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Found 596268 cases in entire database

Case Details (Sorted by Age)

This is page 378 out of 597

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VAERS ID:389710 (history)  Vaccinated:2010-05-26
Age:24.0  Onset:2010-05-26, Days after vaccination: 0
Gender:Female  Submitted:2010-06-01, Days after onset: 6
Location:Idaho  Entered:2010-06-01
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: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.910451012734 SCUN
TDAP: TDAP (ADACEL)SANOFI PASTEURC3383BA UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Nausea, Pain, Pyrexia, Vertigo
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever, body aches, nausea, vertigo.

VAERS ID:389744 (history)  Vaccinated:2010-05-06
Age:24.0  Onset:2010-05-08, Days after vaccination: 2
Gender:Female  Submitted:0000-00-00
Location:Florida  Entered:2010-06-01
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV2350IMRA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV003A0IDLA
Administered by: Military     Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: I woke up around 0330 with a searing pain in my right shoulder area. I couldn''t move or touch it and it even hurt too much to roll my sleeve up to look at it. I finally was able to roll up my sleeve and my whole shoulder was completely swollen. I took a couple of ibuprofen and iced it for about 2 hours. When I woke up it was still painful to lift my arm but the pain had subsided considerably.

VAERS ID:389858 (history)  Vaccinated:2010-04-28
Age:24.0  Onset:2010-05-20, Days after vaccination: 22
Gender:Male  Submitted:2010-06-01, Days after onset: 12
Location:North Carolina  Entered:2010-06-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Without pre-existing medical conditions; no congenital defects; without chronic medical conditions
Diagnostic Lab Data: Lumbar puncture: normal CSF glucose and protein; negative CSF culture; negative CSF PCR studies FR vaccinia and varicella
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A IDUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURD0191 IMUN
Administered by: Military     Purchased by: Military
Symptoms: CSF culture negative, CSF glucose normal, CSF protein normal, CSF virus no organisms observed, Encephalitis, Headache, Intensive care, Lumbar puncture normal, Pain, Polymerase chain reaction, Rash
SMQs:, Anaphylactic reaction (broad), Noninfectious encephalitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 24 y/o patient admitted to ICU via ED with (?) Dx of smallpox vaccinia/encephalitis. SM received primary SPV (LUE), Typhoid VICPS and AVA (RUE) on 28APR10-no other vaccines in 30-day window. Symptoms: Headache (784.0), generalized Pain (780.96), rash, oth nonspecific skin eruption (782.1).

VAERS ID:389871 (history)  Vaccinated:2010-05-27
Age:24.0  Onset:2010-05-31, Days after vaccination: 4
Gender:Female  Submitted:2010-06-02, Days after onset: 2
Location:Colorado  Entered:2010-06-02
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB375AA IMLA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF716AA0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: 4 days after receiving the vaccine she developed a red, itchy area with bumps at the injection site of YFVAX.

VAERS ID:390002 (history)  Vaccinated:2010-05-25
Age:24.0  Onset:2010-05-31, Days after vaccination: 6
Gender:Male  Submitted:2010-06-02, Days after onset: 2
Location:Virginia  Entered:2010-06-04, Days after submission: 2
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 known
Diagnostic Lab Data: None done
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF734AA0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site discolouration, Injection site erythema, Injection site vesicles
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 7 days after receiving the Yellow Fever Vaccine given SQ in (L) upper arm. He presents with a large oval blistered area at the injection site. Red and purple colored around the blister. No swelling noted. No c/o discomfort from this.

VAERS ID:390008 (history)  Vaccinated:2010-06-01
Age:24.0  Onset:2010-06-02, Days after vaccination: 1
Gender:Female  Submitted:2010-06-04, Days after onset: 2
Location:California  Entered:2010-06-04
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: allergies: Sulfa, iodine, morphine, codeine.
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB736BA1IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB302BA1IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B039AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1237Y0SCRA
Administered by: Public     Purchased by: Private
Symptoms: Anxiety, Dyspnoea, Injection site erythema, Injection site swelling, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: States "I get anxiety attacks and that''s what I thought was happening, (anxiety with difficulty breathing) but then my boyfreind noticed a welt on my arm 4 hours later and I knew it was an allergic reaction." Accessed care 06/02/2010 and was given Benadryl. Denies presence of rash. Provider did not note swelling upon inspection of trachea per pt. Swelling and redness noted at posterior right arm. No additional sob from that time until present. Swelling now markedly decreased.

VAERS ID:390055 (history)  Vaccinated:2009-11-07
Age:24.0  Onset:2009-11-09, Days after vaccination: 2
Gender:Male  Submitted:2010-06-06, Days after onset: 208
Location:Alabama  Entered:2010-06-06
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 14 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: NI
Preexisting Conditions: None
Diagnostic Lab Data: NI
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED0144911A IMLA
Administered by: Military     Purchased by: Military
Symptoms: Acute disseminated encephalomyelitis, Confusional state, Headache
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Hypoglycaemia (broad)
Write-up: The patient experienced severe headache and mental confusion after receiving the influenza vaccines a few days at the November Unit Training Assembly. He and his spouse went to the local Emergency Room, but later was transferred to and admitted to Hospital with diagnosis Acute Disseminated Encephalomyelitis.

VAERS ID:390563 (history)  Vaccinated:2010-06-09
Age:24.0  Onset:2010-06-11, Days after vaccination: 2
Gender:Female  Submitted:2010-06-14, Days after onset: 3
Location:Louisiana  Entered:2010-06-14
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: NO
Diagnostic Lab Data: no
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (MENOMUNE)SANOFI PASTEURU3102AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B049AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Diarrhoea, Headache, Musculoskeletal stiffness
SMQs:, Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow)
Write-up: Onset of diarrhea @ 48 hrs, followed by headache, stiff neck. Doesn''t think she had fever. Was taking Tylenol. Symptoms still present on day 5.

VAERS ID:390597 (history)  Vaccinated:2010-06-02
Age:24.0  Onset:2010-06-03, Days after vaccination: 1
Gender:Female  Submitted:2010-06-07, Days after onset: 4
Location:Oregon  Entered:2010-06-14, 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: none
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: OR201016
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB174AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC5ZB043BA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Abdominal pain, Arthralgia, Headache, Influenza like illness, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Flu like symptoms - fever, joint aches, H/A, abd cramping, nauseated. Started 7 pm Thursday ended in 24 hours 6/3/10.

VAERS ID:390704 (history)  Vaccinated:2010-06-04
Age:24.0  Onset:2010-06-05, Days after vaccination: 1
Gender:Female  Submitted:2010-06-07, Days after onset: 2
Location:Connecticut  Entered:2010-06-15, Days after submission: 8
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
TDAP: TDAP (ADACEL)SANOFI PASTEURC3382AA UNRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Local reaction ( R ) arm within 48 hrs very large area of swelling.

VAERS ID:390742 (history)  Vaccinated:2010-06-10
Age:24.0  Onset:2010-06-10, Days after vaccination: 0
Gender:Female  Submitted:2010-06-15, Days after onset: 5
Location:Missouri  Entered:2010-06-15
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.033120UNRA
Administered by: Private     Purchased by: Other
Symptoms: Chills, Cough, Dysphonia, Fatigue, Headache, Immediate post-injection reaction, Influenza like illness, Lacrimation increased, Nasal congestion, Oropharyngeal pain, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Lacrimal disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Received 1st injection GARDASIL. C/o Flu-Like symptoms immediately. Fever/chills, achiness, watery eyes, cough, nasal congestion, headache, fatigue, sore throat, hoarseness.

VAERS ID:391380 (history)  Vaccinated:2008-08-27
Age:24.0  Onset:2008-09-03, Days after vaccination: 7
Gender:Female  Submitted:2010-06-04, Days after onset: 639
Location:Texas  Entered:2010-06-24, Days after submission: 20
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 20 days
    Extended hospital stay? 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.0249Y0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3048AA0UNUN
Administered by: Private     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: Never been ill her life - took vaccine and started having seizures. Have not stopped.

VAERS ID:391498 (history)  Vaccinated:2010-06-22
Age:24.0  Onset:2010-06-24, Days after vaccination: 2
Gender:Female  Submitted:2010-06-25, Days after onset: 1
Location:Arizona  Entered:2010-06-25
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: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1771Y1SCUN
Administered by: Public     Purchased by: Unknown
Symptoms: Erythema, Hot flush, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Vaccine on 6/22/2010, redness and swelling 6/23/2010, increased redness and swelling with pain 6/24/2010 with hot flashes. No other lesions.

VAERS ID:391735 (history)  Vaccinated:2010-06-24
Age:24.0  Onset:2010-06-26, Days after vaccination: 2
Gender:Female  Submitted:2010-06-29, Days after onset: 3
Location:Washington  Entered:2010-06-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data: CMP, CBC, B12/FOLATE PANEL, HCG, TSH, MRI BRAIN W/O CONTRAST
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV2413IMLA
Administered by: Military     Purchased by: Military
Symptoms: Blood folate, Blood human chorionic gonadotropin, Blood thyroid stimulating hormone, Full blood count, Hypoaesthesia, Metabolic function test, Nuclear magnetic resonance imaging brain normal, Paraesthesia, Pregnancy test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Pt c/o numbness and tingling X 4 days on the L side of her body. Pt states it sometimes is one part like her leg and other times it is several parts of her L body at the same time. Pt describes the tingling like ''when you sleep on your arm and it goes to sleep; and when you start to move it, it starts to have the needle feeling.'' Pt states unable to perform simple finger exercises at times during these episodes.

VAERS ID:391815 (history)  Vaccinated:2010-06-25
Age:24.0  Onset:2010-06-25, Days after vaccination: 0
Gender:Female  Submitted:2010-06-30, Days after onset: 5
Location:Tennessee  Entered:2010-06-30
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR  IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Headache, Joint lock, Muscle spasms
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Vestibular disorders (broad)
Write-up: Headache, dizziness, left side of her jaw locked up, and back spasms.

VAERS ID:392011 (history)  Vaccinated:2010-06-16
Age:24.0  Onset:2010-06-25, Days after vaccination: 9
Gender:Male  Submitted:2010-07-03, Days after onset: 8
Location:Virginia  Entered:2010-07-03
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: (+) Troponin (+) CK-MB highest CK 600''s (+) Myoglobin .
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0 LA
Administered by: Military     Purchased by: Military
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, Cardiac enzymes increased, Chest pain, Electrocardiogram abnormal, Myocarditis, Myoglobin blood increased, Troponin increased
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Substernal Chest Pain with elevated Cardiac enzymes and EKG changes noted consistent with myocarditis. Treated with colchine and Motrin.

VAERS ID:392555 (history)  Vaccinated:2010-06-30
Age:24.0  Onset:2010-06-30, Days after vaccination: 0
Gender:Female  Submitted:2010-07-09, Days after onset: 9
Location:Pennsylvania  Entered:2010-07-09
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: prior hx of abnormal PAP allergies to SULFA, DEMEROL
Diagnostic Lab Data: see above
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER    
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Other     Purchased by: Other
Symptoms: Blood calcium normal, Blood thyroid stimulating hormone, Dyskinesia, Liver function test normal, Metabolic function test normal, Myoclonus
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Myoclonic jerks and involuntary movements with a few hours of receiving Gardasil and DPT vaccines at her PCP office. Seen in ER on 6/30 and received Ativan, Benadryl, fluids. Seen in my neurology clinic 7/2 with some residual involuntary movements of the right hand and arm. Bloodwork on 6/30 (BMP, LFTs, TSH, Calcium) was normal. I ordered CPK and Brain MRI 7/2 (but not completed as of today).

VAERS ID:392828 (history)  Vaccinated:2010-07-12
Age:24.0  Onset:2010-07-12, Days after vaccination: 0
Gender:Female  Submitted:2010-07-14, Days after onset: 2
Location:Florida  Entered:2010-07-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Vaccine not specified (no brand name)~UN~24.67~Patient
Other Medications:
Current Illness: None, per client
Preexisting Conditions: None, per client
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB765AA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0857Y1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Rash papular
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: She received the second vaccine in the VZV series on the Left Tricep on 7/12/2010 at approximately 10:00 by the Employee Health Nurse. She states that the site began itching, and started swelling since right after the injection was given. This morning, 7/14/2010, the employee approached me and asked regarding the swelling, the swelling - in diameter, is approximately the size of a tennis ball. It is red, and hot to touch. The client also received Hepatitis B, according to documentation, on the Left Deltoid. She states that the first time she received the VZV vaccine on 06/02/2010, she had a few "bumps" throughout her skin, but they went away in 2 days, and was not sure what had caused them. Currently she is not experiencing any other symptoms.

VAERS ID:392920 (history)  Vaccinated:2010-07-13
Age:24.0  Onset:2010-07-14, Days after vaccination: 1
Gender:Female  Submitted:2010-07-15, Days after onset: 1
Location:Georgia  Entered:2010-07-15
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: Hx Shingles 08/29/2009.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 1 RA
Administered by: Public     Purchased by: Public
Symptoms: Hypoaesthesia, Injection site erythema, Injection site induration, Injection site warmth
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Small red patch at site of injection. Also it was hot and hard. Place cold compress on site. This morning on arising right arm was numb.

VAERS ID:392933 (history)  Vaccinated:2010-07-12
Age:24.0  Onset:2010-07-14, Days after vaccination: 2
Gender:Female  Submitted:2010-07-15, Days after onset: 1
Location:Wisconsin  Entered:2010-07-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: High fever for 4 days~DTP (no brand name)~1~0.25~Patient
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 BIOLOGICALS 1IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEUR 0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Lymph node pain, Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Swelling and pain in the left supraclavicular and subclavian lymph nodes.

VAERS ID:393135 (history)  Vaccinated:2010-07-12
Age:24.0  Onset:2010-07-13, Days after vaccination: 1
Gender:Female  Submitted:2010-07-19, Days after onset: 6
Location:Michigan  Entered:2010-07-19
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
TDAP: TDAP (ADACEL)SANOFI PASTEURUF544CA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dry mouth, Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt reports 4"x5" swelling at injection site 1 day after administration. Redness and warm to to the touch. She also reports dryness around the mouth. Advised pt to apply ice for swelling and to call back if she isn''t getting better. Spoke to pt after the weekend and reports the swelling is completely gone.

VAERS ID:393389 (history)  Vaccinated:2010-07-16
Age:24.0  Onset:2010-07-18, Days after vaccination: 2
Gender:Female  Submitted:2010-07-22, Days after onset: 4
Location:North Carolina  Entered:2010-07-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cat Bite
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLA
Administered by: Military     Purchased by: Other
Symptoms: Erythema, Fatigue, Injection site erythema, Injection site swelling, Lymph node pain, Malaise, Nausea, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)
Write-up: Increased redness and swelling of left upper arm and generalized malaise after receiving tetanus toxoid x48 hours ago for cat bite. Feeling tired (fatigue), nausea, rash. Cold compresses observe for increased erythema tender lymph nodes or fever. Tylenol for fever, prednisone 60mg daily x 5 days.

VAERS ID:393646 (history)  Vaccinated:2010-07-23
Age:24.0  Onset:2010-07-24, Days after vaccination: 1
Gender:Female  Submitted:2010-07-27, Days after onset: 3
Location:Maryland  Entered:2010-07-27
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3488BA IMLA
Administered by: Private     Purchased by: Other
Symptoms: Lymphadenopathy, Pain
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Painful,swollen gland above left clavicle. Went to Patient 1st for evaluation, told it was most likely vaccine related.

VAERS ID:394023 (history)  Vaccinated:2010-07-29
Age:24.0  Onset:2010-08-01, Days after vaccination: 3
Gender:Female  Submitted:2010-08-01, Days after onset: 0
Location:California  Entered:2010-08-01
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: n/a
Diagnostic Lab Data: n/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER   LA
Administered by: Public     Purchased by: Private
Symptoms: Chills, Fatigue, Feeling cold, Injection site pain, Night sweats
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: night sweating cold chills active passing of stools fatigue pain at site of vaccination

VAERS ID:394391 (history)  Vaccinated:2010-07-21
Age:24.0  Onset:2010-08-01, Days after vaccination: 11
Gender:Female  Submitted:2010-08-05, Days after onset: 4
Location:Washington  Entered:2010-08-05
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: Diagnostic tests: Initial PCR confirmation of vaccinia from the Laboratory, pending CDC confirmation.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURUKN0OTUN
Administered by: Military     Purchased by: Military
Symptoms: Blepharitis, Polymerase chain reaction, Rash pustular, Secondary transmission, Skin lesion, Vaccinia virus infection
SMQs:, Periorbital and eyelid disorders (narrow), Ocular infections (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: a. This vaccine adverse event involves a patient who never received the Smallpox Vaccination. Patient was exposed to the vaccine by touching another person while sleeping. She noticed a small pimple like sore Sunday evening, 1 August 2010. She popped the pimple. On Monday morning the lesion continued to get larger and by Monday evening, 2 Aug 2010 noticed that it began to look like the smallpox vaccination site on her boyfriend''s arm. On Tuesday morning, 3 August 2010, she went to sick call. In a personal interview, she claims that the vaccination site on her boyfriend was covered with a band-aid, but he was not wearing a t-shirt. The patient does not wear contacts. She was counseled to take pre-cautions against getting pregnant for the next 30 Days. b. Her primary lesion is an umbillicated pustule above her right eye (on the inferior aspect of the eyebrow on the orbital rim). She has two ocular satellite lesions, one on the inferior orbital rim and another one on the superior aspect to the right of the main lesion. She also has another umbillicated pustule on the right lower extremity. There is no evidence of ocular involvement (e.g. conjunctivitis, keratitis, or frank blepharitis), although there is secondary blepharitis from the periorbital lesions. She is currently being treated prophylactically with Viroptic (2 gtt OU five times daily) to reduce the possibility of frank ocular involvement. c. The person vaccinated stated that he was wearing a band-aid and a T-shirt. He also admitted to receiving the Smallpox Individual''s Briefing prior to being vaccination.

VAERS ID:394425 (history)  Vaccinated:2010-07-19
Age:24.0  Onset:2010-07-24, Days after vaccination: 5
Gender:Female  Submitted:2010-07-30, Days after onset: 6
Location:North Carolina  Entered:2010-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0405Z0SCRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B042BA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Headache, Nausea, Pain, Pyrexia, Rash erythematous, Rash macular
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Talked to pt. 7-30-10; 4 days ago developed headache, worse with eye movement, fever and "really achy", also nausea 4-5 days ago; on 7-29-10 had red splotchy raised rash - large splotches on torso progressing to small on lower half of body - no itching.

VAERS ID:395773 (history)  Vaccinated:2010-03-19
Age:24.0  Onset:2010-03-19, Days after vaccination: 0
Gender:Male  Submitted:2010-07-29, Days after onset: 132
Location:Pennsylvania  Entered:2010-08-06, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rhinitis allergic; Pollen allergy; Allergic to cats; House dust mite allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES1004USA02815
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1339Y IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3355AN IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a currently 24 year old male patient with rhinitis allergic and not known drug reactions or allergies who on 19-MAR-2010, was vaccinated IM with a dose of PNEUMOVAX 23 (Lot # 665402/1339Y). There was no concomitant medication. According to the physician, the patient developed an urticarial reaction at the injection site that lasted for 4 days. At the time of the report the patient had recovered. The patient sought medical attention by an office visit. No diagnostic tests were performed. Follow up information has been received from a physician who indicated that the patient was a male student with pollen, cat, dust mite allergies and rhinitis allergic who on 19-MAR-2010, was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665402/1339Y) into his left deltoid. Concomitant vaccinations included a dose of ADACEL given into his right deltoid. There were no illnesses reported at the time of vaccination. On 19-MAR-2010 the patient experienced hives at the injection site (Left deltoid) that lasted 4 days. On 23-MAR-2010 the patient recovered from hives at the injection site without intervention. Additional information is not expected.

VAERS ID:394970 (history)  Vaccinated:2010-07-16
Age:24.0  Onset:2010-07-20, Days after vaccination: 4
Gender:Female  Submitted:2010-08-09, Days after onset: 20
Location:North Carolina  Entered:2010-08-12, Days after submission: 3
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: CBC; 7-26-10 UTI-UA discovered to have UTI treated with CIPRO
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB798A1IMUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURD054815SCUN
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF716AA0SCUN
Administered by: Public     Purchased by: Public
Symptoms: Blood test, Chills, Fatigue, Full blood count, Headache, Influenza like illness, Nausea, Oropharyngeal pain, Pain, Pyrexia, Urinary tract infection, Urine analysis abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 7-20-10 developed flu like symptoms-fever (100degrees) H.A., vomiting, nausea, chills, body aches-states felt better the next day. ER visit 7-25-10-4 hr stay-received fluids-nausea med (injectable) and BENADRYL. 7-26-10 was seen by MD office had blood work-given med for nausea. 7-28-10-seen by MD office-follow up visit. States since then has had HA''s daily, aches-mostly in shoulder, nausea, and fatigue-all intermittently. Reports developed sore throat starting 8-6-10. 7-26-10 was diagnosed with Urinary Tract Infection treated with CIPRO. Patient did not tell me about the UTI-found out today from MD office.

