Feb2013 the patient''s grand-mother called the reporting physician and reported that the patient experienced pneumonia and died the same day. According to the reporting physician the patient had no relevant medical history and was not taking any concomitant medications. It was reported that the reporting physician has no further information regarding the diagnosis (including medical confirmation), possible therapy of the pneumonia, the patient''s death (including medical confirmation) and about a possible autopsy. In this case it was not possible to assign the pneumonia and death to an etiologically. According to the information received from the reporting physician concomitant diseases as cause for the pneumonia can be excluded. Other causes for the death were not possible to determine since there was a lack of information. The causal relationship between PREVENAR 13, INFANRIX HEXA and the event was formally assessed as possible, according to current practice of agency. But as seen from a clinical perspective the relationship cannot be determined since the reporting physician received the information from a non-HCP. No follow-up attempts possible. No further information expected.


VAERS ID: 488026 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-03-28
Entered: 2013-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Brain neoplasm, Death, Vaccination complication
SMQs:, Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1303ESP013516

Write-up: This spontaneous report as received from a physician through business partner agreement (MFR CONTROL# E2013-02310). Case of fatal outcome received from a physician through a company representative on 21-MAR-2013. The reporter was a physician working at hospital where the patient was hospitalized. The reporter heard about the case but was not the patient''s physician and could not identify the patient''s physician at the time of reporting. Case medically confirmed. A young female patient (age not reported) had received a dose of a HPV vaccine (product name, batch number and route of administration not reported) on an unspecified date and later (date not reported) the patient presented with brainstem tumour that according to other health care professional was due to an adverse event to a HPV. The patient died on an unspecified date. It was not reported whether an autopsy was performed or not. Additional information is not expected.


VAERS ID: 488291 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Female  
Location: Foreign  
Vaccinated:2012-12-27
Onset:2013-01-30
   Days after vaccination:34
Submitted: 2013-03-31
   Days after onset:59
Entered: 2013-04-02
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F61157 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: CSF test abnormal, Death, Meningitis pneumococcal, Pneumococcal infection
SMQs:, Guillain-Barre syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-01-31
   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: Unknown
Allergies:
Diagnostic Lab Data: Cerebral Spinal Fluid Specimen (30Jan2013): pneumococcal infection, serotype 7F with pneumococcal meningitis
CDC Split Type: 2013100092

Write-up: This is a spontaneous report from a contactable healthcare professional via the Agency. A 3-month-old female patient received, at the age of 2 months, her first dose of PREVENAR 13 (lot# F61157) on 27Dec2012. The patient relevant medical history and concomitant medications were not reported. On 30Jan2013, the patient experienced a pneumococcal infection, serotype 7F with pneumococcal meningitis. The specimen was taken from the cerebral spinal fluid on 30Jan2013 which diagnosed the infection. On 31Jan2013, the patient died. No further information was provided regarding cause of death. No follow-up attempts possible. No further information expected.


VAERS ID: 488670 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2013-03-11
Onset:2013-03-11
   Days after vaccination:0
Submitted: 2013-04-08
   Days after onset:28
Entered: 2013-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER 109075 / 1 UN / UN
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR J2139 / 1 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 1C271 / 1 UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER H5118 / 1 MO / PO
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH G04671 / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA650AA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Asphyxia, Aspiration, Autopsy, Death, Incorrect dose administered, Respiratory disorder, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Respiratory failure (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-03-11
   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: CHILD OF HIV POSITIVE MOTHER; PREMATURE BABY; RESPIRATORY DISTRESS; VOMITING
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Weight, 09Dec2013, 1.120kg; Weight, 11Mar2013, 2.8kg
CDC Split Type: B0880507A

