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Case Details (Sorted by Vaccination Date)

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VAERS ID: 426941 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: California  
Vaccinated:2011-07-07
Onset:2011-07-07
   Days after vaccination:0
Submitted: 2011-07-07
   Days after onset:0
Entered: 2011-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0636AA / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: No
Preexisting Conditions: Allergic to Amoxicillin
Allergies:
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Pt. had seizure like actions, lost consciousness for approx. 20 seconds, came around quickly. Cool compresses applied to neck and head. No nausea or vomiting. Dr. evaluated pt. Pt. waited for 15 minutes later, then left with mom and brother.


VAERS ID: 426949 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Male  
Location: California  
Vaccinated:2011-07-07
Onset:2011-07-07
   Days after vaccination:0
Submitted: 2011-07-07
   Days after onset:0
Entered: 2011-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3899AA / 1 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Peanut; other nut allergy; acne
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Giddiness/dizziness 5m after vaccine was administered.


VAERS ID: 426960 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Arizona  
Vaccinated:2011-07-07
Onset:2011-07-07
   Days after vaccination:0
Submitted: 2011-07-07
   Days after onset:0
Entered: 2011-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3542AA / UNK UN / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3719AA / UNK UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1518Z / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Vaccine not specified (no brand name)~UN~5.00~Patient
Other Medications: none
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt became dizzy after shot. Mother came back to clinic and reported above. Briefly lost consciousness. Awake, alert. No pain when leaving 10 min later.


VAERS ID: 427017 (history)  
Form: Version 1.0  
Age: 65.0  
Gender: Female  
Location: Missouri  
Vaccinated:2011-07-07
Onset:2011-07-07
   Days after vaccination:0
Submitted: 2011-07-08
   Days after onset:1
Entered: 2011-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Other
Symptoms: Blood pressure increased, Erythema, Injection site pain, Malaise, Mobility decreased, Oedema peripheral, Pain, Pain in extremity, Pyrexia, Sensation of heaviness, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: The vaccine given me was the Pneumococcal Polysaccharide Vaccine
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Started almost immediately with sore arm where shot given. Continued to hurt but just thought it was given in the muscle. Started feeling "not well" around 1:00 pm with the aching and fevers starting around 4:00 pm. My left arm hurt so bad I could not hardly lift it up. It was swollen, red and hot. My fever at home was about 102.5 and called the doctor. Was advised to go to ER or Urgent Care. Went to ER around 8:00 pm and was seen around 10:00 pm. Fevers were still high, blood pressure was elevated, my body ached all over. My arm felt like it was heavy and I could not move it hardly at all. I was given the Pneumococcal Polysaccharide Vaccine.


VAERS ID: 427032 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: Washington  
Vaccinated:2011-07-07
Onset:2011-07-07
   Days after vaccination:0
Submitted: 2011-07-08
   Days after onset:1
Entered: 2011-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3763AA / 1 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B060CA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0088AA / 2 LA / SC

Administered by: Private       Purchased by: Public
Symptoms: Abdominal pain upper, Discomfort, Throat irritation, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: 2:30pm Widespread urticaria & throat fullness. BENADRYL 50mg given at 2:35pm. While going out to the car after vaccine he complained of stomach ache, throat fullness & general discomfort. He came right back in & was immediately evaluated.


VAERS ID: 427039 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: Washington  
Vaccinated:2011-07-07
Onset:2011-07-07
   Days after vaccination:0
Submitted: 2011-07-08
   Days after onset:1
Entered: 2011-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3718AA / 5 LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR E0330 / 4 RA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0742Z / 2 LA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1419Z / 2 RA / SC

Administered by: Private       Purchased by: Public
Symptoms: Convulsion, Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Swelling of arm below elbow, fever - 100.5, red streak on arm/painful, ? fever induced syncope/seizure.


VAERS ID: 427042 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: California  
Vaccinated:2011-07-07
Onset:2011-07-09
   Days after vaccination:2
Submitted: 2011-07-09
   Days after onset:0
Entered: 2011-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B178CB / 1 LA / UN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 1364Z / 1 LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)

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

Write-up: Localized redness, mild induration.


VAERS ID: 427046 (history)  
Form: Version 1.0  
Age: 65.0  
Gender: Female  
Location: Colorado  
Vaccinated:2011-07-07
Onset:2011-07-08
   Days after vaccination:1
Submitted: 2011-07-10
   Days after onset:2
Entered: 2011-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0361AA / 1 LA / SC

Administered by: Other       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)

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

Write-up: Redness at the injection site and hot to touch. Dr gave Cephalexin 500 mg.


VAERS ID: 427071 (history)  
Form: Version 1.0  
Age: 0.34  
Gender: Male  
Location: Texas  
Vaccinated:2011-07-07
Onset:2011-07-08
   Days after vaccination:1
Submitted: 2011-07-08
   Days after onset:0
Entered: 2011-07-11
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3843AB / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E97569 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0064AA / 2 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Blood calcium normal, Blood phosphorus normal, Blood urine present, Computerised tomogram abnormal, Convulsion, Full blood count, Laboratory test normal, Pyrexia, Urine analysis abnormal, Urine ketone body present, White blood cell count normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Normal Chem 7; Ca; Phosphorous; CT with benign increased extra axial spaces of infancy; UA with 1+ Blood, 2+ Protein; CBC with WBC 15.9
CDC Split Type:

Write-up: Vaccines given 7/7/11, developed fever 7/8/11 to 102.7 with multiple seizures on 7/8/11.


VAERS ID: 427096 (history)  
Form: Version 1.0  
Age: 0.57  
Gender: Female  
Location: Michigan  
Vaccinated:2011-07-07
Onset:2011-07-10
   Days after vaccination:3
Submitted: 2011-07-11
   Days after onset:1
Entered: 2011-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B285A / UNK RL / -

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

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

Write-up: Fever spike 101.3


VAERS ID: 427153 (history)  
Form: Version 1.0  
Age: 0.64  
Gender: Male  
Location: Texas  
Vaccinated:2011-07-07
Onset:2011-07-07
   Days after vaccination:0
Submitted: 2011-07-12
   Days after onset:5
Entered: 2011-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3813AA / 2 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB817BA / 3 LL / IM
PPV: PNEUMO (PNU-IMUNE) / PFIZER/WYETH 914517 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0256AA / 2 MO / PO

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

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

Write-up: Mother brought infant to clinic on 7/8/11 in PM. Raised red blotchy rash noted on face, body & extremities. No s/s of distress or discomfort noted on infant. Infant was afebrile. Instructed mother to inform MD of infants condition. Also instructed mother to call 911 if any s/s of breathing difficulty. P/c to mother on 7/11/11, mother states infants rash got worse following visit to our clinic on 7/8/11. Did not take infant to MD, gave infant Benadryl q 4 hrs. & rash started disappearing. Mother states infant is doing fine @ this time.


VAERS ID: 427178 (history)  
Form: Version 1.0  
Age: 0.37  
Gender: Female  
Location: Ohio  
Vaccinated:2011-07-07
Onset:2011-07-07
   Days after vaccination:0
Submitted: 2011-07-07
   Days after onset:0
Entered: 2011-07-12
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3926AA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916302 / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0259AA / 2 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Injection site discolouration, Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: (L) broken clavicle at birth - healed
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Right upper thigh - no raised, no induration, round - 2 cm diameter, red/purple in color - noticed at 2:30pm (was pink at that time) - PENTACEL.


VAERS ID: 427202 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: South Carolina  
Vaccinated:2011-07-07
Onset:2011-07-07
   Days after vaccination:0
Submitted: 2011-07-12
   Days after onset:5
Entered: 2011-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3473AA / 5 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR E0204 / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1396Z / 2 LA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 2 RA / SC

Administered by: Private       Purchased by: Public
Symptoms: Injection site induration, Injection site oedema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: (L) thigh with golf ball sized edema with central induration but non tender, no discharge. Warm to touch.


VAERS ID: 427262 (history)  
Form: Version 1.0  
Age: 63.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-07-07
Onset:2011-07-07
   Days after vaccination:0
Submitted: 2011-07-13
   Days after onset:6
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 1354Z / UNK LA / SC

Administered by: Other       Purchased by: Private
Symptoms: Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Site swollen & hot to touch 5 x 3 cm. Grow next day to 10 x 9 cm. Over weekend took prednisone, BENADRYL to relieve symptoms. Ok w/flu shot. Only PNC, ASA, CIPRO allergy.


VAERS ID: 427273 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: Texas  
Vaccinated:2011-07-07
Onset:2011-07-08
   Days after vaccination:1
Submitted: 2011-07-13
   Days after onset:5
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3542AA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0550Z / 2 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Abdominal discomfort, Arthralgia, Headache, Injection site erythema, Injection site rash, Injection site warmth, Nausea, Pyrexia, Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: 15 year old male presents with c/o rash Began to have rash in left shoulder this AM. Pt was given Menactra in this shoulder yesterday. Rash is erythematous and warm. Spread across upper chest and back. Has had joint aches, headache, subjective fever. Ibuprofen helps. +nausea and upset GI..


VAERS ID: 427290 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: Oklahoma  
Vaccinated:2011-07-07
Onset:2011-07-10
   Days after vaccination:3
Submitted: 2011-07-13
   Days after onset:3
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U376AA / 1 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B068AA / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1376Z / 2 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Oedema peripheral, Pruritus, Urticaria, Vaccination complication
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Molluscum contagiosum-hx
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Mother reported on 7-10-11 client c/o itching with swelling & hives to underarms bilaterally, arms, legs & top of (L) foot. Reports HA, tired with no fever. Appointment with PCP 7-11-11. PCP advised was reaction to MCV & instructed to take BENADRYL by mouth & prescribed generic DIPROLENE for areas of hives & itching. Injection site red & swollen.


VAERS ID: 427307 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: New York  
Vaccinated:2011-07-07
Onset:2011-07-07
   Days after vaccination:0
Submitted: 2011-07-13
   Days after onset:6
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 09612 / 2 RA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 13132 / 2 LA / SC

Administered by: Unknown       Purchased by: Public
Symptoms: Eye swelling, Sneezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: As per mother, patient began sneezing and having eye swelling.


VAERS ID: 427310 (history)  
Form: Version 1.0  
Age: 1.57  
Gender: Male  
Location: South Dakota  
Vaccinated:2011-07-07
Onset:2011-07-08
   Days after vaccination:1
Submitted: 2011-07-13
   Days after onset:5
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / 2 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 4 LL / UN

Administered by: Private       Purchased by: Private
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)

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

Write-up: Hives - localized (R) thigh. Triamcinolone cream.


VAERS ID: 427340 (history)  
Form: Version 1.0  
Age: 45.0  
Gender: Male  
Location: Oklahoma  
Vaccinated:2011-07-07
Onset:0000-00-00
Submitted: 2011-07-13
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: Other
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Parkinson-like events (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: shingles~Influenza (Seasonal) (no brand name)~~39.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe pain in rt. arm and shoulder, went to E.R., PA couldn''t diagnose what was wrong. Went to Dr. the next day, still in severe pain, couldn''t move arm. Dr. prescribed steroids and antibiotic.


VAERS ID: 427368 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2011-07-07
Onset:2011-07-08
   Days after vaccination:1
Submitted: 2011-07-14
   Days after onset:6
Entered: 2011-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0369AA / 2 LL / IM

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

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

Write-up: HIVES AND ITCHING


VAERS ID: 427390 (history)  
Form: Version 1.0  
Age: 49.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2011-07-07
Onset:2011-07-08
   Days after vaccination:1
Submitted: 2011-07-11
   Days after onset:3
Entered: 2011-07-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1174Z / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Full blood count normal, Injection site erythema, Injection site induration, Injection site pain, Laboratory test normal
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR; Aspirin; FLONASE; ADVAIR; Albuterol
Current Illness: None
Preexisting Conditions: Allergy; Asthma
Allergies:
Diagnostic Lab Data: All labs - CBC drawn prior, normal
CDC Split Type:

Write-up: Pt. received vaccine - in less than 24h. developed pain at site, erythema, induration, Temp 103.


VAERS ID: 427585 (history)  
Form: Version 1.0  
Age: 66.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2011-07-07
Onset:2011-07-09
   Days after vaccination:2
Submitted: 2011-07-10
   Days after onset:1
Entered: 2011-07-18
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0613AA / 1 LA / SC

Administered by: Other       Purchased by: Private
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: 7-9-11: Pt called to say injection site has swollen to the size of a baseball and is very hard and warm to the touch. Did not take anything or use compresses to treat it. 7-10-11: called pt for follow-up: swelling & hardness & warmth has all began to resolve and no treatment used.


VAERS ID: 427587 (history)  
Form: Version 1.0  
Age: 84.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-07-07
Onset:2011-07-08
   Days after vaccination:1
Submitted: 2011-07-11
   Days after onset:3
Entered: 2011-07-18
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0171AA / 1 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
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 (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Redness, swelling, itching appeared at injection site "size of coffee cup", low grade fever, "red spots" inside of swollen area. Seen by Dr. recommended ADVIL, cold compresses. Sx subsiding 4 days after shot given.


VAERS ID: 427682 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: Unknown  
Vaccinated:2011-07-07
Onset:2011-07-07
   Days after vaccination:0
Submitted: 2011-07-15
   Days after onset:8
Entered: 2011-07-19
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Activities of daily living impaired, Arthralgia, Dizziness, Fatigue, Feeling abnormal, Headache, Injection site pain, Lethargy, Myalgia, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: He has only had reactions to Omnicef and Penicillin
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Last week following my son''s Meninningococcal and TDaP vaccines he began having what I originally thought to be normal reactions to the shots. He experienced some soreness at the injection sight and was very achey/sore the next day. He complained of joint/muscle soreness and he said his stomach and head hurt badly. He never vomited, or felt sick to his stomach. He just said he was sore all over. These symptoms continued and he became more lethargic everyday. He said he was tired, dizzy and light-headed. He said it hurt his head when he walked. He is normally a very active child. You cannot keep in inside, let alone in bed, and he has not done any physical activity in several days. I was very concerned and took him to the doctor on Tues. He also developed fever on Tuesday and has had one now for over 3 days. He was completely healthy when we walked into the office last Thursday. When I asked the doctors office to report the reactions he was having they insisted it was a virus not related to the vaccine. I really find that hard to believe. My husband and I both looked up the information and it said these symptoms could be experienced for up to 6 weeks after the vaccinations take place. I really don''t know what to do for my son. He is miserable. The doctors do not seem to have any answers either, except that they really don''t believe the events are related. It seems too coincidental to me! I would love to know or have some idea of how to help/treat him or at least how long these symptoms will last. It is my understanding that the Meningococcal vaccine was not given to younger children until recently. Of course, it''s hard to tell, because the TDaP was given at the same time. I think if he had a problem with the TDaP- we may have noticed some difficulty with the DTaP vaccines he received when he was younger. Like I stated earlier. He has every symptom on the list except for the diarrhea, nausea, and vomiting. It has been a week for most of the symptoms and over 3 days for the fever. His fever has been ranged between 100.8 and 103.6. It is mostly in the middle 101 to 102.


VAERS ID: 427771 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2011-07-07
Onset:0000-00-00
Submitted: 2011-07-08
Entered: 2011-07-20
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR 03916AA / 5 LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR G1083 / 4 UN / SC

Administered by: Private       Purchased by: Private
Symptoms: Hypersensitivity, Local reaction, Vaccination site swelling
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: On 7/7/11 pt had a dose of PENTACEL given IM to his left arm (deltoid). He presented with 14cm x 14cm warm swollen local allergic reaction around the site of the vaccination. He was afebrile and not in significant pain.


VAERS ID: 427905 (history)  
Form: Version 1.0  
Age: 50.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-07-07
Onset:2011-07-17
   Days after vaccination:10
Submitted: 2011-07-22
   Days after onset:5
Entered: 2011-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0603Z / 2 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Type IV hypersensitivity reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Client also states on numerous medications-Wellbutrin, B-12 shots twice a week, Claritin daily and takes "all kinds of vitamins daily", iodine and vitamin D drops.
Current Illness: None
Preexisting Conditions: Low thyroid condition. Allergic to sulfa drugs.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: TC from client on 7/19/11 who states received vaccine on 7/7/11 and sight of injection just painful the next few days. Then on 7/17/11 noted area around site reddened and swollen in an area 4 inches by 1 1/2 inches with some itching and burning also. Denies fever. I discussed symptoms to report to MD and she states she has an appt for 7/21/11 to be seen at MD office. TC to patient again on 7/22/11 and she states that she was diagnosed with delayed hypersensitivity or cellulitis and is now taking Keflex. Patient states the arm feeling worse today and she has again waiting on a call back from the MD office she called today.


VAERS ID: 427908 (history)  
Form: Version 1.0  
Age: 78.0  
Gender: Female  
Location: Maryland  
Vaccinated:2011-07-07
Onset:2011-07-07
   Days after vaccination:0
Submitted: 2011-07-07
   Days after onset:0
Entered: 2011-07-22
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0613AA / 1 LA / SC

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Patient reported localized itching, redness, & swelling at the injection site. She stayed for over 30 minutes after the injection. We gave her an ice pack. She applied it to the area for about 15 minutes. She says the itching subsided & wanted to leave. Called her doctor & he said oral or topical BENADRYL & to call him if it got worse.


VAERS ID: 427914 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Female  
Location: Georgia  
Vaccinated:2011-07-07
Onset:2011-07-09
   Days after vaccination:2
Submitted: 2011-07-11
   Days after onset:2
Entered: 2011-07-22
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB462AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915252 / UNK RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Injection site rash, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Approx. 24-36 hrs. after vaccines listed below patient developed rash across her back and thighs bilat. Mtr. called ER at hosp on 7/10/11 (Sat) soon after & they told her to give child BENADRYL and rash quickly resolved.


