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Case Details

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VAERS ID: 385477 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-01
Onset:2010-04-01
   Days after vaccination:0
Submitted: 2010-04-20
   Days after onset:19
Entered: 2010-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC37B031CC / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Culture negative, Death, Headache, Hypersensitivity, Myocarditis, Pyrexia, Skin lesion
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Culture, Apr2010, NEGATIVE
CDC Split Type: A0854882A

Write-up: This case was reported by a healthcare professional (nurse) and described the occurrence of acute myocarditis in a 15-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 1 April 2010 the subject received unspecified dose of BOOSTRIX (unknown). On 1 April 2010, less than one day after vaccination with BOOSTRIX, the subject experienced possible hypersensitivity reaction and lesion nos. On 2 April 2010, one day after vaccination with BOOSTRIX, the subject experienced headache and fever. On the 4 April 2010, the subject felt fine, "went out and seemed to be ok". The subject''s mother found the subject dead the next morning. The subject died on 4 or 5 April 2010 from acute myocarditis. An autopsy was performed. It could not be excluded that the acute myocarditis was due to a hypersensitivity reaction. It was suspected that the lesions were due to hypersensitivity since they were 2-5 days old which was around the time of the vaccination. The cause was not viral since all the cultures came back negative.


VAERS ID: 385886 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-04-23
Entered: 2010-04-26
   Days after submission:3
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: Death, Hydrocephalus
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: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1004USA03316

Write-up: Information has been received from an author of the published literature article. The author retrieved the case from Health Authority. It was reported that a 12 year old female patient was vaccinated with a dose of MMR II (manufacturer, batch number, route and site of administration not reported) on an unspecified date. It was reported that on an unspecified date the patient developed hydrocephalus and died (no further specified). It was reported that the case was received by Health Authority in 2003. Other business partner number include E2010-02531. No further information is available. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 386367 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-04-29
Entered: 2010-04-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Death
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010022712

Write-up: Report received via media on 23-APR-2010. A female patient received flu vaccination (brand unspecified) on an unknown date. The patient''s medical history and concomitant medications were unknown. On an unknown date, 1 week after vaccination with the suspect drug, the patient had convulsions. The patient died in hospital after having huge convulsions. The report states it was not confirmed that the vaccination caused it. The reporter also states the whole thing seems too coincidental. The event outcome was fatal. The reporter considered events possible to the suspect drug. The case was reported as serious due to fatality. The company considered events possible to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown.


VAERS ID: 386368 (history)  
Form: Version 1.0  
Age: 1.26  
Sex: Male  
Location: Foreign  
Vaccinated:2009-04-08
Onset:2009-04-08
   Days after vaccination:0
Submitted: 2010-04-29
   Days after onset:386
Entered: 2010-04-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 090623502 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adenovirus test positive, Autopsy, Cough, Death, Feeling hot, Nasopharyngitis, Pathology test, Respiratory disorder, Skin warm, Toxicologic test normal, X-ray normal
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010022518

Write-up: Report received from a foreign regulator on 23-APR-2010 (case: 258197). A 1 year and 3 month old male patient received FLUVAX (batch 0906-23502) on 08-APR-2009. The patient''s medical history and concomitant medications were unknown. The patient had a cough, fever, runny nose and cold like symptoms. for 2 weeks prior to vaccination. On 08-APR-2009, the day of vaccination, the patient had a slight cough, felt warm and was given infant paracetamol. He was found deceased that evening. Autopsy showed evidence of intercurrent respiratory illness (viral swabs identified adenovirus). However, there was no evidence of pneumonia or pneumonitis to account for the death. At autopsy, the infant was found to be a well nourished, normal formed male child. No cause of death was identified. No anatomical, radiological, toxicological, biochemistry or infective cause was found for the death. There were no injuries or other markings to indicate other than natural causes of death. The case was consistent with sudden unexplained death in childhood. The history of vaccination was noted and the pathologist found no evidence at autopsy that the vaccine contributed to death. It was noted that childhood vaccination have been shown in most studies to reduce the incidence of sudden death in childhood. The reporter considered events possible to the suspect drug, FLUVAX. The case was reported as serious due to death. The company considered events possible to the suspect drug, FLUVAX. Information derived from this AE report does not change the current safety profile of the product. Batch review results were received for 090623502 on 23-APR-2010. On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot was assessed as having no impact on product quality. All QC testing was satisfactory with no out of specification results reported. There are no outstanding issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported. Cause of death is unknown. Death Date: 08-APR-2009.


VAERS ID: 386374 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-04-08
Onset:2010-04-09
   Days after vaccination:1
Submitted: 2010-04-29
   Days after onset:20
Entered: 2010-04-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 090627402 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Histology normal, Laparoscopy normal, Pathology test, Tryptase
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-09
   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: Temporary loss of function in one leg
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010022572

Write-up: Report received from consumer via media on 25-APR-2010. A 2 year old female patient received seasonal flu vaccination (brand unspecified) on 08-APR-2010 at 3pm. The patient''s medical history and concomitant medications were unknown. The child was ''perfectly fine'' prior to vaccination. The patient died on 09-APR-2010, the day after vaccination with the suspect drug. She was found deceased in her cot at approximately 6:30am. A coroner report was pending. The reporter considered events possible to the suspect drug. The reporter ''could not believe the patient''s death was no linked to a flu shot''. The case was reported was serious due to fatal outcome. The reporter considered events possible to the suspect drug. Follow up information received from a physician on 28-APR-2010. The patient was 2 years and 4 months old. Medical history had nothing of note, the patient was a twin (not known if identical). The patient had a previous history of temporary loss of function in one leg on 2 occasions. This was referred to a paediatrician. Nothing was found, if episode was repeated, patient was to have an MRI. Childhood vaccinations received at 18 months. No other vaccination was provided at the time of FLUVAX. The patient had not received PANVAX as far as the reporter was aware. The patient had no concomitant medications. The patient received FLUVAX JUNIOR (batch unknown) 0.25ml at 4pm on 08-APR-2010. The patient''s twin also had the vaccination at the same time. Both were put to bed and both were fine. The other twin started to vomit around midnight (see case: 2010022576). The patient was found deceased next morning by parent on 09-APR-2010. Autopsy results as follows: no cause of death found, no aspiration in lungs, no cardiac defects found, laparoscopy normal, histology normal, large barrage of testing for pathogens - nothing found tryptase normal, urine found in bladder (making seizure unlikely), no brain haemorrhage, still waiting for some results. Follow up information received from physician on 29-APR-2010: The patient received FLUVAX JUNIOR batch number: 090627402. According to the practice records, the patient had not received PANVAX or 2009 seasonal influenza vaccine. Batch review report received on 29-APR-2010 as follows: On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot were assessed as having no impact on product quality, all QC testing was satisfactory with no out of specification results reported, there are no outstanding issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown.


VAERS ID: 386461 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-03-25
Onset:2010-03-28
   Days after vaccination:3
Submitted: 2010-04-30
   Days after onset:33
Entered: 2010-05-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR 1002026 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Drug exposure during pregnancy, Foetal hypokinesia, Intra-uterine death, Microbiology test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: not reported
Allergies:
Diagnostic Lab Data: The necropsy revealed no fetal malformation and intracavitary pleural effusion. Placenta and microbiology testings were ongoing at the time of the report.
CDC Split Type: 201002492

Write-up: Case received via Sanofi pasteur on 23 April 2010 under the reference number BR2010-102. Case linked with case 2010-022480 (mother''s case). A 37-year-old pregnant female women in her 36-37 week of gestation with no reported medical history had received her injection of PANDEMIC INFLUENZA Vaccine batch number 1002026 on 25 March 2010 (number in series, route and anatomical site of vaccination not reported). On 26 March 2010, i.e. 1 day after the vaccination, the patient''s mother experienced general illness, myalgia and prostation. On 27 March 2010, i.e. 2 days after the vaccination, the patient''s mother presented with chest pain. On 28 March 2010, the patient''s mother noticed arrest of fetal movements. The patient''s mother was submitted to a C-section. It was not reported if the fetus was already dead when the procedure was performed or if the fetus died after it. The patient''s mother underwent a fetal ultrasound 15 days before the adverse events and it was normal. The necropsy revealed no fetal malformation and intracavitary pleural effusion. Placenta and microbiology testings were ongoing at the time of the report. According to the reporter the status of this case was under investigation at the time of the report.


VAERS ID: 386475 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-04-30
Entered: 2010-05-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No information reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: E201002611

Write-up: Case of fatal outcome retrieved from the literature on 20-Apr-2010. In a Foreign country, reporting of adverse events following immunisation (AEFI) has been mandatory by law since 1988. The goal of the study was a detailed analysis of reported AEFI received by the Federal Office of Public Health between 1991 and 2001. Overall, 1013 AEFI were reported during the study period. This case is linked with 7 other cases issued from the literature (same article, different vaccines, different reactions): E2010-02609, E2010-02610, E2010-02612, E2010-02613, E2010-02614, E2010-02615 and E2010-02616. Five infant patients aged 2 to 5 months of unspecified sex reportedly experienced sudden infant death syndrome after receiving an injection of DTaP, HIB and Poliomyelitis vaccine (batch number not reported, manufacturer unknown) on unspecified dates. The time interval between vaccination and death varied between 1 and 28 days without any cluster. None of these deaths were assessed to be causally related to immunisation based on data in the literature disproving a causal relationship between sudden unexpected death in infants and immunisation. No further information expected.


VAERS ID: 386479 (history)  
Form: Version 1.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-04-30
Entered: 2010-05-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Underlying disease: Cholestatic hepatitis with hepatic necrosis.
Allergies:
Diagnostic Lab Data:
CDC Split Type: E201002612

Write-up: Case retrieved from a literature article on 20-Apr-2010. In one particular foreign country, reporting of adverse events following immunisation (AEFI) has been mandatory by law since 1988. The goal of the study was a detailed analysis of reporting AEFI received by a foreign Federal Office of Public Health between 1991 and 2001. Overall, 1013 AEFI were reported during the study period. This case is linked with 13 other cases issued from the literature (same article, different vaccines, different reactions): E2010-02609, E2010-02610, E2010-02611, E2010-02613, E2010-02614, E2010-02615, E2010-02616, E2010-02842, E2010-02843, E2010-02844, E2010-02845, E2010-02846 and E2010-02847. A 54-year-old male patient died 7 days after receiving an injection of Yellow Fever vaccine (batch number not reported, manufacturer not reported) on an unspecified date. Cholestatic hepatitis with hepatic necrosis was reported as underlying disease. The patient''s death was assessed as possibly related to immunisation as it occurred in a plausible time interval after immunisation. A similar reaction occurred after Yellow Fever vaccination (case E2010-02613). No further information expected.


VAERS ID: 386482 (history)  
Form: Version 1.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-04-30
Entered: 2010-05-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Underlying disease: drug-related hepatitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: E201002613

Write-up: Case retrieved from a literature on 20-Apr-2010. In a foreign country, reporting of adverse events following immunisation has been mandatory by law since 1988. The goal of the study was a detailed analysis of reported AEFI received by a Foreign Federal Office of Public Health between 1991 and 2001. Overall, 1013 AEFI were reported during the study period. This case is linked with 13 other cases issued from the literature (same article, different vaccines, different reactions): E2010-02609, E2010-02610, E2010-02611, E2010-02612, E2010-02614, E2010-02615, E2010-02616, E2010-02842, E2010-02843, E2010-02844, E2010-02845, E2010-02846 and E2010-02847. A 54-year-old patient died 21 days after receiving an injection of Yellow Fever vaccine (batch number not reported, manufacturer not reported) on an unspecified date. Drug-related hepatitis was reported as underlying disease. The patient''s death was assessed as possibly related to immunisation as it occurred in a plausible time interval after immunisation. A similar reaction occurred after Yellow Fever vaccination (case E2010-02612). no further information expected.


VAERS ID: 386483 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-04-30
Entered: 2010-05-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: underlying chronic diseases
Allergies:
Diagnostic Lab Data:
CDC Split Type: E201002615

Write-up: Case of fatal outcome retrieved from the literature on 20-Apr-2010. Reporting of adverse events following immunisation (AEFI) has been mandatory by law since 1988. The goal of the study was a detailed analysis of reported AEFI received by an office of public health between 1991 and 2001. Overall, 1013 AEFI were reported during the study period. This case is linked with 13 other cases issued from the literature (same article, different vaccines, different reactions): E2010-02609, E2010-02610, E2010-02611, E2010-02612, E2010-02613, E2010-02614, E2010-02616, E2010-02842, E2010-02843, E2010-02844, E2010-02845, E2010-02846 and E2010-02847. A 75-year-old male patient with underlying chronic diseases died 5 hours to 6 days after receiving an injection with influenza vaccine (batch number, manufacturer unknown) on an unspecified date. The death was assessed to be unrelated to immunisation because of other plausible causes of death: pneumonia with consecutive multiorgan failure. Two similar reactions occurred after influenza vaccination (cases E2010-02614 and E2010-02616). No further information is expected.


VAERS ID: 386484 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-04-30
Entered: 2010-05-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: unspecified several underlying chronic diseases
Allergies:
Diagnostic Lab Data:
CDC Split Type: E201002616

Write-up: Case of fatal outcome retrieved from a literature article on 20-Apr-2010. In one particular foreign country, reporting of adverse events following immunisation (AEFI) has been mandatory by law since 1988. The goal of the study was a detailed analysis of reporting AEFI received by a foreign Federal Office of Public Health between 1991 and 2001. Overall, 1013 AEFI were reported during the study period. This case is linked with 13 other cases issued from the literature (same article, different vaccines, different reactions): E2010-02609, E2010-02610, E2010-02611, E2010-02612, E2010-02613, E2010-02614, E2010-02615, E2010-02842, E2010-02843, E2010-02844, E2010-02845, E2010-02846 and E2010-02847. A 72-year-old female patient with unspecified several underlying chronic diseases was found dead 5 hours after receiving an injection of influenza vaccine (batch number, manufacturer unknown) on an unspecified date. The death was assessed to be unrelated to immunisation because of other plausible causes for death: several underlying chronic diseases. Two similar reactions occurred after influenza vaccination (cases E2010-02614 and E2010-02615). No further information expected.


VAERS ID: 386498 (history)  
Form: Version 1.0  
Age: 1.45  
Sex: Male  
Location: Foreign  
Vaccinated:2010-03-22
Onset:2010-03-23
   Days after vaccination:1
Submitted: 2010-04-30
   Days after onset:38
Entered: 2010-05-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-23
   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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201002505

Write-up: Case received from the Institute through the sanofi pasteur on 23 April 2010 under the local reference number BR2010-093. An 18-month-old male patient, with an unknown medical history, had received his primary dose of Influenza A/H1N1 vaccine (manufactured by sanofi pasteur, batch number, route and anatomical site of administration unknown) on 22 March 2010. The patient''s concomitant therapies were unknown. On 23 March 2010, i.e. the following day post-vaccination, the patient experienced unexpected sudden death. It was not known whether the patient was hospitalized or not. The case was still under investigation at the time of the report. List of documents held by sender: none.


VAERS ID: 386513 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-17
Onset:2010-03-20
   Days after vaccination:3
Submitted: 2010-04-30
   Days after onset:41
Entered: 2010-05-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR 1002024 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-20
   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:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201002485

Write-up: Case received from Institute via the Sanofi Pasteur on 23 April under the reference number BR2010-084. A 2-year-old female patient with no reported medical history had received her injection of PANDEMIC INFLUENZA VACCINE vaccine batch number 1002024 on 17 March 2010 (number in series, route and anatomical site of vaccination not reported). On 20 March 2010, i.e. 3 days after the vaccination, the patient experienced unexpected sudden death. According to the reporter the status of this case was under investigation at the time of the report. List of documents held by sender: none.


VAERS ID: 386625 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-04-23
Onset:2010-04-23
   Days after vaccination:0
Submitted: 2010-05-03
   Days after onset:10
Entered: 2010-05-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Malaise, Sepsis, Sudden death, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-04-23
   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:
Current Illness:
Preexisting Conditions: personal medical history of sickle cell anemia, unknown family medical history and previous history of adverse reaction to a vaccine or a drug.
Allergies:
Diagnostic Lab Data: Autopsy pointed the cause of death to be from serious sepsis
CDC Split Type: 201002538

Write-up: Case received from the a media announcement in a foreign country through the VIS of Sanofi Pasteur on 28 April 2010 under the local reference number BR2010-098. A 20-year-old female patient, with a personal medical history of sickle cell anemia, had received her dose of Influenza A/H1N1 vaccine (manufacturer, batch number, route and anatomical site of administration unknown) on 23 April 2010. The patient''s concomitant therapies were unknown. She also had an unknown family medical history and previous history of adverse reaction to a vaccine or a drug. On 23 April 2010, in the hours post-vaccination, the patient experienced "general illness" and intense vomiting. There was no local reaction. The patient needed medical care and was hospitalized. On 23 April 2010, she had sudden death. The patient was discharged on "28" April 2010. "Autopsy pointed the cause of death to be from serious sepsis". In the announcement, the Director of the health authority stated that the patient''s death was not related to the vaccine.


VAERS ID: 386626 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-05-03
Entered: 2010-05-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Underlying chronic disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: E201002614

Write-up: Case of fatal outcome retrieved from the literature on 20-Apr-2010. Reporting of adverse events following immunisation (AEFI) has been mandatory by law since 1988. The goal of the study was a detailed analysis of reported AEFI received by Office of Public Health between 1991 an 2001. Overall, 1013 AEFI were reported during the study period. This case is linked with 13 other cases issued from the literature (same article, different vaccines, different reactions): E2010-02609, E2010-02610, E2010-02611, E2010-02612, E2010-02613, E2010-02615, E2010-02616, E2010-02842, E2010-02843, E2010-02844, E2010-02845, E2010-02846 and E2010-02847. An elderly patient aged over 70 and of unspecified sex with underlying chronic diseases experienced a fatal myocardial infarction after receiving an injection of influenza vaccine (batch number, manufacturer unknown) on an unspecified date. The time to onset was between 5 hours and 6 days. The death was assessed to be possibly related to immunisation. Two similar reactions occurred after influenza vaccination (cases E2010-02615 and E2010-02616). No further information expected.