Write-up: This case was reported by a healthcare professional and described the occurrence of asphyxia secondary to aspiration in a 3-month-old female subject who was vaccinated with ROTARIX liquid formulation (GlaxoSmithKline), Pneumococcal vaccine (non-GSK, PREVENAR), (non-GSK) PENTAXIM, Hepatitis B vaccine (non-GSK), Poliomyelitis live oral vaccine (non-GSK) and Bacillus Calmette-Guerin vaccine (non-GSK). The subject''s mother had a pregnancy induced hypertension. She was admitted to hospital and delivered by caesarean section. The subject was a premature baby (unspecified week of gestation) and had respiratory distress. Birth weight was 1.120 kg, birth height was not provided. Apgar score was 2/10, 4/10, 7/10. The subject was admitted to hospital and placed in incubator. In January 2013, the subject was discharged. Subject''s mother was Human Immunodeficiency Virus positive (subject was exposed). The subject had no known allergy. The subject was on exclusive formula feeding. On 10 March 2013, according to clinic card, the subject visited the clinic for vomiting. On 11 March 2013, the subject looked clinically well (weight was 2.8 kg). On 11 March 2013, the subject received 1st dose of ROTARIX liquid formulation (oral), 1st dose of PREVENAR (unknown route and injection site), 1st dose of PENTAXIM (unknown route and injection site), 1st dose of Hepatitis B vaccine (unknown route and injection site), 1st dose of Poliomyelitis live oral vaccine and 1st dose of BCG vaccine (unknown route and injection site). It was mentioned that the vaccines were stored in a daily-checked temperature fridge (vaccines received on 15 February 2013). As the subject received a dose of PENTAXIM and a dose of Poliomyelitis vaccine on the same day, the subject experienced overdose of poliomyelitis component. On 11 March 2013, less than one day after vaccination with BCG vaccine, Hepatitis B vaccine (non-GSK), PENTAXIM, Poliomyelitis vaccine inactivated (Non-GSK), PREVENAR and ROTARIX liquid formulation, the subject experienced sleepiness. Then, the subject vomited and experienced breathing disorder. The subject died (unknown cause) on 11 March 2013 at around 19:00. It was unclear if any autopsy was performed. No death certificate was provided. On 13 March 2013, the subject was buried. Follow-up information received on 5 April 2013 from a healthcare professional: An autopsy was performed and it revealed that the subject died from asphyxia secondary to aspiration.


VAERS ID: 488888 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2005-01-01
Submitted: 2013-04-09
   Days after onset:3019
Entered: 2013-04-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Bone loss, Breast pain, Bronchitis, Confusional state, Death, Diarrhoea, Dysphagia, Ear pain, Fall, Fungal infection, Mucous stools, Oesophagitis, Renal cyst, Respiratory distress, Upper limb fracture
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Lipodystrophy (broad), Osteoporosis/osteopenia (narrow), Osteonecrosis (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: BONEFOS; FOSAMAX; FOSAVANCE; Ibuprofen
Current Illness: Unknown
Preexisting Conditions: Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2013DE033673

Write-up: Case number PHHY2013DE033673 is an initial spontaneous report from the foreign Health Authority (reference number: DE-PEI-PEI2013018868) received on 05 Apr 2013. This report refers to a 83-year-old female patient. Her medical history included osteoporosis. Concomitant medications included BONEFOS, FOSAMAX, FOSAVANCE and ibuprofen. She was vaccinated with "first/ second or other dose" of seasonal influenza vaccine INN, (unknown manufacturer, batch number: not reported) in 2004 and with Tetanus vaccine INN, (unknown manufacturer, batch number: not reported) on an unknown date, both doses were given via oral route. It was reported that each time after the last two doses of influenza vaccine, the patient had a fall and was treated in hospital. Due to the fall in 2004, both arms were broken and she was hospitalized for three weeks. During this period the application of FOSAMAX was continued. However instructions for application were not followed and "starting with this severe adverse reactions developed". On 01 Jan 2005, she developed diarrhoea, confusion, bronchitis, esophagitis, fungal infection NOS (not specified), swallowing disorder, respiratory distress, bone loss in jaw, breast pain, ear pain, renal cyst, mucous stool and fall that lasted for 03 years. On an unknown date, the patient died (cause unspecified). The foreign health authority considered diarrhoea, confusion, bronchitis, esophagitis, fungal infection NOS, swallowing disorder, respiratory distress, bone loss in jaw, breast pain, ear pain, renal cyst, mucous stool and fall as adverse events with outcome and seriousness reported as death. The causality of the events were not reported. No further information was available.


