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VAERS ID: 311790 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Unknown  
Location: Foreign  
Vaccinated:2008-04-29
Onset:2008-04-29
   Days after vaccination:0
Submitted: 2008-05-06
   Days after onset:7
Entered: 2008-05-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804KOR00022

Write-up: Information has been received from a physician via a company representative concerning a 6 month old patient who on 29-APR-2008 (the estimated time of vaccination: 11:00 a.m.) was vaccinated with Rotateq in a clinic. Concomitant therapy included RECOMBIVAX. After vaccination, the patient showed adverse event and then transferred to a general hospital (specified time of onset was not reported). However, the patient died at dawn on 30-APR-2008. The cause of death was dyspnoea. The reporter felt that dyspnoea was not related to therapy with Rotateq. Also, the reporter felt that the patient''s dyspnoea might be caused by choking during taking powdered milk or might be cause by crib death. Information on whether or not a post-mortem evaluation was done, the exact cause of death and further additional information has been requested. Additional information has been requested.


VAERS ID: 311923 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2008-04-24
Onset:2008-04-25
   Days after vaccination:1
Submitted: 2008-05-08
   Days after onset:13
Entered: 2008-05-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS B216210409 / 1 LL / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS B216210409 / 1 LL / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER B216210409 / 1 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 32345 / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Crying, Death, Skin discolouration
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), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-04-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cleft lip and palate
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: AEWYEH03850308

Write-up: Information regarding Prevenar was received from a healthcare professional regarding a 11-week-old female patient who experienced crying abnormality, death, off color and arrested. The patient received the first dose on 24-Apr-2008. The patient also received the first dose of INFANRIX-Ipv+Hib (Smith Kline Beecham) on 24-Apr-2008. The patient''s concurrent illness includes cleft lip and palate (deep). Concomitant therapy included BCG Vaccine and Haemophilus B Conjugated Vaccine (Tetanus). On 25-Apr-2008, the child woke up crying abnormally and was off color. The child arrested (cardiac arrest on the way to the hospital and was pronounced death upon arrival. No additional information was available at the time of this report.


VAERS ID: 311936 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2008-04-17
Onset:2008-04-17
   Days after vaccination:0
Submitted: 2008-05-09
   Days after onset:22
Entered: 2008-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B057B / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Purpura, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-04-18
   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: DEATH NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0519194A

Write-up: This case was reported by a physician and described the occurrence of hemorrhagic rash in a 6-month-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). The subject''s mother is HIV infected. Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine; GlaxoSmithKline; given on 21 January 2008 and 21 February 2008. On 17 April 2008, the subject received 3rd dose of INFANRIX (unknown route and injection site). On 17 April 2008, less than one day after vaccination with INFANRIX, the subject experienced fever, leading to treatment with paracetamol. On 18 April 2008, the subject experienced hemorrhagic rash. The physician considered the events were life threatening and clinically significant (or requiring intervention). The subject died on 18 April 2008, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 312293 (history)  
Form: Version 1.0  
Age: 1.06  
Sex: Female  
Location: Foreign  
Vaccinated:2008-04-18
Onset:2008-04-20
   Days after vaccination:2
Submitted: 2008-05-13
   Days after onset:23
Entered: 2008-05-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA386A / 4 LA / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 31081 / 4 RA / 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: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None provided
CDC Split Type: DEWYEG01515308

Write-up: Information regarding Prevenar was received from a healthcare professional via a regulatory authority regarding a 12-month-old female patient who experienced unexplained death. The patient received the fourth dose on 18-Apr-2008. Past vaccinations included Prevenar and Infanrix Hexa in Aug-2007 (first dose), in Oct-2007 (second dose) and in Nov-2007 (third dose). The patient has been fully immunised. Concomitant medications were not reported. The patient experienced unexplained death on 20-Apr-2008. Except for determination of death no further examination were done. The cause of death was reported as death. This case is being treated according to the foreign Act.


VAERS ID: 312343 (history)  
Form: Version 1.0  
Age: 0.7  
Sex: Female  
Location: Foreign  
Vaccinated:2007-10-05
Onset:2008-04-22
   Days after vaccination:200
Submitted: 2008-05-14
   Days after onset:22
Entered: 2008-05-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-22
   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: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0805USC00040

Write-up: Information has been received from an investigator concerning an 8-month-old female with no known previous medical history who entered a study. On 05-OCT-2007, 02-NOV-2007, and 30-NOV-2007, the patient was vaccinated with the first, second, and third doses of blinded therapy, respectively. There was no concomitant medication. On 07-MAY-2008, a field supervisor visited the patient''s home and discovered that she had died on 22-APR-2008. At the time of this report, the patient''s parents were not in the study area and the information was obtained from the uncle. He reported that there was no information regarding the cause of death and that the parents of the infant were difficult to contact. At the time of this report, the cause of death was unknown and the relationship of the death to study therapy was unknown. Additional information has been requested regarding further information surrounding the patient''s death and autopsy results.


VAERS ID: 312344 (history)  
Form: Version 1.0  
Age: 0.8  
Sex: Female  
Location: Foreign  
Vaccinated:2007-10-08
Onset:2008-05-02
   Days after vaccination:207
Submitted: 2008-05-14
   Days after onset:12
Entered: 2008-05-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-05-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0805USC00036

Write-up: Information has been received from an investigator concerning a 10-month-old female with no known previous medical history who entered a study. On 13-AUG-2007, 10-SEP-2007, and 08-OCT-2007, the patient was vaccinated with the first, second, and third doses of blinded therapy, respectively. There was no concomitant medication. On 07-MAY-2008, a field supervisor visited the patient''s home and discovered that she had died on 02-MAY-2008. The patient died while living with her parents for an undetermined amount of time. The parents are still there and no information regarding the death was available at the time of this report. The cause of death was unknown. At this time, it was unknown if the death was related to study therapy. Additional information has been requested regarding a death certificate and any information regarding the events surrounding the patient''s death.


VAERS ID: 314407 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2008-02-25
Onset:0000-00-00
Submitted: 2008-05-30
Entered: 2008-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Blood culture negative, Body temperature decreased, Brain scan normal, C-reactive protein normal, CSF cell count increased, CSF culture negative, CSF white blood cell count increased, Conjunctivitis, Cough, Crying, Culture stool negative, Epstein-Barr virus test negative, Lividity, Mononucleosis heterophile test negative, Platelet count decreased, Red blood cell count decreased, Red blood cells CSF positive, Respiratory syncytial virus serology, Rhinitis, Sudden death, Trismus, White blood cell count normal, X-ray normal
SMQs:, Torsade de pointes/QT prolongation (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-03-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Premature baby
Preexisting Conditions: The subject''s mother was 15-year-old and the subject''s father-18-year-old. The subject was a premature baby, born after 31 weeks of amenorrhea. At birth, he weighted 1.665 kg. The same day, the subject was hospitalized in intensive care unit 19 December 2007. Then, from 31 December 2007 to 10 January 2008, the subject was hospitalized for respiratory syncytial virus bronchiolitis.
Allergies:
Diagnostic Lab Data: Blood culture, 01Mar2008, Negative; Body temperature, 01Mar2008, 30.5Celsius deg; C-reactive protein, 01Mar2008, 6mg/1; CSF culture, 01Mar2008, Negative; Cerebrospinal fluid white cell, 01Mar2008, 567/mm3; Epstein-Barr virus serology, 01Mar2008, Negative; Leukocyte count NOS, 01Mar2008, 11 800/mm3; Platelet count, 01Mar2008, 145 000/mm3; Red blood cell count, 01Mar2008, 1 860 000/mm3; Respiratory syncytial virus se, 01Mar2008, Negative; Scan brain, 01Mar2008, Normal; Stool culture, 01Mar2008, Negative; X-ray, 01Mar2008, Normal; On 01March 2008: - ionogram : postmortem abnormality - cerebrospinal fluid red blood cell count : 228/mm3 - infectious mononucleosis test : negative - bacteriological sample revealed presence of haemophilus influenzae on the right cilium and aureus staphylococcus in right nostril. On 10 March 2008: autopsy. At external verification and visceral macroscopic examination, no malformative abnormality was observed. There was no argument suggestive of an inflammatory pathology on microscopic examination of the samples. No pathological lesion was observed.
CDC Split Type: B0522161A

Write-up: This case was reported by the regulatory authority (AFSSaPS, PV20080111) and described the occurrence of sudden death in a 2-month-old male subject who was vaccinated with INFANRIXQUINTA (GlaxoSmithKline) and PREVENAR (Wyeth labs). The subject''s mother was 15-year-old and the subject''s father 18-year-old. The subject was a premature baby, born after 31 weeks of amenorrhea. At birth, he weighted 1,665 kg. The same day, the subject was hospitalized in intensive care unit 19 December 2007. Then, from 31 December 2007 to 10 January 2008, the subject was hospitalized for respiratory syncytial virus bronchiolitis. On 25 February 2008, he was vaccinated with a dose of INFANRIX QUINTA (batch number not available, intramuscular). On 27 February 2008, he was vaccinated with a dose of PREVENAR (batch number not available, intramuscular). On 29 February 2008, four days after the vaccination with INFANRIX QUINTA, the subject consulted for rhinitis and cough for several days (NOS). A diagnosis of conjunctivitis was made and a treatment with eye drops was initiated. During the night, from 29 February 2008 to 01 March 2008, the subject experienced severe cough. At the end of the night, he cried. After a rhinopharyngeal disobstruction, the subject was put to be on his back. At 08:30, the subject was found lifeless (sudden unexpected death). Several intensive care manoeuvres were performed and he was transferred to hospital. He had 43 weeks of amenorrhea (corrected age), weighted 3.7 kg and measured 53 cm. His cranial perimeter was at 38 cm and body temperature was at 30.5 degrees Celsius. He presented with post-mortem lividity of the right hemibody and of the face. The mouth examination was impossible due to a trismus. There was a clear red serosity in the right nostril. No hepato-splenomegaly, no suspect lesion, no ecchymosis and no sign of physical abuse and trauma was observed. Leukocytes count was at 11 800/mm3, red blood cell count at 860 000/mm3, platelets at 145 000/mm3 and C-reactive protein at 6 mg/1. The electrocyte count showed post-mortem abnormalities. Blood culture and direct research of respiratory syncytial virus were negative. In cerebrospinal fluid, there were 567 leukocytes and 228 red cells /mm3. The CSF culture was negative. Epstein Barr virus serology and infectious mononucleosis test were negative. Stool culture was negative. Bacteriological sample revealed presence of haemophilus influenzae on the right cilium and aureus staphylococcus in right nostril. Cerebral scan was normal. The skeleton X-ray was normal. On 10 March 2008, an autopsy was performed. At external verification and visceral macroscopic examination, no malformative abnormality was observed. There was no argument suggestive of an inflammatory pathology on microscopic examination of the samples. No pathological lesion was observed. The AFSSaPS reported the events as life threatening and considered the infant sudden death as dubiously related to vaccination with INFANRIX QUINTA and PREVENAR, according to the Method of Imputability. This case has been closed; no more information will be available.


VAERS ID: 314410 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2008-04-17
Onset:2008-04-18
   Days after vaccination:1
Submitted: 2008-05-30
   Days after onset:42
Entered: 2008-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA401A / UNK UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA401A / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER A20CA401A / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA526A / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure, Body temperature increased, Brain scan abnormal, C-reactive protein decreased, CSF glucose decreased, CSF protein increased, Cardiac murmur, Central nervous system lesion, Clonus, Coma, Death, Electrocardiogram abnormal, Endotracheal intubation, Eye disorder, Febrile convulsion, Fontanelle bulging, Haemoglobin decreased, Heart rate increased, Hypertonia, Hypotonia, Intracranial pressure increased, Lumbar puncture abnormal, Lymphocyte count normal, Meningitis pneumococcal, Moaning, Neutrophil count decreased, Nuclear magnetic resonance imaging brain abnormal, Oxygen supplementation, Pyrexia, Tachycardia, Vasculitis, White blood cell count decreased, White blood cell count increased
SMQs:, Agranulocytosis (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Vasculitis (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-24
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 19Apr2008, 110/60; Body temperature, 18Apr2008, 39.5Celsius deg; Body temperature, 20Apr2008, Normal; C-reactive protein, 23Apr2008, see text; Cerebrospinal fluid glucose, 19Apr2008, Low; Cerebrospinal fluid protein, 19Apr2008, 0.97g/l; Electrocardiogram, 22Apr2008, Abnormal; Electrocardiogram, 23Apr2008, Abnormal; Heart rate, 19Apr2008, 120; Heart rate, 19Apr2008, 90; Heart rate, 19Apr2008, 189/min; Hemoglobin, 19Apr2008, 9.8; Leukocyte count NOS, 19Apr2008, 2300; Leukocyte count NOS, 23Apr2008, 20 780; Lumbar puncture, 19Apr2008, Abnormal; Lymphocyte count, 19Apr2008, 1400; MRI brain, 23Apr2008, Abnormal; Neutrophils, 19Apr2008, 500; Scan brain, 20Apr2008, Abnormal; On 19 April 2008, recolouring time was lower than 3 seconds, pleuropulmonary examination was normal, lumbar puncture revealed 14 elements, 74 percent of neutrophils and presence of cocci gram positive (at direct exam); cutaneoplantar reflexes in extension, quick and symmetric tendon reflexes, lumbosacral examination, no dysraphy; On 20 April 2008, cerebral scan, presence of hypodense lesions, CSF, sterile; On 22 and 23 April 2008, ECG revealed infra-clinic temporal crisis with almost ground inactivity; On 23 April 2008, MRI brain, confirmed cortico subcortical lesions, lesions incompatible with survival, there was a lot of anoxo-ischemic lesions, C reactive protein decreased (NOS)
CDC Split Type: B0522460A

Write-up: This case was reported by a regulatory authority and described the occurrence of streptococcus pneumoniae meningitis in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline) and INFANRIXQUINTA. On 17 April 2008, the subject was vaccinated with INFANRIX QUINTA (batch number A20CA401A, intramuscular) and ROTARIX (batch number A41CA526A). One day later, on 18 April 2008, in the morning, the subject presented with fever at 39.5 degrees Celsius. During the night from 18 to 19 April 2008, she experienced moaning and convulsion. At the emergency unit at 04H07, the subject was whining, febrile and presented with clonic convulsive crisis of upper limbs. On 19 April 2008, clinical examination revealed an anterior fontanelle bulging, ocular revulsion, clonia of upper limbs, tachycardia at 189 per minute and systolic murmur. Her recolouring time was lower than 3 seconds. There was no chills of the extremity and no purpura. The pleuropulmonary examination was normal. at 04:15, the subject received intrarectal VALIUM at 0.5 mg/kg. Within three minutes, the convulsion resolved. At 04:40, the convulsion reappeared as generalized hypertonia. The subject received GARDENAL at 20 mg/kg. Ten minutes later, at 04:50, convulsion stopped. A lumbar puncture was performed and revealed 14 elements, 74 percent of neutrophils and presence of cocci gram positive (at direct examination). Cerebrospinal fluid protein was increased to 0.97 g/l and there was a hypoglycoracchia. White blood was at 2300 including 500 neutrophils, lymphocytes was at 1400 and haemoglobin at 9.8. Two fluid replacement with isotonic saline solution at 20 mg/kg were given with CLAFORAN, CLAMOXYL and gentamycine (at meningeal dosage) associated with dexamethasone. A diagnosis of bacterial meningitis was made. On 19 April 2008, the subject was hospitalized in pediatric intensive care unit. At the admission, arterial pressure was at 110/60 and heart rate between 120 and 90. She presented with an axial hypotonia, a peripheral hypertonia, cutaneoplantar reflexes in extension and quick and symmetric tendon reflexes. No dysraphy was observed at the lumbosacral examination. A diagnosis of meningitis and cerebral vasculitis due to pneumoniae Streptococcus was made. The antibiotherapy was continued with cefotaxime (monotherapy). On 20 April 2008, the cerebrospinal fluid was sterile. There was no fever. Later on, the state was unfavourable due to a coma and an intracranial hypertension. The subject was anesthetized with TIOPENTAL for intubation and ventilation by oro-tracheal route. On 20 April 2008, the cerebral scan was worrying due to presence of hypodense lesions. On 22 April 2008, ECG revealed infra-clinic temporal crisis with almost ground inactivity. On 23 April 2008, C-reactive protein decreased and leukocytes were at 20 780. On 23 April 2008, ECG was comparable to the ECG performed on 22 April 2008. A brain MRI was performed and confirmed cortico subcortical lesions, incompatible with survival. There was a lot of anoxo-ischemic lesions. There was no argument suggestive of a cerebral venous thrombosis. The intensive care was trivial and it was preferred to do a medical with the parents. On 24 April 2008, the subject died; cause of death was streptococcus pneumoniae meningitis. It was unknown whether an autopsy was performed. The AFSSaPS considered that the events were dubiously related to vaccination with ROTARIX and INFANRIX QUINTA, according to the foreign Method of Imputability. This case has been closed; no more information will be available.


VAERS ID: 314499 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Male  
Location: Foreign  
Vaccinated:2007-08-21
Onset:2007-08-24
   Days after vaccination:3
Submitted: 2008-05-30
   Days after onset:280
Entered: 2008-06-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS 17001 / 2 UN / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. NE44070 / 2 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-08-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Down''s syndrome; Cardiac disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy, inconclusive
CDC Split Type: WAES0805AUS00199

Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form and a Case Line Listing concerning a 17 month old male with a history of Down''s syndrome and cardiac condition who on 21-AUG-2007 was vaccinated with VARIVAX (Batch No. NE44070, Invalid). Other suspect therapy included FLUVAX. On 24-AUG-2007 the patient had unexplained death 3 days after receiving VARIVAX together with a second dose of FLUVAX. The child had no ill health before passing away. Autopsy was performed with inconclusive findings. The agency considered that death was possibly related to VARIVAX and FLUVAX. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 315016 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2008-01-17
Onset:2008-03-06
   Days after vaccination:49
Submitted: 2008-06-04
   Days after onset:89
Entered: 2008-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Acute hepatic failure, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood glucose decreased, Blood product transfusion, Blood sodium decreased, Bradycardia, Bronchospasm, Cardiomegaly, Chest X-ray, Coagulopathy, Cough, Crepitations, Death, Haematocrit decreased, Haemoglobin decreased, Hypoglycaemia, Jaundice, Malaise, Oxygen saturation normal, PCO2 normal, Pallor, Platelet count decreased, Pneumonia, Pyrexia, Respiratory distress, Rhinorrhoea, Sepsis, Transfusion, White blood cell count increased, X-ray abnormal
SMQs:, Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (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), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (narrow), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-03-31
   Days after onset: 24
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Mucopolysaccharidosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Alanine aminotransferase, 21Mar2008, 1558U/l, 8 (low), 78 (high); Aspartate aminotransferase, 21Mar2008, 1967U/l, 18 (low), 74 (high); Blood glucose, 18Mar2008, 22mg/dl, 70 (low), 110 (high); Blood glucose, 21Mar2008, 46mg/dl, 70 (low), 110 (high); Hematocrit, 18Mar2008, 26.5%, 29 (low), 42 (high); Hemoglobin, 18Mar2008, 9.02g/dl, 10 (low), 13 (high); Leukocyte count NOS, 18Mar2008, 38.600mm3, 10 (low), 13 (high); Leukocyte count NOS, 21Mar2008, 1375mm3, 10 (low), 13 (high); O2 saturation, 19Mar2008, 97%; PCO2, 19Mar2008, 29unit; Platelet count, 21Mar2008, 21900mm3, 300000 (low), 700000 (high); Sodium, 21Mar2008, 122mEq/l, 135 (low), 145 (high); Thorax X-ray, 18Mar2008, see textunit.
CDC Split Type: B0522363A

Write-up: This case was reported by a physician in the fame of a study and described the occurrence of acute hepatic failure in a 4 month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included metabolic congenital anomaly mucopolysaccharidosis. On 17 January 2008 the subject received 1st dose of ROTARIX (oral). On 6 March 2008, 49 days after 1st vaccination with ROTARIX, the subject developed cough and hyaline rhinorrhea. On 11 March 2008 the subject received 2nd dose of ROTARIX (oral). On 18 March 2008, 7 days after vaccination with 2nd dose of ROTARIX, the subject suddenly presented respiratory distress and he was admitted to the emergency room. Subject''s physical examination showed pallor, malaise, fever, bronchospasm and bilateral widespread crackles. The same day the thorax x-ray showed bilateral parrahilis reticular infiltrate, without any pulmonary condensation and cardiomegaly. He showed symptoms of septic shock, therefore he was admitted at the intensive care unit. The subject presented Acute hepatic failure, jaundice, coagulopathy and hypoglycemia. After treatment the subject showed improvement. On 25 March 2008 the subject was discharged, however he persisted with respiratory distress, bronchospams and the subject''s conditions worsened. Finally the subject presented refractory bradycardia without response to resuscitation cardio pulmonar. On 31 March 2008 the subject died with the diagnosis of acute hepatic failure, sepsis, and pneumonia. The autopsy was no performed. The subject was hospitalized for 8 days and the physician considered the events were disabling, life threatening, a congenital anomaly and clinically significant (or requiring intervention). The subject was treated with dexamethasone, salbutamol sulphate (Salbutamol), sodium bicarbonate, ceftriaxone, amikacin and dobutamine. The subject also received on 18 March 2008, transfusion of globular package (50ml in 2 hours without complications) and transfusion of fresh plasma (50 ml every 12 h). The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 315975 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2008-03-01
Submitted: 2008-06-09
   Days after onset:99
Entered: 2008-06-11
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 4 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drug ineffective, Meningitis pneumococcal
SMQs:, Lack of efficacy/effect (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: DEWYEG01648708

Write-up: Information regarding PREVENAR was received from a healthcare professional via sales representative regarding a patient (age and gender unknown) who experienced drug ineffective and died due to pneumococcal meningitis. The patient received the fourth dose on an unspecified date. Relevant medical history was not provided. Concomitant medications were not reported. The patient experienced pneumococcal meningitis on an unknown date approximately in Mar-/Apr-2008. The patient was hospitalised altogether in two different hospitals. Finally the patient died on an unknown date approximately two to three months before the information was reported to Wyeth, in Mar-/Apr-2008. The case of death was reported as meningitis pneumococcal. The reporting physician refused to provide follow-up information regarding the adverse event communicated due to the fact that he was not involved in this case at any level and was therefore not able to provide further details on this case.