VAERS ID: 427916 (history)  
Form: Version 1.0  
Age: 73.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-07-07
Onset:2011-07-09
   Days after vaccination:2
Submitted: 2011-07-13
   Days after onset:4
Entered: 2011-07-22
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0171AA / 2 LA / UN

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: On several
Current Illness: None known
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Site of injection - arm is red hot & swollen. Is getting better w time consulted w pharmacist, MD & manufacturer otherwise patient feels fine.


VAERS ID: 428457 (history)  
Form: Version 1.0  
Age: 1.01  
Gender: Female  
Location: Michigan  
Vaccinated:2011-07-07
Onset:2011-07-14
   Days after vaccination:7
Submitted: 2011-07-18
   Days after onset:4
Entered: 2011-08-01
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3854AA / 3 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1596Z / 1 LL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E32474 / 3 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Rash papular, Stomatitis
SMQs:, Severe cutaneous adverse reactions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergic rhinitis; asthma
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Papular rash, sores in mouth, only symptom treatment.


VAERS ID: 438282 (history)  
Form: Version 1.0  
Age: 71.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-07-07
Onset:2011-07-07
   Days after vaccination:0
Submitted: 2011-10-07
   Days after onset:92
Entered: 2011-10-13
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3491CA / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injection site pain, Injection site reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: carvedilol; losartan; aspirin; cetirizine; acetaminophen; amlodipine
Current Illness: None
Preexisting Conditions: Allergy to Iodine, hydrochlorothiazide, triamterene, hydralazine, risperidone; Hypertension; Anxiety; Hyperlipidemia; Tobacco Abuse; Allergic Rhinitis
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Prolonged pain/muscle tenderness at injection site using heat to area.


VAERS ID: 440057 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Male  
Location: Unknown  
Vaccinated:2011-07-07
Onset:2011-07-07
   Days after vaccination:0
Submitted: 2011-08-23
   Days after onset:47
Entered: 2011-10-21
   Days after submission:59
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M10023 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Incorrect drug dosage form administered, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US61540

Write-up: Case number PHHY2011US61540 is an initial spontaneous report received from a medical assistant on 07 Jul 2011. This report refers to an 18 year old male patient. He was vaccinated with MENVEO (batch number: M10023) intramuscularly on 07 Jul 2011. But, the patient received Men A component which was reconstituted with sterile diluent instead of Men C, Y, W-135 liquid conjugate. No adverse event was reported following this drug administration error.


VAERS ID: 442147 (history)  
Form: Version 1.0  
Age: 53.0  
Gender: Female  
Location: California  
Vaccinated:2011-07-07
Onset:2011-11-07
   Days after vaccination:123
Submitted: 2011-11-10
   Days after onset:3
Entered: 2011-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0631AA / 1 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Chills, Impaired driving ability, Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: levothyroxine
Current Illness: slight upper respiratory symptoms
Preexisting Conditions: asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Rigors, chills, almost unable to drive her car. Improved a little with Tylenol and cold medicine. Then 24 hrs after the vaccine, developed red, warm, painful arm where shot was administered which spread around under deltoid, pain radiated to hand. Improved a little 2 d later on Bactrim DS.


VAERS ID: 443938 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Male  
Location: Unknown  
Vaccinated:2011-07-07
Onset:0000-00-00
Submitted: 2011-11-23
Entered: 2011-11-30
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3852AA / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s vaccine history included 2 doses of PENTACEL; lot number C3758AA received on 03 March 2011 and lot number C3806AA received on 12 May 2011.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201111332

Write-up: Initial report received on 18 November 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in an 8-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject''s vaccine history included 3 doses of PENTACEL; lot number C3758AA received on 03 March 2011, lot number C3806A received on 12 May 2011 and lot number C3852AA received on 07 July 2011 (route and site of administration not reported). The subject developed cold-like symptoms on 26 September 2011, approximately 11 weeks after the last dose. On 06 October 2011, the subject developed a paroxysmal cough without a whoop and post-tussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 06 October 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 07 October 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 24 October 2011, the subject''s cough had resolved. The duration of the cough was reported at that time as 35 days. Documents held by sender: None.


VAERS ID: 459352 (history)  
Form: Version 1.0  
Age: 37.0  
Gender: Female  
Location: Florida  
Vaccinated:2011-07-07
Onset:2011-07-10
   Days after vaccination:3
Submitted: 2011-07-29
   Days after onset:19
Entered: 2012-07-11
   Days after submission:348
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3837BA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Axillary pain, Lymphadenopathy, Swelling, Ultrasound scan abnormal
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No known allergies. No medical history and no concomitant medications. She had no illnesses at the time of vaccination and had received no other vaccines within the four previous weeks. She had no adverse events following prior vaccination.
Allergies:
Diagnostic Lab Data: Ultrasound showed enlarged axillary lymph nodes
CDC Split Type: 201104669

Write-up: Cluster of two adult female patients who each developed axillary pain following the administration of ADACEL (lot number C3837BA). Initial report received on 14 July 2011 from a health professional. A 37 year old female patient, with no known allergies and no medical history, received a first left deltoid intramuscular injection of ADACEL (lot number C3837BA) on 07 July 2011. The patient had no concomitant medications. She had no illnesses at the time of vaccination and had received no other vaccines within the four previous weeks. She had no adverse events following prior vaccination. Three days later, on 10 July 2011, the patient developed axillary pain and swelling. She was seen by a physician and sent for an ultrasound, which showed enlarged axillary lymph nodes. At the time of the report, the patient had not recovered. The events for the other patient are captured in case 2011-04670. Follow-up information was received from the healthcare professional on 01 September 2011. The pain and swelling was on the left side where injection was given, left deltoid. Treatment included RICE (rest/ice/compression/elevation) and acetaminophen prn. An ultrasound was performed of the left axilla. Symptoms lasted 7-8 days and then resolved. Documents held by sender: None.


VAERS ID: 490727 (history)  
Form: Version 1.0  
Age: 84.0  
Gender: Male  
Location: Florida  
Vaccinated:2011-07-07
Onset:2013-03-01
   Days after vaccination:603
Submitted: 2013-05-03
   Days after onset:62
Entered: 2013-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Herpes zoster
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1304USA016286

Write-up: This spontaneous report as received from a physician via company representative refers to a 84 year old male patient. On 07-JUL-2011 the patient was vaccinated with ZOSTAVAX, subcutaneous (dose, strength and lot number were not reported). No concomitant medications were reported. On an unspecified date in March 2013 the patient was diagnosed with shingles during an office visit. The outcome of shingles is unknown. The patient sought unspecified medical attention. The relationship between the event and therapy with ZOSTAVAX was unknown. Additional information has been requested.


VAERS ID: 497289 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2011-07-07
Onset:0000-00-00
Submitted: 2013-07-22
Entered: 2013-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307USA008014

Write-up: This spontaneous report as received from a physician assistant refers to her son(age not reported). On 07-JUL-2011 the patient was vaccinated with GARDASIL for vaccination. It was reported that the patient might have received two doses of GARDASIL that were expired (lot# and expiration dates were unspecified, dates expired GARDASIL was administered was unspecified). No adverse event reported. Additional information is not expected.


VAERS ID: 503828 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Alabama  
Vaccinated:2011-07-07
Onset:0000-00-00
Submitted: 2013-09-24
Entered: 2013-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, No adverse event, Ultrasound abdomen abnormal
SMQs:, Retroperitoneal fibrosis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MK-9278
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdomen scan; Diagnostic; Pregnant
CDC Split Type: WAES1108USA01551

Write-up: Information has been received from a licensed practical nurse, for GARDASIL, a Pregnancy Registry product, concerning a female with no pertinent medical history who on 07-JUL-2011 was vaccinated IM with the second dose of 0.5 ml dose of GARDASIL (lot # not reported) and was pregnant. Pregnancy was confirmed by ultrasound. The patient was currently 6 weeks along and her last menstrual cycle was on 22-JUN-2011. The estimated delivery date was 28-MAR-2012. The patient was not experiencing any adverse effects. The patient contacted the physician. No treatment was given to the patient. This is one of several reports received from the same source. Additional information is not expected.


VAERS ID: 534999 (history)  
Form: Version 1.0  
Age: 1.02  
Gender: Male  
Location: Illinois  
Vaccinated:2011-07-07
Onset:2011-07-15
   Days after vaccination:8
Submitted: 2014-06-26
   Days after onset:1077
Entered: 2014-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB517AA / 1 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1509Z / 1 LL / SC
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER 1703Z / 1 LL / SC

Administered by: Public       Purchased by: Unknown
Symptoms: Abasia, Dysstasia, Joint contracture, Weight bearing difficulty
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad)

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

Write-up: In less than a week, patient began taking large exaggerated steps and began to have a bend in his legs. He had been walking fine before the vaccine. By August he could no longer walk, stand or bear any weight on his legs and his legs became severely contracted.


VAERS ID: 426986 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-07-08
Onset:0000-00-00
Submitted: 2011-07-08
Entered: 2011-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1561Z / 1 RA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Abasia, Dizziness, Fall, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

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

Write-up: Pt felt dizzy, she said she could not walk so she just fell into a sitting mode on the floor at 10:15am. Sat pt down and she felt like vomiting and she started spitting up, laid pt down w/feet up and gave some water and crackers.


VAERS ID: 427021 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: Arizona  
Vaccinated:2011-07-08
Onset:2011-07-09
   Days after vaccination:1
Submitted: 2011-07-09
   Days after onset:0
Entered: 2011-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS C3957AA0 / 5 RL / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0037AA / 2 LL / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Convulsion, Dyskinesia, Gaze palsy, Pallor, Posture abnormal, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: No. She was fine.
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: MMR2

Write-up: Child''s face went gray, she fainted. I caught her and laid her on the floor. Her head tilted to the side and began jerking and her eyes rolled back in her head. It lasted about 10 seconds from fainting to the end of the seizure.


VAERS ID: 427022 (history)  
Form: Version 1.0  
Age: 47.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-07-09
   Days after onset:1
Entered: 2011-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: Other
Symptoms: Axillary pain, Erythema, Feeling abnormal, Headache, Pain, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Dementia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cymbalta Zyrtec omoperezol (Prilosec) Methotrexate Folic Acid Tylenol Klonopin as needed
Current Illness: I have Mixed Connective Tissue Disease and Fibromyalgia
Preexisting Conditions: I have Mixed Connective Tissue Disease and Fibromyalgia, Asthma, Allergies to cats, smoke, hayfever & some drugs.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Felt itchy and was welted, started growing and growing..very painful and red. Measured approx 4" X 1 1/2"....morning about a 1/4" bigger and very sore under my Left arm where shot was given...feel like I''m getting flu, headache, achy, took Benadryl 2 - 2x on 7/8/2011.


VAERS ID: 427067 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Male  
Location: Missouri  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-07-11
   Days after onset:3
Entered: 2011-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Other
Symptoms: Grand mal convulsion, Postictal state
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Erysipilus, prescribed antibiotic but had not taken any doses yet
Preexisting Conditions: allergic rhinitis
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Pt received hepatitis A shot at unknown PCP around 12pm. Mom said he was in usual state of health prior to that. Later that day, Mom took child to park and he developed a generalized tonic-clonic seizure that lasted around 2 minutes. He was transported to ED. He had brief post-ictal period but was back to baseline by 3pm.


VAERS ID: 427069 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Female  
Location: Colorado  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-07-11
   Days after onset:3
Entered: 2011-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB459BB / 2 LA / IM
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UH138AA / UNK RA / SC

Administered by: Other       Purchased by: Other
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Hives (waist up) itching. Since Fri 7/8/11. Given ZYRTEC and advised to take BENADRYL at night. No respiratory issues.


VAERS ID: 427084 (history)  
Form: Version 1.0  
Age: 70.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2011-07-08
Onset:2011-07-09
   Days after vaccination:1
Submitted: 2011-07-11
   Days after onset:2
Entered: 2011-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 15452 / 1 LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site warmth, Tenderness
SMQs:, Extravasation events (injections, infusions and implants) (broad)

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

Write-up: red and slightly warm to touch at injection site, tender if bumped advised patient 7/11/11 that Tylenol can be taken for the pain


VAERS ID: 427088 (history)  
Form: Version 1.0  
Age: 53.0  
Gender: Female  
Location: Washington  
Vaccinated:2011-07-08
Onset:2011-07-09
   Days after vaccination:1
Submitted: 2011-07-11
   Days after onset:2
Entered: 2011-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3979DA / UNK LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pain, 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt described Pain and swelling at L deltoid injection site. Erythema and induration noted, max 5cm x 12cm. low grade fever, body aches, chills and mild head ache. Pt reports mild pain from injection site.


VAERS ID: 427095 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: Virginia  
Vaccinated:2011-07-08
Onset:2011-07-09
   Days after vaccination:1
Submitted: 2011-07-11
   Days after onset:2
Entered: 2011-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR A10049/X10049 / 1 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B069EA / 1 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: n/a
Preexisting Conditions: nkda
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt had swelling, heat over the injection, and large erythematous region over the injection site


VAERS ID: 427098 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-07-08
Onset:2011-07-09
   Days after vaccination:1
Submitted: 2011-07-11
   Days after onset:2
Entered: 2011-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3979AA / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Headache, Laboratory test, Musculoskeletal stiffness, Pain in extremity, Pyrexia, Ultrasound scan, X-ray
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diffuse abdominal discomfort
Preexisting Conditions: Allergies: sulfa drugs, tetracycline, Benadryl, penicillin Dx: depression, acne vulgaris, allergic rhinitis
Allergies:
Diagnostic Lab Data: lab work; x-ray; ultrasound
CDC Split Type:

Write-up: ON CALL NOTE 5:45 pm. Patients reports fever to 101.5, headache, stiff neck, severe arm pain over the past few hours. She received Tdap vaccine yesterday. I advised ER evaluation for above symptoms and fever.


VAERS ID: 427099 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Female  
Location: Kansas  
Vaccinated:2011-07-08
Onset:2011-07-10
   Days after vaccination:2
Submitted: 2011-07-11
   Days after onset:1
Entered: 2011-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 915707 / 5 LL / IM

Administered by: Unknown       Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: no
CDC Split Type:

Write-up: fever, redness, swelling to injection site site measuring 13 1/2cm by 10 1/2 cm


VAERS ID: 427106 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: New York  
Vaccinated:2011-07-08
Onset:2011-07-09
   Days after vaccination:1
Submitted: 2011-07-11
   Days after onset:2
Entered: 2011-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3966AA / 2 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0208AA / 2 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Haematochezia, Occult blood positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Mild gastroesophageal reflux
Allergies:
Diagnostic Lab Data: Stool Guaiac: positive
CDC Split Type:

Write-up: Hematochezia that started 1 day after the vaccine was administered.


VAERS ID: 427109 (history)  
Form: Version 1.0  
Age: 65.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2011-07-08
Onset:2011-07-09
   Days after vaccination:1
Submitted: 2011-07-11
   Days after onset:2
Entered: 2011-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 1506Z / 1 LA / SC

Administered by: Other       Purchased by: Private
Symptoms: Erythema, Pain, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril; NASONEX
Current Illness: No
Preexisting Conditions: Hypertension
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Received ZOSTAVAX shot on 7/8/11. Day after was sore, hot & red. Redness spread. Reported back to clinic on 7/11/11. Had an area 5mm x 11mm of hot, red area, some swelling. Treated with KEFLEX 500mg QID x 10 days.


VAERS ID: 427111 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: New Mexico  
Vaccinated:2011-07-08
Onset:2011-07-09
   Days after vaccination:1
Submitted: 2011-07-11
   Days after onset:2
Entered: 2011-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B178DA / UNK LL / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1600Z / 2 LL / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1570Z / 2 RL / UN

Administered by: Private       Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Redness & swelling appeared on 7/9/11 to upper (L) thigh, was painful to touch, no pain now. (1.5 cm induration & 8x4 cm erythema now). F/u w/PCP if fever or increased redness or tenderness.


VAERS ID: 427136 (history)  
Form: Version 1.0  
Age: 51.0  
Gender: Female  
Location: Washington  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-07-11
   Days after onset:3
Entered: 2011-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B048AC / 1 LA / IM
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0662AA / 1 RA / SC

Administered by: Military       Purchased by: Military
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rash on (L) arm (elbow)
Preexisting Conditions: Penicillin; Sulfa
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Large area of redness from (R) elbow up to right deltoid region. Very painful and swollen. Injection site is hard to the touch and very warm x 3 days.


VAERS ID: 427180 (history)  
Form: Version 1.0  
Age: 29.0  
Gender: Female  
Location: Alabama  
Vaccinated:2011-07-08
Onset:2011-07-09
   Days after vaccination:1
Submitted: 2011-07-12
   Days after onset:3
Entered: 2011-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3922AA / 5 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Pain in extremity, Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Patient had swelling, rash, pain to Rt arm, rash went up to neck. Pt took BENADRYL. Pt was out of town.


VAERS ID: 427207 (history)  
Form: Version 1.0  
Age: 10.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-07-08
Onset:0000-00-00
Submitted: 2011-07-11
Entered: 2011-07-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0368AA / 1 LA / SC
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1016Z / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1185Z / 2 RA / SC

Administered by: Public       Purchased by: Public
Symptoms: Unevaluable event
SMQs:

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

Write-up: No adverse reactions reported.


VAERS ID: 427225 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: California  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-07-12
   Days after onset:4
Entered: 2011-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0057AA / 3 LA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Pruritus, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: short stature delayed puberty
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Directly after vaccine given, pt felt tired and experienced abdominal pain, vomiting and diarrhea. Next morning 7/9/11 pt woke up with hives all over body with itching skin. Went to ED on 7/9/11 and received prednisone and Benadryl. Went home on both medications and took until Sunday. Went to follow up appointment on 7/12/11 (today). Hives and itching resolved. Still having loose stool x 3 today and 3/10 abdominal pain with palpation.