VAERS ID: 489006 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-04-09
Entered: 2013-04-11
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial test positive, Death, Meningitis pneumococcal
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 first dose of PREVENAR 13
Allergies:
Diagnostic Lab Data: Laboratory data (unknown date): serotype 10A.
CDC Split Type: 2013109389

Write-up: This is a spontaneous report from a contactable consumer via agency. A 12-month-old female patient received second dose of PREVENAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml single dose. Previously she received the first dose of PREVENAR 13 via an unspecified route of administration on an unspecified date at 0.5 ml single dose. The patient medical history and the patient''s concomitant medications were not reported. The patient died on an very fast running meningitis pneumococcal in Jan2013. The vaccination had not failed because involved serotype involved 10A, not covered by PREVENAR 13. It was unknown if an autopsy was performed.


VAERS ID: 489009 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-03-14
Onset:0000-00-00
Submitted: 2013-04-10
Entered: 2013-04-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 090634602 / 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: EPILIM; Antidepressants; XANAX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013035374

Write-up: This regulator report (initial receipt: 04-Apr-2013) concerns a male patient. Concomitant medications included valproate sodium, alprazolam and desvenlafaxine. On 14-Mar-2013 the patient received FLUVAX (batch number: 090634602) 1 dose unspecified, 1 time intramuscularly. On an unspecified date, the patient was found deceased in bed. The cause of death was not known. Reporter''s comment: The reporter considered the event as possible in relation to FLUVAX.


VAERS ID: 489011 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-04-06
Onset:2013-04-06
   Days after vaccination:0
Submitted: 2013-04-11
   Days after onset:5
Entered: 2013-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA173AE / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Acute pulmonary oedema, Blood pressure abnormal, Cardiac arrest, Cyanosis, Death, Electrocardiogram abnormal, Mechanical ventilation, Mydriasis, Peripheral coldness, Respiratory arrest, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-04-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 06Apr2013, 100/60; Blood pressure, 06Apr2013, 0; Body temperature, 06Apr2013, 36.5deg.C; Electrocardiogram, 06Apr2013, Flatten; Heart rate, 06Apr2013, 0
CDC Split Type: B0882178A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of death due to acute pulmonary edema in a 18-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included 1st dose of CERVARIX (GlaxoSmithKline) given in 6 March 2013 and which was uneventfully. The subject had no concurrent illness, allergies or relevant medical history. On 6 April 2013, at 9 - 10:00AM, the subject received 2nd dose of CERVARIX (.5 ml, intramuscular, left arm). She stayed in the medical center for 30 minutes before making her way home. No reaction was observed during this period. On 6 April 2013, in the afternoon, less than one day after vaccination with CERVARIX, the subject was found as breathless. On the same day, at 17:20, the subject was brought to a 1st hospital for emergency and was hospitalised with cardiac arrest and breathless. The subject had cardiopulmonary resuscitation and face mask ventilation. The subject did not recover and was transferred to a 2nd hospital with cyanosis, cold hands and legs, nul blood pressure and heard beep, mydriasis, body temperature of 36.5 deg.C and flatten ECG. The subject was treated with NaCl and adrenaline. The emergency cares were stopped after 45 minutes by lack of any signal of recovery. The subject finally died due to acute pulmonary edema.