VAERS ID: 316280 (history)  
Form: Version 1.0  
Age: 1.9  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-06-13
Entered: 2008-06-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Amino acid level normal, Apgar score abnormal, Biopsy muscle normal, Blood creatinine increased, Blood glucose decreased, Blood lactic acid normal, Blood pyruvic acid normal, Body temperature increased, Cardiac failure, Carnitine decreased, Coma, Computerised tomogram abnormal, Death, Echocardiogram normal, Electrocardiogram normal, Hypoglycaemia, Hypotonia, Laboratory test abnormal, Laboratory test normal, Measles antibody negative, Mechanical ventilation, Pyrexia, Shock, Tachycardia, Tachypnoea, Urine analysis normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Infective pneumonia (broad), Dehydration (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Brain stem disorder; Thalamic
Preexisting Conditions: Immunisation; Feeding disorder; Hypsarrhythmia; Hypotonia; Respiratory failure; Generalised tonic-clonic seizure; West''s syndrome; Tracheostomy; Neonatal asphyxia; Foetal distress
Allergies:
Diagnostic Lab Data: diagnostic laboratory test, amino acids, organic acids, fatty acids, pyruvate, lactate all normal; head computed axial tomography, brain atrophy; echocardiography, normal; muscular biopsy, no finding in muscle fiber size; diagnostic laboratory test, Kaup index 17.4; electrocardiogram, normal; Apgar score, 2 points/1 minute; blood chemistry, within normal ranges; blood glucose, 13 mg/dl; body temp, 41.0 C; serum measles Ab, no increase; urinalysis, within normal ranges; serum carnitine, 7.4 mmol/L; serum carnitine, 5.6 mmol/L; laboratory test, acylcarnitine, 1.8 mmol/L
CDC Split Type: WAES0806USA00580

Write-up: It has been reported as part of a published article entitled above that a 1-year and 11-month old female infant with bilateral lesions of the thalamus, basal ganglia, cerebellar and brainstem disease died from heart failure 9 days after being vaccinated with a dose of ATTENUVAX (Enders-Edmonston) (manufacturer unknown). She had a high fever, hypocarnitinemic and non-ketotic hypoglycemia, serum levels of total carnitine 7.4 mmol/L, free carnitine 5.6 mmol/L, acylcarnitine 1.8 mmol/L and glucose 13 mg/dl. Due to feeding difficulty, the patient, however, had been administered parenteral elementary nutrition through a feeding tube since early infancy. The commercially available parenteral nutrition solutions do not contain carnitine. A secondary carnitine deficiency followed by non-ketotic hypoglycema-related heart failure may readily develop even in a patient without valproic acid, during high fever. Many patients with severe motor and intellectual disabilities have often been alimented by the parenteral elementary nutrition because of their eating and feeding difficulties. However most of these commercially available parenteral elementary nutrition solutions do not contain carnitine. In this report, a 1-year and 11-month old infant with severe motor and intellectual disabilities died from high fever, hypocarnitinemic hypoglycemia and heart failure 9 days after being administered a measles vaccination. Based on the clinical and laboratory examinations, the cause and its clinical problem are discussed herein. A 1-year and 11-month-old female showed a weak fetal activity and hydramnion during her fetal life. She was delivered by an emergency caesarian section because of fetal distress at 39 weeks of gestation. Her height was 48.5 cm and her weight was 3.010g. Because of neonatal asphyxia (APGAR score: 2 points/1 min) endotracheal intubation and resuscitation were performed. Here neonatal asphyxia was very transient for the immediate resuscitation. But she showed hypotonia and had required assisted ventilation. Generalized tonic-clonic convulsions and myoclonus started at day 0 and thereafter persisted sporadically. Respiratory failure had also persisted and, as a result, a tracheotomy was performed at 4 months after birth. Extension-type tonic spasms and their series formation occurred at 7 months of age and an electroencephalogram showed hypsarrhythmia. Under a diagnosis of symptomatic West syndrome, she was administered clonazepam, no co-therapy of valproic acid. The patient did not show any eye contact, a social smile or head control. Due to feeding difficulty, the patient had to be administered parenteral nutrition, (ELENTAL) which did not contain any carnitine, through a feeding tube since 5 months of age. Routine blood and urine chemistry levels were all within the normal ranges in the early infantile period (from the neonatal period until 4 months of age). The serum levels of amino acids, organic acids, very long chain fatty acids, pyruvate and lactate were also within normal ranges. The electrocardiogram and echocardiogram findings were normal. Head CT/MRI showed brain atrophy mainly in the cerebella and brain stem, and calcification in the basal ganglia. These findings indicated that the patient suffered from bilateral lesions of the thalamus, basal ganglia, cerebellar and brainstem disease. In terms of here severe hypotonia and its differential diagnosis for congenital myopathy, fatty acid metabolic disorder, and others, a muscle biopsy was performed when she was 3 months old with parenteral informed permission. However, it showed no specific finding in the muscle fiber size. No ragged-red fibers, nemaline bodies, central cores or lipid depositions were observed. She did not have any episodes of ketotic hypoglycemia, metabolic acidosis, cardiomyopathy and Reye-like syndrome even during a febrile illness before 1 year and 11 months of age. A varicella vaccination was administered at 7 months and DPT vaccination was administered 3 times between the ages of 1 year 6 months and 1 year 8 months of age. These vaccinations were all uneventful. Then at 1 year 11 months of age, 0.5 ml of a measles vaccination was subcutaneously administered when her seizures and a general condition were fairly stable under the clonazepam administration, without co-therapy of valproic acid. On the early morning of day 8 after the vaccination, she developed a fever, tachycardia and tachypnea, and then was hospitalized. Although the patient''s body weight was 12 kg and her Kaup index was 17.4 (normal range 15-19), her muscle tonus and its volume were reduced. In the afternoon her temperature went up to 41.0 C. Her consciousness changed to coma, and then rapidly fell into a state of shock. An assisted ventilation, rapid rehydration, and the administration of steroids and vasopressors were not effective and she died the next morning. After an abrupt change, non-ketotic hypoglycemia 13 mg/dl was observed. Both serum levels of total carnitine 7.4 mmol/L, free carnitine 5.6 mmol/L and acylcarnitine 1.8 mmol/L decreased. This patient died from a hypocarnitinemic hypoglycemia and heart failure during a measles vaccination-related high fever. Because of the rapidly progressive clinical course, an evaluation of the central nervous system, including a spinal tap, head CT/MRI and autopsy, could not be conducted. Although her serum measles antibody had not increased by day 8 after vaccination, high fever usually developed between 5-12 days after measles vaccination as an adverse effect. This is a first report to show the relationship between carnitine deficiency caused by parenteral elementary nutrition and the adverse effects of measles vaccination. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 316358 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2005-09-13
Onset:2005-09-20
   Days after vaccination:7
Submitted: 2008-06-16
   Days after onset:1000
Entered: 2008-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-09-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0524245A

Write-up: This case was reported by a patients support league and described the occurrence of death nos in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). Previous and/or concurrent vaccination included ENGERIX B (GlaxoSmithKline; unknown) given on 2 August 2005. On 13 September 2005 the subject received 2nd dose of ENGERIX B (unknown, lot number not provided). On 20 September 2005, 7 days after vaccination with ENGERIX B, the subject died. The subject died from death-cause unknown. It was unknown whether an autopsy was performed. This case has been reported to a Regulatory Authority. Additional information has been requested.


VAERS ID: 316751 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-06-20
Entered: 2008-06-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Reaction to preservatives, Regurgitation
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0524993A

Write-up: This case was reported by a regulatory authority and described the occurrence of possible allergy to thimerosal in an infant female subject who was vaccinated with TRITANRIX-HB (GlaxoSmithKline), and HIBERIX. On an unspecified date, the subject received unspecified dose of TRITANRIX-HB (unknown route and injection site), unspecified dose of HIBERIX (unknown route and injection site), lot numbers not provided. One day after vaccination with HIBERIX and TRITANRIX-HB, the subject experienced milk regurgitation, leading to death. The regulatory authority reported that the events were possibly related to vaccination with TRITANRIX-HB and HIBERIX. The reporting physician has adjudicated the death due to thimerosal contents of the vaccine. It was unknown whether an autopsy was performed. Additional information has been requested but could not be obtained. This case has therefore been closed.


VAERS ID: 317250 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2008-06-18
Onset:2008-06-18
   Days after vaccination:0
Submitted: 2008-06-24
   Days after onset:6
Entered: 2008-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-06-18
   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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0525983A

Write-up: This case was reported by a physician and described the occurrence of death nos in a 3-month-old female subject who was vaccinated with TRITANRIX HEPB (GlaxoSmithKline). On 18 June 2008, the subject received the 2nd dose of TRITANRIX HEPB (unknown, lot number not provided). On 18 June 2008, 3 hours after vaccination with TRITANRIX HEPB, the subject died. Cause of death was not reported. It was unknown whether an autopsy was performed. The physician considered the event was possibly related to vaccination with TRITANRIX HEPB. Follow up information received on 22 June 2008: A postmortem has been conducted on the infant and no cause of death was found.


VAERS ID: 317334 (history)  
Form: Version 1.0  
Age: 1.33  
Sex: Female  
Location: Foreign  
Vaccinated:2008-02-01
Onset:2008-02-01
   Days after vaccination:0
Submitted: 2008-06-24
   Days after onset:143
Entered: 2008-06-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 4 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Multi-organ failure, Pneumococcal bacteraemia, Serology test
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Situs ambiguous; Ventricular septal defect
Preexisting Conditions: Premature baby
Allergies:
Diagnostic Lab Data: Blood culture, 00-Feb-2008, detection of pneumococci of serotype 33F
CDC Split Type: DEWYEG01742408

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 16-month-old female patient who experienced pneumococcal bacteraemia without focus and multi organ failure and died due to these events. The patient received the fourth dose in Feb-2008 at the age of 16 months. The patient''s concurrent illnesses include Ivemark''s syndrome, spontaneous occlusion of ventricular septal defect and situs ambiguous with a past history of being a premature baby (gestational week 35). The patient had no immune deficiency. Concomitant medications were not reported. The patient experienced pneumococcal bacteraemia without focus in Feb-2008. The patient was hospitalised altogether in two different hospitals. Blood culture detected pneumococci of serotype 33F. In the second hospital the patient died due to pneumococcal bacteraemia without focus and multi-organ failure on 29-Feb-2008 (at the age of 16 months). Blood culture (results: detection of pneumococci of serotype 33F) was done in Feb-2008. The cause of death was reported as multi-organ failure and pneumococcal bacteraemia.


VAERS ID: 317529 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-02-01
Onset:0000-00-00
Submitted: 2008-06-25
Entered: 2008-06-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Guillain-Barre syndrome, Muscular weakness, Nerve conduction studies, Paraesthesia, Respiratory paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Respiratory failure (narrow), Hypokalaemia (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Coronary artery disease; Chronic obstructive pulmonary disease; Hepatic failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: nerve conduction study
CDC Split Type: WAES0806USA03038

Write-up: Information has been received from a physician concerning a 69 year old male with coronary artery disease, chronic obstructive pulmonary disease, and hepatic failure, who in February 2008, was vaccinated with a dose of PNEUMOVAX 23 vaccine. Subsequently, the patient experienced Guillain-Barre syndrome with symptoms of paresthesia, lower limb weakness that progressed to the upper limbs, and in April 2008 progressed to respiratory paralysis. The patient was hospitalized. A nerve conduction study was performed (results not reported). The patient died during the fourth week of April 2008 on an unspecified date. Additional information is not available.


VAERS ID: 317695 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-04-12
Onset:2008-04-14
   Days after vaccination:2
Submitted: 2008-06-26
   Days after onset:73
Entered: 2008-06-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Death, Haemorrhage, Inappropriate schedule of drug administration
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806MYS00011

Write-up: Information has been received from a health professional concerning a 42 year old female who on 12 Apr 2008 was vaccinated with GARDASIL. Prior to the vaccination, the patient was reported looking weak and lost weight. On 14 Apr 2008, the patient returned to the clinic and complained of abdominal pain and bleeding. The patient was treated with painkillers for abdominal pain and advised to return if pain persists. The patient never came back. The second dose was due on 12 Jun 2008 but the patient did not turn up. On 14 Jun 2008, the clinic was informed that the patient had died. The cause of death was unknown. The reporter felt that abdominal pain, bleeding and death were not related to therapy with GARDASIL. No further information is available.


VAERS ID: 318070 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-07-01
Entered: 2008-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 LL / UN

Administered by: Other       Purchased by: Other
Symptoms: Atelectasis, Autopsy, Brain herniation, Brain oedema, Bronchial wall thickening, Cardiac arrest, Convulsion, Death, Drug screen negative, Hypersensitivity, Interstitial lung disease, Ischaemic cardiomyopathy, Lymphocytic infiltration, Resuscitation, Status epilepticus, Ventricular fibrillation, Visceral congestion
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Interstitial lung disease (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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? 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 drug screen negative, Negativeunit; Urine drug screen, Negativeunit
CDC Split Type: B0526438A

Write-up: This case was reported in a literature article and described the occurrence of lymphocytic interstitial pneumonitis in a 12-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). The subject was healthy and had no relevant previous medical history. She was under no other medication on a regular basis. On an unspecified date, the subject received 3rd dose of Hepatitis B vaccine (unknown route and injection site), lot number not provided. Three days after vaccination with Hepatitis B vaccine, the subject experienced status epilepticus with refractory seizures. She was brought to the emergency ward. During the transfer, the subject had a cardiac arrest, leading to a cardio-pulmonary resuscitation with infusion of epinephrine. Upon admission to the hospital, she had periods of asystole and fine ventricular fibrillation, and then cardio-pulmonary resuscitation was continued. Fine fibrillation persisted and she was defibrillated back into asystole. At this time, the resuscitation attempts had been going on for approximately 1 h, when the patient died. An autopsy was performed and a marked cerebral edema with congestion and herniation was found. Additionally, the anatomical study showed a marked pulmonary atelectasis alternating with areas of hyper-expansion with a mild diffuse interstitial type pneumonitis, mild dilation of the right side of the heart, and a diffuse visceral congestion. Histopathological examination revealed no inflammatory changes, with normal neuronal architecture, no hemorrhages or significant inflammation. Purkinje cells showed mild ischemic changes. In the lungs a slight thickening of the alveolar septa with non-specific mononuclear infiltrates composed of lymphocytes was noted. Drug screens on blood and urine, including ethanol were negative. The author considered the events were related to vaccination with Hepatitis B vaccine. The subject died, cause of death is not specified. The subject suffered from hypersensitivity pneumonitis which might have contributed to the death.


VAERS ID: 318242 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2008-05-22
Onset:2008-05-22
   Days after vaccination:0
Submitted: 2008-07-03
   Days after onset:42
Entered: 2008-07-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-05-23
   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: The patient''s concurrent illness includes rhinorrhoea.
Preexisting Conditions: The patient has a past history of foetal distress syndrome (born at 41 weeks gestation due to this) and conjunctivitis (recent).
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: GBWYEG01679908

Write-up: This is a fatal case. Additional information received from a regulatory authority: medical history, product details, concomitant therapy, event details, cause of death updated. Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 2-month-old female patient who experienced a little temperature, death unexplained - post mortem could not determine reason and was found death at 3am during the night. The patient received a dose on 22-May-2008. The patient experienced a little temperature on 22-May-2008 was given treatment but felt better. Put to bed late at night and was found dead in Moses basket 4 or 5 hours later, on 23-May-2008. Post-mortem showed low copies of Rhinovirus in nose and chronic inflammation and laryngitis, but it looked like they were getting better from the viral infections. Death unexplained - post mortem could not determine reason. Reporter has police details available. The patient had no risk factors and the post mortem could find no other reason why the patient died. Reported as patient had been vaccinated 24 hours earlier. The cause of death was reported as death unexplained and the autopsy cause of death was death. No additional information was available at the time of this report.


VAERS ID: 318243 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-07-03
Entered: 2008-07-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 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: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: NLWYEG01802308

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 3-month-old female patient who experienced death. The patient received the second dose on an unspecified date. Relevant medical history was not provided. Concomitant medications were not reported. The patient died ten days after receiving the second dose of PREVENAR and PEDIACEL. No additional information was available at the time of this report.


VAERS ID: 318244 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-07-03
Entered: 2008-07-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA09042

Write-up: Information has been received from a physician concerning a 20 year old female with no relevant medical history reported who was vaccinated with a first dose of GARDASIL on an unspecified date. Subsequently, exact onset not reported, the patient felt unwell. About 6 weeks post vaccination, she experienced pulmonary embolism with fatal outcome. An autopsy is scheduled. Other business partner numbers included: E2008-05832. Additional information has been requested.


VAERS ID: 318701 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-06-12
Onset:2008-06-17
   Days after vaccination:5
Submitted: 2008-07-10
   Days after onset:23
Entered: 2008-07-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Musculoskeletal chest pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-06-18
   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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA00865

Write-up: Information has been received from a health professional concerning a 9 year old male who on 12-JUN-2008 received his first dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3), manufacturer and batch number not reported. On 17-Jun-2008, five days post vaccination the patient complained of rib pain. On 18-Jun-2008 the patient was sent to Accident and Emergency and collapsed and died the same day. A post mortem was performed but the results were not available at the time of reporting. Other business partner numbers included: E2008-06231.


VAERS ID: 319465 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-06-11
Onset:2008-07-08
   Days after vaccination:27
Submitted: 2008-07-16
   Days after onset:8
Entered: 2008-07-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-07-08
   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: ATROVENT COMP; BURANA; IBUXIN; PHYSIOTENS; SEROQUEL; ZANIDIP; cetirizine hydrochloride
Current Illness: Multiple allergies; Headache; Coxitis; Hypertonia; Insomnia; Chronic obstructive pulmonary disease; Back pain; Poor peripheral circulation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA01914

Write-up: Information has been received from an investigator concerning a 58 year old male with chlorine and nickel allergies, headache, coxitis, hypertonia, insomnia, chronic obstructive pulmonary disease, back pain and poor peripheral circulation who entered a study, title as above. On 11-JUN-2008 the patient was randomized to be vaccinated with a dose of blinded therapy of either V211 blinded therapy or placebo. Concomitant therapy included ZANIDIP, PHYSIOTENS, ATROVENT COMP, SEROQUEL, IBUXIN, BURANA and cetirizine hydrochloride. On 08-JUL-2008 the subject was found dead at home. The cause of death was unknown. An autopsy is to be performed. It is unknown at the time of this report is study therapy was related to cause of death. The record for this patient was unblinded 15-JUL-2008. The patient was vaccinated with 0.65 ml of ZOSTAVAX (Oka/Merck). Additional information has been requested.


VAERS ID: 319633 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2003-06-17
Onset:0000-00-00
Submitted: 2008-07-17
Entered: 2008-07-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pneumonia streptococcal, Streptococcus identification test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: diagnostic laboratory test, strep pneumonia serographed as 22F
CDC Split Type: WAES0807AUS00171

Write-up: Information was obtained on request by the Company from the agency via a Case Line Listing and a Public Case Detail Form concerning a 76 year old male who on 17-JUN-2003 was vaccinated with PNEUMOVAX 23. Subsequently the patient developed streptococcus pneumonia, serographed as 22 F and vaccine failure. At the time of reporting to the agency on 08-NOV-2007 the patient had died. The patient was not seen by a physician prior to his death nor was he hospitalised. The cause of death was thought to be related to invasive pneumococcal disease, awaiting further information. The agency considered that pneumococcal infection and vaccination failure were possibly related to therapy with PNEUMOVAX 23. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 319811 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2004-04-28
Onset:0000-00-00
Submitted: 2008-07-18
Entered: 2008-07-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Lung neoplasm malignant; Prostate cancer
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807AUS00158

Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form and a Case Line Listing concerning a 67 year old male with a history of lung neoplasm malignant and prostate cancer who on 28-APR-2004 was vaccinated with PNEUMOVAX 23. Subsequently the patient developed vaccination failure and pneumonia pneumococcal. The initial presenting complaint to the hospital was unclear. Three days after, blood culture was positive for pneumococcal pneumonia with serotype 23F. 19 days after hospital admission, the patient died. The cause of death was pneumonia pneumococcal. The agency felt that vaccination failure and pneumonia pneumococcal were possibly related to therapy with PNEUMOVAX 23. The original reporting source was not provided. Additional information is not expected.


VAERS ID: 320423 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2007-09-24
Onset:2007-10-01
   Days after vaccination:7
Submitted: 2008-07-25
   Days after onset:298
Entered: 2008-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER 050VFA121Z / 1 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-24
   Days after onset: 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: Unknown
Preexisting Conditions: 1.Systemic Lupus Erythenmatosis (vs. Rheumatoid Arthritis)2. Chronic renal Insufficiency 3.Hypertension 4. s/p Cerebrovascular Accident-2003
Allergies:
Diagnostic Lab Data: See case summary sent to VAERS
CDC Split Type:

Write-up: See deatailed case summary sent to VAERS


VAERS ID: 320546 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2008-07-09
Onset:2008-07-10
   Days after vaccination:1
Submitted: 2008-07-25
   Days after onset:15
Entered: 2008-07-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-07-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: NLWYEG01864008

Write-up: Additional information was received from our regulatory authority regarding patient demographics, product information and event details. Information regarding PREVENAR was received from a healthcare professional regarding a 4-month-old female patient who experienced death. The patient received the third dose on 09-Jul-2008. The patient died in Jul-2009, 1.5 day after receiving the third dose of both vaccinations. The cause of death was reported as unknown. No additional information was available at the time of this report.


VAERS ID: 321627 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-08-08
Entered: 2008-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0058296A

Write-up: This case was reported by a consumer and described the occurrence of death in a 2-month-old subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. Co-suspect vaccination included HEXAVAC (Sanofi Pasteur MSD). In 2003 the subject received unspecified dose of ENGERIX B adult (unknown route and application site) and four weeks later unspecified dose of HEXAVAC (unknown route and application site). At an unspecified time after vaccination with ENGERIX B adult and HEXAVAC, the subject died (not further specified). It was unknown whether an autopsy was performed. Follow-up information has been requested.


VAERS ID: 321780 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:2008-08-04
Onset:2008-08-06
   Days after vaccination:2
Submitted: 2008-08-11
   Days after onset:5
Entered: 2008-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B045BA / 1 UN / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiomegaly, Death, Echocardiogram abnormal, Endotracheal intubation, Heart rate decreased, Moaning, Oral intake reduced, Oxygen saturation decreased, Resuscitation, X-ray abnormal
SMQs:, Cardiac failure (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Echocardiogram, 05Aug2008, see textunit; Heart rate, Aug2008, decreasedunit; X-ray, 05Aug2008, cardiomegalyunit
CDC Split Type: B0532227A

Write-up: This case was reported by a regulatory authority and described the occurrence of death nos in a 2-month-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline), IMOVAX polio. On 4 August 2008 the subject received 1st dose of INFANRIX (unknown), 1st dose of IMOVAX polio (unknown). On 6 August 2008, 30 minutes after vaccination with IMOVAX and INFANRIX, the subject started moaning sound and the amount of intake was reduced. The subject visited the clinic again. No abnormality was found during examination. The subject did not have fever. On 05 August 2008 the symptoms persisted and the subject was transferred to a general hospital. Relevant test included x-ray showing cardiomegaly which was judged not serious. During observation the saturation decreased suddenly, therefore he was intubated. The responsible physician suspected dilated cardiomyopathy and myocarditis according to echocardiogram. Other examination results (details not available) were generally normal. The subject''s heart rate decreased. Cardiopulmonary resuscitation was done but the baby died on 06 August 2008, cause of death was not reported. The hospital recommended an autopsy but the parents refused and the subject''s body was cremated.


VAERS ID: 322065 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-05-28
Onset:2008-06-04
   Days after vaccination:7
Submitted: 2008-08-12
   Days after onset:69
Entered: 2008-08-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-06-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0532562A

Write-up: This case was reported by a regulatory authority (foreign Regulatory Authority # 28.544/021/07/08) and described the occurrence of death nos in a 53-year-old male subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). On 28 May 2008, the subject received 2nd dose of TWINRIX adult (20 mcg, unknown route). Lot number not provided. On 4 June 2008, 7 days after vaccination with TWINRIX adult, the subject experienced death. The subject died on 4 June 2008, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 322222 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2007-09-29
Onset:2007-12-06
   Days after vaccination:68
Submitted: 2008-08-14
   Days after onset:251
Entered: 2008-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Cardio-respiratory arrest, Cough, Death, Gastrostomy, Lower respiratory tract infection, Mechanical ventilation, Metabolic acidosis, Pneumonia, Pseudomonas infection, Pyrexia, Rhinorrhoea, Sepsis, Tracheostomy, X-ray abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2007-12-22
   Days after onset: 16
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Hypotonia
Allergies:
Diagnostic Lab Data: X-ray, Dec2007, See text
CDC Split Type: B0532324A

Write-up: This case was reported by a physician and described the occurrence of lower respiratory tract infection in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject''s medical history included hypotonia. On 29 September 2007, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 6 December 2007, 68 days after vaccination with the 1st dose of ROTARIX, the subject experienced lower respiratory tract infection. The subject was admitted in emergency room on the same day due to 8 days of evolution with nasal secretion, cough and non assessed fever handled with ampicillin and bronchodilator without good response. The subject was hospitalised. The physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). Diagnosis of right apical pneumonia was made by clinic and thorax X-ray with torpid evolution requiring mechanic ventilation, with high suspect of type 1 spinal atrophy (w.Hoffman); tracheostomy and gastromy were performed, presenting sepsis and with isolated Pseudomona aeruginosa, the subject presented decompensate metabolic acidosis and worsening and progressive respiratory, he presented cardiorespiratory arrest, was treated with amine and finally he died on 22 December 2007. It was unknown whether an autopsy was performed. The physician considered the events were possibly related to vaccination with ROTARIX.