VAERS ID: 427228 (history)  
Form: Version 1.0  
Age: 29.0  
Gender: Male  
Location: California  
Vaccinated:2011-07-08
Onset:2011-07-10
   Days after vaccination:2
Submitted: 2011-07-13
   Days after onset:3
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Injection site swelling, Lymphadenopathy, Neuralgia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Weakness, swollen lymph node in between collar bone, swelling at injection site, nerve pain in arms.


VAERS ID: 427276 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-07-08
Onset:2011-07-09
   Days after vaccination:1
Submitted: 2011-07-13
   Days after onset:4
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 15602 / 1 LA / IJ
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 RA / IJ

Administered by: Private       Purchased by: Other
Symptoms: Eye swelling, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Paxil, Augmentin, LoSesonique
Current Illness:
Preexisting Conditions: Sulfa Drug Allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: 15602

Write-up: It started with just forehead swelling and as the weekend progressed my entire face swelled up. My eye was swollen shut.


VAERS ID: 427325 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: Utah  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-07-13
   Days after onset:5
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3845AA / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3898BA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Redness, swelling down arm, hives.


VAERS ID: 427326 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: Utah  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-07-13
   Days after onset:5
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3474AA / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3898BA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Redness, swelling down the arm, hives.


VAERS ID: 427327 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: Utah  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-07-13
   Days after onset:5
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3845AA / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3898BA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Hives, redness, swelling all the way down the arm.


VAERS ID: 427412 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Male  
Location: Maine  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-07-14
   Days after onset:6
Entered: 2011-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3872CA / UNK RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Hypersensitivity, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRN meds only
Current Illness: None
Preexisting Conditions: Mild asthma; Atopy; Rhinitis
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Swollen arm (not just very local) mom states twice the size of other arm. Mom wants report as "he is now sensitive to many things".


VAERS ID: 427524 (history)  
Form: Version 1.0  
Age: 54.0  
Gender: Female  
Location: California  
Vaccinated:2011-07-08
Onset:2011-07-11
   Days after vaccination:3
Submitted: 2011-07-13
   Days after onset:2
Entered: 2011-07-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3111BA / UNK LA / UN

Administered by: Other       Purchased by: Private
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Pt got Tdap & 3 days later got redness & pain & swelling & F/C at injection site & redness spreading, tx''d with BACTRIM 7/13/11.


VAERS ID: 427569 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: Texas  
Vaccinated:2011-07-08
Onset:0000-00-00
Submitted: 2011-07-08
Entered: 2011-07-18
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1569Z / 1 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U351AA / 1 RA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR AC52B056AA / 1 RA / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD skin test; TYLENOL for fever
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Fever. Tenderness at site (R) arm. Nausea day of vaccine. TYLENOL and Promethazine prescribed.


VAERS ID: 427581 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Male  
Location: Texas  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-07-08
   Days after onset:0
Entered: 2011-07-18
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0087Y / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Head injury, Joint sprain, Syncope, X-ray limb
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Knee pain
Allergies:
Diagnostic Lab Data: Xray knee
CDC Split Type:

Write-up: Pt. was waiting outside bathroom door and fainted. Hit head on wall and twisted previously injured knee.


VAERS ID: 427603 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Male  
Location: Illinois  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-07-18
   Days after onset:10
Entered: 2011-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3807AA / 4 LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB472BA / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Erythema, Feeling hot, Gait disturbance, Injection site swelling, Screaming
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: According to documentation from on call (nurses line) pt developed screaming, difficulty walking, redness, hotness, swelling at immun. sites the evening of immun. Mom took pt to Hosp. ER. The following day swelling, redness to thigh increased. Dr contacted by on call line and recommended pt to be taken to another ER.


VAERS ID: 427705 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Male  
Location: Connecticut  
Vaccinated:2011-07-08
Onset:0000-00-00
Submitted: 2011-07-19
Entered: 2011-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Other
Symptoms: Abnormal behaviour, Aggression, Pyrexia, Rash generalised
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: began 7/14 - fever began 7/12 - behavioral changes - violent tantrums began 7/18 - all over body rash


VAERS ID: 427770 (history)  
Form: Version 1.0  
Age: 58.0  
Gender: Male  
Location: Washington  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-07-13
   Days after onset:5
Entered: 2011-07-20
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0659AA / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Body ached all over for 2 days after inject. Had 9 x 3.5 inch area of redness, swelling, tenderness, itching and warmth around site of injection x 5 days.


VAERS ID: 427903 (history)  
Form: Version 1.0  
Age: 69.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-07-21
   Days after onset:13
Entered: 2011-07-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0617AA / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Contusion, Injected limb mobility decreased, Pain in extremity
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Accidents and injuries (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspirin mg
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1107USA02171

Write-up: Information has been received from a registered nurse at a pharmacy clinic concerning a 69 year old male with no pertinent medical history and no drug reactions or allergies who on 08-JUL-2011 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 670616/0617AA). Concomitant therapy included aspirin 325 mg. On 08-JUL-2011 the patient experienced significant bruising and pain on the underside of the arm in which he received ZOSTAVAX (Merck), causing the patient to have difficulty lifting his left arm and completing "activities of daily living". The bruise was reported to be about the size of the "palm of the patient''s hand". The nurse had referred the patient to be seen by his primary care physician to follow up on his condition. At the time of this report, the patient had not recovered from the events and the events did not improve. Having difficulty lifting his left arm and completing "activities of daily living" were considered to be disabling. Additional information has been requested.


VAERS ID: 428026 (history)  
Form: Version 1.0  
Age: 1.27  
Gender: Male  
Location: Utah  
Vaccinated:2011-07-08
Onset:2011-07-15
   Days after vaccination:7
Submitted: 2011-07-19
   Days after onset:4
Entered: 2011-07-25
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B146AA / 4 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH319AA / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0046AA / 1 RL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916302 / 4 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Irritability, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Rash, fever on & off, fussiness x 4 days.


VAERS ID: 428031 (history)  
Form: Version 1.0  
Age: 30.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2011-07-08
Onset:0000-00-00
Submitted: 2011-07-25
Entered: 2011-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3900AA / 1 LA / IJ

Administered by: Private       Purchased by: Private
Symptoms: Blood calcium normal, Blood magnesium normal, Blood phosphorus normal, Blood potassium normal, Injection site pain, Paraesthesia, Tetany
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: K, Ca, Mg, Phos: all normal
CDC Split Type:

Write-up: Pain at injection site followed days later by tingling back of hand and 3rd finger with intermittent tetany.


VAERS ID: 428071 (history)  
Form: Version 1.0  
Age: 1.05  
Gender: Female  
Location: California  
Vaccinated:2011-07-08
Onset:2011-07-14
   Days after vaccination:6
Submitted: 2011-07-26
   Days after onset:12
Entered: 2011-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Other
Symptoms: Mobility decreased, Pyrexia, Rash, Weight bearing difficulty, X-ray limb
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: xrays of her leg
CDC Split Type:

Write-up: Favoring and not wanting touse her right leg. Still favoring and not putting weight on it 7/25/2011. Also on 7/21/11 fever 7/22/11 to 7/24/11 Rash on torso.


VAERS ID: 428097 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: California  
Vaccinated:2011-07-08
Onset:2011-07-09
   Days after vaccination:1
Submitted: 2011-07-20
   Days after onset:11
Entered: 2011-07-26
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1569Z / 1 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A10093 / 1 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Blister, Skin warm
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Stomach ache on-off
Preexisting Conditions: Allergy to Amoxicillin
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: (R) arm rx to GARDASIL, arm hot, swollen blister? Imm given 7/8/11 reaction on 7/9-10? - No tx given.


VAERS ID: 428243 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2011-07-08
Onset:0000-00-00
Submitted: 2011-07-19
Entered: 2011-07-28
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB498CA / 2 LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915671 / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema multiforme, Urticaria
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Pt had h/o egg allergy that had resolved.
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient seen 7/11 and noted to have severe urticaria/erythema multiforme that required oral steroid administration.


VAERS ID: 428453 (history)  
Form: Version 1.0  
Age: 46.0  
Gender: Male  
Location: Washington  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-07-22
   Days after onset:14
Entered: 2011-08-01
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U3007DA / 2 LA / UN

Administered by: Public       Purchased by: Private
Symptoms: Injection site pain, Neck pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)

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

Write-up: Called 7/15/11 and 7/22/11 experiencing, (L) neck and shoulder pain since Td given 7/8/11 - seen at urgent care 7/15/11 given pain medicine -no change in pain as of 7/22/11.


VAERS ID: 428698 (history)  
Form: Version 1.0  
Age: 51.0  
Gender: Female  
Location: New York  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-08-03
   Days after onset:26
Entered: 2011-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0130AA / 1 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Cellulitis, Injection site oedema, Injection site pain, Malaise, Pyrexia, White blood cell count increased
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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: prednisone, chemotherapy, zofran
Current Illness: fatigue s/p most recent round of chemotherapy
Preexisting Conditions: Breast Cancer
Allergies:
Diagnostic Lab Data: elevated white count, on second day of hospitalization, was found to have edema and pain at site of injection, diagnosed with and treated for cellulitis
CDC Split Type:

Write-up: malaise, fever


VAERS ID: 428728 (history)  
Form: Version 1.0  
Age: 0.34  
Gender: Male  
Location: Washington  
Vaccinated:2011-07-08
Onset:2011-07-24
   Days after vaccination:16
Submitted: 2011-08-04
   Days after onset:11
Entered: 2011-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3930AA / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E80081 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1553Z / 2 MO / PO

Administered by: Military       Purchased by: Unknown
Symptoms: Intestinal operation, Intussusception, Small intestinal obstruction
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was admitted for small bowel obstruction which eventually led to operative management which found intussusception.


VAERS ID: 428758 (history)  
Form: Version 1.0  
Age: 9.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-08-02
   Days after onset:25
Entered: 2011-08-04
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0628AA / 2 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NKA; Moderate Persistent Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Mom reports 4-5 hives localized to trunk and armpits. Occurred same day and resolved within 1 day.


VAERS ID: 428850 (history)  
Form: Version 1.0  
Age: 0.18  
Gender: Female  
Location: Georgia  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-08-05
   Days after onset:28
Entered: 2011-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3843AB / UNK - / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1316Z / UNK - / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915704 / UNK - / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB159A / UNK MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Blood culture, Body temperature increased, Diarrhoea, Diarrhoea haemorrhagic, Occult blood positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: no
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: positive hemocult.
CDC Split Type:

Write-up: Bloody diarrhea with mucus, 101.2 temp for three days, positive hemocult.


VAERS ID: 428964 (history)  
Form: Version 1.0  
Age: 57.0  
Gender: Female  
Location: California  
Vaccinated:2011-07-08
Onset:2011-07-09
   Days after vaccination:1
Submitted: 2011-08-05
   Days after onset:27
Entered: 2011-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0658AA / 1 LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Injection site haematoma, Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: No known allergy (NKA); Diabetic
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt states raised red rash w/ itching for several weeks. Today SC site appears black & blue bruised.


VAERS ID: 429308 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Male  
Location: Arizona  
Vaccinated:2011-07-08
Onset:2011-07-19
   Days after vaccination:11
Submitted: 2011-08-02
   Days after onset:14
Entered: 2011-08-10
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 1 RL / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Pyrexia, Rash maculo-papular, Rash morbilliform
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Down syndrome; heart defect
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child developed high fever of 102.4 for 3 days and macular papular confluent rash resembling measles. Supportive care provided with resolution in 4 days.


VAERS ID: 429368 (history)  
Form: Version 1.0  
Age: 66.0  
Gender: Female  
Location: Arizona  
Vaccinated:2011-07-08
Onset:2011-07-15
   Days after vaccination:7
Submitted: 2011-08-09
   Days after onset:25
Entered: 2011-08-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB472AA / 1 RA / UN
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UF805AA / 1 RA / UN

Administered by: Public       Purchased by: Private
Symptoms: Back pain, Nerve injury, Pain in extremity
SMQs:, Retroperitoneal fibrosis (broad), Accidents and injuries (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACTONEL - caused cramping - legs
Current Illness: None
Preexisting Conditions: Cancer - breast
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Started a few days after imms - nerve damage (very painful) in balls of feet & hands & mid back. Better now, but still 4-5 pain scale of 1-10 in hands & feet, 1 - feet.


VAERS ID: 430962 (history)  
Form: Version 1.0  
Age: 79.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2011-07-08
Onset:2011-07-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2011-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hypertension; Cholesterol; Gout
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Severe rash only on right arm from shoulder to wrist. Treated with prescriptions valacyclovir and methylprednisolone.


VAERS ID: 440065 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-07-08
Onset:0000-00-00
Submitted: 2011-08-23
Entered: 2011-10-21
   Days after submission:59
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M10047 / UNK RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52BD56B / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Incorrect drug dosage form administered, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARITIN
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US61987

Write-up: Case number PHHY2011US61987 is an initial up spontaneous report received from a nurse on 08 Jul 2011 and with the follow up report received on 09 Aug 2011. This report refers to a 12 years old female patient. Her concomitant medications included Tdap (batch number: AC52BD56B) 0.5 intramuscularly on 08 Jul 2011 and CLARITIN (batch number: unknown) on unspecified date. She was vaccinated with only the MenA lyophilized component of MENVEO (batch number M10047) reconstituted with sterile water instead of Men CYW liquid conjugate component 0.5ml to right arm intramuscularly on 08 Jul 2011. No other adverse reaction was reported. Follow up report received on 09 Aug 2011: The patient demographics, suspect drug information, concomitant medications and event outcome.


VAERS ID: 442655 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: New York  
Vaccinated:2011-07-08
Onset:2011-07-09
   Days after vaccination:1
Submitted: 2011-11-15
   Days after onset:129
Entered: 2011-11-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0636AA / 2 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Blood test, Cholecystectomy, Decreased appetite, Gallbladder non-functioning, Hepatobiliary scan, Hepatobiliary scan abnormal, Laparotomy, Nausea
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gallbladder related disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: diagnostic laboratory, CCK/HIDA scan: non-functioning gall bladder.
CDC Split Type: WAES1108USA00745

Write-up: Information has been received from a physician concerning a 14 year old female patient with no medical history and no drug reaction or allergy who on 22-FEB-2011 and 08-JUL-2011 was vaccinated with the first dose of GARDASIL (lot number: 666595/0096Z; Expiration date: 12-OCT-2014) and the second dose of GARDASIL (lot number: 669308/0636AA; Expiration date: 11-AUG-2013) respectively. There was no concomitant medication. On 09-JUL-2011 the patient complained of abdominal pain, nausea and decreased appetite after receiving the second dose of GARDASIL. The patient did not have any problem with the first dose. The patient saw the physician and was given PRILOSEC for treatment. Gastrointestinal (GI) test and blood work were performed without results. At the time of the report, the patient had not recovered. Follow-up information has been received from the physician concerning the female patient. The patient had no illness at time of vaccination. The patient received the second dose of GARDASIL (lot number: 669308/0636AA) in left arm (route not reported). One day post the second dose, on 09-JUL-2011 the patient had nausea and abdominal pain. She did not improve on PRILOSEC. Cholecystokinin (CCK) test/ Hepatobiliary Imino-Diacetic Acid (HIDA) scan of abdomen showed non-functioning gallbladder. The patient had laparotomy (LAP) and cholecystectomy on 15-SEP-2011 with complete recovery. Upon internal review, non-functioning gallbladder required laparotomy and cholecystectomy was considered to be an other important medical event. Additional information has been requested.


VAERS ID: 446351 (history)  
Form: Version 1.0  
Age: 1.63  
Gender: Female  
Location: Indiana  
Vaccinated:2011-07-08
Onset:2011-12-20
   Days after vaccination:165
Submitted: 0000-00-00
Entered: 2011-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB498BB / 2 LL / UN

Administered by: Private       Purchased by: Private
Symptoms: Injection site atrophy
SMQs:

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

Write-up: Atrophy of soft tissue atrophy 4x5cm diameter over (L) medial-lateral thigh at site which would correspond with immunization administration. No underlying abnormalities noted, no inflammation, no tenderness; no functional abnormality.


VAERS ID: 451541 (history)  
Form: Version 1.0  
Age: 1.05  
Gender: Female  
Location: Alaska  
Vaccinated:2011-07-08
Onset:2012-03-07
   Days after vaccination:243
Submitted: 2012-03-12
   Days after onset:4
Entered: 2012-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB453AA / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0042AA / 3 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0667Z / 1 LL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E89952 / 4 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1096Z / 1 RA / SC

Administered by: Private       Purchased by: Public
Symptoms: Herpes zoster, Injection site rash
SMQs:, Hypersensitivity (narrow)

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

Write-up: Zoster (shingles) rash on right arm (same arm where she got the vaccine seven months earlier. Patient is otherwise asymptomatic and is expected to recover.