VAERS ID: 489022 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-04-11
Entered: 2013-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Bone loss, Breast pain, Bronchitis, Confusional state, Death, Diarrhoea, Dysphagia, Ear pain, Fall, Fungal infection, Mucous stools, Oesophagitis, Renal cyst, Respiratory distress, Upper limb fracture
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Lipodystrophy (broad), Osteoporosis/osteopenia (narrow), Osteonecrosis (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Disodium clodronate; Alendronate sodium; FOSAVANCE; Ibuprofen
Current Illness: Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0079383A

Write-up: This case was reported by a consumer via a regulatory authority (DE-PEI-PEI2013018868) and described the occurrence of death (not other specified) in an 83-year-old female subject who was vaccinated with Influenza vaccine, Tetanus vaccine. Information in this case was very inconsistent and incomplete, for this reason PEI requested data entry. Concurrent medical conditions included osteoporosis. Concurrent medications included BONEFOS, FOSAMAX, FOSAVANCE and Ibuprofen. In 2004 the subject received unspecified dose of Influenza vaccine (oral). On an unspecified date the subject received unspecified dose of Tetanus vaccine (oral). The consumer (the subject''s daughter) reported the following: After the last two vaccinations with influenza vaccine, the subject fell each time and was hospitalised. In 2004 the subject broke her arm when falling and was in hospital for more than three weeks. FOSAMAX was continued during that time, but not according to recommended scheme and with severe adverse reactions since that time. Additional events reported were: confusion, bronchitis, diarrhea, ear pain, esophagitis, fungal infection, mucus in stool, renal cyst, respiratory distress, swallowing disorder, bone loss in jaw and breast pain. The subject died on an unspecified date. The date probably was the 22 January 2006, as this was reported as end date for all events and medications. The cause of death was not specified. It was unknown whether an autopsy was performed. Follow-up information has been requested by PEI.


VAERS ID: 489053 (history)  
Form: Version 1.0  
Age: 0.44  
Sex: Female  
Location: Foreign  
Vaccinated:2013-04-03
Onset:2013-04-03
   Days after vaccination:0
Submitted: 2013-04-11
   Days after onset:8
Entered: 2013-04-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS KOMP0130 / 2 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G26386 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Autopsy, Death, Dehydration, Flatulence, Fontanelle depressed, Gastrointestinal haemorrhage, Lid sulcus deepened, Loss of consciousness, Malaise, Resuscitation, Scan abnormal, Tumour rupture, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Malignancy related conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Periorbital and eyelid disorders (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 25-JAN-2013, First dose PREVENAR 13; 25-JAN-2013, DTaP/Hib/IPV, First dose; MAR-2013, Vomiting; Hepatic tumor malignant, A big (presumably malignant) liver tumour was found during the autopsy
Allergies:
Diagnostic Lab Data: Autopsy performed.
CDC Split Type: 2013108582

Write-up: This is a spontaneous report from a contactable physician received from the foreign Health and Medicines Authority. Regulatory authority report number DK-DKMA-ADR 22072976. A 5-months-old female patient of an unspecified ethnicity received on 03Apr2013 second dose of PREVENAR 13 (batch no. G26386, expiration date Feb2015) and second dose DI-TE-KI-POL/ACTHIB (batch KOMP0130) at single dose intramuscular. First vaccination with PREVENAR 13 and DI-TE-KI-POL/ACTHIB was performed on 25Jan2013. Concurrent conditions included constipation since 25Oct2012, vomiting since Mar2013 and a big (presumably malignant) liver tumor. Concomitant medication included MOVICOL since Oct2012 for constipation. On 03Apr2013, the child was admitted in unconscious state at the emergency room at the hospital, admitted approximately 4 hours after vaccination. Intensive resuscitation attempts were made which unfortunately were in vain. The medico-legal expert who performed the autopsy informed that the child had been constipated since birth and has been in continuous treatment with MOVICOL. In the week previous to the event occurrence, the child had been vomiting, but had not otherwise been affected. It was unknown if it was due to the vomiting that the parents consulted the general practitioner. During the consultation nothing abnormal was found, so the 5-month prophylaxis vaccinations were administered as the child was there anyhow. At home, 30 minutes to 1 hour later the child experienced malaise. Autopsy results were as follows: a scan showed gas-distended intestines. A large amount of blood is found in the abdomen and a large (presumed malignant) hepatic tumor. Cause of death: Rupture of tumor. In addition he found that the eyes and fontanel were so sunken it indicated that the child had been dehydrated. Blood was taken aside but it was considered if it was necessary to perform a test for anaphylaxis, as the medico-legal expert was convinced that the cause of death had nothing to do with the vaccines. The medico-legal expert who performed the autopsy stated that the event was very unlikely to be related to PREVENAR 13 and DI-TE-KI-POL/ACTHIB.


