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Found 2285 cases where Vaccine is BCG or DT or HEPAB or MMR or OPV or TYP and Symptom is Immune system disorder or Immunodeficiency or Immunoglobulins decreased or Lymphadenopathy

Case Details (Sorted by Age)

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VAERS ID: 27782 (history)  
Age: 0.7  
Gender: Male  
Location: Maryland  
Vaccinated:1990-09-13
Onset:1990-09-15
   Days after vaccination:2
Submitted: 1990-09-17
   Days after onset:2
Entered: 1991-02-06
   Days after submission:142
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / LEDERLE LABORATORIES 238900 / 2 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Angioneurotic oedema, Asthma, Convulsion, Deafness, Lymphadenopathy, Pyrexia, Stupor
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Oropharyngeal allergic conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: on apnea monitor~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: 15SEP90; WBC 13.1; 15SEP90 T.C. normal
CDC Split Type: MD90116

Write-up: Fever 105.0, adenopathy (neck), angioneurotic edema, asthma, marked alteration in LOC, 2 convuls, short term hearing loss.


VAERS ID: 28195 (history)  
Age: 0.2  
Gender: Male  
Location: South Carolina  
Vaccinated:1989-10-11
Onset:1989-10-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 1991-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES 256959 / - - / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 238940 / - - / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site reaction, Lymphadenopathy, Screaming
SMQs:, Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 900170101

Write-up: CDC reports: 2 mo infant developed adenopathy at inject site area & screaming episode for more than 4 hrs following DTP/OPV immunization. Hospitalized 1 day. Child to receive DT only in future.


VAERS ID: 28667 (history)  
Age: 0.4  
Gender: Male  
Location: Kansas  
Vaccinated:1989-09-19
Onset:1989-09-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 1991-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES 9G01042 / - - / A
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / - - / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site reaction, Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions: NA
Diagnostic Lab Data: NA
CDC Split Type: CO3305

Write-up: Local rxn w/local adenopathy;


VAERS ID: 31607 (history)  
Age: 0.8  
Gender: Male  
Location: Unknown  
Vaccinated:1991-03-14
Onset:1991-03-22
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 1991-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 0 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anorexia, Lymphadenopathy, Lymphocytosis, Pharyngitis
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: HibTITER
Current Illness:
Preexisting Conditions: no relevant hx.
Diagnostic Lab Data: Lymphocyte count - 80%.
CDC Split Type: WAES91040025

Write-up: pt. recvd. vax & later developed diffuse lymphadenopathy w/ palpable nodes in inguinal,occipital,& cervical areas.


VAERS ID: 33527 (history)  
Age:   
Gender: Unknown  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 1991-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Lymphadenopathy, Tooth abscess
SMQs:, Osteonecrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: UNK
Current Illness:
Preexisting Conditions: No relevant hx
Diagnostic Lab Data: No relevant data
CDC Split Type: WAES90101379

Write-up: Pt exp mumps p/vax w/MMR;


VAERS ID: 31677 (history)  
Age: 0.0  
Gender: Female  
Location: California  
Vaccinated:1991-04-15
Onset:1991-04-27
   Days after vaccination:12
Submitted: 1991-06-19
   Days after onset:53
Entered: 1991-06-24
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0695S / 0 - / SC

Administered by: Public       Purchased by: Public
Symptoms: Arthralgia, Lymphadenopathy, Paraesthesia, Rash, Urticaria, Vasodilatation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: CA9153

Write-up: Following vax pt felt hot, no temp measured; rash other than @ inject site, generalized adenopathy, hives, pain in joints, tenderness in joints, paresthesis continues as of 20MAY91;


VAERS ID: 32499 (history)  
Age: 0.3  
Gender: Male  
Location: Pennsylvania  
Vaccinated:1990-08-20
Onset:1991-01-14
   Days after vaccination:147
Submitted: 1991-04-22
   Days after onset:97
Entered: 1991-07-12
   Days after submission:81
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 271954 / 1 - / -

Administered by: Private       Purchased by: Private
Symptoms: Globulins decreased, Immune system disorder, Myocarditis, Paralysis flaccid, Poliomyelitis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 90 days
   Extended hospital stay? No
Previous Vaccinations: Pt exp fever x 24hrs p/2nd dose of OPV @ 3.5mo;~ ()~~~In patient
Other Medications:
Current Illness: Fever x 24hrs p/2nd dose
Preexisting Conditions: NONE
Diagnostic Lab Data: Culture bopsy reveals polio type 2;
CDC Split Type: PA91225

Write-up: Pt vaxed w/ 1st & 2nd dose;of DTP/OPV on 29JUN90 &20AUG90 respectively & exp viral myocarditis 14JAN91 admitted to Hosp; Culture biopsy reveals polio type 2, now has flaccid paralysis & graft versus host disease; Dx w/hypogammaglobulinemia;


VAERS ID: 35689 (history)  
Age: 0.2  
Gender: Male  
Location: Virginia  
Vaccinated:1991-08-05
Onset:1991-08-07
   Days after vaccination:2
Submitted: 1991-10-02
   Days after onset:56
Entered: 1991-10-21
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES 304924 / 0 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH M580HC / 0 RL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 304954 / 0 - / PO

Administered by: Public       Purchased by: Public
Symptoms: Agitation, Injection site oedema, Lymphadenopathy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: VA91083

Write-up: PC from MD, pt temp 101; pt would cry but no sound would come out of mouth; some local adenopathy @ inject site of DTP;


VAERS ID: 36352 (history)  
Age: 0.4  
Gender: Male  
Location: Arkansas  
Vaccinated:1991-01-02
Onset:1991-01-03
   Days after vaccination:1
Submitted: 1991-01-10
   Days after onset:7
Entered: 1991-11-14
   Days after submission:308
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES 293950 / 0 RL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0617F / 0 - / PO

Administered by: Public       Purchased by: Public
Symptoms: Cough, Crying, Injection site reaction, Lymphadenopathy, Pyrexia, Rash, Screaming, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: AR912

Write-up: Low grade fever (99.8F), local rxn, rash other than @ inject site, adenophy generalized, abnormal crying $g4 hrs, vomiting; c/o coughing x 10 days;


VAERS ID: 40527 (history)  
Age: 0.3  
Gender: Male  
Location: Washington  
Vaccinated:1991-12-16
Onset:1991-12-16
   Days after vaccination:0
Submitted: 1992-01-06
   Days after onset:21
Entered: 1992-03-23
   Days after submission:77
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES 306924 / 1 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH M680HE / 1 LL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 308957 / 1 - / PO

Administered by: Private       Purchased by: Public
Symptoms: Atelectasis, Haemorrhage, Hepatocellular damage, Lymphadenopathy, Petechiae, Pulmonary oedema, Spleen disorder, Sudden infant death syndrome
SMQs:, Cardiac failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 1991-12-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NA~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: WA92673

Write-up: SIDS found dead in crib;


VAERS ID: 40604 (history)  
Age: 0.2  
Gender: Male  
Location: Virginia  
Vaccinated:1988-08-29
Onset:1988-08-29
   Days after vaccination:0
Submitted: 1992-03-19
   Days after onset:1298
Entered: 1992-03-27
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES 214950 / 0 - / L
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 205608 / 0 - / PO

Administered by: Public       Purchased by: Other
Symptoms: Agitation, Bone disorder, Crying, Immune system disorder, Lymphadenopathy, Neoplasm, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: dx immune system def called histiocytosis-x-hands christian shuller disease;
CDC Split Type:

Write-up: High pitched crying, fever, large lymphnodes appearance x 5 days, not able to eat because of crying so much; lasted a period of days; pt taken to MD & told nothing was wrong, sx still occured & worsened; irritable behavior, jump in sleep;


VAERS ID: 41988 (history)  
Age: 0.2  
Gender: Male  
Location: Ohio  
Vaccinated:1992-03-05
Onset:1992-03-17
   Days after vaccination:12
Submitted: 1992-03-25
   Days after onset:8
Entered: 1992-05-15
   Days after submission:50
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES 316975 / 0 RL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 306956 / 0 - / PO

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: OH92026

Write-up: temp up & down from date of vax until 17MAR92 when mom found swollen gland neck & temp of 101;


VAERS ID: 42047 (history)  
Age: 0.2  
Gender: Unknown  
Location: Michigan  
Vaccinated:1992-04-30
Onset:1992-05-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 1992-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH TR1217A / 0 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH M190HK / 0 LL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0643L / 0 - / PO

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Atelectasis, Bronchitis, Cardiac arrest, Cyanosis, Lymphadenopathy, Petechiae, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 1992-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions: pt had a UTI 1st wk of life;
Diagnostic Lab Data:
CDC Split Type:

Write-up: @ 5AM on 1MAY92 pt was fed & put to sleep, 45 min later pt was foun blue & not breathing; despite CPR & ALLS rescue techniques pt died;


VAERS ID: 37454 (history)  
Age:   
Gender: Unknown  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 1992-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / -

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES91070269

Write-up: Pt recvd MMR vax & 3 wks later pt exp fever, adenopathy, & rash; no further details were provided;


VAERS ID: 44481 (history)  
Age: 0.2  
Gender: Male  
Location: Tennessee  
Vaccinated:1992-05-22
Onset:1992-05-26
   Days after vaccination:4
Submitted: 1992-06-03
   Days after onset:8
Entered: 1992-08-24
   Days after submission:82
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES 318907 / 0 LL / -
HIBV: HIB (HIBTITER) / PFIZER/WYETH M210HK / 0 RL / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0653B / 0 - / PO

Administered by: Public       Purchased by: Public
Symptoms: Asphyxia, Hypoxia, Lung disorder, Lymphadenopathy, Petechiae, Pulmonary oedema, Respiratory disorder
SMQs:, Cardiac failure (narrow), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 1992-05-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: TN9280

Write-up: autopsy results not back sudden infant death synd;


VAERS ID: 47818 (history)  
Age: 0.2  
Gender: Male  
Location: Oklahoma  
Vaccinated:1992-09-24
Onset:1992-09-28
   Days after vaccination:4
Submitted: 1992-12-02
   Days after onset:65
Entered: 1992-12-07
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES 326914 / 0 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH M150JA / 0 LL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / 0 - / -

Administered by: Private       Purchased by: Private
Symptoms: Enteritis, Hepatocellular damage, Laryngeal oedema, Lymphadenopathy, Petechiae, Respiratory disorder, Spleen disorder, Sudden infant death syndrome
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific inflammation (narrow), Neonatal disorders (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 1992-09-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: small for gestational age
Diagnostic Lab Data: autopsy ruled out other causes of death;
CDC Split Type:

Write-up: died SIDS 4 days p/vax;


VAERS ID: 49953 (history)  
Age: 0.5  
Gender: Male  
Location: North Carolina  
Vaccinated:1992-06-05
Onset:1992-06-15
   Days after vaccination:10
Submitted: 1993-01-05
   Days after onset:204
Entered: 1993-02-17
   Days after submission:43
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES 314957 / 1 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH M18HH / 1 LL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0653F / 1 - / PO

Administered by: Public       Purchased by: Public
Symptoms: Haemorrhage, Lymphadenopathy, Stupor, Sudden infant death syndrome
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? Yes
   Date died: 1992-06-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: NC93006

Write-up: pt expired (SIDS) on 15JUN92; pt did not awaken from afternoon nap; pt was not ill;


VAERS ID: 51431 (history)  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:1990-12-05
Onset:0000-00-00
Submitted: 1993-03-19
Entered: 1993-04-01
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -
CHOL: CHOLERA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Military       Purchased by: Military
Symptoms: Arthralgia, Asthenia, Laboratory test abnormal, Lymphadenopathy, Rash
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Anthrax;
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: pos cervical & ax lymp adenopathy; pos Bx-nonsnuclear infilt
CDC Split Type:

Write-up: rash hands, joint pains, fatigue, lymph node swelling;


VAERS ID: 51577 (history)  
Age: 0.6  
Gender: Female  
Location: Oklahoma  
Vaccinated:1993-02-09
Onset:1993-02-11
   Days after vaccination:2
Submitted: 1993-03-10
   Days after onset:27
Entered: 1993-04-05
   Days after submission:25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES 2A41126 / 1 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 150JA / 1 RL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 332973 / 1 - / PO

Administered by: Public       Purchased by: Public
Symptoms: Diarrhoea, Injection site hypersensitivity, Injection site mass, Leukocytosis, Lymphadenopathy
SMQs:, Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: xray of knot in lt neck, blood work w/ inc WBC (small amt);
CDC Split Type: OK9312

Write-up: severe diarrhea 2 days p/vax w/no fever; no fussiness; knot in lt parotid gland that involved lt side of face & neck; prev shots had no knots @ site of inject but this time both inject sites were red & hard x 3 days;


VAERS ID: 52338 (history)  
Age: 0.2  
Gender: Male  
Location: Colorado  
Vaccinated:1993-03-10
Onset:1993-03-16
   Days after vaccination:6
Submitted: 1993-04-19
   Days after onset:33
Entered: 1993-05-03
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES 2A41127 / 0 RL / IM
HEP: HEP B (FOREIGN) / MERCK & CO. INC. 0891T / 1 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH M585JD / 0 LL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0668M / 0 - / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Lung disorder, Lymphadenopathy, Pericarditis, Petechiae, Pneumonia, Pulmonary haemorrhage, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Acute central respiratory depression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: CO93030

Write-up: poss SIDS, bronchopneumonio, mild, respiratory, edema & endocarditis;


VAERS ID: 54411 (history)  
Age:   
Gender: Unknown  
Location: Illinois  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 1993-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / -

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES92100255

Write-up: Pt recvd vax & exp low grade fevers, skin rashes, swollen glands; No further details were provided;


VAERS ID: 56343 (history)  
Age: 0.4  
Gender: Female  
Location: California  
Vaccinated:1993-09-14
Onset:1993-09-14
   Days after vaccination:0
Submitted: 1993-09-22
   Days after onset:8
Entered: 1993-09-28
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES 342972 / 1 RL / -
HIBV: HIB (HIBTITER) / PFIZER/WYETH M110KA / 0 LA / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0690A / 1 - / PO

Administered by: Private       Purchased by: Private
Symptoms: Immune system disorder, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: complement specific immune complex 21 H;
CDC Split Type:

Write-up: pt recvd vax 14SEP93 & parents called that evening pt broke out w/rash all over; advised to bring pt to ER; In ER Atarax was given;


VAERS ID: 56871 (history)  
Age: 0.2  
Gender: Male  
Location: North Dakota  
Vaccinated:1993-10-05
Onset:1993-10-15
   Days after vaccination:10
Submitted: 1993-10-18
   Days after onset:3
Entered: 1993-11-01
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES 3J41063 / 3 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH M175HN / 3 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1690V / 0 RA / SC
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 679M1 / 2 - / PO

Administered by: Public       Purchased by: Public
Symptoms: Lymphadenopathy, Pyrexia, Scrotal oedema, Vasodilatation
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: ND93017

Write-up: t102, swollen glands on neck, red swollen scrotum, glands in genital area also swollen;


VAERS ID: 60401 (history)  
Age: 0.2  
Gender: Male  
Location: Michigan  
Vaccinated:1993-06-25
Onset:1993-06-28
   Days after vaccination:3
Submitted: 1994-02-02
   Days after onset:219
Entered: 1994-03-10
   Days after submission:36
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH TR1219B / 0 - / IM L
HIBV: HIB (HIBTITER) / PFIZER/WYETH M190JF / 0 - / IM L
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 340920 / 0 - / PO

Administered by: Public       Purchased by: Other
Symptoms: Anorexia, Crying, Drug ineffective, Immune system disorder, Infection, Leukopenia, Otitis media, Poliomyelitis
SMQs:, Haematopoietic leukopenia (narrow), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: Pt exp vax @ 2 mos w/OPV #1;~ ()~~~In patient
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt recvd vax & refused to drink formula also devel a fever, was fussy & t102.5; cont to scream a high pitched cry; viral meningitis; JUL93 devel ear infect; stool specimen & the spinal column fluid contained both type 1 & type 2 polio;


VAERS ID: 61813 (history)  
Age: 0.6  
Gender: Male  
Location: Illinois  
Vaccinated:1994-03-09
Onset:1994-03-09
   Days after vaccination:0
Submitted: 1994-03-10
   Days after onset:1
Entered: 1994-04-18
   Days after submission:38
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES 3F51124 / 2 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1414W / 2 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH M005KP / 2 RL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 368982 / 2 - / PO

Administered by: Public       Purchased by: Public
Symptoms: Crying, Injection site mass, Injection site oedema, Injection site pain, Lymphadenopathy, Pyrexia, Screaming, Vasodilatation
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type: IL94029

Write-up: onset of 1st sx t102.4; local react site lt leg; pain swelling, inc warmth induration of lump w/o abscess; adenopathy local (inject site area); screaming episode high pitch lasting 3 hrs;


VAERS ID: 62980 (history)  
Age: 0.3  
Gender: Male  
Location: Virginia  
Vaccinated:1990-09-26
Onset:1990-10-11
   Days after vaccination:15
Submitted: 1993-11-15
   Days after onset:1131
Entered: 1994-05-18
   Days after submission:183
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Private       Purchased by: Other
Symptoms: Arthritis, Drug ineffective, Immune system disorder, Immunoglobulins decreased, Infection, Muscle atrophy, Poliomyelitis, Pyrexia
SMQs:, Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: NA
Preexisting Conditions: NONE diagnosed @ time;
Diagnostic Lab Data: polio disability;
CDC Split Type:

Write-up: recpvered w/polio disability; pt developed fever, rash, then lost use of legs; devel arthritis of both knees; polio dx''d, then found Bruton''s agammaglobulinemia; undergoing PT; walks, but rt leg has muscle atrophy;


VAERS ID: 65536 (history)  
Age:   
Gender: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 1994-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / -

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES93060269

Write-up: pt recvd vax & devel submandibular gland swelling; No further details were provided;


VAERS ID: 63380 (history)  
Age: 0.3  
Gender: Male  
Location: California  
Vaccinated:1994-03-31
Onset:1994-04-08
   Days after vaccination:8
Submitted: 1994-05-24
   Days after onset:46
Entered: 1994-06-13
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 358918 / 1 - / -
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 1268B2 / 1 - / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 364978 / 1 - / -

Administered by: Private       Purchased by: Private
Symptoms: Anaemia, Diarrhoea, Haemolysis, Haemolytic anaemia, Hypochromic anaemia, Immune system disorder, Pallor, Somnolence
SMQs:, Haemolytic disorders (narrow), Haematopoietic erythropenia (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: Blood tests, bone marrow, coombs test; Hemoglobin 2.8; Hematacrit 8.1;
CDC Split Type:

Write-up: 8-10APR excessive sleepiness, diarrhea, pale; 11-15APR pt recvd blood transfusions for profound anemia-hemoglobin 2.8, hematacrit 8.1; 15-19APR blood transfusions dx-autoimmun hemalytic anemia;


VAERS ID: 64754 (history)  
Age:   
Gender: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1994-07-13
Entered: 1994-07-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES - / - - / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / SC
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / - - / PO

Administered by: Private       Purchased by: Private
Symptoms: Autism, Drug ineffective, Immune system disorder
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: none;
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: no relevant data;
CDC Split Type: WAES94061055

Write-up: pt recvd vax & was dx w autism & encephalopathy;


VAERS ID: 64755 (history)  
Age:   
Gender: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1994-07-13
Entered: 1994-07-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES - / - - / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / SC
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / - - / PO

Administered by: Private       Purchased by: Private
Symptoms: Autism, Drug ineffective, Immune system disorder
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: none;
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: no relevant data;
CDC Split Type: WAES94061056

Write-up: pt recvd vax & was dx w/ autism & encephalopathy;


VAERS ID: 64756 (history)  
Age:   
Gender: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1994-07-13
Entered: 1994-07-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES - / - - / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / SC
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / - - / PO

Administered by: Private       Purchased by: Private
Symptoms: Autism, Drug ineffective, Immune system disorder
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: none;
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: no relevant data;
CDC Split Type: WAES94061057

Write-up: pt recvd vax & was dx w/ autism & encephalopathy;


VAERS ID: 64757 (history)  
Age:   
Gender: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1994-07-13
Entered: 1994-07-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES - / - - / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / SC
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / - - / PO

Administered by: Private       Purchased by: Private
Symptoms: Autism, Drug ineffective, Immune system disorder
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: none;
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: no relevant data;
CDC Split Type: WAES94061058

Write-up: pt recvd vax & was dx w/ autism & encephalopathy;


VAERS ID: 64758 (history)  
Age:   
Gender: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1994-07-13
Entered: 1994-07-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES - / - - / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / SC
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / - - / PO

Administered by: Private       Purchased by: Private
Symptoms: Autism, Drug ineffective, Immune system disorder
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: none;
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: no relevant data;
CDC Split Type: WAES94061059

Write-up: pt recvd vax & was dx w/ autism & encephalopathy;


VAERS ID: 64759 (history)  
Age:   
Gender: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1994-07-13
Entered: 1994-07-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES - / - - / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / SC
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / - - / PO

Administered by: Private       Purchased by: Private
Symptoms: Autism, Drug ineffective, Immune system disorder
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: none;
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: no relevant data;
CDC Split Type: WAES94061060

Write-up: pt recvd vax & was dx w/ autism & encephalopathy;


VAERS ID: 64760 (history)  
Age:   
Gender: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1994-07-13
Entered: 1994-07-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES - / - - / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / SC
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / - - / PO

Administered by: Private       Purchased by: Private
Symptoms: Autism, Drug ineffective, Immune system disorder
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: none;
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: no relevant data;
CDC Split Type: WAES94061061

Write-up: pt recvd vax & was dx w/ autism & encephalopathy;


VAERS ID: 64761 (history)  
Age:   
Gender: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1994-07-13
Entered: 1994-07-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES - / - - / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / SC
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / - - / PO

Administered by: Private       Purchased by: Private
Symptoms: Autism, Drug ineffective, Immune system disorder
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: none;
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: no relevant data;
CDC Split Type: WAES94061062

Write-up: pt recvd vax & was dx w/ autism & encephalopathy;


VAERS ID: 64762 (history)  
Age:   
Gender: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1994-07-13
Entered: 1994-07-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES - / - - / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / SC
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / - - / PO

Administered by: Private       Purchased by: Private
Symptoms: Autism, Drug ineffective, Immune system disorder
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: none;
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: no relevant data;
CDC Split Type: WAES94061063

Write-up: pt recvd vax; pt had fever & szs; Pt dx w/ autism & encephalopathy;


VAERS ID: 65907 (history)  
Age: 0.5  
Gender: Male  
Location: Utah  
Vaccinated:1994-04-09
Onset:1994-06-25
   Days after vaccination:77
Submitted: 1994-08-04
   Days after onset:40
Entered: 1994-08-15
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 366948 / 2 LL / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 699F2 / 2 - / PO

Administered by: Private       Purchased by: Private
Symptoms: Drug ineffective, Immune system disorder, Infection, Influenza, Meningitis, Pneumonia, Poliomyelitis, White blood cell disorder
SMQs:, Haematopoietic leukopenia (broad), Lack of efficacy/effect (narrow), Noninfectious meningitis (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 23 days
   Extended hospital stay? Yes
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: bare lymphocyte synd; polio type II virus isolated from stool;
CDC Split Type: UT941818

Write-up: fever & cold-like sx began 25JUN94 pt was given Septra sx did not improve; MD visit 5JUl94 & dx w/pneumonia, ear infections & flu; mom reported child''s lt arm limp 8JUL94; on 9JUL94 visted hosp ER; spinal tap revealed meningitis;


VAERS ID: 72057 (history)  
Age: 0.8  
Gender: Female  
Location: Illinois  
Vaccinated:1995-03-03
Onset:1995-03-05
   Days after vaccination:2
Submitted: 1995-03-06
   Days after onset:1
Entered: 1995-03-13
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES 4H51057 / 1 LL / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1006A / 1 RL / -
HIBV: HIB (HIBTITER) / PFIZER/WYETH 4M51118 / 1 LL / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 384939 / 1 - / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Haemorrhage, Laryngeal oedema, Lymphadenopathy, Petechiae, Pulmonary oedema, Vasodilatation
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 1995-03-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: autopsy is pending;
CDC Split Type:

Write-up: no react-no local react, no fever, no fussiness, no drowsiness, no loss of appetite) Sudden death;


VAERS ID: 73323 (history)  
Age: 0.2  
Gender: Male  
Location: Illinois  
Vaccinated:1993-12-21
Onset:1993-12-25
   Days after vaccination:4
Submitted: 1995-04-13
   Days after onset:473
Entered: 1995-04-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES 3B51020 / 0 RL / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0851W / 0 - / L
HIBV: HIB (HIBTITER) / PFIZER/WYETH M130JC / 0 - / L
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 360952 / 0 - / PO

Administered by: Public       Purchased by: Private
Symptoms: Immune system disorder, Injection site hypersensitivity, Laboratory test abnormal, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: skin biopsy-dx non malignant mastocytosis;
CDC Split Type:

Write-up: urticaria covering body began 4 days p/vax @ inj site; eventual dx of mastocytosis;


VAERS ID: 74100 (history)  
Age: 0.2  
Gender: Male  
Location: Texas  
Vaccinated:1995-04-25
Onset:1995-04-25
   Days after vaccination:0
Submitted: 1995-04-25
   Days after onset:0
Entered: 1995-05-15
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / CONNAUGHT LABORATORIES 4A61103 / 0 RL / -
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 1646B2 / 1 LL / -
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES 4A61103 / 0 RL / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0707B / 0 - / PO

Administered by: Public       Purchased by: Public
Symptoms: Agitation, Crying, Cyanosis, Lymphadenopathy, Pallor, Rhinitis, Vasodilatation
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NA~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: TX95078

Write-up: mom stated pt awoke w/high pitch scream & color was bad advised to take pt to ER;pt had drainage @ back of throat; glands were swollen, color flushed, pale, blue corner of mouth & temple


VAERS ID: 74954 (history)  
Age: 0.6  
Gender: Male  
Location: New York  
Vaccinated:1995-05-17
Onset:1995-05-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 1995-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Agitation, Anorexia, Lymphadenopathy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: none~ ()~~~In patient
Other Medications:
Current Illness: none
Preexisting Conditions: premature
Diagnostic Lab Data:
CDC Split Type: BAS022

Write-up: pt recv vax; swollen glands; fever 103; irritable, loss of appetite


VAERS ID: 75158 (history)  
Age: 0.3  
Gender: Male  
Location: Illinois  
Vaccinated:1995-06-05
Onset:1995-06-05
   Days after vaccination:0
Submitted: 1995-06-07
   Days after onset:2
Entered: 1995-06-19
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0734A / 0 - / SC

Administered by: Public       Purchased by: Public
Symptoms: Agitation, Face oedema, Lymphadenopathy, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: heart murmur premature infant
Diagnostic Lab Data: NONE
CDC Split Type: IL950067

Write-up: 7PM pt began to feel hot, irritable; 730 mom gave APAP, t101.2 @ that time; 830PM temp elevated 103; gave 20 mins tepid bath; temp elevated 103.4; eye swollen, red rash; MD stated rxn to MMR; glands & eyes swollen


