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Case Details (Sorted by Age)

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VAERS ID:316177 (history)  Vaccinated:2008-05-02
Age:15.0  Onset:2008-05-02, Days after vaccination: 0
Gender:Male  Submitted:2008-05-02, Days after onset: 0
Location:Illinois  Entered:2008-06-13, Days after submission: 42
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2582AA0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Headache
SMQs:
Write-up: C/O severe headache

VAERS ID:316190 (history)  Vaccinated:2008-04-28
Age:15.0  Onset:2008-04-29, Days after vaccination: 1
Gender:Male  Submitted:2008-04-29, Days after onset: 0
Location:Unknown  Entered:2008-06-13, Days after submission: 45
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
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2582AA1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Body temperature, Headache, No reaction on previous exposure to drug
SMQs:
Write-up: Spoke with mother of 15 yo who states "took child to ER for c/o terrible headache. No nausea/vomiting slight temperature 99.4. Per mom has taken childhood immunizations OK in the past (still has not been seen by MD).

VAERS ID:316197 (history)  Vaccinated:2008-05-07
Age:15.0  Onset:2008-05-07, Days after vaccination: 0
Gender:Male  Submitted:2008-05-07, Days after onset: 0
Location:Illinois  Entered:2008-06-13, Days after submission: 37
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2616AA0IMRA
Administered by: Other     Purchased by: Public
Symptoms: Headache
SMQs:
Write-up: L temporal lobe scale of 4 (0-10) headache

VAERS ID:316203 (history)  Vaccinated:2008-04-29
Age:15.0  Onset:2008-04-29, Days after vaccination: 0
Gender:Female  Submitted:2008-04-29, Days after onset: 0
Location:Illinois  Entered:2008-06-13, Days after submission: 45
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: None Known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2582AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Grip strength decreased, Headache, Injected limb mobility decreased, Oedema peripheral, Pain in extremity, Palpitations, Skin discolouration, Tenderness
SMQs:, Cardiac failure (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient complained of increased left hand swelling, "turned purple" and pain in hand - thumbs and 1st finger, after receiving vaccine in left deltoid (0.5mL of meningococcal vaccine). Physical exam: no circulatory deficits, no swelling, no sensory deficits of left arm. * See attached: Patient complained of feeling pain in her left hand, swelling of left hand, and that her left hand turned "purple" soon after receiving her meningococcal vaccine, IM in her left deltoid. She also stated that she had a headache - she denied photosensitivity. Exam revealed 2+ radial pulses bilaterally, no circulatory deficits to left hand, no sensory deficits to left hand (simple touch). Patient was reluctant to strong left grip, to abduction of her left arm more than 110 degrees of elevation, because she complained of pain her left deltoid with these activities. Left deltoid (site of vaccination) had no swelling, warmth or erythema, and was somewhat tender to palpation. Patient stated she thought she would be okay during her last class, and had friends to walk her home. She stated she could not take pills, and usually takes pain medicine in liquid form. Since we had no liquid pain medicine available on site, she was instructed to take some pain medication (ibuprofen, acetaminophen) when she arrived home, and to inform her parent(s) and family doctor if she had worsening or persisting pain or discomfort.

VAERS ID:316229 (history)  Vaccinated:2008-06-11
Age:15.0  Onset:2008-06-11, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 2
Location:Wisconsin  Entered:2008-06-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~~0~In Sibling|none~ ()~~0~In Patient|none~ ()~~0~In Sibling
Other Medications: zyrtec 10 mg daily
Current Illness: none
Preexisting Conditions: seasonal allergies, born a month early, five pounds at birth
Diagnostic Lab Data: none was done and I did not receive any information on any possible side effects of the vaccine until after patient had a problem and we were ready to leave Dr. is our family doctor even though there were no doctors present when patient re
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1977U1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Confusional state, Dysarthria, Dysphonia, Eye swelling, Fall, Limb injury, Nervousness, Pallor, Speech disorder, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Patient received her vaccine then sat in a chair while her 14 year old brother got his second chicken pox shot, she was laughing and goofing around with her 12 year old brother. Then within minutes she was on the floor, her body started shaking and she started making noises. The nurse stated that this never happened before and ran out of the room to get Dr. After he was in the room a short time patient came to and he helped her back into the chair. He tried telling me that it was probably ''cause her blood sugar was low from not eating, not true she ate two hours before she got her vaccine. She was pale, confussed and talking slowly. Dr. then gave her some water and put an ice pack on the back of her neck, told me she''d be fine. For the next three hours at home patient was hoarse, had slurred speech and responded to everything very slowly. Her face ended up swollening as did her eyes, her face and eyes are still somewhat swollen today. She hurt her right thumb when she fell, Dr. said it is probably sprained, but never took an x-ray. We went back to see Dr. yesterday, patient still swollen and slow. She stated that maybe Patient just fainted because of being worked up about getting a shot but she has no idea why her speech would be slurred or why she would be hoars. I tried to explain to her that patient was not worked up about the shot and her and her brother were goofing around when patient ended up on the floor but she wouldn''t listen. She said that when people have a siezure they will pee and poop their pants, however I have friends that have siezures and they never have done that. The paper I received after patient''s reaction states that a reaction can happen within minutes to a few hours of the vaccine and the doctor keeps telling me it can''t happen that fast. Patient is still swollen this morning,she just got up so I am not sure how her reactions are. Patient gets almost all staight A+''s in school I am worried how this will effect her.

VAERS ID:316309 (history)  Vaccinated:2008-06-10
Age:15.0  Onset:2008-06-10, Days after vaccination: 0
Gender:Male  Submitted:2008-06-10, Days after onset: 0
Location:Maine  Entered:2008-06-16, 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: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB234BA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2617AA0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Fall, Head injury, Immediate post-injection reaction, Laceration, Syncope, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Syncope ~2 min after injection, fell, struck head (laceration), brief tonic/clonic movement.

VAERS ID:316339 (history)  Vaccinated:2008-06-11
Age:15.0  Onset:2008-06-11, Days after vaccination: 0
Gender:Male  Submitted:2008-06-16, Days after onset: 5
Location:Delaware  Entered:2008-06-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair 5 mg. once a day, Fexofenadine 180 mg. once a day, Multi-vitamin once a day, Albuterol as needed for asthma
Current Illness: N/A
Preexisting Conditions: Augmentin, Thimerosal, Latex Sensitive, & Seasonal Allergies
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2542AA0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Anxiety, Cold sweat, Dizziness, Dyspnoea, Erythema, Fall, Feeling cold, Hyperhidrosis, Loss of consciousness, Nausea, Oedema peripheral, Pruritus, Skin warm, Tenderness
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad)
Write-up: Approximately 5 - 10 minutes after receiving vaccine we were leaving and my son fell into the door frame and then in to me. I lowered him to the floor. He complained of feeling dizzy, nauseated, not being able to see, hard to breathe, and was sweating - although complaining of freezing. His skin was clammy to touch and warm. He never lost consciousness. Clinic staff checked his pulse and put a cool cloth on his head & neck. They told me he "passed out" due to anxiety - although he was NEVER anxious about the vaccine & never passed out completely. After 10 more minutes, I was told to take him home & let him rest. The next day, his left arm from shoulder to elbow was very swollen, dark red, itching, & tender to touch. I gave him benadryl every 6 hours & reported this to his physician. The physician said it sounded like an allergic reaction & continue with benadryl unless he has difficulty breathing & if that occurs, to take him to the ER. The arm remained swollen, red, tender, & itching for 2 more days. Benadryl was given during this time. Time of events were from 06/11/08 until 06/15/08.

VAERS ID:316375 (history)  Vaccinated:2008-06-12
Age:15.0  Onset:2008-06-12, Days after vaccination: 0
Gender:Male  Submitted:2008-06-13, Days after onset: 1
Location:Arizona  Entered:2008-06-16, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: Glucose = 63
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2573AA IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC528020AA IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Blood glucose decreased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt. was faint appox 10 min following inj. Vitals monitored. Pt''s FsBs was 63 - gave juice & crackers resolved within 30 min. Pt instructed to eat breakfast, especially prior to visit.

VAERS ID:316786 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-06-13
Location:Unknown  Entered:2008-06-16, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA00669
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Menstruation delayed
SMQs:, Fertility disorders (broad)
Write-up: Information has been received from a health professional concerning a 15 year old female who was vaccinated on an unspecified date with a dose of GARDASIL (lot# not reported). The patient''s mother called and stated her daughter''s menstrual period was delayed following vaccination. Subsequently, the patient recovered from her menstrual period being delayed. Additional information has been requested.

VAERS ID:316843 (history)  Vaccinated:2008-02-07
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-06-13
Location:Kansas  Entered:2008-06-16, Days after submission: 3
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:
CDC Split Type: WAES0805USA02333
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1287U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Menstruation irregular
SMQs:, Fertility disorders (broad)
Write-up: Information has been received from a registered nurse concerning a female who on 07-FEB-2008 was vaccinated IM in the left deltoid with the first dose of GARDASIL (lot# 655327/1287U). In approximately March 2008, the patient developed irregular menstrual cycles. In the last couple of months, the patient has been having about 2 periods a month compared to her usual 1 cycle monthly. The patient sought unspecified medical attention by contacting her physician''s office. The patient''s irregular menstrual cycles have persisted. There are no other details. Additional information has been requested.

VAERS ID:316848 (history)  Vaccinated:2008-05-12
Age:15.0  Onset:2008-05-12, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 32
Location:Georgia  Entered:2008-06-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA02871
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0152X2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Medical device complication, Pharmaceutical product complaint, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a healthcare worker concerning a 15 year old female who on 07-NOV-2007 was vaccinated with a first dose of GARDASIL (lot # not reported). On 10-JAN-2008 the patient was vaccinated with a second dose of GARDASIL (lot # not reported). On 12-MAY-2008 the patient was vaccinated with a third dose of GARDASIL (lot # 0152X). It was reported that "when attempting to administer the GARDASIL syringe, the plunger would not depress. According to the medical assistant, the white plastic tray was crushed at the end. The plastic seal was loose and up at the damaged end. The carton was not damaged. The syringe was removed from the package and the needle was placed on the syringe. The needle was in the patient''s arm and the plunger would not depress. When the needle was removed from the arm, the safety device activated. The syringe was discarded because the patient fainted and the medical assistant needed to put the syringe in a safe place." It was also reported that "they have been using the syringe for a while and are familiar with its use. The product was ordered directly from Merck. This was a product quality complaint. The patient was vaccinated successfully with another prefilled syringe. There were no problems reported. The SR# is 13050492422. Additional information has been requested.

VAERS ID:316880 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-06-13
Location:Unknown  Entered:2008-06-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Spaced out
Diagnostic Lab Data: None
CDC Split Type: WAES0805USA03625
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Muscle twitching
SMQs:, Dyskinesia (broad), Dystonia (broad)
Write-up: Information has been received from a nurse concerning her 15 year old daughter with a history of "zones out" who was vaccinated on an unspecified date with her second dose of GARDASIL (lot# not reported). There was no concomitant medication. In January 2008, the patient experienced twitching of her hands and feet. The patient''s twitching of her hands and feet persisted. Additional information has been requested.

VAERS ID:316987 (history)  Vaccinated:2008-05-15
Age:15.0  Onset:2008-05-15, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 29
Location:Kentucky  Entered:2008-06-16, 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:
Preexisting Conditions: None
Diagnostic Lab Data: computed axial, 05/15?/08, results not reported; spinal X-ray, 05/15?/08, results not reported
CDC Split Type: WAES0805USA04096
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
TDAP: TDAP (ADACEL)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram, Fall, Immediate post-injection reaction, Spinal X-ray
SMQs:, Accidents and injuries (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 15 year old female patient, with no medical history reported, who on 15-MAY-2008 was vaccinated with the first dose of GARDASIL (Lot #660387/1967U). Concomitant therapy included a dose of MENACTRA and a dose of ADACEL. On 15-MAY-2008 approximately three to four minutes after receiving the vaccine, the patient fell head first to the ground. She was taken to the emergency room but it was unknown if the patient was admitted. Diagnostic testing performed included a computed axial tomography and a cervical spine series, no results reported. At the time of this report the events had improved and the patient was recovering. No product quality complaint was involved. Additional information has been requested.