VAERS ID: 489314 (history)  
Form: Version 1.0  
Age: 0.44  
Sex: Female  
Location: Foreign  
Vaccinated:2013-04-03
Onset:2013-04-03
   Days after vaccination:0
Submitted: 2013-04-15
   Days after onset:12
Entered: 2013-04-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER 0136A / 2 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR H8099 / 2 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G26386 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Flatulence, Fontanelle depressed, Haemorrhage, Hepatic cancer, Lid sulcus deepened, Loss of consciousness, Resuscitation, Scan abdomen abnormal, Tumour rupture
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Malignancy related conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Periorbital and eyelid disorders (narrow), Neonatal disorders (narrow), Liver malignant tumours (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOVICOL
Current Illness:
Preexisting Conditions: The patient had previously received PREVENAR 13 and DITEKIPOL/ACT-HIB on 25-Jan-2013 (batch number not reported). The patient has been constipated since birth and vomiting during the last week. The coroner found that the child was dehydrated.
Allergies:
Diagnostic Lab Data:
CDC Split Type: E201302600

Write-up: Case received from healthcare professional via the Health Authorities on 04-Apr-2013. Case medically confirmed. A 5-month-old female patient had received an injection of ACT-HIB (intramuscular route, batch number H8099) and concomitant with DI-TE-KI-POL (SSI, intramuscular route, batch number 0136A) and Pneumococcal vaccine (intramuscular route, Batch number G26386) on 04-Apr-2013 and later on she developed unconsciouness. Approximately 4 hours post vaccination she was brought to the emergency and intense resuscitation attempts was performed but failed. The outcome was fatal. The patient had previously been vaccinated with ACT-HIB and concomitant with DI-TE-KI-POL (SSI) and Pneumococcal vaccine on 25-Apr-2013 (batch number not reported). The cause of death is reported as unknown. An autopsy will probably be performed. Additional information received from other company on 05-Apr-2013: Autopsy has been performed and a tumor on the liver was found. The liver tumor was reported as the cause of death. Date of vaccination and onset dates were corrected from 04-Apr-2013 to 03-Apr-2013. Additional information received from foreign Health Authority via other company on 08-Apr-2013 under the reference number DK-DKMA-ADR 22072976: Pneumococcal vaccine has been changed to PREVENAR 13. MOVICOL is added as concomitant medication. The reporter had telephone contact with the coroner performing the autopsy. According to the coroner the child has been constipated since birth and been on continous treatment with MOVICOL. Since last week the patient has been vomiting but otherwise not affected. It is unclear if it is because of the vomiting that the parents contacted their own doctor. Nothing abnormal was found during this consultation and therefore the 5 months vaccination is given. After 30 min to 1 hour pv at home the patient turns bad and later on she becomes unconscious. Autopsy findings: Scan displays air in intestines, some blood is found in the peritoneal cavity and a large (probably malignant) liver tumor. Cause of Death: Rupture of the tumor. Moreover he finds it remarkable that the eyes and fontenel is so sunken and believes that the child has been somewhat dehydrated. According to the reporter the coroner consider it not necessary to conduct tests for anaphylaxis as he is convinced that the death was unrelated to the vaccines. No other vaccinations taken. Blood in peritonela cavity, air in intestines, liver tumor, rupture of tumor was not coded by the health authority but mentioned in the narrative. After medical review it was decided to code these event.