VAERS ID: 322223 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2008-05-07
Onset:2008-06-15
   Days after vaccination:39
Submitted: 2008-08-14
   Days after onset:60
Entered: 2008-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Cardio-respiratory arrest, Death, Endotracheal intubation, Extubation, Lower respiratory tract infection, Metabolic acidosis, Neonatal aspiration, Pyrexia, Respiratory disorder, Rhinorrhoea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Neonatal disorders (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-06-19
   Days after onset: 4
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Bronchial dysplasia, bronchopneumonia
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0532321A

Write-up: This case was reported by a physician and described the occurrence of lower respiratory tract infection in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject''s Apgar score was 6-8 and he had aspiration of meconium, which required mechanic intubation with 2 previous hospitalizations due to bronchopneumonia requiring ventilation support and bronchodysplasia. On 7 May 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 15 June 2008, 39 days after vaccination with the 1st dose of ROTARIX, the subject experienced hyaline rhinorrhea, fever and respiratory difficulty, handled with nebulizations without improvement, reason why he required intubation; the subject was transferred to a bigger hospital into the emergency room with respiratory difficulty and by mistake he was extubated and needed to intubate again without radiographic control, poor evolution of the ventilation. During all time that patient was hospitalized, he had a torpid evolution, requiring changes of cannula, but physician did not have any more data to provide. The physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject presented respiratory deterioration, metabolic acidosis with difficulty of control and finally he died due to cardiorespiratory arrest that did not respond on 19 June 2008. It was unknown whether an autopsy was performed. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 322224 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2007-09-05
Onset:2008-04-11
   Days after vaccination:219
Submitted: 2008-08-14
   Days after onset:125
Entered: 2008-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Cardio-respiratory arrest, Coma, Cyanosis, Death, Dyspnoea, Haemorrhage, Lower respiratory tract infection, Mechanical ventilation, Metabolic acidosis, Muscle contractions involuntary, Pyrexia, Respiratory distress, Resuscitation, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0532306A

Write-up: This case was reported by a physician and described the occurrence of lower respiratory tract infection in an 18-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 5 September 2007, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 11 April 2008 (in the emergency room), 7 months after vaccination with the 1st dose of ROTARIX, the subject experienced oral cyanosis and difficulty in breathing. The subject required hospitalization with data of 10 minutes of cardio respiratory arrest. Cardiopulmonary resuscitation was performed, reversing the arrest. The subject was maintained in deep coma with fever and fasciculation. He remained in phase 3 of mechanical ventilation without response to stimuli during all hospitalization with torpid evolution, requiring high parameters of ventilation. The physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with AMPICILLIN, amikacin, cefotaxime, midazolam, PHENOBARBITAL, dexamethasone and parenteral nutrition. The subjects presented respiratory deterioration, hemorrhage from the upper digestive tube, decompensated metabolic acidosis with control difficulty and finally died due to cardio respiratory arrest. It was unknown whether an autopsy was performed. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 322393 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-08-15
Entered: 2008-08-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Diarrhoea, Poor quality drug administered, Pyrexia, Septic shock, Staphylococcal skin infection, Toxic shock syndrome, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA02017

Write-up: It has been reported as part of a published article from an investigator concerning 6 children who were vaccinated with multidoses of ATTENUVAX. Measles vaccination deaths back in 1991-1992 occurred in which 6 children died. All of them developed high fever, diarrhea, and vomiting within 30-60 minutes followed by septic shock typical of toxic shock syndrome. The important finding on field investigation was that the vaccine administered was pink in color. Staphylococcus aureus was injected from culture medium in fresh vials of OPV. DTP and ATTENUVAX. There was no change in OPV vials which remained pink, DTPw vials got flocculated. The reconstituted multidose ATTENUVAX vial turned pink from the original amber yellow color and demonstrated proliferative growth of S. aureus. The findings were submitted to the state government, but were restrained from publishing this information. However, instructions were given to health authorities and health workers to discard any ATTENUVAX vial which turned pink in color. Additional information has been requested. A copy of the published article is attached as further documentation of the patient''s experiences.


VAERS ID: 322542 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-08-18
Entered: 2008-08-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alveolitis, Alveolitis allergic, Atelectasis, Autopsy, Brain herniation, Brain oedema, Cardiac arrest, Cardiomegaly, Cardioversion, Convulsion, Death, Drug screen negative, Histology normal, Interstitial lung disease, Laboratory test normal, Lymphocytic infiltration, Pathology test, Resuscitation, Urine analysis normal, Ventricular fibrillation, Visceral congestion
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Interstitial lung disease (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: diagnostic laboratory test, ??07, Negative; diagnostic pathological examination, ??07, Histopathological examination revealed no inflammatory changes; urinalysis, ??07, Negative
CDC Split Type: WAES0808BRA00012

Write-up: Information has been received concerning a previously healthy 12 year-old girl, without a relevant previous history, who was not taking medication on a regular basis, was admitted to the hospital for refractory seizures after three days of her third dose of HB vaccination. During the transfer to the emergency service, she had a cardiac arrest. Cardio-pulmonary resuscitation (CPR) was performed with infusion of epinephrine. Upon admission to the hospital, she had periods of asystole and fine ventricular fibrillation, and then CPR was continued. Fine fibrillation persisted and she was defibrillated back into asystole. At this time, the resuscitation attempts had been going on for approximately 1 h, when the patient died. An autopsy was performed, and a marked cerebral edema with congestion and herniation was found. Additionally, the anatomical study showed a marked pulmonary atelectasis alternating with areas of hyper-expansion with a mild diffuse interstitial type pneumonitis, mild dilation of the right side of the heart, and a diffuse visceral congestion. Histopathological examination revealed no inflammatory changes, with normal neuronal architecture, no hemorrhage or significant inflammation. Purkinje cells showed mild ischemic changes. In the lungs a slight thickening of the alveolar septa with non-specific mononuclear infiltrates composed of lymphocytes was noted. Drug screens on blood and urine, including ethanol, were negative. Thus, it seems that in additional to the fatal CNS involvement of the HB vaccine, the patient of the present study suffered from hypersensitivity pneumonitis which might have contributed to her death. No further information is available. The literature article has been attached for further documentation of the patients experiences.


VAERS ID: 322543 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2008-08-04
Onset:2008-08-05
   Days after vaccination:1
Submitted: 2008-08-18
   Days after onset:13
Entered: 2008-08-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B045BA / UNK UN / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR B0447 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: no reported medical history
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200802519

Write-up: Report received from the Health Authorities on 06 August 2008. Local reference number SK20080023. A 02-month-old male patient, with no reported medical history, experienced myocarditis on 05 August 2008, leading to his death the next day, i.e. 2 days after receiving a dose of IPOL, lot B0447 on 04 August 2008 at around 12 p.m., simultaneously with a dose of INFANRIX from GSK, lot AC14B045BA. He came back home without specific adverse events after the vaccination. On morning of 05 August 2008, at around 10 a.m., the patient went to the clinic and the doctor recommended his parents to bring him to medical center. The doctor who vaccinated the patient in the clinic stated that she heard the patient had died in the medical center on 06 August 2008 and the cause of death was myocarditis. Myocarditis is often of infectious origin. In the absence of results of infectious work-up and of autopsy report, the case cannot be assessed.


VAERS ID: 323148 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-08-22
Entered: 2008-08-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Diarrhoea, Poor quality drug administered, Pyrexia, Septic shock, Toxic shock syndrome, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA03019

Write-up: It has been reported as part of a published article entitled above from an investigator concerning a child (previously reported as 6 children) who was vaccinated with multidoses of ATTENUVAX (Enders-Edmonston). Measles vaccination deaths back in 1991-1992 occurred in which the child died. The patient developed high fever, diarrhea, and vomiting within 30-60 minutes followed by septic shock typical of toxic shock syndrome. The important finding on field investigation was that the vaccine administered was pink in color. Staphylococcus aureus was injected from culture medium in fresh vials of OPV, DPT and ATTENUVAX (Enders-Edmonston). There was no changed in OPV vials which remained pink, DTPw vials got flocculated. The reconstituted multidose ATTENUVAX (Enders-Edmonston) vial turned pink from the original amber yellow color and demonstrated proliferative growth of S. aureus. The findings were submitted to the state government, but were restrained from publishing this information. However, instructions were given to health authorities and health workers to discard any ATTENUVAX (Enders-Edmonston) vial which turned pink in color. The article also discussed the experience of 5 other children while on therapy with ATTENUVAX (Enders-Edmonston) (WAES# 0808USA02017, 0808USA03020, 0808USA03021, 0808USA03022 and 0808USA03023). Additional information has been requested. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 323149 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-08-22
Entered: 2008-08-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Diarrhoea, Poor quality drug administered, Pyrexia, Septic shock, Toxic shock syndrome, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA03020

Write-up: It has been reported as part of a published article entitled above from an investigator concerning a child (previously reported as 6 children) who was vaccinated with multidoses of ATTENUVAX (Enders-Edmonston). Measles vaccination deaths back in 1991-1992 occurred in which the child died. The patient developed high fever, diarrhea, and vomiting within 30-60 minutes followed by septic shock typical of toxic shock syndrome. The important finding on field investigation was that the vaccine administered was pink in color. Staphylococcus aureus was injected from culture medium in fresh vials of OPV, DPT and ATTENUVAX (Enders-Edmonston). There was no changed in OPV vials which remained pink, DTPw vials got flocculated. The reconstituted multidose ATTENUVAX (Enders-Edmonston) vial turned pink from the original amber yellow color and demonstrated proliferative growth of S. aureus. The findings were submitted to the state government, but were restrained from publishing this information. However, instructions were given to health authorities and health workers to discard any ATTENUVAX (Enders-Edmonston) vial which turned pink in color. The article also discussed the experience of 5 other children while on therapy with ATTENUVAX (Enders-Edmonston) (WAES# 0808USA02017, 0808USA03019, 0808USA03021, 0808USA03022 and 0808USA03023). Additional information has been requested. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 323150 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-08-22
Entered: 2008-08-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Diarrhoea, Poor quality drug administered, Pyrexia, Septic shock, Toxic shock syndrome, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA03021

Write-up: It has been reported as part of a published article concerning a child (previously reported as 6 children) who was vaccinated with multidoses of ATTENUVAX. Measles vaccination deaths back in 1991-1992 occurred in which the child died. The patient developed high fever, diarrhea, and vomiting within 30-60 minutes followed by septic shock typical of toxic shock syndrome. The important finding on field investigation was that the vaccine administered was pink in color. Staphylococcus aureus was injected from culture medium in fresh vials of OPV, DPT and ATTENUVAX. There was no change in OPV vials which remained pink, DTPw vials got flocculated. The reconstituted multidose ATTENUVAX vial turned pink from the original amber yellow color and demonstrated proliferative growth of S. aureus. The findings were submitted to the state authorities, but were restrained from publishing this information. However, instructions were given to health authorities and health workers to discard any measles virus vaccine live vial which turned pink in color. The article also discussed the experience of 5 other children while on therapy with ATTENUVAX (WAES# 0808USA02017, 0808USA03019, 0808USA03020, 0808USA03022 and 0808USA03023). Additional information has been requested. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 323151 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-08-22
Entered: 2008-08-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Diarrhoea, Poor quality drug administered, Pyrexia, Septic shock, Toxic shock syndrome, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA03022

Write-up: It has been reported as part of a published article entitled above from an investigator concerning a child (previously reported as 6 children) who was vaccinated with multidoses of ATTENUVAX (Enders-Edmonston). Measles vaccination deaths back in 1991-1992 occurred in which the child died. The patient developed high fever, diarrhea, and vomiting within 30-60 minutes followed by septic shock typical of toxic shock syndrome. The important finding on field investigation was that the vaccine administered was pink in color. Staphylococcus aureus was injected from culture medium in fresh vials of OPV, DPT and ATTENUVAX (Enders-Edmonston). There was no changed in OPV vials which remained pink, DTPw vials got flocculated. The reconstituted multidose ATTENUVAX (Enders-Edmonston) vial turned pink from the original amber yellow color and demonstrated proliferative growth of S. aureus. The findings were submitted to the state government, but were restrained from publishing this information. However, instructions were given to health authorities and health workers to discard any ATTENUVAX (Enders-Edmonston) vial which turned pink in color. The article also discussed the experience of 5 other children while on therapy with ATTENUVAX (Enders-Edmonston) (WAES# 0808USA02017, 0808USA03019, 0808USA03020, 0808USA03022 and 0808USA03023). Additional information has been requested. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 323152 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-08-22
Entered: 2008-08-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Diarrhoea, Poor quality drug administered, Pyrexia, Septic shock, Toxic shock syndrome, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA03023

Write-up: It has been reported as part of a published article concerning a child (previously reported as 6 children) who were vaccinated with multidoses of ATTENUVAX. Measles vaccination deaths back in 1991-1992 occurred in which the child died. The patient developed high fever, diarrhea, and vomiting within 30-60 minutes following by septic shock typical of toxic shock syndrome. The important finding on field investigation was that the vaccine administered was pink in color. Staphylococcus aureus was injected from culture medium in fresh vials of OPV, DPT and ATTENUVAX. There was no change in OPV vials which remained pink, DTPw vials got flocculated. The reconstituted multidose ATTENUVAX vial turned pink from the original amber yellow color and demonstrated proliferative growth of S. aureus. The findings were submitted to the state authorities, but were restrained from publishing this information. However, instructions were given to health authorities and health workers to discard any ATTENUVAX vial which turned pink in color. The article also discussed the experience of 5 other children while on therapy with ATTENUVAX (WAES# 0808USA02017, 0808USA03019, 0808USA03020, 0808USA03021 and 0808USA03022). Additional information has been requested. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 323155 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Female  
Location: Foreign  
Vaccinated:2007-12-28
Onset:2008-08-11
   Days after vaccination:227
Submitted: 2008-08-22
   Days after onset:11
Entered: 2008-08-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-11
   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: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0808USC00036

Write-up: Information has been received from an investigator concerning an 11-month-old female with no previous medical history who entered a study. On 26-OCT-2007, 23-NOV-2007 and 28-DEC-2007, the patient was vaccinated with the first, second and third doses of blinded therapy, respectively. There was no concomitant medication. During a field visit on 11-AUG-2008 at 7:00 am, the mother reported that her child was well and sleeping. On 13-AUG-2008, the field worker visited the home again and learned that the child had died later in the day on 11-AUG-2008. The mother stated that at 2:00 pm, she fed the child with some porridge and the child fell asleep on her back. At 4:00 pm, she checked on the child and noticed that the child was limp. The mother proceeded to take the child to the local health center, but due to the urgency, she had her child checked by a neighbor, who was a health worker. The neighbor informed her that the child was already deceased. The mother never brought the child to the health center for an AGEE and the child''s height and weight were obtained at study inclusion. The child had not received any medical treatment. According to the investigator, the cause of death was unknown. He stated that it was unlikely that an 11-month-old would aspirate a feeding, and that there was no evidence to support the aspiration. No autopsy was performed and no death certificate was obtained. The reporting investigator felt that the unknown event was of severe intensity and the relationship to study therapy was unknown. Additional information has been requested. Additional information was received from the investigator. The SAE start and stop dates were updated to 11-AUG-2008. The reporting investigator felt that the unknown event was of severe intensity and the relationship to study therapy was unknown. Additional information has been requested regarding causality. Transmission of 7-Day notification to the FDA was made on 21-AUG-2008.


VAERS ID: 323260 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-08-25
Entered: 2008-08-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acidosis, Congenital herpes simplex infection, Convulsion, Death, Disseminated intravascular coagulation, HIV antibody negative, Hepatitis C antibody negative, Herpes simplex DNA test positive, Liver function test abnormal, Malaise, Maternal drugs affecting foetus, Polymerase chain reaction, Pyrexia, Virus tissue specimen test positive, Virus urine test positive
SMQs:, Liver related investigations, signs and symptoms (narrow), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Foetal disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Tumour lysis syndrome (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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: diagnostic laboratory test, polymerase chain reaction test-positive; diagnostic laboratory test, positive blood, throat, and urine polymerase chain reaction tests; whole blood HIV-1 and/or HIV-2 rapid Ab, initial negative; serum hepatitis C antibody test, initial negative
CDC Split Type: WAES0808USA03500

Write-up: Information has been received from the health authority (reference # 20297770) concerning a literature article. On an unknown date the patient was vaccinated with RECOMBIVAX HB (manufacturer unknown). Suspect therapy included VIRAMUNE, lamivudine and zidovudine. This case concerns a female neonate. The patient''s 34 year old mother had hepatitis C virus and was seropositive for HIV, both of which were identified during antenatal screening tests in the 35th weeks of her second pregnancy. The patient''s mother was taking COMBIVIR, and KALETRA for vertical human immunodeficiency virus transmission and methadone for rehabilitation therapy. The mother experienced an emergency vaginal delivery 10 hours after possible membrane rupture and gave birth to a normal baby girl with satisfactory health scores. On an unreported date the baby was treated with lamivudine, zidovudine, and VIRAMUNE for vertical human immunodeficiency virus transmission. The patient also received RECOMBIVAX HB (manufacturer and lot number not reported). The patient was admitted to the neonatal intensive care unit due to a potential threat from opiate rebound syndrome. Initial screening was negative for hepatitis C and HIV infections. The patient became unwell and on the ninth day of life developed fever and deranged liver function tests. The patient''s antiretroviral therapy was discontinued and extensive supportive treatment including acyclovir was initiated immediately. Despite this, the patient''s condition rapidly deteriorated and was complicated by severe acidosis, intractable seizures and disseminated intravascular coagulation. The patient died seven days later. The cause of death was identified as disseminated herpes simplex virus type 2 as evidence by positive blood, throat and urine polymerase chain reaction tests. The patient''s mother declined post mortem examination of the patient. The cause of death coded by the foreign health authority was congenital herpes simplex infection. The patient''s mother described no previous history of genital ulceration and had no genital symptoms preceeding the delivery, however, maternal HSV2 seropositivity was subsequently confirmed. Laboratory results were provided as follows (dates not provided): CD4 lymphocytes: mother baseline 720 x 10^9/L, HIV viral load: mother 740 particles per mL, polymerase chain reaction tests: positive. Other business partner numbers include: E2008-07785. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 323646 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2007-12-26
Onset:2008-01-27
   Days after vaccination:32
Submitted: 2008-08-28
   Days after onset:213
Entered: 2008-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Bronchopneumonia, Cardio-respiratory arrest, Chest X-ray, Cough, Death, Lower respiratory tract infection, Lung infiltration, Odynophagia, Oral intake reduced, Pyrexia, Rales, Respiratory distress, Rhinorrhoea, Vomiting, Wheezing, X-ray abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-01-29
   Days after onset: 2
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Thorax X-ray, Jan2008, see textunit
CDC Split Type: B0534230A

Write-up: This case was reported by a physician and described the occurrence of LRTI (lower respiratory tract infection) in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject did not have relevant medical and family history. Previous vaccination included ROTARIX; GlaxoSmithKline; oral given on 30 October 2007. On 26 December 2007 the subject received 2nd dose of ROTARIX (oral) lot number not provided. On 27 January 2008, 32 days after vaccination with ROTARIX, the subject experienced LRTI (lower respiratory tract infection). The subject was referred to the emergency room with hyaline rhinorrhea, dry cough, odynophagia, nos assess fever, respiratory rales, wheezing and finding respiratory difficulty. Relevant test included thorax x-ray showing bilateral bronchopneumonic infiltration, handled with salbutamol nebulizations, supplementary oxygen, procaine penicillin 350,000 units every 4 hours, amikacin 25 mg every 8 hours and paracetamol as needed. The subject was intolerant to oral intake and decided fasting, with bad response, he presented abundant vomiting (alimentary content by nose and mouth) at 9:00 on 29 January 2008. The subject had cardiorespiratory arrest and he was reanimated for 30 minutes. The subject died on 29 January 2008 at 9:30. The subject was hospitalised and the physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 323848 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2008-04-23
Submitted: 2008-08-29
   Days after onset:128
Entered: 2008-09-02
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Eye rolling, Foaming at mouth, Head titubation
SMQs:, Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA04063