VAERS ID:316997 (history)  Vaccinated:2008-05-20
Age:15.0  Onset:2008-05-20, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 24
Location:Virginia  Entered:2008-06-16, 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: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0805USA04684
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Presyncope, Vaccine positive rechallenge
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning a 15 year old female who on unspecified dates was vaccinated with the first and second dose GARDASIL. On 20-MAY-2008, the patient received the third dose of GARDASIL. Following the immunizations the patient complained of feeling light-headed and dizzy; she didn''t actually pass out, but looked like she would pass out. They laid her back on the table and it resolved without any serious sequelae. Additional information has been requested.

VAERS ID:317009 (history)  Vaccinated:2008-05-08
Age:15.0  Onset:2008-05-08, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 36
Location:Tennessee  Entered:2008-06-16, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: neurological; serum glucose
CDC Split Type: WAES0805USA04907
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose, Dizziness, Neurological examination
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Information has been received from a physician concerning a 15 year old female who on 08-MAY-2008 was vaccinated with her first dose of GARDASIL (lot # unspecified). Concomitant suspect therapy included VARIVAX (lot # unspecified). Other concomitant therapy included MENACTRA and TETANUS TOXOIDS (lot#s unspecified). It was reported by physician, that the patient got really dizzy post vaccination on 08-May-2008. Physician noted that the patient came back on 12-May-2008 and still experiencing some dizziness, but has normal muscle strength. On unspecified date the neuro and glucose check were performed (results not reported). Unspecified medical attention was sought by visiting doctor''s office. At the time of this report, the patient had not recovered. Per physician, the patient will not be receiving any further GARDASIL shots. No further information provided. Additional information has been requested.

VAERS ID:317021 (history)  Vaccinated:2008-05-22
Age:15.0  Onset:2008-05-22, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 22
Location:Unknown  Entered:2008-06-16, 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: Unknown
Current Illness: Asthma; Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0805USA05110
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chills, Dizziness, Injection site erythema, Injection site swelling, Nausea, Paraesthesia, Pyrexia, Tremor
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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)
Write-up: Information has been received from a nurse practitioner concerning a 15 year old female with asthma and allergy to amoxicillin, who on 22-MAY-2008 was vaccinated intramuscularly with her second 0.5ml dose of GARDASIL (lot # 659964/1978U). Shortly after being vaccinated, the patient developed tingling in her arm, swelling and redness at the injection site, low fever (101.8 F), chills, shakiness, nausea and dizziness. It was reported that the patient was seen the next day in office and the symptoms seemed to be improving. At the time of this report, the patient was still recovering. No other information was available. Additional information has been requested.

VAERS ID:317039 (history)  Vaccinated:2008-05-20
Age:15.0  Onset:2008-05-22, Days after vaccination: 2
Gender:Female  Submitted:2008-06-13, Days after onset: 22
Location:Unknown  Entered:2008-06-16, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA06184
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: Information has been received from a physician concerning a 15 year old female who on 20-MAY-2008 was vaccinated with the first dose of GARDASIL (lot not reported). On 22-mAY-2008, 48 hours post vaccination the patient went to the E.R. experiencing shingles rash on her neck. The patient was given unspecified pain medication and discharged from the E.R. The patient''s outcome was not reported. Additional information has been requested.

VAERS ID:317063 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-06-13
Location:Florida  Entered:2008-06-16, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA01039
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Information has been received from a physician concerning a 15 year old female who was inadvertently vaccinated with an unspecified dose of GARDASIL (lot number unspecified) in the hip. Subsequently the patient experienced numbness on her leg. The patient sought unspecified medical treatment. The patient''s numbness in leg persisted. The patient was re-evaluated after 2 days. Her symptoms did not improve. Additional information has been requested.

VAERS ID:316386 (history)  Vaccinated:2008-05-30
Age:15.0  Onset:2008-05-30, Days after vaccination: 0
Gender:Female  Submitted:2008-06-12, Days after onset: 13
Location:Missouri  Entered:2008-06-17, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: unknown
Diagnostic Lab Data:
CDC Split Type: MO200815
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB144A0  RA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2562AA  LA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2771AA  LA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Incorrect dose administered, No adverse event
SMQs:
Write-up: patient given adult dose Hep A #1, patient 15 years old, no adverse effects reported. Immunization Rep instructed me to complete VAERS

VAERS ID:316390 (history)  Vaccinated:2008-06-17
Age:15.0  Onset:2008-06-17, Days after vaccination: 0
Gender:Female  Submitted:2008-06-17, Days after onset: 0
Location:Texas  Entered:2008-06-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic Acid
Current Illness: None
Preexisting Conditions: Thalassemia
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB233AA2IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2573AA1IMLA
Administered by: Public     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)
Write-up: Patient fainted and quickly recovered. The fainting spell lasted approximately 15 seconds. Patient was monitored for 20 minutes after fainting spell occurred. No further incidents were monitored during that time.

VAERS ID:316418 (history)  Vaccinated:2007-07-25
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-06-16
Location:West Virginia  Entered:2008-06-17, 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:
Preexisting Conditions: Papanicolaou smear abnormal
Diagnostic Lab Data: ultrasound, 08/23/2007, normal - reason for test: dating
CDC Split Type: WAES0710USA00505
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.1208F UNUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Caesarean section, Drug exposure during pregnancy, Labour complication, Smear cervix abnormal, Ultrasound scan normal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a physician assistant concerning a female (age not reported) with a history of abnormal Papanicolaou smear (CINI) who on 25-JUL-2007 was vaccinated with a dose of GARDASIL (lot # 654741/1208F) and was 5 weeks pregnant. The patient''s last menstrual period was reported to be on 24-JUN-2007 and an estimated delivery date of 30-MAR-2008. Concomitant therapy vaccination included MMR, vitamins (unspecified), hepatitis B virus vaccine (unspecified) and meningococcal vaccine (unspecified). On 23-AUG-2007 an ultrasound was performed with normal results. A "full prenatal panel" was also performed with an abnormal PAP smear. The patient''s status was reported as "good". Follow up information received on 09-JUN-2008. The physician assistant reported that the patient gave birth to a baby boy at 40 weeks gestation. He was 8lbs 8oz and Apgars were 7 and 8. He is healthy and normal and there were no gross anomalies listed. It was reported that the mother did have a c-section for failure to progress and no dilation, but there were no complications. Upon internal review c-section for failure to progress and no dilation was considered to be an other medical event. Additional information is not expected.

VAERS ID:316448 (history)  Vaccinated:2008-06-06
Age:15.0  Onset:2008-06-06, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Kansas  Entered:2008-06-17
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
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0874U0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2844AA0UNLA
Administered by: Public     Purchased by: Public
Symptoms: Body temperature increased, Injection site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: "Extreme pain" in rt. arm where Hep B was given. Pain cont. for several hours then began vomiting twelve hours later. Also ran temp of 102 degrees. Took ibuprofen.

VAERS ID:316505 (history)  Vaccinated:2008-06-10
Age:15.0  Onset:2008-06-11, Days after vaccination: 1
Gender:Male  Submitted:2008-06-12, Days after onset: 1
Location:Pennsylvania  Entered:2008-06-18, 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: Prozac, Trazadone, Claritin
Current Illness: None
Preexisting Conditions: Depression, Allergic Rhinitis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1775U1SCUN
Administered by: Private     Purchased by: Public
Symptoms: Cellulitis
SMQs:
Write-up: Cellulitis left arm, treated with Bactrim DS 1 BID for 7 days.

VAERS ID:316528 (history)  Vaccinated:2008-06-18
Age:15.0  Onset:2008-06-18, Days after vaccination: 0
Gender:Female  Submitted:2008-06-18, Days after onset: 0
Location:Wisconsin  Entered:2008-06-18
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.0188U1IMRA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Fall
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad)
Write-up: Administered HPV vaccine to patient at approx 8:30 am. Within 5 minutes she became dizzy and dropped to the floor but remained consious throughtout. Laid patient on floor with legs elevated for approx 10 min. Alert and Oriented x3. Shortly thereafter she was able to come to seated position, drinking fluids, sat for another 15 minutes in office and then felt much better. Released at approx. 9:00am w/mother.

VAERS ID:317520 (history)  Vaccinated:2007-05-29
Age:15.0  Onset:2007-05-29, Days after vaccination: 0
Gender:Female  Submitted:2008-05-28, Days after onset: 365
Location:Unknown  Entered:2008-06-18, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA02382
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1282F UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anxiety, Dizziness, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad)
Write-up: Information has been received from a registered nurse concerning a 15 year old female who "2 weeks ago," on approximately 29-MAY-2007, was vaccinated with hepatitis A virus vaccine inactivated (lot #656316/1282F) and became very anxious, dizzy and shaky, but did not faint (determined by nurse to be non-serious events). Subsequently, the patient recovered from very anxious, dizzy and shaky. The product quality complaint unit was not involved. Additional information has been requested.

VAERS ID:317526 (history)  Vaccinated:2007-07-05
Age:15.0  Onset:2007-07-05, Days after vaccination: 0
Gender:Male  Submitted:2008-05-28, Days after onset: 328
Location:New Jersey  Entered:2008-06-18, Days after submission: 21
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: diagnostic laboratory - unspecified
CDC Split Type: WAES0707USA01135
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0246U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNLA
Administered by: Private     Purchased by: Private
Symptoms: Adverse event, Laboratory test
SMQs:
Write-up: Information has been received from a physician concerning a patient who was vaccinated on an unknown date with a pediatric dose of hepatitis A virus vaccine inactivated. Subsequently the patient experienced an adverse event. There were no details to the adverse event, just that one occurred. The outcome was unknown. Follow-up information has been received from the physician concerning a 16-year-old male student with no pre-existing allergies, birth defects or medical conditions who on 05-Jul-2007, at approximately noon, was vaccinated in the right arm with an intramuscular first dose of hepatitis A virus vaccine inactivated (lot# 657304/0246U). Concomitant vaccination included a dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) in the left arm. There was no illness at the time of vaccination. On 05-Jul-2007 at 2 PM an adverse event occurred which required a doctor visit and emergency room (ER) visit. Unspecified diagnostic tests and laboratory data were performed in the ER. The patient recovered on 06-Jul-2007. Additional information has been requested.

VAERS ID:317665 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-30
Location:Unknown  Entered:2008-06-18, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA01770
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Deafness
SMQs:, Hearing impairment (narrow)
Write-up: Information has been received from a registered nurse concerning a 15 year old female who on an unspecified date was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was indicated by the nurse that the patient developed hearing loss after receiving measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). A product quality complaint was not reported. Additional information has been requested.

VAERS ID:317694 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-30
Location:Unknown  Entered:2008-06-18, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA03740
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Deafness
SMQs:, Hearing impairment (narrow)
Write-up: Information has been received from a nurse practitioner concerning a 15-year-old female who in approximately 1997 was vaccinated with a dose of MMR II. Subsequently the patient experienced gradual/significant hearing loss. The patient now uses a bilateral hearing aid. The patient''s gradual/significant hearing loss persisted. Unspecified medical attention was sought. There was no product quality complaint. Gradual/significant hearing loss was considered to be disabling. Additional information has been requested.

VAERS ID:316588 (history)  Vaccinated:2008-04-24
Age:15.0  Onset:2008-04-24, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 50
Location:Unknown  Entered:2008-06-19, 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: Pregnancy NOS, Latex allergy
Preexisting Conditions: Tonsillectomy, LMP = 02/05/2008
Diagnostic Lab Data: beta-human chorionic - positive
CDC Split Type: WAES0805USA01266
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0929U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Malaise, Nausea, Pallor, Pregnancy test positive
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a mother, for the Pregnancy Registry for GARDASIL vaccine (yeast), concerning her 15 year old daughter with a history of latex allergy and tonsillectomy who on 24-APR-2008 was vaccinated with her first dose of GARDASIL vaccine (yeast) (Lot #, size, and route not reported). There was no concomitant medication. On 24-APR-2008 the patient "became pale, and she was nauseous and sick for one day". On an unspecified date, the patient took a pregnancy test which was positive (not further specified) (LMP approximately 05-FEB-2008, "estimated date of conception is 27-Feb-2008"). On 25-APR-2008, the patient fully recovered from paleness, nausea and being sick. The patient sought unspecified medical attention. No additional information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/13/2008.

