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Found 511635 cases where Symptom is Immune system disorder or Immunodeficiency or Immunoglobulins decreased or Lymphadenopathy

Case Details (Sorted by Age)

This is page 304 out of 512

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VAERS ID:305625 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Unknown  Entered:2008-02-19, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA02169
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1061U IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Information has been received from a licensed practical nurse concerning a 19 year old female who was vaccinated with 0.5 ml of Gardasil (Lot #658558/1061U) intramuscularly in the deltoid. The nurse reported that the patient had extreme pain and numbness in her arm after she was given Gardasil. The nurse was unsure which Gardasil dose this occurred with. As of 10-JAN-2008 the patient had not recovered. No other information was available from the nurse. Additional information has been requested.

VAERS ID:305644 (history)  Vaccinated:2008-01-11
Age:19.0  Onset:2008-01-11, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 34
Location:Massachusetts  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Environmental allergy; Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: vital sign, 01/21/08, stable
CDC Split Type: WAES0801USA02521
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1210U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, 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), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a nurse concerning a female who was vaccinated with Gardasil. There was no illness reported at the time of vaccination. The patient had not eaten breakfast. Subsequently, the patient fainted after receiving the vaccine. The patient did not seek medical attention. Subsequently, the patient recovered from fainting. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008. Initial and follow up information has been received from a registered nurse concerning a 19 year old white female with drug hypersensitivity to codeine and environmental allergies who on 11-JAN-2008 was vaccinated with her first dose of 0.5 ml GARDASIL (Lot #655154/1220U) intramuscularly in the left deltoid at 10:00 am. There was no illness reported at the time of vaccination. Two to three minutes after the injection the patient felt dizzy and passed out. Her vital signs remained stable. The patient stated that she had not eaten yet an d felt better after eating and drinking something. The patient recovered on 11-JAN-2008. No further information is expected.

VAERS ID:305675 (history)  Vaccinated:2008-01-10
Age:19.0  Onset:2008-01-10, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 35
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA02903
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure decreased, Feeling hot, Nausea, Swollen tongue, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a consumer, via a company representative, regarding the consumer''s 19 year old daughter (also the niece of the representative), with no pertinent medical history, who on 10-JAN-2008 was vaccinated with the first dose of Gardasil (lot # not reported). There was no concomitant medication. Approximately 10 or 15 minutes after the vaccination, the consumer''s daughter experienced nausea, swelling of the tongue, and her ears "felt steaming in heat." She also fainted. The mother reported that her daughter''s blood pressure also dropped (value not provided). Her daughter was given "a large dose" of diphenhydramine (BENADRYL), and the swelling of the tongue "subsided." At the time of this report, the outcome of the events was unknown. No further information is available.

VAERS ID:305816 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Ohio  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Urinary tract infection, 01/14/08, unknown
CDC Split Type: WAES0801USA03337
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IJGM
Administered by: Private     Purchased by: Other
Symptoms: Injection site pain, Urinary tract infection
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning a female who was vaccinated with a third dose of Gardasil. It was reported that the patient received all three doses in her bottom. It was reported that the patient experienced sore gluteus muscle after the vaccination in the gluteus muscle. Physician did not specify which vaccination caused the soreness. It was unknown whether medical attention was sought. The patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested. 07/08/08 Follow up information indicated that the patient received all 3 doses in the gluteus muscle. The physician did not know whether the patient received adequate dose IM. Additional information has been requested.

VAERS ID:305817 (history)  Vaccinated:2008-01-11
Age:19.0  Onset:2008-01-11, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 34
Location:Michigan  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Penicillin allergy
Diagnostic Lab Data:
CDC Split Type: WAES0801USA03375
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB225AA1IMUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U IM 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Feeling hot, Nausea, Similar reaction on previous exposure to drug, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning a female who was vaccinated intramuscularly with Gardasil. It was not known if this was the first, second or third dose. Subsequently the patient felt dizzy and had to be kept in the examination room for 25 minutes until she recovered. The patient sought unspecified medical attention. Per the reporter, the patient has had the same reaction to other vaccines, but the identity of those vaccines was unknown. Additional information has been requested. 02/10/2010 Follow up information received on B-form (26-FEB-2008): Per the reporter, within a few minutes after receiving the vaccines, the patient complained of feeling faint, hot, nauseous. The patien''s color was gray and blood pressure was 110/70. The patient continued to feel weak and dizzy. The physician came to see the patient. The exam was normal and the patient was diagnosed with a syncopal episode post -injection. The patient''s blood pressure was 109/72 and pulse was 67. The patient was allowed to rest until the symptoms subsided. This is in follow-up to report(s) previously submitted on 2/14/2008; 4/7/2008. Information has been received from a physician concerning a 19 year old female with a history of AMOXIL allergy who on 11-JAN-2008 was vaccinated IM with the first dose of GARDASIL (659439/1267U) (duration and dose not reported)(Lot# reported as 1462U). Other concomitant therapy included HAVRIX (GSK) (AHAVB225AA). On 11-JAN-2008 the patient experienced syncopal episode. Subsequently, the patient recovered from syncopal episode.

VAERS ID:305925 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:2008-01-05
Gender:Female  Submitted:2008-02-14, Days after onset: 40
Location:Pennsylvania  Entered:2008-02-19, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA04183
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dry skin, Rash macular, Skin warm, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a consumer concerning her 19 year old daughter who was vaccinated with all 3 doses of Gardasil. On 05-JAN-2008, after the second dose, the patient experienced mild hives and blotches. After receiving the third dose, the patient had huge red blotches on her face that became dry and warm to the touch. As of 18-JAN-2008, the patient was recovering. Additional information has been requested.

VAERS ID:305929 (history)  Vaccinated:2008-01-02
Age:19.0  Onset:2008-01-13, Days after vaccination: 11
Gender:Female  Submitted:2008-02-14, Days after onset: 32
Location:Pennsylvania  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anaemia
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA04291
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaemia, Dizziness, Dyspnoea, Electrocardiogram normal, Haemoglobin decreased, Laboratory test normal, Loss of consciousness, Malaise, Nausea, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a physician concerning a 19 year old female with anaemia who on 02-JAN-2008 was intramuscularly vaccinated with her first dose of Gardasil (lot # 659437/1266U). On 13-JAN-2008 the patient experienced syncope. She went to the ER and was found to be slightly anemic. On 19-JAN-2008 the patient had an office visit and experienced shortness of breath and generally did not feel well. Subsequently, the patient recovered from syncope but not from the shortness of breath. Additional information has been requested. 02/10/2010 In follow up report from the doctor''s office and medical record it was indicated that patient had diagnosis of sycope/near syncope on admission to ER. It occured while she was standing after taking a shower. She became nausous, dizzy and then she passed out. She had no prior history of similar problems. Her discharge diagnoses from teh mergency room was syncope vasovagal. In the emergency room laboratroy result revealed her hemoglobin was 10.9 which was low. Her blood pressure meausrment was 110/60, heart reate was 77, repiration was 10 and oral temperature as 97.3 F. She had no pain and pulse oximety was 100% in room air. Head computed axial tomographyic of brain showed no caute intracranial abnormality. Electrcardiogram showed normal sinus rhythm and was sent to her physician. All other laboratory results were within normal range. No other information was avaiable.

VAERS ID:305983 (history)  Vaccinated:2007-05-09
Age:19.0  Onset:2007-05-16, Days after vaccination: 7
Gender:Female  Submitted:2008-02-14, Days after onset: 274
Location:Kansas  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO EVRA
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA04740
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0244U0UNUN
Administered by: Private     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 19 year old black female with no pertinent medical history who on 09-MAY-2007 was vaccinated into the deltoid with a first dose of GARDASIL (lot #656051/0244U) Concomitant therapy included ORTHO EVRA. On 16-MAY-2007 the patient experienced urticaria. The patient required 2 emergency room visits. The patient was treated with SOLU-MEDROL, prednisone and BENADRYL. Subsequently, the patient recovered from urticaria. No further information is available.

VAERS ID:306021 (history)  Vaccinated:2008-01-18
Age:19.0  Onset:2008-01-18, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 27
Location:Michigan  Entered:2008-02-19, Days after submission: 5
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: Migraine
Diagnostic Lab Data: vital sign, 01/18/08, normal
CDC Split Type: WAES0801USA05019
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U2IMUN
Administered by: Private     Purchased by: Private
Symptoms: Fall, Loss of consciousness, No reaction on previous exposure to drug, Presyncope, Traumatic brain injury
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a physician concerning a 19 year old female with a history of migraines who on 18-JAN-2008 was vaccinated with her third dose of Gardasil. Concomitant therapy included MANTOUX SKIN TEST. Approximately 15 minutes after receiving the vaccination on 18-JAN-2008 the patient fell down and had a loss of consciousness for a few seconds. The patient was taken to the emergency room where her vital signs were checked and everything was normal. She was discharged that day with a "clean bill of health." The patient did not have an adverse reaction to the first or second dose of the vaccine. Subsequently, the patient recovered on 21-JAN-2008 from falling down and loss of consciousness for a few seconds. Additional information has been requested. Follow-up received 04/16/2008. Concomitant therapy included tuberculin purified protein derivative (MANTOUX SKIN TEST) (LOT # C2670AA) and topical acne medications. Approximately 15 minutes after receiving the vaccination on 18-JAN-2008 the patient fell down and struck her head, completely breaking through the dry wall and had a loss of consciousness for a few seconds. Patient was alert within 10-15 seconds. Her vital signs immediately following the episode were within normal limits. The patient was transferred to the emergency room with a neck collar and back board where she was evaluated and diagnosed with a closed head injury adn vaso-vagal reaction. She was discharged that day with a "clean bill of health." The patient did not have an adverse reaction to the first or second dose of the vaccine. Subsequently, the patient recovered on 21-JAN-2008 from falling down and loss of consciousness for a few seconds. Additional information has been requested.

VAERS ID:306022 (history)  Vaccinated:2008-01-15
Age:19.0  Onset:2008-01-16, Days after vaccination: 1
Gender:Female  Submitted:2008-02-14, Days after onset: 29
Location:Unknown  Entered:2008-02-19, 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: OVCON 35
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA05039
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Dizziness, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Information has been received from a health professional concerning a 19 year old female who on 15-NOV-2007 was vaccinated with her first dose of Gardasil. Concomitant therapy included OVCON 35. On 15-JAN-2008 the patient was vaccinated with her second dose of Gardasil (lot# 659653/1448U). On 16-JAN-2008 the patient felt dizzy, nauseated, slight abdominal pain and her head hurt. The patient''s dizziness, nausea, slight abdominal pain and head hurt persisted. As of 24-JAN-2008 the patient still had a headache and was going to be seen in the office that afternoon. The patient had no adverse reaction after the first dose. Additional information has been requested.

VAERS ID:306108 (history)  Vaccinated:2007-11-19
Age:19.0  Onset:2007-11-19, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 87
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypersensitivity
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA06122
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a nurse concerning a female who in November 2007, was vaccinated with the first dose of Gardasil. Subsequently, the patient experienced localized reaction at the injection site consisting of redness, warmth, and itching. Unknown medical attention was sought. The reaction resolved completely (date unknown). No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008. Information has been received from a nurse concerning a 19 year old female who with very sensitive to medication, on 19-November 2007, was vaccinated in the left deltoid with the first dose of GARDASIL (lot# 658219/0755U). On 11-Jan-2008 she received the second dose in the right deltoid (lot# 658219/0755U). Two hours after the first dose, shot site became red with swelling. Two weeks after the vaccination the patient experienced nausea and vomiting. Two weeks after the second vaccination the patient experienced nausea and vomiting. Unknown medical attention was sought. The patient was recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:306158 (history)  Vaccinated:2008-01-22
Age:19.0  Onset:2008-01-24, Days after vaccination: 2
Gender:Female  Submitted:2008-02-14, Days after onset: 21
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0802USA00348
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Cough, Headache, Malaise, Nausea, Oropharyngeal pain, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a health professional concerning a 20 year old female who on 22-JAN-2008 was vaccinated with first dose of GARDASIL. Per the reporter, on 24-JAN-2008 the patient called the office and complained she had a headache, nausea, vomiting and did not feel good. The office recommended that the patient treat the symptoms with over the counter medication and to call back on Monday. Per the reporter, the patient has not called back and calls to the patient''s house have gone unanswered. The patient''s present status is unknown and no other information is available. Additional information has been requested. Follow-up received 04/16/2008. Information from B Form 15-FEB-2008. The patient''s adverse events were reported as a cough, vomiting, slight sore throat and an increased temperature. The patient''s status is still unknown.

VAERS ID:306163 (history)  Vaccinated:2008-01-09
Age:19.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 36
Location:Unknown  Entered:2008-02-19, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA02036
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Pain in extremity
SMQs:
Write-up: Information has been received from a registered nurse concerning a 19 year old female with no known allergies and no reported medical history who on 09-JAN-2008 was vaccinated with her first dose of 0.5 ml GARDASIL (Lot #659055/1522U) intramuscularly. On 09-JAN-2008 the patient developed severe pain on both legs. The pain had not been resolved. No other details were reported. Additional information has been requested.

VAERS ID:305241 (history)  Vaccinated:2008-02-14
Age:19.0  Onset:2008-02-14, Days after vaccination: 0
Gender:Female  Submitted:2008-02-20, Days after onset: 6
Location:Missouri  Entered:2008-02-20
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. 1  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient was given 2nd Gardasil vaccine 9:00am on 2/14. Patient was fine until after dinner when she fainted. She came to my clinic on 2/20 and no signs of any additional problems.

VAERS ID:305488 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-22
Location:Texas  Entered:2008-02-22
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: Unknown
CDC Split Type: WAES0802USA01925
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Loss of consciousness, Pallor, 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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician concerning a 19 year old female who on an unspecified date was vaccinated via injection with the first dose of Gardasil, (lot number not reported). Concomitant therapy included BOOSTRIX and MENACTRA. Subsequently the patient passed out, was pale white, shaking and having convulsions after receiving the first dose of Gardasil. The physician reported that the patient did not have a seizure. The physician also reported that it was unknown whether or not the patient would receive the second and third doses of Gardasil. Subsequently, the patient recovered from passing out, being pale white, shaking and having convulsions. Unspecified medical attention was sought. Upon medical review it was determined that convulsions was considered an other important medical event. Additional information has been requested.

VAERS ID:305491 (history)  Vaccinated:2007-10-05
Age:19.0  Onset:2007-10-07, Days after vaccination: 2
Gender:Female  Submitted:2008-02-21, Days after onset: 137
Location:Illinois  Entered:2008-02-22, 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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA02670
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0680U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a registered nurse concerning a 19 year old female who on 03-AUG-2007 was vaccinated with a first dose of Gardasil (lot # 657872/0515U) 0.5 ml IM. On 05-OCT-2007, the patient was vaccinated with a second dose of Gardasil (lot # 658219/0680U 0.5 ml IM. On approximately 07-OCT-2007, about two days after the second dose, the patient developed a raised rash over her entire body. She went to the local emergency room for treatment. She was placed on prednisone dose pack at the emergency room and was then released. Subsequently, she fully recovered about 1 week post vaccination. The nurse felt that the raised red rash was serious and needed intervention (Other Important Medical Event). Additional information has been requested.