VAERS ID: 455249 (history)  
Form: Version 1.0  
Age: 45.0  
Gender: Male  
Location: Washington  
Vaccinated:2011-07-08
Onset:0000-00-00
Submitted: 2011-10-25
Entered: 2012-05-09
   Days after submission:197
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Fatigue, Hyperacusis, Photophobia
SMQs:, Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Fatigue~Rabies (Imovax)~1~0.00~Patient|Fatigue~Rabies (Imovax)~2~0.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions: The patient had a history of allergy to artificial strawberries. He had been ill since February with multiple problems including prostatitis and tonsillitis. The patient has been in bed most of June but felt better when started the vaccines. His concomitant medications were not reported. The patient had a dog bite on 28 June 2011. The patient received dose 1 of IMOVAX Rabies on 29 June 2011, dose 2 on 04 July 2011 and dose 3 on 08 July 2011. The patient developed the feeling of a little fatigued after the first three doses of IMOVAX Rabies. From information received on 01 September 2011, the patient received their first dose of IMOVAX Rabies vaccine as an intramuscular left deltoid injection on 01 July 2011.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201105023

Write-up: Initial case received from a health care professional on 19 July 2011. A 45-year-old male patient received dose 3 of IMOVAX Rabies, sanofi pasteur SA lot number not reported, on 08 July 2011. The patient had a history of allergy to artificial strawberries. He had been ill since February with multiple problems including prostatitis and tonsillitis. The patient has been in bed most of June but felt better when started the vaccines. His concomitant medications were not reported. The patient had a dog bite on 28 June 2011. The patient received dose 1 of IMOVAX Rabies on 29 June 2011, dose 2 on 04 July 2011 and dose 3 on 08 July 2011. The patient developed the feeling of a little fatigued after the first three doses. He complained of feeling very weak and feels he had an increased sensitivity to noises and light. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 26 August 2011. The patient had only received one dose of the rabies vaccine at the hospital and the lot number was not recorded. It was discovered that the patient had been the initial reporter which was previously reported as a health care professional. No further information was available. The outcome remained not recovered. Follow-up information was received 01 September 2011 from a health care professional. According to the reporter, the patient had only received a first dose of IMOVAX Rabies vaccine (intramuscular left deltoid injection) on 01 July 2011 (previously reported as 29 June 2011) at their facility and that lot number had not been charted by the nurse. Outcome remained not recovered. Follow-up information received on 17 October 2011 from a health care professional. Per the reporter, only the first dose of IMOVAX Rabies was administered at the facility. The lot number was not documented. No information was provided regarding the patient''s recovery status. The event after the first three doses of IMOVAX Rabies was captured in case 2011-05016. Documents held by sender: None.


VAERS ID: 459485 (history)  
Form: Version 1.0  
Age: 34.0  
Gender: Male  
Location: Hawaii  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2012-07-17
   Days after onset:375
Entered: 2012-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV283 / UNK RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Activities of daily living impaired, Injection site swelling, Pain, Pyrexia, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: Amoxicillin
Allergies:
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Significant swelling of the upper arm where vaccine was placed. Arm was hot to touch and caused a low grade fever of around 100 degrees. Treated with 800mg of Motrin. Pain and swelling continued through 9 July 2011, continued to treat with Motrin. Spent all of 8 July in bed with fever.


VAERS ID: 511854 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: California  
Vaccinated:2011-07-08
Onset:0000-00-00
Submitted: 2013-11-07
Entered: 2013-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 07/08/2011 Human chorionic gonadotropin: Positive
CDC Split Type: WAES1107USA01248

Write-up: Information has been received from a physician for HPV, a Pregnancy Registry product, concerning a 15 year old female patient who on 08-JUL-2011 was vaccinated with a dose of HPV (Lot number 0886D) (not ad valid HPV vaccine lot number), when they did a urine pregnancy test which came back positive. It was reported that the patient last menstrual period (LMP) was last month in June 2011 so they determined that the patient was less than eight weeks pregnant. Her delivery date (EDD) was approximately on 07-MAR-2012. No adverse events were reported. Follow up information was received from the reporting physician. The physician stated that the patient was in a foster home and was unsure if she was going to keep the pregnancy. The patient then moved back with her mother but physician was unable to contact the patient after her move. The physician reported that this patient was lost to follow up. Additional information is not expected.


VAERS ID: 520343 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Unknown  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2014-01-23
   Days after onset:930
Entered: 2014-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA009155

Write-up: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-JUL-2011, the patient was administered with a dose of VARIVAX (Lot # 0750Z expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.


VAERS ID: 691836 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Colorado  
Vaccinated:2011-07-08
Onset:2011-07-28
   Days after vaccination:20
Submitted: 2017-04-25
   Days after onset:2098
Entered: 2017-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0181AA / 1 AR / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS U3514AA / 2 AR / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2011-07-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: autopsy determined unknown cause of death
CDC Split Type:

Write-up: Layed down to take a nap and never woke up.


VAERS ID: 701000 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: California  
Vaccinated:2011-07-08
Onset:2011-09-08
   Days after vaccination:62
Submitted: 2017-06-26
   Days after onset:2118
Entered: 2017-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1247Z / 3 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Arthritis, Back pain, Costochondritis, Discomfort, Feeling abnormal, Gait disturbance, Headache, Inflammation, Inflammatory marker increased, Juvenile idiopathic arthritis, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain, Pain in extremity, Spinal pain, X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No immediate illness initially after vaccine. Symptoms started 4 weeks after last Gardasil shot.
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Labs show little inflammation, however MRI and X-rays document severe inflammation in all of her joints. She was ultimately diagnosed with Juvenile Onset Arthritis with no known cause or family history.
CDC Split Type:

Write-up: 4 weeks after having been administered the 3rd Gardasil vaccine, my daughter started having unusual severe joint pain, and headaches. Initially it was causing costochondritis and she was uncomfortable receiving a hug or being touched. This pain & inflammation progressed to her knees, elbows, shoulders, back, spine, and hands. She was miserable with pain and could barely walk up 1 flight of stairs to her bedroom.


VAERS ID: 427733 (history)  
Form: Version 1.0  
Age: 1.8  
Gender: Female  
Location: Foreign  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-07-19
   Days after onset:11
Entered: 2011-07-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G1154 / 4 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Clonic convulsion, Febrile convulsion, Pharyngitis, Pyrexia
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Oropharyngeal infections (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergy for eggs, milk and wheat. No concomitant therapy at the time of immunization. Temperature before vaccination: 37.4 degrees C.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201104744

Write-up: Case received on 11 July 2011 from Health Authorities (reference number HIB-210), through local affiliates under local reference number A201100504. Case medically confirmed. A 22-month-old female patient presented with febrile convulsion on 8 July 2011 after receiving a fourth subcutaneous dose of ACTHIB (batch number G1154) on the right upper arm on 8 July 2011 at 04:00 pm. No concomitant therapy was administered. The patient had a medical history of allergy for egg, milk and wheat. The temperature before immunization was 37.4 degrees C. On 8 July 2011, at around 06:00 pm, the patient developed pyrexia. Her body temperature rose to 38 degrees C. At around 07:30 pm, the patient developed febrile convulsion (3 minutes/clonic) and was taken to hospital by ambulance. On admission, the patient had a clear sensorium. At the time of reporting, the patient was under treatment for acute pharyngitis. The patient had not recovered from the events at the time of the report. The physician''s comment: The patient developed pyrexia and febrile convulsion after receiving the vaccination with ACTHIB. The case was not serious and was not related to ACTHIB. Acute pharyngitis may be related to the event. Upon internal review, this case was assessed as serious due to other medically condition. Documents held by sender: none.


VAERS ID: 428903 (history)  
Form: Version 1.0  
Age: 0.25  
Gender: Unknown  
Location: Foreign  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-08-04
   Days after onset:27
Entered: 2011-08-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR E5251 / 1 UN / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER E5943 / UNK UN / UN
PER: PERTUSSIS (NO BRAND NAME) / UNKNOWN MANUFACTURER 0870310 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201105830

Write-up: Initial report received on 27 July 2011 from the foreign agency under reference number 84 (local reference number: RS-2011-0060). A 3-month-old patient (gender unknown), with no medical history reported, experienced crying inconsolable and urticaria localisata the day he/she received the first intramuscular ACTHIB (batch number E5251, anatomical site not reported), the ALDIPETE-T (other manufacturer, pertussis vaccine, batch number 0870310-14, route, anatomical site and side not reported) on 08 July 2011. The OPV (VERO) vaccine (batch number E5943-2) was also reported as concomitant therapy, but the vaccination date was not provided. After the vaccination, the patient experienced crying inconsolable for three hours. Child did not have fever. Eight hours after vaccination, urticaria appeared over the skin of the trunk and disappeared spontaneously. The day after the vaccination, urticaria appeared again and the patient consulted a physician. Urticaria localisata was diagnosed. AVIL syrup was administered as corrective treatment. Later in the evening, changes intensified and the patient was taken to the Emergency room. No more information provided.


VAERS ID: 429017 (history)  
Form: Version 1.0  
Age: 48.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-08-05
   Days after onset:28
Entered: 2011-08-08
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR VH376AB / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had a medical history of arrhythmia; No reported concomitant therapy
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201105743

Write-up: Case received from a Healthcare Professional on 25 July 2011 under the reference number PA2011016. This case is a part of a cluster of 9 cases: 2011-05735, 2011-05736, 2011-05741, 2011-05743, 2011-05744, 2011-05745, 2011-05746, 2011-05747 and 2011-05748. A 48-year-old female patient, with a medical history of arrhythmia and no reported concomitant therapy, had received her primary dose of FLUZONE (batch number VH376AB, route and site of administration not reported) on 08 July 2011. On 08 July 2011, the patient experienced dyspnea and cough. She was treated with SOLUCORTEF IV and CLOROTRIMETRON IV. The patient recovered on an unspecified date. The case was reported as non serious. Upon internal review, it was upgared to serious due to other important medical condition.


VAERS ID: 430494 (history)  
Form: Version 1.0  
Age: 6.0  
Gender: Male  
Location: Foreign  
Vaccinated:2011-07-08
Onset:2011-08-04
   Days after vaccination:27
Submitted: 2011-08-19
   Days after onset:15
Entered: 2011-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS AC20B134AD / 2 UN / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Myalgia, Myelitis, Neurogenic bladder, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0739121A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of myelitis in a 6-year-old male subject who was vaccinated with INFANRIX-IPV (GlaxoSmithKline), OPV. The subject was due for 2nd booster of dpt + polio + mmr in school-primary. The vaccines were not given as no stock (however, was given 2 drops of oral polio on 7 or 8 July 2011). Then the subject was brought by his mother on 8 July 2011 for vaccination. On 7 or 8 July 2011, the subject received unspecified dose of OPV (2 drop(s), route unknown) and on 8 July 2011, the subject received 2nd dose of INFANRIX-IPV (intramuscular, injection site unknown). On 4 August 2011, 28 or 27 days after vaccination with OPV and 27 days after vaccination with INFANRIX-IPV, the subject experienced diffuse myelitis, leg pain, muscle pain and neurogenic bladder. The subject was hospitalised and the physician considered the events were disabling and life threatening. At the time of reporting, the events were unresolved.


VAERS ID: 432916 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: Foreign  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-08-30
   Days after onset:53
Entered: 2011-09-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G1183 / UNK LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 10J03A / UNK RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR
Current Illness:
Preexisting Conditions: Asthma bronchial; Vesicoureteric reflux
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011177718

Write-up: This is a spontaneous report from a contactable pediatrician communicated to a Pfizer sales representative with follow-up from the contactable pediatrician via a Pfizer sales representative. A 4-year-old male patient received a dose of PREVENAR subcutaneously, on 08Jul2011, in the upper right arm. He was also administered a dose of ACT-HIB at a dose of 0.5 ml subcutaneously in the left arm. Relevant medical history includes bronchial from 16Sep2008 and ongoing, and vesiculouretral reflux from 23Feb2007 to 07Oct2009. Concomitant medications included oral SINGULAIR granules at a dose of 4 mg daily from 12Mar2010, and ongoing, for asthma. Past product history was not provided. On 06Jul2011, the patient developed injection site redness on the upper right arm. On 09Jul2011, the patient developed injection site swelling on the right arm, and on 11Jul2011, injection site warmth on the right arm. On 18Jul2011, the patient recovered from all events without any treatment. On 01Aug2011, at a periodic medical check, no sequelae or other findings were observed. The pediatrician classified the events as serious (medically significant) and assessed them as definitely related to PREVENAR. Follow-up (05Aug2011 and 08Aug2011): New information reported from the same pediatrician through a Pfizer sales representative includes: patient demographics, medical history, a change in event onset date for vaccination site swelling, serious criteria of medically significant, and causality assessment. Follow-up attempts completed. No further information was expected. Follow-up (23Aug2011): This follow-up spontaneous report obtained from the same pediatrician through a Pfizer sales representative included: patient demographics, product details, concomitant vaccine, concomitant medication, additional events, course of events, recovery, recovery date, and physician relatedness assessment. Follow-up attempts completed. No further information expected.


VAERS ID: 433361 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-09-06
   Days after onset:60
Entered: 2011-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA1290A / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactoid reaction, Cough, Dyspnoea, Palpitations, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0739253A

Write-up: This case was reported by a physician and described the occurrence of anaphylactoid reaction in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 8 July 2011, the subject received unspecified dose of CERVARIX (intramuscular, left deltoid). On 9 July 2011, 1 day after vaccination with CERVARIX, the subject experienced anaphylactoid reaction. The physician considered the event was clinically significant (or requiring intervention). On 11 July 2011, the event was resolved. The physician considered the event was related to vaccination with CERVARIX. Follow-up information received on 26 August 2011: The family history or personal past history did not include the following: cardiac disease, epilepsy, metabolic abnormality (such as diabetes mellitus), or allergy (such as vaccine-induced allergy, vaccine-component-induced allergy, food allergy, allergic rhinitis, eczema or asthma). The subject had no past history of loss of consciousness. The anaphylactoid reaction (category 4) started on 8 July 2011 (instead of 9 July 2011), less than 1 day after vaccination with CERVARIX. The subject was not stressed by any painful or emotional stimulus before the onset of the event and any sweating or feeling warm. She did not have any aura or alarm regarding the episode. On 9 July 2011, at 1 or 2 am, 8 hours after vaccination with CERVARIX, the subject was sleeping when she suddenly developed dyspnoea, cough, wheezing, shortness of breath, and palpitations. No urticaria was observed. It was unknown if she presented pallor, cyanosis, or flushing. No tongue bite and no complete loss of consciousness was observed. Vital signs were not specified. She did not undergo any special test. The subject did not visit a medical facility, because the symptoms were bearable. She did not receive any medication. The events repeated improvement and exacerbation for 3 days, and at the time of reporting, they were resolved. On 8 August 2011, the subject visited the reporting physician''s hospital to receive the planned second vaccination with CERVARIX. The above-mentioned symptoms were reported to the physician and the second vaccination was cancelled.


VAERS ID: 435148 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2011-07-08
Onset:2011-07-08
   Days after vaccination:0
Submitted: 2011-09-20
   Days after onset:74
Entered: 2011-09-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1621Z / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Diarrhoea, Intussusception
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Diarrhoea
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1109USA01445

Write-up: This case was received from a physician on 09-SEP-2011. Case was medically confirmed. This case was linked with non-serious case E2011-05430 (same reporter, same patient, reaction after the first dose). A 3-month-old female infant received the second dose of ROTATEQ (lot#: 668877/1621Z) orally on 08-JUL-2011. A few hours later the patient presented with severe abdominal pain. "Possible intussusception" was suspected, which resolved spontaneously within an unspecified time. The reporter stated that the event had severely impaired the patient temporarily. The reporter assessed the drug event to be probably and possibly related to the vaccination of ROTATEQ. She stated that the third dose of ROTATEQ would not be administered. The patient experienced diarrhoea after first dose of ROTATEQ (lot#: 668877/1621Z) was given orally on 01-JUN-2011 (E2011-05430). Upon medical review the company considered the events of intussusception and abdominal pain to be medically significant. Other business partner numbers include E2011-05422. FILE CLOSED.


VAERS ID: 436022 (history)  
Form: Version 1.0  
Age: 3.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-07-08
Onset:0000-00-00
Submitted: 2011-09-26
Entered: 2011-09-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH383AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Erythema, Local reaction, Pain, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201108861

Write-up: This case report is part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate, from the "Ministry of Health" (local reference number BR-BT2011-3736). A female patient, whose medical history and concomitant therapies were not reported, had received a dose of FLUZONE (batch number UH383AA, route and anatomical site of administration not reported) on 08 July 2011. On an unspecified date, the patient experienced not severe local reaction with pain, redness and heat. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The Ministry of Health classified the adverse events on Local Reaction. The "causality classification" was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). Documents held by sender: none.