VAERS ID:316599 (history)  Vaccinated:2008-01-21
Age:15.0  Onset:2008-01-21, Days after vaccination: 0
Gender:Female  Submitted:2008-06-18, Days after onset: 148
Location:Unknown  Entered:2008-06-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0806USA02446
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.126701IMUN
Administered by: Other     Purchased by: Other
Symptoms: Alcohol abuse, Depression, Drug abuse, Neck pain
SMQs:, Drug abuse and dependence (narrow), Depression (excl suicide and self injury) (narrow), Arthritis (broad)
Write-up: Information has been received from a nurse practitioner concerning a 16 year old female with pertinent medical history and drug reactions/allergies reported as unspecified, who on 19-NOV-2007 was vaccinated IM with the first dose of GARDASIL. Concomitant medications were reported as none. It was reported that the second dose of GARDASIL was given IM on 21-JAN-2008, and subsequently the patient experienced neck pain. The patient did not notify the nurse practitioner of this experience until she went in to received her third dose of GARDASIL on 11-JUN-2008. The patient did not go on to complete the series and was waiting till more information was available regarding this. The patient sought medical attention at the hospital on an unspecified date, where she was observed and then released. No treatment information had been provided. The neck pain healed "on its own". Additional information has been requested. 10/10/08 Hospital medical records reviewed for 6/2008. FINAL DX: alcohol & cannabis abuse, possible recurrent depression.

VAERS ID:316657 (history)  Vaccinated:2008-06-19
Age:15.0  Onset:2008-06-19, Days after vaccination: 0
Gender:Female  Submitted:2008-06-19, Days after onset: 0
Location:Iowa  Entered:2008-06-19
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.1976U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2537AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Hypotonia, Pallor
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: pt received menactra and gardasil. Within 30-60 seconds she was pale around the mough and then limp in her chair. Assisted her to the floor and fanned her. Recovery began within the next 1-2 minutes. Allowed her to lay, then sit on floor, then to chair before leaving at approx 15 mins. Denied any reoccuring feelings, and insisted she felt ok at that time.

VAERS ID:316690 (history)  Vaccinated:2007-07-01
Age:15.0  Onset:2007-07-01, Days after vaccination: 0
Gender:Female  Submitted:2008-06-19, Days after onset: 354
Location:Unknown  Entered:2008-06-20, 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: Unknown
Current Illness: Pregnancy NOS (LMP = Unknown)
Preexisting Conditions:
Diagnostic Lab Data: Apgar score, 01/31/08, 9/9
CDC Split Type: WAES0709USA00326
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Apgar score normal, Arrested labour, Caesarean section, Drug exposure during pregnancy, Foetal distress syndrome, Foetal heart rate decreased
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)
Write-up: Initial and follow up information has been received from a certified nurse midwife and a nurse for the Pregnancy Registry for GARDASIL concerning a female (age not reported) who in July 2007, was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL. The certified nurse midwife reported that the patient was already pregnant (about 20 weeks gestation) when she received her first dose of GARDASIL. The patient sought unspecified medical attention. No other symptoms were noted. There was no product quality complaint involved. On 06-JUN-2008 a follow up telephone call was made to the doctor''s office to know the patient''s pregnancy outcome information and a telephone message was left. ON 11-JUN-2008 a nurse called back and reported that the patient had a primary cesarean section at term on 31-JAN-2008 and delivered a healthy and normal male baby weighing 7 lb, 10 oz. The baby''s apgar score was 9/9. It was reported that the reason for the C-section was arrested descent in second stage with fetal intolerance to labor resulting in multiple deep variable decelerations. No complication was reported. Upon internal review patient having arrested descent in second stage of labor and fetal intolerance to labor resulting in multiple deep variable decelerations which required a cesarean section delivery were determined to be other important medical events. Additional information is not expected.

VAERS ID:316764 (history)  Vaccinated:2008-06-18
Age:15.0  Onset:2008-06-18, Days after vaccination: 0
Gender:Female  Submitted:2008-06-20, Days after onset: 2
Location:Maine  Entered:2008-06-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2633AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Deltoid swollen, red, hot touch, painful. Ice, Advil/Tylenol prn.

VAERS ID:316872 (history)  Vaccinated:2008-06-18
Age:15.0  Onset:2008-06-18, Days after vaccination: 0
Gender:Female  Submitted:2008-06-18, Days after onset: 0
Location:Ohio  Entered:2008-06-23, 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: Robitussin CF for cough
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Blood pressure, Dizziness, Heart rate, Respiratory rate
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: 1022 Immunisation given, sat in chair with nurse until 1027. Walked with nurse and father - she felt lightheaded, legs buckled, escorted to chair, smelling salts used, assisted to bench in lying position, legs elevated, cold compress and cold drink given. BP 110/50, P 56, R 20 assessed by doctor. Color returned, sitting up for 5 min. Escorted out by father.

VAERS ID:316944 (history)  Vaccinated:2008-05-09
Age:15.0  Onset:2008-05-10, Days after vaccination: 1
Gender:Male  Submitted:2008-05-12, Days after onset: 2
Location:Texas  Entered:2008-06-23, Days after submission: 42
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NONE~ ()~NULL~~In Patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1465U1SCRA
Administered by: Unknown     Purchased by: Public
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: PER MOM: 5/9/08 - SON C/O R.A. "SORE". 5/10/08 - ARM WAS RED & SLIGHT SWELLING 5/11/08 - INCREASED SWELLING, ALMOST DOUBLE THE SIZE FROM 5/10, ABOUT 5". TAKEN TO ER AT 11:00 PM - MD DX CELLULITIS TR. BACTRIM TO TAKE QID. X14D.NO CULTURE OR LABS DONE. AN ULTRASOUND DONE: NO ABSCESS SEEN UNDER THE SKIN. TOLD TO APPLY HEAT PAD TO SITE. FOLLOW UP WITH PCP THIS WEEK. HE MISSED SCHOOL 5/12/08 DUE TO REACTION. THINKS MAY BE STAPH OR STREP INFECTION CELLULITIS.

VAERS ID:316947 (history)  Vaccinated:2008-05-24
Age:15.0  Onset:2008-06-10, Days after vaccination: 17
Gender:Female  Submitted:2008-06-23, Days after onset: 13
Location:New York  Entered:2008-06-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None known
Preexisting Conditions: systemic lupus erythmatosis and lupus nephritis 7/3/08-records received- Diagnosed with SLE with nephritis 2007.
Diagnostic Lab Data: awaitng results for viral culture obtained 6/20/08
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.L5L4U   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Acne, Blister, Conjunctival hyperaemia, Eye swelling, Eyelid oedema, Local swelling, Pyrexia, Rash macular, Rash pustular, Rhinorrhoea, Varicella, Virus culture
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conjunctival disorders (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: Afew days after recieving the vaccine the pt developed runny nose and swelling in the rt side of her neck. No fever at that time. On June 10(22 days after dose) pt noted a "pimple on her face" followed on June 11th by 3 vesicles on her left arm, no fever. She was seen by PMD and was treated with ibuprofen and augementin at that time. By 6/15/08 lesions had spead to legs, trunk and face. On 6/17/08 she developed a fever to 102 and was seen at ER. She was started on acyclovir and her Mycophenolate was stopped that that time. ON 6/19/08 she was again seen in the ER for worsening lesions including swelling of right eye. She was admitted for IV acyclovir treatmetn at this time. 7/3/08-records received for DOS 6/19-6/25/08-DC DX: Varicella. SLE with nephritis. C/O generalized vesicles, pustules, fever, rash macular, right eyelid swelling, mild conjunctival injection. Vaccine administered on 5/24/08 and first presented on 6/17/08.

VAERS ID:316950 (history)  Vaccinated:2008-06-20
Age:15.0  Onset:2008-06-20, Days after vaccination: 0
Gender:Female  Submitted:2008-06-23, Days after onset: 3
Location:Maine  Entered:2008-06-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: well visit
Preexisting Conditions: chiari 1 malformation, NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B020AA1IMRA
Administered by: Private     Purchased by: Public
Symptoms: Head injury, Nervousness, Syncope, Syncope vasovagal, 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), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Vaso Vagal event: Patient was very nervous prior to receiving vaccine. Tolerated vaccination well, sat 10 minutes after receiving vaccine. Mother was checking out and patient met mother at reception desk. After 3 minutes or so patient fainted. Hit back of head on exit door. She was out for 10-15 seconds. Patient came to, fundus was clear w/o PE. Patient alert and responsive and appropriate when questioned.

VAERS ID:316982 (history)  Vaccinated:2007-04-13
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-06-16
Location:Pennsylvania  Entered:2008-06-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? Yes
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: blood work; breast ultra sound
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0017U0UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0388U0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2225AA0UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Blood test, Fibroadenoma of breast, Surgery, Ultrasound breast
SMQs:
Write-up: surgical removal of giant fibroidenoma from left breast. Further plastic surgery required. Tumor was 14cm by 13cm by 6cm.

VAERS ID:317064 (history)  Vaccinated:2008-06-16
Age:15.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:2008-06-23, Days after onset: 7
Location:Pennsylvania  Entered:2008-06-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0067X0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Syncope- this pt actually passed out about 3 minutes after receiving the injection. We had to use an ammonia inhalant to help her come to.

VAERS ID:317148 (history)  Vaccinated:2007-02-03
Age:15.0  Onset:2007-11-01, Days after vaccination: 271
Gender:Female  Submitted:2008-06-16, Days after onset: 228
Location:Indiana  Entered:2008-06-24, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.AHAVB163AB UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2228AA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Alopecia, Dizziness, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad)
Write-up: (1) hair loss June 08'', (2) eye lashes falling out Nov 07'', (3) dizzy/shaking/light headedness Nov 07''

VAERS ID:317171 (history)  Vaccinated:2008-06-19
Age:15.0  Onset:2008-06-19, Days after vaccination: 0
Gender:Female  Submitted:2008-06-19, Days after onset: 0
Location:Pennsylvania  Entered:2008-06-24, 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: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U0IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Head injury, Joint injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient had received her 1st GARDASIL injection. While receiving return visit instructions, patient fainted, hitting her head L elbow & L knee. Attended by staff & MD. Vital signs WNL, examined by MD & given po fluids prior to discharge home.

VAERS ID:317223 (history)  Vaccinated:2008-02-12
Age:15.0  Onset:2008-02-20, Days after vaccination: 8
Gender:Male  Submitted:2008-02-21, Days after onset: 1
Location:Texas  Entered:2008-06-24, Days after submission: 123
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DAD SAID "ACNE" MED/TOPICAL
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2550AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2844AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Fatigue, Malaise, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: FACIAL RASH; GENERAL MALAISE/FATIGUE ADVISED DAD TO V /C PHYSICIAN. WILL LET ME KNOW HOW PT IS.

VAERS ID:317268 (history)  Vaccinated:2008-01-23
Age:15.0  Onset:2008-02-14, Days after vaccination: 22
Gender:Female  Submitted:2008-06-22, Days after onset: 128
Location:Massachusetts  Entered:2008-06-24, 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: ORTHO TRI-CYCLEN
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.05220IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Malaise, Pain in extremity, Skin exfoliation, Urticaria
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives all over body, x 5days, scaling feet and hands, pain feet with walking, c/w severe sickness; treated Prednisone P8. Benadryl. hives still continue /on/off

VAERS ID:317337 (history)  Vaccinated:2007-09-10
Age:15.0  Onset:2007-09-10, Days after vaccination: 0
Gender:Female  Submitted:2008-06-24, Days after onset: 288
Location:Ohio  Entered:2008-06-25, 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: Unknown
Current Illness:
Preexisting Conditions: Ear disorder
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA03564
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Caesarean section, Drug exposure during pregnancy, Labour complication, Live birth
SMQs:, 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 her 15 year old daughter with a history of ear problems who on 10-SEP-2007 was vaccinated with her first dose of GARDASIL and is pregnant. Her last menstrual period was reported as 22-AUG-2007 and her estimated delivery date was 28-MAY-2008. The patient sought unspecified medical attention. Follow-up information has been obtained from a registered nurse who reported that the patient delivered a full term 9 pound 21 inch long, normal, healthy, female via primary cesarean section on 22-MAY-2008. There were no reported complications or congenital anomalies. Upon internal review it was determined that the labour complication that required a cesarean section was an other important medical event. Additional information has been requested.