VAERS ID:395125 (history)  Vaccinated:2010-07-09
Age:24.0  Onset:0000-00-00
Gender:Female  Submitted:2010-08-12
Location:Unknown  Entered:2010-08-13, 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: Pregnancy NOS (LMP = 6/15/2010)
Preexisting Conditions:
Diagnostic Lab Data: urine beta-human, 07/09/10, pregnancy, the indicator was so light that it was missed
CDC Split Type: WAES1007USA02894
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1178Y0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a licensed nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female pregnant patient (last menstrual period was 15-JUN-2010) with no known drug reactions, allergies or pertinent medical history who on 09-JUL-2010 was vaccinated IM with a first dose of GARDASIL (lot number 663559/1178Y). The nurse reported that an urine pregnancy test was performed but the positive pregnancy indicator was so light that it was missed and the dose of GARDASIL was given. No known adverse effects were reported. Estimated delivery date is 25-MAR-2011. Follow up information has been received from the nurse practitioner who reported that the patient decided to electively terminate the pregnancy. The nurse reported that the patient would be having the procedure done on 05-AUG-2010. The nurse also reported that the termination was not vaccine related. The nurse reported that the patient "just did not want the pregnancy". At the time of the report that patient''s outcome was unknown. Upon internal review "the patient decided to electively terminate the pregnancy" was considered to be an other important medical event. No further information is available.

VAERS ID:395190 (history)  Vaccinated:2010-07-28
Age:24.0  Onset:2010-07-29, Days after vaccination: 1
Gender:Female  Submitted:2010-08-13, Days after onset: 15
Location:Illinois  Entered:2010-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3446AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (narrow)
Write-up: Pt had redness, swelling, pain at injection site and went to the ER the next day. Has had several more trips to the doctor since then. Says she has take several different antibiotics and a steroid. Her mother says she told patient to rub the injection site after the shot because she thought that was what you shoud do after a tetanus shot. Client says her doctor said the shot was given too low in her arm, and not given deep enough. As of 8-13-10, she continues to have redness, soreness & pain in arm. She says the doctor is not sure what is going on with it, and may do an ultrasound on 8-16-10 if it is not better.

VAERS ID:395220 (history)  Vaccinated:2009-06-01
Age:24.0  Onset:2009-06-01, Days after vaccination: 0
Gender:Female  Submitted:2010-08-14, Days after onset: 439
Location:Arizona  Entered:2010-08-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: son born with birth defects~HPV (Gardasil)~3~24.92~Patient
Other Medications:
Current Illness: none
Preexisting Conditions: My self only had sesonal allergies
Diagnostic Lab Data: n/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0100Y2IMLA
Administered by: Private     Purchased by: Other
Symptoms: Dizziness, Headache, Hypoaesthesia, Injection site pain, Nausea, Paraesthesia, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Pain at injection site, numbness and tingling in arms and fingers, syncope, dizziness, nausea and vomiting, frequent headaches after the vaccine up till feb 2010. Currently I still experience numbness and tingling in my arms and fingers, nausea, and frequent headaches.

VAERS ID:395426 (history)  Vaccinated:2010-08-11
Age:24.0  Onset:2010-08-11, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:California  Entered:2010-08-17
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: COMPAZINE with dystonia reaction
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1318Y1IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Abnormal dreams, Clonus, Faecal incontinence, Immediate post-injection reaction, Nausea, No reaction on previous exposure to drug, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (broad), Hypoglycaemia (broad)
Write-up: Before administering vaccine discussed possible SE''s & denied previous syncope or presyncope with HPV #1 vaccine. This pt provided with HPV #2 vaccine and w/in 5 seconds of injection pt had full syncopal episode with clonic like behavioral as well as loss of bowel control & a vivid dream. Pt denied post-injection or post syncopal confusion. Pt laid down with improvement, but did develop n/v.

VAERS ID:395501 (history)  Vaccinated:2010-08-17
Age:24.0  Onset:2010-08-17, Days after vaccination: 0
Gender:Male  Submitted:2010-08-18, Days after onset: 1
Location:Oklahoma  Entered:2010-08-18
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
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS))NOVARTIS VACCINES AND DIAGNOSTICS  IMRA
Administered by: Other     Purchased by: Private
Symptoms: Convulsion, Erythema, Immediate post-injection reaction, Respiratory arrest, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Pt fainted after shot and appeared to have a mild seizure, his face became really red and appeared to stop breathing briefly. The whole reaction lasted about a minute and when I was about to use an epi pen he came to and assured me he was fine.

VAERS ID:396166 (history)  Vaccinated:1998-10-23
Age:24.0  Onset:0000-00-00
Gender:Female  Submitted:2010-08-20
Location:Unknown  Entered:2010-08-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: (Separate VAERS filed for July 2010, H1N1).~Influenza (Seasonal) (no brand name)~UN~0.00~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: Peanut allergy; Seasonal allergies; NKDA
Diagnostic Lab Data: Dec 2007, negative egg skin testing
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Military     Purchased by: Military
Symptoms: Cough, Diarrhoea, Epistaxis, Fatigue, Influenza like illness, Pain, Pneumonia primary atypical, Pyrexia, Skin test negative, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: SM did not receive any flu vaccines until she was in the military. She recalls that following her first flu vaccines, she developed vomiting, diarrhea and frequent bloody noses. She also developed symptoms of the flu including a cough. Talking and coughing led to vomiting and she was given a voice waiver. Most symptoms persisted x 3 mos during which time she was evaluated and treated, with no reported underlying cause. She eventually was told she had walking pneumonia. The bloody noses stopped after "charcoal" treatment by ENT. She avoided flu shots for a few years after that, but when she was required to take the seasonal flu shots annually, the first five years, she developed diarrhea and vomiting, as well as fatigue, fever, and aching. To the best of her recollection, her symptoms usually started within the first 24 hours after vaccine receipt and usually did not last more than 1-2 weeks. Since then, her reactions after receipt of seasonal flu vaccines do not include diarrhea and vomiting, but usually include viral-type symptoms, lasting for 1-2 weeks and requiring quarters following vaccine receipt. She denies developing hives/rashes, angioedema, difficulty breathing or swallowing. She does not recall specifics of receipts of FLUMIST (x2); specifically, she does not recall reacting differently to FLUMIST than to flu vaccines administered IM. Since 2007, after she skin tested negative for eggs, she has received only injectable flu vaccines. She has tried pretreatment with Naproxen 500 mg every 6 hours, starting 24 hours before vaccine receipt and continuing for 48 hours post-vaccine without a significant reduction in symptoms following vaccine receipt.

VAERS ID:396231 (history)  Vaccinated:2010-08-20
Age:24.0  Onset:2010-08-22, Days after vaccination: 2
Gender:Male  Submitted:2010-08-23, Days after onset: 1
Location:Georgia  Entered:2010-08-23
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU3110GA IMRA
Administered by: Other     Purchased by: Other
Symptoms: Axillary pain, Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: enlarged lymph node right axillary region with tenderness, no fever

VAERS ID:396237 (history)  Vaccinated:2010-08-14
Age:24.0  Onset:2010-08-15, Days after vaccination: 1
Gender:Male  Submitted:2010-08-23, Days after onset: 8
Location:Oregon  Entered:2010-08-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NA
Preexisting Conditions: HX pneumonia HX asthma
Diagnostic Lab Data: NA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)SANOFI PASTEURU3349BA0IM 
Administered by: Other     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 starting next AM with some pruritis bilateraly to thighs X4 days.

VAERS ID:396482 (history)  Vaccinated:2010-08-24
Age:24.0  Onset:2010-08-24, Days after vaccination: 0
Gender:Female  Submitted:2010-08-26, Days after onset: 2
Location:Georgia  Entered:2010-08-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: I had cold symptoms. That evening I got a 102 fever which has last over 24 hours.
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Other
Symptoms: Chills, Heart rate increased, Hyperhidrosis, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Fever of 102, fast heat beat, shivering, sweating, pain at the injection sight

VAERS ID:396526 (history)  Vaccinated:2010-08-23
Age:24.0  Onset:2010-08-24, Days after vaccination: 1
Gender:Female  Submitted:2010-08-24, Days after onset: 0
Location:Michigan  Entered:2010-08-26, Days after submission: 2
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) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1116891P0IMAR
Administered by: Public     Purchased by: Private
Symptoms: Chills, Dyspnoea, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)
Write-up: Chills, shaking, SOB.

VAERS ID:396749 (history)  Vaccinated:2010-08-26
Age:24.0  Onset:2010-08-27, Days after vaccination: 1
Gender:Female  Submitted:2010-08-28, Days after onset: 1
Location:Unknown  Entered:2010-08-30, Days after submission: 2
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: Scoliosis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS111796P10IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Redness @ injection site and soreness of muscle.

VAERS ID:396771 (history)  Vaccinated:2010-08-27
Age:24.0  Onset:2010-08-27, Days after vaccination: 0
Gender:Male  Submitted:2010-08-30, Days after onset: 3
Location:Massachusetts  Entered:2010-08-30
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1431Y UNLA
Administered by: Military     Purchased by: Other
Symptoms: Dizziness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Dizziness. Fever.

VAERS ID:397057 (history)  Vaccinated:2010-08-17
Age:24.0  Onset:2010-08-27, Days after vaccination: 10
Gender:Male  Submitted:2010-09-01, Days after onset: 5
Location:Florida  Entered:2010-09-01
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
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV2480IMRA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0OTLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B063CA0IMRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURD01910IMRA
Administered by: Military     Purchased by: Military
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: rash on arms and upper back

VAERS ID:397287 (history)  Vaccinated:2010-08-30
Age:24.0  Onset:2010-09-02, Days after vaccination: 3
Gender:Female  Submitted:2010-09-03, Days after onset: 1
Location:New York  Entered:2010-09-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Muscle weakness
Preexisting Conditions: Depression; Anxiety
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0854Y1UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Muscle spasms, Myalgia, Neck pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 5 days of neck pain, fever, muscle spasm, muscle pain, neck pain. Pt seen at office on 9/3/10 - pt sent to ER after I called CDC.

VAERS ID:397429 (history)  Vaccinated:2010-09-06
Age:24.0  Onset:2010-09-06, Days after vaccination: 0
Gender:Female  Submitted:2010-09-06, Days after onset: 0
Location:Oregon  Entered:2010-09-06
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: Allergic to Codeine
Diagnostic Lab Data: Paramedics took the patient''s blood pressure, pulse rate, pulse ox. They said vitals were all WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3651AA1IMLA
Administered by: Other     Purchased by: Private
Symptoms: Adverse event, Convulsion, Gaze palsy, Immediate post-injection reaction, Malaise, Mydriasis, Syncope, Vaccination complication, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: The patient came in to receive a flu shot to Pharmacy. The initial flu shot did not take well into the patient''s deltoid causing the vaccine to squirt back out. A new vaccine was prepared for readministration. The patient fainted immediately after receiving the vaccination. Her eyes rolled back and pupils became dilated. 911 was immediately called. Her head was supported and she began to seize slightly. Epipen was immediately administered after and the patient quickly woke up again. The patient felt sick and vomited. The patient was instructed to lie supine on the floor and was closely monitored for 10 minutes until paramedics arrived. The paramedics checked the patient''s vital signs and offered to take her to the hospital. The patient declined a visit to the hospital and was cleared by the paramedics.

VAERS ID:397570 (history)  Vaccinated:2010-04-06
Age:24.0  Onset:2010-04-28, Days after vaccination: 22
Gender:Female  Submitted:2010-09-03, Days after onset: 128
Location:Unknown  Entered:2010-09-07, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = Unknown)
Preexisting Conditions:
Diagnostic Lab Data: beta-human chorionic, 04/28/10, posit; beta-human chorionic, 04/06/10, negat
CDC Split Type: WAES1008USA03841
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1178Y1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Laparoscopic surgery
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from registered nurse (R.N.), for GARDASIL, a Pregnancy Registry Product, concerning a 24 year old female patient with no reported allergies who on 07-AUG-2007 was vaccinated IM with the first 0.5ml dose of GARDASIL and second dose on 05-APR-2010. There was no concomitant medication. In March 2009, the patient underwent a laparoscopic surgery. At the end of March 2010, the patient experienced miscarriage and was hospitalized for a specific length of time (location unknown). The patient sought unspecified medical attention and was recovering. The patient required hospitalization and the reporter considered the event was serious. Follow-up information was received on 31-AUG-2010 from the nurse who reported that the patient on 10-AUG-2007 received the first dose of GARDASIL (IM, 0.5 mL), Lot number 657737/0522U. There were no concomitant vaccinations administered at that time. On 06-APR-2010, the patient had a Pregnancy Test prior to the administration of the second dose of GARDASIL. The Pregnancy Test was negative. On 06-APR-2010, the patient received the second dose of GARDASIL (IM, 0.5 mL), lot number 663559/1178Y. There were no concomitant vaccinations administered at that time. The patient reported that on 28-APR-2010, she had another Pregnancy Test and the result was positive. At the end of May 2010, the patient had a miscarriage. She was 8 to 10 weeks pregnant at the time of the miscarriage. On 26-AUG-2010, the patient returned to the Health Department Clinic and received the third dose of GARDASIL (IM, 0.5 mL), lot number 666121/0597Z. There were no concomitant vaccinations administered at that time. The patient stated that she had not seen her family physician after she had the miscarriage. The patient reported that she was having regular periods and was doing fine. The patient was restarted on Birth Control pills. The patient''s next Health Department appointment was scheduled for 07-APR-2011. Upon internal review, laparoscopic surgery was considered to be an other important medical event. Additional information has been requested.

VAERS ID:397590 (history)  Vaccinated:2010-09-03
Age:24.0  Onset:2010-09-04, Days after vaccination: 1
Gender:Female  Submitted:2010-09-07, Days after onset: 3
Location:North Carolina  Entered:2010-09-07
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.148441IMLA
Administered by: Public     Purchased by: Private
Symptoms: Asthenia, Dizziness, Headache, Mass, Somnolence, Vaccination site swelling, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)
Write-up: Hepatitis B #2 vaccine given 9-3-10 (Fri). She woke up Sat AM with a small knot size of dime & she felt lightheaded & only wanted to sleep. Sunday AM 9-5-10 woke up vomiting headache, weakness & swollen, large (L) upper arm at vaccine site. She went to ED 4cm reaction. NORCO given, & antiemetic.

VAERS ID:397643 (history)  Vaccinated:2010-09-03
Age:24.0  Onset:2010-09-04, Days after vaccination: 1
Gender:Female  Submitted:2010-09-07, Days after onset: 3
Location:Pennsylvania  Entered:2010-09-08, 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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3516AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Mass, Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Arm pain and swelling, which then turned into a lump on arm with a lot of pain. Having pain in shoulder down to injection spot.

VAERS ID:397710 (history)  Vaccinated:2010-08-27
Age:24.0  Onset:2010-08-27, Days after vaccination: 0
Gender:Female  Submitted:2010-09-08, Days after onset: 12
Location:Indiana  Entered:2010-09-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: There were no concomitant vaccinations or medications. It was unknown whether the subject had experienced adverse events following previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0878957A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA113AA0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Chills, Dizziness, Dyspnoea, Myalgia, Nausea, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of chills in a 24-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 27 August 2010 at 10:30 the subject received 1st dose of CERVARIX (1 ml, unknown route and site). On 27 August 2010, within 45 minutes after vaccination with CERVARIX, the subject experienced chills, nausea, vomiting, shortness of breath, dizziness, lightheadedness and muscular pain all over the body. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with ZOFRAN, TORADOL and Normal saline. At the time of reporting the events were resolved. The healthcare professional reported that the subject received 1st dose of CERVARIX at 10:30, and experienced all of the reported adverse events within 45 minutes of the dose. She was taken to a local Emergency Room (was not admitted to the actual hospital), received 2 doses of ZOFRAN IM, 1 dose of TORADOL IM (the mg dose of both is not known), and IV normal saline infusion (total amount not known). Admission to ER reported as 14:43, and discharge from ER at 17:00. At the time of discharge from ER the subject reported that all adverse events had resolved.

VAERS ID:398170 (history)  Vaccinated:2009-06-15
Age:24.0  Onset:2009-06-15, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 415
Location:Missouri  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 5/25/2009); Migraine; Anxiety; Depression; Hypersensitivity; Nausea; Tooth pain
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound, 08/28/09, normal; Ultrasound, 10/14/09, normal; Ultrasound, 01/13/2010, normal; Urinalysis; Apgar score, 02/22/10, 8/9
CDC Split Type: WAES0907USA00071
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0571X0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Ultrasound scan normal, Urine analysis, Vaginitis bacterial
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received for the pregnancy registry of GARDASIL, from a 24 year old female patient who on 15-JUN-2009 was vaccinated with a first 0.5 mL dose of GARDASIL (LOT #660620/0571X). There was no concomitant medication. It was reported that as of 30-JUN-2009 the patient was 8 weeks pregnant. On an unknown date a urine test was performed; results were not reported. The patient''s last menstrual period was 25-MAY-2009 and the estimated delivery date is 01-MAR-2010. The patient sought unspecified medical attention. No adverse events were involved. Follow up information received from a registered nurse indicated that the patient was a female with migraine, anxiety, depression, hypersensitivity, nausea and tooth pain, and a previous live birth. Concomitant therapy included CLARITIN, PROZAC, COMPAZINE, XANAX and TYLENOL WITH CODEINE. On an unspecified date during her pregnancy, the patient developed bacterial vaginosis. The patient was treated with CLEOCIN VAGINAL, cream and with METROGEL VAGINAL cream. The outcome of the patient''s bacterial vaginosis was not reported. On 28-AUG-2009, 14-OCT-2009 and 13-JAN-2010 the patient had normal ultrasounds tests done. On 22-FEB-2010 at 39 weeks and 4 days from her last menstrual period, the patient gave birth to a normal female who weighed "07.3" ounces, the baby''s length was 20 inches and her apgar score was 8/9. Follow up information received via medical records indicated that the patient had a term baby through a repeat c-section. On 01-MAR-2010, the baby had a newborn weight check and the assessment was a normal newborn. Additional information has been requested.

VAERS ID:398176 (history)  Vaccinated:2009-06-25
Age:24.0  Onset:2009-06-28, Days after vaccination: 3
Gender:Female  Submitted:2010-08-04, Days after onset: 402
Location:Texas  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Contraception
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0907USA00232
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Fatigue
SMQs:
Write-up: Information has been received from a physician concerning a 24 year old female on birth control who on 25-JUN-2009 was vaccinated with first 0.5mL dose of GARDASIL (route and lot number not reported). Concomitant therapy included NUVARING. On 28-JUN-2009, the patient experienced tiredness and fatigue. On 29-JUN-2009, the patient called the physician''s office and reported that she was exhausted and was still experiencing tiredness. No lab studies were performed. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:398303 (history)  Vaccinated:2009-05-11
Age:24.0  Onset:2009-05-11, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 450
Location:Unknown  Entered:2010-09-08, Days after submission: 35
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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0907USA01651
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a Nurse Practitioner (N.P) concerning a 24 year old female patient who on 11-MAY-2009 was vaccinated with the first dose of GARDASIL intramuscularly into the left deltoid. It was reported that the patient had been experiencing intermittent arm pain since receiving her initial dose of GARDASIL. The pain came and went with no pattern. The pain was described as muscle pain and felt like the day she initially received the vaccine. It was reported that the patient had arm pain when given the GARDASIL on 11-MAY-2009. The last time the patient had pain in that arm was two weeks ago. It was reported that the patient said it could be weeks between episodes of pain. The outcome of the patient was not reported. Additional information has been requested.

VAERS ID:398527 (history)  Vaccinated:2009-04-06
Age:24.0  Onset:0000-00-00
Gender:Female  Submitted:2010-08-04
Location:Unknown  Entered:2010-09-08, Days after submission: 35
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: Atypical squamous cells of undetermined significance
Diagnostic Lab Data: Colposcopy, 05/29/09, moderate dysplasia, Focal High-grade, CIN 2; loop electrosurgical, 07/10/09, Mild dysplasia, CIN 1; Pap test, 04/06/09, ASCUS, positive for HPV; Pap test, 10/17/08, positive for HPV
CDC Split Type: WAES0907USA03028
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1312X2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cervical dysplasia, Colposcopy abnormal, Loop electrosurgical excision procedure, Papilloma viral infection, Smear cervix abnormal
SMQs:, Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad)
Write-up: Information has been received from a nurse practitioner concerning a roughly 22 year old female who completed the GARDASIL series (0.5ml/3 shots). The patient developed CIN 2, 3 after the series. At the report time the outcome was unknown. Follow up information was received from a nurse practitioner on 27-JUL-2009: The patient received the GARDASIL on the following dates: the first dose on 17-OCT-2008, Lot# 660557/0072X; the second dose on 12-DEC-2008, Lot# 661703/0651X; the third dose on 06-APR-2009, Lot# 661846/1312X. In November 2007 the patient''s Pap smear results were atypical squamous cells of undetermined significance (ASCUS) with negative high risk. On 17-OCT-2008, the patient''s Pap smear was positive for HPV. The patient received the first dose of GARDASIL on 17-OCT-2008. The patient''s Colposcopy was negative. The patient was a recent converter to HPV. On 06-APR-2009, the patient''s Pap smear results were ASCUS, positive for HPV. The patient had received the third dose of GARDASIL on 06-APR-2009. On 29-MAY-2009 the patient had a Colposcopy which revealed moderate dysplasia, Focal High-grade, CIN 2. On 10-JUL-2009 the patient had a LEEP Procedure, which revealed Mild dysplasia, CIN 1. The patient had a scheduled follow-up appointment for 18-Jan-2010. Additional information has been requested.