VAERS ID: 386723 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2010-03-10
Onset:2010-03-12
   Days after vaccination:2
Submitted: 2010-05-05
   Days after onset:53
Entered: 2010-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IJ
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Cardiac arrest, Sudden infant death syndrome
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), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-03-12
   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: B0650884A

Write-up: This case was reported by a regulatory authority (# 101854) and described the occurrence of cardiac arrest in a 3-month-old male subject who was vaccinated with INFANRIX-IPV/HIB (GlaxoSmithKline), PREVENAR (non-gsk). On check-up at the Children''s clinic on 10 March 2010, the subject had a normal status. On 10 March 2010, the subject received unspecified dose of INFANRIX-IPV/HIB (route and injection site unknown, batch number not provided) and unspecified dose of PREVENAR (route and injection site unknown). On 12 March 2010, 2 days after vaccination with INFANRIX-IPV/HIB and PREVENAR, the subject woke up at 1 am and was breastfed as usual. The subject came to the children''s emergency room with cardiac arrest at 7 am. A sudden infant death syndrome was suspected. The regulatory authority reported that the event was unrelated to vaccination with INFANRIX-IPV/HIB and PREVENAR (dead due to other reason then drug). The subject died on 12 March 2010 from unknown cause of death. An autopsy was performed.


VAERS ID: 387029 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-04-28
Onset:2010-04-28
   Days after vaccination:0
Submitted: 2010-05-07
   Days after onset:9
Entered: 2010-05-10
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Cardiac failure, Cardio-respiratory arrest, Condition aggravated, Death, Resuscitation, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (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), Cardiomyopathy (broad), Respiratory failure (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ANTICOAGULANTS; ANTIHYPERTENSIVE DRUGS; CARDIOTONIC
Current Illness: Unknown
Preexisting Conditions: Cardiac failure; Device failure; Arrhythmia; Oedema peripheral; Acute pulmonary oedema; Pneumonia; Tachycardia
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2010AR28991

Write-up: Initial report received from a consumer on 05 May 2010: This polymedicated patient had medical history of heart failure, pump failure, arrhythmia and lower-limb swelling. The patient had been hospitalized for three times in past due to acute pulmonary oedema. Pneumonia and tachycardia prolonged the hospitalization in intensive care unit. The patient was vaccinated with seasonal influenza vaccines (manufacturer and batch number unknown) on 28 April 2010. Less than one hour after vaccination, the patient died. The physician stated that, cause of death was cardio-respiratory arrest due to severe heart failure. The physician informed that resuscitation maneuvers were performed unsuccessfully.


VAERS ID: 387174 (history)  
Form: Version 1.0  
Age: 0.27  
Sex: Female  
Location: Foreign  
Vaccinated:2010-04-20
Onset:0000-00-00
Submitted: 2010-05-10
Entered: 2010-05-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D22766 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood creatinine increased, Blood glucose decreased, Blood potassium increased, Blood urea increased, Body temperature increased, C-reactive protein increased, Cyanosis, Death, Dehydration, Dyspnoea, Endotracheal intubation, Fluid intake reduced, Haemoglobin decreased, Hypoxia, Loss of consciousness, Multi-organ failure, Platelet count decreased, Pyrexia, Renal failure acute, Shock, Urine output decreased, Vomiting, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), 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), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (narrow), Infective pneumonia (broad), Dehydration (narrow), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: The patient was delivered via caesarean section (patient was at term). Past therapies included DPT (one dose), HIB (one dose), HEP B (two doses), IPOL (two doses) and BCG (one dose). Date of vaccinations were not provided.
Allergies:
Diagnostic Lab Data: On 28-Apr-2010 test results were: haemoglobin (results: 9.5); white blood cell count (results: 20,190); platelet count (results: 78,000); blood creatinine (results: 1); body temperature (results: 38.8 deg. C.); blood glucose (results: at 10:50 am (41 mg%) at 3:45 pm (< 10 mg%)); blood potassium (results: 8.4); c-reactive protein (results: 4); and blood urea (results: 37).
CDC Split Type: IDWYEH14931210

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 3-month-old female patient who experienced two episodes of vomiting, decreased fluid intake, multi-organ failure, shock, unconsciousness, fever, hypoxia, severe dehydration, difficulty of breathing and cyanosis. The patient received the first dose on 20-Apr-2010. On 20-Apr-2010, the patient received the first dose of PREVENAR. On 21-Apr-2010, the parents stated that the child''s total milk intake was decreased and up to few days before admission to the hospital she consumed approximately 400 cc/day. There was no fever, diarrhea or seizure. The baby did not urinate starting the day before she came to the hospital. The patient vomited two times before being admitted to the hospital. According to the physician there were no specific symptoms during the period from vaccination until she was admitted to the hospital. On 28-Apr-2010, the patient was brought to the ER with difficulty breathing, severe dehydration, shock, cyanosis and was unconscious. The physician attempted to start an infusion without success due to a collapsed vein and dehydration. At 9:20 am, the same day, the physician gave an intra osseous infusion of approximately 245 cc. At 9:33 am, the patient was intubated and at 9:45 am, the patient was rehydrated with Lactated Ringer''s solution. At 10:50 am the Lactated Ringer''s solution was changed to Dextrose 10%. Dexamethasone and Meronem therapies were initiated at 2:45 pm. At 6:00 pm, the patient''s body temperature was measured at 38.8 deg C. Due to the lab results, the patient''s care was referred to a nephrologist who provided a working diagnosis of acute renal failure. At 7:50 pm the patient died. Final diagnosis was multi-organ failure due to hypoxia and dehydration. The cause of death was reported as dehydration, multi-organ failure and hypoxia.


VAERS ID: 387357 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2001-06-11
Onset:2001-06-11
   Days after vaccination:0
Submitted: 2010-05-12
   Days after onset:3257
Entered: 2010-05-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MER: MEASLES + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Apnoea, Aspartate aminotransferase increased, Aspiration bronchial, Autopsy, Blood alkaline phosphatase increased, Body temperature increased, Cardio-respiratory arrest, Chest X-ray abnormal, Chills, Cyanosis, Disseminated tuberculosis, Dyspnoea, Gamma-glutamyltransferase increased, Haemoptysis, Headache, Hepatic enzyme increased, Leukopenia, Loss of consciousness, Lung disorder, Lung infiltration, Lymphadenopathy, Myalgia, Mycobacterium test negative, Nausea, Pathology test, Polymerase chain reaction, Pyrexia, White blood cell count decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), 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), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: chest X-ray, 18Jun01, pulmonary infiltration: mild reticular densities in both lung fields; chest X-ray,25Jun01, Postmortem: Increased reticular densities in both lower lung fields. Small nodular; WBC count, 16Jun01, 1300 /microliter; body temp, 16Jun01, 39.1 Celsius; serum alanine aminotransferase, 18Jun01, 317 IU/L; serum alkaline phosphatase, 18Jun01, 364, IU/L; serum aspartate aminotransferase, 18Jun01, 295 IU/L; serum gamma glutamyl transferase, 18Jun01, 156 IU/L; serum alanine aminotransferase, 21Jun01, 151 IU/L; serum aspartate aminotransferase, 21Jun01, 157 IU/L
CDC Split Type: WAES1005KOR00024

Write-up: Information has been received in a published article, regarding a fatal case of disseminated tuberculosis in a 14 year old female who on 11-JUN-2001 was vaccinated with measles-rubella vaccine (manufacturer unknown). On 11-JUN-2001 the patient developed a mild fever, a chilling sensation, and generalized myalgia from 9:00 pm. The next day, she developed a high fever of up to 39 Celsius so she visited a public health center and a clinic. Even after she took some cold medicine including antipyretics, her fever persisted. She also had a headache and nausea. On 16-JUN-2001, she was admitted to a hospital, and received antibiotic medication including penicillin and tetracycline derivatives. On the day of admission she developed a cough with blood-tinged sputum, and laboratory test showed leukopenia (WBC count of 1300/microliter). On 18-JUN-2001, chest X-ray showed pulmonary infiltration, and laboratory test showed elevated liver enzyme levels. On 21-JUN-2001, she began slightly dyspneic and febrile, the headache, chill and cough persisted, but chest X-ray findings were unchanged. Sputum smear for acid-fast bacilli was negative with many Gram positive bacteria. On 23-JUN-2001, because of her parent''s strong insist on discharge, she was discharged against recommendation. Medications including oral antibiotics(not antituberculosis medication) were prescribed. On 25-JUN-2001, she was brought to the emergency department of a general hospital due to cardio-respiratory arrest. On arrival, she was unconscious, totally apneic, and generally cyanotic without any vital signs. On chest X-ray, both lungs were totally hazy. On the following day, an autopsy was performed at the request of governmental health authorities. The pathologic findings were compatible with tuberculosis infection. PCR for acid-fast bacillus was positive for postmortem bronchial aspirate, lung, liver, brain, and peribronchial lymph nodes. It was reported that it was reasonable to presume that measles-rubella vaccination was done during the active stage of tuberculosis infection, considering the incubation period of tuberculosis. However, the possibility that coincident vaccination during the tuberculosis incubation period might have accelerated the clinical course was also suggested by the protracted nature of the clinical course. The authors could not identify any possible cause of the tuberculosis aggravation in this case, with the exception of measles-rubella vaccination. Additional information is not expected.


VAERS ID: 387594 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-01-22
Onset:2010-04-28
   Days after vaccination:96
Submitted: 2010-05-14
   Days after onset:16
Entered: 2010-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-29
   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: WAES1005USA01063

Write-up: Information has been received from a physician via the Program for Appropriate Technology concerning an 11 year old patient who on 21-JUL-2009 and 09-OCT-2009 was vaccinated with a first and second dose of GARDASIL respectively (routes, site of injection and lot numbers not reported). On 22-JAN-2010, the patient received her third dose of GARDASIL respectively (route, site of injection and lot number not reported). Subsequently, the patient died on 29-APR-2010, 96 days after the patient received her third dose. Additional information has been expected.


VAERS ID: 387645 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-01-26
Onset:0000-00-00
Submitted: 2010-05-17
Entered: 2010-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC37B040AB / 1 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Echocardiogram abnormal, Extracorporeal membrane oxygenation, General physical health deterioration, Injection site swelling, Multi-organ failure, No reaction on previous exposure to drug, Pulmonary embolism, Resuscitation, Tricuspid valve incompetence, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-01-31
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: Cardiac septal defect; Extrasystole
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0067562A

Write-up: This case was reported by a foreign regulatory authority (DE-PEI-PEI2010012345) and described the occurrence of ventricular fibrillation and death due to multiorgan failure in an 18-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included cardiac septal defect and extrasystole. Previous vaccinations not further specified vaccines have been well tolerated. On 26 January 2010 the subject received the first dose of BOOSTRIX (0.5 ml, intramuscular, unknown deltoid). Less than one week post vaccination with BOOSTRIX, on an unknown date in January 2010, the subject experienced mild transient injection site swelling without fever or general postvaccinal reaction. On an unknown date in January 2010 the event was resolved. Approximately four days post vaccination with BOOSTRIX, on 30 January 2010, the subject was hospitalised. The subject died post resuscitation. The cause of death was not reported. An autopsy was not performed. The foreign regulatory authority has received information concerning hospitalisation and death from a regional pharmacovigilance center. The batch number reported by the foreign regulatory authority has been corrected according original information to AC37B040AB. Follow-up information was received on 12 May 2010 from the foreign regulatory authority. The foreign regulatory authority has received this information from a regional pharmacovigilance center. Approximately four days post vaccination with BOOSTRIX, on 30 January 2010, after having eaten, the subject was found lifeless at home. No resuscitation by a lay person has been performed. An emergency service was called. When medical emergency service arrived the subject was diagnosed with ventricular fibrillation and resuscitation was started. After 90 minutes of resuscitation the subject arrived at a hospital. The subject still showed instable circulatory function and resuscitation was continued. Echocardiogram showed dilated right heart, tricuspid regurgitation and possible floated structure in pulmonary circulation. Pulmonary embolism was suspected and treatment included lysis therapy and extra corporeal membrane oxygenation (ECMO) implantation. Nevertheless the subject experienced further reduction of general condition in died on 31 January 2010 early in the morning from fulminant multiorgan failure. External post mortem examination was performed in the presence of two detectives from a Criminal Investigation Department (CID). No signs of external force have been detected. An autopsy was not performed. The subject was buried on 08 February 2010. Both the emergency physician(s) and the hospital physician(s) considered that the cause of death was unknown. A causal relationship of the events and death to previous vaccination with BOOSTRIX was considered to be rather unlikely due to sudden onset of the events but could not be excluded with certainty. No further information will be available.


VAERS ID: 387747 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-25
Onset:2010-03-25
   Days after vaccination:0
Submitted: 2010-05-18
   Days after onset:54
Entered: 2010-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Blood culture negative, CSF culture positive, Death, Fontanelle bulging, Gram stain positive, Pneumonia pneumococcal, Pyrexia, Streptococcus test positive, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood culture, 2010, Negative; CSF culture, 2010, see text
CDC Split Type: B0652265A

Write-up: This case was reported by a physician and described the occurrence of cause unknown, death in a 3-year-old female subject who was vaccinated with meningococcal polysaccharide vaccine group C (manufacturer unspecified), DTP-HIB (A or W not known), poliomyelitis vaccine unspecified and rotavirus vaccine. On 25 March 2010, the subject received unspecified dose of Meningococcal polysaccharide vaccine group C (unknown route of administration, lot number not provided), unspecified dose of DTP-HIB (A or W not known) (unknown route of administration, lot number not provided), unspecified dose of Poliomyelitis vaccine (unknown route of administration, lot number not provided), unspecified dose of Rotavirus vaccine (unknown route of administration, lot number not provided). The physician informed that the subject was not healthy at the time of vaccination, but she couldn''t provide details about the subject''s clinical condition. On 25 March 2010, 10 hours after vaccination with DTP-HIB (A or W not known), Meningococcal polysaccharide vaccine group C, Poliomyelitis vaccine and Rotavirus vaccine, the subject experienced fever (not specified), vomiting and bulging fontanel. The subject was hospitalised and evolved to death. Purulent CSF; CSF culture: streptococcus pneumoniae positive; Blood culture: negative; Blood gram: diplococcus gram positive. The subject died, cause of death is not specified. It was unknown whether an autopsy was performed. The physician couldn''t state if the event was related to the vaccines, because the case was still under investigation.


VAERS ID: 388083 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-05-11
Onset:2010-05-11
   Days after vaccination:0
Submitted: 2010-05-18
   Days after onset:7
Entered: 2010-05-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 27402 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Road traffic accident
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010023142

Write-up: Report received on 13-May-2010. A male patient received single dose of FLUVAX (Batch no. 27402) on 11-May-2010 at an unknown time. Medical history and concomitant medications are unknown. On 11-May-2010, the same day as receiving FLUVAX vaccination, the patient was observed in the clinic for 15 minutes. He did not show any allergic symptoms post vaccination and was well when he left the clinic. Subsequently, the patient was involved in a motor car accident on his way home. The single vehicle accident resulted in death. The reporter considered the event possibly related to the suspect drug, FLUVAX. This case was reported as serious due to death. The company considered the event possibly related to the suspect drug, FLUVAX. Information derived from this AE report does not change the current safety profile of the product. Batch review results were received for 090627402 on 29-Apr-2010. On completion of this investigation, it has been determined that, all deviations related to the manufacturer of this lot were assessed as having no impact on product quality. All QC testing was satisfactory with no out of specification results reported. There are no outstanding issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event report. Cause (s) of death: Motor vehicle accident Death date: 11-May-2010


VAERS ID: 388808 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-12-01
Onset:0000-00-00
Submitted: 2010-05-20
Entered: 2010-05-21
   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, Dyspnoea, Laboratory test abnormal, Mycoplasma test, Pleural effusion, Pneumonia, Pyrexia, X-ray abnormal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-13
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: Pneumonia aspiration
Allergies:
Diagnostic Lab Data: X-ray, 09?, shadow
CDC Split Type: WAES1005USA02367

Write-up: Information has been received from a pharmacist concerning an 89 year old female with a history of pneumonia aspiration requiring repetitive hospitalization who in December 2009, was vaccinated with a dose of PNEUMOVAX 23 (dose, inoculation date, route, indication and lot number not reported). No information on concomitant therapy was provided. On the 10th day from the vaccination, the patient had a fever. The patient complained of breathing difficulty. The patient was admitted to the hospital due to pneumonia. An X-ray examination found shadow, and the tests revealed mycoplasma (-), capsular antigen (+) and pleural effusion. On 13-FEB-2010, the patient died. The reporting pharmacist considered that pneumonia was serious due to death and hospitalization. The reporting pharmacist did not assess the relationship of pneumonia to PNEUMOVAX 23. Additional information has been requested. The reporting pharmacist''s comment: the patient''s family suspected that this event occurred due to PNEUMOVAX 23 because the event occurred 10 days after the vaccination.


VAERS ID: 389474 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-05-26
Entered: 2010-05-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Inappropriate schedule 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:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1005USA03004

Write-up: A news reporter stated that shortly after the vaccine was introduced in a foreign country in 1988, a 6 month old patient was vaccinated with a dose of MMR II (manufacturer unknown) and died aged six months, 10 days after receiving the vaccine. Subsequently, it was reported that before then, the patient did not need medical treatment. It was reported that the officials advised that the baby''s death was probably not vaccine related. Full evidence was reviewed and it was judged that there was no link. Additional information is not expected.


VAERS ID: 389500 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-03-11
Onset:2010-03-23
   Days after vaccination:12
Submitted: 2010-05-27
   Days after onset:65
Entered: 2010-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB847BA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Death, Encephalomyelitis, Grand mal convulsion, Headache, Pyrexia, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Demyelination (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-16
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0653786A

Write-up: This case was reported by a regulatory authority and described the occurrence of encephalomyelitis in a 14-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 11 March 2010, the subject received an unspecified dose of ENGERIX B (administration site and route unknown, batch number not provided). On 23 March 2010, 12 days after vaccination with ENGERIX B, the subject experienced epilepsy which was grand mal during 1 minute, headache and fever. At an unspecified time after vaccination with ENGERIX B, the subject experienced encephalomyelitis. The subject was treated with antibiotic. When the treatment was stopped, fever started again and new type of antibiotic was given. The subject died on 16 April 2010 from heart stopping and stopped breathing. It was unknown whether an autopsy was performed.


VAERS ID: 389806 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-06-01
Entered: 2010-06-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Completed suicide, Death
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1005USA04360

Write-up: Information has been received from a health professional, via the Program for Appropriate Technology (PATH), concerning a female patient who on an unspecified date, was vaccinated with the third dose of GARDASIL. Subsequently, on an unspecified date, the patient committed suicide. The cause of death was suicide. At this time, relationship of suicide death to GARDASIL is unknown. Additional information has been requested.