VAERS ID:317389 (history)  Vaccinated:2008-06-25
Age:15.0  Onset:2008-06-25, Days after vaccination: 0
Gender:Female  Submitted:2008-06-25, Days after onset: 0
Location:Ohio  Entered:2008-06-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Said she was having stomach cramps from menses
Preexisting Conditions: allergic to zithromax
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0379U2IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U1IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1781U1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Gaze palsy, Musculoskeletal stiffness, Pallor, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: After injection of Hep B and varicella in the left arm and then Gardasil in the right arm, patient became very pale and she lay back on the exam table and was nonresponsive. Her eyes rolled back and her legs and arms stiffened. Eyes remained open throughout the episode and she "came to" within 1 minute. She continued to be pale for about 5 minutes but was oriented to person and place immediately upon "coming to". She sat up after about 10 minutes, color slowly came back to her lips.

VAERS ID:317608 (history)  Vaccinated:1997-12-29
Age:15.0  Onset:1997-12-29, Days after vaccination: 0
Gender:Male  Submitted:2008-06-27, Days after onset: 3832
Location:Texas  Entered:2008-06-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fatigue
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 2UNUN
Administered by: Public     Purchased by: Private
Symptoms: Fatigue, Hypersomnia, Impaired work ability
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad)
Write-up: Constant fatigue starting upon date of vaccination. Have not fully recovered, was not aware of vaccine related condition until recently. Assumed normal condition. I feel tired and tend to need a lot of sleep. I am able to average about 3 days of work per week before the fatigue forces me to rest.

VAERS ID:317630 (history)  Vaccinated:2008-05-21
Age:15.0  Onset:2008-05-21, Days after vaccination: 0
Gender:Female  Submitted:2008-06-26, Days after onset: 36
Location:Alabama  Entered:2008-06-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0927U2IMRA
Administered by: Private     Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: pt fainted approximately 3-4 minutes past receiving vaccination. No treatment required.

VAERS ID:317752 (history)  Vaccinated:2008-06-13
Age:15.0  Onset:2008-06-13, Days after vaccination: 0
Gender:Unknown  Submitted:2008-06-27, Days after onset: 14
Location:California  Entered:2008-06-27
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
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B069AB1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2546AA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0168X1SCRA
Administered by: Unknown     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:
Write-up: GAVE DTAP INSTEAD TDAP

VAERS ID:317757 (history)  Vaccinated:2008-06-13
Age:15.0  Onset:2008-06-15, Days after vaccination: 2
Gender:Female  Submitted:2008-06-27, Days after onset: 12
Location:Indiana  Entered:2008-06-27
Life Threatening? No
Died? Yes
   Date died: 2008-06-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: overweight PMH: recurrent colds/sore throat, neg strep.
Diagnostic Lab Data: toxicology and other test came back negative expect trace amount of nicotine (father heavy smoker)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1447U0UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arrhythmia, Cardiomegaly, Cardiomyopathy, Cyanosis, Death, Left ventricular hypertrophy, Muscle rigidity, Obesity, Passive smoking, Pulmonary oedema, Splenomegaly, Toxicologic test normal, Unresponsive to stimuli
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Death -coroner says enlarged heart & enlarge spleen 7/4/08 Reviewed PCP medical records of 1999-6/2008 which included vax record. In 8/2007, c/o of tiredness & loss of appetite. Monospot (-). On day of vax, patient was well, weight noted as 237, otherwise no complaints. 7/8/08 Autopsy report states COD as arrhythmia due to cardiomyopathy.States anatomic findings of obesity, pulmonary edema, mild & left ventricular hypertrophy w/myocardial nuclear enlargement. Patient had been found non-responsive by family. EMS found patient cyanotic w/rigor & no further resuscitation was performed. Family reported patient had been well earlier in the evening. Albuterol inhaler was found at scene but no suspicious features at scene.

VAERS ID:317762 (history)  Vaccinated:2008-05-06
Age:15.0  Onset:2008-05-07, Days after vaccination: 1
Gender:Male  Submitted:2008-06-27, Days after onset: 51
Location:New York  Entered:2008-06-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: none~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1|none~ ()~NULL~~In Sibling2
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: sensitive to pennicillan
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2568AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Chills, Confusional state, Fatigue, Feeling abnormal, Grip strength decreased, Hypotonia, Injection site pain, Injection site swelling, Injection site warmth, Loss of consciousness, Muscular weakness, Musculoskeletal stiffness, Pallor, Pyrexia, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad)
Write-up: Patient was otherwise healthy, had one small cold in over a year. Vaccine was at 3:30pm on 5/6/08. By that night, patient''s vaccine site was swollen, warm and painful. Patient had 100mg. of Ibuprofen and ice on site. When patient woke in morning of 5/7/08 at 5:45am, he complained that he was unusually tired. He seemed a bit spaced out. He went to school. Not recognizing he was not well, he said his legs were really tired through the day, and at Gym class (9:30am)he realized that he kept losing grip of a baseball bat. He ate lunch at 10:30am and still felt a bit tired. By 2:00pm it seems he lost conciousness in the classroom. He said everything turned white and he fainted. At this point he might have hit his head, had symptoms of a concusion. He blacked out a few times in a wheel chair to and at the health office at school. I arrived at the school by 2:30pm. I witnessed his confusion and dazed behavior. He was shaking and had the chills. His temperature was 99, he had a stiff appearence. The most startling event that I witnessed and the EMT said was not typical of a concusion was that his face seemed almost paralyzed. His face was green/greyish and lack of color. He had no muscle tone in his face. One eye was somewhat lower than the other. The EMT checked for signs of a stroke, it was negative. They took him to the Emergency room. He was given glucose and orange juice and by 5:00pm he was more like himself, including color and muscle-tone in his face. His arms and legs were still weak and still had a low fever for another 2 days. The injection site was swollen for another few days. The Doctors denied that this might have been an adverse reaction to the Menactra vaccine. I think it''s just too much of a coincidence for it not to be related. Thankfuly he recovered.

VAERS ID:317789 (history)  Vaccinated:2008-06-27
Age:15.0  Onset:2008-06-27, Days after vaccination: 0
Gender:Male  Submitted:2008-06-27, Days after onset: 0
Location:Georgia  Entered:2008-06-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB249AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2766AA0UNLA
Administered by: Public     Purchased by: Unknown
Symptoms: Dizziness, Feeling hot, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: 2 vaccines administered, one to each deltoid muscle. Client stood up after approximately one minute and began to "feel lightheaded and hot." He sat down and then fainted. he recovered completely within 2-3 minutes. His father was present/assisted him out.

VAERS ID:317968 (history)  Vaccinated:2008-06-20
Age:15.0  Onset:2008-06-27, Days after vaccination: 7
Gender:Female  Submitted:2008-07-01, Days after onset: 4
Location:Florida  Entered:2008-07-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none stated 7/21/08-records received-PMH: anorexia, migraine headaches.
Diagnostic Lab Data: unsure 7/21/08-records received-CXR normal. WBC 14.2, neurtrophils 85.7. 8/13/08 Yellow Fever Lab Results from CDC lab: Note: Temporary related to typhoid vaccine, not consistent with YF vaccine AE, no labs obtained
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD3001378 PO 
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF301A SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Chest X-ray normal, Fatigue, Headache, Myalgia, Nausea, Neutrophil count increased, Pain, Pyrexia, Rash, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Recieved yellow fever vaccine and oral typhoid vaccine on 6/20/08. Mother called on 6/27/08 and left message with RN, stating that patient was running fever of 101F and was complaining of achiness and headache when she took the oral typhoid and had just finished the last of the doses that morning. Mother stated that this happened with each typhoid dose. RN then came to me with the information and we looked at the side effects for each vaccine on the VIS''s and returned mother''s called telling her that the symptoms patient was having were within the possible side effects for the vaccines according the VIS but as we were not able to see her daughter if she felt that she needed medical attention to call her daughter''s Dr or take her to the ER. I spoke with the mother 7/1/08 and she stated that she spoke with a friend who is Dr of infectious diease and he told her to bring patient to ER where she was admitted and given IV antibiotics, mother was not sure which antibiotic she was given but patient was discharged 6/30/08 to home and was apparently doing well. Mother was at the gym and she was unable to talk long. 7/21/08-records received for DOS 6/27/08 presented to ED with E/O fever and not beeling well. Symptoms began today, loss of appetite, muscle aches, fatigue, skin rash. Throbbing global headache associated with nausea. Clinical impression:fever possible typhoid.

VAERS ID:317993 (history)  Vaccinated:2008-06-20
Age:15.0  Onset:2008-06-20, Days after vaccination: 0
Gender:Female  Submitted:2008-06-20, Days after onset: 0
Location:North Carolina  Entered:2008-07-01, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: mom states child had dizzy faint/hot feeling one hour after hepatitis A vaccine~Hep A (no brand name)~UN~0~In Patient
Other Medications: None
Current Illness: None -$g at office for vaccine
Preexisting Conditions: NKA
Diagnostic Lab Data: None done
CDC Split Type: NC08083
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0053X1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood pressure, Cold sweat, Dyskinesia, Heart rate normal, Respiratory rate increased, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt given vaccine & spoke a few words & 1-2 min later closed eyes & mildly jerked a couple of times & unresponsive. Pt breathing without difficulty. Skin cool & clammy. After 10 seconds became responsive & answered nurse. Once awakened child was oriented to person & place. VS BP 92/52 HR 72 R 28. Pt rested laying down. Dr. examined child. After 30 min child alert/smiling. Skin warm & dry. No complaints BP 90/52 P 76 R 24. Oriented to person/place/time.

VAERS ID:318005 (history)  Vaccinated:2008-06-20
Age:15.0  Onset:2008-06-21, Days after vaccination: 1
Gender:Female  Submitted:2008-06-25, Days after onset: 4
Location:Texas  Entered:2008-07-01, 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: ADVAIR DISKUS, DUAC OS, SEROQUEL XR, XOPENEX HFA
Current Illness:
Preexisting Conditions: NKDA, asthma, depression
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0017U1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU26369AA0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site pain, Injection site papule, Injection site pruritus, Injection site rash, Injection site swelling, Pruritus, Rash papular
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Pain & swelling R deltoid. Papular rash at R & L deltoid & upper back with itching. Pt began having symptoms 06/21/08.

VAERS ID:318006 (history)  Vaccinated:2003-06-24
Age:15.0  Onset:2003-06-24, Days after vaccination: 0
Gender:Female  Submitted:2008-06-25, Days after onset: 1828
Location:Pennsylvania  Entered:2008-07-01, 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: Ortho Tricycline Lo
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB224BA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0063X0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2774AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Hypotonia, Pallor
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: After receiving 3rd and last vaccine, turned pale and became limp while sitting on exam table. Had her lay down and was OK with seconds although still pale. BP 118/70. Checked by doctor. Left office after 20 min and appeared fine.