VAERS ID:398606 (history)  Vaccinated:2009-03-06
Age:24.0  Onset:2009-03-27, Days after vaccination: 21
Gender:Female  Submitted:2010-08-04, Days after onset: 495
Location:New Jersey  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0908USA04234
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1311X1IMLA
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: Information has been received from a certified nurse midwife concerning a 25 year old female student with no known drugs allergies, who on 06-MAR-2009 was vaccinated with a second dose of GARDASIL (lot # 661531/1311X), intramuscularly into the left deltoid. Three weeks post vaccination the patient developed severe hives and was hospitalized. The patient recovered on an unspecified date. Additional information has been requested.

VAERS ID:399172 (history)  Vaccinated:2010-01-07
Age:24.0  Onset:2010-01-08, Days after vaccination: 1
Gender:Female  Submitted:2010-08-04, Days after onset: 207
Location:Unknown  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1001USA02986
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Headache, Injection site pain, Nausea, Rash, Tenderness
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a 24 year old female consumer with penicillin allergy who on 07-JAN-2010 was vaccinated with a first dose of GARDASIL. On 08-JAN-2010 the patient experienced dizziness, nausea, rash between her breast, tenderness and pain at injection site and headache. Therapy with GARDASIL was discontinued. The patient did not seek medical attention. At the time of this report the patient had not recovered. Attempts to obtain additional follow up information have been unsuccessful. Additional information is not expected.

VAERS ID:399220 (history)  Vaccinated:2009-11-19
Age:24.0  Onset:2009-11-19, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 257
Location:Maryland  Entered:2010-09-08, Days after submission: 35
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: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0912USA01362
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0819Y0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Hypoaesthesia, Pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Information has been received from a registered nurse concerning a 24 year old female patient with no pre-existing allergies, birth defects, medical conditions and no illness at the time of vaccination who on 19-NOV-2009 at 15:45 pm was vaccinated IM in the left deltoid with the first dose of GARDASIL (Lot#663558/0819Y). On 19-NOV-2009 at 15:45 pm the patient experienced injection caused stinging sensation down arm. Since injection patient had pain, followed by numbness, when she lifted arm up high. The patient had sought medical attention by doctor visit. The doctor of medicine referred patient to physical therapy on 01-DEC-2009. At the time of report the patient''s status was not recovered. Additional information has been requested.

VAERS ID:399248 (history)  Vaccinated:2009-10-22
Age:24.0  Onset:2009-10-22, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 286
Location:California  Entered:2010-09-08, Days after submission: 35
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: Unknown
Diagnostic Lab Data: Blood pressure, 110/60 and 124/88; Total heartbeat count, pulse was 102
CDC Split Type: WAES1001USA00709
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0819Y0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cyanosis, Hyperhidrosis, Immediate post-injection reaction, Pallor, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 24 year old female patient with no known allergies who on 22-OCT-2009 was vaccinated with a first dose of GARDASIL. Concomitant therapy included "birth control" that the patient has been taking for a long time. Immediately post-vaccination the patient became diaphoretic, pale, lips blue and became unresponsive for 3 to 4 seconds. Code blue was called and oxygen administered. Blood pressure readings were 110/60 and 124/80, and her pulse was 102. The patient recovered in the office and was able to drive herself home. During a follow-up conversation the patient indicated to the physician that she fully recovered. Follow up information has been received from a licensed practical nurse who confirmed that on 22-OCT-2009 the patient was vaccinated with a first dose of GARDASIL (Lot #663558/0819Y). The patient did not receive any concomitant vaccination at that time. Follow up information has been received from a licensed practical nurse who indicated that a Code Blue was called when the patient became diaphoretic, pale, lips blue and became unresponsive for 3 to 4 seconds. She explained that Code Blue is an urgent Care Response. The responders are Urgent Care Physicians and also certain members of the staff that are trained to respond in an emergency. The patient regained consciousness quickly and the patient stated that she felt better. Oxygen was administered as safety precaution only. The patient recovered. Additional information has been requested.

VAERS ID:399263 (history)  Vaccinated:0000-00-00
Age:24.0  Onset:0000-00-00
Gender:Female  Submitted:2010-08-04
Location:Unknown  Entered:2010-09-08, Days after submission: 35
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: Unknown
CDC Split Type: WAES0912USA01970
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a Certified Medical Assistant in a physician''s office concerning her 24 year old daughter who on unspecified dates were vaccinated intramuscularly with the first and second 0.5 mL dose of GARDASIL (LOT# not reported). After receiving her second and third dose of GARDASIL the patient developed syncope. The syncope was recovered on unspecified dates. No further information is available at the time of reporting. Additional information has been requested.

VAERS ID:399267 (history)  Vaccinated:2009-09-15
Age:24.0  Onset:2009-10-15, Days after vaccination: 30
Gender:Female  Submitted:2010-08-04, Days after onset: 293
Location:Unknown  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0921USA01972
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Amenorrhoea, Blood test, Urine analysis
SMQs:, Fertility disorders (broad)
Write-up: Information has been received from a consumer concerning his 24 year old wife with no medical history or drug allergies who on approximately 15-SEP-2009 (3 months ago) was vaccinated with the first 0.5ml injection of GARDASIL (lot# not reported). There was no concomitant medication. Subsequently the patient didn''t get her menstrual period from two months (approximately on 15-Oct-2009) after getting GARDASIL three months ago. Blood and urine test was performed but the results not provided. The patient sought medical attention via physician. Additional information has been requested.

VAERS ID:399297 (history)  Vaccinated:2009-11-10
Age:24.0  Onset:2009-11-12, Days after vaccination: 2
Gender:Female  Submitted:2010-08-04, Days after onset: 264
Location:Connecticut  Entered:2010-09-08, Days after submission: 35
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: temperature measurement, 101
CDC Split Type: WAES0911USA02868
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1350Y0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Chills, Nasopharyngitis, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a Registered Nurse concerning a 24 year old female who on 10-NOV-2009 was vaccinated IM with a first dose of GARDASIL (lot number: 663552/1350Y). The nurse told that the patient called at the office and stated that she experienced a high fever of 101 with chills and aches on 12-NOV-2009. The patient reported that the symptoms resolved within 24 hours of onset (on 13-NOV-2009). The patient sought medical attention at the physician''s office. Follow up information has been received from Registered Nurse who reported that 24 year old female patient who on 10-NOV-2009 was vaccinated with a first dose of GARDASIL (lot number: 663552/1350Y) in the left deltoid. On 13-NOV-2009 " (also reported by Registered Nurse as on 12-NOV-2009)", the patient complained of temperature of 101 with chills. As of 13-NOV-2009, she was feeling better. It was reported that she felt it may be due to GARDASIL but today. On 16-NOV-2009, a telephone follow up to the patient who reported that she was feeling better and the symptoms were developed into a cold. Additional information is no expected.

VAERS ID:399304 (history)  Vaccinated:2009-11-09
Age:24.0  Onset:2009-11-09, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 267
Location:Unknown  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0911USA04154
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Nausea, No reaction on previous exposure to drug
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Information has been received from a 24 year old female with allergy to penicillin and without a pertinent medical history who 20-APR-2009 was vaccinated with the first dose of GARDASIL (Lot # was not provided). On 20-JUN-2009, the patient was vaccinated with the second dose of GARDASIL. The patient did not experience any AE after first or second dose. On 09-NOV-2009, the patient was vaccinated with the third dose of GARDASIL, 0.5 ml (lot number was not provided). There was no concomitant medication. The reporter mentioned that on 09-NOV-2009 she experienced headache, dizziness, lost of appetite, nausea and she felt very tired after getting the third dose of GARDASIL. No laboratory or test diagnostics were performed. The patient sought a physician for medical attention. At the time of reporting the patient had not recovered. No further information is available.

VAERS ID:399324 (history)  Vaccinated:2009-11-11
Age:24.0  Onset:2009-11-13, Days after vaccination: 2
Gender:Female  Submitted:2010-08-04, Days after onset: 263
Location:New York  Entered:2010-09-08, Days after submission: 35
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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0911USA03109
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0981Y0IMRA
Administered by: Private     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a registered nurse concerning a 24 year old patient who on 11-NOV-2009 was vaccinated with the first dose of GARDASIL (LOT#0981Y). The registered nurse reported that on 13-NOV-2009, the patient had hives after the vaccination with GARDASIL. The patient sought medical attention by contacting with the office. It was unspecified if lab tests were performed. On an unspecified date, the patient had recovered. Follow up information has been received from the registered nurse regarding the 24 year old female patient with no known drug allergies who on 11-NOV-2009 was intramuscularly vaccinated in the right deltoid with the first dose of GARDASIL (LOT#0981Y) at 10:30 a.m. The registered nurse reported that two day after the vaccination with GARDAIL, on 13-NOV-2009, the patient developed hives. Oral steroid treatment was given to the patient and she was send to her primary care physician. At the time of the report, the patient''s outcome was reported as unknown (previously reported as recovered). Additional information is not expected.

VAERS ID:399340 (history)  Vaccinated:2009-08-18
Age:24.0  Onset:2009-08-18, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 351
Location:Pennsylvania  Entered:2010-09-08, Days after submission: 35
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: None
Diagnostic Lab Data: None
CDC Split Type: WAES0910USA03898
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Arthralgia, Musculoskeletal stiffness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a 0.5 ml first dose of GARDASIL (Lot number unspecified). The physician stated that the patient called the office and mentioned that she experienced muscle and joint tenderness sand soreness mostly in her hands and arms after having received the first dose of GARDASIL. The consumer stated that the symptoms did go away eventually; however, the consumer decided not to receive any more doses of GARDASIL. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number (if applicable), lot number (if applicable), date of event, recovery status, hospital name (if applicable), healthcare provider name and contact information. Follow up information has been received from a registered nurse concerning the 24 year old female housekeeper with no pre-existing allergies or other relevant medical history who on 18-AUG-2009, at 15:15, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot # 659182/1757U) into her left arm. On 18-AUG-2009 the patient developed muscle and joint tenderness in hands and arms. The patient stated that she could not move her fingers for a couple of days and her legs were really stiff. There was no illness at time of vaccination. There were no laboratory diagnostics studies performed. On an unspecified date, the patient recovered. Additional information is not expected.

VAERS ID:399379 (history)  Vaccinated:2009-05-01
Age:24.0  Onset:2009-07-01, Days after vaccination: 61
Gender:Female  Submitted:2010-08-04, Days after onset: 399
Location:New York  Entered:2010-09-08, Days after submission: 35
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: None
Diagnostic Lab Data: diagnostic laboratory, Blood tests (results normal); beta-human chorionic, negative
CDC Split Type: WAES0911USA00195
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Amenorrhoea, Blood human chorionic gonadotropin negative, Blood test normal
SMQs:, Fertility disorders (broad)
Write-up: Information has been received from a 24 year old female pharmacist with no known drug reactions/allergies or pertinent medical history who in May 2009, was intramuscularly vaccinated with her third dose of GARDASIL 0.5 mL. Concomitant therapy included birth control pills (unspecified). In July 2009, two months after she completed the GARDASIL series, she experienced amenorrhea. The pharmacist stated "at times it is spotty for a day and then there''s nothing. Other times I have gone a month or two with nothing". The pharmacist stated that she was not pregnant, confirmed with a home pregnancy test. Medical attention was sought by an office visit. Blood tests were performed and the results were normal. At the time of the report, the pharmacist had not recovered. The pharmacist noted that all three doses of GARDASIL were given as per the dosing schedule. Additional information has been requested.

VAERS ID:399390 (history)  Vaccinated:0000-00-00
Age:24.0  Onset:0000-00-00
Gender:Female  Submitted:2010-08-04
Location:Unknown  Entered:2010-09-08, Days after submission: 35
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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0910USA01622
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cervical dysplasia
SMQs:, Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad)
Write-up: Information has been received from a consumer concerning her currently 24 year old daughter who in approximately 2007 was vaccinated with series of GARDASIL (lot#, route and site of administration not reported). It was reported that the patient had been diagnosed with cervical dysplasia. The patient had not had multiple sex partners and had had yearly Pap smears. The consumer was wondering if cervical dysplasia was related to GARDASIL. At the time of this report, the patient''s outcome was unknown. No further information is available.

VAERS ID:399398 (history)  Vaccinated:2009-09-11
Age:24.0  Onset:0000-00-00
Gender:Female  Submitted:2010-08-04
Location:Unknown  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 8/24/2009); Asthma
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 10/15/09, ok, FHR +
CDC Split Type: WAES0910USA01943
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0249Y2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Hypersensitivity, Ultrasound scan abnormal
SMQs:, Angioedema (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a 23 year old female patient, for GARDASIL, a Pregnancy Registry product, who on 11-SEP-2009 was vaccinated intramuscularly with the third dose of 0.65 ml GARDASIL. Concomitant therapy included SYMBICORT and prenatal vitamins. The patient had been pregnant for 7 weeks when she was given her third dose of GARDASIL. Blood work was performed (result not reported). The patient''s date of last menstrual period was approximately on 24-JUL-2009 and estimated delivery date was on 30-APR-2010. No adverse event reported. Medical attention had been sought. Follow up information was received from a registered nurse, for GARDASIL, a Pregnancy Registry product, which reported that on 11-SEP-2009, the female patient with asthma and with a history of 1 previous pregnancy and 1 previous full term delivery was vaccinated with the third dose of GARDASIL (lot # 663453/0249Y) while she was pregnant. Concomitant therapy included SYMBICORT, prenatal vitamins and PULMICORT. Her LMP was on approximately 24-AUG-2009, the estimated conception date was on approximately 07-SEP-2009, and EDD was on approximately 03-JUN-2010. On an unspecified date, the patient developed allergies. She was given EQUATE ALLERGY MEDICATION daily to treat allergies. On 15-OCT-2009, ultrasound was performed for dating which was ok, the patient was 6 weeks and 6 days of pregnancy and there was fetal heart rate (FHR). Additional information has been requested.

VAERS ID:399413 (history)  Vaccinated:2009-05-05
Age:24.0  Onset:2009-05-05, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 456
Location:Unknown  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 6/15/1009)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 10/12/09, normal; ultrasound, 11/18?/09, Baby''s weight: 1 pound; ultrasound, 09/01/09, normal; serum beta-human, 09/01/09, positive
CDC Split Type: WAES0911USA02261
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1312X1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood human chorionic gonadotropin positive, Dermatitis, Drug exposure before pregnancy, Hepatic enzyme increased, Ultrasound scan normal
SMQs:, Liver related investigations, signs and symptoms (narrow), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient who on 03-MAR-2009 and 05-MAY-2009 was vaccinated IM with the first and second 0.5ml doses of GARDASIL (lot# not reported). Then the patient discovered that she was pregnant. No adverse effects noted. The patient sought unspecified medical attention. On 01-SEP-2009. a blood test was performed and it was positive for pregnancy. On 12-OCT-2009, an ultrasound was performed, and it showed normal prenatal ultrasound. The patient''s last menstrual period was reported as 15-JUN-2009. The estimated delivery date would be 22-MAR-2010. This is one of several reports received from the same source. Follow-up information was received from a Nurse Practitioner who stated that the patient received GARDASIL. (Both doses were Lot number: 661846/1312X). It was reported that the patient was not sure of diagnosis but was having liver problems (elevated liver enzymes and dermatitis. The reporter stated that the same thing happened with a previous pregnant. It was performed an ultrasound on 01-SEP-2009 with a normal result. According of last week''s ultrasound (on approximately 18-NOV-2009) the baby weighs 1 pound. It was also mentioned that the patient would be seen on 01-DEC-2009 by a specialist. The patient sought medical attention in office visit. Additional information has been requested.

VAERS ID:399695 (history)  Vaccinated:2010-04-14
Age:24.0  Onset:2010-04-17, Days after vaccination: 3
Gender:Female  Submitted:2010-08-04, Days after onset: 109
Location:Pennsylvania  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity
Preexisting Conditions: Neuralgia
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1004USA03157
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning a 24 year old female patient with CARBATROL allergy and a history of neuralgia who was vaccinated IM with the first 0.5 mL dose of GARDASIL last Wednesday (on 14-APR-2010). On approximately 17-APR-2010, 3 or 4 days after the injection, the patient experienced a rash under her knees and on her calves. It was reported that the patient developed rash/hives on both legs below the knees. Treatment recommended was BENADRYL. Client was not pregnant. The patient sought unspecified medical attention. Client did not follow up with physician so patient''s present status was unknown. Physician stated that he did not think GARDASIL caused this reaction. Additional information has been requested.

VAERS ID:399700 (history)  Vaccinated:2009-01-09
Age:24.0  Onset:2009-01-09, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 571
Location:Unknown  Entered:2010-09-08, Days after submission: 35
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: Unknown
CDC Split Type: WAES1004USA03185
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Palpitations
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: Information has been received from a nurse concerning a 24 year old female who on 09-JAN-2009 was initial vaccinated with the dose of GARDASIL (LOT# not reported). Concomitant therapy included hormonal contraceptives (unspecified). On 09-JAN-2009, the patient experienced dizziness and palpitations after vaccination. On an unspecified date, the symptoms recovered spontaneously without treatment. Follow-up information has been received from the nurse who reported that the 24 year old female on 09-JAN-2009 was vaccinated with the first 0.5 mL dose of GARDASIL (LOT# not reported). Other concomitant therapy included TRI-SPRINTEC. On 09-JAN-2009, the patient experienced heart compression and dizziness after vaccination. Unspecified medical attention was sought. On an unspecified date the patient recovered from heart compression and dizziness. The patient went to office on 13-MAR-2009 to receive the second dose of GARDASIL but nurse didn''t give her the second dose due to the AE from the first dose. Additional information has been requested.

VAERS ID:399719 (history)  Vaccinated:2010-03-26
Age:24.0  Onset:2010-03-26, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 131
Location:Minnesota  Entered:2010-09-08, Days after submission: 35
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: None
Diagnostic Lab Data: None
CDC Split Type: WAES1004USA00532
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1099Y0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Feeling hot, Immediate post-injection reaction, Malaise, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a registered nurse, concerning a 24 year old female patient, with no pertinent medical history and not known drug reactions or allergies, who on 26-MAR-2010, was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (lot number 662299/1099Y). There was no concomitant medication. The nurse reported that within second of receiving the vaccine, the patient had a warm sensation and then fainted. The patient was lowered to the floor and was not injured. The patient was unresponsive for 30-60 seconds. The patient laid down for 15 minutes and was then able to leave the office. The patient sought unspecified medical attention. No labs or diagnostics studies were performed. At the time of the report, the outcome of warm sensation was not reported. Follow-up information has been received from a registered nurse, concerning the female patient who on 26-MAR-2010, at 9:00AM, received in the left deltoid the first dose of GARDASIL. The registered nurse stated that on 26-MAR-2010, at 9:00AM, within minutes of receiving GARDASIL, the patient complained of not feeling well, asked for water and then fainted. The patient came to in approximately 1 minute. The patient was taken to exam room to lie down for 15 minutes. At the time of reporting, the patient had recovered. No further information is available.

VAERS ID:399782 (history)  Vaccinated:2009-11-10
Age:24.0  Onset:2010-01-17, Days after vaccination: 68
Gender:Female  Submitted:2010-08-04, Days after onset: 198
Location:Virginia  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 1/17/2010)
Preexisting Conditions:
Diagnostic Lab Data: Urine beta-human, 11/10/09, negative; urine beta-human, 02/24/10, positive
CDC Split Type: WAES1002USA03827
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0672Y0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Haemorrhage, Urine human chorionic gonadotropin positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a nurse, for the Pregnancy Registry for GARDASIL, concerning a 24 year old female patient with no medical history, drug reactions or allergies reported, who on 10-NOV-2009 was vaccinated with a 0.5 mL first dose of GARDASIL intramuscular route (lot # 663454/0672Y) after a negative urine pregnancy test. Concomitant therapy included birth control pills. The nurse stated that on 24-FEB-2010, the patient returned to the office for her second dose of GARDASIL but a urine pregnancy test was positive and the second dose was not given. The nurse also reported that on 24-FEB-2010, some bleeding was noted. A beta quant blood test was performed with unspecified results. The patient''s last menstrual period was approximately on 17-JAN-2010 and the delivery date is 24-OCT-2010. The patient sought unspecified medical attention. At the time of the report the patient''s outcome was unknown. Follow up information has been received from the physician who reported that the patient was not under her care and she had no information. No further information is available.