VAERS ID: 446965 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-07-08
Onset:0000-00-00
Submitted: 2012-01-06
Entered: 2012-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB219AG / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain upper, Acute respiratory distress syndrome, Adenovirus test positive, Alanine aminotransferase increased, Alpha 2 globulin, Angiotensin converting enzyme increased, Antineutrophil cytoplasmic antibody positive, Aspartate aminotransferase increased, Bacterial test negative, Biopsy liver abnormal, Blood albumin, Blood alkaline phosphatase increased, Blood calcium normal, Blood fibrinogen increased, Blood iron decreased, Blood lactate dehydrogenase increased, C-reactive protein increased, Candida test positive, Candidiasis, Central venous catheterisation, Cholecystectomy, Cholecystitis, Cholecystitis acute, Colonoscopy abnormal, Constipation, Cytology abnormal, Dyspnoea exertional, Echocardiogram normal, Endoscopic retrograde cholangiopancreatography normal, Endotracheal intubation, Eosinophil count increased, Febrile infection, Fungal test negative, Gallbladder oedema, Gamma-glutamyltransferase increased, Glomerular filtration rate normal, Granulomatous liver disease, Haematocrit decreased, Haemoglobin decreased, Hepatic enzyme increased, Hepatic fibrosis, Hepatic lesion, Hepatic steatosis, Hepatitis A antibody positive, Hepatitis B surface antibody positive, Hepatomegaly, Hydrocholecystis, Immunoglobulins, International normalised ratio, Intestinal polyp, Iron deficiency anaemia, Laparoscopic surgery, Liver abscess, Liver disorder, Liver function test abnormal, Lobar pneumonia, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased, Mean cell volume decreased, Mycobacterium tuberculosis complex test negative, Nausea, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal, Pancreatic cyst, Platelet count increased, Pleural effusion, Pneumonia, Pneumonia viral, Polyuria, Protein total increased, Pyrexia, Red blood cell sedimentation rate increased, Respiratory failure, Sepsis, Splenomegaly, Staphylococcus test positive, Streptococcus test positive, Systemic inflammatory response syndrome, Tachycardia, Ultrasound abdomen abnormal, Ultrasound scan abnormal, Ultrasound scan normal, Vaccination site reaction
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver infections (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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), Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (narrow), Infectious biliary disorders (narrow), Biliary system related investigations, signs and symptoms (broad), Gallbladder related disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Vasculitis (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Adenovirus test, Aug2011, increased; Alanine aminotransferase, 29Aug2011, 52U/l; Alanine aminotransferase, 11Sep2011, 16U/l; Alanine aminotransferase, 17Nov2011, 42U/l; Albumin, 17Nov2011, 54.7%; Alkaline phosphatase, 28Aug2011, 398U/l; Alkaline phosphatase, 18Oct2011, 187U/l; Alpha 2 globulin, 29Aug2011, 14.6%; Angiotensin converting enzyme, 17Nov2011, 85U/l; Anti-HBs antibody, 29Nov2011, 395s/co; Aspartate aminotransferase, 11Sep2011, 25U/l; Aspartate aminotransferase, 18Oct2011, 37U/l; Aspartate aminotransferase, 17Nov2011, 39U/l; Body temperature, Jul2011, up to 40.2degC; Body temperature, 27Aug2011, up to 39degC; C-reactive protein, 28Aug2011, 10.4mg/dl; C-reactive protein, 11Sep2011, 1.8mg/dl; C-reactive protein, 18Oct2011, 2.1mg/dl; Calcium, 17Nov2011, 2.65mmol; Candida test positive, Aug2011, positive; Eosinophil count, 29Aug2011, 0.6/nl; Erythrocyte sedimentation rate, Oct2011, increased; Fibrinogen, 29Aug2011, 492mg/dl; Gamma GT, 01Sep2011, 222U/l; Gamma GT, 18Sep2011, 66U/l; Gamma GT, 17Nov2011, 102U/l; Gamma globulin, 17Nov2011, 22.8%; Glomerular filtration rate, 18Oct2011, more than 60ml/m; Hematocrit, 04Sep2011, 26.9%; Hematocrit, 18Oct2011, 36.6%; Hematocrit, 21Oct2011, 34.1%; Hemoglobin, 04Sep2011, 8.6g/dl; Hemoglobin, 18Oct2011, 11.4g/dl; Hemoglobin, 21Oct2011, 10.6g/dl; Hemoglobin, 17Nov2011, 11.8g/dl; Hepatitis A virus IgG antibody, 29Nov2011, 1.22s/co; International normalized ratio, 20Oct2011, 1.1; Iron, 18Oct2011, 13mcg/dl; Lactate dehydrogenase, 17Nov2011, 303U/l; MCH, 04Sep2011, 24.5%; MCH, 18Oct2011, 22.9pg; MCH, 20Oct2011, 23.3pg; MCH, 17Nov2011, 22.1pg; MCHC, 01Sep2011, 76.5fl; MCHC, 18Oct2011, 31.1g/dl; MCHC, 20Oct2011, 31.6g/dl; MCV, 18Oct2011, 73.5fl; MCV, 21Oct2011, 72.6fl; MCV, 17Nov2011, 71.3fl; Mycobacterium tuberculosis com, 25Oct2011, negative; Plate count, 03Sep2011, 612/nl; Plate count, 18Oct2011, 473/nl; Plate count, 20Oct2011, 410/nl; Plate count, 21Oct2011, 449/nl; Protein total, 17Nov2011, 8.9g/dl; Staphylococcus test, 01Sep2011, positive; Streptococcus test, 01Sep2011, positive
CDC Split Type: D0073924A

Write-up: This case was reported by a physician via regulatory authority (# DE-PEI-PEI2011041477) and described the occurrence of granulomatous hepatitis in a 22-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). Co-suspect vaccine included TYPHORAL L (non-gsk) (Novartis Behring). On 8 July 2011 the subject received 1st dose of TWINRIX adult (unknown route and application site). On 18 July 2011, 20 July 2011 and 22 July 2011 the subject received 1st dose, 2nd dose and 3rd dose of TYPHORAL L (oral) for traveling in a foreign country. First hospital report, signed on 22 August 2011: In the end of July 2011, less than one month after 1st vaccination with TWINRIX adult and 1st and 2nd vaccination with TYPHORAL L, less then one week after 3rd vaccination with TYPHORAL L, the subject experienced fever with body temperatures up to 40.2 degC. nausea, stomach cramps, exertional dyspnea and obstipation. Since 02 August 2011 the subject was treated with intensive care medicine for highly febrile infection with systemic inflammatory response syndrome. The subject was transferred to another hospital unit on 04 August 2011 due to typical signs of acute cholecystitis by sonography. On 04 August 2011, the subject underwent laparoscopic cholecystectomy. During surgery, hydrocholecystis and gallbladder edema were found. Liver was septically increased. After operation, the subject was intubated due to respiratory insufficiency after acute respiratory distress syndrome until 10 August 2011. Pneumonia of both lungs (lower lobes) was diagnosed and the subject was treated with ZIENAM, CIPROBAY, and ZYVOXID. Antidepressant (Catecholamines (unspecified)) treatment was needed until 07 August 2011. Subsequently, her condition improved. Due to lack of vigilance without sedative treatment cranial nuclear magnetic resonance was performed and showed normal results. Liver values were increased. Serology of hepatitis showed no landmark. Adenoviral antibody count (IgA) was increased and Candida was detected in secretion of trachea. As working hypothesis was viral pneumonia with bacterial superinfection was assumed. Due to tachycardia and short phase of dyspnoea during release of central vein catheter, ultrasound of veins and echocardiography were performed and showed normal results. Inflammatory symptoms normalised. On 18 August 2011 the subject was discharged from hospital. Diagnosis was sepsis of unclear genesis. Intercurrent diagnosis were mild chronic acalculous cholecystitis, polyuria, pleural effusion, acute respiratory distress syndrome, bilateral base pneumonia and iron deficiency anemia. Second hospital report, signed on 13 September 2011: Concurrent medical conditions included penicillin allergy. On 24 August 2011, the subject developed again increased subfebrile temperature. The subject was hospitalised again from 26 August to 13 September 2011. Electrophoresis of serum on 29 August 2011 showed distinctly increased alpha-2-Globulin, gamma-globulin and total protein. Sonography of abdomen on 26 and 29 August as well as on 02 September 2011 showed ventral unclear echoarm structures at left lobe of the liver (e.g. abscess) and at ventral corpus of pancreas. Since 27 August 2011, body temperature was up to 39 degC. Magnetic resonance tomogram (MRT) of liver on 30 August 2011 showed multiple parenchyma lesion of liver and small parenchyma cyst of pancreas at right-sided corpus of pancreas. Liver puncture was performed on 01 September 2011. Cytological examination showed almost exclusively granulocytes, which fits to abscesses. There were positive results for Staphylococcus capitis and Streptococcus anginosus. A test showed positive results for P-antineutrophil cytoplasmic antibody (ANCA), but rheumatological disease could be excluded. An endoscopic retrograde cholangiopancreatography performed on 12 September 2011 was uneventful. The subject was treated with CEFTRIAXON, METRONIDAZOL, ZIENAM, TARGOCID, ciprofloxacin and clindamycin. Subsequently, inflammatory signs improved. Fever resolved. Third hospital report, signed on 21 October 2011: Candida-infection of biliary tract was detected. The subject was treated with FLUCANAZOL. Magnetic resonance tomogram (MRT) of liver on 18 October 2011 showed mild regressive liver disease compared to examination in September 2011, but showed still single progressive liver lesions and mildly increased liver size as well as hints for possible cholangitis. The subject was hospitalised from 20 to 21 October 2011. Liver puncture was performed on 20 October 2011. Laboratory examination showed negative results for acid-fast rods. Polymerase chain reaction for Mycobacterium tuberculosis showed negative results. Fungi could not be detected. Staphylococcus epidermidis was found. Histological examinations of liver puncture on 27 October 2011 showed granulomatous hepatitis of unclear aetiology with mild fibrosis and mild steatosis. It was commented that the combination of granulomas and abscesses can be besides others the beginning of a primary manifestation of Morbus Crohn. Granulomatous vasculitis, purulent destructive cholangitis and Morbus Wegener (due to missing eosinophilia) as well as malignity were excluded. She was ambulatory treated before hospitalisation on 17 November 2011. Magnetic resonance tomogram (MRT) of liver showed regressive size of liver and most likely abscess respectively. Liver metastasis could not be excluded. There was a mild splenomegaly. The subject was hospitalised again from 28 to 30 November 2011. Tuberculosis and other infectious diseases as well as sarcoidosis was excluded. Salmonella typhi serology was also negative. Colonoscopy on 29 November 2011 showed multiple polypoid lesions at terminal ileum. The physician reported that the events could be related to vaccination. Vaccination site reaction was considered as differential diagnosis. According to completed questionnaire, signed on 07 December 2011, the subject received 1st dose of TWINRIX adult (unknown) on 8 July 2011. On 18 July 2011, 20 July 2011 and 22 July 2011 the subject received 1st dose, 2nd dose and 3rd dose of TYPHORAL (oral). Since October 2011, the subject developed granulomatous hepatitis. She developed unclear sepsis with obstipation, abdominal pain and fever with body temperature up to 40 degC as well as with cholecystitis from 04 to 18 August 2011. State after multiple liver abscesses was mentioned. The subject was hospitalised and the reporter reported that the events were life threatening. At the time of reporting the events were resolved. No further information will be available.


VAERS ID: 512976 (history)  
Form: Version 1.0  
Age: 0.46  
Gender: Male  
Location: Foreign  
Vaccinated:2011-07-08
Onset:2011-11-01
   Days after vaccination:116
Submitted: 2013-11-12
   Days after onset:742
Entered: 2013-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB046B / 3 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH PAA012842 / 3 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA410BF / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Bronchitis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0081740A

Write-up: This case was reported by a regulatory authority (# DE-PEI-PEI2013065832) and described the occurrence of spastic bronchitis in a 9-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline) and INFANRIX HEXA (GlaxoSmithKline). Co-suspect vaccinations included PREVENAR 13 (Pfizer Pharma). Concomitant medication was not reported. Previous vaccination with the first dose of ROTARIX (GlaxoSmithKline), given on 19 May 2011, and the first two doses of INFANRIX HEXA (GlaxoSmithKline) and PREVENAR 13 (Pfizer Pharma), given on 14 April 2011 and 19 May 2011, have been well tolerated. On 08 July 2011 the subject received the second dose of ROTARIX (1.5 ml, oral) in combination with the third dose of INFANRIX HEXA (0.5 ml, unknown) and the third dose of PREVENAR 13 (0.5 ml, unknown). Approximately four months post vaccination with ROTARIX, INFANRIX HEXA and PREVENAR 13, on an unspecified date in November 2011, the subject experienced spastic bronchitis. The regulatory authority reported that the event was clinically significant requiring intervention. The subject was treated with KORTISON spray for about half a year. At the time of reporting, on 31 October 2013, the event was improved but not completely resolved. No further information will be available.


VAERS ID: 608821 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2011-07-08
Onset:2011-07-25
   Days after vaccination:17
Submitted: 2015-09-03
   Days after onset:1501
Entered: 2015-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB801AC / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autoimmune neutropenia, Biopsy bone marrow abnormal, Neutrophil count decreased, Pyrexia
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Malignant lymphomas (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: romiplostim
Current Illness: Unknown
Preexisting Conditions: Immune thrombocytopenic Purpura
Allergies:
Diagnostic Lab Data: Biopsy bone marrow, Autoimmune Neutropenia; 08/04/2011, Blood test, Low neutrophil count; 08/24/2011, Blood test, Normal neutrophil count; 09/21/2011, Blood test, Low neutrophil count; 01/27/2012, Neutrophil count, low normal range: 2.5
CDC Split Type: GB2015124371

Write-up: This case was reported by an other health professional via regulatory authority and described the occurrence of pyrexia in a 56-year-old female patient who received ENGERIX B (batch number AHBVB801AC, expiry date unknown) and ENGERIX B (batch number AHBVB801AC, expiry date unknown). The patient''s past medical history included autoimmune thrombocytopenia. Concomitant products included romiplostim. On 8th July 2011, the patient received the 1st dose of ENGERIX B (intramuscular) 20 ug. On 25th July 2011, 17 days after receiving 1st dose ENGERIX B, the patient experienced pyrexia (serious criteria other). On 29th July 2011, the outcome of the pyrexia was recovered/resolved. On 4th August 2011, the patient experienced autoimmune neutropenia (serious criteria GSK medically significant and other). On 10th August 2011, the patient received the 2nd dose of ENGERIX B (intramuscular) 20 ug. On 7th September 2011, the patient received the 3rd dose of ENGERIX B (intramuscular) 20 ug. It was reported the autoimmune neutropenia continued. On an unknown date, the outcome of the autoimmune neutropenia was recovered/resolved. It was unknown if the reporter considered the pyrexia and autoimmune neutropenia to be related to ENGERIX B. Additional information: The autoimmune neutropenia start date was entered as 04 August 2011. However this precedes the administration date of doses 2 and 3 of ENGERIX B, which were considered suspect by the authority. Therefore 04 August 2011 was removed from the structured fields. Regulatory authority verbatim: Have immune thrombocytopenia (ITP) so have regular blood tests. Hepatitis B vaccination given. High temperature for 5 days. Blood tests shows drop in neutrophil count which had recovered by next blood test. Severe drop in neutrophil count noted and continued causing concern. Blood tests and a bone marrow biopsy carried out. Diagnosis of Autoimmune Neutropenia caused by the vaccination subsequently made. Follow up received: The manufacturer of Hepatitis B was Glaxo Smith Kline and the brand is ENGERIX B (20 micogrammes per ml). Blood neutrophil count approximately 6 months after receiving ENGERIX B was in the low normal range at 2.5 which suggests that there has been a spontaneous recovery. No treatment was given just the blood was tested for the neutrophil count.


VAERS ID: 427028 (history)  
Form: Version 1.0  
Age: 57.0  
Gender: Male  
Location: Alabama  
Vaccinated:2011-07-09
Onset:2011-07-09
   Days after vaccination:0
Submitted: 2011-07-10
   Days after onset:1
Entered: 2011-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV284 / 7+ LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Headache, Musculoskeletal stiffness, Neck pain
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: hand and finger joint pain~Anthrax (Biothrax)~4~49.00~Patient
Other Medications:
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Persistent global headache that is still ongoing more than 24 hours post vaccination. Neck soreness and stiffness started about 18 hours post vaccination. No meningismus. Only partial relief with acetaminophen.


VAERS ID: 427029 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-07-09
Onset:2011-07-09
   Days after vaccination:0
Submitted: 2011-07-10
   Days after onset:1
Entered: 2011-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: dizziness, fainting, vomited


VAERS ID: 427101 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Female  
Location: California  
Vaccinated:2011-07-09
Onset:2011-07-10
   Days after vaccination:1
Submitted: 2011-07-11
   Days after onset:1
Entered: 2011-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV284 / 1 RA / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR D1087 / 1 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Chills, Flank pain, Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AZO (over-the-counter UTI medication)
Current Illness: None noted
Preexisting Conditions: Pt had urinary tract infection treated with over-the-counter medication for two weeks prior; not disclosed to clinic staff at time of immunization.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Presented to clinic with chills, fever 103 degrees, lethargy, flank pain on palpation.


VAERS ID: 427102 (history)  
Form: Version 1.0  
Age: 58.0  
Gender: Male  
Location: Unknown  
Vaccinated:2011-07-09
Onset:2011-07-11
   Days after vaccination:2
Submitted: 2011-07-11
   Days after onset:0
Entered: 2011-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV277 / 7+ LA / IM

Administered by: Other       Purchased by: Military
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hypertension, Hypercholesterolemia
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Erythema, Pain, Edema over Lt Deltoid and upper arm. Dx of cellulitis. Tx''d with Rifampin / Septra DS


VAERS ID: 427243 (history)  
Form: Version 1.0  
Age: 70.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-07-09
Onset:2011-07-11
   Days after vaccination:2
Submitted: 2011-07-12
   Days after onset:1
Entered: 2011-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0360AA / 1 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Decreased appetite, Herpes zoster, Herpes zoster oticus, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Ramsay Hunt Syndrome sx per patient fever, nausea, loss appetite. She experienced these symptoms 1 month ago when she had active case of shingles.


VAERS ID: 427842 (history)  
Form: Version 1.0  
Age: 31.0  
Gender: Male  
Location: California  
Vaccinated:2011-07-09
Onset:2011-07-20
   Days after vaccination:11
Submitted: 2011-07-21
   Days after onset:1
Entered: 2011-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK RA / IM
SMALL: SMALLPOX (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK LA / ID

Administered by: Military       Purchased by: Other
Symptoms: Erythema, Induration, Infection, Oedema, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Patient took off bandage on 20JUL2011 and noticed that part of the pustule came off and redness, induration, edema, and warm to touch. Appears to be some infection. Talked to Medical Doctor and Bactrim was given.


VAERS ID: 427938 (history)  
Form: Version 1.0  
Age: 1.76  
Gender: Female  
Location: California  
Vaccinated:2011-07-09
Onset:2011-07-19
   Days after vaccination:10
Submitted: 2011-07-20
   Days after onset:1
Entered: 2011-07-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B277BA / UNK RA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB461CA / 1 LA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1009Z / 1 RA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH E88942 / 2 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1320Z / 1 LA / SC

Administered by: Private       Purchased by: Public
Symptoms: Pruritus, Pyrexia, Rash generalised, Tongue discolouration
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: anemia 6/8/10 Hgb=9.9; NKDA
Allergies:
Diagnostic Lab Data: Ordered CBC & Varicella IgG & IgM titer
CDC Split Type:

Write-up: Parents brought in child on 7/20/11 c/o rash all over body, non toxic appearance, since morning positive fever overnight. Rash initially started on face and has spread to trunk, arms & legs, positive pruritus. Negative n/v, positive white coating on tongue. No known ill contacts. Pt has 5 siblings none of which have rash. Pt is eating & sleeping well. Pt had immunizations given on 7/9/11. Mother denied any fever/rash/vesicles or irritability following immunizations. Pt given TYLENOL, BENADRYL & Nystatin oral swish. ER precautions given & f/u in 24 hrs.