VAERS ID: 77540 (history)  
Age: 0.2  
Gender: Male  
Location: Pennsylvania  
Vaccinated:1995-09-12
Onset:1995-09-12
   Days after vaccination:0
Submitted: 1995-09-12
   Days after onset:0
Entered: 1995-09-19
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 428033 / 0 LL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0723L / 0 - / PO

Administered by: Private       Purchased by: Private
Symptoms: Immune system disorder, Screaming
SMQs:, Hostility/aggression (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt sibling exp crying 10hrs, swollen leg, local rxn @ 2mos w/DTP/HIB 1st dose~ ()~~~In Sibling
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: unconsolable crying for 5 hrs p/vax; pt recovered; uneventfully


VAERS ID: 77914 (history)  
Age: 0.2  
Gender: Female  
Location: California  
Vaccinated:1994-11-14
Onset:1995-01-17
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 1995-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Private       Purchased by: Private
Symptoms: Convulsion, Drug ineffective, Hypocalcaemia, Immune system disorder, Infection, Paralysis flaccid, Poliomyelitis, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 210 days
   Extended hospital stay? Yes
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: pt recvd vax & devel rash-dx''d seborrhea given Pred;next couple days limbs stopped moving, became floppy, wgt loss, high BP, hospitalized w/low CA x 1 1/2mo;to another hosp told had advanced stage polio;dx''d genetic immune disorder;


VAERS ID: 78203 (history)  
Age: 0.2  
Gender: Male  
Location: California  
Vaccinated:1995-10-03
Onset:1995-10-05
   Days after vaccination:2
Submitted: 1995-10-09
   Days after onset:4
Entered: 1995-10-18
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 428037 / 0 LA / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 720M2 / 0 - / PO

Administered by: Private       Purchased by: Private
Symptoms: Lymphadenopathy, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: observed
CDC Split Type:

Write-up: diffuse over lying erythema & Pecan size (2-3cm) reactive lymphadenitis in lt inguinal area above inj site on lt thigh;no inj site inflammation nor abscess


VAERS ID: 82824 (history)  
Age: 0.3  
Gender: Female  
Location: Virginia  
Vaccinated:1995-08-10
Onset:1995-08-10
   Days after vaccination:0
Submitted: 1995-08-18
   Days after onset:8
Entered: 1996-01-11
   Days after submission:146
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / LEDERLE LABORATORIES - / 1 - / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / 1 - / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / - - / PO

Administered by: Private       Purchased by: Private
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: unk
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 895262005L

Write-up: pt recvd vax & devel lymphadenopathy on rt side of neck;


VAERS ID: 86703 (history)  
Age:   
Gender: Female  
Location: New Jersey  
Vaccinated:1995-04-07
Onset:1995-04-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 1996-06-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / -

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Injection site pain, Lymphadenopathy, Oedema peripheral, Pharyngitis, Pyrexia
SMQs:, Cardiac failure (broad), Agranulocytosis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: no relevant data
CDC Split Type: WAES95040725

Write-up: pt recv vax 7APR95 & 8APR95 or 9APR95 pt exp pain around site & swelling;lymph node in the lt axilla swelled;14APR95 t103 & soreness & enlargement of the node cont;MD gave cephalexin for tx;15 or 16APR95 pt exp joint pain, sore throat;


VAERS ID: 87052 (history)  
Age:   
Gender: Unknown  
Location: Wisconsin  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 1996-06-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / -

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: no relevant data;
CDC Split Type: WAES96021108

Write-up: pt recv vax & pt devel swollen glands 48hrs p/vax given;no further details were provided;


VAERS ID: 92303 (history)  
Age: 0.3  
Gender: Male  
Location: California  
Vaccinated:1996-11-14
Onset:1996-11-14
   Days after vaccination:0
Submitted: 1996-11-21
   Days after onset:7
Entered: 1996-11-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 439193 / 1 RL / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0750A / 1 - / PO

Administered by: Private       Purchased by: Private
Symptoms: Agitation, Coronary artery disease, Dehydration, Lymphadenopathy, Mucous membrane disorder, Pyrexia, Vasculitis, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Other ischaemic heart disease (narrow), Vasculitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: cardiac echo
CDC Split Type:

Write-up: pt devel fever, irritability, vomiting win 2hr of vax;pt became dehydrated, devel mucositis & was found to have kawasakis disease (mucocataneous lymph node synd) w/coronary artery deilation dx 6 day p/vax;


VAERS ID: 94642 (history)  
Age: 0.0  
Gender: Male  
Location: Texas  
Vaccinated:1996-01-31
Onset:1996-02-01
   Days after vaccination:1
Submitted: 1996-04-04
   Days after onset:63
Entered: 1997-01-21
   Days after submission:292
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (TICE) / ORGANON-TEKNIKA - / 0 LA / SC

Administered by: Private       Purchased by: Other
Symptoms: Injection site abscess, Injection site mass, Injection site oedema, Leukocytosis, Lymphadenopathy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations: NA~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: MAR96 blood cult-negative;WBC inc;spinal tap-nl, x-ray (arm) nl;US-nl;liver function-nl immunoglobulin-nl;
CDC Split Type: 1925

Write-up: arm became swollen;early abscess formation occurred;ax lymph node was swollen to 2x2cm & supraclavicular node was 1x1cm;t103 & adm to hosp;few days later fever persisted;dx lymphadenopathy/fever;affected area indurated;elevated WBC;


VAERS ID: 100026 (history)  
Age:   
Gender: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 1997-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / -

Administered by: Other       Purchased by: Other
Symptoms: Drug ineffective, Infection, Lymphadenopathy, Rash
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES96110052

Write-up: pt recv vax & devel a rash & inflammation of lymph nodes;pt was dx w/rubella by MD;


VAERS ID: 100082 (history)  
Age:   
Gender: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 1997-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / -

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: No relevant data;
CDC Split Type: WAES97020797

Write-up: pt recv vax & 7 days p/vax pt devel sx indicative of measles, including gen rash, swollen glands, fever of 102-103;


VAERS ID: 99842 (history)  
Age: 0.1  
Gender: Female  
Location: Arizona  
Vaccinated:1996-02-29
Onset:1996-03-06
   Days after vaccination:6
Submitted: 1997-07-01
   Days after onset:481
Entered: 1997-07-09
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 426115 / - RL / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0094B / - LL / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 7334E / - - / PO

Administered by: Private       Purchased by: Private
Symptoms: Agitation, Apnoea, Cyst, Encephalitis, Infection, Lymphadenopathy, Pneumonia, Vasodilatation
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? Yes
   Date died: 1996-03-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: Autopsy report: interstitual pneumonia, mesenteric lymphadenopathy, passive congestion of viscera, benign ovarian cysts, & acute encephalomyelitis;COD pneumonia;
CDC Split Type:

Write-up: 6 days p/vax pt died suddenly @ home;father was holding pt & fell asleep when awoke pt not breathing- had be fussier than usual;Autopsy report: interstitual pneumonia, mesenteric lymphadenopathy, passive congestion of viscera;COD pneumonia


VAERS ID: 102768 (history)  
Age: 0.4  
Gender: Female  
Location: Ohio  
Vaccinated:1997-01-30
Onset:1997-02-04
   Days after vaccination:5
Submitted: 1997-09-15
   Days after onset:222
Entered: 1997-09-29
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 438621 / 1 LL / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 439871 / 1 - / PO

Administered by: Private       Purchased by: Private
Symptoms: Anorexia, Apnoea, Cardiac arrest, Coagulopathy, Haemolytic anaemia, Immune system disorder, Renal failure acute, Urinary tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemolytic disorders (narrow), 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), 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), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 1997-02-07
   Days after onset: 3
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Ceftriaxone, tremethoprim;sulfamethoxazole, acetaminophen
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: 4FEB positive leukocyte esterase;6FEB hemoglobin 2.3;WBC 65;coombs test positive;
CDC Split Type:

Write-up: 4FEB97 fussy, dec oral intake, fever, nasal congestion;impression: UTI. Plan: ceftriaxone & Bactrim 3/4 teas 12hr x 1wk;6FEB97 lethargy, irritability;hosp hemolytic anemia;7FEB97 acute renal failure, disseminated intravascular coagulation


VAERS ID: 102826 (history)  
Age: 0.3  
Gender: Male  
Location: Texas  
Vaccinated:1997-05-26
Onset:1997-06-09
   Days after vaccination:14
Submitted: 1997-06-24
   Days after onset:15
Entered: 1997-09-30
   Days after submission:98
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 443264 / 1 LL / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0760L / 1 - / PO

Administered by: Private       Purchased by: Private
Symptoms: Cough, Hypokinesia, Infection, Lymphadenopathy, Paralysis, Poliomyelitis, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: Keflex for peri rectal abscess @ that time;
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: spinal tap being done that revealed 48 WBC, 2RBC, 100% lymphocytes;spinal fluid glucose was 44;protein 55;sodium 139, potassium 4.5, chloride 102, co2 21 creatinine 0.2;WBC 12,300 w/48segs & 52 lymph
CDC Split Type: TX97117

Write-up: pt recv vax & devel fever 10 days;v x2, fussy,sl cough, neck & ax nodes;dx viral synd;fever x 2 1/2 days;pt reported not to use or be moving lt leg;dec activity lt leg;referred to orthopedist;lt leg paresis;dx viral infect;


VAERS ID: 107095 (history)  
Age: 0.5  
Gender: Male  
Location: New Jersey  
Vaccinated:1991-12-30
Onset:0000-00-00
Submitted: 1997-11-04
Entered: 1998-01-21
   Days after submission:78
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES - / - - / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / - - / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0645F / 2 - / PO

Administered by: Private       Purchased by: Other
Symptoms: Anorexia, Hyperkinesia, Immune system disorder, Infection, Mental retardation severity unspecified, Thinking abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: unk
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 897324004L

Write-up: pt recv vax & mom report child is having problems w/child mentally & physically;dx of attention deficit hyperactivity disorder made a number of times;mom attributes problems to stealth virus infect & believes orimune to be the source of inf


VAERS ID: 109835 (history)  
Age: 0.7  
Gender: Female  
Location: Arizona  
Vaccinated:1998-04-01
Onset:1998-04-09
   Days after vaccination:8
Submitted: 1998-04-10
   Days after onset:1
Entered: 1998-04-20
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES 091578 / 3 LA / -
HIBV: HIB (HIBTITER) / PFIZER/WYETH M195RF / 3 - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 10009E / 0 - / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1326E / 0 - / SC

Administered by: Public       Purchased by: Public
Symptoms: Face oedema, Lymphadenopathy, Rash maculo-papular
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NA~ ()~~~In patient
Other Medications: APAP & motrin
Current Illness:
Preexisting Conditions: hx amoxicillin allergy-rash in past
Diagnostic Lab Data: NA
CDC Split Type: AZ9833

Write-up: maculopapular rash cheeks $g small amount trunk & chest & legs;mild upper eyelid edema;cervical node rt;


VAERS ID: 111617 (history)  
Age:   
Gender: Female  
Location: Florida  
Vaccinated:1997-07-10
Onset:1997-07-30
   Days after vaccination:20
Submitted: 1998-05-29
   Days after onset:303
Entered: 1998-06-02
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / -

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: No relevant data;~ ()~~~In patient
Other Medications: unk
Current Illness:
Preexisting Conditions: unk
Diagnostic Lab Data:
CDC Split Type: WAES97080126

Write-up: pt was exposed to a child who recv vax 10JUL97 & 30JUL97 pt felt that through household contact may have measles;devel swollen glands;


VAERS ID: 111709 (history)  
Age:   
Gender: Unknown  
Location: Florida  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1998-05-29
Entered: 1998-06-02
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / - - / -

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: No relevant data;~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions: unk
Diagnostic Lab Data:
CDC Split Type: WAES97111470

Write-up: pt recv vax & 3wk p/vax pt exp swollen lymph nodes all over the body;


VAERS ID: 114751 (history)  
Age:   
Gender: Female  
Location: Kentucky  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1998-09-30
Entered: 1998-10-06
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0738E / - LA / SC

Administered by: Public       Purchased by: Other
Symptoms: Diarrhoea, Headache, Injection site pain, Lymphadenopathy, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: unk~ ()~~~In patient
Other Medications: Synthroid, Zantac, Propulsid, Vit B12;
Current Illness: NONE
Preexisting Conditions: allergies, HTN, gastric,bypass,negative varicella titer also
Diagnostic Lab Data: WNL titer MMR 6wk from administration;
CDC Split Type:

Write-up: T99 to 101;soreness in area shot given (2wk lasting);swollen glands under jaw line;nausea, h/a, diarrhea;titer negative to MMR prior to vaccine;


VAERS ID: 115465 (history)  
Age: 0.0  
Gender: Male  
Location: Ohio  
Vaccinated:1998-05-05
Onset:0000-00-00
Submitted: 1998-07-24
Entered: 1998-10-30
   Days after submission:98
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (TICE) / ORGANON-TEKNIKA 451C023 / 0 RA / -

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: hepatitis vaccine
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: cult of removed lymph nodes-revealed acid fast bacilli
CDC Split Type: BOO4798

Write-up: pt recv vax & devel T104 maximum & inflamed rt axillary lymph nodes;approx the beginning of JUL pt lymph nodes had to be removed;cult of rt axillary lymph nodes revealed acid fact bacilli;sl swollen lymph & low temp;


VAERS ID: 116376 (history)  
Age:   
Gender: Unknown  
Location: Minnesota  
Vaccinated:1998-09-15
Onset:1998-10-12
   Days after vaccination:27
Submitted: 1998-10-13
   Days after onset:1
Entered: 1998-11-13
   Days after submission:31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0769E / - - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Ear pain, Face oedema, Infection, Lymphadenopathy, Pyrexia
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: pt recv vax 15SEP98 & on 12OCT98 pt came down w/a fever & earache;13OCT98 reported to MD w/rt sided neck swelling in addition to the above complaints;MD dx vaccine induce mumps since there is no known exposure;


VAERS ID: 118486 (history)  
Age:   
Gender: Male  
Location: Arizona  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1998-09-25
Entered: 1999-02-01
   Days after submission:129
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / CONNAUGHT LABORATORIES PO323 / - - / -

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: UNK~ ()~~~In patient
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: U199800554

Write-up: Pt recv vax on unknown day; post vax pt exp swollen lymph nodes of the inguinal region


VAERS ID: 120511 (history)  
Age:   
Gender: Male  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1999-03-03
Entered: 1999-03-23
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / - - / PO

Administered by: Other       Purchased by: Other
Symptoms: Immune system disorder, Infection, Paralysis flaccid
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: pt sibling also had a severe immune deficiency & devel vax assoc paralytic polio~ ()~~~In Sibling
Other Medications: unk
Current Illness: unk
Preexisting Conditions: severe immune deficiency
Diagnostic Lab Data: unk
CDC Split Type: 899072060A

Write-up: MD reported pt recv vax & devel vaccine-associated paralytic poliomyelitis;it was later determined that pt had severe immune deficiency;the child died 8 or 9 years ago d/t the immunodeficiency;MD stated event poss reported to CDC;


VAERS ID: 120512 (history)  
Age:   
Gender: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1999-03-03
Entered: 1999-03-23
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / - - / PO

Administered by: Other       Purchased by: Other
Symptoms: Immune system disorder, Infection, Paralysis flaccid
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: pt sibling had severe immune deficienty & devel vax assoc paralytic polio~ ()~~~In Sibling
Other Medications: unk
Current Illness: unk
Preexisting Conditions: severe immune deficiency
Diagnostic Lab Data: unk
CDC Split Type: 899077002L

Write-up: pt recv vax & devel vaccine-associated paralytic poliomyelitis;it was later determined that the pt had severe immun deficiency;the child died 4 or 5 year ago d/t the immunodeficiency;MD stated this event may have been reported to CDC;


VAERS ID: 121673 (history)  
Age:   
Gender: Unknown  
Location: Alabama  
Vaccinated:1999-04-14
Onset:1999-04-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 1999-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES 6916CB / 0 LA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR I) / MERCK & CO. INC. 1916H / 1 RA / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0801F / 3 - / PO

Administered by: Private       Purchased by: Private
Symptoms: Injection site hypersensitivity, Injection site mass, Lymphadenopathy
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt recv vax on 4/14/99; on 4/15/99 pt exp LA area of erythema &induration, tender lt axillary node


VAERS ID: 127748 (history)  
Age: 0.5  
Gender: Female  
Location: Michigan  
Vaccinated:1999-08-20
Onset:1999-08-20
   Days after vaccination:0
Submitted: 1999-08-23
   Days after onset:3
Entered: 1999-08-30
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH 462316 / 2 RL / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0079J / 2 LL / -
HIBV: HIB (HIBTITER) / PFIZER/WYETH 450253A / 2 RL / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 463281 / 2 - / PO

Administered by: Private       Purchased by: Public
Symptoms: Lymphadenopathy, Pyrexia, Rash, Rhinitis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: nitoral, triamenic;APAP
Current Illness: congestion, maculopapular rash on belly & upper thigh
Preexisting Conditions: has had condidiasis in the past 7 tx w/Niztral;
Diagnostic Lab Data: ordered CBC w/diff;
CDC Split Type:

Write-up: immed p/vax mom states lump appeared behind ear;parents state that it could have been there a/vax;rash appeared that noc on head & back, now on belly & axillae;congestion, clear mucous, had fever 102 @ home;afeb today;


VAERS ID: 129211 (history)  
Age: 0.2  
Gender: Male  
Location: Arkansas  
Vaccinated:1999-09-14
Onset:1999-09-21
   Days after vaccination:7
Submitted: 1999-10-05
   Days after onset:14
Entered: 1999-10-12
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - RA / -

Administered by: Public       Purchased by: Unknown
Symptoms: Arthralgia, Lymphadenopathy, Pharyngitis, Pyrexia, Rhinitis
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: strep screen negative;
CDC Split Type:

Write-up: arthralgias, low grade fever, adenopathy, rhinitis, pharyngitis;


VAERS ID: 155191 (history)  
Age:   
Gender: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-05-24
Entered: 2000-06-21
   Days after submission:28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / SC

Administered by: Other       Purchased by: Other
Symptoms: Immunoglobulins decreased
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Diagnostic lab-rubella IgG antibodies-negative; Diagnostic lab-MMR-BIA <15
CDC Split Type: WAES99080250

Write-up: Information has been received from a veterinarian concerning a "couple of older" female pts who were vaccinated with MMR and 2 months, post vax, the pts'' lab results revealed a lack of seroconversion. Follow-up information from a veterinarian reported that the first antibody titer was done 52 days, post vax, and the EIA <15. Only the rubella titer was done and the IgG checked. Additional information has been requested.


VAERS ID: 157182 (history)  
Age:   
Gender: Male  
Location: Texas  
Vaccinated:2000-05-18
Onset:2000-06-04
   Days after vaccination:17
Submitted: 2000-06-13
   Days after onset:9
Entered: 2000-07-18
   Days after submission:35
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 914A2 / - LA / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. P1231 / 2 LA / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1976H / 0 RA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1727J / 0 RA / SC

Administered by: Public       Purchased by: Public
Symptoms: Face oedema, Lymphadenopathy, Oedema, Pyrexia, Viral infection
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: CBC - results consistent with viral infection
CDC Split Type: TX0074

Write-up: Great grandmother noted "Slight fever" June 4 &5. On June 6 there was slight swelling under his ears, more swelling there on June 7. The morning of June 9, his neck was swollen, even facial, under eye area was swollen area was like a hard knot. She took child to MD. Dx Mumps.


VAERS ID: 166517 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-02-22
Entered: 2001-03-05
   Days after submission:377
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID VI POLYSACCHARIDE (ACETONE INACTIVATED DRIED) / PFIZER/WYETH - / - - / SC

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: HQ1106317FEB2000

Write-up: A pt reported that she received a vaccine 12/99 and subsequently developed lymphadenopathy in her groin. The pt is being seen by the physician; the lymphadenopathy persists.


VAERS ID: 169162 (history)  
Age:   
Gender: Female  
Location: California  
Vaccinated:2001-04-13
Onset:2001-04-20
   Days after vaccination:7
Submitted: 2001-04-25
   Days after onset:5
Entered: 2001-04-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0987K / - LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: This patient had swollen cervical and occipital lymph glands, fever, and myalgias.


VAERS ID: 169396 (history)  
Age: 0.08  
Gender: Male  
Location: Virginia  
Vaccinated:1992-08-25
Onset:1992-08-25
   Days after vaccination:0
Submitted: 2001-04-20
   Days after onset:3160
Entered: 2001-05-04
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (ACEL-IMUNE) / PFIZER/WYETH 331912 / - RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH M130SB / - RA / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0659E / - - / PO

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain, Antisocial behaviour, Autism, Diarrhoea, Drug ineffective, Dyskinesia, Immune system disorder, Injection site erythema, Injection site swelling, Intestinal perforation, Nervous system disorder, Neurodevelopmental disorder, Pyrexia, Screaming, Speech disorder, Staring, Vomiting
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Dyskinesia (narrow), Gastrointestinal perforation (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: Not immune to Mumps, Measles or Rubella although vaccinated.
CDC Split Type:

Write-up: It is reported by the pt''s mother stating that she noticed mild neurological change during the course of his immunization schedule from 1992 to 1997. After each course of vaccines he reacted with swollen shot sight fever screaming and 10 to 15 days later high fever hives malice. In 1994, he was placed in special pre-ed at 3-, 1/2 yrs for speech and motor skill delays. She noticed a decline in health speech motor skills after every immunization visit. It wasn''t until his big 5 year old prekindergarten mega dose DPT, Pollomeyelitis, and MMR that she connected his decline with vaccinations. After the last round of vaccines he was never the same. The day of the vaccination on 05/28/1997 within six hours red hot swollen shot site: Given both in left and right arm, glassed look, fever, arms to sore to lift six days of fever, malice, glass look lethargic. The mother reported these symptoms to his pediatrician and talked about her concerns but he was vaccinated anyway. She states that,"he vomited every time I washed his hair, he heard noises that pained him severely, he had to be wrapped in sleeping bags to control him at school, he suffered from severe abdominal pain, his hands could not hold onto a swing, he banged himself into the wall, he conforted himself by total absorption in lining up his plastic animals, he slept restlessly, he was insistent on routine and structure, his health declined:strep infection fever severe diarrhea and constipation, he varied from extreme hyper activity to extreme muscle fatigue, no social skills, delayed toilet training not able to sit down to have bowel movement, biting growling violent angry."


VAERS ID: 169399 (history)  
Age: 0.4  
Gender: Male  
Location: Ohio  
Vaccinated:1990-06-11
Onset:1990-06-11
   Days after vaccination:0
Submitted: 2001-04-18
   Days after onset:3964
Entered: 2001-05-04
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / PO

Administered by: Private       Purchased by: Private
Symptoms: Apraxia, Asthenia, Crying, Drooling, Ear disorder, Encephalopathy, Erythema, Gastrointestinal disorder, Hypotonia, Immune system disorder, Infection, Irritability, Nervous system disorder, Pyrexia, Staring
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~DTP (no brand name)~~0.50~In Sibling
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Red, crying, temperature, irritable. Given Tylenol, same day, sick with ear infections for weeks after. Given antibiotics. Was drooling 6-8 weeks later, lost eye contact 4 months later and weakness 4 months later. Auto-immune disorder; encephalopathy, apraxia hypotonic. The 60 day follow-up report states neurological immune disorder gastrointestinal. This child was developing normally and was insulted by vaccines over a period of time not a single vaccine caused this much regression on his systems. Missing vaccine information not available. Dx autoimmune encephalopathy, high functioning autistic. Tx aricet solu- Medrol and IVIG. Poor social skills. Limited eye contact. low mptor strength. Encorpresis. Also notes generalized weakness and droopy eyes before 8 months of age. Onset unrecalled.


VAERS ID: 170873 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2000-11-01
Onset:2000-11-06
   Days after vaccination:5
Submitted: 2001-05-30
   Days after onset:204
Entered: 2001-06-01
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / -

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Asthenia, Fatigue, Hyperhidrosis, Infection, Lymphadenopathy, Pyrexia, Screaming, Sleep disorder
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data:
CDC Split Type: WAES00111211

Write-up: Asthenia/Fatigue, behavioral disturbance, lymphauenopathy; Perspiration, fever - Information has been received from a pharmacist concerning her daughter who on 01 Nov 2000 was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. Five days post-vaccination, the patient became very lethergic and unusually waking up at night screaming. It was also noted that the patient developed a fever and sweats. Ten days post vaccination, the patient developed swollen lymph glands in the groin area. The reporter was concerned about her daughter receiving a booster dose because she felt that her daughter had adverse reactions from the MMR vaccine. Additional information has been requested.


VAERS ID: 170954 (history)  
Age:   
Gender: Female  
Location: Georgia  
Vaccinated:1994-12-01
Onset:1994-12-15
   Days after vaccination:14
Submitted: 2001-05-30
   Days after onset:2357
Entered: 2001-06-01
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Lymphadenopathy, Polyarthritis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES#01033343

Write-up: fever, arthralgia,lymphadenopathy - Information has been received from a physician concerning her sister (nurse practitioner) who in early december 1994, was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation. After two to three weeks, the patient developed a low grade fever, lymphadenopathy and arthralgia. The physician reported that she feels the vaccine virus may have been transmitted to her (waes# 01033343) (also reported as transmission of rubella from this vaccinated individual). No further detail were provide. On follow-up the physician reported that her sister developed lymphadenopathy, polyarthritis and low grade fever after vaccination. No further details were provided.


VAERS ID: 174766 (history)  
Age:   
Gender: Male  
Location: Florida  
Vaccinated:1975-02-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2001-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ADEN: ADENOVIRUS (TYPE 4, NO BRAND NAME) / PFIZER/WYETH - / - - / PO
ADEN: ADENOVIRUS (TYPE 7, NO BRAND NAME) / PFIZER/WYETH - / - - / PO
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / 0 - / PO

Administered by: Military       Purchased by: Military
Symptoms: Epistaxis, Hepatitis C virus, Lymphadenopathy, Pharyngitis
SMQs:, Agranulocytosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal infections (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: HQ8156805JUL2000

Write-up: A male pt reported that he received a dose of Adenovirus Vaccine Live Oral Type 4, Adenovirus Vaccine Live Oral Type 7, Poliomyelitis virus and Influenza Bivalent vaccines on 2/4/75 when he was in the military. The pt noted that his medical records indicate that a "couple of days" after vaccination, he developed "nose bleeding and neck adenopathy". He also reported that he has been dx''d with chronic Hepatitis C. The reporter indicated that "his neck is swollen to this day". Additional information received on 7/11/00 included the pt''s medical records which indicated that the pt had recurrent nose bleeds from his right nostril, his throat was inflammed and had neck adenopathy.