VAERS ID:399878 (history)  Vaccinated:2010-02-01
Age:24.0  Onset:2010-02-21, Days after vaccination: 20
Gender:Female  Submitted:2010-08-04, Days after onset: 163
Location:Texas  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES1002USA03586
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hyperaesthesia
SMQs:
Write-up: Information has been received from a physician assistant concerning a 24 year old female with no medical history or concurrent condition who on 21-FEB-2010 developed hyperesthesia after receiving a dose of GARDASIL. Concomitant therapy included VALTREX. Approximately two or three days after receiving the vaccine, she complained of sensitivity to touches. The reporter wasn''t sure if this vaccine dose was her second or third dose. The patient sought unspecified medical attention. At the time of report the patient had not recovered. Follow up information was received from a physician assistant on 24-FEB-2010 via telephone. It was reported the patient had received the third dose of GARDASIL at another physician''s office. The patient complained of sensitivity to touch over her whole body. The patient was placed on therapy with NEURONTIN, 300 mg, twice a day for pain. The patient had a follow-up appointment with the P.A. in a couple of days. The information if the patient''s OB-GYN physician was also provided. Additional information has been requested.

VAERS ID:399879 (history)  Vaccinated:2009-11-01
Age:24.0  Onset:2010-01-14, Days after vaccination: 74
Gender:Female  Submitted:2010-08-04, Days after onset: 201
Location:Unknown  Entered:2010-09-08, Days after submission: 35
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: None
Diagnostic Lab Data: None
CDC Split Type: WAES1002USA02181
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning a 24 year old female with no medical history or allergies who in November 2009, was vaccinated IM, 0.5 ml, with her second dose of GARDASIL. The patient received both her first and second dosed of GARDASIL in the same arm. Concomitant therapy included unspecified birth control pills. On 14-JAN-2010 the patient experienced persistent pain at the injection site of the right deltoid muscle since administration of her second dose of GARDASIL. The patient was prescribed non-steroidal anti-inflammatory medication with only slight improvement in symptoms. There were no visible signs of inflammation, including no swelling, redness, warmth, etc. There was no interference with range of motion or strength, and no pain elsewhere in the arm. There were no laboratory studies performed. The patient had an office visit to seek medical attention. Additional information has been requested.

VAERS ID:399908 (history)  Vaccinated:0000-00-00
Age:24.0  Onset:0000-00-00
Gender:Female  Submitted:2010-08-04
Location:Unknown  Entered:2010-09-08, Days after submission: 35
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: Unknown
CDC Split Type: WAES1002USA00851
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a female medical assistant who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not reported). Subsequently on an unspecified date the patient''s arm became swollen, red and hot for 3 days. It was unknown if medial attention was sought. At the time of the report, the patient had recovered. No further information is available.

VAERS ID:399966 (history)  Vaccinated:2009-08-17
Age:24.0  Onset:2009-08-18, Days after vaccination: 1
Gender:Female  Submitted:2010-08-04, Days after onset: 351
Location:Pennsylvania  Entered:2010-09-08, Days after submission: 35
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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1002USA03500
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0947X1UNUN
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: Information has been received from an obstetric technologist concerning a 24 year old female who on 23-JUN-2009 and 17-AUG-2009 was vaccinated with the first and second dose of GARDASIL (0.5ml, lot # 0947X) in her left deltoid respectively. On 18-AUG-2009 the patient experienced hives on chest, upper back and arms. On 22-FEB-2010, the patient did not present with rash, however still experienced transient rashes. The patient had sensitivity to "Tide" detergent. The patient did not intend to receive the third dose of GARDASIL. Additional information has been requested.

VAERS ID:399989 (history)  Vaccinated:2010-01-26
Age:24.0  Onset:2010-01-27, Days after vaccination: 1
Gender:Female  Submitted:2010-08-04, Days after onset: 188
Location:Unknown  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic reaction to antibiotics; Sulfonamide allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES1002USA00467
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0100Y0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Pruritus generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a nurse practitioner concerning a 24 year old female with allergic reaction to CECLOR, KEFLEX and BACTRIM allergy and no pertinent medical history who on 26-JAN-2010 was vaccinated intramuscularly with the first dose of GARDASIL (lot # 662300/0100Y). Concomitant therapy included TOPAMAX and NUVARING. On 27-JAN-2010 the patient experienced itchiness all over her body. Only when the patient scratched the area, it turned to "hives". There were no lad diagnostic studies performed. At the time of the report the patient was recovering. Additional information has been requested.

VAERS ID:399997 (history)  Vaccinated:2007-08-08
Age:24.0  Onset:2009-12-08, Days after vaccination: 853
Gender:Female  Submitted:2010-08-04, Days after onset: 238
Location:Georgia  Entered:2010-09-08, Days after submission: 35
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: Unknown
Diagnostic Lab Data: diagnostic laboratory, HPV positive; Pap test, 12/08/09, abnormal
CDC Split Type: WAES1001USA03199
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0469U2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
SMQs:
Write-up: Information has been received from a nurse practitioner concerning a 25 year old female who on 09-FEB-2007 was vaccinated with the first dose of GARDASIL (lot # 653736/0014U), the second dose (no lot#) on 10-APR-2007 and the third dose (lot # 0469U) on 08-AUG-2007. The patient had PAP test abnormal on 08-DEC-2009, tested positive for HPV after vaccination. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. This is one several reports received from the same source. Additional information is not expected.

VAERS ID:399999 (history)  Vaccinated:2010-01-11
Age:24.0  Onset:2010-01-11, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 204
Location:Alabama  Entered:2010-09-08, Days after submission: 35
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: None
Diagnostic Lab Data: None
CDC Split Type: WAES1001USA03257
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1013Y0IMUN
Administered by: Private     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated intramuscularly with a dose of GARDASIL (lot # not reported). The patient fainted right after receiving the vaccination. No injuries were noted. Unspecified medical attention was sought. At the time of this report, the patient had recovered. Follow up information has been received from the nurse practitioner concerning the 24 year old female patient with no other relevant medical history or allergies who on 11-JAN-2010, in the morning, was vaccinated intramuscularly with the first dose of GARDASIL (lot# not reported). On the same day, in the morning, the patient fainted, but she did not fall. She recovered within a few minutes with no damage. There was no illness at time of vaccination. There were no laboratory diagnostics studies performed. Follow up information has been received from the nurse practitioner concerning the female patient who on 11-JAN-2010, in the morning, was vaccinated intramuscularly with the first dose of GARDASIL (lot# 662304/1013Y) into her arm. On the same day, in the morning, the patient fainted, but she did not fall. She recovered quickly within a few minutes with no damage. It was stated that the patient fainted easily. Additional information is not expected.

VAERS ID:400050 (history)  Vaccinated:2009-06-01
Age:24.0  Onset:2009-08-05, Days after vaccination: 65
Gender:Female  Submitted:2010-08-04, Days after onset: 364
Location:Michigan  Entered:2010-09-08, Days after submission: 35
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: Hair loss
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0908USA04526
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alopecia
SMQs:
Write-up: Information has been received from a physician concerning a 25 year old female with a history of hair loss who in June 2009, was vaccinated with the third dose of GARDASIL. There was no concomitant medication. On approximately 05-AUG-2009, 3 weeks ago the patient experienced "mild" hair loss. The patient had a past history of temporary hair loss after she had received a series of hepatitis B virus vaccine (unspecified) when she was in high school. At the reporting time the patient had not recovered. Additional information has been requested.

VAERS ID:400172 (history)  Vaccinated:2009-08-18
Age:24.0  Onset:2009-08-18, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 351
Location:Unknown  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0908USA03259
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0672Y0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse practitioner concerning a 24 year old female patient with no pertinent medical history and no drug reactions/allergies who on 18-AUG-2009 was vaccinated with a first 0.5ml dose of GARDASIL (lot#663454/0672Y) intramuscularly in her right arm. Concomitant therapy included DEPO-PROVERA. On approximately 18-AUG-2009, the patient became dizzy and lightheaded, then developed "hives" on her right arm at the injection site after receiving her first dose of GARDASIL. The patient had sought medical attention by phone call. No laboratory diagnostics study was performed. At the time of the report, the patient''s outcome was unknown. Additional information has been requested.

VAERS ID:400186 (history)  Vaccinated:2009-08-22
Age:24.0  Onset:2009-08-22, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 347
Location:Unknown  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sulfonamide allergy; Hypersensitivity test positive; Reaction to azo-dyes; Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0908USA04750
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0652X1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Allergy test positive, Chest discomfort, Dyspnoea, Urticaria
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: Information has been received from a physician''s assistant concerning a 24 year old female with allergic reaction to sulfa, IMITREX, TB test solution, flu shots, contrast dye, codeine, morphine, MYLANTA and MAALOX who on 01-APR-2008 was vaccinated with the first dose of GARDASIL. On 22-AUG-2009 the patient received the second dose of GARDASIL (lot# 661766/0652X). 10 minutes after the vaccination, the patient experienced hives, shortness of breath and tightness in her chest. She was taken to the ER and received BENADRYL and epinephrine. She recovered within 45 minutes and was released. Additional information has been requested.

VAERS ID:400233 (history)  Vaccinated:2009-08-03
Age:24.0  Onset:2009-08-04, Days after vaccination: 1
Gender:Female  Submitted:2010-08-04, Days after onset: 365
Location:Maryland  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0908USA00586
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0312Y1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain upper, Injection site pain, Malaise, Nausea, No reaction on previous exposure to drug
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a nurse concerning a 24 year old female with an allergy to "laughing gas" who on 03-JUN-2009 was vaccinated IM with the first dose of GARDASIL. On 03-AUG-2009 the patient was vaccinated IM with the second dose of GARDASIL (Lot#662404/0312Y). Concomitant therapy included NUVARING. On 04-AUG-2009 this morning the patient called the office stated that she woke up with stomach ache, nausea, soreness at the injection site and a "generalized feeling of not feeling well". There were no laboratory or diagnostic tests performed. At the time of report the patient''s status was recovering. Follow-up information has been received from a registered nurse concerning a 24 year old female patient with allergic to laughing gas and with no illness at time of vaccination who was vaccinated with the second dose of GARDASIL (Lot#662404/0312Y) at left deltoid at 9:00 on 03-AUG-2009. The patient had no adverse event after vaccination with the first dose of GARDASIL. On 04-AUG-2009 at 8:00am the patient had nausea and felt like she wanted to vomit. She described that she was feeling of "not feeling well all". The patient had not sought medical attention. There were no relevant diagnostic tests. On 05-AUG-2009 the patient had recovered. Additional information is not expected.

VAERS ID:400295 (history)  Vaccinated:2009-04-24
Age:24.0  Onset:2009-04-26, Days after vaccination: 2
Gender:Female  Submitted:2010-08-04, Days after onset: 465
Location:Unknown  Entered:2010-09-08, Days after submission: 35
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: None
Diagnostic Lab Data: None
CDC Split Type: WAES0908USA01743
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1129X1IMAR
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Fatigue, Lethargy, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a medical assistant concerning a 24 year old female with no pertinent medical history and no drug allergies who on 24-FEB-2009 and on 24-APR-2009 was vaccinated with the first and second doses of GARDASIL (lot#661952/1129X). There was no concomitant medication. "Two days after the second dose", on 26-APR-2009 the patient felt lethargic and dizzy. She did not seek medical attention. No lab diagnostics studies were performed. One week after the beginning of the symptoms, the patient recovered. Follow-up information has been received from a certified medical assistant who reported that at 1:30 PM on 24-APR-2009 the patient was vaccinated with the second dose of GARDASIL (lot#661952/1129X) IM in her deltoid. Two days after the vaccination, the patient developed vomiting, fatigue and dizziness. Medical attention was not sought. The patient recovered approximately one week later. No further information is available.

VAERS ID:400449 (history)  Vaccinated:2009-08-11
Age:24.0  Onset:2009-08-11, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 358
Location:Michigan  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 7/12/2009); Epilepsy
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 09/29/09, WNL; diagnostic laboratory, 09/10/09, CF screen: negative; urine beta-human, positive; serum alpha-fetoprotein, 09/29/09, Pt.1 negative; serum alpha-fetoprotein, 10/27/09, Pt.2 negative
CDC Split Type: WAES0909USA01380
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0100Y0IMUN
Administered by: Private     Purchased by: Public
Symptoms: Alpha 1 foetoprotein normal, Cytogenetic analysis normal, Drug exposure during pregnancy, Injection site erythema, Injection site pruritus, Injection site swelling, Laboratory test normal, Otitis media, Pharyngitis, Ultrasound scan normal, Urine human chorionic gonadotropin positive
SMQs:, Agranulocytosis (broad), Tumour markers (narrow), Oropharyngeal infections (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female with no pertinent medical history and no known drug allergies who on 11-AUG-2009 was vaccinated with her first dose of GARDASIL (lot# 662300/0100Y). There was no concomitant medication. The patient received her first dose of GARDASIL while pregnant. Pregnancy was normal to date. At the time of the report, the patient''s gestational age was 8 weeks and 3 days. On an unspecified date, a urine pregnancy test was performed. The patient sought medical attention through an office visit. The patient''s last menstrual period was 12-JUL-2009. Expected date of delivery was 18-APR-2010. Follow up information was received from a Registered Nurse (R.N.) concerning a 24 year old female patient with one previous pregnancy (delivered full term) and no known birth defects or infant complications in the previous pregnancy who on 11-AUG-2009 was vaccinated with the first dose of GARDASIL (lot# 662300/0100Y). Concomitant therapy used during the pregnancy included prenatal vitamins (unspecified) taken daily for the pregnancy. It was reported that the laboratory diagnostic tests have not been performed yet. The last menstrual period was on 12-JUL-2009 and the estimated delivery date was on 19-APR-2010. Follow-up information was received from a Registered Nurse (R.N.) concerning the 24 year old female patient. The nurse reported that the patient delivered a healthy baby. Follow-up information was received from a Registered Nurse (R.N.) concerning the 24 year old female patient with epilepsy and one previous pregnancy and 2 full term deliveries who on 11-AUG-2009 at 09:00 hrs was vaccinated IM with a first dose of GARDASIL (lot# 662300/0100Y) into the left upper outer quadrant. On 17-AUG-2009 (reported as 17-AUG-2010), at 13:31 hrs, the patient experienced redness, swelling and itching at the injection site, from which she recovered on an unspecified date. On 10-SEP-2009, the patient had a CF screen for genetic screening which resulted negative. On 10-SEP-2009, the patient was placed on prenatal vitamins on a daily basis for pregnancy. On 29-SEP-2009, the patient had ultrasound done for pregnancy dating (result: WNL) and a maternal serum alpha-fetoprotein test done for genetic screening (Pt.1, negative). On 27-OCT-2009, another maternal serum alpha-fetoprotein test was done (Pt.2, negative). During pregnancy, the patient also had otitis media and pharyngitis (onset date and outcome not reported). On 10-MAR-2010, the patient was placed on daily Z-PAK for the treatment of pharyngitis and otitis media. On 24-APR-2010, the patient gave birth to a normal male infant with no congenital anomalies (weight 9 lb 10 oz, length 21 /4", apgar score 9/9, head circumference 14''/4). Additional information is not expected.

VAERS ID:400485 (history)  Vaccinated:0000-00-00
Age:24.0  Onset:0000-00-00
Gender:Female  Submitted:2010-08-04
Location:Unknown  Entered:2010-09-08, Days after submission: 35
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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0909USA01705
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Pruritus, Skin irritation
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a nurse practitioner concerning a 24 year old female patient who in 2007 was vaccinated with a second dose of GARDASIL. The nurse practitioner reported that after the patient received the second dose of GARDASIL, she experienced irritation and itching. The nurse practitioner also reported that the patient was recently detected with GARDASIL despite finishing the dosing schedule of GARDASIL in 2007. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Additional information has been requested.

VAERS ID:400582 (history)  Vaccinated:0000-00-00
Age:24.0  Onset:2009-09-15
Gender:Female  Submitted:2010-08-04, Days after onset: 323
Location:Arizona  Entered:2010-09-08, Days after submission: 35
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: None
Diagnostic Lab Data: Pap test, HPV DNA detected about 10HPV types which included 16 and 18
CDC Split Type: WAES0909USA04245
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
SMQs:
Write-up: Information has been received from a 24 year old female doctor of pharmacy with no known drug reactions/allergies or pertinent medical history who "a few years ago" was vaccinated with the 3 doses of GARDASIL. Concomitant therapy included YASMIN. It was reported that on 15-SEP-2009 the patient got PAP results that said there was detected about 10 HPV types which include 16 and 18 HPV DNA. The patient sought medical attention by an office visit. It was noted that the doctor of pharmacy would be going to another physician for more tests. Additional information has been requested.

VAERS ID:400642 (history)  Vaccinated:2009-03-01
Age:24.0  Onset:2009-03-01, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 520
Location:Unknown  Entered:2010-09-08, Days after submission: 35
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: None
Diagnostic Lab Data: None
CDC Split Type: WAES0910USA00699
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chills, Injection site pain, Oral herpes, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a healthcare student concerning herself with no pertinent medical history and no drug reactions/allergies who in March 2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL. There was no concomitant medication. On the same day the patient developed a "high fever", chills, a cold sore and arm pain at the injection site. About five days after receiving the first dose of GARDASIL the patient recovered. The patient had sought medical attention, phone call. There were no lab diagnostic tests performed. The patient received her second dose of GARDASIL in June 2009 with no adverse experience. Additional information has been requested.

VAERS ID:400652 (history)  Vaccinated:2009-09-25
Age:24.0  Onset:2009-10-05, Days after vaccination: 10
Gender:Female  Submitted:2010-08-04, Days after onset: 303
Location:Unknown  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0910USA00807
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0249Y1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site mass, Myalgia, Oedema peripheral
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a Nurse Practitioner concerning a 23 year old female who "approximately 11 day ago" on approximately 26-SEP-2009 was vaccinated with the second dose of GARDASIL (Lot number was not specified). The reporter mentioned that the patient experienced a lump at the injection site and muscle pain in her arm after vaccination. The patient did not seek medical attention. At the time of reporting the patient''s outcome was unknown. Follow-up information was received from a certified nurse midwife who stated that a 24 (previously reported as 23) year old female patient with allergy to morphine who on 25-SEP-2009 (previously reported as approximately 26-SEP-2009) received her second dose of GARDASIL (lot # 663453/0249Y). The reporter stated that the patient had swelling in her arm 10 days later on 05-OCT-2009. It was mentioned that patient told to follow up with her family Doctor. The reporter stated that the patient rested her arm. It was also reported that this was patient''s second injection in the 3 injection series. The patient recovered from the swollen arm 15 days later on 19-OCT-2009. No further information is available.

VAERS ID:400657 (history)  Vaccinated:2007-07-01
Age:24.0  Onset:2007-09-01, Days after vaccination: 62
Gender:Female  Submitted:2010-08-04, Days after onset: 1068
Location:Virginia  Entered:2010-09-08, Days after submission: 35
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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0909USA04000
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alopecia, Blood test
SMQs:
Write-up: Information has been received from a 24 year old female patient who was vaccinated with a complete series of GARDASIL (lot # not reported). The first dose was received in April 2007, the second dose in July 2007 and the third dose in October 2007. Concomitant therapy included birth control pills (unspecified). In approximately September ("Fall of 2007"), the patient started to notice that she had been losing hair more than normal and it had gotten worse recently. At the time of the report the patient''s adverse experience had not improved and the patient had not recovered. Blood work was conducted by an endocrinologist. Additional information has been requested.

VAERS ID:398231 (history)  Vaccinated:2010-08-30
Age:24.0  Onset:2010-09-09, Days after vaccination: 10
Gender:Female  Submitted:2010-09-14, Days after onset: 5
Location:Michigan  Entered:2010-09-14
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: IBD - related arthritis Crohns Disease irregular bleeding
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0738Z0SCLA
Administered by: Public     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: red and swelling around injection site

VAERS ID:398415 (history)  Vaccinated:2010-09-13
Age:24.0  Onset:2010-09-13, Days after vaccination: 0
Gender:Female  Submitted:2010-09-15, Days after onset: 2
Location:Tennessee  Entered:2010-09-15
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
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Public     Purchased by: Other
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Lower grade fever, chills, muscle aches, headache, fatigue. All symptoms were from around 3:00 pm 09/13/2010 til 12:00 pm 09/14/10. Headache (varied intensity) lasted until late afternoon of 09/15/10.