VAERS ID: 430551 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: Illinois  
Vaccinated:2011-07-09
Onset:2011-08-05
   Days after vaccination:27
Submitted: 2011-08-16
   Days after onset:11
Entered: 2011-08-22
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3668AA / 1 UN / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B068AA / 1 UN / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Records not available
CDC Split Type:

Write-up: Patient developed GUILLAIN BARRE SYNDROME and was hospitalized at hospital.


VAERS ID: 435320 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Male  
Location: Virginia  
Vaccinated:2011-07-09
Onset:2011-07-10
   Days after vaccination:1
Submitted: 2011-09-08
   Days after onset:60
Entered: 2011-09-22
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / MICHIGAN DEPT PUB HLTH FAV284 / 1 UN / UN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR E12871 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Albumin urine absent, Blood albumin decreased, Blood calcium decreased, Blood catecholamines increased, Blood cholesterol normal, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood creatinine increased, Blood potassium decreased, Blood thyroid stimulating hormone normal, Blood triglycerides normal, Blood urea normal, Brain natriuretic peptide increased, Chest X-ray abnormal, Condition aggravated, Cough, Creatinine urine increased, Crepitations, Differential white blood cell count normal, Drug screen positive, Dyspnoea, Electrocardiogram abnormal, Epstein-Barr virus antibody negative, Epstein-Barr virus antibody positive, Femoral pulse decreased, Full blood count normal, Haematocrit decreased, Haemoglobin decreased, High density lipoprotein normal, Hypertensive crisis, Hypokinesia, Laboratory test normal, Low density lipoprotein normal, N-terminal prohormone brain natriuretic peptide increased, Protein total decreased, Protein urine present, Pulmonary oedema, Red blood cell count decreased, Respiratory distress, Respiratory tract congestion, Thyroxine free normal, Troponin increased, Vomiting, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Proteinuria (narrow), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Untreated hypertension, 2 months of shortness of breath and dry cough
Preexisting Conditions: Not treated with meds; allergic rhinitis
Allergies:
Diagnostic Lab Data: 7/12/2011: troponin, 0.07 (elevated); CPK, 511; CPKMB, 1.3; WBC, 9.2 with normal differential except lymph 20%; RBC, 4.63; hgb, 12; hct, 35.3; creatine, 1.8; BUN, 18; potassium, 3.3; calcium, 8.1; total protein, 6; albumin, 2.9; urine with 30 mg/dL protein; drug test positive for benzodiazepine; 7/12-13/2011 PRO BNP, 2640; CK, 412-302-245; CMB, 1.99-1.1-1.4; TnI, 0.053-0.035-0.030; aldosterone, 13; renin, 4.88; TSH, 3.28; FT4, 1.15; microalbumin UA, 24.3; creat UA, 154.6; microalb/cr ratio, 157; 7/14/2011 total catecholamines, 442; CBC, normal; BUN, 20; creat, 1.7; BUN/CR ratio, 12; K, 3.4; CA, 8.5, normal chemistry; chol, 190; trig, 121, HDL, 39; LDL CALC, 127; 8/2/2011: BNP, 43; EBV IGM, neg; EBV IgG, positive; EBNA IGG, positive (suggests previous infection); 7/12/2011 upright CXR with questionable mild bilateral increased interstitial markings. A repeat CXR 24 hour later showed clearing of earlier bilateral pulmonary edema, with heart at upper limits of normal by cardiothoracic ration with a slight globular configuration. EKG with diffuse inverted t wave V3-6, I and aVL, TTE with LVEF 35-40%, moderate global hypokinesis LV, and mild LV hypertrophy.
CDC Split Type:

Write-up: First Anthrax and Typhoid Vi on 7/9/2011. Approximately 12 hours later he stated he vomited (x1) and was short of breath. His shortness of breath was described as difficulty with deep breathing and a recurrent dry cough and had been occurring for about 2 months. He did not seek medical care for these problems. He advised he fell asleep and awoke without any concerns being back to normal health. Approximately 36 hours later (late afternoon 7/11/2011) he vomited again. He denied eating any new food groups, liquids, spicy foods and was not working outside in heat. He presented to medical 7/12/2011 with "concerns with breathing and requests for blood pressure medications" where he commented to staff he was self treating HBP with lifestyle changes and diet since "he didn''t want to take BP medications forever". He had not had his BP checked in about 1 year. His blood pressure was noted to be 210/120 - 190/130 with O2 sats 96% and weight 203 lb (69 inches). An EKG was normal; he was treated with clonidine 0.2 mg orally and transferred from clinic to nearby civilian ER. He stated his difficulty in breathing began after training (about 1.5 weeks earlier) as a mild shortness of breath with 2-3 days of cough and chest congestion that worsened on 7/10/2011. He denied any exertional SOB, but relates his respiratory distress to "altitude change" (airplane travel). His BP was 210/133. He was treated medically with oral HCTZ, ASA, NORVASC, TYLENOL, IV Labetalol, and LASIX, and NTG paste and ultimately admitted for hypertensive emergency. He denied any headaches, diplopia, blurred vision or distortion, chest or abdominal pain, dyspnea, rash, body aches, fatigue, depression or any other symptoms. His exam showed a 12mmHg difference in R vs L arm BPs, decreased femoral pulses vs radial pulses, minimal L$gR crackels, a loud 2 without murmur and no peripheral edema.


VAERS ID: 494212 (history)  
Form: Version 1.0  
Age: 29.0  
Gender: Female  
Location: Alabama  
Vaccinated:2011-07-09
Onset:0000-00-00
Submitted: 2013-06-14
Entered: 2013-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0342AA / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Pregnancy test positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Cardiac murmur, medical history comment, recently an asymptomatic atrial septal defect
Allergies:
Diagnostic Lab Data: Human chorionic gonodotropin, positive; 10/11/2011, Pregnancy test, positive
CDC Split Type: WAES1110USA02130

Write-up: Information has been received from a Doctor of osteopathic for (Merck), a Pregnancy Registry product, concerning a 29 year old female patient with no allergies and a history recently discovered of heart murmur an asymptomatic an atrial septal defect who on 09-JUL-2011 was vaccinated with a SQ dose of VARIVAX (Merck) (Lot # 669920/0342AA, Expiry date 07-MAR-2013) (does not reported). There was no concomitant medication. The doctor stated that the patient had been exposed to varicella by a co-worker who had chickenpox. The doctor mentioned that the patient might or might not had been pregnant when administered the VARIVAX (Merck). On 11-OCT-2011 via positive pregnancy test, the doctor confirmed that the patient was pregnant. The doctor also described that two positive pregnancy tests were performed. The patient performed a home pregnancy test and the physician had a "positive blood serum HCG". The patient was seen in the physician''s office. At the time of the report, the patient had 6 weeks of gestation (LMP on 28-AUG-2011; EDD on 03-JUN-2012). Follow up information has been received from the clinic coordinator indicating that the patient had a healthy full term baby boy in June 2012 without any congenital anomalies. There was no other information received about her pregnancy or her child. Additional information is not expected.


VAERS ID: 543622 (history)  
Form: Version 1.0  
Age: 1.3  
Gender: Male  
Location: Illinois  
Vaccinated:2011-07-09
Onset:2011-08-20
   Days after vaccination:42
Submitted: 2014-09-13
   Days after onset:1120
Entered: 2014-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR CB718AA / 4 LL / UN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB517AA / 1 UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Abnormal behaviour, Antisocial behaviour, Aphasia, Autism, Cognitive disorder, Crying, Decreased eye contact, Dyspraxia, Food aversion, Hypotonia, Insomnia, Sensory disturbance, Speech disorder developmental
SMQs:, Peripheral neuropathy (narrow), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Diagnosed by a pediatric developmental specialist on 11/5/2013 with mild to moderate autism, hypotonia and severe language delay. Also diagnosed in 4/2013 with apraxia of speech.
CDC Split Type:

Write-up: Severe unprovicated crying; lack of sleep; Sensory processing issues; regression of speech (complete loss); anti-social behavior; limited to no eye-contact; aversion to certain food textures; repetitive behaviors and delayed cognitive skills.


VAERS ID: 430726 (history)  
Form: Version 1.0  
Age: 0.31  
Gender: Female  
Location: Foreign  
Vaccinated:2011-07-09
Onset:2011-07-11
   Days after vaccination:2
Submitted: 2011-08-23
   Days after onset:43
Entered: 2011-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR - / UNK - / -
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / UNK - / -

Administered by: Unknown       Purchased by: Other
Symptoms: Bacterial test negative, Brain injury, Coma, Death, Flatulence, Intensive care, Laboratory test normal, Life support, Pyrexia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-07-26
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: NO
Allergies:
Diagnostic Lab Data: Meningitis-Negative No salmonella She was not found to have any illness
CDC Split Type:

Write-up: Baby stopped breathing in her sleep and was rushed to the hospital and put on life support. She was in ICU for 16 days. Swollen flatulence, brain damage due to the lack of oxygen, high fever. She was in a Coma.


VAERS ID: 430881 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-07-09
Onset:2011-07-09
   Days after vaccination:0
Submitted: 2011-08-23
   Days after onset:45
Entered: 2011-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA123AA / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Loss of consciousness, Malaise, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 09Jul2011, 110/50mm Hg
CDC Split Type: B0740774A

Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 9 July 2011, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left upper arm). On 9 July 2011, 1 minute after vaccination with CERVARIX, the subject experienced loss of consciousness and slipped from the chair. She had facial pallor. Blood pressure was 110/50 mm Hg. Loss of consciousness persisted for a few seconds. On the same day, the subject also experienced anaphylaxis. Even after being treated with infusion, and kept at rest, general malaise was still severe. Therefore, the subject was hospitalised. On 10 July 2011, the symptoms improved, anaphylaxis was reported as resolved and the subject was discharged from hospital. The causal relationship between anaphylaxis and CERVARIX was unassessable, and related to vagal reflex due to inoculation.


VAERS ID: 436093 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: Foreign  
Vaccinated:2011-07-09
Onset:0000-00-00
Submitted: 2011-09-26
Entered: 2011-09-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH043AB / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Rash generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: No data
CDC Split Type: 201108839

Write-up: This case report is a part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate in a foreign country, from the "Foreign Ministry of Health" (local case reference number BR-BT2011-3760). A male patient, whose medical history and concomitant therapies were not reported, had received a dose of H1N1 (batch number UH043AB, route and anatomical site of administration not reported) on 09 July 2011. On an unspecified date, the patient experienced generalized urticaria (intensity classification: not severe). Generalized rash was reported as serious adverse event. The patient was hospitalized. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The Ministry of Health classified the adverse events on AEFI (Adverse Event Following Immunization). The "causality classification" was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). Documents held by sender: none.


VAERS ID: 448215 (history)  
Form: Version 1.0  
Age: 7.0  
Gender: Male  
Location: Foreign  
Vaccinated:2011-07-09
Onset:2011-07-09
   Days after vaccination:0
Submitted: 2012-01-26
   Days after onset:201
Entered: 2012-01-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UH043AB / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201200856

Write-up: This initial case report is part of a batch of several hundred reports associated with several products that was received on 17 January 2012 by Sanofi Pasteur affiliate in a foreign country, from the "foreign Ministry of Health" (local case reference number BR-BT2012-0017). A "07-year-08-month-02-day" old male patient, whose medical history and concomitant therapies were not reported, had received his dose of pandemic influenza vaccine (batch number UH043AB, route and anatomical site of administration not reported) on 09 July 2011. The vaccine was administered in a vaccination campaign and the dose number was not checked. 2 hours post-vaccination, the patient experienced hypersensivity reaction. The patient recovered ("cure") without sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The case was "confirmed" as per the Ministry of Health, i.e. related to the vaccine. It was also reported that this case was "causality 1", i.e. "confirmed" corresponding to any clinical event that has linked plausible temporal association with administration of a vaccine and can not be explained by concurrent disease or administration of other drugs or chemicals. The Ministry of Health classified this case in category 1, i.e. Adverse Reaction Following Immunization (ARFI). Documents held by sender: none.


VAERS ID: 427514 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Female  
Location: Florida  
Vaccinated:2011-07-10
Onset:2011-07-11
   Days after vaccination:1
Submitted: 2011-07-17
   Days after onset:6
Entered: 2011-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD 3002083 / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Angina pectoris, Chills, Dizziness, Feeling abnormal, Hyperhidrosis, Oesophageal pain, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acetaminophen taken one week prior to start of vaccination course.
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Strong and sharp pain in esophagus and stomach, although felt like it was in heart. Area under chin, near jawbone felt very dense. Lightheaded feeling. Chills would last 10 minutes then body would sweat and alternate back and forth. Lasted 2-3 hours, pain resurfaced every other day for about 1 week. Vomited once in early morning towards end of week of occurrence, fluid was mainly clear with some cloudiness and bits of food eaten night before.


VAERS ID: 439994 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-07-10
Onset:2011-07-10
   Days after vaccination:0
Submitted: 2011-08-23
   Days after onset:44
Entered: 2011-10-21
   Days after submission:59
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS X10034 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Incorrect drug dosage form administered, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US65897

Write-up: Case number PHHY2011US65897 is an initial spontaneous report received from a health care professional (physician assistant) on 21 Jul 2011. This report refers to a 20 year old female patient. She was vaccinated with MENVEO (batch number: X10034) intramuscularly on 10 Jul 2011. But, the patient received only the Men CYW-135 liquid conjugate component without reconstituting it with Men A lyophilized powder component. No adverse reaction was reported following this drug administration error.


VAERS ID: 445276 (history)  
Form: Version 1.0  
Age: 30.0  
Gender: Male  
Location: Virginia  
Vaccinated:2011-07-10
Onset:2011-08-04
   Days after vaccination:25
Submitted: 2011-12-09
   Days after onset:127
Entered: 2011-12-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR - / UNK UN / -

Administered by: Military       Purchased by: Military
Symptoms: Cardiomyopathy, Electrocardiogram, Lumbar puncture, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Troponin I
SMQs:, Cardiomyopathy (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history was not available.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201111732

Write-up: This study case was received from the investigator on 30 November 2011. A 30-year-old male subject with an unknown medical history was found to have Cardiomyopathy 25 days after he had received on 10 July 2011 ACAM2000 (lot number, route and site of administration not reported). The subject had also received on 09 July 2011 ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported). The subject''s Troponin I, ECG, Lumbar puncture and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. The subject''s outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.


VAERS ID: 427462 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2011-07-10
Onset:2011-07-10
   Days after vaccination:0
Submitted: 2011-07-14
   Days after onset:4
Entered: 2011-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Auricular swelling, Rash papular, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Pneumonia
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0732020A

Write-up: This case was reported by a physician via a medical representative and described the occurrence of urticaria in a 2-month-old female subject who was vaccinated with INFANRIX-POLIO-HIB (GlaxoSmithKline). The subject''s medical history included pneumonia. On 10 July 2011, the subject received unspecified dose of INFANRIX-POLIO-HIB (intramuscular, unknown injection site). Lot number not provided. On 10 July 2011, 8 hours after vaccination with INFANRIX-POLIO-HIB, the subject experienced erythematous papular rash over neck and both axilla and swelling of both ear pinna without any mucosal involvement. The subject was hospitalised and urticaria was diagnosed. The subject was treated with fluid therapy (unspecified) (Fluid) and chlorpheniramine maleate. On 11 July 2011, the rash and urticaria were improved but both ear pinna were still swollen. The vaccination course with INFANRIX-POLIO-HIB was discontinued. The physician considered the events were almost certainly related to vaccination with INFANRIX-POLIO-HIB. Follow up information has been requested.


VAERS ID: 459020 (history)  
Form: Version 1.0  
Age: 0.19  
Gender: Female  
Location: Foreign  
Vaccinated:2011-07-10
Onset:0000-00-00
Submitted: 2012-07-10
Entered: 2012-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS ASPNA044AA / UNK UN / SYR
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA291BA / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0812645A

Write-up: This case was reported by a healthcare professional via another manufacturer (Fiocruz) and described the occurrence of hypotonic-hyporesponsive episode in a 2-month-old female subject who was vaccinated with SYNFLORIX (GlaxoSmithKline). Concurrent vaccination included DTPa-Hib (non-GSK), ROTARIX (GlaxoSmithKline) and OPV (non-GSK), all given on 10 July 2011. On 10 July 2011, the subject received unspecified dose of SYNFLORIX (unknown route of administration, unspecified injection site). At an unspecified time after vaccination with SYNFLORIX, the subject experienced hypotonic-hyporesponsive episode and headache. The subject was hospitalised, for unknown time. At the time of reporting the events were resolved without sequelae. This report is one of cases received as part of a line-listing, each one containing minimal information. No further information can be obtained; this case has therefore been closed. Follow-up information was received on 26 June 2012: ROTARIX was also suspected.


VAERS ID: 427105 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: Washington  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-07-11
   Days after onset:0
Entered: 2011-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3477AA / 2 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B048AC / 1 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Convulsion, Pallor
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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

Write-up: Pt went pale and started seizing up for about 20 secs. Time was around 1120 am 11 July 2011. Pt given oxygen and laid down. Pt returned to normal after doctor cleared.


VAERS ID: 427141 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Colorado  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-07-12
   Days after onset:1
Entered: 2011-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3360AA / 1 RA / IM

Administered by: Public       Purchased by: Other
Symptoms: Convulsion, Dizziness, Musculoskeletal stiffness, Syncope, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Hypoglycaemia (broad)

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

Write-up: Patient recieved the Menactra vaccine. Within approx. 3 minutes she had mini seizure and had an episode of syncope that lasted approx. 1 minute. Patient stiffened up and slid out of a chair from a sitting position and was lowered to the floor. Dizziness and vertigo lasted for about 20 minutes after and then started to ease.