VAERS ID: 489508 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-03-26
Onset:2013-03-26
   Days after vaccination:0
Submitted: 2013-04-16
   Days after onset:21
Entered: 2013-04-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G49219 / UNK AR / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Pyrexia, Toxicologic test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-04-09
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Liver biopsy, postnatal investigation, liver lab values monitoring by the paediatrician; Hepatic vein thrombosis, favorable evolution; INFANRIX HEXA, at 2 months; INFANRIX HEXA, at 3 months; INFANRIX HEXA, at 4 months
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013113910

Write-up: This is a spontaneous report from contactable physician (family GP) via agency, institution for infective diseases and vaccinations. The regulatory authorities were informed by agency. And the subsequent follow-up information was received from another contactable physician who administered the vaccine (from a child consultation agency). A 12 months-old male patient received the first dose of PREVENAR 13 (lot# G49219, batch# PAA 012823, expiration date: Apr2015) at 0.5 ml single dose intramuscularly in his deltoid, on 26Mar2013 in the afternoon. The patient had received previous dosed of INFANRIX HEXA at 2, 3 and 4 months of age. As per the physician who vaccinated the infant, the patient did not receive any previous vaccine dose of PREVENAR 13, at 8 weeks and 16 weeks of age (based on legal vaccination scheme) due to refusal from parents. The parents also refused to administer for meazles/mumps/rubella (MBR) vaccine and rotavirus vaccine to the patient. The patient took no concomitant medications. Medical history included a liver biopsy as postnatal investigation, and intrahepatic thrombosis with a favorable evolution afterwards. Since his birth, the patient had ongoing liver test monitoring by the paediatrician. After vaccination on 26Mar2013, the patient experienced fever for 2 days. On 09Apr2013, the patient experienced death of unknown cause. An autopsy and toxicologic examination were performed, but results were not available at the time of reporting. The family GP had a suspicion of relatedness for PREVENAR 13 to the fatal event. The physician, who vaccinated the infant, stated that there was no causal relationship between the vaccination and sudden death, and the event was not due to the drug interaction. He had no idea about the possible etiological factor.


VAERS ID: 489723 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-04-18
Entered: 2013-04-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adenovirus test, Altered state of consciousness, Autopsy, Bacterial test positive, Bradycardia, Brain oedema, C-reactive protein increased, CSF virus no organisms observed, Cerebral hypoperfusion, Coma scale abnormal, Computerised tomogram head abnormal, Cytomegalovirus test negative, Dehydration, Electroencephalogram abnormal, Encephalitis, Epstein-Barr virus test negative, Headache, Lethargy, Mastoiditis, Musculoskeletal stiffness, Mydriasis, Neurological examination abnormal, Nuclear magnetic resonance imaging brain abnormal, Otitis media acute, Pallor, Parvovirus B19 test negative, Pneumococcal infection, Pyrexia, Somnolence, Streptococcus test positive, Tachycardia, Tachypnoea, Varicella virus test negative, Vomiting, White blood cell count normal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Fever, three days history; Lethargy; Headache; Vomiting, five episodes; PREVENAR, first dose; PREVENAR, second dose
Allergies:
Diagnostic Lab Data: Blood pressure systolic, 160 mmHg; C-reactive protein, 305 mg/l; Pyrexia, 40.7 Centigrade; White blood cell count, 90 g/l; heart rate (unknown date): tachycardia (124/''); respiratory rate (unknown date): tachypnea (40/''); Neurological examination (unknown date): minimal nuchal stiffness, a dubious Kernig and Brudzinski with no focal neurological signs; Physical examination (unknown date): areactive bilateral mydriasis and altered consciousness with GCS of 8; heart rate (unknown date): bradycardia (80/''); Cerebral CT-scan(unknown date): extensive cerebral oedema with lateral ventricles collapse, and right-sided acute mastoiditis.; Laboratory work-up (unknown date); raised CRP 305 mg/lL; Microbiologic cultures (unknown date): positive for Streptococcus pneumoniae serotype 7; Viral tests in CSF (unknown date): (herpes, varicella, Epstein-Barr virus; Parvovirus, cytomegalovirus, adenovirus) remained negative.; Second cerebral CT-scan (date unknown; six hours after admission to PICU): extensive cerebral edema with absent cerebral perfusion; EEG (unknown date): non-reactive; Cerebral MRI (unknown date): confirmed diffuse cerebral edema without cerebral perfusion; Autopsy (unknown date): confirmed pneumococcal meningoencephalitis
CDC Split Type: 2013119300