VAERS ID:398526 (history)  Vaccinated:2010-09-13
Age:24.0  Onset:2010-09-14, Days after vaccination: 1
Gender:Female  Submitted:2010-09-16, Days after onset: 2
Location:Kansas  Entered:2010-09-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Redness & swelling
Preexisting Conditions: History of chicken pox called pt after injection & had ch. pox as child.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.501013P0IN 
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0177Z0UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B051BB0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: 09/14/2010 Mild other patient was supposed to receive MMR, but was given PROQUAD instead.

VAERS ID:398780 (history)  Vaccinated:2010-08-12
Age:24.0  Onset:2010-08-12, Days after vaccination: 0
Gender:Female  Submitted:2010-09-17, Days after onset: 36
Location:D.C.  Entered:2010-09-20, 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: TRI-SPRINTEC
Current Illness: Drug hypersensitivity
Preexisting Conditions: Rhinoplasty
Diagnostic Lab Data: head computed axial, 08/12/10, Left pre-orbital hematoma, no intracranial hemorrhage; blood pressure, 08/12/10, 80/50; electrocardiogram, 08/12/10, sinus bradycardia; blood pressure, 08/12/10, 97/61; total heartbeat count, 08/12/10, 50; total heartbeat count, 08/12/10, 63; respiratory rate, 08/12/10, 16; arterial blood O2, 08/12/10, 100%
CDC Split Type: WAES1008USA02813
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0664Z2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Computerised tomogram abnormal, Computerised tomogram head, Dizziness, Electrocardiogram abnormal, Excoriation, Eye injury, Eye swelling, Fall, Feeling abnormal, Haemorrhage, Headache, Loss of consciousness, Movement disorder, Nausea, Pallor, Periorbital haematoma, Sinus bradycardia, Skin laceration, Syncope, Tenderness
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), Disorders of sinus node function (narrow), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Corneal disorders (broad), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), 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: Information has been received from a registered nurse concerning a 24 year old female patient with codeine allergy and no pertinent medical history who in 2008, was vaccinated IM with the first dose of GARDASIL (Lot#:not reported). On 12-AUG-2010, the patient was vaccinated IM with the third dose of GARDASIL (Lot number 666163/0664Z). Concomitant therapy included hormonal contraceptives (unspecified). The registered nurse stated that shortly afterward the patient had received the 3rd dose, as she was leaving the office, the patient fainted and fell. She hit a chair. She got a cut on her forehead, a bump over her eye, and a scrape on the arm. The patient was sent to the emergency room where tests were performed (results not provided). On 12-AUG-2010, the patient had recovered. Follow up information has been received from a registered nurse via medical records concerning a 24 year old female event planner with codeine allergy and a history of rhinoplasty who in 2008 was vaccinated with the first dose of GARDASIL. On 12-AUG-2010 at 10:00 am, the patient received the third dose of GARDASIL (Lot number 666163/0664Z) intramuscularly in the left arm. Concomitant therapy included TRI-SPRINTEC. Approximately 5 minutes after vaccination with GARDASIL the patient fainted while waiting to check out, she had loss of consciousness. She hit her shoulder and head on the chair arm. She was bleeding, developed a very swollen eye, had an abrasion on the shoulder. It was reported that she almost appeared like if she was seizuring. Her BP was 80/50 and her pulse was 50''s. The patient was dazed, dizzy and pale. She was transported to the ER at 10:14 am, with tenderness, pain in the head (grade 5-7 per a word scale), left eye bruising, nausea and syncope. In the medical examination the patient''s vitals were a heart rate of 64, respiratory rate 16 and a blood pressure of 97/61. The patient''s EKG showed sinus rhythm and her head CT showed left periorbital hematoma, no old fractures of the poster wall was left maxillary sinus; clinically correlate to patient''s history. No other fractures noted. There was no acute intracranial hemorrhage. The patient was treated with ibuprofen for her headache and nausea. She was discharged on 12-AUG-2010 at 13:20 pm completely recovered. Syncopal episode, fall, she hit a chair and cut on her forehead, shoulder abrasion, loss of consciousness, left pero-orbital hematoma, appeared as she was seizuring, dizzy, daze, pale, and headache (verbal grade 6-7) were considered to be an other important medical event by the reporter. No further information is available.

VAERS ID:398930 (history)  Vaccinated:2010-09-01
Age:24.0  Onset:2010-09-08, Days after vaccination: 7
Gender:Male  Submitted:2010-09-20, Days after onset: 12
Location:Kansas  Entered:2010-09-20
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: Alopecia; Fatigue
Diagnostic Lab Data: Exam: peppering of secondary sites inferior to primary
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)MICHIGAN DEPT PUB HLTHFAV2421IMUN
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0IDUN
Administered by: Military     Purchased by: Military
Symptoms: Secondary transmission, Sunburn
SMQs:, Accidents and injuries (narrow)
Write-up: Multiple secondary sites -$g Quarters restriction sunburn noted, noncompliance with care instructions suspected. Sunburn confirms no shirt. No systemic symptoms.

VAERS ID:398933 (history)  Vaccinated:2010-09-16
Age:24.0  Onset:2010-09-16, Days after vaccination: 0
Gender:Female  Submitted:2010-09-17, Days after onset: 1
Location:Illinois  Entered:2010-09-20, 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: No illness
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURB10900UNLA
Administered by: Public     Purchased by: Private
Symptoms: Dyspnoea, Nausea, Tremor, Visual impairment
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)
Write-up: Patient described jogging 30 minutes after receiving vaccine. 25 minutes of running patient had difficulty breathing, hard to catch breath. Visual problems from bright colors to everything turning white. Nausea and shaking.

VAERS ID:398982 (history)  Vaccinated:2010-09-14
Age:24.0  Onset:2010-09-15, Days after vaccination: 1
Gender:Female  Submitted:2010-09-21, Days after onset: 6
Location:Michigan  Entered:2010-09-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Health history of asthma and experiencing an asthma flare up at the time of administration.
Preexisting Conditions: Allergy to Morphine. Newly diagnosed Graves disease
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0321Z0SCLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B054BA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Haematoma infection, Impaired work ability, Pain, Pyrexia, Skin warm, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient woke up with a round red warm area on her left arm that morning and by the end of the day 9/15 area increased in size and was painful. On morning of 9/16 the reddened and now swollen area was 5 by 4 inches and raised to egg size area and she had a fever of 101 F. Patient went to own MD on 9/16 and he diagnosed an infected hematoma-prescribed Keflex and Prednisone. MD also instructed her to stay home from work for 9/16 and 9/17 due to fever. Call to patient on 9/17 and she states worse, swollen area in left arm now doubled in size, pain from shoulder to elbow, continued reddened, fever of 101 continues. TC again to patient on 9/17 by HD staff and she was again seen by MD on 9/17 and to continue Keflex for 10 days and to contact MD if area gets any larger. TC to patient on 9/20 by HD staff and area started shrink on 9/18 and is now less tender, improving.

VAERS ID:399005 (history)  Vaccinated:2010-09-12
Age:24.0  Onset:2010-09-13, Days after vaccination: 1
Gender:Female  Submitted:2010-09-15, Days after onset: 2
Location:Nevada  Entered:2010-09-21, Days after submission: 6
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) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS111775P11IMRA
Administered by: Other     Purchased by: Private
Symptoms: Headache, Injection site erythema, Injection site inflammation, Injection site nodule, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Patient described rash/cyst-like nodules around injection site of right deltoid muscle. (8-10 in number). Also report headache for 2 days. Nodules seem inflamed or red on 9/14/10.

VAERS ID:399044 (history)  Vaccinated:2010-09-02
Age:24.0  Onset:2010-09-09, Days after vaccination: 7
Gender:Female  Submitted:2010-09-20, Days after onset: 11
Location:Unknown  Entered:2010-09-21, 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:
Current Illness:
Preexisting Conditions: Vaginitis bacterial
Diagnostic Lab Data: urine beta-human, 09/02?/10, Negat; beta-human chorionic, 09/06/10, Posit
CDC Split Type: WAES1009USA03257
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Bacterial test, Chlamydia test, Drug exposure during pregnancy, Pregnancy test positive, Urine human chorionic gonadotropin negative, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient with no known allergies and a history of bacterio vaginosis who on 02-SEP-2010 was vaccinated intramuscularly with her first 0.5 mL dose of GARDASIL (lot number not reported). Concomitant therapy included metronidazole. The nurse stated that the patient received the dose of GARDASIL after having a negative urine pregnancy test. On 06-SEP-2010, the patient had a positive pregnancy test . On 09-SEP-2010, the patient visited an unspecified emergency room complaining of vaginal bleeding. The patient was diagnosed as miscarrying at that time. Gonorrhea and Chlamydia tests were performed with no results provided. The nurse also reported that the patient visited an unspecified emergency room on another unspecified occasion since 09-SEP-2010, complaining of vaginal bleeding. At the time of report, the patient had not recovered from vaginal bleeding. Last menstrual period 02-AUG-2010. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.

VAERS ID:399103 (history)  Vaccinated:2010-09-10
Age:24.0  Onset:2010-09-16, Days after vaccination: 6
Gender:Female  Submitted:2010-09-21, Days after onset: 5
Location:D.C.  Entered:2010-09-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Patient denies any illnesses
Preexisting Conditions: Good
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF798AA IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Rash in deltoid/posterior left arm region. Patient feels improved since yesterday.

VAERS ID:399108 (history)  Vaccinated:2010-06-19
Age:24.0  Onset:2010-06-29, Days after vaccination: 10
Gender:Male  Submitted:2010-09-21, Days after onset: 84
Location:Kentucky  Entered:2010-09-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None documented
Preexisting Conditions: None documented
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0IDRA
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Injection site reaction, warmth, redness.

VAERS ID:400382 (history)  Vaccinated:2010-08-31
Age:24.0  Onset:2010-09-01, Days after vaccination: 1
Gender:Male  Submitted:2010-09-17, Days after onset: 16
Location:Massachusetts  Entered:2010-09-24, 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: no illness local reaction (see #7)
Preexisting Conditions: Infantile Cerebral Palsy; Quadriplegic; Seizure d/o; DM type II; legal blindness; osteoporosis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA576BA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0564Z IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Site of injection (right deltoid) 4 cm area was red, hard, raised, and warm and patient had a low grade fever of 99.2 temporal. Pt treated with KEFLEX 500mg one po qid X 7 days for possible cellulitis.

VAERS ID:400364 (history)  Vaccinated:2010-09-14
Age:24.0  Onset:0000-00-00
Gender:Male  Submitted:2010-09-26
Location:Unknown  Entered:2010-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV242  LA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A  RA
Administered by: Military     Purchased by: Military
Symptoms: Headache, Skin lesion
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Headache, lesions on back and chest.

VAERS ID:400712 (history)  Vaccinated:2010-09-24
Age:24.0  Onset:2010-09-24, Days after vaccination: 0
Gender:Female  Submitted:2010-09-27, Days after onset: 3
Location:California  Entered:2010-09-27
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: Depression; Epilepsy.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11259706 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Feeling hot, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Started Friday night with pain. She is feeling dizzy and warm. Which started on 9/26/2010 after taking a shower. She has been putting ice and took Ibuprofen and EXCEDRIN. Rash on chest started Sat. night (9/25/10).

VAERS ID:400749 (history)  Vaccinated:2010-09-24
Age:24.0  Onset:2010-09-25, Days after vaccination: 1
Gender:Female  Submitted:2010-09-27, Days after onset: 2
Location:Nevada  Entered:2010-09-27
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS111807P1 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Left upper arm along the midshaft of the arm there is a erythematous, mildly indurated patch elliptical in shape. The height from tip to tip 7 cm and width 4 cm. Patient complained it was itchy. It appears to be almost completely resolved.

VAERS ID:400880 (history)  Vaccinated:2010-09-27
Age:24.0  Onset:2010-09-27, Days after vaccination: 0
Gender:Female  Submitted:2010-09-28, Days after onset: 1
Location:California  Entered:2010-09-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA; unknown birth defects; no medical conditions reported
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1118UP1 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site rash, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient received FLUVIRIN around 7:40 PM 9/27/10. Within 5 minutes developed rash at injection site and on chest and neck. Patient was given 100 mg of BENADRYL, at around 7:45 PM, rashes subsided by 8:00 pm. EMT''s arrived at about 8:05 to double check patient''s condition.

VAERS ID:401492 (history)  Vaccinated:2010-09-21
Age:24.0  Onset:2010-09-27, Days after vaccination: 6
Gender:Female  Submitted:2010-10-01, Days after onset: 4
Location:Mississippi  Entered:2010-10-01
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Codeine allergy
Preexisting Conditions: Concomitant medications and relevant medical history were unknown. No adverse events were reported with previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0884088A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Erythema, Movement disorder, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician via sales representative and described the occurrence of pain in a 24-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included codeine allergy. On 21 September 2010 the subject received 1st dose of BOOSTRIX (.5 ml, unknown, left arm). On 27 September 2010, 6 days after vaccination with BOOSTRIX, the subject experienced pain, fever, chills and erythema. The area of erythema on the left arm was 15 x 18 centimeters (cm). The subject also experienced lack of use of arm. The subject was hospitalised and the physician considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the pain, fever, chills, erythema and lack of use of arm were unresolved. The physician considered the events were probably related to vaccination with BOOSTRIX.

VAERS ID:401523 (history)  Vaccinated:2010-09-13
Age:24.0  Onset:2010-09-13, Days after vaccination: 0
Gender:Female  Submitted:2010-10-01, Days after onset: 18
Location:Kansas  Entered:2010-10-01
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT3588BA UNLA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site pain, Joint range of motion decreased
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Left shoulder pain without improvement since injection 9/13/2010. Decreased ROM to shoulder.

VAERS ID:401730 (history)  Vaccinated:2010-09-21
Age:24.0  Onset:2010-09-30, Days after vaccination: 9
Gender:Male  Submitted:2010-10-04, Days after onset: 4
Location:Texas  Entered:2010-10-04
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: throat culture to r/o strep
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV2360IMRA
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500431P4IN 
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0IDLA
Administered by: Military     Purchased by: Military
Symptoms: Culture throat, Oropharyngeal pain, Rash pustular, Skin lesion
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt states he was eating on Saturday, Sep 25, when his smallpox bandage fell off his arm and landed in his food. Pt continued eating. Around Sep 30, pt began experiencing a sore throat and notice white pus pockets in the back of his throat. Pt came into clinic for evaluation by a family physician. The family physician determined the pus pockets to be satellite lesions from the primary smallpox site.

VAERS ID:401746 (history)  Vaccinated:2010-09-28
Age:24.0  Onset:2010-10-02, Days after vaccination: 4
Gender:Male  Submitted:2010-10-04, Days after onset: 2
Location:California  Entered:2010-10-04
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
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSUNK2IMRA
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.UNK IN 
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0IDLA
Administered by: Military     Purchased by: Military
Symptoms: Blister, Malaise, Rash, Rash maculo-papular, Systemic lupus erythematosus rash
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: systemic rash: red, maculopapular lesions, some vesicles; no pustules; afebrile; no myalgias; some malaise; rash on arms, trunk--chest/back

VAERS ID:401821 (history)  Vaccinated:2010-09-11
Age:24.0  Onset:2010-09-11, Days after vaccination: 0
Gender:Male  Submitted:2010-10-04, Days after onset: 23
Location:Tennessee  Entered:2010-10-04
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV2350IMRA
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED0994911B5IMLA
Administered by: Military     Purchased by: Military
Symptoms: Abdominal discomfort, Arthralgia, Burning sensation, Chest discomfort, Dizziness, Dyspnoea, Feeling abnormal, Headache, Injection site pain, Malaise, Nausea, Oedema peripheral, Pain of skin, Scab
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: 17Feb 2010 received call from SM stating that he had a reaction "to the Anthrax vaccine" on 11Sept 10 Anthrax given in (R) deltoid after member educated on Anthrax vaccine and possible side effects. Member signed Anthrax education 600 over print and questions answered. SM stated understanding. SM called 17 Sep at 1930 and stated that he started having burning in (R) arm and (R) hand "a few minutes after receiving vaccine. Lasted approx 1 hour and "then injection site was just sore." Sunday a.m awakened with joint pain, chest tightness, dyspnea and nausea, dizziness and malaise throughout the day. Did not go to work, but SM did not go to ED or physician. SM stated that, "On Tuesday, felt better in a hazy dream like state until late Thursday (L) forearm began swelling - palm increased inside of elbow 1 1/2" to outer forearm redness and raised area. SM c/o soreness - pulsing pain in arm with flu shot - not arm with anthrax injection. When SM called he stated that he was feeling better on this day until (L) side of scalp started hurting around 9-10 a.m. - at this time SM realized that he had solid black scab on (L) side of head - denied hitting head. Member also c/o intestinal burning that started on Sunday (day after shot) no vomiting, - 1 loose stool. SM stated that he has felt "bad - on and off since time he received shots". Also, stated that he had sharp "flash like" pains in his head that lasted 15-20 seconds that started on 17Sep 2010. Instructed member to go to ED if symptoms returned or worsened. Also, to have information emailed/sent ASAP and report on Oct drill to see physician.

VAERS ID:401973 (history)  Vaccinated:2010-10-05
Age:24.0  Onset:2010-10-05, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Washington  Entered:2010-10-05
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH201AA UNLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB472AA0UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURE0123 UNRA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF702AA SCRA
Administered by: Private     Purchased by: Private
Symptoms: Grand mal 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: Seizure activity after finishing 4 injections. Tonic-clonic symptoms resolved. Pt refused further medical workup. Pt had not had breakfast prior to appt.

VAERS ID:402133 (history)  Vaccinated:2010-09-05
Age:24.0  Onset:2010-09-05, Days after vaccination: 0
Gender:Female  Submitted:2010-09-10, Days after onset: 5
Location:Michigan  Entered:2010-10-06, Days after submission: 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
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS111775P10UNUN
Administered by: Public     Purchased by: Unknown
Symptoms: Hypoaesthesia, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)
Write-up: Arm pain and numbness for many days after shot administered.

VAERS ID:402178 (history)  Vaccinated:2010-09-30
Age:24.0  Onset:2010-09-30, Days after vaccination: 0
Gender:Female  Submitted:2010-10-01, Days after onset: 1
Location:Michigan  Entered:2010-10-06, 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: None
Diagnostic Lab Data: Vital signs taken WNL; afebrile; LCTA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS111813P10IMRA
Administered by: Other     Purchased by: Private
Symptoms: Breath sounds, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Received influenza vaccine 0130AM 9/30/10 within 4-6 hrs. developed hives on neck and trunk denies SOB or difficulty breathing. VS WNL once assessed following day.

VAERS ID:402338 (history)  Vaccinated:2010-10-07
Age:24.0  Onset:2010-10-07, Days after vaccination: 0
Gender:Male  Submitted:2010-10-07, Days after onset: 0
Location:South Carolina  Entered:2010-10-07
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: unknown at this time
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS111805P10IMRA
Administered by: Public     Purchased by: Other
Symptoms: Face injury, Fall, Head injury, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Patient had vaccine fully administered and retracted from skin and reported that the vaccine went well. As I was disposing the needle in the sharps container he passed out while still seated and fell to the floor hitting his head and nose on the floor. He was unconscious for appr. 10 sec before he came to. EMS arrived within 5 minutes of adverse reaction.

VAERS ID:402466 (history)  Vaccinated:2010-10-07
Age:24.0  Onset:2010-10-07, Days after vaccination: 0
Gender:Female  Submitted:2010-10-07, Days after onset: 0
Location:Kansas  Entered:2010-10-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Patient denies
Preexisting Conditions: Thoracotomy 2005 for remove of tumor or heart glomerulonephritis 2007
Diagnostic Lab Data: O2 sats 100% normal; Peak flows 400-400-350 normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3700AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chest discomfort, Dyspnoea, Oxygen saturation normal, Peak expiratory flow rate normal
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Flu vaccine administered at 8:45AM. Symptoms started approximately 1345pm at home with shortness of breath and chest heaviness. Arrived at clinic 1521pm. Stable. Doctors orders given. Follow up phone call on 9-8-10 - Pt much better. Was given Ibuprofen and BIAXIN to prevent bronchitis.

VAERS ID:402602 (history)  Vaccinated:2010-10-07
Age:24.0  Onset:2010-10-07, Days after vaccination: 0
Gender:Female  Submitted:2010-10-09, Days after onset: 2
Location:Utah  Entered:2010-10-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: 34 Weeks Pregnant
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Private
Symptoms: Back pain, Drug exposure during pregnancy, Influenza like illness, Injection site induration, Injection site mass, Malaise, Nausea, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Received the new flu shot that has the H1N1 vaccine included. Not long after I got horribly sick, flu like symptoms. Fever, horrible nausea, bad back aches as well as a large hard lump (about the size of a flattened golf ball) at the injection site and a very sore arm. Everything but the lump was gone within 24 hours. The lump remains exactly the same 48 hours later with no signs of changing.