VAERS ID: 389914 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-12-15
Onset:2009-12-16
   Days after vaccination:1
Submitted: 2010-06-02
   Days after onset:167
Entered: 2010-06-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 73H / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER B5952 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Body temperature normal, Central nervous system necrosis, Cyanosis, Death, Grand mal convulsion, Hypoxic encephalopathy, Lethargy, Pyrexia, Somnolence
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: 2010-02-25
   Days after onset: 71
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had no outpatient or medical history, no allergies.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201002937

Write-up: Case received from the Health Authorities on 25 May 2010 under a non-reported reference number. A 5-year-old male patient with no outpatient or medical history, no allergies, had received his intramuscular injection of IMOVAX POLIO vaccine batch number B5952 on 15 December 2009 and his intramuscular injection of DPT vaccine from another manufacturer batch number 73-H (numbers in series and anatomical site of vaccinations not reported). 30 minutes after the vaccination the patient''s temperature was normal and the patient was sent back home. On 16 December 2009 at 6am the patient''s temperature was of 37.5 degrees C. On 16 December 2009, i.e. one day after vaccination, the patient experienced "tonic/clonic"seizures defined as "sporadic convulsions" by the patient''s mother, fever, drowsiness and lethargy. The seizures were associated with apnea and cyanosis. The patient was hospitalized. He received corrective treatment with IM RELANIUM. The patient also suffered from post-hypoxic encephalopathy and post-vaccination total necrosis of brain on unspecified dates. On 19 February 2010 the patient was sent to the neurological department. The patient died on 25 February 2010 at 10 am. List of documents held by sender: Health Authorities cover letter.


VAERS ID: 389991 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-27
Onset:2010-04-27
   Days after vaccination:0
Submitted: 2010-06-03
   Days after onset:37
Entered: 2010-06-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A211CA672B / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E02919 / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0485Y / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Death, Heart rate decreased, Inappropriate schedule of drug administration, Oxygen saturation decreased, Respiratory disorder, Resuscitation, Skin discolouration, Sudden infant death syndrome
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Medication errors (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac monitoring
Preexisting Conditions: Premature birth
Allergies:
Diagnostic Lab Data: arterial blood O2 saturation, 27Apr10, 94%; total heartbeat count, 27Apr10, $g100bpm
CDC Split Type: WAES1005USA04643

Write-up: Information has been received from a physician via CSL as a part of a business agreement concerning a 9 week old male patient who at 09:30 on 27-APR-2010 was vaccinated with the first dose of ROTATEQ (lot# 664294/0485Y). Concomitant therapy included PREVENAR (lot# E02919) and INFANRIX HEXA (lot# A211CA672B). At approximately 21:15 on the same day, the patient experienced apnoea episode, the baby went dusky, had reduced O2 saturations and decreased heart rate occurred. First check of heart rate was more than 100bpm. Spontaneous respiration recurred. Saturation of O2 was 94%. Extension of left arm was observed. The patient was observed and monitored in isolette overnight. The patient had eye reviews while in hospital. The patient was observed in SCN for 48 hours post event. Then the patient was discharged home the next day. The patient had an apnoeic episode at home 3 days after hospitalization (total 5 days after vaccination) and was not able to be resuscitated. The patient had SIDS death at home. A lot check has been initiated. Additional information has been requested.


VAERS ID: 389998 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-05-12
Onset:0000-00-00
Submitted: 2010-06-02
Entered: 2010-06-04
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Cardio-respiratory arrest, Convulsion, Death, Neurological examination normal, Pyrexia, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), 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), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Febrile seizure~Influenza (Seasonal) (no brand name)~0~18.00~Patient
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: simple febrile seizure at 18 months of age
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2010AR35307

Write-up: Initial information received from ministry of health on 31 May 2010: This child had medical history of simple febrile seizure at 18 months of age after being vaccinated with the corresponding vaccines of childhood immunizations calendar and together with seasonal influenza vaccine. Results of neurological study were normal. The patient was vaccinated with influenza monovalent vaccine (manufacturer and batch number unknown) on 12 May 2010 (at the age of 2.5 year). On the same day after vaccination, the patient experienced febrile episode (registry of temperature was not informed) which was treated with antipyretic. In night, the patient experienced convulsive episode which lasted two hours approximately. This child experienced cardio-respiratory arrest which lasted 15 minutes (exact date not specified). The patient was transferred to other town in order to receive a better assistance. During the transfer, the child experienced cardio-respiratory arrest which lasted for 15 minutes. When arriving to that town, the child was already with encephalic death. Notwithstanding, the child was taken to other city where encephalic death and child death were confirmed. The reported commented that this case was assessed as related to the vaccine in spite of the fact that the vaccine was not directly the cause of death.


VAERS ID: 390076 (history)  
Form: Version 1.0  
Age: 1.3  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-06-04
Entered: 2010-06-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER VNS1H02B / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0392Y / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1006USA00473

Write-up: Information has been received from a physician-epidemiologist on 01-JUN-2010 under the reference number RIVM20100619. A 16-month-old female patient had received a dose of MMR II (LOT # 664460/0392Y, batch # NL03720) and NEISVAC-C (manufacturer Baxter, lot VNS1H02B) on an unknown date. Eleven days after the vaccination, the patient passed away. No information on medical history reported. Precise circumstances not known at the time of reporting (case reported to health agency on 28-MAY-2010 afternoon). Health agency will investigate upon this case as usual. A lot check has been initiated. Other business partner numbers included: E2010-03420. No further information is available.


VAERS ID: 390097 (history)  
Form: Version 1.0  
Age: 1.4  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:1995-06-01
Submitted: 2010-06-04
   Days after onset:5482
Entered: 2010-06-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Immunodeficiency, Paralysis, Poliomyelitis post vaccine, Viral test positive
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history of undefined hypogammaglobulinemia
Allergies:
Diagnostic Lab Data: VDPV TYPE 2 collected in fecal specimens 3-6 days after onset of paralysis
CDC Split Type: 201003108

Write-up: Case report from literature in a foreign country received on 22 May 2010. This case is linked with case reports in the same article: 2010-03109, 2010-03110, 2010-03111, 2010-03112, 2010-03113. These 6 cases described vaccine associated paralytic poliomyelitis in immunodeficient patient (iVAPP) caused by vaccine derived polioviruses (iVDPV). Case report n 1: A 17-month-old female patient with a medical history of antibody deficiency had received IPV, manufacturer, batch number, route and administration site unknown, on an unspecified date and presented with vaccine associated paralytic poliomyelitis in immunodeficient patient (iVAPP) caused by vaccine derived polioviruses (iVDPV). She was a household contact of a healthy OPV-vaccinated sibling. Limited data indicated that paralysis became evident in June 1995. All 3 fecal specimens collected 3-6 days after onset of paralysis yielded vaccine-derived polioviruses (VDPV) type 2. Recombination with the Sabin 1 strain was detected, with a crossover site at nt 5355 (3A). The girl died 8 days after onset of paralysis with obscured etiology. List of Documents held by Sender: none.


VAERS ID: 390134 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-06-07
Entered: 2010-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Brain oedema, Death, Encephalitis
SMQs:, Noninfectious encephalitis (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: B0658324A

Write-up: This case was reported in a literature article and described the occurrence of cerebral edema in a 1-year-old child who was vaccinated with HIB (manufacturer unspecified), MMR (strain not specified), MMR II, strain not specified and MENINGITIS C. On an unspecified date the subject received unspecified dose of HIB (unknown), unspecified dose of MMR (unknown), unspecified dose of MENINGITIS C (unknown). Ten days after vaccination with HIB, MMR and MENINGITIS C vaccinations, the subject onset the illness. Twelve days after vaccination the subject died. The cause of death was reported to be cerebral edema due to encephalitis. The author considered the events were unlikely to be related to vaccination with HIB, MMR and MENINGITIS C vaccination.


VAERS ID: 390302 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2009-11-28
Onset:2009-12-06
   Days after vaccination:8
Submitted: 2010-06-09
   Days after onset:184
Entered: 2010-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Aortic arteriosclerosis, Asthenia, Autopsy, Bilevel positive airway pressure, Cardio-respiratory arrest, Cardiomegaly, Computerised tomogram normal, Coronary artery disease, Coronary artery occlusion, Death, Demyelinating polyneuropathy, Depressed level of consciousness, Feeling cold, Guillain-Barre syndrome, Immunoglobulin therapy, Infarction, Laboratory test normal, Left ventricular failure, Left ventricular hypertrophy, Nervous system disorder, Pulmonary congestion, Pulmonary oedema, Respiratory acidosis, Respiratory arrest, Respiratory failure, Swelling
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Demyelination (narrow), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Glaucoma; Hypertension; Osteoporosis; Pneumonia; Respiratory problem
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: All kinds of tests (unspecified) came back negative. CT scan head and neck showed no apparent cord compression.
CDC Split Type: A0860663A

Write-up: This case was reported by a consumer (subject''s daughter) and confirmed by a physician and described the occurrence of "couldn''t breathe and was very cold" in a 87-year-old female subject who was vaccinated with AREPANRIX H1N1 (GlaxoSmithKline). Concurrent medical conditions included glaucoma, hypertension and osteoporosis. Initially the case was reported by the consumer. On 28 November 2009 the subject received unspecified dose of AREPANRIX H1N1 (unknown). On 6 December 2009, eight days after vaccination with AREPANRIX H1N1, the subject could not breathe, and was very cold. Her granddaughter called the ambulance and the patient was taken to the hospital at 1000 hours. All kinds of test (not specified) were done and "all came back negative". The patient died at the hospital on 7 December 2009. The subject was independent and perfectly healthy prior to this. An autopsy was performed and the clinical summary in the autopsy report stated that on 6 December 2009, the subject presented with weakness and decreased level of consciousness and was hospitalized. In the hospital, the subject was found to have respiratory acidosis and was kept on bipap. CT scan of the head and neck showed no apparent cord compression. As per the physician, the clinical picture was most consistent with respiratory failure developing from possible GUILLAIN BARRE SYNDROME following vaccination with AREPANRIX H1N1. The subject was treated with intravenous immunoglobulin. The subject was not intubated as per family request; the subject died on 7 December 2009 at 1915 hours. An autopsy, limited to examination of the lungs, heart and central nervous system, was performed on 08 December 2009; however microscopic examination of the brain, spinal cord and portions of skeletal muscle, sural nerve and peroneal nerve were referred to a neuropathologist for expert opinion. The final autopsy diagnosis reported acute demyelinating polyneuropathy, moderate-to-severe coronary artery disease, with 70-75% luminal occlusion of the right coronary and left circumflex arteries and 80% luminal occlusion of the left anterior descending artery, cardiomegaly and left ventricular hypertrophy, pulmonary edema and congestion, with no evidence of pneumonia and moderate atherosclerosis of the proximal aorta. In the summary of autopsy findings, the pathologist reported the most likely cause of death to be cardiopulmonary arrest due to moderate to severe pulmonary edema in a patient with cardiomegaly and left ventricular failure. Subsequently, examination of the brain, spinal cord and portions of peripheral nerves and skeletal muscle was completed by a neuropathologist, who provided a final diagnosis of spinal cord roots and peripheral nerve with areas of axonal swelling and spheroid formation not associated with demyelination, recent central zone ischemic infarction of the cervical/thoracic region (likely a pre-terminal event) and skeletal muscle with mild neurogenic type changes. The comment provided by the neuropathologist states the findings "suggest an autoimmune axonal pathology consistent with the predominantly axonal form of GUILLAIN-BARRE syndrome." An addendum to the autopsy report provided the results of additional testing completed on the spinal cord and revealed involvement of dorsal and ventral roots at multiple levels of the spinal cord, consistent with a mixed sensory motor pattern of involvement and confirmed the absence of any macrophage-mediated demyelination. Follow-up was received from the subject''s daughter on 04 June 2010. On 28 November 2009 the subject was vaccinated with unspecified dose of AREPANRIX H1N1 (unknown), unspecified dose of Flu Shot (Seasonal trivalent Influenza vaccine) and unspecified dose of B12 injection (Cyanocobalamin). Medical history included hospitalization on 21 September 1995 for respiratory problems and pneumonia.


VAERS ID: 390371 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-27
Onset:2010-04-27
   Days after vaccination:0
Submitted: 2010-06-09
   Days after onset:43
Entered: 2010-06-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA672B / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E02919 / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0485Y / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Death, Dyskinesia, Heart rate decreased, Intermittent positive pressure breathing, Mechanical ventilation, Oxygen saturation decreased, Pallor, Resuscitation, Skin discolouration, Sudden infant death syndrome, Ultrasound skull normal
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Acute central respiratory depression (narrow), Noninfectious encephalopathy/delirium (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-02
   Days after onset: 5
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: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: The patient has a past history of premature baby. Upon follow up, it was reported that the patient was premature at 26 weeks gestation and was kept in hospital. The baby was not on oxygen prior to discharge, was on suck feeds, gaining weight and was otherwise well. The baby was due to go home the next day after immunisations and had been on an apnoea monitor.
Allergies:
Diagnostic Lab Data: Oxygen saturation (results: reduced, then greater than 94%) and heart rate decreased (results: decreased heart rate, then heart rate $g 100bpm) were done on 27-Apr-2010. Additionally, ultrasound skull (results: no abnormalities detected) and ophthalmological examination (results: no abnormalities detected) were done on an unspecified date.
CDC Split Type: AUWYEG06183310

Write-up: This case was reversioned due to additional information received upon follow up regarding source details, patient details, product details, event details, patient history and lab details. This case was considered medically important for all events. The events of Sudden Infant Death Syndrome and Apnoea were fatal. Information regarding PREVENAR was received from a healthcare professional regarding a patient "around 2 months of age" who experienced apnoea, baby went dusky, reduced O2 saturations, decreased heart rate and sudden infant death syndrome. The patient received a dose on an unspecified date. Upon follow up, it was reported that PREVENAR was administered on 27-Apr-2010 at 9.30am. Dose regimen was 1. suspect batch E02919. Additional suspect medication included ROTATEQ (oral) suspect batch 0485Y and INFANRIX HEXA suspect batch A21CA672B, both administered on the 27-Apr-2010 at 9.30am. Upon follow up, it was reported that the patient had an apnoea episode "12 hours and 1 minute" following the administration of the vaccine. The "baby went dusky", had "reduced O2 saturations", and "decreased heart rate" "at approximately 2115" on 27-Apr-2010. Duration of symptoms were unknown. The baby was seen by a paediatrician who gave "tactile stimulation and intermittent positive pressure ventilation with neopuff for 2 minutes". The baby''s heart rate was then "greater than 100bpm and spontaneous respiration resumed". O2 saturation was greater than 94%, an extension of the left arm observed and possible tonic contraction. The baby was observed and monitored in isolette overnight. The patient had a cranial ultrasound and eye reviews while in hospital - both no abnormalities detected. The patient was due to go home the next day after immunisation however, the patient was observed in special care nursery for 48 hours post event and discharged home. The event prolonged hospitalisation. The patient had an apnoeic episode at home 3 days after discharge - total of 5 days after immunisations and was not able to be resuscitated. The patient had a SIDS death at home (sudden infant death syndrome) on 02-May-2010. Outcome of the apnoea and sudden infant death syndrome were fatal. Outcome of the oxygen saturation decreased, pallor and heart rate decreased were unknown. The relatedness assessment for the events were reported as possible. No consent for follow up with the parents were obtained. The cause of death was reported as sudden infant death syndrome and apnoea. No additional information was available at the time of this report.


VAERS ID: 390401 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2007-05-01
Submitted: 2010-06-09
   Days after onset:1135
Entered: 2010-06-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Disability, Guillain-Barre syndrome, Hypertension, Hypoaesthesia, Lung infection, Paralysis, Septic shock, Tracheostomy
SMQs:, Angioedema (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Toxic-septic shock conditions (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Hypertension (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-26
   Days after onset: 148
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 120 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Drug for pressure control
Current Illness:
Preexisting Conditions: Personal medical history of 3 cardiac saphenous surgeries. Unknown family medical history. Unknown previous history of adverse reaction to a vaccine or a drug. Concomitant therapy for "pressure control". The patient had received influenza vaccine in the previous years. He was in a good health condition otherwise.
Allergies:
Diagnostic Lab Data: unknown
CDC Split Type: 201003063

Write-up: Case received from a consumer (patient''s son) through the Sanofi Pasteur on 28 May 2010 under the local reference number BR2010-157. An 81-year-old male patient, with a personal medical history of 3 cardiac saphenous surgeries, had received his booster dose of Influenza vaccine (manufacturer not reported, batch number, route and anatomical site of administration unknown) on an unspecified date between March and April 2007. The patient had an unknown family medical history and an unknown previous history of adverse reaction to a vaccine or a drug. He had a concomitant therapy for "pressure control". The patient had received influenza vaccine in the previous years. He was in a good health condition otherwise. Probably in May 2007, the patient developed numbness in the lower limbs while driving. He drove to the hospital and was admitted due to numbness in the lower limbs which evolved to paralysis. The diagnosis was GUILLAIN-BARRE SYNDROME. He stayed in the hospital for 4 months. During this time, he developed complications and remained with tracheotomy. Complementary investigations performed and corrective treatment were unknown. The patient died on 26 September 2007. According to the death certificate, the causes of death were septic shock and pulmonary infection. According to the reporter, the patient''s symptoms led to persistent disability/incapacity. List of documents held by sender: none.


VAERS ID: 390849 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-02-29
Onset:2008-03-03
   Days after vaccination:3
Submitted: 2010-06-16
   Days after onset:834
Entered: 2010-06-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Computerised tomogram, Death, Encephalitis, Speech disorder
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (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: 2008-05-24
   Days after onset: 81
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: WAES1006USA01739

Write-up: Information has been received from a Health Authority (20636211) concerning a 24 year old male patient. Details of the patient''s medical history and concomitant medications had not been reported. The patient received a first dose of RECOMBIVAX HB parenterally (manufacturer, batch number and site not reported) on 29-FEB-2008. On 03-MAR-2008, four days post vaccination and according to the coroners notes, the patient developed speech problems. Computerized tomography was performed but the results are unknown. On 07-MAR-2008, the patient received the second dose of RECOMBIVAX HB parenterally (manufacturer, batch number and site not reported) one week after the first dose. Three days later, the patient was readmitted to hospital and then transferred to a different hospital a few days later. A psychiatric diagnosis was discounted and the patient was transferred to a third hospital 23 days after the initial vaccination, where the patient died on 24-MAY-2008. The reported cause of death was encephalitic reaction which was reported to have started on 03-MAR-2008. It was unknown if a post mortem was performed. The outcome of the speech disorder was reported as unknown. The reporter and the health authority considered this to be a serious reaction as the patient died. The Health authority coded the events of encephalitic reaction and speech disorder. Other business partner numbers include: E2010-03603. No further information is available.