VAERS ID: 427204 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2011-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3999AA / 2 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Asthenia, Body temperature increased, Dizziness, Fall, Muscle twitching, Pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: diarrhea for 3 weeks
Preexisting Conditions: anxiety
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The afternoon of the vaccine, patient''s whole body ached. She felt weak and fell over getting up. No syncope. Temp 100-101. Side of body where she got vaccine was "twitching" per mother. She was dizzy. Today, day after vaccine, side of body where she got vaccine is achy.


VAERS ID: 427214 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: New York  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-07-12
   Days after onset:1
Entered: 2011-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 RA / IM
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / IM

Administered by: Other       Purchased by: Public
Symptoms: Asthenia, Dizziness, Fatigue
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: Patient did not report any symptoms of any current illnesses.
Preexisting Conditions: None known
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 10 minutes post vaccine patient complained of feeling weak, and dizzy. Pt. stated, "I feel tired."


VAERS ID: 427218 (history)  
Form: Version 1.0  
Age: 7.0  
Gender: Female  
Location: Missouri  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-12
   Days after onset:0
Entered: 2011-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0012AA / 2 LL / SC

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)

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

Write-up: Erythemic, non-pruritic area to vaccine administration site measuring 5cm x 4 cm


VAERS ID: 427219 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Female  
Location: Florida  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-12
   Days after onset:0
Entered: 2011-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Public       Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Skin tightness
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: entire arm swollen , hot, red~DTaP (no brand name)~5~5.00~Patient|crying for hours/fever~DTaP+IPV+HepB+Hib (no brand name)~~0.17
Other Medications:
Current Illness: No
Preexisting Conditions: N/A
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Noticed that her arm was huge, swollen, red, hot, skin hard and tight from shoulder to elbow. Called Health Dept. and was assured she would be ok. to give ibuprofen, cold compress and elevate arm.


VAERS ID: 427227 (history)  
Form: Version 1.0  
Age: 26.0  
Gender: Male  
Location: Unknown  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-12
   Days after onset:0
Entered: 2011-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1150Z / 1 RA / IM
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR - / 1 UN / ID

Administered by: Military       Purchased by: Other
Symptoms: Computerised tomogram, Computerised tomogram abdomen normal, Computerised tomogram head, Computerised tomogram normal, Headache, Hypotension, Injection site erythema, Injection site pain, Lumbar puncture normal, Nausea, Nuclear magnetic resonance imaging brain normal, Sinus tachycardia, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: minocycline 100mg bid
Current Illness: no
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: please see above. Patient is still an inpatient. I am his admitting physician
CDC Split Type:

Write-up: Patient presented to the ER with severe headache, nausea and pain at the injection site. Vital signs noted hypotension and sinus tachycardia. Labs notable for wbc 24.6. Further work up for wbc included a negative CT brain, MRI brain, lumbar puncture and CT abdomen and pelvis. He had redness at the site of injection which was treated for possible cellulitis.


VAERS ID: 427257 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: New York  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-13
   Days after onset:1
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B139AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: (L) deltoid with redness, warmth, swelling. Mom gave BENADRYL and applied ice pack.


VAERS ID: 427294 (history)  
Form: Version 1.0  
Age: 61.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-13
   Days after onset:1
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 1360Z / 1 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Asthma; hyperthyroid
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Monday got vaccine about 4pm fine right away & Mon Tues noticed some itching at site, breathing little stressed - used inhaler. Currently red/itchy/warm/swollen at site. Will take BENADRYL & inform Dr.


VAERS ID: 427308 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: Florida  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-13
   Days after onset:1
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B178DA / 5 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1427Z / 2 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 17032 / 2 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Gait disturbance, Injection site pain, Injection site rash, Injection site swelling
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None, was prescribed that day Loratadine.
Current Illness: Allergic Rhinitis
Preexisting Conditions: Allergic Rhinitis, Speech Delay (315.39)
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: As per mother, patient had a normal response to vaccine during first day. Yesterday child was refusing to walk, was limping favoring the right lower extemity. Today a rash and swelling of the thigh area was noticed. Patient states it hurts, but walks and runs. Mother was so concerned about an infectious cellulitis, that took child to ER.


VAERS ID: 427311 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: Virgin Islands  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-13
   Days after onset:1
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B141BA / UNK LA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1640Z / 1 RA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1700Z / 1 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Injection site pruritus, Injection site rash
SMQs:, Hypersensitivity (narrow)

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

Write-up: Child developed pinpoint itchy rash to both upper extremities.


VAERS ID: 427323 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Male  
Location: California  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-13
   Days after onset:1
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B121BB / 4 LL / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Swelling of the tissues surrounding injection site.


VAERS ID: 427341 (history)  
Form: Version 1.0  
Age: 1.07  
Gender: Female  
Location: California  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-07-13
   Days after onset:2
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3855AA / 4 RL / -
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB481AB / 1 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0742Z / 1 RL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916006 / 4 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1492Z / 1 LL / SC

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: redness and swelling on left leg and fevers


VAERS ID: 427342 (history)  
Form: Version 1.0  
Age: 40.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-07-13
   Days after onset:2
Entered: 2011-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3921AA / UNK RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Headache, Nausea, Oedema peripheral
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Depression, HTN. NKDA
Allergies:
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: nausea, headache, swollen arm


VAERS ID: 427401 (history)  
Form: Version 1.0  
Age: 89.0  
Gender: Female  
Location: North Dakota  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-07-14
   Days after onset:3
Entered: 2011-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0386AA / UNK RA / IM
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U3815AA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin B12, Coumadin, Lanoxin, Synthroid, dyazide, Lipitor, Vitamin D, Vasotec, Aspirin, Calcium, Tylenol, Vitamin B6.
Current Illness: None
Preexisting Conditions: Celebrex, propoxyphene, latex
Allergies:
Diagnostic Lab Data: NA
CDC Split Type: ND1115

Write-up: Rt arm became very swollen, red, warm, very painful from below injection site to wrist.


VAERS ID: 427403 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: Arkansas  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-07-14
   Days after onset:3
Entered: 2011-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB498BB / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3677AA / 1 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS ACS2B0676A / 1 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Syncope, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: none
CDC Split Type: AR1115

Write-up: vertigo followed by brief syncopal episode five minutes after immunizations given, recovered spontaneously


VAERS ID: 427410 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Female  
Location: Washington  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-14
   Days after onset:2
Entered: 2011-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0131AA / UNK RA / SC

Administered by: Military       Purchased by: Private
Symptoms: Erythema, Pain of skin, Paraesthesia, Skin induration, Skin warm
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetic KetoAcidosis
Preexisting Conditions: Penicillin
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Arm is reddened, firm, warm and tender to touch. Patient c/o tingling to right hand. Warm packs applied and arm elevated. Dr. notified with orders received for warm packs and Percocet prn.


VAERS ID: 427421 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: Florida  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-07-14
   Days after onset:3
Entered: 2011-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB498BB / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3709AA / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3554BA / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Hypoaesthesia facial, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Acetaminophen-Codeine #3
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received vaccines around 12:30 and 3 hours later called stating child''s face was numb & looked swollen. Advised to go to ER ASAP possible allergic reaction. Mom gave BENADRYL & went to ER. He was given Prednisone medication.


VAERS ID: 427422 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Male  
Location: Arkansas  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-07-14
   Days after onset:3
Entered: 2011-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3519AA / UNK LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0782Z / 2 LA / SC

Administered by: Unknown       Purchased by: Public
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Environmental allergies; Urethral stenosis repair 2004; Rotavirus 2001; Pneumonia 2002
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received Tdap & varicella on 7/11/11. Mom reported that pt began having swelling in LUA on date of injections, pt came to clinic on 7/13/11. Had 5cm red, raised lump in LUA at site of varicella injection. Advised to apply ice & OTC cortisone.


VAERS ID: 427427 (history)  
Form: Version 1.0  
Age: 74.0  
Gender: Female  
Location: Indiana  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-14
   Days after onset:2
Entered: 2011-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1111Z / 1 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling, Oedema peripheral, Pain, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Pt developed redness, swelling involving (R) upper arm. Initially on lateral aspect. Then developed large hives & swelling involving medial aspect of her (R) arm. No resp. problems. Painful.


VAERS ID: 427429 (history)  
Form: Version 1.0  
Age: 29.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2011-07-11
Onset:2011-07-13
   Days after vaccination:2
Submitted: 2011-07-14
   Days after onset:1
Entered: 2011-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Onset of local redness, swelling, pain, pruritus at site of AVA injection.


VAERS ID: 427433 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: California  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-14
   Days after onset:2
Entered: 2011-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Erythema, Full blood count, Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: (L) deltoid arm, skin redness, swelling which began worsening 1d after vaccination today measured as 6.5 cm erythema (+) tenderness.


VAERS ID: 427448 (history)  
Form: Version 1.0  
Age: 1.08  
Gender: Female  
Location: Indiana  
Vaccinated:2011-07-11
Onset:2011-07-14
   Days after vaccination:3
Submitted: 2011-07-14
   Days after onset:0
Entered: 2011-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LL / -
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 RL / -

Administered by: Public       Purchased by: Public
Symptoms: Asthenia, Chills, Decreased appetite, Gaze palsy, Irritability, Pyrexia, Staring
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Ocular motility disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: still don''t feel good at the moment 07/14/2011 4:45 PM.
CDC Split Type:

Write-up: Fever, chills, weakness, rolling and staring eyes, irritable, fussy and loss of appetite. Gave childrens Tylenol, luke warm bath, and rest.


VAERS ID: 427454 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Female  
Location: California  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-07-14
   Days after onset:3
Entered: 2011-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB520AA / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3846AA / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3828AA / 6 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Anxiety, Mood swings, Psychiatric evaluation
SMQs:, Dementia (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOXYL; INTUNIV ER; TRILEPTAL; AMBIEN; SOLODYN ER
Current Illness: None
Preexisting Conditions: h/o seizure disorder; bipolar; hypothyroid; acne
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 20 yo with h/o bipolar disorder & sz. disorder given immunization Tdap, meningitis, & Hep A. Mother reports anxiety & mood swings requiring psychiatric evaluation & initiation of INDERAL.


VAERS ID: 427490 (history)  
Form: Version 1.0  
Age: 1.02  
Gender: Male  
Location: Texas  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-07-15
   Days after onset:4
Entered: 2011-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1024Z / 1 LA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0969Z / 1 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Pallor, Respiratory rate increased, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Received MMR & Varicella vaccine at 1-2 pm - went home. At approx 8pm - mom states infant very sleepy, pale, rapid breathing. Took to ER. ER doctor thinks possible reaction to vaccines no rash or swelling noted. Saw private physician yesterday et mom sent to HD to fill out VAERS report.


VAERS ID: 427491 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: North Carolina  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2011-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3973BA / 1 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Redness, swelling & warmth at injection site.


VAERS ID: 427493 (history)  
Form: Version 1.0  
Age: 9.0  
Gender: Male  
Location: Washington  
Vaccinated:2011-07-11
Onset:0000-00-00
Submitted: 2011-07-15
Entered: 2011-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3718AA / UNK RA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB472BA / UNK RA / IM

Administered by: Unknown       Purchased by: Public
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Administration error. Gave DTaP to 9 year old male child. No adverse effects on child.


VAERS ID: 427498 (history)  
Form: Version 1.0  
Age: 0.22  
Gender: Female  
Location: Indiana  
Vaccinated:2011-07-11
Onset:2011-07-13
   Days after vaccination:2
Submitted: 2011-07-15
   Days after onset:2
Entered: 2011-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC218285AA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1688Z / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E32474 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB154A / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KEFLEX 1/4 tsp. for ureter inflammation.
Current Illness: NO
Preexisting Conditions: BABY BORN WITH 1 KIDNEY. PT AT HOSPITAL. PT. WAS ON KEFLEX 1/4 TSP. AT TIME OF VACCINATIONS. THIS INFORMATION WAS NOT DISCLOSED AT TIME OF VACCINATION.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: FATHER STATES THAT BABY HAS BEEN VOMITING "A LOT" AFTER EACH FEEDING, MAYBE ALL OF FEEDING (BOTTLE FED). NO CRYING, STILL HAS WET DIAPERS, STOOLS SOFT, NO TEMPERATURE.


VAERS ID: 427500 (history)  
Form: Version 1.0  
Age: 47.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-07-11
Onset:0000-00-00
Submitted: 2011-07-15
Entered: 2011-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3819AA / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metoprolol 50mg; ROBAXIN 750mg
Current Illness: Hypertension follow up
Preexisting Conditions: HTN
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reports pain, erythema, swelling and warmth at site. Treated with clindamycin 300mg 3 times a day for 10 days.


VAERS ID: 427506 (history)  
Form: Version 1.0  
Age: 58.0  
Gender: Female  
Location: California  
Vaccinated:2011-07-11
Onset:2011-07-13
   Days after vaccination:2
Submitted: 2011-07-14
   Days after onset:1
Entered: 2011-07-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0364AA / 1 LA / SC

Administered by: Unknown       Purchased by: Private
Symptoms: Herpes zoster
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none per patient
Preexisting Conditions: none per patient
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received the ZOSTAVAX injection on Mon, 7/11/11, and called on Thurs, 7/14 saying she got shingles.


VAERS ID: 427617 (history)  
Form: Version 1.0  
Age: 49.0  
Gender: Female  
Location: Michigan  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-13
   Days after onset:1
Entered: 2011-07-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U3979AA / UNK LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Fatigue, Feeling cold, Feeling hot, Headache
SMQs:

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

Write-up: Pt feels like she has had a fever for 2 days. She has not checked her temperature. She c/o fatigue, headache, and feeling chilled.


VAERS ID: 427618 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: California  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-07-11
   Days after onset:0
Entered: 2011-07-18
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1569Z / UNK RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3762AA / 2 LA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3922AA / 6 RA / UN

Administered by: Public       Purchased by: Public
Symptoms: Blood culture, Fall, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: ICON (-); Hemocue 12
CDC Split Type:

Write-up: Patient fainted and fell to floor no LOC after receiving Tdap, GARDASIL, and MENACTRA. No seizure like activity.


VAERS ID: 427675 (history)  
Form: Version 1.0  
Age: 67.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-07-11
Onset:2011-07-13
   Days after vaccination:2
Submitted: 2011-07-14
   Days after onset:1
Entered: 2011-07-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0359AA / 1 RA / SC

Administered by: Other       Purchased by: Private
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)

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

Write-up: Vaccine administered on 7/11/11. Patient said on 7/13/11 in evening noticed redness, itching, soreness & warmth at injection site. Denied prior symptoms to this. patient instructed to take BENADRYL and ice area, if symptoms become worse contact physician or go to ER if needed.


VAERS ID: 427750 (history)  
Form: Version 1.0  
Age: 1.68  
Gender: Female  
Location: Minnesota  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-07-14
   Days after onset:3
Entered: 2011-07-20
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1482Z / 1 LL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E56496 / 4 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1693Z / 1 RL / SC

Administered by: Public       Purchased by: Public
Symptoms: Chest X-ray, Drooling, Gaze palsy, Pyrexia, Salivary hypersecretion, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Ocular motility disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: By moms report CXR
CDC Split Type:

Write-up: Started shaking & eyes rolled ups & increased saliva drooling. Mom called ambulance. Took to ER. Was given Ibuprofen in ER & observed. Sent home after "an hour or two" fever in ER was 104.?.


VAERS ID: 427755 (history)  
Form: Version 1.0  
Age: 8.0  
Gender: Male  
Location: California  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-13
   Days after onset:1
Entered: 2011-07-20
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3618AA / 1 LA / IJ

Administered by: Public       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Received Tdap (Dtap) Iz to left deltoid on 7/11/11 at clinic. Pt. c/o itching to left shoulder after injection. On 7/12/11 pt returned to clinic with c/o redness, pain & swelling to (L) deltoid. Adv ice packs to area & rx for MOTRIN.


VAERS ID: 427757 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: Michigan  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-13
   Days after onset:1
Entered: 2011-07-20
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3514AA / 5 RL / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR G1083 / 4 RL / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0009AA / 2 LL / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1700Z / 2 LL / UN

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site warmth, Local reaction, Skin lesion
SMQs:, Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: 5 x4 1/2 cm red, warm skin lesion on the upper Rt thigh. No limping, seems fine, no fever, no adenopathy. Local reaction.


VAERS ID: 427767 (history)  
Form: Version 1.0  
Age: 10.0  
Gender: Male  
Location: Iowa  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-13
   Days after onset:1
Entered: 2011-07-20
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1493Z / 2 RA / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Erythema, Injection site urticaria, Skin induration, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VERAMYST nasal spray; Albuterol Inhaler; XYZAL 5mg; D Allergy PSE
Current Illness: Otitis Externa "Resolved"
Preexisting Conditions: Rhinitis; Bronchospasms
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Received vaccine approx 4pm - the next morning mom noticed a 50 cent piece size welt at injection site. Today 7-13-11 mom states he has a large size red, warm, hard area on arm (measured 5 1/2" diameter).


VAERS ID: 427769 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Female  
Location: Nebraska  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-13
   Days after onset:1
Entered: 2011-07-20
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3514AA / 5 LA / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR E02041 / 4 RA / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1395Z / 2 LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1682Z / 2 RA / UN

Administered by: Private       Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Pt received shots 7/11/11, mom noticed area was red, swollen, 7/12/11, hot to touch area measured 1.5in x 1.5in. Pt was told to ice area and use BENADRYL q 6 hours. 7/13/11 pt returned area was larger 3 1/2 in x 2 1/2in. Red, swollen, hot to touch. Painful. Pt given TOPICORT to apply BID, continue BENADRYL q 6 hours & apply ice. DTaP shot was given in affected area.