VAERS ID:402759 (history)  Vaccinated:2010-10-06
Age:24.0  Onset:2010-10-07, Days after vaccination: 1
Gender:Female  Submitted:2010-10-11, Days after onset: 4
Location:Texas  Entered:2010-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Reported no illnesses
Preexisting Conditions: Reported Latex, Sulfa, Penicillin
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT3568BA IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B041CA IMRA
Administered by: Public     Purchased by: Other
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Reported to RN on 10/11/10 that she had a localized red raised rash around site and that it was warm to the touch.

VAERS ID:402948 (history)  Vaccinated:2009-01-21
Age:24.0  Onset:2009-01-21, Days after vaccination: 0
Gender:Female  Submitted:2010-10-11, Days after onset: 627
Location:New Jersey  Entered:2010-10-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 12/26/2008); Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Cardiac monitoring, 10/??/09, funct; cardiac monitoring, 12/??/09, heart; cardiac monitoring, 04/02?/10, heart; beta-human chorionic, 01/??/09, posit
CDC Split Type: WAES0902USA01055
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood human chorionic gonadotropin positive, Cardiac function test abnormal, Cardiac monitoring, Cardiomegaly, Cardiomyopathy, Complication of pregnancy, Drug exposure during pregnancy
SMQs:, Cardiac failure (broad), Tumour markers (narrow), Cardiomyopathy (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a consumer for the pregnancy registry for GARDASIL concerning a his a 24 year old wife with allergic to many drugs but unspecified which ones and no pertinent medical history who on 21-JAN-2009 was vaccinated with first dose of GARDASIL (Lot # not reported). There was no concomitant medication. On 21-JAN-2009 after she received the first dose of vaccine she found she was pregnant. She had a pregnancy test done before getting the vaccine and it came back negative, however when she did pregnancy test again couple days after got the vaccine it came back positive. Follow-up information has been received from the patient''s husband. The patient''s husband provided the information as his wife did not speak English. The husband provided the following pregnancy outcome information. He reported that his wife never went to the original physician whose name he provided since her insurance changed and that person didn''t accept it. She was seen by a group of physicians at a clinic and delivered a baby on 02-OCT-2009 in a hospital. He stated the baby was fine and healthy. His wife, however, had complications during pregnancy. This was her first pregnancy and at the time of delivery it was discovered that she had a heart enlargement, she was diagnosed with cardiomyopathy, and her cardiac function was reduced to 15%. She had a vaginal delivery and the baby was very healthy and a normal to big size. After the delivery his wife was transferred to the cardiac unit in the hospital where she spent the next week being treated (not specified). She couldn''t breastfeed because of the heart medications (not specified) she was taking. The patient''s husband added that after two months her cardiac function increased from 15% to 18% and then by six months she was up to 25%. He said his wife had continued to improve and had a follow-up appointment with her cardiologist on 01-OCT-2010. His wife and he were also advised that she not have any more pregnancies or children. The husband also reported that the baby was one year old on 02-OCT-2010. The husband added that the patient''s clinic where she received prenatal care was closed and the obstetrician was retired. Additional information has been requested.

VAERS ID:403010 (history)  Vaccinated:2010-09-08
Age:24.0  Onset:2010-09-08, Days after vaccination: 0
Gender:Female  Submitted:2010-10-12, Days after onset: 34
Location:Texas  Entered:2010-10-12
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: latex sensitivity
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV2410 UN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURD10870 UN
Administered by: Military     Purchased by: Military
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: urticaria

VAERS ID:403019 (history)  Vaccinated:2010-10-11
Age:24.0  Onset:2010-10-11, Days after vaccination: 0
Gender:Female  Submitted:2010-10-12, Days after onset: 1
Location:California  Entered:2010-10-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: I developed a high fever and cough. I then head headaches and extreme soreness in my arm where the shot was administered. Due to the headache and fever, I was unable to sleep well at night. It''s been over 24 hours and I still have a fever / headache / soreness but have taken aspirin so I''m not in as much discomfort.
Preexisting Conditions:
Diagnostic Lab Data: Still currently sick.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER    
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Public     Purchased by: Private
Symptoms: Cough, Discomfort, Headache, Injection site pain, Malaise, Pyrexia, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Developed high fever, cough, and headache.

VAERS ID:403094 (history)  Vaccinated:2010-10-11
Age:24.0  Onset:2010-10-13, Days after vaccination: 2
Gender:Female  Submitted:2010-10-13, Days after onset: 0
Location:South Carolina  Entered:2010-10-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Bells Palsy~Hep B (no brand name)~1~11.50~Patient|Bells Palsy Relapse~Hep B (no brand name)~2~12.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions: SLE (lupus)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0IJLA
Administered by: Public     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Woke up covered in hives, was covered on my arms, back, stomach, and legs.

VAERS ID:403574 (history)  Vaccinated:2010-10-14
Age:24.0  Onset:2010-10-14, Days after vaccination: 0
Gender:Female  Submitted:2010-10-15, Days after onset: 1
Location:Massachusetts  Entered:2010-10-15
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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFFLA618AA UNLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Nausea, Paraesthesia, Skin warm, Throat tightness, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Approx. time of flu shot 2:10 PM, then approx. 2:25 PM vomiting, red and hot facial cheeks, tingling in (R) arm and felt throat closing or tight. EPI given at 2:31 PM 911 was called. Client taken to hospital at 2:45 PM approx. Still with nausea on 10/15/10.

VAERS ID:403645 (history)  Vaccinated:2010-10-12
Age:24.0  Onset:2010-10-12, Days after vaccination: 0
Gender:Male  Submitted:2010-10-15, Days after onset: 3
Location:California  Entered:2010-10-15
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: weakness of entire body~Vaccine not specified (no brand name)~~24.83~Patient|fainted~Vaccine not specified (no brand name)~~24.8
Other Medications:
Current Illness: 100% healthy. No sickness what so ever.
Preexisting Conditions: None
Diagnostic Lab Data: Doctor''s are unsure of why I fainted. Waiting for explanation.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3488BA UNUN
Administered by: Unknown     Purchased by: Private
Symptoms: Contusion, Dyspnoea, Face injury, Fall, Immediate post-injection reaction, Loss of consciousness, Skin laceration, Syncope, Wound closure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: I recieved my vaccine shot at about 4:20 pm, 1-3 minutes immediately after recieving the shot, I fainted and fell flat onto my face. I was unconcious for about 5-6. After regaining conciousness I immediately had trouble breathing. Paramedics were called to the scene. I lacerated the left side of my face when I fell; and cut and bruised my face also. I had to have 5 stitches for the wound to my face.

VAERS ID:403702 (history)  Vaccinated:2010-10-16
Age:24.0  Onset:2010-10-16, Days after vaccination: 0
Gender:Male  Submitted:2010-10-17, Days after onset: 1
Location:Massachusetts  Entered:2010-10-17
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
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0IJLA
Administered by: Military     Purchased by: Military
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Hives have formed on the Arms and Backs.

VAERS ID:403791 (history)  Vaccinated:2010-10-16
Age:24.0  Onset:2010-10-17, Days after vaccination: 1
Gender:Female  Submitted:2010-10-18, Days after onset: 1
Location:New Hampshire  Entered:2010-10-18
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS))NOVARTIS VACCINES AND DIAGNOSTICS111773P1 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Med. sized red, itchy area, sore, hard area at injection site.

VAERS ID:403827 (history)  Vaccinated:2008-10-30
Age:24.0  Onset:2009-10-28, Days after vaccination: 363
Gender:Male  Submitted:2010-10-18, Days after onset: 355
Location:Arizona  Entered:2010-10-18
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Alopecia areata (symptoms started in Nov 2008); NKDA
Diagnostic Lab Data: 19 Nov 2009, Plasma - Glucose 692 (H*) mg/dL; Sodium 127 (L) mmol/L; Potassium 5.7 (H) mmol/L; Chloride 86 (L) mmol/L; Carbon Dioxide 25 mmol/L; Creatinine 0.8 mg/dl; Urea Nitrogen 27 (H) mg/dL; Urate 4.1 (L) mg/dL; Thyrotropin Sensitive 1.77 mIU/mL; Thyroxine free 1.28 ng/dL; 19 Nov 2009, Blood - Hemoglobin A1c 13.6 (H)%
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER  SCUN
Administered by: Military     Purchased by: Military
Symptoms: Blood chloride decreased, Blood creatinine normal, Blood glucose abnormal, Blood potassium increased, Blood sodium abnormal, Blood thyroid stimulating hormone normal, Blood urea increased, Blood uric acid decreased, Carbon dioxide normal, Diabetic ketoacidosis, Fatigue, Glycosylated haemoglobin increased, Intensive care, Malaise, Pollakiuria, Thirst, Thyroxine free normal, Type 1 diabetes mellitus, Weight decreased
SMQs:, Acute renal failure (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Internal Medicine note date 19 Nov 2009, reports evaluation at medical center 7 days ago - Admitted to MICU on Insulin drip (11 Nov), then transferred to ward on LANTUS/NOVOLOG. Discharged just over 24 hours after presentation (13 Nov), on METFORMIN 500 mg BID. Two to three weeks prior to admission (end of Oct 2009), SM noted increased thirst, increased urination, and fatigue, as well as 20-pound weight loss. After initial evaluation and discharge, SM sought evaluation again on 19 Nov 2009 and reported not feeling well since discharge, with lowest BG level of 270 per self blood glucose monitoring. At time of this re-evaluation, SM was admitted to medical center with diagnosis of Diabetic Ketoacidosis (DKA) and diagnosed with T1DM. After 3 days, he was discharged on bedtime GLARGINE and premeal NOVOLOG with regular outpatient follow-up. On 19 Nov 2009, his serum glucose level was 692, his HgbA1c was 13.6. SM received diabetes self management training. SM''s diabetes has been followed by local health care providers, including nurse practitioner in Endocrinology and another Endocrinologist. He is currently on an insulin pump. *SM received Flu vaccine (Aventis, U3254DA) on 17 Nov 2009 which was after symptom onset but prior to diagnosis of T1DM.

VAERS ID:403873 (history)  Vaccinated:2010-10-13
Age:24.0  Onset:2010-10-13, Days after vaccination: 0
Gender:Female  Submitted:2010-10-18, Days after onset: 5
Location:Michigan  Entered:2010-10-18
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: Allergic to COMPAZINE; REGLAN; DUPERADOL (? S6)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3655AA IMRA
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB184BA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1332Y0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0564Z0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Burning sensation, Injected limb mobility decreased, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Tendinopathies and ligament disorders (broad)
Write-up: On 10/15/10 client reported her right upper arm difficult to lift and began hurting and pain increased about 3 hrs after vaccines given. Client reports burning, radiating pain present the evening of 10/13 lasting about 3 hrs. This burning was in armpit area and right breast and radiated to right upper lung field and states when she took deep breath also had burning sensation. 10/15 - can lift arm, but states still painful, but pain is decreasing.

VAERS ID:403931 (history)  Vaccinated:2010-10-11
Age:24.0  Onset:2010-10-12, Days after vaccination: 1
Gender:Female  Submitted:2010-10-16, Days after onset: 4
Location:Florida  Entered:2010-10-18, Days after submission: 2
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: Allergic rhinitis; Chronic rhinosinusitis; Recurrent infections; Gastritis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0651Z0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Chills, Injection site erythema, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever, chills, aches about 24 hours of injection. Large area of erythema at injection site (T. 99 in office).

VAERS ID:404006 (history)  Vaccinated:2010-10-13
Age:24.0  Onset:2010-10-16, Days after vaccination: 3
Gender:Female  Submitted:2010-10-18, Days after onset: 2
Location:Georgia  Entered:2010-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: asthma
Preexisting Conditions: allergies: trees, grass, pollen, cats
Diagnostic Lab Data: Stated having allergy shots prior to vaccination
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS111787P10IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Body temperature increased, Feeling abnormal, Injection site pruritus, Injection site urticaria, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Dementia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: lactic acid feeling in thigh on side of injection (left-side) (24-48 hours later) 2 welts on arm near injection site Saturday it itches. Sunday and Monday welts. Temp 99.5 10/18/10 No fever otherwise noticed

VAERS ID:404011 (history)  Vaccinated:2010-10-06
Age:24.0  Onset:2010-10-07, Days after vaccination: 1
Gender:Male  Submitted:2010-10-13, Days after onset: 6
Location:Texas  Entered:2010-10-19, Days after submission: 6
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: Pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA594BA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Cough, Dyspnoea, Myalgia, Pyrexia, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever, rash, arthralgias, myalgias, dry cough, SOB beginning 24 hrs after injection lasting $g1 wk.

VAERS ID:404579 (history)  Vaccinated:2010-10-19
Age:24.0  Onset:2010-10-19, Days after vaccination: 0
Gender:Female  Submitted:2010-10-21, Days after onset: 2
Location:Texas  Entered:2010-10-21
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUM201AA IMRA
Administered by: Unknown     Purchased by: Other
Symptoms: Injection site nodule, Injection site warmth, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)
Write-up: half dollar size knot at injection site, hot to touch, and entire arm painful.

VAERS ID:405423 (history)  Vaccinated:2010-10-19
Age:24.0  Onset:2010-10-20, Days after vaccination: 1
Gender:Female  Submitted:2010-10-26, Days after onset: 6
Location:Massachusetts  Entered:2010-10-26
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: Lymphangioleiomyomatosis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS111626050IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0883Z0IMRA
Administered by: Unknown     Purchased by: Other
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Pyrexia, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: On 10/20/10 the patient called to report soreness at the vaccine site. She denied redness and had a temp of 100 degrees that had since resolved. The patient was instructed to seek medical attention for fever, redness, or difficulty moving her arm. On 10/22/10 the patient presented to her local ED with c/o fever to 102 and redness at the vaccine site. She was diagnosed with a vaccine reaction and treated with NSAID''s. On 10//24/10 she returned to the ED with persistent symptoms. She was treated with a single dose of IV antibiotics and a course of oral antibiotics for cellulitis.

VAERS ID:405653 (history)  Vaccinated:2010-10-15
Age:24.0  Onset:0000-00-00
Gender:Female  Submitted:2010-10-25
Location:Minnesota  Entered:2010-10-27, Days after submission: 2
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
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV2310IMLA
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH183AA IMRA
Administered by: Military     Purchased by: Unknown
Symptoms: Expired drug administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Expired ANTHRAX administered. Lot FAV231, Exp date 4Oct10. Given 15 Oct 10. No adverse reaction noted.

VAERS ID:405921 (history)  Vaccinated:2010-08-02
Age:24.0  Onset:2010-08-05, Days after vaccination: 3
Gender:Female  Submitted:2010-09-07, Days after onset: 33
Location:Colorado  Entered:2010-10-28, Days after submission: 51
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: WBC 11.2; strep - neg
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Fatigue, Malaise, Pruritus, Rash macular, Streptococcus test negative, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash started morning of 8/5 around neck and spread to chest, back, abdomen, and upper arms. Reports itching, malaise/tired, loose stool x1 (not diarrhea). Denies fever, chills, SOB headache. No urticaria, rash described as 1-2mm erythema macules. Treated with methylprednisolone 4mg pak as directed. On 8/10 patient was told she could take BENADRYL 25mg three times daily as needed for itching and the rash may take 2-3 weeks to resolve.

VAERS ID:406042 (history)  Vaccinated:2010-10-22
Age:24.0  Onset:2010-10-22, Days after vaccination: 0
Gender:Female  Submitted:2010-10-28, Days after onset: 6
Location:New Hampshire  Entered:2010-10-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dysuria; (-) for UTI
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS116930UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3519AA0UNRA
Administered by: Private     Purchased by: Other
Symptoms: Back pain, Pain in extremity
SMQs:, Retroperitoneal fibrosis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Thoracic back pain, (L) arm pain both w/in 1 hour of vaccines. Pt seen and treated at hospital ED 10/23/10, Dx ? reaction to immunizations.

VAERS ID:406132 (history)  Vaccinated:0000-00-00
Age:24.0  Onset:0000-00-00
Gender:Female  Submitted:2010-10-01
Location:Tennessee  Entered:2010-10-29, Days after submission: 28
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) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA590AA UNLA
Administered by: Public     Purchased by: Unknown
Symptoms: Arthralgia
SMQs:, Arthritis (broad)
Write-up: Elbow pain 2 hours after vaccination.

VAERS ID:406153 (history)  Vaccinated:2008-06-25
Age:24.0  Onset:2008-06-26, Days after vaccination: 1
Gender:Male  Submitted:2010-11-01, Days after onset: 858
Location:Missouri  Entered:2010-11-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Localized reaction, nausea, rapid heart beat, high blood pressure, vomiting, sweating, swollen cartilage in left shoulder, dizziness
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER 0 LA
Administered by: Military     Purchased by: Military
Symptoms: Chondropathy, Dizziness, Heart rate increased, Hyperhidrosis, Hypertension, Local reaction, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)
Write-up: Localized reaction, rapid heart rate, high blood pressure, nausea, vomiting, dizziness, swollen cartilage in shoulder.

VAERS ID:406314 (history)  Vaccinated:2010-10-27
Age:24.0  Onset:2010-10-29, Days after vaccination: 2
Gender:Female  Submitted:2010-11-01, Days after onset: 3
Location:Massachusetts  Entered:2010-11-01
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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH224AC IMGM
TDAP: TDAP (ADACEL)SANOFI PASTEURC3517AA IMGM
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 6 x 4cm tender patch of erythema Lt buttock w/ induration (Flu shot) without heat. 3 cm tender patch of erythema Rt buttock w/ induration (ADACEL) without heat. No fever, no chills no SOB no cough.

VAERS ID:406356 (history)  Vaccinated:0000-00-00
Age:24.0  Onset:0000-00-00
Gender:Female  Submitted:2010-10-29
Location:North Carolina  Entered:2010-11-02, Days after submission: 4
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH223AC IMRA
Administered by: Public     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: Patient reports hives/itching all over top half of body 1 hour after flu vaccine administered. Treated w/BENADRYL 50mg - resolved hives. Reappeared 24 hours later - retreated w/BENADRYL 50mg resolved.

VAERS ID:406412 (history)  Vaccinated:2009-07-15
Age:24.0  Onset:2009-07-20, Days after vaccination: 5
Gender:Female  Submitted:2010-11-02, Days after onset: 470
Location:Texas  Entered:2010-11-02
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 20 days
    Extended hospital stay? No
Previous Vaccinations: SEVERE BACK PAIN AND LEG NUMBNESS~HPV (Gardasil)~UN~24.50~Patient|GALLBLADDER DISEASE~HPV (Gardasil)~1~25.33~Patient
Other Medications: NECON 35, METFORMIN
Current Illness: No
Preexisting Conditions: Polycystic Ovarian Syndrome
Diagnostic Lab Data: MRI, MRA, CT SCAN OF THE HEAD, EEG, ECG, ECHOCARDIOGRAM, TESTS OF THE KIDNEYS. UPPER GI TESTS, EKG, HOLTER MONITOR, CHEST X-RAY
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0070X2IMRA
Administered by: Private     Purchased by: Private
Symptoms: Back pain, Chest X-ray, Cholecystectomy, Computerised tomogram, Computerised tomogram head, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Electroencephalogram, Gallbladder disorder, Heart rate decreased, Heart rate increased, Hypoaesthesia, Hypotension, Laboratory test, Loss of consciousness, Migraine, Nuclear magnetic resonance imaging, Pain in extremity, Renal function test, Syncope, Wheelchair user, X-ray with contrast upper gastrointestinal tract
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gallbladder related disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: Began having chronic migraines along with passing out unconsciously, severe back pain, leg pain with numbness. Had to have Gallbladder removed due to it being diseased. Also developed chronic low blood pressure. Had numerous tests done and received numerous medication in a attempt to stop migraines and fainting spells. From that day forward chronic migraines continued on a daily basis. Hospitalized from migraines and fainting spells off and on over the course of 07/20/2009 to 09/24/2009 with numerous visits to primary care physician for infusion for migraines along with many visits to the emergency room to receive shots to stop migraines. Currently still experiencing fainting spells and migraines. Now under cardiologist care receiving medication for Chronic Low Blood Pressure and high/low heart rate and also taking a preventative medicine for migraines. For 6 months wheelchair bound off and on due to leg numbness and fainting spells.

VAERS ID:406622 (history)  Vaccinated:2010-11-02
Age:24.0  Onset:2010-11-03, Days after vaccination: 1
Gender:Male  Submitted:2010-11-03, Days after onset: 0
Location:Colorado  Entered:2010-11-03
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: Allergic to Penicillin and Erythromycin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0IJLA
Administered by: Other     Purchased by: Private
Symptoms: Abdominal pain, Chills, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Severe chills and fever started around midnight and continued for about an hour. Treated with fluids and ibuprofen. Fever persisted until about 4 am although chills subsided after the first hour. Chills were severe enough to wake me and result in abdominal soreness the next morning.

