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Case Details (Sorted by Age)

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VAERS ID: 254455 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Puerto Rico  
Vaccinated:1991-01-26
Onset:1991-01-26
   Days after vaccination:0
Submitted: 2006-05-20
   Days after onset:5592
Entered: 2006-04-24
   Days after submission:26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS UNK / UNK UN / -

Administered by: Military       Purchased by: Military
Symptoms: Abdominal pain, Arthralgia, Back pain, Bone disorder, Eye pain, Headache, Hearing impaired, Influenza like illness, Muscle spasms, Myalgia, Pain, Pharyngitis, Rhinitis, Visual disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Oropharyngeal infections (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hearing impairment (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Abdominal pain, aches bone, aches joints, aches joints and muscles, cramps legs, cold and flu like symptoms, headaches, hearing problems, visions problem, pain legs, knee and hips, pain lower back pain eye, pain back.


VAERS ID: 254457 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Idaho  
Vaccinated:2006-04-18
Onset:2006-04-19
   Days after vaccination:1
Submitted: 2006-04-24
   Days after onset:5
Entered: 2006-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2454AA / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Lymphadenopathy
SMQs:, Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Tdap in Right arm 4/18/2006 -reported redness around noon an 4/19/2006. 4/20/2006 1 1/2" diameter redness on right arm, tenderness to axillary area with lymph nodes swollen approximately 1/4" diameter per report. Denies fever.


VAERS ID: 254520 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Georgia  
Vaccinated:2006-04-08
Onset:2006-04-08
   Days after vaccination:0
Submitted: 2006-04-21
   Days after onset:13
Entered: 2006-04-25
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Arthralgia, Cardiomegaly, Fatigue, Haemoptysis, Laboratory test abnormal, Pain, Pleural effusion, Pulmonary infarction, Pyrexia
SMQs:, Cardiac failure (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Percocet, Decadron tablets.
Current Illness:
Preexisting Conditions: Sickle cell anemia, Hospitalization.
Allergies:
Diagnostic Lab Data: Abnormal CXR''s & thoracic ultrasound. WBC elevated. Low H&H. Low Na & K.
CDC Split Type: WAES0604USA01757

Write-up: Information has been received from the mother of a 22 year old hospitalized female with sickle cell anemia and no allergies who on 4/8/2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine, for sickle cell anemia. Concomitant therapy included dexamethasone (manufacturer unknown) and acetaminophen oxycodone hydrochloride (Percocet). It was noted that the patient was hospitalized for her sickle cell anemia. On 4/8/2006 she was released after receiving the pneumococcal 23v polysaccharide vaccine. On 4/8/2006, at bed time, the patient experienced fever, soreness and tiredness. On 4/9/2006 the patient was again hospitalized. At the time of the report, the patient was hospitalized and considered to be not recovered. Additional information has been requested. 5/11/06 Received hospital medical records which reveal patient was hospitalized 4/5/06 w/dx sickle cell crises, hypokalemia & leukocytosis. Hematologist found patient to have severe & symptomatic vaso-occlusive crisis, jaundice, fever & leukocytosis. Received pneumovax prior to d/c on 4/8/06. Readmitted on 4/9/06 w/recurrent sickle cell crises. CXR 4/13 revealed RLL consolidation & cardiomegaly. Thoracic US revealed right side pleural effusion vs empyema. Cardiologist noted +S4. Chest tube inserted RLL. ID consult done. CXR revealed diffuse bilateral interstitial infiltrate. Dx made of acute chest syndrome & patient received exchange transfusion to which she responded very well but CXR showed RLL consolidation & dx w/pulmonary infarct. Received IV antibiotics & partially resolved. D/C home 4/20/06./ss


VAERS ID: 254824 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Colorado  
Vaccinated:2006-04-18
Onset:2006-04-18
   Days after vaccination:0
Submitted: 2006-04-28
   Days after onset:10
Entered: 2006-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 229AA / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Asthenia, Dizziness, Face oedema, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Inoc. 4/18/06: pt left work with pain in shoulder (front and back) weak and nausea. 4/19/2006 continued weakness and nausea, lightheaded and dizzy. 4/20/06 upper lip swollen until 4/21/06 even after 2 Benadryl. Saw Dr 4/26/06.


VAERS ID: 254808 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Wisconsin  
Vaccinated:2003-10-01
Onset:2006-10-15
   Days after vaccination:1110
Submitted: 2006-04-30
   Days after onset:168
Entered: 2006-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / 1 NS / IN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Rhinitis allergic
SMQs:, Hypersensitivity (narrow)

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

Write-up: Increased symptoms of seasonal rhinitis every year after receiving FluMist vaccine. Treatment with Perscription Zyrtec effective.


VAERS ID: 255063 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2006-04-25
Onset:2006-04-26
   Days after vaccination:1
Submitted: 2006-04-27
   Days after onset:1
Entered: 2006-05-04
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / AVENTIS PASTEUR U1618CA / UNK RA / -

Administered by: Public       Purchased by: Other
Symptoms: Diarrhoea, Dizziness, Headache, Hypokinesia, Injection site induration, Injection site oedema, Injection site pain, Injection site warmth, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Oral birth control
Current Illness:
Preexisting Conditions: Recent diagnosis of Gluten allergy.
Allergies:
Diagnostic Lab Data: Blood test (drawn) either on 4/19/06 or 4/20/06 unknown reason for blood drawn.
CDC Split Type:

Write-up: 04/26/06 am right arm site of injection warm to touch, pain, swollen at site of injection, 1/2 inch induration, unable to move arm. 4/26/06 pm body aches, nausea, dizzy, fever, diarrhea, headache. Pt also started oral Typhoid vaccination on 4/24/06 (1 dose).


VAERS ID: 255308 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Alabama  
Vaccinated:2006-04-17
Onset:2006-04-18
   Days after vaccination:1
Submitted: 2006-05-10
   Days after onset:22
Entered: 2006-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB229AA / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pruritus, Rash erythematous, Rash pustular
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: Ortho Tricyclen Birth Control Pilld
Current Illness: none
Preexisting Conditions: none known
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: devoloped rash (red, raised, with pustules)and severe itching 1-3 days after vaccine. She was treated by primary care physician 05-03-06 with Decadron and Benadryl.


VAERS ID: 255441 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Alaska  
Vaccinated:2006-04-14
Onset:2006-04-22
   Days after vaccination:8
Submitted: 2006-05-11
   Days after onset:19
Entered: 2006-05-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHA00043CC / 2 RA / UN
HEPA: HEP A (VAQTA) / MERCK & CO. INC. AHA00043CC / 2 RA / UN
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020072 / 1 LA / -

Administered by: Military       Purchased by: Military
Symptoms: Headache, Injection site reaction, Malaise
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: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 24 y/o male, presents with multiple erythemic papules 3cm in diameter across trunk. Pt had H/A and malaise. Site was robust with enlarged lesion.


VAERS ID: 255819 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Georgia  
Vaccinated:2006-05-01
Onset:2006-05-12
   Days after vaccination:11
Submitted: 2006-05-13
   Days after onset:1
Entered: 2006-05-19
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK RA / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK RA / IM
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020072 / 1 LA / -

Administered by: Military       Purchased by: Military
Symptoms: Aspartate aminotransferase increased, Chest pain, Electrocardiogram abnormal, Hypokinesia, Laboratory test abnormal, Myocarditis, Red blood cell sedimentation rate increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PPD
Current Illness:
Preexisting Conditions: Medical records state cold, cough, fever. msv
Allergies:
Diagnostic Lab Data: EKG ST increase, V5 V6, increased troponin, Echo Global hypokinesis. Medical records state increased ERS, elevated AST. msv
CDC Split Type:

Write-up: 23 year old male who presented with chest pain 11 days following his smallpox immunization. EKG and echo are consistent with mild myocarditis. Pt is being transferred to hospital. Per 60 day follow up: After the patient left foreign country to return to the US, I have not heard any further reports about this patient. I am unsure of where he is at this time.


VAERS ID: 257854 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Michigan  
Vaccinated:2004-07-28
Onset:2004-07-28
   Days after vaccination:0
Submitted: 2006-06-19
   Days after onset:691
Entered: 2006-05-22
   Days after submission:28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Pregnancy NOS (LMP-5/22/04)
Allergies:
Diagnostic Lab Data: Ultrasound on 10/15/04 and 12/16/04-results not reported; beta-human chorionic-positive
CDC Split Type: WAES0409USA00470

Write-up: Info has been received from a health professional concerning a 23 year old white female who on 7/28/04 was vaccinated with a dose of MMRII. Subsequently, the pt became pregnant (LMP 5/22/04). The pt had no prior pregnancies. The pt took prenatal vitamins during her pregnancy. The pt had ultrasounds on 10/15/04 and on 12/16/04 (results not reported). The pt had an upper respiratory infection 19 weeks from LMP and on 2/11/05. At 19 weeks LMP the pt was given azithromycin (Zithromax), "Z-pack", butoconazole nitrate (Gynezol), terconarole (Terazol). The pt had a viral GI upset in 12/04. In 2/05, the pt had taken metoclopramide hydrochloride (Reglan) (10 mg), promethazine hydrochloride (Phenergan), and benzonatate (Tessalon). On 3/1/05 (40 weeks from LMP) the pt gave birth to a normal 6 lb 9 oz male. There were no complications and no congenital anomalies. No further info is available.


VAERS ID: 256134 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Illinois  
Vaccinated:2006-04-04
Onset:0000-00-00
Submitted: 2006-05-23
Entered: 2006-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0728R / UNK LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Medication error
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: birth control pill
Current Illness: none
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Client requested MMR currently taking birth control pills. Client finds out later that she was 4 weeks pregnant at time of vaccination.


VAERS ID: 256369 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Michigan  
Vaccinated:2006-05-12
Onset:2006-05-14
   Days after vaccination:2
Submitted: 2006-05-19
   Days after onset:5
Entered: 2006-05-24
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS 043BA / 3 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Benadryl, Allegra, Cortisone cream, BCP.
Current Illness: NONE
Preexisting Conditions: Cats, tree sap
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Red papular rash. Employee states it began on 5/14/06. By 05/18/2006 rash was just on chest. Had been taking Benadryl25mg every 4-6 hrs. Had a script for Allegra for another issue from her personal Dr was not taking it. On 05/19/06 Dr advised. Allegra qd and Medrol dose pack.


VAERS ID: 256429 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2006-05-02
Onset:2006-05-02
   Days after vaccination:0
Submitted: 2006-05-24
   Days after onset:22
Entered: 2006-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C245AA / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pain, Shoulder pain
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Pt. has allergy to PCN, makes her break out in rash, "red bumps"; Otherwise she is a very healthy & health conscious student.
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt. stopped by 5/11/2006 with complaint of recurrent pain in left arm/shoulder. She described the change in pain from the initial day following her Tdap/Adacel IM injection until this visit. She described it as hurting for approximately 3-4 days (improved when she took Advil), then the pain subsided for approximately 3 days and then it began hurting severely again the past few days. When questioned about the pain, she said the pain was a sharp pain from her shoulder to her collar bone & that was most painful when lifting something up, pushing & pulling with a bent elbow or when she was swimming laps. Questioned further regarding swimming & this is her routine form of exercise, regular exercise is 80 laps/day. She "gradually" worked back to her routine by one day of 40 laps and one day of 80 laps, between the 40 & the 80 is when her pain soared from mild to severe. We developed a plan of 40 laps/one week, then 60 times one week, then return to 80 laps in the third week. Shoulder therapy: Warm up in the morning with heat as need and ice at the end of the work out. Medicate: Motrin/Advil 400-600 twice daily for 1 week. Mantoux Skin Test given at the same time using 0.1 mm dose (TB syringe/needle). Given in left forearm, no reaction noted after 48 hours.


VAERS ID: 257644 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: New York  
Vaccinated:2006-05-26
Onset:2006-05-26
   Days after vaccination:0
Submitted: 2006-05-26
   Days after onset:0
Entered: 2006-06-02
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB058AA / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR UE519AA / 1 LA / SC
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UB630AA / 1 RA / SC

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

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

Write-up: Syncope X 2, after all 3 shots given. Tx: oxygen, apple juice


VAERS ID: 258082 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Iowa  
Vaccinated:2006-04-26
Onset:2006-04-26
   Days after vaccination:0
Submitted: 2006-04-26
   Days after onset:0
Entered: 2006-06-07
   Days after submission:42
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0148F / 2 LA / SC

Administered by: Public       Purchased by: Other
Symptoms: Blood pressure decreased, Difficulty in walking, Hypoaesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (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: NONE
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: C/o feeling numb, as if she can''t walk. Sat down BPC 10:20 AM 98/52-60-12 at 10:32 BP 102/68, 12/18 after lying down for 10/12 minutes felt much better.


VAERS ID: 258199 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2004-02-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2006-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Arthralgia, Bone pain, Chest pain, Cough, Headache, Myalgia, Pain in extremity, Paraesthesia, Pyrexia, Rash, Sinusitis, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Hypersensitivity (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Aches joints and muscles, fever, headache continuous, cough, vomiting, pain stomach, pain chest, pain knees and hips, pain elbow and shoulder, pain bone and joint, pain in feet like electrical shocks, skin rashes, extremely painful, sinus nasal continuous,


VAERS ID: 258275 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Ohio  
Vaccinated:2006-05-11
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2006-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / MASS. PUB HLTH BIOL LAB TD142 / UNK LA / IM

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

Write-up: 24 hours after vaccine, slight erythema. At 144 hours, 2" induration with erythema, pain.


VAERS ID: 258521 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Maryland  
Vaccinated:2006-05-21
Onset:2006-05-23
   Days after vaccination:2
Submitted: 2006-06-16
   Days after onset:24
Entered: 2006-06-19
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UE631AA / 2 - / -

Administered by: Military       Purchased by: Military
Symptoms: Blister, Erythema, Pruritus, Swelling
SMQs:, Severe cutaneous adverse reactions (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No tests or labs done. Treated with Prednisone 40mg 1 tab po x 7 days. Allegra 180mg tab po q d and Benadryl 50mg 1 tab po HS. RTC in 1 week for evaluation.
CDC Split Type:

Write-up: Description: Large area of redness with blisters, swelling and itchy of upper arm 2 days after receiving yellow fever vaccine. Denies fever, SOB, chest or joint pains, headache, nausea or vomiting. Reports slight amount of swelling evening of the injection that progressed the following day to include advance of the redness and swelling from triceps area to just below his elbow with blister formation along the outer aspect of his arm. Also had 3 blisters along inner aspect of the arm with redness extending upward to @ 4 inches below left axilla.


VAERS ID: 258542 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2006-05-31
Onset:2006-05-31
   Days after vaccination:0
Submitted: 2006-06-02
   Days after onset:2
Entered: 2006-06-19
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0253F / 1 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Injection site urticaria, Nausea, Pruritus
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: After this episode, pt states similar reaction to PCN and Shellfish.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approximately, 20 minutes after receiving MMR vaccine, pt c/o itching all over and nausea. Urticaria found at injection site and her abdomen. Pt was taken to her PMD and received "an injection" and diphenhydramine capsules. Client states sx resolved within an hour and was released.


VAERS ID: 258759 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2006-06-20
Onset:2006-06-23
   Days after vaccination:3
Submitted: 2006-06-23
   Days after onset:0
Entered: 2006-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2151AC / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Type III immune complex mediated reaction
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: verapamil 240 mg BID dyazide 50/25 qd propanolol 80 mg daily zomig prn vicodin es 1-2 q 6 hours prn
Current Illness:
Preexisting Conditions: amoxil, codeine
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: ARTHUS REACTION DAY 3 AFTER INJECTION ABX


VAERS ID: 259139 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: California  
Vaccinated:2006-06-08
Onset:2006-06-09
   Days after vaccination:1
Submitted: 2006-06-14
   Days after onset:5
Entered: 2006-07-05
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2340AA / 1 LA / -

Administered by: Other       Purchased by: Other
Symptoms: Hypokinesia, Injection site oedema, Injection site pain
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (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: UNK
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Swelling of injection site L deltoid, pain of injection site L deltoid, difficulty moving arm.


VAERS ID: 259196 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2006-06-08
Onset:2006-06-16
   Days after vaccination:8
Submitted: 2006-07-05
   Days after onset:19
Entered: 2006-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB043AB / 2 - / -
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020072 / 1 - / -
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z0042 / 1 - / -

Administered by: Military       Purchased by: Military
Symptoms: Cellulitis, Dehydration, Erythema, Fatigue, Influenza like illness, Laboratory test abnormal, Malaise, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Keflex QID; Percocet prn pain; Both meds given 1-2 days prior to hospitalization.
Current Illness: None
Preexisting Conditions: Allergic to sulfur.
Allergies:
Diagnostic Lab Data: Labs: CBC (done 6/21-22/06): WBC 6.6, hbg 14.8; hct 42.5%, plt 186k. Machine differential: naut 66%, lymphs 17.7%. Monos 14%. All absolute counts were normal. LFTs: AST 60, ALT 107; Monospot negative.
CDC Split Type:

Write-up: Pt was inoculated with primary SPV on 6/8/06. He developed flu-like sxs 7-10 days later and went to after hours clinic who diagnosed him with dehydration and eventually cellulitis. He was admitted to hospital on 06/22/06. Symptom: fever -start: 06/16/06, end: 06/20/06. Comment: started about 1 wk after SPV inoculation. Symptom: Flu-like symptoms$g96 hrs. Start: 06/16/06, end: 06/22/06 comment: see HPI. Symptom: Muscle pain start: 6/18/06, end: 06/22/06 comment: reported diffuse muscle aches. Symptom: erythema start: 06/16/06, end: 06/22/06 comment: increased erythema over the left shoulder. Medical records state fatigue, malaise. msv


VAERS ID: 259278 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2006-06-20
Onset:2006-06-20
   Days after vaccination:0
Submitted: 2006-06-26
   Days after onset:6
Entered: 2006-07-07
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1040P / 1 RA / -
TD: TD ADSORBED (NO BRAND NAME) / MASS. PUB HLTH BIOL LAB TD160 / UNK LA / -

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

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

Write-up: Redness, warmth, pain, swelling in right upper arm axillary area.


VAERS ID: 259558 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2003-03-02
Onset:0000-00-00
Submitted: 2006-07-14
Entered: 2006-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS UNK / 2 UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER ENG5444A4 / 4 UN / IM
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER 0981M / 4 UN / IM
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH UNK / 2 UN / -
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UNK / 2 UN / IM

Administered by: Military       Purchased by: Other
Symptoms: Abdominal pain upper, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: They only give me prescription for the burn in my stomach and for the rash they told is nothing, they just gave to me cream (calamine).
CDC Split Type:

Write-up: At this time I have a permanent rash in my left hand, stomach burn fluid, for the stomach give me some prescription (omaproxen) and for my rash give me Calamine I still with the problem. I have 4 shots of anthrax.


VAERS ID: 259586 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2002-10-26
Onset:2003-02-10
   Days after vaccination:107
Submitted: 0000-00-00
Entered: 2006-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV064 / UNK - / -

Administered by: Military       Purchased by: Military
Symptoms: Arthralgia, Dermatitis, Disturbance in attention, Dizziness, Headache, Hypercholesterolaemia, Hypertension, Hypotension, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Lipodystrophy (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe headaches followed by high blood pressure, achy joints, dizziness, high cholesterol, loss of concentration, muscle aches, dermatitis (severe). Also blood pressure tends to spike and drop.


VAERS ID: 259683 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Vermont  
Vaccinated:2006-07-12
Onset:2006-07-12
   Days after vaccination:0
Submitted: 2006-07-14
   Days after onset:2
Entered: 2006-07-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR 20401 / 2 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Nausea, Pyrexia, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Total body rash, fever 101, nausea, vomiting, lasted 48 hours so far, Dramamine, Phenergan 25mg TID.


VAERS ID: 259720 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Oklahoma  
Vaccinated:2006-06-02
Onset:2006-07-12
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2006-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR V0794 / 1 LA / -

Administered by: Military       Purchased by: Military
Symptoms: Unintended pregnancy
SMQs:, Normal pregnancy conditions and outcomes (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:
Allergies:
Diagnostic Lab Data: Positive HCG (pregnancy test)
CDC Split Type:

Write-up: Discovered a positive pregnancy test after she took smallpox vaccine. Took pregnancy 5-6 weeks after vaccine. Test taken before vaccine was negative. Now 3 months pregnant according to ultrasound.


VAERS ID: 259873 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Oklahoma  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-03-13
Entered: 2006-07-24
   Days after submission:497
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500340P / 1 NS / IN
TD: TD ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Headache, Pain, Rash, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: State tightness in throat, rash on upper lip and headache times 2 weeks with generalized achiness.


VAERS ID: 261171 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2006-07-14
Onset:2006-07-17
   Days after vaccination:3
Submitted: 2006-08-02
   Days after onset:16
Entered: 2006-08-07
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / AVENTIS PASTEUR U1608BA / UNK - / ID

Administered by: Other       Purchased by: Private
Symptoms: Erythema, Incorrect route of drug administration
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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? 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: Chest X ray normal
CDC Split Type:

Write-up: Local erythema of forearm within 48 hours, vaccine inadvertently administered as if it were PPD in error, Topical treatment.


VAERS ID: 261181 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Wisconsin  
Vaccinated:2006-07-08
Onset:2006-07-14
   Days after vaccination:6
Submitted: 2006-08-07
   Days after onset:24
Entered: 2006-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020072 / 1 LA / ID
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z0425 / 1 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Dehydration, Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data: CBC, BMP, UA. Granulocytes 78.5, Monos 3.6, Glucose 108, all other labs wnl
CDC Split Type:

Write-up: Presented to clinic on 7/17/06 with c/o Nausea, Vomiting, HA, x 2-3 days. Had smallpox vaccination on 7/8/06. Mildly dehydrated. 0.9% Normal Saline 1000cc IV given, Phenergan 25mg. To f/u on Wednesday 7/9/06.


VAERS ID: 261712 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Ohio  
Vaccinated:2006-08-02
Onset:2006-08-02
   Days after vaccination:0
Submitted: 2006-08-05
   Days after onset:3
Entered: 2006-08-17
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 387011A / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dysphagia, Dyspnoea, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad)

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

Write-up: Approximately 35 minutes after receiving rabies vaccine, while walking home, experienced a tight feeling in throat, slight difficulty breathing and swallowing, symptoms lasted 1-2 minutes and then went away. Denies any other symptoms or any further problems.


VAERS ID: 261734 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Wisconsin  
Vaccinated:2006-07-25
Onset:2006-08-01
   Days after vaccination:7
Submitted: 2006-08-17
   Days after onset:16
Entered: 2006-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER AHBVB289AA / 3 RA / IM
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020072 / 1 LA / ID

Administered by: Military       Purchased by: Military
Symptoms: Chills, Headache, Pyrexia, Viral infection
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: None
Current Illness: None
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Presented to clinic on 8/4/06 with c/o HA, fever, and chills. Diagnosed as Smallpox viremia. Toradol 30mg given IM. To push fluids. Discharged with Motrin order and return to clinic prn.


VAERS ID: 261735 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Wisconsin  
Vaccinated:2006-07-24
Onset:2006-08-02
   Days after vaccination:9
Submitted: 2006-08-17
   Days after onset:15
Entered: 2006-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020072 / 1 LA / ID
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER Z0663 / 1 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Joint stiffness, Nausea, Pain, Pyrexia, Rash, Rash pustular, Viral infection
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (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? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Presented to clinic on 8/4/06 with c/o rash to bilateral hands x 2 days, fever, body aches, stiffness, and nausea. Pustular rash present to hand and arm, non-pruritic. Diagnosed as smallpox viremia vs possible insect bites. Orders given for Motrin 800mg tid with food 10 day supply provided, no refills, Claritin 1 po qd, 30 day supply given, no refills. To follow up at the clinic prn. Returned to duty.


VAERS ID: 261866 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2005-07-27
Onset:2005-12-13
   Days after vaccination:139
Submitted: 2006-08-18
   Days after onset:247
Entered: 2006-08-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase increased, Blood pressure increased, Blood urea increased, Fluid retention, Haemoglobin decreased, Hyperlipidaemia, Hypoalbuminaemia, Medication error, Nephrotic syndrome, Oedema peripheral, Proteinuria, Pyuria, Renal disorder, Weight increased
SMQs:, Acute renal failure (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Angioedema (broad), Dyslipidaemia (narrow), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Lipodystrophy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (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: Ortho Tri Cyclen (Ethinyloestradiol + Norgestimate + oral contraceptive placeb).
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Alanine Aminotransferase 12/13/05 39, Albumin 12/13/05 2.7, Aspartate aminotransferase 12/13/05 30, bilirubin total 0.1, blood glucose 95, blood pressure 160/88, blood urea nitrogen 25, calcium 7.9, carbon dioxide 23, complement factor C3 normal, Complement factor C4 normal, creatinine 1.1, heart rate 78, hemoglobin 11.9, plate count 212, potassium 4, protein total 5.1, respiratory rate 18, sodium 139, urinary protein positive 3+, weight 89.5 kg, white blood cells 7.
CDC Split Type: B0433639A

Write-up: This 23 year old female subject was enrolled in a blinded study. The subject received IM investigational product single dose on 2/18/05, 3/11/05 and 7/27/05, site of injection was the left deltoid. On 2/18/05, 3/11/05 and 7/27/05, the subject received the 1st, 2nd and 3rd IM injection of blinded study vaccine in the left deltoid. The subject had been randomized to received the herpes simplex virus HSV, lot number AHS1020A2. on 2/18/05 and 3/11/05 the subject received a third dose of Hepatitis A vaccine due to an error. From 1/19/03 to 12/14/05 the subject took Orthotricyclen. On 12/13/05 nine months after the 2nd dose of five months after the 3rd dose of blinded vaccine, this 23 year old subject developed minimal change disease. The subject came in with complaints of fluid retention, increased leg edema and weight gain. Relevant test results included weight 89.5kg, blood pressure 160/88, heart rate 78, respiration 18, urinalysis showed 3+ protein, white blood cell 60-75 per high power filed. occasional red blood cells and chemistry panel calcium 7.9 and albumin 2.7. This subject with elevated blood pressure, hypoalbuminenia with nephrotic range proteinuria, asymptomatic pyuria and normal complement factor, was referred to a nephrologist. On 12/14/05 the subject was placed on Frusemide and valsartan for fluid reduction and blood pressure control. A kidney biopsy was performed on 1/4/06 which revealed minimal change disease. The subject was subsequently started on prednisolone, in addition to Frusemide and valsartan. On 1/27/06 she continued to have complaint of fluid retention, elevated blood pressure and lower extremity pitting edema 4+. Medications remained the same (prednisolone, Frusemide and valsartan). The subject continued to be followed closely by a nephrologist. In May 2006 she was followed up by her nephrologist and found to be Prednisolone resistant. She was placed on Cyclophosphamide. On 7/26/06 physically the subject felt much better with decreased fluid retention, decreased edema and better blood pressure control. However, the subject became resistant to the prednisolone and the dose was tapered to 10 mg daily. She was subsequently started on Cyclophosphamide, simvastatin and Gemfibrozil due to new onset hyperlipidemia secondary to the nephrotic syndrome. At time of reporting, the SAE was reported as ongoing. This event has been considered to be medically important (OMIC) secondary to the prednisolone resistant minimal change disease, requiring an immune modulator. The investigator considered that there was a reasonable possibility that the minimal change disease may have been caused by investigational product.


VAERS ID: 262081 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2006-08-02
Onset:2006-08-03
   Days after vaccination:1
Submitted: 2006-08-24
   Days after onset:21
Entered: 2006-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV102 / 1 - / -
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z01222 / 1 - / -

Administered by: Military       Purchased by: Military
Symptoms: Migraine, Photophobia
SMQs:, Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal 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: NONE
Current Illness: NONE
Preexisting Conditions: Wasp Anaphylaxis, allergic rhinitis seasonal
Allergies:
Diagnostic Lab Data: CT head normal
CDC Split Type:

Write-up: New onset throbbing migraine headaches with photophobia commencing several hrs after AVA 1 and Typhoid vi. Migraine episodes have continued.


VAERS ID: 262128 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Texas  
Vaccinated:2006-08-14
Onset:2006-08-16
   Days after vaccination:2
Submitted: 2006-08-25
   Days after onset:9
Entered: 2006-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB308AA / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site mass, Skin discolouration, Tenderness
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad)

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

Write-up: Pt. received Vaccine on 8/14/06, presents to clinic on 8/25/06 with a knot to left deltoid the size of 3mm(roughly) and some tenderness upon palpating. No fever, slight discoloration to area of injection.


VAERS ID: 262173 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Utah  
Vaccinated:2006-08-01
Onset:2006-08-01
   Days after vaccination:0
Submitted: 2006-08-07
   Days after onset:6
Entered: 2006-08-28
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0175R / 2 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2457AA / 1 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Chills, 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? 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: Chilling fever of 103, nausea, flu like symptoms.


VAERS ID: 262237 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Puerto Rico  
Vaccinated:2004-09-17
Onset:0000-00-00
Submitted: 2006-08-28
Entered: 2006-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / 4 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Amnesia, Arthralgia, Arthritis, Hypersensitivity, Rheumatoid arthritis, Shoulder pain, Synovitis, Weight increased
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Dementia (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Synovitis, inflamation in most of the joint, Rheumatoid Arthritis.
CDC Split Type:

Write-up: Joint pain, inflamatory joints, right shoulder pain (I had surgery), loss of memory, allergies, gain weight, had therapy, pills, etc... 02/02/2010 Inflammatory joint changes.


VAERS ID: 262266 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2006-08-18
Onset:2006-08-19
   Days after vaccination:1
Submitted: 2006-08-21
   Days after onset:2
Entered: 2006-08-29
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2492BA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site mass, 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:
Current Illness: NONE
Preexisting Conditions: Seasonal allergies, cats, dander, dogs, trees, grass, mold
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: 18 hrs after administration of vaccine, she woke with pain, redness and swelling around injection site. Treated with ice/heat and Midol. On 8/21/06 observed induration and erythema 13cm x 4 cm L deltoid.


VAERS ID: 262482 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Rhode Island  
Vaccinated:2006-07-25
Onset:2006-07-26
   Days after vaccination:1
Submitted: 2006-08-31
   Days after onset:36
Entered: 2006-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

Administered by: Military       Purchased by: Unknown
Symptoms: Fatigue, Feeling hot, Injection site hypersensitivity, Injection site mass, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hard painful lump at site of injection, red, site is hot to the touch. Pt states feeling "tired & run down" since injection.


VAERS ID: 263063 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2006-08-02
Onset:2006-08-12
   Days after vaccination:10
Submitted: 2006-09-08
   Days after onset:27
Entered: 2006-09-15
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020072 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations: ~Smallpox (Dryvax)~1~23.00~In Patient
Other Medications:
Current Illness: chronic acne severe
Preexisting Conditions: Acne. Recurrent folliculitis/furuncles along RUE, known to be streptococcus beta hemolytic but past cultures.
Allergies:
Diagnostic Lab Data: HIV testing was done to r/o immune deficiency & was neg. WBC 6.5
CDC Split Type:

Write-up: 10 days after shot pimples like bumps came up all over chest, stomach, arms, and few on thighs area. Went to ER due to possible infection of vaccine. 10/2/06 Received medical records from patient for hospitalization 8/12-8/13/06 with final Dx: reaction to small pox vaccine (pustular nonviral pustulosis vs eczema vaccinatum vs disseminated cowpox). ID & DOD were consulted. Photos were taken & mailed to DOD for diagnosis. Patient was initially placed in strict isolation while hospitalized but DOD recommended not needed & patient was d/c home to be followed at AFB next day.


VAERS ID: 263162 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2006-09-06
Onset:2006-09-06
   Days after vaccination:0
Submitted: 2006-09-08
   Days after onset:2
Entered: 2006-09-19
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / UN
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Cold sweat, Erythema, Heart rate irregular, Hypertension, Injection site rash, Injection site reaction, Pallor, Rash macular, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pt is on Depo Provera, Nitrofurantoin PM.
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt given both vaccines left deltoid. 15-30 sec after 2nd vaccine, yellow fever, pt became pale. She said she felt fine. She was clammy and damp to touch. Head was reclined BP 122/90, P72. Nose running, face red and blotchy. BP 140/100, P 56. Physician called to room at 1110. BP at 11:15 142/100, P 70. Pt transported to urgent care in house for monitoring. Minimal pink rash at yellow fever injection site. Pt monitored until 11:50. VS returned to NL at 11:20. No progression of symptoms thereafter.


VAERS ID: 263235 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2006-08-18
Onset:2006-08-23
   Days after vaccination:5
Submitted: 2007-01-05
   Days after onset:135
Entered: 2006-09-19
   Days after submission:108
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0608USA06869

Write-up: This is in follow-up to report(s) previously submitted on 9/14/2006. Information has been received from a physician concerning a 23 year old female with no known drug allergies was vaccinated intramuscularly on 18-AUG-2006 at 15:00 in the deltoid muscle with GARDASIL (yeast). On 24-AUG-2006 the patient developed a rash with itching and minimal swelling on the back of her neck, arms, ribs, back and behind her left knee. Follow up information stated that the patient was treated with Benadryl, 50 mg and topical hydrocortisone cream. It was reported that on 24-AUG-2006 the patient had recovered. Additional information is not expected.


VAERS ID: 263242 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-09-14
Entered: 2006-09-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Pallor
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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: WAES0609USA00264

Write-up: Information has been received from a physician concerning a 23 year old female. It was reported that it was "not known if the patient was pregnant, if she was taking any other medications or had a history of drug reactions or allergies." On an unspecified date, the patient was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast). It was reported that the patient felt "light headed and dizzy" after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast). The patient also "turned very pale", but did not faint. At the time of this report, the outcome of the events were unknown. Additional information has been requested.


VAERS ID: 263523 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Ohio  
Vaccinated:2006-07-31
Onset:2006-07-31
   Days after vaccination:0
Submitted: 2006-09-25
   Days after onset:56
Entered: 2006-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB259CA / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? 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: After receiving injection approx. 4 hours later became short of breath.


VAERS ID: 263592 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Wisconsin  
Vaccinated:2006-08-16
Onset:2006-08-18
   Days after vaccination:2
Submitted: 2006-09-26
   Days after onset:39
Entered: 2006-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB055AA / 3 RA / IM
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 1 LA / ID
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER Z0663 / 1 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Dizziness, Nausea, Vision blurred
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

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

Write-up: Soldier presented on 8/18/06 with c/o light headedness, blurred vision, and nausea. Diagnosed as probable mild reaction to multiple vaccinations. No evidence suggesting smallpox vaccine reaction. Reassurance given.


VAERS ID: 263970 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2006-09-21
Onset:2006-09-21
   Days after vaccination:0
Submitted: 2006-09-21
   Days after onset:0
Entered: 2006-10-03
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
JEV: JAPANESE ENCEPHALITIS (JE-VAX) / SANOFI PASTEUR EJN2215 / 3 - / SC

Administered by: Military       Purchased by: Military
Symptoms: Dizziness, Euphoric mood
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

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

Write-up: Lightheadedness, dizziness, euphoric feeling.


VAERS ID: 264051 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Wisconsin  
Vaccinated:2006-09-19
Onset:2006-09-29
   Days after vaccination:10
Submitted: 2006-10-05
   Days after onset:6
Entered: 2006-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020072 / 1 LA / ID

Administered by: Military       Purchased by: Military
Symptoms: Headache, Hyperhidrosis, Influenza, Lymphadenopathy, Pain
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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: NKDA
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Presented on 9/29/06 with c/o HA, sweats, bodyaches. Reported receiving smallpox vaccine approximately 1 week prior. Physical exam noted + Tender lymphadenopathy to the L axilla. Smallpox vaccination site within normal limits. Diagnosed as "spv flu". Orders given for quarters times 48 hours (may go to FOB, if able but continue quarters if necessary), f/u on Monday at TMC, Toradol 60mg IM given for HA, 1L normal saline given IV, Mobic 7.5mg 1-2 at supper, Tylenol #3 prn.


VAERS ID: 264062 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Ohio  
Vaccinated:2006-10-02
Onset:2006-10-03
   Days after vaccination:1
Submitted: 2006-10-05
   Days after onset:2
Entered: 2006-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 69427 / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 1/2 Synthroid 125mcg
Current Illness: none
Preexisting Conditions: Amoxicillan, Biaxin, and gentamyacin
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 10/3/06 started itching all over body around 2:30pm-3:00pm and Right eye swelling started called Dr. Put on Prednisone 10 mg, taking 6 tablets one day and reducing down by one until gone. Went to see Dr. on 10/05/06 had albuteral breathing treatment, advised to use Advair Diskus 100/50 1 puff twice a day until better. Also told to get Benadryl 25mg 1 pill twice a day, and artificial tears to help with swelling of eye.


VAERS ID: 264368 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Oregon  
Vaccinated:2006-08-31
Onset:2006-08-31
   Days after vaccination:0
Submitted: 2007-01-05
   Days after onset:127
Entered: 2006-10-11
   Days after submission:86
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0800F / 1 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Injury, Medical device complication, Medication error, Scratch
SMQs:, Accidents and injuries (narrow), Hostility/aggression (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: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0609USA00688

Write-up: Information has been received from a medical assistant concerning a 23 year old female with no pertinent medical history or drug reaction/allergies, who on 8/31/06 was vaccinated IM with a pre filled syringe HPV rL1 6 11 16 18 VLP vaccine yeast (lot 654540/0800F). There was no concomitant therapy. The medical assistant reported that the spring action activated so forceful the needle and spring popped out of the clients left arm and scratched her. It was reported that all the vaccine was administered and that the pts left arm was washed with soap and water. She also reported that the pt did not bleed. No further details were provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/6/2006. Initial and follow-up information has been received from a medical assistant concerning a 23 year old white female with no partinent medical history of drug reactions/allergies, who on 31-AUG-2006 at 2:00 PM was vaccinated intramuscularly in the left deltoid with the first dose of a pre-filled syringe of GARDASIL (Lot # 654540/0800F). There was no concomitant therapy and no illnesses at time of vaccination. The medical assistant reported that "when the needle safety device was activated, it came down so forceful that the needle and syringe popped out of the client''s left arm, struck the patient, and scratched her." The reporter stated that the "syringe deployed as it should have, but was unexpected" by the health care provider. It was reported that the plunger was released before removing the needle from the arm of the patient. The reporter stated that there was no damage noted to the syringe. It was reported that all of the vaccine was administered and that the patient''s left arm was washed with soap and water and a bandaid was placed over the puncture site and scratch. The reporter also stated that the patient did not bleed and taht there was no adverse reaction to the patient. The patient subsequently recovered. No further information is expected.


VAERS ID: 264647 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2006-10-05
Onset:2006-10-06
   Days after vaccination:1
Submitted: 2006-10-16
   Days after onset:10
Entered: 2006-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U1880AA / UNK RA / IM

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

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

Write-up: Follow up with Employee health presented with a reddened edematous site of injection. Documented fever associated with no other clinical symptoms.


VAERS ID: 264756 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2006-09-18
Onset:2006-09-18
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:25
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site reaction
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: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0609USA05009

Write-up: Information has been received from a nurse practitioner concerning a female who on 18-SEP-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced injection site reaction. The patient sought unspecified medical attention. Injection site reaction persists. Additional information has been requested.


VAERS ID: 264774 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: New York  
Vaccinated:2006-09-26
Onset:2006-09-26
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:17
Entered: 2006-10-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Medication error, Pain
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Concurrent conditions: cervical dysplasia, colposcopy
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0609USA08128

Write-up: Information has been received from a nurse practitioner concerning a 23 year old female with mild cervical dysplasia with colposcopy and no known allergies or adverse drug reactions reported. On 26-SEP-2006, the patient was vaccinated with the first dose of 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication reported. It was reported that the pre-filled syringe had been stored at 34F. On 26-SEP-2006 the patient developed severe pain during administration with lightheadedness and dizziness. The patient was laid on the exam table and given ibuprofen (MOTRIN) for pain. The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the events. Additional information has been requested.


VAERS ID: 265013 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2006-10-09
Onset:2006-10-16
   Days after vaccination:7
Submitted: 2006-10-17
   Days after onset:1
Entered: 2006-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Headache, Injection site reaction, Pruritus, Thermal burn
SMQs:, Anaphylactic reaction (broad), Accidents and injuries (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: Lexapro, Effexor, Yasmin, HCTZ, Elmiron, Parida Plus, Claritin.
Current Illness:
Preexisting Conditions: Sulfa Allergy, Hypertension, Intestinal cystitis.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Localized reaction at injection site right del itching and burning beginning 7 day post injection, also headache. Txd symptoms with Benadryl, Tylenol, Hydrocortisone cream.


VAERS ID: 265202 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Mississippi  
Vaccinated:2006-10-19
Onset:2006-10-19
   Days after vaccination:0
Submitted: 2006-10-23
   Days after onset:4
Entered: 2006-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 70737 / 5 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dyspnoea, Hypoxia, Respiratory distress, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: XOPENEX INHALER
Current Illness: NEW ONSET ASTHMA 2 MOS PRIOR TO VACCINE. HAD D/C SINGULAIR ONE WEEK PRIOR. STATED CHEST FELT TIGHT IN AM. DID NOT REPORT THIS PRIOR TO VACCINATION.
Preexisting Conditions: PREMIE, HAD ASTHMA UNTIL AGE 3, NO PROBLEMS AGAIN UNTIL 2 MOS AGO WHEN SHE WAS HOSPITALIZED WITH ASTHMA.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PT IS NURSE AT OUR HOSPITAL, CAME TO INF. CONTROL FOR INFLUENZA VACCINE AT 1300. REC''D VACCINE WHICH SHE HAS TAKEN EVERY YEAR FOR THE LAST 4-5 YEARS AND NEVER HAD A PROBLEM. APPROX. 5-10 MINUTES AFTER GETTING THE SHOT SHE REPORTED TO A COWORKER THAT SHE "WAS HAVING TROUBLE GETTING HER BREATH. tHE COWORKER BROUGHT HER TO THE ER IMMEDIATELY WHERE SHE WAS FOUND TO BE IN EXTREME RESP. DISTRESS WITH AUDIBLE WHEEZING AND AN INITIAL OXYGEN SAT OF 85%. SHE WAS TREATED WITH CONTINUOUS NEBULIZERS, XOPENEX (SHE TOOK 4 PUFFS FROM HER MDI ENROUTE TO ER), ALBUTEROL AND RACEMIC EPINEPHRINE. SHE REC''D 0.4 EPINEPHRINE SUB Q AND SOLUMEDROL 250MG IV. SHE IMPROVED SOMEWHAT BUT HAD TO TRANSFERRED TO A PULMONOLOGIST AND AN ALLERGIST. THEY BOTH TOLD HER THEY BELIEVED THE REACTION WAS FROM THE FLU SHOT--NOT HER ASTHMA. SHE IS A NEWLY DIAGNOSED ASTHMATIC AND WAS HOSP. ABOUT 2 MOS PRIOR TO VACCINATION WITH ASTHMA. INCIDENTLY, SHE HAD STOPPED TAKING HER SINGULAIR ABOUT ONE WEEK PRIOR TO VACCINATION AS ORDERED.


VAERS ID: 265323 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Maryland  
Vaccinated:2006-10-24
Onset:2006-10-25
   Days after vaccination:1
Submitted: 2006-10-25
   Days after onset:0
Entered: 2006-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. 500430P / UNK NS / IN

Administered by: Military       Purchased by: Military
Symptoms: Asthenia, Dizziness, Epistaxis, Feeling abnormal, Palpitations
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: GLUCOSE TEST: DR STATE IT WAS NORMAL EKG: DR STATE IT WAS NORMAL
CDC Split Type:

Write-up: ON 24 OCT 06, RECIEVED LIVE INTRANASAL FLU VACCINE. ON 25 OCT @ 0600 PT STATES HAD A NOSE BLEED CONTINIOUS BLOOD FLOW FROM THE RIGHT NOSTRIL. BEGIN TO FEEL DIZZY, LIGHT HEAD, HEART PALPITATIONS, BEGAN TO FEEL FUNNY AND WEAK. PT WAS SEEN FOR TREATMENT. IV THERAPY, PT RECEIVED 24 HR QUARTERS.


VAERS ID: 265365 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Kansas  
Vaccinated:2006-06-06
Onset:2006-10-12
   Days after vaccination:128
Submitted: 2006-10-25
   Days after onset:13
Entered: 2006-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV107 / 5 RA / ID
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z0042 / 3 LA / ID

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

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

Write-up: ON 06JUNE2006 I RECEIVED MY 5TH ANTHRAX SHOT. FIRST TWO VACCINATIONS WENT FINE; ON THIRD AND FOURTH I HAD LOCALIZED SWELLING, BURNING, AND ITCHING WHICH WENT AWAY WITHIN A WEEK OR TWO. ON MY LAST VACCINATION (THE 5TH ONE) I WOKE UP THE DAY AND NOTICED THAT MY RIGHT UPPER ARM WAS SWOLLEN WHERE I HAD RECEIVED THE VACCINATION. I FOLLOWED UP W/ MY DOCTOR. HE TOLD ME THAT IS WAS A LOCALIZED REACTION AND INFORMED ME THAT I MIGHT WANT TO CONSIDER TURNING THAT VACCINE DOWN IN THE FUTURE, SINCE IT IS VOLUNTARY, BUT IF I DO DECIDE TO RECEIVE MORE IN THE FUTURE TO TAKE BENADRYL BEFORE RECEIVING ANY MORE. ON OCTOBER 13, 2006 (ABOUT FOUR MONTHS AFTER VACCINE) I NOTICED THAT MY ARM HAD SWELLED BACK UP AND WAS ITCHING BADLY. I WENT BACK TO THE DOCTOR AND HAD HIM LOOK AT IT AGAIN, HE PRESCRIBED ME ATARAX TO REDUCE THE ITCHING SENSATION. HE TOLD ME THAT HE UNSURE WHEN THIS PROBLEM WOULD GO AWAY BUT TO COME BACK IN IF ANY MORE PROBLEMS OCCUR. TO THIS DAY THE ITCHING IS STILL INTERMITTENT/RECURRENT.


VAERS ID: 265582 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Idaho  
Vaccinated:2006-10-25
Onset:0000-00-00
Submitted: 2006-10-26
Entered: 2006-10-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA208BA / 1 - / SC

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

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

Write-up: Red area with slight warmth around injection site, Painful to touch.


VAERS ID: 265850 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2006-10-18
Onset:2006-10-23
   Days after vaccination:5
Submitted: 2006-11-02
   Days after onset:10
Entered: 2006-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 1 UN / -
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z04252 / 1 UN / -

Administered by: Military       Purchased by: Military
Symptoms: Blood chloride normal, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium decreased, Blood triglycerides increased, Blood urea normal, Brain natriuretic peptide increased, C-reactive protein normal, Carbon dioxide normal, Cardiac flutter, Chest X-ray normal, Chest pain, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Full blood count, Haematocrit normal, Haemoglobin normal, High density lipoprotein normal, Hyperhidrosis, Lipids normal, Low density lipoprotein normal, Palpitations, Platelet count normal, Pleurisy, Pyrexia, Red blood cell sedimentation rate normal, Syphilis test negative, Troponin increased, Urine analysis normal, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Lipodystrophy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: smoker
Allergies:
Diagnostic Lab Data: Echocardiogram performed 10/25/06 result full report available EF 65% no effusion, no wall motion abnormalities. Chest X ray neg normal chest, lab CK CK-MB troponin 10/24 1451 164 5.46 0.437 (NL 0.0-0.029), 10/24 2137 115 3.38 0.573, 10/25 0318 108 3.09 0.5162010/25 0836 92 2.79 0.302, CBC WBC 7.8K, HgB 15.1., HCT 44%, PLT 268K, ESR 13, Brain natriuretic Peptide 266 (NL 5-125pg/ml), C reactive Protein 1.0 mg%, NA +135, CL 101 Co2 26, K+ 4.2, Glucose 92mg%, BUN 11, Creat 0.9%, Previous labs lipids tchol 178 LDL 100, HDL 45, TRIG 165 RPR neg, UA neg. EKGs showed T wave inversions and ST /T wave elevations not present on EKG 1 week prior. Serial Troponin levels elevated x 4 at 0.302, 0.516, 0.573, and 0.437. BNP high at 266. Serial CK-MB WNL. CXR-normal. Echocardiogram of 10/25/06 normal with EF=65%.
CDC Split Type:

Write-up: 23 year old male SM developed chest pain 5-6 days after primary SPV and Typhoid vaccinations. Symptom: Fever Start: 10/21/2006 End: 10/25/2006. Comment: Ranged from 100-102F for days prior to chest pain onset. Symptom: Chest pain Start: 10/23/2006 End: 10/24/2006. Comment: Major episode occurred in the early hours of 10/24, lasting for 15 minutes before resolving. Symptoms: Palpations Start: 10/23/2006 End: 10/24/2006 Comment: heart fluttering episodes described to research staff prompting referrals to emergency department. Symptom: Diaphoresis Start: 10/24/2006 Comment: noted in association with the chest pain. Symptom: Dyspnea (shortness of breath) Start: 10/24/2006 End: 10/25/2006 Comment: Dyspnea and pleurisy noted in association with the chest pain. MR received revealing a previously healthy 23 yr old male smoker who on 10/23/06 developed chest pain, dyspnea, diaphoresis, and a feeling that his heart was skipping beats, 5 days after smallpox and typhoid vax. on 10/18/06. Fever, cough, and night sweats had been present from 10/20-23/06. Admitted to ICU for testing and observation. No further episodes occured in the hospital. Discharge Diagnosis: "Myopericarditis 2'' Vaccinia innoculation" made on 10/25/06. 1/11/2010 The service member continues to have palpitations despite medication.


VAERS ID: 265948 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2006-10-14
Onset:2006-10-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2006-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0256F / 2 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Erythema, Injection site reaction, Injection site urticaria, Rash macular, Skin burning sensation
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: passed out~Influenza (Seasonal) (no brand name)~1~14.00~In Patient
Other Medications:
Current Illness:
Preexisting Conditions: PCN
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received 2nd series of Hep A at 1400, At 1500 pt started to having burning at injection sit right deltoid and positive urticaria, red blotches noted on bilateral upper extremities. no sob no difficulty swallowing. Pt seen by MD who administered Benadryl 50 mg PO at 15:15. Pt observed for 30 minutes after.


VAERS ID: 266063 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Texas  
Vaccinated:2006-10-20
Onset:2006-10-20
   Days after vaccination:0
Submitted: 2006-10-20
   Days after onset:0
Entered: 2006-11-06
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2212AA / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Codeine
Current Illness: Sharp pain left eye
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: O2 sat at 1630 96% with pulse 66.
CDC Split Type: TX06073

Write-up: SOB at 1500 seen by provider given Benadryl 25g PO, SXS resolved.


VAERS ID: 266104 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Nebraska  
Vaccinated:2006-10-25
Onset:2006-10-25
   Days after vaccination:0
Submitted: 2006-10-26
   Days after onset:1
Entered: 2006-11-06
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

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

Write-up: Noted itching of body at 2400 was not severe. completed shift, went home and to bed. Woke up and was itching severely all over body no visible rash. Except had raised welts around waist and skin pink/red. Developing welts behind both ears which are raised and some on face. Denies respiratory difficulty.


VAERS ID: 266105 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Georgia  
Vaccinated:2006-10-24
Onset:2006-10-25
   Days after vaccination:1
Submitted: 2006-10-26
   Days after onset:1
Entered: 2006-11-06
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / MASS. PUB HLTH BIOL LAB TD155 / 1 LA / -

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

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

Write-up: Left deltoid swollen and red around injection site (1-2 inches), not hot to touch, no itching; Painful to student. Prednisone 60 mg.


VAERS ID: 266146 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Colorado  
Vaccinated:2006-11-06
Onset:2006-11-06
   Days after vaccination:0
Submitted: 2006-11-06
   Days after onset:0
Entered: 2006-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 71647 / UNK LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Vaccine injected 8:52 am. Client returned at 9:13 saying she felt dizzy, light headed, if she closed her eyes she would pass out. 9:15 B/P 154/100, P 129, 9:20 126/78 P 124. 9:47 143/103 P 100, no change. Mothers MD office called client refused, 911 called client taken to ER.


VAERS ID: 266236 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2006-11-06
Onset:2006-11-06
   Days after vaccination:0
Submitted: 2006-11-07
   Days after onset:1
Entered: 2006-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2248AA / 3 RA / -

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Injection site mass, 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: red, fever, knot~Influenza (Seasonal) (Fluzone)~1~23.00~In Patient
Other Medications:
Current Illness: NONE
Preexisting Conditions: IBS
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Red, knot with fever in it cm right deltoid where flu shot was given! 3.5 cm by 3.5 cm


VAERS ID: 266249 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Colorado  
Vaccinated:2006-10-24
Onset:2006-10-24
   Days after vaccination:0
Submitted: 2006-10-31
   Days after onset:7
Entered: 2006-11-08
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 69480 / UNK LA / -

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Depressed level of consciousness, Disorientation, Hypersensitivity, Laboratory test abnormal, Loss of consciousness, Malaise, Vaccination complication
SMQs:, Torsade de pointes/QT prolongation (broad), Angioedema (broad), 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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Viral illness 24 hours before vaccine
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: LABS: WBC 14,300, lymphs 9.7, mono 0.7, NE# 12. CT of head was WNL. EKG was WNL.
CDC Split Type:

Write-up: Pt passed out approx 5 min after vaccine administration, for about 1 minute. Felt well, returned to work at approx 30 mins after vaccine admin. didn''t feel well and became disoriented. Had amnesia for next few hours until hospitalization. Was hospitalized x 24 hours and had w/u including MRI, Lab, Exam all neg. 12/8/06 Received medical records from hospital which reveal patient had flu shot at work & became confused approx 2 hours s/p flu shot. Patient had been ill & left work day before flu vax. Was admitted to hospital 10/24/06 & remained overnight for observation. Neuro consult done Final Dx: Acute mental status changes & increased bilirubin. Allergy to flu shot.


VAERS ID: 266572 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2006-09-26
Onset:2006-10-08
   Days after vaccination:12
Submitted: 2006-10-10
   Days after onset:2
Entered: 2006-11-13
   Days after submission:34
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4030013 / UNK RA / -

Administered by: Military       Purchased by: Military
Symptoms: Rash maculo-papular, Rash pustular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Vaccinia reaction on trunk (anterior chest and back) Maculopapular rash. 2 pustules. no treatment given. Rash began Day 12


VAERS ID: 266677 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2006-10-19
Onset:2006-10-19
   Days after vaccination:0
Submitted: 2006-11-13
   Days after onset:25
Entered: 2006-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA202BA / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Was given Fluarix vaccine IM 10/19/06 at workplace by RN on site. Has reported today pain in arm since and peels as if worsening. Didn''t note any swelling/hot/redness or hardening of skin muscle. Hurts when using arm to dress, move, etc.


VAERS ID: 267013 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Ohio  
Vaccinated:2006-11-15
Onset:2006-11-15
   Days after vaccination:0
Submitted: 2006-11-16
   Days after onset:1
Entered: 2006-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2260AA / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Dyspnoea, Pruritus
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ortho Tri-Cyclen Wellbutrin 100 mgm every day
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: none done
CDC Split Type:

Write-up: Received inactivated flu vaccine approx. 0830 11/15/06 was sent to outpatient tx. unit approx 1440 with c/o itching then dry cough and some dypsnea. BP 122/79, P 91, R 22 O2 sat 100%, 1444 epinephrine 0.4 given IM right deltiod, albuteral via nebulizer x3 starting at 1445, IV of 0.9%NS started , 1505 Benadryl 50mgm given IVP, 1510 Solu-medrol 125mggm given IVP at this time BP 146/71, P123, O2 sat 98%. Monitored for 3 hours and discharged to home-respiratory symptoms resolved


VAERS ID: 267443 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Texas  
Vaccinated:2006-10-03
Onset:2006-10-03
   Days after vaccination:0
Submitted: 2006-11-14
   Days after onset:42
Entered: 2006-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Loss of consciousness, Muscle contractions involuntary
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), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0610USA11404

Write-up: Information has been received from a 23 year old female who on 03-OCT-2006 was vaccinated with a 0.5 mL dose of GARDASIL. The patient reported that the vaccine was given in the front part of the thigh muscle. Subsequently, the muscle contracted and the patient passed out due to pain. Unspecified medical attention was sought. When the patient woke up, she reported that she "felt fine." On 03-OCT-2006, the patient recovered from the events. Additional information is not expected.


VAERS ID: 267054 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Oregon  
Vaccinated:2006-11-13
Onset:2006-11-13
   Days after vaccination:0
Submitted: 2006-11-13
   Days after onset:0
Entered: 2006-11-17
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (NO BRAND NAME) / SANOFI PASTEUR U1398AA / 1 RL / IM

Administered by: Other       Purchased by: Private
Symptoms: Dizziness, Malaise, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: 7.3 T.P. G/100 ml NA at this time 11/14/06
CDC Split Type:

Write-up: Onset dizzy/faint feeling, pallor, general malaise and slightly "funny" feeling in stomach.


VAERS ID: 267117 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Maine  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2006-10-31
   Days after onset:4
Entered: 2006-11-17
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA208BA / 1 LA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Paraesthesia, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (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: 7:55 a.m. Client received a flu shot in left deltoid. Gave her a sheet on (What you need to known 2006-07 Influenza vaccines. instructed her to stay around people for the next 30 minutes in case of an allergic reaction. 8:10 a.m. Client came back to office complaining that her throat feels tight and has tingling in her hands. Client states" My throat started feeling different when I got back to class but it kept getting worse. My throat has a fullness to it now it is getting worse." 8:15 a.m. Epi-pen 0.3 mg administered to RIGHT THIGH LOT#5EM436 expires 03/07. 2 Puffs from Albuterol inhaler and Benadryl (50mg) given. Person name called ambulance service and client''s husband. Blood pressure 140/80, pulse 90. 8:25 a.m. Ambulance Service arrived and transported to hospital emergency room.


VAERS ID: 267311 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Texas  
Vaccinated:2006-10-12
Onset:2006-10-12
   Days after vaccination:0
Submitted: 2006-10-24
   Days after onset:12
Entered: 2006-11-20
   Days after submission:27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2257AA / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Pain, Shoulder pain
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? 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: Severe Pain radiating down the arm for a period of three days followed by aching pain in shoulder over the next 3-4 days.


VAERS ID: 267681 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2006-10-25
Onset:2006-10-25
   Days after vaccination:0
Submitted: 2006-11-24
   Days after onset:30
Entered: 2006-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA210AA / 5 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaphylactoid reaction, Dizziness, Dyspnoea, Fall, Hypersensitivity, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma. Allergies= salicylates, old bay, cinnamon, tree nuts. (now influenza vaccine)
Allergies:
Diagnostic Lab Data: Non
CDC Split Type:

Write-up: Allergic (anaphylactoid) reaction resulting in acute shortness of breath with wheezing occuring within 5 to 10 minutes post injection, light-headedness resulting in loss of balance and falling. Treated with methylprednisolone IV, famotidine IV, Anzemet IV, diphenhydramine IV and albuterol/ipratropium inhalation treatments x4.


VAERS ID: 268028 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Indiana  
Vaccinated:2006-10-09
Onset:2006-10-09
   Days after vaccination:0
Submitted: 2006-10-13
   Days after onset:4
Entered: 2006-11-30
   Days after submission:48
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (NO BRAND NAME) / SANOFI PASTEUR U1398AA / 2 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Headache, Injection site pain, Injection site swelling, Injection site warmth, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Roderick complains of headaches, muscle aches, shooting sharp pain at injection site, warmth, soreness and swelling at site.


VAERS ID: 268044 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Missouri  
Vaccinated:2006-11-06
Onset:2006-11-08
   Days after vaccination:2
Submitted: 2006-11-08
   Days after onset:0
Entered: 2006-11-30
   Days after submission:22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 69898 / 1 RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0618F / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest pain, Rash pruritic, Somnolence
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: allergies: RCN=skin rash, Bactrium DS=flairs ulcer, cortison=hyperactivity Medical conditions: bowel problems, HTN, Stroke, liver disease, stomach ulcer, ear problems, mental illness
Allergies:
Diagnostic Lab Data:
CDC Split Type: MO200644

Write-up: Patient had flu and pneumonia injections Monday. Came to office yesterday (Wednesday) with an itchy rash on face and back. Patient also stated he had chest pains and very sleep but these symptoms were better at visit.


VAERS ID: 268146 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Illinois  
Vaccinated:2006-11-27
Onset:2006-11-28
   Days after vaccination:1
Submitted: 2006-12-01
   Days after onset:3
Entered: 2006-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Private       Purchased by: Unknown
Symptoms: Dizziness, Vertigo
SMQs:, Anticholinergic syndrome (broad), Vestibular 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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ortho-Evra patch
Current Illness:
Preexisting Conditions: Previous abnormal pap. PMH: abnormal PAP smear, otherwise healthy. Allergies: NKA.
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: significant for a serum glucose of 146 (after IV with dextrose) and K+ of 3.3. UA showed 2+blood, 5-10 WBCs. UC showed mixed urogenital flora. HCG (-). CT of brain (-).
CDC Split Type:

Write-up: Gardasil administered 11/27/06, dizziness 11/28/06, severe vertigo 11/29/06, hospitalized 11/29/06-12/01/06. MR received for ER admit for c/o dizziness, vertigo, and vomiting x2 days beginning within 24 hours of Gardasil vax. PE: WNL and in no distress as long as she holds still. Txd with IV fluids, Valium and Antivert. D/Cd home on Meclizine after 48 hours. Discharge DX: Acute vertigo, possible adverse reaction to Gardasil vaccine. 02/05/2007 Tag-2 received. No new codes.


VAERS ID: 268346 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2006-11-21
Onset:2006-11-21
   Days after vaccination:0
Submitted: 2006-11-21
   Days after onset:0
Entered: 2006-12-05
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV102 / 2 LA / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Allegra
Current Illness:
Preexisting Conditions: Environmental allergies-on antihistamine and epi pen
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Generalized rash on shoulder and chest/face.


VAERS ID: 268385 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2002-12-05
Onset:2005-11-15
   Days after vaccination:1076
Submitted: 2006-12-05
   Days after onset:385
Entered: 2006-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV083 / UNK - / -

Administered by: Military       Purchased by: Military
Symptoms: Arthritis, Headache, Memory impairment, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Labs:WNL, ESR normal in single figure. HLA B27 negative. Liver function test normal with CRP of 1. Angiotensin converting enzyme normal 66. Immunoglobulins, electrophoreses, TSH, uric acid, CK normal.
CDC Split Type:

Write-up: Ongoing sero negative spodyloarthritis. Daily Headaches, problems with memory, muscle pain. Currently take multiple morphine, percocet, ultram, indocin, daily to treat pain as well as methotrexate. All conditions started slowly after administration of anthrax shots starting in 02 and ending in 04. Currently going through medical board to retire me from military. 03/07/07-records received. PMH:hypermobility, involved in number of traffic accidents. Widespread musculoskeltal pain. Chronic back pain with chiropractic treatment over several years DX:Spondylitis. Signs and symptoms of mild synovitis do suggest a low grade sero negative arthropathy. Sacroiliac joints normal. C/O pain in neck, back and hands and toes and fatigability. Per 60 day follow up: Currently diagnosed with seronegative spondyloarthritis & fibromyalgia.


VAERS ID: 268859 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Illinois  
Vaccinated:2003-02-24
Onset:2003-03-01
   Days after vaccination:5
Submitted: 2006-12-11
   Days after onset:1381
Entered: 2006-12-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV070 / 3 - / -

Administered by: Military       Purchased by: Military
Symptoms: Eye oedema, Hypersensitivity, Rash, Rash erythematous, Rash pruritic, Skin discolouration, Skin hyperpigmentation, Skin ulcer, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypotonic-hyporesponsive episode (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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: 11/24/06 CBC WBC 10.41, RBC 4.27, H/H 13.3/38.7, PLT 294, ESR 11
CDC Split Type:

Write-up: On 2/24/03 service member received AVA 1 she denies a significant local reaction to vaccine site. She recalls feeling nauseated for a few hours right after vaccine receipt, but denies any unusual or prolonged systemic symptoms. This was the only vaccine received on 2/24/03. On 3/8/03 service member received AVA 2 this was the only vaccination received on this date. Service member dose no recall specific details regarding this vaccination because she was getting ready to deploy. (Deployment was later postponed to Dec 2003. She does not recall any local reactions, but knows that this was the time of onset of her first break out, which she thought might be an allergic reaction to food or something. She had never previously experienced similar symptoms. Her reaction started with her eyes becoming swollen and then hives appeared under her arms and later, on her hips and on her neck and back. The affected areas were pruritic, raised and red. Lesions began as individual welts, but on hips, the welts coalesced. She did not seek evaluation and the hives resolved within 24-48 hours after vaccine receipt. She had no other reactions until after she received her next anthrax vaccine. On 11/13/03 service member received AVA 3 she also received Hep A, Hep B Typhoid and Influenza vaccination on this date. Service member does no recall any unusual local reactions at her vaccination sites. She denies any unusual or prolonged systemic symptoms except for recurrence of urticaria. Her records show lab results CBC from 11/24/03 from an ER visit for evaluation of this reaction had she also had photos of this reaction dated 11/24/03. This was about 11 days following vaccine receipt. AT the ER she was treated with 1-2 week course of prednisone, with complete resolution of hives but residual hyperpigmentation. For the next year, she continued to experience similar episodes of urticaria about once every 2-3 weeks. She was seen by a civilian dermatologist prior to deployment, she recalls the dermatologist performing a number of tests including a biopsy. During her deployment, she was evaluated and treated at troop medical clinics multiple times and and she was evaluated by an allergist. During the time she was treated with Prednisone, Zyrtec, Allegra and Zantac, as well Claritin, Between episodes, the areas remained discolored, and then with recurrent episodes, the discoloration was replaced with hives. Service member denies associated signs and symptoms such as rhinorrhea, wheezing or breathing difficulties, angioedema, metallic taste, diarrhea or vomiting, hoarseness, cough or tightness of or itchy throat. Last episode of urticaria was in November 2004.


VAERS ID: 269081 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Arizona  
Vaccinated:2006-11-08
Onset:2006-11-08
   Days after vaccination:0
Submitted: 2006-12-14
   Days after onset:36
Entered: 2006-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Eye irritation, Feeling hot, Medication error
SMQs:, Corneal disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0611USA03569

Write-up: Information has been received from a 23 year old female nursing student, with no medical history and no allergies, who on 08 Nov 2006, was vaccinating a baby with a dose of rotavirus vaccine and the baby spit up some of the vaccine and it went into her left eye. There was no concomitant medication. The nursing student felt warmth in her eye. She immediately washed her eye out with water and felt burning. The nursing student reported no other symptoms. The patient reported that her eye felt fine later the same day. No product quality complaint was involved. No other information was provided. Additional information has been requested.


VAERS ID: 269501 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: South Dakota  
Vaccinated:2006-12-18
Onset:2006-12-19
   Days after vaccination:1
Submitted: 2006-12-21
   Days after onset:2
Entered: 2006-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UE896AA / UNK LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Feeling hot, Injection site erythema, Pyrexia
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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: College student with friends ill at the time
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Recieved immunization on 12/18. Contacted on 12/19 with redness at site of injection approx. the size of a quarter site warm to touch at this time. Contacted on 12/21 with increase in redness to the size of a clenched fist and pt. c/o fever, unknown temp due to pt. not owning a thermometer.


VAERS ID: 269538 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2006-10-26
Onset:2006-10-27
   Days after vaccination:1
Submitted: 2006-12-08
   Days after onset:42
Entered: 2006-12-22
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA221AA / 1 LA / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site rash, Injection site reaction, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (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: Soreness in the arm~Influenza (Seasonal) (no brand name)~~0.00~In Patient
Other Medications:
Current Illness: UNK
Preexisting Conditions: The subject had no pre-existing medical conditions. The subject''s concurrent conditions and concurrent medications were not reported.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0625455A

Write-up: This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 23-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subject had experienced soreness in the arm without any rash following receipt of prior immunizations of influenza virus vaccine. On 26 October 2006 the subject received a dose of Fluarix in the left arm. On 27 October 2006, 1 day after vaccination with Fluarix, the subject experienced injection site soreness, "a rash in a ring around the injection site", and body aches. The outcome of the events was not reported. The healthcare professional considered the events were probably related to vaccination with Fluarix. Follow-up received on 10 November 2006 indicated that on 28 October 2006 the subject was evaluated on 28 October 2006 to rule out underlying pain issues. The reporter stated that the subject experienced a "halo type rash around the site of injection,a arm pain and generalized body aches. The subject was in no distress and denied any difficulty breathing, swallowing, fever or swelling. At the time of this report, the healthcare professional considered the events were possibly related to vaccination with Fluarix.


VAERS ID: 269832 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2006-12-27
Onset:2006-12-27
   Days after vaccination:0
Submitted: 2006-12-27
   Days after onset:0
Entered: 2006-12-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA204AA / 2 LA / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 8058F / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2341AA / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Pruritus, 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: Leulen, Desmopression Acetate, Trazodone
Current Illness:
Preexisting Conditions: Allergy- Codeine
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient in for travel appointment, given appropriate immunization for area traveling into. Tdap given after 15 minutes. Patient noted "itchy" around injection site, progressed with swelling to area and redness from 25 cent size to covering all of deltoid area. Benadryl 50 mg IM given and ice pack to area.


VAERS ID: 270262 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Missouri  
Vaccinated:2006-11-01
Onset:2006-11-23
   Days after vaccination:22
Submitted: 2007-01-05
   Days after onset:43
Entered: 2007-01-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / 1 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Lymphadenopathy
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: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0612USA01065

Write-up: This is in follow-up to report(s) previously submitted on 1/5/2007. Information has been received from a physician concerning a 23 year old female who on 01-NOV-2006 was vaccinated, in the left arm, with a first dose of GARDASIL (lot #653938/0954F). On approximately 23-NOV-2006, the patient developed swelling in her lymph node in her axilla (previously reported as swelling in her lymph node area). Unspecified medical attention was sought. On approximately 03-JAN-2007, the patient recovered. Additional information is not available.


VAERS ID: 270357 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-01-10
Onset:2007-01-10
   Days after vaccination:0
Submitted: 2007-01-10
   Days after onset:0
Entered: 2007-01-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / UNK RA / -

Administered by: Public       Purchased by: Unknown
Symptoms: Feeling hot, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Pt c/o being hot and sweaty. Pt laid down on exam bed and given water. Pt stayed in clinic for 30 mins and stated she was feeling fine.


VAERS ID: 270660 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Maryland  
Vaccinated:2006-05-23
Onset:2006-09-15
   Days after vaccination:115
Submitted: 2007-01-11
   Days after onset:118
Entered: 2007-01-17
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB166AA / 3 UN / -

Administered by: Private       Purchased by: Private
Symptoms: Therapeutic response decreased
SMQs:, Lack of efficacy/effect (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: Amitriptyline HCl
Current Illness: ALCOHOL USE
Preexisting Conditions: There was no relevant medical history or concurrent conditions. The healthcare professional also reported that she knew of others in the medical field that had been non-responders and some have had to leave the medical field. She did not provided a finite number for these other non-responders.
Allergies:
Diagnostic Lab Data: Hepatitis B surface antibody 15Sep2006 7.7 MIU/ml
CDC Split Type: A0621090A

Write-up: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 23-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. There was no noted relevant medical history. Concurrent medications included amitripyline (Elavil). Concurrent conditions were not reported. On 23 November 2005, the subject received 1st dose of Engerix-B. On 23 December 2006, the subject received 2nd dose of Engerix-B. On 23 May 2006, the subject received 3rd dose of Engerix-B. On 15 September 2006, approximately four months following 3rd dose of Engerix0B, the subject had a hepatitis B surface antibody titre drawn. The resulting level was 7.7 mIu/ml. This was considered to be a decreased therapeutic response. No additional details were known at the time of reporting. The outcome of the event was unknown. Follow-up information was received on 04 October 2006 via the reporter. The subject had no relevant medical history., concurrent conditions, or concurrent medications. The subject drank four to five servings of alcohol per month and did not use tobacco. The dose of Engerix-B given on 23 May 2006 was 20 mcg. It was planned to repeat the Engerix-B vaccine series. The nurse practitioner considered the events were related to Engerix-B. The nurse practitioner also considered the events could have been associated with lack of efficacy.


VAERS ID: 270899 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Arizona  
Vaccinated:2006-12-15
Onset:2006-12-25
   Days after vaccination:10
Submitted: 2007-01-04
   Days after onset:10
Entered: 2007-01-22
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV103 / UNK LA / SC
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKDALE PHARMACEUTICALS U230FAA / 2 LA / IM
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH Y020072 / UNK LA / SC
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF) / BERNA BIOTECH, LTD. Z0425-2 / UNK LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Injection site cellulitis, Injection site erythema, Pyrexia, Rash vesicular, Vaccinia
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? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Reaction to cedar in past.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: 2 weeks after receiving smallpox vaccine developed erythema at site and vesicular rash on back and chest, fever. Received Bactrim at ER for presumed cellulitis at vaccine site. Diagnosed cellulitis, generalized vaccina


VAERS ID: 271289 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: California  
Vaccinated:2007-01-09
Onset:2007-01-12
   Days after vaccination:3
Submitted: 2007-01-23
   Days after onset:11
Entered: 2007-01-25
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. 0904F / 2 RA / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0254F / UNK LA / SC
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2556AA / UNK LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Left upper arm painful, swollen, temperature 98.3, and headache. Tdap left deltoid 1-9-07. Admitted to hospital 1-13-07 temperature 101.


VAERS ID: 271505 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Oklahoma  
Vaccinated:2007-01-22
Onset:2007-01-22
   Days after vaccination:0
Submitted: 2007-01-22
   Days after onset:0
Entered: 2007-01-30
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA243BA / 1 - / IM
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB068AA / 1 - / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z00182 / 1 - / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1026F / 1 - / SC
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1922AB / 1 - / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B011CA / 1 - / IM

Administered by: Military       Purchased by: Military
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: UNK
Current Illness: NONE
Preexisting Conditions: PCN, Amoxicillin, Zithromax
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Received call from instructors , found patient lying on ground, assessed airway, given 2 doses of Epi-pen, given IV, stayed with patient. Until EMS arrived. 01/31/07-records received and reviewed. Patient seen in follow-up to ER visit, no records available. Received 7 immunizations day prior to visit. HX of treatment at ER, did not receive epinepherine but some other type of IV medication. Allergic to PCN, zithromax. No complaints at the time of office visit. Did not take Benadryl, slept all night. PE:WNL. Assessment:other specified adverse effects not elsewhere classified. Patient had 7 immunizations unknown which was offending agent.


VAERS ID: 271956 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2007-01-23
Onset:2007-01-24
   Days after vaccination:1
Submitted: 2007-02-08
   Days after onset:15
Entered: 2007-02-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER 1426F / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Headache, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Mircette, Claritin prn, Imitrex, Naprosyn, Valtrex
Current Illness:
Preexisting Conditions: migraines, eczema, condyloma, herpes simplex, lactose intolerance
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: headache and nausea different than usual migraine for 2 wks beginning day after Gardasil vaccine administration


VAERS ID: 271975 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Puerto Rico  
Vaccinated:2003-03-01
Onset:2003-09-20
   Days after vaccination:203
Submitted: 2007-02-06
   Days after onset:1235
Entered: 2007-02-08
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / 3 UN / -

Administered by: Military       Purchased by: Military
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Back pain, Blindness, Diarrhoea, Gastric disorder, Headache, Insomnia, Libido decreased, Migraine, Nausea, Rash, Sinusitis, Sleep disorder, Vomiting, Weight decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Gastric after administration
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Gastric problems diarrhea, vomiting, nausea, stomach pain, loss of vision, headache, back pain, sinusitis, migraine, joint pain, lack of sleep, lost weight, skin rash, loss of energy, sexual relationship lack. 02/21/07-records received and reviewed- DX:allergic rhinitis, tobacco use disorder, torticollis, refractive error, pain in joint involving shoulder region, dermatophytosis of groin and perianal area, unspecified gastritis and gastroduodenitis without mention of hemorrhage. Criteria not meet for DX of PTSD but has criteria of depression NOS. MRI right shoulder, posterior capsule thinning and redundancy. no hill sachs or reverse hill sachs evident. small posterior peripheral labral tear. 3/31/2010 Follow up: Still rash in the skin; stomach pain, himpotensia, memory loss and other disease.


VAERS ID: 272001 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2007-02-03
Onset:2007-02-03
   Days after vaccination:0
Submitted: 2007-02-03
   Days after onset:0
Entered: 2007-02-09
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2308AA / 1 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: pt complained of past vaso-vagal response
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: 1515-pt presented with complaints of being shaky after having blood drawn in the lab. I administered the flu vaccine im and pt reported he was fine but then experienced syncope so we had him recline with knees up until he had recovered.


VAERS ID: 272131 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Alabama  
Vaccinated:2007-01-21
Onset:2007-01-24
   Days after vaccination:3
Submitted: 2007-02-12
   Days after onset:19
Entered: 2007-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U23108AA / 4 RA / IM
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR U2136AA / 2 RA / SC
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z0663 / 4 LA / IM

Administered by: Military       Purchased by: Military
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: No
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: pt. reported to civilian MD. Larger area of erythema and color secondary to a meningococcal vaccine and was treated.


VAERS ID: 272272 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Washington  
Vaccinated:2006-10-20
Onset:2006-10-20
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:117
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion threatened, Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Foetal non-stress test, No adverse effect, Pregnancy, Ultrasound scan, Wrong drug administered
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), 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:
Current Illness:
Preexisting Conditions: Hospitalisation: premature labour, yeast infection, artificial rupture of membrane, abortion threatened. Pregnancy NOS (LMP=3/1/2006), kidney infection, smoker, premature labour, cervical dysplasia, cervical incompetence, allergic reaction to antibiotic, hypersensitivity
Allergies:
Diagnostic Lab Data: Test, Date, Value, Unit, Normal Range, Comment diagnostic nonstress test, 06/26/06, "maternal serum alphafetoprotein-in range normal" fetal nonstress test, 11/15/06 fetal nonstress test, 11/15/06 fetal nonstress test, 11/16/06 fetal nonstress test, 11/20/06 ultrasound, 04/21/06, "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus" ultrasound, 04/14/06, "positive intrauterine pregnancy (IUP), gestational sac only, negative fetal heart tone, right corpu ultrasond, 05/02/06, "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus" ultrasound, 05/02/056, "gestational age, threatened abortion" ultraound, 11/06/06, "amniotic fluid index=28.4" "rule out ruptured membranes"
CDC Split Type: WAES0610USA12632

Write-up: Initial and follow up information has been received through the Merck regulatory pregnancy registry from a registered nurse at a health department and an unspecified family member concerning a 23 year old white female smoker who was 34 weeks pregnant with cervical incompetence, allergies to erythromycin and moxifloxacin hydrochloride (AVALOX) and had a history of premature labour from a prior pregnancy, a history of 3 pregnancies and 2 live births, a yeast infection, a threatened abortion, "ruptured membranes/delivery" and cervical dysplasia that had required a LEEP surgery, however, this procedure was not performed as the patient became pregnant. On 14-APR-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), gestational sac only, negative fetal heart tone, right corpus". On 21-APR-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus". On 02-MAY-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus" and "gestational age, threatened abortion". On 26-JUN-2006, the patient underwent a maternal serum alphafetoprotein (MSAFP) which revealed "in range normal". It was reported that on an unspecified date, the patient had been hospitalized due to "lower back contractions". The patient had been diagnosed with a kidney infection and was advised to see her primary care physician for a flu shot. On 17-OCT-2006, (conflicting information also reported as 20-OCT-2006), the patient went to her physician and received one dose of 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast) administered intramuscularly instead of the flu shot. Concomitant therapy included prenatal vitamins and unspecified therapies (reported as "tributylene", "suflexan" and "cyclomenzaprene"). On 16-OCT-2006 (conflicting information also reported as 20-OCT-2006), the patient was not having any adverse reaction. It was reported that the patient had already been experiencing pre-term labour, prior to receiving the shot. The patient sought unspecified medical attention. On 24-OCT-2006, the patient received a 1 cc flu shot. On 02-NOV-2006, the patient received betamethasone (CELESTONE), 12 mg, intramuscularly to "decrease contractions". On 06-NOV-2006, the patient underwent an ultrasound which revealed "amniotic fluid index=28.4" and "rule out ruptured membranes". On 15-NOV-2006, 16-NOV-2006, and 20-NOV-2006, the patient underwent a fetal nonstress test (NST) (results not reported). On an unspecified date, the patient received acetaminophen/codeine phosphate (TYLENOL WITH CODEINE #3) for migraines. At the time of this report, the outcome of the events were unknown. The reporter stated that the patient had been hospitalized "prior to receiving the hpv rl1 6 11 16 18 vlp vaccine (yeast) vaccination for an unrelated kidney infection and lower back contractions". Additional information has been requested.


VAERS ID: 272289 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: South Carolina  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0701USA00644

Write-up: Information has been received from a physician concerning a female (age not reported) with pertinent medical history and drug reactions/allergies not reported who on an unspecified date was vaccinated with the first dose of Gardasil, injection, 0.5ml. Concomitant medications was not reported. Subsequently on an unspecified date, the patient developed a rash on her chest and arm after receiving the first dose of Gardasil. The physician gave the patient an antihistamine (unspecified) and the rash on her chest and arm cleared in about 20 minutes. Subsequently the same day, the patient recovered from rash on her chest and arm. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a physician concerning a 23 year old, female student with no pertinent medical history who on an unspecified date was vaccinated, intramuscularly, into the deltoid with the first dose of GARDASIL injection 0.5 ml. Concomitant medication was not reported. Subsequently on an unspecified date, the patient developed a rash on her chest and arm after receiving the first dose of GARDASIL. The physician gave the patient an antihistamine (unspecified) and the rash on her chest and arm cleared in about 20 minutes. Subsequently the same day, the patient recovered from the rash on her chest and arms. Additional information is not available.


VAERS ID: 272298 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: 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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA00828

Write-up: Information has been received from a registered nurse concerning a 23 year old female office employee in her office with drug reactions/allergies and pertinent medical history reported as unspecified who on an unspecified date was vaccinated with first dose of Gardasil (yeast) (lot# not reported) intramuscularly. Concomitant therapy was unspecified. On an unspecified date, the patient was vaccinated in the gluteal area and she experienced injection site pain. The patient sought medical attention. At the time of reporting, the outcome of the event was unspecified. No other information was provided. Additional information has been requested.


VAERS ID: 272580 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2006-08-25
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
SMQs:, 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? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: pregnancy
Preexisting Conditions: Cervical dysplasia, Caesarean section; Urinary tract infection; blood pressure high, sulfonamide allergy, drug hypersensitivity
Allergies:
Diagnostic Lab Data: serum beta-human, 09/20/06, (+), positive for pregnancy
CDC Split Type: WAES0701USA04643

Write-up: Information has been received from a registered nurse through a Merck Pregnancy Registry concerning a 23 year old female with allergies to sulfamethoxazole (+) trimethoprim (BACTRIM) and nitrofurantoin (MACROBID) high blood pressure but no current blood pressure medication. Rhesus antibodies (RH) negative, and a history of cervical dysplasia, urinary tract infections and Caesarian (C) section for first child, year 2006, who on 25-AUG-2006 was vaccinated with HPV vaccine (yeast). The nurse reported that the patient was scheduled for a leep procedure, due to cervical dysplasia on 20-SEP-2006 and before the procedure a blood serum pregnancy test was taken, and result was positive for pregnancy. Additional information has been requested.


VAERS ID: 272584 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2006-10-27
Onset:2006-10-27
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:110
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0954F / UNK AR / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0701USA04679

Write-up: Information has been received from a registered nurse concerning an approximately 23 year old female who was vaccinated with HPV vaccine (yeast). The registered nurse reported that she had another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm she the needle withdrawn". The nurse further commented that there was "nothing wrong with the patient, she didn''t even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved and the patient was sent home. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a registered nurse concerning an approximately 23 year old female (patient 1 of 4) with no known drug allergies, who on 27-OCT-2006 was vaccinated IM into the deltoid area with a dose of GARDASIL (lot# 653938/0954F). The registered nurse reported that she and another nurse had given "numerous" GARDASIL vaccinations. Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn". The bleeding only lasted a few seconds. The nurse further commented that there was "nothing wrong with the patient, she didn''t even notice" and "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Pressure was applied and a bandaid. Bleeding resolved and the patient was sent home. Additional information is not expected.


VAERS ID: 272602 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-01-29
Onset:2007-01-29
   Days after vaccination:0
Submitted: 2007-02-14
   Days after onset:16
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Disturbance in attention, Feeling abnormal
SMQs:, Dementia (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (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: UNK
Current Illness: Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA05003

Write-up: Information has been received from a 23 year old female emergency medical attention with a penicillin allergy who on 29-JAN-2007 was vaccinated IM with a second 0.5 ml dose of Gardasil (yeast). On 29-JAN-2007 the patient reported feeling "weird or slow in the head" and "can not concentrate or think clearly". The patient received a first IM 0.5 dose of Gardasil (yeast) on 12-DEC-2006. Additional information has been requested.


VAERS ID: 272609 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Washington  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / -

Administered by: Other       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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA05074

Write-up: Information has been received from a receptionist at a physician''s office concerning a 23 year old female who "about a month ago" in approximately December 2006 was vaccinated with a first dose of Gardasil. Subsequently, the patient developed a sore arm. Additional information has been requested.


VAERS ID: 272611 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA00126

Write-up: Information has been received from a registered nurse concerning an approximately 23 year old female (patient 2 of 4) who was vaccinated with Gardasil (yeast). The registered nurse reported that she another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn". The nurse further commented that there was "nothing wrong with the patient, she didn''t even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved and the patient was sent home. Additional information has been requested.


VAERS ID: 272612 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA00127

Write-up: Information has been received from a registered nurse concerning an approximately 23 year old female (patient 3 of 4) who was vaccinated with Gardasil. The registered nurse reported that she and another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn". The nurse further commented that there was "nothing wrong with the patient, she didn''t even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved ant the patient was sent home. Additional information has been requested.


VAERS ID: 272613 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-02-14
Entered: 2007-02-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA00128

Write-up: Information has been received from a registered nurse concerning an approximately 23 year old female (patient 4 of 4) who was vaccinated with HPV vaccine (yeast). The registered nurse reported that she and another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn". The nurse further commented that there was "nothing wrong with the patient, she didn''t even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved and the patient was sent home. Additional information has been requested.


VAERS ID: 272847 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Colorado  
Vaccinated:2007-02-15
Onset:2007-02-18
   Days after vaccination:3
Submitted: 2007-02-21
   Days after onset:3
Entered: 2007-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0962F / 1 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Injection site pain, Injection site rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Routine Pap smear
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: HPV vaccine given 2/15/07. PT called office 2/20/07 with reports of "breaking out from vaccine". States on 2/18 she had hives on waist up, dry and flaky. Only "pain and pimple" at injection site (R arm). Pt denied any other changes in detergents, soap, food, perfume, lotion, etc. Pt told to take Benadryl.


VAERS ID: 272895 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Maryland  
Vaccinated:2007-02-20
Onset:2007-02-20
   Days after vaccination:0
Submitted: 2007-02-22
   Days after onset:2
Entered: 2007-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 02634 / 2 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Arrhythmia, Blood pressure, Computerised tomogram, Dyspnoea, Dysstasia, Electrocardiogram, Fall, Feeling hot, Fluid replacement, Heart rate, Hyperhidrosis, Hyperventilation, Injury, Loss of consciousness, Nausea, Paraesthesia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (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: I take Ortho Try Cyclen Lo, daily and a multi-vitamin
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: CAT Scan, EKG, blood pressure, heart rate
CDC Split Type:

Write-up: I received the vaccination at approximately 8:20 AM and felt nothing (my arm slightly ached where the vaccine had been injected, but I felt nothing out of the ordinary post-injection). I walked over to the check-in counter to schedule my third a final injection in the series and put on my jacket. I remember the nurse saying 8:00 AM on Wednesday, June 20 and then the next thing I remember is being surrounded by people on the floor of the office. I blacked out while standing up and hit the left side of my body (mainly my lower jaw, neck, and clavicle) and when my body hit the floor the center, back of my head slammed to the floor. No one actually saw what parts of my body hit where during the fall because the nurse was behind the counter sitting at the computer (below eyesight of my fall) and patients in the waiting room were seated behind a wall. Based on where I remember standing before blacking out and where my body hurt after waking up, I think I am pretty certain I know what was hit. After waking up the doctor and several nurses helped me sit up and recommended calling an ambulance to have my head checked out. At first I declined because I did not think I had any serious problems, but after I tried standing and could not, I agreed to the ambulance. My face was tingly, I had trouble breathing (when I first woke up I was hyperventilating), I was sweating, and my legs were not stable. The EMT arrived and took my blood pressure and decided I should go to the emergency room for a check-up. When we arrived at the ER my head and lower jaw were throbbing from the fall. The ER staff gave me an IV for hydration and ran the typical tests (blood pressure, heart rate, etc.), an EKG, and later received a CAT scan. After returning from the CAT Scan I was still a bit shaken but was breathing normal. My left arm ached from the injection (my right arm ached after the first injection in series, so I ignored that aches). After being in the hospital for at least two hours I suddenly blacked out again. My sister was sitting with me and said my face turned a green/yellow shade. I remember feeling nauseas and becoming very hot and it was very hard to breath. My sister called the nurse who came and hooked me up to the heart monitors and also started another IV. Awhile later the nurse came back and said I had probably had an arrhythmia, but they were not sure. I stayed in the ER for the remainder of the day and nothing else happened. I was later discharged and told I had had an arrhythmia (I was never told what may have happened in the morning, but it too was most likely an arrthmia). I told everyone after arriving at the ER I had received my second injection in the Gardasil series that morning and had eaten a small breakfast (I assumed I would eat a larger one when I arrived at work). The staff said they were not certain of side effects of Gardasil as it was so new, but they were very certain the blacking out happening on the same day as the vaccination was just coincidence. My mother was reading about Gardasil and came across the following: "Deaths ? Across the clinical studies, 17 deaths were reported in 21,464 male and female subjects. The events reported were consistent with events expected in healthy adolescent and adult populations?In addition, there were 2 cases of sepsis, 1 case of pancreatic cancer, and 1 case of arrhythmia in the group that received GARDASIL, and 1 case of asphyxia in the placebo group." This particular page is what prompted me to write to VAERS. Arrthmia is a documented "serious" side effect of Gardasil and the office staff at my OB/GYN and at the Hospital ER were not aware my condition was connected to the injection.


VAERS ID: 273075 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Nebraska  
Vaccinated:2007-02-16
Onset:2007-02-16
   Days after vaccination:0
Submitted: 2007-02-16
   Days after onset:0
Entered: 2007-02-26
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB260AA / 3 RA / IM

Administered by: Unknown       Purchased by: Unknown
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:
Current Illness:
Preexisting Conditions: Environmental allergies-seasonal-spring
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: pt received Hepatitis b vaccine, 3 rd shot @ 0855 am 02/16/07, approx 12:15 am felt dizzy, nauseated and headache as stated. States feels ok prior to coming to work. -----not feelin sick.


VAERS ID: 273091 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Iowa  
Vaccinated:2006-09-15
Onset:2006-10-19
   Days after vaccination:34
Submitted: 2007-02-22
   Days after onset:126
Entered: 2007-02-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B033AA / UNK LA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB109EA / UNK LA / IM
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UE804AA / UNK LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, Medication error, No adverse effect, Wrong drug administered
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Due to pharmacy substitution, pt received Infanrix Dtap vaccination rather than Adacel Tdap vaccination. University drug information center indicated that the pediatric Infanrix version contains the same amounts of tetanus and pertussis and in creased amount of diphtheria component. The patient should be adequately immunized. They may, however, be at an increased risk of adverse reaction due to the elevated diphtheria component. The patient was contacted and did not experience any serious adverse reactions. Follow up corrective actions are being taken at center.


VAERS ID: 273193 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Arizona  
Vaccinated:2007-02-21
Onset:2007-02-21
   Days after vaccination:0
Submitted: 2007-02-21
   Days after onset:0
Entered: 2007-02-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB287BA / UNK - / IM

Administered by: Other       Purchased by: Private
Symptoms: Eye disorder, Eye pain, Nasal congestion, Nausea, Pruritus, Pruritus generalised, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Calcium and Omaga Vit
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type:

Write-up: Employee reports to being lightheaded immediately after getting immunized. 2/21/07 states feeling nausea and having pain to the eyes. Reports having nasal drainage, stated her legs started to itch while talking to her at 1055. Employee is itching whole body and reports feeling congestion in nose and eyes. Per Dr sent employee for follow up. VS at 1045 130/73 with pulse 64 BPM, Temp 96.4, VS at 1115 132/72 with pulse 55 BPM.


VAERS ID: 273242 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Michigan  
Vaccinated:2006-04-11
Onset:2006-04-12
   Days after vaccination:1
Submitted: 2007-01-29
   Days after onset:292
Entered: 2007-03-01
   Days after submission:31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV104 / 3 LA / SC

Administered by: Other       Purchased by: Private
Symptoms: Hypoaesthesia oral, Pyrexia, Swollen tongue, Tongue discolouration, Tongue disorder
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth Control
Current Illness: NONE
Preexisting Conditions: Allergy Drug hypersensitivity sulfa drugs
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: 06AV00130SP

Write-up: Noted tongue swollen, bumps both side, tongue white and sides if tongue numb on 4/12/06. Patient reports feeling feverish 4/12/06 and 4/13/06, putting cold water on face to cool off. On 4/15/06 tip of tongue also numb. Seen in ER ON 4/15/06. Given Prednisone (oral) and Pepcid. On 4/16/06 took Benadryl (2) capsules. Tongue felt slightly less swollen after Benadryl, no change in other symptoms. On 4/17/06 tongue feels as it did before Benadryl. All other symptoms continue.


VAERS ID: 273250 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Michigan  
Vaccinated:2006-10-10
Onset:2006-10-10
   Days after vaccination:0
Submitted: 2007-01-29
   Days after onset:111
Entered: 2007-03-01
   Days after submission:31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV102 / 2 LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Headache, Myalgia, Nausea, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (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: Celexa, Depo Provera
Current Illness: NONE
Preexisting Conditions: Anxiety, Abnormal cells on pap with cold cone 3/06
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: 06AV00314SP

Write-up: Approximately 9 hours after she experienced nausea, headache and lightheadedness. Treatment of Tylenol and sleep. In the am she states her symptoms had improved end she reported to work as usual. Her symptoms worsened over the morning and she also reports muscle aches and an episode of blurred vision when she stood up. She left work to go home and sleep. She reports all of her symptoms resolved as of 7:00 pm on 10/11/2006.


VAERS ID: 273253 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2004-06-01
Onset:2004-12-01
   Days after vaccination:183
Submitted: 2007-01-29
   Days after onset:789
Entered: 2007-03-01
   Days after submission:31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV080 / 5 UN / -

Administered by: Military       Purchased by: Military
Symptoms: Burning sensation, Pruritus, Skin burning sensation, Skin reaction, Urticaria, Urticaria thermal
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 06AV00415SP

Write-up: Subject first noticed her fingertips itching and burning in the winter of 2004. She had previously experienced this sensation as a child. She developed skin splints and stress fracture in Sept 2005 for which she was taking Naprosyn. In December 2005 subject noted a more severe skin reaction - itching and burning with hives all over (including in her throat). She began seeing an allergist and was treated with Claritin. She was diagnosed with Cold-Induced Urticaria for which she takes cyproheptadine and carries and epipen. Prior vaccination history includes Anthrax dose #1 FAV071, #2 FAV075, #3 FAV071, #4 FAV080, Influenza NOV-2003 and Smallpox MAR-2003.


VAERS ID: 273311 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: California  
Vaccinated:2007-02-09
Onset:2007-02-11
   Days after vaccination:2
Submitted: 2007-02-22
   Days after onset:11
Entered: 2007-03-02
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 411011A / 1 RA / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z06632 / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Diabetes mellitus inadequate control, Erythema, Malaise, Nodule, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Red lump on the back of left arm and has been ill for the last 2 days with fever up to 104. Taking Motrin. Diabetes out of control. Advised by MD to take aspirin, fluids, IV hydration was offered due to vomiting.


VAERS ID: 273478 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Colorado  
Vaccinated:2006-05-08
Onset:2006-05-08
   Days after vaccination:0
Submitted: 2006-06-06
   Days after onset:29
Entered: 2007-03-05
   Days after submission:272
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
JEV: JAPANESE ENCEPHALITIS (JE-VAX) / SANOFI PASTEUR EJN221A / 2 RA / SC

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Erythema, Fatigue, Headache, Paraesthesia, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had no pre existing medical conditions. Other medications included Ataral as needed, but he was on no medications at the time of vaccination. He had a mild cough at the time of vaccination.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200601197

Write-up: Initial report received from a healthcare provider on 17/May/2006. A 23 year odl male patient, with no pre existing medicla history, had recieved a subcutaneous, right extremity, second dose injection of JE VAX, lot number EJN221A, on 08/May/02006. On the same day, he developed headache, fatigue, and dizziness which lasted for one to two days. Two days later, he developed a red rash generalized throughout his body and tingling in his hands and feet. The patient ha drecieved prior vaccinations on 01/May/2006 which included a subcutaneous, right extremity, first dose injection of JE VAX, lot number EJN221A, and a second dose injection of Hepatitis A vaccine, lot number AHAVB106. the patient had also recieved the follwoing vaccinations within four weeks of the 08/May/2006 vacciantion (date of these vaccinations was not specified. an injection of YF VAX, lot number UE664AB, and in injection of Typhim VI, lto number Z0479-2. Routes and sites of administration were not provided. At the time of this report, the patient had recovered. Follow up information recieved on 05/Jun/2006 from a health care professional JE VAX (second dose) was adminiastered in the right arm, JE VAX (first dose) was administered in the right arm, YF Vax was administered subcutaneously in the right arm, Typhim VI was administered in the left deltoid, and Hepatitis A vaccine was administered in the right deltoid. Other medications which had included Ataral was amended to Adderall (as needed).


VAERS ID: 273580 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Virginia  
Vaccinated:2007-02-15
Onset:0000-00-00
Submitted: 2007-03-07
Entered: 2007-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 1 - / -

Administered by: Military       Purchased by: Military
Symptoms: Erythema, Injection site cellulitis, Staphylococcal skin infection, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Cellulitis of the small pox vaccination site. Service member received primary smallpox vaccine on 15 Feb 07. He reports that the next day he had a tattoo placed under the smallpox vaccine site. On 24 Feb 07 while visiting he was evaluated at a medical center for a robust take that extended beyond the parameters of a normal "take". A culture was taken that grew out staph aureaus. Pt was treated with Keflex 500 mg QID Z 5 days. Today he states that he is afebrile, has no LAD, and smallpox site is scabbed over and healing well. He is being deployed tomorrow. No further TX needed. Swelling, erythema.


VAERS ID: 273932 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-01-28
Onset:2007-02-06
   Days after vaccination:9
Submitted: 2007-02-09
   Days after onset:3
Entered: 2007-03-14
   Days after submission:32
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 1 RA / -

Administered by: Other       Purchased by: Military
Symptoms: Erythema, Lacrimation increased, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Lacrimal disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Edema, erythema, watery right eye.


VAERS ID: 274032 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-02-20
Onset:2007-02-22
   Days after vaccination:2
Submitted: 2007-03-14
   Days after onset:19
Entered: 2007-03-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2644AA / 1 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Cough, Headache, Nausea, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Patient called 3-2-07 to report "reaction since 2-22-07 with c/o headaches and nausea which subsided 2-24-07. Physician with f/u with phone call if sxs. returned. 3-12/07 pt called with "persistent cough waking her up at night"


VAERS ID: 274213 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2006-12-01
Onset:2006-12-01
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:102
Entered: 2007-03-16
   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: Blood pressure increased, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA01991

Write-up: Information has been received from a physician concerning a 23 year old female who in December 2006, was vaccinated with a second dose of Gardasil (yeast). In December 2006, the patient''s blood pressure went up and she developed shortness of breath. After 30 minutes, the patient''s blood pressure returned to normal. The patient was not pregnant. At the time of this report, the outcome of the shortness of breath was unknown. Additional information has been requested.


VAERS ID: 274223 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2006-12-01
Onset:2006-12-01
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:102
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Anogenital warts
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0702USA02542

Write-up: Information has been received from a physician''s assistant concerning a 23 year old female with genital warts who in December 2006, was vaccinated with first dose of HPV (lot # not reported) 0.5 ml injection. Concomitant therapy was unspecified. The patient sought medical attention. In December 2006, after taking the first dose of vaccine, the genital warts seemed to worsen. The patient was treated with thioguanine and cytarabine (TCA). On approximately 07-FEB-2007, the patient was given the second dose of HPV (lot # not reported) 0.5 ml injection. The outcome of the worsening genital warts was not specified. No further information was provided at the time of reporting. Additional information has been requested.


VAERS ID: 274295 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Colorado  
Vaccinated:2006-10-20
Onset:2006-10-22
   Days after vaccination:2
Submitted: 2007-03-14
   Days after onset:143
Entered: 2007-03-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Pruritus
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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YASMIN
Current Illness: Sulfonamide allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0702USA03446

Write-up: Information has been received from a physician concerning a 23 year old female with sulfonamide allergy and no pertinent medical history who on 20-OCT-2006 was vaccinated with Gardasil. Concomitant therapy included YASMIN. On 22-OCT-2006, 48 hours after receiving the immunization, the patient developed itching without a visible rash. The patient sought unspecified medical attention. No laboratory tests were performed. The itching persisted for 3 weeks. At the time of reporting, the patient had recovered from the itching on approximately 10-NOV-2006. No other information was available at the time of reporting. Additional information has been requested.


VAERS ID: 274170 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2007-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

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

Write-up: On day 6th after 1st dose of HPV and Influenza vaccine given at health center, forearms, hands, palms maculopapular erythematous rash that became heavy and spread to entire body. Patient had been seen by 2 dermatologist, patches/hives last for 1 1/2 weeks. Required treatment with oral steroids (Medrol pack). No other current illness such as fever, headache, arthralgia, arthritis or myalgia. Reaction developed despite oral Claritin daily.


VAERS ID: 274236 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: New York  
Vaccinated:2007-02-01
Onset:2007-02-01
   Days after vaccination:0
Submitted: 2007-03-16
   Days after onset:42
Entered: 2007-03-19
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1425F / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Full blood count normal, Haematology test normal, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE 11/13/07-records received-PMH: polycystic ovarian disease, hypertension, hyperlipidemia.
Allergies:
Diagnostic Lab Data: complete blood cell - normal results, hematology - normal results 11/13/07-records received- Labs: Potassium 3.3, phosphorus 2.3, eosinphils 7.3, sed rate 34, blood culture, urine culutre, spinal fluid culture no growth. EBNA IgG 7.36, EBV IgG 4.75, C-RP 5.8. CT paranasal sinuses: chronic sinusitis. CT cervical spine: negative. CXR negative 3/4/09-lab reports received for 2/26/07- synovial fluid glucose 55, protein 32.
CDC Split Type: WAES0703USA02171

Write-up: Information has been received from a physician concerning a 22 year old female with no pertinent medical history who in February 2007, was vaccinated with a first dose of Gardasil. There was no concomitant medication. Approximately two weeks post vaccination, the patient experienced paresthesia of hands and feet and was hospitalized. The patient was in the hospital for approximately 5 days and was treated with immune globulin. The physician reported that "blood studies" and "agency reported" had normal results. The patient was discharged from the hospital and had subsequently fully recovered. The reporting physician considered paresthesia of hands and feet to be disabling and an other important medical event. Additional information has been requested. 11/13/07-records received for DOS 2/21-2/26/07-DC DX: Infection polyneuritis. Spontaneous Ecchymoses. Epistaxis. Cardiac Dysrhythmias. Seen in ED for C/O bloody nose since Sunday, fever, numbness, tingling of hands and feet for several days, day seen in ED C/O neck stiffness, areas of ecchymosis of arm, leg and breast. PE: decrease to pinprick sensation distally hands and feet.


VAERS ID: 274374 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2007-01-15
Onset:2007-01-22
   Days after vaccination:7
Submitted: 2007-03-19
   Days after onset:55
Entered: 2007-03-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 LA / IM

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: ORTHO TRICYCLEN
Current Illness:
Preexisting Conditions: Neurofibromytosis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received vaccine/GARDASIL 1/15/07. One week later, developed hives which lasted one week. Pt treated with BENADRYL for symptoms relief. Follow-up information received - Date of vaccination and Adverese event onset date.


VAERS ID: 274397 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Illinois  
Vaccinated:2007-03-07
Onset:2007-03-13
   Days after vaccination:6
Submitted: 2007-03-19
   Days after onset:6
Entered: 2007-03-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0243U / 1 LA / -

Administered by: Private       Purchased by: Unknown
Symptoms: C-reactive protein normal, Full blood count normal, Unevaluable event
SMQs:

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

Write-up: None Stated 04/02/07-records received from facility. Developed rash around injection site, pulse 100, felt shaky, tightness in chest and heart felt like it was racing. Feels anxious, agitated, lightheaded. PE:WNL. DX: Anxiety disorder.


VAERS ID: 274628 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Georgia  
Vaccinated:2007-03-21
Onset:2007-03-21
   Days after vaccination:0
Submitted: 2007-03-23
   Days after onset:2
Entered: 2007-03-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U1853BB / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2556AA / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cold compress therapy, Headache, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (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: none~ ()~~0.00~In Patient|none~ ()~~0.00~In Sibling
Other Medications: Tuberculin Skin Test
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient went to Doctor due to headache and swelling and pain under both arm pits around brachial artery. Shots were given on March 21, 2007 at 4:45 p.m. Doctor instructed patient to use cold compresses under arms and take Motrin.


VAERS ID: 274644 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-03-08
Onset:2007-03-08
   Days after vaccination:0
Submitted: 2007-03-22
   Days after onset:13
Entered: 2007-03-24
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / 4 LA / -

Administered by: Military       Purchased by: Military
Symptoms: Asthenia, Dysphagia, Eating disorder, Headache, Pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? 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 for 48 hrs within 30 minutes after injection, arm very painful, fever on and off for two weeks, body aches and pains, very low energy, infected throat which led to self check in due to inability to eat/ swallow.


VAERS ID: 274781 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2003-12-18
Onset:2003-12-19
   Days after vaccination:1
Submitted: 2007-03-21
   Days after onset:1187
Entered: 2007-03-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / UNK - / -
SMALL: SMALLPOX (NO BRAND NAME) / UNKNOWN MANUFACTURER 4030013 / UNK - / -

Administered by: Military       Purchased by: Military
Symptoms: Arthralgia, Dizziness, Heart rate increased, Joint swelling
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Dehydration (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: Pain relieve, muscle relaxers
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swollen joints (knees, shoulder and elbows)-daily; aching joints-daily; fast heart beat-staying still; Dizziness-Walking


VAERS ID: 274803 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Puerto Rico  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-03-19
Entered: 2007-03-26
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / UNK - / -

Administered by: Military       Purchased by: Military
Symptoms: Fatigue, Headache, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Headache, fatigue, muscle aches


VAERS ID: 274951 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Missouri  
Vaccinated:2007-03-26
Onset:2007-03-26
   Days after vaccination:0
Submitted: 2007-03-26
   Days after onset:0
Entered: 2007-03-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 00440 / 1 - / IM

Administered by: Private       Purchased by: Unknown
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Get lightheaded with blood draws
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Nausea, lightheaded x 5 min right after injection.


VAERS ID: 275202 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Oklahoma  
Vaccinated:2007-03-18
Onset:2007-03-18
   Days after vaccination:0
Submitted: 2007-03-20
   Days after onset:2
Entered: 2007-03-29
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB287BA / 3 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Arthralgia, Contusion, Headache, Nausea, Pruritus, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Headache, nausea/vomiting, arthralgia, bruising, itching and hives.


VAERS ID: 275293 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Virginia  
Vaccinated:2007-03-27
Onset:2007-03-28
   Days after vaccination:1
Submitted: 2007-03-30
   Days after onset:2
Entered: 2007-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2688AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Blood creatine phosphokinase, Full blood count normal, Myalgia, Pyrexia, Red blood cell sedimentation rate, Urine analysis normal
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOTRIN; LEXAPRO
Current Illness: None; Td previous in 2002
Preexisting Conditions: SYRINGOMYELIA IN PAST WITH MILD LOSS OF SENSATION IN FEET PERSISTING
Allergies:
Diagnostic Lab Data: CBC wnl UA neg ESR and CPK pending
CDC Split Type:

Write-up: Fever 12 horus after vaccine , myalgias and achign joints. No shortness of breath, no hives, no warm or red joints.


VAERS ID: 275392 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Virginia  
Vaccinated:2007-02-07
Onset:2007-03-01
   Days after vaccination:22
Submitted: 2007-03-25
   Days after onset:23
Entered: 2007-04-02
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1447F / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Anogenital warts
SMQs:

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

Write-up: Complained of rectal condyloma within 3 weeks of getting vaccine. No exposure there.


VAERS ID: 275423 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Virginia  
Vaccinated:2007-03-27
Onset:2007-03-27
   Days after vaccination:0
Submitted: 2007-04-02
   Days after onset:6
Entered: 2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB043AB / 2 RA / IM
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 411011A / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Feeling hot, Sluggishness, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: None
Current Illness: None according to pt.
Preexisting Conditions: None according to pt.
Allergies:
Diagnostic Lab Data: None
CDC Split Type: VA07004

Write-up: pt stated she went to her mother''s office (Mom is an MD) after receiving immunizations. Added she felt "hot" & "sluggish". Shortly after ariving, she developed hives to both arms & tightening of her mouth. Nurse in office administered Benadryl 25 mg IV. According to pt & nurse, she immediately felt better. No follow up recommended


VAERS ID: 275476 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Mississippi  
Vaccinated:2007-03-12
Onset:2007-03-23
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2007-04-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV103 / 1 LA / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 1 LA / -
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 1 RA / -

Administered by: Military       Purchased by: Military
Symptoms: Abdominal pain, Back pain, Pyrexia, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 1-2 wk-fever, lower back pain, lower abdominal pain. 23-MAR-broke out in small red bumps that got bigger and itched really bad.


VAERS ID: 275542 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: New York  
Vaccinated:2007-03-27
Onset:2007-03-29
   Days after vaccination:2
Submitted: 2007-04-03
   Days after onset:5
Entered: 2007-04-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Pruritus, Skin burning sensation, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (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: Estrostep 28
Current Illness: None
Preexisting Conditions: NKA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient went tanning at tanning booth, has tanned previous to vaccine. Did not use sun tanning lotion. 2 hrs post tanning after showering noticed hives on chest, breasts and armpits. C/O burning and itching, pt instructed no tanning until further notice per doctor. No other c/o symptoms. Hives lasted 8 hr then disappeared.


VAERS ID: 275562 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Maine  
Vaccinated:2007-03-30
Onset:2007-04-03
   Days after vaccination:4
Submitted: 2007-04-03
   Days after onset:0
Entered: 2007-04-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / 2 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Local reaction, 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: mIRENA iud
Current Illness: NO
Preexisting Conditions: CODEINE,SULFA,CEFZIL
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: LOCAL REACTION WITH URTICARIA


VAERS ID: 275779 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Illinois  
Vaccinated:2006-11-28
Onset:2007-01-31
   Days after vaccination:64
Submitted: 2007-04-06
   Days after onset:64
Entered: 2007-04-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0688F / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Gynaecological examination, Laboratory test, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? 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 = 1/31/2007)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Diagnostic laboratory 02/26/07, gynecological 02/26/07, ultrasound 02/26/07
CDC Split Type: WAES0704USA00075

Write-up: Information has been received from a consumer and a licensed practical nurse, through the pregnancy registry, concerning a 23 year old female, who was vaccinated on 28-SEP-2006 with the first dose of Gardasil, and on 28-NOV-2006 with the second dose of Gardasil (Lot # 653735/0688F). There was no concomitant medication. The nurse reported that on 26-FEB-2007 (consumer reported as 13-MAR-2007, "some time after"she received the second dose) the patient had a miscarriage. The date of the last LMP was approximately 31-JAN-2007 ("late January"). According to the consumer, lab diagnostic tests included "several blood tests, ultrasounds, vaginal probe" (results not provided). On 29-MAR-2007, the third dose of Gardasil (Lot # 654389/0961F) was administered to the patient, and the nurse reported the patient "was fine" at that visit. The miscarriage was considered to be an other important medical event. Additional information has been requested.


VAERS ID: 275797 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Washington  
Vaccinated:0000-00-00
Onset:2007-03-25
Submitted: 2007-04-09
   Days after onset:15
Entered: 2007-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthropod bite, Blister, Cellulitis, Induration, Polymerase chain reaction, Rash erythematous, Rash pruritic, Rash pustular, Skin ulcer, Swelling, Tenderness, Vaccinia
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: None (not pregnant, no history of eczema, no immuno-compromise.
Allergies:
Diagnostic Lab Data: Testing of clinical specimen obtained at second visit was performed at NM public health laboratory and was PCR positive for orthopox and non-variola orthopox (using LRN methodology). Follow-up testing at CDC is pending.
CDC Split Type:

Write-up: On 3/25/2007, six days after contact with a soldier who had been vaccinated for smallpox sometime during the week of 3/12/2007, patient noted area of induration, swelling and blisters on inner thigh. Three days prior to blisters, patient noted a bruised sensation in the same area. First treatment was for presumed cellulitis secondary to insect bite on 3/29/07 (Augmentin BID and NSAIDS); next treatment on 3/30/07 was for suspected vaccinia (different provider) with Augmentin continued, Doxycycline added (at this stage there was single approximately 2 cm tender, pruritic, erythematous ulceration that was deep with grey whiteish pustule in center that was lanced and packed. Patient was seen in follow-up (by third provider) on 4/3/07 when ulceration was only about 6 mm in size with no associated erythema: antibiotics discontinued and patient released back to work.


VAERS ID: 276126 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Texas  
Vaccinated:2006-12-01
Onset:0000-00-00
Submitted: 2007-04-06
Entered: 2007-04-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unk
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: WAES0703USA00440

Write-up: Information has been received from a physician concerning a 23 year old female who in December 2006, was vaccinated into the left arm with a 0.5mL first dose of Gardasil. Subsequently, on an unspecified date, the patient developed a swollen arm (reported via company representative). The physician also reported that the patient developed a "nodule on the left arm under the skin, "a pouch, which intermittently becomes itchy." (date not reported). At the time of the report, the patient had not recovered. The patient sough unspecified medical attention. Additional information is not available.


VAERS ID: 276136 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-03-01
Onset:2007-03-01
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:35
Entered: 2007-04-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0243U / 1 RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain upper, Asthenia, Dizziness
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0703USA00629

Write-up: Information has been received from a physician concerning a 23 year old female patient who on 01-MAR-2007 was vaccinated in right deltoid with a first dose of GARDASIL vaccine, lot #656372/0243U. The patient became dizzy after receiving the injection. She also had stomach cramps when she got home (severe). Weakness and the start of menses shortly after the vaccination. Unspecified medical attention was sought. The patient''s outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/6/2007. The patient recovered from stomach cramps and weakness on 01-MAR-2007. The outcome of dizziness was unknown. Additional information is not expected.


VAERS ID: 276231 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-04-06
Entered: 2007-04-09
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? 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: Diabetes
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0703USA01307

Write-up: Information has been received from an office manager concerning a female patient who was vaccinated with a first dose of Gardasil and fainted after receiving the injection. Unspecified medical attention was sought. The patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/6/2007. In follow up information it was reported that patient had episode of syncope after the injection and it was reaction to needle, not medication (occurred immediatley after withdraw of needle. Used amnoia capsule. On 03-Nov-2006 the patient recovered. Additional information is not expected.


VAERS ID: 275809 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-04
Onset:2007-04-05
   Days after vaccination:1
Submitted: 2007-04-10
   Days after onset:5
Entered: 2007-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV106 / 2 LA / SC

Administered by: Military       Purchased by: Military
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:
Current Illness: NO
Preexisting Conditions: ALDARA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Red all around shot, itchy 55mm in size


VAERS ID: 275948 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2006-09-29
Onset:2006-09-29
   Days after vaccination:0
Submitted: 2006-10-06
   Days after onset:7
Entered: 2007-04-10
   Days after submission:186
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA201AA / UNK LA / IM

Administered by: Military       Purchased by: Private
Symptoms: Injection site erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: No labs done at med visit.
CDC Split Type:

Write-up: No fever local left arm red from shoulder to elbow, swollen.


VAERS ID: 275965 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-03-07
Onset:2007-03-07
   Days after vaccination:0
Submitted: 2007-03-14
   Days after onset:6
Entered: 2007-04-10
   Days after submission:27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV 103 / 1 LA / SC

Administered by: Military       Purchased by: Military
Symptoms: Diarrhoea, Dry mouth, Dry throat, Flatulence, Headache, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: Elavil
Current Illness: not ill
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: nausea, headache, diarrhea, gas, low-grade fever, dry mouth/trought


VAERS ID: 276300 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Delaware  
Vaccinated:2007-03-15
Onset:0000-00-00
Submitted: 2007-04-13
Entered: 2007-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / 1 LA / -

Administered by: Private       Purchased by: Public
Symptoms: Injection site pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: c/o soreness in arm since injection on 3/15/07. Pt came in 4/13/07 with above symptoms not note to us before this date


VAERS ID: 276310 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2007-04-10
Onset:2007-04-11
   Days after vaccination:1
Submitted: 2007-04-12
   Days after onset:1
Entered: 2007-04-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1503F / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Cellulitis, Hypersensitivity, Injection site pain, Injection site rash, Injection site swelling
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Prior vaccine 3/13/07 Rxn Dx''d as Cellulitis later (3/27/07)
CDC Split Type:

Write-up: Rash, Pain, swelling at injection site starting after 24 hrs. Seen by MD 4-12-07 dx''d allergic rxn. treated with Benadryl, Ice packs


VAERS ID: 276407 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-04-09
Onset:2007-04-09
   Days after vaccination:0
Submitted: 2007-04-09
   Days after onset:0
Entered: 2007-04-16
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 411011A / 2 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site warmth, Nausea, Skin warm
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Client Stated redness from left deltoid to wrist, warm to touch, warm sensation all over, and nausea symptoms happened within 4 hours of shot after client went back to work. client toke Benadryl PO and had someone call us with information on reaction. Spoke with client and had her come into the clinic. The L arm was warm and pink from the shoulder to above the wrist.


VAERS ID: 276673 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-03-12
Onset:0000-00-00
Submitted: 2007-04-13
Entered: 2007-04-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Dysgeusia, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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:
CDC Split Type: WAES0703USA02394

Write-up: Information has been received from a 23 year old female with pertinent medical history and drug reactions/allergies not reported who on 12-MAR-2007 was vaccinated with Gardasil, 0.5 ml, once. Concomitant medication was not reported. Subsequently, on an unspecified date, the patient experienced a feeling of her throat closing 5 minutes after receiving Gardasil. One hour after the vaccination, the patient "felt like she was having an asthmatic attack with a metallic taste in her mouth" . The patient called the physician''s office and was advised to go to the local emergency room. The outcome and causality of the event was not reported. Additional information has been requested.


VAERS ID: 276842 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Iowa  
Vaccinated:2007-01-11
Onset:2007-01-14
   Days after vaccination:3
Submitted: 2007-04-13
   Days after onset:88
Entered: 2007-04-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash pustular
SMQs:, 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: ORTHO TRI-CYCLEN LO; hormonal contraceptives
Current Illness: Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0703USA03963

Write-up: Information has been received from a Nurse Practitioner (N.P.) concerning a 23 year old female with penicillin allergy who on 11-JAN-2007 was vaccinated IM with a first dose of Gardasil. Concomitant therapy included lot# 655619/1427F. Concomitant therapy included Ortho-Tri-Cyclen. The patient developed pustular lesions on her face, chest, umbilical area and bilateral upper extremities one and a half days after receiving the first injection. The patient self-treated with Proactiv solution. On 20-MAR-2007, it was noted on examination that the lesions remained "about the same." Additional information has been requested. 01/07/2008 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a Nurse Practitioner (N.P.) concerning a 24 year old (previously reported as 23 year old) female patient with penicillin allergy who on 11-JAN-2007 was vaccinated IM into left deltoid with a first dose of GARDASIL lot# 655619/1427F. In follow up it was reported that patient was given second dose on 27-MAR-2007 and on 17-JUL-2007 received the third dose of GARDASIL. Concomitant therapy included ORTHO TRI-CYCLEN LO. The patient developed pustular lesions on her face, chest, umbilical area and bilateral upper extremities one and a half days after receiving the first injection. The patient self-treated with PROACTIV solution. On 20-MAR-2007, it was noted on examination that the lesions on her arms had resolved but the remaining lesions remained "about the same". In follow up it was reported that patient had no shortness of breath, "nonpurited". The pustular type acne started about 3 days after the first immunization. She was seen at the doctor''s office on 20-MAR-2007 and was treated for acne and they changed her birth control pill (unspecified). There were no adverse events after the second and third dose. On 27-MAR-2007 patient recovered. Additional information is not expected.


VAERS ID: 276847 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Nebraska  
Vaccinated:2007-01-03
Onset:2007-01-03
   Days after vaccination:0
Submitted: 2007-04-13
   Days after onset:99
Entered: 2007-04-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1425F / 1 LA / IM

Administered by: Private       Purchased by: Other
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:
Preexisting Conditions: Cervical intraepithelial neoplasia
Allergies:
Diagnostic Lab Data: Unknown None
CDC Split Type: WAES0703USA03986

Write-up: Information has been received from a physician concerning a 23 year old female with a history of cervical intraepithelial neoplasia who on 03-JAN-2007 was vaccinated intramuscularly into the left arm with a first dose of GARDASIL vaccine (lot#655165/1425F)). There was no concomitant medication. On 03-JAN-2007 the patient experienced hives all over her body after vaccination with GARDASIL vaccine. The hives appeared all over her body on the day of vaccination. BENADRYL was prescribed to the patient and she fully recovered 48 hours after the vaccination. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. No laboratory diagnositic studies were performed. The patient fully recovered 48 hours after the vaccination (also reported as 04-JAN-2007). No further information is available.


VAERS ID: 276851 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Louisiana  
Vaccinated:2007-02-05
Onset:2007-03-06
   Days after vaccination:29
Submitted: 2007-04-13
   Days after onset:37
Entered: 2007-04-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 3 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOESTRIN; ZOLOFT
Current Illness: Allergic skin reaction
Preexisting Conditions: Drug rash
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0703USA04011

Write-up: Information has been received from a registered nurse concerning a 23 year old female with skin allergies and a rash to other medications in the past who on 05-FEB-2007 was vaccinated IM in the right deltoid with a third dose of Gardasil vaccine (yeast) (lot # 654702/0011U). There was no concomitant medication. The patient tolerated the vaccination well. 3 to 4 weeks post vaccination on 06-MAR-2007 the patient noticed a lump at the injection site deep in the muscle. The lump was a pea in size and was oblong in shape in the right deltoid approximately 1 cm, which was the injection site deep in the muscle. No redness, pain or fever noted. The patient took therapy with ADVIL as needed. The patient was seen last week, on approximately 13-MAR-2007, and the lump had gotten smaller from the last week. As of 20-MAR-2007 the patient had not fully recovered. The patient took therapy with ADVIL as needed. The patient was seen last week, on approximately 13-Mar-2007, and the lump had gotton smaller from the last week. As of 20-Mar-2007 the patient had not fully recovered.Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. The patient had no illness at the time of vaccination. Concomitant therapy included ZOLOFT and LOESTRIN. No additional information is expected.


VAERS ID: 276879 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Kansas  
Vaccinated:2007-03-19
Onset:2007-03-19
   Days after vaccination:0
Submitted: 2007-04-13
   Days after onset:25
Entered: 2007-04-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Penicillin allergy; Allergic reaction to antibiotics
Preexisting Conditions: unknown
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0703USA04366

Write-up: Information has been received from a Nurse Practitioner (N. P.) concerning a 23 year old female patient who on 19-MAR-2007 was vaccinated with a first dose of Gardasil (yeast). About two hours later the patient developed itchiness. On the morning of 20-MAR-2007 the patient broke out in hives about the size of a half dollar and they were painful. The NP reported that they treated the patient with a methylprednisolone (MEDROL DOS-PACK) and sterile triamcinolone acetonide (KENOLOG-40) high dose steroid. The patient was improving , but they will not continue the Gardasil vaccination series for the patient. Patient to be followed up. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow-up information has been received from a Nurse Practitioner and Medical Assistant concerning a 23 year old female with allergies to penicillin and OMNICEF for which she carried an epinephrine pen; who on 19-MAR-2007 at 12:30 pmwas vaccinated with a first dose of GARDASIL IM in right deltoid (lot# 656049/0187U). She had no illness at the time of the vaccination. On 19-MAR-2007, about 2 hours post-vaccination, the patient experienced itchiness. On 20-MAR-2007 at 03:00 (AM or PM not specified) the patient broke out in painful, itchy hives about the size of a half dollar. The hives were all over her body, and were worse around the hairline and joints. The reporter stated that they treated the patient with small dose of methylprednisolone at first then high dose taper, IM sterile KENOLOG-40 high dose steroid and for itching ATARAX. The NP reported that they will not continue with the GARDASIL vaccination series for the patient. Follow up report indicated that on 27-MAR-2007 the patient completely recovered. No additional information is expected.


VAERS ID: 276894 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Washington  
Vaccinated:2007-03-15
Onset:2007-03-15
   Days after vaccination:0
Submitted: 2007-04-13
   Days after onset:29
Entered: 2007-04-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
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: Unk
Current Illness:
Preexisting Conditions: Unk
Allergies:
Diagnostic Lab Data: Unk
CDC Split Type: WAES0703USA04785

Write-up: Information has been received from a nurse practitioner and two registered nurses, concerning a female patient in her late teens, who was vaccinated (date not specified) with the second dose of Gardasil. Subsequently the patient experienced induration and erythema, associated with the second dose. The reporters indicated they believed the induration and erythema lasted "a couple of days." Additional information has been requested.


VAERS ID: 276900 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-02-05
Onset:2007-02-26
   Days after vaccination:21
Submitted: 2007-04-13
   Days after onset:45
Entered: 2007-04-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blister, Vulval disorder
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? 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: WAES0703USA04925

Write-up: Information has been received from a nurse practitioner concerning a 23 year old female who on 05-FEB-2007 was vaccinated with a first dose of Gardasil (lot# 655618/1427F). On 26-FEB-2007 the patient experienced three separate "vulvar-type blisters" which were "slightly raised" with a white, plaque-like surface. The patient was re-examined on 12-Mar-2007, and the above lesions had completely resolved. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 276577 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Oregon  
Vaccinated:2007-04-11
Onset:2007-04-12
   Days after vaccination:1
Submitted: 2007-04-12
   Days after onset:0
Entered: 2007-04-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB260AA / 1 LA / IM

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

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

Write-up: Nausea and vomiting


VAERS ID: 276595 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-03-23
Onset:0000-00-00
Submitted: 2007-04-10
Entered: 2007-04-17
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0456A / 2 LA / SC
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U1738CB / 2 LA / IM

Administered by: Public       Purchased by: Public
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: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: MMR #2 given 3/23/2007 patient denied pregnancy, steroids or prednisone. Had MMR #1 and TD #1 on 1/23/2007. TD #2 also given 3/23/2007.


VAERS ID: 277102 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Michigan  
Vaccinated:2007-04-19
Onset:2007-04-19
   Days after vaccination:0
Submitted: 2007-04-20
   Days after onset:1
Entered: 2007-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1208F / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Balance disorder, Convulsion, Dizziness, Headache
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: High functioning Down''s Syndrome CVA 10-12 yrs prior, brain surg x2. moya-moya disease, OSA, ventricle sypass. Downs syndrome
Allergies:
Diagnostic Lab Data: LABS: CT of head revealed stable old ischemic event involving large portion of left cerebral hemisphere; small vessel ischemic disease on right; bilateral post op changes, craniotomies; no acute changes. WBC 4.0, lymphs 0.9. Na 135, Ca 8.2. UA was WNL.
CDC Split Type:

Write-up: Had HPV4 immunization at approx. 6:00pm and at 9:00pm patient had a seizure. she was taken to the Emergency department and kept overnight. This Am she is still experiencing severe dizziness with loss of balance and headache. 5/18/07 Received medical records from ER which reveal patient was at hospital getting ready for sleep study when she had abdominal pain & a witnessed seizure. Loaded w/Pb & referred to PCP. PMH: FINAL DX: new onset seizures.


VAERS ID: 277139 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-04-11
Onset:2007-04-12
   Days after vaccination:1
Submitted: 2007-04-16
   Days after onset:4
Entered: 2007-04-20
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0384U / 2 RA / -

Administered by: Private       Purchased by: Unknown
Symptoms: Cellulitis, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt stated had reaction to 1s injection determined not related to Gardasil . C/O cellulitis to L finger/hand inj given in L delt. 2nd injection to R delt, pt c/o same reaction - swelling, pain to L finger/hand again - saw PCP tx for cellulitis. Atzo given.


VAERS ID: 277211 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-02-01
Onset:2007-02-01
   Days after vaccination:0
Submitted: 2007-03-23
   Days after onset:49
Entered: 2007-04-23
   Days after submission:31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0013U / 1 LA / -

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

Write-up: Pain at injection site lasting greater than 2 months.


VAERS ID: 277515 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2007-04-19
Onset:2007-04-21
   Days after vaccination:2
Submitted: 2007-04-27
   Days after onset:6
Entered: 2007-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABAVERT) / NOVARTIS VACCINES AND DIAGNOSTICS 411011A / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Hypoaesthesia oral, Paraesthesia, Speech disorder, Visual disturbance
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (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: pt. denied any illness
Preexisting Conditions: none per pt. report
Allergies:
Diagnostic Lab Data: Records Received 5/15/07-CBC WNL. 7/11/07-MRI normal
CDC Split Type:

Write-up: Pt. returned for Rabies#2 on 4-26-07. Received Rabies #1 on 04-19-2007. Pt. stated that on Saturday, 4-21-2007 around 12 noon, that he began to have tingling in Right arm, difficulty seeing in Right eye,unable to speak for approximately 3-4 minutes and numbness on right side of lip. His father witnessed this episode. After several minutes, pt. states he was weak. Pt. able to go lay down. He states he took a nap for two hours. Upon awaking, he was completely well. Pt. states he did not seek medical help because he felt better. Denies any previous episodes or any since that time. Rabies #2 not given. Referred for MD evaluation. 05/15/07-records received for DOS 4/26/07-C/O loss of vision in right eye, aphasia, right side numbness and facial droop. Occurred a few days after rabies shot. PE unremarkable. Assessment:Episode of acute visual changes/aphasia/paresthesia, differential includes TIA and migraine equivalent. MRI/MRA to be scheduled.


VAERS ID: 277659 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Washington  
Vaccinated:2007-04-24
Onset:2007-04-24
   Days after vaccination:0
Submitted: 2007-04-30
   Days after onset:6
Entered: 2007-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIVAC) / NOVARTIS VACCINES AND DIAGNOSTICS 412011A / 1 - / IM

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

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

Write-up: Rash to chest area and complained of general discomfort.


VAERS ID: 277864 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2007-04-13
Onset:2007-04-27
   Days after vaccination:14
Submitted: 2007-05-03
   Days after onset:6
Entered: 2007-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. 0257F / 1 UN / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB115AA / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1150F / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blister, Headache, Pyrexia
SMQs:, Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ultrase MT 18 7-10 tabs with meals and 2-4 tabs with snacks Lorazepam 0.5 mg po prn Celexa 10 mg po qhs Ritalin 10 mg po q9am, 5 mg q12pm, 5 mg q3pm Ursodiol 300 mg po tid Vitamin K 5 mg po bid Azithromycin 500 mg po qod Nexium 20 mg po dai
Current Illness: cystic fibrosis, diabetes mellitus
Preexisting Conditions: Cystic Fibrosis: Has been admitted numerous times for clean-outs. PFT (11/06): FEV1 98%, FVC 71%, FEV1/FVC 60%, TLC 93%, DLCO 99%/87% Hemoptysis - s/p multiple IR embolizations to RUL (last 8/06, had 4 in 2006, 2 in 2004, started 2003) o o o o Biliary Cirrhosis: Secondary to CF. EGD 12/06 - Grade II esophageal varices without bleeding, UGI bleed x2, hematemesis/melena in ''98 Portal HTN Splenomegaly o o o o DM: Also secondary to CF. Insulin dependent. HbA1c 7.1% 11/06. Candida Parapsilosis fungemia 3/6/07 in setting of port-a-cath which was removed - treated with Fluconazole, surveillance cultures negative as of 4/13/07. s/p Sinus surgery for polyps and sinusitis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Attenuated varicella - scattered vesicles expressing minimal fluid; low-grade fever; headache


VAERS ID: 278129 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-05-02
Onset:2007-05-02
   Days after vaccination:0
Submitted: 2007-05-03
   Days after onset:1
Entered: 2007-05-08
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB130AA / 1 LA / IM
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR VE998AC / 1 RA / SC

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

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

Write-up: Hives, pruritic, over arms, chest, and upper back


VAERS ID: 278187 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Arizona  
Vaccinated:2007-01-23
Onset:2007-01-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2007-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 2 LA / IM

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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zovia
Current Illness:
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: diarrhea since day of vaccine 1st dose and continuing.


VAERS ID: 278340 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-05-07
Onset:2007-05-08
   Days after vaccination:1
Submitted: 2007-05-11
   Days after onset:3
Entered: 2007-05-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2609AA / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Headache, Hypoaesthesia, Injection site swelling, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (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)

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: oral contraception (Levlen)
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 5/10/07 Telephone consult with patient stated nausea and extensive swelling at Tdap site (R) Deltoid. Described (L) sided numbness (L) leg and arm and buttocks, High fever, Headache, and extreme weakness. 48 hours later, most symptoms resolved but patient still c/o (L) shoulder swelling at site.


VAERS ID: 278426 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-05-03
Onset:2007-05-05
   Days after vaccination:2
Submitted: 2007-05-11
   Days after onset:6
Entered: 2007-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV102 / 2 LA / SC

Administered by: Military       Purchased by: Military
Symptoms: Herpes zoster
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: local reaction with residual hypopigmentation left shoulder in same site as current adverse reaction~Smallpox (Dryvax)~1~23.30~I
Other Medications:
Current Illness: No active illness at time of vaccination.
Preexisting Conditions: H/o herpetic outbreaks on shoulders including an episode on her right shoulder within the month prior to vaccination site reaction. H/o allergic rhinitis and possible allergic contact reaction of eyes on Mar 19 2007. Diagnosed with HPV infection left buttocks in April 2007.
Allergies:
Diagnostic Lab Data: No diagnostic capabilities to determine if HSV or VZV.
CDC Split Type:

Write-up: Patient developed herpetic lesion in vaccination site 3 days after vaccination.


VAERS ID: 278514 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Arizona  
Vaccinated:2007-05-07
Onset:0000-00-00
Submitted: 2007-05-08
Entered: 2007-05-14
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0637F / UNK RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Injection site pruritus, Injection site pustule
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Small pimple-like sore at the injection site. Itching at the injection site.


VAERS ID: 278530 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Missouri  
Vaccinated:2007-04-20
Onset:2007-04-26
   Days after vaccination:6
Submitted: 2007-05-08
   Days after onset:12
Entered: 2007-05-14
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0388U / 2 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site mass, Injection site pain
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: Yaz
Current Illness:
Preexisting Conditions: Naprosyn and Band aids
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt states she noticed nickel size knot at inj site around 6 days post inj. Has not D''d in site-tender to touch.


VAERS ID: 278785 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2006-12-08
Onset:2006-12-14
   Days after vaccination:6
Submitted: 2007-05-16
   Days after onset:152
Entered: 2007-05-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Pregnancy NOS (LMP = 11/16/2006)
Allergies:
Diagnostic Lab Data: beta-human chorionic 12/14/06 - positive
CDC Split Type: WAES0612USA02963

Write-up: Initial and follow up information has been received from a nurse and manufacturer pregnancy registry concerning a 23 year old black female patient with one previous pregnancy who on 08-DEC-2006 was vaccinated with a dose of Gardasil. On 14-DEC-2006 a pregnancy test was positive. The patient''s LMP was late November 2006. On 07-MAY-2007 the nurse reported that the patient had not been to the office since the original prenatal appointment on 12-FEB-2007. She had cancelled 3 appointments on 05-March-2007, 12-MAR-2007 and 19-MAR-2007. Follow up information from the nurse indicated that on 16-NOV-2006 patient had her last menstrual period and her estimated delivery date 20-AUG-2007. She called back on 07-MAY-2007 but did not give any information about the miscarriage. On 24-APR-2007 patient reported that she had miscarried. No date was identified when the patient miscarried. Unspecified medical attention was sought. The outcome was unknown. Upon internal review, miscarriage was considered an other important medical event. Additional information has been requested.


VAERS ID: 279037 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Indiana  
Vaccinated:2007-04-02
Onset:2007-04-02
   Days after vaccination:0
Submitted: 2007-05-14
   Days after onset:42
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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: hormonal contraceptives
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0704USA00315

Write-up: Information has been received from a medical assistant concerning a 23 year old female with no pertinent medical history who on approximately 02-FEB-2007 was vaccinated with a first dose of Gardasil. On 02-APR-2007, the patient was vaccinated, intramuscularly, with a second dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On 02-APR-2007, within a few hours of the vaccination, the patient experienced shortness of breath and nausea. She called the physician''s office and the physician prescribed Benadryl. There were no laboratory or diagnostic tests performed. The patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 279168 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-01-19
Onset:2007-01-19
   Days after vaccination:0
Submitted: 2007-05-14
   Days after onset:114
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site irritation, Injection site pain, Smear cervix, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (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? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADVAIR
Current Illness: Food allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Pap test -
CDC Split Type: WAES0704USA01198

Write-up: Information has been received from a nurse concerning a 23 year old female patient with an unspecified food allergy who on 19-JAN-2007 was vaccinated IM with a first dose of Gardasil lot #654702/0011U. Concomitant therapy included Yasmin and Advair. On 19-JAN-2007 the patient experienced some irritation around the injection site after the first injection. She reported soreness, burning, erythema at injection site. On 05-APR-2007 patient''s father (a physician) administered the second dose of Gardasil lot #656372/0243U to the patient. Within 24 hours of receiving the second injection she developed hives which covered her entire body. The injection site was red, swollen, and burned. She was prescribed Benadryl. The patient was recovering. Additional information has been requested.


VAERS ID: 279175 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-02-01
Onset:2007-02-01
   Days after vaccination:0
Submitted: 2007-05-14
   Days after onset:101
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA01362

Write-up: Information has been received from a nurse practitioner concerning a 23 year old female who in approximately February 207, was vaccinated with the first dose of Gardasil. The patient complained of a sore arm for several weeks after the injection. The patient recovered from the sore arm. The patient does not want to return for the second dose. Medical attention was sought.


VAERS ID: 279180 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-04-03
Onset:2007-04-03
   Days after vaccination:0
Submitted: 2007-05-14
   Days after onset:41
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0245U / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness: Drug hypersensitivity; Seasonal allergy; Dermatitis contact
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA01509

Write-up: Information has been received from a physician, via a company representative, concerning a 23 year old female patient with drug hypersensitivity to Wellbutrin who on 03-APR-2007 was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot #656050/0245U). Concomitant therapy included hormonal contraceptives (unspecified). On 03-APR-2007, after the vaccine was administered, the patient fainted, the patient confirmed that she had not had breakfast before the vaccination was given. The physician reported that the patient recovered on the same day. The patient sought unspecified medical attention. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a physician, concerning a 23 year old female patient with drug hypersensitivity to WELLBUTRIN, contact dermatitis and seasonal allergies, who on 03-APR-2007 was vaccinated with the first dose, 0.5ml, IM, of GARDASIL (Lot #656050/0245U). Concomitant therapy included hormonal contraceptives (unspecified). On 03-APR-2007, after the vaccine was administered, the patient felt dizzy and "had a syncopal episode". The patient, who confirmed that she had not had breakfast before the vaccination was given, was moved to the exam room, monitored and given a drink. The physician reported that the patient recovered "within a half hour". No further information is expected.


VAERS ID: 279196 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-05-14
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), 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: Unknown
CDC Split Type: WAES0704USA02230

Write-up: Information has been received from a physician office manager, via a company representative, concerning the office manager''s 23 year old daughter, who was vaccinated with a dose, 0.5ml, of Gardasil (date unspecified). Subsequently the patient experienced dizziness and menstrual bleeding. At the time of this report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. No further information is expected.


VAERS ID: 279505 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: New Hampshire  
Vaccinated:2007-02-27
Onset:2007-02-27
   Days after vaccination:0
Submitted: 2007-05-14
   Days after onset:75
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Cervical dysplasia, Drug exposure during pregnancy, Nausea, Smear cervix, Urine human chorionic gonadotropin positive
SMQs:, Acute pancreatitis (broad), Reproductive premalignant disorders (narrow), Tumour markers (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Uterine and fallopian tube malignant tumours (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: MIRENA
Current Illness: Pregnancy NOS (LMP = 1/2/2007); Dysplasia
Preexisting Conditions: Loop electrosurgical excision procedure
Allergies:
Diagnostic Lab Data: cervical smear 03/05/07 - moderate dysplasia CIN, urine beta-human - positive
CDC Split Type: WAES0704USA04296

Write-up: Information has been received from a Certified Medical Assistant through Merck Pregnancy concerning a 23 year old female patient with moderate dysplasia of the cervix and a history of loop electrosurgical excision procedure (LEEP) who on 02-JAN-2007 was vaccinated IM in right deltoid with a first dose of Gardasil and had menstruation cycle on that day. On 27-FEB-2007 the patient was vaccinated IM in right deltoid with a second dose of Gardasil. Concomitant therapy included Mirena IUD birth control. On 05-MAR-2007 the patient presented to office experiencing nausea. Urine pregnancy test was performed and it was positive for pregnancy. The reporter stated that client had unusual history; her birth control was a Mirena IUD but on manual examination it was not found. The MA stated that it must have expulsed. She had a cervical smear (PAP) test done which showed moderate dysplasia. On 04-NOV-2006 patient had Leep procedure performed. The patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 279543 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-05-14
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0091U / 3 - / -

Administered by: Other       Purchased by: Other
Symptoms: Axillary pain, Musculoskeletal pain, Pain in extremity
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: WAES0704USA05194

Write-up: Information has been received from a physician concerning a 23 year old female who was vaccinated with Gardasil. Subsequently the patient experienced pain in her arm pit and shoulder one week after receiving the vaccine. The patient sought unspecified medical attention. At the time of this report, the patient''s pain in arm pit and pain in shoulder persisted. Additional information has been requested.


VAERS ID: 279545 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Kansas  
Vaccinated:2006-12-01
Onset:2006-12-18
   Days after vaccination:17
Submitted: 2007-05-14
   Days after onset:146
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Paraesthesia, Vaccine positive rechallenge
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA05220

Write-up: Information has been received from a physician her 23 year old daughter who in December 2006, was vaccinated with a first dose of Gardasil. On 18-DEC-2006, following the vaccination, the patient developed paraesthesia from the shoulder to elbow. On approximately 25-DEC-2006 the patient recovered. In February 2007, the patient was vaccinated with a second dose of Gardasil. On 14-FEB-2007, following the vaccination, the patient developed paraesthesia from the shoulder to elbow. On approximately 21-FEB-2007, the patient recovered. No further information is available.


VAERS ID: 279550 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-05-14
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Injection site mass, No reaction on previous exposure to drug
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0704USA05534

Write-up: Information has been received from a health professional concerning a 23 year old female who was vaccinated with a second dose of Gardasil (date unspecified). Subsequently, one week following the injection, the patient developed a bump at the injection site. It was reported that the patient had no adverse events following the first dose of Gardasil (date unspecified). Additional information has been requested.


VAERS ID: 279634 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-04-02
Onset:2007-04-02
   Days after vaccination:0
Submitted: 2007-05-14
   Days after onset:42
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0188U / 3 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site mass
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: Drug hypersensitivity, allergic reaction to antibiotics
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA06246

Write-up: Information has been received from a health care worker concerning a 23 year old female with drug reactions to "emytin" and Cipro who on 02-APR-2007 was vaccinated intramuscularly with a third dose of Gardasil (Lot # 657006/0188U). On 02-APR-2007 the patient developed a lump on her right arm after administration of the vaccine. The patient sought unspecified medical attention. At the time of this report, the patient''s lump on her right arm persisted. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 279660 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-05-14
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Nausea
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0705USA00092

Write-up: Information has been received from a registered nurse concerning a 23 year old female who was vaccinated with her first dose of Gardasil. There was no concomitant medication. Subsequently the patient experienced weakness and nausea after receiving the vaccination. Unspecified medical attention was sought. Subsequently, the patient recovered from the symptoms. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 279687 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2006-10-03
Onset:2006-10-03
   Days after vaccination:0
Submitted: 2007-05-14
   Days after onset:223
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pain, Vaccine positive rechallenge
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: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0705USA01296

Write-up: Information has been received from a physician concerning a 23 year old female who on 03-OCT-2006 was vaccinated with Gardasil (lot # 653736/0689F). The patient received her second dose of Gardasil (lot # 653736/0689F) on 08-DEC-2006 and her third dose (lot # 653736/0014U) on 02-APR-2007. The patient experienced soreness and pain for 2 to 3 days after each dose of Gardasil. The patient''s outcome was not recovered. No further information is available.


VAERS ID: 279029 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Utah  
Vaccinated:2007-05-09
Onset:2007-05-09
   Days after vaccination:0
Submitted: 2007-05-20
   Days after onset:11
Entered: 2007-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Dyspnoea, Fatigue, Headache, Heart rate increased, Injection site erythema, Injection site induration, Injection site necrosis, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth, Migraine, Myalgia, Nausea, Pain, Pyrexia, Wheezing
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 5/9/07 16:30 Pain at the injection site. 5/9/07 22:00 Headache, fatigue 5/10/07 15:00 Body aches, fever, chills, headache, tiredness, mild nausea, joint pain 5/10/07 19:00 Severe muscle pain (all over body), migraine 5/10/07 20:30 Fever over 102 F, severe nausea/nearly vomiting, difficulty breathing, wheezing, violent muscle pain, weakness (could barely stand up), dizziness, rapid heart beat, redness and significant swelling at injection site 5/11/07 11:00 Symptoms had subsided over night, but worsened again 5/12/07 17:30 Rash around injection site with about 4 inch radius (might have been there previously, but didn''t notice it before.) Still experiencing muscle aches, fatigue, persistent headache 5/16/07--Injection site still sore, red, swollen, warm, and hard.


VAERS ID: 279126 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: New York  
Vaccinated:2007-05-08
Onset:2007-05-10
   Days after vaccination:2
Submitted: 2007-05-16
   Days after onset:6
Entered: 2007-05-21
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Dizziness, Lymphadenopathy, Pharyngolaryngeal pain
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre 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: Tetracycline, Yasmin
Current Illness: denies
Preexisting Conditions: denies
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Weakness, dizziness, sore throat, swollen glands w/in 2d of vaccine.


VAERS ID: 279250 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Washington  
Vaccinated:2007-04-19
Onset:2007-04-20
   Days after vaccination:1
Submitted: 2007-05-21
   Days after onset:31
Entered: 2007-05-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Asthma, Condition aggravated, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VENTOLINE (ALBUTEROL SULFATE, LORATIDINE D, SINGULAIR
Current Illness: Asthma; Hypersensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0705USA02873

Write-up: Information has been received from a health professional concerning a 23 year old black/white female receptionist with asthma (diagnosed at the age of 5 year old) and outdoor allergies who on 19-APR-2007 at 01:15 (AM or PM not reported) was vaccinated IM in left arm deltoid with a first dose of Gardasil lot #655849/0263U. Concomitant therapy included montelukast sodium (MSD) loratadine (+) pseudoephedrine sulfate (LORATIDINE D) and albuterol sulfate (VENTOLINE (albuterol sulfate)). On 20-APR-2007, Friday night at 11:00 PM patient woke up with short of breath. Her rescue inhaler did not help so she used her nebulizer. On 21-APR-2007 she used her nebulizer again around 6:30 AM and through out that day 4 to 6x. On 22-APR-2007, Sunday she did 6 nebulizer treatment within one-two hours before being admitted at the hospital. In the hospital she had additional nebulizer treatment (10+) times and steroid injections. Patient stated that this was her worst asthma attack since being diagnosed. Patient recovered. Additional information is not expected.


VAERS ID: 279584 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-05-07
Onset:2007-05-09
   Days after vaccination:2
Submitted: 2007-05-24
   Days after onset:15
Entered: 2007-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV111 / 1 LA / SC
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS UNKNOWN / 1 LA / IM

Administered by: Military       Purchased by: Military
Symptoms: Erythema, Induration, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: 8X6 inch area of warmth, erythema and enduration 48 hours post Anthrax immunization


VAERS ID: 279616 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Delaware  
Vaccinated:2007-05-18
Onset:2007-05-18
   Days after vaccination:0
Submitted: 2007-05-21
   Days after onset:3
Entered: 2007-05-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB287BA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (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: Non-Alcoholic Fatty Liver Disease
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: About 15 min after injection ,pt c/o dizziness and blurry vision. He was escorted back to exam room to lay on exam table and given water (which he requested). He denied HA, abdominal pain, nausea, SOB, chest pain, or palpitations. At about 2:00 he indicated that his sxs had resolved and he was released to care of his brother at 2:34 PM.


VAERS ID: 280766 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2006-04-14
Onset:2006-04-24
   Days after vaccination:10
Submitted: 2007-05-16
   Days after onset:387
Entered: 2007-05-24
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1110R / 1 UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Drug ineffective, Herpes zoster, Varicella
SMQs:, Lack of efficacy/effect (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:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: VZV stain no results provided
CDC Split Type: WAES0606USA00387

Write-up: Information has been received from a registered nurse concerning a 23 year old female, with no medical history and no allergies, who on 14-APR-2006 was vaccinated (route unknown) with a first dose in the left arm of Varivax (Lot # 650235/1110R). There was no concomitant medication. There was no illness at the time of vaccination and no adverse events following prior vaccination. On 24-APR-2006 the patient developed a scattered maculopapular rash, bilateral, on her upper arms, trunk, back, shoulders, and scalp with pruritus. There was no oozing, drainage, fever, or diarrhea. The patient was seen by a company physician and diagnosed with varicella. She was treated with an over the counter antihistamine (unspecified). Subsequently, the patient fully recovered on an unspecified date. The lab diagnostic studies performed indicated that the patient had a titer prior to vaccination. No product quality complaint was involved. Additional information is not expected.


VAERS ID: 279981 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Nebraska  
Vaccinated:2007-05-16
Onset:2007-05-16
   Days after vaccination:0
Submitted: 2007-05-22
   Days after onset:6
Entered: 2007-05-30
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0216F / 3 LA / SC

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

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

Write-up: Severe dizziness within 15 minutes of immunization. S/S increased a few hours after injection. She did not pass out.


VAERS ID: 280049 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-05-08
Onset:2007-05-15
   Days after vaccination:7
Submitted: 2007-05-30
   Days after onset:15
Entered: 2007-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0388U / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Patient received vaccine on 5-8-2007 in L Deltoid. The site hurt initially but the discomfort was gone the next day. The site began hurting again 1 week later and called office and was instructed to use warm compresses and Tylenol or Advil and to call back if no better.The patient denied any redness at the site and denied fever. She states her arm did feel better but became very sore on May 27th. Hurts more at night than during the day. States she can not lift her arm above her head and getting dressed is difficult. States she feels fine otherwise, denies redness, swelling at site or fever.


VAERS ID: 280102 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Ohio  
Vaccinated:2007-05-16
Onset:2007-05-17
   Days after vaccination:1
Submitted: 2007-05-23
   Days after onset:6
Entered: 2007-05-31
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB403AA / 1 LA / IM

Administered by: Other       Purchased by: Other
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: Codeine
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Had 1st Hep B vaccine on Wednesday (5/16) at 1:00pm. Noticed hives on forehead, cheeks, behind ears and back of neck at 11:0am (5/17). Took Benadryl and Chlorpheneramine but did not notice improvement. Hives left Monday night roughly (5/21). Had little on Tuesday (5/22).


VAERS ID: 280253 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Mississippi  
Vaccinated:2007-05-21
Onset:2007-05-22
   Days after vaccination:1
Submitted: 2007-05-29
   Days after onset:7
Entered: 2007-06-04
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U1621AA / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth, Rash generalised
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: CUT @ RT LOWER LEG
Preexisting Conditions: NONE IDENTIFIED
Allergies:
Diagnostic Lab Data: None
CDC Split Type: MS0718

Write-up: Left deltoid swelling, bruising, warm at site, rash over all of body. Small bumps began day after Td given 5/21/07. Patient seen by Dr, PMD seen 5/22/07. Given antibiotics requested Td due to cut to right lower leg.


VAERS ID: 283417 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:1990-03-01
Onset:2006-06-12
   Days after vaccination:5947
Submitted: 2007-05-30
   Days after onset:352
Entered: 2007-06-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antibody test positive, Blood immunoglobulin G, Measles antibody positive, No adverse reaction, Rubella antibody positive
SMQs:, Vasculitis (broad), Hypersensitivity (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: hydrochlorothiazide mg
Current Illness:
Preexisting Conditions: Anti-HBs antibody negative
Allergies:
Diagnostic Lab Data: serum measles IgG 06/12/06 2.28 - positive; serum mumps IgG antibody 06/12/06 <_91 - ; serum rubella IgG 06/12/06 101.3 - positive
CDC Split Type: WAES0607USA00974

Write-up: Information has been received from a pharmacist and registered nurse concerning a 23 year old male with no known drug allergies and a history of low titer to Hepatitis B, who on 05-FEB-1985 was vaccinated with his first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The patient received the second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 01-MAR-1990. Concomitant therapy included hydrochlorothiazide (start date unspecified). The nurse reported that the patient had a partial failure to M-M-R vaccine involving a mumps titer. A mumps titer performed 12-JUN-2006 was less than 0.91. Results for component products were positive on this date, Rubella titer 101.3 and Measles titer 2.28. Unspecified medical attention was sought. At the time of this report, the patient outcome was unknown. A product quality complaint was not involved. Subsequently, the patient experienced an event with hepatitis B virus vaccine rHBsAg (yeast) vaccine (WAES# 0607USA00971).


VAERS ID: 283484 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Texas  
Vaccinated:2006-10-19
Onset:2006-10-31
   Days after vaccination:12
Submitted: 2007-05-30
   Days after onset:210
Entered: 2007-06-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0216F / UNK UN / SC

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Eosinophil count decreased, Erythema, Lymphadenopathy, Myalgia, Pyrexia, Rash, Rash maculo-papular, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: eosinophil count 10/31/06 13 - slightly decreased; body temp 10/31/06 $g100 - low fever; WBC count 10/31/06 3.3 - slightly decreased
CDC Split Type: WAES0611USA01077

Write-up: Information has been received from a nurse practitioner concerning a 23 year old white male with no medical history or allergies who on 19-OCT-2006 at 14:30 was vaccinated in the right arm with a SC 0.5 mL dose of MMR (lot # 653338/0216F). Vaccination history was not available. There patient was illness at the time of vaccination. Vaccination history not available. On 31-OCT-2006 the patient reported developing a low fever($g100), muscle aches, and a red rash on his shoulders. It was also reported that the morning of 31-OCT-2006 the patient developed lymphadenopathy, post-cervical and post-auricular. He also developed a generalized maculo-papular rash over his face with a few patches on his chest and upper back. Unspecified medical attention was sought. A CBC was performed that indicated slightly low levels of white blood cells(3.3) and eosinophils(13). All other values were normal. The patient recovered. The patient did not experience any adverse events following prior vaccinations. There was no product quality complaint involved. Additional information is not expected.


VAERS ID: 283498 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2006-12-06
Onset:2006-12-06
   Days after vaccination:0
Submitted: 2008-03-12
   Days after onset:461
Entered: 2007-06-04
   Days after submission:282
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0805F / UNK - / SC

Administered by: Other       Purchased by: Other
Symptoms: Accidental exposure, Eye irritation, Laboratory test normal
SMQs:, Corneal disorders (broad), Medication errors (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: MIRENA, naproxen
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: laboratory test, 12/06/06, labs sent out; diagnostic laboratory;
CDC Split Type: WAES0612USA00966

Write-up: Information has been received from a registered nurse concerning a 23 year old female, with no medical history, who on 06-DEC-2006 got a small amount of MMR II (Lot# 654821/0805F) splashed into her right eye. Concomitant therapy included Naproxen and MIRENA. Initially, on 06-DEC-2006, the patient experienced burning. A medical assistant irrigated the affected eye and the eye was no longer burning. It was noted that the patient was doing fine and she went to see a health care professional. No product quality complaint was involved. No other information was provided. Additional information has been requested. Follow-up received 06/18/2008. Medical attention was sought and general labs were performed. No medical problems were reported. No further information is expected. This is in follow-up to report (s) previously submitted on 5/30/2007. It has been determined that WAES #0612USA00966 is a duplicate of WAES #0612USA01077. Therefore, WAES #0612USA00966 is being deleted from our files and the reports consolidated into WAES #0612USA01077. Additional information has been requested.


VAERS ID: 281181 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Wisconsin  
Vaccinated:2007-05-27
Onset:2007-06-05
   Days after vaccination:9
Submitted: 2007-06-11
   Days after onset:6
Entered: 2007-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 1 LA / ID
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z06632 / 1 RA / IM

Administered by: Military       Purchased by: Military
Symptoms: Body temperature increased, Headache, Mental status changes, Nausea, Pharyngolaryngeal pain, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Unknown
Preexisting Conditions: Penicillin. PMH:PCN allergy.
Allergies:
Diagnostic Lab Data: Unknown, full work up was done, records are unavailable at this time. Labs and Diagnostics: CBC and Chem unremarkable. UA (-). Blood cultures (-). Rapid strep (-). ECG with non-specific T wave abnormality.
CDC Split Type:

Write-up: Seen at the Medical Clinic on 6/5/07 with c/o HA, vomiting, sore throat and mental status change. Elevated temp of 102.6. Sent to ER for full work up and was admitted due to continue Febrile status. IV fluids given. D/C''d to home on 6/7/07 and followed up with the Medical Clinic on 6/8/07 with c/o vertigo and nausea. Patient reported at that time that he had a spike in his temperature the previous night. Patient had received smallpox vaccination on 5/27/07. Given quarters x 48 hours, ordered Ibuprofen and Meclizine prn and Azithromycin was started. 06/14/2007 Additional records received from reporter for 3 OV of June 5,8,& 11 2007. Initial visit of 6/5/07 for c/o fever, vomiting, dizziness, feeling of passing out, h/a and sore throat as well as pain at smallpox injection site. Appeared lethargic and and had difficulty answering questions upon PE. Disoriented. Not well hydrated. Tenderness noted on lateral aspect of neck. Coordination and cerrebellum abnormalities noted. Assessment: Mental Status Change. Refered to ER. 2nd visit 6/8/07 in F/U of ER visit with DX of Febrile Viral Illness vs Smallpox Reaction. Still c/o fever, vertigo, and nausea. Still appearing lethargic but now oriented x3. A/P Infectious Disease-Viral. F/u 6/11/2007 reports no better with cont H/A, nausea, vomiting, fevers, and pain. A/P Headache Syndromes with ? etiology-new onset migraines vs viral./pc 06/18/2007 MR received for admission 6/5-7/2007 for fever, chills, vertigo and vomiting. Pt had headache and sore throat x 3 days. (+) fatigue, lethargy and malaise. PE (+) for temp of 104.1''F (40.1''C). Pulse 105. Otherwise WNL. Remained weak during admission, and C/o mild SOB with ambulation. Throat pain remained. Discharge DX: Fevers and lethargy, viral syndrome vs. reaction to small pox vaccine. 02/01/2010 Combined with headaches one month post vaccination and reported palpitatiosn and SOB at noc x 3.5 mm that started 19 June 07 fast reset to our TMC 21 hre 07.


VAERS ID: 281434 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2007-05-08
Onset:2007-05-08
   Days after vaccination:0
Submitted: 2007-06-12
   Days after onset:35
Entered: 2007-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0389U / 3 LA / IM

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

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

Write-up: Became very faint after getting immunization (Gardasil) put in supine position w/legs elevated.


VAERS ID: 282572 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Male  
Location: Iowa  
Vaccinated:2007-03-21
Onset:2007-03-22
   Days after vaccination:1
Submitted: 2007-05-17
   Days after onset:56
Entered: 2007-06-18
   Days after submission:32
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0904F / 1 RA / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1278F / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2632AA / 1 LA / IM
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UE998AA / 1 LA / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Body temperature increased, Chills, Full blood count normal, Laboratory test normal, Pain, Pain in extremity
SMQs:, Neuroleptic malignant syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: He did not have any medical history, was not on any medications and did not have any illness at the time of the vaccinations.
Allergies:
Diagnostic Lab Data: CMP and CBC Unremarkable
CDC Split Type: 200701314

Write-up: Initial report received from a health care professional in the USA on 18 April 2007. A 23 year old, male patient complained of a temperature of 100F overnight, chills, aching arm and generalized achiness, after he received Adacel (lot number not known, route and site of administration not known) and YF-Vax (lot number UE998AC, route and site administration not known) on 21 March 2007. He also received Hepatitis A vaccine and Hepatitis B vaccine (lot number (s) not known, tradename (s), route (s) and site (s) of administration not known) on the same day. He did not have ant medical history, was not on any medications and did not have any illness at the time of the vaccinations. He was not treated with medications. His symptoms resolved within 24 hours and he recovered. Follow-up information received on 14 May 2007 from a health care professional provided the following batch numbers: Adacel (C2632AA) given intramuscularly in the left deltoid, YF-Vax (UE998AC) given subcutaneously in the left arm, Hepatitis A (1278F) given intramuscularly in the right upper deltoid, and Hepatitis B (0904F) given intramuscularly in the right lower deltoid. A complete metabolic panel and complete blood count were noted to be unremarkable, and no treatment was given. No given information is expected. This case has the same reporter as case 2007-01315.


VAERS ID: 283789 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Maryland  
Vaccinated:2007-04-20
Onset:2007-04-20
   Days after vaccination:0
Submitted: 2007-06-14
   Days after onset:55
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route<