Write-up: This is a literature spontaneous report from agency dated 2013. This is 2 of 3 reports. This report refers to case number two. A 2-year-old child was admitted to the emergency ward with a three day history of fever (40.7 degrees Celsius) associated with lethargy, headache and five episodes of vomiting. His past medical history was unremarkable; he had received 3 doses of 7-VCV. Physical examination revealed tachycardia (124/''), tachypnea (40/''), pallor, mild signs of dehydration and right acute otitis media. Although he was drowsy, he responded normally to verbal stimuli. Neurological examination revealed minimal nuchal stiffness, a dubious Kernig and Brudzinski with no focal neurological signs. A fluid bolus with normal saline was administered along with 100 mg/kg ceftriaxone. The clinical response was rapid, his general condition improved and he was able to take few steps. He was admitted to the ward for observation. Suddenly, his condition worsened with the occurrence of generalized tonic-clonic seizures with left lateralization that stopped after intravenous administration of 0.5 mg/kg diazepam. Physical examination at this point revealed areactive bilateral mydriasis and altered consciousness with Glasgow Coma Scale (GCS) of 8. The child also developed rapidly Cushing''s triad (systolic blood pressure 160 mmHg, bradycardia 80/'' and irregular respiratory pattern). He was rapidly intubated and transferred to the PICU for subsequent management. Cerebral CT-scan showed extensive cerebral oedema with lateral ventricles collapse, and right-sided acute mastoiditis. Despite maximal neurological support, hypertonic fluid administration (mannitol and 3% NaCl) and corticosteroid treatment, his state worsened: bilateral non-reactive mydriasis persisted along with a loss of brainstem reflexes. Intracranial hypertension was complicated by diabetes insipidus requiring desmopressin therapy. Hemodynamic instability developed, requiring a vasoactive treatment with norepinephrine and dopamine. The laboratory work-up showed raised CRP 305 mg/lL and WBC of 90 G/L. Microbiologic cultures were positive for Streptococcus pneumoniae serotype 7. Viral tests in CSF (herpes, varicella, Epstein-Barr virus, Parvovirus, cytomegalovirus, adenovirus) remained negative. A second cerebral CT-scan performed six hours after admission to PICU to evaluate the indication for decompression craniotomy showed an extensive cerebral edema with absent cerebral perfusion. EEG was non-reactive and the cerebral MRI confirmed the diffuse cerebral edema without cerebral perfusion. The child died on day 2. The autopsy confirmed pneumococcal meningoencephalitis. Pfizer is Marketing Authorization Holder for PREVENAR in the reporter''s country. This may be a duplicate report in situations where another Marketing Authorization Holder of PREVENAR has submitted the same report to the regulatory authorities.


VAERS ID: 489728 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-04-19
Entered: 2013-04-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013035440

Write-up: This serious consumer report (initial receipt: 11-Apr-2013) concerns an elderly patient in his 70 - 80''s. On 3 separate occasions, the patient was administered FLUVAX (batch number was not reported) and within 1 - 2 weeks of administration, he experienced a heart attack or stroke. The doctor did not attribute the stroke or heart attack to FLUVAX administration. The events occurred years ago (no specific dates known). The patient had since died at 85 years of age, no related to FLUVAX administration. Cause(s) of death: Unknown cause of death.


