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Case Details (Sorted by Age)

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VAERS ID:464952 (history)  Vaccinated:2012-08-22
Age:13.0  Onset:0000-00-00
Gender:Male  Submitted:2012-08-29
Location:Iowa  Entered:2012-09-13, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Not reported
CDC Split Type: 201207902
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache, Injection site erythema, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)
Write-up: A 13-year-old male patient, whose medical history and concomitant medications were unknown, received a dose of MENACTRA vaccine sanofi pasteur Inc. (lot number unknown) intramuscularly in the right arm on 22 AUGUST 2012. On 22 August 2012, 10 minutes after vaccination, the patient presented with nausea, headache, arm pain and redness at the injection site about 4 cm diameters on right arm. Correct medications and laboratory investigations were not reported. The patient''s outcome was not recovered. List of documents held by sender: None.

VAERS ID:464976 (history)  Vaccinated:2012-08-08
Age:13.0  Onset:2012-08-14, Days after vaccination: 6
Gender:Male  Submitted:2012-08-28, Days after onset: 14
Location:Montana  Entered:2012-09-13, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Did all types of viral testing all were negative - treated for Herpes and West Nile both came by negative - dia was meningitis probably viral
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1508AA1UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4287AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4008AA0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0610AE1UNLA
Administered by: Public     Purchased by: Private
Symptoms: Convulsion, Headache, Herpes simplex serology negative, Loss of consciousness, Meningitis viral, Pyrexia, Viral test negative, West Nile virus test negative
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Headache Tues 8/14/12 & fever. 5:30 seizure Wed (went uncon.) 8/15/12. Was ambulance / air to another location then to hospital in another city by air.

VAERS ID:465014 (history)  Vaccinated:2012-08-01
Age:13.0  Onset:2012-08-02, Days after vaccination: 1
Gender:Female  Submitted:2012-09-13, Days after onset: 42
Location:North Carolina  Entered:2012-09-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illnesses
Preexisting Conditions: None
Diagnostic Lab Data: EEG inpatient; 48 hr outpatient protable EEG; CT Scan; MRI; Sleep study
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
Administered by: Unknown     Purchased by: Private
Symptoms: Computerised tomogram, Electroencephalogram, Muscular weakness, Nuclear magnetic resonance imaging, Paraesthesia, Sleep study
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: My daugther complained about her knees feeling weak and wanting to give out from under her and that there was a tingling feeling.

VAERS ID:465042 (history)  Vaccinated:2012-09-11
Age:13.0  Onset:2012-09-11, Days after vaccination: 0
Gender:Female  Submitted:2012-09-13, Days after onset: 2
Location:Connecticut  Entered:2012-09-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH714AB IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site rash, Injection site urticaria, Local reaction
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient got FLUZONE & had rash & hives reaction locally at the site. Recommended use of BENADRYL topical.

VAERS ID:469186 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Male  Submitted:2012-09-14
Location:Pennsylvania  Entered:2012-09-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Patient''s father has type 2 diabetes
Diagnostic Lab Data:
CDC Split Type: WAES1209USA002871
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Type 1 diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)
Write-up: This spontaneous report was received from a physician refers to a 13 years old male patient with a family history of diabetes, his father had type two diabetes, who on an unknown date, was vaccinated with a 0.5 ml dose of MMR II (route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that about a week after getting MMR II on an unknown date, the patient had a sudden onset of type one diabetes. The patient was 13 years old at the time of vaccination. No treatment information was reported. At the time of the report, the patient''s outcome was unknown. It was unknown if this was the patient''s first dose or not. The patient sought unspecified medical attention. The relatedness for the patient has a sudden onset of type one diabetes was unknown for MMR II. Additional information is not expected.

VAERS ID:465367 (history)  Vaccinated:2012-09-10
Age:13.0  Onset:2012-09-10, Days after vaccination: 0
Gender:Female  Submitted:2012-09-11, Days after onset: 1
Location:Minnesota  Entered:2012-09-16, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergic rhinitis; acne (mild)
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA698BA3IMRA
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA174BJ1IMLA
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)
Write-up: Patient age 13 yr. 4 months seen for follow-up on acne and allergic rhinitis. Given HPV2 - sat in room for 5 minutes then on way to lobby stopped in bathroom - fainted while washing hands and again en route to exam room. Full recovery in 30 minutes.

VAERS ID:465281 (history)  Vaccinated:2012-09-05
Age:13.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-09-17, Days after onset: 12
Location:Maryland  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB550CA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0459AE0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4262AC0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0074511SCRA
Administered by: Public     Purchased by: Public
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Syncope and fainting for a few seconds, recovered quickly and was ambulatory upon discharge from clinic.

VAERS ID:465368 (history)  Vaccinated:2012-09-07
Age:13.0  Onset:2012-09-07, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:California  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Warts; Tinea corporis
Preexisting Conditions: None
Diagnostic Lab Data: CBC; CRP; Normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUROH720AB0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0636AE0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0611AE1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, C-reactive protein normal, Full blood count normal, Headache, Pyrexia, Rash, Serum sickness
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: (Fever, rash) (Serum sickness) (Headache, joint pains) x 7 days.

VAERS ID:468429 (history)  Vaccinated:2010-09-01
Age:13.0  Onset:2010-09-01, Days after vaccination: 0
Gender:Female  Submitted:2012-09-17, Days after onset: 747
Location:Idaho  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA005143
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Fall, Syncope, Upper limb fracture
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This spontaneous report as received from a physician refers to a current 13 years old female patient without pertinent medical history. The patient was vaccinated with 0.5 ml unspecified dose of GARDASIL (lot number not provided) in approximately September 2010, "2 years ago". No other co-suspects were reported. No concomitant medications were reported. In approximately September 2010, "2 years ago", when the patient was 11 years old, she was given GARDASIL, and afterwards she fainted, fell down and broke her elbow. She was sent to the ER but was not admitted. The patient had sought unspecified medical attention. Adverse events improved after stopping therapy. The outcome of broke her elbow, fainted and fell down was reported as recovered in approximately September 2010, "2 years ago". Additional information has been requested.

VAERS ID:465615 (history)  Vaccinated:2011-08-08
Age:13.0  Onset:2011-08-08, Days after vaccination: 0
Gender:Female  Submitted:2012-09-19, Days after onset: 408
Location:North Dakota  Entered:2012-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: ND1215
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0476AA0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Patient had dizziness after injection.

VAERS ID:465688 (history)  Vaccinated:2012-09-18
Age:13.0  Onset:2012-09-19, Days after vaccination: 1
Gender:Male  Submitted:2012-09-20, Days after onset: 1
Location:Montana  Entered:2012-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA; Hypothyroid; ADHD; Developmental disabilities; Insomnia; Anxiety; Autism
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4481CD IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0420AE0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Injection site erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (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)
Write-up: Mom states redness & "some puffiness" noted last night at bath time. States she gave patient BENADRYL at that time. Mom brought patient to clinic 9-20-12 0810 2" x 2" red bound reaction noted on (R) deltoid area.

VAERS ID:465797 (history)  Vaccinated:2012-08-16
Age:13.0  Onset:2012-08-18, Days after vaccination: 2
Gender:Female  Submitted:2012-09-20, Days after onset: 33
Location:Washington  Entered:2012-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hypothyroidism; Psoriasis; Irregular menstrual cycles
Diagnostic Lab Data: MRI Brain & spine; Lumbar puncture with fluoroscopic guidance on 9/11 showed increased CSF protein level
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0022AE0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4079AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3941AA0IMRA
Administered by: Private     Purchased by: Other
Symptoms: Asthenia, CSF protein increased, Diplopia, Fall, Gait disturbance, Lumbar puncture abnormal, Musculoskeletal pain, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Pain in extremity, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Ocular motility disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: Developed paresthesias in her hands & feet approx 1-2 days after receiving HPV & meningococcal vaccines, she then developed pain in her legs, shoulder & weakness. Weakness & pain progressed & she was unable to walk up stairs & was falling. She also began to experience double vision. She was taken to ER on 9/9/12.

VAERS ID:465802 (history)  Vaccinated:2012-09-17
Age:13.0  Onset:2012-09-18, Days after vaccination: 1
Gender:Female  Submitted:2012-09-20, Days after onset: 2
Location:Texas  Entered:2012-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergic rhinitis; Eczema
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0420AE1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Pelvic pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: On 7/16/12, patient received GARDASIL #1. Patient c/o pain & swelling in pelvis. Patient was on her period for HPV #1 so mom attributed sxs to menses. With GARDASIL #2 on 9/17/12, patient again experienced the same sxs, and she was not having her period. Patient was seen in an urgent care center. She has improved.