VAERS ID: 179191 (history)  
Age:   
Gender: Female  
Location: California  
Vaccinated:2001-11-09
Onset:2001-12-11
   Days after vaccination:32
Submitted: 2001-12-10
   Days after onset:1
Entered: 2001-12-18
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1093L / - - / SC

Administered by: Private       Purchased by: Public
Symptoms: Cough, Dizziness, Dysphonia, Lymphadenopathy, Malaise, Pulmonary congestion
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: negative titer for rubella 10/30/01
CDC Split Type:

Write-up: 11/30/01 malaise , lightheaded, 12/1/01 no change, 12/2/01 stated slight cough, 12/4-12/6/01 hoarseness, chest congestion started 12/4 & cough productive (yellow-green) no F/U lump on neck since 12/6 R knee twisted in bed 12/6 better now. apparently better today. Treated for URI and released.


VAERS ID: 180751 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:1996-07-25
Onset:0000-00-00
Submitted: 2002-01-28
Entered: 2002-01-31
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES - / - - / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / - - / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / - - / PO

Administered by: Other       Purchased by: Other
Symptoms: Contusion, Haemolytic anaemia, Immune system disorder, Infection, Platelet disorder, Pyrexia, Screaming, Splenomegaly
SMQs:, Haemolytic disorders (narrow), Haematopoietic thrombocytopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: HQ0057022JAN2002

Write-up: Information has been received regarding a female pt who, as an infant, received Orimune, DTP, Hib and Hep-B vaccines on 7/25/96. According the her mother, the pt developed a "high" fever, bruised thighs and "high-pitched" crying on the day of vaccinations. Reportedly, the pt has experienced "recurring infection and fever ever since". The mother indicated that her daughter has received a total of 4 doses of DTP vaccine, the last dose of which was administered in 11/97. The mother has refused all vaccinations in her daughter since 11/97. The mother indicated that in 6/98, her daughter presented with "signs and symptoms of leukemia," which was subsequently ruled out. Reportedly, the pt was dx''d with hemolytic anemia, splenomegaly and a platelet disorder; the mother attributed these events to DTP administration. Follow-up information from a physician, provided the pt''s name as well as a birth month and year of May, 1996. The physician indicated that the pt has an autoimmune disease requiring weekly lab testing; however, no test results were reported. The events were considered to be "Other Important Medical Events". No further information was available at the date of this report.


VAERS ID: 183430 (history)  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2001-09-01
Onset:0000-00-00
Submitted: 2002-04-08
Entered: 2002-04-15
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / SC

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Immunoglobulins increased, Lymphadenopathy
SMQs:, Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: IgM and IgG-elevated; "drainage and culture" of the gland
CDC Split Type: WAES0203USA02894

Write-up: Information has been received on 3/26/02 from an RN concerning a male child who in 9/01 was vaccinated with a dose of MMRII. It was reported that "later", the pt had a positive IgM and had a swollen gland. The pt was reportedly taken to the hospital, was dx''d with mumps and had "drainage and culture" of the gland. The reporter did not think this was a vaccine failure and was concerned how long an IgM and IgG remained elevated, post vax. Follow-up information received on 4/1/02, reported that the child was admitted to the hospital for a staphylococcal infection, "that had nothing to do with the MMRII vaccination and that he child did not have the mumps". Additional information has been requested.


VAERS ID: 198801 (history)  
Age: 0.3  
Gender: Male  
Location: Connecticut  
Vaccinated:1995-04-25
Onset:2003-04-27
   Days after vaccination:2924
Submitted: 2003-02-25
   Days after onset:60
Entered: 2003-03-05
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 RL / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Private       Purchased by: Other
Symptoms: Chromosome abnormality, Convulsion, Drug toxicity, Immune system disorder, Neuropathy
SMQs:, Peripheral neuropathy (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: My son had a seizure less than 48 hours after his 4 month DPT vaccine. He was hospitalized and continues to have seizures to this day. The medical record states Kleinelter''s syndrome and neurodegenerative disorder. My son still has seizures on a daily basis. He is developmentally delayed. His immune system is damaged. He has heavy metal toxicity due to these vaccines CDPT- from the thimersol. He does not live a normal childhood and hasn''t since the age of 4 months and lost his identical twin due to these vaccines.


VAERS ID: 204348 (history)  
Age: 0.5  
Gender: Male  
Location: Unknown  
Vaccinated:1982-06-27
Onset:1982-06-28
   Days after vaccination:1
Submitted: 2003-05-30
   Days after onset:7641
Entered: 2003-06-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / -

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy, Pyrexia, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: WAES0208USA02006

Write-up: Information has been received from a consumer concerning her 6 month old son with no past medical history and no known allergies who on 6/27/82 was vaccinated with a dose of MMR (second generation). There was no concomitant medication. On 6/28/82, the next day, the patient''s gland on the right side of his neck swelled up. The patient also had a fever and his white blood cells were elevated. The swelling lasted several months. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 204425 (history)  
Age:   
Gender: Female  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-05-30
Entered: 2003-06-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - - / -

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data:
CDC Split Type: WAES0211USA02036

Write-up: Information has been received from a nurse practitioner concerning a female who was vaccinated with MMR II. Subsequently the pt developed enlarged lymph nodes and myalgia without fever. After a few days the pt recovered. The pt sought unspecified medical attention. Additional info has been requested.


VAERS ID: 204857 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:1993-05-01
Onset:1993-05-01
   Days after vaccination:0
Submitted: 2003-06-10
   Days after onset:3692
Entered: 2003-06-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Drug ineffective, Immune system disorder, Systemic lupus erythematosus
SMQs:, Lack of efficacy/effect (narrow), Systemic lupus erythematosus (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Medical history: Immune system disorder: Pregnancy.
Diagnostic Lab Data: Immune to measles 1991, 1992, 1997; susceptible to rubella May 1993; immune to rubella 1991
CDC Split Type: WAES0306USA00323

Write-up: It was reported in a published article that a female patient in 1983 was vaccinated with a first dose of MMR (second generation) because of a measles outbreak in college. She tested immune to measles in 1991, 1992, and 1997. During her first pregnancy in 1991, she tested immune to rubella and had a healthy, normal son. At the birth of her second son, in May 1993, she was found to be rubella susceptible and was given a second dose of MMR (second generation) in the postpartum period. The patient now had markers for lupus. Upon internal review, lupus was considered to be an important medical event (OMIC). It was unknown if medical attention was sought. It was reported in a published article, title as stated above, that this patient had developed measles, rubella and mumps despite being vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Because of a diagnosis of "some immune problem", the patient received injections of gamma globulin for awhile. It was reported that the patient received the hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) series in 1998-1999. Upon internal review, lupus was considered to be an important medical event. The reporter indicated that the patient''s son had autism (WAES #0306USA00452). It was unknow if medical attention was sought.


VAERS ID: 216828 (history)  
Age:   
Gender: Female  
Location: California  
Vaccinated:2003-09-17
Onset:2004-09-28
   Days after vaccination:377
Submitted: 2004-02-24
   Days after onset:216
Entered: 2004-02-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (VIRIVAC) / MERCK & CO. INC. 0633N / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Lymphadenopathy, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pruritic rash on trunk and proximal arms; anterior cervical lymphadenopathy; throat irritation with oropharyngeal erythema.


VAERS ID: 220048 (history)  
Age:   
Gender: Male  
Location: California  
Vaccinated:2004-04-22
Onset:2004-04-28
   Days after vaccination:6
Submitted: 2004-04-30
   Days after onset:2
Entered: 2004-05-07
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0392N / 0 LA / PO

Administered by: Public       Purchased by: Unknown
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Exposure to Mumps case
Preexisting Conditions: NONE
Diagnostic Lab Data: Pending- Sed egg R 1gg
CDC Split Type:

Write-up: Pt was exposed to mumps case 4/10 by hugging. 4/10 came for immunization 4/22, no prc h/o immunization. Developed right peri-auricular lymphadenopathy x2


VAERS ID: 227804 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2004-09-13
Onset:2004-09-16
   Days after vaccination:3
Submitted: 2004-10-08
   Days after onset:22
Entered: 2004-10-15
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0093P / - - / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0809N / - - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Erythema, Feeling hot, Immune system disorder, Injection site mass, Injection site pain
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Received Dtap in right thigh.
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Axillary temp= 98 on 09/17/04
CDC Split Type:

Write-up: Pt received HIB and MMR immunizations in left thigh on 9/13/04. On 9/16/04 mom called clinic complaining that area was sore and had a lump which felt like a golf ball. The area also was warm to the touch. Mom and daughter came to clinic on 09/17/04 for follow up. Temp was 98 Lump was 4-5cm on left lateral thigh w/no discharge, slight erythema. Looked more like immune response than frank infection. The pt had full sensation down leg. Mom advised to use children''s ibuprofen and RTC or ER if pt becomes febrile, stops eating, has N/V, or lump changes shape, color, or has discharge. As of 10/8/04, no further follow up has been needed.


VAERS ID: 235207 (history)  
Age:   
Gender: Male  
Location: Georgia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2005-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1699AA / 3 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1040 / 2 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0312P / - LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A57559E / - LL / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: the patient has a history of transient thrombocytopenia which occurred as a neonate. He also has a sibling with a history of febrile seizures. He did not have any illness at the time of vaccination.
Diagnostic Lab Data:
CDC Split Type: 200403779

Write-up: From initial infomation received on 11/22/2004


VAERS ID: 258113 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2005-09-30
Onset:2005-09-30
   Days after vaccination:0
Submitted: 2006-05-19
   Days after onset:231
Entered: 2006-05-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / -

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Lymphadenopathy, Unintended pregnancy
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Normal pregnancy conditions and outcomes (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Pregnancy NOS (LMP=unknown)
Diagnostic Lab Data: UNK
CDC Split Type: WAES0502USA04365

Write-up: Information has been received from a consumer concerning her daughter, who lives in another country, who on 30-SEP-2005 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (manufacturer unknown). The reporter indicated that her daughter was vaccinated against "measles and rubella". She became pregnant and feels that 01-OCT-2005 was the conception date. The vaccines were given " a day or two before conception" to her daughter by the "nurse on the street" and she did not know any specifics on dosage or how they were delivered. Her daughter had since developed swollen lymph nodes and was always dizzy. There was no product quality complaint involved. Additional information has been requested.


VAERS ID: 258394 (history)  
Age:   
Gender: Male  
Location: Iowa  
Vaccinated:2006-05-02
Onset:2006-05-12
   Days after vaccination:10
Submitted: 2006-05-15
   Days after onset:3
Entered: 2006-06-14
   Days after submission:30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0729R / 0 - / SC

Administered by: Public       Purchased by: Public
Symptoms: Fatigue, Lymphadenopathy, Oral intake reduced, Pharyngolaryngeal pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: IA06011

Write-up: MMR shot Tues. 5/2. Wed. t/10 thru Mon May 15, pt had fever, mild sore throat, swollen glands on side of neck, fatigue, decreased appetite. In addition to above symptoms on Mon. May 15, he complained of headache. Tues. May 16, starting to feel better. Back to school on Wed. May 17. Treated with Tylenol and Motrin, alternating q 4-6 hrs for 2 1/2 days.


VAERS ID: 262215 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2006-08-25
Onset:2006-08-25
   Days after vaccination:0
Submitted: 2006-08-28
   Days after onset:3
Entered: 2006-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -
TD: TD ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Lymphadenopathy, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data: Also c/o swollen glands, temp 99.3 (0) noted "dots on feet", offered appt today at student health.
CDC Split Type:

Write-up: Warmth, swelling and redness at left arm below site of Td injection, size 2" x 4". Plans to visit provider who administered vaccine for follow up tomorrow 8/29/06 AM.


VAERS ID: 268663 (history)  
Age:   
Gender: Female  
Location: Maryland  
Vaccinated:2006-10-06
Onset:2006-11-17
   Days after vaccination:42
Submitted: 2006-11-30
   Days after onset:13
Entered: 2006-12-11
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0292R / 0 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Joint stiffness, Lymphadenopathy, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Glucosin, Diovan, Lipitor, Folic acid, Calc, Baby ASA
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received MMR 10/06/06 on 11/17/06 developed swollen lymph nodes in neck, 11/20 rash on trunk, 11/22 joint pain, stiffness, 11/26 fine and asymptomatic.


VAERS ID: 283703 (history)  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-05-30
Entered: 2007-06-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy, Mumps
SMQs:, Oropharyngeal infections (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0702USA01838

Write-up: Information has been received from a physician concerning his son, who was vaccinated "many years ago" with MMR II. Subsequently the patient experienced mumps and swelling of the neck glands. No further information is available.


VAERS ID: 315275 (history)  
Age:   
Gender: Female  
Location: Georgia  
Vaccinated:2008-05-09
Onset:2008-05-10
   Days after vaccination:1
Submitted: 2008-06-06
   Days after onset:27
Entered: 2008-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0871U / - LA / SC

Administered by: Public       Purchased by: Private
Symptoms: Feeling hot, Lymphadenopathy, Malaise, Pyrexia, Rash, Tenderness
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: zoloft 100mg protonix40mgsingulair 10mgnasonex 50mcg,depakote er 500mg, glucophage 850 mg
Current Illness: none
Preexisting Conditions: Depression, prolonged, asthma, seizure disorder, polycystic ovaries/stein-leventhal syndrome, over weight status,allergic arthritis, GERD esophageal reflux
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient got sick the night of MMR administration. States just did not feel well, nonspecific. She had a fever, did not take temperature, states felt warm. She then developed a rash with swollen lymph nodes, some tenderness. No fever or chills or other problems. This is documented by physician on 05-21-08.


VAERS ID: 321222 (history)  
Age:   
Gender: Male  
Location: Puerto Rico  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2008-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Immune system disorder, Intestinal functional disorder, Sensory disturbance, Walking disability
SMQs:, Peripheral neuropathy (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific inflammation (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: Celiac disease and autism
Preexisting Conditions: Allergies to milk, specific to casein and immunology problems.
Diagnostic Lab Data: He have autism and celiac disease and his autism not is specific.
CDC Split Type:

Write-up: After the vaccine my son began to walk in a feet''s tip and he began to present serious sensory problems. He have after the vaccine serious and grave problems in his intestine and immunology like a candida albicans. he have special diets now.


VAERS ID: 382611 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2009-05-11
Onset:2009-05-22
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2010-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD - / - - / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Lymph node pain, Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: BERNA20090194

Write-up: The patient started VIVOTIF oral vaccination (batch no: unknown) on 11.May.2009 for her trip on 25.May.2009 and administered all capsules at the scheduled times. On 22.May.2009 she developed swollen and painful lymph nodes under her arm. The symptoms were persistent at time of reporting. At the time of reporting they are still swollen, bilateral, however pain was relieving. Follow-up request was sent to the reporter on 23.Jun.2009 regarding batch no. and filling the VAERS form.


VAERS ID: 388390 (history)  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2002-06-06
Onset:2002-06-17
   Days after vaccination:11
Submitted: 2010-05-14
   Days after onset:2888
Entered: 2010-05-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autoimmune disorder, Condition aggravated, Fall, Immune system disorder, Infection, Neuroblastoma, Opsoclonus myoclonus
SMQs:, Accidents and injuries (narrow), Ocular motility disorders (narrow), Neonatal disorders (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Neuroblastoma
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0907USA00667

Write-up: Information has been received from a case in litigation via a case report concerning a male child patient who on approximately 06-JUN-2002 was vaccinated with a dose of MMR II (Lot number not reported). Subsequently, the patient experienced OMS. On 17-JUN-2002 approximately 11 days after the vaccination, the patient fell and cut his upper lip, according to the record. Twenty days after vaccination, his mother took him to the doctor because he had been falling frequently for the previous five days. A physician reported that the MMR vaccination triggered an autoimmune response in a child whose immune system was already under assault by a neuroblastoma and various infections. No further information is available.


VAERS ID: 388755 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-05-14
Entered: 2010-05-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Lymphadenopathy, Pyrexia, Rash papular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: body temp, 103 F
CDC Split Type: WAES1002USA03492

Write-up: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with MMR II. Subsequently the patient experienced a fever as high as 103 F, a papular rash and submandibular lymphadenopathy two weeks after vaccination. The patient sought unspecified medical attention. Subsequently, on an unspecified date the patient recovered from these events. Additional information has been requested.


VAERS ID: 412600 (history)  
Age:   
Gender: Unknown  
Location: Unknown  
Vaccinated:2010-04-26
Onset:0000-00-00
Submitted: 2010-11-02
Entered: 2010-11-23
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Lymphadenopathy, Vaccine positive rechallenge
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Antibiotics
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: A0878222A

Write-up: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of swollen gland in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medications at the time of the 2nd dose of TWINRIX included Antibiotics. On 26 April 2010 and 20 August 2010 the subject received 1st dose and 2nd dose of TWINRIX (details unknown). In April 2010 and August 2010, within 1 or 2 days of each vaccination with TWINRIX, the subject experienced swollen glands and exhaustion. The events occurred after each dose of TWINRIX. The healthcare professional was inquiring as to whether the subject should receive the 3rd dose of TWINRIX. At the time of reporting the outcome of the events was unspecified.


VAERS ID: 424403 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2010-10-06
Onset:2010-10-18
   Days after vaccination:12
Submitted: 2011-05-26
   Days after onset:220
Entered: 2011-06-01
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenitis, Lymphadenopathy, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Body temp, 10/19/10, 104 F
CDC Split Type: WAES1010USA03523

Write-up: Information has been received from a physical therapist concerning her daughter with no pertinent medical history and no drug reactions/allergies who on 06-OCT-2010 was vaccinated with the first dose of MMR II. There was no concomitant medication. On 18-OCT-2010 the patient developed swollen glands on the left side of her neck. The patient was examined by her unspecified physician on that date and was diagnosed with cervical lymphadenopathy or lymphadenitis. She was prescribed AUGMENTIN. On 19-OCT-2010, the patient developed vomiting and a fever of 104F. She was admitted on that date to an unspecified hospital and was treated intravenously with multiple unspecified antibiotics. The patient was discharged from the hospital on 25-OCT-2010. She was currently taking an oral antibiotic at home. The patient was afebrile but the lymphadenopathy was unchanged. At the time of reporting, the patient was recovering from these adverse events. Cervical lymphadenopathy or lymphadenitis, vomiting and a fever of 104F were considered to be other important medical events by the reporter. Additional information has been requested.


VAERS ID: 424643 (history)  
Age: 0.98  
Gender: Male  
Location: Illinois  
Vaccinated:1997-03-10
Onset:0000-00-00
Submitted: 2011-05-26
Entered: 2011-06-01
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1002D / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Immunodeficiency
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1009USA04884

Write-up: Information has been received from a registered nurse (R.N.) concerning an approximately 14 year old male patient who on 10-MAR-1997 was vaccinated with the first dose of MMR II (lot # 620001/1002D). The patient presented to the office years later and became "immune compromised". The nurse didn''t know the nature of the disease. At the time of reporting, the patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 426752 (history)  
Age:   
Gender: Female  
Location: Maine  
Vaccinated:2011-06-23
Onset:2011-06-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2011-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0154Z / - LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Lymphadenopathy, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Body aches, pain, low-grade fever, swollen glands.


VAERS ID: 486018 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2013-01-30
Onset:2013-02-02
   Days after vaccination:3
Submitted: 2013-03-01
   Days after onset:27
Entered: 2013-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. H012569 / - UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Decreased appetite, Feeling hot, Headache, Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1302USA013420

Write-up: This spontaneous report as received from a pharmacist refers to a female patient of unknown age who on 30-JAN-2013 was vaccinated with a 0.5 ml dose of M-M-R II subcutaneously (anatomical location was not provided) lot number reported as H0125569. On 02-FEB2013, the patient experienced a headache, her body was warm all over and she had not appetite. The patient visited to physician and was diagnosed with lymphadenopathy. The patient was treated with unspecified steroids. The outcome of lymphadenopathy was unknown. The relatedness for lymphadenopathy was unknown for M-M-R II. Additional information is not expected. This is one of several reports received from the same source.


VAERS ID: 487963 (history)  
Age:   
Gender: Male  
Location: California  
Vaccinated:2013-03-05
Onset:2013-03-14
   Days after vaccination:9
Submitted: 2013-03-25
   Days after onset:11
Entered: 2013-03-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR - / - UN / ID
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Bronchitis, Lymphadenopathy, Nasal congestion, Productive cough, Rhinorrhoea, Troponin increased
SMQs:, Myocardial infarction (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data:
CDC Split Type: 201304190

Write-up: This study case was received from the investigator on 19 March 2013. A male subject (date of birth not reported) had received the following vaccinations on 05 March 2013: ACAM2000 (lot number, route and site not reported), Typhoid (Manufacturer Unknown, lot number, route and site not reported), and Anthrax (Other Manufacturer, lot number, route and site not reported). Nine days later, on 14 March 2013, the subject was found to have an elevated Troponin level. Rapid results for blood draw were negative. The troponin lab values were drawn on 13 March 2013 with an elevated value of 0.12 ng/ml (<0.10). The subject had no cardiac symptoms. The subject also experienced bronchitis which included the symptoms of producing cough, nasal congestion and nasal draining which started on 06 March 2013 and swollen glands which started on 08 March 2013 and stopped on 09 March 2013. Treatment included MUCINEX 600mg twice daily (BID). The subject''s troponin will be retested and an ECG will be done when the subject is well enough to come in. The subject''s smallpox injection site looked normal. The subject''s outcome was not recovered. According to the Investigator, the event of elevated troponin was considered an important event and possibly related. Documents held by sender: None.


VAERS ID: 514020 (history)  
Age:   
Gender: Male  
Location: Arkansas  
Vaccinated:2013-01-01
Onset:2013-01-01
   Days after vaccination:0
Submitted: 2013-10-14
   Days after onset:285
Entered: 2013-11-20
   Days after submission:37
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 UN / UN

Administered by: Public       Purchased by: Public
Symptoms: Erythema, Lymphadenopathy, Skin warm, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: There were no other vaccinations administered on the same date. At the time of reporting, there were no concomitant medications or relevant medical history.
Diagnostic Lab Data: UNK
CDC Split Type: A1031531A

Write-up: This case was reported by a healthcare professional and described the occurrence of swollen lymph nodes in neck and axillary region in a male subject aged between 20 and 29 years old who was vaccinated with TWINIX. In January 2013 the subject received 1st dose of TWINRIX (1 "dose", unknown route, unknown deltoid). In January 2013, within hours after vaccination with TWINRIX (described as "later that night"), the subject experienced swollen lymph nodes in neck and axillary region, erythema neck area, neck tenderness and warm to touch. The events of erythema neck area, neck tenderness and warm to touch described the lymph nodes in the neck and arm pit areas. Per the reporter, the arm pit was “the arm where the injection was administered.” The healthcare professional stated that the subject “returned to the office so they can see it” and “no medication was given.” At the time of reporting the outcome of the events were unspecified.


VAERS ID: 517026 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2013-11-01
Submitted: 2013-12-18
   Days after onset:47
Entered: 2013-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy, Mumps, Smear buccal, Viral test
SMQs:, Oropharyngeal infections (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1312USA006064

Write-up: This spontaneous report, as received from a company representative, refers to a female patient of less than twenty years old (not further specified). Her medical history was unknown. On an unspecified date, the patient was allegedly vaccinated with M-M-R II. She then (about a month ago, in November 2013) developed mumps and symptoms of extremely swollen glands in the lymph node area under the ears. The patient sought medical attention because of the adverse events, by going to the health department. A buccal test and blood test for mumps were performed on an unknown date. The results of the tests were unknown. The outcome of mumps and symptoms of extremely swollen glands in the lymph node area under the ears was unknown. A causality assessment was not provided. This report is linked with report 1312USA006048, 1312USA006053 and 1312USA008378, received from the same reporter, regarding the additional patients, who also allegedly underwent vaccination with M-M-R II, and then developed mumps. It was stated that all patients in the linked reports were in close contact to one another by being related or working together. Additional information has been requested.


VAERS ID: 517430 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2013-12-08
Submitted: 2013-12-23
   Days after onset:15
Entered: 2013-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Lymphadenopathy, Malaise, Mumps, Mumps antibody test, Oropharyngeal pain, Smear buccal
SMQs:, Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1312USA006053

Write-up: This spontaneous report as received from a company representative refers to a female patient over 40 years of age. On an unknown date the patient was "allergedly" vaccinated with M-M-R II (subcutaneous injection). Dosing information and lot number were not provided. On 08-DEC-2013 the patient developed mumps, sore throat, fatigue, "extreme" malaise and swollen glands. The patient sought medical attention because of the adverse events, by going to the health department. A buccal test and blood test for mumps were performed on an unknown date. The results of the tests were unknown. The patient had not recovered from the events. A causality assessment was not provided. This report is linked with report 1312USA006048, 1312USA006064 and 1312USA008378, received from the same reporter, regarding five additional patients, who also allegedly underwent vaccination with M-M-R II, and then developed mumps. It was stated that all patients in the linked reports were in close contact to one another by being related or working together. Additional information has been requested.


VAERS ID: 529829 (history)  
Age:   
Gender: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-04-30
Entered: 2014-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: DiGeorge''s syndrome
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0989131A

Write-up: This case was reported in a literature article and described the occurrence of croup in a subject of unspecified age and gender born between 1974 and 2008 who was vaccinated with DTaP (manufacturer unspecified), MMR vaccine (non-gsk) and IPV (non-gsk). This case refers to a subject. Concurrent medical conditions included DiGeorge''s syndrome and had a chromosome 22q11.2 microdeletion detected by fluorescence in situ hybridization assay. No further information on the subject''s medical, family history or concurrent medication is available. On an unspecified date, the subject received an unspecified dose of DTaP (small content) (administration site and route unknown, batch number not provided), an unspecified dose of MMR vaccine (Non-GSK) (unknown) and an unspecified dose of IPV (Non-GSK) (unknown). 39 days after vaccination with DTaP (small content), MMR vaccine (Non-GSK) and IPV (Non-GSK), the subject experienced croup, fever and lymphadenopathy. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. The author''s conclusion stated that their data expanded the findings of smaller studies indicating that live vaccination of patients with DGS with mild-to-moderate immuno-suppression was well-tolerated. Prospective studies are needed to confirm their findings and offer guidance for live vaccination. Because this study included few patients with DGS with severe immunosuppression, further retrospective investigation of this population is warranted. This case is one of the 18 cases reported in the same literature article.


VAERS ID: 531292 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2014-05-08
Onset:0000-00-00
Submitted: 2014-05-19
Entered: 2014-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 0 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1405USA008789

Write-up: This spontaneous report as received from a nurse refers to an adult female patient of unknown age, who worked in a nursing home. On approximately 08-MAY-2014 (also reported as last week), the patient was vaccinated with her first dose of M-M-R II injection, dose (unknown) and route of administration (unknown). No concomitant medications were reported. In approximately MAY 2014 (also reported as on an unspecified date), the patient developed cervical lymphadenopathy. Patient sought medical attention (unknown type). Action taken with respect to M-M-R II was not applicable. No product quality complaint was involved. The outcome of cervical lymphadenopathy was not resolved. Causality was not reported. No further information provided. Additional information has been requested.