VAERS ID: 427803 (history)  
Form: Version 1.0  
Age: 0.18  
Gender: Female  
Location: Ohio  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-20
   Days after onset:8
Entered: 2011-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3926AB / 1 RL / IJ
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916043 / 1 LL / IJ
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0062AA / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Cough, Dyspnoea, Feeding disorder of infancy or early childhood, Hypotonia, Irritability, Musculoskeletal stiffness, Seizure like phenomena
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tylenol Gripe Water Mylicon Drops
Current Illness: Raspy breathing (possible cold in chest)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Wasn''t eating the night before very well, coughing, fussy, Seizure like symptoms, stiffened up then went limp and took a gasp for air about every 5 seconds. Called 911 ambulance took to Hospital, then transferred to another Hospital by life flight.


VAERS ID: 427814 (history)  
Form: Version 1.0  
Age: 0.51  
Gender: Female  
Location: Texas  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-07-20
   Days after onset:9
Entered: 2011-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3880AA / 3 RL / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB976AA / 3 RL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915704 / 3 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0256AA / 3 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Rash maculo-papular, Roseola, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Less than 24 hours after receiving vaccines, patient developed fever to 102 degrees x 2-3 days. Subsequently developed full body maculopapular erythematous rash after fever stopped. Working dx: roseola v. vaccine reaction.


VAERS ID: 427860 (history)  
Form: Version 1.0  
Age: 61.0  
Gender: Male  
Location: Arizona  
Vaccinated:2011-07-11
Onset:2011-07-14
   Days after vaccination:3
Submitted: 2011-07-21
   Days after onset:7
Entered: 2011-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0361AA / 1 RA / SC

Administered by: Other       Purchased by: Private
Symptoms: Cough, Herpes zoster, Lip swelling, Local swelling, Pain of skin, Sinus congestion, Skin lesion
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: Possibly. Patient had an itchy throat at time of vaccine but was in otherwise good health. He attributed the itchy throat to allergies. However, he developed sinus congestion and a cough the following day, per his wife.
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling of lips and nose, development of painful lesions on trunk, arms and scalp. Patient consulted physician and was told he had shingles according to his wife.


VAERS ID: 427862 (history)  
Form: Version 1.0  
Age: 0.84  
Gender: Female  
Location: Wisconsin  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-07-21
   Days after onset:10
Entered: 2011-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1688Z / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915706 / 1 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Body temperature increased, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Mother of patient stated that she was "sleepy", and that a rectal temp taken was 104 degrees F. Went for MD visit at 4:30pm and told to "keep an eye on her". Increased sleepiness and elevated temps continued through PM of 7/14/11 (103 on 7/12, 102 on 7/13, and 101 on 7/14). Mother denies any other signs or symptoms.


VAERS ID: 427964 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Male  
Location: Unknown  
Vaccinated:2011-07-11
Onset:2011-07-15
   Days after vaccination:4
Submitted: 2011-07-25
   Days after onset:10
Entered: 2011-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (ACAM2000) / SANOFI PASTEUR VV04003A / 1 LA / ID

Administered by: Military       Purchased by: Military
Symptoms: CSF culture negative, CSF glucose decreased, CSF protein normal, CSF test normal, CSF white blood cell count negative, Generalised vaccinia, Gram stain, Gram stain negative, Haemoglobin normal, Headache, Lumbar puncture normal, Metabolic function test, Nausea, Platelet count decreased, Pyrexia, Rash, Rash maculo-papular, Rash vesicular, Vomiting, White blood cell count normal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: WBC 7.1 Hgb 15 Plt 143 Comprehensive metabolic panel normal CSF: clear and colorless; RBC 0 WBC 1 glu 49 pro 40 gram stain negative; culture negative Vaccinia PCR pending on skin lesion samples as well as CSF.
CDC Split Type:

Write-up: Generalized vaccinia - presenting as diffuse macular-papular vesicular rash on face/torso/chest/left shoulder. Worsened over next 5 days and admitted to isolation bed at medical center for supportive care. Fevers, headache, nausea and vomiting upon admission. Negative lumbar puncture and resolving symptoms now HD#4. Case discussed with Vaccine Healthcare Network provider, medical center.


VAERS ID: 428048 (history)  
Form: Version 1.0  
Age: 1.01  
Gender: Male  
Location: Illinois  
Vaccinated:2011-07-11
Onset:2011-07-20
   Days after vaccination:9
Submitted: 2011-07-21
   Days after onset:1
Entered: 2011-07-25
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB509BA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916043 / 4 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0032AA / 1 LL / SC

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: 5 x 2 cm erythematous edematous over at varicella injection site 10 days after injection. Treated with BACTRIM x 10 days.


VAERS ID: 428095 (history)  
Form: Version 1.0  
Age: 0.16  
Gender: Female  
Location: Nevada  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-20
   Days after onset:8
Entered: 2011-07-26
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AG21B300AA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH258AA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916006 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB163A / 1 UN / UN

Administered by: Public       Purchased by: Public
Symptoms: Blood culture, Chest X-ray, Culture urine, Full blood count, Lumbar puncture, Pyrexia, Urine analysis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: 38 wk; possible CHARGE syndrome; ASD; microphthalmia & other dysmorphisms
Allergies:
Diagnostic Lab Data: CBC; UA/UC; LP; B.C.; chest x-ray
CDC Split Type:

Write-up: Fever 103.5 AX within 24 hours of receiving vaccines - child was taken to ER.


VAERS ID: 428246 (history)  
Form: Version 1.0  
Age: 58.0  
Gender: Female  
Location: Ohio  
Vaccinated:2011-07-11
Onset:2011-07-13
   Days after vaccination:2
Submitted: 2011-07-28
   Days after onset:15
Entered: 2011-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / MASS. PUB HLTH BIOL LAB A028A / 2 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Asthenia, Bone pain, Chills, Feeling abnormal, Feeling jittery, Headache, Jaw disorder, Muscle spasms, Muscle tightness, Neck pain, Nervousness, Night sweats, Oropharyngeal pain, Paraesthesia, Tension headache
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Osteonecrosis (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BACTRIM DS
Current Illness: None
Preexisting Conditions: Environmental - Asthma; GERD
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: At the time I was on BACTRIM DS for a UTI. I finished it on 7-13-11 and started CIPRO 500mg 1 twice a day. Mon. 7-11-11 I was bitten by a dog (more of a nip but it did break the skin on my face) at approx. 11 am. The dog has had all its shots. I washed the wound with soap and water and then peroxide and then put NEOSPORIN on it. I went home and cleaned it again and put POLYSPORIN on it. I did this 3 times a day for a week. The wound healed very quickly. I went to the Health dept. and got a Td shot at approx. 3:30 pm the same day. Wed. 7-13-11 Monday and Tuesday I was feeling nervous inside. On Wed. I started getting a tingling sensation on my face mostly on my forehead and temple area across the face from ear to ear. My head felt like I was wearing a tight hat. Still feeling nervous. Tingling and nervousness continues Thurs. and Friday. Sat. 7-16-11 Nervousness when I first got up. In the afternoon I got a chill from the A/C and got very nervous and had a neck spasm. However, I have neck problems anyway so not sure if it is related to this or not. It lasted about an hour. Sun. 7-17-11 I still have tingling in the face and some nervousness and some, not much, itching. Mon. 7-18-11 I went to Dr. and he assured me it was NOT Tetanus and put me on a MEDROL Dose Pak and gave me a script for Hydroxyzine for itching if needed. I went to my Chiropractor and got adjusted and then my husband and I went out of town for the week. Tues. 7-19-11 I had a light neck spasm in the afternoon. Wed. 7-20-11 I woke up with my head feeling kind of floaty and still having some tingling on my face. In the afternoon my neck was on the edge of a spasm. Wed. during the night I got chilled and got nervous feeling. It lasted for about an hour. Thurs. 7-21-11 I got up feeling jittery, I felt pretty good the rest of the day. Fri. 7-22-11 I got up feeling nervous. Some neck tightening and jaws are feeling strange. I took some TYLENOL. We drove back home Friday night. Sat. 7-23-11 Some nervousness when I woke up. I felt good most of the day. Some tightness in right calf. I got cold after supper and tingling in face and nervousness and jaws felt strange again but not as bad as yesterday. I fell asleep for about an hour. I still feel jittery and tingly. I have a slight sore throat but I think that is due to GERD. Sun. 7-24-11 I woke up feeling nervous, jittery, and weak but went to church. I came home and rested and started feeling better around 2pm. Neck slightly hurting. Mon. 7-25-11 I woke up with some nervousness and weakness but better than yesterday. I got the dishes done this afternoon. In the evening my cheek bones were aching and upper back and neck. Tues. 7-26-11 I woke up with slight nervousness and feel the best I have since this all started. Overnight I had some night sweats which I get at times anyway so don''t know if it''s related. Wed. 7-27-11 Headache - pressure an (L) jaw line - from temporal area to neck. Thurs. 7-28-11 Headache.


VAERS ID: 428264 (history)  
Form: Version 1.0  
Age: 1.15  
Gender: Female  
Location: California  
Vaccinated:2011-07-11
Onset:2011-07-18
   Days after vaccination:7
Submitted: 2011-07-20
   Days after onset:2
Entered: 2011-07-28
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1089Z / 1 RL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 916006 / 4 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1188Z / 1 LL / SC

Administered by: Private       Purchased by: Public
Symptoms: Injection site erosion, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: 2cm x 4cm area of redness in left thigh involves skin and subcutaneous tissue, slightly excoriated and raised. Recommend topical CALAMINE lotion and BENADRYL.


VAERS ID: 428456 (history)  
Form: Version 1.0  
Age: 71.0  
Gender: Male  
Location: Washington  
Vaccinated:2011-07-11
Onset:2011-07-13
   Days after vaccination:2
Submitted: 2011-07-16
   Days after onset:3
Entered: 2011-08-01
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0620AA / UNK LA / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin; gemfibrozil; Glyburide/Metformin generic; VICODIN; amlodipine/benazepril
Current Illness: None
Preexisting Conditions: Diabetes; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient called two days, Wednesday, after vaccination to report development of "bumps" "like mosquito bites" on both lower legs, called again on Thursday a.m. to report no change, I called on Sat a.m. no change still has 4 spots on one leg 1 on other.


VAERS ID: 428510 (history)  
Form: Version 1.0  
Age: 40.0  
Gender: Female  
Location: Texas  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-08-01
   Days after onset:21
Entered: 2011-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3898BA / UNK LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Oedema peripheral, Pain in extremity, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIOVAN; Medroxyprogesterone
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Arm itchy, swollen and painful two weeks after receiving vaccine.


VAERS ID: 428590 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2011-07-11
Onset:2011-07-24
   Days after vaccination:13
Submitted: 2011-08-02
   Days after onset:9
Entered: 2011-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1024Z / UNK LA / SC
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3922A / UNK RA / IM

Administered by: Public       Purchased by: Other
Symptoms: Diarrhoea, Fatigue, Headache, Lymph node pain, Lymphadenopathy, Rash
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Minocycline, metformin, clindamycin phosphate, metronidazole, Zantac
Current Illness: None
Preexisting Conditions: Asthma, Diabetes, arthritis, depression, rosacea
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Diarrhea, headaches, painful swollen lymphnodes, fatigue, rash on chest, neck, face, and back.


VAERS ID: 428661 (history)  
Form: Version 1.0  
Age: 1.03  
Gender: Female  
Location: Montana  
Vaccinated:2011-07-11
Onset:2011-07-19
   Days after vaccination:8
Submitted: 2011-08-01
   Days after onset:13
Entered: 2011-08-03
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B208AB / 3 UN / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1617Y / 3 UN / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0106Z / 1 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915704 / 3 UN / IM

Administered by: Public       Purchased by: Public
Symptoms: Convulsion, Feeling hot, Injection site macule, Otitis media, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Mom noted pt felt warm at 345 am (7/19/11). Gave her TYLENOL & seemed ok. Took her to daycare. Between 5-5pm, pt had high fever (104.8 Rectal) & seizure. Transported by EMS to ER. Given 150 mg TYLENOL, fever decreased. Otitis media diagnosed, antibiotics prescribed (AMOXIL). Some macules over arms/legs, & fine rash on facial cheeks bilat.


VAERS ID: 428957 (history)  
Form: Version 1.0  
Age: 19.0  
Gender: Male  
Location: Missouri  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-08-05
   Days after onset:25
Entered: 2011-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

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

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

Write-up: Patient received TWINRIX vaccine w/o incident. After walking away from immediate shot area, patient lost consciousness and fell.


VAERS ID: 428946 (history)  
Form: Version 1.0  
Age: 1.02  
Gender: Female  
Location: Massachusetts  
Vaccinated:2011-07-11
Onset:2011-07-19
   Days after vaccination:8
Submitted: 2011-08-06
   Days after onset:18
Entered: 2011-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 4 - / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 - / -

Administered by: Private       Purchased by: Other
Symptoms: Crying, Insomnia, Irritability, Rash
SMQs:, Anaphylactic reaction (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None of which we were aware.
Preexisting Conditions: None.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: In first couple of days after MMR shots (also got HEP A, Pevnar 13, and Varivax) she was irritable and cried more often when trying to sleep, but seemed to improve after first couple days. Then woke up around 5 AM (usually sleeps until around 7 AM) crying on July 19, 2011 and rubbing her head. Over the course of the next few hours she continued to rub her head, often violently and a rash began to appear on her forehead, behind her ears, neck, stomach and around her back. Did not appear on legs or arms as far as we could tell. The rash then lasted a few days (possibly up to about a week), although faded after first couple days, especially fading where it had been worst on her head and neck. After the first two days she stopped rubbing her head, however, although it interfered with her sleep most significantly the night of July 19, 2011-July 20, 2011. We did not give her any treatment other than liquid Benadryl as instructed by her doctor for the first day or two for the rubbing the head, which the doctor was not sure was related, although the doctor thought the rash seemed to be an MMR reaction rash.


VAERS ID: 429417 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Male  
Location: Connecticut  
Vaccinated:2011-07-11
Onset:0000-00-00
Submitted: 2011-07-19
Entered: 2011-08-11
   Days after submission:23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4008AA / UNK LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0930Z / UNK LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Erythema, Headache, Joint range of motion decreased, Nausea, Pain in extremity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID; Albuterol
Current Illness:
Preexisting Conditions: The patient had a history of asthma and no known allergies.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201104789

Write-up: Initial report was received 15 July 2011 from a health care professional. An 18-year-old male patient had received an intramuscular left deltoid injection of MENACTRA, lot number U4008AA and an intramuscular left deltoid injection of PENUMOVAX 23 (manufacturer Merck, lot number 0930Z) on 11 July 2011 and within 24 hours post vaccination, he developed a fever 101-102 degrees Fahrenheit, a headache, nausea and complained of a red, painful arm with limited range of motion. He had not received any other vaccines within the four weeks prior, he had no concurrent illness, and he had not experienced any adverse events following prior vaccinations. The patient had a history of asthma. Concomitant medications consisted of Albuterol prn and SYNTHROID 2.5 mcg. Outcome was not recovered. Documents held by sender: None.


VAERS ID: 429478 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: Kansas  
Vaccinated:2011-07-11
Onset:2011-07-14
   Days after vaccination:3
Submitted: 2011-07-14
   Days after onset:0
Entered: 2011-08-11
   Days after submission:28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3718AA / 5 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR D1086 / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1393Z / 2 RL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0028AA / 2 LL / SC

Administered by: Private       Purchased by: Public
Symptoms: Injection site swelling, 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt had swelling in left leg with fever.


VAERS ID: 429547 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: New York  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-13
   Days after onset:1
Entered: 2011-08-12
   Days after submission:30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C3718AA / 5 LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR G1068 / 4 RA / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0184Z / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Developed warmth, redness, swelling, left deltoid only after receiving DTAP, MMRV Left Deltoid on 7/11/11. Seen on 7/13/11.


VAERS ID: 429636 (history)  
Form: Version 1.0  
Age: 35.0  
Gender: Female  
Location: Georgia  
Vaccinated:2011-07-11
Onset:2011-07-11
   Days after vaccination:0
Submitted: 2011-07-13
   Days after onset:2
Entered: 2011-08-12
   Days after submission:30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0225Z / 1 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GA11015

Write-up: Redness & swelling at Inj site back of Lt arm began about 8pm. Size of 50mm in diameter. C/o itching.


VAERS ID: 431976 (history)  
Form: Version 1.0  
Age: 55.0  
Gender: Female  
Location: Washington  
Vaccinated:2011-07-11
Onset:2011-07-31
   Days after vaccination:20
Submitted: 2011-08-30
   Days after onset:30
Entered: 2011-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB945BA / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Cholelithiasis, Flatulence, Hepatic enzyme increased, Pancreatic duct obstruction, Pancreatitis, Ultrasound biliary tract, Ultrasound scan abnormal, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations: gallstones/pancreatits~Hep B (Engerix-B)~1~55.75~Patient
Other Medications: n/a
Current Illness: No.
Preexisting Conditions: High triglycerides, Low HDL, High LDL
Allergies:
Diagnostic Lab Data: Elevated liver enzymes. Ultrasound revealed gallstones. Blocked pancreatic duct. Pancreatitis.
CDC Split Type:

Write-up: 1st vomited on 7/31. I vomited again on Aug. 5. I had gas pains spreading up my back. I received a 2nd Hep B vaccine on Aug. 8th


VAERS ID: 434191 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2011-07-11
Onset:2011-07-12
   Days after vaccination:1
Submitted: 2011-07-13
   Days after onset:1
Entered: 2011-09-13
   Days after submission:62
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS AC20B164CA / 5 RA / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1394Z / 2 LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1489Z / 2 RA / UN

Administered by: Public       Purchased by: Public
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)

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

Write-up: Right arm wheal measures 17cm x 14cm at deltoid/upper arm. Prescribed oral steroids.


VAERS ID: 437873 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Female  
Location: Florida  
Vaccinated:2011-07-11
Onset:2011-10-02
   Days after vaccination:83
Submitted: 2011-10-05
   Days after onset:3
Entered: 2011-10-12
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB477 / 1 RA / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 915572 / 4 LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1704Z / 1 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Varicella
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagn