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Case Details (Sorted by Vaccination Date)

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VAERS ID: 284777 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2007-07-16
Onset:0000-00-00
Submitted: 2007-07-16
Entered: 2007-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1751BA / 6 RA / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0527 / 4 RA / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1029F / 2 LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0720U / 1 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, Overdose
SMQs:, Drug abuse and dependence (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient inadvertantly given DTaP and IPV when vaccines had already been administered on 6/27/07. Patient also received MMR #2 at 19 days instead of at 30 days. Patient returned to clinic on same day and showed no signs or symptoms of an adverse reaction; no further treatment if warrented at this time.


VAERS ID: 284859 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: New Hampshire  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-07-17
   Days after onset:1
Entered: 2007-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 417011C / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Abdominal pain upper, Blood amylase increased, Lipase increased, Pancreatitis acute, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (narrow), Neuroleptic malignant 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? Yes
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: none
Preexisting Conditions: none 8/23/07-records received- HX of chronic heartburn.
Allergies:
Diagnostic Lab Data: Amylase 334, Lipase 3349, WBC 17.6, Seg 63, Band 12 8/23/07-records received-US revealed a clot in the aorta near branch of mesenteric artery non-occlusive. Loculated cyst in right kidney. WBC 17.6, neutrophils 88, lymphs 5, absolute neutrophils 15.43, absolute lymph 0.94, absolute mono 1.11. Blood glucose 114, total bilirubin 4.3, alk phos 79, acetone in urine 3+. Occult blood in stool 4+ and fecal leukocytes. INR 1.3 gibrinogen quatitative 479. Amylase 300. Lipase 3349. Platelets 293, potassium 2.7
CDC Split Type:

Write-up: 1830 severe abd epigastic pain with vomiting requiring IV fluids, anti emetics in ED. 2130 transfer to medical center. DX Acute Pancreatitis 7/18/07-partial med rec received as patient remains in facility. Presented with pancreatitis, hyperbilirubinemia, hematemeses and hematochezia following the treatment for a dog bite. Presented to hospital with abdominal pain and recurrent vomiting with bloody diarrhea approximately 4 hours after vaccine and IVIG as well as Augmentin. No clear etiology. 8/23/07-DC summary received for DOS 7/16-7/20/07-DC DX: Pancreatitis. Seconary diagnosis: Gastrointestingal bleed. Likely immune reaction to rabies immunoglobulin. Transaminitis. Presume esophagitis. PE: Circumferential scleral icterus.


VAERS ID: 284945 (history)  
Form: Version 1.0  
Age: 0.33  
Gender: Female  
Location: New York  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-07-17
   Days after onset:1
Entered: 2007-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2651AA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF163AA / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0527 / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B58845A / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0409U / 2 MO / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Irritability, Lip swelling, Pain in extremity, Pyrexia, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow), 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREVACID
Current Illness: NONE
Preexisting Conditions: REFLUX
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: FEVER (TEMP 102, tm), LIP & TONGUE SWELLING (~12 HRS AFTER VACCINE), FUSSINESS AND LEG SORENESS. NO SOB, WHEEZING. SXS IMPROVED WITH BENADRYL AND TYLENOL. FUSSINESS AND SORENESS IN BOTH LEGS (AND ALL OVER) PERSISTS.


VAERS ID: 284951 (history)  
Form: Version 1.0  
Age: 37.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-17
   Days after onset:0
Entered: 2007-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR 02730AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), 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: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: none at this date
CDC Split Type:

Write-up: within 24 hours the patient experienced mild/moderate nausea, mild dizziness and severe headache. He was treated with ibuprofen 600mg tid.


VAERS ID: 284978 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: California  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-07-17
   Days after onset:1
Entered: 2007-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Contusion, Disorientation, Fall, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (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: topical wart remover
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient passed out/fainted, fell to floor from examination table. Bruised, disoriented.


VAERS ID: 284997 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: Oklahoma  
Vaccinated:2007-07-16
Onset:2007-07-18
   Days after vaccination:2
Submitted: 2007-07-18
   Days after onset:0
Entered: 2007-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0247A / 2 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B015AA / 6 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0725U / 3 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Headache, Injected limb mobility decreased, Injection site erythema, Injection site inflammation, Injection site mass, Injection site pain, Injection site warmth, Nausea, Pharyngolaryngeal pain
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (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: None
Current Illness: None known.
Preexisting Conditions: None known.
Allergies:
Diagnostic Lab Data: Assessment done. No lab done.
CDC Split Type:

Write-up: Client received Varicella vaccination in Left Arm, subcutaneous on 7/16/07 around 1100. - Mid day on 7/17/07, client''s mother says he came home from camp with headache, sore throat and extreme nausea and went to bed. - Early AM on 7/18/07, mother checked child''s left upper arm because of complaints of being "really painful" with movement. Mother noted "baseball sized" red area on posterior left upper arm that was "hot to touch". Child reports not feeling ill on 7/18 but his Left arm just "hurt alot". Around 8:45 a.m. on 7/18, Mother & child returned to health department for assessment of injection site. Immunizations nurses X 2 evaulated site and noted a reddened, inflammed area approximately 6 1/2 cm X 7 1/2 cm, round in shape and warm to touch. Mother & child both verbalized child was not longer "feeling bad" except for his arm. Child was alert, animated, smiling and visiting with staff. Mother was told just to monitor site and to notify health department if symptoms changed, child began feeling ill again or injection site worsened. Mother agreed and left without concern.


VAERS ID: 285006 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Female  
Location: Illinois  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-18
   Days after onset:1
Entered: 2007-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0067U / 3 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1031F / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B826510A / 4 LL / IM

Administered by: Private       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? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: FEVER OVER 104 DEG


VAERS ID: 285015 (history)  
Form: Version 1.0  
Age: 40.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-18
   Days after onset:1
Entered: 2007-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 LA / -
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK RA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Nausea, Pyrexia, Somnolence
SMQs:, 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), Haemodynamic oedema, effusions and fluid overload (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Only Advil pm after reactions
Current Illness: None
Preexisting Conditions: Seasonal allergies and IBS with diarrhea
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: All symptoms started approximately 30 hours after vaccine was given. The symptoms were: dull headache, extreme fatgiue, grogginess, mild nasea, fever of 102.5 with chills, warm, sore injection site that was light reddish pink. No form was given so spouse called the pharmacy and asked if symptoms were normal. The response was yes. I (patient dozed on & off for 4 hours then took two Advil pm (for arm pain) and went to bed. The next morning 48 hours later, most all symptoms had disappeared except dull headache and extremely sore arm. It was noticed about 50 hours after vaccine by a friend that the injection site was still swollen and had a large pink perimeter around swollen injection site. I (patient) called the nurse at the clinic and was told to come in and have a nurse look at the injection site. So 51 hours after vaccine I went back to the clinic and two nurses, including administering nurse evaluted the injection site. A pen mark was drawn around the reddish pink part to measure its possible expansion in the next few days. I was told to apply frequent heat to site and to come back by Friday if the reddish area grew larger. Both nurses acknowledged the symptoms I had were not normal for this shot. Now, 54 hours later it is possible to apply heat and will monitor situation. The only symptoms right now are a dull headache and a very painful injection site. Just thought this should be reported and information for this site was obtained off the CDC vaccine page I was given today.


VAERS ID: 285035 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-07-18
   Days after onset:2
Entered: 2007-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1813BA / 5 LL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB141AA / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0326 / 4 LL / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0430 / 1 RL / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Unevaluable event
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:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 4x6 cm


VAERS ID: 285027 (history)  
Form: Version 1.0  
Age: 0.33  
Gender: Male  
Location: Ohio  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-07-18
   Days after onset:2
Entered: 2007-07-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1985AB / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF088AA / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0306 / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B086928 / 2 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0577F / 2 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Crying, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (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: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever 100.6 prolonged crying


VAERS ID: 285208 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-18
   Days after onset:1
Entered: 2007-07-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: Private
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: ~Varicella (Varivax)~~0.00~In Sibling
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 24 Hours after Varicella injection, mom noticed child''s leg at site of injection, warm, red, area redness 1 1/2" x 3", no fever.


VAERS ID: 285251 (history)  
Form: Version 1.0  
Age: 43.0  
Gender: Female  
Location: Alabama  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-19
   Days after onset:2
Entered: 2007-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB287AA / 1 RA / IM
TD: TD ADSORBED (NO BRAND NAME) / MASS. PUB HLTH BIOL LAB TD168 / UNK LA / IM
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER C2512AC / UNK RA / ID

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular 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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient received Td in left deltoid and Hepatitis B #1 in right deltoid IM on 7/16/07 at 11:20am; no local reaction after 30 minutes went. Patient called 7/17/07 at 1330 - c/o dizziness and fever of 102.2 since 0530 that AM. Denied diarrhea, vomiting or rash. Temp at 1340 = 101.7. NP advised to come to clinic for observation. Patient refused, advised patient to go to ER immediately if symptoms worsen. Patient - NP tried to call patient at 1900. Patient called back - feeling better, temp 99.0 and not dizzy. Follow-up on 7/18 no local reaction at site and no complaints per patient.


VAERS ID: 285252 (history)  
Form: Version 1.0  
Age: 59.0  
Gender: Male  
Location: Washington  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-07-18
   Days after onset:2
Entered: 2007-07-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2734AA / 1 LL / IM
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER C2513AB / UNK LA / ID

Administered by: Other       Purchased by: Other
Symptoms: Chills, Fatigue, Nausea, Pain, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illness
Preexisting Conditions: Not know but with NKDA
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient was given Tdap and PPD for employee health on 7-16-07. Presented today with c/o systemic bodyaches, nausea, chills, per patient had fever, and fatigue. No erythema at injection site pain at Tdap injection site.


VAERS ID: 285262 (history)  
Form: Version 1.0  
Age: 1.5  
Gender: Male  
Location: New York  
Vaccinated:2007-07-16
Onset:2007-07-18
   Days after vaccination:2
Submitted: 2007-07-19
   Days after onset:1
Entered: 2007-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2651AA / 1 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B47442C / 4 RL / UN

Administered by: Private       Purchased by: Public
Symptoms: Erythema, 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? 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: Child had swollen left thigh and the area was red and warm. Child was seen by Doctor on 7/18/07 and was prescribed Keflex antibiotic and recommended warm soaks.


VAERS ID: 285267 (history)  
Form: Version 1.0  
Age: 0.22  
Gender: Male  
Location: New York  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-18
   Days after onset:1
Entered: 2007-07-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C25698AA / 1 LA / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 0029F / 2 RA / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UFO64AA / 1 LA / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / PFIZER/WYETH Z0872 / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacteraemia, Convulsion, Full blood count, Pyrexia, Urine analysis
SMQs:, 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: CBC SMA7, Urine analysis, Culture/Sensitivity records received 8/8/07-Blood cultures negative. Urine culture positive for staph aureus. CSF culture no bacteria seen. Grossly bloody tap
CDC Split Type:

Write-up: Fever and seizures. Patient was admitted to hospital on 7/17/07 to Dr. with the diagnosis of Bacteremia and Seizure. Initial treatment was: Rocephin 125 mg IVPB Q12 hrs, Tylenol 80 mg Q4hrs x3 then prn for fever. 8/8/07-records received for DOS 7/18-7/21/07 DC DX: UTI, Sepsis. Admitted with high fever and seizure Temp in ER 103.4 (R).


VAERS ID: 285270 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-19
   Days after onset:2
Entered: 2007-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1447F / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Asthenia, Vomiting
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concerta 27mg daily
Current Illness: stomach ache, vomiting, weak
Preexisting Conditions: none records received 8/8/07-PMH: ADHD.
Allergies:
Diagnostic Lab Data: none records received 8/8/07-WBC 29.6.
CDC Split Type:

Write-up: patient presented with stomach pains, vomiting and weakness. 8/8/07-records received, DX: acute appendicitis. Seen in ER on 7/17/07-four day history abdominal pain, followed by vomiting two and three days ago. Pain on right side of abdomen. No stool at all in past 3 days.


VAERS ID: 285274 (history)  
Form: Version 1.0  
Age: 62.0  
Gender: Male  
Location: Maryland  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-07-19
   Days after onset:3
Entered: 2007-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / UNKNOWN MANUFACTURER TD-166 / UNK LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site induration, Injection site warmth, Insomnia, Pain, Pain in extremity
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 7/16/07 A.M. Received Td vaccine left deltoid 7/16/07 P.M. Noted pain in (L) arm, chills, aches; did not sleep well. 7/17/07: Noted red, raised area around shot site; aches chills at night continued; did not sleep well. 7/18/07: returned to health center; Temp= 101.3F. Area around injection site 3" diam red, indurated, warm to touch. Given Ibuprofen 600 mg. P.O. 7/18/07: returned to health center; Temp+ 98.8F. Left upper arm swelling decreased, induration decreased. No chills or aciness last night. Slept well. Denies any previous reaction to Td immunization.


VAERS ID: 285283 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Male  
Location: Minnesota  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-19
   Days after onset:2
Entered: 2007-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0424F / 2 LA / SC
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2734AA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0592U / 2 RA / SC

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Nausea, Oedema, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Erythema, Edema, Warmth. Patient experienced nausea. No fever and no temperature.


VAERS ID: 285390 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: California  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-20
   Days after onset:3
Entered: 2007-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 LA / ID

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Chills, Headache, Hypoaesthesia, Injection site pain, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre 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? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NYSTATIN,IBUPROFEN
Current Illness: WELL PHYSICAL
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: PER RN PT VERBALIZED A/A AND WELL AMBULATORY, NO SOB
CDC Split Type:

Write-up: FEVER,FEELING WEAK,HEADACHE,CHILLS. INJECTION SITE TO LEFT ARM FEELS SOREAND HAD EPISODE OF NUMBNESS TO LEFT ARM PER RN 07/17/07 AT 1256


VAERS ID: 285407 (history)  
Form: Version 1.0  
Age: 1.67  
Gender: Female  
Location: Washington  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-07-22
   Days after onset:6
Entered: 2007-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / 1 LA / SC

Administered by: Private       Purchased by: Private
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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: mvi
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever 103.7 8 hrs after admistration of Varivax


VAERS ID: 285526 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Male  
Location: Kentucky  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-07-16
   Days after onset:0
Entered: 2007-07-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2062AA / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2631AA / 1 RA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Catatonia, 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), Psychosis and psychotic disorders (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Drug allergy to Ceclor and Biaxin
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Passed out, catatonic response, tonic response, Revived with ammonia inhalant sent to PCP office.


VAERS ID: 285528 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-07-18
   Days after onset:2
Entered: 2007-07-23
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2342CA / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), 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: Plexidacon, Nortriiptyline 25 mg q hs, Benzadin top: differening cream
Current Illness: None
Preexisting Conditions: Migraines, acne
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Complains of dizziness same day vaccination was administered.


VAERS ID: 285568 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2007-07-16
Onset:2007-07-21
   Days after vaccination:5
Submitted: 2007-07-23
   Days after onset:2
Entered: 2007-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U227BA / 1 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B009 / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site discomfort, Pain
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Mom called pt. had body aches and discomfort at site of vaccine


VAERS ID: 285584 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-07-16
Onset:0000-00-00
Submitted: 2007-07-16
Entered: 2007-07-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF012AA / 4 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y10322 / 4 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08684H / 4 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 01734 / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received polio #4 vaccine but she is only 12 months old, Polio #4 is normally due at 5 YO.


VAERS ID: 285589 (history)  
Form: Version 1.0  
Age: 8.0  
Gender: Female  
Location: Virginia  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-18
   Days after onset:1
Entered: 2007-07-23
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0778U / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Pain, Skin warm, Tenderness
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? No
Previous Vaccinations:
Other Medications: Claritin
Current Illness: None
Preexisting Conditions: seasonal and food allergies
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: local large (10 cm x 12 cm) erythematous, warm, tender patch. Pt complains of pain. (L) arm circumference 2mm $g than (R) arm circumference.


VAERS ID: 285599 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Washington  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-07-16
   Days after onset:0
Entered: 2007-07-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2569AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF067AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0527 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08681E / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Crying, Screaming, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (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: Zantac
Current Illness: None
Preexisting Conditions: polydactly, GERD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: inconsolable high pitched screaming treatment-Tylenol, ibuprofen (R) thigh sl. swollen and tender


VAERS ID: 285713 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2007-07-16
Onset:2007-07-18
   Days after vaccination:2
Submitted: 2007-07-19
   Days after onset:1
Entered: 2007-07-24
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0524U / 2 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Rash papular, Skin hyperpigmentation
SMQs:, 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: Rash, flesh colored papules to shoulder with surrounding hyperpigmentation also with flesh colored papules to chest.


VAERS ID: 285735 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-07-19
   Days after onset:3
Entered: 2007-07-24
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2327AA / 1 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Axillary pain, Lymphadenopathy
SMQs:, 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: None
Current Illness: None
Preexisting Conditions: Myocarditis (resolved0 12/04
Allergies:
Diagnostic Lab Data: None
CDC Split Type: NC07079

Write-up: Tender, large ipsilateral axillary lymph node appearing after the injection. Regressing some by 3 days later.


VAERS ID: 285744 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: Alabama  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-24
   Days after onset:7
Entered: 2007-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR - / 4 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Arthralgia, Arthritis, Dizziness, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Arthritis (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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 7-16-07 Rec''d 4th Rabies shot (Imovax). 7-17-07 woke up with arthralgia, arthritis, dizziness, fever, headache. 7-24-07 arthralgia, arthritis, dizziness is gone. Only signs of headache now.


VAERS ID: 285752 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: Ohio  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-24
   Days after onset:7
Entered: 2007-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2605AA / 2 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF100AA / 2 UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0548 / 2 UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B26510K / 2 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0236U / 2 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram normal, Eye rolling, Laryngospasm, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), 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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: EEG Normal MRI Normal CT Normal. Labs and Diagnostics: Head CT-normal. EEG normal. Brain MRI normal
CDC Split Type:

Write-up: The night of receiving the vaccines, had an episode which was either seizure like or laryngospasm. Had susequent episodes over the next few days total of 4 episodes - one with shaking which appeared to be consistent with seizure. 8/27/2007 MR received for DOS 7/19-20/2007 for c/o 3 episodes over 2 days of arm flexing, staring/eyes rolling back and blue lips. Child had another episode during hospitalization where she had trembling of all extremities, staring straight ahead, and unresponsiveness to verbal or tactile stim. This episode was considered to be c/w seizure activity, and the child started on phenobarb. DX: Spells.


VAERS ID: 285754 (history)  
Form: Version 1.0  
Age: 38.0  
Gender: Female  
Location: Alabama  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-07-24
   Days after onset:8
Entered: 2007-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2632AA / UNK LA / ID

Administered by: Private       Purchased by: Private
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Muscle spasms, Myalgia, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (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: Unknown
Current Illness: None
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Vaccine given at noon on 7/16/07 and pt reports onset of arm pain and myalgias that evening. Over the next 2 days, she developed fever up to 101, leg cramps and increasing arm pain. Seen at an urgent care clinic and diagnosed with cellulitis, given antibiotics and came here the next day. Concentric erythema with superficial induration at injection site but no streaking seen. Started on Ibuprofen 800mg q8h. 24 hours later decreased pain and slight decrease in erythema. Patient failed to return for subsequent follow-up as directed.


VAERS ID: 285756 (history)  
Form: Version 1.0  
Age: 61.0  
Gender: Male  
Location: Georgia  
Vaccinated:2007-07-16
Onset:2007-07-22
   Days after vaccination:6
Submitted: 2007-07-24
   Days after onset:2
Entered: 2007-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR PMCC2609AA / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Erythema
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? 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: Client received immunization of Tdap on 7/16/2007, on 7/22/2007, client noticed arm getting red between the elbow and below the injection site.


VAERS ID: 285757 (history)  
Form: Version 1.0  
Age: 38.0  
Gender: Female  
Location: Maryland  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-07-24
   Days after onset:8
Entered: 2007-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Activities of daily living impaired, Anorexia, Back pain, Fatigue, Headache, Influenza like illness, Injection site erythema, Injection site swelling, Pain
SMQs:, Retroperitoneal fibrosis (broad), Dementia (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:
Preexisting Conditions: Allergic to codene and elocon cream
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Loss of appetite, swelling and rash at injection site, tired, lower back pain, headache, flu-like symptoms. I called the Dr. office and the nurse told me that my symptoms weren''t adverse reactions to the shot and that I should move my arm like she told me to. Onset of symptoms were that evening with the worst being two days later. I had to miss work because I couldn''t keep my eyes open and was too achy all over to make it out of bed.


VAERS ID: 285771 (history)  
Form: Version 1.0  
Age: 6.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-18
   Days after onset:1
Entered: 2007-07-24
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0495U / UNK LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0674U / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site induration
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: None
Current Illness: None
Preexisting Conditions: Shellfish, Cipro, PCN
Allergies:
Diagnostic Lab Data: None
CDC Split Type: NC07078

Write-up: Redness and induration at injection site noticed less than 24 hours after injection.


VAERS ID: 285787 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Male  
Location: Virginia  
Vaccinated:2007-07-16
Onset:2007-07-19
   Days after vaccination:3
Submitted: 2007-07-19
   Days after onset:0
Entered: 2007-07-24
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0494U / 1 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0280U / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B26510H / 4 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Dysphonia
SMQs:, Parkinson-like events (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: None
CDC Split Type:

Write-up: Mom called office on 7/18/07 notices child is hoarse. No other symptom, instructed to monitor. Seen in office 7/19/07 with c/o hoarseness only. Question 2nd viral croup, extra crying vocal cord abuse. Report VAERS - possible side effect.


VAERS ID: 286025 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-21
   Days after onset:4
Entered: 2007-07-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPPHIB: DTP + IPV + ACT-HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 LL / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 3 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Computerised tomogram normal, Fontanelle bulging, Lumbar puncture normal
SMQs:, Neonatal disorders (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: CAT scan-normal & Lumbar puncture (spinal tap)-normal
CDC Split Type:

Write-up: Bulging fontanelle morning following vaccines. Doctors recommended visit to ER. Had CAT scan to check for fluid on brain/brain swelling. Spinal tap to check for meningitis. Bulging lasted approx. 24 hours. No remaining side effects


VAERS ID: 286034 (history)  
Form: Version 1.0  
Age: 9.0  
Gender: Male  
Location: Maryland  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-20
   Days after onset:3
Entered: 2007-07-26
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0718U / 2 RA / SC

Administered by: Private       Purchased by: Private
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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: 2" round erythema , positive heat at injection site


VAERS ID: 286040 (history)  
Form: Version 1.0  
Age: 7.0  
Gender: Female  
Location: Colorado  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-19
   Days after onset:2
Entered: 2007-07-26
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0442U / 1 LL / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0644U / 2 RL / UN

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Pruritus, Tenderness
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? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 3" diameter area of solid red - tenderness, itchy skin.


VAERS ID: 286059 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2007-07-16
Onset:2007-07-25
   Days after vaccination:9
Submitted: 2007-07-26
   Days after onset:1
Entered: 2007-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / UNK LA / -

Administered by: Military       Purchased by: Military
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: SM c/o redness, swelling, pain and pruritus at smallpox vaccination site x 1 day. He c/o chills, headache, body ache x2 day - rec''d smallpox on 7/16/07 on lt arm. Was seen by medical provider.


VAERS ID: 286152 (history)  
Form: Version 1.0  
Age: 65.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-27
   Days after onset:10
Entered: 2007-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0743U / UNK LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Herpes zoster
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: DM HTN elevated chol Hypothyroid
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Developed shingles 24 hr after vaccine


VAERS ID: 286221 (history)  
Form: Version 1.0  
Age: 10.0  
Gender: Male  
Location: Michigan  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-24
   Days after onset:7
Entered: 2007-07-30
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / 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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Received Hep A P.M. on 7/16/07; several hours later broke out in hives via phone call to on-call doctor


VAERS ID: 286262 (history)  
Form: Version 1.0  
Age: 1.7  
Gender: Male  
Location: California  
Vaccinated:2007-07-16
Onset:0000-00-00
Submitted: 2007-07-30
Entered: 2007-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2628AA / 3 LL / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0079U / 3 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 8474428 / 3 RL / UN

Administered by: Private       Purchased by: Unknown
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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Keflex 125 mg every 6 hr given 7/18-7/28 recheck
CDC Split Type:

Write-up: 19th after patient received DTaP 7/16/07. Markedly swelling and red injection site 14 cm x 5 cm and tender on 7/18/07.


VAERS ID: 286306 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Male  
Location: Louisiana  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-18
   Days after onset:1
Entered: 2007-07-31
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2159AA / 1 LA / UN
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2690AA / 1 RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Neck pain
SMQs:, Arthritis (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: DDAVP
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Woke up 7/17/07 with left side of neck hurting, felt sharp pain when he turned his head. Came in on 7/18/07 and was treated with Valium 2mg QID x2 days and had full recovery.


VAERS ID: 286324 (history)  
Form: Version 1.0  
Age: 58.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-31
   Days after onset:14
Entered: 2007-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2959AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Nausea
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (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:
Current Illness: None
Preexisting Conditions: Priazide, ACE, Claritin, Prednisone, DJD, GERD, HTN, Diabetes
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt became nauseous on 7/17/07, injection site became red, hot, sore. Pt took Benadryl r/d at office given Keflex, warm compresses 7/23 doing much better.


VAERS ID: 286506 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Male  
Location: Washington  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-07-27
   Days after onset:11
Entered: 2007-08-02
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2223AA / 1 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Asthenia, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (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:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever of 100.5 x 2 days Myalgias, unable to get out of bed x 2 days


VAERS ID: 286517 (history)  
Form: Version 1.0  
Age: 1.3  
Gender: Female  
Location: Arizona  
Vaccinated:2007-07-16
Onset:2007-07-18
   Days after vaccination:2
Submitted: 2007-07-19
   Days after onset:1
Entered: 2007-08-02
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B044BA / 4 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0076U / 4 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Injection site infection
SMQs:

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: Infection at injection site (left thigh)


VAERS ID: 286862 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: North Dakota  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-17
   Days after onset:0
Entered: 2007-08-06
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B046AA / UNK LA / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR 21069 / UNK RA / UN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0815F / UNK RA / UN

Administered by: Public       Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Skin warm
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Left arm swollen, reddened and warm to touch. Deltoid up to shoulder.


VAERS ID: 287352 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Illinois  
Vaccinated:2007-07-16
Onset:2007-07-19
   Days after vaccination:3
Submitted: 2007-08-02
   Days after onset:14
Entered: 2007-08-08
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAZB162CB / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2069AA / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2720AA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0598U / 1 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had no illness at the time of vaccination and was on no other medications. She had a history of headaches and had been evaluated for multiple sclerosis "six to twelve months" prior to vaccination for which the results were negative. 1/10/08-records received-Seen year before by neurologist for worsening headaches and visual disturbances and was diagnosed with ophthalmoplegia and had an MRI which showed white matter change.
Allergies:
Diagnostic Lab Data: 10/10/07-records received laboratory reports received 7/21/07-CBC-RBC polychromosia occasional burr cell, WBC reactive lymph seen on scan. Spinal fluid mono 12. Protein 22.Basic metabolic WNL except for alkaline phosphatase 79 and potassium 5.5. C reactive protein <3. EB Virus IgG 640. Oligoclonal bands present. Negative Lyme and West Nile. 1/10/08-records received-MRI during admission showed increasing number of lesions of white matter and a decrease in some of previous lesions consistent with MS. CXR normal. LP, CSF negative for bacteria and fungi. Normal visual evoked response bilaterally.
CDC Split Type: 200702627

Write-up: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT Initial report received on 25 July 2007 from a health care professional. A 13-year-old female patient, who had a history of a prior evaluation for multiple sclerosis, had received an intramuscular, left deltoid injection of Adacel, lot number C2720AA; a first dose, intramuscular, right deltoid injection of Menactra, lot number U2069AA; a first dose, subcutaneous, left arm injection of Varivax, manufacturer Merck, lot number 0598U; and a first dose, intramuscular, right deltoid injection of Havrix, manufacturer GSK, lot number AHAZB162CB; on 16 July 2007. Three days later, the patient experienced "left sided numbness and tingling from head to toe along lateral aspect of the upper and lower extremities." The patient was examined in an emergency room and was scheduled for a neurological evaluation. The patient had a history of headaches and had been evaluated for multiple sclerosis "six to twelve months ago." Test results were negative, and the patient was supposed to have a repeat MRI "six months ago, but never did." Recovery status was unknown. 1/10/08-records received for DOS 7/21-7/24/08-DC DX: left-sided paresthesias/multiple sclerosis flare. Presented with 4 day history of worsening paresthesias on her left side beginning in left hand and progressing into the left leg. Described as tingling and numbness.


VAERS ID: 287396 (history)  
Form: Version 1.0  
Age: 60.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-08-03
   Days after onset:18
Entered: 2007-08-08
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2365AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Pyrexia, Rash macular, Wrong drug administered
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Medication errors (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: Chronic Idiopathic urticaria, Borderline HTN, Arthritis knee
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Developed fever 101.1 and then fine macular rash on extremities. Fever lasted 24 hours, rash faded same interval. No other sequelae. Treated with Tylenol and Claritin


VAERS ID: 287617 (history)  
Form: Version 1.0  
Age: 10.0  
Gender: Female  
Location: California  
Vaccinated:2007-07-16
Onset:2007-07-19
   Days after vaccination:3
Submitted: 2007-07-20
   Days after onset:1
Entered: 2007-08-09
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0596U / 2 UN / SC

Administered by: Public       Purchased by: Public
Symptoms: Injection site erythema, Injection site pruritus
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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Erythematous lesion, oval shape 3x5cm on the injection site with itching 24 hour after receiving varicella vaccine


VAERS ID: 287620 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-08-09
   Days after onset:23
Entered: 2007-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER NA / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NA / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR 02524AA / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dizziness, Migraine, Nausea, Visual disturbance
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe nausea lasting more than two weeks. Severe migrane headaches and vision disturbances. Dizziness. All of these have lasted more than two weeks and are currently ongoing.


VAERS ID: 288061 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-08-06
   Days after onset:20
Entered: 2007-08-14
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Full blood count, Pyrexia, Skin nodule
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic 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? 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: CBC
CDC Split Type:

Write-up: Knot, fever in left arm


VAERS ID: 288153 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: Georgia  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-25
   Days after onset:8
Entered: 2007-08-15
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1857CA / 5 LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR V1051 / 4 RA / SC
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0226U / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08666K / 2 LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Cough, Lip swelling, Pruritus, Rash morbilliform, Urticaria
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: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: PGM called about 8:40 AM 7/17/07. Stated child had a measle-like rash on lower abdomen and groin area. C/O of some itching. Denied any other problems at this time. Discussed taking some Benadryl or using "Caladryl" lotion. She called back in about 10 min. stating child''s lips were swelling had had whelps on upper chest. Denied SOB but stated he was coughing some. Told her to give him some Benadryl. Advised her to take to PMD or take to nearest ER. Took child to doctor this morning. Stated by the time the doctor saw child the rash was almost gone and lips were not as swollen. GM stated that the doctor didn''t know if this was food allergy - reaction to shots or combination of both. Doctor gave him medicine but GM doesn''t know the name. I tried several times to speak with nurse at doctors office but have been unsuccessful. 7-18-07 and 7-19-07 I spoke with child''s grandmother and she stated child was fine.


VAERS ID: 288326 (history)  
Form: Version 1.0  
Age: 0.1  
Gender: Unknown  
Location: Florida  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-08-14
   Days after onset:29
Entered: 2007-08-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Unevaluable 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA02615

Write-up: Information has been received from a physician concerning a 7-day-old patient who on 16-JUL-2007 was vaccinated with the first dose of Rotateq. It was unknown if medical attention was sought. No adverse experience was reported. This is one of several reports from the same source. Additional information has been requested.


VAERS ID: 289463 (history)  
Form: Version 1.0  
Age: 19.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-08-14
   Days after onset:29
Entered: 2007-08-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0524U / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Headache, Influenza like illness, 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: temperature measurement 07/16/07 102
CDC Split Type: WAES0707USA02881

Write-up: Information is in follow-up to report (s) previously submitted on 8/14/2007. Information has been received from a nurse concerning a female who on unspecified dates was vaccinated with a first and second dose of GARDSIL (658094/0524U) 0.5mL. On 16-JUL-2007 the patient was vaccinated with her third dose of GARDASIL (lot# unknown). On 16-JUL-2007, the patient developed a fever over 102 degrees F, nausea, headache and "flu like symptoms". Medical attention was sought. At the time of reporting the patient had not recovered. Additional information has been requested. Follow-up information was received. The onset of the adverse event was also reported as 17-JUL-2007 (previously reported as 16-JUL-2007. The patient also experienced chills. At the time of reporting it was unknown if the patient had recovered. Additional information is not expected.


VAERS ID: 289467 (history)  
Form: Version 1.0  
Age: 25.0  
Gender: Female  
Location: New York  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-08-14
   Days after onset:29
Entered: 2007-08-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0525U / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: beta-human chorionic 07/16/07 negat - prior to vaccination
CDC Split Type: WAES0707USA02940

Write-up: Information has been received from a registered nurse concerning a 25 year old female who on 10-JAN-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 655619/1427F). On 15-MAR-2007 the patient was vaccinated with a second dose of Gardasil (lot # 657006/0188U). On 16-JUL-2007 the patient had a beta-human chorionic gonadotropin test (unspecified) and the results were reported as negative. On that same day the patient was vaccinated with a third dose of Gardasil (lot # 658100/0525U). On 16-JUL-2007 the patient experienced dizziness and nausea after the vaccination. Unspecified medical attention was sought. The patient''s lightheadedness and nausea persisted. Additional information has been requested.


VAERS ID: 289810 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Michigan  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-08-14
   Days after onset:29
Entered: 2007-08-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / UN

Administered by: Other       Purchased by: Other
Symptoms: Musculoskeletal pain, No reaction on previous exposure to drug
SMQs:, Rhabdomyolysis/myopathy (broad), 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA04970

Write-up: Information has been received from a physician concerning a 16 year old female who, on approximately 16-JUL-2007 was vaccinated with a second dose of Gardasil. Subsequently, the patient experienced pain in shoulder that lasted for about a week after the vaccination. It was reported that the patient did not experienced pain when she received the first dose of the vaccination. The patient sought unspecified medical attention. At the time of the report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 289919 (history)  
Form: Version 1.0  
Age: 24.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-08-14
   Days after onset:29
Entered: 2007-08-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0319U / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), 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:
Other Medications: NUVARING,hormonal contraceptives
Current Illness: Lactose intolerance
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data: blood pressure, 07/16/07, 112/6; blood pressure, 07/16/07, 133/8; blood pressure, 7/16/07; 117/7; body weight measurement, 07/16/07m 74.39 kg; total heart count, 07/16/07, 104; total hearbeat count, 07/16/07, 63; total heart count, 07/16/07. 68
CDC Split Type: WAES0708USA00069

Write-up: Information has been received from a registered nurse concerning a 24 year old female lactose intolerant with a history of asthma and no previous history of Guillan-Barre Syndrome who on 16-JUL-2007 at 11:30 am was vaccinated with the first dose of Gardasil (lot #654272/0319U), 0.5ml, IM left deltoid of the non-dominant arm (manufacturer unspecified). She planned on switching to NUVARING) on 22-Jul-2007. Her last menstrual period was on 19-Jun-2007. Concomitant medication was reported as none. On 16-JUL-2007 within five minutes of receiving the dose of Gardasil, as the patient was making her way to her next appointment, she felt lightheadness, and faint and she started to fall. She was lowered to the floor by the medical assistant. She did not hit her head or other body part or loose consciousness. Her blood pressure was 133/88 and pulse was 104. She was a bit diaphoretic. She was talking and able to take some water. An ice pack was placed on her forehead. She rested a bit on the floor and was then wheeled into the non stress test room where she rested on the lounge chair. Her blood pressure was rechecked at 117/79 with a pulse of 62. She reported feeling fine after about 5 minutes and was taking water. The injection site was without redness or swelling. She felt ok to leave and upon standing, did not feel dizzy. Blood pressuer was stable and she left the office. She was to stay well hydrated and follow-up in 2 months for the next injection of GARDASIL. On 30-JUL-2007, the patient called to report that she experienced pain in arm that the vaccine was administered and that she can not raise her arm. Left arm was weak and she was having problems raising it all the way. She could raise it to chest height, but not to her head. If she tried to raise it to her head, there was pain. She felt some tingling in her hand at times, but had full use of her hand. It was suggested that she try ADVIL 400-600 mg 3 - 4 times per day for 1 - 2 days to see if she notes any improvement. No product quality complaint was reported. On 24-Aug-2007 the patient reported the arm was better but was still having some residula discmfort with certain movements. She was advised to see her primary care physician for presistant pain after injection. On 24-Aug-2007 the paitnet was "mostly" recovered. . No product quality complaint was reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/14/2007. Additional information is not expected.


VAERS ID: 288397 (history)  
Form: Version 1.0  
Age: 50.0  
Gender: Female  
Location: Virginia  
Vaccinated:2007-07-16
Onset:2007-07-19
   Days after vaccination:3
Submitted: 2007-08-17
   Days after onset:29
Entered: 2007-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (VIRIVAC) / MERCK & CO. INC. 1025F / UNK RA / -
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR C2212AA / UNK LA / -

Administered by: Public       Purchased by: Public
Symptoms: Arthralgia, Cough, Joint swelling, Nasal congestion, Oedema peripheral, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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:
Current Illness: denies
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: none
CDC Split Type: VA07:010

Write-up: "Bronchitis" on 7/19/07: fever, cough/congested. 8/3/07: coughing only. knees & ankles painful, swollen 7/31/07. Hands swollen - onset 7/30: Left hand more swollen. 8/7/07: Pt continues to cough (productive). Fingers swollen. Wrist better. Left hand better. Did not see MD for evaluation. (Patient also received PPD - left forearm - at the time of vaccination.)


VAERS ID: 289033 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Female  
Location: Maryland  
Vaccinated:2007-07-16
Onset:2007-08-14
   Days after vaccination:29
Submitted: 2007-08-24
   Days after onset:10
Entered: 2007-08-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea haemorrhagic, Intussusception, Pyrexia, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), 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? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown PMH: possible HIV exposure, asthma, atopic cellulitis, family hx asthma.
Allergies:
Diagnostic Lab Data: Unknown, LABS: Abdominal x-ray revealed SBO. Abdominal US revealed RUQ IS. Air contrast enema reduced. F/U x-ray s/p air contrast enema revealed bowel perforation. HIV tests.
CDC Split Type: WAES0708USA03539

Write-up: Information has been received from a a physician concerning a 7 month old female with no drug allergies who on 16-JUL-2007 was vaccinated with a 2ml oral dose of Rotateq. On 14-AUG-2007 the patient developed intussusception characterized by vomiting, low grade fever, and bloody diarrhea. Medical attention was sought via emergency room visit and the patient was hospitalized. Numerous tests (unspecified), confirmed a diagnosis of intussusception and a partial iliac resection was performed. Subsequently the patient was noted to still be hospitalized and recovering. There was no product quality complaint. The event was also considered to be immediately life-threatening and other important medical event (surgery) by the reporter. Additional information has been requested. 08/31/2007 Received hospital medical records of 8/14-8/22/2007. FINAL DX: Intussusception w/terminal ileum perforation & necrosis. Records reveal patient experienced fever & decreased oral intake x 4 days, 1 day of bilious emesis & 1 episode of bloody stool. Taken to OR for exp laparotomy, small bowel resection & appendectomy. Admitted to PICU post operatively. Received IV antibiotics via PICC line & was weaned from mech ventilation successfully. TPN started & progressed to oral feeds. Tolerated feeds well & stooling normally. D/C to home w/pcp & peds surg f/u. 10/2/07 Received vax record from hospital which reveals patient did not receive RO on any date. 5/1/08 Received PCP medical records for 1/24/07-3/3/08 which included vax record different from that received from hospital. but still confirm that patient did not receive Rotateq vaccine at any time. 7/27 visit for wheezing, runny nose & cough x 3 days. 8/13 visit, had been out of state. Had vomiting & fever x 2 days & seen in ER out of state x 2. Lethargic & seen in local Er day before. Dx w/viral gastroenteritis. 8/16 notified of hospitalization. 8/31 f/u hospitalization vs progressing well. Returned 9/6, 10/18, 10/29, 11/26, facial cellulitis, atopic dermatitis w/wheezing, couth & runny nose.


VAERS ID: 289069 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: Nebraska  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-08-21
   Days after onset:36
Entered: 2007-08-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2651AA / 5 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0169 / 4 LL / SC
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0542J / 1 RL / SC

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain, Inappropriate schedule of drug administration
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Abd pain - diffuse 1-2 hours after.


VAERS ID: 289143 (history)  
Form: Version 1.0  
Age: 43.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-07-16
Onset:2007-07-27
   Days after vaccination:11
Submitted: 2007-08-09
   Days after onset:13
Entered: 2007-08-27
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1469F / UNK RA / SC

Administered by: Public       Purchased by: Private
Symptoms: Fatigue, Headache, 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: Ziac, Synthroid
Current Illness:
Preexisting Conditions: Hypothyroidism, Hypertension
Allergies:
Diagnostic Lab Data: 6/26/07 Rubella titer neg. 03 <.8 neg $g.99 Positive = scale for interpretation
CDC Split Type:

Write-up: Patient experienced mild headache, fatigue, rash pink, pinpoint over face and chest


VAERS ID: 289841 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: Utah  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-20
   Days after onset:3
Entered: 2007-09-05
   Days after submission:47
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U2857BA / 5 LA / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0672R / 3 RA / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0017U / 2 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0127U / 2 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Headache, 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Congenital malformation of the esophagus - requires periodic dilation.
Allergies:
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Redness and swelling at site of DTaP injection with a fever of 100 the day after receiving shots. She worsened the following day with a fever of 103; headache, and swelling up to 10 cm. Child was taken to Dr. whose plan was to monitor. She began to feel better the next day, July 19th, with less redness and a temp of 102. It was on this day that she returned to the clinic and the reaction was noted. The father was phoned the following day, July 20th, and he stated she was continuing to improve.


VAERS ID: 290214 (history)  
Form: Version 1.0  
Age: 1.3  
Gender: Female  
Location: Idaho  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-07-23
   Days after onset:7
Entered: 2007-09-10
   Days after submission:49
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B046AA / 4 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0079U / 3 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH LEB47442D / 4 RL / IM

Administered by: Private       Purchased by: Other
Symptoms: Hyperpyrexia, 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: Benadryl
Current Illness: rash x 3 days
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: ID07027

Write-up: fever 104.8 began 4 hours after immunizations given, hyperpyrexia. Tylenol, Motrin, continue observation recheck if no improvement


VAERS ID: 290679 (history)  
Form: Version 1.0  
Age: 1.31  
Gender: Male  
Location: Indiana  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-09-17
   Days after onset:63
Entered: 2007-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Allergy test negative, Body temperature increased, Erythema, Muscle spasms, Tremor, Urticaria, Viral infection
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (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: high fever, shaking~Measles + Mumps + Rubella (no brand name)~1~1.00~Patient
Other Medications:
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: allergy tests show patient is not allergic to peanuts, cows milk or wheat.
CDC Split Type:

Write-up: The dpt shot was administered late morning on July 16, 2007. By afternoon, our child was running a 104 degree temperature. He awoke from his afternoon nap red and shaking. His temperature was 105. He was put in cold water to bring his temperature down. He was given motrine continously, every four hours after receiving the shot. We took him to see the doctor at 5:00pm. His temperature and shaking had stopped and he was acting normal. During the early am hours, our child awoke again with a nearly 105 degree temperature. This time he was shake and having muscle spasms every 15 seconds. Some of these spasms caused him to bounce in his baby bed. (This lasted over an hour.) We gave him more mortin immediately. We called the doctor and spoke to a nurse. We took patient to the emergency room, but by the time we arrived he was acting completely normal again and we were advised not to check him in, but to take him back home because he had no symptoms at that time. The fever and muscle spasms were gone within 48 hours of the shot. About a month later our son began to break out with hives. They are telling us these are due to a viral infection. My husband and I believe that the hives are due to this shot reaction. He has had the hives for one month. Milk, peanuts, and wheat now cause him to break out severely. He had no allergies to foods prior to this shot. The allergist says that the foods are unrelated, and that this will pass with time. He said it is a viral induced case of hives that could last 3 or 4 weeks or so. He has had them now for four weeks. They keep coming and going. He has taken almost four bottles of benadryl and is now taking zyrtec. Some hive outbreaks are severe and cause his mouth to water. We are still waiting for the hives to resolve.


VAERS ID: 291542 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: New York  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-09-17
   Days after onset:63
Entered: 2007-09-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Rotavirus test positive
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: Gastroschisis
Allergies:
Diagnostic Lab Data: stool culture 07/16/07 - positive for rotavirus
CDC Split Type: WAES0708USA01851

Write-up: Information has been received from a health professional concerning an 8 week old male with a history of gastroschisis repaired shortly after birth and no allergies, who on 16-JUL-2007 was vaccinated with an oral one tube dose of Rotateq (Lot# "0240U"). Concomitant vaccines included a dose of COMVAX, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, IPOL and a dose of PREVNAR. The patient''s mother informed the reporter that the patient had loose stools, up to 6 or 7 daily since the date of vaccination, on 16-JUL-2007. A stool culture was positive for rotavirus. No other symptoms were noted. At the time of the report the patient was recovering. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 291796 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-09-17
   Days after onset:63
Entered: 2007-09-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug administered at inappropriate site, Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad), Medication errors (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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0708USA02509

Write-up: Information has been received from a registered nurse concerning a female patient who was vaccinated IM into the lower part of her arm (not sure if it was the deltoid, she felt it was in the fatty part of her arm) with a third 0.5ml dose of Gardasil. Subsequently, the patient developed a lump in the injection area. Unspecified medical attention was sought. At the time of this report, the patient''s outcome was unknown. Follow up information stated that the lump in the injection area has not gotten any bigger nor smaller. No product quality complaint was involved. Additional information has been requested. 1/5/10 follow up - injection site mass; drug administered at inappropriate site. inappropriate schedule of drug administration


VAERS ID: 292076 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-09-17
   Days after onset:63
Entered: 2007-09-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0523U / 1 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Pain in extremity
SMQs:, 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:
Current Illness:
Preexisting Conditions: Unknown; None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0708USA01496

Write-up: Information has been received from a registered nurse concerning a 22 year old female who on 16-JUL-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included NUVARING. On 16-JUL-2007 the patient experienced arm "full of pain". There was no redness or itching. The patient''s arm "just hurts really badly." Unspecified medical attention was sought. The patient''s arm "full of pain" persisted. Additional information has been requested. This is in follow-up information has been received from a registered nurse and a health care professional concerning a 21 year old female with no medical history, who on 16-JUL-2007 was vaccinated IM in the right deltoin with a first dose of GARDASIL vaccine (previously reported as lot # 657868/0523U). Concomitant therapy included NUVARING. On 16-JUL-2007 the patient experienced arm "full of pain". There was no redness or itching. The patients arm "just hurts really badly." On 08-AUG-2007 the patient''s mother called the office and reported that the patient complained of a sore arm for two weeks and denied redness of lump. The office prescribed ice and ADVIL. The patient recovered on an unspecified date. On 16-SEP-2007 the patient received the second dose of GARDASIL without incidents. The patient was advised to call office. Additional information is not expected.


VAERS ID: 291269 (history)  
Form: Version 1.0  
Age: 70.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-08-30
   Days after onset:44
Entered: 2007-09-24
   Days after submission:25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB443AA / 1 LA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site pruritus
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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received 1st Hepatitis B vaccine on 7/16/07 and next AM notice itching at injection site.


VAERS ID: 291307 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-08-15
   Days after onset:30
Entered: 2007-09-25
   Days after submission:41
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0927U / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2377BA / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular 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: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headache, fever, dizziness x 2-3 days


VAERS ID: 291316 (history)  
Form: Version 1.0  
Age: 0.17  
Gender: Female  
Location: Utah  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-09-21
   Days after onset:67
Entered: 2007-09-25
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B124AA / 1 UN / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0067U / 1 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B54013K / 1 UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0504U / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), 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:
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Had 6-10 loose stools per day from giving the Rotateq. Lasted 3 wks.


VAERS ID: 294886 (history)  
Form: Version 1.0  
Age: 74.0  
Gender: Female  
Location: Illinois  
Vaccinated:2007-07-16
Onset:2007-07-18
   Days after vaccination:2
Submitted: 2007-09-24
   Days after onset:68
Entered: 2007-09-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0692F / UNK UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site inflammation, 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: FIORICET; ALLEGRA; PREVACID; LEVOXYL; LORAZEPAN; PROVIGIL; SINGULAIR; TIGAN
Current Illness: Sulfonamide allergy; adhesive tape allergy; hypersensitivity; irritable bowel syndrom; gastrooesophageal reflux disease; migraine; hypothyroidism
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0708USA00064

Write-up: This is in follow-up to report (s) previously submitted on 9/24/2007. Information has been received from a registered nurse (R.N.) concerning a female "over 60 years of age" who was vaccinated with a subcutaneous injection of Zostavax (Oka/Merck). Subsequently, on an unspecified date, the patient experienced "injection site swelling which was severely inflated and enormous." The patient visited the physicians office for follow-up where they treated her with steroids to keep inflammation down. The outcome is not reported. No product quality complaint was involved. Additional information received indicates that the patient is a 74-year-old female with allergies to sulfa, tape, and amoxicillin, and concurrent medical conditions IBS, GERD, mirgraines and hypothyroidism. On 16-Jul-2007 at 11:30, the patient received an intramusclar dose in the left deltoid of PNEUMOVAX 23 (LOT# 655592/0662F) (previously reported as zoster vaccine live (Oka/Merck)). Concomitant medications included FIORICET TABLETS, ALLERGRA, PREVACID, LEVOXYL, TIGAN, PROVIGIL, montelukast sodium (MSD), LORAZEPAN, "onlan" and "suspar". There was no illness at the time of vaccination. On 18-Jul-2007, the patient developed redness, welts and pain at the injectio site. The area below the injection site was moderately swollen. No laboratory or diagnostic test were performed. The patient was given 60 milligrams intramuscularly or KENALOG, and oral prednisone. On 23-Jul-2007, the patient recovered. The reporter considered the adverse events to be other important medical events that required medical attention. Additional information is not expected.


VAERS ID: 294914 (history)  
Form: Version 1.0  
Age: 62.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-09-24
   Days after onset:70
Entered: 2007-09-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0585U / 1 RA / IM

Administered by: Private       Purchased by: Other
Symptoms: Alanine aminotransferase increased, Angiomyolipoma, Blood alkaline phosphatase increased, Body temperature increased, Chest X-ray normal, Epstein-Barr virus antibody positive, Hepatic steatosis, Incorrect route of drug administration, Laboratory test normal, Pyrexia, Ultrasound scan abnormal, Urine analysis normal
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Biliary system related investigations, signs and symptoms (broad), Medication errors (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: LIPITOR; OGEN
Current Illness: Drug hypersensitivity
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: chest X-ray, 07/26/07, negat; diagnostic laboratory, 07/26?/07, negative; body temp, 07/16?/07, 101.9 degre; urinalysis, 07/26/07, negat; body temp, 07/26?/07, 98.6 degre; body temp, 07/26/07, 101.2 degre; hepatic ultrasound, 08/06?07, steatosis; renal computed axial, 08/10/07, 2 cm apparent angiomyolipoma; hepatic ultrasound, 08/06/07, right renal nodule 2.2 x 2.2 x 2.3 cm; serum Epstein-Barr VCA, 08/02/07, positive; serum aspartate, 08/06/07, 46; serum alanine, 08/06/07, 69; serum alkaline, 08/06/07, 169; serum Epstein-Barr VCA, 08/02/07, positive
CDC Split Type: waes0707usa04312

Write-up: Information has been received from a nurse concerning a 62 year old female with an allergy to BENADRYL who on 16-JUL-2007 was vaccinated intramuscularly in the right deltoid, with a first dose of Zostavax (Oka/Merck) (Lot#657765/0585U). The patient developed a "fever of 101 degrees" days after receiving the vaccination. Unspecified medical attention was sought. There was no other information provided. There was no product quality complaint involved. Follow up information indicated that the patient began running a low grade fever on the night of vaccination. (previously reported as days after vaccination) the patient had a maximum fever of 101.9 degrees Fahrenheit. The fever persisted for several days until the patient was seen in the office on 26-JUL-2007. Her temperature was 101.2 degrees that morning, but after being treated with TYLENOL in the office her temperature dropped to 98.6 degrees. Urinalysis, unspecified labs and chest x-ray taken in the emergency room were all negative. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Follow up information received from the nurse indicated that Epstein Barr IGG and IGM studies were positive, but there was the possibility of cross-reactivity with the varicella zoster antibodies. Other lab studies of alkaline phosphatase, ALT< and AST were improving. The transaminitis was normalizing. The patient had a liver sonogram which was consistent with steatosis. Also noted in the study was a 2.2x2.2x2.3 cm right renal nodule. The patient had a CAT scan of the right kidney which revealed a 2-cm apparent angiomyolipoma. There was no illness at the time of vaccination. Additional information is not expected.


VAERS ID: 294937 (history)  
Form: Version 1.0  
Age: 70.0  
Gender: Female  
Location: Georgia  
Vaccinated:2007-07-16
Onset:2007-07-20
   Days after vaccination:4
Submitted: 2007-09-24
   Days after onset:66
Entered: 2007-09-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Breast pain, Herpes zoster
SMQs:, Lipodystrophy (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: COUMADIN
Current Illness:
Preexisting Conditions: Stroke
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0707USA03555

Write-up: Information has been received from a physician concerning an approximately 70 year old female with a history of strokes and no known allergies who during the week of 16-JUL-2007 was vaccinated subcutaneously with a 0.5 ml dose of Zostavax (Oka/Merck). Concomitant therapy included COUMADIN. On 20-JUL-2007 the patient returned to the office with a characteristic shingles rash with pain on her left breast. No labs were performed. At the time of this report the patient had not recovered. No additional information was provided. There was no product quality complaint involved. Additional information has been requested.


VAERS ID: 294946 (history)  
Form: Version 1.0  
Age: 76.0  
Gender: Female  
Location: North Dakota  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-09-24
   Days after onset:69
Entered: 2007-09-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0584U / UNK UN / SC

Administered by: Other       Purchased by: Other
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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0707USA03614

Write-up: Information has been received from a pharmacist concerning a 76 year old female with no allergies who on 16-JUL-2007 was vaccinated SC in the left upper arm with a dose of Zostavax (Oka/Merck) (lot # 657764/0584U). On 17-JUL-2007, one day after administration, the patient developed redness, warmth, soreness, and swelling at the injection site. The pharmacist suggested the use of ibuprofen and the application of ice compresses to the affected area. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. No further information is available.


VAERS ID: 294950 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-09-24
   Days after onset:69
Entered: 2007-09-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Herpes zoster, Pain, Rash pruritic
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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0707USA03682

Write-up: Information has been received from a female patient who on 16-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck). It was reported that on 17-JUL-2007 night the patient had an itchy bump on her left shoulder. On 18-JUL-2007 night, the patient developed shingles on left shoulder and left breast. The patient described it as "quite unsightly" and a painful itching mess. On 19-JUL-2007 the patient saw the physician.


VAERS ID: 291629 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Texas  
Vaccinated:2007-07-16
Onset:2007-07-20
   Days after vaccination:4
Submitted: 2007-09-19
   Days after onset:61
Entered: 2007-09-28
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2655AA / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1415F / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0547 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B26510H / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Breast feeding, Crying, Irritability, Musculoskeletal stiffness, Screaming, Vomiting
SMQs:, Acute pancreatitis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), 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: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: On 7-20-07 He started vomiting appropriately 10-12x/ day. No diarrhea still was vomiting on 7/22 and started screaming and crying inconsolably. His abdomen moved get tight and extremities, would get stiff. Had Pedialyte for 2 feeding vomiting decrease but still fussy and irritable. By 7-23-07 was keeping 1/2str and Full str breast milk down and vomiting had stopped, but was still irritable.


VAERS ID: 298135 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-10-12
   Days after onset:88
Entered: 2007-10-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0802U / 1 RA / IM

Administered by: Private       Purchased by: Other
Symptoms: Asthenia, Blood pressure normal, Dizziness, Heart rate normal, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 07/16/07, 100/68 after syncope; total heartbeat count, 07/16/07, 76 post syncope
CDC Split Type: WAES0709USA01480

Write-up: Information has been received from a Registered Nurse (R.N.) concerning a female patient with penicillin allergy who on 16-JUL-2007 was vaccinated IM into the right arm with a first dose of Gardasil lot #658490/0802U. The nurse reported that the patient went out to the waiting room and fainted after she got her first injection. They gave client cold compress and took her blood pressure which was normal, and monitored her in the waiting room for 15 to 20 minutes. The patient recovered quickly. Additional information has been requested. 01/07/2008 This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a female student with penicillin allergy (rash) who on 16-JUL-2007, at 10:45 AM was vaccinated IM into the right deltoid with a first dose of GARDASIL lot #658490/0802U. The nurse reported that the patient went out to the waiting room and fainted after she got her first injection. In follow up it was reported that patient became dizzy, weak and had syncopal attack after the injection lasting few seconds. They gave client cold compress and took her blood pressure which was normal, and monitored her in the waiting room for 15 to 20 minutes. In follow up it was reported that her blood pressure (BP) was 100/68 and total heartbeat was 76. She was then watched for 15 minutes and then went home walking. The patient recovered quickly on 16-JUL-2007. Additional information is not expected.


VAERS ID: 298601 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2007-10-12
   Days after onset:88
Entered: 2007-10-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0524U / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Palpitations, Presyncope
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Cough; Sinusitis
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Blood pressure, 07/16/2007, 114/6; Total heartbeat count; 07/16/07, 66; Respiratory rate, 07/16/07, 22; Temperature measurement, 07/16/07, 35.4 celcius; Pulse oximetry, 07/16/07, 98%
CDC Split Type: WAES0709USA03772

Write-up: Information has been received from a registered nurse concerning a 16 year old female with no pertinent medical history who on 16-JUL-2007 was vaccinated with a 0.5 ml first dose of Gardasil (Lot #658094/0524U). There was no concomitant medication. On 16-JUL-2007 the patient almost fainted. The patient went home and later that evening, the patient experienced abdominal pain that lasted for one hour. The patient also experienced This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a registered nurse concerning a 16 year old non smoking female with sinusitis and a cough (for 4 weeks) being treated with AUGMENTIN at the time of vaccination who on 15-JUL-2003 at 6:30 pm was vaccinated intramuscularly into the right upper arm with a 0.5 ml first dose of GARDASIL (Lot #658094/0524U). On the same day at 6:30 pm, the patient was vaccinated intramuscularly into the left upper arm with a first dose of MENACTRA (Lot #02366A). On 16-JUL-2007 the patient almost fainted. The patient''s mom called the office and reported that the patient had a reaction to GARDASIL. At 10:00 pm on the night of vaccination the patient doubled over crying with stomach pain. She complained of feeling her heart race at the same time. Teh mother stated that the patient reported her heart felt like it was racing only during the time she was crying (approximately 15-20 minutes) By the time they arrived to the emergency room (ER) the patient had calmed down and the heart rate felt normal. The patient complained of feeling dizzy and nauseated in the ER. The abdominal discomfort lasted approximately one hour and then was completely gone. The mother reported that the ER did nothing except monitor the patient for the short time. Her blood pressure was 114/64, pulse was 66, pulse oxygenation was 98 percent, respiration was 22 and temperature was 35. 4 celcius. On 16-JUL-2007, the patient recovered and was sent her home. Additional information has been requested.


VAERS ID: 300165 (history)  
Form: Version 1.0  
Age: 25.0  
Gender: Female  
Location: Hawaii  
Vaccinated:2007-07-16
Onset:2007-07-23
   Days after vaccination:7
Submitted: 2007-11-14
   Days after onset:114
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Rash generalised, Skin warm
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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0710USA02716

Write-up: Information has been received from a health professional concerning a 26 year old female, with no known allergies, who on 16-JUL-2007 was vaccinated with a first dose of Gardasil vaccine. Concomitant therapy included Yasmin. On approximately 23-JUL-2007, the patient developed a rash over her entire body. The rash became worse and was red and warm to the touch. She was seeing a dermatologist and allergist for treatment. Additional information has been requested.


VAERS ID: 300111 (history)  
Form: Version 1.0  
Age: 0.1  
Gender: Male  
Location: Illinois  
Vaccinated:2007-07-16
Onset:2007-07-18
   Days after vaccination:2
Submitted: 2007-12-11
   Days after onset:146
Entered: 2007-12-17
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0494U / 1 - / -

Administered by: Private       Purchased by: Private
Symptoms: Decreased appetite, Feeling hot, Wrong drug administered
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: 48 hours after mistakenly received Hepatitis A instead of Hepatitis B vaccination at one month visit, baby had low appetite, seemed uncomfortable, felt warm (no temperature taken). Did fine by the next day. Discovered mistaken Hepatitis A for B at next visit.


VAERS ID: 300507 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Male  
Location: Illinois  
Vaccinated:2007-07-16
Onset:0000-00-00
Submitted: 2007-08-28
Entered: 2007-12-17
   Days after submission:111
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2370A / UNK LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Chest pain, Chills, Headache, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: The patient had no illnesses at the time of vaccination on 16/July2007
Preexisting Conditions: Allergic to "PCN" (penicillin) and Cephalosporins.
Allergies:
Diagnostic Lab Data: None
CDC Split Type: 200702556

Write-up: This case was received from a health professional on 17 July 2007. A 20-year-old male patient with no reported medical history received an intramuscular left deltoid injection of Menactra (lot number U2370AA). Approximately 12 hours later, he experienced chest pain, headache, malaise, chills, and a fever of 102 degrees Fahrenheit. He was seen in his physician''s office on 17 July 2007, and was treated with Advil. At the time of the report, the event was resolving. Follow-up information received on 27 August 2007 from a health care professional. The patient has medical history of allergy to "PCN" (penicillin) and Cephalosporins. He had no illnesses at the time of the Menactra vaccination on 16 July 2007. The patient had no relevant diagnostic tests or laboratory data performed for the reported events in this case. It was reported the patient recovered from the events, however a recovery date was not provided. No further information is expected.


VAERS ID: 300676 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-07-16
Onset:2007-07-24
   Days after vaccination:8
Submitted: 2007-12-14
   Days after onset:143
Entered: 2007-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0524U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema nodosum
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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0711USA01679

Write-up: Information has been received from a physician concerning a 15 year old female who on 16-JUL-2007 was vaccinated with Gardasil (Lot no. 658094/0524U). Concomitant therapy included Menactra. On 24-JUL-2007 the patient experienced "erythrocythemia nodosum" The patient sought medical attention. Additional information has been requested.


VAERS ID: 301788 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2008-01-07
   Days after onset:175
Entered: 2008-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0523U / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pharyngeal oedema, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (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: DEPACOTE, LAMICTAL, SEASONAL
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PT RECEIVED HER FIRST GARDASIL ON 7/16/2007. WHILE PT WAS AT THE OFFICE HAD NO COMPLAINTS. SHE HAD THE GARDASIL WHILE AWAY AT COLLEGE. SHE RETURNED TO US LAST WEEK FOR FU AND REPORTED THAT AFTER BOTH 1ST & 2ND INJECTIONS SHE HAD HIVES AND THROAT SWELLING.


VAERS ID: 304098 (history)  
Form: Version 1.0  
Age: 43.0  
Gender: Female  
Location: Illinois  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2007-07-20
   Days after onset:3
Entered: 2008-01-29
   Days after submission:193
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHB7B287AA / UNK RA / IM
TD: TD ADSORBED (NO BRAND NAME) / MASS. PUB HLTH BIOL LAB TD168 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular 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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: AE0729

Write-up: Patient received Td and Hepatitis B vaccines, as well as the PPD test, on 07/16/07 and on 07/17/07 experienced fever of 102.2 and dizziness. Patient noted that she always gets dizzy when she gets a fever. On 07/18/07 patient went to the doctor''s office for a follow up visit, felt much better and fever was gone.


VAERS ID: 304653 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Male  
Location: Nevada  
Vaccinated:2007-07-16
Onset:2008-01-18
   Days after vaccination:186
Submitted: 2008-02-06
   Days after onset:19
Entered: 2008-02-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C2606AA / 4 LL / IM
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER 0800U / 2 LL / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER 200AA / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER 0284U / 2 RL / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2139A / 2 RL / IM
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER 1294F / 2 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase normal, Blood albumin normal, Blood bicarbonate decreased, Blood calcium decreased, Blood chloride increased, Blood creatinine increased, Blood glucose decreased, Blood glucose increased, Blood ketone body increased, Blood phosphorus, Blood potassium increased, Blood pressure, Blood sodium normal, Blood thyroid stimulating hormone decreased, Blood urea increased, Blood urea nitrogen/creatinine ratio increased, C-reactive protein normal, Carbon dioxide abnormal, Carbon dioxide decreased, Chest X-ray normal, Conjunctivitis, Crying, Decreased activity, Dehydration, Diabetes mellitus, Diabetic ketoacidosis, Fatigue, Glycosylated haemoglobin increased, Haematocrit increased, Hyperglycaemia, Irritability, Mucosal dryness, Oral intake reduced, Oxygen saturation normal, Pallor, Platelet count increased, Pollakiuria, Pyrexia, Red blood cell sedimentation rate increased, Somnolence, Thirst, Urine ketone body present, Vomiting, Weight decreased, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Depression (excl suicide and self injury) (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Infective pneumonia (broad), Dehydration (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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None reported
Allergies:
Diagnostic Lab Data: 18/Jan/2008: (ER laboratory results) - Blood glucose (703); bicarbonate (17); moderate ketones in blood and urine; WBC (9.9); hematocrit (47.5%); platelets (589,000); sed rate (elevated; 77); sodium (138); potassium (4.7); chloride (96); CO2 (19); BUN (22); creatinine (0.9); calcium (9.3); albumin (4.5); AST (46); ALT slightly elevated (43); acetone (moderate); CRP (<0.5); TSH (1.14). 18/Jan/2008: Chest X-ray: no cardiopulmonary disease. 18/Jan/2008 14:55 - high/low abnormal results: glucose 377(H); BUN/CRT ratio 28.0(H); calcium 6.4(L); potassium 8.8(H); chloride 119(H); CO2 12(L); HgbA1C 11.6(H). 18/Jan/2008 16:10 - high/low abnormal results: glucose 289(H); BUN/CRT ratio 22.9(H); CO2 20(L). 18/Jan/2008 21:10 - glucose 113(H); all other tests normal ranges. 19/Jan/2008 06:00 - high/low abnormal results: glucose 58(L); creatinine 0.4(L); potassium 3.4(L); phosphorus 4.6(H).
CDC Split Type: 200800278

Write-up: Initial report received on 28 January 2008 from an investigator participating in a trial under the reference number MTA44. An 18-month-old male subject developed hyperglycemia 186 days after he received a right thigh intramuscular dose of Menactra, lot number U2139AA. During a follow-up office visit on 15 October 2007, the subject also received an intramuscular injection of DTAP, lot number C2606AA, an intramuscular injection of Hib, lot number 200AA, an intramuscular injection of MMR, lot number 0284U, an intramuscular injection of Varicella, lot number 1249F and an intramuscular injection of Hepatitis A, lot number 0800U. The subject had no reported medical history. On 15 January 2008, 183 days after receiving the vaccine, the subject experienced decreased activity. The subject subsequently began to experience vomiting on 17 January 2008 leading to hospitalization the following day on 18 January 2008. According to hospital records received, the subject began to experience some weight loss, vomiting, and decreased p.o. intake and had been a little bit sleepier, beginning two to three days prior to admission. He had been drinking significant amounts and had significant urination with many diaper changes every day. On the day prior to admission, the subject had been seen by their primary care physician. They had been diagnosed with conjunctivitis, and had been sent home with some eye drops and a "slip for blood draw if the parents felt that they wanted to follow up on his labs per the parents. They (the parents) note that the doctor said that they could check for labs but did not have to". The subject reportedly had a low grade fever outside the emergency department but had been negative for cough, congestion, runny nose and diarrhea. ER physical assessment findings; temperature 96.7 degrees Fahrenheit, pulse 120, respiratory rate 26, blood pressure 120/92 with crying; saturation 98% room air, slightly dry mucous membranes, slightly pale skin, alert and arousable but appeared tired, fussy and irritable. Laboratory results revealed blood glucose levels at 703, with a bicarbonate of 17 and moderate ketones in the blood and urine, WBC (9.9), Hematocrit (47.5%), platelets (589,000), sed rate (elevated; 77), sodium (138), potassium (4.7), chloride (96), CO2 (19), BUN (22), creatinine (0.9), calcium (9.3), albumin (4.5), AST (46), ALT slightly elevated (43), acetone (moderate), CRP (<0.5) and TSH (1.14). The subject was administered IV fluids normal saline 10 ml per kilo x1 and started on IV fluids with normal saline and KCL 20 mEq per liter at approximately 2 times maintenance. The ER physician''s final impression indicated the subject had dehydration, likely due to diabetic ketoacidosis as the patient had ketoacidosis and new onset diabetes type I. The subject was then transferred to a pediatric intensive care unit (PICU). While in the PICU, an insulin drip was started and glucose was monitored hourly. On 19 January 2008, the subject''s chemistries normalized and the subject was found to be ketone negative. Sugars were well under control and the insulin drip was transitioned to subcutaneous insulin and prior IV fluids were heparin locked. Lantus was started that evening, with insulin to carb ratios, based on the subject''s size and age. The parents were educated about diabetes management and the subject was discharged on 23 January 2008 with instructions to continue with 4 units of Lantus subcutaneously nightly, and to follow the prescribed insulin to carb ratio diet. The subject was scheduled for follow-up evaluations at one week and four weeks post discharge. According to the hospital summary, the discharge diagnosis was "Diabetic ketoacidosis and new onset diabetes mellitus". According to the investigator, the event was related to the study product and the subject''s recovery status remained ongoing. Documents held by sender: hospital records.


VAERS ID: 307469 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-07-16
Onset:0000-00-00
Submitted: 2008-03-14
Entered: 2008-03-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / UNK - / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0384U / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hypomenorrhoea, Vaccine positive rechallenge
SMQs:, Fertility 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: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA00472

Write-up: Information has been received from a physician concerning a 12 year old female who on 16-JUL-2007 was vaccinated with the first dose (lot number: 657617/0384U), on 20-SEP-2007 with the second dose (lot number: 658282/0929U) and 20-JAN-2008 with the third dose of Gardasil (lot number not provided). Concomitant therapy included VAQTA. It was reported that the patient had "gotten her first period after receiving the vaccine, but it only had lasted for a day." It was also reported that this "also occurred after she had received her second dose of Gardasil, with her period only lasting a day." The patient''s mother was reluctant and didn''t schedule her for her third dose. The patient recovered. On an unspecified date the patient received her third dose. No further information is available. This is in follow up to report(s) previously submitted on 3/14/2008. Informatino has been received from a physician concerning a 12 year old female who on 16-JUL-2007 was vaccinated with the first dose (lot number: 657617/0384U), on 20-SEP-2007 with the second dose: lot number: 658282/0829U) and 20-JAN-2008 with the third dose of GARDASIL (lot number: 058563/1063U). Concomitant therapy included VAQTA. It was reported that the patient had "gotten her first period after receiving the vaccine, but it only had lasted for a day." It was also reported that this "also occurred after she had received her second dose of GARDASIL, with her period only lasting a day." The patient''s mother was reluctant and didn''t schedule her for her third dose. The patient recovered. On an unspecified date the patient received her third dose. Follow-up information was received on 19-Mar-2008 the mom reports that child began first period after dose of 1 of GARDASIL for 1-2 days. Then the second cycle for 1-2 days after 2nd dose of GARDASIL. Mom held off for one month for dose 3 and child had third cycle at time that the third dose was to be received. No further information is available.


VAERS ID: 311900 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Female  
Location: Nebraska  
Vaccinated:2007-07-16
Onset:2007-08-16
   Days after vaccination:31
Submitted: 2008-05-08
   Days after onset:266
Entered: 2008-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0494U / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood glucose increased, Blood ketone body, Diabetic vascular disorder, Ear infection, Type 1 diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)

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:
Preexisting Conditions: PMH: family hx type 1 diabetes & autoimmune diseases. Recurrent ear infections.
Allergies:
Diagnostic Lab Data: Blood glucose levels $g 600 and ketones present LABS: UA on 8/16 w/glucose 2000+, large ketones, sp gr 1.010. Blood glucose 611(H). C-peptide level (L). ICA panel (+). HgbA1c 11.7%(H)
CDC Split Type:

Write-up: Type I Diabetes 6/6/08 Reviewed outpatient clinic records & vax records. FINAL DX: Type 1 diabetes w/peripheral cirvulatory disorder Records indicate that by 8/15 patient having difficulty sleeping, appetite decreased,irritability, polyuria & polydipsia x 2-3 weeks. Referred to peds endocrinologist & started on insulin. Returned to clinic 11/13 for recheck of acute suppurative OM, had completed antibiotics from 2 wks prior. Developed hives 1/8/2008 s/p insulin injection. 6/10/08 Reviewed Endocrinology clinic medical records of 8/16/2007-5/9/2008. FINAL DX: New onset Type 1 diabetes Records reveal patient picky eater, father primary caregiver. Family instructed on insulin & diet. Patient received flu vaccine 10/18/07, no lot # available. Continued w/fair diabetic control, felt would benefit from insulin pump & process started. Follow-up: Patient was diagnosed with Type 1 diabetes 1 month after receiving the Hep A vaccination. The high blood sugar symptoms began within about a week of receiving the vaccine. Type 1 diabetes will never go away. Although we recognize that Type 1 diabetes begins with an inherited susceptibility, we do still believe this vaccine had the environmental trigger that started the diabetes.


VAERS ID: 312072 (history)  
Form: Version 1.0  
Age: 25.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2008-05-09
   Days after onset:298
Entered: 2008-05-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0525U / 2 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Foetal disorder, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (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: None
Current Illness: Pregnancy NOS (LMP = 6/27/2007); Nervous system disorder; Allergic reaction to antibiotics; Penicillin allergy
Preexisting Conditions: Malignant melanoma; Abortion spontaneous
Allergies:
Diagnostic Lab Data: beta-human chorionic, 08/03/07, posit
CDC Split Type: WAES0708USA01488

Write-up: Initial and follow up information has been received through the Merck Pregnancy Registry from a registered nurse concerning a 25 year old female with a history of a spontaneous abortion at five weeks from her last menstrual period and malignant melanoma at age 19, with a dysplastic nervous system, and an allergy to penicillin and an allergic reaction to CECLOR, who on 16-MAY-2007 was vaccinated IM in the left deltoid with a 0.5 ml first dose of Gardasil (lot # 657736/0389U). On 16-JUL-2007 the patient was vaccinated IM in the right deltoid with a 0.5 ml second dose of Gardasil (lot # 658100/0525U). There was no concomitant medication. Subsequently the patient became pregnant. Unspecified medical attention was sought. On 03-AUG-2007 the patient had a positive beta-human chorionic gonadotropin test (unspecified). Her last menstrual period was 27-JUN-2007. The estimated date of delivery was 03-APR-2008. It was reported that the patient had one previous pregnancy and one spontaneous abortion at 5 weeks. At the time of the report, the outcome of the patient was unknown. Follow-up information indicated that 39 weeks from her last menstrual period on 27-MAR-2008 the patient gave birth to a male infant. The infant weighed 7 pounds 6 ounces, was 19.5 inches long, and had an Apgar score of 8/9. It was reported that the infant was normal, with no complications or abnormalities. The infant did develop a minimal cleft lip. Other medications used during the pregnancy were ZITHROMAX for a urinary tract infection, prenatal vitamins, and GYNAZOLE for candida. The reporter considered the minimal cleft lip to be a congenital anomaly. Additional information has been requested.


VAERS ID: 314432 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Male  
Location: Virginia  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2008-05-16
   Days after onset:304
Entered: 2008-05-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0076U / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Erythema, 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0708USA00119

Write-up: Information has been received concerning a 13 year old male who on 16-JUL-2007 was vaccinated subcutaneously in the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot#654282/0776U). On 17-JUL-2007, the patient developed redness and swelling. No further information was provided. Additional information has been requested. This is one of several reports from the same source.


VAERS ID: 315353 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Unknown  
Location: Tennessee  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2008-05-16
   Days after onset:305
Entered: 2008-05-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH CRM197 / UNK UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 657718/0778U / UNK UN / UN

Administered by: Other       Purchased by: Other
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:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0707USA02929

Write-up: Information has been received from a physician concerning a 12 month old patient on 16-JUL-2007 was vaccinated with varicella virus vaccine live (Lot # 657718/0778U). Concomitant therapy included hepatitis A virus vaccine (unspecified) and pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR). On 16-JUL-2007 the patient experienced an injection site reaction from varicella virus vaccine and MMR (655420/0279U) (WAES0709USA03971. The patient developed raised "ring" like wheal on right thigh where the patient received varicella virus vaccine. Diphenhydramine hydrochloride (BENADRYL) was prescribed and on 17-JUL-2007 the patient recovered. Additional information has been requested.


VAERS ID: 315385 (history)  
Form: Version 1.0  
Age: 7.0  
Gender: Male  
Location: Virginia  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2008-05-16
   Days after onset:304
Entered: 2008-05-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0457U / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0707USA04122

Write-up: Information has been received from a nurse concerning an 8 year old white male with no medical history or drug allergies, who on 16-JUL-2007 at 15:30 was vaccinated with his second 0.5ml SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 656692/0457U) in the left arm. On 17-JUL-2007 in the AM, the patient developed redness, itching, and swelling at the injection site. No medical attention was sought. No labs were performed. Subsequently, the patient recovered on 20-JUL-2007. There was no product quality complaint. Additional information has been requested.


VAERS ID: 315398 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2008-05-16
   Days after onset:305
Entered: 2008-05-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / UN
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 2 - / SC

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site rash, Injection site warmth, Pain, Pyrexia, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: WBC count 07/16/07 Norma; body temp 07/17/07 - low grade fever
CDC Split Type: WAES0707USA04383

Write-up: Information has been received from a nurse practitioner concerning an 11 year old female who on 16-JUL-2007 was vaccinated subcutaneously with a second single dose of varicella virus vaccine live (Oka/Merck) (Lot# 657620/0536U). Additional suspect vaccination included Gardasil vaccine (MSD). Other concomitant therapy included Menactra and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). Within 12 hours of being vaccinated the patient developed a severe injection site reaction that continued to become "more severe." The injection site rash was about 7 inches in diameter and wrapped around the patients arm, was warm, hard to touch in the middle and was less red on the outside of the rash. On a follow-up visit to the doctor the next day (on 17-JUL-2007) the patient had a low grade fever and a general feeling of achiness. Nurse practitioner was concerned that the patient might have cellulitis. On the third day following vaccination the patient returned for another follow up visit, the rash had stabilized. It was noted that the nurse practitioner treated the patient with Benadryl. Lab studies for a white blood cell count were normal. No other information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.


VAERS ID: 318274 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2007-07-16
Onset:2007-08-18
   Days after vaccination:33
Submitted: 2008-07-03
   Days after onset:320
Entered: 2008-07-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Premature labour, Urine human chorionic gonadotropin 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? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Albuterol
Current Illness: Pregnancy NOS (LMP = 8/18/2007)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: urine beta-human, 09/17/07, positive HCG, client pregnant
CDC Split Type: WAES0709USA03475

Write-up: Information has been received from the Merck pregnancy registry for GARDASIL from a physician concerning a 17 year old female who on 16-JUL-2007 was first vaccinated with 0.5 ml, GARDASIL. Concomitant therapy included albuterol which the patient used infrequently. On 17-SEP-2007, the patient presented to the office to get her second dose of GARDASIL but a urine test showed positive HCG and the client was pregnant (LMP 18-AUG-2007). The second dose of GARDASIL was not administered. Followup phone call information from a pediatrician reported that the patient had not been back to the pediatrician''s office since she found out she was pregnant. However, the pediatrician was able to report that via their tracking system, it appeared that the patient was still pregnant and had an upcoming appointment. She also reported the patient had been admitted to the hospital for pre-term labor from 28-MAY-2008 to 31-MAY-2008. No outcome information was reported. Additional information has been requested.


VAERS ID: 321498 (history)  
Form: Version 1.0  
Age: 58.0  
Gender: Female  
Location: Virginia  
Vaccinated:2007-07-16
Onset:0000-00-00
Submitted: 2007-09-25
Entered: 2008-07-19
   Days after submission:298
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (NO BRAND NAME) / SANOFI PASTEUR U1856B / UNK LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Headache, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLEGRA, ZANTAC
Current Illness:
Preexisting Conditions: Allergic to penicillin. The patient had no illness at the time of vaccination. Concomitant medications: ALLEGRA AND ZANTAC
Allergies:
Diagnostic Lab Data: None
CDC Split Type: 200702593

Write-up: Initial non-serous report received from a health care professional on 20 July 2007. A 58-year-old female with a history of allergy to penicillin received a left deltoid intramuscular injection of Tetanus Toxoid Adsorbed (Lot number U1856BA) on 10 July 2007 and 48 hours later developed pain, itching and swelling at the injection site. She visited her doctor on 20 July 2007 complaining of swelling of the left deltoid to underarm, headache, achiness, fever and site being warm to touch. The event was treated with erythromycin and hydroxyzine. Recovery status was reported as "not recovered." The patient had no illness at the time of vaccination. No additional details were provided at the time of this report. The initial report also indicated that the office had three additional patients with similar reactions the previous month. At the time of this report, the patients were unidentified and their reactions were not specified. Follow-up information was received from a health care professional on 21 September 2007. Corrections were provided for the date of vaccination and the date of onset for the event. The date of vaccination had been 16 July 2007 and the event was reported to have started on 18 July 2007. The patients recovery status was changed from "not recovered" to "unknown." No additional information was provided.


VAERS ID: 321830 (history)  
Form: Version 1.0  
Age: 74.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-07-16
Onset:2007-07-17
   Days after vaccination:1
Submitted: 2008-07-30
   Days after onset:379
Entered: 2008-08-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1175F / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, 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: FOSAMAX; aspirin; LIPITOR; folic acid; PLAQUENIL; methotrexate; MEDROL; torsemide
Current Illness: Rheumatoid arthritis; Coronary artery disease; Osteoporosis
Preexisting Conditions: Bladder cancer
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0707USA03010

Write-up: Information has been received from a certified medical assistant concerning a 74 year old female with rheumatoid arthritis, coronary artery disease and osteoporosis and a history cancer who on 16-JUL-2007 was vaccinated IM into the left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 655592/1175F). Concomitant therapy included LIPITOR, alendronate sodium (MSD), methotrexate, folic acid, PLAQUENIL, MEDROL, aspirin and torsemide. On 17-JUL-2007, the patient experienced an injection site reaction. Symptoms were described as swelling of the left arm, "hard" and erythema which extended to the elbow. Also, the patient had difficulty in lifting the arm. Unspecified medical treatment was sought. The patient was ordered on ice and TYLENOL. At the time of the report, the patient had not recovered. The medical assistant is requesting a lot check. This is one of three reports from the same source. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.


VAERS ID: 321834 (history)  
Form: Version 1.0  
Age: 61.0  
Gender: Male  
Location: California  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2008-07-30
   Days after onset:380
Entered: 2008-08-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site pain
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: Unknown
Current Illness:
Preexisting Conditions: Lymphoma
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0707USA03601

Write-up: Information has been received from a healthcare worker concerning a 61 year old male with a history of lymphoma with no drug reactions/allergies who on 16-JUL-2007 was vaccinated with PNEUMOVAX 23 (lot # unknown) at another physician office practice. On an unspecified date the patient developed redness and soreness at the injection site. Medical attention was sought. The patient will be following up with his primary care physician. At the time of reporting the patient has not recovered. Additional information has been requested.


VAERS ID: 340745 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Louisiana  
Vaccinated:2007-07-16
Onset:2008-12-22
   Days after vaccination:525
Submitted: 2009-02-13
   Days after onset:53
Entered: 2009-02-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0243U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Full blood count, Protein urine present, Urine human chorionic gonadotropin positive
SMQs:, Acute renal failure (broad), Systemic lupus erythematosus (broad), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (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: YASMIN
Current Illness: Pregnancy NOS (LMP = Unknown) Urinary frequency; Obesity; Hypertension
Preexisting Conditions: Tonsillitis
Allergies:
Diagnostic Lab Data: urinalysis - positive for protein; urine beta-human 12/22/08 - negative; urine beta-human 12/29/08 - positive
CDC Split Type: WAES0901USA00342

Write-up: Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning an 18 year old female with urinary frequency, obesity and hypertension, a history of tonsillitis and no drug allergies who was intramuscularly vaccinated with the first and second 0.5 ml doses of GARDASIL on 16-JUL-2007 and 22-DEC-2008 (1st lot # 656372/0243U, 2nd lot # 651044/0548X), respectively. Concomitant therapy included YASMIN. On 22-DEC-2008 the patient had a negative early pregnancy test and on 29-DEC-2008 it was positive. It was also reported that the urine analysis positive for protein, and a complete blood cell count was performed. No other adverse effects were reported. The patient was seen for medical attention. Additional information has been requested.


VAERS ID: 381328 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-07-16
Onset:2007-07-16
   Days after vaccination:0
Submitted: 2010-02-25
   Days after onset:955
Entered: 2010-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB163AB / UNK LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0243U / UNK RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Acute lymphocytic leukaemia, Biopsy, Biopsy bone marrow, Computerised tomogram, Full blood count, Musculoskeletal pain, Pain in extremity, Smear test
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad), Haematological malignant tumours (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, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: do not remember
Preexisting Conditions: hydrocephalus.
Allergies:
Diagnostic Lab Data: bone marrow report; biopsy; CBC; CT chest, abdomen pelvic w/contrast; aspirate smears; core biopsy; clot section.
CDC Split Type:

Write-up: Pain in L arm and shoulder, lasted to the end of the month. Diagnose with acute lymphoblastic leukemia. Some of T-cells had problem and hospitalization was required.


VAERS ID: 307161 (history)  
Form: Version 1.0  
Age: 26.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-07-16
Onset:2008-02-25
   Days after vaccination:224
Submitted: 2008-03-14
   Days after onset:17
Entered: 2008-03-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0192U / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Injection site pain, Skin burning sensation
SMQs:, Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (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: Ethinyl estradiol/norgestimate (Unknown)
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803CAN00024

Write-up: Information has been received from a 26 year old female pharmacist who on 25-FEB-2008 was vaccinated with the third dose of Gardasil. On 16-JUL-2007 the patient was vaccinated with the first dose of Gardasil (Lot # 0192U/NG27430) and second dose on 27-SEP-2007. Concomitant therapy included ethinyl estradiol/norgestimate (TRI-CYCLEN). On 25-FEB-2008 the patient experienced burning hot pain in the area above the injection site on right arm and it gradually got worse. The pharmacist reported severe radiating burning pain, not being able to move her right arm forward or back enough. The pharmacist was unable to open prescription bottles or lift her right arm above her head. The pain was "initially on a scale from 3 to 4 and now was at 9." The pharmacist also reported if she didn''t move her right arm then she didn''t feel pain but as soon as she moved it she had shooting pain. The pharmacist mentioned that she did not have any problems with the first and second dose of Gardasil. The patient''s burning hot pain in the area above the injection site and burning hot pain in the area above the injection site persisted. Burning hot pain in the area above the injection site and burning hot pain in the area above the injection site were considered to be disabling. Additional information has been requested.


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