VAERS ID:318058 (history)  Vaccinated:2008-03-25
Age:15.0  Onset:2008-05-12, Days after vaccination: 48
Gender:Female  Submitted:2008-07-01, Days after onset: 50
Location:Rhode Island  Entered:2008-07-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: allergy to amoxicillin (reaction not known); no birth defects or medical conditions
Diagnostic Lab Data: EEG shows subclinical seizures, MRI shows symmetric abnormal T2 bright signal within the head, body, and tail of the hippocampus bilaterally, worse on the right side. CSF IgG synthesis rate is increased. 8/21/08-records received-CSF 94 white blood cells. EEG showed 2 right subclinical seizures. Labs negative for infection. MRI abnormal with increased hippocampal uptake and limbic encephalopathy involving grey matter more than white matter. Holter monitor normal.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Aura, Blood product transfusion, CSF immunoglobulin increased, CSF test normal, Cognitive disorder, Convulsion, Dyspnoea, Electrocardiogram ambulatory normal, Electroencephalogram abnormal, Encephalopathy, Fatigue, Feeling abnormal, Headache, Memory impairment, Nausea, Nuclear magnetic resonance imaging abnormal, Pallor, Palpitations, Personality change, Supraventricular tachycardia, Tachycardia, Weight increased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad)
Write-up: Patient is on our inpatient service, currently on hospital day 13, admitted with 7 week history of limbic encephalopathy of unknown etiology. Symptoms inlcude 7 week history of episodes of palpitations and an olfactory aura, often followed by headache. Clinically, she demonstrates severe impairment in ability to form new long-term memories. 8/21/08-records received for DOS 6/19-7/2/08-DC DX: Limbic encephalopathy of unknown etiology. Presented with tachycardia and or pallor in setting of memory dysfunction. C/O episodes of fatigue, tachycardia associated with intermittent and occasional shortness of breath, pallor and dazed expression, nausea. Memory changes. On 5/12 presented to ED and diagnosed with questionable supraventricular tachycardia. Seen by neurologist for headaches. Personality changes increased laughter and hyperphasia and weight gain. Treated with IVIG. 1/25/2010 Persisted, severe cognitive impairments particulary memory. Unable to return to regular school. Personality change as well. Follow-up Information 15-OCT-2008: 1st doses HPV 1-28-08. 2nd doses HPV 3-25-08. 3rd doses Pt was hospitalized was not administered.

VAERS ID:318310 (history)  Vaccinated:2006-06-30
Age:15.0  Onset:2006-06-30, Days after vaccination: 0
Gender:Female  Submitted:2006-06-30, Days after onset: 0
Location:Massachusetts  Entered:2008-07-07, Days after submission: 738
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: JRA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0072X0IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2550AA0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Blood pressure, Dizziness, Gaze palsy, Heart rate decreased, Hyperhidrosis, Nausea, Pallor, Syncope, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Pt felt lightheaded and fainted. Some LUE tonic/clonic movement, eyes rolled back, head turned to R. This episode lasted less than 10 sec. Pt was pale, diaphoretic with nausea. Monitor pt for 30 min. BP 116/68 - 104/70 HR 52, lips pink, good cap. refill - color improved, sm. sip of cl. liquid. D/C home with mom.

VAERS ID:318365 (history)  Vaccinated:2008-07-02
Age:15.0  Onset:2008-07-04, Days after vaccination: 2
Gender:Female  Submitted:2008-07-07, Days after onset: 3
Location:Missouri  Entered:2008-07-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: BENADRYL
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.149301SCLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 6 cm x 4 cm (L) arm redness. ATARAX 25 mg one to two tabs po q 6-8 hrs. AUGMENTIN 875 mg 1 tab po bid as prophylaxis.

VAERS ID:318378 (history)  Vaccinated:2008-07-07
Age:15.0  Onset:2008-07-07, Days after vaccination: 0
Gender:Unknown  Submitted:2008-07-07, Days after onset: 0
Location:Maryland  Entered:2008-07-07
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: Penicillins and SULFA drugs
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U5IMLA
Administered by: Military     Purchased by: Military
Symptoms: Dizziness, Hyperhidrosis, Pallor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Light headedness, diaphoresis, and pale skin color after HPV vaccination. These symptoms resolved within 5 minutes after patient was assisted to a seated position and a cool compress applied to her forehead.

VAERS ID:318438 (history)  Vaccinated:2008-06-27
Age:15.0  Onset:2008-06-27, Days after vaccination: 0
Gender:Female  Submitted:2008-07-02, Days after onset: 5
Location:Connecticut  Entered:2008-07-08, 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: None
Diagnostic Lab Data: Allergic reaction
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Depressed mood, Dizziness, Hypersensitivity, Nausea, Pharyngeal oedema
SMQs:, Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Several hours after receiving HPV #1, pt + nausea, lightheaded, dizzy, depressed, throat swelling.

VAERS ID:318458 (history)  Vaccinated:2008-07-01
Age:15.0  Onset:2008-07-02, Days after vaccination: 1
Gender:Female  Submitted:2008-07-03, Days after onset: 1
Location:Oklahoma  Entered:2008-07-08, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPO PROVERA 150mg/ml at time of immu. in pt''s R hip IM
Current Illness:
Preexisting Conditions: NKDA
Diagnostic Lab Data: 7/3/08, evaluation/measurement
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1973U1SCLA
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Pallor, Tenderness, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: L lateral brachial inferior marked erythema measuring 7cm x 4cm x 4cm tender to palpation/urticaria/blanching spreading. Pseudo-cellulitis.

VAERS ID:318481 (history)  Vaccinated:2007-08-14
Age:15.0  Onset:2007-08-25, Days after vaccination: 11
Gender:Female  Submitted:2008-07-08, Days after onset: 318
Location:South Carolina  Entered:2008-07-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None. PMH: Anxiety
Diagnostic Lab Data: Abdominal ultrasound, HIDA scan, endoscopy, gastric emptying study, CAT scan, other laboratory tests. Labs and Diagnostics: K+ 3.1. Urinalysis with 2+ ketones. Gastric emptying study (+) for abnormal gastric emptying. Labs and Diagnostics: Endoscopy (+) for antritis.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0523U1  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain upper, Abdominal tenderness, Blood potassium decreased, Cholecystectomy, Computerised tomogram, Constipation, Decreased appetite, Dehydration, Diarrhoea, Dyspepsia, Early satiety, Endoscopy abnormal, Fatigue, Gallbladder disorder, Gallbladder operation, Gastritis, Gastrointestinal disorder, Gastrointestinal motility disorder, Hepatobiliary scan, Hypokalaemia, Impaired gastric emptying, Laboratory test, Nausea, Stress, Ultrasound abdomen, Urine ketone body present, Vaccine positive rechallenge, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gallbladder related disorders (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Patient experienced severe gastrointestinal symptoms after Gardasil injections. Injections 6/12/07 and 8/14/2007 followed by emergency room visits 8/25/07 and 11/1/07, third injection 12/20/07 followed by emergency room visit and extended hospitalization 2/08. Severe abdominal pain and vomiting occured each time which would not stop without emergency medical and drug intervention. Multiple diagnostic and lab tests indicated possibility of gall bladder involvement. Gall bladder was removed 12/5/07. The final Gardasil injection was after gall bladder surgery and another gastrointestinal episode with emergency treatment and a 5 day hospitalization occured after this. Patient had no history of gall bladder or gastrointestinal symptoms before beginning series of Gardasil injections. No underlying cause has been clearly established for these conditions, symptoms or multiple episodes by either primary physician, surgeon, gynecologists or gastroenterologist. Tests indicated slow gall bladder emptying, slow gastric emptying and slight gastritis concurrent with these multiple episodes, but patient had no symptoms indicating slow stomach or gallbladder functioning prior to beginning Gardasil. All other tests and screens were negative for anything unusual. Patient has had no recurrence of the symptoms since 2/08, but she is on continuing drug treatment for the gastrointestinal issues. We are reporting this to assist in identifying any trends related to similar gastrointestinal symptoms, since these conditions are not typical for a 15/16 year old female and the timing of the three injections and the repeated recurrence of these unusual and previously nonexistent symptoms seems a bit more than coincidental. 7/23/08 MR received for several OVs beginning in 11/2007 through 3/2008. Seen 11/7/2007 with c/o 3 episodes of nausea, vomiting and abdominal pain. One episode required IV fluids for dehydration. Pt reports early satiety, weight loss, decreased appetite, fatigue, stress, indigestion, constipation, abdominal bloating, cramping and epigastric pain as well as above. PE (+) for epigastric and RUQ tenderness otherwise WNL. Endoscopy scheduled. (+) for antritis. Impression: Antritis. Pt had Lap chole 12/5/07. Hospital Consult dated 2/7/08 for persistant nausea and vomiting. Impression: Persistant nausea and vomiting-etiology unclear. Abdominal pain, epigastric and LUQ, etiology unclear. Hx antritis. F/U 2/20/08 Impression: Gastroparesis. 9/8/2008 MR received for multiple Er visits and admission DOS 2/6-11/2008 with D/C DX: 1) Gastric motility disorder. 2) Prolonged vomiting. 3) Dehydration 2'' to #2. Hypokalemia 2'' to #2. Pt presented with onset of nausea, vomiting and diarrhea x 3 days. Seen at both PCP office and ER several times prior to admission. 1/25/2010 Follow up: continuing digestive/gastrointestinal problems.

VAERS ID:318483 (history)  Vaccinated:2007-05-02
Age:15.0  Onset:2007-06-24, Days after vaccination: 53
Gender:Female  Submitted:2008-07-08, Days after onset: 380
Location:New Hampshire  Entered:2008-07-08
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: GERD
Diagnostic Lab Data: Several different lab studies, ultra sounds, x-rays, ct scans and an appointment with the endocrinologist which didn''t do us any good. She was a prefectly healthy kid until she received this vaccine. Labs and Diagnostics: Abd US 2/18/08 WNL. Ultrasound 6/24/08 of RUQ (-). CT of Abd and Pelvis (-). KUB 6/25/07 (-). CXR (-). Chems unremarkable. ESR WNL. Cortisol WNL. Mono screen (-). TSH 1.78. CBC
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0524U1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Abdominal pain upper, Abdominal rigidity, Abdominal tenderness, Anxiety, Asthenia, Autonomic nervous system imbalance, Back pain, Blood cortisol normal, Blood thyroid stimulating hormone, Cheilitis, Chest X-ray normal, Chest pain, Computerised tomogram, Computerised tomogram normal, Crying, Delusional perception, Dizziness, Dysuria, Feeling abnormal, Feeling hot, Full blood count, Hot flush, Hyperhidrosis, Laboratory test, Laboratory test normal, Loss of consciousness, Mononucleosis heterophile test negative, Myalgia, Nausea, Pain, Petit mal epilepsy, Presyncope, Pyrexia, Red blood cell sedimentation rate normal, Syncope, Tenderness, Ultrasound abdomen normal, Ultrasound scan, Unresponsive to stimuli, Urinary system X-ray, Vaccine positive rechallenge, Visual disturbance, Vomiting, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: lightheadedness,dizzy,seeing spots,abd pn, nausea,and Left upper quad pain. After 2nd dose in July of 07 she experienced all of these plus severe hot flashes, sweats,severe muscle pain and weakness, collapsing and passing out as well as chest pain. She is now sick on a monthly basis and her sickness usually lasts 7-8 days. She also becomes delusional at times and spacey. 7/14/2008 MR received from PCP from 5/2/2007 through 7/3/2008. HPV #1 5/2/07. Seen 6/15/07 with c/o several week hx of abdominal pain, nausea and fever. PE WNL. Assessment: Abdominal pain, nausea of ? etiology. Referred to ER PRN. F/U ER visit 6/24/07. PE (+) for abd tenderness, worse in LUQ and epigastric area. (+) guarding. Assess: Abd pain NYD ? constipation. 7/30/07 2nd HPV. ER visit for abdominal pain 1/24/08 with Assess: Abdominal pain, possibly due to medication intolerance, benign exam. Hx sinusitis. Anxiety componant. Seen 2/28/08 where pt became hot, started crying, c/o body aches, felt like passing out. BS 89. Seen 3/2/2008 w/ c/o constant back pain which radiates to the chest, feeling dizzy. PE (+) for abd tenderness and tenderness over L chest wall, costochondral joint. DX: Abd pain LUQ. ? Splenomegaly. Chest wall pain. dizziness. Refered to endocrinology clinic. Seen for unusual spells with features of power, diaphoresis, visual disturbance, abdominal pain, and vomiting. Witnessed absence spell where pt became pale and unresponsive. BS 87. Pulse 80. No clear dx. ? conversion rxn. Seen 6/9/08 with R sided abd pain and feeling faint. PE (+) for abd tenderness, perleche. Assessment syncope. 6/30/08 seen w/ c/o dysuria, recuurent back pain with vasomotor symptoms. Paraspinus muscle spasms noted L2-4. 7/3/08 pain and vomiting persist. .