VAERS ID:305518 (history)  Vaccinated:2008-01-07
Age:19.0  Onset:2008-01-27, Days after vaccination: 20
Gender:Female  Submitted:2008-02-22, Days after onset: 26
Location:Mississippi  Entered:2008-02-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: 1/9/08, neg HcG (urine)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETH40200766IDUN
Administered by: Military     Purchased by: Military
Symptoms: Drug exposure during pregnancy, Pregnancy, Urine human chorionic gonadotropin negative
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Soldier was given smallpox on 1/7/08. Pregnancy test on 1/7/08 neg. Soldier later had pregnancy test done at local hospital on 1/27/08 positive. Soldier was referred back to home station.

VAERS ID:305734 (history)  Vaccinated:2008-02-20
Age:19.0  Onset:2008-02-22, Days after vaccination: 2
Gender:Female  Submitted:2008-02-26, Days after onset: 4
Location:Vermont  Entered:2008-02-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: oral contraceptive
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data: Monospot negative; WBC 10.8; diff: 79Neu, 15Lym, 2 bands, 3 monos, 1 basos; Hgb 13.1; Hct 39.4; Plt 413;
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1486U2IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Auricular swelling, Basophil count normal, Dermatitis allergic, Dyspnoea, Erythema, Haematocrit normal, Haemoglobin normal, Lymphadenopathy, Lymphocyte count decreased, Monocyte count normal, Mononucleosis heterophile test negative, Neutrophil count increased, Pharyngeal oedema, Pharyngolaryngeal pain, Platelet count normal, Pruritus, Rash pruritic, Throat irritation, White blood cell count
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Pt developed sore throat on 2/22, developed itching, burning, swelling in throat and ears on 2/25. Tender cervical LAD, felt short of breath. Red, pruritic rash across abdomen and upper thighs with some involvement of arms, appears allergic in nature. No source of infection on examination. Patient d/c''ed from clinic with fexofenadine.

VAERS ID:305795 (history)  Vaccinated:2008-02-09
Age:19.0  Onset:2008-02-12, Days after vaccination: 3
Gender:Male  Submitted:2008-02-13, Days after onset: 1
Location:Minnesota  Entered:2008-02-26, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURERFAV1580SCLA
Administered by: Military     Purchased by: Military
Symptoms: Vaccination complication
SMQs:
Write-up: Patient had anthrax vac on 9Feb08 and had adverse reaction on or about 11-12Feb08. Member did seek medical care.

VAERS ID:305867 (history)  Vaccinated:2008-02-27
Age:19.0  Onset:2008-02-27, Days after vaccination: 0
Gender:Male  Submitted:2008-02-27, Days after onset: 0
Location:Maryland  Entered:2008-02-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 2IMRA
HEPA: HEP A (VAQTA)MERCK & CO. INC. 1IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR 0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Fall
SMQs:, Accidents and injuries (narrow)
Write-up: Patient was being given the following vaccines hep a hep b typhoid when giving the vaccines hep a and typhoid the patient was given bandages then the hn was going to give the hep b in the other arm and he fell to the floor hn got help and then returned to the patient and he was awake hn help him to a chair and he went to lay in the back were he was deemed ok by the doc.

VAERS ID:306468 (history)  Vaccinated:2007-04-09
Age:19.0  Onset:2007-04-17, Days after vaccination: 8
Gender:Female  Submitted:2007-07-24, Days after onset: 98
Location:Kansas  Entered:2008-02-29, Days after submission: 220
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORATADINE
Current Illness:
Preexisting Conditions: Allergic rhinitis
Diagnostic Lab Data:
CDC Split Type: 200701364
Vaccination
Manufacturer
Lot
Dose
Route
Site
JEV: JAPANESE ENCEPHALITIS (JE-VAX)SANOFI PASTEUREJN228A1SCRA
Administered by: Other     Purchased by: Other
Symptoms: Eye swelling, Infectious mononucleosis, Lymphadenopathy, Pharyngolaryngeal pain, Respiratory tract congestion, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Initial report received from a physician on 19 April 2007. A 19 year old, female patient developed swelling of both eyes after she received her second dose of JE-VAX (lot number EJN228A) subcutaneously in the right arm on 09 April 2007. She also had a sore throat, congestion and lymph node enlargement-neck. She received her first dose of JE-VAX (lot number EJN228A) subcutaneously in the left arm on 02 April 2007. She was treated with Benadryl on 18 April 2007. At the time of the report, she had not recovered. Follow up information received on 02 July 2007 from a physician in USA; The patient had recovered. No sensitization tests done as she declined further service since 20 April 2007. On 23 April 2007 the patient''s mother reported that the patient diagnosed with "mono" and "UTI". On 08 May 2007 the patient did not report any prolonged symptoms. Follow-up information received on 23 July 2007 from a health care professional. The reported events were confirmed as mononucleosis and urinary tract infection. Per the reporter, any laboratory results done between 20 April and 23 April were done by the patient''s primary care physician "not my clinic."

VAERS ID:306226 (history)  Vaccinated:2008-03-01
Age:19.0  Onset:2008-03-01, Days after vaccination: 0
Gender:Male  Submitted:2008-03-01, Days after onset: 0
Location:New York  Entered:2008-03-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Getting over being sick
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB1831IMUN
Administered by: Military     Purchased by: Military
Symptoms: Dizziness, Dry skin, Head injury, Loss of consciousness, Skin warm
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Pt felt dizzy after receiving Hep A vaccine. He left the immunes room and walked to the dental room across the hall. Pt passed out and hit head on door several times until someone noticed he had passed out. On assessment post vaccination, skin was unremarkably warm and dry. Not on any medications. Pt then told us, he had not eaten or drank much over past 48 hours. Lungs clear, temp of 102.9. EKG done. MD assessed. EMTS came to evaluate pt. Did not go to hospital.

VAERS ID:306292 (history)  Vaccinated:2008-02-05
Age:19.0  Onset:0000-00-00
Gender:Male  Submitted:2008-03-03
Location:Michigan  Entered:2008-03-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB288-A2IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B015AA2IMLA
Administered by: Public     Purchased by: Public
Symptoms: Expired drug administered
SMQs:
Write-up: Was administered Hepatitis B vaccine which expired 1/25/08

VAERS ID:306307 (history)  Vaccinated:2008-03-01
Age:19.0  Onset:2008-03-01, Days after vaccination: 0
Gender:Female  Submitted:2008-03-03, Days after onset: 2
Location:Ohio  Entered:2008-03-03
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: CBC, CMP, PO4, Mg, EKG = normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB216AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Dizziness, Electrocardiogram normal, Full blood count, Metabolic function test, Syncope, Tonic clonic movements, Vaccine positive rechallenge
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: After receiving Gardasil #2, Hep A #1 vaccines, pt was placed supine (b/c hx of feeling dizzy after 1st Gardasil). Approx 1 min. after vaccines, pt had 3 second tonic clonic activity of arms and legs with flexion of neck twice. No incontinence. Pt was lucid, AA and ) immediately post-event. Pt felt lightheaded for 30-40 mins. She slowly transitioned from supine to sitting to ambulatory. Exam was non-focal and VS normal. Dx: syncope with seizure.

VAERS ID:306409 (history)  Vaccinated:2008-02-25
Age:19.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-02-28, Days after onset: 2
Location:Maryland  Entered:2008-03-04, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0013X1UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1506U0UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Body temperature, Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient noticed redness and swelling at injection site with itching - area 7cm x 5cm, red and raised. Temperature 99.

VAERS ID:306680 (history)  Vaccinated:2007-11-01
Age:19.0  Onset:2007-12-01, Days after vaccination: 30
Gender:Female  Submitted:2008-03-07, Days after onset: 97
Location:Colorado  Entered:2008-03-07
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: asthma
Diagnostic Lab Data: Several diagnostic labs including internal and external cultures / smears
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Unknown
Symptoms: Culture, Fungal infection, Injection site pain, Laboratory test, Smear test
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: At the time of the injection (date is uncertain) and soon afterward only pain at site were a problem. Within a week or so, a stubborn yeast infection started that is still recurring and never quite clears up even today, 4 months later, with agressive physician care and prolonged internal and external medical treatment. As the HPV vaccine is yeast based, I believe there is a definite correlation. There is no history previously of recurrent yeast infections in her.

VAERS ID:306883 (history)  Vaccinated:2008-03-07
Age:19.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-11, Days after onset: 3
Location:Indiana  Entered:2008-03-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: No Known Allergies
Diagnostic Lab Data: Blood draw from that day is not back as yet.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.UNKNOWN1UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Amnesia, Blood test, Chills, Crying, Feeling abnormal, Hypoaesthesia, Hypoxia, Opisthotonus, Paralysis, Peripheral coldness, Speech disorder, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient received HPV vaccination. She then went into blood drawing area to have blood checked for anemia. This was 45 min after vaccination. All was going well and then she felt odd, hands went numb, became temporarily paralyzed, could not move arms and difficult time speaking all the time alert to what was going on. She became ice cold, blood would no longer flow, she was eased to the floor, and then became very distraught with her inability to move arms, arched back, shivered. She did not lose bladder control, did not become diaphoretic as I would expect with a vasovagal response, she did lose partial memory for some of the event but was able to relay my phone number to the phlebotomist who called me, her father and a physician. Ambulance was already called and arrived just as I arrived, because she was not responding to regular supportive measures. After one hour of stable vitals she was able to sit up, and after 90 mins she was no longer orthostatic and she was able to leave the clinic. I was called to the blood draw clinic at 12:48 PM. It took 90 mins for patient to be able to stand and get food, fluids etc. Phlebotomist did complete her draw with no vagal reaction to this second attempt. We left the clinic, got light lunch, fluids, and after 2.5 hours she was safe to drive home. She followed me. She slept for two hours that afternoon and seems to have no more adverse affects. I suspected a vagal response and she insisted she had blood drawn before and this has never happened, and the paralysis of her hands and arms she found spooky, and terrifying. She had numbness of her hands but no peri-oral numbness until she began to come around and then became weepy. She responded to attention, but her extremities were quite cold, hypoxic appearing, yet she was not seen to hyperventilate or hypoventilate. The ambulance took a biox, I do not have that report, the ambulance also took vitals and I was told they were stable. I am a physiatrist and I was most concerned about learning if she had fallen and hit her head. I was assured she had not. I am also an acupuncturist and needled GV 27 a point used in acute syncope, and HT 7, used for anxiety, my presumptive dx at the time was still vasovagal reaction. She responded became more alert and less anxious. Her color improved but as I said it took 90 minutes before she could hold her head up without being symptomatic. Although I suspected a vagal response she insisted it was not, and my wife, not a physician, read the patient education literature from the physician''s office and proposed to me, this evening, that this may have been an adverse reaction. I decided to read the material myself and I am inclined to agree with her. At the very least we do not intend to give her the second dose of HPV. The paralysis was the feature most disturbing to my daughter and not what I would expect with either hyperventilation or vasovagal reaction. I see both in clinic with some frequency and this episode just did not fit, yet I led myself to believe this was all that had taken place. My daughters insistence that she knows what it is like to faint and this was very different, leads me to believe this was an adverse reaction. She has returned to college and has no complaints now.

VAERS ID:307159 (history)  Vaccinated:2007-05-16
Age:19.0  Onset:2007-05-16, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 303
Location:Florida  Entered:2008-03-17, 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: Pregnancy NOS (LMP = 5/1/2007); Pregnancy
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound 06/20/07 WNL, new OB; Ultrasound 08/22/07 WNL, 18 week U/S.
CDC Split Type: WAES0705USA05491
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arrested labour, Caesarean section, Drug exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a Licensed Practical Nurse (LPN) for the pregnancy registry for Gardasil concerning a 19 year old female (last menstrual period was early May 2007) with no pertinent medical history, drug reactions or allergies who on 16-MAY-2007 was vaccinated with her first dose of Gardasil, 0.5 ml, intramuscular administration (IM), and was subsequently determined to be pregnant. There was no concomitant medication. The LPN reported the patient did not experience any problems. Product Quality Control (PQC) was not involved. Follow-up information has been received from a pregnancy questionnaire. The patient, with no past medical history or conditions, had no complications during pregnancy, diagnostic test during pregnancy or during labor/delivery. However, 38 weeks from LMP, the patient had a cesarean section due to failure to descend. On 20-JUN-2007 and 22-AUG-2007 the patient had an ultrasound (results WNL) due to new OB and 18 weeks U/S. It was reported that the patient declined to have a MSAFP test. On 23-JAN-2008 a normal female baby was born at 7 lbs 7 oz with an APGAR score of 5/9. Concomitant medication during pregnancy (JAN-2005 through February 2008) included prenatal vitamins ("Tandem") once a day for pregnancy. No previous pregnancies were noted. Upon internal review cesarean section due to failure to descend was considered to be an other important medical event. Additional information is not expected.

VAERS ID:307477 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-14
Location:Georgia  Entered:2008-03-17, 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: Ferrous sulfate mg; Vitamins (unspecified)
Current Illness:
Preexisting Conditions: Papanicolaou smear abnormal; Termination of pregnancy - elective; Colposcopy.
Diagnostic Lab Data: Ultrasound complete previa; Ultrasound 12/18/07 complete previa; Hemoglobin (value) 9.5
CDC Split Type: WAES0802USA00498
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Haemoglobin decreased, Placental disorder, Ultrasound abdomen
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a 19 year old black female, with no drug allergies, a medical history of an abnormal pap smear, a colposcopy in 2007, one pregnancy, and an elective termination of a subsequent pregnancy in 2002 (LMP was 16 weeks), and a family history of heart disease, hypertension and diabetes. The patient was vaccinated with her second dose of 0.5 ml of GARDASIL intramuscularly on an unspecified date. Concomitant therapy during the pregnancy included ferrous sulfate (FeSO4) and prenatal vitamins. The patient became pregnant sometime after receiving her second dose of GARDASIL. The patient did not seek medical attention. No adverse event was reported. Follow up information has been received from a certified nurse midwife. The patient sought medical attention and on the 20th of an unspecified month and 18-DEC-2007 ultrasounds were performed which revealed complete previa. Additional information was not readable. The comment was that previa was cleared. Other diagnostic laboratory tests included haemoglobin at 9.5. The patient was started on ferrous sulfate (FeSO4). Additional information has been requested.

VAERS ID:307478 (history)  Vaccinated:2008-02-01
Age:19.0  Onset:2008-02-01, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 41
Location:Michigan  Entered:2008-03-17, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA00500
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a health professional concerning a 19 year old female who on 01-FEB-2008 was IM vaccinated with her first dose of GARDASIL (Lot # 659439/1267U). On 01-FEB-2008 the patient experienced syncope. The patient sought unspecified medical treatment. Subsequently, the patient recovered from syncope. Additional information has been requested. 02/12/2010 Follow up information obtained on 03-Apr-2008 indicated the nurse does not have any additional information. The nurse does not plan to follow up letter to her.

VAERS ID:307540 (history)  Vaccinated:2008-01-21
Age:19.0  Onset:2008-01-26, Days after vaccination: 5
Gender:Female  Submitted:2008-03-14, Days after onset: 47
Location:Unknown  Entered:2008-03-17, 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: Attention deficit/hyperactivity disorder
Preexisting Conditions:
Diagnostic Lab Data: Electrocardiogram normal
CDC Split Type: WAES0802USA01575
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal discomfort, Chest pain, Dizziness, Electrocardiogram normal, Muscle strain, Pharyngolaryngeal pain
SMQs:, Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: Information has been received from a physician concerning a 19 year old female with attention deficit/hyperactivity disorder who on 21-JAN-2008 was vaccinated with her third dose of GARDASIL. The patient experienced transient abdominal discomfort with a prior dose of GARDASIL. On 26-JAN-2008 the patient was seen for complaints of a sore throat and felt to have neck muscle strain accounting for her pain. On 29-JAN-2008 the patient was seen again for chest pain and light headedness. An electrocardiogram (EKG) was normal. Pain seemed to be musculoskeletal in nature (costochondritis). Anti-inflammatory agents were prescribed, which the patient did not take, but instead went to the emergency room for narcotic analgesics. The physician does not feel that these complaints are related to GARDASIL, but rather to heavy lifting (patient works in a nursing home). The patients outcome is unknown. Additional information has been requested.

VAERS ID:307644 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-14
Location:California  Entered:2008-03-17, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA03024
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a member of a physician''s office staff concerning a 19 year old female who was vaccinated with her first dose of GARDASIL. The patient experienced closing and tightening of the throat right after administration of GARDASIL. The patient also developed hives on an unspecified part of the body. The patient sought medical attention. The patient recovered a couple of days after receiving GARDASIL. Additional information has been requested.

VAERS ID:307745 (history)  Vaccinated:2007-07-25
Age:19.0  Onset:2008-02-08, Days after vaccination: 198
Gender:Female  Submitted:2008-03-14, Days after onset: 34
Location:Unknown  Entered:2008-03-17, 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: hormonal contraceptives
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory 02/08/08 - positive for high risk HPV; Pap test 02/08/08 norma
CDC Split Type: WAES0802USA04636
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0515U2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Human papilloma virus test positive, Smear cervix normal
SMQs:
Write-up: Information has been received from a nurse practitioner concerning a 19 year old female who on 12-JAN-2007 was IM with her 1st dose of GARDASIL (lot#653736/0868F). On 13-MAR-2007 the patient was vaccinated IM with her 2nd dose of GARDASIL (lot# 653736/0014U). On 25-JUL-2007 the patient was vaccinated IM with her 3rd dose of GARDASIL (lot# 657872/0515U). It was reported that the patient received all three vaccinations with a pre-filled syringe prior to being sexually active. Concomitant therapy included administration of meningococcal vaccine (unspecified) on 12-JAN-2007 and hormonal contraceptives (unspecified started therapy in September 2007). It was reported that on 08-FEB-2008 the patient had a normal pap test, but the patient tested positive for high risk HPV. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:307795 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:2008-01-18
Gender:Female  Submitted:2008-03-14, Days after onset: 55
Location:Unknown  Entered:2008-03-17, 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: Mercury poisoning
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA05482
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug interaction, Lip swelling, Pharyngeal oedema, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a pharmaceutical company as part of a business agreement (manufacturer report number 080118-0000044) and a pharmacist concerning a 19 year old female, who, on an unspecified date, was vaccinated with a dose of Gardasil. Concomitant suspect therapy included CHEMET. On 18-JAN-2008 the patient experienced throat swelling, swelling of face, swelling of lips, and a drug interaction. The duration between the administration of the vaccine and the onset of the symptoms was unknown. The patient temporarily discontinued CHEMET for 3 to 4 weeks. When the patient resumed treatment with CHEMET she experienced the same events. Subsequently, the CHEMET was permanently discontinued. The Gardasil was considered a co-suspect drug. The reporter considered the events to be possibly related. Additional information is not expected.

VAERS ID:307823 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-14
Location:Florida  Entered:2008-03-17, 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: Ovarian cyst
Diagnostic Lab Data: beta-human chorionic, 12/??/07, Not pregnant
CDC Split Type: WAES0802USA05967
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Menstruation delayed, Pregnancy test negative
SMQs:, Fertility disorders (broad)
Write-up: Information has been received from a physician concerning a 19 year old female with a history of ovarian cysts who sometime in December 2007 was vaccinated with the first dose of Gardasil. In December the patient''s period came approximately 3 weeks late. A pregnancy test was done and the patient was not pregnant. The patient sought unspecified medical attention. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:307824 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-14
Location:New Jersey  Entered:2008-03-17, 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: None
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA05976
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.UNK1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Oral herpes
SMQs:, Oropharyngeal infections (narrow)
Write-up: Information has been received from a consumer concerning her 19 year old daughter with no medical history or allergies reported, who was vaccinated intramuscularly with a second 0.5 ml dose of Gardasil. There was no concomitant medication reported. Subsequently, the patient experienced a severe case of fever blisters after receiving the second dose of Gardasil. The patient was not seen by a physician for the outbreak. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:307829 (history)  Vaccinated:2007-08-27
Age:19.0  Onset:2008-01-27, Days after vaccination: 153
Gender:Female  Submitted:2008-03-14, Days after onset: 46
Location:Florida  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA06024
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Guillain-Barre syndrome, Upper respiratory tract infection
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Information has been received from a physician concerning a 19 year old female who on approximately 27-AUG-2007 was vaccinated IM with a 0.5 ml first dose of GARDASIL. On approximately 27-JAN-2008 the patient developed an upper respiratory infection. On approximately 13-FEB-2008 the patient developed Guillain-Barre syndrome and was hospitalized. The patient was discharged from the hospital to a rehabilitation center. At the time of the report, the patient had not recovered. The reporting physician felt that GARDASIL vaccination "has nothing to do with the patient''s diagnosis." No further information is available.

VAERS ID:307930 (history)  Vaccinated:2008-01-03
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-14
Location:New York  Entered:2008-03-17, 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: colposcopy; Pap test abnormal
CDC Split Type: WAES0803USA01379
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1061U2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Colposcopy, Smear cervix abnormal
SMQs:
Write-up: Information has been received from a physician concerning a 19 year old single female who on 19-JUN-2007 was vaccinated with the first dose of GARDASIL (Lot # "0389U"), on 23-Aug-2007 was vaccinated with the second dose of GARDASIL (Lot # 658488/0930U) and on 03-Jan-2008 was vaccinated with the third dose of GARDASIL (Lot # 658558/1061U). The patient had an abnormal PAP test since receiving the vaccinations. The patient needed a colposcopy. The patient did not have a positive PAP test prior to receiving the vaccinations. Medical attention was sought in the office. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2008. No further information is available.

VAERS ID:307231 (history)  Vaccinated:2007-10-30
Age:19.0  Onset:2007-10-30, Days after vaccination: 0
Gender:Male  Submitted:2007-12-20, Days after onset: 51
Location:Ohio  Entered:2008-03-18, Days after submission: 88
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALBUTEROL ,CLONIPINE, ZOLOFT
Current Illness:
Preexisting Conditions: NKA (No Known Allergies), asthma, anxiety, depression.
Diagnostic Lab Data:
CDC Split Type: 200704244
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2427A IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Initial report received on 12 December 2007 from a health care professional in the United States. A 19 year-old male patient received on 30 October 2007 Menactra (lot#U2427AA) and at the evening of the same day, began having pain in his entire left arm. He had pain when he moved his arm a certain way and he could not lift a weight over his head. The muscle felt tired. There was no redness or swelling. Treated with Medrol dose pack with no change (in his condition). The patient was seen again by a physician as the pain was becoming worse. Naproxen was prescribed but there was no change (in his condition). The patient was planning to see an orthopedic PhD and to get an MRI. No relevant laboratory or diagnostic tests were done. The patient had no illness at vaccination time. No other vaccines were given around the same time. The patient''s medical history included: NKA (No Known Allergies), asthma, anxiety and depression. The patient''s concomitant medications included: albuterol inhaler, Clonipine and Zoloft. No adverse event was reported following prior vaccination. The patient had not recovered. Upon internal review: the initial report received on 11 December 2007 (and not as reported previously) from a health care professional.

VAERS ID:307275 (history)  Vaccinated:2008-03-05
Age:19.0  Onset:2008-03-06, Days after vaccination: 1
Gender:Female  Submitted:2008-03-10, Days after onset: 3
Location:New Mexico  Entered:2008-03-18, 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: None
Current Illness: none
Preexisting Conditions: NKDA or medical conditions
Diagnostic Lab Data: none.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2342CA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2862AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Lip swelling, Pruritus, Rash, Rash maculo-papular, Rash papular, Rash pustular, Skin lesion
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Patient states onset of itchiness of skin and lips within 24 hours of vaccine administration, with onset of rash shortly after. Patient has swelling of the lips with numerous 2-3mm papules on upper and lower lips but few on face, neck. Skin rash primarily on arms - red maculopapular rash of variable size lesions 3-4mm - 12-15mm, some with a tiny central pustule (1mm). Skin lesions scattered, mainly on arms, with few lesions on abd, neck; Patient seen for rash 3/9/08 and 3/10 ; no fever, SOB, respiratory symptoms; Itching treated with Diphenhydramine

VAERS ID:307943 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-07
Location:Georgia  Entered:2008-03-19, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CARBATROL; NEURONTIN
Current Illness: Allergic reaction to antibiotics; Convulsion
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0702USA01726
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Aura
SMQs:, Convulsions (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a certified medical assistant concerning a 19-year-old female with allergic reaction to antibiotics and a history of seizures who was vaccinated with her first dose of RECOMBIVAX HB (manufacturer unknown). Concomitant therapy included CARBATROL and NEURONTIN. Subsequently the day after vaccination, the patient experienced a pre-seizure visual aura with no accompanying seizure. It was noted that the patient never had a seizure with this aura, the date and duration of the aura was unclear. Subsequently, the patient recovered from pre-seizure visual aura. The series was not continued. The patient''s medications at the time of this event were unknown. Additional information to report. Additional information has been requested.

VAERS ID:307719 (history)  Vaccinated:2008-03-06
Age:19.0  Onset:2008-03-07, Days after vaccination: 1
Gender:Male  Submitted:2008-03-11, Days after onset: 3
Location:Missouri  Entered:2008-03-21, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)MICHIGAN DEPT PUB HLTHFAV163 UNUN
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETH4020076  UN
TYP: TYPHOID LIVE ORAL TY21A (NO BRAND NAME)UNKNOWN MANUFACTURERA0221 UNUN
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Rash pustular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Sur with 16-20 Erythema pustule on left arm around recent tattoo. Symptoms can decrease with time.

VAERS ID:307971 (history)  Vaccinated:2008-03-17
Age:19.0  Onset:2008-03-17, Days after vaccination: 0
Gender:Male  Submitted:2008-03-24, Days after onset: 7
Location:Virginia  Entered:2008-03-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1740SCLA
Administered by: Military     Purchased by: Military
Symptoms: Cyanosis, Feeling hot, Nausea, Pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: 3 hours after receipt of AVA#1 pt pt had nausea, general body aches and he felt feverish. Temp not taken. Symptoms worsened over next 24 hours. Pt did not eat, drink and take anything for sx. The next day pt also noted cyanotic hands and lips. Within 24 hours all symptoms subsided.

VAERS ID:308089 (history)  Vaccinated:2008-03-05
Age:19.0  Onset:2008-03-05, Days after vaccination: 0
Gender:Female  Submitted:2008-03-06, Days after onset: 1
Location:California  Entered:2008-03-25, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Loestrin 24 Fe
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB216AA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U1IMLL
Administered by: Private     Purchased by: Private
Symptoms: Pruritus, Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 2 hours after receiving vaccines stomach starting itching. Woke up next morning with whole body itching.

VAERS ID:308288 (history)  Vaccinated:2008-03-11
Age:19.0  Onset:2008-03-11, Days after vaccination: 0
Gender:Female  Submitted:2008-03-26, Days after onset: 15
Location:Iowa  Entered:2008-03-26
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: Allergic to Pertussis. Pt reports headaches starting with first Gardasil 6/21/2007. PMH: breast lump
Diagnostic Lab Data: Labs and Diagnostics: CBC with WBCs 10K, Hgb 13.6, and platelets 125K. CT brain shows no acute abnormality.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Abdominal pain upper, Asthenia, Computerised tomogram normal, Diarrhoea, Fatigue, Food aversion, Frequent bowel movements, Full blood count, Haemoglobin normal, Hypoaesthesia, Insomnia, Migraine, Muscle twitching, Musculoskeletal stiffness, Myalgia, Nausea, Pain, Paraesthesia, Parosmia, Platelet count decreased, Pyrexia, Scan brain, Thinking abnormal, Tinnitus, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow)
Write-up: Achy muscles, stiff neck and back, extreme fatigue, nausea, migraines, diarrhea, ringing in ears, sharp stabbing pains in belly, severe abdominal cramping, numbness and tingling in limbs, impaired thinking, aversions to foods, strong aversion/nausea upon smelling strong scents, trouble sleeping, fevers. 4/2/2008 MR received for OV 3/27/2008 and PMH back to 12/2006. Pt presented to office with c/o ? reaction to 3rd Gardasil vax. Pt reports migraines x 10 in the week following vax, now with constant, throbbing pain in the R eye area with pressure. Pt also reports diarrhea and abd cramping, 10 stools yesterday. Legs go numb during BM. Smells bother pt now. Pt reports fevers. Temp 99.8 at OV. Pt reports paresthesias in the L leg which began 3/25/08. Pt also reports weakness, fatigue and twitching. PE WNL. Assessment: R Frontal Headaches. Abdominal Pain, cramping & diarrhea. Paresthesias of the legs. Tag2 received from PCP (308590 to be linked). 4/7/08 RN in PCP office reports pt''s sx have improved with Medrol dose pack.

VAERS ID:308416 (history)  Vaccinated:2008-03-25
Age:19.0  Onset:2008-03-25, Days after vaccination: 0
Gender:Male  Submitted:2008-03-27, Days after onset: 2
Location:Oregon  Entered:2008-03-27
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB108AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2767AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Insomnia, Lymphadenopathy, Malaise, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Onset of symptom began 2 hrs. post-vaccination; headache, mild fever, malaise, swelling and arm pain at injection site. Over the next 28 hours pt. had nausea, vomiting, chills, fever 100 F., insomnia, severe headache and lymphadenopathy in L axilla (side of injection). Presented to our clinic 48 hrs after injection and was evaluated by our Occupational Medicine Physician; given Rx for Ibuprofen 600 mg. t.i.d. and Phenergan 25 mg. po q 4-6 hrs. and sent home to rest, push fluids. Pt. was vaccinated due to his his employment by a construction co. His vaccination history is unknown. He was born and raised in another country, unable to obtain records.

VAERS ID:308437 (history)  Vaccinated:2008-03-27
Age:19.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-03-27, Days after onset: 0
Location:North Carolina  Entered:2008-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None known
Preexisting Conditions: Allergic to PCN, sulfa drugs, pollen, cat hair, red ants, mold and dust mites.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2393BA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Eye swelling, Hypersensitivity, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Mother of client called and reported "she had an allergic reaction. Her eyes swelled and her throat was closing up". Reports client took Benadryl, but had to go to clinic for treatment. States "She''s ok now".

VAERS ID:308508 (history)  Vaccinated:2008-03-17
Age:19.0  Onset:2008-03-26, Days after vaccination: 9
Gender:Male  Submitted:2008-03-28, Days after onset: 2
Location:Georgia  Entered:2008-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONS    
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA05222   
Administered by: Military     Purchased by: Military
Symptoms: Dizziness, Headache, Injection site induration, Injection site pain, Injection site warmth, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Pt received smallpox vaccine in left shoulder on 17 Mar 08. He Presented to day c/o dizziness, nausea, vomiting, frontal headaches pain level #4 for the past two days. Denies visual changes, and tinnitis. Vaccine site is tender and warm to touch. Firm underlying tissue circum: 50 mm around the injection site. Sites appears within normal variances according to smallpox trifold VIS dated 1 Aug 07. Physician ordered anti inflammatory meds. Pt is instructed to return to clinic on 31 Mar 2008 and or to ER if symptons worsen over the weekend. PT recieved Anthrax, Typhoid, PPD and Smallpox on 17 Mar 2008.

VAERS ID:308691 (history)  Vaccinated:2008-03-27
Age:19.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-03-28, Days after onset: 1
Location:Missouri  Entered:2008-04-01, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pt was taking Multivitamins and Seasonique
Current Illness:
Preexisting Conditions: Pt is allergic to PCN.
Diagnostic Lab Data: No testing done.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure decreased, Dizziness, Fall, Loss of consciousness, No reaction on previous exposure to drug
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Pt was given Gardasil injection. About 5 min after getting vac, pt got light headed and passed out, falling to the floor. Pt lost consciousness for less than 30 seconds. Pt''s BP after the fainting spell was 92/50. Pt was given water and crackers and was moved to recliner located in office. 15 minutes after event, pt''s BP had returned to normal 100/64. Lot # 1487U, exp 05AUG10. This was the pt''s second Gardasil. Pt had no problems with 1st. Pt reports that she had not ate anything yet when Gardasil given at 10:00 a.m.

VAERS ID:308719 (history)  Vaccinated:2007-11-20
Age:19.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2008-04-01, Days after onset: 132
Location:Wisconsin  Entered:2008-04-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Pneumonia - cough - chest x-ray effusion +/- sm. right pleural right lower lobe pneumonia.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Public     Purchased by: Other
Symptoms: Chest X-ray abnormal, Cough, Dysphonia, Dyspnoea, Lobar pneumonia, Musculoskeletal stiffness, Pharyngolaryngeal pain, Pleural effusion, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad)
Write-up: HPV given 11/20/07 - In clinic 11/25/07 with 5 days of cough, hoarseness, fever. Non-productive cough - sore throat, stiff neck - hurting to take deep breath.

VAERS ID:308823 (history)  Vaccinated:2004-09-08
Age:19.0  Onset:2004-09-08, Days after vaccination: 0
Gender:Male  Submitted:2008-03-31, Days after onset: 1300
Location:Unknown  Entered:2008-04-03, 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:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.0035N2IMRA
HEPA: HEP A (VAQTA)MERCK & CO. INC.0643P1IMLA
Administered by: Military     Purchased by: Military
Symptoms: Rash papular
SMQs:
Write-up: Developed pruretic papules in the deltoid area bilaterally, rt$glt. Hep B #3 placed in rt deltoid, Hep A #1 placed in left deltoid. Lesions still visible when seen by the hospital on 13 Sep 04.

VAERS ID:309245 (history)  Vaccinated:2008-04-04
Age:19.0  Onset:2008-04-07, Days after vaccination: 3
Gender:Female  Submitted:2008-04-07, Days after onset: 0
Location:Connecticut  Entered:2008-04-10, 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: Yaz
Current Illness:
Preexisting Conditions: NKA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1658U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 5 x 4 cm patch erythema.

VAERS ID:309271 (history)  Vaccinated:2008-04-08
Age:19.0  Onset:2008-04-08, Days after vaccination: 0
Gender:Female  Submitted:2008-04-10, Days after onset: 2
Location:Georgia  Entered:2008-04-10
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.0552U2IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2775AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1274U0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Headache, Neck pain, Pain, Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Patient reports having a small area after recieving the vaccine. States noticed her arm had more redness yesterday evening with some pain radiating up the arm to her neck, also c/o headache. Area appears to be around 3 inches diameter, raised, and red. Advised patient to take Benadryl as directed until reaction subsides. Also to alternate warm and cold compress as needed. Advised patient if area worsens to seek medical care.

VAERS ID:309479 (history)  Vaccinated:2008-02-29
Age:19.0  Onset:2008-02-29, Days after vaccination: 0
Gender:Male  Submitted:2008-03-21, Days after onset: 20
Location:Arizona  Entered:2008-04-14, Days after submission: 24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: N/A
Preexisting Conditions: 2004 had a fatty tumor removed from left chest. No cancer.
Diagnostic Lab Data: None per donor. States temp taken, no tests/labs.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)SANOFI PASTEURU1856AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Headache, Nasal congestion, Pharyngitis, Pharyngolaryngeal pain, Sleep disorder
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow)
Write-up: Reports temp 100 at 7 pm 2/29/08. Woke up 3/1/08 5 am - temp 102 unk duration. Headache 5 AM with sx lasting off/on until 11:00 AM 3/1/08. (Stuffy nose 5 am 3/1/08 - 8 or 9 am), sore throat 5 am 3/1/08 until 3/2/08 8 or 9am. Went to hospital 3/1/08 at 11 am or 12 pm and dx with "throat virus". Antibiotics given (unk names) t bid - finished 2/6/08. Temp 100 3/4/08. Temp 99.9 3/4/08. Temp 99 3/2/208.

VAERS ID:309621 (history)  Vaccinated:2008-03-25
Age:19.0  Onset:2008-03-27, Days after vaccination: 2
Gender:Female  Submitted:2008-04-07, Days after onset: 11
Location:Nebraska  Entered:2008-04-16, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Acne
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Rash generalised, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: 1 1/2 days after Gardasil shot given in left deltoid: - reaction started Thursday morning - face swelled and rash all over body. Took Benadryl Thursday pm and better by Friday A.M. (History of allergy to pertussis as child).

VAERS ID:309667 (history)  Vaccinated:2008-02-09
Age:19.0  Onset:2008-02-25, Days after vaccination: 16
Gender:Male  Submitted:2008-04-10, Days after onset: 44
Location:Texas  Entered:2008-04-16, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONS 0 RA
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETH40200760 LA
Administered by: Military     Purchased by: Military
Symptoms: Oedema peripheral, Rash papular, Skin lesion
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient received smallpox vaccination 9 FEB 08. 26 FEB patient was seen in ER for swelling of both hands, elbow and ears with lesions and papules. Hibiclens ordered.

VAERS ID:309707 (history)  Vaccinated:2008-04-08
Age:19.0  Onset:2008-04-09, Days after vaccination: 1
Gender:Female  Submitted:2008-04-09, Days after onset: 0
Location:Indiana  Entered:2008-04-16, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Microgestin, Tylenol
Current Illness: Sore throat
Preexisting Conditions: None
Diagnostic Lab Data: Strep test (rapid), neg.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB224BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Chills, Fatigue, Headache, Hyperhidrosis, Laboratory test normal, Pyrexia, Streptococcus identification test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad)
Write-up: Fever-current 99.3-has had chills/sweats today. Sore throat-predated immunization. Fatigue-all day today. Skipped class. Headache-all day today.

VAERS ID:310239 (history)  Vaccinated:2007-08-20
Age:19.0  Onset:2007-08-20, Days after vaccination: 0
Gender:Female  Submitted:2008-04-07, Days after onset: 231
Location:Maine  Entered:2008-04-16, Days after submission: 9
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: WAES0803USA00988
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a pharmacist concerning a 20 year old female patient who on 20-AUG-2007 at 11:30 AM was vaccinated IM into the left arm with a first dose of Gardasil lot # 656U50/0245U. On 20-AUG-2007 the patient received her second and third dose of Gardasil and on 03-MAR-2008 she received her third dose of Gardisil (the lot numbers were not reported for the first and second injection). The reporter reported that the patient experienced nausea and fainted after the first injection. The pharmacist reported that the patient also experienced nausea and dizziness after her second dose of Gardasil. She did not experience any adverse events after her third injection. No further information was available. The patient recovered on an unknown date. Additional information has been requested. 2/16/2010 In follow up information the reporter reported that on 20-AUG-2008 after the first injection patient had a difficult time getting injections. SHe drove four hours to get to the doctor''s office from her school and was tired and had not eaten anything. SHe got the injection and felt weak, nauseated, and then passed out for a few seconds. This happened outside of the office. SHe was instructed to eat before taking injection and the office made her stay little longer in the office after the other two injections. SHe did not have any other reactions after the vaccination. No further information was available. The patient recovered on the same day of vaccination of first dose. Additinal informational is not expected.

VAERS ID:310240 (history)  Vaccinated:2008-01-22
Age:19.0  Onset:2008-01-31, Days after vaccination: 9
Gender:Female  Submitted:2008-04-07, Days after onset: 66
Location:Florida  Entered:2008-04-16, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: buspirone hydrochloride; clonazepam
Current Illness: Anxiety; Depression; Chronic fatigue; Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: diagnostic laboratory, 01/??/08, complete bloodwork: no results reported
CDC Split Type: WAES0803USA00995
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test, Dizziness, Fatigue, Palpitations, Tremor, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad)
Write-up: Information has been received from a physician through the Merck Pregnancy Registry concerning a 19 year old female with anxiety, depression, chronic fatigue and drug allergy to acetaminophen who on 22-JAN-2008 was vaccinated IM with a 0.5 mL dose of Gardasil (Lot# unknown). Concomitant therapy included clonazepam and buspirone HCl. On 31-JAN-2008 the patient began experiencing tremors, fatigue, lightheadedness, a faint feeling, heart palpitations and blurred vision. She reported that "complete bloodwork" was done (results not reported). At the time of the report, the patient had not recovered. Additional information has been requested.

VAERS ID:310248 (history)  Vaccinated:2008-03-05
Age:19.0  Onset:2008-03-06, Days after vaccination: 1
Gender:Female  Submitted:2008-04-07, Days after onset: 31
Location:Massachusetts  Entered:2008-04-16, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA01229
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a female who on 05-MAR-2008 was vaccinated with her first dose of Gardasil (Lot # not reported). On 07-MAR-2008 the patient broke out with an itchy rash all over her body, "from head to toes". The physician reported that the patient had taken BACTRIM for a period of time prior to receiving Gardasil. The patient sought unspecified medical attention. Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/7/2008. Information has been received from a physician concerning a female who on 05-MAR-2008 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL (lot # 660387/1967U). On 06-Mar-2008, previously reported as 07-MAR-2008, the patient broke out with an itchy rash all over her body, "fromhead to toes". The physician reported that the patient had taken BACTRIM for a period of time prior to receiving GARDASIL. The patient sought unspecified medical attention. Follow-up information received 11-APR-2008 from a medical assistant, reported that the patient had an itchy red rash all over her body and was treated with BENADRYL for relief. The patient recovered from the itchy red rash on an unspecified date. On 27-FEB-2008, also reported as one prior to vaccination, the patient had a urinary tract infection and was treated with BACTRIM. No additional information is expected.

VAERS ID:310436 (history)  Vaccinated:2008-03-03
Age:19.0  Onset:2008-03-03, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 41
Location:Unknown  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Miscarriage
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA01514
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Drug exposure during pregnancy, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a 19 year old female for the Pregnancy Registry for GARDASIL with a history of miscarriage who on 31-JUL-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot# not reported). On 03-MAR-2008 the patient was vaccinated intramuscularly with her third dose of GARDASIL (lot# not reported). Concomitant therapy included hepatitis A virus vaccine (unspecified). On 07-MAR-2008 the patient found out she was pregnant. Her LMP was 06-FEB-2008. The patient also stated that she was experiencing pain from her stomach to her knees. The pain goes away when she stays in bed, but comes back when she walks around. She did not think the pain was caused from the pregnancy. The patient''s outcome was not reported. No further information is available.

VAERS ID:311133 (history)  Vaccinated:2007-10-23
Age:19.0  Onset:2007-10-23, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 174
Location:California  Entered:2008-04-16, 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: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA00043
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1063U2UNUN
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Pain in extremity, 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 physician concerning her 19 year old daughter with no drug reactions/allergies who on 23-OCT-2007 was vaccinated with a third dose of Gardasil (lot# 658563/1063U). Concomitant therapy on the same day included a tetanus vaccination in the same arm. On 23-OCT-2007, the patient was standing when given the Gardasil. The patient became faint after receiving the Gardasil but may not have lost consciousness. The patient''s arm was sore after the Gardasil injection and the patient complained of pain for 3 days post vaccination. Unspecified medical attention was sought. No further information was available. At the time of reporting on an unspecified date the patient recovered. Additional information has been requested.

VAERS ID:311134 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:2008-03-24
Gender:Female  Submitted:2008-04-14, Days after onset: 21
Location:Unknown  Entered:2008-04-16, 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: None
Current Illness:
Preexisting Conditions: Human papilloma virus test negative
Diagnostic Lab Data: Pap test 03/24?/08 positive - "high risk"; Pap test negative - negative for HPV prior to receiving GARDASIL
CDC Split Type: WAES0804USA00045
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Human papilloma virus test positive
SMQs:
Write-up: Information has been received from a 19 year old female with a history of negative PAP test for human papilloma virus who in November 2006, was vaccinated with a first dose of GARDASIL. There was no concomitant medication. In June or July 2007, the patient was vaccinated IM with her third, 0.5 mL dose of GARDASIL. On approximately 24-MAR-2008 the patient''s PAP test was positive for human papilloma virus. She did not have any information on the type of human papilloma virus, only that it was "high risk". Additional information has been requested.

VAERS ID:311143 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-04-14
Location:Unknown  Entered:2008-04-16, 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: cervical smear - normal; cervical smear - high risk HPV positive
CDC Split Type: WAES0804USA00115
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0524U2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Human papilloma virus test positive, Smear cervix abnormal, Smear cervix normal
SMQs:
Write-up: Information has been received from a nurse concerning a 19 year old female who was vaccinated with all three doses of GARDASIL (lot# dose 1, 654389/0961F, dose 2, 657617/0384U, dose 3, 658094/0524U). The nurse stated that prior to receiving GARDASIL the patient''s PAP test results were normal. However, following the completion of the series the patient received another PAP test which showed "High-Risk HPV positive". The nurse also stated that the patient tolerated all of three doses well. It was unknown whether medical attention was sought. The patient''s outcome was unknown. Additional information has been requested.

VAERS ID:309795 (history)  Vaccinated:2008-02-08
Age:19.0  Onset:2008-02-23, Days after vaccination: 15
Gender:Female  Submitted:2008-04-16, Days after onset: 52
Location:Kentucky  Entered:2008-04-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Diagnostic laboratory strep throat test negative; Diagnostic laboratory spleen tests within normal limits; Hepatic function tests within normal limits; Complete blood cell within normal limits; Serum TSH within normal limits; Blood glucose within normal limits; Erythrocyte within normal limits.
CDC Split Type: WAES0804USA01880
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Blood glucose normal, Blood thyroid stimulating hormone normal, Cough, Full blood count normal, Hypoaesthesia, Liver function test normal, Paraesthesia, Pharyngolaryngeal pain, Rhinorrhoea, Streptococcus identification test negative
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Arthritis (broad)
Write-up: Information has been received from a registered nurse (RN) concerning her 19 year old daughter who on 30-JUL-2007 was vaccinated with her first dose of GARDASIL (lot, route and site not reported). On 05-OCT-2007 she was vaccinated with her second dose of GARDASIL (lot, route and site not reported) and on 08-FEB-2008 was vaccinated with her third dose of GARDASIL (lot, route and site not reported). Concomitant therapy included hepatitis A virus vaccine (unspecified) (manufacturer unknown) on 30-JUL-2007 and a booster of hepatitis A virus vaccine (unspecified) (manufacturer unknown) on 08-FEB-2008, meningococcal vaccine (unspecified) on 30-JUL-2007, influenza virus vaccine (unspecified) on 05-OCT-2007, and fexofenadine hydrochloride (ALLEGRA), pseudoephedrine HC1 (SUDAFED) and hormonal contraceptives (unspecified). The nurse stated that after completing the series, on 23-FEB-2008 her daughter developed a sore throat, arthralgia, coughing, runny nose, hand numbness and tingling. The patient contacted the physician on an unspecified date. A test for strep throat (date not reported) was negative. The patient''s liver and spleen were within normal limits. Also, the patient''s complete blood count, thyroid stimulating hormone, glucose, and erythrocyte sedimentation rate were within normal limits. At the time of reporting the patient had not recovered. No other information was available. Sore throat, arthralgia, coughing, runny nose, hand numbness and tingling were considered to be disabling by the reporter. Additional information has been requested.

VAERS ID:309807 (history)  Vaccinated:2007-11-19
Age:19.0  Onset:2007-12-24, Days after vaccination: 35
Gender:Female  Submitted:2008-04-14, Days after onset: 111
Location:Minnesota  Entered:2008-04-17, 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: The patient had no illnesses, pre-existing medical conditions, or use of other medications at the time of the vaccinations on 19 November 2007.
Diagnostic Lab Data: 24 December 2007: EKG and diagnostic laboratory data were within normal limits.
CDC Split Type: 200801053
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0748U1SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2842A0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest pain, Electrocardiogram normal, Skin discolouration
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Initial report received on 10 April 2008 from a pharmacist. A 19-year-old female patient, with no concurrent illnesses, pre-existing medical conditions, or use of other medications, had received a first, intramuscular, left arm dose of ADACEL (Lot # C2842AA), and a second, subcutaneous, left arm dose of "MMRII" (manufacturer Merck, Lot # 0748U) on 19 November 2007. Thirty-five days after receiving the vaccinations, the patient developed chest pain and her hands turned blue. She was taken to the emergency room where cardiac and neurology consults were completed. An Echocardiogram and diagnostic laboratory data were within normal limits. The patient was discharged from the emergency room with a heart monitor that she wore for one month. The results of the heart monitor readings were not provided. One-hundred-five days later, the patient again developed chest pain, and her hands turned blue. It was not reported whether the patient was medically evaluated that time, or if treatments were received, or diagnostic tests performed. The recovery status of the patient was not reported.

VAERS ID:310485 (history)  Vaccinated:2007-07-26
Age:19.0  Onset:2007-07-26, Days after vaccination: 0
Gender:Female  Submitted:2008-04-21, Days after onset: 270
Location:Arizona  Entered:2008-04-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: vitamins (unspecified)
Current Illness:
Preexisting Conditions: Anxiety disorder
Diagnostic Lab Data: ultrasound, 11/29/07, normal anatomy; Apgar score, 03/25/08, 2/5 and 8 at 10 minutes
CDC Split Type: WAES0710USA00765
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0802U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Apgar score, Chorioamnionitis, Drug exposure during pregnancy, Fatigue, Ultrasound scan normal, Vacuum extractor delivery
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)
Write-up: Information has been received through the Merck pregnancy registry from a physician concerning a female with a history of 0 pregnancies and 0 live births and a history of anxiety disorder who on 26-JUL-2007 was vaccinated with the first dose of Gardasil (658490/0802U). Concomitant therapy included prenatal vitamins. Subsequently, the patient was determined to be pregnant (last menstrual serious 09-JUL-2007). On 29-NOV-2007, the patient had an ultrasound which revealed normal anatomy. Estimated date of delivery was 26-MAR-2008. It was reported that on an unspecified date the patient was admitted to the hospital for one week due to possible sepsis. Subsequently, the patient developed chorioamnioitis. On 25-MAR-2008, the patient developed maternal exhaustion while pushing and had a vacuum assisted vaginal delivery. She delivered a normal male infant, Apgar score was 2/5 and 8 at 10 minutes. The baby weight 3200 grams and head circumference was 33 1/4 cm. Additional information has been requested.

VAERS ID:310506 (history)  Vaccinated:2008-03-27
Age:19.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-04-15, Days after onset: 19
Location:Missouri  Entered:2008-04-22, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin; Seasonique
Current Illness: None
Preexisting Conditions: Patient allergic to penicillin
Diagnostic Lab Data: BP post Gardasil et blackout was 92/50.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Hypotension, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Patient became light headed and passed out after receiving Gardasil.

VAERS ID:310677 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-04-14
Location:Indiana  Entered:2008-04-23, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = Unknown); Inflammation; Cholecystitis; Spleen disorder
Preexisting Conditions: Infectious mononucleosis
Diagnostic Lab Data: urine beta-human, Patient is pregnant; serum beta-human
CDC Split Type: WAES0803USA04552
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Dehydration, Drug exposure during pregnancy, Haemorrhage, Nausea, Pregnancy test, Urine human chorionic gonadotropin positive
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Tumour markers (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received for Merck Pregnancy Registry for Gardasil from a mother of a nineteen year old patient witno allergies, inflammation of appendix, cholecystitis "needed to go out", and spleen disorder. She also had a history of infectious mononucleosis in September 2007. The patient received a first dose of Gardasil on an unspecified day and on 31-OCT-2007 she received the second injection. Concomitant therapy included PRENATE, ferrous sulfate, children''s vitamins (unspecified) and iron supplement (unspecified). It was reported that PRENATE and ferrous sulfate were discontinued since it upset her stomach (no date for start and stop of therapy reported). The reporter reported that her daughter got pregnant after she received the injection. She had been to the emergency room four times because of dehydration. She experienced pregnancy related nausea. Patient also experienced abdominal pain and had a urine beta-human chorionic gonadotropin test (PAP) which caused some bleeding. She was in the emergency room (E.R) on 13-MAR-2008 and was given morphine and intravenous (I.V) fluids. Serum beta-human chorionic gonadotropin tests were done but result was not reported. She had not needed hospitalization during this time. No other information was available. The outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Additional information has been received from a Nurse who reported that the patient on 20-AUG-2008 had a healthy and normal baby. Additional information is not expected.

VAERS ID:310930 (history)  Vaccinated:2008-04-18
Age:19.0  Onset:2008-04-23, Days after vaccination: 5
Gender:Female  Submitted:2008-04-25, Days after onset: 2
Location:Louisiana  Entered:2008-04-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Alveolar RMS
Diagnostic Lab Data: CBC. Platelet count 163.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Contusion, Full blood count, Petechiae, Platelet count normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)
Write-up: Bruising, palatal petechiae. 6/30/2008 MR received for OV 4/25/2008 with c/o bruising following both Gardasil injections. Petechiae noted on posterior palate and bruising on arms and legs.

VAERS ID:311291 (history)  Vaccinated:2008-04-04
Age:19.0  Onset:2008-04-07, Days after vaccination: 3
Gender:Female  Submitted:2008-04-28, Days after onset: 21
Location:New York  Entered:2008-04-30, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1060U1IMLA
Administered by: Private     Purchased by: Other
Symptoms: Back pain, Herpes zoster, Rash
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Hypersensitivity (narrow)
Write-up: Student had #1 HPV done at hospital 1/18/08 - 2/2 broke out in rash, on abdomen, lower back with pain. Came to school 2/4. Diagnosed with herpes zoster. Treat with Zovirax for 7 days - labs drawn (nml) above reported ko Merck spec/ and med staff. No contraindication #2 HPV. #2 HPV given 4/4/08 - student returned 1 week later.

VAERS ID:311442 (history)  Vaccinated:2008-04-21
Age:19.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-05-01, Days after onset: 10
Location:Ohio  Entered:2008-05-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U2UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Arthralgia, Asthenia, Blood test normal, Dizziness, Headache, Hyperventilation
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: 1 hrs after receiving Gardasil pt felt weak, dizzy, hyperventilated. Pt felt dizzy & weak with a headache for 5 days post injection. Pt went to pediatrician had blood tests-all were WNL. Pt has fully recovered. Pt. also complained of joints aching.

VAERS ID:311457 (history)  Vaccinated:2008-04-09
Age:19.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-05-01, Days after onset: 22
Location:Texas  Entered:2008-05-02, 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: total serum human, did not show patient was pregnant
CDC Split Type: WAES0804USA05085
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin negative, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a medical assistant concerning a 19 year old female, who on 09-APR-2008 was vaccinated with a 0.5mL first dose of Gardasil. Subsequently, the patient was pregnant. It was reported that the office did not conduct a pregnancy test prior to the vaccination. The patient called the office to report that she experienced a miscarriage on 21-APR-2008. The patient went to see the physician. A total serum human chorionic gonadotropin test was performed and did not show that the patient was pregnant. On 09-APR-2008 the patient experienced received first dose while pregnant. At the time of the report, the outcome of the patient was unknown. Upon internal review miscarriage was considered to be an other important medical event. Additional information has been requested.

VAERS ID:311472 (history)  Vaccinated:2008-04-21
Age:19.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-04-29, Days after onset: 8
Location:New Jersey  Entered:2008-05-02, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: No adverse effect~Rabies (Imovax)~1~0~In Patient
Other Medications: MINOCYCLINE
Current Illness:
Preexisting Conditions: No known allergies; history of acne.
Diagnostic Lab Data:
CDC Split Type: 200801181
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEURA023921IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cardiac flutter, Chest discomfort, Tachycardia, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Tachyarrhythmia terms, nonspecific (narrow)
Write-up: This case was received from a health professional on 21 April 2008. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A 19-year-old female patient, with no known allergies, received a second intramuscular injection of Imovax Rabies (lot number A0239-2) on 21 April 2008. The dose was given as part of a pre-exposure series, and no adverse effects had been reported following dose one. Approximately 45 minutes after vaccination, the patient developed tachycardia (112 beats per minute), chest discomfort described as "fluttering", and shaking of the arms and legs. At the time of the report, the event had been ongoing for approximately one and one-half to two hours. The patient had a history of acne, and was taking Minocycline concomitantly.

VAERS ID:311501 (history)  Vaccinated:2008-04-16
Age:19.0  Onset:2008-04-30, Days after vaccination: 14
Gender:Male  Submitted:2008-05-02, Days after onset: 2
Location:Missouri  Entered:2008-05-02
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1740SCRA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURW04-003A0OTLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA03940IMRA
Administered by: Military     Purchased by: Military
Symptoms: Pruritus, Rash, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 1 Week post vaccination, patient developed a 3"x4" fine Vesicular rash on his lower left side of the abdomen. Began to fade in 1 day, site itchy. No other contacts.

VAERS ID:311580 (history)  Vaccinated:2008-03-14
Age:19.0  Onset:2008-03-18, Days after vaccination: 4
Gender:Female  Submitted:2008-04-29, Days after onset: 42
Location:Georgia  Entered:2008-05-05, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: unsure if she had mono or CMV
Preexisting Conditions: none PMH: possible prior hepatitis. Family Hx: NIDDM. Had lived out of county for several months. Allergic: sulfa, nausea. Sinus surgery, 12/2007.
Diagnostic Lab Data: Hospital LABS: H/H 8.3/25.9. Plts 199, WBC 2.7, neutros 69%, bands 4%, lymphs 16%, monos 10%, Malarian screen (-). BUN 10, creatinine 0.5. LDH 992. Total bilirubin 0.3. AST 99, ALT 46, Alk phos 76. RA factor (-).(+) Coombs. ANA (+). CT chest/abdomen/pelvis abnormal w/mesenteric lymphadenopathy. Bone marrow biopsy. PCP LABS: EBV, CMV, Parvovirus, Toxoplasma & West Nile virus all (+). SGOT 388, SGPT 200. Strep & mono tests neg.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U1UNUN
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain, Activities of daily living impaired, Alanine aminotransferase increased, Anaemia, Anaemia haemolytic autoimmune, Antinuclear antibody positive, Aspartate aminotransferase increased, Asthenia, Back pain, Biopsy bone marrow, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood creatinine normal, Blood lactate dehydrogenase increased, Blood urea normal, Cardiac murmur, Chills, Chromaturia, Computerised tomogram abnormal, Coombs positive haemolytic anaemia, Cytomegalovirus test positive, Decreased appetite, Dyspnoea, Epstein-Barr virus test positive, Exposure to communicable disease, Fatigue, Gait disturbance, Haematocrit decreased, Haemoglobin decreased, Headache, Hepatitis, Hepatomegaly, Leukopenia, Lupus-like syndrome, Lymphadenopathy, Lymphocyte percentage decreased, Malaise, Malaria antibody test, Monocyte percentage increased, Mononucleosis heterophile test negative, Mononucleosis syndrome, Myalgia, Nausea, Pain, Parvovirus B19 serology positive, Pharyngolaryngeal pain, Pyrexia, Red blood cell count decreased, Rheumatoid factor negative, Splenomegaly, Stomach discomfort, Streptococcus identification test negative, Toxoplasma serology positive, Viral infection, Virus serology test positive, Vomiting, Weight decreased, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad)
Write-up: My daughter is currently in hospital on steroids. After receiving the vaccine Gardasil around March 14th - she began having a FOU for over 30 days. Her white & red blood count have dropped (8.0) and her immunity is active. Unknown cause. 5/16/08 Reviewed hospital medical records for 4/24-5/1/2008. FINAL DX: fever & leukopenia; autoimmune hemolytic anemia. Records reveal patient experienced fever for more than 30 days w/nausea, intermittent vomiting, malaise, poor appetite, weight loss, stomach discomfort, weakness, fatigue, HA, shotty cervical lymphadenopathy, muscle aches/pains, leukopenia, anemia & hepatitis. Exam revealed mild spenic enlargment & intermittent heart murmur. Heme & Rheum consults done. Tx w/steroids & d/c to home on continued steroids w/f/u. 5/23/08 Reviewed PCP medical records which included vax records, student health records, consultant records, hospital records & labs. Non-duplicated hospital records will be scaned. Records reveal patient was fatigued after vaccination on 3/14. Developed fever, chills, sore throat, body aches, decreased energy & seen by PCP on 3/21. Pts college roomate currently had mono. Dx w/viral syndrome. Began to feel very weak, had difficulty walking & soon became unable to complete college classes. Seen in student health center 3/31 w/fever, chills, sore throat, body aches, fatigue, nausea & mono-like symptoms. Dx w/viral syndrome & anemia. Health continued to decline w/vomiting, loss of appetite, weight loss, pain in low back & abdomen. Internal med consult 4/11/08. ID consult of 4/15/08 Admitted to hospital 4/24. Follow-up Information 22-MAY-2008: Pt was a freshman at university when she became ill in March 2008. She had received the second Gardasil Vaccine at doctor on March 14th, 2008. She felt fatigued after the vaccine and went to bed early that day. Since then, she has lost 25 lbs, and currently her WBC is (2.3) Lymp (14), Neut (1.9) HGB (9.6) platelet count (159) has developed hemolytic anemia. She was admitted and hospitalzied for FUO (fevers as high as 104) at hospital for 7 days and released on May 1, 2008. She tested positive for coombs, double-strand DNA and very high ANA in the 2500''s. She has been diagnosed by several Drs-all listed on next page: internists, infectious disease, hematologist and rhuematologist at the hospital. We are still unsure what is wrong with her. History: Patient became fatigued after receiving the vaccine. Her health began to decline and she followed up with a Pediatrician visit a week later. Mono tests were negative, diagnosis was viral. Patient returned to college and continued to feel weak and ill. Soon she developed lower leg weakness, vomitting, and fever. She started feeling very tired during activity and soon had difficulty walking to class and doing everyday activities. She began sleeping excessively, and feeling fluish. Dr examined her at the health clinic at university on 3-31 for fever, chills sore throat, body aches, fatigue, nausea and mono like symptoms. Her labwork indicated a viral syndrome and anemia. She had a low white and red blood count, vomiting, no appetite, enflamed liver and spleen, dark urine, shortness of breath. She lost her appetite and her condition continued to decline. She had FUO for 37 days and she began vomiting when she attempted to eat. She had severe discomfort and pain in her lower back and abdomen area. Her mother drove to school and checked her into a hotel so she could try to finish the semester and take care of her. They went to doctor for internal medicine. After no diagnosis and much lab work, doctor referred her to his colleague in Infectious disease. Doctor tested her for several disease and after 10 days of uncomfirmed diagnosis, recommended that patient be put into a hospital for FUO and low white and red blood counts. Her SGOT was 388. Doctor also found a small heart murmur. Family drove back home and went to Cardiology doctor. He found her heart in good condition. Doc

VAERS ID:311624 (history)  Vaccinated:2005-02-02
Age:19.0  Onset:2005-02-17, Days after vaccination: 15
Gender:Male  Submitted:2008-05-05, Days after onset: 1172
Location:Maryland  Entered:2008-05-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA, Essentially negative health history
Diagnostic Lab Data: DFA for varicella zoster: positive, PCR for vaccinia not performed
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETH40300132OT 
Administered by: Military     Purchased by: Military
Symptoms: Rash erythematous, Scab, Secondary transmission, Skin lesion, Viral DNA test positive
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: SECONDARY TRANSMISSION NONVACCINEE - To prevent an altercarion, the patient (contact) grabbed the arms of a barracks-mate (vaccinee), who had recently been vaccinated with the smallpox vaccine. The vaccinee''s vaccine site was not covered with a dressing or shirt. When the patient restrained the barracks-mate (vaccinee), the vessicle at his smallpox site popped and the patient''s right upper arm came in contact with vaccinia-containing fluid. About 2 days later, the patient (contact) noted about 5-7 "red bumps" on his upper right arm where the contact had been. These bumps later became "whiteheads", and then scabbed over (about 2 weeks after exposure). A few days after the initial lesions on the upper arm appeared, the patient (contact) developed 2 lesions on his left posterior neck; he believes that he might have scratched the lesions on his arm during sleep, and then scratched his neck. The vaccinee had told the patient that the lesions looked similar to his SPV site, and instructed him on the importance of handwashing. The patient had also changed the barracks-mate''s (vaccinee''s) SPV site bandage on a few occasions prior to this incident. The patient only sought medical evaluation because his 1st SGT instructed him to do so. Patient had never received SPV himself. He denies any history of chronic skin conditions, increased risks for CAD, or chronic diseases affecting his immune system. He is taking no medications. Over the past 2 weeks, he denies significant systemic symptoms such as headaches, fever, chills, bodyaches, or fatigue.

VAERS ID:311647 (history)  Vaccinated:2007-05-30
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-05
Location:Missouri  Entered:2008-05-05
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.0384U0SCRA
Administered by: Other     Purchased by: Other
Symptoms: Headache, Nausea, Pain, Vaccine positive rechallenge, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Pt received Gardasil on 5-30-07 and 8-13-07. States both times felt nauseated, vomited, ached all over body, had bad H/A. When asked why pt did not reveal S&S on 2nd dose, pt stated "she wanted to tough it out". Refused 3rd shot.

VAERS ID:311706 (history)  Vaccinated:2008-04-09
Age:19.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-04-30, Days after onset: 21
Location:North Carolina  Entered:2008-05-06, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Depo Provera 104mg SQ
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHABB103AA2IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB103AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2720AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt reported a pruritic rash over abdomen and back that started soon after 04/09/08 clinic visit and lasted a few days.

VAERS ID:311741 (history)  Vaccinated:2008-04-30
Age:19.0  Onset:2008-05-02, Days after vaccination: 2
Gender:Female  Submitted:2008-05-06, Days after onset: 4
Location:Rhode Island  Entered:2008-05-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Infected ear piercing
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEURA04831IMRA
Administered by: Private     Purchased by: Private
Symptoms: Paraesthesia oral, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: Hives and tingling mouth. 2+ to 3+ diffuse hives head to toe. As of 5/5/08 pt is still getting hives. IV steroids in ER on 5/3/08. Prescribed prednisone x 4 days, zantac, and benadryl.

VAERS ID:311747 (history)  Vaccinated:2008-05-01
Age:19.0  Onset:2008-05-02, Days after vaccination: 1
Gender:Female  Submitted:2008-05-06, Days after onset: 4
Location:Michigan  Entered:2008-05-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acutane
Current Illness: None
Preexisting Conditions: Acne
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB208AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2604AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2889AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Dyspnoea, Injection site bruising, Injection site erythema, Injection site swelling, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: 5-2-08 Body Aches, 5-3-08 Fever, Body Aches & shortness of Breath took advil symptoms resolved by 5-4-08. Had developed increased Redness, swelling and brusing at the injection site (right deltoid) 5-2-2008. The patient called the family physician and he recommended taking benadrylx2.

VAERS ID:311931 (history)  Vaccinated:2008-01-09
Age:19.0  Onset:2008-02-01, Days after vaccination: 23
Gender:Female  Submitted:2008-05-08, Days after onset: 96
Location:Unknown  Entered:2008-05-09, Days after submission: 1
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: YAZ
Current Illness: Contraception; Allergic reaction to antibiotics
Preexisting Conditions: PMH: Hashimoto''s thyroiditis at age 7, hypothyroidism; pneumonia at age 9; vascular gum irregularity; irregular periods; MVA 4 yrs ago;anxiety. Allergy: zithromax, hives. On Yasmin contraceptive & minocycline for acne. Family hx: heart disease, Hashimotos disease & goiter.
Diagnostic Lab Data: LABS: CT brain WNL. MRI & MRA WNL. Repeat MRI abnormal w/possible focal demyelination. Carotid duplex WNL. Echocardiogram WNL. TEE WNL. Vit B12 194 (L). Influenza A&B neg. ECG w/sinus tachycardia. ANA (H). MRA of neck WNL.
CDC Split Type: WAES0805USA00064
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1063U1IMRA
Administered by: Private     Purchased by: Other
Symptoms: Angiogram, Antinuclear antibody increased, Anxiety, Cerebellar artery occlusion, Cerebrovascular accident, Demyelination, Diplopia, Dizziness, Dysstasia, Echocardiogram, Echocardiogram normal, Electrocardiogram abnormal, Gait disturbance, Influenza serology negative, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Pyrexia, Scan brain, Sinus tachycardia, Ultrasound Doppler, Vitamin B12 abnormal, Vitamin B12 deficiency, Vomiting, Wallenberg syndrome, Weight increased
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic cerebrovascular conditions (narrow), Haemorrhagic cerebrovascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Demyelination (narrow), Vestibular disorders (broad), Ocular motility disorders (broad)
Write-up: Information has been received from a consumer concerning her 20 year old daughter with allergy to azithromycin (ZITHROMAX) who on 09-NOV-2007 was vaccinated with the first dose of GARDASIL, 0.5 mL, (injection form) (Lot # not reported). On 09-JAN-2008, the patient was vaccinated with the second dose of GARDASIL, 0.5 mL, (injection form) (Lot # not reported). Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). On 01-FEB-2008, after getting the second dose of GARDASIL, the patient experienced a stroke and was hospitalized. The patient stayed in the hospital for one week. At the time of this report, the patient was recovering from the event. The causality of the event was not reported. No product quality complaint was involved. Additional information has been requested. 6/3/08 Reviewed hospital medical records for 2/4-2/8/2008. FINAL DX: small right CVA; vitamin B12 deficiency; sinus tachycardia; Wallenberg syndrome. Records reveal patient experienced dizziness, left sided numbness, diplopia, fever & vomiting x 2 days. Developed sinus tachycardia & anxiety controlled w/meds. Cardio & neuro consults done. Improved left face & arm paresthesias but left thigh & lower leg paresthesias persisted at d/c to home. Difficulty getting OOB & walking. To have outpatient PT/OT as well as f/u w/neuro & cardio. 9/5/08 Reviewed heme, neuro & rheum consultant medical records of 3/10-5/30/2008. FINAL DX: CVA, lateral medullary syndrome (Wallenberg''s) related to the occlusion of the posterior inferior cerebellar artery. Records reveal patient experienced recent CVA, 20# weight gain since CVA.

VAERS ID:311941 (history)  Vaccinated:2008-04-19
Age:19.0  Onset:2008-04-24, Days after vaccination: 5
Gender:Male  Submitted:2008-04-30, Days after onset: 6
Location:North Carolina  Entered:2008-05-09, Days after submission: 9
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: NKDA; FACIAL ACNE
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURER 0IDUN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURERA05220IMUN
Administered by: Military     Purchased by: Military
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 19 y/o male ADSM is referred from clinic to FBVHC for evaluation of skin rash eruption in temporal relationship with the receipt of Smallpox vaccine. Symptom: Pruritus Start: 04/24/2008 Comment: Related to skin rash. Symptom: Rash, diffuse Start: 04/24/2008 Comment: See summary for description.

VAERS ID:312179 (history)  Vaccinated:2008-04-30
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-01
Location:Texas  Entered:2008-05-13, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: migraines, allergic rhinitis, post concussion syndrome
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2403AA1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Patient was given Menactra on 4/30/08 & it was later discovered that she had Menactra on 5/23/06.

VAERS ID:312218 (history)  Vaccinated:2008-05-05
Age:19.0  Onset:2008-05-06, Days after vaccination: 1
Gender:Male  Submitted:2008-05-07, Days after onset: 1
Location:Massachusetts  Entered:2008-05-13, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2560AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 5-5-08 MENACTRA 3:30 pm. 5-6-08 awake with headache, sore left arm site of injection. 5-7-08 painful, red, warm to touch, swollen left deltoid site of injection.

VAERS ID:312294 (history)  Vaccinated:2007-03-19
Age:19.0  Onset:2007-05-19, Days after vaccination: 61
Gender:Female  Submitted:2008-05-13, Days after onset: 360
Location:Pennsylvania  Entered:2008-05-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 4/16/2007); Group B betahaemolytic streptococcal positive
Preexisting Conditions:
Diagnostic Lab Data: chest X-ray 01/28/08 right lower lobe pneumonia; cesarean section 01/28/08; respiratory rate 01/18/08 increased; vaginal Streptococcus positive
CDC Split Type: WAES0709USA00587
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0955F0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Caesarean section, Drug exposure during pregnancy, Foetal disorder, Streptococcus identification test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)
Write-up: Information has been received through the Pregnancy registry concerning a 19 year old female patient, who on 19-MAY-2007 was vaccinated with a second dose of Gardasil. It was reported that the patient was 20 weeks pregnant. The patients last menstrual period was 16-APR-2007 and her estimated delivery date was 21-JAN-2008. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Follow up information was received on 24-MAR-2008 and 02-APR-2008. The patient delivered a baby boy on 28-JAN-2008 (weeks from LMP-40). The baby was born with pneumonia. He weighed 9 lbs. 2 oz. The baby''s pediatrician was called on 02-APR-2008. The nurse confirmed the patient had well visits and was seen multiple times during the month of February for pneumonia and what looked like abdominal pain. A request for Medical Records was faxed to the nurse to obtain the baby''s records. Follow up information received in the form of physician''s notes, indicated that on 28-JAN-2008, the infant first had a "vacuum attempt without success and positive meconium." The physician noted the infant was status post "C-section for failure to progress," and added that the mother was group B strep positive. After birth, the infant had an increased respiratory rate and "was on oxyhood overnight." The chest X-ray revealed right lower lobe pneumonia. Treatment in the hospital included IV ampicillin and gentamycin, and the infant "continued to do well with respiratory rate decreasing and 99% spO2 room air, feeding well." The infant was discharged on 02-FEB-2008 ("two days ago"). On 04-FEB-2008, the infant was seen in follow up at the physician''s office, and was "improving clinically" the physician''s assessment was pneumonia due to streptococcus, group B. Mild facial jaundice was documented. He was also diagnosed with diaper rash-candida, also noted as etoxicum rash; nystatin was prescribed, with follow up in 2 days. The infant was continued on AUGMENTIN. On 06-FEB-2008, the infant was seen by the physician and was improved clinically, with no jaundice noted and only mild etoxicum rash. On 14-FEB-2008, the infant visited the physician for a recheck, with notes of visiting the emergency department, 4 days earlier (10-FEB-2008), because he was "wheezing and crying uncontrollably." Treatment at the ED included Vaponeb, and he improved. At home, the mother used a nebulizer a few times. The physician indicated the infant had "cephalohematoma right posterior scalp." and also noted "well baby. Pneumonia resolved." On 22-FEB-2008, the infant was brought to the physician with "purple feet," and was also noted as being inconsolable, with pulling his legs up and crying. The physician indicated that infant had a "little color change with cold reassurance," and colic was diagnosed. Treatment included nutramagen movement, tight swaddle and white noise. The physician also noted the head had no abnormalities, lesions or masses. On 24-MAR-2008, the infant was brought to the physician with a runny nose and congestion, and reports that "he spits up almost every feeding." The diagnosis was "well baby" The infant was vaccinated with DTaP (+) poliovirus vaccine inactivated (+) tetanus toxoid (manufacturer not specified), HIB (manfacturer not specified), PREVNAR and ROTATEQ. The physician noted that the infant had no previous immunization reaction. Upon internal review, "C-section for failure to progress" was determined to be serious as an other important medical event. Additional information is not expected.

VAERS ID:312473 (history)  Vaccinated:2008-03-12
Age:19.0  Onset:2008-03-12, Days after vaccination: 0
Gender:Male  Submitted:2008-05-16, Days after onset: 65
Location:West Virginia  Entered:2008-05-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: none
CDC Split Type: WV0812
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS09371IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: None

VAERS ID:312479 (history)  Vaccinated:2008-04-04
Age:19.0  Onset:2008-05-01, Days after vaccination: 27
Gender:Female  Submitted:2008-05-16, Days after onset: 15
Location:Texas  Entered:2008-05-16
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 24 days
    Extended hospital stay? Yes
Previous Vaccinations: none~ ()~~0~In Patient|none~ ()~~0~In Sibling
Other Medications: none
Current Illness: none
Preexisting Conditions: none. PMH: none
Diagnostic Lab Data: pancytopenia, increased liver enzymes; bone marrow biopsy on 5-5-08 showed acute myelogenous leukemia;Gardasil series: 9-26-07, 11-21-07 & 4-4-08 (#13does not allow Gardasil to be entered). Labs and Diagnostics: Urine dipstick orange with
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0525U2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal discomfort, Acute myeloid leukaemia, Back pain, Bilirubinuria, Biopsy bone marrow abnormal, Blood culture negative, Colitis, Computerised tomogram abnormal, Fungal infection, Gastrointestinal tract mucosal discolouration, Gene mutation identification test positive, HLA marker study, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Hepatic enzyme increased, Hepatitis A antibody, Hepatitis B e antigen negative, Hepatitis B surface antigen negative, Hepatitis C antibody negative, Hypotension, Malaise, Mean cell volume abnormal, Multiple gated acquisition scan normal, Nausea, Occult blood positive, Pancytopenia, Pharyngolaryngeal pain, Platelet count decreased, Protein urine present, Pyrexia, Red blood cell count decreased, Sputum culture positive, Thrombosis in device, Ultrasound Doppler abnormal, Ultrasound abdomen abnormal, Ultrasound pelvis, Urine analysis abnormal, Urine bilirubin increased, Urine ketone body present, Urobilin urine present, Vitamin B12 abnormal, Vomiting, Weight decreased, White blood cell count decreased
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Malignant tumours (narrow), Chronic kidney disease (broad), Malignant lymphomas (broad), Myelodysplastic syndrome (broad), Noninfectious diarrhoea (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad)
Write-up: weight loss, nausea & vomiting, malaise. 5/20/08 Office records received including vax record. Seen for sick visit 5/01/08 with c/o nausea, vomiting, and stomach feeling whoozy x 1 month. Impression Nausea & Vomiting. Tx with metoclopramide. Seen again 5/5/08 with c/o sore throat, nausea, back pain. Impression: N&V, Bilirubinuria, pancytopenia. Referral made to Oncologist. 07/01/2008 MR received for DOS 05/7-31/2008 with D/C DX: Acute Myeloid Leukemia. Pt presented with pancytopenia for eval to r/o acute leukemia. Bone marrow bx confirmed AML. Started on chemo which initially was well tolerated but later developed severe abdominal c/o with hematochezia. DX with pancolitis, likely infectious. Pt had intermittent high fevers and hypotension. Pt developed a clot in her PICC line and it was removed. Blood counts somewhat recovered and pt d/c 5/31/08.

VAERS ID:312509 (history)  Vaccinated:2008-05-12
Age:19.0  Onset:2008-05-12, Days after vaccination: 0
Gender:Female  Submitted:2008-05-16, Days after onset: 4
Location:Louisiana  Entered:2008-05-16
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
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2351AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Anorexia, Erythema, Fatigue, Headache, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad)
Write-up: Right upper arm redness, fever, headache, loss of appetite, fatigue.

VAERS ID:312548 (history)  Vaccinated:2008-02-28
Age:19.0  Onset:2008-04-07, Days after vaccination: 39
Gender:Female  Submitted:2008-04-07, Days after onset: 0
Location:Virginia  Entered:2008-05-19, 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:
Preexisting Conditions:
Diagnostic Lab Data: Pregnancy
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1287U1IMUN
Administered by: Private     Purchased by: Private
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Positive pregnancy on 4/7/08, 5 6/7 week gestation.

VAERS ID:312600 (history)  Vaccinated:2008-05-19
Age:19.0  Onset:2008-05-19, Days after vaccination: 0
Gender:Female  Submitted:2008-05-19, Days after onset: 0
Location:Missouri  Entered:2008-05-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None Noted
Preexisting Conditions: None Noted
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U1IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Nausea, Tremor, Vertigo
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow)
Write-up: Vaccine Admin. at 10:30 AM. Pt called the office at 1:00PM with complaints of nausea, shakiness, vertigo and SOB. Pt told to go to ER & call PMD. Pt went to Medical Center and was treated with Prednisone, Benadryl and Xanax(all of this per pt). At approx. 2pm pt called back and talked to RN..pt feeling much better after ER visit and treatment given.

VAERS ID:312797 (history)  Vaccinated:2007-11-14
Age:19.0  Onset:2007-11-15, Days after vaccination: 1
Gender:Female  Submitted:2008-05-14, Days after onset: 180
Location:Unknown  Entered:2008-05-19, 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: LOESTRIN
Current Illness:
Preexisting Conditions: Allergic reaction to antibiotics
Diagnostic Lab Data:
CDC Split Type: WAES0804USA00354
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received concerning a 19 year old female with a history of allergic reaction to antibiotics who on 14-NOV-2007 was vaccinated IM in the deltoid with the first dose of GARDASIL (658560/1062U). Concomitant therapy included LOESTRIN. On 15-NOV-2007 the patient experienced nausea, vomiting, fever, chills and headache. Additional information received from NSC call (14-APR-2008): The caller states that she continues to receive letters from WPS about WAES 0804USA00354. The caller does not know who the WPS letter was addressed to. The caller was unable to locate the SR associated with this WAES #. The caller states that she has returned a previous letter from WPS and does not want to receive any more letters. Additional information is not expected.

VAERS ID:312798 (history)  Vaccinated:2007-10-18
Age:19.0  Onset:2007-10-18, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 209
Location:New York  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA00384
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1264U0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Rash generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 19 year old female with penicillin allergy who on 18-OCT-2007 was vaccinated intramuscularly in the left deltoid with a first dose of GARDASIL (Lot # 658488/1264U). There was no concomitant medication. On 18-OCT-2007, within hours of vaccination, the patient developed hives all over her body. Subsequently, several days later, the patient recovered from hives all over her body without any treatment. Additional information has been requested.

VAERS ID:312813 (history)  Vaccinated:2008-03-01
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-14
Location:Tennessee  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA00975
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This is in follow-up to report(s) previously submitted on 5/14/2008. Information has been received from a medical assistant concerning a female in her teens with no pertinent medical history who in March 2008, was vaccinated with a first dose of GARDASIL from her OB/GYN. There was no concomitant medication. Subsequently, "soon after administration" the patient developed persistent nausea for the last 2 weeks. The patient has an appointment to see the office (her primary physician). At the time of reporting the patient had not recovered. Additional information has been requested. Follow-up information was received from a health care professional. The office did not administer the GARDASIL however the patient was presented to the office on 02-APR-2008 and stated she might have had a reaction to the GARDASIL. Her symptoms were nausea. The patient also had recently began taking a new birth control pill (unspecified). The physician had seen the patient and explained that he could not determine if the nausea was due to the vaccine. The physician felt like it was more possible that it was due to the change in her OCP. The patient was prescribed medication for nausea. At the time of reporting it was unknown if the patient had recovered. Additional information is not expected.

VAERS ID:312845 (history)  Vaccinated:2007-01-09
Age:19.0  Onset:2007-03-01, Days after vaccination: 51
Gender:Female  Submitted:2008-05-14, Days after onset: 439
Location:Nevada  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0804USA01411
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Private     Purchased by: Private
Symptoms: Skin papilloma
SMQs:
Write-up: Information has been received from a physician concerning a 20 year old female who on 09-JAN-2007 was vaccinated in the right arm with the first dose of GARDASIL (lot# not reported). On 09-MAR-2007 the patient was vaccinated in the left arm with the second dose of GARDASIL (lot# not reported). On 11-JUL-2007 the patient was vaccinated in the right arm with the third dose of GARDASIL (lot# not reported). Per the reporter, the patient experienced one large plantar wart on her right heel immediately following the second dose of GARDASIL. The patient was treated by a podiatrist and had the wart burned off, but 7 more warts branched out on the heel. These were treated with a combination of burning or surgical removal. The patient is still being treated by the podiatrist who feels this is related to GARDASIL. The primary care physician does not feel this is related to GARDASIL. The patient''s warts have persisted. No additional information is available at this time. Additional information has been requested.

VAERS ID:312861 (history)  Vaccinated:2007-09-11
Age:19.0  Onset:2007-09-11, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 246
Location:Massachusetts  Entered:2008-05-19, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA01782
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a physician concerning a 19 year old female who on 11-SEP-2007 was vaccinated intramuscularly with her second dose of GARDASIL (lot# reported "0232U"). Within 2 minutes of getting GARDASIL, the patient experienced lightheaded and passed out. The patient has a history of getting lightheaded with vaccines. The patient was monitored until feeling better then left the office. Subsequently, the patient recovered from lightheaded and passing out. Additional information has been requested.

VAERS ID:312880 (history)  Vaccinated:2008-01-02
Age:19.0  Onset:2008-01-16, Days after vaccination: 14
Gender:Female  Submitted:2008-05-14, Days after onset: 118
Location:Unknown  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy; Sulfonamide allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA02220
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Lip swelling, Oedema peripheral, Swelling face, Vaccine positive rechallenge
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse practitioner through the patient''s mother concerning her 19 year old daughter with an allergy to penicillin and sulfanomide who on 02-JAN-2008 was vaccinated IM in the deltoid with the first 0.5 ml dose of GARDASIL (Lot # 659055/1522U) and on 05-MAR-2008 was vaccinated IM in the deltoid with the second 0.5 ml dose of GARDASIL (Lot # 659657/1487U). Concomitant therapy included LEVORA. Approximately two weeks after receiving the first dose of GARDASIL the patient experienced swelling of lips. Approximately two weeks after receiving the second dose of GARDASIL the patient experienced more severe swelling of lips, swelling of the face and swelling of the hands. The patient was treated by an unspecified primary care physician after the second occurrence of swelling with unspecified steroids. The symptoms resolved by an unspecified date. No other symptoms or treatment reported. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/5008. Initial and follow up information has been received from a nurse practitioner through the paitent''s mother concerning her 19 year old daughter with an allergy to penicillin and sulfonamide who on 02-JAN-2008 was vaccinated IM in the deltoid with the first 0.5 ml dose of GARDASIL vaccine (Lot # 659059/1522U) and on 05-MAR-2008 was vaccinated IM in the deltoid with the second 0.5 ml dose of GARDASIL vaccine (Lot # 539657/1487U). Other medication included 10 mg PO LEVORA started on02-JAN-2008 for dysmenorrhoea. Phone call from patient''s mother on 09-APR-2008 indicated that the patient has swelling of lips 2 weeks after vaccine (16-JAN-2008). The second dose of the vaccine, 2 weeks after injection (19-MAR-2008) the patient noted swelling of lips, face and hands. The patient was treated by an unspecified primary care physician after the second occurrence of swellilng with prednisolone. The symptoms resolved by an unspecified date. No other symptoms or treatment reported. No product quality complaint was involved. Additional information has been requested.

VAERS ID:313058 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-14
Location:Michigan  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA02848
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Vaccine positive rechallenge
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Information has been received from a nurse concerning her 19 year old daughter who in 2007 was vaccinated with three dose series (0.5 ml) of GARDASIL (No lot numbers were provided). The patient experienced dizziness after each dose of the three doses series of GARDASIL. The dizziness only lasted approximately 24 hours after each injection. Medical attention was not sought. Patient outcome was recovered on an unspecified date. No product quality complaint was involved. No further information is available.

VAERS ID:313109 (history)  Vaccinated:2008-04-08
Age:19.0  Onset:2008-04-10, Days after vaccination: 2
Gender:Female  Submitted:2008-05-14, Days after onset: 34
Location:New Mexico  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA03971
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Exfoliative rash, Injection site rash, Rash, Rash erythematous, Rash vesicular
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 19 year old female who on 08-APR-2008 was vaccinated with her second dose of GARDASIL (lot# not provided). On 10-APR-2008 the patient experienced a rash at the injection site, rash on her chest and rash on her abdomen. The rash was a scaly red rash with vesicles. The patient feels well and was afebrile. The patient was being seen at the urgent care center. The patient''s rash at the injection site and rash on her chest and rash on her abdomen persisted. No further information is available.

VAERS ID:313115 (history)  Vaccinated:2008-04-04
Age:19.0  Onset:2008-04-04, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 40
Location:Florida  Entered:2008-05-19, Days after submission: 5
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: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA02627
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0052X1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Medical device complication, Pain in extremity
SMQs:
Write-up: Information has been received from a physician concerning a 19 year old female with unknown medical history, who on 04-APR-2008 was vaccinated (route unknown) with a second dose of GARDASIL (Lot # 655604/0052X). The date and the lot number of the first vaccination were not reported. The physician reported that the patient was "stuck" twice with two different prefilled syringes, because the first syringe did not function properly and did not release the vaccine. The patient reported arm pain to the physician. No laboratory diagnostic studies were performed. The patient sought unspecified medical attention at the physician''s office. Subsequently, on an unspecified date the patient recovered. This is one of several reports from the same source. Additional information has been requested.

VAERS ID:313120 (history)  Vaccinated:2008-02-08
Age:19.0  Onset:2008-02-08, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 95
Location:Pennsylvania  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Acne
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA04052
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chest discomfort
SMQs:, Anaphylactic reaction (broad)
Write-up: Information has been received from medical assistant concerning a 19 year old female with no previous medical history and no known drug allergies, who on 08-FEB-2008 was vaccinated IM with the first dose of GARDASIL (Lot # 660387/1967U). There was no concomitant medication. The patient developed chest tightening that started after she left the office the same day she received the dose of vaccination. Unknown medical attention was sought in the office. The patient did not report the event until she arrive for her second dose of GARDASIL, which she did not receive. Patient outcome was recovered on an unknown date. No product quality complaint was involved. Additional information has been requested.