VAERS ID: 535782 (history)  
Age:   
Gender: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-07-03
Entered: 2014-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Laboratory test, Lymphadenopathy, Pyrexia, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medicaitons
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1407USA000434

Write-up: This spontaneous report as received from the patient''s mother, concerning her child of unknown age and gender. On an unknown date the patient was vaccinated with a dose of M-M-R II (lot #, dose and route not reported). Concomitant therapy was not reported. The reporter stated that on an unknown date her child had serous side effects after receiving M-M-R II. The patient had a different set of symptoms, high fever and lymph node problems, the child underwent many tests (data not reported) and an unspecified health care professional determined that it was a reaction to the M-M-R II. The outcome of reaction to the M-M-R II, high fever and lymph nodes problems was unknown. This is one of several reports received from the same reporter: MARRS: 1407USA000508 and 1407USA000509. Additional information is not expected.


VAERS ID: 549045 (history)  
Age: 0.6  
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-17
Entered: 2014-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LA / SYR
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / PO

Administered by: Other       Purchased by: Other
Symptoms: Anal sphincter atony, Anxiety, Areflexia, Axillary mass, B-lymphocyte count, B-lymphocyte count decreased, Bacterial test negative, Biopsy lymph gland abnormal, Blood immunoglobulin A normal, Blood immunoglobulin M normal, Blood test normal, CD4 lymphocytes decreased, CD8 lymphocytes decreased, CSF cell count normal, CSF glucose normal, CSF protein normal, CSF white blood cell count increased, Chest X-ray normal, Computerised tomogram abnormal, Cytomegalovirus test negative, Death, Enterovirus test positive, Fatigue, Fungal test negative, Gram stain negative, HIV test negative, Herpes simplex serology negative, Hyporeflexia, Injection site discharge, Injection site reaction, Irritability, Laboratory test normal, Lymphadenitis, Lymphadenopathy, Lymphocyte percentage decreased, Mobility decreased, Mycobacterium tuberculosis complex test positive, Neutrophil percentage, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Poliomyelitis post vaccine, Poliovirus test positive, Polymerase chain reaction, Pyrexia, Respiratory distress, Scan with contrast abnormal, Skin lesion, Stool analysis, T-lymphocyte count decreased, Tenderness, Ultrasound abdomen abnormal, Unresponsive to stimuli, Vaccination complication, White blood cell count, Withdrawal of life support
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Malignant lymphomas (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Severe combined immunodeficiency syndrome
Preexisting Conditions: UNK
Diagnostic Lab Data: CD3=6 cells/mm3, CD19=1, CD16/56=189; Imaging: Chest radiograph was normal, Brain and Spine MRI showed 8 mm lesion in right cerebral peduncle, prominent abnormal T2 weighted signal at cord T11 level on the left: additional abnormal signal and contrast enhancement of several nerve roots. Chest, abdomen and pelvis CT scan showed enlarged lymph nodes, left supraclavicular, and left axilla, retroperitoneal. Microbiology: Blood test showed no bacterial growth at 48 hours, later positive for AFB identified as mycobacterium bovis/BCG. Cerebrospinal fluid showed negative bacterial meningitis screen and gram stain, negative fungal smear and culture, negative PCR for HSV-1, HSV-2 and CMV. Stool analysis- enterovirus isolated, identified as immunodefi
CDC Split Type: 2014SA141550

Write-up: Initial literature report received on 11 October 2014. A 7-month-old male patient, whose concomitant medications were not reported, had received a dose of BCG (in left deltoid, batch number and route of administration were not reported) and a dose of OPV (batch number, route and anatomical site of administration were not reported) of unknown manufacturer on an unspecified date. The patient has a medical history of SCIDS (severe combined immunodeficiency). It was reported that, after vaccination, the patient was brought to hospital emergency department in July 2013; he had a 6-week history of intermittent fever associated with draining skin lesion over the left deltoid at the site of BCG vaccination. The patient was diagnosed with acute lymphadenitis and prescribed trimethoprim and sulfamethoxazole and sent home. The patient was again brought to the emergency department with increased irritability and decreased movement of the left leg and was admitted to the hospital for the further evaluation. The patient appeared tired and anxious but was responsive to touch. The physical examination was negative for meningococcal signs, no evidence of respiratory distress was found. A firm, mobile, tender, 2x2 cm mass was palpated under the left axilla. The patient did not move his left leg spontaneously or in response to pain. Deep tendon reflexes were absent in the left leg and diminished in the right. Decreased anal sphincter tone was noted. The rest of the physical examination was found to be normal. The patient was diagnosed with VAPP (vaccine-associated paralytic poliomyelitis) after laboratory investigations. Laboratory investigations: Complete blood count- ALC-216 cells/mm3, lymphocytes subsets- CD3 6 cells/mm3, CD4 2, CD8 0, CD 19 1, CD16/56 189, HIV 1/2 was negative, Immunoglobulins- IgA and IgM undetectable, IgG 140 mg/dl. Cerebrospinal fluid test: White blood cell 83 cell/mm3, Polymorph nuclear neutrophils 50%, mononuclear cells 2%, protein 48 mg/dl, glucose 49 mg/dl. Imaging: Chest radiograph was normal, Brain and Spine MRI showed 8 mm lesion in right cerebral peduncle, prominent abnormal T2 weighted signal at cord T11 level on the left: additional abnormal signal and contrast enhancement of several nerve roots. Chest, abdomen and pelvis CT scan showed enlarged lymph nodes, left supraclavicular, and left axilla, retroperitoneal. Microbiology: Blood test showed no bacterial growth at 48 hours, later positive for AFB identified as mycobacterium bovis/BCG. Cerebrospinal fluid showed negative bacterial meningitis screen and gram stain, negative fungal smear and culture, negative PCR for HSV-1, HSV-2 and CMV. Stool analysis- enterovirus isolated, identified as immunodeficiency associated vaccine derived poliovirus type, Lymph node fine needle aspiration showed AFB stain positive. On an unspecified date, the child progressed to respiratory distress during further observation. It was reported that after consultation with multiple specialist physicians and with ethics committee review, the family chose to withdraw support and the child died shortly thereafter. Documents held by sender: None.


VAERS ID: 693585 (history)  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-04
Entered: 2017-05-09
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Amylase increased, Blood culture negative, Blood sodium decreased, Computerised tomogram head abnormal, Cough, Hyperaemia, Influenza A virus test positive, Influenza B virus test, Influenza virus test negative, Lymphadenopathy, Myalgia, Oropharyngeal pain, Parotid gland enlargement, Parotitis, Pyrexia, Respiratory syncytial virus test negative, Swelling face
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hyponatraemia/SIADH (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Atrial fibrillation; Hypertension; Aortic valve stenosis; Heart valve replacement
Diagnostic Lab Data: Physical examination: Heart rate - 102 (as reported, no units mentioned), no tachypnea. Appeared volume replete and well-nourished. Head examination - Enlarged left parotid gland without palpable fluctuance. Stensen''s duct - Hyperemic but without purulent discharge. CT scan of head/neck - Enlarged enhancing left parotid gland consistent with parotitis with inflammatory changes in surrounding soft tissues without cervical lymphadenopathy, focal fluid collections, masses or obstructing lesion or sialolith in the parotid duct. Nasopharyngeal swab - Positive for Influenza A; Amylase, 615, elevated; Blood sodium, 131, depressed; Body temperature, 39, elevated; Heart rate, 102
CDC Split Type: 201700468

Write-up: This literature case, initially received on 26-Apr-2017 was reported by other health professional concerns an 82 years old elderly male patient. The patient''s medical history includes paroxysmal atrial fibrillation, hypertension, severe aortic valve stenosis, heart valve replacement (replacement with a tissue valve). On an unspecified date, the patient received INN Flu Vaccine Seasonal and MMR (dose, route of administration, anatomical site, batch number, expiration date: not reported). Indication not reported. On an unspecified date the patient received MMR and Influenza vaccine for that season and was presented to primary care with 3 days of cough, myalgias and sore throat. He received azithromycin empirically. The next day he had left cheek swelling. On physical examination, he was febrile at 39 degree Celsius with a heart rate of 102 (not tachypnea). He appeared volume replete and well nourished. Head examination revealed an enlarged gland without palpable fluctuance. Stensen''s duct was hyperemic but without purulent discharge. Laboratory tests were within normal limits except for depressed sodium level - 131 mmol/L- and elevated amylase - 615 mmol/L. There was no leucocytosis. CT scan of his head/neck revealed an enlarged enhancing left parotid gland consistent with parotitis with inflammatory changes in surrounding soft tissues without cervical lymphadenopathy, focal fluid collections, masses or obstructing lesion or sialolith in the parotid duct. Nasopharyngeal swab was positive for influenza A, other viral tests (influenza B, respiratory syncytial virus) and blood cultures were negative. The patient was discharged on amoxicillin/clavulanic acid. Action taken with the drug was not reported. The parotitis resolved in 5 days without sequelae. Reporter''s Assessment: The reporter did not provide the causality between the events and the suspect influenza vaccine. This case report was serious (medically significant, hospitalization).


VAERS ID: 158893 (history)  
Age: 0.75  
Gender: Female  
Location: Foreign  
Vaccinated:2000-07-05
Onset:2000-07-28
   Days after vaccination:23
Submitted: 2000-08-10
   Days after onset:13
Entered: 2000-08-16
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES - / 2 - / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES - / 2 - / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anorexia, Apathy, CSF test abnormal, Convulsion, Electrocardiogram abnormal, Encephalitis, Hemiparesis, Hypotonia, Inflammation, Lymphadenopathy, Pain, Platelet count increased, Pyrexia, Rash macular, Respiratory acidosis, Skull malformation
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Tick bite at the end of 5/00
Diagnostic Lab Data: NMR exam-leuco-encephalitis, metabolic analysis-pending; ECG on 7/31/00-slow electrogenesis compatible with diffuse pain; 8/2/00, still electrogenesis with asymmetry at the expense of left derivations; 8/11/00-marked improvement; LP-increased protein and RBC in the rachis, 8/9/00-nml; 9/14 and 9/15 night ECG-no anomaly of electrogenesis especially no paroxystic dysfunction; cerebral and cervical marrow MMR: bilateral mesial schlerosis with left predominence and small hypertintense lacunar focus of the corpus callosum swelling-nml white substance-nml myelinization according to the 2nd hospitalization 9/20/00 to 9/26/00: Biology: inflammatory syndrome: thrombocytosis; serology: neg; marrow punction-nml; neck echography: left adeno-phlegmon wi
CDC Split Type: U2000005970

Write-up: "It was reported that a 9 month old baby girl was vaccinated for the 3rd time with a DTP and Haemophilus influenza type B vaccine (combined vaccination of ActHib and Triamer) on 7/5/00. She received at the same moment an Oral Polio Vaccine. The pt had no fever short after vaccination (preventively she had received acetylsalicylic acid). On 7/28/00, the pt presented with fever (around 38-38.5C) and was hospitalized for left lateralized convulsions. The pt had neither antecedents nor pathology. A NMR exam reveals an under cortical diffuse leuco-encephalitis of unknown origin. The pt is slightly recuperating but is still suffering of hypotonia and is not taking food. Further information is awaited. F/U on 8/11/00: The pt presented with right side hemiparesis on 7/28/00 which was treated with anticonvulsives of diazepam and phenobarbital. F/U on 3/2/01: The pt was hospitalized from 7/28/00 to 8/11/00 because of prolonged convulsion episode. A respiratory acidosis had also been signaled before admission but no more dx''d afterwards. On 7/29/00, the pt again had convulsions (left laterized) and was feverish (however, no source of infection could explain the fever. Amoxicillin was given). The pt stayed hypotonic and apathic, refusing to eat. 48 hours after her admission, she presented an atypia maculous eruption on the left part of the body. When discharged on 8/11/00, the rash was gone, she was sitting alone, moved all 4 limbs with a right hand side minor weakness, a facial asymmetry and a tendency to lean the head towards the left. Phenobarbital (2x10mg) was prescribed at the moment of the discharge. Between 9/20/00 and 9/26/00, the pt was hospitalized again. On 9/20/00, in the AM, the pt had to undergo a marrow punction to explore her thrombocytosis. She started having fever in the PM of up to 40C then a submandibular swelling appeared and the inflammatory syndrome was then much more important than in the AM. The pt was treated with amoicillin IV and had no more fever the next day. Platelets were still elevated. Other treatment was ibuprofen syrup 100ml, amoxicillin 80mg syrup 250mg and Phenobarbital 30mg at night. The after effects of the leuco-encephalitis-type infection are then considered as minor. At 13 months of age, the pt was functioning normally. F/U on 10/5/01: The etiology of the encephalopathy remains uncertain. No balance disorder but language development is optimal. The pt is off phenobarbital.


VAERS ID: 166111 (history)  
Age: 0.8  
Gender: Female  
Location: Foreign  
Vaccinated:1997-10-01
Onset:1997-12-18
   Days after vaccination:78
Submitted: 2001-02-20
   Days after onset:1160
Entered: 2001-02-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR - / - RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Granuloma skin, Lymphadenopathy, Skin necrosis
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: She had 2 older brothers who were born in Bangladesh and had received BCG vaccinations without complication.
Diagnostic Lab Data: Histopathology of the lymph node revealed a centrally necrotizing granuloma typical of mycobacterial infection. Ziehl-Nielsen stain was positive for mycobacteria. Culture grew mycobacteria of a BCG strain sensitive to ethambtol, isoniazid and Rifampicin. DNA probe tests showed mycobacterium tuberculosis complex.
CDC Split Type: U200000866

Write-up: Assessed as serious on basis of "Medical Judgement". "A 10 month old girl of Bangladesh parents, after a Mantoux skin test performed on 10/13/97 was negative, was vaccinated on her right deltoid with 0.05 ml, of BCG vaccine (CSL/Connaught) intradermally. The pt was sent back by her local medical doctor 2 months later (12/18/97) due to an enlarged and firm right supraclavicular lymph node which measured 3cm and was almost on the verge of rupturing through the skin. Excision of the lymph node was carried out. The pt was started on a 3 month regimen of isoniazid and Rifampicin. She tolerated the medications well and showed signs of resolution after 1 week. No further follow-up was continued after the family returned to Bangladesh. Upon follow-up review from 2/15/01, it was determined that version zero of this report was incorrectly reported to the wrong product. The correct product for this report was BCG-Mycobax not BCG-Theracys as previously reported.


VAERS ID: 169140 (history)  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-05-06
Entered: 2001-04-27
   Days after submission:374
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (TICE) / ORGANON-TEKNIKA - / 0 - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Chromosome abnormality, Cough, Hepatomegaly, Irritability, Lymphadenopathy, Oral intake reduced, Pancytopenia, Pyrexia, Respiratory failure, Splenomegaly
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Myelodysplastic syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 32 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: At autopy-M. Bovis var BCG, was recovered from lung tissue and numerous acid-fast bacilli were observed in bone marrow and 1 adrenal gland, confirming the dx of disseminated BCG infection. Immunologic investigations revealed normal number of T & B lymphocytes and related functions. A defect was detected in the IFNGRI gene.
CDC Split Type: U200100661

Write-up: "Male infant was born in 8/96, following a normal pregnancy. He was well initially. BCG vaccine was administered in the left arm at 3 weeks of age. At 9 weeks of age, he was seen in hospital with a brief history of cough and fever. He was found to have markedly enlarged liver, spleen and was admitted for investigation. CMV was cultured from his urine; treatment was undertaken with ganciclovir and IV immunoglobulin on suspicion that the virus was responsible for his hepatosplenomegaly. While in hospital, that infant developed enlarged left axillary nodes. At the same time, his liver enlargement increased and pancytopenia became severe, necessitating repeated platelet infusions. Excision biopsy of an axillary lymph node showed abundant acid-fast bacilli, later identified as M. bovis, var BCG. He was treated with isoniazid, rifampin, pyrazinamide and clarithromycin on suspicion that he had disseminated BCG infection. However, he failed to improve and died of respiratory failure after 32 days in hospital; 17 days of anti-TB therapy took place during this time. Details of the infant''s disorder and studies of his parents will be published separately. The parents were healthy and unrelated. F/U received 4/16/01; F/U-has been published as Disseminated bacille Calmette-Guerin infection in an infant with a novel deletion in the interferon-gamma receptor gene. From fazed correspondence on 4/29/02-6 weeks after receiving BCG vax, an aboriginal infant presented with suspected sepsis, lymphadenopathy and hepatosplenomegaly. Other mutations in this gene have led to disseminated atypical mycobacterial infections in children as well. The authors believed that the infant''s impaired response to anti-tuberculosis therapy and eventual fatal infection was consistent with the interferon-gamma receptor gene mutation. Standard 0.05ml BCG vaccine was administered in the left deltoid at 2 weeks of age. He presented at 8 weeks of age with a 3 day history of cough, irritability, decreased feeding and a 1 day history of fever. The liver edge was approx. 9cm below the right costal margin, with significant spenomegaly. The latest date of F/U info was 4/26/02 not 4/29/02 as reported. From faxed correspondence recieved on 04/29/02, states that six weeks after receiving BCG vaccination, an aboriginal infant presented with suspected sepsis, lymphadenopathy and hepatosplenomegaly. Lymphnode biopsy revealed macrophages filled with acid-fast bacilli. Mycobacterium bovis was cultured from tissue specimens and there was evidence of concomitant cytomegalovirus disease. The infant died of disseminated BCG infection. A novel deletion at nucleotide 165 in the interferon-gama receptor was identified. Other mutations in this gene have led to disseminated atypical mycobacterial infections in children as well. The authors believed that the infant''s impaired response to antituberculosis therapy and eventual fatal injection was consistent with the interferon-gamma receptor gene mutation. Standard 0.05ml BCG vaccine was administered in the left deltoid at 2 weeks of age. He presented at 8 weeks of age with a 3 day history of cough, irritability, decreased feeding and a day history of fever. The liver edge was approximately 9cm below the right costal margin, with significant splenomegaly.


VAERS ID: 172993 (history)  
Age: 0.25  
Gender: Male  
Location: Foreign  
Vaccinated:1993-09-02
Onset:1993-11-01
   Days after vaccination:60
Submitted: 2001-06-28
   Days after onset:2795
Entered: 2001-07-06
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0261W / - - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Abdominal pain, Abnormal behaviour, Alpha 1 foetoprotein increased, Clumsiness, Constipation, Coordination abnormal, Diarrhoea, Disturbance in attention, Electroencephalogram abnormal, Febrile convulsion, Gastrointestinal disorder, Immunoglobulins decreased, Infection, Neurodevelopmental disorder, Psychomotor hyperactivity, Sleep disorder, Urine analysis abnormal
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Tumour markers (narrow), Akathisia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Foetal disorders (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Febrile seizure; measles
Diagnostic Lab Data: EEG-"very abnormal" on 9/95; On 3/25/96 all nml results on MRI of brain; Visual evoked potentials; ERG; Urea; Electrolytes; Creatinine; Calcium; Magnesium; liver function; Urate; ammonia; Blood and CSF lactate; CBC, etc. Abnormal tests included: EEG-some posterior slow waves; Urine amino acids showed a few abn peaks; Alpha-fetoprotein was slightly high at 14; IgG-6, IgA-0.08, IgM-0.6 (low); Serum electrophoresis-nml
CDC Split Type: WAES99031502

Write-up: Information has been received from a foreign legal firm concerning a male who on 9/2/93 was vaccinated with MMRII (lot 791750U, 606926/0261W). It is alleged that the pt suffers from epilepsy, ataxia, behavioral problems, severe learning difficulties and gastrointestinal problems. The pt had 2 febrile convulsions associated with measles infection on 8/10/93. He had additional convulsions during 12/93, 4/95 and 8/95. Within 2 months, post vax, he was noted to have become clumsy, bumping into things and falling over. Sudden deterioration in sleep pattern, concentration span and speech development. By 8/94, he developed behavioral difficulties including hyperactivity. On 10/12/95, he was dx''d with epilepsy. This was noted to be in conjunction with developmental problems, slow speech, poor concentration, abnormal social interaction and hyperactivity. In 1/98, he had started suffering from persistent abdominal pain and bloating with stools alternating between solid and loose. Upon internal review epilepsy, convulsions and febrile convulsion associated with measles infection were determined to be "Other Important Medical Events". No further information is available. F/U info from a foreign legal firm indicated that the pt was seen by a consulting pediatrician on 12/4/95 and he noted that there had been a change in the pattern of the pt''s epilepsy and that he was having astatic drop attacks, atonic seizures and probable myoclonic jerks. Current treatment included carbamazepine 200mg bid and sodium valproate 400mg bid. On 3/25/96, the pt was admitted to the hospital for further testing. The neurologist believed the pt''s ataxia was epilepsy related. On 6/21/96, a physician concluded that the pt "has a difficult form of epilepsy which is poorly controlled. He may also have some developmental problems with slow speech and poor concentration, rather abnormal social interaction".


VAERS ID: 186324 (history)  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2001-11-28
Onset:2002-02-22
   Days after vaccination:86
Submitted: 2002-11-22
   Days after onset:273
Entered: 2002-06-12
   Days after submission:163
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 2 - / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abscess drainage, Anorexia, Body temperature increased, Cough, Crying, Jaundice, Leukopenia, Lymphadenopathy, Lymphocyte morphology abnormal, Neutropenia, Protein bound iodine increased, Pyrexia, Rash papular, Viral infection, Vomiting
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Depression (excl suicide and self injury) (broad), Malignant lymphomas (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D
Current Illness:
Preexisting Conditions: Jaundice neonatal; benign neoplasm of eyelid, including canthus; telangiectsia; umbilical hernia NOS
Diagnostic Lab Data: Ultrasound - Multiple cervical adenopathies; Ultrasound - adenopathy; Temperature measurement - fever; WBC count; Band neutrophil count; Neutrophil count; Serum C-reactive protein- High; Temperature measurement - normal; Temperature measurement - normal; WBC; Band neutrophil count; Lymphocyte count - High; Monocyte count - high; Neutrophil count; Throat culture - negative; WBC count; Band neutrophil count; Lymphocyte count - high; Monocyte count - high; Neutrophil Count; Serum C-reactive protein - high; WBC count, 7/24/02, 10.1 x 10^9/L, range 5.0-12.5; Lymphocyte count, 7/24/02, 7.3 x 10^9/L, range 2.000-8.800; Monocyte count, 7/24/02, 1.31 x 10^9/L, range 0.100-1.000; Neutrophil count, 7/24/02, 0.606 x 10^9/L, range 2.300-3.500, comment -
CDC Split Type: WAES0203CAN00001

Write-up: Information has been received from an investigator concerning a 21 week old male child with right blepharal nevus with telangiectasia and umbilical hernia and a history of jaundice neonatal who entered a study. On 11/28/2001, the pt was allocated and randomized to either one of three formulations of HRSI vaccine (diphtheria toxoid/haemophilus b conjugate vaccine/hep b vaccine recombinant/pertussis vaccine/poliovirus vaccine/tetanus toxoid) or Pentacel diphtheria toxoid/haemophilus b conjugate vaccine/pertussis vaccine/poliovirus vaccine/tetanus toxiid) and (hep b vaccine recombinant) control vaccines. Pt was randomized to received control vaccines (Pentacel and hep b vaccine recombinant) and was vaccinated on 11/28/2001 with the first dose and on 02/11/2002 with the second dose. Concomitant therapy included vitamin D. After the vaccination, the pt experienced fever with a peak at 39.8 deg C for 5-6 days controlled with Tylenol. He subsequently developed a papular rash on the neck and a viral infection associated with vomiting (x2), dry cough, loss of appetite and increased crying. On 02/22/2002, the pt went to ER because of the sudden apparition of a 2.5cm X 2.5cm cervical mass. The pt had dry cough, vomited twice and his temp was normal at 37 deg C and 37.6 deg C rectal. He had consultations with pediatrics and infectious diseases and was admitted to hospital with a cervical *adenitis* diagnosis. His WBC was 12.4 without any bands and neutrophils, C-reactive protein was increased to 25mg/L. A cervical ultrasound revealed multiple cervical adenopathies. On 02/23/2002, WBC was 10.4 without any bands and neutrophils, lymphocyte count was increased to 6.1 x 10^9/L, monocyte count was increased to 3.4 x 10^9/L and viral throat culture was negative. On 02/24/2002, WBC was increased to 13.8 without any bands and neutrophils, lymphocyte count was increased to 7.7 x 10^9/L, monocyte count was increased to 5.2 x 10^9/L and C-reactive protein was increased to 29mg/L. On 02/25/2002, cervical ultrasound was repeated and ademopathies were still present. During hospitalization, the pt was treated with clindamycin, ceftriaxone sodium. The final diagnosis was: "Cervical adenopathy of unknown etiology." On 02/26/2002, the pt was discharged from hosptial with Biaxin for 10 days. As per nursing notes, the pediatricians confirmed that, on 03/15/2002, the pt recovered from cervical lymphadenitis. **F-UP report on 12/2/02: On 7/24/02, the PT had a bone marrow biopsy (myalogram) which revealed immature cells (bone marrow immaturity). The bone marrow pathology and cytogenetics reports did not mention any specific diagnosis. The next day, on blood smear, WBC was 10.1 x 10^9/L, neutrophil count was 0.606 x 10^9/L, lymphocyte count was 7.3 x 10^9/L and monocyte count was 1.31 x 10^9/L. Following these lab results, the PT''s severe nautropanis was considered moderate in intensity. The PT''s neutropenia persisted.** The reporting investigator felt that cervical lymphadenitis was possibly related to study therapy. Additional info is not expected. *This is an amended report. The SAL verbatim has been changed from "acute cervical lymphadenitis" to "acute cervical adenitis". This report is corrected, as amended. **On 11/11/02, as per investigator and internal review, the PT"s neutropenia was considered to be an other important medical event (OMIC). No further info is avaiable.** Follow up report dated 1/18/2003: Safety, tolerability and immunogenicity of 3 different formulations of a liquid hexavalent combination vaccine, RSI (Haemophilus Influenzae Type b conjugate. Recombinant hepatitis B surface antigen, diphtheria toxoid, tetanus toxoid. 5-component acellular pertussus vaccine, and inactivated poliovirus type 1, 2, and 3. When administered healthy hepatitis B vaccine-naive infants at 2, 4, 6, and 12 to 14 months of age. Information has been received from an investigator concerning a 21 week old white male child with right blepharal nevus with telangioctasi


VAERS ID: 189184 (history)  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:2002-08-01
Onset:2002-08-02
   Days after vaccination:1
Submitted: 2002-08-16
   Days after onset:14
Entered: 2002-08-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Headache, Hepatosplenomegaly, Laboratory test abnormal, Lymphadenopathy, Pain, Pyrexia, White blood cell count decreased
SMQs:, Liver related investigations, signs and symptoms (narrow), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: 8/2002: Alanine Transaminase, serum-37; Aspartate Transaminase, serum-19; C-Reactive Protein, serum-79; WBC-6,000; Exam-Hepatosplenomegaly; 8/5/02 Temperature-39C
CDC Split Type: D0039086A

Write-up: On 8/1/02, the pt received the 1st dose of Twinrix adult. Approx. 1 day, post vax, on 8/2/02, the pt experienced fever, headache, limb pain and swollen lymph nodes on the neck. Treatment included cortisone. The events improved at first, but on 8/5/02, the pt had to be hospitalized due to worsening conditions including fever of 39C. Exam showed elevated transaminases, elevated C-reactive protein and hepatosplenomegaly. The most recent information received on 8/7/02, reported the outcome of the event as not resolved. The reporter did not specify the relation of the events to vaccination with Twinrix adult. Additional information has been requested.


VAERS ID: 189254 (history)  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:1994-07-21
Onset:1994-07-28
   Days after vaccination:7
Submitted: 2002-11-20
   Days after onset:3037
Entered: 2002-08-23
   Days after submission:89
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1503W / - - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal behaviour, Decreased appetite, Diarrhoea, Hearing impaired, Irritability, Listless, Lymphadenopathy, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Dementia (broad), Pseudomembranous colitis (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Unk
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0208USA01694

Write-up: Information has been received from a foreign legal firm concerning a male child who on 21 JUL 1994 was vaccinated with MMR (second generation)(lot # 609505/1503W: batch # 851790U). It is alleged that subsequent to the vaccination the patient experienced behavioral and hearing problems. Upon internal review, the patient''s hearing and behavioral problems were considered to be other important medical events. No further information is available. The follow up states the pt''s legal claim form was received as follow up and reported that around seven days after the vaccination the pt became listless, irritable and developed swollen glands in his neck and groin. His behavior altered between screaming fits and periods of listlessness. Fourteen days later he developed spots and started pulling at his ears. At that time he developed sickness and chronic diarrhea. The diarrhea remained chronic for twelve months after the vaccination and continued intermittently with severe episodes for several years. Four months after the vaccination the pt''s behavior deteriorated and he develpoed angry temper tantrusm. At the same time he had very little appetite and started to lose weight. Five months post vaccination the pt''s mother recalled her son with chronic diarrhea, swollen glands, extremely thin, no appetite and deranged behavior. In September of 1996, the pt was assessed by a speech and language therapist who noted hte pt''s understanding of language and expressive language were at the lower end of hte normal range. In January of 2000, a physician felt that the pt was suffering from depression and started him on amytryptilline, which was stopped a few weeks later by his mother. Another physician felt that there was not engouh evidence to diagnose a depressive illness. At the time that this legal claim was written, the pt displayed routine-based behavior, social withdrawl, preferring his won company. He also continued to be a picky eater. It was noted that the pt was suspected of having measles on 1/27/97. A letter written by a consultant pediatrician and dated 8/25/94 was received as follow-up. The pt had received the vaccination four weeks prior to this visit and it was mentioned that he had been "not quite himself" and that his mother had noticed some glands in his groin that concerned her. The pt''s natural functions were all described as normal but he would get irritable during the day and the irritability seemed to be helped by paracetamol. Vomiting and urinary distrubance were denied. On examination he was not clinically anemic but was pale skinned. There were no abnormal lymph glands found, but the inguinal glands were palpable, all were less than 1 cm to freely mobile. There was some ear was present in both ears and the tonsils were small, other systems were normal. It was felt that the pt may have had a non-specific reaction to the vaccine or might be reacting with other viruses that he might have picked up. A speech and language therapy assessment dated 9/20/96, reported that the pt''s understanding of language and expressive language was at the lower end of the normal range. His speech sound system developed was age appropriate and he was n o longer dribbling. The pt''s mother reported a history of late talking. It was noted that the pt, in the six months prior to this assessment had shown good progress in his talking development, going from using single words to communicate, to using sentences. Sentences of up to five words were heard in the clinic. It was felt that further speech and language therapy intervention was not indicated at that time. Another consultant letter regarding a visit with the pt and his mother that took place on 6/6/00 was received as follow up. The pt''s mother was concerned about the pt''s growth and weight, hearing problemss and moodiness. She reported that for a few motnhs the pt was very depressed and would go right to bed as soon as he got back from school, refusing to engage in any play or activities, or to t


VAERS ID: 201464 (history)  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:2001-09-14
Onset:2001-09-18
   Days after vaccination:4
Submitted: 2003-04-09
   Days after onset:568
Entered: 2003-04-15
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR 51500 / 2 GM / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. HL48260 / 0 GM / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Depressed level of consciousness, Diarrhoea, Epilepsy, Lymphadenopathy, Pyrexia, Rash papular, Rhinitis, Tremor
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Parkinson-like events (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 (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pulmicort; Bricanyl
Current Illness:
Preexisting Conditions: Asthma, foodstuff allergy: pea, chocolate, strawberry, cocoa, fish and additionally one unclear foodstuff.
Diagnostic Lab Data: The clinical analysis on the 9/27/01 showed S-ParvAbG<10 EIU, S-ParvAbm negative, leukocytes was 6.9E9/l, B-Eryt 4.54 E12/L, B-HB 127g/L, B-HKR 0.37, E-MCV 82fl, E-MCH 28pg, E-MCHC 338 g/l, B-Trom 189 E9/l, S-VirLab and S-InfACF was 8 (no units reported). The values of S-VirLab, S-InfBCF, S-AdenCF, S-RSVCF, S-ParaCF, S-MypnCF, S-ChpsCf, HSVCF, S-VZVCF, S-CMVCF, S-EnteCF, S-RotaCF were <8 (no units reported). B-La was 8mm/h. The results of U-Tutk-l (Gluk, keto, Eryt, Prot, Nitr, Leuk) were negative.
CDC Split Type: E200300188

Write-up: It was reported that a boy was vaccinated with the 3rd dose of a Hib (Act-Hib, 51500) vaccine and the 1st dose of MMR II (batch HL48260) on 9/14/01. On 9/18/01 the pt presented with an anterior, small papule, red rash. The most of it on the thighs, legs and arms and only little on the face. 8 days after vaccination he got fever, enlarged glands behind the ears and in the neck. On the 9/24/01, he got medication Atarax and Panadol. On 10/26/01, the child was examined by the doctor. The child had slight rhinitis, been sick and has not been eaten well during couple of days. Faeces were clear looser than usual, usually has more constipation. He had the most intensive rash on the thighs, but also on the legs, on lower and upper arms, on front and back of the body. He had slight pimples on clustering and pimply, elevated on the skin, quite pale red. Palms and soles were near. There was no rash history in the family. General condition was OK, no erythema in the pharynx. Tonsils were clean. On 10/9/01, the rash was weakly visible, glands was most unvisible. The child was in a good condition all the time. The mother told that the child got an epileptic seizure while sleeping his afternoon nap on two consecutive days. About some hours after he felt asleep he "snapped" strongly with his mouth and foam-slime become out of his mouth. The child was trembling and couldn''t be waked up. In February 2002 he had a clear convulsions seizure for 10-15 min. He was hospitalized and epilepsy was diagnosed. After that left side limbs have been powerless and speech a little bit mushy for 2 days. Medication for epilepsy has started and seizures were absent until October 2002, when the medication was terminated and the amount of seizures increased again. In October 2002 a video EEG was done at first aid and a lot of outburst was detected during sleep. The medication has decided to change and after that seizure symptoms have been under control. Epileptic symptoms have been partly absence/aura symptoms and symptoms during sleep. Even after the medication has changed no grand mal has existed, but a constant surveillance is required due to possible seizures. Outcome: unknown. File to be completed. Follow up on 1/29/04: It is reported by health authority that the AE lasted for 3.5 weeks and ended on 10/9/01, except for Epileptic seizure (outcome unknown). No more information is available. Case is closed.


VAERS ID: 213647 (history)  
Age: 0.25  
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-12-05
Entered: 2003-12-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Infection, Lymphadenopathy, Pyrexia, Rash papular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: The haemogram, biochemistry, and urinalysis showed no abnormalities. Chest and bone x-rays were normal. A Mantoux test gave a finding of 16mm. Staining and culturing the adenopathy exudate for mycobacteria gave negative findings. Human immunodeficiency virus (HIV) serology was negative. The haemogram, biochemistry and urinalysis showed no abnormalities. Chest and bone x-rays were normal. A Mantoux test gave a finding of 16mm. Staining and culturing the adenopathy exudate for mycobacteria gave negative findings. Human immunodeficiency virus (HIV) serology was negative.
CDC Split Type: 200303253

Write-up: It was reported through literature a case of adenitis as a complication of BCG vaccine in a baby. A 7 month old boy was referred to our hospital for assessment of an axillry lesion that had been present for 3 and a half months. The picture had begun as a left axillary adenopathy which steadily grew in size, accompanied initially by self-limiting febrile syndrome of short duration. After 6 weeks the adenopathy was large and was starting to fistulize. The epidemiologic history revealed that the pt was an immigrant, where he had been vacinated in accordance with the BCG vaccination calendar at 3 months of age, 15 days before the above-mentioned picture began. He had no known relevant personal or family history and no known contact with tuberculosis. Examination revealed two left axillary adenopathiese measuring 3x3cm and 1.5x1.5cm, hard, with no adhesions. A fistulization crifice was visible on the anterolateral aspect of the thorax, near the larger adenopathy, with slight suppuration. The posterior region of the left arm showed a purple papule at the site of innoculation of the BCG vaccine. The remaining findings were unremarkable. The haemogram, biochemistry and urinalysis showed no abnormalities. Chest and bone x-rays were normal. A Mantoux test gave a finding of 16mm. Staining and culturing the adenopathy exudate for mycobacteria gave negative findings. Human immunodeficiency virus serology was negative. In view of the epidemiologic history and clinical picture the pt was diagnosed with localized BCGitis. Oral isoniazid for 3 months was prescribed. During this period the adenopathies regressed, and at 3 months all that remained was a minimal adenopathy. File to be completed. Follow up on 12/16/03: "According to the author: the incidence of adverse reactions to BCG is low, although it may possibly be underestimated given the benign nature of most of the cases. Regional lymphadenitis is the most frequent complication, with an incidence of between 0.5 and 5%. Suppuration is exceptional; it occurs in only 1% of cases. Various factors that might influence the incidence and severity of the associated complications have been considered: age, vaccine dose, administration technique, storage, number of viable bacilli and change of vaccine strain. In reality the ultimate cause of their onset is unknown. At high dose and at young age the incidence is higher, particularly in neonates. Thus, some authors suggest contraindication below the age of 3 months. The lymph node chain most frequently affected is the left axillary, being the most usual administration site. There is no unanimity concerning treatment. Even without treatment the natural course is total regression. Nevertheless, treatment is frequently introduced with the aim of shortening the symptomatology and reducing the associated discomfort, although the medical literature provides no evidence that specific treatment brings any benefit.


VAERS ID: 219548 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-04-27
Entered: 2004-04-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / - - / -

Administered by: Other       Purchased by: Other
Symptoms: Hepatitis, Immune system disorder, Jaundice
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Hepatitis, non-infectious (narrow), Acute pancreatitis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0043628A

Write-up: This case was reported by a physician and described the occurrence of possible auto-immune hepatitis in a juvenile female subject who was vaccinated with hepatitis A-B vaccine for prophylaxis. The subject''s past medical history has not been reported. In autumn 2003, the subject received the first two doses of hepatitis A-B vaccine. Approximately half a year post vaccination, in spring 2004, the subject developed jaundice and was diagnosed with possible auto-immune hepatitis. The outcome of the events was not reported. According to the reporting physician, the subject''s mother suspected a relationship between auto-immune hepatitis and vaccination with hepatitis A-B vaccine. The reporting physician was not the treating physician. The subject does not live in the same city and the reporting physician did not know the subject''s family doctor. No further information will be available.


VAERS ID: 221870 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-05-25
Entered: 2004-05-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / - - / -

Administered by: Other       Purchased by: Other
Symptoms: Cardiovascular disorder, Dizziness, Injection site reaction, Lymphadenopathy
SMQs:, Anticholinergic syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0043825A

Write-up: A physician reported the occurrence of a severe injection site reaction in a female subject of unknown age who was vaccinated with hepatitis A-B vaccine for prophylaxis. In the subject''s family, severe injection site reaction were known. On a date not specified the subject received the third dose of hepatitis A-B vaccine. On a date no specified post vaccination the subject developed a severe injection site reaction with enlarged lymph nodes, circulatory disturbance and dizziness. The subject was not able to work for two days. Follow up on 06/07/04 states: "The events resolved on 04/17/04. The reporting physician considered that the event after the third vaccination were probably related to vaccination with hepatitis A-B vaccine."


VAERS ID: 244148 (history)  
Age: 0.01  
Gender: Female  
Location: Foreign  
Vaccinated:2004-06-07
Onset:2004-09-11
   Days after vaccination:96
Submitted: 2005-09-14
   Days after onset:368
Entered: 2005-09-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR C1685 / - LA / ID

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had no medical history, concurrent conditions, was on no concurrent medications and had no illnesses at the time of vaccination.
Diagnostic Lab Data: Cultures taken showed heavy Strep A.
CDC Split Type: 200501355

Write-up: Initial report of a cluster of 4 cases with swelling of lymph nodes was received from a nurse on July 2005. Case 4: A child, age not reported, developed swelling of the lymph nodes, latency not reported, after receiving an intra dermal injection in the left upper deltoid of BCG vaccine, lot number C1685AE. The administration date was not reported. As of July 13 2005, reporters states, no more information other than what was recorded. Follow up information received on Sept 07 2005. This case has been upgraded to serious based on follow up information received. The patients date of birth is June 03 2004 and was vaccinated on June 07 2004 when 4 days old. the patient had no medical history, concurrent conditions, was on no concurrent medications and had no illnesses at the time of vaccination. At the age of 3 months the patient developed a left axillary lump node which burst on Sept 11 2004. Cultures taken showed heavy Strep A. The patient was hospitalized from Sept 12 2004 to Sept 14 2004 and was treated with Cefprozil Q8H. the patient fully recovered, date unknown. The reporter noted that 4 out of 50 children immunized with BCG lot number C1685AE developed swelling of lymph nodes. Same reporter as cases 200501352, 200501353, 20501354. These three patients did not require hospitalization.


VAERS ID: 244241 (history)  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-09-09
Entered: 2005-09-19
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Immune system disorder, Infection
SMQs:

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: SCID
Diagnostic Lab Data:
CDC Split Type: 2005132297NL

Write-up: Clinical events: Disseminated BCG infection (Disseminated Tuberculosis) Narrative: Child was vaccinated with BCG (brand unknown) at 2 days of age for multiple infection in 1993. Patient had a severe immunodeficiency disorder. Patient had concomitant infections and subsequently died. Out come: Fatal


VAERS ID: 244242 (history)  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-09-09
Entered: 2005-09-19
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR UNK / - UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Immune system disorder, Infection
SMQs:

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: SCID, Bone marrow transplant
Diagnostic Lab Data:
CDC Split Type: 2005132292NL

Write-up: Clinical events: Disseminated BCG infection (Disseminated Tuberculosis) Narrative: child was vaccinated with BCG (brand unknown) at birth for multiple infection in 1993. Patient had a severe immunodeficiency disorder. Patient had concomitant infections and subsequently died after bone marrow transplant. Outcome: fatal.


VAERS ID: 244243 (history)  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-09-09
Entered: 2005-09-19
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / - UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Immune system disorder, Tuberculosis
SMQs:

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: SCID
Diagnostic Lab Data:
CDC Split Type: 2005132291NL

Write-up: Clinical events: Disseminated BCG infection (Disseminated Tuberculosis) Narrative: child vaccinated with BCG (brand unknown) at 1 day of age for multiple infection in 1993. Patient had a severe immunodeficiency disorder. Patient had concomitant infections and subsequently dies. Outcome fatal.


VAERS ID: 244244 (history)  
Age: 0.08  
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-09-09
Entered: 2005-09-19
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / - UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Immune system disorder, Tuberculosis
SMQs:

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: IFN-y receptor deficiency
Diagnostic Lab Data:
CDC Split Type: 205132289NL

Write-up: Clinical events: Disseminated BCG infection (disseminated tuberculosis). Narrative: child was vaccinated with BCG (brand unknown) at 3 weeks of age for multiple infection in 1993. Patient had an IFN-y receptor deficiency. Patient had concomitant infections and subsequently died. Outcome: fatal.


VAERS ID: 244246 (history)  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-09-09
Entered: 2005-09-19
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Immune system disorder, Tuberculosis
SMQs:

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: SCID
Diagnostic Lab Data:
CDC Split Type: 2005132270NL

Write-up: Clinical events: Disseminated BCG infection (Disseminated Tuberculosis). Narrative: child was vaccinated with BCG (brand unknown) at 3 days of age form multiple infection in 1993. Patient has a sever immunodeficiency disorder, Patient had concomitant infections and subsequently died. Outcome: fatal.


VAERS ID: 251284 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-02-07
Entered: 2006-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / - UN / -

Administered by: Other       Purchased by: Other
Symptoms: Hepatitis, Immune system disorder
SMQs:, Hepatitis, non-infectious (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: B0409049A

Write-up: This case was reported by a physician and described the occurrence of an autoimmune hepatitis in a female subject of unspecified age who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine Twinrix, for prophylaxis. On an unspecified date the subject received a dose of Twinrix. At an unknown time following vaccination, the subject developed an autoimmune hepatitis. The physician considered the event was clinically significant (or requiring intervention) (OMIC). AT the time of reporting the outcome of the event was unspecified. Further information has been requested.


VAERS ID: 262343 (history)  
Age: 0.33  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-08-23
Entered: 2006-08-30
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - - / SC
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 0 - / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Anaemia, Aspartate aminotransferase increased, Granuloma, Haemolysis, Hepatosplenomegaly, Laboratory test abnormal, Liver function test abnormal, Lymphadenitis, Lymphadenopathy, Neutropenia, Pallor, Pyrexia, Renal failure, Sepsis, Thrombocytopenia, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Haemolytic disorders (narrow), Agranulocytosis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? Yes
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Immunophenotypic analysis flow cytometry abnormally low expression of the alfa chain of the IFN gamma receptor, Serum C reactive protein (high), Serum CMV IgM ab (high) level of IgM class anti CMV reactive antibodies, Serum alanine aminotransferase (elevated). Serum aspartate aminotransferase (elevated). Acid fast bacilli stain test (negative), periodic acid Schiff stain test negative for acid fast bacilli, examination of blood cell morphology anemia, thrombocytopenia.
CDC Split Type: WAES0608POL00005

Write-up: It was reported in a published article, that a 4 month old girl exhibited enlargement of left axillary lymph nodes during a 1.5 month period (year unknown) as a rare complication of antituberculous vaccination. She was a second child of healthy parents, with no family history of genetic disorders or TB. The first dose of BCG and anti hepatic B virus vaccination (unknown product, unknown manufacturer) the pt received the first day of life, followed by vaccination against diphtheria, tetanus, pertussis, poliomyelitis, and the second dose of anti hepatic B virus vaccination (unknown product) after 6 weeks. On hospital admission the pt was in reasonably good condition but pale, with grossly enlarged adjacent left axillary lymph nodes and hepatosplenomegaly. Lab test showed anemia, thrombocytopenia, elevated transaminase activity, a high C reactive protein level. and high level of IgM class anti cytomegalovirus reactive antibodies, flow cytometry measurements 20% lymphocytes expressed CD 119 (IFN gamma receptor outer subunit R1), chest and bone radiographs negative for infection, Ziehl Neelsen and periodic acid Schiff staining-did not show acid fast bacilli. CMV infection was suspected. The pt was administered a 14 day regimen of ganciclovir., Liver function test and blood count normalized, hepatosplenomegaly decreased. However, the lymph nodes continued to enlarge. Diagnostic excision and bone marrow aspiration were performed to exclude a neoplastic process. A histopathologic image of the excised lymph nodes showed caseating granulomas and tuberculous lymphadenitis was suggested. At that time a diagnosis of disseminated BCG infection as a complication of TB vaccination in a presumed immunocompromised pt was proposed. Flow cytometry measurements showed abnormally low expression of the alpha chain of the interferon IPN gamma receptor on peripheral blood lymphocytes. Only 20% lymphocytes expressed CD 119 (IFN gamma receptor outer subunit R1). Three drug anti tuberculos therapy (rifamipin, Isoniazid and Streptomycin) was introduced despite chest and bone radiographs that were negative for infection. No abnormalities were found on fundoscopy and negative results of Ziehl Neelsen staining of lymph node tissue. Despite this therapy the child''s conditions worsened. She exhibited a high temperature, hemolysis and progressive neutropenia, thrombocytopenia, cholestasis and renal failure. Uncontrolled sepsis developed and the child died. A post mortem examination the diagnostic of disseminated BCG infection was made on the basis of multiple TB like granulomas in the lungs, lymph nodes, meninges, liver, spleen and kidney. However direct microbiologic confirmation of BCG infection was lacking because culture were negative and Ziehl Neelsen and periodic acid Schiff staining did not show acid fast bacilli, other bacteria of fungi in these specimens. According to the authors of the article this case represents a rare complication of antituberculous vaccination that is a progressive, disseminated BCG infection in a pt with deficiency of IFN Gamma receptor. Additional information is not available. A copy of the published article is attached as further documentation of the pts experience.


VAERS ID: 269852 (history)  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-12-28
Entered: 2006-12-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Immune system disorder, Thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES0612TWN00009

Write-up: Information has been received from the authors of the above entitled published literature article concerning a patient who was vaccinated with MMR II (manufacturer unknown). Subsequently the patient experienced acute immune thrombocytopenic purpura and was hospitalized. Subsequently, the patient recovered from acute immune thrombocytopenic purpura. The reporter felt that acute immune thrombocytopenic purpura was related to therapy with MMR II. No further information is available.


VAERS ID: 276711 (history)  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-04-17
Entered: 2007-04-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autism, Immune system disorder, Multiple allergies
SMQs:, Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA01702

Write-up: It was reported in a published article, title as stated above that on an unspecified date a male child was vaccinated with a first dose of MMR (manufacturer unknown). Subsequently, on an unspecified date following vaccination, he was diagnosed with severe autism. Unspecified medical attention was sought. It was reported that the patient did not receive a second dose of MMR. No outcome was reported, but the patient''s mother reported, "... if you look at my son he has all these allergies and he reacts to everything and I mean. We have to prepare all his food separately and all the rest of it, and he''s so sensitive, and I always say his immune system is wonky... totally off kilter...". The authors concluded, "so little is still known about the opinions of parents caring for children with autism, illustrators how limited the scope of the research on the autism/MMR controversy has been. This research has highlighted the considerable negative impact that the MMR controversy had had on this group of vulnerable parents. This has implications for health professionals, who need to be particularly aware of the issues these parents face in future MMR decision-making for their affected child and younger siblings. In general, these parents, perhaps more than most, face a particularly difficult decision when trying to decide whether vaccination is in their child''s best interests. Health professionals also need to be sensitive to the fact that some of these parents may feel in part responsible for having sanctioned an intervention that they believe may have contributed to their child''s autism. More generally, there is a need to promote a greater awareness of the important role health visitors can play in parental decision-making and for research examining whether health professionals feel they receive sufficient training in communication skills. Upon internal review, severe autism was determined to be an other important medical event. This is one of several reports received from the same source. No further information is expected. A copy of published article is attached as further documentation of the patient''s experience.


VAERS ID: 276738 (history)  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-04-17
Entered: 2007-04-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autism, Immune system disorder
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA01729

Write-up: It was reported in a published article, title as stated above that on an unspecified date a male child was vaccinated with a first dose of MMR (manufacturer unknown). Subsequently, on an unspecified date following vaccination, the patient was diagnosed with autism. Unspecified medical attention was sought. It was reported that the patient did not receive a second dose of MMR. No outcome was reported. The patient''s mother was interviewed and noted the following, "... his immune system is shot to pieces... He, he does seem to be one of these children who follows the, the path for antibiotics and then vaccinations and then autism. When he gets a cough or cold he seems to have it much, much longer... But he just gets really ill...it puts him into hospital... I actually asked the consultant before he discharged him last time. I said ''you know, he does seem to be poorly a lot of the time, you known and he does have autism and I think there''s a link between his autism and his immune system'' and the consultant said ''no, that''s absolutely not true, there''s no correlation between autism and the immune, his immune system''. He dismissed it - so I said ''well okay'' but I just felt that I had to say something." The authors concluded, "so little is still known about the opinions of parents caring for children with autism, illustrators how limited the scope of the research on the autism/MMR controversy has been. This research has highlighted the considerable negative impact that the MMR controversy had had on this group of vulnerable parents. This has implications for health professionals, who need to be particularly aware of the issues these parents face in future MMR decision-making for their affected child and younger siblings. In general, these parents, perhaps more than most, face a particularly difficult decision when trying to decide whether vaccination is in their child''s best interests. Health professionals also need to be sensitive to the fact that some of these parents may feel in part responsible for having sanctioned an intervention that they believe may have contributed to their child''s autism. More generally, there is a need to promote a greater awareness of the important role health visitors can play in parental decision-making and for research examining whether health professionals feel they receive sufficient training on communication skills. Upon internal review, autism was determined to be an other important medical event. This is one of several reports received from the same source. No further information is expected. A copy of published article is attached as further documentation of the patient''s experience.


VAERS ID: 295848 (history)  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2007-08-27
Onset:2007-08-28
   Days after vaccination:1
Submitted: 2007-11-05
   Days after onset:69
Entered: 2007-11-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR 1093 / 0 GM / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER 20060601 / 0 - / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, CSF test normal, Cerebral haemorrhage, Convulsion, Demyelination, Foaming at mouth, Gaze palsy, Hyperreflexia, Hypokinesia, Hypotonia, Immunodeficiency, Immunoglobulins decreased, Muscle twitching, Nervous system disorder, Nuchal rigidity, Pupil fixed, Pyrexia, Reye's syndrome, Ultrasound abdomen abnormal, White blood cell count increased
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No concurrent illnesses.
Preexisting Conditions: No known allergies, no pre-existing medical history. He had received the 1st intramuscular dose of Hepatitis B vaccine on 27 June 2007, BCG vaccine on 28 June 2007, and the 2nd dose of Hepatitis B on 30 July 2007. The patient had not experienced any adverse events following prior vaccinations.
Diagnostic Lab Data: Lab test revealed: WBC 17.36*10^9/L on blood routine test; B Ultrasonograph showed obvious abdominal distension.
CDC Split Type: 200703591

Write-up: Report received from a healthcare professional on 25 October 2007 via our company representative. A 02-month-old male patient, with no relevant medical history, had received in the morning of 27 August 2007 the 1st dose of Act-Hib, lot reported as "?1093-2" intra-muscularly in the buttock associated with OPV. In the afternoon of 28 August 2007, he experienced fever at 38.5C. After treatment as an outpatient in local healthcare unit, the temperature dropped to normal. On 01 September 2007, the patient presented with eyes fixation, left extremities twitch, right extremities movement decreased and foaming at the mouth. Then the patient was admitted to hospital for further treatment and diagnosis. On 01 September 2007, the physical examination showed: T= 37C, R= 40, P= 120, vomit-milk, extremities muscle power normal, left extremities decreased muscular tone, neck rigidity, knee jerk hyperreflexia, Babinski sign positive. Lab test revealed: WBC 17.36*10^9/L on blood routine test; B Ultrasonograph showed obvious abdominal distension. Preliminary Diagnosis were : 1. central nervous system infection; 2. Intracranial hemorrhage, 3 Convulsion due to brain develop defects, 4 blood poisoning, 5 Reye syndrome. Then the patient received treatment for central nervous system purulent infection on 02 September 2007, but on 03 September 2007, the result of cerebrospinal fluid was normal, and purulent meningitis was excluded. Total immunoglobulin was less than 4g/L, suggesting the possibility of immunodeficiency. On 04 September 2007, he had neck rigidity. Muscle power 3 degree in right lower extremity, left and right upper extremities muscle power was normal. On 05 September 2007, it was noted muscle power 2 degree in the right lower extremity. On 07 September 2007, he presented with muscle power 3 degree in right lower extremity, right knee jerk hyporeflexia. On 08 September 2007, he had muscle power 4 degree in right lower extremity, right knee jerk hyporeflexia. Doctor considered whether there was demyelination following immunization. The outcome was not reported.


VAERS ID: 324112 (history)  
Age: 0.5  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-09-03
Entered: 2008-09-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 RA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: B-lymphocyte count decreased, Blood immunoglobulin A, Blood immunoglobulin A normal, Blood immunoglobulin E, Blood immunoglobulin G decreased, Blood immunoglobulin M, Blood immunoglobulin M normal, Blood product transfusion, Bone marrow transplant, Bone scan abnormal, CD4 lymphocytes abnormal, CD4 lymphocytes decreased, Candidiasis, Chest X-ray abnormal, Computerised tomogram abnormal, Culture positive, Diarrhoea, Diarrhoea infectious, Failure to thrive, Graft versus host disease, Granuloma, HIV antibody negative, Haematocrit normal, Haemoglobin normal, Hepatomegaly, Hepatosplenomegaly, Immunodeficiency, Injection site abscess, Leukocytosis, Lung infiltration, Lymphocyte percentage, Mycobacterial infection, Neutrophil percentage, Neutrophilia, Osteomyelitis, Platelet count increased, Pneumonia, Polymerase chain reaction, Rash erythematous, Skin lesion, Subcutaneous nodule, T-lymphocyte count decreased, Weight decreased, White blood cell count increased, Whole body scan
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Neonatal disorders (broad), Hypersensitivity (narrow), Myelodysplastic syndrome (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: She was the 2nd child of healthy 1st degree consanguineous parents. The patient''s sister died at 3 months of age due to sepsis.
Diagnostic Lab Data: Physical examination revealed a wasted female (weight 4 kg, <3rd percentile) with hepatomegaly. There was no palpable spleen or lymphadenopathy. Erythematous patch with satellite lesions were noted on her neck and chest. Laboratory studies on admission revealed hemoglobin 11.8 g/dL, hematocrit 36.6%, WBC 17,830/mm3 (neutrophils 66%, lymphocytes 21%) and platelet count 568000/mm3. Chest X-ray showed perihilar infiltration and absence of thymic shadow. Antibody of human immunodeficiency virus of the patient and her mother were non-reactive. Immunologic studies revealed IgG 44 mg/dL, IgM 26 mg/dL, IgA <5.7 mg/dL, IgE <4.5 IU/mL, CD3 7 cells/mm3, CD4 1 cell/mm3, CD8 8 cells/mm3, CD19 2.082 cells/mm3 and CD16/CD56 663 cells/mm3. Lymphocyt
CDC Split Type: 200802770

Write-up: Literature report received on 26 August 2008. A 06-month-old female patient had received her 1st dose of BCG vaccine (MFR UNK, batch number not reported) in the right deltoid muscle on the 1st day of life without any local or systemic reaction. She was referred to hospital on an unspecified date due to chronic diarrhea, failure to thrive and generalized candidiasis. The patient experienced multiple infections, including infectious diarrhea and recurrent pneumonia since the age of 4 weeks. She was the 2nd child of healthy 1st degree consanguineous parents. The patient''s sister died at 3 months of age due to sepsis. Physical examination revealed a wasted female (weight 4 kg, <3rd percentile) with hepatomegaly. There was no palpable spleen or lymphadenopathy. Erythematous patch with satellite lesions were noted on her neck and chest. Laboratory studies on admission revealed hemoglobin 11.8 g/dL, hematocrit 36.6%, WBC 17.830/mm3 (neutrophils 66%, lymphocytes 21%) and platelet count 568000/mm3. Chest X-ray showed perihilar infiltration and absence of thymic shadow. Antibody of human immunodeficiency virus of the patient and her mother were non-reactive. Immunologic studies revealed IgG 44 mg/dL, IgM 26 mg/dL, IgA < 5.7 mg/dL, IgE < 4.5 IU/mL, CD3 7 cells/mm3, CD4 1 cell/mm3, CD8 8 cells/mm3, CD19 2.082 cells/mm3 and CD16/CD56 663 cells/mm3. Lymphocyte proliferation in response to phytohaemagglutinin and purified protein derivative were absent. These findings were compatible with T-B+NK+ severe combined immunodeficiency (SCID). The diagnosis of IL-7Raplha deficiency SCID was confirmed by a mutation analysis. The patient received IV immunoglobulin and prophylactic cotrimoxazole. Bone marrow transplantation (BMT) was attempted at the age of 8 months. She underwent conditioning therapy with fludarabine, busulfan and anti-thymocyte globulin. The purified CD34haploidentical bone marrow from the patient''s father was infused to the patient. Graft versus host disease soon developed and there was no evidence of engraftment. At 15 months of age, the patient developed abscesses at the site of BCG inoculation. Numerous acid-fast bacilli (AFB) were demonstrated from abscesses. Mycobacterium tuberculosis complex was identified by polymerase chain reaction and culture. The patient initially received isoniazid, rifampicin, pyrazinamide and amikacin. In spite of 4 anti-TB therapies, she progressively developed multiple subcutaneous nodules ranged from 1-2 cm in diameter, on anterior chest, left upper thigh and knee. The nodule biopsy showed granuloma and numerous AFB. Ethambutol and levofloxacin were added to previous anti-TB medications. According to in-vitro antimicrobial sensitivities of the culture, M. tuberculosis complex was resistant to pyrazinamide and this medication was discontinued. Despite of the anti-TB treatment for 2 months, the patient continued to develop hepatosplenomegaly and osteomyelitis of the left femur. A diagnosis of disseminated BCG infection was made. Radiological study revealed the cystic lesions in the proximal left femor. Whole body bone scan showed slightly increased blood flow and soft tissue uptake at the same area of the femur. There was no other abnormality in the rest of skeleton. Computed tomography scan of the abdomen revealed hepatosplenomegaly without space taking and no intra-abdominal lymphadenopathy. Granulocyte colony stimulating factor was added to the treatment at 18 months of age. The dose of G-CSF was titrated to keep absolut neutrophil count $g 15000/mm3. After 2 months of G-CSF therapy, the abscesses and multiple subcutaneous nodules were healed. Hepatosplenomegaly and bone lesions of the left femur were improved. Ethambutol and amikacin were stopped after 3 months of G-CSF treatment. During G-CSF therapy there was no serious complication, expect mild leukocytosis and neutrophilia. G-CSF was given for 4.5 months while triple anti-TB drugs and monthly IV Ig were planned to be given until the proceeding


VAERS ID: 335825 (history)  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-12-19
Entered: 2008-12-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abscess, Acid fast bacilli infection, Acid fast stain positive, Cachexia, Fluctuance, Hyperaemia, Incisional drainage, Infection, Injection site ulcer, Lymphadenopathy, Oral candidiasis, Purulence, Regressive behaviour, Respiratory tract infection
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: HIV-positive parents
Diagnostic Lab Data: Nodal aspiration revealed purulent material which stained positive for acid-fast bacilli (AFB) on Zeihl-Neelsen stain.
CDC Split Type: 200803988

Write-up: This case is linked with 2008-03989 and 2008-03990 (different patients in the same article). A male patient born to HIV-positive parents had received his dose of BCG vaccine (MFR UNK, batch number, route and site of administration not reported) at 6 weeks of age. He presented at age 5 months with respiratory tract infection, oral candidiasis, generalized wasting and regression of milestones. First-line HAART (highly active antiretroviral therapy) was commenced at age 7 months with ZIDOVUDINE, LAMIVUDINE and NEVIRAPINE. Three weeks later, the patient developed ulceration at the site of his BCG inoculation and an enlarged right axillary lymph node (5 x 4 cm) which increased to 10 x 6 cm and became fluctuant and hyperaemic. Concomitantly, the patient showed marked improvement in his nutritional, neurological and immunological status. Nodal aspiration revealed purulent material which stained positive for acid-fast bacilli (AFB) on Zeihl-Neelsen stain. Ongoing management comprised incision and drainage, daily dressings, oral and topical antibiotics for presumed secondary bacterial infection. The abscess and ulceration slowly resolved over a 6-month period. The outcome was not reported in the article.


VAERS ID: 346094 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-02
Onset:2009-04-16
   Days after vaccination:14
Submitted: 2009-05-11
   Days after onset:25
Entered: 2009-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Leukocytosis, Lymphadenopathy, Lymphocyte percentage increased, Lymphocytosis, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Lymphocyte percentage, Apr2009, 60%; White blood cell count, Apr2009, 20000
CDC Split Type: D0061465A

Write-up: This case was reported by a physician and described the occurrence of leukocytosis in an adult female subject of unspecified age who was vaccinated with TWINRIX adult (GlaxoSmithKline). The subject was the wife of the reporting physician. Previous vaccination with the first dose of TWINRIX adult (GlaxoSmithKline) was given about 10 years ago. On 02 April 2009 the subject received the second dose of TWINRIX adult (1 ml, unknown). Approximately 14 days post vaccination with TWINRIX adult, on an unknown date in April 2009, within the scope of a preventive medical examination, the subject showed leukocytosis (white blood cell count of 20000), proportional lymphocytosis (lymphocyte percentage 60%) and axillary lymph node swelling both sides. This case was assessed as medically serious by GSK criteria. At the time of reporting the outcome of the events was unspecified. Follow-up information has been requested.


VAERS ID: 353027 (history)  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:2009-05-21
Onset:2009-05-22
   Days after vaccination:1
Submitted: 2009-07-31
   Days after onset:70
Entered: 2009-08-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR C2861A / - UN / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER AOPVB580AD / - - / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site oedema, Lymphadenopathy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 200903188

Write-up: Initial report received on 23 July 2009 from the foreign Health Authorities (identification number PLURPLOCR20090617002) whose initial reporter was a physician in foreign country. A child received TRIPACEL (lot number C2861A) intramuscularly and Poliovirus vaccine live oral (manufacturer unknown, lot number AOPVB580AD) on 21 May 2009. On 22 May 2009 the patient developed a fever of 39 degrees C, injection site edema, and enlarged axillary lymph nodes of the vaccinated arm. Subsequently the patient was hospitalized. The patient was reported as recovered. List of Documents held by Sender: none.


VAERS ID: 353252 (history)  
Age: 0.6  
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-08-05
Entered: 2009-08-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Biopsy lymph gland abnormal, Bovine tuberculosis, Death, HIV test negative, Injection site ulcer, Lymphadenopathy, Polymerase chain reaction, Surgery
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Extravasation events (injections, infusions and implants) (broad), Malignant lymphomas (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: see narrative description.
CDC Split Type: 200903283

Write-up: Literature was case received on 30 July 2009. A seven month-old male patient who had received BCG vaccination (manufacturer, batch number, route and site of administration not reported) when three days old, presented with swelling in the left axilla and an ulcer at the site of BCG inoculation of three months duration. Routine investigations were within normal limits and he was HIV negative. Biopsy revealed a matted group of lymph nodes adherent to axillary vessels, which were excised. Pathological findings: Gross examination revealed two gray white tissue masses, larger measuring 5x 3.5x2cm and the smaller measuring 5x2x1 cm. Out surface of the masses were gray white and nodular. No area of necrosis was noted. On light microscopy, the lymph node showed effacement of architecture with proliferation of spindle cells arranged in sheets and fascicles. The cells had indistinct cell borders with eosinophilic granular cytoplasm and round to oval nuclei. These cells were admixed with capillaries, inflammatory cells including small lymphocytes, plasma cells and neutrophils. No multinucleated giant cells, mitotic figures, pleomorphism or necrosis were observed. the ZIEHL NEELSEN stain revealed numerous elongated acid-fast bacilli both within and outside the macrophages. The spindle cells were immunoreactive to CD 68. They were negative for desmin and showed focal positive for S-100 protein. PCR was done on paraffin embedded blocks with two sets of extracts for the IS6110 gene of Mycobacterium tuberculosis complex (includes M. tuberculosis hominis and M. tuberculosis bovis strains). One of the tubes (Phenol-Chloroform extract) was positive by PCR, while the second tube (kit extract) was negative, which was attributed to improper protocol for DNA extraction using the kit. Per the author, proliferation of spindle cells arranged in sheets and fascicles mimicking a spindle cell neoplasm which is one form of pathological pattern for BCG infection associated with immunodeficiency. The immune status of the patient could not be assessed, as the child died 10 days after the surgery.


VAERS ID: 356759 (history)  
Age: 0.5  
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-09-08
Entered: 2009-09-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture negative, C-reactive protein increased, Computerised tomogram normal, Culture stool negative, Diarrhoea, Erythema, Flow cytometry, Hypochromic anaemia, Immunoglobulins normal, Leukocytosis, Lymphadenitis, Lymphadenopathy, Lymphocyte count normal, Microbiology test abnormal, Microscopy, Pyrexia, Red blood cell sedimentation rate increased, Ultrasound abdomen normal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: He had been born at 1900 g following 32 weeks of gestation as one of twins, no parental consanguinity was present, his twin sister was healthy. Growth percentiles were within the normal range.
Diagnostic Lab Data: Erythrocyte sedimentation rate, 65 mm/h; C-reactive protein, 6.6 mg/dL. Blood and stool culture results were normal. Ultrasonography (USG) indicated three contiguous lymph nodes. Over the course of the disease, fluctuation was palpated and a puncture was performed. Microscopy indicated acidoresistant bacilli, hence the diagnosis of BCG lymphadenitis. Computed tomography of the thorax and abdominal USG performed for the investigation of possible systemic involvement were normal. Serum immunoglobulins and subgroups and lymphocyte subgroup analysis were within normal limits. The patient was then evaluated for possible defects of the lymphocyte macrophage activation pathway, and flow cytometry of lymphocytes stimulated in vitro by phytohemagglu
CDC Split Type: 200903795

Write-up: Literature report retrieved on 03 September 2009. A 06-month-old male patient was admitted to hospital for diarrhea and fever. He had a 4 day history of clear watery diarrhea and fever up to 39 C. He had been born at 1900 g following 32 weeks of gestation as one of twins, no parental consanguinity was present, his twin sister was healthy and he had a BCG vaccination (manufacturer, batch number, route and site of administration not reported) at 2 months of age. Growth percentiles were within normal range. A mobile, painless lymphadenopathy with a diameter of 1 cm was palpated in the left axillary region. The evaluation of other body systems was unremarkable. He had a moderate hypochromic microcytic anemia and leukocytosis with neutrophilic predominance. His acute phase reactants were elevated (erythrocyte sedimentation rate, 65 mm/h; C-reactive protein, 6.6 mg/dL). Blood and stool culture results were normal. On the third day of hospitalization the diameter of the left axillary swelling increased with erythema of the overlying skin. Ultrasonography (USG) indicated three contiguous lymph nodes. Over the course of the disease, fluctuation was palpated and a puncture was performed. Microscopy indicated acidoresistant bacilli, hence the diagnosis of BCG lymphadenitis. The patient was then put on follow up without treatment. Two months later the patient was readmitted because the diameter of the lesion had enlarged to 12 cm, and was draining. Multiple lymph nodes up to 2.5 cm in diameter were observed on USG. Histopathology of the excised biopsy material was consistent with granulomatous lymphadenitis. Computed tomography of the thorax and abdominal USG performed for the investigation of possible systemic involvement were normal. Serum immunoglobulins and subgroups and lymphocyte subgroup analysis were within normal limits. The patient was then evaluated for possible defects of the lymphocyte macrophage activation pathway, and flow cytometry of lymphocytes stimulated in vitro by phytohemagglutinin indicated that surface expression of IL-12/IL23Rb1 was <1% and that of IFN-gR was normal. Flow cytometry for the parents and twin sister was normal. Finally, mutation analysis indicated a homozygotic mutation (R486X) on exon 12 of the IL-12/IL-23Rb1 gene, causing a stop codon. Nucleotide change responsible for this mutation was 1520C$gT. As for its homozygosity, mutation analysis was not requested from the parents. The patient was put on antimycobacterial treatment (isoniazid, streptomycin and rifampicin) and was doing well by the eight month of therapy.


VAERS ID: 379297 (history)  
Age: 0.1  
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-02-02
Entered: 2010-02-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - AR / ID

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial culture negative, CSF test normal, Chest X-ray normal, Differential white blood cell count normal, Haematocrit decreased, Haemoglobin normal, Histology abnormal, Immunology test normal, Lymphadenectomy, Lymphadenitis, Lymphadenopathy, Red blood cell sedimentation rate increased, Tuberculin test positive, White blood cell count increased
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The mother had give birth to an immunocompetent boy after uncomplicated full term pregnancy and delivery.
Diagnostic Lab Data: Haemoglobin was 10.5 g/dl, haematocrit 31% and white cell count 12.3 G/L with a normal differential count. Erythrocyte sedimentation rate was 60 mm/hr and cerebrospinal fluid was normal. Chest X-ray was normal and a Mantoux skin test ( 1 TU of PPD RT 23) resulted in induration of 12 mm (Mantoux tests are undertaken on all admissions to the hospital). Results of humoral and cellular immunity investigations were normal. Histological examination demonstrated an abundance of tubercles with caseous necrotic centres surrounded by epithelioid cells, lymphocytes and Langhans-type giant cells. A great number of acid-fast bacilli on Ziehl-Neelsen stain were detected. Cultures for mycobacteria and other common bacteria were negative.
CDC Split Type: E201000511

Write-up: Case of misuse initially received on 19-Jan-2010 through literature. This case is taken from a literature. On an unreported date, a 45 day-old male received vaccination with bacille Calmette-Guerin strain (Pasteur vaccine strain batch number not reported) half a dose intradermally to the upper part of each arm, 0.05 ml in total. The mother had give birth to an immunocompetent boy after uncomplicated full term pregnancy and delivery. The patient had been admitted at 45 days of age with bilateral axillary lymphadenitis. Two months later, the patient experienced swelling of his right axillary lymph node. The boy was treated with isoniazid in a dose of 20 mg/kg/day. After 2 months and while the patient was still on isoniazid, swelling of his left axillary lymph node was noticed and erythromycin was added. He was readmitted to hospital 6 months later. Results of physical examination were unremarkable, apart from bilateral axillary adenitis. The affected lymph nodes were not tender, well demarcated, adhered to the skin and were ready to drain. The largest lymph node was 3 cm in diameter. Haemoglobin was 10.5 g/dl, haematocrit 31% and white cell count 12.3 G/L with a normal differential count. Erythrocyte sedimentation rate was 60 mm/hr and cerebrospinal fluid was normal. Chest X-ray was normal and a Mantoux skin test ( 1 TU of PPD RT 23) resulted in induration of 12 mm (Mantoux tests are undertaken on all admissions to the hospital). Results of humoral and cellular immunity investigations were normal. The affected nodes in both axillae were excised and the wounds were sutured. Histological examination demonstrated an abundance of tubercles with caseous necrotic centres surrounded by epithelioid cells, lymphocytes and Langhans-type giant cells. A great number of acid-fast bacilli on Ziehl-Neelsen stain were detected. Cultures for mycobacteria and other common bacteria were negative. The surgical incisions healed completely over the next few days and isoniazid was stopped. No recurrence was detected during 18 months follow-up. The authors thought that bilateral lymphadenitis can occur even when BCG vaccine is administered as half a dose (0.025 ml) to each arm. Therefore, this practice should be considered neither safe not an alternative mode of prevention. Where there is advanced fluctuating lymphadenitis, surgical excision is the treatment of choice.


VAERS ID: 383596 (history)  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-23
Entered: 2010-03-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bovine tuberculosis, Death, Laboratory test abnormal, Liver disorder, Lymphadenopathy
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had personal immunodeficiency disorders: SCID (severe combined immunodeficiency). The patient had a family history of immunodeficiency and of consanguinity.
Diagnostic Lab Data: Immune defect tests showed SCID Rag2 deficiency T-B-NK+
CDC Split Type: 201001575

Write-up: Literature article from a foreign country received on 12 March 2010 involving 11 case reports. This case is linked with cases 2010-10574, 2010-01562, 2010-01576, 2010-01577, 2010-01578, 2010-01579, 2010-01580, 2010-01581, 2010-0582, 2010-01583. This case will described adverse event on case number 3. The aim of this prospective study was to determine the role of immunodeficiency disorders in exciting disseminated BCG infection in patients with disseminated BCG infection following immunization at birth with BCG sub strain Pasteur vaccine. Through 2 years all infants with BCG adenitis or other complications of this vaccine that had suspicious BCG infection were referred to hospital and health centers. Evaluation of immune system and in some cases genetic survey was performed in infants with evidence of histopathologic demonstration of acid-fast bacilli. Then frequency of infants who had disseminated BCG infection with immunodeficiency was defined. Clinical manifestations and hematological and immunologic changes were compared between two different groups of cases: Patients (who are children with disseminated BCG infection) and control group (who are children with complications of BCG vaccination but without disseminated BCG infection). Then frequency of patients with disseminated BCG infection who had immunodeficiency was reported. From 122093 BCG vaccinated children through 24 month period, 48 infants with BCG lymphadenitis, within range of 2-62 months (mean +- SD: 9.9 +- 9.85) were selected. 28 infants were male (58.3%) and 20 infants were female (41.7%). Onset age was between 1-21 months (mean +- SD: 6.36 +- 4.62). Twenty four cases had multiple lymphadenitis near to BCG incubation such as cervical, axiliary, and supraclaviculs, 11 cases had suppurative lymphadenitis with fistula and abscesses and 5 cases had ulcer of BCG incubation. Osteomyelitis due to BCG vaccination was detected in 2 cases and disseminated BCG infection in 11 cases (22.9%) with multi organ involvement and systemic symptoms were detected. Family history of BCG infection or immunodeficiency was positive in 22.9% of control group and the rate of consanguineous marriages in the parent of them was 37.5% (18 cases). Disseminated BCG infection was diagnosed in 11 cases with multi organ involvement and systemic symptoms, almost all of whom had immunodeficiency. Definitive immunodeficiency was detected in approximately all of children with disseminated BCG infection including: SCID in 7 cases with homozygous mutation and homozygous polymorphism in Rag2 in one patient with heterozygous for the Rag 2 mutation and polymorphism in the both parents of him and exclusion of Rag1, Rag2 and Artemis defect in another patient. Other cases were CGD, IL12RB1 deficiency and MSMD. In one cases of MSMD we could exclude an IL12RB1 deficiency. So he had a normal expression of IL12RB1 on cell surface with two different antibodies. HIV was not identified in any of the cases. Overall, the mortality rate was 72.8% (8 cases). Consanguineous was found in more than half (7 cases) of patients and family history of disseminated BCG infection or immunodeficiency was found in nearly one third (3 cases) of patients. A chi-square test comparing the clinical manifestations in children with disseminated BCG infection with control group showed statistically significant differences for the two groups of children. Comparison of immunologic markers showed that significant differences were seen between two groups of children. The mean value of CD3 in patients was (P = 0.005) in comparison with control group and the mean value of CD4 in patients was (P < 0.001) in comparison with control group (Table 3). Although antimycobacterial regimens used for the treatment of patients with 4 drugs, but 8 of the patients died despite aggressive management. Case report #3: A 04-month-old male patient had a disseminated BCG infection after immunization at birth with BCG sub strain Pasteur vaccine (Manufacturer and b


VAERS ID: 383599 (history)  
Age: 0.5  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-23
Entered: 2010-03-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bovine tuberculosis, Death, Gastric disorder, Immunology test abnormal, Lymphadenopathy
SMQs:, Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had personal immunodeficiency disorders: severe combined immunodeficiency (SCID) T-B-NK+. The patient had no family history of immunodeficiency, no consanguinity
Diagnostic Lab Data: Immune defect tests showed SCID T-B-NK+
CDC Split Type: 201001577

Write-up: Foreign literature article received on 12 March 2010 involving 11 case reports. This case is linked with cases 2010-01562, 2010-01574, 2010-01575, 2010-01576, 2010-01578, 2010-01579, 2010-01580, 2010-01581, 2010-0582, 2010-01583. This case will describe adverse event on case number 5. The aim of this prospective study was to determine the role of immunodeficiency disorder in exciting disseminated BCG infection in patients with disseminated BCG infection following immunization at birth with BCG sub strain Pasteur vaccine. Through 2 years all infants with BCG adenitis or other complications of this vaccine that had suspicious BCG infection were referred to a hospital and health centers. Evaluation of immune system and in some cases genetic survey was performed in infants with evidence of histopathologic demonstration of acid-fast bacilli. Then frequency of infants who had disseminated BCG infection with immunodeficiency was defined. Clinical manifestations and hematological and immunologic changes were compared between two different groups of cases: Patients (who are children with disseminated BCG infection) and control group (who are children with complications of BCG vaccination but without disseminated BCG infection). Then frequency of patients with disseminated BCG infection who had immunodeficiency was reported. From 122093 BCG vaccinated children through 24 month period. 48 infants with BCG lymphadenitis, within range of 2-62 months (mean +- SD: 9.9 +- 9.85) were selected. 28 infants were male (58.3%) and 20 infants were female (41.7%). Onset age was between 1-21 months (mean +- SD: 6.36 +- 4.62). Twenty four caseshad multiple lymphadenitis near to BCG incubation such as cervical, axiliary, and supraclaviculs, 11 case had suppurative lymphadenitis with fistula and abscesses and 5 cases had ulcer of BCG incubation. Osteomyelitis due to BCG vaccination was detected in 2 cases and disseminated BCG infection in 11 cases (22.9%) with multi organ involvement and systemic symptoms was detected. Family history of BCG infection or immunodeficiency was positive in 22.9% of control group and the rate of consanguineous marriages in the parents of them was 37.5% (18 cases). Disseminated BCG infection was diagnosed in 11 cases with multi organ involvement and systemic symptoms, almost all of whom had immunodeficiency. Definitive immunodeficiency was detected in approximately all of children with disseminated BCG infection including: SCID in 7 cases with homozygous mutation and homozygous polymorphism in Rag2 in one patient with heterozygous for the Rag2 mutation and polymorphism in the both parents of him and exclusion of Rag1, Rag2 and Artemis defect in another patient. Other cases were CGD, IL12RB1 deficiency and MSMD. In one cases of MSMD we could exclude in IL12RB1 deficiency. So he had a normal expression of IL12RB1 on cell surface with two different antibodies. HIV was not identified in any of the cases. Overall, the mortality rate was 72.8% (8 cases). Consanguineous was found in more than half (7 cases) of patients and family history of disseminated BCG infection or immunodeficiency was found in nearly on third (3 cases) of patients. A chi-square test comparing the clinical manifestations in children with disseminated BCG infection with control group showed statistically significant differences for the two groups of children. Comparison of immunologic markers showed that significant differences were seen between two groups of children. The mean value of CD3 in patients was (P = 0.005) in comparison with control group and the mean of CD4 in patients was (P < 0.001) in comparison with control group (Table 3). Although antimycobacterial regimens used for the treatment of patients with 4 drugs, but 8 of the patients died despite aggressive management. Case report # 5: A 06-month-old female patient had a disseminated BCG infection after immunization at birth with BCG sub strain pasteur vaccine (Manufacturer andbatch number unknown) Th