VAERS ID:318521 (history)  Vaccinated:2008-07-08
Age:15.0  Onset:2008-07-08, Days after vaccination: 0
Gender:Female  Submitted:2008-07-08, Days after onset: 0
Location:Michigan  Entered:2008-07-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol
Current Illness: serous otitis media
Preexisting Conditions: asthma, allergic rhinitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0067X1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2621AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Local reaction, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Pruritus of R forearm - hives like local reaction.

VAERS ID:318557 (history)  Vaccinated:2008-07-07
Age:15.0  Onset:2008-07-07, Days after vaccination: 0
Gender:Female  Submitted:2008-07-08, Days after onset: 1
Location:Maryland  Entered:2008-07-09, 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:
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB222AA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0067X0IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Clonus, Convulsion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Syncopal episode immediately following injection with a few seconds of convulsive seizure-like clonic movements. No postictal Sx after event. Vital signs stable.

VAERS ID:318574 (history)  Vaccinated:2008-04-23
Age:15.0  Onset:2008-04-24, Days after vaccination: 1
Gender:Female  Submitted:2008-07-09, Days after onset: 76
Location:Georgia  Entered:2008-07-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: n/a~ ()~NULL~~In Patient
Other Medications: none
Current Illness: none
Preexisting Conditions: n/a
Diagnostic Lab Data: CBC: WBC 8.7, Neut %81.6, lymph 8.0, hgb 12.2, hct 37.3, plt 179, na 132, k 3.7, cl 98, co2 26.2, gluc 110, bun 12, creat 0.8, UA: trace protein, Specific gravity 1.015, ph 6.0 ketones 3+, urobili 4.0, trace blood, wbc occ, epithelial cell
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0524U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2417AA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Abdominal pain, Asthenia, Blood chloride normal, Blood creatinine normal, Blood glucose increased, Blood potassium normal, Blood sodium decreased, Blood urea normal, Carbon dioxide decreased, Dizziness, Epstein-Barr virus test negative, Haematocrit normal, Haemoglobin normal, Lymphocyte count abnormal, Mucous membrane disorder, Nasal congestion, Neutrophil percentage increased, Platelet count normal, Pregnancy test negative, Pyrexia, Red blood cells urine positive, Tachycardia, Urinary sediment present, Urine analysis abnormal, Urine ketone body present, Urine protein, quantitative, Urobilin urine present, White blood cell count
SMQs:, Liver related investigations, signs and symptoms (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Vestibular disorders (broad), Chronic kidney disease (broad)
Write-up: Fever started after getting vaccine, pt went to ER w/ fever 103.5, dizziness weakness, nasal congestion, abdominal pain, dry mucous membranes, tachycardia, moderate distress

VAERS ID:318591 (history)  Vaccinated:2008-04-15
Age:15.0  Onset:2008-04-21, Days after vaccination: 6
Gender:Female  Submitted:2008-07-09, Days after onset: 79
Location:Oregon  Entered:2008-07-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sore throat
Preexisting Conditions:
Diagnostic Lab Data: CMP, EKG, EEG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0524U0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Convulsion, Electrocardiogram, Electroencephalogram, Fall, Laboratory test
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient had a ground level fall, she landed on the right side of her head, this occurred while she was "warming up" to run track. EMS called. Bystanders suggest there might have been some seizure-type activity.

VAERS ID:318594 (history)  Vaccinated:2007-10-22
Age:15.0  Onset:2007-10-30, Days after vaccination: 8
Gender:Female  Submitted:2008-07-09, Days after onset: 253
Location:Iowa  Entered:2008-07-09
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: Food Allergies; Environmental Allergies; Eposodic Asthma; Antibiotic Allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.UNKNOWN1IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Activities of daily living impaired, Arthralgia, Blood test normal, Chest pain, Disturbance in attention, Dyspnoea, Fatigue, Headache, Hyperaesthesia, Lymphadenopathy, Malaise, Mononucleosis heterophile test negative, Pain, Pneumonia, Sinusitis, Streptococcus identification test positive
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad)
Write-up: On July 25, 2007 patient went into the Pediatrician''s office for a School Physical. The nurse practitioner recommended the Gardasil vaccine. After discussing with her the possible side effects and the fact that patient, has many allergies and I was concerned about possible reactions to the vaccine. The nurse assured us that the vaccine that should not give her a problem. I agreed to the vaccine. The second shot was given to patient on or about October 22, 2007. Within a week of getting, the second vaccine patient started complaining of generally not feeling well. Patient began feeling very tired and generally "achy" all over. She started missing school. Through the entire month of November, patient missed school occasionally due to fatigue and overall achiness. This progressed and became worse. By the end of December, patient had started missing entire weeks of school. She had headaches, joint pain, ached all over, fatigue, difficulty breathing on occasion. Because patient was so ill that when it was time to receive the 3rd shot of Gardasil, we chose to wait even though the doctors reassured us that it would be alright. The symptoms appeared to be consistent with Mono, so in early January we took her to the doctor. He ran Mono tests, Strep tests and blood tests. The strep test was positive, the mono test was negative and the blood tests showed no problems. The doctor prescribed on Antibiotics for the strep. Through the entire Month of January, she was ill, and went through several rounds of antibiotics. Her glands were swollen, her body was in pain, her stomach and chest hurt, legs and joints hurt (at times you could not even touch her, she would cry in pain). There were days that she just could not get out of bed, severe fatigue. By February, patient had developed pneumonia and was so ill that the doctor contemplated putting her in the hospital. The only reason he did not hospitalize her was that due to her allergies to antibiotics he indicated that he really did not have anything he could treat her with intravenously and "there are things going around the hospital that if she were to get, we would have no defense for!" We were visiting the doctor''s office on a weekly basis. Prior to the diagnosis of pneumonia, the diagnosis was"just a virus." By the beginning of March, patient started having the severe headaches, stomach pain, fatigue and continued with overall pain. The doctor diagnosed her with a "sinus infection," and put her on Antibiotics for several weeks. After two or three rounds of the antibiotic, with no improvement in her condition, she stopped taking the antibiotics. n addition to the above noted symptoms reported to the doctors, patient reported difficulty concentrating. We have enlisted the help of a Integrated Manual Therapist to get the toxins out of her body. She has been in treatment since mid April and has been improving. She still has occasional severe headaches and stomach pain, but not to the extent, they were. The fatigue is still an issue but much less.

VAERS ID:318622 (history)  Vaccinated:2008-07-09
Age:15.0  Onset:2008-07-09, Days after vaccination: 0
Gender:Female  Submitted:2008-07-09, Days after onset: 0
Location:Iowa  Entered:2008-07-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: IA08008
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1662U1SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Fall, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Client fainted after administration of vaccines. Approximately 5 minutes after given was standing up and fell to floor. No apparent injury.

VAERS ID:318610 (history)  Vaccinated:2008-07-08
Age:15.0  Onset:2008-07-08, Days after vaccination: 0
Gender:Female  Submitted:2008-07-10, Days after onset: 2
Location:Florida  Entered:2008-07-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMRA
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Inflammation, Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Myalgia, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad)
Write-up: Pt received highly recommended vaccinations of Meningococcal AND HPV into right deltoid. The first 12 hours very sore with localized redness and some swelling; ice compress and ibuprofen choice of treatment. 48 hours post injection the site is very painful, red, swollen. A new isolated area below primary site is now becoming inflamed with shooting pain radiating to right ring finger. Also discomfort to right pectoralis. No s/s of dyspnea,pallor,or parasthesia; Benadryl 25mg by mouth administered along with thin topical benadryl cream.

VAERS ID:318667 (history)  Vaccinated:2008-06-28
Age:15.0  Onset:2008-06-28, Days after vaccination: 0
Gender:Female  Submitted:2008-07-10, Days after onset: 12
Location:Texas  Entered:2008-07-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/a
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0070X2IMLL
Administered by: Public     Purchased by: Public
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Continual pain at admin. site.

VAERS ID:318680 (history)  Vaccinated:2007-07-31
Age:15.0  Onset:2007-11-22, Days after vaccination: 114
Gender:Female  Submitted:2008-07-10, Days after onset: 230
Location:Virginia  Entered:2008-07-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Albuterol Inhaler for PRN use
Current Illness: None
Preexisting Conditions: Reactive Airway Disease 7/21/08-records received-PMH:ulcerative colitis diagnosed 11/2007.
Diagnostic Lab Data: Bloodwork, colonoscopy 7/21/08-records received-Sed rate increased 37, amylase increased 102 and lipase 470, WBC 15.1 and CRP 3.55. Abdominal series 11/22/07-no acute abdominal findings. Abdominal series:11/5/07-large amount of retained st
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.093060IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Anaemia, Arthralgia, Blood amylase increased, Blood gases abnormal, Blood test, C-reactive protein increased, Colitis ulcerative, Colonoscopy, Diarrhoea, Diarrhoea haemorrhagic, Hypoalbuminaemia, Influenza, Lipase increased, Nausea, Red blood cell sedimentation rate increased, Weight decreased, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (broad), Acute pancreatitis (narrow), Haematopoietic erythropenia (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Chronic kidney disease (broad), Arthritis (broad), Noninfectious diarrhoea (narrow)
Write-up: Symptoms of and diagnosed with ulcerative colitis in November 2007 requiring 2 hospitalizations for exacerbation since 11/2007 7/14/08-records received-office visit 7/31/07-C/O tired. 11/28/81-DX ulcerative colitis. Loose stools and abdominal spasms. Tired weak. 12/24/07-GI consults-history of ulcerative colitis in remission. Presented with abdominal pain, diarrhea, anemia and hypoalbuminemia. Weight loss, joint pains. 2/18/08-Continues in remission. Flu symptoms 10 days ago. Intermittent shoulder, ankle and wrist pain. 5/30/08-Sick visit, off steroids. Three days prior increasing stooling and minor bleeding and severe cramps. 7/21/08-records received for DOS 5/31-6/4/08-DC DX: ulcerative colitis flare. Presented with 2 weeks of abdominal cramping and 3 days of diarrhea tht had become bloody. Nausea.

VAERS ID:318742 (history)  Vaccinated:2008-04-17
Age:15.0  Onset:2008-04-20, Days after vaccination: 3
Gender:Female  Submitted:2008-07-13, Days after onset: 84
Location:Louisiana  Entered:2008-07-11, 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: eczema as a child
Diagnostic Lab Data: None
CDC Split Type: LA080701
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2549AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2863AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Rash pustular
SMQs:, Hypersensitivity (narrow)
Write-up: 7-1-08 mother called called to report that within 3-4 days of 4-17-08 + 6-17-08, daughter broke out with pustules on her legs, arms, and abdomen. She was brought to PMD on both occasions. He ordered antibiotics and could not give a dx. Pustules resolved within 1-2 wks. Mother seems to think it may be related to HPV vaccine.

VAERS ID:318792 (history)  Vaccinated:2008-07-10
Age:15.0  Onset:2008-07-11, Days after vaccination: 1
Gender:Female  Submitted:2008-07-13, Days after onset: 2
Location:New Jersey  Entered:2008-07-11, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2640AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Oedema peripheral, Pain
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Severe left arm swelling, pain and cellulitis.

VAERS ID:318973 (history)  Vaccinated:2008-04-18
Age:15.0  Onset:2008-04-25, Days after vaccination: 7
Gender:Female  Submitted:2008-07-08, Days after onset: 74
Location:Texas  Entered:2008-07-11, 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: Attention deficit/hyperactivity disorder; Penicillin allergy; Drug hypersensitivity; Allergic reaction to antibiotics
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA00620
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Lip swelling, No reaction on previous exposure to drug, Oedema mouth, Oedema peripheral, Pruritus, Swelling face, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This is in follow-up to report(s) previously submitted on 7/8/2008. Initial and follow up information has been received from a physician and the mother of a 15 year old female (98 lb; height not reported) with attention deficit/hyperactivity disorder, allergies to penicillin, erythromycin, amoxicillin, azithromycin (ZITHROMAX), PHENERGAN with CODEINE, SILVADENE, and PROMETHAZINE with CODEINE), who on 19-FEB-2008 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 659962/1740U; site not reported). On 18-APR-2008, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 660387/1967U; site not reported). Concomitant therapy included ADDERALL TABLETS and ORTHO EVRA. It was reported that the therapy with ORTHO EVRA started "concomitantly with the vaccine" (reported as on 18-APR-2008, 20-APR-2008 and 21-APR-2008). On approximately 25-APR-2008 (also reported as 27-APR-2008 and "within one week of the vaccine") the patient developed hives all over her body. The next morning, 26-APR-2008, the patient had swelling in her hands and feet and the patient was treated with ALLEGRA and prednisone (unspecified) (also reported as treatment occurring on 27-APR-2008 in the ER). On 27-APR-2008, the patient developed swelling on her face, mouth and lips. On 27-APR-2008, the patient went to the emergency room for outpatient treatment and received a "steroid shot" (not further specified), BENADRYL and ZANTAC. "The itching persisted for a little while and then all symptoms resolved" (date unspecified). On approximately 27-APR-2008, the patient discontinued therapy with ORTHO EVRA. It was reported that the patient had no adverse effects or problems with the first dose of GARDASIL. The physician suspected that the reactions were related to either GARDASIL or ORTHO EVRA. Additional information has been requested.

VAERS ID:318988 (history)  Vaccinated:2007-12-27
Age:15.0  Onset:2007-12-27, Days after vaccination: 0
Gender:Female  Submitted:2008-07-08, Days after onset: 193
Location:Georgia  Entered:2008-07-11, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Pap test 12/27/07 - "low-grade" abnormality
CDC Split Type: WAES0806USA01134
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Smear cervix abnormal
SMQs:
Write-up: Information has been received from a medical assistant concerning a 15 year old female who on 27-DEC-2007 was vaccinated with GARDASIL vaccine (lot# unspecified). There was no concomitant medication. It was reported that on the same day the PAP test was performed and that the results showed a "lot-grade" abnormality. No other information was available. Additional information has been requested.

VAERS ID:319121 (history)  Vaccinated:2008-04-01
Age:15.0  Onset:2008-04-01, Days after vaccination: 0
Gender:Female  Submitted:2008-07-08, Days after onset: 98
Location:Kentucky  Entered:2008-07-11, 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: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA01292
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IM 
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a consumer concerning her 15 year old daughter who in April 2008, was vaccinated IM with the first 0.5 mL dose of GARDASIL vaccine. There was no concomitant medication. The patient felt faint after receiving the vaccine. The patient also fainted after additional blood work was done after she received the vaccine. The patient''s mother decided that she will not continue the dosing series. Unknown medical attention was sought. The patient recovered the day after the vaccination. Additional information has been requested.

VAERS ID:318884 (history)  Vaccinated:2008-07-07
Age:15.0  Onset:2008-07-08, Days after vaccination: 1
Gender:Male  Submitted:2008-07-14, Days after onset: 6
Location:New York  Entered:2008-07-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: The subject had no relevant medical history and no history of adverse reactions following previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0737542A
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B024AA0UNUN
Administered by: Private     Purchased by: Private
Symptoms: Facial palsy
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of facial palsy in a 15-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included MENACTRA (Sanofi) given on 7 July 2008. There were no concurrent medications. On 7 July 2008 the subject received 1st dose of BOOSTRIX at 1.0 ml in the left arm. On the evening of 8 July 2008, 1 day after vaccination with BOOSTRIX, the subject experienced facial palsy, a systemic reaction. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX.

VAERS ID:319010 (history)  Vaccinated:2008-04-21
Age:15.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Female  Submitted:2008-07-08, Days after onset: 77
Location:Iowa  Entered:2008-07-15, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FOCALEN XR 20mg
Current Illness: cold/sinus infection
Preexisting Conditions: ADHD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2551AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Cough, Dyspnoea, Eye swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Swelling in eyes, coughing, trouble breathing.

VAERS ID:319017 (history)  Vaccinated:2008-06-09
Age:15.0  Onset:2008-06-30, Days after vaccination: 21
Gender:Female  Submitted:2008-07-09, Days after onset: 9
Location:Missouri  Entered:2008-07-15, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0063X1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Headache, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Severe hives began 6/30/08. Received Gardasil #2 6/9/08. Hives several days = at office with hives, chills and headache 7/9/08 = 10 days.

VAERS ID:319021 (history)  Vaccinated:2008-07-01
Age:15.0  Onset:2008-07-04, Days after vaccination: 3
Gender:Female  Submitted:2008-07-11, Days after onset: 7
Location:Wisconsin  Entered:2008-07-15, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Syncope~HPV (Gardasil)~2~15~In Patient
Other Medications:
Current Illness: No
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X2IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Bronchitis, Dyskinesia, Eye rolling, Fatigue, Loss of consciousness, Malaise, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: 3 days after 2nd HPV (2/28/08), she had a syncopal episode. She was also ill at time, seen in clinic and diagnosed with bronchitis. 3 days after 3rd HPV (7/1/08), she was sitting in a chair, said "I don''t feel well", then mom saw her eyes roll back. She had LOC. Mom noted brief jerking of arms and legs. Within 1 minute she was alert and coherent. Felt tired rest of day. No illness. Felt was prior two days.

VAERS ID:319072 (history)  Vaccinated:2008-07-14
Age:15.0  Onset:2008-07-14, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 1
Location:Maryland  Entered:2008-07-15
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
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB253BA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0955F0IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0273-24IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2329AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2826AA0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Loss of consciousness, Paraesthesia, Syncope, Unresponsive to stimuli, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: PT FAINTED AFTER RECEIVING 5 VACCINES: (HPV#1; HAV#2 - RT DELTOID) AND (IPV, MENACTRA, AND TDAP - LT DELTOID). PT SAID RT ARM WAS TINGLING PRIOR TO HER PASSING OUT. PT WAS UNRESPONSIVE FOR APPROX. ONE MINUTE AND ONE EPISODE OF VOMITING AFTER REGAINING CONSCIOUSNESS.

VAERS ID:319292 (history)  Vaccinated:2008-03-01
Age:15.0  Onset:2008-03-01, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 135
Location:California  Entered:2008-07-16, 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: Unknown
Current Illness: Pregnancy NOS (LMP = 11/25/2007)
Preexisting Conditions:
Diagnostic Lab Data: beta-human chorionic, 07/01/08, pregnancy
CDC Split Type: WAES0807USA01664
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Premature baby, Premature labour
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a physician, for the pregnancy registry for GARDASIL concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL (route and administrating site not reported). In March 2008, the patient was vaccinated with a second dose of GARDASIL (route and administrating site not reported). The patient became pregnant during the GARDASIL series. On approximately 01-JUL-2008 the patient was attempting to get clearance from her physician for a sport physical. The physician insisted on a pregnancy test which was positive. On approximately 07-JUL-2008 the patient delivered and the infant was born at 32 weeks gestation. The infant was placed on a respirator in the Neonatal Intensive Care Unit. Additional information has been requested.

VAERS ID:319386 (history)  Vaccinated:2008-07-14
Age:15.0  Onset:2008-07-14, Days after vaccination: 0
Gender:Female  Submitted:2008-07-16, Days after onset: 2
Location:California  Entered:2008-07-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2572AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1889U1SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Had swelling, redness, warmth to right arm after varicella injection

VAERS ID:319399 (history)  Vaccinated:2008-07-15
Age:15.0  Onset:2008-07-15, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 0
Location:Florida  Entered:2008-07-16, 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: YAZ
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0070X1IMRA
Administered by: Private     Purchased by: Other
Symptoms: Blood pressure, Disorientation, Dizziness, Hyperhidrosis, Pallor, Skin discolouration
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Sweating/perspiration, discoloration (pallor), dizziness, disorientation. BP 100/62 patient laid down ammonia capsule administered.

VAERS ID:319470 (history)  Vaccinated:2008-07-07
Age:15.0  Onset:2008-07-07, Days after vaccination: 0
Gender:Male  Submitted:2008-07-15, Days after onset: 8
Location:New York  Entered:2008-07-17, Days after submission: 2
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: The patient had no illnesses, pre-existing medical conditions, or use of other medications at the time of the vaccination on 07 July 2008. It was "unknown" if the patient had received any other vaccinations within four weeks of 07 July 2008, or with prior vaccinations.
Diagnostic Lab Data: Not reported
CDC Split Type: 200802225
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2562A UNRA
Administered by: Private     Purchased by: Private
Symptoms: Facial palsy
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: Initial report received on 09 July 2008 from a health care professional. A 15-year-old male patient, who had no concurrent illnesses, pre-existing medical conditions or use of other medications, had received on 07 July 2008 in the morning a right arm dose of MENACTRA (Lot # U2562AA, route not provided), and a dose of DTAP (trade name, manufacturer name, lot #, route and site of administration not provided). Overnight, the patient developed "facial symptoms" and was subsequently evaluated by a physician two days later and was diagnosed with facial Bell''s Palsy. It was not reported whether the patient received any treatment, or if any diagnostic tests were performed. At the time of this report, the patient had not recovered.

VAERS ID:319783 (history)  Vaccinated:2007-05-15
Age:15.0  Onset:2007-05-17, Days after vaccination: 2
Gender:Female  Submitted:2008-07-15, Days after onset: 425
Location:Iowa  Entered:2008-07-17, 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: PROZAC; magnesium (unspecified); PROTONIX; SEROQUEL; ZONEGRAN
Current Illness: Pregnancy NOS (LMP = 5/17/2007)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 06/15?/07 - patient was 4.5 to 6.5 weeks pregnant; beta-human chorionic, 05/15/07 - negative; beta-human chorionic, 05/31/07 - positive;
CDC Split Type: WAES0706USA03778
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0244U0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Ultrasound scan normal
SMQs:, 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 for the Merck Pregnancy Registry for the GARDASIL via a medical assistant concerning a 15 year old female with no pertinent medical history who on 15-MAY-2007 was vaccinated intramuscularly with the first 0.5 ml dose of the GARDASIL (Lot # 656051/0244U). Concomitant therapy included PROTONIX, PROZAC, magnesium supplement (unspecified), SEROQUEL and ZONEGRAN. A blood HCG test was performed on 15-MAY-2007 and was negative. The blood HCG test was repeated on 31-MAY-2007 and was positive. An ultrasound was performed on approximately 15-JUN-2007 which showed that the patient is approximately 4.5 to 6.5 weeks pregnant. The patient''s last menstrual period was approximately 17-May-2007 and the estimated due date was 21-Feb-2008. The reporter stated that "the patient will not be having a therapeutic abortion." Follow up information has been received from a health professional at the pediatrician''s office and from a registered nurse at the obstetrician''s office, concerning the outcome of the pregnancy. There were no complications or illnesses during the patient''s pregnancy. The health professional and the nurse reported that on 27-JAN-2008, the patient gave birth to a healthy and normal male infant, apgar: 8/1; weight: (3668gms), 8lbs 1oz; length 21; and head circumference: 14. The health professional noted that the infant had no congenital anomalies. The baby however experienced respiratory distress and fever during delivery. No further information was provided. Additional information was provided. Additional information is not expected.

VAERS ID:319792 (history)  Vaccinated:2007-08-03
Age:15.0  Onset:2007-08-03, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 347
Location:Unknown  Entered:2008-07-17, 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: Pregnancy NOS (LMP = 4/15/2007)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 11/25/07 - polyhydramnios; serum beta-human - positive
CDC Split Type: WAES0710USA03974
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Polyhydramnios, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial and follow up information has been received from a nurse and a certified nurse midwife for the Pregnancy Registry for GARDASIL concerning a 15 year old female who on 03-AUG-007 was vaccinated with the first dose of GARDASIL (Lot #, site and route not reported). Concomitant therapy included vaccination with the meningococcal vaccine (unspecified). Subsequently, it was determined that the patient was pregnant (LMP 15-Apr-2007). The patient sought unspecified medical attention. On 25-NOV-2007, ''(also reported as 32 weeks gestation), the patient was sent for a amniotic fluid index (AFI) and the prenatal sonogram found that the patient had polyhydramnios. No numeric AFI was reported. On 20-JAN-2008, the patient delivered vaginally at term with "massive polyhydramnios". She delivered a healthy, and normal baby weighing 7 lbs, 6 oz. Both the mother and baby are doing well. Additional information is not expected.