Write-up: It has been reported in a published article that on 23-APR-2008 four children died soon after receiving a dose of ATTENUVAX (Enders-Edmonston) (manufacturer unknown) stored in ice boxes in vaccination camps in two villages. As per parents and other eye witnesses, all children developed frothing at the mouth, drooping of the head, rolling of eye balls and died within 15 - 20 minutes of vaccination. No resuscitative equipment was available on site. This event created a lot of panic amongst parents and pediatricians about the safety of vaccines particularly measles. Faulty vaccine is the first thought that comes to mind. However in the present case, almost 20,000 doses of the same batch were administered to children in that area on the same day with no other causalities. If the vaccine was faulty more casualties could be expected. Also, subsequent analysis of vaccine vials of the same batch has shown them to be of standard quality thus ruling out this possibility. Anaphylaxis to the vaccine is another possibility worth considering. The incidence of anaphylactic or severe allergic reactions to vaccines is very low, less than one case per million vaccine doses. The cause of the reaction is usually not the immunizing antigen itself, but rather some other vaccine ingredient such as egg protein from the production process or gelatin added as a stabilizer. Subject of allergic reactions to vaccines containing egg protein has been well studied and it is clear that vaccines containing egg protein are safe even in children with egg allergy. Majority of vaccines presently contain only trace of egg protein. In contrast, there is little knowledge about allergy to other substances such as gelatin and others. In highly allergic children, one in ten dilution of vaccine is administered intradermally to check for anaphylaxis. Since in most children it is impossible to predict the likelihood of anaphylaxis, it is crucial that knowledge and equipment for resuscitation is available at any center where vaccines are administered. In the current case, it is highly unlikely that all four children died on the same day in the same locality due to an extremely rare event such as anaphylaxis. Toxic shock syndrome has been reported in the past as a cause of serious adverse events and even death following vaccination with measles vaccine. It is reported with multi dose vials of vaccines that have been stored after reconstitution beyond the recommended time of 3-4 hours. These vaccine vials act as culture media for bacteria chiefly exotoxin producing- S. aureus. Toxic shock syndrome may also occur following the use of unsterile syringes or needles. Symptoms occur within a few hours after vaccination and consist of fever, vomiting, diarrhea, shock and finally death within 24 hours. In the current case, toxic shock syndrome is a strong possibility. However, symptoms in the current case began almost immediately following vaccination which is unusual for toxic shock syndrome. Accidental dilution of lyophilized vaccine with another drug such as succinylcholine/pancuronium instead of the diluent has been associated with measles / BCG vaccine related deaths in the past. In this eventuality, symptoms occur almost immediately following vaccination and consist of hypotonia, cyanosis, dyspnea, hypersalivation and immediate death. In the current case scenario, symptoms of affected children were similar. However, the event happened in a camp where the vaccine and diluent were carried in a cold box rather than in a PHC where mix up between drugs can happen. Moreover the nurse said that the diluent though supplied was of a manufacturer different from that of the vaccine itself but was measles vaccine diluent all right. The real cause for vaccination related deaths may never be known as the incriminated vial is not available for analysis. However, they appear to be due to human error and eminently preventable. It also appears that it would have been possible to resuscitate the affected children had resuscitative equipment and knowledge been available at site. Pediatricians should make all attempts to allay anxiety of parents regarding vaccine safety. They should make all attempts to maintain cold chain, keep resuscitative equipment on stand by and discard any left over vaccine beyond the recommended time of administration." It also been reported in a published article that "according to reports in newspapers and television media, 4 infants died on 23-APR-2008 within hours of taking measles vaccination in a village outreach clinic. No official or authenticated information on this issue is available. The newspapers published statements of various versions of what happened and their explanations, interpretations and responses. The versions included the possible injection of substance other than measles vaccine, the use of alternative vaccine diluent, ''dirty'' syringes/needles and anaphylaxis. The particular batch of measles vaccine, from a particular manufacturer, was incriminated by the officials as responsible for the AEFI. The responses were to suspend measles vaccination in the area and to suspend the use of that particular batch of measles vaccine or all batches from that manufacturer in other states. Such was the panic reaction without understanding the problem or application of mind. The manufacturer''s spokesperson clarified that the facility is pre-qualified by another agency. Their measles vaccine had passed all quality checks including those of the national testing facility and several batches of vaccine had been used in several states. Even the incriminated batch had been used widely elsewhere, including in this reporting area without event. This episode exposes two problems -systemic and specific. The lack of systematic monitoring of AEFI, of its professional management and of accountability to inform the public and health professionals of facts is obvious. The training of village health workers and the suspension of outreach vaccination clinics appear to be grossly inadequate. The incident-specific problem was responded to without collecting facts and details. The devil is indeed in the detail. According to media reports, 5 infants were ill within about half to one hour after getting ATTENUVAX (Enders-Edmonston) in the morning session of an outreach clinic and 3 died. In the afternoon session two more were similarly affected and one died. The tragic AEFI were thus confined in time to one particular day, which clearly points to a local and limited problem, most probably related to one multi-dose vial of vaccine or perhaps a maximum of two. There was no need or justification to blame all measles vaccine from the manufacturer or even the one particular batch that happened to be in use. Health workers know that multi-dose DTP can be used over several days within the expiry date. They might not know that DTP vials contain anti-bacterial preservative. Human tendency is similarly to save left-over measles vaccine for later use rather than wasting it. As the vaccine contains live virus it cannot have preservative. The rule for multi-dose vials is to use reconstituted measles vaccine within 4-6 hours and to discard whatever doses are left unused in the vial. There are two potential problems if reconstituted vaccine is kept longer. The virus content may fall since temperature-stability is low in liquid state-this will affect the efficacy of vaccine. The second problem is bacterial contamination. If contaminated while puncturing the cap the liquid vaccine acts as a rich bacterial culture medium. Some contamination is virtually unavoidable but it goes unrecognized as DPT (manufacturer unknown) contains preservative and ATTENUVAX (Enders-Edmonston) is not allowed to remain more than 4-6 hours after reconstitution. If Staphylococcus aureus happens to be the contaminant in measles vaccine that was kept too long, it will multiply and secrete several exotoxins. From information available in news reports such a conclusion was the most logical one with immediate relevance as announced in a news report on 25-APR-2008. If preformed exotoxin is injected, the consequence is shock - as in Toxic Shock Syndrome (TSS). Other contaminating bacteria are not usually life-threatening. It is quite likely that the disease in the 7 affected children was (TSS) and that all of them were vaccinated from one vial (or at the most 2 vials), reconstituted the previous day. Instead of examining the sequence of events and picking only the one vial (or the 2 as the case may be) several vials were collected from that batch of vaccines-thus losing the opportunity to establish evidence to pinpoint the cause. Other vials of the same batch may not have been contaminated by S. aureus. Five days after the news report on (TSS) the investigating committee agreed with that diagnosis, putting to rest all other speculations on the manufacturer, measles vaccine in general and the particular batch used on that day. By then much damage had been done to measles vaccine under UIP and the vaccine had already been called "killer measles vaccine" in the media. That the specific problem was not investigated in detail-as if reconstructing the sequence at the scene of a crime-illustrates the systemic problem of the lack of supervision of outreach immunizations and of routine monitoring and reporting of AEFI. Since just one vial (or possibly 2) was involved in a particular clinic on a particular day, jumping to the conclusion that the whole batch of vaccine was not safe shows the lack of clear thinking in the face of a crisis situation. It is quite possible that measles vaccine vials had been habitually reconstituted by health workers the day before the vaccination clinics, but this short-cut might not have been detected due to insufficient supervision. On the fateful day the vial probably had S. aureus, whereas in the past other less pathogenic microbes might have been injected without serious AEFI. Such measles vaccine vials my have contributed to increased frequency of AEFI such as pain, fever, local inflammation, abscess etc. and also to lower vaccines efficacy in inducing measles immunity. Routine monitoring of AEFI would have helped identify such practice, if it existed. Routine monitoring of measles and vaccination history of children with measles is essential to detect variations in efficacy of measles vaccines of different batches and manufacturers." The article also discussed the experience of 3 other infants who died while on therapy with ATTENUVAX (Enders-Edmonston) (manufacturer unknown) (WAES# 808USA02580, 0808USA04061 and 0808USA04062). Additional information has been requested. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 323849 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2008-04-23
Submitted: 2008-08-29
   Days after onset:128
Entered: 2008-09-02
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Eye rolling, Foaming at mouth, Head titubation
SMQs:, Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA04062

Write-up: It has been reported in a published article that on 23-APR-2008 four children died soon after receiving the dose of Attenuvax (manufacturer unknown) stored in ice boxes in vaccination camps in two villages. As per parents and other eye witnesses, all children developed frothing at the mouth, drooping of the head, rolling of eye balls and died within 15-20 minutes of vaccination. No resuscitative equipment was available on site. This event created a lot of panic amongst parents and pediatricians about the safety of vaccines particularly measles. Faulty vaccine is the first thought that comes to the mind. However in the present case, almost 20,000 doses of the same batch were administered to children in that area on the same day with no other casualties. If the vaccine was faulty more casualties could be expected. Also, subsequent analysis of vaccine vials of the same batch has shown them to be of standard quality thus ruling out this possibility. Anaphylaxis to the vaccine is another possibility worth considering. The incidence of anaphylactic or severe allergic reactions to vaccines is very low, less than one case per million vaccine doses. The cause of the reaction is usually not the immunizing antigen itself, but rather some other vaccine ingredient such as egg protein from the production process or gelatin added as a stabilizer. Subject of allergic reactions to vaccines containing egg protein has been well studied and it is clear that vaccines containing egg protein are safe even in children with egg allergy. Majority of vaccines presently contain only tract of egg protein. In contrast, there is little knowledge about allergy to other substances such as gelatin and others. In highly allergic children, one in ten dilution of vaccine is administered intradermally to check for anaphylaxis. Since in most children it is impossible to predict the likelihood of anaphylaxis, it is crucial that knowledge and equipment for resuscitation is available at any center where vaccines are administered. In the current case, it is highly unlikely that all four children died on the same day in the same locality due to an extremely rare event such as anaphylaxis. Toxic shock syndrome has been reported in the past as a cause of serious adverse events and events and even death following vaccination with measles vaccine. It is reported with multi dose vials of vaccines that have been stored after reconstitution beyond the recommended time of 3-4 hours. These vaccine vials act as culture media for bacteria chiefly exotoxin producing- S. aureus. Toxic shock syndrome may also occur following use of unsterile syringes or needles. Symptoms occur within a few hours after vaccination and consist of fever, vomiting, diarrhea, shock and finally death within 24 hours. In the current case, toxic shock syndrome is a strong possibility. However, symptoms in the current case began almost immediately following vaccination which is unusual for toxic shock syndrome. Accidental dilution of lyophilized vaccine with another drug such as succinylcholine/pancuronium instead of the diluent has been associated with measles/BCG vaccine related deaths in the past. In this eventuality, symptoms occur almost immediately following vaccination and consist of hypotonia, cyanosis, dypsnoea, hypersalivation and immediate death. In the current case scenario, symptoms of affected children were similar. However, the event happened in a camp where the vaccine and diluent were carried in a cold box rather than in a PHC where mix up between drugs can happen. Moreover the nurse said that the diluent though supplied was of a manufacturer different from that of the vaccine itself but was measles vaccine diluent all right. The real cause for vaccination related deaths may never be known as the incriminated vial is not available for analysis. However, they appear to be due to human error and eminently preventable. It also appears that it would have been possible to resuscitate the affected children had resuscitative equipment and knowledge been available at site. Pediatricians should make all attempts to allay anxiety of parents regarding vaccine safety. They should make all attempts to maintain cold chain, keep resuscitative equipment on stand by and discard any left over vaccine beyond the recommended time of administration." It has also been reported in a published article, 4 infant died on 23-APR-2008 within hours of taking measles vaccination in a village outreach clinic. No official or authenticated information on this issue is available. The newspapers published statements of various versions of what happened and their explanations, interpretations and responses. The versions included the possible injection of a substance other than measles vaccine, the use of alternate vaccine diluent, ''dirty'' syringes/needles and anaphylaxis. The particular batch of measles vaccine, from a particular manufacturer, was incriminated by the officials as responsible for the AEFI. The responses were to suspend measles vaccination in the area and to suspend the use of that particular batch of measles vaccine or all batches from that manufacturer in other states. Such was the panic reaction without understanding the problems or application of mind. The manufacturer''s spokesperson clarified that the facility is pre-qualified by another agency. Their measles vaccine had passed all quality checks including those of the national testing facility and several batches of vaccine had been used in several states. Even the incriminated batch had been used widely elsewhere, including in this reporting area without event. This episode exposes two problems-systemic and specific. The lack of systematic monitoring of AEFI, of its professional management and of accountability to inform the public and health professional of facts is obvious. The training of village health workers and the suspension of outreach vaccination clinics appear to be grossly inadequate. The incident-specific problem was responded to without collecting facts and details. The devil is indeed in the detail. According to media reports, 5 infants were ill within about half to one hour after getting measles vaccine in the morning session of an outreach clinic and 3 died. In the afternoon session two more were similarly affected and one died. The tragic AEFI were thus confined in time to one particular day, which clearly points to a local and limited problem, most probably related to one multi-dose vial of vaccine or perhaps a maximum of two. There was no need or justification to blame all measles vaccine from the manufacturer or even the one particular batch that happened to be in use. Health workers know that multi-dose DTaP vials can be used over several days within the expiry date. They might not know that DTaP (unspecified) vials contain anti-bacterial preservative. Human tendency is similarly to save left-over measles vaccine for later use rather than wasting it. As the vaccine contain live virus it cannot have preservative. The rule for multi-dose vials is to use reconstituted measles vaccine within 4-6 hours and to discard whatever doses are left unused in the vial. There are two potential problems if reconstitute vaccine is kept longer. The virus content may fall since temperature-stability is low in liquid state-this will affect the efficacy of vaccine. The second problem is bacterial contamination. If contaminated while puncturing the cap the liquid vaccine acts as a rich bacterial culture medium. Some contamination is virtually unavoidable but is goes unrecognized as DTaP (manufacturer unknown) contains preservative and measles vaccine is not allowed to remain more than 4-6 hours after reconstitution. If Staphylococcus aureus happens to be the contaminant in measles vaccine that was kept for long, it will multiply and secrete several exotoxins. From information available in news reports such as conclusion was the most logical one with immediate relevance as announced in a news report on 25-APR-2008. If performed exotoxin is injected, the consequence is shock -as in Toxic Shock Syndrome (TSS). Other contaminating bacteria are not usually life-threatening. It is quite likely that the disease in the 7 affected children was (TSS) and that all of them were vaccinated from one vial (or at the most 2 vials), reconstituted the previous day. Instead of examining the sequence of events and picking only the one vial (or the 2 as the case may be) several vials were collected from the batch of vaccines-thus losing the opportunity to establish evidence to pinpoint the cause. Other vials of the same batch may not have been contaminated by S. aureus. Five days after the news report on (TSS) the investigating committee agreed with that diagnosis, putting to rest all other speculations on the manufacturer, measles vaccine in general and the particular batch used on that day. By then much damage had been done to measles vaccination under UIP and the vaccine had already been called "killer measles vaccine" in the media. That the specific problem was not investigated in detail-as if reconstructing the sequence at the scene of a crime-illustrates the systemic problem of the lack of supervision of outreach immunizations and of routine monitoring and reporting of AEFI. Since just one vial (or possibly 2) was involved in a particular clinic on a particular day, jumping to the conclusion that the whole batch of vaccine was not safe shows the lack of clear thinking in the face of a crisis situation. It is quite possible that measles vaccine vials had been habitually reconstituted by health workers the day before the vaccination clinics, but this short-cut might not have been detected due to insufficient supervision. On the fateful day the vial probably had S. aureus, whereas in the past other less pathogenic microbes might have been injected without serious AEFI. Such measles vaccine vials may have contributed to increased frequency of AEFI such as pain, fever, local inflammation, abscess etc. and also to lower vaccine efficacy in inducing measles immunity. Routine monitoring of AEFI would have helped identify such practice, if it existed. Routine monitoring of measles and vaccination history of children with measles is essential to detect variations in efficacy of measles vaccines of different batches and manufacturers." The article also discussed the experience of 3 other infants who died while on therapy with measles vaccine (manufacturer unknown) (WAES# 808USA02580, 0808USA04061 and 0808USA04063). Additional information has been requested. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 323850 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2008-04-23
Onset:2008-04-23
   Days after vaccination:0
Submitted: 2008-08-29
   Days after onset:128
Entered: 2008-09-02
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Eye rolling, Foaming at mouth, Head titubation
SMQs:, Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA04061

Write-up: It has been reported in a published article that on 23-APR-2008 four children died soon after receiving a dose of ATTENUVAX (Enders-Edmonston) (manufacturer unknown) stored in ice boxes in vaccination camps in two villages. As per parents and other eye witnesses, all children developed frothing at the mouth, drooping of the head, rolling of eye balls and died within 15 - 20 minutes of vaccination. No resuscitative equipment was available on site. This event created a lot of panic amongst parents and pediatricians about the safety of vaccines particularly measles. Faulty vaccine is the first thought that comes to mind. However in the present case, almost 20,000 doses of the same batch were administered to children in that area on the same day with no other causalities. If the vaccine was faulty more casualties could be expected. Also, subsequent analysis of vaccine vials of the same batch has shown them to be of standard quality thus ruling out this possibility. Anaphylaxis to the vaccine is another possibility worth considering. The incidence of anaphylactic or severe allergic reactions to vaccines is very low, less than one case per million vaccine doses. The cause of the reaction is usually not the immunizing antigen itself, but rather some other vaccine ingredient such as egg protein from the production process or gelatin added as a stabilizer. Subject of allergic reactions to vaccines containing egg protein has been well studied and it is clear that vaccines containing egg protein are safe even in children with egg allergy. Majority of vaccines presently contain only trace of egg protein. In contrast, there is little knowledge about allergy to other substances such as gelatin and others. In highly allergic children, one in ten dilution of vaccine is administered intradermally to check for anaphylaxis. Since in most children it is impossible to predict the likelihood of anaphylaxis, it is crucial that knowledge and equipment for resuscitation is available at any center where vaccines are administered. In the current case, it is highly unlikely that all four children died on the same day in the same locality due to an extremely rare event such as anaphylaxis. Toxic shock syndrome has been reported in the past as a cause of serious adverse events and even death following vaccination with measles vaccine. It is reported with multi dose vials of vaccines that have been stored after reconstitution beyond the recommended time of 3-4 hours. These vaccine vials act as culture media for bacteria chiefly exotoxin producing- S. aureus. Toxic shock syndrome may also occur following the use of unsterile syringes or needles. Symptoms occur within a few hours after vaccination and consist of fever, vomiting, diarrhea, shock and finally death within 24 hours. In the current case, toxic shock syndrome is a strong possibility. However, symptoms in the current case began almost immediately following vaccination which is unusual for toxic shock syndrome. Accidental dilution of lyophilized vaccine with another drug such as succinylcholine/pancuronium instead of the diluent has been associated with measles / BCG vaccine related deaths in the past. In this eventuality, symptoms occur almost immediately following vaccination and consist of hypotonia, cyanosis, dyspnea, hypersalivation and immediate death. In the current case scenario, symptoms of affected children were similar. However, the event happened in a camp where the vaccine and diluent were carried in a cold box rather than in a PHC where mix up between drugs can happen. Moreover the nurse said that the diluent though supplied was of a manufacturer different from that of the vaccine itself but was measles vaccine diluent all right. The real cause for vaccination related deaths may never be known as the incriminated vial is not available for analysis. However, they appear to be due to human error and eminently preventable. It also appears that it would have been possible to resuscitate the affected children had resuscitative equipment and knowledge been available at site. Pediatricians should make all attempts to allay anxiety of parents regarding vaccine safety. They should make all attempts to maintain cold chain, keep resuscitative equipment on stand by and discard any left over vaccine beyond the recommended time of administration." It also been reported in a published article that "according to reports in newspapers and television media, 4 infants died on 23-APR-2008 within hours of taking measles vaccination in a village outreach clinic. No official or authenticated information on this issue is available. The newspapers published statements of various versions of what happened and their explanations, interpretations and responses. The versions included the possible injection of substance other than measles vaccine, the use of alternative vaccine diluent, ''dirty'' syringes/needles and anaphylaxis. The particular batch of measles vaccine, from a particular manufacturer, was incriminated by the officials as responsible for the AEFI. The responses were to suspend measles vaccination in the area and to suspend the use of that particular batch of measles vaccine or all batches from that manufacturer in other states. Such was the panic reaction without understanding the problem or application of mind. The manufacturer''s spokesperson clarified that the facility is pre-qualified by another agency. Their measles vaccine had passed all quality checks including those of the national testing facility and several batches of vaccine had been used in several states. Even the incriminated batch had been used widely elsewhere, including in this reporting area without event. This episode exposes two problems -systemic and specific. The lack of systematic monitoring of AEFI, of its professional management and of accountability to inform the public and health professionals of facts is obvious. The training of village health workers and the suspension of outreach vaccination clinics appear to be grossly inadequate. The incident-specific problem was responded to without collecting facts and details. The devil is indeed in the detail. According to media reports, 5 infants were ill within about half to one hour after getting ATTENUVAX (Enders-Edmonston) in the morning session of an outreach clinic and 3 died. In the afternoon session two more were similarly affected and one died. The tragic AEFI were thus confined in time to one particular day, which clearly points to a local and limited problem, most probably related to one multi-dose vial of vaccine or perhaps a maximum of two. There was no need or justification to blame all measles vaccine from the manufacturer or even the one particular batch that happened to be in use. Health workers know that multi-dose DTP can be used over several days within the expiry date. They might not know that DTP vials contain anti-bacterial preservative. Human tendency is similarly to save left-over measles vaccine for later use rather than wasting it. As the vaccine contains live virus it cannot have preservative. The rule for multi-dose vials is to use reconstituted measles vaccine within 4-6 hours and to discard whatever doses are left unused in the vial. There are two potential problems if reconstituted vaccine is kept longer. The virus content may fall since temperature-stability is low in liquid state-this will affect the efficacy of vaccine. The second problem is bacterial contamination. If contaminated while puncturing the cap the liquid vaccine acts as a rich bacterial culture medium. Some contamination is virtually unavoidable but it goes unrecognized as DPT (manufacturer unknown) contains preservative and ATTENUVAX (Enders-Edmonston) is not allowed to remain more than 4-6 hours after reconstitution. If Staphylococcus aureus happens to be the contaminant in measles vaccine that was kept too long, it will multiply and secrete several exotoxins. From information available in news reports such a conclusion was the most logical one with immediate relevance as announced in a news report on 25-APR-2008. If preformed exotoxin is injected, the consequence is shock - as in Toxic Shock Syndrome (TSS). Other contaminating bacteria are not usually life-threatening. It is quite likely that the disease in the 7 affected children was (TSS) and that all of them were vaccinated from one vial (or at the most 2 vials), reconstituted the previous day. Instead of examining the sequence of events and picking only the one vial (or the 2 as the case may be) several vials were collected from that batch of vaccines-thus losing the opportunity to establish evidence to pinpoint the cause. Other vials of the same batch may not have been contaminated by S. aureus. Five days after the news report on (TSS) the investigating committee agreed with that diagnosis, putting to rest all other speculations on the manufacturer, measles vaccine in general and the particular batch used on that day. By then much damage had been done to measles vaccine under UIP and the vaccine had already been called "killer measles vaccine" in the media. That the specific problem was not investigated in detail-as if reconstructing the sequence at the scene of a crime-illustrates the systemic problem of the lack of supervision of outreach immunizations and of routine monitoring and reporting of AEFI. Since just one vial (or possibly 2) was involved in a particular clinic on a particular day, jumping to the conclusion that the whole batch of vaccine was not safe shows the lack of clear thinking in the face of a crisis situation. It is quite possible that measles vaccine vials had been habitually reconstituted by health workers the day before the vaccination clinics, but this short-cut might not have been detected due to insufficient supervision. On the fateful day the vial probably had S. aureus, whereas in the past other less pathogenic microbes might have been injected without serious AEFI. Such measles vaccine vials my have contributed to increased frequency of AEFI such as pain, fever, local inflammation, abscess etc. and also to lower vaccines efficacy in inducing measles immunity. Routine monitoring of AEFI would have helped identify such practice, if it existed. Routine monitoring of measles and vaccination history of children with measles is essential to detect variations in efficacy of measles vaccines of different batches and manufacturers." The article also discussed the experience of 3 other infants who died while on therapy with ATTENUVAX (Enders-Edmonston) (manufacturer unknown) (WAES# 808USA02580, 0808USA04062 and 0808USA04063). Additional information has been requested. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 323851 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2008-04-23
Submitted: 2008-08-29
   Days after onset:128
Entered: 2008-09-02
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (ATTENUVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Eye rolling, Foaming at mouth, Head titubation
SMQs:, Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA02580