VAERS ID: 383601 (history)  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-23
Entered: 2010-03-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Immunology test abnormal, Liver disorder, Lymphadenopathy
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had personal immunodeficiency disorders of severe combined immunodeficiency (SCID). The patient had a family history of immunodeficiency and consanguinity.
Diagnostic Lab Data: Immune defect tests showed T-B-NK+ SCID
CDC Split Type: 201001578

Write-up: Literature article received on 12 March 2010 involving 11 case reports. This case is linked with cases 2010-01562, 2010-01574, 2010-01575, 2010-01576, 2010-01577, 2010-01579, 2010-01580, 2010-01581, 2010-01582, 2010-01583. This case will describe adverse event on case number 6. Through 2 years all infants with BCG adenitis or other complications of this vaccine that had suspicious BCG infection were referred to hospital and health centers. Evaluation of immune system and in some cases genetic survey was performed in infants with evidence of histopathologic demonstration of acid-fast bacilli. Then frequency of infants who had dissmeninated BCG infection with immunodeficiency was defined. Clinical manifestations and hematological and immunologic changes were compared between two different groups of cases: Patients (who are children with disseminated BCG infection) and control group (who are children with complication of BCG vaccination but without disseminated BCG infection). Then frequency of patients with disseminated BCG infection who had immunodeficiency was reported. From 122093 BCG vaccinated children through 24 month period, 48 infants with BCG lymphadenitis, within range of 2-62 months (mean + SD: 9.9 + 9.85) were selected. 28 infants were male (58.3%) and 20 infants were female (41.7%). Onset age was between 1-21 months (mean + SD: 6.36 + 4.62). Twenty four cases had multiple lymphadenitis near to BCG incubation such as cervical, axiliary, and supraclaviculs, 11 cases had suppurative lymphadenitis with fistula and abscesses and 5 cases had ulcer of BCG incubation. Osteomyelitis due to BCG vaccination was detected in 2 cases and disseminated BCG infection in 11 cases (22.9%) with multi organ involvement and systemic symptoms was detected. Family history of BCG infection or immunodeficiency was positive in 22.9% of control group and the rate of consanguineous marriages in the parents of them was 37.5% (18 cases). Disseminated BCG infection was diagnosed in 11 cases with multi organ involvement and systemic symptoms, almost all of whom had immunodeficiency. Definitive immunodeficiency was detected in approximately all of children with disseminated BCG infection including: SCID in 7 cases with homozygous mutation and homozygous polymorphism in Rag2 in one patient with heterozygous for the Rag2 mutation and polymorphism in the both parents of him and exclusion of Rag1, Rag2 and Artemis defect in another patient. Other cases were CGD, IL12RB1 deficiency and MSMD. In one cases of MSMD we could exclude an IL12RB1 deficiency. So he had a normal expression of IL12RB1on cell surface with two different antibodies. HIV was not identified in any of the cases. Overall, the mortality rate was 72.8% (8 cases). Consanguineous was found in more than half (7 cases) of patients and family history of dissmeninated BCG infection or immunodeficiency was found in nearly one third (3 cases) of patients. A chi-square test comparing the clinical manifestations in children with disseminated BCG infection with control group showed statistically significant differences for the two groups of children. Comparison of immunologic markers showed that significant differences were seen between two groups of children. The mean value of CD3 in patients was (P = 0.005) in comparison with control group and the mean value of CD4 in patients was (P < 0.001) in comparison with control group (Table 3). Although antimycobacterial regimens used for the treatment of patients with 4 drugs, but 8 of the patients died despite aggressive management. Case report # 6: A 05-month-old female patient had a disseminated BCG infection after immunization at birth with BCG sub strain Pasteur vaccine (Manufacturer and batch number unknown). The patient had personal immunodeficiency disorders of severe combined immunodeficiency (SCID), T-B-NK+. The patient had a family history of immunodeficiency and consanguinity. The patient was referred to hospital. The sites of dissemination wer


VAERS ID: 383602 (history)  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-23
Entered: 2010-03-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Ascites, Bovine tuberculosis, Death, Immunology test abnormal, Liver disorder, Lymphadenopathy
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had personal immunodeficiency disorders: severe combined immunodeficiency (SCID), The patient had a family history of immunodeficiency. History of consanguinity
Diagnostic Lab Data: Immune defect tests showed SCID - T-B+NK+
CDC Split Type: 201001580

Write-up: Literature article received on 12 March 2010 involving 11 case reports. This case is linked with cases 2010-01562, 2010-01574, 2010-01575, 2010-01576, 2010-01577, 2010-01578, 2010-01579, 2010-01580, 2010-01581, 2010-01582, 2010-01583. This case will describe adverse event on case number 8. The aim of this prospective study was to determine the role of immunodeficiency disorders in exciting disseminated BCG infection in patients with disseminated BCG infection following immunization at birth with BCG sub strain Pasteur vaccine. Through 2 years all infants with BCG adenitis or other complications of this vaccine that had suspicious BCG infection were referred to hospital and health centers. Evaluation of immune system and in some cases genetic survey was performed in infants with evidence of histopathologic demonstration of acid-fast bacilli. Then frequency of infants who had disseminated BCG infection with immunodeficiency was defined. Clinical manifestations and hematological and immunologic changes were compared between two different groups of cases: Patients (who are children with disseminated BCG infection) and control group (who are children with complications of BCG vaccination but without disseminated BCG infection). Then frequency of patients with disseminated BCG infection who had immunodeficiency was reported. From 122093 BCG vaccinated children through 24 month period, 48 infants with BCG lymphadenitis, within range of 2-62 months (mean +_ SD: 9.9 +_ 9.85) were selected. 28 infants were male (58.3%) and 20 infants were female (41.7%). Onset age was between 1-21 months (mean +_ SD: 6.36 +_ 4.62). Twenty four cases had multiple lymphadenitis near to BCG incubation such as cervical, axiliary, and supraclaviculs, 11 cases had suppurative lymphadenitis with fistula and abscesses and 5 cases had ulcer of BCG incubation. Osteomyelitis due to BCG vaccination was detected in 2 cases and disseminated BCG infection in 11 cases (22.9%) with multi organ involvement and systemic symptoms was detected. Family history of BCG infection or immunodeficiency was positive in 22.9% of control group and the rate of consanguineous marriages in the parents of them was 37.5% (18 cases). Disseminated BCG infection was diagnosed on 11 cases with multi organ involvement and systemic symptoms, almost all of whom had immunodeficiency. Definitive immunodeficiency was detected in approximately all of children with disseminated BCG infection including: SCID in 7 cases with homozygous mutation and homozygous polymorphism in Rag2 in one patient with heterozygous for the Rag2 mutation and polymorphism in the both parents of him and exclusion of Rag1, Rag2 and Artemis defect in another patient. Other cases were CGD, IL12RB1 deficiency and MSMD. In one cases of MSMD we could exclude an IL12RB1 deficiency. So he had a normal expression of IL12RB1 on cell surface with two different antibodies. HIV was not identified in any of the cases. Overall, the mortality rate was 72.8% (8 cases). Consanguineous was found in nearly one third (3 cases) of patients. A chi-square test comparing the clinical manifestations in children with disseminated BCG infection with control group showed statistically significant differences for the two groups of children. Comparison of immunologic markers showed that significant differences were seen between two groups of children. The mean value of CD3 in patients was (P=0.005) in comparison with control group and the mean value of CD4 in patients was (P<0.001) in comparison with control group (Table 3). Although antimycobacterial regimens used for the treatment of patients with 4 drugs, but 8 of the patients died despite aggressive management. A 06-month-old female patient had a disseminated BCG infection after immunization at birth with BCG sub strain Pasteur vaccine (manufacturer and batch number unknown). The patient had personal immunodeficiency disorders of severe combined immunodeficiency, T-B+NK+. The patient had a family hist


VAERS ID: 383604 (history)  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-23
Entered: 2010-03-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bovine tuberculosis, Death, Disseminated tuberculosis, Eye disorder, Immunology test abnormal, Lymphadenopathy
SMQs:, Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had personal immunodeficiency disorders of severe combined immunodeficiency (SCID). The patient had no family history of immunodeficiency and history of consanguinity.
Diagnostic Lab Data: Immune defect tests showed T-B-NK+ (exclusion of Rag1, Rag2 and Artemis defect)
CDC Split Type: 201001579

Write-up: Literature article received on 12 March 2010 involving 11 case reports. This case is linked with cases 2010-01562, 2010-01574, 2010-01575, 2010-01576, 2010-01577, 2010-01578, 2010-0582, 2010-01583. This case will describe adverse event on case number 7. The aim of this prospective study was to determine the role of immunodeficiency disorders in exciting disseminated BCG infection in patients with disseminated BCG infection following immunization at birth with BCG sub strain Pasteur vaccine. Through 2 years all infants with BCG adenitis or other complications of this vaccine that had suspicious BCG infection were referred to hospital and health centers. Evaluation of immune system and in some cases genetic survey was performed in infants with evidence of histopathologic demonstration of acid-fast bacilli. Then frequency of infants who had disseminated BCG infection with immunodeficiency was defined. Clinical manifestations and hematological and immunologic changes were compared between two different groups of cases: Patients (who are children with disseminated BCG infection) and control group (who are children with complications of BCG vaccination but without disseminated BCG infection). The frequency of patients with disseminated BCG infection who had immunodeficiency was reported. From 122093 BCG vaccinated children through 24 month period, 48 infants with BCG lymphadentitis, within range of 2-62 months (mean + SD: 9.9 + 9.85) were selected. 28 infants were male (58.3%) and 20 infants were female (41.7%). Onset age was between 1-21 months (mean SD: 6.36 + 4.62). Twenty four cases had multiple lymphadentitis near to BCG incubation such as cervical, axilliary, and supraclaviculs, 11 cases had suppurative lymphadentitis with fistula and abscesses and 5 cases had ulcer of BCG incubation. Osteomyelitis due to BCG vaccination was detected in 2 cases and disseminated BCG infection in 11 cases (22.9%) with multi organ involvement and systemic symptoms was detected. Family history of BCG infection or immunodeficiency was positive in 22.9% of control group and the rate of consanguineous marriages in the parents of them was 37.5% (18 cases). Disseminated BCG infection was diagnosed in 11 cases with multi-organ involvement and systemic symptoms, almost all of whom had immunodeficiency. Definitive immunodeficiency was detected in approximately all of children with disseminated BCG infection including: SCID in 7 cases with homozygous mutation and homozygous polymorphism in Rag2 in on patient with heterozygous for the Rag2 mutation and polymorphism in the both parents of him and exclusion of Rag1, Rag2 and Artemis defect in another patient. Other cases were CGD, IL12RB1 deficiency and MSMD. In on cases of MSMD we could exclude an IL12RB1 deficiency. So he had a normal expression of IL12RB1 on cell surface with two different antibodies. HIV was not identified in any of the cases. Overall, the mortality rate was 72.8% (8 cases). Consanguineous was found in more than half (7 cases) of patients and family history of disseminated BCG infection or immunodeficiency was found in nearly one third (3 cases) of patients. A chi-square test comparing the clinical manifestations in children with disseminated BCG infection with control group showed statistically significant differences for the two groups of children. Comparison of immunologic markers showed that significant differences were seen between two groups of children. The mean value of CD3 in patients was (P =0.005) in comparison with control group and the mean value of CD4 in patients was (P < 0.001) in comparison with control group (Table 3). Although antimycobacterial regimens used for the treatment of patients with 4 drugs, but 8 out of the patients died despite aggressive management. Case report #7: A 4/5 month-male patient had a disseminated BCG infection after immunization at birth with BCG sub strain Pasteur vaccine (Manufacturer and batch number unknown). The patient had persona immunode


VAERS ID: 383633 (history)  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-23
Entered: 2010-03-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abscess, Aspiration, Bovine tuberculosis, Combined immunodeficiency, Fistula, Immunodeficiency, Immunology test abnormal
SMQs:, Congenital, familial and genetic disorders (narrow), Hypersensitivity (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had personal immunodeficiency disorder of severe combined immunodeficiency (SCID). The patient has no family history of immunodeficiency. History of consanguinity.
Diagnostic Lab Data: Immune defect tests showed IL12R deficiency
CDC Split Type: 201001582

Write-up: Literature article received on 12 March 2010 involving 11 case reports. This case is linked with cases 2010-01562, 2010-01574, 2010-01575, 2010-01576, 2010-01577, 2010-01578, 2010-01579, 2010-01580, 2010-01581, 2010-01583. This case will describe adverse event on case number 10. The aim of this prospective study was to determine the role of immunodeficiency disorders in exciting disseminated BCG infection in patients with disseminated BCG infection following immunization at birth with BCG sub strain Pasteur vaccine. Through 2 years all infants with BCG adenitis or other complications of this vaccine that had suspicious BCG infection were referred to hospital and health centers. Evaluation of immune system and in some cases genetic survey was performed in infants with evidence of histopathologic demonstration of acid-fast bacilli. Then frequency of infants who had disseminated BCG infection with immunodeficiency was defined. Clinical manifestations and hematological and immunologic changes were compared between two different groups of cases: Patients (who are children with disseminated BCG infection) and control group (who are children with complications of BCG vaccination but without disseminated BCG infection). Then frequency of patients with disseminated BCG infection who had immunodeficiency was reported. From122093 BCG vaccinated children through 24 month period, 48 infants with BCG lymphadenitis, within range of 2-62 months (mean +- SD: 9.9 +- 9.85) were selected. 28 infants were male (58.3%) and 20 infants were female (41.7%). Onset age was between 1-21 months (mean +- SD: 6.36 +- 4.62). Twenty four caseshad multiple lymphadenitis near to BCG incubation such as cervical, axiliary, and supraclaviculs, 11 cases had suppurative lymphadenitis with fistula and abscesses and 5 cases had ulcer of BCG incubation. Osteomyelitis due to BCG vaccination was detected in 2 cases and disseminated BCG infection in 11 cases (22.9%) with multi organ involvement and systemic symptoms was detected. Family history of BCG infection or immunodeficiency was positive in 22.9% of control group and the rate of consanguineous marriages in parents of them was 37.5% (18 cases). Disseminated BCG was diagnosed in 11 cases with multi organ involvement and systemic symptoms, almost all of whom had immunodeficiency. Definitive immunodeficiency was detected in approximately all of children with disseminated BCG infection including: SCID in 7 cases with homozygous mutation and homozygous polymorphism in Rag2 in one patient with heterozygous for the Rag2 mutation and polymorphism in the both parents of him and exclusion of Rag1, Rag2 and Artemis defect in another patient. Other cases were CGD, IL12RB1 deficiency and MSMD. In one cases of MSMD we could exclude an IL12RB1 deficiency. So he had a normal expression of IL12RB1on cell surface with two different antibodies. HIV was not identified in any of the cases. Overall, the mortality rate was 72.8% (8 cases). Consanguineous was found in more than half (7 cases) of patients and family history of disseminated BCG infection or immunodeficiency was found in nearly one third (3 cases) of patients. A chi-square test comparing the clinical manifestations in children with disseminated BCG infection with control group show statistically significant differences for the two groups of children. Comparison of immunologic markers showed that significant differences were seen between two groups of children. The mean value of CD3 in patients was (P = 0.005) in comparison with control group and the mean value of CD4 in patients was (P < 0.001) in comparison with control group (Table 3). Although antimycobacterial regimens used for the treatment of patients with 4 drugs, but 8 of the patients died despite aggressive management. A 04-month-old female patient had a disseminated BCG infection after immunization at birth with BCG sub strain Pasteur vaccine (Manufacturer and batch number unknown) The patient had personal immunodefi


VAERS ID: 383747 (history)  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-03-26
Entered: 2010-03-29
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Antibody test positive, Aphthous stomatitis, Blood immunoglobulin G normal, C-reactive protein increased, Chills, Complement factor normal, Decreased appetite, Fatigue, Granulocyte count, Immunoglobulins normal, Irritability, Laboratory test normal, Lymphadenopathy, Lymphocyte count normal, Lymphocyte transformation test negative, Pharyngitis, Pyelonephritis, Pyrexia, Red blood cell sedimentation rate increased, Tonsillectomy, Tonsillitis
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Vasculitis (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic procedure, Examination of the humoral immunity: Normal immunoglobulin levels and normal IgG subclasses; diagnostic laboratory test, titration of pneumococcal antibody: Significant antibody response; diagnostic laboratory test, Granulocyte chemotaxis: Normal; diagnostic laboratory test, lymphocyte transformation test: Normal; blood CD19 count, normal; lymphocyte count, normal; serum C-reactive protein, increased (between 3 -8 mg/dl); erythrocyte sedimentation rate, increased sedimentation (50 mm after 1 h); complement assays, complement system: normal
CDC Split Type: WAES1003USA03118

Write-up: Information has been received from a physician via a literature article title as stated above, on 15-MAR-2010. The patient (birth date and gender unknown) experienced very high fever approximately on week after he received a dose of MMR (trade name, batch number and date of vaccination not reported). Secondary suspect vaccination included PREVNAR, on an unspecified date. Regular episodes of fever followed each other since then. Medical history: at the age of 1 year, the patient experienced high fever during 3-4 days for which he received an antipyretic treatment; fever lasted for 4 days. Since then, he showed likewise episodes almost every month, introduced by general fatigue, irritability, decreased appetite, and finally leading to 3-5 days of high fever frequently associated with fever shivering. Mostly, at the same time, a bilateral cervical adenophaty appeared and a non-purulent tonsillitis was diagnosed. No other systemic complaints or symptoms were observed. About 4 months later, the symptom-free intervals decreased to 2-3 weeks. Antibiotic treatment did not influence the clinical development of such episodes. Pyelonephritis was diagnosed at the age of 1.5 years. Since then, the frequency of fever episodes increased to 2 weeks. Generally, blood analysis showed an increase of C reactive proteins (CRP) (Between 3 to 8 mg/dl), without important leukocytosis but with increased sedimentation (50 mm after 1 hour). Examination of the humoral immunity showed normal immunoglobulin levels and normal IgG subclasses. Titration of pneumococcal antibodies after PREVNAR showed a significant antibody response. Titration of B-lymphocytes and T lymphocytes: normal. Lymphocytes transformation test, granulocyte chemotaxis and the complement system were normal. The recurrence of the fever episodes with bilateral cervical adenophaty, with or without tonsillitis/ pharyngitis, normal cellular and humoral immunity frames the experienced periodic fever into the category "periodic fever, aphtous stomatitis, pharyngitis and adenopathy (PFAFA) syndrome". The patient has a tonsillectomy and the recurrent episodes of fever disappeared. Very high fever, periodic fever, aphthous stomatitis, pharyngitis, bilateral cervical adenopathy, pyelonephritis, non-purulent tonsillitis, general fatigue, irritability, decreased appetite, shivering, blood sedimentation increased and increase of C reactive proteins were considered to be an other important medical events by the reporter. Other business partner number include E2010-01693. No further information is available.


VAERS ID: 387339 (history)  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-05-12
Entered: 2010-05-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Biopsy lymph gland abnormal, Bovine tuberculosis, Culture positive, Cytomegalovirus test positive, Epstein-Barr virus antibody positive, Gene mutation identification test positive, HIV test negative, Ileitis, Immunodeficiency, Interferon gamma receptor deficiency, Lymphadenitis, Peritonitis, Salmonella sepsis, Tuberculosis, Typhoid fever, Varicella virus test positive
SMQs:, Agranulocytosis (broad), Congenital, familial and genetic disorders (narrow), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation (narrow), Gastrointestinal nonspecific inflammation (narrow), Malignant lymphomas (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Patient and sibling brother with complete interleukin-12 receptor b1 deficiency. The parents and a sister were healthy and had been vaccinated with BCG, with no adverse effect.
Diagnostic Lab Data: Negative for human immunodeficiency virus using serologic methods. M. bovis BCG was cultured from bronchoaveolar lavage fluid and a lymph node biopsy sample. Classic immunodeficiencies and IFN gamma R1 and IFN gamma R2 deficiencies were at first excluded. Mutations were found in the IL12RB1 gene. The patient was tested negative for human immunodeficiency virus using serologic methods. The patient had high titers of serum IgG antibodies specific for cytomegalovirus, Epstein-Barr virus, and varicella-zoster virus.
CDC Split Type: E201003041

Write-up: Case retrieved from the literature in foreign country on 27-Apr-2010. This case is linked with the case E2010-03071 (same article, same vaccination in the patient''s sibling sister). A male patient (child) with complete interleukin-12 receptor b1 deficiency was vaccinated at birth with BCG (MFR UNK, batch number not reported). The patient was one of two siblings born to consanguineous (first-cousins) parents from foreign country who were investigated. The family lived in foreign country, where tuberculosis was endemic and BCG vaccination was compulsory. Shortly after vaccination the patient developed disseminated BCG infection. M bovis BCG was cultured from bronchoaveolar lavage fluid and a lymph node biopsy sample. The patient responds well to a 12-month course of antimycobacterial therapy. It was specified that at age 4 years, he developed Salmonella typhimurium adenitis and, at age 7 years, he developed S. typhimurium septicemia. Both infections responded well to antibiotics. He is now well at 14 years, with no prophylactic treatment. Classic immunodeficiencies and IFN gamma R1 and IFN gamma R2 deficiencies were at first excluded. Mutations were found in the IL12RB1 gene. The patient was tested negative for human immunodeficiency virus using serologic methods. The patient had high titers of serum IgG antibodies specific for cytomegalovirus, Epstein-Barr virus, and varicella-zoster virus. To be noted that it was specified in the article that the patient''s sister, with interleukin-12 receptor betal deficiency, had received the injection of BCG substrain Pasteur at birth and at ages 6 and 15 years. She showed no adverse reaction, despite 3 inoculations with live BCG, but developed ileitis, peritonitis, and mesenteric adenitis due to Mycobacterium tuberculosis (Case E2010-03071). It was also specified that the parents and a sister were healthy and have been vaccinated with BCG vaccine with no adverse effects.


VAERS ID: 462557 (history)  
Age: 0.01  
Gender: Male  
Location: Foreign  
Vaccinated:2011-07-12
Onset:0000-00-00
Submitted: 2012-08-20
Entered: 2012-08-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER G3787AA / 0 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Granuloma, Lymphadenopathy, Mass excision
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history and concomitant medications were not reported.
Diagnostic Lab Data: Not reported
CDC Split Type: 201207575

Write-up: Initial case received from Health Authorities in a foreign country on 10 August 2012 under the reference AU2012-119 (HA''s number 302017). A 12-month-old male patient, with no reported medical history and concomitant medications, had received a first dose of BCG vaccine, batch number G3787AA, route and site of administration not reported, on 12 July 2011. In March 2012, the patient developed granuloma and enlarged auxiliary left node leading to hospitalization (dates not reported). The patient underwent excision in May 2012. The patient recovered (date not reported). The causality was reported as probable. The Health Authorities coded: "granuloma" and "lymphadenitis". Documents held by sender: none.


VAERS ID: 466303 (history)  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-09-25
Entered: 2012-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Aspiration bone marrow abnormal, Biopsy lymph gland abnormal, Culture negative, Culture positive, Cytomegalovirus test, Cytomegalovirus test negative, Epstein-Barr virus test negative, Fluorescent in situ hybridisation negative, Granuloma, Immunohistochemistry, Inguinal mass, Lymphadenitis, Lymphadenopathy, Lymphoma, Necrosis, Neoplasm malignant, Nuclear magnetic resonance imaging normal, Polymerase chain reaction, Pseudolymphoma, Red blood cell sedimentation rate increased, Tumour marker test, Ultrasound scan abnormal, Vaccination complication
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Malignant lymphomas (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Haematological malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Biopsy, see text; Bone marrow aspiration, see text; Cytomegalovirus serology, negative; Diagnostic ultrasound, conglomerate of; Epstein-Barr virus serology, negative; Erythrocyte sedimentation rate, mild elevated; Fluorescent in situ hybridizat, see text; Immunohistochemistry, see text; Nuclear magnetic resonance ima, see text; Polymerase chain reaction, see text
CDC Split Type: B0830999A

Write-up: This case was reported in a literature article and described the occurrence of lymphoma-like reaction in a 2-week-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline), Bacillus calmette-guerin vaccine (non-gsk). The subject was immunocompetent and without history of HIV infection. On an unspecified date, the subject received 1st dose of ENGERIX B (unknown route and injection site, batch number not provided), 1st dose of Bacillus Calmette-Guerin vaccine (unknown route and injection site, batch number not provided). The subject was vaccinated at birth as part of the immunisation protocol. Less than one month after vaccination with Bacillus Calmette-Guerin vaccine and ENGERIX B, the subject presented with a rapidly enlarging inguinal mass growing to a diameter of 3 cm over a period of 1 week. This case was assessed as medically serious by GSK. At presentation, the only detected abnormality was a mildly elevated erythrocyte sedimentation rate, but otherwise the subject was well. An ultrasound scan revealed a conglomerate of lymph nodes in the right inguinal region. As lymphadenopathy was not in the lymphatic drainage area of the vaccination sites, there was high clinical suspicion of malignancy. The clinical picture raised suspicion of a neoplasm. A fine needle aspiration showed atypical lymphoid cells suspicious of lymphoma. The bone marrow aspirate showed no abnormality on flow cytometrical examination. An excision biopsy was performed. A 2-cm lymph node was excised which macroscopically appeared homogeneous and showed small foci of necrosis. . Coalescent palisading granulomas with copious necrosis were also noted, but no acid-fast bacilli could be identified. The immunostains highlighted effacement of the lymph node architecture. The diffuse proliferation of blasts was of T-cell phenotype with virtually no residual B-cell areas (the lack of CD20-positive cells). There was a considerable restriction to the expression of CD8 over CD4. The majority of the cells had an activated cytotoxic TIA1/granzyme B/perforin-positive phenotype in a background of abundant evenly distributed histiocytes (CD68 positive). No aberrant loss of Tcell markers including CD2, CD3, CD5, CD7, and CD43 was seen. There were scattered CD30-positive blasts. However, most cells showed strong expression of CD99 (a high proliferation index of 90% as assessed by Ki-67 immunostaining). These atypical features prompted the local pathologist to make a diagnosis of T-cell lymphoma, probably of lymphoblastic type. Upon expert review, additional immunohistochemistry showed no expression of TdT, CD34, CD10, or CD117. Epstein-Barr virus-encoded RNA was not detected by in situ hybridization. The polymerase chain reaction using the Biomed-2 T-cell receptor beta and gamma primers showed reproducible polyclonal smears. The lymph node culture was negative for BCG but grew Gemella Morbillorum, a streptococcus-like anaerobic bacterium rarely associated with disease in humans. Epstein Bar virus and Cytomegalovirus serology were negative. Upon expert review and additional molecular diagnostics, the initial pathological diagnosis of lymphoblastic T-cell lymphoma was changed to ectopic BCG lymphadenitis and hyperimmune post-vaccinal reaction. The atypical T-cell proliferation was most likely a result of the adjuvant effects of the co-administered vaccines. The subject was treated with antibiotics. The ultrasound and whole-body magnetic resonance imaging scans performed after 2 months showed no evidence of lymphadenopathy or organomegaly. Eight months after the event, the subject remained well, with no signs of disease. The author considered the events were almost certainly related to vaccination with ENGERIX B and Bacillus Calmette-Guerin vaccine.