VAERS ID:465861 (history)  Vaccinated:2012-08-30
Age:13.0  Onset:2012-08-30, Days after vaccination: 0
Gender:Male  Submitted:2012-09-18, Days after onset: 19
Location:Arkansas  Entered:2012-09-21, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Otitis media
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB605AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1745AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM101320IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0660AE1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 8 x 8 cm red, swollen area to left arm where VARIVAX was given.

VAERS ID:468783 (history)  Vaccinated:2012-08-13
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2012-09-21
Location:Unknown  Entered:2012-09-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ANAPROX; BACTROBAN
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA001180
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0475AE0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Decreased appetite, Nausea, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This spontaneous report as received from a nurse (L.P.N.) refers to an approximately 14 years old female patient with none of pertinent Medical History, none of drug Reactions/Allergies. The patient was vaccinated with dose 1, 0.5 ml GARDASIL (lot number reported as 0475AE, exp date: 13-DEC-2014) on 13-AUG-2012. No other co-suspects were reported. Concomitant medications included ANAPROX and BACTROBAN. The patient has lost 13 pounds in 15 days following vaccination (date unspecified). Patient experienced loss of appetite and nausea. Patient had called the office. No treatment was given. No lab diagnostics studies performed. The outcome of lost 13 pounds in 15 days following vaccination, loss of appetite and nausea were unknown. Additional information has been requested.

VAERS ID:470429 (history)  Vaccinated:2012-07-19
Age:13.0  Onset:2012-07-19, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-21, Days after onset: 64
Location:Unknown  Entered:2012-09-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA005330
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0926Z SCUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: This spontaneous report as received from a registered nurse refers to a 13 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (merck) (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.

VAERS ID:466139 (history)  Vaccinated:2012-09-17
Age:13.0  Onset:2012-09-18, Days after vaccination: 1
Gender:Male  Submitted:2012-09-19, Days after onset: 1
Location:Maryland  Entered:2012-09-24, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH729AB5IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4412BA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Abscess sterile, Erythema, Induration, Injection site pain, Injection site swelling, Tenderness, Vaccination complication
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)
Write-up: Awoke 9/18/12 in AM with very painful, swollen, painful to touch (L) deltoid. Exam on 9/19/12 showed localized erythema induration & tenderness to 2 1/2 inches. Diagnosed as sterile abscess vaccine reaction. Treated with AUGMENTIN BID x 7 days.

VAERS ID:466298 (history)  Vaccinated:2012-09-19
Age:13.0  Onset:2012-09-19, Days after vaccination: 0
Gender:Male  Submitted:2012-09-19, Days after onset: 0
Location:Illinois  Entered:2012-09-25, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0113502IMLA
Administered by: Private     Purchased by: Private
Symptoms: Fatigue
SMQs:
Write-up: Approx 40 minutes after injection became excessively tired. Brought back to office for MD assessment. Vital signs - WNL - kept in office to observe for 1 hour.

VAERS ID:466388 (history)  Vaccinated:2012-07-26
Age:13.0  Onset:2012-09-25, Days after vaccination: 61
Gender:Female  Submitted:2012-09-25, Days after onset: 0
Location:New Jersey  Entered:2012-09-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0629AE0UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: Continue arm pain.

VAERS ID:466445 (history)  Vaccinated:2012-09-26
Age:13.0  Onset:2012-09-26, Days after vaccination: 0
Gender:Female  Submitted:2012-09-26, Days after onset: 0
Location:West Virginia  Entered:2012-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB549CA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0106491IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0119121SCLA
Administered by: Public     Purchased by: Private
Symptoms: Dizziness, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: 10 minutes after receivng vaccines patient started to feel dizzy then said everything was going balck and she was going to pass out. Patient then passed out for about 30 seconds and then was coherent and talking normally.

VAERS ID:466543 (history)  Vaccinated:2012-09-25
Age:13.0  Onset:2012-09-25, Days after vaccination: 0
Gender:Female  Submitted:2012-09-26, Days after onset: 1
Location:Iowa  Entered:2012-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None observed or discussed
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH478AB IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0101231IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4342AA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Headache, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Mother called clinic, stated daughter began to feel "achy and had a headache while at school on 9/25/2012." Was very achy and sore during volleyball game. Had fever overnight temp 103 per report and still feeling the same symptoms day of report on 9/26/2012. Patient recieved Menactra MCV4, Influenza IM Fluzone, pres free, and HPV Gardasil (second dose) immunizations during this visit. Encouraged supportive care at this time, possible side effects of vaccine per VIS sheet and encouraged to contact physician if worsening conditions as could be some other illness not immunization.

VAERS ID:466615 (history)  Vaccinated:2011-10-10
Age:13.0  Onset:2011-10-10, Days after vaccination: 0
Gender:Female  Submitted:2012-09-27, Days after onset: 353
Location:North Dakota  Entered:2012-09-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: ND1216
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0963AA1IM 
Administered by: Private     Purchased by: Private
Symptoms: Nausea, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: About 30 minutes after injection, patient got pale, faint, and nausea which lasted the rest of the day.

VAERS ID:466633 (history)  Vaccinated:2012-09-26
Age:13.0  Onset:2012-09-26, Days after vaccination: 0
Gender:Male  Submitted:2012-09-27, Days after onset: 1
Location:Pennsylvania  Entered:2012-09-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH717AB3IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0129731IMLA
Administered by: Private     Purchased by: Private
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Patient received HPV Gardasil vaccine in left deltoid muscle. Within 5 minutes complained of numbness extending from left side of neck extending down arm to hand. Monitored in office for 45 minutes, referred to ER for evaluation.

VAERS ID:466745 (history)  Vaccinated:2012-03-23
Age:13.0  Onset:2012-04-09, Days after vaccination: 17
Gender:Female  Submitted:2012-09-27, Days after onset: 171
Location:California  Entered:2012-09-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Biopsy of spot on calf, bloodwork negative for all other likely causes of erythema nodosum.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMLA
Administered by: Unknown     Purchased by: Other
Symptoms: Biopsy skin normal, Blood test normal, Contusion, Erythema nodosum, Induration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Hard, bruise like spots appeared on legs. Continued to multiply on legs and existing spots darkened over the month. Erythema Nodosum was diagnosed 05/30/2012 with likely cause recent HPV injection.

VAERS ID:466751 (history)  Vaccinated:2012-09-27
Age:13.0  Onset:2012-09-27, Days after vaccination: 0
Gender:Female  Submitted:2012-09-27, Days after onset: 0
Location:Georgia  Entered:2012-09-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Seizures
Diagnostic Lab Data: Blood pressure within normal limits. Finger stick blood glucose within normal limits
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ21431IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.1860AA0IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG106814SCLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR02428AA0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Blood glucose normal, Hypotonia, Immediate post-injection reaction, Lethargy
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: HPV .5ml IM Rt deltoid/5 sec after injection at 1157. Pt became limp, lethargic NSQ pull code button & call for help. Staff MD arrive to assist. Nurse and asses patient.

VAERS ID:466979 (history)  Vaccinated:2012-07-31
Age:13.0  Onset:2012-08-03, Days after vaccination: 3
Gender:Female  Submitted:2012-09-28, Days after onset: 56
Location:California  Entered:2012-09-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0459AE0IMLA
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)
Write-up: Patient given HPV on 7/31/2012, returned to the office on 8/6/2012 with hives. Treated for the hives.

VAERS ID:469998 (history)  Vaccinated:2012-09-18
Age:13.0  Onset:2012-09-18, Days after vaccination: 0
Gender:Female  Submitted:2012-09-28, Days after onset: 10
Location:Georgia  Entered:2012-09-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Influenza immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA009523
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.1745AA1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea, Inappropriate schedule of drug administration, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a company representative who was told by a Nurse Practitioner, that on 18Sep2012 a patient was given her second dose of GARDASIL (lot # 672547/1745AA, expiration date 13Sep2014), .5ml. The patient concomitantly received the FLUARIX (GSK manufacturer). It was reported that the patient''s first dose of GARDASIL was administered 2 years prior. The following day (19Sep2012) the patient went to an emergency room because she was short of breath and had a fever of 102.4 degrees. It was unspecified if the fever and shortness of breath started on the 18Sep2012 or the following day. After waiting in the hospital for four hours, the patient left without receiving treatment. The following day the patient returned to her physician''s office. Her temperature and breath were back to normal. The physician recommended that she drink fluids and take MOTRIN if needed. It was reported that the medication was not reintroduced. Additional information has been requested.

VAERS ID:467118 (history)  Vaccinated:2012-09-19
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2012-10-01
Location:New York  Entered:2012-10-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy to nuts; legumes; Seeds; Peach; Melon; Shellfish
Diagnostic Lab Data: NL BP/HR
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ2108 IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0106491IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Paraesthesia oral
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Immediately after vaccine pt c/o severe headache, dizziness, tongue tingling. No hives or local reaction. No trouble swallowing. Resolved without rx after about 2 mins.

VAERS ID:467217 (history)  Vaccinated:2011-12-22
Age:13.0  Onset:2011-12-22, Days after vaccination: 0
Gender:Male  Submitted:2012-10-02, Days after onset: 284
Location:Texas  Entered:2012-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: blood work and test
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1171AA0SYRRA
Administered by: Unknown     Purchased by: Public
Symptoms: Blood test, Confusional state, Convulsion, Gaze palsy, Loss of consciousness, Memory impairment, Weight bearing difficulty
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Patient passed out and then went into convulsions his eyes rolled into the back of his head like he was having a seizure. He has never had any reaction like this before with any other vaccine about a month later he was hospitalized with weak legs he couldn''t support his weight. Very confused and forgetful. He has had "spells" of confusion.

VAERS ID:467258 (history)  Vaccinated:2012-09-19
Age:13.0  Onset:2012-09-21, Days after vaccination: 2
Gender:Male  Submitted:2012-10-02, Days after onset: 11
Location:Virginia  Entered:2012-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0096391SCRA
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Feeling hot, Local swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (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)
Write-up: Localized redness, warmth & swelling to dorsal side of the right arm arm. Cool Compress applied to the area.

VAERS ID:467331 (history)  Vaccinated:2012-10-01
Age:13.0  Onset:2012-10-01, Days after vaccination: 0
Gender:Male  Submitted:2012-10-02, Days after onset: 1
Location:Colorado  Entered:2012-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ21092IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0139770IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Hives on trunk - from umbilicus up.

VAERS ID:467485 (history)  Vaccinated:2012-09-29
Age:13.0  Onset:2012-10-03, Days after vaccination: 4
Gender:Female  Submitted:2012-10-03, Days after onset: 0
Location:Wisconsin  Entered:2012-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: She had a cold with sneezing
Preexisting Conditions: Allergic to amoxicillin
Diagnostic Lab Data: A strep test was performed and the rapid test came back negative.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 2SYRLA
Administered by: Public     Purchased by: Other
Symptoms: Streptococcus test negative, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Legs were covered with hives and moved to arms. Went to doctor''s office at 10:50 AM and the hives were disappearing. It''s now 8:40 PM and she has more hives on arms and a couple appeared on her face.

VAERS ID:467508 (history)  Vaccinated:2012-10-01
Age:13.0  Onset:0000-00-00
Gender:Male  Submitted:2012-10-03
Location:Arkansas  Entered:2012-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None per father
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNRA
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNRA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Oedema peripheral
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)
Write-up: Redness & swelling to right posterior upper arm started within 24 hours worsening next 24 hours. Red area approx 9 cm diameter soft, non-tender. Watchful waiting RTD if symptoms worsening. Pt dad stated that the tetanus shot was given in the fatty area.

VAERS ID:468388 (history)  Vaccinated:2012-10-04
Age:13.0  Onset:2012-10-04, Days after vaccination: 0
Gender:Female  Submitted:2012-10-05, Days after onset: 1
Location:Illinois  Entered:2012-10-08, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH712AA UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0636AE0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Dyspnoea, Flushing, Headache, Lip swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Within 2 hours of vaccine administration, she developed c/o SOB, facial flushing and lip swelling with headache.

VAERS ID:468450 (history)  Vaccinated:2012-10-03
Age:13.0  Onset:2012-10-08, Days after vaccination: 5
Gender:Male  Submitted:2012-10-08, Days after onset: 0
Location:Kentucky  Entered:2012-10-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Scoliosis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.H0156220UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4263AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Lymph node pain, Oedema peripheral, Similar reaction on previous exposure to drug
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)
Write-up: Pt received Hep B #2 at our office on 10/3/12. Retrd to office 10/8/12 with red swollen arm and tender lymph node in axilla (L) side. Had same reaction 03/12 after receiving Hep B #1.

VAERS ID:468387 (history)  Vaccinated:2012-07-31
Age:13.0  Onset:2012-08-01, Days after vaccination: 1
Gender:Male  Submitted:2012-10-09, Days after onset: 69
Location:Ohio  Entered:2012-10-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: EKG ordered
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1696AA0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Confusional state, Electrocardiogram, Eye disorder, Head injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Mom reports he did fine the rest of the day after vaccine, no fever or syncope. He got up the next day, ate breakfast and went outdoors to ride his bike. He rode his bike around the neighborhood for awhile and then "felt like my eyes needed to close" and the next thing he knew a neighbor was shaking him awake. He had apparently fainted, unable to describe much of a prodrome. Unknown how long he was "out" but likely seconds to a minute. Hit his head (not wearing a helmet)and scraped up his left side. Some residual confusion after (rang doorbell at his own home) but was fine in the days after. Mom did not report event to our office until several weeks later.

VAERS ID:468708 (history)  Vaccinated:2010-10-01
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2012-10-10
Location:Unknown  Entered:2012-10-10
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210GBR004502
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Malaise, Pain in extremity, Post viral fatigue syndrome
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by the Health Authority on 04/Oct/2012, the original reporter was the consumer, Ref: GB-MHRA-ADR 21862962. This case is not medically confirmed. A 13 year old female patient patient with with unreported medical history received HPV vaccine, batch and manufacturer not reported, on 01/Oct/2010, dose and route of administration not reported. An unreported time post vaccination on an unreported date, the patient experienced chronic fatigue, post viral fatigue syndrome, aching in limb, dizziness, feeling sick, headache and weakness. The patient had not recovered from the chronic fatigue and post viral fatigue syndrome and the outcome of the remaining events was unknown at the time of reporting to the agency. Pacing was recommended for the patient. The reporter and the agency considered the case to be serious due to disability and being medically significant.

VAERS ID:470014 (history)  Vaccinated:2012-09-14
Age:13.0  Onset:2012-09-14, Days after vaccination: 0
Gender:Female  Submitted:2012-10-10, Days after onset: 26
Location:Unknown  Entered:2012-10-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA008151
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)
Write-up: This spontaneous report was received from a healthcare worker regarding an approximately 13-year-old female patient. On 31-AUG-2012, the patient was vaccinated with dose 1, 0.5 milliliter (ml) GARDASIL (lot# not reported) intramuscularly. No concomitant medications were reported. On 14-SEP-2012 the patient was vaccinated with her second dose of 0.5 ml GARDASIL (lot # not reported) intramuscularly. No adverse effects reported. No other information provided. Additional information is not expected.

VAERS ID:468984 (history)  Vaccinated:2012-10-09
Age:13.0  Onset:2012-10-09, Days after vaccination: 0
Gender:Male  Submitted:2012-10-11, Days after onset: 2
Location:California  Entered:2012-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AH2109 IN 
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB522BA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4032AA0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Headache, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: C/O HEADACHE, NAUSEA. RESTED IN CLINIC, PROVIDED SNACK AND LUNCH. CONTACTED FATHER. CONTINUED TO OBSERVE STUDENT UNTIL END OF SCHOOL DAY AT 1:32 PM. RELEASED TO FATHER.

VAERS ID:469150 (history)  Vaccinated:2012-10-06
Age:13.0  Onset:2012-10-07, Days after vaccination: 1
Gender:Female  Submitted:2012-10-11, Days after onset: 4
Location:Oregon  Entered:2012-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: It has been 5 days. Site of the injection is fading in color. Still a large lump and very red and itchy. Also very uncomfortable.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0077041UNLA
Administered by: Unknown     Purchased by: Other
Symptoms: Activities of daily living impaired, Injection site discomfort, Injection site erythema, Injection site mass, Injection site pruritus, Injection site vesicles, Injection site warmth, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever, large welt (approx. 5 inches by 3 inches) the site of shot was hot and getting larger. Also blisters formed. 2 forms of antibiotics were given. ER visit and 2 trips to the Dr. Patient missed 2 days of school.

VAERS ID:469583 (history)  Vaccinated:2012-10-04
Age:13.0  Onset:2012-10-04, Days after vaccination: 0
Gender:Male  Submitted:2012-10-04, Days after onset: 0
Location:Pennsylvania  Entered:2012-10-13, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergy not found
Diagnostic Lab Data: Blood sugar
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH720AA0IMUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.1561AA1IMUN
Administered by: Private     Purchased by: Public
Symptoms: Blood glucose, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Syncope

VAERS ID:469675 (history)  Vaccinated:2012-10-10
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2012-10-12
Location:Washington  Entered:2012-10-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12262P0IN 
Administered by: Other     Purchased by: Public
Symptoms: Incorrect route of drug administration, Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Fluviron vaccine was used for nasal spray flu vaccine instead of FLUMIST: (no needle used) on 10 people.

VAERS ID:469732 (history)  Vaccinated:2012-10-10
Age:13.0  Onset:0000-00-00
Gender:Male  Submitted:2012-10-12
Location:Washington  Entered:2012-10-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12262P0IN 
Administered by: Other     Purchased by: Public
Symptoms: Incorrect dose administered, Incorrect route of drug administration
SMQs:, Medication errors (narrow)
Write-up: FLUVIRIN vaccine was used for nasal spray flu vaccine instead of FLUMIST: (no needle used) on 10 people.

VAERS ID:469740 (history)  Vaccinated:2012-10-10
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2012-10-12
Location:Washington  Entered:2012-10-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12262P0IN 
Administered by: Other     Purchased by: Public
Symptoms: Incorrect route of drug administration, Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Fluviron vaccine was used for nasal spray flu vaccine instead of FLUMIST: (no needle used) on 10 people.

VAERS ID:469909 (history)  Vaccinated:2012-10-08
Age:13.0  Onset:2012-10-08, Days after vaccination: 0
Gender:Male  Submitted:2012-10-08, Days after onset: 0
Location:Arkansas  Entered:2012-10-15, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anaphylaxis
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204301 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1947AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)
Write-up: Patient given 1 dose each of FLUVIRIN and PNEUMOVAX 23. Patient developed immediate anaphylaxis reaction. Treated with EPIPEN and promptly recovered.

VAERS ID:470092 (history)  Vaccinated:2012-10-03
Age:13.0  Onset:2012-10-14, Days after vaccination: 11
Gender:Male  Submitted:2012-10-15, Days after onset: 1
Location:Ohio  Entered:2012-10-16, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4273AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4030AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0105571SCRA
Administered by: Public     Purchased by: Public
Symptoms: Rash papular, Rash pustular, Rash vesicular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt woke on 10/14 AM w/rash - papules, pustules, & vesicles all noted on exam about 1 pm 10/14. Pt o/w well, no fever, no known exposure to CPOX.

VAERS ID:469970 (history)  Vaccinated:2012-10-05
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2012-10-17
Location:Pennsylvania  Entered:2012-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to arthropod sting
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210USA006582
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Eye pain, Fatigue, Full blood count, Headache, Malaise, Metabolic function test, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This spontaneous report as received from a physician assistant refers to a 13 years old female patient with bees and wasps allergy and no pertinent medical history. The patient was vaccinated with 0.5 ml GARDASIL intramuscularly on 05-OCT-2012. Lot# was unspecified. No other co-suspects were reported. Concomitant medications included vitamin B and vitamin D. On 05-OCT-2012, the patient received GARDASIL and 2-3 hours after the vaccination had diarrhea. In the days following the vaccination the patient had malaise, fatigue, headache, low grade temperature and pain behind both eyes. The patient might be admitted to hospital. No treatment was given for the events. The patient did a complete blood count (CBC) and basic metabolic profile at outside facility. The reporter was waiting for the information from the other facility and no lab resulted was provided at reporting time. The patient was not recovered. The patient also visited primary care physician and visit to emergency room to seek medical attention. Additional information has been requested.

VAERS ID:470315 (history)  Vaccinated:2012-10-10
Age:13.0  Onset:2012-10-11, Days after vaccination: 1
Gender:Female  Submitted:2012-10-17, Days after onset: 6
Location:Kansas  Entered:2012-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0101AE1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Dyspnoea, Injection site erythema
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad)
Write-up: Pt. c/o feeling SOB in nasal passage et c/o red area over injection site.

VAERS ID:470413 (history)  Vaccinated:2012-10-17
Age:13.0  Onset:2012-10-17, Days after vaccination: 0
Gender:Male  Submitted:2012-10-17, Days after onset: 0
Location:Massachusetts  Entered:2012-10-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH717AA3IMLA
HEPA: HEP A (VAQTA)MERCK & CO. INC.H0126421IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0150300IMRA
Administered by: Private     Purchased by: Private
Symptoms: Head injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Received 3 vaccines listed below without incident. Standing at check out desk with mother, fainted, struck head on wall. Recovered spontaneously in 60-90 seconds.

VAERS ID:470491 (history)  Vaccinated:2012-10-16
Age:13.0  Onset:2012-10-16, Days after vaccination: 0
Gender:Female  Submitted:2012-10-18, Days after onset: 2
Location:Ohio  Entered:2012-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ2143 IN 
HEPA: HEP A (VAQTA)MERCK & CO. INC.0628AE0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0097460IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4289AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B088AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Skin discolouration, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: After the last injection was given (HPV), the child''s color changed slightly and she fainted (put her head in her lap). We moved her to a lying down position. She recovered quickly and we monitored her for about 15 minutes, gave her juice and she left with no problems.

VAERS ID:470510 (history)  Vaccinated:2012-10-17
Age:13.0  Onset:2012-10-17, Days after vaccination: 0
Gender:Male  Submitted:2012-10-17, Days after onset: 0
Location:Arizona  Entered:2012-10-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Vomiting and pale
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ21060IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.0629AE0IMRA
Administered by: Other     Purchased by: Public
Symptoms: Dizziness, Immediate post-injection reaction, Pallor, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Vaccines were administered, right after he stated he felt dizzy and threw up and turned very pale.

VAERS ID:474883 (history)  Vaccinated:2012-10-15
Age:13.0  Onset:2012-10-15, Days after vaccination: 0
Gender:Unknown  Submitted:2012-10-18, Days after onset: 3
Location:Unknown  Entered:2012-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210USA007288
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1003Z SCRA
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: This spontaneous report as received from a Registered Nurse concerning to an approximately 13 years old patient who was vaccinated with an expired 0.5 ml VARIVAX (merck), SQ, right arm, (Lot # 1003Z, Exp 28-JUL-2012) on 15-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.

VAERS ID:470661 (history)  Vaccinated:2012-07-18
Age:13.0  Onset:2012-09-07, Days after vaccination: 51
Gender:Male  Submitted:2012-10-21, Days after onset: 44
Location:Tennessee  Entered:2012-10-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210USA008004
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.U4262AC UNUN
Administered by: Other     Purchased by: Other
Symptoms: Meningitis
SMQs:, Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This spontaneous report as received from a consumer refers to her son who was a 13 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with PNEUMOVAX 23 (Lot# reported as U4262AC, dose and route unspecified) on 18-JUL-2012. There was no concomitant therapy. On 07-SEP-2012 the patient was then hospitalized and later diagnosed with meningitis. The patient had sought medical attention and antibiotics was given for the event. At the time of reporting the outcome of meningitis was unknown. Additional information has been requested.

VAERS ID:471035 (history)  Vaccinated:2012-09-13
Age:13.0  Onset:2012-10-03, Days after vaccination: 20
Gender:Male  Submitted:2012-10-11, Days after onset: 8
Location:Arizona  Entered:2012-10-22, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Acne
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1696AA2IMLA
Administered by: Public     Purchased by: Public
Symptoms: VIIth nerve paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)
Write-up: Left Bell''s Palsy.

VAERS ID:471412 (history)  Vaccinated:2012-09-04
Age:13.0  Onset:2012-09-06, Days after vaccination: 2
Gender:Male  Submitted:2012-10-23, Days after onset: 47
Location:Idaho  Entered:2012-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4001AA0IMUN
TDAP: TDAP (ADACEL)SANOFI PASTEURC3922A0IMUN
Administered by: Private     Purchased by: Public
Symptoms: Abdominal pain upper, Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Vomiting, stomach pain, diarrhea.

VAERS ID:471429 (history)  Vaccinated:2012-10-22
Age:13.0  Onset:2012-10-22, Days after vaccination: 0
Gender:Female  Submitted:2012-10-23, Days after onset: 1
Location:Texas  Entered:2012-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Deaf mute since birth
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0636AE0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Dyskinesia, Gaze palsy, Hypotonia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Administered HPV to (L) arm, pt reacted, pt eyes rolled back and body became limp, jerky movement to upper body for about 5 seconds then regained control of body. She then became alert, let her sit for 15 min, pt was okay and left with mother.

VAERS ID:471622 (history)  Vaccinated:2012-10-22
Age:13.0  Onset:2012-10-22, Days after vaccination: 0
Gender:Female  Submitted:2012-10-23, Days after onset: 1
Location:Connecticut  Entered:2012-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PROVENTIL inhaler; DRYSOL 20% solution
Current Illness: None
Preexisting Conditions: Asthma; Hyperhidrosis
Diagnostic Lab Data: Urine analysis is negative
CDC Split Type: CT201210
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH751AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0636AE0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Body temperature increased, Feeling cold, Nausea, Pallor, Paraesthesia, Peripheral coldness, Urine analysis normal, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 10am on 10/22/12 vaccinated arm hurt did not go back to school. 11am 10/22/12 felt cold, was pale, ibuprofen given. By 4:30pm pt nauseous and vomiting, index finger (left) 4th finger (right) feeling cold; all fingers left hand tingly. Bad headache all over head. Temp 103.3 at 6:30pm.

VAERS ID:472147 (history)  Vaccinated:2012-10-12
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2012-10-23
Location:Unknown  Entered:2012-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210USA008408
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0629AE1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)
Write-up: This spontaneous report as received from a registered nurse refers to a 7 years old and 11 month old female patient. On unknown dates, the patient received 3 doses of GARDASIL (dose, route and lot # not reported) when she was 7 year 11 month, 8 year 2 months, and 8 year and 4 month old when the patient was in a different country. The name of the country was unknown. No concomitant medication was reported. No adverse effect was reported. Additional information has been requested.

VAERS ID:472498 (history)  Vaccinated:2012-06-20
Age:13.0  Onset:2012-06-20, Days after vaccination: 0
Gender:Male  Submitted:2012-10-23, Days after onset: 125
Location:Unknown  Entered:2012-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210USA007822
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0131AE2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a registered nurse concerning a patient of unknown age and gender, who on 28-MAR-2012, was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported), on 30-MAY-2012 the patient received the second dose of GARDASIL (dose, route and lot # not reported) and the third dose of GARDASIL (dose, route and lot # not reported) on 20-JUN-2012. The patient was not experiencing any known symptoms. Additional information has been requested.

VAERS ID:471286 (history)  Vaccinated:2012-10-23
Age:13.0  Onset:2012-10-24, Days after vaccination: 1
Gender:Female  Submitted:2012-10-24, Days after onset: 0
Location:Unknown  Entered:2012-10-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH733AA   
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA11071   
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)
Write-up: Hives.

VAERS ID:471504 (history)  Vaccinated:2012-10-23
Age:13.0  Onset:2012-10-23, Days after vaccination: 0
Gender:Male  Submitted:2012-10-25, Days after onset: 2
Location:Florida  Entered:2012-10-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE KNOWN
Preexisting Conditions: ALLERGIC TO AMOXICILLIN AND TO CEPHALOSPORINS.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0022AE0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4242AA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3941AA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.HO146261SCRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: MOTHER CALLED NURSE ON 10/25/12 AT 12:15 PM AT HD TO REPORT CHILD DEVELOPING A HIVE ON RIGHT UPPER ARM AT 6PM ON 10/23/12. ON 10/24/12 MOTHER GAVE CHILD IBUPROFEN 200MG X 2. AT 8:30 AM AND TYLENOL X 2 AT 11:30 PM. THE HIVE IS NOW DOUBLE THE SIZE: 2 1/2 INCHES X4 1/2 INCHES PER THE MOTHER. MOTHER ALSO GAVE CHILD BENADRYL 25 MG. AT 9PM ON 10/24/12 AND 50MG ON 10/25/12 AT8:30 AM. IBUPROFEN 200MG X 2 TABLETS WAS ALSO GIVEN ON 10/25/12 PER THE MOTHER.

VAERS ID:471512 (history)  Vaccinated:2012-10-18
Age:13.0  Onset:2012-10-19, Days after vaccination: 1
Gender:Male  Submitted:2012-10-25, Days after onset: 6
Location:California  Entered:2012-10-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Patient''s CBC shows a normal white blood cell count of 8.5, hemoglobin 13.7, hematocrit 40.8, and his electrolytes are within normal limits. His CRP, however, was elevated. A pediatrician was consulted and he feels that this is likely a reaction to the vaccination. He actually says that this is becoming more common as patients are getting boosters and he feels that just symptomatic treatment is warranted in this patient.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH719AD4IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB509AA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1860AA2IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4097AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0609AE1SCRA
Administered by: Other     Purchased by: Public
Symptoms: Blood electrolytes normal, C-reactive protein increased, Full blood count normal, Haematocrit normal, Haemoglobin normal, Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling, Vaccination complication, White blood cell count normal
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)
Write-up: Redness, swelling, and itching began on left deltoid region where the patient had received MCV4 #1 and 1 inch below that, HPV #3 on 10/18/12 (the day before). On 10/20/12, pt was taken to the ER where it was determined to be an "allergic reaction" from vaccines rather than cellulitis.

VAERS ID:471770 (history)  Vaccinated:2012-10-22
Age:13.0  Onset:2012-10-22, Days after vaccination: 0
Gender:Male  Submitted:2012-10-26, Days after onset: 4
Location:California  Entered:2012-10-26
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210USA010454
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Balance disorder, Fatigue, Gaze palsy, Mobility decreased, Musculoskeletal stiffness, Somnolence, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: This spontaneous report as received from a physician refers to a 13 years old male patient with asthma and no drug reactions. On 22-OCT-2012, the patient was vaccinated with a 0.5 mL dose of intramuscular GARDASIL. There were no concomitant medications. On the same date almost fell backward, stiffened up, eyes were opened and rolled up for no more than 20 seconds and then the patient was alert. The patient stated that he felt whitish blurry and tired and felt like he was going to go to sleep and could hear but could not get up. The physician stated that the patient had a history of feeling squeamish with seeing blood. Physician stated after the patient received GARDASIL, that he walked out of the room sit in the waiting room and then walked back to the room to get a PPD test. After the purified protein derivative (PPD-turberculosis skin test) was done the patient experienced the adverse events. No further information was available. No treatment was given. The events were considered to be life threatening by the reporting physician. The outcome of the events was recovered on 22-OCT-2012. The relatedness of the events with GARDASIL was unknown. Additional information has been requested.

VAERS ID:471740 (history)  Vaccinated:2012-10-16
Age:13.0  Onset:2012-10-16, Days after vaccination: 0
Gender:Male  Submitted:2012-10-28, Days after onset: 12
Location:Texas  Entered:2012-10-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Public
Symptoms: Coordination abnormal, Gait disturbance, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)
Write-up: Child reported numbness in both feet that over time went up his legs. After Dr apt in am he went back to school. He called from school reporting difficulty with coordination and walking. Took child to ER.

VAERS ID:472127 (history)  Vaccinated:2012-09-28
Age:13.0  Onset:2012-10-15, Days after vaccination: 17
Gender:Female  Submitted:2012-10-25, Days after onset: 10
Location:Tennessee  Entered:2012-10-29, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: To see Neurologist 11/29/2012
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH747AB IMRA
HEPA: HEP A (VAQTA)MERCK & CO. INC.0628AE1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0636AE1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Ear pain, Urinary tract infection, VIIth nerve paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)
Write-up: 2 week hx right facial paralysis. Preceded by URI symptoms and mild right ear pain. Flu, Hep A & HPV shots 1-2 weeks prior to symptoms. Previous flu shots, Hep A & HPV without problems. Wears glasses. Bell''s Palsy handout given. Eye care/protection discussed, VAERS given. F/U no improvement referral - Neurology.

VAERS ID:472289 (history)  Vaccinated:2009-10-06
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2012-10-30
Location:Washington  Entered:2012-10-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other meds at time of shot
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Normal renal & bladder US 4-30-10
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3204AA2IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.024970IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1007Y0SCLA
Administered by: Private     Purchased by: Public
Symptoms: Abdominal pain, Anxiety, Blood urine present, Depression, Renal pain, Ultrasound bladder normal, Ultrasound kidney normal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad)
Write-up: When patient was 13 yo she received one HPV vaccine. Her mother feels her ongoing symptoms of anxiety, depression, abdominal pain, kidney pain & blood in urine and due to HPV. Ongoing appts to treat anxiety depression.

VAERS ID:472408 (history)  Vaccinated:2009-09-01
Age:13.0  Onset:2009-09-01, Days after vaccination: 0
Gender:Male  Submitted:2012-10-31, Days after onset: 1156
Location:Wisconsin  Entered:2012-10-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 5IM 
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age
SMQs:, Medication errors (narrow)
Write-up: Wrong vaccine given per patients age and patient received correct vaccine a year and a half prior.

VAERS ID:475487 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:2012-10-26
Gender:Female  Submitted:2012-11-01, Days after onset: 6
Location:Unknown  Entered:2012-11-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1211USA000241
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
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)
Write-up: The primary reporter is the field representative. The representative reported this AE as he heard it from an HCP. The HCP had a patient who developed hives "all over her body" after receiving her second dose of GARDASIL. She also received a flu shot concomitantly; however, it was not AFLURIA. This AE refers only to the GARDASIL AE. No further AE information was provided. Treatment given: oral prednisone and referred to allergist.

VAERS ID:472685 (history)  Vaccinated:2010-09-02
Age:13.0  Onset:2012-09-22, Days after vaccination: 751
Gender:Female  Submitted:2012-10-27, Days after onset: 35
Location:Georgia  Entered:2012-11-02, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations: Adverse event.~HPV (no brand name)~1~13.00~Patient
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS0216V0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Abasia, Abdominal pain upper, Crying, Haematemesis, Headache, Loss of consciousness, Muscle spasms, Panic attack, Pelvic pain, Urticaria
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Dr. gave 1st HPV 9-2-10. Within a few days, pt. passed out, in 2 weeks passed out again. Spit up blood, bad headaches, stomach ache, hives. Dr. gave her HPV shot; recommended booster in 1 month. She passed out a week later, had panic attack, bad headaches, stomach and pelvic pain, legs cramping up at night. Waking crying, couldn''t walk at first.

VAERS ID:472787 (history)  Vaccinated:2012-10-19
Age:13.0  Onset:2012-10-30, Days after vaccination: 11
Gender:Male  Submitted:2012-11-02, Days after onset: 3
Location:Florida  Entered:2012-11-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMAR
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMAR
Administered by: Private     Purchased by: Private
Symptoms: Lymphadenopathy, Pityriasis rosea, Skin disorder
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient received the 3rd dosage of the Gardasil vaccination on 10/19/2012. Developed herald mark and diagnosed at phyisicans office with pityriasis rosea and swollen lymph node on 11/2/2012.

VAERS ID:473199 (history)  Vaccinated:2012-10-01
Age:13.0  Onset:2012-10-04, Days after vaccination: 3
Gender:Male  Submitted:2012-11-01, Days after onset: 28
Location:California  Entered:2012-11-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin
Current Illness: Sore throat
Preexisting Conditions: None
Diagnostic Lab Data: EBV IgM (-); IgG (+); Normal CBC
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ20242IN 
Administered by: Private     Purchased by: Private
Symptoms: Affect lability, Dizziness, Epstein-Barr virus antibody negative, Fatigue, Full blood count normal
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad)
Write-up: Fatigue, dizzy, emotional lability.

VAERS ID:472844 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2012-11-05
Location:Unknown  Entered:2012-11-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210USA013412
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This spontaneous report as received from a pharmacist as part of a marketing research program conducted by the agency refers to a 13 years old female patient with no relevant medical history. The patient was vaccinated with a dose of GARDASIL (lot #, dose and route not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient experienced seizure (medically significant) and fainted after injection. No treatment information was reported. No diagnostic studies were performed. The outcome of seizure and fainted after injection was reported as recovered/resolved on an unknown date soon after the event. The reporter felt that seizure and fainted after injection were related to therapy with GARDASIL. Upon internal review, seizure was considered to be medically significant. Additional information is not expected.

VAERS ID:472919 (history)  Vaccinated:2012-09-11
Age:13.0  Onset:2012-09-12, Days after vaccination: 1
Gender:Female  Submitted:2012-11-05, Days after onset: 54
Location:Michigan  Entered:2012-11-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ROCALTROL
Current Illness: Hypocalcaemia
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1211USA000354
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.1009AA1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Cyanosis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This spontaneous report as received from a medical assistant refers to a 13 years old female patient with hypocalcemia and no drug reactions/allergies. The patient was vaccinated with dose 1 of GARDASIL (dose, route and lot # not reported) on 10-AUG-2012. On 11-SEP-2012, the patient was vaccinated with the second 0.5 ml dose of GARDASIL (Lot # 1009AA) intramuscularly and a dose of FLUZONE concomitantly. Concomitant medications included: ROCALTROL. The reporter stated that the patient''s hands turned blue on 12-SEP-2012 after receiving GARDASIL and FLUZONE concomitantly. This reaction lasted two or three days with chronic blue appearance and continued to happen intermittently to date. There was no discernable pattern to these incidences. The medical assistant reported that the patient''s hands continued to turn bluer as they sat together. The patient was seen by her health care professional. The patient was prescribed a tapering dose of prednisone (unspecified manufacturer) 10 mg 3x daily for 3 days, then 2x daily for 3 days, then 1x daily for 3 days to treat the experience, but it did not help. The reporter states that the patient was not going to receive the final shot in the series of GARDASIL injection. The outcome of patient''s hands turned blue was reported as not recovered. The relatedness for patient''s hands turned blue was unknown for GARDASIL. Additional information has been requested.

VAERS ID:473051 (history)  Vaccinated:2012-10-24
Age:13.0  Onset:2012-10-24, Days after vaccination: 0
Gender:Female  Submitted:2012-11-05, Days after onset: 12
Location:Wisconsin  Entered:2012-11-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AH21090IN 
Administered by: Other     Purchased by: Public
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Student in class for 30 mins. Had seizure in classroom. After vaccine received became aware of recent history of prior seizures.

VAERS ID:475947 (history)  Vaccinated:2012-08-15
Age:13.0  Onset:2012-08-15, Days after vaccination: 0
Gender:Female  Submitted:2012-11-05, Days after onset: 82
Location:California  Entered:2012-11-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Z-PAK
Current Illness: Contact dermatitis of the nose
Preexisting Conditions:
Diagnostic Lab Data: 08/15/2012, Body temperature, 102 degrees
CDC Split Type: WAES1210USA000553
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0636AE0IMUN
Administered by: Private     Purchased by: Other
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This spontaneous report was received from a physician refers to a 13-year-old female patient, with no drug reactions or allergies and no pertinent medical history. Current condition included contact dermatitis of the nose. The patient was vaccinated with dose 1, 0.5 milliliter (ml) GARDASIL (lot # 0636AE, expiration date unspecified) intramuscularly on 15-AUG-2012. Concomitant medications included: Z-PAK (reported as Z-Pack). The patient had been seen for contact dermatitis of her nose on 15-AUG-2012 and was prescribed Z-PAK and was administered GARDASIL, on the same visit. On the same date on 15-AUG-2012 the patient developed fever 102 degrees. The fever resolved on 16-AUG-2012. The physician did not administer the scheduled second dose of GARDASIL on 27-SEP-2012 because of the fever with the first dose. Treatment information was unspecified by the reporter. Medical attention was not sought for the events. No further information was provided. Additional information has been requested.

VAERS ID:473248 (history)  Vaccinated:2012-09-30
Age:13.0  Onset:2012-10-11, Days after vaccination: 11
Gender:Male  Submitted:2012-11-06, Days after onset: 26
Location:California  Entered:2012-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Blood test, neurological exam, lumbar puncture/CSF analysis, EEG, MRI, viral titers, NMDA, etc.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH755AB0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Abdominal pain, Anti-NMDA antibody, Blood test, CSF test, Electroencephalogram, Lumbar puncture, Meningitis aseptic, Myoclonus, Neurological examination, Neurological symptom, Nuclear magnetic resonance imaging, Pyrexia, Viral test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initially started as abdominal pain, by 10/13/12 patient had fever of 104F. Went to Emergency Room on 10/15/12. Admitted to hospital on 10/16/12 with high fever and neurological symptoms. Diagnosed with postinfectious or parainfectious myoclonus and aseptic meningitis.

VAERS ID:473386 (history)  Vaccinated:2012-07-20
Age:13.0  Onset:2012-07-20, Days after vaccination: 0
Gender:Female  Submitted:2012-10-23, Days after onset: 95
Location:Unknown  Entered:2012-11-07, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA10057 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Incorrect drug dosage form administered
SMQs:, Medication errors (narrow)
Write-up: Clinic manager notified me-pharmacist- that they believe that a MENVEO vaccine was diluted with sterile diluent vs. the provided liquid component. Unsure of which pt it happened. There was a report requested of the dates that the vaccine could have been given. After the report was provided it was narrowed down to a 13 yof that the product use error occurred on.

VAERS ID:473480 (history)  Vaccinated:2012-11-05
Age:13.0  Onset:2012-11-05, Days after vaccination: 0
Gender:Male  Submitted:2012-11-07, Days after onset: 2
Location:Pennsylvania  Entered:2012-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Undocumented Reactive Airway Disease; Alsperger Syndrome
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ21580IN 
Administered by: Other     Purchased by: Public
Symptoms: Contraindication to vaccination
SMQs:, Medication errors (broad)
Write-up: It was not documented by parent that child has Reactive Airway Diseaese. Should not have received Flu Mist. MD instructed parent to give him Vitamin C and to go to bed early.

VAERS ID:476432 (history)  Vaccinated:2012-11-05
Age:13.0  Onset:2012-11-05, Days after vaccination: 0
Gender:Female  Submitted:2012-11-07, Days after onset: 2
Location:Florida  Entered:2012-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergy to penicillin - amoxicillin - aspirin
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.0384AE IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13541 SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0497AE SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4242AA IMLA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURC4114BA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H011724 SCLA
Administered by: Public     Purchased by: Public
Symptoms: Eye swelling, Food allergy
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Client received vaccines at approx 9:45 AM. Parents brought client back to clinic at 1:00 PM stating "her eyes are swollen since 45 min after vaccines given". Instr. to take to Emergency Room. Phoned Dad next day - he states "she is fine today" - Dr. said it was from a food allergy".

VAERS ID:476451 (history)  Vaccinated:2012-10-22
Age:13.0  Onset:2012-10-23, Days after vaccination: 1
Gender:Female  Submitted:2012-10-24, Days after onset: 1
Location:Minnesota  Entered:2012-11-08, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0692AA0IMUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B094AA0IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0120431SCUN
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Red, swollen, warm, itchy area on right arm about the size of a baseball.

VAERS ID:473683 (history)  Vaccinated:2012-11-07
Age:13.0  Onset:2012-11-08, Days after vaccination: 1
Gender:Male  Submitted:2012-11-09, Days after onset: 1
Location:Hawaii  Entered:2012-11-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: JRA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Military     Purchased by: Unknown
Symptoms: Abdominal pain, Chills, Dizziness, Headache, Hyperhidrosis, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Chills, fever, diaphoretic, significant headache, dizzy, nauseated, significant abdominal pain.

VAERS ID:473764 (history)  Vaccinated:2012-10-17
Age:13.0  Onset:2012-11-03, Days after vaccination: 17
Gender:Male  Submitted:2012-11-08, Days after onset: 5
Location:Georgia  Entered:2012-11-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: See Attached
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.A121580IN 
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB605BA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0459AE0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Decreased appetite, Liver function test abnormal, Nausea, Neutropenia, Pyrexia
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)
Write-up: Fever x 5 days up to 104. Nausea. Decrease appetite. Neutropenia. Elevated liver function test.

VAERS ID:473809 (history)  Vaccinated:2012-11-08
Age:13.0  Onset:2012-11-08, Days after vaccination: 0
Gender:Male  Submitted:2012-11-09, Days after onset: 1
Location:California  Entered:2012-11-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No, but given at same time as FLU MIST
Preexisting Conditions: None
Diagnostic Lab Data: None at this time, but I am concerned about long term effects from this vaccination.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC. 4IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0  
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Chills, Dizziness, Feeling of body temperature change, Gaze palsy, Hot flush, Hyperhidrosis, Nausea, Syncope, Tremor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Lightheaded, eyes went back in his head, fainting, violent body shakes, followed by sweating, hot and cold flashes, weakness, nausea. 15 minutes later my son began vomiting which lasted for 5 hours and required Zofan for nausea. We had to stay at the Dr. office for over 2 hours until he was stable enough to return home. Upon returning home he continued with vomiting, nausea and chills for the entire day.

VAERS ID:476573 (history)  Vaccinated:2012-08-17
Age:13.0  Onset:2012-09-24, Days after vaccination: 38
Gender:Female  Submitted:2012-11-09, Days after onset: 46
Location:Unknown  Entered:2012-11-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1211USA000133
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1016Z1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Chest pain, Fatigue, Headache, Laboratory test, Pain
SMQs:, Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: This spontaneous report as received from a nurse refers to a 13 years old female patient. No medical history of concomitant conditions were reported. It was reported that the patient had no known allergies. The nurse reported that the patient received the first dose of GARDASIL on 12-JUN-2012 (lot number reported as 1016Z with an expiration date of 22-NOV-2012). The second dose was received on 17-AUG-2012 (lot number reported as 1016Z with an expiration date of 22-NOV-2012). The route of administration and anatomical location were not reported. No co-suspects or concomitant medications were reported. The patient developed fatigue with whole body pain, but mostly abdominal and back pain on 24-SEP-2012. About a week later the patient experienced a headache with worsening of the pain (whole body pain but mostly abdominal and back pain) and a burning sensation (discomfort) in the chest. Fatigue was reported as a significant disability or incapacity because the patient was unable to attend school for the last month due to fatigue. The patient was evaluated for a urinary tract infection and Rocky Mountain Spotted Fever. No results were provided. The patient had an emergency room visit in the first week of October which was pain related. No treatment information was provided and the patient did not recover from the events. The reporter relatedness for fatigue, burning sensation (discomfort) in the chest, headache, whole body pain but mostly abdominal and back pain is unknown for GARDASIL. No further information was provided. Additional information has been requested.

VAERS ID:474235 (history)  Vaccinated:2012-11-08
Age:13.0  Onset:2012-11-08, Days after vaccination: 0
Gender:Female  Submitted:2012-11-12, Days after onset: 4
Location:Virginia  Entered:2012-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Hypoaesthesia, Joint range of motion decreased, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Painful, swollen arm w/some numbness in right arm down to hand; no fever. Limited range of motion & abduction for a brief period after shot.

VAERS ID:473991 (history)  Vaccinated:2012-10-10
Age:13.0  Onset:2012-10-12, Days after vaccination: 2
Gender:Male  Submitted:2012-11-13, Days after onset: 32
Location:Missouri  Entered:2012-11-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MO201212
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH720AA0UNLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB642CA0UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0555AE0UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4006AA0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4383AA0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0098401UNRA
Administered by: Public     Purchased by: Other
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site nodule, Pain in extremity, Vaccination complication
SMQs:, Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)
Write-up: Client received vaccines on 10-10-12. Father called on 10-12-12 and states client has had a reaction to the vaccines. Father states that client has a small knot and redness the size of a baseball on the fatty part of his right arm. Father denies client experience of fever, SOB, DIB. Father states client c/o a lot of pain in his R arm. Father called back on 10-19-12 asking for school excuse and states prior symtoms have resolved.

VAERS ID:474056 (history)  Vaccinated:2012-11-12
Age:13.0  Onset:2012-11-12, Days after vaccination: 0
Gender:Female  Submitted:2012-11-13, Days after onset: 1
Location:Florida  Entered:2012-11-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illness at all
Preexisting Conditions: None
Diagnostic Lab Data: Not yet.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER  SYR 
Administered by: Unknown     Purchased by: Private
Symptoms: Abdominal discomfort, Dyspnoea, Hypoaesthesia, Oropharyngeal pain, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient developed shortness of breath about 4:30 pm. Both she and her sister who also had the shot complained of sore throat and upset stomach about 6:30PM. Both developed fevers by 9:PM. Patient''s reached 103 by midnight and by 4:30 her hands were numb and she was short of breath. She then vomited and went back to sleep. She has been sleeping with a 102 temp. since then and it is 3:40 PM 11/13/2012. These are all reactions listed on the HPV handout.

VAERS ID:474363 (history)  Vaccinated:2012-10-31
Age:13.0  Onset:2012-10-31, Days after vaccination: 0
Gender:Female  Submitted:2012-11-05, Days after onset: 5
Location:Florida  Entered:2012-11-13, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data: Had fingerstick for CBC done prior to immunizations.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH759AB0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0138310IMLA
Administered by: Private     Purchased by: Private
Symptoms: Seizure like phenomena
SMQs:, Convulsions (narrow)
Write-up: Patient was in office for well check-up. Had a fingerstick for CBC followed by 2 immunizations, GARDASIL and FLUZONE. Shortly after, patient experienced seizure-like movements observed by this nurse. Feet elevated above heart, supportive care given and pt. walked out of office independently with mother.

VAERS ID:474140 (history)  Vaccinated:2012-11-14
Age:13.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Male  Submitted:2012-11-14, Days after onset: 0
Location:Georgia  Entered:2012-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: New PT
Diagnostic Lab Data: BP WNL
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ20250IN 
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB646AA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0629AE0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4273AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B085CA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Syncope, Wart excision
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: PT had an episode of syncope post vaccinations and wart removal. PT was assessed and monitored, vitals stable in care to mother to home.

VAERS ID:474157 (history)  Vaccinated:2012-11-13
Age:13.0  Onset:2012-11-13, Days after vaccination: 0
Gender:Female  Submitted:2012-11-14, Days after onset: 1
Location:South Dakota  Entered:2012-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH734AC IMLA
Administered by: Other     Purchased by: Public
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Client attended the flu shot clinic. She received a 0.5cc flu injection, Sanofi, Lot # UH734AC, Expiration date 6/30/13, in the left deltoid muscle at 1630 hours by RN. After receiving the injection the client reported she felt like she was going to faint. RN instructed the client to remain seated and allowed her to lean forward with her head between her knees. RN then put a wrapped cold pack to the back of the client''s neck and retrieved this nurse to assist. This nurse retrieved the emergency kit and a mat for the client to lie down on. When this nurse got to the client with the mat, the client refused to lie down and stated she was feeling better. This nurse assessed vital signs at 1640 hours: Blood pressure 108/62, pulse 74, respirations 16. The client was allowed to stand and walk to the bleachers with her mother for further observation. The client remained on the bleachers without further problems for another 15 minutes. Client was released with her mother at 1655 hours. This nurse spoke with the client''s mother today (11/14/12) at 0854 hours. Her mother reports no further concerns and stated the client is doing well. This nurse then called the client''s physician''s office at 0903 hours and reported the incident to an office nurse.

VAERS ID:474158 (history)  Vaccinated:2012-11-14
Age:13.0  Onset:2012-11-14, Days after vaccination: 0
Gender:Female  Submitted:2012-11-14, Days after onset: 0
Location:Michigan  Entered:2012-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4283AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Pallor, Syncope
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), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Client had syncope after receiving vaccine. She lost consciousness for 2 seconds, skin pale, dizzy, and diaphoretic.

VAERS ID:474252 (history)  Vaccinated:2012-07-16
Age:13.0  Onset:2012-08-03, Days after vaccination: 18
Gender:Male  Submitted:2012-11-15, Days after onset: 104
Location:New York  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Asthma (mild intermittent)
Diagnostic Lab Data: Has gone on to experience additional seizures and been diagnosed with epilepsy.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0459AE0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Convulsion, Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Seizure.

VAERS ID:474264 (history)  Vaccinated:2012-02-20
Age:13.0  Onset:2012-06-14, Days after vaccination: 115
Gender:Male  Submitted:2012-11-15, Days after onset: 154
Location:South Carolina  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER 1SYRLA
Administered by: Unknown     Purchased by: Private
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Multiple seizure.

VAERS ID:474519 (history)  Vaccinated:2012-11-06
Age:13.0  Onset:2012-11-14, Days after vaccination: 8
Gender:Female  Submitted:2012-11-15, Days after onset: 1
Location:Utah  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12233P0IMRA
Administered by: Public     Purchased by: Other
Symptoms: Pain, Rash macular, Tenderness
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: No tx currently. Right forearm is painful to touch/movement, blotchy by hand sx noticed 11/14/12 am, flu on admin 11/06/12 pm.

VAERS ID:474569 (history)  Vaccinated:2012-11-10
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Connecticut  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: CBC; electrolytes; glucose; Lyme IgG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH734AB1IMUN
Administered by: Private     Purchased by: Unknown
Symptoms: Blood electrolytes, Blood glucose, Borrelia test, Full blood count, Vertigo
SMQs:, Vestibular disorders (narrow)
Write-up: Developed vertigo the evening after she received the influenza vaccine - (injection).

VAERS ID:474617 (history)  Vaccinated:2012-11-16
Age:13.0  Onset:2012-11-16, Days after vaccination: 0
Gender:Female  Submitted:2012-11-16, Days after onset: 0
Location:Illinois  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: Normal chemistry studies, CBC, and CT of brain.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Other
Symptoms: Computerised tomogram head normal, Convulsion, Fall, Full blood count normal, Laboratory test normal, Musculoskeletal stiffness, Tonic clonic movements
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Hypoglycaemia (broad)
Write-up: Patient waiting in line at fast food restaurant. Became stiff, fell to floor, tonic clonic movements lasting 30-40 sec. Brought to ER for further eval, no further problem following seizure.

VAERS ID:474623 (history)  Vaccinated:2012-10-09
Age:13.0  Onset:2012-11-15, Days after vaccination: 37
Gender:Male  Submitted:2012-11-16, Days after onset: 1
Location:California  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Albuterol inhaler
Current Illness: No
Preexisting Conditions: Asthma
Diagnostic Lab Data: CBC, lumbar puncture, MRI, CT
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ21061IN 
Administered by: Private     Purchased by: Public
Symptoms: Computerised tomogram, Full blood count, Gait disturbance, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging, Sensation of heaviness, Sensory disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)
Write-up: Bilateral lower extremity weakness, difficulty walking, complaining of "heaviness" in legs. Decreased feeling in left lower extremity. Sent to ER for further evaluation.

VAERS ID:475247 (history)  Vaccinated:2012-10-28
Age:13.0  Onset:2012-10-28, Days after vaccination: 0
Gender:Male  Submitted:2012-11-11, Days after onset: 14
Location:Georgia  Entered:2012-11-20, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FOCALIN; Clonidine; STRATTERA; Risperidone
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1231235UNLA
Administered by: Other     Purchased by: Private
Symptoms: Laceration, Suture insertion, Syncope, Tooth fracture
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: After the flu vaccine was given approx. 8 minutes she started to go look for item in store (drug), walked approx. 15 feet & fainted, required stitches under chin (#11) & chipped tooth; she came to & taken to ER immediately .

VAERS ID:475815 (history)  Vaccinated:2011-10-11
Age:13.0  Onset:2011-10-12, Days after vaccination: 1
Gender:Female  Submitted:2012-10-21, Days after onset: 375
Location:California  Entered:2012-11-20, Days after submission: 30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Illness at the time of vaccination was not reported. Pre-existing condition included allergy to amoxicillin and scoliosis.
Diagnostic Lab Data: Not reported.
CDC Split Type: 201109995
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT481AA IMLA
Administered by: Private     Purchased by: Other
Symptoms: Headache, Vision blurred, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)
Write-up: Initial report was received from a health care professional on 14 October 2011. A 13-year-old female patient had received an intramuscular injection of FLUZONE, lot number UT481AA (site of administration not reported) on 11 October 2011. The patient developed headache, blurry vision, and vomiting after the vaccine on the next day. No further information was available at the time of the report. The patient''s outcome was recovered. Documents held by sender: None.

VAERS ID:475106 (history)  Vaccinated:2012-11-17
Age:13.0  Onset:2012-11-17, Days after vaccination: 0
Gender:Male  Submitted:2012-11-21, Days after onset: 4
Location:Kentucky  Entered:2012-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH760AC IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Hives, itching on torso and upper extremities.

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