Write-up: It has been reported in a published article that on 23-APR-2008 four children died soon after receiving a dose of ATTENUVAX stored in ice boxes in vaccination camps in two villages. As per parents and other eye witnesses, all children developed frothing at the mouth, drooping of the head, rolling of eye balls and died within 15 - 20 minutes of vaccination. No resuscitative equipment was available on site. This event created a lot of panic amongst parents and pediatricians about the safety of vaccines particularly measles. Faulty vaccine is the first thought that comes to the mind. However in the present case, almost 20,000 doses of the same batch were administered to children in that area on the same day with no other casualties. If the vaccine was faulty more casualties could be expected. Also, subsequent analysis of vaccine vials of the same batch has shown them to be of standard quality thus ruling out this possibility. Anaphylaxis to the vaccine is another possibility worth considering. The incidence of anaphylactic or severe allergic reactions to vaccines is very low, less than one case per million vaccine doses. The cause of the reaction is usually not the immunizing antigen itself, but rather some other vaccine ingredient such as egg protein from the production process or gelatin added as a stabilizer. Subject of allergic reactions to vaccines containing egg protein has been well studied and it is clear that vaccines containing egg protein are safe event in children with egg allergy. Majority of vaccines presently contain only trace of egg protein. In contrast, there is little knowledge about allergy to other substances such as gelatin and others. In highly allergic children, one in ten dilution of vaccine is administered intradermally to check for anaphylaxis. Since in most children it is impossible to predict the likelihood of anaphylaxis, it is crucial that knowledge and equipment for resuscitation is available at any center where vaccines are administered. In the current case, it is highly unlikely that all four children died on the same day in the same locality due to an extremely rare event such as anaphylaxis. Toxic shock syndrome has been reported in the past as a cause of serious adverse events and even death following vaccination with measles vaccine. It is reported with multi dose vials of vaccines that have been stored after reconstitution beyond the recommended time of 3-4 hours. These vaccine vials act as culture media for bacteria chiefly exotoxin producing- S. aureus. Toxic shock syndrome may also occur following use of unsterile syringes or needles. Symptoms occur within a few hours after vaccination and consist of fever, vomiting, diarrhea, shock and finally death within 24 hours. In the current case, toxic shock syndrome is a strong possibility. However, symptoms in the current case began almost immediately following vaccination which is unusual for toxic shock syndrome. Accidental dilution of lyophilized vaccine with another drug such as succinylcholine/pancuronium instead of the diluent has been associated with measles/BCG vaccine related deaths in the past. In this eventuality, symptoms occur almost immediately following vaccination and consist of hypotonia, cyanosis, dyspnea, hypersalivation and immediate death. In the current case scenario, symptoms of affected children were similar. However, the event happened in a camp where the vaccine and diluent were carried in a cold box rather than in a PHC where mix up between drugs can happen. Moreover the nurse said that the diluent though supplied was a manufacturer different from that of the vaccine itself but was measles vaccine diluent all right. The real cause for vaccination related deaths may never be known as the incriminated vial is not available for analysis. However, they appear to be due to human error and eminently preventable. It also appears that it would have been possible to resuscitate the affected children had resuscitative equipment and knowledge been available at site. Pediatricians should make all attempts to allay anxiety of parents regarding vaccine safety. They should make all attempts to maintain cold chain, keep resuscitative equipment on stand by and discard any left over vaccine beyond the recommended time of administration." It also been reported in a published article that "according to reports in newspapers and television media, 4 infants died on 23-APR-2008 within hours of taking measles vaccination in a village outreach clinic. No official or authenticated information on this issue is available. The newspapers published statements of various versions of what happened and their explanations, interpretations and responses. The versions included the possible injection of a substance other than measles vaccine, the use of alternate vaccine diluent, ''dirty'' syringes/needles and anaphylaxis. The particular batch of measles vaccine, from a particular manufacturer, was incriminated by the officials as responsible for the AEFI. The responses were to suspend the use of that particular batch of measles vaccine or all batches from that manufacturer in other states. Such was the panic reaction without understanding the problem or application of mind. The manufacturer''s spokesperson clarified that the facility is pre-qualified by another agency. Their measles vaccine had passed all quality checks including those of the national testing facility and several batches of vaccines had been used in several states. Even the incriminated batch had been used widely elsewhere, including in this reporting area without event. This episode exposes two problems - systemic and specific. The lack of systematic monitoring of AEFI, of its professional management and of accountability to inform the public and health professionals of facts is obvious. The training of village health workers and the suspension of outreach vaccination clinics appear to be grossly inadequate. The incident-specific problem was responded to without collecting facts and details. The devil is indeed in the detail. According to media reports, 5 infants were ill within about half to one hour after getting ATTENUVAX in the morning session of an outreach clinic and 3 died. In the afternoon session two more were similarly affected and one died. The tragic AEFI were thus confined in time to one particular day, which clearly points to a local and limited problem, most probably related to one multi-dose vial of vaccine or perhaps a maximum of two. There was no need or justification to blame all measles vaccine from the manufacturer or even the one particular batch that happened to be in use. Health workers know that multi-dose diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid vaccine vials can be used over several days within the expiry date. They might not know that diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid vials contain anti-bacterial preservative. Human tendency is similarly to save left-over measles vaccine for later use rather than wasting it. As the vaccine contains live virus it cannot have preservative. The rule for multi-dose vials is to use reconstituted measles vaccine within 4-6 hours and to discard whatever doses are left unused in the vial. There are two potential problems if reconstituted vaccine is kept longer. The virus content may fall since temperature-stability is low in liquid state-this will affect the efficacy of vaccine. The second problem is bacterial contamination. If contaminated while puncturing the cap the liquid vaccine acts as a rich bacterial culture medium. Some contamination is virtually unavoidable but it goes unrecognized as diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (DPT) (manufacturer unknown) contains preservative and ATTENUVAX is not allowed to remain more than 4-6 hours after reconstitution. If Staphylococcus aureus happens to be the contaminant in measles vaccine that was kept for long, it will multiply and secrete several exotoxins. From information available in new reports such a conclusion was the most logical one with immediate relevance as announced in a news report on 25-APR-2008. If preformed exotoxin is injected, the consequence is shock - as in Toxic Shock Syndrome (TSS). Other contaminating bacteria are not usually life-threatening. It is quite likely that the disease in the 7 affected children was (TSS) and that all of them were vaccinated from one vial (or at the most 2 vials), reconstituted the previous day. Instead of examining the sequence of events and picking only the one vial (or the 2 as the case may be) several vials were collected from that batch of vaccines-thus losing the opportunity to establish evidence to pinpoint the cause. Other vials of the same batch may not have been contaminated by S. aureus. Five days after the news report on (TSS) the investigating committee agreed with that diagnosis, putting to rest all other speculations on the manufacturer, measles vaccine in general and the particular batch used on that day. By then much damage had been done to measles vaccination under UIP and the vaccine had already been called "killer measles vaccine" in the media. That the specific problem was not investigated in detail-as if reconstructing the sequence at the scene of the crime-illustrates the systemic problem of the lack of supervision of outreach immunizations and of particular clinic on a particular day, jumping to the conclusion that the whole batch of vaccine was not safe shows the lack of clear thinking in the face of a crisis situation. It is quite possible that measles vaccine vials had been habitually reconstituted by health workers the day before the vaccination clinics, but this short-cut might not have been detected due to insufficient supervision. On the fateful day the vial probably had S. aureus, whereas in the past other less pathogenic microbes might have been injected without serious AEFI. Such measles vaccine vials may have contributed to increased frequency of AEFI such as pain, fever, local inflammation, abscess etc. and also to lower vaccine efficacy in inducing measles immunity. Routine monitoring of AEFI would have helped identify such practice, if it existed. Routine monitoring of measles and vaccination history of children with measles is essential to detect variations in efficacy of measles vaccines of different batches and manufacturers." The article also discussed the experience of 3 other infants who died while on therapy with ATTENUVAX (WAES# 0808USA04061, 0808USA04062 and 0808USA04063). Additional information has been requested. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 325062 (history)  
Form: Version 1.0  
Age: 1.2  
Sex: Female  
Location: Foreign  
Vaccinated:2008-08-07
Onset:2008-09-03
   Days after vaccination:27
Submitted: 2008-09-12
   Days after onset:9
Entered: 2008-09-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 4 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningococcal infection, Microbiology test abnormal, Waterhouse-Friderichsen syndrome
SMQs:, Sepsis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Microbiology test, 00-Sep-2008, detection of meningococci
CDC Split Type: DEWYEG02134808

Write-up: Information regarding PREVENAR was received from a healthcare professional via a sales representative regarding a 14-month-old female patient who died from meningococcal Waterhouse-Friderichsen syndrome. The patient received the fourth dose on 07-Aug-2008. 4 weeks after vaccination the patient experienced meningococcal Waterhouse-Friderichsen syndrome on vaccination on 03-Sep-2008. The patient was hospitalized and died 20 hours later on 04-Sep-2008 at 12.30 pm due to meningococcal Waterhouse-Friderichsen syndrome. The reporting physician was bothered about the temporal connection between the vaccination and the meningococcal infection and her assessment of relatedness was possibly related.


VAERS ID: 325257 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2008-02-16
Onset:0000-00-00
Submitted: 2008-09-16
Entered: 2008-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Bronchopneumonia, Cardiopulmonary failure, Cough, Death, Haemoglobin normal, Neonatal respiratory distress syndrome, Platelet count decreased, Purpura, Pyrexia, Rales, Respiratory disorder, Respiratory failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-08-06
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Zidovudine; Lamivudine
Current Illness: Human immunodeficiency virus infect
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hemoglobin, 06Aug2008, 12.1mg/dL; Platelet count, 06Aug2008, 42200/mm3
CDC Split Type: B0536365A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of bronchopneumonia in a 9-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included human immunodeficiency virus infection. Concurrent medications included NARVIR, ZIDOVUDINE and LAMIVUDINE. On 16 February 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On unspecified date, at an unspecified time after the vaccination with the 1st dose of ROTARIX, the subject experienced bronchopneumonia. The subject was admitted to ER. The subject was treated and was discharged on 1 August 2008 in good clinical conditions. On 3 August 2008, the subject experienced purpuric syndrome. On 6 August 2008, the subject was taken to ER because of cough, fever and respiratory difficulty. Physical exam was with respiratory distress syndrome and bronchoalveolar rales in both lungs. The subject was hospitalised and the physician considered the events were life threatening. Laboratory tests were performed and showed the following: Hemoglobin: 12.1 mg/dL; Platelets count: 42200/mm3. The subject was treated with antibiotics, ambroxol, dipyrone (Metamizol), phenoxymethylpenicillin potassium (Penicillin) and oxygen without improvement. The subject presented cardiorespiratory failure which was resolved by mechanical assistance. She presented a second cardiorespiratory failure and she died on 6 August 2008. Primary cause of death was respiratory insufficiency. Secondary cause of death was bronchopneumonia. It was unknown whether an autopsy was performed. The physician considered the events were unrelated to vaccination with ROTARIX.


VAERS ID: 325258 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2008-03-18
Onset:2008-06-15
   Days after vaccination:89
Submitted: 2008-09-16
   Days after onset:93
Entered: 2008-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Activated partial thromboplastin time shortened, Alanine aminotransferase normal, Aspartate aminotransferase normal, Base excess decreased, Blood albumin decreased, Blood alkaline phosphatase normal, Blood bicarbonate increased, Blood calcium increased, Blood creatinine normal, Blood fibrinogen normal, Blood glucose normal, Blood magnesium increased, Blood pH decreased, Blood pH normal, Blood potassium decreased, Blood sodium decreased, Blood sodium increased, Blood urea decreased, Bronchospasm, Calcium ionised decreased, Carbon dioxide increased, Cardiopulmonary failure, Coma, Death, Grand mal convulsion, Haematocrit normal, Haemoglobin normal, Lymphocyte count decreased, Mechanical ventilation, Neutrophil count normal, Oxygen saturation decreased, PO2 decreased, PO2 increased, Platelet count decreased, Pneumonia, Protein total decreased, Prothrombin time prolonged, Rales, Respiratory distress, Status epilepticus, White blood cell count decreased
SMQs:, Cardiac failure (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-08-19
   Days after onset: 65
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Valproic acid
Current Illness: Developmental motor delay, early-infantile epileptic encephalo
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Alanine aminotransferase, 23Jul2008, 17U/L; Albumin, 23Jul2008, 3.5g/dl; Alkaline phosphatase, 23Jul2008, 91U/L; Arterial blood pH, 01Aug2008, 7.24; Aspartate aminotransferase, 23Jul2008, 35U/L; Base excess, 19Jul2008, -3.3; Blood bicarbonate, 19Jul2008, 22mEq/L; Blood bicarbonate, 01Aug2008, 26mEq/L; Blood carbon dioxide, 19Jul2008, 38.5mmHg; Blood carbon dioxide, 01Aug2008, 73mmHg; Blood glucose, 23Jul2008, 73mg/dl; Calcium, 23Jul2008, 9.7mEq/L; Creatinine, 23Jul2008, 0.4mg/dl; Fibrinogen, 23Jul2008, 231mg/ml; Hematocrit, 23Jul2008, 33%; Hemoglobin, 23Jul2008, 11.2g/dl; Ionized calcium, 19Jul2008, 1.03mEq/L; Leukocyte count NOS, 23Jul2008, 5370/mm3; Lymphocytes, 23Jul2008, 760/mm3; Magnesium, 23Jul2008, 2.2mEq/L; Neutrophil count, 23Jul2008, 4050/mm3; Oxygen saturation, 01Aug2008, 85%; Oxygen tension, 19Jul2008, 103.8mmHg; Oxygen tension, 01Aug2008, 59mmHg; Partial prothrombin time, 23Jul2008, 38.4sec; Platelet count, 23Jul2008, 167000/mm3; Potassium, 19Jul2008, 4.07mEq/L; Potassium, 23Jul2008, 5.1mEq/L; Protein total, 23Jul2008, 5.4g/dl; Prothrombin time, 23Jul2008, 16.5sec; Sodium, 19Jul2008, 122.5mEq/L; Sodium, 23Jul2008, 152mEq/L; Urea, 23Jul2008, 2mg/dl
CDC Split Type: B0537029A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of severe respiratory distress in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included developmental motor delay and congenital anomaly which was Ohtahara Syndrome (early-infantile epileptic encephalopathy). Concurrent medications included Valporoic acid. On 18 March 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 15 July 2008, 4 months after vaccination with ROTARIX, the subject experienced tonic-clonic seizures (6 per day). He was admitted at hospital on 18 July 2008 with diagnosis of status epilepticus. The acute treatment was diazepam but it was not resolved. He was admitted at ICU to barbiturate coma with thiopental and mechanical ventilation. In ICU, the subject presented pneumonia in right base with rale in both lungs with poor evolution and persistent status epilepticus. On 19 August 2008, the patient showed severe bronchospasm and severe respiratory distress with irreversible cardiorespiratory failure and died. The subject was hospitalised and the physician considered the events were life-threatening. Laboratory tests performed on 19 July 2008 and showed the following results: Blood pH: 7.37; Blood pCO2 38.5 mmHg; Blood pO2: 103.8 mmHg; Blood HCO3: 22 mEq/L; Base Excess: -3.3; Sodium: 122.5 mEq/L; Potassium: 4.07 mEq/L, Ionised Calcium: 1.03 mEq/L. Laboratory tests were performed on 23 July 2008 and showed the following results: Hemoglobin: 11.2 g/dL; Hematocrit: 33%; Leukocytes: 5370/mm3; Neutrophils: 4050/mm3; Lymphocytes: 760/mm3; Blood glucose: 73 mg/dL; Urea: 2 mg/dL; Creatinine: 0.4 mg/dL; Protein Total: 5.4 g/dL; Albumin: 3.5 g/dL; ALT: 17U/L; AST: 35 U/L; Alkaline phosphatase: 91 U/L; Calcium: 9.7 mEq/L; Sodium: 152 mEq/L; Sodium: 152 mEq/L; Potassium: 5.1 mEq/L; Magnesium: 2.2 mEq/L; PT: 16.5 sec; PTT: 38.4 sec; Fibrinogen: 231 mg/ml. Laboratory tests were performed on 1 August 2008 and showed the following results: Blood pH: 7.24; Blood pCO2: 73 mmHg; Blood pO2: 59 mmHg; Blood HCO3: 26 mEq/L; Oxygen saturation: 85%. The subject was treated with mechanical ventilation, RANITIDINE, phenytoin, diazepam, cefotaxime, THIOPENTAL, omeprazole, albumin, albumin (Albumin 20%), nalbuphine, methylprednisolone, vitamin K, FUROSEMIDE, midazolam, ambroxol, normal immunoglobulin (Immune globulin), CEFTAZIDINIE, vancomycin, metoclopramide and nifedipine. The physician considered the events were unrelated to vaccination with ROTARIX. The subject died on 19 August 2008. Primary cause of death was severe respiratory distress and the secondary cause of death was severe bronchospasm, pneumonia in right base, barbiturate coma and status epilepticus. An autopsy was not performed. No further information expected, the case has been closed.


VAERS ID: 325558 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2008-05-22
Onset:2008-05-22
   Days after vaccination:0
Submitted: 2008-09-18
   Days after onset:119
Entered: 2008-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Pyrexia, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-05-23
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0536723A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20270674) and described the occurrence of sudden infant death in a 2-month-old female patient who was vaccinated with INFANRIX-IPV/HIB and PREVENAR. On 22 May 2008 the patient received unspecified dose of INFANRIX-IPV/HIB (intramuscular), and unspecified dose of PREVENAR (intramuscular). On 22 May 2008, 6 hours after vaccination with INFANRIX-IPV/HIB and PREVENAR, the patient experienced fever. The fever resolved with CALPOL treatment. The patient was found dead at 3am the following morning. The patient died from sudden infant death on 23 May 2008. An autopsy was not performed. MHRA Verbatim Text: Sudden infant death (cause not known - post mortem report awaiting). One injection then six hours later had a slight fever, responded to CALPOL. Found dead at 3am during the night.


VAERS ID: 325793 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2008-09-09
Onset:2008-09-10
   Days after vaccination:1
Submitted: 2008-09-22
   Days after onset:12
Entered: 2008-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (TRITANRIX) / GLAXOSMITHKLINE BIOLOGICALS AT15B529AC / UNK LL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A72CA429A / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asphyxia, Aspiration, Death
SMQs:, Acute central respiratory depression (broad), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0537293A

Write-up: This case was reported by a physician and described the occurrence of asphyxia in a 2-month-old male subject who was vaccinated with TRITANRIX HEPB (GlaxoSmithKline), HIBERIX. The subject had no medical history or allergy. On 9 September 2008, at 10:00 am, the subject received unspecified dose of TRITANRIX HEPB (intramuscular, unknown thigh), unspecified dose of HIBERIX (intramuscular, unknown thigh). On 10 September 2008, at 02:30 am, 16 hours after vaccination with HIBERIX and TRITANRIX HEPB, the subject experienced asphyxia and aspiration of liquid. The subject died on 10 September 2008, cause of death was asphyxia due to milk aspiration. Follow up received on 18 September from the physician: Confirmation of vaccine, lot number and injection site received. An autopsy was performed.


VAERS ID: 325795 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-09-18
Onset:2008-09-18
   Days after vaccination:0
Submitted: 2008-09-22
   Days after onset:4
Entered: 2008-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA360AD / UNK LL / UN

Administered by: Other       Purchased by: Other
Symptoms: Circulatory collapse, Death, Pharmaceutical product complaint
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-18
   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: Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0058780A

Write-up: This case was reported by a physician and described the occurrence of acute cardiovascular failure in a 78-year-old female subject who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). This was received as a product complaint. Concurrent medical conditions included arterial hypertension. On 18 September 2008 the subject received unspecified dose of INFLUSPLIT SSW (unknown route and application site). On 18 September 2008, 3 minutes after vaccination with INFLUSPLIT SSW, the subject experienced acute cardiovascular failure. Reanimation was without success. Cardiac infarction was suspected. The physician considered the events were unlikely to be related to vaccination with INFLUSPLIT SSW. The subject died on 18 September 2008 from possible cardiac infarction. It was unknown whether an autopsy was performed. Follow-up information has been requested.


VAERS ID: 326382 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-09-26
Entered: 2008-09-29
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Cardiac failure, Death, Feeding disorder, Haemoglobin decreased, Histiocytosis haematophagic, Irritability
SMQs:, Cardiac failure (narrow), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None reported.
Allergies:
Diagnostic Lab Data: Haemoglobin, 4.5 g/dl
CDC Split Type: E200808724

Write-up: This case was initially reported to SPMSD by the health authority on 18-Sep-2008. ADR 20313410. This case was identified in the following literature article; This case concerns an infant of unknown age and gender. The patient received DTP vaccine, Hib vaccine, meningococcal C vaccine and oral poliomyelitis vaccine, manufacturers and batch numbers not reported, on an unreported date. On an unreported date, one day post vaccination, the patient arrested. The patient had developed difficulty in feeding and had been irritable for six hours previously. Post mortem results showed haemophagocytosis in the spleen and bone marrow which was responsible for a low haemoglobin of 4.5g/dl. The anaemia had induced cardiac failure. The cause of death was reported by the MHRA as cardiac failure and haemophagocytosis. The outcome of the events of difficulty in feeding, irritability and anaemia were unknown. Case is closed. The cause of death in this case was haemophagocytosis leading to anemia and cardiac failure. Haemophagocytosis is an unusual syndrome characterized by fever, splenomegaly, jaundice, and the pathological finding of haemophagocytosis in bone marrow and other tissues. This could be genetic or acquired. Acquired disease has no known underlying immune deficiency. Both acquired and genetic forms are triggered by infections, mostly viruses, other stimuli. The cause was not determined in this case. Events reported one day post vaccination i.e. irritability and difficulty in feed are known symptoms of this disease. Administration of vaccine seems co-incidental.


VAERS ID: 326697 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2008-02-18
Onset:2008-02-28
   Days after vaccination:10
Submitted: 2008-10-01
   Days after onset:215
Entered: 2008-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Activated partial thromboplastin time shortened, Blood calcium normal, Blood creatinine normal, Blood glucose increased, Blood group O, Blood potassium increased, Blood sodium normal, Blood urea increased, Bradycardia, Bradypnoea, Cardio-respiratory arrest, Cyanosis, Death, Decreased activity, Dehydration, Grand mal convulsion, Haematochezia, Haematocrit decreased, Haemoglobin normal, Hyponatraemia, Hypovolaemic shock, Ileostomy, Ileus paralytic, Intestinal anastomosis, Intestinal dilatation, Intestinal obstruction, Intestinal resection, Intussusception, Irritability, Metabolic disorder, Pain, Pharyngeal erythema, Platelet count increased, Prothrombin time shortened, Pyrexia, Rales, Rectal haemorrhage, Respiratory distress, Resuscitation, Rhesus antibodies positive, Status epilepticus, Surgery, Tachycardia, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute renal failure (broad), Haemolytic disorders (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-03-15
   Days after onset: 15
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cough, Meckel diverticulum
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 02Mar2008, see textunit; Abdominal X-ray, 08Mar2008, see textunit; Abdominal X-ray, 12Mar2008, see textunit; Blood glucose, 02Mar2008, 94mg/dl; Blood grouping, 02Mar2008, ORh+; Calcium, 02Mar2008, 9.2mEq/l; Creatinine, 02Mar2008, 0.8mg/dl; Hematocrit, 02Mar2008, 34.6%; Hemoglobin, 02Mar2008, 11.6mg/dl; Leukocyte count NOS, 02Mar2008, 20470mm3; Partial thromboplastin time pr, 02Mar2008, 29..9s; Platelet count, 02Mar2008, 710000mm3; Potassium, 02Mar2008, 5.8mEq/l; Prothrombin time, 02Mar2008, 10.6s; Sodium, 02Mar2008, 134mEq/l; Urea, 02Mar2008, 62.6mg/dl
CDC Split Type: B0538764A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included Meckel diverticulum. Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 13 December 2007. Six days before hospital admission the subject had cough. On 18 February 2008 the subject received 2nd dose of ROTARIX (oral). On 28 February 2008, 10 days after vaccination with ROTARIX, the subject experienced vomiting (10 episodes) abdominal distention and fever. On 02 March 2008 the subject was admitted at the emergency room presenting hypo activity, hyperemic pharynx, tachycardia, fever, abdominal pain with distention, dehydration, rectal tact with expulsion of fresh bloody stool and rectal bloody. The same day relevant test included abdominal x-ray showing intestinal occlusion and intussusception. Therefore the subject underwent a surgery which revealed Ileo Ileocolic intussusception with a necrotic mass (Meckel diverticulum considered congenital anomaly) and 300 cc of peritoneal free liquid. Intestinal resection of 10 cm was made with term to term anastomosis without further surgical correction. However the subject had unfavorable clinical evolution. He presented epileptic status with general tonic clonic seizures, hyponatremia and hypovolemic shock. On 08 March 2008 the subject showed abdominal distention. The same day the abdominal x-ray showed lack of intestinal air and rectal ampoule. The subject underwent again a surgery which showed intestinal occlusion, dysfunctional term to term anastomosis, damaged ileum and 100 cc of peritoneal liquid. A terminal ileum resection was required with a new ileal anastomosis. Post surgical evolution of the 2nd surgery was favorable for 2 days. On 11 March 2008 the subject presented irritability, abdominal distention, painfulness palpation and gastrobiliar liquid flow by nasogastric tube. Abdominal X-ray showed absence of intestinal air and air fluid levels. On 13 March 2008 the subject underwent a 3rd surgery which showed paralyzed colon, big intestinal dilatation of ileum and jejunum. The last anastomosis of the 2nd surgery was occluded in 90% of the lumen, loop to loop bridas, 60 cc of free serohematic liquid in abdominal cavity, bridas lysis, loops decompression and ileostomy of 2 stomas. The subject was discharged of surgery in favorable conditions. However on 14 March 2008 the subject presented crackles and slight respiratory distress without fever or infection evidence. On 15 March 2008 the subject had suddenly alveolar crackles in both lungs, cyanosis, bradycardia, bradypnea and finally cardio pulmonary arrest without response to resuscitation for 50 minutes. The physician considered the events were disabling, life threatening. The subject was treated with surgery, ceftriaxone, metamizole, metronadizole, vancomycin, omeprazole, THIOPENTAL, diazepam, phenytoin, clindamycin, metoclopramide, octreotide, salmeterol xinafoate, dexamethasone, dopamine, albumin, insulin, FUROSEMIDE, KETOROLAC and blood. The physician considered the events were possibly related to vaccination with ROTARIX. On 15 March 2008 the subject died from intestinal obstruction, intussusception and metabolic disorder.


VAERS ID: 327097 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Unknown  
Location: Foreign  
Vaccinated:2008-09-23
Onset:2008-09-23
   Days after vaccination:0
Submitted: 2008-10-03
   Days after onset:10
Entered: 2008-10-06
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20906002C / UNK UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UVA0727 / UNK UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR A9739 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anxiety, Circulatory collapse, Death, Epistaxis, Hypotonia, Hypotonic-hyporesponsive episode, Pyrexia, Respiratory arrest, Resuscitation, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No reported medical history
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 200802990

Write-up: Report received from the Health Authorities in a foreign country on 26 September 2008. HA reference number PL-URPL-OCR-20080926002. Other reference number URPL paper id N667/2008. A 01-month-old patient (gender not reported), with no reported medical history, experienced fatal hypotonic-hyporesponsive episode, epistaxis, circulatory collapse and respiratory arrest on 24 September 2008, i.e. 1 day after receiving an intra-muscular dose of ACT-HIB*, lot A9739-2, concomitantly with vaccines from other manufacturers: EUVAX B*, lot UVA0727 and DTP vaccine, lot 20906002C (IM route) on 23 September 2008. In the evening time on the vaccination day, i.e. on 23 September 2008, fever at 37.5 C was noted (considered as not serious). The patient was calm, at night had a calm sleep, in the morning drank milk then fell asleep. Parents didn''t measure the temperature. Before 11 am the patient became anxious, the father noticed after taking the patient from the crib that he/she was flaccid and has got blood in nasal ducts. They came to the outpatient clinic, where circulatory and respiratory arrest and no response on stimulus were found. Resuscitation was performed. The patient was taken by the rescue team to the intensive care unit. The patient died in the hospital on 24 September 2008. Very limited information is provided in this case report with fatal outcome. Consequently, in the absence of certificate death and autopsy report, no conclusion can be drawn.


VAERS ID: 327379 (history)  
Form: Version 1.0  
Age: 8.0  
Sex: Male  
Location: Foreign  
Vaccinated:2003-10-21
Onset:0000-00-00
Submitted: 2008-10-07
Entered: 2008-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 UN / ID
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Hydrophobia, Inappropriate schedule of drug administration, Irritability, Phobia of flying, Pyrexia, Restlessness, Salivary hypersecretion
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Anti-Tetanus Serum, 21-OCT-2003 00:00/21-OCT-2003 00:00; Horse Rabies Antiserum (Rabies Antiserum), 21-OCT-2003 00:00/Unknown
Current Illness:
Preexisting Conditions: 21-OCT-2003 to Unknown, Dog bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20081998

Write-up: On 23 SEP 2008 we received the following literature case: Recommended treatment for severe rabies exposure in unvaccinated individuals includes wound cleaning, administration of rabies immunoglobulins (RIG), and rabies vaccination. A survey of rabies treatment outcomes in the country was conducted. This was a case series involving 7,660 patients (4 months to 98 years of age) given purified equine RIG (pERIG) at the institute from July 2003 to August 2004 following Category II or III exposures. Data on local and systemic adverse reactions (AR) within 28 days and biting animal status were recorded; outcome data were obtained by telephone or home visit 6-29 months post-exposure. Follow-up data were collected for 6,464 patients (see case MA2008-1999). Of 151 patients with laboratory-confirmed rabies exposure, 143 were in good health 6-48 months later, seven could not be contacted, and one 4-year old girl died. Of 16 deaths in total, 14 were unrelated to rabies exposure or treatment. Two deaths were considered PEP failures: the 4-year-old girl, who had multiple deep lacerated wounds from a rabid dog of the nape, neck and shoulders requiring suturing on the day of exposure (see case MA2008-1997), and an 8-year-old boy who only received rabies PEP on the day of exposure. This extensive review of outcomes in persons with Category III exposure shows the recommended treatment schedule at institute using pERIG is well tolerated, while survival of 143 laboratory-confirmed rabies exposures confirms the intervention efficacy. Two PEP intervention failures demonstrate that sustained education and training is essential in rabies management. This case concerns a boy who only received treatment on the day he was bitten by a rabid dog, although this was not confirmed. With no subsequent vaccinations the boy died. On 21 OCT 2003 an 8-year-old boy was bitten by a pet dog and seen at institute the same day with a Category III single laceration of the right eyelid. He received pERIG (purified equine rabies immunoglobulins), partly infiltrated around the wound with the remaining volume administered IM in the buttocks (precise volume not recorded) and a first dose of rabies vaccine (0.1 mL ID in both deltoids). He also received anti-tetanus serum (3,000 IU IM), tetanus toxoid (0.5 mL IM) and cloxacillin (125 mg/mL, 11 mL every 6 hours). It was not documented whether wound cleaning was performed. A 7-year-old cousin bitten by the same dog resulting in a similar facial lesion received the same day 0 treatment. Both children returned with their parents to their home towns. On 20 NOV 2003, the 8-year-old boy presented with a moderate fever and was seen by a family practitioner. Five days later he was seen at the Emergency Ward with restlessness, irritability and increased salivation. During consultation, hydrophobia and aerophobia could be elicited. The history revealed the boy had not received any further doses of rabies vaccine. The family refused hospital admittance; the boy died at home and was buried the same day, so no post-mortem investigations were conducted. No laboratory investigations on the animal had been initiated either. The organization recommendations /TRS931) state that in cases of multiple severe exposures, HRIG if available should be infiltrated in the wounds, otherwise pERIG should be used and a maximum quantity must be infiltrated undiluted in the lesions. Seriousness criterion: death. Causality: not related. Inappropriate exposure treatment (only one dose of rabies vaccine) led to rabies infection. Expectedness assessment according to EU label: The reported symptoms are not expected after vaccination with RABIPUR. No change in benefit-risk-ratio. No measures necessary.


VAERS ID: 327380 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-10-07
Entered: 2008-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / ID

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Horse Rabies Antiserum; Unknown
Current Illness: Malnutrition
Preexisting Conditions: Extensive dog bite lacerations on shoulder, back, nape
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20081997

Write-up: On 23 SEP 2008 we received the following literature case: Recommended treatment for severe rabies exposure in unvaccinated individuals includes wound cleaning, administration of rabies immunoglobulins (RIG), and rabies vaccination. Survey of rabies treatment outcomes in foreign country was conducted. This was a case series involving 7,660 patients (4 months to 98 years of age) given purified equine RIG (pERIG) at the Institute from July 2003 to August 2004 following Category II or III exposures. Data on local and systemic adverse reactions (AR) within 28 days and biting animal status were recorded; outcome data were obtained by telephone or home visit 6-29 months post-exposure. Follow-up data were collected for 6,464 patients (see case MA2008-1999). Of 151 patients with laboratory-confirmed rabies exposure, 143 were in good health 6-48 months later, seven could not be contacted, and one 4-year-old girl died. Of 16 deaths in total, 14 were unrelated to rabies exposure or treatment. Two deaths were considered PEP failures: the 4-year-old girl, who had multiple deep lacerated wounds from a rabid dog of the nape, neck and shoulders requiring suturing on the day of exposure, and an 8-year-old boy who only received rabies PEP on the day of exposure (see case MA2008-1998). This extensive review of outcomes in persons with Category III exposure shows the recommended treatment schedule at institute using pERIG is well tolerated, while survival of 143 laboratory-confirmed rabies exposures confirms the intervention efficacy. Two PEP intervention failures demonstrate that sustained education and training is essential in rabies management. A 4-year-old malnourished girl was presented to the institute 1 1/2 hours after being attacked by a dog which had to be forcefully separated from the child by an uncle (who was also bitten). She had multiple deep lesions on the shoulder, back and nape. Immediate treatment consisted of wound washing, wound infiltration with diluted pERIG and intramuscular injection of the remaining volume, and rabies vaccine by ID route. Before returning home, the wounds were sutured because of their severity and continued bleeding. She received subsequent doses of rabies vaccine ID as scheduled. On day 24, however, she was hospitalised at institute with signs and symptoms of rabies and died 55 days post-exposure. She was the first bite victim of the dog and therefore probably received a large inoculum of the virus in highly innervated areas. Further, given her extensive lacerations with persistent bleeding, her wounds were sutured which is contraindicated for approximate post-exposure treatment. She did subsequently develop an adequate immune response to the vaccine, as described for other malnourished children, but still succumbed to the rabies infection. The organization recommendations/TRS931) state that in cases of multiple severe exposures, HRIG if available should be infiltrated in the wounds, otherwise pERIG should be used and a maximum quantity must be infiltrated undiluted in the lesions. Seriousness criteria death, hospitalisation. Causality: not related. Incorrect post exposure treatment and severity of wounds led to rabies infection. Expectedness assessment according to agency label: The reported rabies infection is not expected, vaccine failure is expected, after vaccination with Rabipur. On a case level, the case is considered not expected. No change in benefit risk-ratio.


VAERS ID: 327685 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2008-01-24
Onset:0000-00-00
Submitted: 2008-10-08
Entered: 2008-10-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2735AA / UNK UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR C2735AA / UNK UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR C2735AA / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 27057 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Condition aggravated, 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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Spinal muscular atrophy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: NLWYEG02282708

Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 3-month-old male patient who experienced worsening of Werdnig Hoffman disease (SMA type 1, spinal muscular atrophy). The patient received the second dose on 24-Jan-2008. The patient''s concurrent illness includes spinal muscular atrophy. Additional suspect medication included PEDIACEL. Concomitant medications were not reported. The patient experienced worsening of Werdnig Hoffman disease (SMA type 1, spinal muscular atrophy) (condition aggravated). He was subsequently hospitalised and died. The cause of death was reported as spinal muscular atrophy and condition aggravated. No additional information was available at the time of this report.


VAERS ID: 327686 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2008-09-01
Onset:2008-09-01
   Days after vaccination:0
Submitted: 2008-10-08
   Days after onset:37
Entered: 2008-10-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Prior cardiac problems.
Allergies:
Diagnostic Lab Data: None provided.
CDC Split Type: ZAWYEG02288008

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 5-month-old male patient who experienced cardiac death. The patient received the first dose in Sep-2008. Prior cardiac problems. Concomitant medications were not reported. The patient experienced cardiac death in Sep-2008. The cause of death was reported as cardiac death. No additional information was available at the time of this report.


VAERS ID: 327687 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-10-06
Entered: 2008-10-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drug ineffective, Pneumococcal infection, Pneumonia pneumococcal
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (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: PREVENAR (WYETH PHARMACEUTICALS INC.), Route/ Vacc. Site: , 1 DOSE /Prev Doses: 1; PREVENAR (WYETH PHARMACEUTICALS INC.), Route/ Vacc. Site: , 1 DOSE /Prev Doses: 0
Current Illness:
Preexisting Conditions: Unk
Allergies:
Diagnostic Lab Data: None provided.
CDC Split Type: ATWYEG02262208

Write-up: Information regarding PREVENAR was received from a healthcare professional via a registry regarding a participant in a study who experienced invasive Streptococcus pneumoniae disease and drug ineffective. The participant received three doses on an unspecified date. Relevant medical history was not provided. Concomitant therapy included PREVENAR as a first and second vaccine. The patient experienced drug ineffective and invasive Streptococcus pneumoniae disease. The cause of death was reported as pneumococcal infection. The assessments of the investigator(s) and medical monitor(s) for pneumococcal infection and drug ineffective were unknown. No additional information was available at the time of this report.


VAERS ID: 328042 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-10-09
Entered: 2008-10-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drug ineffective, Meningitis pneumococcal, Serology test
SMQs:, Lack of efficacy/effect (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: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: None provided.
CDC Split Type: BEWYEG02304908

Write-up: New version was created to correct data in event and product details. Information regarding PREVENAR was received from a healthcare professional regarding a 6-month-old male patient who experienced drug ineffective and meningitis pneumococcal. The patient received the second dose on an unspecified date. Relevant medical history was not provided. Concomitant medications were not reported. The patient experienced drug ineffective and meningitis pneumococcal and died when he was 6 months. The physician is researching to know which serotype was implicated in this death. The cause of death was reported as pneumococcal meningitis. No additional information was available at the time of this report.


VAERS ID: 328043 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-10-09
Entered: 2008-10-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis pneumococcal, Serology positive, Vaccination failure
SMQs:, Lack of efficacy/effect (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: Unknown
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Laboratory test, 00-UNK-2006, Pneumococcus serotype was determined to be 19F
CDC Split Type: FRWYEG02290308

Write-up: Information regarding PREVENAR was received from a healthcare professional via a foreign agency regarding a 3.3-month-old patient (gender and initials unspecified) who experienced meningitis due to Pneumococcus serotype 19F. The patient received the first dose in 2006. Relevant medical history was not provided. Concomitant medications were not reported. In 2006, reportedly 0.3 months (about 9 days) after the first dose of PREVENAR, the patient experienced meningitis due to Pneumococcus serotype 19F and died. The cause of death was reported as pneumococcal meningitis. No additional information was available at the time of this report. Laboratory test (results: Pneumococcus serotype was determined to be 19F) was done in 2006. This is one of 9 cases of pneumococcal meningitis received from the foreign agency (see related cases: FR-WYE-G02300308 (adverse event, expedited); FR-WYE-G02291108 (adverse event, expedited); FR-WYE-G02291008 (adverse event, expedited); FR-WYE-G02290908 (adverse event, expedited); FR-WYE-G02290608 (adverse event, expedited); FR-WYE-G02290408 (adverse event, expedited); FR-WYE-G02290208 (adverse event, expedited); and FR-WYE-G02289808 (adverse event, expedited)).


VAERS ID: 328250 (history)  
Form: Version 1.0  
Age: 1.7  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-10-10
Entered: 2008-10-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 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: Unknown
Current Illness:
Preexisting Conditions: Unk
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: ATWYEG01163308

Write-up: ICSR # AT-WYE-G02262208 was determined to be a duplicate of this ICSR and all information from the duplicate ICSR has been combined into this ICSR, which will remain the official of record. Information regarding PREVENAR was received from an independent study regarding a 20-month-old female participant in a study who experienced pneumococcal meningitis. Relevant medical history was not provided. Product was administered on an unspecified date. Concomitant medications were not reported. The patient experienced pneumococcal meningitis. Three days after the first symptoms occurred the patient died. The cause of death was reported as meningitis pneumococcal. The identified serotype was not included in the seven serotypes of PREVENAR vaccination. The assessments of the investigator(s) and medical monitor(s) for meningitis pneumococcal were unknown. No additional information was available at the time of this report.


VAERS ID: 328251 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Male  
Location: Foreign  
Vaccinated:2008-09-25
Onset:2008-09-27
   Days after vaccination:2
Submitted: 2008-10-10
   Days after onset:13
Entered: 2008-10-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20907001D / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 0430047 / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR A9739 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Healthy before vaccination, weighed 4.150.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200803095

Write-up: Initial report received from health authorities in a foreign country on 8 October 2008 under the authority reference number: 697/2008 (local reference no: 2008/0270). A 46-day-old male patient previously healthy received vaccinations with ACT-HIB, batch no: A 9739-2, DTP (batch 20907001D) and HEPAVAX GENE (batch 0430047) on 25 September 2008. The vaccination was done according to national immunisation programme. After vaccination the patient did not have any worrying symptoms. Two days later, on 27 September 2008, whilst feeding at 00.30 hours, no worrying symptoms were observed. At the feeding time at 03:30 hours, "the patient was inert". The patient received both out patient and hospital treatment (unspecified). The resuscitation was ineffective. The death was stated on 27 September 2008.


VAERS ID: 328393 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2008-07-01
Onset:2008-07-01
   Days after vaccination:0
Submitted: 2008-10-13
   Days after onset:104
Entered: 2008-10-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH P661965 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Cardiac arrest, Death, Pericardial effusion
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-07-15
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Atrial septal defect; Congenital pulmonary valve atresia; Ventricular septal defect
Allergies:
Diagnostic Lab Data: None provided
CDC Split Type: DEWYEG02324108

Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 2-month-old female patient who experienced pericardial effusion, cardiac arrest and suspicion of acute cardiac arrhythmia. The patient received the first dose on 01-Jul-2008. The patient has a past history of atrial septal defect, ventricular septal defect and congenital pulmonary valve atresia. The patient had a pulmonary atresia with VSD right aortic arch, ASD II, MAPCA. A conduit between right ventricle and pulmonary artery was applied including ligature of the ductus arteriosus on 08-May-2008. Additional suspect medication included INFANRIX HEXA. Concomitant medications were not reported. The patient experienced pericardial effusion in Jul-2008 requiring conservative treatment in the hospital from 08-Jul-2008 to 10-Jul-2008 and 11-Jul-2008 to 12-Jul-2008. The patient obviously recovered from this event. The patient experienced cardiac arrest with reanimation attempt and suspicion of acute cardiac arrhythmia on 15-Jul-2008. The patient died on 15-Jul-2008. The cause of death was reported as cardiac arrest and arrhythmia. According to the autopsy report the sutures of the conduit were in good condition and the most likely cause of death was an acute cardiac arrhythmia. This case is being treated according to the foreign act.


VAERS ID: 328394 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-10-13
Entered: 2008-10-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial test positive, Death, Meningitis pneumococcal, Serology positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: The patient had already experienced vaccination failure with pneumococcal meningitis due to serotype 14 at the age of 6 months (see related case FR-WYE-G02289808). Immunological deficiency was considered probable but no more information was provided.
Allergies:
Diagnostic Lab Data: Bacterial test, 00-UNK-2007, Streptococcus pneumoniae, serotype 19F
CDC Split Type: FRWYEG02300308

Write-up: This case was considered medically important. Information regarding PREVENAR was received from a foreign observatory via a healthcare professional regarding a 11-month-old patient (gender unknown) who experienced pneumococcal meningitis due to serotype 19F and death. The patient received the third dose on an unspecified date. The patient had already experienced vaccination failure with pneumococcal meningitis due to serotype 14 at the age of 6 months (see related case FR-WYE-G02289808). Immunological deficiency was considered probable but no more information was provided. Product was administered on an unspecified date. The patient had received a complete primary series with three doses administered at the age of 1.5, 2.6, and 3.6 months. Concomitant medications were not reported. The patient experienced pneumococcal meningitis due to serotype 19F in 2007, 8 months after the last dose of PREVENAR. It was reported that the patient was dead but it was not specified whether the death was due to the adverse event. Bacterial test (results: Streptococcus pneumoniae, serotype 19F) was done in 2007. See related case(s) from the same source: FR-WYE-G02289808 concerning the same patient and FR-WYE-G02291108; FR-WYE-G02291008; FR-WYE-G02290908; FR-WYE-G02290608; FR-WYE-G02290408; FR-WYE-G02290308; and FR-WYE-G02290208. No additional information was available at the time of this report.


VAERS ID: 328446 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-09-23
Onset:2008-09-24
   Days after vaccination:1
Submitted: 2008-10-14
   Days after onset:20
Entered: 2008-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS ASLUA362BA / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: D0058995A

Write-up: This case was reported by a regulatory authority (foreign Regulatory Authority (vaccines, biologicals) # DE-PEI-PEI2008015729) and described the occurrence of death- at present cause unknown- in a 73-year-old male subject who was vaccinated with INFLUSPLIT SSW 2008/2009 (GlaxoSmithKline). Previous vaccinations included INFLUSPLIT SSW 2007/2008 (GlaxoSmithKline). On 23 September 2008 the subject received a dose of INFLUSPLIT SSW 2008/2009 (0.5 ml, intramuscular, unknown gluteal). Approximately one day post vaccination with INFLUSPLIT SSW 2008/2009, on 24 September 2008, the subject died. At present the cause of death was unknown. An autopsy has been ordered. The autopsy results have not been provided. No further information will be available.


VAERS ID: 328618 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-10-15
Entered: 2008-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Completed suicide, Death, Hepatic enzyme increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Suicide/self-injury (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: A0751268A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of committed suicide in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). Previous and/or concurrent vaccinations included TWINRIX (GlaxoSmithKline) unknown given on an unspecified date. On an unspecified date the subject received 3rd dose of TWINRIX (unknown) from the rapid schedule. At an unspecified time after vaccination with TWINRIX, within the last year the subject experienced elevated liver enzymes and afterward within the last year the subject committed suicide. The subject died from committed suicide. It was unknown whether an autopsy was performed.


VAERS ID: 328677 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Female  
Location: Foreign  
Vaccinated:2007-09-26
Onset:2008-10-07
   Days after vaccination:377
Submitted: 2008-10-15
   Days after onset:8
Entered: 2008-10-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acne, Body temperature increased, Convulsion, Cough, Death, Drug toxicity, Malaria, Salivary hypersecretion
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Drug abuse and dependence (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), 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: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0810USC00039

Write-up: Information has been received from an investigator concerning a 13-month-old female with no previous medical history who entered a study, title as stated above. On 26-SEP-2007, 24-OCT-2007, and 21-NOV-2007 the patient was vaccinated with the first, second, and third doses of blinded therapy. There was no concomitant medication. On 07-OCT-2008 the patient was seen by the field worker during a weekly visit when the mother explained that the child had some "boutons" (pimples) on her body. The field worker suggested she bring the patient to the health center for a consultation, which she did on 09-OCT-2008. Her temperature was 39.4 degrees Celsius, the physical exam was normal and she did not have diarrhea or vomiting. She was prescribed injectable quinine 0.2 mg and injectable aspegic 0.5 mg for presumed malaria, though no thick smear for malaria was performed. A nurse at the health center administered the medication and immediately afterwards the patient started to cough and convulse with salivation. The nurse brought her to the doctor''s office but he was not present. They then took the child to a neighboring center with help from the CVD staff where she was noted to have died. It was concluded that the patient died secondary to a toxic reaction to either the quinine or aspegic medication that was administered. An autopsy was not performed and the death certificate was pending. The reporting investigator felt that malaria was of moderate intensity and not related to study therapy and that toxic reaction to medication was of severe intensity. At this time, relationship of toxic reaction to medication to study therapy is unknown. Additional information has been requested.


VAERS ID: 328680 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-10-15
Entered: 2008-10-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, CSF culture positive, Death, Drug ineffective, Meningitis pneumococcal
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: Unknown
Current Illness: Immunodeficiency; Asplenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood culture, pneumococci of serotype 7F; CSF culture, pneumococci of serotype 7F
CDC Split Type: DEWYEG02335108

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 5-year-old female patient who experienced meningitis pneumococcal and drug ineffective. The patient received the first dose on an unspecified date. The patient''s concurrent illnesses include anatomical or functional asplenia as well as an unspecified immunodeficiency. The patient was not a premature baby. Concomitant medications were not reported. The patient experienced meningitis pneumococcal approximately 3 months after the first vaccination with PREVENAR. Blood and CSF culture revealed pneumococci of serotype 7F. The patient died. CSF culture (results: pneumococci of serotype 7F) and blood culture (results: pneumococci of serotyp 7F) were done on unspecified date. The cause of death was reported as meningitis pneumococcal and drug ineffective. No additional information was available at the time of this report.


VAERS ID: 328681 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-10-15
Entered: 2008-10-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Incorrect route of drug administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Heart disease congenital
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: HRWYEH06373908

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 2-month-old female patient who experienced death most likely due to congenital heart malformation. The patient received a dose in 2008. The patient''s concurrent illness includes heart disease congenital. Concomitant medications were not reported. On an unspecified date in 2008, the patient received a dose of PREVENAR subcutaneously. Three days post-vaccination, the reporter indicated that the patient died, most likely due to congenital heart malformation. Treatment was not reported. Additionally, it was noted that in the Physician''s opinion the event was unrelated to the use of PREVENAR. No additional information was available at the time of this report.


VAERS ID: 329107 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2008-08-15
Onset:2008-08-18
   Days after vaccination:3
Submitted: 2008-10-17
   Days after onset:60
Entered: 2008-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0324X / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Coronary artery aneurysm, Death, Diarrhoea, Epstein-Barr virus antigen positive, Kawasaki's disease, Mass, Myocardial infarction, Pyrexia, Rash, Restlessness
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vasculitis (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-09-11
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Serum EBV nuclear antigen IgM antibody, increased
CDC Split Type: WAES0810USA02529

Write-up: Information has been received from a pediatrician concerning a 3 month old male who on 15-AUG-2008 was vaccinated with a second dose of ROTATEQ (lot# 659684/0324X). The patient was vaccinated with the first dose of ROTATEQ on 25-JUN-2008 and was well tolerated. On 18-AUG-2008, the patient developed diarrhea, restlessness and slight fever. On 27-AUG-2008 he developed an exanthema. In the further course the fever increased indolently. The fever did not respond to antibiotic treatment. Inflammatory parameter were slightly increased. The patient was hospitalized on an unspecified date. Increased EBV-IgM-titer was detected. The patient died on 11-SEP-2008. Autopsy showed atypical Kawasaki''s syndrome, cardiac infarction, aneurysms of the coronary vessels and a pseudotumor in the intestine. A lot check has been requested. Other business partner numbers included: E2008-09397.


VAERS ID: 329283 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2007-08-01
Onset:0000-00-00
Submitted: 2008-10-20
Entered: 2008-10-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 MO / PO

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: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0810USC00042

Write-up: Information has been received from an investigator concerning a female with no previous medical history who entered a study, title as stated above. On 01-AUG-2007, 29-AUG-2007, and 26-SEP-2007 the patient was vaccinated with the first, second, and third doses of blinded therapy. There was no concomitant medication. The patient and her parents went to the village in June 2008 to work in the fields during the rainy season. On 09-OCT-2008, a field supervisor learned that the patient died approximately three weeks earlier while in the village. The reporter did not know the circumstances of the patient''s death or the date her death occurred. On 10-OCt-2008, the team searched to learn more information without success. An autopsy was not performed and the cause of death was unknown. At this time, relationship of the event to study therapy is unknown. Additional information has been requested. Transmission of 7-Day notification to the FDA was made on 17-OCT-2008.


VAERS ID: 329567 (history)  
Form: Version 1.0  
Age: 1.4  
Sex: Female  
Location: Foreign  
Vaccinated:2007-11-13
Onset:2007-11-21
   Days after vaccination:8
Submitted: 2008-10-21
   Days after onset:334
Entered: 2008-10-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 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: 2007-11-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA03280

Write-up: Information has been received from a Health Authority concerning a 17 month old female who on 13-NOV-2007 was vaccinated with parenteral MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (manufacturer unknown). On 21-NOV-2007 the patient developed sudden infant death and died. Health Authority assessed the causality as possibly related to MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3). The outcome was fatal. Case is closed. Other business partner numbers include: E2008-09594.


VAERS ID: 329901 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-10-07
Onset:2008-10-07
   Days after vaccination:0
Submitted: 2008-10-23
   Days after onset:16
Entered: 2008-10-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 0986K009 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Death, Sepsis, Shock, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-08
   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: Date of death: 08-Oct-2008; The patient had a past medical history of chronic pain and leukocytopenia.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200814198

Write-up: Report received from the foreign regulatory authority via a foreign license partner on 20-OCT-2008. A 69 year old female patient (initial: K; DOB: unknown) received influenza vaccine, HV: FLukovax PF Ini (CSL bulk no: 0980K009) (KV batch no: PI080801; expiry: 31-JUL-2009), on 07-OCT-2008 at 10:00. The patient had a past medical history of chronic pain and leukocytopenia. No details of concomitant medication were provided. On 07-OCT-2008, at 12:00 (two hours after influenza vaccine administration) the patient vomited. Between 19:00 and 20:00 (9 or 10 hours after influenza vaccine administration), the patient developed shock and arrhythmia. The patient died at 15:40 on 08-OCT-2008. The patient''s doctor diagnosed sepsis as the cause of death and stated that there was no relation between the cause of death and the injected vaccine. The company considered events as unassessable/unclassifiable in relation to suspect drug. The authority assessed these events as unrelated to the vaccination. This case was reported as serious because of death. Information derived from this AE report does not change the current safety profile of CSL influenza vaccine (FLUVAX). Follow-up received on 22-OCT-2008 from reporting foreign license partner - CSL batch number for the influenza vaccine used in this case is 0986K009. No further information was provided.


VAERS ID: 329902 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-10-13
Onset:2008-10-13
   Days after vaccination:0
Submitted: 2008-10-23
   Days after onset:10
Entered: 2008-10-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 0986K009 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Date of death: 13-Oct-2008; The patient had a history of hypertension.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200814197

Write-up: Report received from the foreign regulatory authority via a foreign license partner on 20-OCT-2008. A 70 year old male patient (initial S, DOB unknown) received KV FLUKOVAX PF Ini. (CSL influenza vaccine from bulk no: 0980K009) (KV batch no: PI080801; expiry date: 31-JUL-2009) on the morning of 13-OCT-2008. The patient had a history of hypertension. No details of concomitant medications were provided. On 13-OCT-2008 at 13:10 the patient collapsed. At 13:30 (twenty minutes later) the patient was unconscious. The patient died at 15:10 on 13-OCT-2008. The company considered events as unassessable/unclassifiable in relation to the suspect drug. The authority has assessed these events as unrelated to the vaccine. Information derived from this AE report does not change the current safety profile of CSL influenza vaccine (FLUVAX). This case was reported as serious because of death. Follow-up received on 22-OCT-2008 from reporting foreign license partner - CSL batch number for the influenza vaccine used in this case is 0986K009. No further information was provided.


VAERS ID: 330077 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2008-10-08
Onset:2008-10-09
   Days after vaccination:1
Submitted: 2008-10-24
   Days after onset:15
Entered: 2008-10-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / PFIZER/WYETH - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER B0950 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-09
   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: body weight at birth: 2.7 kg; no medical history, no concomitant therapies
Allergies:
Diagnostic Lab Data: not reported
CDC Split Type: 200803185

Write-up: Case received from a healthcare professional on 14 October 2008 under the local reference number SK20080025. A 02-month-old male patient, with no medical history and no concomitant therapies, had received his intramuscular dose of IMOVAX POLIO, batch number B0950, and his intramuscular dose of DTP vaccine (other MFR, batch number not reported) in a public health care center on 08 October 2008 (11:00 am). The patient''s body weight at birth was 2.7 kg. The reporter (nurse who administered the vaccines to the patient) was informed by the patient''s mother that the patient was dead when he arrived at the hospital on 09 October 2008 (11:30 am). The reporter was not informed of the patient''s events before his death.


VAERS ID: 330078 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2008-10-10
Onset:2008-10-16
   Days after vaccination:6
Submitted: 2008-10-24
   Days after onset:8
Entered: 2008-10-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER P0147 / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER P0147 / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER P0147 / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER 63AS6020 / UNK MO / PO
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 07004 / 3 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bronchiolitis, Cardiac arrest, Cardiomegaly, Cardiomyopathy, Chest X-ray abnormal, Convulsion, Cough, Crepitations, Death, Diarrhoea, Dyskinesia, Endotracheal intubation, Eosinophil percentage, Gaze palsy, Grunting, Haemoglobin decreased, Heart rate, Intercostal retraction, Lymphocyte percentage increased, Monocyte percentage, Nasopharyngitis, Neutrophil percentage decreased, Nystagmus, Oral intake reduced, Oxygen saturation decreased, Pallor, Platelet count increased, Respiratory rate, Resuscitation, Rhonchi, Tachycardia, Tachypnoea, Unresponsive to stimuli, Viral myocarditis, Viral upper respiratory tract infection, White blood cell count normal
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Agranulocytosis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Pseudomembranous colitis (broad), Dyskinesia (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-17
   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: Concomitant therapy included Salbutamol, Cetirizine and Salinex Nasal Drops.
Current Illness: Cough; Diarrhea; Rhinitis.
Preexisting Conditions: Death of relative; Eye disorder; Birth Weight: 2.27 kg
Allergies:
Diagnostic Lab Data: white blood cell count (results: 9300 mm^3); platelet count (results: 4.991akh/cumm normal range 1.5-4.5lakh/cumm); neutrophil percentage (results: 43%); lymphocyte percentage (results: 50%); eosinophil percentage (results: 3%); monocyte percentage (results: 4%); heart rate (results: 140/min); respiratory rate (results: 58/min); oxygen saturation (results: 92% on room air); oxygen saturation (results: 100% on 4 liters head box O2); chest X-ray (results: PA view cardiomegaly with cardiothoracic (CT) ratio of 57% with normal lung fields and suspicion of an enlarged thymus but not conclusive due to poor positioning of the patient); haemoglobin (results: 9.3gm% normal range 12-14gm%); and physical examination (results: persistent cough, tachypnea, bilateral rhonchi, basal crepitations, subcostal and intercostal retractions, grunting, afebrile, liver to be 2 cm below the right costal margin, spleen 2 cm, and nystagmus). On 17-Oct-2008 test results were: physical examination (results: pale, mild distress, and tachycardiac); heart rate (results: 140/min); and respiratory rate (results: 64/min)
CDC Split Type: INWYEH06425808

Write-up: This report contains a fatal event. Information regarding PREVENAR was received from an investigator regarding a 3-month-old female participant in a study who experienced cardiac arrest due to viral myocarditis. The participant received her third dose of the test article on 10-Oct-2008. The patient''s concurrent illnesses include arthritis, cough, and loose stools (present for several days at time of vaccination). No history of similar complaints in the past. There is a past history of a death of a 4 month old female sibling that died due to a "heart" problem. The first born sibling also had an eye disorder, probably syndromic. Concomitant therapy included EASYFIVE, Oral Polio Vaccine, SALBUTAMOL, CETIRIZINE and SALINEX NASAL DROPS. The patient experienced viral myocarditis on 16-Oct-2008 and cardiac arrest due to viral myocarditis on 17-Oct-2008. On 14-Oct-2008 the patient presented to the hospital outpatient department with a six day history of cough, cold, and diarrhea. Records indicate no bluish discoloration, seizures, loss of consciousness, or vomiting. A clinical examination revealed bilateral rhonchi and a viral upper respiratory tract infection was diagnosed. Treatment consisted of outpatient SYR-SALBUTAMOL, SYR-CETRIZINE and Saline Nasal Drops. On 16-OCT-2008 the patient was examined at the site for persistent cough. Cold and diarrhea symptoms had subsided. Adrenaline nebulizer was administered without relief. The patient was admitted to the hospital for further evaluation and management of a provisional diagnosis of bronchiolitis. On examination the patient was tachypneic with bilateral rhonchi and basal crepitations on auscultation, subcostal and intercostal retractions, and grunting. The patient was afebrile, with a pulse rate of 140/min and a respiratory rate of 58/min. Oxygen saturation on room air was 92% and on 4 liters head box O2 it was 100%. Physical examination also revealed the liver to be 2 cm below the right costal margin, soft, non-tender, spleen 2 cm. She was also noted to have a nystagmus. In-house treatment consisted of Oxygen inhalation, IV fluids, adrenaline nebulization, and saline nasal drops. A chest x-ray revealed cardiomegaly with a cardiothoracic ratio of 57% but was a rotated film with a suspicion of an enlarged thymus. See test results below. On 17-Oct-2008, during morning rounds, the investigator noticed the patient was pale with mild distress and tachycardia. Her pulse rate was 140/min and her respiratory rate was 64/min with mild retractions. It was reported that the child had decreased "intake of feeds" since the evening of 16-Oct-2008. An urgent 2D echocardiogram was ordered to rule out structural or functional cardiac abnormalities but was never able to be performed. At approximately 11:30 am the patient experienced a seizure (up rolling of eyes, jerky movements of both limbs followed by unresponsiveness) and was placed back in the oxygen hood. When rechecked moments later, later, there was an absence of heart sounds and respiration. CPR was initiated, the patient was intubated, Inj-Adrenaline was given IV, and a Dobutamine infusion was started. The subject was revived but experienced a sudden cardiac arrest at 12:15 pm and CPR was given. The patient could not be revived and was pronounced dead at 12:45 pm on 17-Oct-2008. The cause of death was reported as cardiac arrest and viral myocarditis. The following differential diagnoses were considered by the Principal and Co-Investigators and the medical team members: 1) Viral Bronchiolitis with Myocarditis and possible arrhythmia as the terminal event, 2) Underlying Dilated Cardiomyopathy with Viral Bronchiolitis as the terminal event. The team performed a literature review consisting of Alstrom syndrome, Leigh''s disease/Leigh''s like illness, Oxidative phosphorylation and Fatty acid oxidation disorders of childhood, and Immune mediated cardiac involvement as possible reasons for the cardiomyopathy. All are noted as possible underlying conditions that could present with cardiomyopathy and ophthalmic findings. It was concluded, in view of the above discussion and literature review, the investigator is of the opinion that the subject probably had a pre-existing cardiac abnormality (either metabolic or syndromic disorder), but a worsening of the underlying condition secondary to an infection or vaccination cannot be ruled out. The records indicate a past history of a female sibling that expired due to a suspect "heart" disease and associated anomalies including limb contractures. No additional information was available at the time of this report. Physical examination (results: bilateral rhonchi) was done on 14-Oct-2008. On 16-Oct-2008 test results were: white blood cell count (results: 9300 mm^3); platelet count (results: 4.991akh/cumm normal range 1.5-4.5lakh/cumm); neutrophil percentage (results: 43%); lymphocyte percentage (results: 50%); eosinophil percentage (results: 3%); monocyte percentage (results: 4%); heart rate (results: 140/min); respiratory rate (results: 58/min); oxygen saturation (results: 92% on room air); oxygen saturation (results: 100% on 4 liters head box O2); chest X-ray (results: PA view cardiomegaly with cardiothoracic (CT) ratio of 57% with normal lung fields and suspicion of an enlarged thymus but not conclusive due to poor positioning of the patient); haemoglobin (results: 9.3gm% normal range 12-14gm%); and physical examination (results: persistent cough, tachypnea, bilateral rhonchi, basal crepitations, subcostal and intercostal retractions, grunting, afebrile, liver to be 2 cm below the right costal margin, spleen 2 cm, and nystagmus). On 17-Oct-2008 test results were: physical examination (results: pale, mild distress, and tachycardiac); heart rate (results: 140/min); and respiratory rate (results: 64/min). The medical monitor considered cardiac arrest due to viral myocarditis not related to the study product, protocol required procedures, or protocol required vaccines. The investigator is of the opinino that the subject probably had a pre-existing cardiac abnormality (either metabolic or syndromic disorder), but a worsening of the underlying condition secondary to an infection or vaccination cannot be ruled out.


VAERS ID: 330187 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Female  
Location: Foreign  
Vaccinated:2008-08-28
Onset:2008-08-29
   Days after vaccination:1
Submitted: 2008-10-27
   Days after onset:59
Entered: 2008-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Alpha haemolytic streptococcal infection, Autopsy, Blood culture positive, CSF cell count normal, Cytomegalovirus test positive, Enterococcal infection, Klebsiella infection, Polymerase chain reaction, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-08-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood culture, Aug2008, See lab text; CSF test, Aug 2008, See lab text; Polymerase chain reaction, Aug 2008, See lab text. Results of autopsy have been considered as non significant. Virological analysis by PCR: presence of Cytomegalovirus in heart and lungs. Bacteriological analysis: In the cerebrospinal fluid: no abnormality. In the heart: presence of Klebsiella pneumoniae, Enterococcus. In the upper respiratory tracts: presence of Klebiella oxytoca, alpha-hemolytic Streptococcus and non-hemolytic Streptococcus. In the liver: presence of Klebsiella pneumoniae, Enterococcus. In the lungs: presence of Klebsiella pneumoniae, Enterococcus and alpha-hemolytic Streptococcus. Blood hemoculture (one bottle): presence of alpha-hemolytic Streptococcus
CDC Split Type: B0541645A

Write-up: This case was reported by the foreign regulatory authority (Afssaps MP20080733 and MP0800720) and described the occurrence of sudden infant death in a 6-month-old female subject who was vaccinated with INFANRIXQUINTA, GlaxoSmithKline and PREVENAR, Wyeth Labs. On 28 August 2008, the subject received unspecified dose of INFANRIXQUINTA (intramuscular, unknown site of injection, batch number not available) and unspecified dose of PREVENAR (intramuscular, unknown site of injection, batch number not available). On 29 August 2008, one day after vaccination with INFANRIXQUINTA and PREVENAR, the subject died from sudden infant death. An autopsy was performed and results have been considered as non significant (NOS). Virological analysis revealed the presence of Cytomegalovirus in heart and lungs, detected by polymerase chain reaction. Bacteriological analysis revealed the presence of both Klebsiella pneumoniae and Enterococcus in the heart, liver and lungs. Klebsiella oxytoca and non-hemolytic Streptococcus were present in upper respiratory tracts and alpha-hemolytic Streptococcus was present in upper respiratory tracts and lungs. No abnormality was present in the cerebrospinal fluid. Blood culture detected alpha-hemolytic Streptococcus. The AFSSaPS reported sudden infant death as unlikely related to vaccination with INFANRIXQUINTA and PREVENAR, according to the foreign method of imputability. This case has been closed; no more information will be available.


VAERS ID: 330970 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-04-14
Onset:2008-05-20
   Days after vaccination:36
Submitted: 2008-10-31
   Days after onset:164
Entered: 2008-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / SANOFI PASTEUR A0975 / UNK UN / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS ATYAB016AD / UNK UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0975 / UNK UN / IM
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER ATYAB016AD / UNK UN / IM
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Acidosis, Activated partial thromboplastin time prolonged, Aspartate aminotransferase increased, Autopsy, Base excess increased, Blood alkaline phosphatase normal, Blood bilirubin increased, Blood creatinine increased, Blood culture positive, Blood fibrinogen decreased, Blood pH decreased, Blood potassium normal, Blood product transfusion, Blood sodium normal, Blood urea decreased, C-reactive protein increased, Chest discomfort, Circulatory collapse, Death, Diarrhoea, Disseminated intravascular coagulation, Dizziness, Endotracheal intubation, Haemoglobin decreased, Hypotension, Intensive care, Liver disorder, Lymphadenopathy, Malaise, Mean cell volume normal, Neutrophil count decreased, Peripheral coldness, Pharyngitis, Platelet count decreased, Platelet transfusion, Pneumococcal sepsis, Prothrombin time prolonged, Purpura, Resuscitation, Sepsis, Septic shock, Shock, Spleen disorder, Vascular anomaly, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (narrow), Agranulocytosis (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Congenital, familial and genetic disorders (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-05-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MICROGYNON (Ethinyloestradiol + Levonorgestrol)
Current Illness: Unknown
Preexisting Conditions: Eczema; Nonsmoker; Fit and well at time of vaccination
Allergies:
Diagnostic Lab Data: Activated partial thromboplast, 20Sep2008, $g200; Alkaline phosphatase, 20Sep2008, 68; Aspartate aminotransferase, 20Sep2008, 136; Bilirubin, 20Sep2008, 16; C-reactive protein, 20Sep2008, 148; Creatinine, 20Sep2008, 195; Fibrinogen, 20Sep2008, 0.28; Haemoglobulin, 20Sep2008, 10.1; Mean cell volume, 20Sep2008, 88 ;Neutrophil count, 20Sep2008, 1.3; Platelet count, 20Sep2008, 21000; Potassium, 20Sep2008, 3.5; Prothrombin time, 20Sep2008, 38; Sodium, 20Sep2008, 138; Total white blood cell count, 20Sep2008, 2.1; Urea, 20Sep2008, 8.9; pH, 20Sep2008, 7.27; pH-7.27 base excess of 15.8.
CDC Split Type: B0544236A

Write-up: This case was reported by a regulatory authority (foreign Medicines and Healthcare products Regulatory Agency # GB-MHRA-ADR 20268603 and described the occurrence of disseminated intravascular coagulation in a 26-year-old female subject who was vaccinated with HEPATYRIX, REVAXIS and STAMARIL. The subject''s medical history included eczema. It was reported that the patient was a nonsmoker. Concurrent medications included MICROGYNON. On 14 April 2008 the subject received a dose of HEPATYRIX (1 ml, intramuscular), and a dose of REVAXIS (.5 ml, intramuscular). On 19 May 2008 the subject received an unspecified dose of STAMARIL (subcutaneous). On 20 May 2008, approximately 6 days after vaccination with HEPATYRIX and REVAXIS and 1 day after vaccination with STAMARIL, the subject experienced disseminated intravascular coagulation, circulatory collapse, pharyngitis, lymphadenopathy, abdominal pain, acidosis, chest tightness, diarrhea, dizziness, hypotension, peripheral coldness, purpuric rash, shock, streptococcus pneumoniae septicemia and felt unwell. The subject was hospitalised. The subject died on 21 May 2008 from disseminated intravascular coagulation and sepsis. An autopsy was performed and showed sepsis. Verbatim text: The patient was fit and well at the time of vaccination. The morning after vaccination, the patient was found haemodynamically collapsed. She was admitted to intensive care unit with disseminated intravascular coagulation. At the time of admission viscerotropic disease was suspected, however, streptococcus pneumoniae was later isolated and the patient was diagnosed with pneumococcal septicaemia. The patient died. An autopsy was performed and showed sepsis. Follow up: The patient was brought into the accident and emergency department with a history of becoming unwell four hours after she had a yellow fever vaccine the previous day given at the general practitioners surgery. The patient had felt unwell during the day and gradually deteriorated overnight feeling very faint, unwell and one episode of diarrhoea. Whilst in the accident and emergency department she started to develop a rash on the forehead which later became confluent and was purpuric. She was hypotensive with cold peripheries. The patient was resuscitated with intravenous fluid and was also given intravenous ceftriaxone, adrenaline and hydrocortisone. The patient was severely acidotic and shocked. There were no localising signs. A diagnosis of septicaemia with disseminated intravascular coagulation was made. The patient was seen by the haematology registrar who prescribed two pools of platelets, fresh frozen plasma and cryoprecipitate. The patient condition continued to deteriorate and blood remained low, she started to develop abdominal pain and chest tightness and it was clear that she was deteriorating further. The patient was transferred to the intensive care unit and was intubated. Blood cultures returned growing pneumococcal septicaemia. The patient died. Her post mortem showed classic septic shock with DIC. The liver had chagnes consistent with DIC and not hepatitis. She had obvious pharyngitis with adenopathy. The post mortem also showed that the patient was hypo-splenic with a spleen weighing only 42 grams. This was secondary to a vascular malformation and so was probably failure to develop properly.