VAERS ID: 489730 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-04-18
Entered: 2013-04-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial test positive, Blood culture positive, Brain abscess, Brain oedema, C-reactive protein increased, CSF culture positive, Coma scale abnormal, Convulsion, Culture urine, Death, Diarrhoea, Electroencephalogram abnormal, Febrile convulsion, General physical health deterioration, Grand mal convulsion, Granulocyte percentage, Haemodynamic instability, Hemiplegia, Intensive care, Intracranial pressure increased, Loss of consciousness, Mechanical ventilation, Meningitis, Mydriasis, Necrosis, Neurological decompensation, Nuclear magnetic resonance imaging brain abnormal, Otitis media acute, Partial seizures, Postictal state, Purulent discharge, Pyrexia, Streptococcus test positive, VIIth nerve paralysis, Vasopressive therapy, Vomiting, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (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), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Associated with high fever (40 degrees C) 3 days prior to presentation, Diarrhea; Associated with high fever (40 degrees C) 3 days prior to presentation, Vomiting; First dose, Pneumococcal conjugate vaccine, 7-valent
Allergies:
Diagnostic Lab Data: Body temperature, 40 Centigrade; C-reactive protein 54 mg/l; C-reactive protein, 260 mg/l; Intracranial pressure increased, 18 mmHg; White blood cell count, 25.3 g/l; White blood cell count, 12.0 g/l; Glasgow Coma Scale (GCS) (date unknown): 9; WBC (date unknown): Second laboratory work-up showed a WBC 22.0G/L and showed immature 42% forms; Cerebral computed tomography (CT)-scan (date unknown): showed severe right sided brain edema with significant deviation of midline structures to the left. Glasgow structures to the left. Glasgow Coma Scale (date unknown): 4; Decompression craniotomy (date unknown): showed mildly raised intracranial pressure (18 mm Hg), signs of purulent meningitis as well as multiple brain abscesses. Microbiologic cultures (date unknown): positive for Streptococcus pneumonia serotype 1 [blood, urines, cerebrospinal fluid (CSF) and nasopharyngeal secretions]. Brain magnetic resonance imaging (MRI) (on day 5) (date unknown): showed widespread bilateral cytotoxic edema and necrosis. Electroencephalogram (EEG) (date unknown): major cortical depression.
CDC Split Type: 2013119293

Write-up: This is a literature spontaneous report. This is 1 of 3 reports. This report refers to case number one. An 11-month-old girl with unremarkable medical history, who had received two doses of 7-VCV, presented with chief complaint of 10 min partial seizure involving left hemi-face. Three days prior to presentation she had developed high fever (40 degrees Celsius) that was associated with diarrhea and vomiting. Seizure activity had ceased upon arrival on emergency ward and was soon after followed by another generalized seizure lasting 45 min and requiring 5 mg intra-rectal diazepam and 0.2 mg intravenous clonazepam to resolve. On admission, a post ictal left facial paralysis was noted, which spontaneously resolved 3 h later. Clinical examination revealed bilateral acute otitis media. Initial work-up showed mildly raised C-reactive protein (CRP 54 mg/L), white blood cell (WBC) count 25.3 G/L with 13.5% immature granulocytes. As the child was recovering normal clinical status, the diagnosis retained was an atypical febrile seizure, and the child was admitted for observation for 24 h. During the night she presented tonico-clonic seizures associated with loss of consciousness, bilateral mydriasis and right-sided hemi syndrome that was managed with two injections of benzodiazepine. The child''s neurological status remained seriously impaired with Glasgow Coma Scale (GCS) of 9, and left-sided hemi paresis. The second laboratory work-up showed a CRP of 260 mg/L, WBC 12.0G/L and 42% immature forms. Cerebral computed tomography (CT)-scan showed severe right-sided brain edema with significant deviation of midline structures to the left. A dose of 100 mg/kg of ceftriaxone was administered and the child transferred to Pediatric Intensive Care Unit (PICU) where her condition worsened with hemodynamic instability and GCS of 4, needing mechanical ventilatory support and vasopressive therapy. Decompression craniotomy showed mildly raised intracranial pressure (18 mm Hg), signs of purulent meningitis as well as multiple brain abscesses. Microbiologic cultures were positive for Streptococcus pneumonia serotype 1 [blood, urines, cerebrospinal fluid (CSF) and nasopharyngeal secretions]. Despite very active management, she developed diabetes insipidus; the brain magnetic resonance imaging (MRI) performed on day 5 showed widespread bilateral cytotoxic edema and necrosis and electroencephalogram (EEG) major cortical depression. The child died on day 6. Pfizer is Marketing Authorization Holder of pneumococcal 7-valent conjugated vaccine in the reporter''s country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 7-valent conjugated vaccine has submitted the same report to the regulatory authorities.


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