VAERS ID:319841 (history)  Vaccinated:2008-03-15
Age:15.0  Onset:2008-03-15, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 122
Location:Maryland  Entered:2008-07-17, 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: Acne
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA02211
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Myalgia, Pyrexia, Vaccine positive rechallenge
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: Initial and follow up information has been received from a registered nurse concerning a 15 female with acne who on 15-MAR-2008 was vaccinated IM with a first 0.5ml dose of GARDASIL (Lot#659182/175U). Concomitant therapy BENZACLIN and RETIN-A. The patient developed widespread muscle aching and a low grade fever within hours of receiving her first dose which resolved in 1-2 days with out requiring treatment. On 10-JUN-2008 the patient was vaccinated IM with a second 0.5ml dose of GARDASIL (Lot#660391/0063X). After the second dose, the patient''s mother contacted the office by phone to report her daughter''s symptoms of muscle aching, low grade fever, as well as left knee pain that occurred within a few hours of the dose. Rest and ibuprofen were prescribed. At the time of the report, the patient had not recovered. The nurse did not known if the patient was scheduled to receive the third dose. Additional information has been requested.

VAERS ID:319875 (history)  Vaccinated:2008-06-02
Age:15.0  Onset:2008-06-02, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 43
Location:California  Entered:2008-07-17, 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:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA02562
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 15 year old female who on 02-JUN-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast). There was no concomitant medication. Subsequently, the patient fainted after the administration. The patient did not sustain any injuries. The patient sought medical attention in the office. At the time of the report the patient had recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/15/2008 Inital and follow up information has been received from a physician and a health professional concerning a 15 year old femaile who on 02-JUN-2008 at 4:50 PM was vaccinated IM with scond dose of GARDASIL (Lot #660553/0070X) in the left deltoid. There was no concomitant medication.After vaccination at 5:10PM, the patient left the office and had a syncopal event at a pharmacy. The patient required medical attention in the office. On 02-JUN-2008, the patient had recovered. Additional information is not expected.

VAERS ID:319995 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-15
Location:Ohio  Entered:2008-07-17, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Pap test - 05/27/08 - abnor, cervix HPV DNA assay - 05/27/08 - posit - high risk HPV DNA
CDC Split Type: WAES0806USA07749
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: DNA antibody positive, Human papilloma virus test positive, Smear cervix abnormal
SMQs:, Systemic lupus erythematosus (broad)
Write-up: Information has been received from a medical assistant concerning a 15 year old female with no known drug reactions or allergies who was vaccinated with a dose of GARDASIL vaccine (yeast) and now has tested positive for high risk HPV DNA and has an abnormal Pap test. The patient received at least one and possibly two vaccinations with GARDASIL vaccine (yeast) prior to the abnormal Pap and HPV DNA test on 27-MAY-2008. The vaccination with GARDASIL vaccine (yeast) were not administered at the office in the case. The patient had never had an abnormal Pap or positive HPV DNA test in the past. It was unknown whether the patient sought medical attention. Patient outcome was not reported. Additional information has been requested.

VAERS ID:320006 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:2008-04-01
Gender:Female  Submitted:2008-07-15, Days after onset: 105
Location:Illinois  Entered:2008-07-17, Days after submission: 2
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: Splenomegaly
Diagnostic Lab Data: Serum albumin, 06/20/2008, 3.3; Serum albumin, 06/23/2008, 3.1; Total serum protein, 06/23/08, 5.6; Total serum protein, 06/20/08, 6.5
CDC Split Type: WAES0806USA08058
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0152X1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood albumin decreased, Computerised tomogram, Oedema peripheral, Protein total decreased, Protein total normal, Ultrasound Doppler
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a third dose of GARDASIL vaccine (yeast) 0.5 ml (lot# 0152X). Concomitant therapy included albuterol sulfate (VENTOLIN (albuterol sulfate)), "topical acne medicine" dermatologic (unspecified) and fluticasone propionate (FLOVENT). On 19-JUN-2008 the patient experienced leg edema. The patient was brought to emergency room on 20-JUN-2008 but was not admitted to the hospital. The patient''s leg edema persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/15/2008. Follow-up information was received from a physician concerning the patient developed edema of both lower legs/feet beginning on 19-JUN-2008. The patient had had a 10-12 pound weight gain since April, 2008. The physician mentioned in follow up that the patient was still having swelling in the legs and feet. The patient had seen a cardiologist, gastroenterologist and had had a doppler study and CT of the abdomen. Additional information has been requested.

VAERS ID:320007 (history)  Vaccinated:2008-05-10
Age:15.0  Onset:2008-05-10, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 66
Location:Illinois  Entered:2008-07-17, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA08095
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning a 16 year old female patient who on 10-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 10-MAY-2008 the patient had an injection site reaction (local reaction with erythema) for a few days. Subsequently, the patient recovered from local reaction with erythema for a few days. Additional information has been requested.

VAERS ID:320010 (history)  Vaccinated:2008-06-18
Age:15.0  Onset:2008-06-18, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 27
Location:New York  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anxiety, Overweight
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA08142
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Inappropriate schedule of drug administration, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning an overweight 15 year old female with anxiety and no drug reactions/allergies history reported who on 18-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) 0.5 ml IM (lot# 660555/0279X). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 18-JUN-2008 the patient became lightheaded, diaphoretic and hypotensive after her first dose of GARDASIL vaccine (yeast). The patient had a consult with a cardiologist due to these adverse experiences and was diagnosed with a vasovagal response to the immunizations. Additional information has been requested.

VAERS ID:320014 (history)  Vaccinated:2008-06-13
Age:15.0  Onset:2008-06-14, Days after vaccination: 1
Gender:Female  Submitted:2008-07-15, Days after onset: 31
Location:New Jersey  Entered:2008-07-17, 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: Unknown
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA08226
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0063X0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Asthma, Axillary pain, Lymphadenopathy
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Information has been received from a physician concerning a 15 year old white female student with asthma who on 13-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot# 660391/0063X) intramuscularly into left deltoid. Suspect therapy given the same day included a first dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (lot #0063X) IM into left deltoid. On 14-JUN-2008 the patient developed left axillary adenopathy, left axillary pain and also asthma exacerbation. There was no illness at the time of vaccination. It was unknown by the reporter if the patient had recovered. Additional information has been requested.

VAERS ID:320030 (history)  Vaccinated:2008-06-10
Age:15.0  Onset:2008-06-10, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 35
Location:Unknown  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NASONEX
Current Illness: Rhinitis allergic
Preexisting Conditions: Headache, Meningitis
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA08390
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Dizziness postural, Headache
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Information has been received from a licensed visiting nurse (LVN) concerning a 15 year old female with allergic rhinitis and a history of headache and meningitis (at 7 years of age) who on 25-MAR-2008 (Lot 659657/1487U), 10-JUN-2008 and 24-JUN-2008 (Lot #660391/0063X) was vaccinated IM with 0.5 mL doses of GARDASIL vaccine (yeast). Concomitant therapy included mometasone furoate (NASONEX). On 24-JUN-2008, after vaccination, the patient became dizzy/lightheaded upon standing and also developed a headache. The patient was treated with ibuprofen (MOTRIN) 800 mg for the headache. The patient did not require hospitalization, but was seen in the office. At the time of this report, the patient''s dizziness/lightheadedness and headache persisted. Additional information has been requested.

VAERS ID:320059 (history)  Vaccinated:2008-05-23
Age:15.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 53
Location:Unknown  Entered:2008-07-17, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA08649
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a physician assistant concerning a 15 year old female who on 23-MAY-2008 was vaccinated with a first dose of GARDASIL vaccine and included hepatitis A virus vaccine (manufacturer unknown). The physician assistant reported that the patient received the first vaccination with GARDASIL VACCINE on 23-MAY-2008 and passed out. The patient became pale in color and passed out while sitting on the examination table. The patient was treated with cold compresses and recovered after an unspecified time frame. The patient was asked to wait in the office after recovery, but mother needed to leave. There was no product quality complaint. Additional information has been requested.

VAERS ID:320096 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-15
Location:Arizona  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Headache~HPV (no brand name)~1~12~In Sibling|Local reaction~HPV (no brand name)~1~12~In Sibling
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA08872
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Headache, Local reaction, Pain in extremity
SMQs:, Guillain-Barre syndrome (broad)
Write-up: Information has been received from a physician concerning a 15 year old female who was vaccinated with a first dose of GARDASIL vaccine (yeast). Subsequently the patient experienced arm pain, weakness, headache and local reaction. At the time of report, no outcomes were reported. The physician also reported that the patient''s sister experienced the same symptoms after received GARDASIL vaccine (yeast) (WAES# 0806USA08863). Additional information has been requested.

VAERS ID:320097 (history)  Vaccinated:2008-06-19
Age:15.0  Onset:2008-06-19, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 26
Location:Ohio  Entered:2008-07-17, Days after submission: 2
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: WAES0806USA08925
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Private     Purchased by: Other
Symptoms: Loss of consciousness, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a certified medical assistant concerning a female who in June 2008 was vaccinated with the second dose of GARDASIL vaccine. The patient had "trouble getting shots or giving blood." The patient laid down for 15 minutes post vaccination and was monitored. When the patient walked down the hall way the patient fainted, and it took the patient about 30 second to revive. Smelly salts were place under the patient''s nose. Subsequently, the patient recovered from faint. The patient sought medical attention at the office. This is one of several reports from the same source. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 7/15/2008. Information has been received from a certified medical assistant concerning a 15 year old female who on 10-APR-2008 was vaccinated with the first dose of GARDASIL (lot# 659182/1757U) at 1900. On 19-JUN-2008 the patient was vaccinated with the second dose of GARDASIL at 10:00. The patient attempted to leave and started to feel nauseated after the second dose at 10:00 on 19-JUN-2008. The patient ran into the wall and passed out. The patient was put on floor and it took the patient about 30 second to revive. Smelly salts were placed under the patient''s nose. Subsequently, the patient recovered from faint but still nauseated. The patient did not eat anything prior to shot. The patient was advised to eat prior to the last shot. This is one of several reports from the same source. Additional information has been requested.

VAERS ID:319637 (history)  Vaccinated:2007-08-20
Age:15.0  Onset:2007-09-22, Days after vaccination: 33
Gender:Female  Submitted:2008-07-17, Days after onset: 299
Location:New York  Entered:2008-07-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: folic acid; MINOCIN
Current Illness:
Preexisting Conditions: Wheezing. PMH: ADD. Asthma. NKDA. Mom had seizures ages 13-15, cousin w/ seizures, sibling with Chiari malformation
Diagnostic Lab Data: None. Labs and Diagnostics: Head CT WNL. Tox screen (-). Video EEGs abnormal.
CDC Split Type: WAES0807USA02471
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0524U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Disturbance in attention, Electroencephalogram abnormal, Epilepsy, Excessive eye blinking, Fall, Grand mal convulsion, Loss of consciousness, Postictal state, Scan brain, Staring, Toxicologic test normal, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician concerning a 16 year old female with a history of wheezing who on 20-AUG-2007 was vaccinated with her first dose of GARDASIL. On 22-SEP-2007 the patient experienced tonic clonic seizure and was hospitalized. On 15-NOV-2007, the patient received the second dose of GARDASIL. The patient was admitted to the hospital for an unspecified period of time on three separate occasions since the onset of the first seizure. The patient has a positive familial history of seizures. The patient''s last seizure occurred on an unspecified date in January 2008. Concomitant therapy included folic acid and MINOCIN. No other symptoms and no other treatment reported. Additional information has been requested. 8/11/2008 MR received for multiple DOS 9/22-25/2007, 10/29-11/01/2007, 11/7-12/2007 and ER 1/18/2008 with DX: Epilepsy. Pt presented with 1st seizure 9/22/07. Pt lost consciouness, fell and had generalized convulsion with shaking of upper and lower extremities. Sleepy after. Started on Keppra following EEG. Staring episodes noted with adventitial movements during video. D/C for outpt f/u. Returned again 10/29/07 with 2 episodes of seizure on meds. Recent increase in blinking and decreased attention. Keppra increased. Returned again due to allergic rxn to Keppra. Med changed to Zonegran. ER visit for seizure in school. Dose increased.

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