VAERS ID:406954 (history)  Vaccinated:2010-11-03
Age:24.0  Onset:2010-11-03, Days after vaccination: 0
Gender:Male  Submitted:2010-11-04, Days after onset: 1
Location:Oregon  Entered:2010-11-04
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 DIAGNOSTICS111796P1 IMRA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: Following injection, pt immediately produced an injection site reaction with redness around the site, a little puffiness and warm to the touch as well as feeling a bit feverish. Pt denied and SOB or change in heart rate and asked to remain in the pharmacy for approximately 30 min. When pt appeared well enough to leave, he was instructed to take Benadryl if the inj site reaction looked to be getting worse, ice pack the site and seek emergency medical care if trouble breathing. The following day the patient was followed up with and the site reaction had resolved. He did state however that he felt profuse sweating and dizziness for about 20 minutes after he left the pharmacy but felt fine after that. Pt did mention the following day that he vaguely remembers having had a reaction similar to this in the past but was unsure of the type of vaccine and when it occurred.

VAERS ID:407036 (history)  Vaccinated:2009-09-10
Age:24.0  Onset:2009-09-10, Days after vaccination: 0
Gender:Female  Submitted:2010-11-05, Days after onset: 421
Location:Pennsylvania  Entered:2010-11-05
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations: Swelling/Fever~Tetanus Toxoid (no brand name)~~17.00~Patient
Other Medications:
Current Illness: No acute illness at the time
Preexisting Conditions: Asthma, seasonal allergies, latex allergy
Diagnostic Lab Data: Arterial Blood Gas showed respiratory compromise and hypoxia. Chest x-ray was negative, no substances found in blood system.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURUF499AA IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Blood gases abnormal, Blood test normal, Chest X-ray normal, Confusional state, Dizziness, Dyspnoea, Hypersensitivity, Hypoxia, Respiratory disorder, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Lactic acidosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Systemic allergic reaction with wheezing and shortness of breath within 15 minutes. Called ambulance when began to get dizzy and confused. Doctors in the ER said I almost died and had called my parents to warn them that they were not sure if I would make it.

VAERS ID:407293 (history)  Vaccinated:2010-11-05
Age:24.0  Onset:2010-11-05, Days after vaccination: 0
Gender:Female  Submitted:2010-11-08, Days after onset: 3
Location:Idaho  Entered:2010-11-08
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: None Known
Diagnostic Lab Data: CBC, CRP
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT3621GA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1021Z IMLA
Administered by: Other     Purchased by: Other
Symptoms: Back pain, C-reactive protein, Chest pain, Erythema, Fatigue, Full blood count, Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site warmth, Oedema peripheral, Pain in extremity, Pyrexia, Rash macular, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Left arm redness, heat, swelling, pain onset 4 hours after flu and Pneumovax injections yesterday, tired, body aches-head chest back fever 101.6 this am. Left upper arm with 4 cm area of blotchy erythema, and induration extending about 8 cm diameter, very tender to palpation, warm to touch.

VAERS ID:407719 (history)  Vaccinated:2010-11-03
Age:24.0  Onset:2010-11-04, Days after vaccination: 1
Gender:Female  Submitted:2010-11-10, Days after onset: 6
Location:Washington  Entered:2010-11-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Mild cold symptoms, no fevers
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDM543091IMLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site pain, Neck pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever (up to 100.4), severly painful arm where injection was given, pain up into L side of neck.

VAERS ID:407818 (history)  Vaccinated:2010-11-10
Age:24.0  Onset:2010-11-10, Days after vaccination: 0
Gender:Male  Submitted:2010-11-10, Days after onset: 0
Location:Florida  Entered:2010-11-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Yes, I was recovering from a mild cold. Had the cold for about 5 days. Was feeling better the day I was vaccinated.
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0IJRA
Administered by: Other     Purchased by: Other
Symptoms: Cough, Influenza, Pain, Paraesthesia, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever, aching, cough, (general flu symptoms). Intense tingling/itchy feeling in hands.

VAERS ID:407861 (history)  Vaccinated:2010-10-04
Age:24.0  Onset:0000-00-00
Gender:Female  Submitted:2010-11-11
Location:Georgia  Entered:2010-11-11
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) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS111772P1 IDRA
Administered by: Other     Purchased by: Private
Symptoms: Bone pain, Injection site pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Osteonecrosis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Arm pain (aside from pain at injection site). Patient states 1 month of arm/bone pain. Has sought medical treatment at 2 facilities and will go to an orthopaedist soon.

VAERS ID:407999 (history)  Vaccinated:2010-11-09
Age:24.0  Onset:2010-11-11, Days after vaccination: 2
Gender:Female  Submitted:2010-11-12, Days after onset: 1
Location:Georgia  Entered:2010-11-12
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
TDAP: TDAP (ADACEL)SANOFI PASTEURU3110BA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt. c/o swollen Lt arm, warm to touch and redness observed. Pt. noticed that her Lt arm was swollen last night. Pt. instructed to apply cool compress to Lt arm for 3 - 5 minutes.

VAERS ID:408067 (history)  Vaccinated:2010-10-26
Age:24.0  Onset:2010-10-27, Days after vaccination: 1
Gender:Female  Submitted:2010-11-01, Days after onset: 5
Location:Washington  Entered:2010-11-12, 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: None known
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSU3721AA0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site reaction, Muscle twitching, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Dyskinesia (broad), Dystonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt called 10/29/10 said she has a welt around site. Said she could not take BENADRYL. Pt advised to put hydrocortisone cream on it. Pt called 11/1/10 & said that welt resolved. On Wednesday day following the day shot received, 10/27/10, her finger started twitching. The index finger in her right hand. It has not quit twitching. I told her that I would file a report and she should contact her doctor. She said she couldn''t afford to see him, should she go to the ER? I said I couldn''t advise her on that. She rang off.

VAERS ID:410877 (history)  Vaccinated:2010-01-20
Age:24.0  Onset:2010-01-20, Days after vaccination: 0
Gender:Female  Submitted:2010-08-16, Days after onset: 207
Location:New Mexico  Entered:2010-11-12, Days after submission: 88
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: MEDI0010238
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE))MEDIMMUNE VACCINES, INC.500781P IN 
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, No adverse event
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: A non-serious spontaneous report of "we gave H1N1 LAIV to a woman who is pregnant" was received from a registered nurse concerning a 24-year-old pregnant female. The patient had no past medical history. The patient''s concomitant medications included prenatal vitamins, Rho(D) immune globulin, vitamin C and iron during the pregnancy. The obstetrical history included gravida two and para one. Gestation period at the time of vaccination was 15 weeks and four days. She was in her second trimester of pregnancy with the estimated date of delivery as 10-Jul-2010. On 20-Jan-2010, the patient received the H1N1, Intranasal for an unknown indication. On 16-June-2010 at 39 weeks gestation, the patient vaginally delivered a female infant. The infant weighed seven lbs & four ozs; apgar at one minute was eight and at five mins was nine. There were no complications at delivery for mother or the infant. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments were not applicable. The outcome of vaccine exposure during pregnancy was considered resolved. This case is linked to MEDI-0011481. Additional information was received on 12-Feb-2010 and incorporated in narrative: Patient history, concomitant medications, obstetrical history, LMP date and expected delivery date received. Other additional information received: Reporter title and address. Additional information received on 16-Aug-2010 and incorporated in narrative: Pregnancy outcome, concomitant medications and infant information. Other additional information received was Reporter information, patient name, responsible physician information.

VAERS ID:408583 (history)  Vaccinated:2010-10-26
Age:24.0  Onset:2010-10-26, Days after vaccination: 0
Gender:Female  Submitted:2010-10-29, Days after onset: 3
Location:Idaho  Entered:2010-11-15, Days after submission: 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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU36544CA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Headache, Injection site erythema, Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: C/o significant injection site erythema, pain, redness, headache, myalgia $g 3 days duration.

VAERS ID:408638 (history)  Vaccinated:2010-10-19
Age:24.0  Onset:2010-10-20, Days after vaccination: 1
Gender:Female  Submitted:2010-11-05, Days after onset: 16
Location:Missouri  Entered:2010-11-15, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: May have already had diarrhea and vomiting
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS111771P11UNLA
Administered by: Private     Purchased by: Public
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow)
Write-up: 10/21/10 - 2PM - Site red, swollen, hot to touch, tender to touch, afebrile. C/o nausea and diarrhea. Saw physician 10/28 and c/o vomiting and diarrhea. Returned to work 11/2/10.

VAERS ID:408709 (history)  Vaccinated:2010-11-15
Age:24.0  Onset:2010-11-15, Days after vaccination: 0
Gender:Female  Submitted:2010-11-15, Days after onset: 0
Location:South Dakota  Entered:2010-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3666BA1IMLA
Administered by: Other     Purchased by: Private
Symptoms: Abnormal sensation in eye, Dyspnoea, Eye pruritus, Paraesthesia, Sensation of heaviness, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Corneal disorders (broad), Hypersensitivity (broad)
Write-up: Tightness in Throat, heaviness in throat, with shortness of breath. Bilateral Eyes- feels like "pins and needles, making them itch. OTC Claritin given at 1600. BP 121/74, temp 98.5

VAERS ID:408834 (history)  Vaccinated:2010-10-08
Age:24.0  Onset:2010-10-08, Days after vaccination: 0
Gender:Female  Submitted:2010-11-11, Days after onset: 34
Location:Wisconsin  Entered:2010-11-16, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA602AA IMRA
Administered by: Other     Purchased by: Private
Symptoms: Immediate post-injection reaction, Injection site pain, Musculoskeletal stiffness, Pain in extremity
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Burning sensation when vaccine given with immediate right arm pain stiffness in right side neck 5-6 hours following vaccination lasted 2 days. Used ice pack on right arm, heat pack on neck, used TYLENOL, too.

VAERS ID:408844 (history)  Vaccinated:2010-10-22
Age:24.0  Onset:2010-10-22, Days after vaccination: 0
Gender:Female  Submitted:2010-11-15, Days after onset: 24
Location:Ohio  Entered:2010-11-16, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1011USA00683
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.101721IMUN
Administered by: Other     Purchased by: Other
Symptoms: Mobility decreased, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning a 24 year old female who on 22-OCT-2010 was intramuscularly vaccinated with a second dose of GARDASIL (lot # "10172"). After receiving vaccine, the patient reported that her arm was sore and swollen. The physician had prescribed the patient BENADRYL. On 02-NOV-2010, the patient called the doctor''s office stating that the diphenhydramine hydrochloride did not work and that her arm hurt even worse, with pain extending from her shoulder to her finger. The patient stated that she was not able to use her arm. She was then sent to urgent care (location and duration unspecified) and was given ibuprofen and a muscle relaxer. No diagnostic laboratory tests were performed. On 03-NOV-2010 the patient called said she was slightly better but not recovered. According to the reporter the patient''s arm sore and swollen were considered to be disabling. The reporter also considered that the events were other important medical event since the patient "was treated with diphenhydramine hcl and a muscle relaxer." Additional information has been requested.

VAERS ID:408856 (history)  Vaccinated:2010-10-25
Age:24.0  Onset:2010-10-25, Days after vaccination: 0
Gender:Male  Submitted:2010-11-10, Days after onset: 16
Location:Minnesota  Entered:2010-11-16, Days after submission: 6
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: No
Diagnostic Lab Data: WBC - normal; Rapid flu swab negative
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH201AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Chills, Headache, Malaise, Nausea, Pain, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: 4 hrs after vaccine - Malaise, chills, faint, nausea severe body ache fever 102.4F oral headache. Seen 5:44pm on same day at Urgent Care clinic temp 102.7 - No focal infection. Dx: Febrile vaccine reaction. Rx: NSAID''s.

VAERS ID:408900 (history)  Vaccinated:1990-10-01
Age:24.0  Onset:2007-01-01, Days after vaccination: 5936
Gender:Female  Submitted:2010-11-16, Days after onset: 1415
Location:North Carolina  Entered:2010-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: nausea, ear ringing
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Military     Purchased by: Other
Symptoms: Myalgia, Rash, Tinnitus
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash on hand, ringing in ear, muscle pain in legs, knee, lower back

VAERS ID:408968 (history)  Vaccinated:2010-11-10
Age:24.0  Onset:2010-11-10, Days after vaccination: 0
Gender:Female  Submitted:2010-11-10, Days after onset: 0
Location:Indiana  Entered:2010-11-16, Days after submission: 6
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
TDAP: TDAP (ADACEL)SANOFI PASTEURC3539AA IMRA
Administered by: Private     Purchased by: Other
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: Pain to palm of (R) hand 15 min after injection. Pt to take OTC analgesia f/u with Dr if prob persist.

VAERS ID:409022 (history)  Vaccinated:2010-11-08
Age:24.0  Onset:2010-11-08, Days after vaccination: 0
Gender:Female  Submitted:2010-11-09, Days after onset: 1
Location:Arizona  Entered:2010-11-17, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Acute tonsillitis
Preexisting Conditions: Allergic rhinitis; Asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1427Y IMRA
Administered by: Other     Purchased by: Private
Symptoms: Chills, Dyspnoea, Injection site oedema, Injection site pain, Injection site warmth, Musculoskeletal chest pain, Neck pain, Oedema peripheral, Wheezing
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: (R) arm edema, warmth, severe pain radiates to (R) neck and chest wall (shoulder to elbow), chills, dyspnea (had bilat upper lobe wheezing). Tx - MEDROL dose pack 11/9/10, albuterol inhaler.

VAERS ID:409179 (history)  Vaccinated:0000-00-00
Age:24.0  Onset:0000-00-00
Gender:Unknown  Submitted:0000-00-00
Location:California  Entered:2010-11-18
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) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS111799P10IMUN
Administered by: Unknown     Purchased by: Unknown
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: Pt fainted after seeing the needle.

VAERS ID:409353 (history)  Vaccinated:2010-11-13
Age:24.0  Onset:2010-11-14, Days after vaccination: 1
Gender:Female  Submitted:2010-11-19, Days after onset: 5
Location:California  Entered:2010-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: Strep A Probe: Negative
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0 LA
Administered by: Private     Purchased by: Other
Symptoms: Oropharyngeal pain, Pyrexia, Streptococcus test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Low grade fever, intense sore throat

VAERS ID:409372 (history)  Vaccinated:2010-11-10
Age:24.0  Onset:2010-11-17, Days after vaccination: 7
Gender:Male  Submitted:2010-11-19, Days after onset: 2
Location:Unknown  Entered:2010-11-19
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: No
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEUR0726180 LA
Administered by: Military     Purchased by: Military
Symptoms: Chest pain, Dizziness, Nausea, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Small nickle size itchy rash progressing to 3x size originally noted. Lightheadedness, nausea, and chest pain.

VAERS ID:409443 (history)  Vaccinated:2010-11-17
Age:24.0  Onset:2010-11-18, Days after vaccination: 1
Gender:Female  Submitted:2010-11-19, Days after onset: 1
Location:Minnesota  Entered:2010-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported at time of vaccination. Client later reported having pneumonia 2 weeks prior.
Preexisting Conditions: Athletically induced asthma.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3737AA1IMRA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB891CA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0597Z0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0449Z0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Activities of daily living impaired, Erythema, Injected limb mobility decreased, Injection site discharge, Injection site swelling, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Client called on 11/19/2010 @ 9 am to report that she was having severe swelling, redness, and pain in her right arm. She said "at first it was bubbly and puffy where I got the shot and then it got worse and became searing pain up to my armpit. I can''t move my right arm." Client stated she was unable to work or go to school because of the pain. Public Health Nurse recommended a cold compress and take analgesic medication and to seek medical evaluation. Client stated she had already done the first aid activities and was scheduled to see a doctor on 11/19/2010.

VAERS ID:410979 (history)  Vaccinated:2010-03-16
Age:24.0  Onset:2010-03-16, Days after vaccination: 0
Gender:Female  Submitted:2010-09-27, Days after onset: 195
Location:Unknown  Entered:2010-11-23, Days after submission: 57
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: PHHY2010US15686
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS))NOVARTIS VACCINES AND DIAGNOSTICS102147P1 SCUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect route of drug administration, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Initial report received from healthcare professional on 16 Mar 2010: This patient was vaccinated with S-OIV FLUVIRIN, batch no: 102147P1, subcutaneously, on 16 Mar 2010. This patient inadvertently received a dose of Novartis H1N1 vaccine subcutaneously, on 16 Mar 2010. No other adverse reaction was occurred. The outcome of the event was not reported.

VAERS ID:410157 (history)  Vaccinated:2010-09-14
Age:24.0  Onset:0000-00-00
Gender:Female  Submitted:2010-11-18
Location:Delaware  Entered:2010-11-24, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Just penicillin allergy; n/a medical condition
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS111809P10IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Burning sensation, Dizziness, Immediate post-injection reaction, Injection site pain, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Painful as soon as he gave it. Then after, pt''s whole arm was on fire, burning. Lasted few hours then pain started; just dizzy later. Pt. couldn''t reach for anything, pain ongoing.

VAERS ID:410158 (history)  Vaccinated:2010-11-11
Age:24.0  Onset:2010-11-11, Days after vaccination: 0
Gender:Female  Submitted:2010-11-17, Days after onset: 6
Location:Pennsylvania  Entered:2010-11-29, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: 2 weeks post-op tonsillectomy and 1 week treatment for C. diff.
Preexisting Conditions: H/o asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3788AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.9874603 IMLA
Administered by: Private     Purchased by: Other
Symptoms: Arthralgia, Body temperature increased, Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Nausea, Neck pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Temp (101.7) headache, neck pain, joint pain (severe), muscle aches (severe), swelling, redness, pain at injection site from deltoid to elbow, nausea, fatigue. Treatment: TYLENOL, MOTRIN, BENADRYL, cool showers, fluids, ice and heat to arm.

VAERS ID:410230 (history)  Vaccinated:2010-04-09
Age:24.0  Onset:2010-04-13, Days after vaccination: 4
Gender:Female  Submitted:2010-11-29, Days after onset: 230
Location:New York  Entered:2010-11-29
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: Vitiligo
Diagnostic Lab Data: Everything
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IJLA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal discomfort, Dizziness, Headache, Heart rate increased, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)
Write-up: Rapid Heat beat, sweating, headache, dizziness, upset stomach

VAERS ID:410597 (history)  Vaccinated:2010-11-18
Age:24.0  Onset:2010-11-18, Days after vaccination: 0
Gender:Female  Submitted:2010-11-30, Days after onset: 12
Location:Arizona  Entered:2010-11-30
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 DIAGNOSTICS111806P110IMLA
Administered by: Other     Purchased by: Private
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt. developed rash and hives. Pt came to pharmacy 1 week later and reported incident. Pt self treated with Benadryl.

VAERS ID:411090 (history)  Vaccinated:2010-11-16
Age:24.0  Onset:2010-11-30, Days after vaccination: 14
Gender:Female  Submitted:2010-12-02, Days after onset: 2
Location:Missouri  Entered:2010-12-02
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: No
Diagnostic Lab Data: Saw doctor at Urgent Care and he diagnosed Shingles.
CDC Split Type: Gardasil2ndof3shots
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IJLA
Administered by: Private     Purchased by: Other
Symptoms: Herpes zoster, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Noticed pain and Rash on back. Went to Dr. at 6pm on 12/1/2010 and was diagnosed with Shingles. I am being treated with Valtrex twice a day for 5 days.

VAERS ID:411693 (history)  Vaccinated:2010-09-28
Age:24.0  Onset:2010-11-16, Days after vaccination: 49
Gender:Female  Submitted:2010-11-30, Days after onset: 14
Location:Kentucky  Entered:2010-12-06, 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: low sodium - per pt
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0597Z0UNRA
Administered by: Public     Purchased by: Other
Symptoms: Asthenia, Condition aggravated, Nervousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Weakness, syncope, increased nervousness (Has hx of syncope since child, has gotten worse since receiving GARDASIL).

VAERS ID:411726 (history)  Vaccinated:2010-10-06
Age:24.0  Onset:0000-00-00
Gender:Female  Submitted:2010-10-12
Location:Arizona  Entered:2010-12-06, Days after submission: 55
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
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS111800P10UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0903Z0UNRA
Administered by: Other     Purchased by: Other
Symptoms: Unevaluable event
SMQs:
Write-up: Phone has been disconnected. No reply.

VAERS ID:411998 (history)  Vaccinated:2010-11-29
Age:24.0  Onset:2010-12-02, Days after vaccination: 3
Gender:Male  Submitted:2010-12-03, Days after onset: 1
Location:Virginia  Entered:2010-12-08, Days after submission: 5
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: Chest X-ray; EKG; CBC; Basic Chem7; Troponins
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURERFAV263 IMRA
Administered by: Military     Purchased by: Other
Symptoms: Chest X-ray, Chest discomfort, Dyspnoea, Electrocardiogram, Full blood count, Laboratory test, Oropharyngeal discomfort, Respiratory disorder, Troponin
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad)
Write-up: Throat discomfort interfering with breathing, shortness of breath, tightness of chest.