VAERS ID: 331190 (history)  
Form: Version 1.0  
Age: 1.3  
Sex: Male  
Location: Foreign  
Vaccinated:2008-03-28
Onset:2008-04-07
   Days after vaccination:10
Submitted: 2008-11-03
   Days after onset:210
Entered: 2008-11-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0736F / 1 UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 29437 / 3 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial test, Body temperature increased, Cardiac arrest, Crying, Death, Febrile infection, Hyperplasia, Laboratory test, Loss of consciousness, Lymphadenopathy, Microbiology test, Poor quality sleep, Pyrexia, Respiration abnormal, Resuscitation, Tracheobronchitis, Upper respiratory tract infection, Viral test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (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: 2008-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: diagnostic laboratory test, 07Apr08; bacteriological, virology, neuropathology, microbiological and fluid balance samples-no results; body temp, 07Apr08, 39.2 degrees C; body temp, 07Apr08, 39 degrees C
CDC Split Type: WAES0810USA05001

Write-up: Information has been received from a Health Authority concerning a 15 month old male who on 28-MAR-2008 was vaccinated with the first dose of SQ MMR II (Lot # 655062/0736F, Batch # NE33140) and his third dose of IM PREVENAR (WYETH, Lot 29437). During the night of 07-APR-2008, the patient had restless sleep and was awake several times and cried. In the morning on 07-APR-2008, the patient had fever (39.2 degrees C). The patient received treatment with PANODIL JUNIOR suppository (dose not reported). During the day, the patient slept a few times, ate and drank normally and had wet diapers. No rash was noticed. At approximately 15:00 the child''s temperature was 39 degrees C. No medication was given since the child already had received treatment with PANODIL JUNIOR suppository. The child was put to bed. Approximately 1 hour after the child was put to bed, it was found lifeless lying on his stomach with his face in the duvet. An ambulance was called and the father attempted resuscitation immediately. Upon arrival of the ambulance, asystolia was detected. Attempts at resuscitation were continued. Resuscitation attempts were unsuccessful on arrival to the hospital. The autopsy report revealed an acute upper respiratory tract infection and enlarged lymph nodes were found in thoracic cavity, abdominal cavity and hepatic portal. There was accumulation of fluid in the pericardial sac (7 mL). Some acute signs of air excess in the lungs as can be seen in case of compromised respiration. The child had no malformations and there were no signs of neglect or violence. The diagnosis of the autopsy report included (febrilia), tracheobronchitis acuta, hyperplasia lymphonodorum thoracalium. abdominalium et portae hepatic mango gradu, emphysema pulmonum levi gradu, tentaminis resuscitation sequelae and velnera puncta variae. A final cause of death could not be concluded, however upper respiratory tract infection was possibly contributing to fatal outcome. Bacteriological, virology, neuropathology, microbiological and fluid balance samples were extracted for additional examination. Results from these exams are expected. Other business partner numbers include: E2008-09965.


VAERS ID: 331475 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2007-11-06
Onset:0000-00-00
Submitted: 2008-11-05
Entered: 2008-11-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 MO / PO

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: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0811USC00003

Write-up: Information has been received from an investigator concerning a female with no previous medical history who entered a study. On 11-SEP-2007, 09-OCT-2007, and 06-NOV-2007, the patient was vaccinated with the first, second, and third doses of blinded therapy. There was no concomitant medication. The last contact the field worker had with the patient''s father was on 26-AUG-2008. On 28-OCT-2008, while making local visits, the field worker was informed by a neighbor that the patient had died. An autopsy was not performed, a death certificate was not obtained, and the cause of death was unknown. At this time, relationship of unknown cause of death to study therapy is unknown, though the Investigator stated it seemed unlikely. Additional information has been requested.


VAERS ID: 331785 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-10-07
Onset:2008-10-07
   Days after vaccination:0
Submitted: 2008-11-06
   Days after onset:30
Entered: 2008-11-10
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 0980K009 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Death, Sepsis, Shock, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-08
   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: Date of death: 08-Oct-2008
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200814283

Write-up: Report received from the foreign regulatory authority via a foreign license partner on 20-Oct-2008. A 69 year old female patient (initial: K; DOB: unknown) received influenza vaccine, *KV: FLUKOVAX PF INI (CSL bulk no: 0980K009) (KV batch no: PI080801; expiry: 31-JUL-2009), on 07-OCT-2008 at 10:00. The patient had a past medical history of chronic pain and leukocytopenia. No details of concomitant medication were provided. On 07-OCT-2008, at 12:00 (two hours after influenza vaccine administration) the patient vomited. Between 19:00 and 20:00 (9 or 10 hours after influenza vaccine administration), the patient developed shock and arrhythmia. The patient died at 15:40 on 08-OCT-2008. The patient''s doctor diagnosed sepsis as the cause of death and stated that there was no relation between the cause of death and the injected vaccine. The company considered the events as unassessable/unclassifiable in relation to the suspect drug. The authority assessed these events as unrelated to the vaccination. This case was reported as serious because of death. Information derived from this AE report does not change the current safety profile of CSL FLUVAX. Follow-up received on 22-OCT-2008 from reporting foreign license partner - CSL batch number for the influenza vaccine used in this case is 0986K009. No further information was provided. This case is identical a previous case number KP-BEH-200814198, which had to be inactivated due to inaccurate country coding. The country code in this new case KR-BEH-200814283 is now correct with ''foreign''.


VAERS ID: 332008 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-11-10
Entered: 2008-11-12
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH BN31636 / 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: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: GBWYEG02530008

Write-up: Information regarding PREVENAR was received from a healthcare professional via MHRA regarding an 8-week-old male patient who died. The patient received a dose on an unspecified date. Additional suspect medication included PEDIACEL. The patient died in a local shopping centre on an unknown date following administration of PREVENAR and PEDIACEL. The cause of death was reported as unknown. No further information was provided.


VAERS ID: 332019 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-11-11
Entered: 2008-11-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-10-23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0811USC00021

Write-up: Information has been received from an investigator concerning a female who entered a study. The patient was vaccinated with blinded therapy on an unspecified date. There was no concomitant medication. On 05-NOV-2008, the site was notified that the patient died on 23-OCT-2008. The details surrounding her death and the relationship to study therapy were unknown at the time of this report. Additional information has been requested.


VAERS ID: 332152 (history)  
Form: Version 1.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-05
Onset:2008-11-05
   Days after vaccination:0
Submitted: 2008-11-12
   Days after onset:7
Entered: 2008-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Condition aggravated, Death
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0545050A

Write-up: This case was reported by a physician and described the occurrence of death nos in a 39-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included asthma in stationary phase. On 5 November 2008, the subject received unspecified dose of FLUARIX (intramuscular, unknown injection site). Lot number not provided. On 5 November 2008, in the evening, less than one day after vaccination with FLUARIX, the subject experienced asthmatic attack and died. The physician considered the events were unrelated to vaccination with FLUARIX. The subject died on 5 November 2008, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 332886 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2008-11-11
Onset:2008-11-12
   Days after vaccination:1
Submitted: 2008-11-20
   Days after onset:8
Entered: 2008-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Death, Hypotonia, Hypoxia, Resuscitation
SMQs:, Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0547003A

Write-up: This case was reported by a regulatory authority and described the occurrence of convulsion in a 2-month-old male subject who was vaccinated with TRITANRIX HEPB (GlaxoSmithKline). On 11 November 2008, the subject received 1st dose of TRITANRIX HEPB (subcutaneous, unknown injection site). On 12 November 2008, 1 day after vaccination with TRITANRIX HEPB, the subject experienced convulsion, hypoxia and hypotonia. He was sent to hospital and the cardiopulmonary resuscitation performed was unsuccessful. The regulatory authority reported that the events were possibly related to vaccination with TRITANRIX HEPB. The subject died on 12 November 2008, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 333078 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2008-10-02
Onset:0000-00-00
Submitted: 2008-11-21
Entered: 2008-11-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, HIV antibody positive, Oral candidiasis, Respiratory tract infection
SMQs:, Oropharyngeal infections (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sulfamethoxazole/trimethoprim, 01Sep08 - Unk; vitamins (unspecified), 01Sep08 - Unk
Current Illness:
Preexisting Conditions: HIV infection
Allergies:
Diagnostic Lab Data: plasma HIV-1 AMPLICOR MONITOR, 01Sep08, positive; plasma Multispot rapid HIV-1/2 EIA Ab, 01Sep08, positive
CDC Split Type: WAES0811USC00035

Write-up: Information has been received from an investigator concerning a 19-week-old female with a history of HIV infection who entered a study, titled as stated above. On 01-SEP-2008 and 02-OCT-2008 the patient was vaccinated with the first and second doses of blinded therapy. Concomitant therapy included Cotrimoxazole and multivitamins (unspecified). On 29-OCT-2008, the patient was seen on an unscheduled visit with oral candidiasis and respiratory tract infection. Treatment included oral fluconazole 1.25 ml once daily for 2 weeks and oral erythromycin 2.5 ml every 6 hours for 1 week. The patient was reported to have died at home on 14-NOV-2008. An autopsy was not performed and a death certificate was not obtained. The cause of death was unknown. At the time of this report, the relationship of the patient''s death to study therapy is unknown. Additional information has been requested.


VAERS ID: 333422 (history)  
Form: Version 1.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2006-12-05
Onset:2008-05-08
   Days after vaccination:520
Submitted: 2008-11-28
   Days after onset:204
Entered: 2008-11-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS 1319 / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-05-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 05-DEC-2006 to Unknown, Dog bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20082872

Write-up: On 13 NOV 2008 we received the following information: A female patient was bitten by a dog on 5 DEC 2006 and therefore she started with a series of RABIPUR on 5 DEC 2006. She received the further vaccinations with RABIPUR on 8 DEC 2006, 12 DEC 2006, 19 DEC 2006 and the fifth dose on 2 JAN 2007. 17 months after the vaccination, on 8 MAY 2008, the symptoms of rabies infection have been observed. Patient died on 8 MAY 2008 at 7.45 p.m. during treatment. It seemed that no HRIG was given. On 14 NOV 2008 we received the original documents in foreign language. No change in assessment. On 15 NOV 2008 we received the information that the patient was 38 years old. The patient has had high breathing problems and did not drink water. She was also scared when she saw a glass of water and her face changed. No change in assessment. On 19 NOV 2008 we received the following additional information: It was reported that 1 ml of RABIPUR was given at each dose and that the batch no. probably was 1319. No history of wound toilet or RIG was given. No change in assessment. On 24 NOV 2008 we received the result of the batch review: Manufacturing protocols demonstrated that there were no deviations affecting product. No change in assessment.


VAERS ID: 333540 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2008-03-01
Onset:0000-00-00
Submitted: 2008-12-01
Entered: 2008-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Encephalitis herpes, Viral test negative
SMQs:, Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: B0547857A

Write-up: This case was reported by a physician and described the occurrence of symptoms (unspecified) in a male patient of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date around March 2008 the patient received the 1st dose of ENGERIX B (1 injection) following the accelerated schedule (0, 7, 21 and 12 month). A few days later the patient experienced unspecified symptoms. A week later the patient received the 2nd dose of ENGERIX B (1 injection). On an unspecified date the subject died. The doctor stated that it appears that the patient died from herpes encephalitis however all the tests for viruses were negative. It was unknown whether an autopsy was performed. On the 25th of November 2008 a doctor reported that a male patient received the first dose of an ENGERIX B accelerated schedule (0, 7, 21 day and 12 month) around March 2008 and a few days later unspecified symptoms appeared. The second ENGERIX B dose was administered a week later. The doctor stated that it appears that the patient died of herpes encephalitis however all the tests for viruses were negative.


VAERS ID: 333751 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-18
Onset:2008-11-21
   Days after vaccination:3
Submitted: 2008-12-03
   Days after onset:12
Entered: 2008-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature increased, Death, HIV antibody positive, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-24
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vitamins (unspecified); isoniazid; pyrazinamide; rifampin; sulfamethoxazole/trimethoprim
Current Illness: Tuberculosis; HIV infection; Pulmonary tuberculosis
Preexisting Conditions: Hospitalisation; Oropharyngeal candidiasis; Acute gastroenteritis
Allergies:
Diagnostic Lab Data: plasma HIV-1 AMPLICOR MONITOR, 06Oct08, Positive; whole blood HIV-1 and/or HIV-2 rapid Ab, 06Oct08, Positive; body temp, 21Nov08, 37.5 degrees Celsius
CDC Split Type: WAES0812USC00006

Write-up: Information has been received from an investigator concerning a 12-week-old female with tuberculosis, HIV infection and pulmonary tuberculosis and a history of hospitalization from 21-OCT-2008 to 17-NOV-2008, oropharyngeal candidiasis and acute gastroenteritis, who entered a study. On 06-OCT-2008, HIV Rapid and PCR tests were positive. The baby''s height and weight were taken on 17-NOV-2008. On 06-OCT-2008 and 18-NOV-2008, the patient was vaccinated with the first and second doses of blinded therapy. Concomitant therapy included sulfamethoxazole/trimethoprim, vitamins (unspecified), rifampin, isoniazid and pyrazinamide. The baby had been admitted to the hospital and discharged on anti-tuberculosis drugs and opportunistic infection prophylaxis when acute gastroenteritis and oral candidiasis had resolved. On 21-NOV-2008, during a home visit, the mother reported that the child had a fever with a recorded temperature of 37.5 degrees Celsius. The mother was asked to bring the baby to the hospital but she declined. During another home visit on 26-NOV-2008, the baby was reported to have died on 24-NOV-2008. On an unspecified date, blinded therapy was discontinued. The cause of death was unknown. At this time, relationship to study therapy was unknown. Additional information has been requested.


VAERS ID: 333752 (history)  
Form: Version 1.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-11-11
Onset:2008-11-11
   Days after vaccination:0
Submitted: 2008-12-03
   Days after onset:22
Entered: 2008-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA362BA / 2 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Inappropriate schedule of drug administration, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-28
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Handicap; Living in nursing home; Neonatal brain damage; Renal function impairment; Spasticity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: D0059689A

Write-up: This case was reported by a physician and described the occurrence of death due to renal failure in an approximately 43-year-old male subject who was vaccinated with INFLUSPLIT SSW 2008/2009 (GlaxoSmithKline). Concurrent medical conditions included neonatal brain damage, pre-existing renal function impairment and spasticity. The subject was very severely handicapped and was living in nursing home. On 30 September 2008 the subject received the first dose of INFLUSPLIT SSW 2008/2009 (0.5 ml, unknown). On 11 November 2008 the subject received by error the second dose of INFLUSPLIT SSW 2008/2009 (0.5 ml, unknown). This vaccination with the second dose of INFLUSPLIT SSW 2008/2009 was inappropriate. According to initial information, the subject died from renal failure on 26 November 2008, approximately 15 days post vaccination with the second dose of INFLUSPLIT SSW 2008/2009. According to follow-up information, the subject died from renal failure on 28 November 2008, approximately 17 days post vaccination with the second dose of INFLUSPLIT SSW 2008/2009. It was unknown whether or not an autopsy was performed. The reporting physician considered that the event was unrelated to vaccination with INFLUSPLIT SSW 2008/2009 and vaccination with the second dose of INFLUSPLIT SSW 2008/2009. Follow-up information has been requested.


VAERS ID: 334014 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-25
Onset:2008-11-25
   Days after vaccination:0
Submitted: 2008-12-04
   Days after onset:9
Entered: 2008-12-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Death, Syncope
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), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0812USA00220

Write-up: Information has been received from a physician concerning a 75 year old female patient who on 25-NOV-2008, at 11:30, was vaccinated with a dose of PNEUMOVAX 23 (lot number, route and injection site not reported). The patient''s primary disease and concurrent conditions were unknown. No information on concomitant medication was provided. On 25-NOV-2008, at past 12:00, the patient returned home. Later, she went out with her friend and collapsed at the outside location. At 14:45, the patient was taken to another hospital with cardio-respiratory arrest, and the reporting physician was informed about it at 15:00. At 17:15, police informed the reporting physician of the patient''s death by phone. As there was no contact thereafter, the cause of death was unknown. The reporting physician felt that causal relationship between the patient''s death and PNEUMOVAX 23 was unknown. The physician considered death to be serious (due to death). Additional information has been requested.


VAERS ID: 334613 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-11-25
Onset:2008-11-30
   Days after vaccination:5
Submitted: 2008-12-09
   Days after onset:9
Entered: 2008-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR D0632 / UNK UN / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB192AD / 1 UN / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-11-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dysphagia; Infantile cerebral paralysis; Percutaneous endoscopic gastrostomy; Possible gastroesophageal reflux; Spastic paresis
Preexisting Conditions: Previous vaccinations have been well tolerated.
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: D0059792A

Write-up: This case was reported by a regulatory authority (foreign regulatory authority (vaccines, biologicals) # DE-PEI-PEI2008019287) and described the occurrence of death from an unknown cause in a 4-year-old male subject who was vaccinated with HAVRIX 720 Junior (GlaxoSmithKline). Co-suspect vaccinations MUTAGRIP 2008/2009 (Sanofi Pasteur MSD). Concurrent medical conditions included infantile spastic cerebral paresis, dysphagia, possible gastroesophageal reflux and percutaneous endoscopic gastrostomy tube insertion. Previous vaccinations included seasonal influenza virus vaccine (non-GSK) (MUTAGRIP 2006/2007, Sanofi Pasteur MSD) and seasonal influenza virus vaccine (non-GSK) (MUTAGRIP 2007/2008, Sanofi Pasteur MSD), given on 02 November 2006 and 27 November 2007, respectively. Previous vaccinations have been well tolerated. On 25 November 2008 the subject received the first dose of HAVRIX 720 Junior (0.5 ml, intramuscular, unknown deltoid) and a dose of MUTAGRIP 2008/2009 (intramuscular, unknown deltoid). Approximately five days post vaccination with HAVRIX 720 Junior and MUTAGRIP 2008/2009, on 30 November 2008 at 07:00, the subject died from an unknown cause. An autopsy was not performed. The subject was buried on 03 December 2008. The reporter stated having reported this case only due to timely relationship between death and vaccination with HAVRIX 720 Junior and MUTAGRIP 2008/2009. No further information will be available.


VAERS ID: 335268 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-07
Onset:2008-11-07
   Days after vaccination:0
Submitted: 2008-12-12
   Days after onset:35
Entered: 2008-12-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-07
   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: Date of death: 07-Nov-2008; Osteoarthritis; Shoulder pain; Spondylosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200814428

Write-up: Report received from the agency (No.: GB-MHRA--ADR20347390): An 82-year-old female patient (initials and date of birth unknown) was vaccinated with ENZIRA (CLS influenza vaccine, lot number unknown) 0.5mL by intramuscular injection on 07-Nov-2008. The patient died on the same day as vaccine injection. The death was reported as unexplained. A post mortem report is awaited.


VAERS ID: 335270 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-04-21
Onset:2008-07-16
   Days after vaccination:86
Submitted: 2008-12-12
   Days after onset:149
Entered: 2008-12-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Headache, No reaction on previous exposure to drug, Pain, Ruptured cerebral aneurysm
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KESTINE; NASACORT; SERETIDE; albuterol
Current Illness: Pollen allergy; Allergic asthma; Overweight
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0812USA02421

Write-up: Information has been received from a general practitioner concerning an 18 year old female with pollen allergy, allergic asthma and who was overweight, with a family history of the mother having multiple sclerosis, who on 12-MAR-2008 was vaccinated with the first dose of GARDASIL, lot # not reported, which was well tolerated. It was reported that the second dose of GARDASIL, lot # not reported, was given intramuscularly (IM) to the right deltoid on 21-APR-2008. Concomitant therapy included SERETIDE, albuterol, NASACORT and KESTINE. There was no contraceptive use. On 16-JUL-2008 the patient experienced sudden brutal cephalgia and then she suffered from a pain evocating an aneurysm during rupture. The patient suddenly died in spite of resuscitation technique performed by the agency which evoked a ruptured aneurysm. An autopsy was on-going and the results would be provided. As to the reporter there may not be any link between adverse effect and vaccination. The reported cause of death by the ageny was ruptured cerebral aneurysm, but it had not been confirmed yet by the results of the autopsy which were still pending. Additional information has been requested. Other business partner numbers include E2008-11575.


VAERS ID: 335318 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:2007-06-18
Onset:2007-06-22
   Days after vaccination:4
Submitted: 2008-12-15
   Days after onset:542
Entered: 2008-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA298A / UNK UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS A20CA298A / UNK UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA298A / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER A20CA298A / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 24360 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asphyxia, Autopsy, Histology abnormal, Inflammation, Lymphocytic infiltration, Pulmonary haemorrhage, Sudden infant death syndrome, Viral infection
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Hostility/aggression (broad), Neonatal disorders (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-06-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject was the second child of the family. She had no relevant past medical history.
Allergies:
Diagnostic Lab Data: Autopsy, Jun2007, see text; On 22 June 2007: Prior to autopsy, different explorations (nos) were normal. The autopsy revealed a normal macroscopic exam. At microscopic level, myocard, liver, kidney and suprarenal glands were normal. However, at upper respiratory tract level, there was several lymphocytic clusters (not mainy). According to the whole investigations, it was concluded that two elements could have contributed to the sudden death. Firstly, the infant was found on ventral decubitus, there was thus a certain asphyxiant degree prior to death. This was confirmed by histological lung exam which revealed a characteristic haemorrhagic suffusion. Secondly, there was an inflammatory context at lung and upper respiratory tract areas at histological exam, which could evoke a probable starting viral infection.
CDC Split Type: B0549295A

Write-up: This case was reported by the foreign regulatory authority (AFSSaPS number: MP20080834) and described the occurrence of sudden infant death in a 5-month-old female subject who was vaccinated with INFANRIXQUINTA (GlaxoSmithKline) and PREVENAR (Wyeth Labs). Vaccinal history included a first dose of INFANRIXQUINTA (batch and injection site unknown) and PREVENAR (batch 23864, injection site unknown) on 03 April 2007, a second dose of INFANRIXQUINTA (batch A20CA300B, injection site unknown) and PREVENAR (batch 24358, injection site unknown) on 15 May 2007. The subject had no relevant past medical history. It was the second child of the family and weighted 6.3 kg. On 18 June 2007, the subject received a 3rd dose of INFANRIXQUINTA (intramuscular, unknown site, batch A20CA298A) and a 3rd dose of PREVENAR (intramuscular, unknown site, batch 24360). On 21 June 2007, the subject took her last bottle-feed at 09h30 PM, then the subject was put to bed on the back. She was seen alive at 03 AM, on 22 June 2007. On 22 June 2007 in the morning, 4 days after vaccination with INFANRIXQUINTA and PREVENAR, the subject was found dead, lying on belly. Several intensive care manoeuvres were unsuccessful. Prior to autopsy, different explorations (nos) were normal. The autopsy revealed a normal macroscopic exam. At microscopic level, myocard, liver, kidney and suprarenal glands were normal. However, at upper respiratory tract level, there was several lymphocytic clusters (not mainy). According to the whole investigations, it was concluded that two elements could have contributed to the sudden death. Firstly, the infant was found on ventral decubitus, there was thus a certain asphyxiant degree prior to death. This was confirmed by histological lung exam which revealed a characteristic haemorrhagic suffusion. Secondly, there was an inflammatory context at lung and upper respiratory tract areas at histological exam, which could evoke a probable starting viral infection. The AFSSaPS considered that the events were unlikely related to vaccinations with INFANRIX QUINTA and PREVENAR, according to the foreign method of imputability. This case has been closed; no more information will be available.


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