VAERS ID: 391028 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2008-02-29
Onset:2008-03-03
   Days after vaccination:3
Submitted: 2010-06-18
   Days after onset:836
Entered: 2010-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram, Death, Encephalitis, Speech disorder
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (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: 2008-05-24
   Days after onset: 81
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: No patient notes currently available to the reporter.
Allergies:
Diagnostic Lab Data: Computerised tomography, 06Mar2008, unknown results
CDC Split Type: B0659412A

Write-up: This case was reported by the regulatory authority (# GB-MHRA-ADR 20636211) and described the occurrence of encephalitic reaction in a 24-year-old male subject who was vaccinated with Hepatitis B. On 29 February 2008 and 7 March 2008 the subject received the 1st and 2nd dose of Hepatitis B vaccine (1 IU Axa) respectively. On 3 March 2008, 3 days after vaccination with the 1st dose of Hepatitis B vaccine, the subject experienced encephalitic reaction and speech disorder. The subject died on 24 May 2008 from encephalitic reaction. It was unknown whether an autopsy was performed. it was reported that psychiatric diagnosis was discounted. Coroner notes development of speech problems following the Hepatitis B vaccination. Computerised tomography done. Second Hepatitis B vaccination was given one week after the first. 3 days later, the patient was re-admitted to hospital and then transferred to a different hospital a few days later. Psychiatric diagnosis discounted and the patient was then transferred to a third hospital 23 days after the initial vaccination, where the patient died.


VAERS ID: 391248 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2009-10-22
Onset:2009-10-31
   Days after vaccination:9
Submitted: 2010-06-18
   Days after onset:230
Entered: 2010-06-23
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED 090200402 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Myelopathy, Neuropathy peripheral, Pneumonia aspiration
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-03
   Days after onset: 3
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010024405

Write-up: Report received from the Foreign Regulator on 10-Jun-2010 (case: 261905). A 90 year old male patient received a single dose of PANVAX H1N1 vaccine (batch: 090200402) on 22-Oct-2009. On 31-Oct-2009, 12 days after vaccination, the patient was admitted to hospital with peripheral neuropathy. On 03-Nov-2009, the patient died due to aspiration pneumonitis as a result of ascending myelopathy. The reporter considered the event of peripheral neuropathy to be serious due to inpatient hospitalisation and assessed the causality as possible in relation to the suspect drug PANVAX H1N1 vaccine. The company considered the event of peripheral neuropathy to be possibly related to the suspect drug PANVAX H1N1 vaccine, and considered the events of aspiration pneumonitis and ascending myelopathy to be unlikely related. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown. Death date: 03-Nov-2009.


VAERS ID: 391339 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-06-23
Entered: 2010-06-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Ovarian cancer
SMQs:, Ovarian malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1006USA03011

Write-up: Information has been received from a physician via CSL as part of a business agreement (manufacturer control # 20100617KC1) concerning a 16 year old female who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not reported). After the GARDASIL vaccination, 3 months later, the patient died of ovarian cancer. The patient was treated at a women''s hospital. The physician stated that there was no causal relationship between the vaccine and death. Additional information has been requested.


VAERS ID: 391548 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2010-04-01
Submitted: 2010-06-25
   Days after onset:85
Entered: 2010-06-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: autopsy included numerous laboratory tests (not provided)
CDC Split Type: 201003406

Write-up: Case report from 2 literature articles received on 15 June 2010. A 2-year-old female patient with no reported medical history died in early April 2010, the day after she had received a seasonal flu vaccination (manufacturer, batch number not reported). According to the articles, an autopsy was performed; the autopsy results were provided by a health pathologist to the coroner and the results were released: the autopsy included numerous laboratory tests, but did not determine a definitive cause of death. According to the chief health officer, the autopsy has found no evidence linking the vaccine to the death of the patient receiving the flu vaccine. Coronial investigations into the death were continuing. List of documents held by sender: 2 literature articles.


VAERS ID: 391562 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: Foreign  
Vaccinated:2010-01-15
Onset:2010-02-19
   Days after vaccination:35
Submitted: 2010-06-25
   Days after onset:125
Entered: 2010-06-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / IJ

Administered by: Unknown       Purchased by: Unknown
Symptoms: Altered state of consciousness, Bacterial test positive, Body temperature increased, Brain scan normal, CSF test abnormal, Coma, Convulsion, Death, Diarrhoea, Electroencephalogram abnormal, Lumbar puncture abnormal, Meningitis pneumococcal, Procalcitonin, Pyrexia, Septic shock, Therapeutic product ineffective, Vomiting
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Convulsions (narrow), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-02-25
   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: Concomitant therapy included the second dose of INFANRIX HEXA administered on 15-Jan-2010.
Current Illness:
Preexisting Conditions: The patient was born at full term, birth height was 49 cm and birth weight 3140 Gr. He had no relevant medical history before nasopharyngitis that was his first infectious episode and that has been treated by CLAMOXYL from 11 to 17-Feb-2010. On 21-Feb-2010, the patient was brought to hospital and was found with hypotonia of left pyelocaliceal cavity but received no treatment and returned back home. Past therapies included one dose of INFANRIX-QUINTA on 12-Dec-2009 and one dose of INFANRIX HEXA on 06-Nov-2009 concomitantly to the first dose of PREVENAR.
Allergies:
Diagnostic Lab Data: Body temperature (results: 40 deg. C.) was done on 19-Feb-2010. On 22-Feb-2010 test results were: procalcitonin (results: 20); electroencephalogram (results: showed no reaction to stimulation and asymmetry at the expense of the right side); lumbar puncture (results: numerous diplococcus were found in the CSF as well as pneumococcus soluble antigen.); and scan brain (results: normal). Bacterial test (results: Pneumococcal serotype was identified to be 19F) was done in Apr-2010.
CDC Split Type: FRWYEG06297510

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 5-month-old male patient who experienced pneumococcal meningitis due to serotype 19 F associated with convulsion septic shock and near coma. The patient received the second dose on 15-Jan-2010. On 19-Feb-2010, the patient experienced fever at 40 degrees C. On 21-Feb-2010, he was brought to hospital due to fever associated with vomiting and one liquid stool but he returned back to home. On 22-Feb-2010 he was hospitalized due to fever, convulsion and near coma. Lumbar puncture revealed numerous diplococcus and pneumococcus soluble antigen was found in the CSF. Brain scan was normal, EEG showed no reaction to stimulation and asymmetry at the expense of the right side. The patient was diagnosed with septic shock and pneumococcal meningitis. The pneumococcal serotype was later identified to be vaccine serotype 19F. The patient was treated with VANCOMYCIN, CLAFORAN and CORTICOSTEROIDS. The patient died on 25-Feb-2010. The cause of death was reported as meningitis pneumococcal, therapeutic product ineffective and septic shock.


VAERS ID: 391797 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2010-06-19
Onset:2010-06-19
   Days after vaccination:0
Submitted: 2010-06-30
   Days after onset:11
Entered: 2010-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB720AM / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Convulsion, Death, Dehydration, Diarrhoea, Pyrexia, Resuscitation, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-06-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0662721A

Write-up: This case was reported by a physician and described the occurrence of cardiac arrest in a 6-month-old male subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline). On 19 June 2010, the subject received 3rd dose of ENGERIX B pediatric (0,5 ml, intramuscular, unknown injection site). Lot number not provided. On 19 June 2010, within hours of vaccination with ENGERIX B pediatric, the subject experienced high fever, 10 episodes of diarrhea and vomiting. 7 hours after vaccination, the subject was taken to emergency unit with severe dehydration and he experienced convulsion. At 19:35, the baby experienced cardiac arrest. The subject was treated with STESOLID, cardiopulmonary resuscitation and electrolytes. The subject died on 19 June 2010 at 20:18, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 391943 (history)  
Form: Version 1.0  
Age: 1.04  
Sex: Male  
Location: Foreign  
Vaccinated:2008-12-02
Onset:2010-03-30
   Days after vaccination:483
Submitted: 2010-06-30
   Days after onset:92
Entered: 2010-07-02
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 33718 / 4 LG / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial test positive, CSF test abnormal, Death, Intensive care, Meningitis pneumococcal, Thrombotic microangiopathy
SMQs:, Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Renovascular disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-17
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 18 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant therapy included three doses of Infanrix-Quinta administered concomitantly to Prevenar on 26-Feb-2008, 01-Apr-2008 and 02-May-2008 and Priorix Vaccine concomitantly to Prevenar on 02-Dec-2008.
Current Illness: The patient''s concurrent illness includes tonsillitis, occurred 4 days before the hospitalization (estimated on 26-Mar-2010) treated with Amoxicillin.
Preexisting Conditions: The patient had no other relevant medical history.
Allergies:
Diagnostic Lab Data: Bacterial test (results: Pneumococcus soluble antigen was found in the CSF but no germ was isolated and serotype identification was not possible) was done in Apr-2010.
CDC Split Type: FRWYEG06318410

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 28-month-old male patient who experienced pneumococcal meningitis and thrombotic microangiopathy. The patient received the fourth dose on 01-Dec-2008. Concomitant therapy included PRIORIX Vaccine concomitantly to PREVENAR on 02-Dec-2008. The patient was hospitalized in intensive care unit from 30-Mar-2010 to 17-Apr-2010 due to pneumococcal meningitis. The diagnosis was based on pneumococcus soluble antigen found in the CSF. However, no germ was isolated and consequently the serotype identification was not possible. The patient died on 17-Apr-2010. The cause of death was reported as pneumococcal meningitis complicated with thrombotic microangiopathy. No additional information was available at the time of this report.


VAERS ID: 391953 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-07-01
Entered: 2010-07-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) / CSL LIMITED - / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-09
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amlodipine; AVASTIN; CALTRATE; FERRUM H
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010024954

Write-up: Report received from a foreign Regulator on 21-JUN-2010 (case: 269157). A patient received a single dose of PANVAX H1N1 (batch #: unknown) on 28-OCT-2010. Further clarification on correct vaccination date has been requested. Concomitant medication that the patient was receiving included amlodipine, AVASTIN, CALTRATE and FERRUM H. Medical history was not provided at the time of reporting. On an unknown date the patient developed Staphylococcus aureus septicemia with H1N1 vaccination. The patient died on 09-NOV-2009. The reporter considered the event possibly related to PANVAX. It was reported that the vial was possibly contaminated. The reporter stated that the death outcome ''maybe drug''. The case was reported as serious because of the patient''s death. The company considered the event conditionally related to the suspect drug PANVAX H1N1 pending follow-up information on clarification of injection date. Information derived from this AE report does not change the current safety profile of the product. Cause of death is unknown. Death date: 09-Nov-2009.


VAERS ID: 392054 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2006-01-24
Submitted: 2010-07-05
   Days after onset:1622
Entered: 2010-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Death, Nervous system disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-01-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2010IT43054

Write-up: Initial report received from a consumer''s lawyer by legal service on 30 Jun 2010: This patient received AGRIPPAL S (batch number unknown), unknown dose on an unknown date. The patient developed severe neurological disorders on unspecified date and on 24 Jan 2006, the patient died. Cause of death was not reported. No autopsy information was provided. The causality was provided as suspected.


VAERS ID: 392108 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Foreign  
Vaccinated:2006-09-26
Onset:2006-10-03
   Days after vaccination:7
Submitted: 2010-07-06
   Days after onset:1372
Entered: 2010-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Death, Haematochezia, Intussusception, Rectal haemorrhage, Sepsis, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-10-06
   Days after onset: 3
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: X-ray, 04Oct2006, IS
CDC Split Type: B0662987A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of intussusception in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 26 September 2006, the subject received 1st dose of ROTARIX (oral, lot number not provided). On 3 October 2006, 7 days after vaccination with ROTARIX, the subject experienced vomiting, abdominal pain, rectal bleeding, bloody stools and abdominal distension which leaded to medical care. On 3 October 2006, the subject was hospitalised. On 4 October 2006, X-ray suggested intussusception leading to surgery without resection. Sepsis leaded to death on 06 October 2006. Cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 392601 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-15
Onset:2010-04-29
   Days after vaccination:14
Submitted: 2010-07-09
   Days after onset:71
Entered: 2010-07-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 090626902 / UNK UN / IJ

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Recalcitrant hypertension; "Cardiac history"; Chronic depression; Substance abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010024989

Write-up: Report received from the regulator on 29-JUN-2010 (case number: 269814). A 74 year old male patient received one dose of FLUVAX (batch number: 090626902) on 15-Apr-2010. The Patient also received PANVAX on 18-Mar-2010. The patient''s medical history includes recalcitrant hypertension, an unknown cardiac condition since 2000, chronic depression and substance abuse. On 29-Apr-2010, 2 weeks after vaccination with FLUVAX, the patient was found deceased in his house. The patient had passed away due to a heart attack from a long-standing cardiac condition. The reporter assessed this event as serious (death). The reporter considered events possibly related to the suspect drug, FLUVAX. The company considered events serious (death) and possibly related to FLUVAX. Information derived from this AE report does not change the current safety profile of the product. Cause(s) of death: Heart attack. Death Date: 29-Apr-2010.


VAERS ID: 392853 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-07-13
Entered: 2010-07-14
   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: Abdominal pain upper, Antibody test abnormal, Antimicrobial susceptibility test sensitive, Apnoea, Areflexia, Autopsy, Base excess decreased, Base excess negative, Blood bicarbonate decreased, Blood culture positive, Blood lactic acid increased, Blood magnesium normal, Blood osmolarity increased, Blood pH decreased, Blood sodium increased, Body temperature increased, Bradycardia, Brain death, C-reactive protein increased, CD4 lymphocytes increased, CNS ventriculitis, CSF culture positive, CSF glucose decreased, CSF protein increased, CSF white blood cell count increased, Cardio-respiratory arrest, Coma scale, Death, Depressed level of consciousness, Diabetes insipidus, Electroencephalogram abnormal, Endotracheal intubation, General physical health deterioration, Haemodynamic instability, Headache, Hyperlactacidaemia, Hypertension, Hypomagnesaemia, Intensive care, Intracranial pressure increased, Lumbar puncture abnormal, Meningism, Meningitis bacterial, Meningitis pneumococcal, Metabolic acidosis, Mydriasis, Nausea, Neutrophil count normal, Pneumococcal bacteraemia, Polyuria, Poor peripheral circulation, Pyrexia, Scan brain, Specific gravity urine, Urine osmolarity, Urine sodium decreased, Vaccination failure, Viral load increased, White blood cell count decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic leukopenia (narrow), Lack of efficacy/effect (narrow), Lactic acidosis (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Hypertension (narrow), Vasculitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (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: Concomitant therapy included AGENERASE, Lamivudine and Zidovudine.
Current Illness: The patient''s concurrent illnesses include HIV infection (via vertical transmission) and encephalopathy (idiopathic spastic).
Preexisting Conditions: The child had a complete vaccination calendar.
Allergies:
Diagnostic Lab Data: The following tests were done on an unspecified date: viral load (results: 13,431 cop/mL at age 6 years); CD4 lymphocytes (results: 2,063 cells/ul at age 6 years); viral load (results: 32,400 cop/mL at age 10 years); CD4 lymphocytes (results: 1,000 cells/ul 15 days before admission); viral load (results: 3,800 cop/mL 15 days before admission); blood culture (results: Streptococcus pneumoniae, serotype 18 C); CSF culture (results: Streptococcus pneumoniae, serotype 18 C); antibody test (results: on a blood sample for antibodies against S. pneumoniae performed on the day of admission Result: anti-pneumococcus (serotype not specified) protective titers 2.11ug/mL); physical examination (results: on admission only the patient''s usual spasticity increases); white blood cell count (results: on admission 9230 cells/uL); neutrophil count (results: on admission 7660 cells/uL); c-reactive protein (results: on admission 1.3 mg/L); blood magnesium (results: on admission 1.6 mg/dL); c-reactive protein (results: 36 hours after admission 195.9 mg/L); scan brain (results: performed urgently 36 hours after admission showed no significant acute changes); lumbar puncture (results: cytochemical changes consistent with acute bacterial meningitis); CSF glucose (results: 22 mg/dL); CSF protein (results: 274.3 mg/dL); CSF white blood cell count (results: 230 cells/uL, 85% of which were polymorphonuclear and gram-positive cocci);antimicrobial susceptibility test (results: for blood and CSF culture: sensitive to penicillin, ampicillin, cefotaxime, cefepime, meropenem, vancomycin, teicoplanin, chloramphenicol and rifampicin and with intermediate resistance to co-trimoxazole); coma scale (results: 8/15: 2, 2, 4); blood osmolarity (results: 317 mOsm/L); urine osmolarity (results: 54 mOsm/L); specific gravity urine (results: 1000-1005); urine sodium (results: -7.5); blood bicarbonate (results: 18.4 mmol/L); blood lactic acid (results: 5.5 mmol/L); c-reactive protein (results: 213 mg/L) white blood cell count (results: 4460 cells/uL); neutrophil count (results: 3460 cells/uL); PCO2 (results: 35 mmHg); physical examination (results: mild non-reactive bilateral mydriasis, with an absence of encephalic trunk reflexes and signs of intracranial hypertension (arterial hypertension and bradycardia)); electroencephalogram (results: absence of cerebral electric activity); CD4 lymphocytes (results: above 500 cell/ul upon arrival at the hospital); body temperature (results: High); and CD4 lymphocytes (results: 1,315 cells/ul at age 10 years).
CDC Split Type: ESWYEH16045210

Write-up: This report includes a fatal event. New information was received that indicated that # ES-WYE-H08429209, which was previously cancelled, is a valid number. Therefore, all information from # ES-WYE-H08429209 and # ES-WYE-G05704510 (which was found to be a duplicate) is included in # ES-WYE-H16045210 which is the number of record. Of note, this case report contains no new safety information and was previously distributed. Information regarding PREVENAR was received from a literature source regarding a 13-year-old male patient who experienced vaccination failure, streptococcus pneumoniae, serotype 18C, detected in blood culture, streptococcus pneumoniae meningitis and vaccination with PREVNAR at age 10. The patient received the first dose on an unspecified date. Additional suspect medication included PNEUMOVAX 23. On unknown dates the child was administered two doses of PREVENAR at age 10. On an unknown date, at age 13, the child was admitted to the emergency department with sudden onset of high fever of a few hours duration and epigastric abdominal pain. Physical examination and analytical monitoring was performed including leukocytes, neutrophils and C-reactive protein (see test results below) and slight hypomagnesemia (1.6 mg/dL) was detected which was the reason for his admission. On admission the child presented anti-pneumococcus (serotype not specified) protective titers of 2.11 ug/mL in a blood sample. Thirty-six hours after his admission he presented with intense frontal headache, nausea and signs of meningismus. An urgent cranial CT, further blood analysis and lumbar puncture was performed (see test results below). Streptococcus pneumoniae, serotype 18C was detected in both blood and cerebrospinal cultures with cytochemical changes consistent with acute bacterial meningitis seen during analysis of cerebrospinal fluid. Treatment with IV cefotaxime and IV vancomycin was empirically initiated (see culture and sensitivity results below). A change in the patient''s level of consciousness prompted a decision that he be admitted to the pediatric intensive care unit. Upon his arrival, deterioration in his general condition and signs of poor peripheral perfusion were observed, together with a significantly reduced level of consciousness. As a result, intubation was elected. In the hours following, marked polyuria appeared, secondary to central diabetes insipidus (see test results below), which lead to a reduction in the tensional figures. He received crystalloids and dopamine in continuous perfusion and desmopresine intravenously until the hemodynamic situation was stabilized. Metabolic acidosis with hyperlactatemia was analyzed (see test results below) which was progressively corrected. Anti-edema measures were taken consisting of 3% saline administration, hyperventilation and dexamethasone intravenously. A few hours later, the child presented with mild non-reactive bilateral mydriasis, with an absence of encephalic trunk reflexes and signs of intracranial hypertension as evidenced by arterial hypertension and bradycardia. An electroencephalogram detected an absence of cerebral electric activity. This was all consistent with brain death. Therapeutic effort was limited and central apnea was confirmed, leading to cardiorespiratory arrest and the death of the child. During the necropsy, signs of acute meningitis were observed with focal parenchymatose infiltration, early stage ventriculitis and focal hypophysitis, as well as perivascular microcalcifications in the lenticular nucleus noted as chronic lesions. The cause of death was reported as pneumococcal bacteremia, vaccination failure and meningitis pneumococcal. The author noted that, "in the country, only one autonomous community includes PREVENAR in their calendar of vaccinations. Our patient followed the vaccination guidelines recommended for an HIV-infected child". The author also noted that "HIV-infected children have abnormal humoral reactivity, their memory B cells do not recover their functionality even with tri-therapy treatment and a good control of the disease, and therefore the response to vaccination may be lower, both quantitatively (concentration of antibodies) and qualitatively (avidity and function of these antibodies)". No additional information was available at the time of this report.


VAERS ID: 393523 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-11-07
Onset:2008-11-28
   Days after vaccination:21
Submitted: 2010-07-23
   Days after onset:601
Entered: 2010-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA021AA / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Ascites, Autopsy, Bronchopneumonia, Cardiac arrest, Cough, Death, Dyspnoea, Endotracheal intubation, Generalised oedema, Hypotension, Inflammation, Lower respiratory tract infection, Mechanical ventilation, Mediastinitis, Necrosis, Oedema, Pleural effusion, Pleurisy, Pyrexia, Respiratory distress, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Skin oedema, Speech disorder, Streptococcal sepsis, Streptococcus test positive, Tachycardia, Tachypnoea, Tracheitis, Upper respiratory tract infection, Upper respiratory tract inflammation
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), 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), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-11-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body height, 02Dec2008, 172cm; Respiratory rate, 28Nov2008, 60 (at admission); Weight, 02Dec2008, 59kg; 02 Dec 2008: Bacterial test B haemolytic strep group B. 02 Dec 2008: Viral test. Nasal swab: respiratory syncytical virus.
CDC Split Type: B0554054A

Write-up: This case was reported by the Medicines and Healthcare products Regulatory Agency (GB-MHRA-ADR 20357549) and described the occurrence of streptococcal septicemia in a 12-year-old female subject who was vaccinated with CERVARIX. Previous vaccinations included 1st dose CERVARIX given 07 October 2008, smallpox vaccine 1996 and November 2000, Meningococcal c vaccine 22 November 2000, MMR vaccine 22 November 2000, Diphtheria toxoid 1996 and November 2000, Hib vaccine 1996 and November 2000, bacillus clostridium tetani 1996 and November 2000, whooping cough vaccine 1996 and November 2000 and poliomyelitis vaccine 1996 and November 2000. On 7 November 2008 the subject received unspecified second dose of CERVARIX (.5 ml, intramuscular, batch AHPVA021AA). At an unspecified time after vaccination with CERVARIX, the subject experienced streptococcal septicemia. The subject died on 30 November 2008 from streptococcal septicemia. It was unknown whether an autopsy was performed. MHRA Verbatim Text: Patient died 3 weeks following 2nd HPV Vaccination. Reported to have died due to Streptococcal A Septicemia. Still awaiting coroners verdict. Follow-up information received on 14 July 2010 from the MHRA: The patient had a cough for one week and then developed fever for three days. Patient was admitted to hospital three weeks after CERVARIX vaccination when the cough got worse and they developed difficulty breathing. On admission the respiratory rate was 60 per minute and they were distressed. They became so distressed they were unable to speak. The patient was transferred to the high dependency unit. On 28 November 2008 the patient then became tachycardic and a chest infection was diagnosed and the patient was taken to the theatre and intubated and ventilated. The patient crashed an hour later and had arrests characterized by very severe hypotension. The patient became asystolic. Despite all efforts the decision that further attempts were futile was made and the patient died on 28 November 2008. The cause of death was streptococcal septicemia. The coroner states that there is no doubt death was due to a group A streptococcal septicaemia. There was active inflammation of the upper respiratory tracts, the mediastinum, and focally the lungs. Group A streptococcus was cultured from multiple sites both at post-mortem and during the short terminal illness. It was noted that a respiratory syncytial virus was identified from the nose swab. According to the coroner it was probable that an upper respiratory tract infection was the portal of the devastating bacterial infection that caused death and it was possible that the respiratory syncytial virus was significant here. Post mortem results: A post mortem was carried out and there was found to be a considerable degree of generalized subcutaneous oedema. Both pleural cavities contained approximately 150mls of turbid yellow fluid. The lungs were found to have a necrotizing pleuritis with some extension of acute inflammation into the pulmonary parenchyma that is immediately adjacent to the pleural surface, though extensive pneumonia is not identified. Some inflammation and oedema extends into the pulmonary interstitium in the areas close to the pleural and mediastinal surface of the lungs. Some areas of bronchopneumonia are identified. The pericardial cavity contains approximately 50ml of clear liquid and the peritoneal cavity contains approximately 250-300ml of clear yellow fluid. The trachea shows evidence of an acute tracheitis with mediastinitis of the upper mediastinum. The larynx shows evidence of an upper respiratory tract infection. The thymus shows marked oedema, and the presence of scattered inflammatory cells.


VAERS ID: 393583 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-07-11
Onset:2010-07-14
   Days after vaccination:3
Submitted: 2010-07-23
   Days after onset:9
Entered: 2010-07-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Death, Mood altered
SMQs:, Cardiac failure (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-07-14
   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: No relevant medical history and no concomitant therapy
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201003875

Write-up: Case received from a Healthcare Professional in a foreign country on 15 July 2010 under the reference number CN2010077. A 03-month-old patient, with no relevant medical history and concomitant therapy, had received a dose of ACTHIB (batch number, route and site of administration not reported) on about 11 July 2010. Two days post-vaccination, the patient was admitted to hospital due to "poor spirit". One day later, in the evening on 14 July 2010, the patient died. The death diagnosis was heart failure. List of documents held by sender: none.


VAERS ID: 393871 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-05-25
Onset:2010-05-28
   Days after vaccination:3
Submitted: 2010-07-28
   Days after onset:61
Entered: 2010-07-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NJ29430 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Completed suicide, Death
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Depression
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1007USA03148

Write-up: Information has been received from the agency via a Case Line Listing via CSL, as part of a business agreement, concerning a 15 year old female patient with a history of depression who on 25-MAY-2010, was vaccinated with the second 0.5 ml IM dose of GARDASIL (batch # NK20450, lot # NJ29430). On 28-MAY-2010, within one week following vaccination, the patient experienced suicide (severe) and died. The cause of death was suicide. The agency felt that suicide was unlikely related to therapy with GARDASIL. No further information is available. A lot check has been initiated. This was originally reported by a practice nurse.


VAERS ID: 393966 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-07-22
Onset:2010-07-23
   Days after vaccination:1
Submitted: 2010-07-30
   Days after onset:7
Entered: 2010-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-07-23
   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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0667066A

Write-up: This case was reported by a physician and described the occurrence of death unexplained in a 18-month-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On 22 July 2010 the subject received unspecified dose of INFANRIX (intramuscular). On 23 July 2010, 1 day after vaccination with INFANRIX, the subject experienced death unexplained. The subject died on 23 July 2010, cause of death was not reported.


VAERS ID: 395126 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2006-11-08
Onset:0000-00-00
Submitted: 2010-08-12
Entered: 2010-08-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0136F / UNK UN / IJ

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1008USA00532

Write-up: This case of vaccination failure with fatal outcome was received from Health Authority on 03-AUG-2010 under the reference number 046613. This case was medically confirmed. A 85 year old female patient (age at the time of vaccination) with a medical history of diabetes mellitus (concomitant medication not reported) had received a dose of PNEUMOVAX 23 (Batch # ND62630, Lot # 654492/0136F) route and site not reported on 08-NOV-2006 and developed a pneumococcal infection which resulted in death (date of death not reported) According to the reporter and the IMB, the vaccine may have been contributory to the patient''s death. The IMB have coded the events of pneumococcal infection and vaccination failure. A lot check has been initiated. Other business partner numbers included E2010-04616. No further information is available.


VAERS ID: 395413 (history)  
Form: Version 1.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-27
Onset:2010-04-15
   Days after vaccination:19
Submitted: 2010-08-16
   Days after onset:123
Entered: 2010-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 106836P1 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2010CO36664

Write-up: Initial report received from a physician on 03 Jun 2010: This pregnant patient was vaccinated with H1N1 (manufacturer unknown; batch number 106836P1) intramuscularly on 27 Mar 2010. The patient died on 15 Apr 2010 which was reported as early postpartum maternal mortality. The reporter did not suspect a causal relationship between drug and the event. Follow up report received from the quality assurance department on 11 Aug 2010: Initially reported batch number 106836P1 of given influenza vaccine was confirmed to be a Novartis pandemic vaccine S-OIV FLUVIRIN.


VAERS ID: 396027 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-08-19
Entered: 2010-08-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1008USA01799

Write-up: Information has been received from a consumer, as part of a marketing research program concerning a 14 year old female who on an unspecified date was vaccinated with the second dose of GARDASIL (Lot # unknown). The consumer reported that the patient who was a friend of her daughter died suddenly 2 weeks after receiving the second dose of GARDASIL. No further information is available.


VAERS ID: 397330 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-28
Onset:2010-04-28
   Days after vaccination:0
Submitted: 2010-09-02
   Days after onset:127
Entered: 2010-09-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UH001AH / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 1003091 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Convulsion, Death
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), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Diabetes, hypertension and stroke sequelae. In March 2010, he was hospitalized for 28 days due to decompensated diabetes and ARI (Acute Respiratory Insufficiency). Unknown family medical history. Unknown previous history of adverse events to a vaccine or a drug. Unknown concomitant therapy.
Allergies:
Diagnostic Lab Data: unknown
CDC Split Type: 201004651

Write-up: Case received from the VIS (Vaccination Information Service) of Sanofi Pasteur on 25 August 2010 under the local reference number BR2010-251. A 59-year-old male patient, with an unknown family medical history, an unknown previous history of adverse event to a vaccine or a drug and unknown concomitant therapies, had received his dose of H1N1, batch number UH001AH, route and anatomical site of administration unknown, concomitantly with his dose of seasonal flu vaccine (MFR UNK, batch number 1003091), route and anatomical site of administration unknown, on 28 April 2010. The patient had a personal medical history of diabetes, hypertension and stroke sequelae. In March 2010, he was hospitalized for 28 days due to decompensated diabetes and ARI (Acute Respiratory Insufficiency). On 28 April 2010, 45 minutes post-vaccination, the patient experienced seizure leading to hospitalization. Two hours later, he presented with cardio-respiratory arrest and died. The cause of death was not certain at the time of report. This case was also assessed as a significant medical condition. Documents held by sender: none.


VAERS ID: 397332 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-19
Onset:2010-04-21
   Days after vaccination:2
Submitted: 2010-09-02
   Days after onset:134
Entered: 2010-09-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UH040AA / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown personal and family medical history; unknown previous history of adverse event to a vaccine or a drug; unknown concomitant therapies.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201004657

Write-up: Case received from Institute through the VIS (Vaccine Information Service) of sanofi pasteur on 25 August 2010 under the local reference number BR2010-259. A 27-year-old male patient, with an unknown personal and family medical history, an unknown previous history of adverse event to a vaccine or a drug and unknown concomitant therapies, had received his dose of H1N1, batch number UH040AA, route and anatomical site of administration unknown, on 19 April 2010. The patient was well the day of vaccination and he worked in the subway (no further details provided). The patient worked normally until 21 October 2010. On 21 April 2010 at night, i.e. 2 days post-vaccination, the patient was found dead in his bedroom. Autopsy results were not available at the time of the report. This case was also assessed as a significant medical condition. Documents held by sender: none.


VAERS ID: 397656 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-09-03
Entered: 2010-09-08
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / UN

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: 2010-08-29
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: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: ARWYEH17197410

Write-up: Information regarding PREVENAR was received from a physician regarding a 1-year-old female patient who experienced drug ineffective and pneumococcal meningitis. The patient received the third dose on an unspecified date. The patient experienced pneumococcal meningitis and drug ineffective on an unknown date in 2010. The patient was hospitalized. Serotyping was not performed. Treatments were not reported. The outcome of pneumococcal meningitis was fatal. The patient died on 29-Aug-2010. No additional information was available at the time of this report. The cause of death was reported as meningitis pneumococcal.


VAERS ID: 397669 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-05-18
Onset:2010-05-20
   Days after vaccination:2
Submitted: 2010-09-07
   Days after onset:110
Entered: 2010-09-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP212A / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute respiratory distress syndrome, Brain oedema, CSF protein abnormal, Death, Guillain-Barre syndrome, Muscular weakness, Respiratory failure, Thymus hypoplasia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Interstitial lung disease (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), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2010-06-06
   Days after onset: 17
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: History included an unspecified chronic disease. Unknown family medical history. Unknown previous history of adverse event to a vaccine or a drug. Unknown concomitant therapy.
Allergies:
Diagnostic Lab Data: CSF study: protein-cytological dissociation
CDC Split Type: 201004724

Write-up: Case received from Institute through the VIS (Vaccination Information Service) of sanofi pasteur on 25 August 2010 under the local reference number BR2010-334. A 7-year-old male patient, with an unspecified chronic disease, unknown family medical history, an unknown previous history of adverse event to a vaccine or a drug and unknown concomitant therapies, had received a dose of H1N1, batch number UP212A, route and anatomical site of administration unknown, on 18 May 2010. On 20 May 2010, the patient presented with ascending muscle weakness, ascending paralysis in the lower limbs and respiratory failure. The patient was hospitalized on an unknown date. A CSF study protein revealed cytological dissociation. Corrective treatment was unknown. On 06 June 2010, the patient died. As per the "Deaths Verifications Service": diffuse cerebral edema / acute respiratory syndrome in adults (aRSA) / thymic hypoplasia. According to the report the case was under investigation. No other information was provided. Documents held by sender: none.


VAERS ID: 397696 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2010-08-26
Onset:2010-08-26
   Days after vaccination:0
Submitted: 2010-09-07
   Days after onset:12
Entered: 2010-09-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR D0373 / 2 LA / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER D0448 / 2 RA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Feeling abnormal
SMQs:, Dementia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-08-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No "other" relevant history, no "other" concomitant drug
Allergies:
Diagnostic Lab Data: No data
CDC Split Type: 201004611

Write-up: Case received from a healthcare professional on 30 August 2010 under the reference number CN2010099. A 3-month-old female patient with no reported medical history and no concomitant drug had received a second intramuscular dose of ACT-HIB (batch number D0373-1) in the left deltoid and a second dose of IPV (batch number D0448-2) in the right deltoid on 26 August 2010 at about 3:00 pm. Following immunization, on 26 August 2010, the patient experienced poor spirit. On 27 August 2010 and about 9:00 am the patient died. List of Documents held by Sender: none.


VAERS ID: 398153 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-09-13
Entered: 2010-09-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1009USA00697

Write-up: Information has been received from a health professional via a literature article. In foreign country, reporting of adverse events following immunization (AEFI) has been mandatory by law since 1988. The goal of the study was a detailed analysis of reported AEFI received by the foreign Federal Office of Public Health between 1991 and 2001. Overall, 1013 AEFI were reported during the study period. This case is linked with 13 other cases issued from the literature (same article, different vaccines, and different reactions): E2010-02609, E2010-02610, E2010-02612, E2010-02613, E2010-02614, E2010-02615 and E2010-02616. Five infant patients aged 2 to 5 months of unspecified sex reportedly experienced sudden infant death syndrome after receiving an injection of DTAP-HIB-IPV (batch number not reported, manufacturer unknown) on unspecified dates. The time interval between vaccination and deaths were assessed to causally related to immunisation based on data in the literature disproving a causal relationship between sudden unexpected death in infants and immunisation. The reporter mentioned 2 cases (initially reported as 5 cases). The patients received in fact 3 vaccines for the 5 valences initially reported, ie a dose of HIB (OMPC) (batch number not reported), a dose of DTAP (manufacturer unknown) and a dose of oral IPV (manufacturer unknown). Other business partners numbers included: E2010-02611. No further information is expected. The case is closed.


VAERS ID: 398755 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2010-09-01
Onset:2010-09-01
   Days after vaccination:0
Submitted: 2010-09-16
   Days after onset:15
Entered: 2010-09-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drug exposure via breast milk, General physical health deterioration
SMQs:, Neonatal exposures via breast milk (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: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES1009USA00625B1

Write-up: Information has been received from a physician for the pregnancy registry for GARDASIL, concerning a female who on 01-SEP-2010 was vaccinated with the first dose of GARDASIL (lot number not reported) intramuscularly while breastfed her baby was 40 day old (WAES 1009USA00625), it was reported that the mother''s and baby''s health were good (well controlled). On 02-SEP-2010, in the morning, the baby''s condition was still good but in the afternoon the condition suddenly drop. The family immediately took the baby to hospital and it did not help since the baby died shortly after that. The cause of death was not reported, it was also reported as "not recovered from death". No further information is available.


VAERS ID: 398772 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:1995-07-27
Onset:0000-00-00
Submitted: 2010-09-17
Entered: 2010-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 4 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anti-HBs antibody positive, Completed suicide, Death, Disability, Extrapyramidal disorder, Laboratory test abnormal, Multiple sclerosis, Multiple sclerosis relapse, Nervous system disorder, Optic neuritis, Paraesthesia
SMQs:, Liver infections (narrow), Peripheral neuropathy (broad), Suicide/self-injury (narrow), Neuroleptic malignant syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Optic nerve disorders (narrow), Demyelination (narrow), Ocular infections (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-02
Permanent Disability? Yes
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: Anti-HBs antibody, 2000, upper than 1000I; Expended disability status scale (2009): 5.5.
CDC Split Type: B0674099A

Write-up: This case was reported by the foreign regulatory authority (number MA20101673) and described the occurrence of multiple sclerosis in a 20-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), (non-gsk) GENHEVAC B. The subject belonged to the association (number 2464). On 24 May and 28 June 1994 the subject received 1st dose and 2nd dose of GENHEVAC B (intramuscular, unknown batch number and injection site). On 27 July 1994 and 27 July 1995, the subject received 3rd dose and 4th dose of ENGERIX B (intramuscular, unknown batch number and injection site). In 1998, three years after vaccination with ENGERIX B, she presented with paresthesia in lower limbs and retrobulbar optic neuritis. In 2000, biological work-up showed anti-HBS antibody level upper than 1000 IU / L. In December 2001, the subject experienced her first flare-up of remittent multiple sclerosis (NOS). In 2009, she presented with cerebello-pyramidal sequalae (nos) with expended disability status scale at 5.5. The agency reported that the events were disabling. On 02 November 2009, the subject committed suicide. According to the agency, the death was not related to paresthesia and optic neuritis but multiple sclerosis could have led to the suicide. The agency considered the multiple sclerosis, paresthesia and the optic neuritis as dubiously related to vaccination with ENGERIX B and GENHEVAC B, according to the foreign method of assessment.


VAERS ID: 400621 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-09-27
Entered: 2010-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, CSF test abnormal, Death, Nuclear magnetic resonance imaging abnormal, Quadriplegia, Respiratory depression
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Cerebrospinal fluid abnormal, ADEM; Nuclear magnetic resonance ima, ADEM
CDC Split Type: B0674505A

Write-up: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a 75-year-old female subject who was vaccinated with influenza vaccine trivalent (seasonal Influenza vaccine unspecified, manufacturer unspecified). On an unspecified date the subject received unspecified dose of seasonal Influenza vaccine unspecified (unknown). Within 3 to 5 weeks after vaccination with seasonal Influenza vaccine unspecified, the subject experienced quadriplegia and respiratory depression. Relevant test results included cerebrospinal fluid and magnetic resonance imaging which revealed acute disseminated encephalomyelitis. The subject was treated with methylprednisolone and plasma exchange therapy. The subject subsequently expired. Although a rare occurrence, the clear indication that certain vaccines could trigger serious autoimmune diseases should be recognized.


VAERS ID: 401699 (history)  
Form: Version 1.0  
Age: 0.13  
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-05-12
Onset:2010-05-13
   Days after vaccination:1
Submitted: 2010-10-01
   Days after onset:141
Entered: 2010-10-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER E40241 / UNK UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 8C3703 / UNK UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER E40241 / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER E40241 / UNK UN / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER E5320 / UNK MO / PO
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D99042 / 1 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death neonatal
SMQs:, Acute central respiratory depression (broad), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-13
   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: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: The patient has a past history of premature baby (Born preterm due to foetal distress, with APGARS of 9/10 and 10/10.). At the immunisation visit on 12-May-2010, the baby appeared healthy with normal milestones.
Allergies:
Diagnostic Lab Data: None provided.
CDC Split Type: ZAWYEG06758010

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 6-week-old patient who experienced death within 24 hours after immunisation. The patient received the first dose on 12-May-2010. Additional suspect medication included PENTAXIM and Hepatitis B Vaccine. The patient experienced death within 24 hours after immunisation on 13-May-2010. No additional information is anticipated.


VAERS ID: 401942 (history)  
Form: Version 1.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-10-05
Entered: 2010-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0069009A

Write-up: This case was reported by a physician via another manufacturer and described the occurrence of death - at present cause unknown - in a 95-year-old female subject who was vaccinated with INFLUSPLIT SSW 2010/2011 (GlaxoSmithKline). On an unknown date in 2010 the subject received a dose of INFLUSPLIT SSW 2010/2011 (0.5 ml, unknown). Approximately one day post vaccination with INFLUSPLIT SSW 2010/2011, on an unknown date in 2010, the subject died from an unknown cause (death - at present cause unknown). It was unknown whether an autopsy was performed. The reporting physician considered that death - at present cause unknown - was unrelated to vaccination with INFLUSPLIT SSW 2010/2011. The case was received from foreign country. Follow-up information has been requested.


VAERS ID: 401943 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-09-28
Onset:2010-09-28
   Days after vaccination:0
Submitted: 2010-10-05
   Days after onset:7
Entered: 2010-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Pyrexia, Shock
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0677145A

Write-up: This case was reported by a physician and described the occurrence of death due shock in a 2-month-old subject of unspecified gender who was vaccinated with HIBERIX (GlaxoSmithKline). On 28 September 2010, the subject received unspecified dose of HIBERIX (.5 ml, intramuscular, injection site unknown, batch number not provided). On 28 September 2010, less than one day after vaccination with HIBERIX, the subject experienced fever. In September 2010, at an unspecified time after vaccination with HIBERIX, the subject experienced death shock. The subject died in September 2010 from unknown cause of death. It was unknown whether an autopsy was performed.


VAERS ID: 403817 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2005-09-05
Onset:2010-07-08
   Days after vaccination:1767
Submitted: 2010-10-15
   Days after onset:99
Entered: 2010-10-18
   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, Streptococcal infection, Streptococcus test positive
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-07-09
   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: Unknown
Allergies:
Diagnostic Lab Data: blood culture, 08Jul10, positive for serotype 11A
CDC Split Type: WAES1010USA00912

Write-up: Information has been received by the company from the agency via a public case detail form concerning a 94 year old male patient who on 05-SEP-2005 was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). On 08-JUL-2010 the patient developed pneumonia and a blood culture was positive for serotype 11A. The events caused or prolonged inpatient hospitalization. On 09-JUL-2010, the patient died. The agency considered that blood culture positive serotype 11A and pneumonia were possibly related to vaccination with PNEUMOVAX 23. The original reporting source was not provided. No further information is available.


VAERS ID: 404097 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-05-04
Onset:2010-05-04
   Days after vaccination:0
Submitted: 2010-10-18
   Days after onset:167
Entered: 2010-10-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UH040AB / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Chest pain, Cyanosis, Hyperhidrosis, Loss of consciousness, Resuscitation, Sudden death, Syncope, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History of epilepsy and hypertension. Concomitant medications were not reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201005280

Write-up: This Case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the Ministry of Health through foreign Institute (local case reference number BR2010-665). A 49-year-old female patient, whose medical history included epilepsy and hypertension, received a dose of H1N1 vaccine (manufactured by sanofi pasteur, batch number UH040AB, route and anatomical site of administration not reported), on 04 May 2010. Twenty-five minutes after vaccination, the patient returned to the Health Unit with a strong chest pain, BP 180/100 mmHg, sweating, cyanosis, fainting, loss of consciousness, wheezing, and subsequent apnea. Resuscitation measures were performed unsuccessfully and the patient died. No other information was provided. The case was classified as "severe". This case was assessed as serious due to the mention of unexpected sudden death. Documents held by sender: None.


VAERS ID: 404810 (history)  
Form: Version 1.0  
Age: 1.78  
Sex: Female  
Location: Foreign  
Vaccinated:2010-06-09
Onset:2010-06-10
   Days after vaccination:1
Submitted: 2010-10-19
   Days after onset:131
Entered: 2010-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER UP223AA / 2 UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aspiration bronchial, Death, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-06-10
   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:
Preexisting Conditions: Medical history and concomitant medications were not reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201005310

Write-up: This Case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the Ministry of Health through foreign Institute (local case reference number BR2010-676). A 21-month-old female patient, whose medical history and concomitant therapies were not reported, received a second dose of H1N1 vaccine (manufactured by sanofi pasteur, batch number UP223AA, route and anatomical site of administration not reported), on 09 June 2010. The patient had also received an unspecified polio vaccine during a polio campaign (date and details not provided). As per the patient''s father, the patient had been vaccinated on 09 June 2010 at 09:30 and she had been well throughout the day, ate normally and went to bed at 20:40. The next day, the child was found dead. The death record indicated that the cause of death was respiratory failure and bronchoaspiration. No other information was provided. The case was classified as "severe". Documents held by sender: None.


VAERS ID: 404831 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-04-15
Onset:2010-04-28
   Days after vaccination:13
Submitted: 2010-10-19
   Days after onset:174
Entered: 2010-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cerebrovascular accident, Death, Haemorrhage intracranial, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201005321

Write-up: This case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by Sanofi Pasteur, from the "Ministry of Health" through foreign Institute (local case reference number BR2010-620). A 24-year-old female patient had received a dose of H1N1 vaccine (manufacturer and batch number unknown, route and anatomical site of administration not reported) on 15 April 2010, and 13 days later on 28 April 2010, she was found dead. Unexpected sudden death was also reported. Autopsy findings revealed extensive diffuse intracranial brain hemorrhage. According to the report, the cause of death was hemorrhagic CVA. Outcome was fatal. The case was classified as "Severe". No further information was provided. Unexpected sudden death. Documents held by sender: None.


VAERS ID: 404835 (history)  
Form: Version 1.0  
Age: 1.83  
Sex: Male  
Location: Foreign  
Vaccinated:2010-03-26
Onset:2010-03-26
   Days after vaccination:0
Submitted: 2010-10-19
   Days after onset:207
Entered: 2010-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER 956330 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Cardiac arrest, Coma, Death, Decreased appetite, Disseminated intravascular coagulation, Neurogenic shock, Somnolence, Thrombosis, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201005323

Write-up: This case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur affiliate, from the "Ministry of Health" through foreign Institute (local case reference number BR2010-642). A 22-month-old male patient, with no reported medical history, no reported concomitant therapy and "no other vaccine", had received his 1st dose of H1N1 vaccine (manufacturer unknown, batch number "956330", route and anatomical site of administration not reported) on 26 March 2010. On 26 March 2010, 4 hours post-vaccination, the patient experienced drowsiness and vomiting. He was hospitalized for 14 hours. On admission, the patient''s temperature was 37.2 degrees C. He was prescribed "oral serum" and IM PLASIL. On 27 March 2010, the patient presented with hyporexia and temperature (max 37.8 degrees C). He also developed acute disseminated encephalomyelitis and died. The death records mentioned asystole, neurogenic shock, coma, acute disseminated encephalomyelitis, disseminated intravascular coagulation and thrombosis of the right upper limb. This case was considered as "severe". This case was also assessed as dealing with a significant medical condition. Documents held by sender: none.


VAERS ID: 404838 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2010-05-05
Submitted: 2010-10-19
   Days after onset:167
Entered: 2010-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER VM00244 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Drug exposure during pregnancy, Intra-uterine death
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Mother''s obstetric history included six pregnancies and one abortion.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201005580

Write-up: This Case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur affiliate, from the "Ministry of Health" through foreign Institute (local case reference number BR2010-669). This case is for a fetal death which occurred on 05 May 2010 (gestational age not reported). The mother had received an H1N1 vaccine (batch number VM00244), on 01 April 2010. The events for the mother are captured in case 2010-05296, which included the following description: A 39-year-old female patient, whose medical history and concomitant therapies were not reported, received a dose of H1N1 vaccine (batch number "VM00244", route and anatomical site of administration not reported), on 01 April 2010. No other vaccines were administered. On 04 May 2010, the patient developed a headache, myalgia , and low fever. The next day, she returned to the health unit with metrorrhagia and metro systole which resulted in abortion with fetal death (referred to institute). The patient had six pregnancies and one abortion. She was also hypertensive (onset date not reported, unclear if this was medical history). On 05 August 2010, the report from the institute confirmed placenta failure and early placental separation. The patient''s outcome was unknown. No other information was provided. The case was classified as "severe". Documents held by sender: None.


VAERS ID: 407028 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-09
Onset:2010-03-09
   Days after vaccination:0
Submitted: 2010-10-19
   Days after onset:223
Entered: 2010-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Fatigue, Headache, Hyperhidrosis, Hypertension, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: not reported
CDC Split Type: 201005326

Write-up: This case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the Ministry of Health through foreign institute (local case reference number BR2010626). A 49-year-old female patient, with no reported medical history, no reported concomitant therapy and "no other vaccine", had received her dose of H1N1 vaccine (manufacturer and batch number unknown, route and anatomical site of administration not reported) on 09 March 2010. On 09 March 2010, 30 minutes post-vaccination, the patient experienced sweating, fatigue and hypertension (BP 15 x 11). On 11 March 2010, the patient developed headache and "maintained hypertension" (148 x 107). He was reevaluated at the medical service the same day. The patient received corrective therapies with analgesics and antihypertensive drugs. On 12 March 2010, there was a new medical assessment (rest of the information was cut on the source document). The patient was hospitalized on unspecified dates. The patient finally experienced unexpected sudden death on an unspecified date. This case was considered as "severe". Documents held by sender: none.


VAERS ID: 407052 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-23
Onset:2010-04-21
Submitted: 2010-10-19
   Days after onset:181
Entered: 2010-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER UH001AH / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-30
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hydrocephaly
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201005343

Write-up: This case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the "Ministry of Health" through foreign institute (local case reference number BR2010-650). A 06-year-old male patient, with a medical history of hydrocephaly, no reported concomitant therapy and "no other vaccine", had received his dose of H1N1 vaccine (batch number UH001AH, route and anatomical site of administration not reported) on 23 April 2010. Sanofi pasteur Inc. lot number is UH001AH and the corresponding lot number allocated at packaging by institute is 1003060. On 21 April 2010, i.e. 2 days pre-vaccination, the patient experienced fatal intracranial hypertensive syndrome and hydrocephalus. To be noted that the date of death was also reported to be 7 days post-vaccination. Unexpected sudden death was also mentioned. The patient was hospitalized on unspecified date. This case was considered as "severe". Documents held by sender: none.


VAERS ID: 407056 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-04-10
Onset:2010-04-11
   Days after vaccination:1
Submitted: 2010-10-19
   Days after onset:191
Entered: 2010-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER VH040AB / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Convulsion, Death, Intensive care, Loss of consciousness, Renal failure acute, Resuscitation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (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), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201005348

Write-up: This Case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the Ministry of Health through foreign Institute (local case reference number BR2010-653). A 24-year-old female patient, whose medical history and concomitant therapies were not reported, had received a dose of H1N1 vaccine (batch number "VH040AB", route and anatomical site of administration not reported) on 10 April 2010 and 31 hours after vaccination the patient presented with sudden seizures followed by loss of consciousness and cardio-respiratory arrest. She was revived by the mobile medical emergency service and subsequently referred to the hospital and transferred to ICU progressing to seizures, acute renal failure and death. Date and cause of death were not reported. Unexpected sudden death was reported. The case was classified as "Severe". Outcome was reported as death. No further information was provided. No seriousness criterion was reported for this case; however it has been assessed as a significant medical condition due to severe seizures and acute renal failure, and unexpected sudden death. Documents held by sender: None.


VAERS ID: 407564 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-05
Onset:2010-04-05
   Days after vaccination:0
Submitted: 2010-10-19
   Days after onset:197
Entered: 2010-10-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER UH001AH / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Convulsion, Dizziness, Musculoskeletal chest pain, Nausea, Sudden death, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Epilepsy that was treated with medication; however the patient had stopped his medication on an unknown date.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201005351

Write-up: This case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the "Ministry of Health" through foreign institute (local case reference number BR2010-655). A 25-year-old male patient, who has medical history of epilepsy and who had stopped taking his medication (date not reported), had received a dose of H1N1 vaccine (Sanofi pasteur Inc. lot number UH001AH corresponding to lot number 1003060 which was allocated at packaging by institute, route and anatomical site of administration not reported) on 05 April 2010 and 4 hours after vaccination the patient presented with dizziness, nausea and vomiting. He also complained of intense pain in the intercostal left side that was radiating to the epigastrium. On 23 April 2010, the patient received medical assistance, presenting with seizures. The patient was hospitalized (dates not reported). The case was classified as "Severe". Outcome was reported as unexpected sudden death. No further information was provided. No seriousness criterion was reported for this case; however it has been assessed as a significant medical condition due to the Seizures and unexpected sudden death. Documents held by sender: None.


VAERS ID: 407026 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-07-27
Onset:2010-04-27
Submitted: 2010-10-19
   Days after onset:175
Entered: 2010-10-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 1003091 / UNK UN / UN
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER UH001AH / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute myocardial infarction, Cardio-respiratory arrest, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

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: Lung cancer diagnosed in January 2009 and submitted to radiotherapy and chemotherapy.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201005352

Write-up: This Case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur from the Ministry of Health through foreign Institute (local case reference number BR2010-656). A 67-year-old male patient, who has medical history of lung cancer in January 2009 and submitted to radiotherapy and chemotherapy, had received a dose of H1N1 vaccine (Sanofi pasteur Inc. lot number UH001AH corresponding to lot number 1003060 which was allocated at packing by the agency, route and anatomical site of administration not reported) on 27 July 2010. On "27 April 2010" (date is noted to be prior to vaccination) it was reported the patient was admitted to the hospital emergency room with cardiopulmonary arrest and attested acute myocardial infarction. It was reported the patient was not hospitalized. The case was classified as "Severe". Outcome was reported as unexpected sudden death (cause of death not reported). No further information was provided. No seriousness criterion was reported for this case; however it has been assessed as a significant medical condition due to cardiopulmonary arrest and acute myocardial infarction with unexpected sudden death. Documents held by sender: None. Corrective version performed to clarify the vaccination date and the onset date: The vaccination date was reported as 27 July 2010 and the onset date was reported as 27 April 2010 (clarification was requested). Relevant Test/Laboratory Data: Not reported


VAERS ID: 407053 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2010-05-10
Submitted: 2010-10-19
   Days after onset:162
Entered: 2010-10-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER UH003AC / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Drug exposure during pregnancy, Intra-uterine death
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-05-10
   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:
Preexisting Conditions: Mother received a dose of H1N1 vaccine at approximately 32 weeks of gestation.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201005470

Write-up: This Case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the Ministry of Health through foreign Institute (local case reference number BR2010-680). This case is for a fetal death that was noted by ultrasound scan on 10 May 2010. The mother had received H1N1 vaccine (sanofi pasteur, batch number UH003AC), on 08 April 2010, at approximately 32 weeks gestation. The events for the mother are captured in case 2010-05316, which included the following description: A 23-year-old female patient, whose medical history and concomitant therapies were not reported, received a dose of H1N1 vaccine (manufactured by sanofi pasteur, batch number UH003AC, route and anatomical site of administration not reported), on 08 April 2010. The patient was pregnant at the time of vaccination. No other vaccines were administered. On 09 May 2010, 31 days after vaccination, the patient was 37 weeks pregnant and presented pain in the lower abdomen and bleeding. An ultrasound scan done the following day indicated fetal death and pronounced "oligoamnio". The outcome was a stillbirth. The patient had a hypertensive peak three months ago. No other information was provided. Documents held by sender: None.


VAERS ID: 405206 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Female  
Location: Foreign  
Vaccinated:2010-09-01
Onset:2010-09-01
   Days after vaccination:0
Submitted: 2010-10-21
   Days after onset:50
Entered: 2010-10-25
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-09-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: The grandmother was looking after the baby when the condition changed. She said when the mother came back with the baby from the clinic the baby was crying continuously. They put ice covered with a cloth on the injection site as the mother was told to do so. The mother left the baby with her. She managed to feed the baby and then took the baby upstairs and left her sleeping. When she went to check the baby later she noticed blood coming from the nostril. The baby was taken to Hospital where the baby found to be a D.O.A. The Baby was confirmed dead by Dr.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: ZAWYEG06797910

Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 6-week-old female patient who experienced death due to unknown causes. The patient received the first dose on 01-Sep-2010. Additional suspect medication included PENTAXIM, Hepatitis B Vaccine, Poliovirus Vaccine Live Oral and Retinol. The patient experienced death due to unknown causes on 01-Sep-2010. No additional information is anticipated.


VAERS ID: 405327 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-05
Onset:2010-10-06
   Days after vaccination:1
Submitted: 2010-10-25
   Days after onset:19
Entered: 2010-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Death, Vaccination complication
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2010DE70854

Write-up: Initial report received from the foreign Health Authority (reference number PEI2010030411) on 20 Oct 2010: This patient with an unknown medical history received influenza virus vaccine (manufacturer and batch number unknown) on 05 Oct 2010. The patient experienced vaccination reaction on 06 Oct 2010. The event was reported as serious (life threatening). After 11 days on an unspecified date the patient died. It was not known whether autopsy was performed or not. The health authority diagnosed the event as vaccination adverse reaction.


VAERS ID: 405381 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-10-25
Entered: 2010-10-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1010PHL00038

Write-up: Information has been received from a physician concerning a friend of her patient who was vaccinated with GARDASIL. Subsequently the patient''s friend died. The cause of death was not reported. The patient decided to discontinue vaccination due to the incident. No further information is available. Attempts to confirm an identifiable patient had been unsuccessful.


VAERS ID: 406022 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-11
Onset:2010-10-11
   Days after vaccination:0
Submitted: 2010-10-29
   Days after onset:18
Entered: 2010-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 108601 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Altered state of consciousness, Base excess decreased, Blood bicarbonate decreased, Blood potassium increased, Cardiac arrest, Cardiac failure acute, Death, Electrocardiogram abnormal, Heart rate irregular, Malaise, Oxygen saturation decreased, PCO2 increased, Pallor, Posture abnormal, Resuscitation, pH body fluid increased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prostate cancer; Hepatic cancer metastasis, Very active pancreatic cancer with metastasis in the liver; Malaise, Ill with decreased appetite 3-4 days prior to vaccination; Decreased appetite, Ill with decreased appetite 3-4 days prior to vaccination; Heart rate irregular; Pancreatic carcinoma metastatic, Very active pancreatic cancer with metastasis in the liver
Preexisting Conditions: Vascular graft; Very active pancreatic cancer with metastasis in the liver; Ill with decreased appetite 3-4 days prior to vaccination
Allergies:
Diagnostic Lab Data: Base excess; 27.4; Low; Blood bicarbonate; 6.3; Low; Blood potassium; 83; High; Oxygen saturation; 84%; Low; PCO2; 9.24; High; pH body fluid, 6.76; High
CDC Split Type: PHHY2010DK71270

Write-up: Initial serious report received from a physician via Health Authority on 25 Oct 2010: The patient had medical history of very active pancreatic cancer with metastasis in the liver, prostate cancer and bypass surgery. The patient was ill with decreased appetite, 3-4 days prior to vaccination and came to the consultation in order to get clarification about future treatment. Due to unwell felling since 3-4 days, an electrocardiogram (ECG) was performed on an unknown date which showed an irregular heartbeat. It was agreed that the patient should be hospitalized sub acutely. Afterward the patient went home. The patient was vaccinated with AGRIPPAL (batch number 108601) on 11 Oct 2010. About half to one hour after vaccination, the patient experienced sudden cardiac arrest (acute heart failure). The patient''s head suddenly fell back, and the patient seemed very distant and suddenly became pale. An ambulance was called for. The paramedics found a shock-able heart rhythm. The patient was given shocks eight times and appropriate medication by the paramedics. On the way to the ambulance, the patient went into asystole and appropriate medical treatment was provided. The patient was taken to the hospital while given persistent artificial respiration. In total, the patient received 600 mg CORDARONE IV, 8 mg epinephrine IV and 3 mg ATROPINE, all without effect. Artificial respiration was continued at the hospital. The patient was resuscitated for a total of 55 minutes. Based on the patient''s cancer, the patient was pronounced dead. Investigations performed at the hospital included an A puncture which showed a pH of 6.78, partial pressure of carbon dioxide (pCO2) of 9.24, base excess of 27.4, bicarbonate of 6.3, SAT 84%, potassium level of 8.3, and lactate level of 13.4 (units not specified). According to the physician, the patient was under the circumstances well when he left the praxis. The physician did not believe that there was a connection between the vaccination and the patient''s death.


VAERS ID: 407578 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:2010-07-26
Onset:2010-07-29
   Days after vaccination:3
Submitted: 2010-10-29
   Days after onset:92
Entered: 2010-11-01
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 3E12A / UNK UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR E0558 / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-07-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history (including allergy)
Allergies:
Diagnostic Lab Data: legal autopsy conducted: no result at time of report
CDC Split Type: 201006072

Write-up: Report received from a healthcare professional (nurse) on 19 October 2010. Local reference number JVA1000783. A 5-month-old female patient, with no relevant medical history including allergy, experienced respiratory arrest leading to her death on 29 July 2010, i.e. 3 days after receiving a subcutaneous dose of ACT-HIB, batch number E0558 and a subcutaneous dose of vaccine from another manufacturer : DPT from Biken, lot number 3E12A on 26 July 2010 at 12:30 (injection site not reported). On 29 July 2010, the guardian confirmed that the patient''s respiratory was abnormal at 1:00 am. After that the patient had respiratory arrest and she died subsequently. Legal autopsy was conducted (no reported results). According to the reporting doctor, this case was unrelated to ACT-HIB.


VAERS ID: 407609 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-10-04
Onset:2010-10-06
   Days after vaccination:2
Submitted: 2010-11-01
   Days after onset:26
Entered: 2010-11-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-06
   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: None
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1010USA03259

Write-up: Initial information has been received from a physician concerning a 80 year old female patient who on 04-OCT-2010 was vaccinated PNEUMOVAX 23, 0.5mL once a day. No information on concomitant medication was provided. The patient was in aged care facility and she had been repeatedly hospitalized at respiratory disease hospital. On 04-OCT-2010, the patient was vaccinated PNEUMOVAX 23. On approximately 06-OCT-2010, the patient died. There were no information for cause of death and autopsy. The reporting physician considered that the adverse event was serious due to death. The reporting physician did not provide a relationship between adverse event and PNEUMOVAX 23. Additional information has been requested.


VAERS ID: 407613 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2010-10-04
Onset:2010-10-06
   Days after vaccination:2
Submitted: 2010-11-01
   Days after onset:26
Entered: 2010-11-02
   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
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-06
   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: None
Current Illness: Productive cough; Asthenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1010USA03258

Write-up: Initial information has been received from a physician concerning a 92 year old female patient who on 04-OCT-2010 was vaccinated with PNEUMOVAX 23, 0.5mL once a day. No information on concomitant medication was provided. The patient was in an aged care facility and she was extremely frail and had chronically had sputum on her airway. On 04-OCT-2010, the patient was vaccinated PNEUMOVAX 23. On 06-OCT-2010, the patient died. There were no information for cause of death and autopsy. The reporting physician considered that the adverse event was serious due to death. The reporting physician did not provide a relationship between adverse event and PNEUMOVAX 23. Additional information has been requested.


VAERS ID: 407922 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-25
Onset:2010-10-26
   Days after vaccination:1
Submitted: 2010-11-05
   Days after onset:10
Entered: 2010-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLU538AB / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acute pulmonary oedema, Death, Resuscitation, Septic shock
SMQs:, Cardiac failure (narrow), Toxic-septic shock conditions (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: HEMODIALYSIS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0682882A

Write-up: This case was reported by a regulatory authority (# 126424) and described the occurrence of acute pulmonary edema in a 80-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included hemodialysis. On 25 October 2010 the subject received unspecified dose of FLUARIX (intramuscular). On 26 October 2010, 1 day after vaccination with FLUARIX, the subject experienced acute pulmonary edema and septic shock. The subject was treated with cardiopulmonary resuscitation, antibiotics, amine and cortisone. The regulatory authority reported that the events were possibly related to vaccination with FLUARIX. The subject died on 27 October 2010, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 407930 (history)  
Form: Version 1.0  
Age: 0.49  
Sex: Male  
Location: Foreign  
Vaccinated:2010-06-07
Onset:2010-06-07
   Days after vaccination:0
Submitted: 2010-11-05
   Days after onset:151
Entered: 2010-11-08
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E31165 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adenovirus test, Autopsy, C-reactive protein normal, Cardiac arrest, Cyanosis, Death, Enterovirus test negative, Epistaxis, Histology abnormal, Hypotonia, Hypotonic-hyporesponsive episode, Inflammation, Influenza virus test negative, Interstitial lung disease, Irritability, Lumbar puncture normal, Lung infiltration, Lymphocyte percentage increased, Myocardial infarction, Myocarditis, Pulmonary oedema, Pyrexia, Respiratory syncytial virus test negative, Resuscitation, Skin warm, Sudden infant death syndrome, Viral infection, Viral test negative, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), 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: Concomitant therapy included Omeprazole, Dimeticone and Domperidone.
Current Illness: The patient''s concurrent illness includes gastrooesophageal reflux disease treated with anti-regurgitation mil, DOMPERIDONE, MOPRAL and DIMETICONE.
Preexisting Conditions: The patient was born at full-term with a past history of foetal macrosomia, foetal arrhythmia and gastroenteritis (at the end of Apr-2010). He was uneventfully vaccinated with 3 doses of INFANRIX-QUINTA in Feb, Mar and Apr-2010 and he also received BCG vaccine in Jan-2010. The patient was full-term born at 39 weeks of pregnancy +5 days by cesarean section because of macrosomia and abnormal foetal cardiac rhythm. His born weight was 4430 g, born height 50 cm and born cranial perimeter 36 cm.
Allergies:
Diagnostic Lab Data: In Jun-2010 test results were: white blood cell count (results: 39000 cells with 90% lymphocytes); c-reactive protein (results: normal); and lumbar puncture (results: normal). On 10-Jun-2010 test results were: histology (results: was suggestive of viral origin); laboratory test (results: routine examinations found no virus including no Respiratory syncytial virus, Influenza virus, Para-influenza virus, Adenovirus or Enterovirus.); and autopsy (results: Histology of lungs found some intra-alveolar oedema and presence of interstitial lymphocytic inflammatory infiltrate and some foci of food inhalation without contact inflammatory reaction. Moderate lymphocytic inflammatory infiltrate was found in the proximal bronchi; examination of the heart showed presence of several foci of interstitial lymphocytic inflammatory infiltrate of myocardium, sometimes accompanied by necrosis of cardiomyocytes. No viral inclusion. Focal myocardial fibres of ischemic aspect were also found of non-systemic repartition. These cardiac lesions showed histological aspect of lymphocytic myocarditis. By conclusion of the autopsy, the patient was found to have viral-type inflammatory lesions in the upper airways and in myocardium, so that diagnosis of interstitial lymphocytic pneumopathy and lymphocytic myocarditis were done.).
CDC Split Type: FRWYEG06307810

Write-up: Follow-up information was received from a foreign regulatory authority regarding the patient''s medical history, product details and autopsy results providing causes of death. Information regarding PREVENAR was received from a healthcare professional via a foreign regulatory authority regarding a 5-month-old male patient who experienced suspected fever, interstitial lymphocytic pneumonia, lymphocytic myocarditis, grumbling and sudden infant death. The patient received the first dose on 07-Jun-2010. 07-Jun-2010, the patient was well and physical examination was normal before vaccination. On 07-Jun-2010 in the evening, the patient was grumbling and he was found warm. Despite body temperature was not measured, fever was suspected and the patient was given one suppository of DOLIPRANE (dose unknown). The patient had not presented any further event during the night. On 08-Jun-2010 in the morning the patient was well. At 08:00 am, he was given his bottle feeding; he drank well and his behaviour was normal. At 10:30 am, he slept in his baby-carriage in semi-sit position. At 11:40 am, he was still in the same semi-sit position, but was cyanosed, dead-still, areactive and very hypotonic. When the emergency staff arrived, the patient was in cardio-circulatory arrest and had bloody serosity in nose. The patient unsuccessfully received cardiac resuscitation. He was diagnosed with sudden death while taking a nap at his wet-nurse home. Autopsy was performed on 10-Jun-2010, which found no signs of trauma and no cardiac malformation. Upper airways were free. Histology of lungs found some intra-alveolar oedema and presence of interstitial lymphocytic inflammatory infiltrate and some foci of food inhalation without contact inflammatory reaction. Moderate lymphocytic inflammatory infiltrate was found on the proximal bronchi; examination of the heart showed presence of several foci of interstitial lymphocytic inflammatory infiltrate of myocardium, sometimes accompanied by necrosis of cardiomyocytes. No viral inclusion. Focal myocardial fibres of ischemic aspect were also found of non-systematic repartition. These cardiac lesions showed histological aspect of lymphocytic myocarditis. By conclusion of the autopsy, the patient was found to have viral-type inflammatory lesions in the upper airways and in myocardium, so that diagnosis of interstitial lymphocytic pneumonia and lymphocytic myocarditis were done. These lesions could have been responsible for the patient''s death since they were susceptible to generate cardiac rhythm disorders. Results of histology were suggestive of viral origin. However, routine examinations found no virus including no Respiratory syncytial virus, Influenza virus, Para-influenza virus, Adenovirus or Enterovirus. The cause of death was reported as sudden infant death syndrome and the autopsy cause of death was myocarditis and interstitial lung disease. No additional information was available at the time of this report.


VAERS ID: 407697 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-27
Onset:0000-00-00
Submitted: 2010-11-08
Entered: 2010-11-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA637AA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Infection, Product quality issue
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-30
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: A0890390A

Write-up: This case was reported by a nurse via a sales representative and described the occurrence of death nos in an adult male subject who was vaccinated with FLUVIRAL (GlaxoSmithKline). On 27 October 2010 the subject received unspecified dose of FLUVIRAL (unknown). On 30 October 2010, three days after vaccination with FLUVIRAL, the subject experienced death nos. This was also considered a pharmaceutical product complaint. The subject died on 30 October 2010 from death nos. It was unknown whether an autopsy was performed. Additional information received from the sales representative on 3 November 2010 indicated that infection (onset date not specified) was suspected as a possible cause of death, and that an autopsy was going to be performed.


VAERS ID: 407943 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-09
Onset:2010-10-09
   Days after vaccination:0
Submitted: 2010-11-11
   Days after onset:33
Entered: 2010-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-09
   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: Diltiazem hydrochloride; Tiotropium; Allopurinol; Symbicort; Carbocisteine; Isosorbide mononitrate; Ramipril; Salbutamol sulphate; Nicotine
Current Illness: Ischemic heart disease; unwell
Preexisting Conditions: Myocardial infarction
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0682334A

Write-up: This case was reported by a physician via the regulatory authority (GB-MHRA-ADR 20728958) and described the occurrence of sudden death in a 78-year-old male patient who was vaccinated with FLUARIX. The patient''s medical included myocardial infarction. Concurrent medical conditions included ischemic heart disease and unwell. Concurrent medications included diltiazem, nitroglycerine (GTN), co-codamol, aspirin, clopidogrel, simvastatin, tiotroprium, allupurinol, SYMBICORT, carbocisteine, isosorbide mononitrate, ramipril, salbutamol sulphate, and nicotine. On 09 October 2010 the patient received an unspecified dose of FLUARIX (.5ml, intramuscular). On the same day 09 October 2010, the patient was fine after receiving the FLUARIX but 4.5 hours after vaccination with the FLUARIX, the subject experienced sudden death. Health authorities reported that the patient did not experience any anaphylactic reaction immediately after receiving the FLUARIX. An autopsy was performed. The pathologist did not feel that a post-mortem would provide information that would narrow down any possible reaction to flu jab. It was reported that the ''death was not felt to be linked to FLAURIX. from the history it was felt that the patient died from the natural causes rather than a reaction to the FLUARIX. Advised to report incident, but death is not felt to be linked to flu jab. Received ''flu jab and was fine after injection, but four and a half hours later died at home lying on their bed. Had a history of ischaemic heart disease and myocardial infarction eight months previously. From history it was felt they died from natural causes rather than reaction to ''flu jab (coroner in agreement). No anaphylactic reaction immediately after the ''flu jab. Spouse reported they had not been well for some time. Pathologist did not feel a post-mortem would provide information that would narrow down any possible reaction to ''flu jab. Coroner not aware of any link between flu jab and sudden death.


VAERS ID: 408214 (history)  
Form: Version 1.0  
Age: 0.7  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-11-12
Entered: 2010-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activated partial thromboplastin time prolonged, Acute hepatic failure, Alanine aminotransferase increased, Anti-HBc IgM antibody positive, Asterixis, Bacterial test negative, Bilirubin conjugated increased, Blood HIV RNA increased, Blood bilirubin increased, Blood lactate dehydrogenase increased, Brain oedema, CD4 lymphocytes decreased, CSF culture negative, CSF glucose normal, CSF lymphocyte count, CSF protein normal, Chest X-ray abnormal, Coagulopathy, Computerised tomogram abnormal, Convulsion, Death, Haemorrhage, Hepatic cirrhosis, Hepatic encephalopathy, Hepatic function abnormal, Hepatitis B, Hepatitis B surface antigen positive, Hepatotoxicity, Immune reconstitution syndrome, International normalised ratio increased, Liver function test abnormal, Lymphadenitis, Mental status changes, Mycobacterium tuberculosis complex test negative, Prothrombin time prolonged, Scan brain, Vaccination failure
SMQs:, 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), Liver infections (narrow), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Biliary system related investigations, signs and symptoms (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Co-trimoxazole; Isoniazid; Rifampicin; Pyrazinamide; Ethambutol; Ciprofloxacin; Amikacin; Ethambutol
Current Illness: HIV ENCEPHALOPATHY; MYCOBACTERIUM TUBERCULOSIS
Preexisting Conditions: Bacille Calmette Guerin Vaccination; post-mortem biopsies; Cirrhosis of liver; No granulomas and granulomatous lesions in lymph node; Auramin stain and mycobacterial culture - negative
Allergies:
Diagnostic Lab Data: Alanine aminotransferase, 107IU/L; Alanine aminotransferase, 2418IU/L; Bilirubin direct, 112mmol/L; Bilirubin direct, 92mmol/L; Bilirubin total, 269mmol/L; Bilirubin total, 158mmol/L; CD4 lymphocytes, 0.78%; CD4 lymphocytes, 6.5%; CD4 lymphocytes, 6.6%; HIV viral load, 13000copies/mL; HIV viral load, 690000copies/mL; International normalized ratio, 1.63; International normalized ratio, greater than 10; Lactate dehydrogenase, 2942IU/L; Prothrombin time, greater than 120; partial thromboplastin time 127 s; brain CT scan - cerebral edema no hemorrhage; cerebral spinal fluid - 420 lymphocytes/mm^3, normal protein 0.34 g/L, normal glucose 3.3 mmol/L, negative cultures for bacteria and M.tuberculosis; hepatitis serology - positive surface Ag, core IgM and hepatitis B e Ag (HBeAg); chest x-ray - hilar lymph nodes and bilateral patchy changes present
CDC Split Type: B0683935A

Write-up: This case was reported in a literature article and described the occurrence of hepatitis b in a 8-month-old female patient who received zidovudine (brandname/tradename unknown) for human immunodeficiency virus infection. Concurrent medical conditions included HIV encephalopathy and mycobacterium tuberculosis. The patient also received HEBERBIOVAC 10ug at 6, 10 and 14 weeks of life. Co-suspect medication included Lamivudine (brandname/tradename unknown), Lopinavir + ritonavir, Ritonavir and BCG vaccine. Concurrent medications included Cotrimoxazole, Isoniazid, Rifampicin, Pyrazinamide, Ethambutol, Ciprofloxacin and Amikacin. Her CD4 count and HIV viral load prior to receiving combination anti-retroviral therapy (cART) were 0.78% and 690000 copies/ml respectively. On an unknown date seven weeks after starting anti-tuberculosis (TB) therapy, the patient received cART consisting of zidovudine (unknown), lamivudine, lopinavir/ritonavir boosted with additional ritonavir. Approximately six weeks after starting cART, she developed acute liver failure with hepatic encephalopathy (altered mental status, hepatic flap and seizures). Her baseline liver function tests were normal, but her alanine aminotransferase, total bilirubin, direct bilirubin and lactate dehydrogenase had increased to 2418 IU/L, 269 mmol/L, 112 mmol/L and 2942 IU/L respectively. Coagulopathy was present with an international normalised ratio (INR) of greater than 10, prothrombin time greater than 120s and partial thromboplastin time of 127s. A brain CT showed cerebral edema but no hemorrhage. Cerebral spinal fluid showed 420 lymphocytes/mm^3 with normal protein (0.34g/L), normal glucose (3.3 mmol/L) and cultures for bacteria and M. tuberculosis were negative. Toxicity to treatment was suspected and cART and TB treatment were stopped. She received supportive treatment consisting of fresh dried plasma, vitamin K, lactulose, fluid management and control of seizures and hypoglycemia. Hepatitis serology showed a positive surface Ag, core IgM and hepatitis B e Ag (HBeAg). Her CD4 level had increased to 6.6 % and her viral load was 13000 copies/mL. One month later, there was a slight improvement of the liver function tests (ALT 107 Iu/L, total bilirubin 158 mmol/L, direct bilirubin 92 mmol/L) and INR 1.63. She received non-hepatotoxic anti-TB drugs consisting of ciprofloxacin, amikacin and ethambutol. In addition, her cART drugs, isoniazid and rifampicin were also re-started. Unfortunately, her liver function deteriorated. She had a persistent coagulopathy which required multiple blood and fibrinogen degradation product transfusion and daily vitamin K injections. Despite reverting to less hepatotoxic anti-TB drugs again, the patient died three months later due to liver failure plus severe diffuse bleeding. Ten days prior to her death (and five months after starting cART), worsening of her right axillary lymphadenitis was noted. Chest x-rays showed hilar lymph nodes and bilateral patchy changes. Post-mortem analysis showed liver cirrhosis without granulomas or granulomatous lesions in the lymph node. Auramin stain and mycobacterial cultures were negative and the CD4 level was 6.5%. The author considered the events were related to treatment with Zidovudine, lamivudine and the other cART agents. They commented "hepatotoxicity is common after initiation of cART in HIV-infected patients...hepatotoxicity generated minimal morbidity and was rarely fatal, but concomitant TB therapy and HBsAg significantly increased the risk of hepatotoxicity. Our patient had both risk factors for hepatotoxicity." They also commented "the less probable figure that the child horizontally acquired HBV after receiving three documented immunizations we could hypothesize HBV vaccine failure...we postulate that our patient developed IRIS (immune reconstitution inflammatory syndrome) to HBV and BCG. The timing of liver failure, 7 weeks after initiating cART and the enlarging right axillary nodes after 3 months, together with evidence of virological and immunological response to cART are supportive of this".


VAERS ID: 409228 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-01
Onset:0000-00-00
Submitted: 2010-11-17
Entered: 2010-11-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Culture positive, Death neonatal, Fontanelle depressed, Lumbar puncture abnormal, Malaise, Meningitis pneumococcal
SMQs:, Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Neonatal disorders (narrow), Respiratory failure (broad), Dehydration (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Spinal tap and cultures (date unknown): Results of both of these tests confirmed pneumococcal meningitis infection, no units provided.
CDC Split Type: 2010144167

Write-up: Case Description: This is a report of a spontaneous adverse event involving PREVENAR reported to a Pfizer sales representative by a contactable physician. This case is of a 6-week-old male patient who was given his first vaccines at 6 weeks on an unknown date last month (OCT2010). The vaccines given were PREVENAR, PENTAXIM and ROTARIX. Later on the same day the child got sick and the mother was advised to given PANADO after the onset of meningitis-(treatment received). The following day the baby got sicker and was taken to the doctor. On examination, the fontanel was already sunken. Cultures and spinal tapping were conducted. Pneumococcal meningitis was confirmed. The baby also experienced malaise. The treating physician believes that the baby was infected prior to vaccinations judging by the severity of the symptoms and given the incubation period, vaccines had nothing to do with this case. The patient died on an unknown date in 2010. It is unknown if an autopsy was performed and the reported cause of death was pneumococcal meningitis. Case Comment: Based on the information currently available, the company agrees with the assessment of the reporting physician and does not attribute the events to PREVENAR.


VAERS ID: 409237 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-11-18
Entered: 2010-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR - / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Culture positive, Death, Fontanelle depressed, Lumbar puncture abnormal, Malaise, Mechanical ventilation, Meningitis pneumococcal
SMQs:, Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Neonatal disorders (narrow), Respiratory failure (broad), Dehydration (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0684242A

Write-up: This case was reported by a physician and described the occurrence of pneumococcal meningitis in a 6-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), (non-GSK) PREVENAR and DTPA-POLIO-HIB (non-GSK). On an unspecified date the subject received 1st dose of ROTARIX (oral), 1st dose of PREVENAR (unknown route), 1st dose of DTPA-POLIO-HIB (Non-GSK) (unknown route). Lot numbers were not provided. Less than one day after vaccination with DTPA-POLIO-HIB (Non-GSK), PREVENAR and ROTARIX, the subject became sick and the mother was advised to give the baby PARACETAMOL (treatment received). The following day the baby''s condition worsened and was taken to the doctor. On examination, the fontanel was already sunken. Cultures and spinal tap were conducted. Pneumococcal meningitis was confirmed. The subject was treated with PARACETAMOL and mechanical ventilation. The physician considered the events were unrelated to vaccination with ROTARIX, PREVENAR and DTPA-POLIO-HIB (Non-GSK). The subject died from pneumococcal meningitis. It was unknown whether an autopsy was performed. The treating physician believed that the baby was infected prior to vaccinations. Judging by the severity of the symptoms and given the intubation period, the physician considered the vaccines had nothing to do with the case.


VAERS ID: 409239 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-11-10
Onset:2010-11-10
   Days after vaccination:0
Submitted: 2010-11-18
   Days after onset:8
Entered: 2010-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-10
   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: B0684542A

Write-up: This case was reported by a physician and described the occurrence of sudden death in a 6-month-old subject of unspecified gender who was vaccinated with INFANRIX-POLIO (GlaxoSmithKline), haemophilus influenzae type b vaccine (non-GSK). The subject was healthy and had no relevant medical history and no reaction to previous vaccinations. On 10 November 2010 the subject received 3rd dose of INFANRIX-POLIO (unknown route, unknown injection site), 2nd dose of Haemophilus influenzae type b vaccine (Non-GSK) (unknown route, unknown injection site). Lot numbers were not provided. On 10 November 2010, less than one day after vaccination with Haemophilus influenzae type b vaccine (Non-GSK) and INFANRIX-POLIO, the subject experienced sudden death. The subject died on 10 November 2010, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 409366 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Male  
Location: Foreign  
Vaccinated:2010-09-13
Onset:0000-00-00
Submitted: 2010-11-11
Entered: 2010-11-18
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA740A / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E34002 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis
SMQs:, Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-09-25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2010142291

Write-up: This a spontaneous report received from a foreign Regulatory Authority report number NL-LRB-111158, RIVM number NL-RIVM-2010-01.229. This contactable physician reported that a 56-day old male patient started to receive PREVENAR and INFANRIX HEXA on 13Sep2010. The reporter specified that the patient received his first immunizations of both products in the Childhood Immunization programme. Medical history and comedication were not reported. Twelve days after the vaccinations the patient died, supposedly due to meningitis. Hospital report was not received at the time of this report (29Oct2010).


VAERS ID: 409823 (history)  
Form: Version 1.0  
Age: 1.35  
Sex: Male  
Location: Foreign  
Vaccinated:2010-11-06
Onset:2010-11-08
   Days after vaccination:2
Submitted: 2010-11-23
   Days after onset:15
Entered: 2010-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IJ
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Biopsy brain abnormal, Death, Diarrhoea, Intensive care, Meningitis pneumococcal, Meningitis viral, Streptococcus test positive
SMQs:, Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-10
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Biopsy brain, Nov2010, positive. Postmortem meningeal biopsy found positive results for pneumococcus. Phenotyping was ongoing.
CDC Split Type: B0684786A

Write-up: This case was reported by a pharmacist and described the occurrence of viral meningitis in a sixteen-month-old male subject who was vaccinated with PRIORIX (GlaxoSmithKline), and INFANRIXQUINTA. Medical history and concurrent medications were unspecified. On 06 November 2010, the subject received an unspecified dose of PRIORIX (injection) (unknown route, batch and injection site) and an unspecified dose of INFANRIXQUINTA (injection) (unknown route, batch and injection site). On 08 November 2010, two days after vaccination with INFANRIXQUINTA and PRIORIX, the subject experienced viral meningitis and severe diarrhea. The subject was hospitalised. He was treated with TIORFAN, oral ADIARIL and DOLIPRANE. On 10 November 2010, the subject died of not contagious viral meningitis. It was unknown whether an autopsy was performed. At the time of reporting, the outcome of the event diarrhea was unknown and the outcome of the event viral meningitis was fatal. Causality assessment was not provided. Follow-up received on 17 November 2010 from the physician of Intensive Care Unit: Upon follow-up information, postmortem meningeal biopsy found positive results for pneumococcus. Phenotyping was ongoing. Diagnosis of pneumococcal meningitis was made. The reporter assessed the causal relationship of pneumococcal meningitis with PRIORIX and INFANRIXQUINTA as unrelated. Causality assessment of diarrhea was unknown.


VAERS ID: 410055 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-04-07
Onset:2010-04-07
   Days after vaccination:0
Submitted: 2010-11-23
   Days after onset:230
Entered: 2010-11-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER UH001AH / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-04-07
   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:
Current Illness:
Preexisting Conditions: The patient presented diarrhea 15 days before vaccination. No corrective treatment was given to the patient for the diarrhea.
Allergies:
Diagnostic Lab Data: not reported
CDC Split Type: 201006585

Write-up: This case report is part of a batch of several hundred reports associated with H1N1 vaccine, that was received by sanofi pasteur affiliate under local case reference number BR2010-723 from foreign Institute who received these reports on 08 November 2010 from the "Ministry of Health". A 2-year-old male patient, with a medical history of diarrhea 15 days before vaccination, experienced unexpected sudden death the same day he had received his injection of H1N1 vaccine package (batch number UH001AH, number in series, route and site of administration not reported) on 7 April 2010. No concomitant vaccine was administered at the time of immunization. Sanofi pasteur Inc. lot number is UH001AH and the corresponding lot number allocated at packaging is 1003060. It was reported that the mother was inattentive to the patient. The days care center reported that the patient presented with diarrhea 15 days before immunization but the mother refused to treat him. The patient''s mother had some troubles with social services because of bad treatment of her child and inattentiveness. No corrective treatment was reported. The reporter stated that the status of the case was "descarted" (i.e. the event was not related to the vaccine). Documents held by sender: none.


VAERS ID: 410308 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Unknown  
Location: Foreign  
Vaccinated:2010-11-09
Onset:2010-11-09
   Days after vaccination:0
Submitted: 2010-11-25
   Days after onset:16
Entered: 2010-11-29
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR D9841 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical, no family nor immunization history reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201006586

Write-up: Case received from the Health Authority through the WHO and through the local affiliate (local reference number not reported) on 15 November 2010. A 6-month-old patient, with no medical history reported, experienced SIDS (Sudden death infant syndrome) on 9 November 2010, on the day he had received a dose of ACTHIB (batch number D9841-1, number in series, route and site of administration not reported) and DTaP-IVP vaccine (manufacturer unknown, batch number, number in series, route and site of administration not reported). No corrective treatment was reported. Outcome was fatal. Extensive testing would be performed. At the time of reporting, the cause of death was unknown. Documents held by sender: none.


VAERS ID: 410672 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2010-10-13
Onset:2010-10-14
   Days after vaccination:1
Submitted: 2010-11-29
   Days after onset:46
Entered: 2010-11-30
   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: Blood pH decreased, Blood pH increased, Cell marker, Computerised tomogram abnormal, Condition aggravated, Death, Inflammatory marker increased, Interstitial lung disease, Laboratory test, Lung infiltration, PCO2 decreased, PO2 decreased, Pyrexia, Sputum culture
SMQs:, Asthma/bronchospasm (broad), Lactic acidosis (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-11
   Days after onset: 28
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: PASIL; Unk - Unk;cefazolin sodium; Unk - Unk; meropenem; Unk - Unk; piperacillin sodium; Unk - Unk
Current Illness: Chronic obstructive pulmonary disease; Intervertebral disc protrusion; Dementia; Deep vein thrombosis
Preexisting Conditions: Interstitial lung disease; Myocardial infarction; Cerebral infarction; Hypertension; Subdural haematoma
Allergies:
Diagnostic Lab Data: Computed axial tomography, ground-glass opacity and infiltrative shadow; Serum Krebs Von Den Lunge-6 test, ??10; 429 U/mL; Arterial blood PO (2), 28Oct10, 62.6 mmHg; Arterial blood pCO(2), 28Oct10, 33.7 mmHg; Arterial blood pH, 28Oct10, 7.408; Arterial blood PO (2), 01Nov10, 44.3 mmHg; Arterial blood pCO (2), 01Nov10, 31.5 mmHg; Arterial blood pH, 01Nov10, 4.404; Arterial blood PO (2), 04Nov10, 70.6 mmHg; Arterial blood pCO (2), 04Nov10, 35.1 mmHg; Arterial blood pH, 04Nov10, 7.332; Arterial blood PO (2), 07Nov10, 84.7 mmHg; Arterial blood pCO (2), 07Nov10, 44.6 mmHg; Arterial blood pH, 07Nov10, 7.359; Arterial blood PO (2), 08Nov10, 63.6 mmHg; Arterial blood pCO (2), 08Nov10, 45.3 mmHg; Arterial blood pH, 08Nov10, 7.393
CDC Split Type: WAES1011USA02001

Write-up: Initial and follow-up information has been received from a physician concerning a 92 year old male patient with chronic obstructive pulmonary disease (COPD), lumbar disc herniation, dementia, deep vein thrombosis and a history of interstitial pneumonia, myocardial infarction, late effects of cerebral infarction, hypertension, chronic subdural haematoma who on 13-OCT-2010 was vaccinated with PNEUMOVAX 23 (dose, indication, route and site unknown). Other suspect therapy included PREDONINE tablet, 30 mg once a day started on 28-OCT-2010 (indication not reported), SOL-MELCORT injection drug, 500 mg once a day started on 04-NOV-2010 (indication not reported) and SOL-MELCORT 125 mg once a day started on 07-NOV-2010 (indication not reported). No information on other concomitant medications was provided. On 14-OCT-2010, fever over 38 degrees C persisted. Antibiotics (cefazolin sodium, piperacillin sodium, PASIL were administered but there was no effect. On 26-OCT-2010, the patient was transferred with referral to the reporting physician''s hospital. CT showed ground-glass opacity and infiltration shadow, which confirmed the presence of interstitial pneumonia. On an unspecified date, KL-6 was 429U/mL. On an unspecified date, inflammatory markers, sputum culture and collagen disorder-related tests were performed for differential diagnosis (results not reported). On 28-OCT-2010, PaO2, 62.6; PaCO2, 33.7; pH, 7.408. Therapy with PREDONINE 30 mg once a day was initiated. A gradual worsening was observed despite steroid administration. On 01-NOV-2010, PaO2, 44.3; PaCO2, 35.5; pH, 7.404. On 04-NOV-2010, PaO2, 70.6; PaCO2, 35.1; pH 7.332. PREDONINE was discontinued and SOL-MELCORT 500 mg once a day was started. On 07-NOV-2010, PaO2, 84.7; PaCO2, 44.6; pH 7.359. The dose of SOL-MELCORT was changed to 125 mg once a day. On 08-NOV-2010, PaO2, 63.6; PaCO2, 45.3 and pH 7.393. On 11-NOV-2010, the patient died. No information on autopsy was provided. Pyrexia occurred from the next day of the inoculation of vaccine. It is highly likely that this vaccine affected the clinical course. The reporting physician considered that pyrexia and interstitial pneumonia were serious due to death. The reporting physician felt that pyrexia and interstitial pneumonia were definitely related to PNEUMOVAX 23, PREDONINE and SOL-MELCORT. Additional information has been requested. Follow-up information: Seriousness for pyrexia has been changed from serious as hospitalization to as death. Relationship has been changed from "possibly related" to "definitely related".


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