VAERS ID:412123 (history)  Vaccinated:2010-12-06
Age:24.0  Onset:2010-12-06, Days after vaccination: 0
Gender:Female  Submitted:2010-12-08, Days after onset: 2
Location:Massachusetts  Entered:2010-12-08
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: Asthma
Diagnostic Lab Data: Albuterol inhaler 2 puffs po, Epinephrine 0.5mL Im, 50 mg Benadryl po, and oxygen
CDC Split Type: MA1010
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH224AC IMLA
Administered by: Public     Purchased by: Public
Symptoms: Cough, Throat irritation, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Scratchy throat that progressed to a persistent cough and auditory wheeze upon inhalation.

VAERS ID:412202 (history)  Vaccinated:2010-12-07
Age:24.0  Onset:2010-12-07, Days after vaccination: 0
Gender:Female  Submitted:2010-12-08, Days after onset: 1
Location:Pennsylvania  Entered:2010-12-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE REPORTED AT TIME OF SCREENING
Preexisting Conditions: NONE REPORTED AT TIME OF SCREENING
Diagnostic Lab Data: Diagnosed with resulting cellulitis and abscess of upper arm and forearm. Prescribed cephalexin and going back in for follow up visit.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS111771P1 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Diarrhoea, Dizziness, Headache, Hyperhidrosis, Immediate post-injection reaction, Injection site abscess, Injection site cellulitis, Injection site erythema, Injection site swelling, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)
Write-up: Patient had an immediate acute reaction. Nausea, headache, sweating, loose bowels, dizziness, redness and swelling at injection site.

VAERS ID:412269 (history)  Vaccinated:2010-10-29
Age:24.0  Onset:2010-11-05, Days after vaccination: 7
Gender:Female  Submitted:2010-12-01, Days after onset: 26
Location:Oregon  Entered:2010-12-08, 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: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1539Y1UNLA
Administered by: Public     Purchased by: Unknown
Symptoms: Pain, Pain in extremity, Tenderness
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: 11/5 -$g present sharp spreading pain when lifting arm; tender/painful to touch at specific point on arm/shoulder on day of vaccine & following 3-5 days - spreading pain in arm.

VAERS ID:412560 (history)  Vaccinated:2010-12-01
Age:24.0  Onset:2010-12-02, Days after vaccination: 1
Gender:Female  Submitted:2010-12-03, Days after onset: 1
Location:Louisiana  Entered:2010-12-13, Days after submission: 10
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS111824P10IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site cellulitis
SMQs:
Write-up: Cellulitis at injection site.

VAERS ID:412905 (history)  Vaccinated:2007-06-01
Age:24.0  Onset:2007-06-01, Days after vaccination: 0
Gender:Female  Submitted:2010-12-14, Days after onset: 1292
Location:Unknown  Entered:2010-12-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory, positive
CDC Split Type: WAES1012USA01992
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Back disorder, Back pain, Convulsion, Extraocular muscle paresis, Headache, Hypoaesthesia facial, Laboratory test abnormal, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Information has been received via the internet from a 24 year old female consumer with no history of seizures who was vaccinated with the third dose of GARDASIL in June 2007. In August 2007 the patient was hospitalized due to back problems. It was reported that "the following day", the patient experienced seizures (it was also reported that the onset date of back pain and seizures was in June 2007). The patient stated she experienced the following "preliminary symptoms: left eye weakens, strong pain in left side of the head, tremors and no feeling in face etc." After several days of seizures they disappear for several months and then reoccur. The patient stated that she had referred to a neurologist who did not know how to help her. The patient visited an epilepsy clinic where she was told that it was all in her mind because all the tests came positive. The outcome of the back pain was unknown and at the time of this report the patient had not recovered from the seizures. The reporter felt that the seizures were related to therapy with GARDASIL. Upon internal review seizures were considered to be an Other Medical Event. Additional information is not expected.

VAERS ID:413084 (history)  Vaccinated:2010-12-16
Age:24.0  Onset:2010-12-16, Days after vaccination: 0
Gender:Female  Submitted:2010-12-17, Days after onset: 1
Location:Arizona  Entered:2010-12-17
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: no
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 0 LA
Administered by: Public     Purchased by: Private
Symptoms: Injection site discomfort, Injection site pain, Muscle fatigue
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Pretty severe pain and discomfort at the injection site. Muscle fatigue ...

VAERS ID:413119 (history)  Vaccinated:2010-11-10
Age:24.0  Onset:2010-11-11, Days after vaccination: 1
Gender:Female  Submitted:2010-11-12, Days after onset: 1
Location:Michigan  Entered:2010-12-17, Days after submission: 35
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: TYLENOL with codeine allergy
Diagnostic Lab Data:
CDC Split Type: MI2010025
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB174AA0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0647Z1SCRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3353AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1774Y0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Took (2) ALEVE yesterday - 2 PM warm compresses to site (varicella site). Posterior aspect of (L) upper arm red, swollen, itching & painful. Swelling approximately baseball size lump. Started swelling 11-11-10 & getting worse. Will see primary MD today. 11-12-10 Dr saw her & gave her a MEDROL pack & KEFLEX 500 mg BID x 10 days. 11-15-10 T/C - (L) upper arm feeling much better still some swelling.

VAERS ID:413154 (history)  Vaccinated:2010-12-09
Age:24.0  Onset:2010-12-09, Days after vaccination: 0
Gender:Female  Submitted:2010-12-20, Days after onset: 11
Location:Georgia  Entered:2010-12-20
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: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI))SANOFI PASTEURU3741AA  RA
Administered by: Other     Purchased by: Other
Symptoms: Skin discolouration, Skin exfoliation, Skin irritation, Skin mass
SMQs:, Severe cutaneous adverse reactions (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: The reaction I''m reporting may have been from the pain ease that was administered at the injection site with the flu vaccine. That product is by Gebauer's Pain ease and is a topical anesthetic spray. My arm had a big black spot that turned into a sore and begin to peel.

VAERS ID:413259 (history)  Vaccinated:2009-09-01
Age:24.0  Onset:2010-04-19, Days after vaccination: 230
Gender:Female  Submitted:2010-12-17, Days after onset: 242
Location:New York  Entered:2010-12-20, 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:
Preexisting Conditions: Caesarean section
Diagnostic Lab Data: beta-human chorionic, positive
CDC Split Type: WAES1003USA00488
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Pregnancy test positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a 25 year old female with no known drug reactions/allergies and with a history of caesarean section for first pregnancy who in approximately September 2009, "about six months ago" was vaccinated with the first dose of GARDASIL. Concomitant therapy included SUBOXONE. The patient reported that she received the third dose of GARDASIL the same day she had a positive pregnancy test. The patient reported to be about 1 month pregnant. The last menstrual period was estimated happened in January 2010 and the estimated delivery date is 08-OCT-2010. The patient sought medical attention visiting the physician. Follow up information has been received from a physician from a pregnancy questionnaire who reported that the patient had an elective termination of pregnancy on 19-APR-2010, 11 weeks from last menstrual period. It was unknown if the products of conception were examined. It was unknown if the fetus was normal. The patient''s last menstrual period was on 01-JAN-2010. Upon internal review elective termination was considered to be an other important medical event. No further information is available.

VAERS ID:413385 (history)  Vaccinated:2010-12-22
Age:24.0  Onset:2010-12-22, Days after vaccination: 0
Gender:Female  Submitted:2010-12-22, Days after onset: 0
Location:Oklahoma  Entered:2010-12-22
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: NA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB910AA IMRA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: NAUSEA/VOMITING, DIZZINESS, LIGHTHEADEDNESS, SYMPTOMS LASTED APPROX 30 MINS, TREATED WITH COLD COMPRESSES AND REST

VAERS ID:413476 (history)  Vaccinated:2010-10-14
Age:24.0  Onset:2010-12-08, Days after vaccination: 55
Gender:Male  Submitted:2010-12-23, Days after onset: 15
Location:Pennsylvania  Entered:2010-12-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CAT Scan, MRI, E.G.G., Cardio test, etc
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3730AA IJRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3476AA IJLA
Administered by: Private     Purchased by: Private
Symptoms: Cardiac function test normal, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Nuclear magnetic resonance imaging normal, 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: First time Seizure/Fainting. Went to see Doctor and tests came back normal. On 12/22/2010 around 9:30am had another seizure/fainting episode. Required Hospitalization.

VAERS ID:413700 (history)  Vaccinated:2010-12-21
Age:24.0  Onset:2010-12-21, Days after vaccination: 0
Gender:Female  Submitted:2010-12-27, Days after onset: 6
Location:Washington  Entered:2010-12-29, Days after submission: 2
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: Allergy to BENADRYL
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3666BA IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Chest pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: After receiving the flu shot had chest pain and troubles breathing. Was seen in the Emergency department. Meds given. All symptoms gone after about 48 hours.

VAERS ID:414037 (history)  Vaccinated:0000-00-00
Age:24.0  Onset:2009-12-01
Gender:Female  Submitted:2010-11-22, Days after onset: 356
Location:D.C.  Entered:2011-01-05, Days after submission: 44
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: None
Diagnostic Lab Data: Pap test, 12/??/09, CIM-3 abnormality with carcinoma in situ; Pap test, 09/08/10, no HPV was present
CDC Split Type: WAES1011USA01821
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Carcinoma in situ, Cervical dysplasia, Loop electrosurgical excision procedure
SMQs:, Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad), Non-haematological malignant tumours (narrow)
Write-up: Information has been received from a physician concerning a 24 year old female with no pertinent medical history and no drug reaction and allergies who on an unspecified day was vaccinated IM with the first 0.5ml dose of GARDASIL (lot number not provided). Concomitant therapy included oral contraceptive. In December 2009, some time after the first dose of GARDASIL, the patient had an abnormal Papanicolaou (pap) smear. The smear revealed a "CIM-3 abnormality with carcinoma in situ." On 12-FEB-2010 the physician performed a LEAP procedure on the patient. On 08-SEP-2010 this patient''s follow-up smear revealed that no HPV was present. The physician also mentioned that the patient received a second dose of GARDASIL (lot number not provided) late on 10-NOV-2010. At time of the report the patient was recovered. Upon internal review, a "CIM-3 abnormality with carcinoma in situ". was determined to be an other important medical event. Additional information has been requested.

VAERS ID:414046 (history)  Vaccinated:2008-11-01
Age:24.0  Onset:2009-10-07, Days after vaccination: 340
Gender:Female  Submitted:2010-11-22, Days after onset: 411
Location:Illinois  Entered:2011-01-05, Days after submission: 44
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 2/1/2009)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1011USA01568
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0947X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test, Drug exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient, with no pertinent medical history and no drug reactions or allergies, who in November 2008, was vaccinated with a first dose of GARDASIL (lot # 0947X, expire date 05-JUL-2010), 0.5 ml, intramuscularly. Concomitant therapy included vitamins. Subsequently, the patient realized she was pregnant. On an unspecified date, blood test and ultrasound (also reported as: ultrasound) were performed for routine prenatal care. The patient delivered a healthy male on 07-OCT-2009. During delivery, on 07-OCT-2009, the patient required IV and oxygen. In January 2010, the patient was vaccinated with the second dose of GARDASIL (lot # 1423X, expire date 20-JUN-2011), 0.5 ml, intramuscularly. "No adverse symptoms noted". On 11-NOV-2010, she was vaccinated with the third dose of GARDASIL (lot #, expire date not reported), 0.5 ml, intramuscularly. The registered nurse considered IV and oxygen requirements during delivery to be other important medical event. Additional information has been requested.

VAERS ID:414421 (history)  Vaccinated:2010-12-22
Age:24.0  Onset:2011-01-07, Days after vaccination: 16
Gender:Female  Submitted:2011-01-10, Days after onset: 3
Location:Texas  Entered:2011-01-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: soreness at infection site~HPV (Gardasil)~2~0.00~Patient
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. 2  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site mass, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: There was some swelling at site of injection after this HPV vaccine and it went away in days. There is now a bump at injection site that appeared weeks later and its tender.

VAERS ID:414522 (history)  Vaccinated:2011-01-03
Age:24.0  Onset:2011-01-12, Days after vaccination: 9
Gender:Male  Submitted:2011-01-12, Days after onset: 0
Location:Ohio  Entered:2011-01-12
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: None
Preexisting Conditions: None
Diagnostic Lab Data: ECG with ST elevation Elevated troponin and CK Normal echocardiogram
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04-003A0IDLA
Administered by: Military     Purchased by: Military
Symptoms: Blood creatine phosphokinase increased, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Myopericarditis, Troponin increased
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient arrived with chest pain to the emergency department. ECG demonstrated diffuse ST elevation consistent with pericarditis. Cardiac biomarkers to include CK and troponin were elevated thereby confirming myopericarditis.

VAERS ID:414600 (history)  Vaccinated:2009-11-04
Age:24.0  Onset:2009-11-20, Days after vaccination: 16
Gender:Female  Submitted:2011-01-13, Days after onset: 419
Location:Maryland  Entered:2011-01-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: Elevated CRP, platelets, erosive changes in hand x rays.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI))SANOFI PASTEURUP020AA IMLA
Administered by: Unknown     Purchased by: Other
Symptoms: C-reactive protein increased, Fatigue, Hypoaesthesia, Joint swelling, Musculoskeletal pain, Oedema peripheral, Paraesthesia, Platelet count increased, Rheumatoid arthritis, X-ray limb abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Osteonecrosis (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Started with shoulder pain, the shoulder the shot was given in. Fatigue was present at the same time. Then I had numbness and tingling in the lower arm and hand of the same side. The symptoms then presented in both arms/shoulder, then knees, ankles, feet, then I had swelling of the hands, feet and knees. The intial symptoms started in mid November and progressed quickly into December with worsening in January. I started seeing a doctor in early December, then a Neurologist late that month and then finally a Rheumatologist in February, who then diagnosed me with Rheumatoid Arthritis.

VAERS ID:414715 (history)  Vaccinated:2011-01-07
Age:24.0  Onset:2011-01-07, Days after vaccination: 0
Gender:Female  Submitted:2011-01-11, Days after onset: 4
Location:Tennessee  Entered:2011-01-14, 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: No
Preexisting Conditions: ASA; PCN; MOTRIN; Codeine; latex; DILAUDID
Diagnostic Lab Data: No testing
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3489AA UNLA
Administered by: Public     Purchased by: Public
Symptoms: Eye irritation, Oedema peripheral, Pain, Rash macular, Swelling face
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Corneal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Left-eye burning and had blotches under my eye. Went to sleep and after an hour whole face was swollen and had pain all over my body and had swelling of hands & feet, prescribed steroids and BENADRYL.

VAERS ID:415045 (history)  Vaccinated:2011-01-11
Age:24.0  Onset:2011-01-12, Days after vaccination: 1
Gender:Male  Submitted:2011-01-20, Days after onset: 8
Location:Wyoming  Entered:2011-01-20
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: EKG=normal variant
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.111320SCLA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Electrocardiogram normal, Heart rate irregular, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad)
Write-up: Dizziness, nausea, feeling of irregular heart rate. Had driven three days from state to state (elevation 7,220 ft)just prior to receiving vaccine.

VAERS ID:415097 (history)  Vaccinated:2011-01-11
Age:24.0  Onset:2011-01-11, Days after vaccination: 0
Gender:Female  Submitted:2011-01-19, Days after onset: 8
Location:California  Entered:2011-01-20, 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: Elevated CPK = 205 u/L
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1377Y2IMLA
Administered by: Other     Purchased by: Private
Symptoms: Blood creatine phosphokinase increased, Chest discomfort, Headache, Myalgia, Palpitations, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: Headache, muscle aches, chest tightness, unable to focus and palpitations.

VAERS ID:415297 (history)  Vaccinated:2010-08-10
Age:24.0  Onset:2010-11-07, Days after vaccination: 89
Gender:Female  Submitted:2011-01-24, Days after onset: 78
Location:Virginia  Entered:2011-01-24
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: The subject had no relevant medical history and no history of adverse events following previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0907909A
Vaccination
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Lot
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Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0UNLA
Administered by: Private     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: This retrospective pregnancy case was reported by a consumer and described the occurrence of miscarriage in a 24-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline) while pregnant. A physician or other health care professional has not verified this report. Concurrent medications included Multivitamins. On 10 August 2010 at 11:00 the subject received 1st dose of CERVARIX in the left arm. The subject discovered she was pregnant one week later on 18 August 2010. The subject experienced vaccine exposure during pregnancy. The date of last menstrual period was not provided and her estimated date of delivery was 20 May 2011. On 7 November 2010, 89 days after vaccination with CERVARIX, the subject experienced a miscarriage. This case was assessed as medically serious by agency. No additional details were provided.

VAERS ID:415373 (history)  Vaccinated:2011-01-19
Age:24.0  Onset:0000-00-00
Gender:Male  Submitted:2011-01-19
Location:Illinois  Entered:2011-01-25, Days after submission: 6
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
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Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH181AB1UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: None stated.

VAERS ID:415400 (history)  Vaccinated:2011-01-12
Age:24.0  Onset:2011-01-13, Days after vaccination: 1
Gender:Female  Submitted:2011-01-16, Days after onset: 3
Location:Utah  Entered:2011-01-25, Days after submission: 9
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: Allergic to strawberries; Asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
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Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU3553AA UNLA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Pain, Pruritus, Pyrexia, Swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Got the shot on 01-12-2011 - swelling - red - soreness - fevered - welted - itchy.

VAERS ID:415584 (history)  Vaccinated:2010-10-20
Age:24.0  Onset:2011-01-13, Days after vaccination: 85
Gender:Female  Submitted:2011-01-27, Days after onset: 14
Location:Texas  Entered:2011-01-27
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 is pregnant
Diagnostic Lab Data: 1) Rapid flu, A (+); 2) PCR confirmed, A (+) seasonal H3N2
CDC Split Type:
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH184AA IMUN
Administered by: Public     Purchased by: Unknown
Symptoms: Chills, Cough, Drug exposure during pregnancy, Influenza, Influenza A virus test positive, Pain, Paranasal sinus hypersecretion, Polymerase chain reaction, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Body aches, cough, chills and sinus drainage. Vaccine failure.

VAERS ID:415585 (history)  Vaccinated:2010-10-07
Age:24.0  Onset:2010-12-27, Days after vaccination: 81
Gender:Female  Submitted:2011-01-26, Days after onset: 30
Location:Texas  Entered:2011-01-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Patient is pregnant. GIPOAO at 40 wks, Oligohydramnios.
Diagnostic Lab Data: (1) Influenza An B antigen NP Swab 12/28/10 10:00 A - (+) Pos Type A; (2) Influenza PCR, influenza A H3 seasonal, 1/5/11
CDC Split Type:
Vaccination
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Lot
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Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3655AA0IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Drug exposure during pregnancy, Influenza, Influenza A virus test positive, Myalgia, Polymerase chain reaction, Pyrexia, Tachycardia, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient presented w/complaint of myalgia, subjective fevers at home. Mildly tachycardic. Tachycardia resolved with fluid bolus. Patient G/POAO at 40 wod. Tx: 1) Proceed with misoprostol induction of labor. 2) Start TAMIFLU. 3) IV fluids. 4) Anticipate SVD. Vaccine failure.

VAERS ID:415666 (history)  Vaccinated:2011-01-03
Age:24.0  Onset:2011-01-15, Days after vaccination: 12
Gender:Female  Submitted:2011-01-18, Days after onset: 3
Location:Minnesota  Entered:2011-01-28, Days after submission: 10
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: WBC-diff. normal values
CDC Split Type:
Vaccination
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Lot
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VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0895Z0UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Differential white blood cell count normal, Erythema, Injection site cellulitis, Oedema peripheral, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Seen in urgent care 1/17/11. Varicella vaccine 1/3/11. 2 days ago, 1/15 red, raised area on right arm which increased in size. Prior to redness, itchy. Size 3cm x 2cm. Treated for cellulitis at site 1/19/11 with LEVAQUIN.

VAERS ID:415708 (history)  Vaccinated:2011-01-27
Age:24.0  Onset:2011-01-27, Days after vaccination: 0
Gender:Female  Submitted:2011-01-28, Days after onset: 1
Location:South Dakota  Entered:2011-01-28
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: NKA; H/o asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3730AA3IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1021Z0IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Localized 6cm swollen area of erythema around immunization site no systemic effects.

VAERS ID:415783 (history)  Vaccinated:2011-01-10
Age:24.0  Onset:2011-01-13, Days after vaccination: 3
Gender:Female  Submitted:2011-01-30, Days after onset: 17
Location:Tennessee  Entered:2011-01-30
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: No
Diagnostic Lab Data:
CDC Split Type: HPV
Vaccination
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Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1 LA
Administered by: Public