VAERS ID: 481840 (history)  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:2012-09-28
Onset:2012-10-07
   Days after vaccination:9
Submitted: 2013-01-18
   Days after onset:103
Entered: 2013-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Aphonia, Ear pain, Lethargy, Lymphadenopathy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1301GBR008140

Write-up: This case was received from the health authority on 10-Jan-2013. GB-MHRA-ADR 21881247. This case is not medically confirmed as it was reported by consumer. This case is linked to E2013-00300 and E2013-00301. A patient (age and gender unknown), with no reported medical history or concomitant medication, received an injection of measles, mumps and rubella vaccine (manufacturer unknown, batch number, dose, site and route of administration not reported) on 28-Sep-2012. Six days after the vaccination, on 04-Oct-2012, the patient experienced swollen glands and was lethargic. Eight days after the vaccination, on 06-Oct-2012, the patient had ear ache and 9 days after the vaccination, on 07-Oct-2012, the patient experienced voicelessness. The patient''s outcome was not reported. The original report from the agency concerned the adverse events experienced by the patient''s brother (case E2012-00300). According to the parents, their three children experienced very similar reactions at exactly the same time. All three children received the vaccine at the same time. A seriousness assessment for this case not provided but, as the adverse events were exactly the same, the company entered the same seriousness criteria as the original report. The other cases are described in linked cases # E2013-00300 and E2013-00301.


VAERS ID: 484332 (history)  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:2002-10-08
Onset:0000-00-00
Submitted: 2013-02-12
Entered: 2013-02-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Blastocystis infection, Blood elastase increased, Blood immunoglobulin A, Blood immunoglobulin M, Chest discomfort, Chronic fatigue syndrome, Delayed sleep phase, Disturbance in attention, Dizziness, Eosinophil percentage increased, Eosinophilia, Epstein-Barr virus antibody positive, Eructation, Fatigue, Flatulence, Gastrointestinal disorder, Immune system disorder, Influenza like illness, Malaise, Natural killer cell count decreased, Neurological examination normal, Paraesthesia, Pollakiuria, Somatoform disorder, Thinking abnormal, Weight decreased, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No information reported.
Diagnostic Lab Data:
CDC Split Type: E201301060

Write-up: Case received from a medical advisor from a specialised medical advising office for representatives of injury victims on 31-Jan-2013 under the reference numbers MIE2833, MIE2834, MIE2835. Medically confirmed. Upon internal review the company considered the case as serious. An adult male patient (39 years old at the time of reporting), who joined in 1996 and was vaccinated according to the following schedule (manufacturers of the vaccines could not be traced. Batch numbers were not reported): 09-Sep-1997 Hepatitis A dose 1, unit dose 1ml; 10-Mar-1998 Hepatitis A booster, unit dose 1ml. 23-Jun-1998, Diphtheria, tetanus, polio vaccine dose 1 unit dose 1ml. 12-Jan-1999 Diphtheria, tetanus, polio vaccine revaccination, unit dose 1ml. 12-Jan-1999 Hepatitis B dose 1, unit dose 1ml. 19-Feb-1999 Measles, mumps, rubella vaccine. 19-FEB-1999 Hepatitis B dose 2, unit dose 1ml. 18-Aug-1999 Hepatitis B dose 3, unit dose 1ml. 08-Oct-2002 Typhoid vaccine, unit dose 0,5ml. 29-Sep-2003 Meningococcal vaccine ACWY (other MFR), unit dose 0,5ml. Afterwards (on an unspecified date), the patient developed flu-like symptoms with dizziness, fatigue and impaired concentration. The complaints increased in 2003. In 2005, the Epstein Barr virus appeared to be IgG positive, and it was assumed that he had gone through infectious mononucleosis in 2003. At that time he had been sick for three days. Patient continued despite the complaints, which is in accordance with his personality and the culture. In 2005, the complaints were: unable to think clearly, difficulty with concentration, fatigue, sometimes wheezing, sometimes chest pressure, belching and farting, frequent urination, sometimes tingling in the hands, some loss of strength in the legs and waking up exhausted in the morning. From 2005 he lost 15 kilogrammes of weight, after which his weight was 60 kilogrammes, with a length of 1m79. In that year, a Blastocystis hominis with mild eosinophilia was diagnosed. Various clinicians made the following diagnoses: PUS (physically unexplained symptoms), undifferentiated somatoform disorder, chronic fatigue syndrome (CFS), an immunological problem (internist), leaky gut (physician-professor), seriously delayed melatonin production with delayed sleep phase syndrome. According to a physician (internist infectious disease specialist at the clinic), on request of the court: "extensive literature review and our experience" have not brought forward that a relationship may exist between the concomitant vaccines and chronic insomnia and exhaustion. This was not further substantiated. At the time of reporting, an eosinophilia of 14% still existed, the patient was advised to be examined. All other neurological and internal examinations do not show any abnormalities, except the following, according to a physician-professor: high leucocyte elastase activity, IgA and IgM for intestinal bacteria in the peripheral blood and a low percentage of NK (Natural Killer) cells.


VAERS ID: 486809 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-03-12
Entered: 2013-03-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bronchial disorder, Bronchospasm, Cold sweat, Condition aggravated, Cough, Dyspnoea, Fatigue, Hyperhidrosis, Lung disorder, Lymphadenopathy, Nasopharyngitis, Rales, Respiratory disorder, Rhinitis, Sinus operation, Sinusitis, Temperature intolerance, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient''s medical history included recurrent rhinopharyngitis, bronchitis and strongly positive tuberculin test. The patient''s sister was schizophrenic and the patient''s sister and aunt were asthmatic.
Diagnostic Lab Data:
CDC Split Type: E201301522

Write-up: Case retrieved from the literature on 20-Feb-2013. Case medically confirmed. An 8-year-old female patient had received a dose of BCG (manufacturer unknown, batch number not reported) on an unspecified date before June 1990 and in June 1990 she developed dry wheezing cough that was worse upon waking, she had difficulty breathing and foul-smelling, greenish purulent rhinitis. She was permanently fatigued and experienced profuse sweating. Multiple lymph nodes were enlarged and lung auscultation confirmed crackles with bronchospasm. Her medical history included recurrent rhinopharyngitis, bronchitis and strongly positive tuberculin test. The patient''s recurrent lung diseases were attributed to BCG vaccination (dosage, route, indication and time to onset not stated). She had previously received corrective treatment with antibacterial medication but her condition had not improved. She was then given homeopathic remedies and at a follow-up visit 1 month later her cough had disappeared. Ten years later, in 2000, the patient was doing well. Author comment: Homeopathy permanently cured recurrent BCG-induced lung disease in a child. At the time of reporting, only an abstract from the article was available. Full article received on 28-Feb-2013: It was reported that the patient developed recurrent pulmonary dysfunctions after she received a dose of BCG (manufacturer unknown) on an unspecified date. In 1988, she experienced cough and recurrent pneumopathy in the right middle lobe with probable bronchodilation which was treated with antibiotics, inhaled LOMUDAL, ZADITEN and physiotherapy. In 1989, she developed sinusitis which led to the fitting of a drain. In 1990, she experienced pneumopathy in the left lower lobe and she was given antibiotics, aerosol and physiotherapy. In Jun-1990, the patient consulted a homeopathic physician further to the previously reported events. Her condition had not improved despite treatment with antibiotics. She was not feverish but she was experiencing profuse sweating of head and feet and high sensitivity to cold and dampness. She was prescribed BRYONIA 4 CH and IPECA 4 CH to be taken alternatively on Sundays, THUYA 9 CH, SILICEA 9 CH, SULPHUR IODATUM 9 CH and AVIAIRE 9 CH as corrective treatment. In Jul-2010, 1 month later, cough which had persisted for 2 years resolved, sweating decreased, only mild rhinitis persisted and the physician prescribed the same treatment again. In Sep-1990, the patient was in good condition and she was given SILICEA 9 CH, 1 monthly dose for 3 months. In 2000, the patient was still in good condition, she had experienced a few episodes of rhinopharyngitis which were quickly resolved by taking a dose of SILICEA 9 CH. To be noted that the patient''s sister was schizophrenic and the patient''s sister and aunt were asthmatic. The patient was 8 years old in Jun-1990 and not at the time of onset.


VAERS ID: 499716 (history)  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2013-03-20
Onset:2013-06-13
   Days after vaccination:85
Submitted: 2013-08-16
   Days after onset:64
Entered: 2013-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Infection, Lymphadenopathy, Surgery
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1308GBR002941

Write-up: This spontaneous report was received from a regulatory authority (No: GB-MHRA-EYC 00102351) refers to a 5 month old male patient. A 5 month old male patient developed infection and lymph node disorder on 13-JUN-2013, approximately 3 months after administration of BCG vaccine (manufacturer unknown) SSI (invalid batch no.: 110020A). He received an unknown dose of the BCG vaccine (manufacturer unknown) by subcutaneous route (wrong route of administration) on 20-MAR-2013. The father reported the child developed an infection of the lymph nodes of the left arm, which require a surgical procedure and a lengthy hospital stay. It was reported that the doctors have attributed the infection/reaction to the Bacillus Calmette-Guerin (BCG) vaccine (manufacturer unknown). At the time of reporting, he had recovered (reported as 10-JUL-2013). Additional information is not expected.


VAERS ID: 514730 (history)  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2010-10-01
Onset:0000-00-00
Submitted: 2013-11-26
Entered: 2013-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER 109047C / - UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Appetite disorder, Lymphadenopathy, Pain, Pyrexia, Weight increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin
Current Illness: Unknown
Preexisting Conditions: Premature baby
Diagnostic Lab Data:
CDC Split Type: WAES1311GBR008875

Write-up: Information has been received from unspecified consumer or other non-health professional refer to a 3 months old female premature baby via regulatory authority (ADR 22315089) who on 25-AUG-2010 was vaccinated with a dose of Hepatitis B Vaccine (manufacturer unknown), batch# NK34710, lot # 1646U, expiry date 12-OCT-2010 (expiry date reported as September 2010) via parenteral. On 01-OCT-2010 was vaccinated with a dose of BCG live (manufacturer unknown), batch# 109047C via parenteral. Concomitant therapy included amoxicillin. On an unspecified date, the patient presented with severe high fever, painful to touch or lift, enlarged lymph nodes of 1 cm and above, general well being affected included appetite and weight gain. It was reported that possibly the hepatitis B vaccine was no longer good as it was close to its expiry date. It was administered with an expiry date of a month later and or the BCG live (manufacturer unknown) was administered a little too early as the child was born premature. The patient could not build immune system as a full term child. The patient was monitored at the outpatient clinic''s children unit and accident and emergency by the doctors. The outcome of enlarged lymph nodes of 1 cm and above was recovering. The outcome of other adverse events was unknown. The reporter considered the events to be other medically significant. Additional information is not expected.


VAERS ID: 514899 (history)  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2013-10-01
Onset:0000-00-00
Submitted: 2013-11-27
Entered: 2013-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER 109047C / - UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Decreased appetite, Lymphadenopathy, Pyrexia, Tenderness, Weight gain poor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin
Current Illness: Immunisation
Preexisting Conditions: Premature baby
Diagnostic Lab Data:
CDC Split Type: WAES1311GBR010809

Write-up: Information has been received from Sanofi Pasteur MSD (E2013-09618) on 19-NOV-2013 via health authority in the foreign country. GB-MHRA ADR 22315089. The case is not medically confirmed as it was reported by a consumer. A 3 month old female patient (weight 5 kg), who was a premature baby, received an injection of HBVAXPRO (batch number NK34710, lot# 1646U expiry date Sep-2010) thimerosal-free, dose in series, route and site of administration not reported, on 25-Aug-2010 and an injection of Bacillus Calmette Guerin vaccine (other manufacturer as the batch number 109047C did not correspond to SPMSD format of vaccine) dose in series, route and site of administration not reported, on 01-Oct-2010 and on an unspecified date, she experienced severe high fever, painful to touch or lift, enlarged nodes of 1 cm and, general well being affected including reduced appetite and weight gain. According to the reporter, possibly HBVAXPRO was no longer good as it was close to its expiry date and the Bacillus Calmette Guerin vaccine could have been administered a little too early as the child was born prematurely and she could not build immune system as a full term child. The patient was monitored at the outpatient clinic''s children unit and at the accident and emergency department by the doctors. She received concomitant treatment with amoxicillin (manufacturer unknown). At the time of reporting, the patient was recovering for lymph nodes and the outcome for all other adverse events was unknown. The regulatory authority considered that case serious due to be medically significant.


VAERS ID: 522736 (history)  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2013-05-23
Onset:2013-12-16
   Days after vaccination:207
Submitted: 2014-02-11
   Days after onset:57
Entered: 2014-02-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER K11178 / - UN / UN
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER V092A / 2 UN / UN
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR J0084 / 2 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abasia, Biopsy bone normal, Bone tuberculosis, Culture positive, Cytogenetic analysis abnormal, Imaging procedure, Lymphadenitis bacterial, Lymphadenopathy, Polymerase chain reaction, Primary immunodeficiency syndrome, Pyrexia, Tuberculin test positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown; Family history: Paternal grandmother, uncle and cousin had STAT1 deficiency and the cousin was under treatment for multifocal tuberculous osteomyelitis (not known at the time of vaccination)
Diagnostic Lab Data: On 24-Dec-2013, image examination was performed and revealed signs of multifocal osteomyelitis. A genetic test was requested and performed and diagnosis of STAT1 deficiency was made. T-SPOT was negative; Body temperature, 23MAY2013, 37.4 Degree C; Tuberculin test, UNK, Positive; bone biopsy, 26DEC2013, Negative PCR; culture, 16Jan2014, Mycobacterium tuberculosis
CDC Split Type: 2014SA016108

Write-up: Initial report received from the authority (Ref: #V13001158) via healthcare professional in a foreign country on 06 February 2014. A 05-month-old male patient had received a subcutaneous primary third dose of IMOVAX POLIO (Lot number: J0084, anatomical site of administration was not reported), received a dose of BCG vaccine (lot number: K11178, route and anatomical site of administration were not reported) and primary third dose of DPT vaccine (lot number: V092A, route and anatomical site of administration were not reported) all vaccines on 23 May 2013. Family history included paternal grandmother, uncle and cousin with STAT1 deficiency and the cousin was under treatment for multifocal tuberculous osteomyelitis (not known at the time of vaccination). On 15 April2013, the patient was vaccinated with primary third dose of ACTHIB (Lot number: H1620), primary third dose of PREVENAR (Lot number: 12F02A), primary second dose of DPT vaccine (Lot number: V091C) and subcutaneous primary second dose of IMOVAX POLIO. His body temperature before the vaccination was 37.4 degrees C. In early Jul-2013, he presented with swollen left axillary lymph nodes. In Oct-2013, the event resolved spontaneously. On 16 December2013, the patient presented with pyrexia. On 18-December 2013, the patient developed abasia and was hospitalized for further evaluation. At first, the patient was diagnosed with pyrexia of unknown origin and started to receive Antibiotics, however, the pyrexia did not resolve. It was reported that the patient''s cousin had been diagnosed with mycobacterium tuberculosis infection osteomyelitis with a similar clinical course and was under treatment. Therefore, on 24 December 2013, image examination was performed and revealed signs of multifocal osteomyelitis. Tuberculin test was strongly positive. T-SPOT was negative. On 26 December 2013, bone biopsy showed negative PCR; however, tuberculosis treatment was initiated. On 29 December 2013, the patient''s general condition was improving. On 07 January 2014, the patient became afebrile and remained afebrile since then. On 16 January 2014, culture of specimen collected in bone biopsy revealed Mycobacterium tuberculosis. It was determined that the Mycobacterium tuberculosis was of BCG strain. At the time of reporting, he was still under tuberculosis treatment in the hospital. As of 04 February 2014, the patient had not recovered from events. Multifocal tuberculous osteomyelitis. Reporting pediatrician''s seriousness assessment: Serious (inpatient/prolonged hospitalization). Reporting pediatrician''s causality assessment: Related. Lymphadenitis suppurative. Reporting pediatrician''s seriousness assessment: Serious (inpatient/prolonged hospitalization). Reporting pediatrician''s causality assessment: Related. Reporting pediatrician''s comment: There was no alternative explanation for the event of multifocal tuberculous osteomyelitis. A genetic test was requested and performed at a hospital, and diagnosis of STAT1 deficiency was made. The patient''s paternal grandmother, uncle and cousin had STAT1 deficiency as well. The cousin was currently under treatment for multifocal tuberculous osteomyelitis.


VAERS ID: 524022 (history)  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-25
Entered: 2014-02-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS - / - UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dyspepsia, General physical health deterioration, Immediate post-injection reaction, Immune system disorder, Nervous system disorder
SMQs:, Gastrointestinal nonspecific dysfunction (narrow), Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: 2014049053

Write-up: This is a spontaneous report from a non-contactable consumer, the mother of the patient. The report was received via a web page customer engagement program. A child patient of an unspecified gender received PREVENAR and PRIORIX, both via unspecified routes of administration on an unspecified date at single doses. Medical history included drug hypersensitivity reported as the patient was sensitive to any drugs and always experienced adverse events. The mother reported that the health state of the patient started to rapidly deteriorate right after the vaccinations. On unknown dates, the patient developed neurologic problems, immunity was destroyed, had serious digestive problems, etc. It was reported that the patient was permanently disabled and needed continuous care. The clinical outcome of the event, neurologic problems, immunity was destroyed, had serious digestive problems, was unknown.


VAERS ID: 547139 (history)  
Age: 0.45  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-28
Onset:2013-06-28
   Days after vaccination:0
Submitted: 2014-10-09
   Days after onset:468
Entered: 2014-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER 112030A / - UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H015303 / 2 - / PO

Administered by: Other       Purchased by: Other
Symptoms: Allergy test negative, Blood test normal, Computerised tomogram abnormal, Cough, Crying, Decreased appetite, Diarrhoea, Injection site erythema, Injection site pustule, Injection site scar, Lymph node tuberculosis, Lymphadenopathy, Toxoplasma serology negative, Vaccination site reaction
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Tuberculosis bladder; Immunisation
Preexisting Conditions: Malaise
Diagnostic Lab Data: (Unknown date): blood test: allergic test negative, cow milk intolerance test negative, toxoplasmosis test negative; (Unknown date): CT scan: cervical adenopathy (abnormal)
CDC Split Type: WAES1410FRA003677

Write-up: Information has been received from Sanofi Pasteur MSD (MFR# E2014-09022) on 07-OCT-2014. Case received from a pharmacist on 30-Sep-2014: A 6-month-old female patient had received a dose of BCG vaccine (SSI, batch number 112030A) on 28-Jun-2013. Subsequently the infant began to cough and develop adenopathies. She was followed at hospital (probable hospitalization) and ganglionic tuberculosis was diagnosed. The patient had potentially also received a dose of ROTATEQ at the same time as the BCG vaccine but it was not certain. At hospital, a blood work-up was performed. The patient also experienced a normal local reaction at the vaccination site, with no particular problem. To be noted that the child used to be sick very often. At the time of reporting, the outcome was not provided. Follow-up received on 02-Oct-2014: The patient''s initials and date of birth were provided. She was hospitalized on an unspecified date at the haematology/oncology department. She presented with ganglionic tuberculosis. This case is a duplicate with both non serious cases E2014-06110 and E2014-08010. Data from these two cases were merged in the serious case E2014-09022. The non serious cases E2014-06110 and E2014-08010 will be deleted. It was confirmed that the reporter, who was the same for these 3 cases, was not a health professional. Thus, the case is no longer medically confirmed. On 04-Jul-2014 the consumer reported: A 5-month-old female patient had received a dose of BCG vaccine (SSE, batch number 112030A) on 28-Jun-2013. On that same day, she developed redness at injection site and then experienced persistent crying the whole night. One month post-vaccination, she experienced injection site suppuration with loss of appetite, inconsolable crying and chronic cough. At the time of reporting on July 2014, the outcome was unknown. On 03-Sep-2014, the consumer called again. The female patient received a dose of BCG vaccine in the arm and probably the dose 3 of ROTATEQ (batch number H015303) on the same day (the date was not reported in the vaccination record but only the batch number was mentioned). The patient had received the dose 2 of ROTATEQ (batch number H01533) on 18-Apr-2013 and the dose 1 of ROTATEQ (batch number 0513AE) on 14-Mar-2013. A week after D1 of ROTATEQ, the patient experienced chronic diarrhea, that still lasted at the time of reporting with 2 loose stools per day. Various blood tests were performed and were negative for toxoplasmosis. It showed no allergy to cow''s milk proteins, allergy tests were negative. Following the discovery of a cervical lymph node, a CT scan was performed and confirmed the presence of a cervical adenopathy which would have appeared a few months before reporting. The psychomotor and staturo-ponderal development of the patient were normal. There was no sign of dehydration. The mother changed the diet of the patient by replacing the cow''s milk with plant milks. At the time of reporting the patient was receiving a solid diet. The mother confirmed that the patient had experienced a reaction of BCG vaccination which had left a scar. During this period, the patient also presented with cough. The mother had also suspected the medication with VILANTEROL and therefore she had discontinued this treatment. At the time of reporting on 02-Oct-2014, the outcome for ganglionic tuberculosis, cough and cervical adenopathy was not reported. The outcome for appetite loss was unknown. The patient had recovered from persistent crying, vaccination site suppuration and injection site redness but she had not recovered from chronic diarrhea.


VAERS ID: 552986 (history)  
Age: 0.5  
Gender: Female  
Location: Foreign  
Vaccinated:2014-06-19
Onset:2014-09-10
   Days after vaccination:83
Submitted: 2014-10-24
   Days after onset:44
Entered: 2014-10-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER KH197 / 0 UN / UN
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER V095B / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1753 / 2 UN / SC
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR J0210 / 1 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 13J03A / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Lymphadenitis bacterial, Lymphadenopathy, Mass
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Body temperature, 36.8 degree C
CDC Split Type: 2014SA144572

Write-up: Initial case was received from a physician via healthcare professional on 20 October 2014. Health authority number: V14000421. A 06-month-old female patient, with no medical history and whose concomitant medications were not reported, had received simultaneous subcutaneous third dose of ACTHIB (batch number J1753, anatomical site of administration not reported), subcutaneous second dose of IMOVAX POLIO 0.5 ml (batch number J0210, anatomical site of administration not reported), first dose of BCG vaccine (batch number KH197, dose, route and anatomical site of administration not reported), second dose of DTP (batch number V095B, dose, route and anatomical site of administration not reported) and third dose of PREVENAR 13 (batch number 13J03A, dose, route and anatomical site of administration not reported) on 19 June 2014 at 10:57 am. The patient''s body temperature before the vaccination 36.8 degrees Celsius. On 10 September 2014, the patient developed suppurative lymphadenitis; when being given a bath, she was noted to have a mass on the left iliac region. On 11-Sep-2014, she was taken to the clinic and found to have enlarged lymph node of the left axilla as well. No corrective treatment or laboratory details were reported. The outcome of the events was not provided. Reporting physician''s seriousness assessment: Non-serious. Reporting physician''s causality assessment: Related to ACTHIB and IMOVAX. Reporting physician''s comment: Other than the vaccination, no causative factors for the event were identified. The list of documents held by sender: none.


VAERS ID: 643108 (history)  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-10
Entered: 2016-06-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Enanthema, Leukopenia, Lymphadenopathy, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1606ESP005054

Write-up: Information has been received from Sanofi Pasteur MSD (report number ES-1577272925-2016006040), on 09-JUN-2016. Case retrieved from unsolicited literature on 05-Jun-2016. This is a non valid case as required minimum information is missing about the patient. A patient of unknown sex/age received M-M-R vaccine, live (product name not reported, batch number unknown) on an unknown date. The patient experienced MEASLES in 2014. The patient''s outcome was reported as Unknown. This case is linked with the source case 2016006036 and cases 2016006038, 2016006039, 2016006041. According to the abstract: One series of six patients (see linked cases) who were diagnosed in an Emergency Department. They were under 31 years old and they consulted for influenza-like illness with high fever and exanthema. Five of them had been properly vaccinated and one was health professional. According to the article: Six patients, with unknown medical history, between twelve months and 31 years old who consulted between February and April 2014 for influenza-like syndrome and exanthema. As epidemiological history, one had an aunt who was admitted for measles pneumonia and another was a professional of the Emergency Department. Five of these six patients had received two vaccine doses. The six present general discomfort, fever higher than 38.5 degrees C and exanthema of 24-48 hours of evolution. Characteristically, the rash had begun in the face, had progressed to the trunk, to ultimately affect centrifugally to upper and lower extremities, respecting palms and soles (except in one patient). Measles serology was obtained, held in the Emergency Department, positive IgM in five patients and weak IgG conversion in two patients. No patient had complication measles and all were discharged with isolation guidelines, performing outpatient monitoring. According to the authors: these previously vaccinated patients had a type of measles with longer incubation period (14 to 21 days) and prodromal and exanthematic phases less intense, so described this form of measles as modified measles. This case concerns a patient (gender not reported, range of age between 12 months to 31 years) who presented with the following symptoms: Exanthema, fever greater than 38.5 degrees C. Physical exam: adenopathy and enanthema. Laboratory: leukopenia. The patient had received 2 doses of a M-M-R vaccine (product name and batch number not reported) on unspecified dates.


VAERS ID: 643185 (history)  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-17
Entered: 2016-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy, Pain in extremity, Rheumatoid arthritis, Vaccination complication
SMQs:, Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: DE2016GSK085703

Write-up: This case was reported by a physician and described the occurrence of rheumatoid arthritis in a male patient who received TWINRIX. Concomitant products included TWINRIX and REPEVAX. On an unknown date, the patient received the 2nd dose of TWINRIX. On an unknown date, an unknown time after receiving TWINRIX, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant), pain in arm and enlargement of lymph nodes. On an unknown date, the outcome of the rheumatoid arthritis, pain in arm and enlargement of lymph nodes were not reported. It was unknown if the reporter considered the rheumatoid arthritis, pain in arm and enlargement of lymph nodes to be related to TWINRIX. Additional information was provided as follows: Age at vaccination was not reported. The reporter was not the vaccinating physician. In 2013, the patient received 1st dose of TWINRIX and received 2nd dose one month after the first dose. The events were considered to be a reaction to vaccination. Later, the reporting physician was informed (letter from patient''s attorney) that the patient also experienced rheumatoid arthritis. The physician will also report the case to regulatory authority.


VAERS ID: 644897 (history)  
Age: 0.0  
Gender: Male  
Location: Foreign  
Vaccinated:2015-08-03
Onset:2015-08-06
   Days after vaccination:3
Submitted: 2016-07-27
   Days after onset:356
Entered: 2016-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (MYCOBAX) / SANOFI PASTEUR 00614 / - UN / SC
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UFA14011 / - UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal faeces, Anaemia, Cardiac disorder, Crying, Erythema, Eye disorder, Faeces discoloured, Fear, Gastric disorder, Hydrocele, Inflammation, Inguinal hernia, Irritability, Jaundice neonatal, Lymphadenopathy, Neoplasm skin, Petechiae, Pneumonia, Poor weight gain neonatal, Renal disorder, Tenderness,