VAERS ID:313175 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:2008-04-18
Gender:Female  Submitted:2008-05-14, Days after onset: 26
Location:Unknown  Entered:2008-05-19, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA04717
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Incorrect route of drug administration, Pain in extremity
SMQs:, Retroperitoneal fibrosis (broad)
Write-up: Information has been received from a physician concerning a 19 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL IM. On approximately 18-APR-2008 was vaccinated with a second dose of GARDASIL IM. The patient received the first dose of vaccine in her arm and experienced so much pain that for her second dose the physician injected it in her back. The patient experienced the same pain in her back as she did in her arm. The outcome of the event was not reported. No further information is available.

VAERS ID:313282 (history)  Vaccinated:2008-04-24
Age:19.0  Onset:2008-04-24, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 20
Location:Florida  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPO-PROVERA
Current Illness: Papilloma viral infection; Papanicolaou smear abnormal.
Preexisting Conditions:
Diagnostic Lab Data: Colposcopy, 04/23/08, colposcopy with biopsy; Pap test, CIN 2 with high risk HPV types identified.
CDC Split Type: WAES0804USA05435
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Cold sweat, Colposcopy, Deafness, Dizziness, Flushing, Injection site pain, Smear cervix abnormal, Visual disturbance
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: Information has been received from a physician concerning a 19 year old Caucasian female student with moderate dysplasia, HPV, and abnormal pap smear (CIN 2 with high risk HPV types) who on 24-APR-2008 was vaccinated IM in the left deltoid with the first 0.5 ml dose of GARDASIL (Lot# 659437/1266U). Concomitant therapy included DEPO-PROVERA. On 24-APR-2008 the patient became dizzy, clammy, flushed and reported that the injection was painful. Subsequently, the patient recovered on 24-APR-2008 from dizzy, clammy, flushed and injection pain. Unknown medical attention was sought in the office. No product quality complaint was involved. Follow up information was received that indicated that immediately following the injection, the patient became very dizzy, clammy, and her cheeks were flushed. The patient felt as though she was going to lose consciousness. She also reported visual and audible "waves". The symptoms lasted approximately 8 - 10 minutes. On 24-APR-2008, the patient was recovered. Additional information has been requested.

VAERS ID:313292 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-14
Location:Maine  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Human papilloma virus infection
Preexisting Conditions: Unknown
Diagnostic Lab Data: cervical smear, positive for HPV
CDC Split Type: WAES0804USA06067
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site reaction, Smear cervix abnormal
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow-up information has been received from a physician concerning a 19 year old female with Human papilloma virus infection (16,18,31,33,35,39,45,51,52,56,58,59,68) and no allergies, who, on an unspecified date, was vaccinated with a second dose of GARDASIL. There was no illnesses at the time of vaccination. Subsequently, the patient developed a delayed injection site reaction. It was reported that the vaccine was administered on a Friday and Saturday the patient developed redness at the injection site. On Sunday the patient developed a hard lump on the arm and pain that lasted for 2 to 3 days. It was noted that the patient had tested positive for human papilloma virus at a prior Pap smear. The patient sought unspecified medical attention. It was reported that the patient was not seen by medical personnel because she was away. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.

VAERS ID:313337 (history)  Vaccinated:2008-01-01
Age:19.0  Onset:2008-01-01, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 133
Location:Unknown  Entered:2008-05-19, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0805USA00272
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Depression, Feeling abnormal, Mood swings, Panic attack
SMQs:, Dementia (broad), Depression (excl suicide and self injury) (narrow)
Write-up: Information has been received from the mother of a 19 year old female consumer who in early January 2008, was vaccinated with the first dose of GARDASIL (lot not reported), In later February 2008 the patient was vaccinated with the second dose of GARDASIL (lot not reported). There was no concomitant medication. In January 2008, the patient began to experience depression and a feeling of "just not being herself with no known reason". Two weeks after her second dose of GARDASIL (lot not reported), she experienced a panic attack. Her current condition was described as resembling a "hormonal mood swing reaction." There does not seem to be an explanation for these feelings. She experienced these feeling away at college as well as at home. She is being seen by a physician and has an upcoming appointment in early May 2008 for these symptoms. The patient''s status was reported as not recovered. No further information is available.

VAERS ID:312713 (history)  Vaccinated:2008-05-16
Age:19.0  Onset:2008-05-16, Days after vaccination: 0
Gender:Male  Submitted:2008-05-20, Days after onset: 4
Location:Kentucky  Entered:2008-05-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: No Allergies, birth defects or other medical conditions listed on DD Form 2808 (Report of Medical Examination) dated 29 Jan 2008 and signed by MD.
Diagnostic Lab Data: Blood Lab results taken on 14 May 2008. Showed the pt. was immune to Hep A, Hep B, Rubella, Rubeola, and Varicella. Labs and Diagnostics: K+ 3.4. CT brain (-). PE WNL except for being sleepy 2'' to Ativan. EEG with slow background activity. No epileptiform activity
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA049AA IMLA
Administered by: Military     Purchased by: Military
Symptoms: Blood potassium decreased, Blood pressure, Blood test, Chest discomfort, Computerised tomogram normal, Convulsion, Dizziness, Dyskinesia, Electroencephalogram, Electroencephalogram abnormal, Gait disturbance, Heart rate, Hepatitis A antibody positive, Hepatitis B antibody positive, Loss of consciousness, Measles antibody positive, Respiratory rate, Rubella antibody positive, Scan brain, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Liver infections (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (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), Dyskinesia (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Approx, 10 minutes after a flu shot was given, the pt. passed out. Ammonia inhalants were used to revive pt. After 30 sec. to 1 min, pt. passed out again. He did this two more times. EMS personnel were called and arrived a few minutes later. Emergency personnel walked him to the ambulance and transported to the Hospital ER. Vitals signs were taken before pt. left. BP-128/102, Resp. 32, Pulse- 108. In the ER the pt. was given ativan, then transferred on 5/16, treated with Cerebyx (fosphenytoin), then onto dilantin, evaluated with EEGs, discharged on 5/18, with diagnosis of new onset of seizures. 6/9/2008 MR received for DOS 5/16-18/2008 with D/C Dx: Vasovagal Syncope. Pt presented to ER after an episode of loss of consciousness after flu vax with jerking movements bilaterally. Pt was awake and talking while the jerking movements were happening. Tx with Ativan as thought to be Grand Mal Seizures. Neuro consult with Impression: Loss of consciousness. ? vasovagal syncope. Seen 5/17 following episode with no LOC. Atypical seizures vs vasovagal Seen 5/18/08 with reported chest tightness, dizziness. Pt swaying upon standing and walking. D/C to f/u with PCP.

VAERS ID:312723 (history)  Vaccinated:2008-05-16
Age:19.0  Onset:2008-05-20, Days after vaccination: 4
Gender:Female  Submitted:2008-05-20, Days after onset: 0
Location:Minnesota  Entered:2008-05-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NKDA; Ethinyl estradiol, cetirizine, celecoxib, calcium
Current Illness: avascular necrosis
Preexisting Conditions: lymphoblastic lymphoma, avascular necrosis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1287U2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Malaise
SMQs:, Arthritis (broad)
Write-up: Patient had felt sick all weekend (received vaccine on friday); joint pain significantly increased 4 days following injection; patient given opoid medication for pain

VAERS ID:312974 (history)  Vaccinated:2008-05-21
Age:19.0  Onset:2008-05-21, Days after vaccination: 0
Gender:Male  Submitted:2008-05-22, Days after onset: 1
Location:California  Entered:2008-05-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Loratidine
Current Illness: None
Preexisting Conditions: Allergy to cats
Diagnostic Lab Data: Normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN4IDRA
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN0IMRA
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN0IDLA
Administered by: Public     Purchased by: Private
Symptoms: Dysphagia, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (broad)
Write-up: Mild difficulty swallowing 15 minutes after shot administered. Mild muscle tension in the throat as well. Went to the ER, was given adrenaline, benadryl, and pregnazone. Symptoms went away after these treatments.

VAERS ID:313037 (history)  Vaccinated:2008-05-22
Age:19.0  Onset:2008-05-22, Days after vaccination: 0
Gender:Female  Submitted:2008-05-22, Days after onset: 0
Location:Illinois  Entered:2008-05-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: fluoxetine 20mg daily; methylphenidate 20mg three times daily as needed (not filled since 12/07)
Current Illness: Pt reported a cough (not observed)
Preexisting Conditions: n/a
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0073X2IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Amnesia, Fall, Immediate post-injection reaction, Loss of consciousness, Malaise
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), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Immediately after administering vaccination, the patient reported feeling "not good". Pt laid head down on coutner for a moment, then slumped over, unconscious. After helping pt sit up, she immediately awoke and denied further medical intervention. Pt was observed for 15 minutes and showed no further signs of fainting, but reported no memory of event.

VAERS ID:313203 (history)  Vaccinated:2008-05-06
Age:19.0  Onset:2008-05-06, Days after vaccination: 0
Gender:Female  Submitted:2008-05-23, Days after onset: 17
Location:New York  Entered:2008-05-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: NO
Diagnostic Lab Data: NA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB252AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure, Dizziness, Heart rate normal, Hyperhidrosis, Loss of consciousness, Pallor, Respiratory rate
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Right after shot patient feeling faint, intructed head to knee position while seated in chair in exam room. Water given. 5 minutes ambulated to traement room when she stated began to "black out". LOC approxiamtely 5 seconds. Diaphoretic .With assiatance from my coworker aided student to the floor. Lying down elevated legs with pillows. Dr. was made aware. P: 60R: 18 cool cloth to forehead.Within 5 minutes: color back to face feeling better. 10 minutes later sitting up , gatorade given and crackers. Amulated without difficulty to infirmary to lie down in bed. P: 60 B/P 100/70 R: 18 Additional 40 minutes rested in infirmary feeling better Before discharge: P: 72 R 18 B/P 100/70 Stable, Alert and oriented.

VAERS ID:313224 (history)  Vaccinated:2008-05-21
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-22
Location:Ohio  Entered:2008-05-23, 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: Hypoglycemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0052X0UNRA
Administered by: Private     Purchased by: Private
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: Pt walked to front making next appointment. The next thing the pt fainted. Pt got up rested a few minutes and was fine. Pt walked to front of the office and fell down. We helped her up a made her rest we gave her water/pop and crakers.

VAERS ID:314706 (history)  Vaccinated:2007-03-20
Age:19.0  Onset:2007-03-22, Days after vaccination: 2
Gender:Female  Submitted:2008-05-16, Days after onset: 421
Location:Rhode Island  Entered:2008-05-23, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0708USA04949
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1302F UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site cellulitis
SMQs:
Write-up: Information has been received from a physician concerning a 19 year old female who on 20-MAR-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot no. 655994/1302F). On 22-MAR-2007, the patient developed a localized reaction at the injection which was cellulitis. Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:315044 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-16
Location:Unknown  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID
Current Illness: Hypothyroidism, Asthma
Preexisting Conditions: Hypertension
Diagnostic Lab Data: serum varicella zoster - 06/11/07 - -serocon.
CDC Split Type: WAES0706USA03105
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Seroconversion test negative
SMQs:
Write-up: Information has been received from a physician concerning an approximately 33 year old female speech pathologist with hypothyroidism and asthma and a history of hypertension who in 1993 and 200 was vaccinated with the first dose and second dose of varicella virus vaccine live (Oka/Merck), respectively. Concomitant therapy included levothyroxine Na (SYNTHROID). In June 2007 (last week), the patient had an antibody test drawn at the hospital and she failed to seroconvert. The patient sought unspecified medical attention. No product quality complaint was involved. Follow-up information was received from the physician who reported "I did not immunize the patient, but she gave a history of receiving immunization x 2 without becoming immune." No additional information is expected.

VAERS ID:315766 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:2007-04-01
Gender:Male  Submitted:2008-05-16, Days after onset: 411
Location:Florida  Entered:2008-05-23, Days after submission: 7
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: WAES0705USA01628
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: Information has been received from a physician concerning an age approximately 19-20 year old male who "a couple of years ago" at approximately 17-18 years of age was vaccinated with a 0.5mL dose of varicella virus vaccine live (Oka/Merck). It was reported that "a couple weeks ago" on approximately April-2007, the patient developed shingles. The patient''s status is recovering. No product quality complaint was involved. Additional information has been requested.

VAERS ID:313735 (history)  Vaccinated:2007-03-08
Age:19.0  Onset:2007-03-08, Days after vaccination: 0
Gender:Female  Submitted:2008-05-27, Days after onset: 445
Location:Louisiana  Entered:2008-05-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 4/19/2007); Papanicolaou smear abnormal
Preexisting Conditions: Hypothyroidism
Diagnostic Lab Data: ultrasound, 06/01/07, norma; ultrasound, 07/17/07, norma - Twins/cervix length; ultrasound, 08/31/07, abnor - showed funneling; ultrasound, 09/13/07, abnor - showed blood clot only; urine beta-human - positive
CDC Split Type: WAES0705USA04399
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0186U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Caesarean section, Cervix disorder, Drug exposure during pregnancy, Foetal disorder, Thrombosis, Ultrasound scan abnormal, Urine human chorionic gonadotropin positive
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Tumour markers (narrow), Thrombophlebitis (broad), 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 have been received from a registered nurse and a licensed practical nurse through a Merck pregnancy registry concerning a 19 year old female with papanicolaou smear abnormal and a history of hypothyroidism who on 22-DEC-2009 was vaccinated with the first dose of GARDASIL (Lot #653938/0954F). On 08-MAR-2007, the patient received the second dose of GARDASIL (Lot #655618/0186U). Concomitant medication was not reported. In approximately April 2007, it was determined that the patient was pregnant. On an unspecified date, the patient had a positive urine pregnancy test. The date of the patient''s last menstrual period was 19-APR-2007 and estimated delivery date is 24-JAN-2008. On 01-JUN-2007 and 17-JUL-2007, ultrasounds performed were normal. On 31-AUG-2007, was third ultrasound performed showed funneling of the cervix. On 13-SEP-2007, a fourth ultrasound showed a blood clot only. On 03-OCT-2007 at 26 weeks and 2 days of pregnancy, the patient had an emergency caesarean section performed due to the funneling of the cervix. At this time, the patient delivered two normal male infants one weighed 1 lb 12 oz and the second weighed 1 lb 13 oz with no congenital anomalies. Apgar scores were 6/7 for both infants. The infants experienced the following complications or abnormalities prematurity, bronchopulmonary dysplasia and ductus arteriosus. It was reported that there were no infections or illnesses during pregnancy and no complications during labor/delivery. The outcome and causality of these events were not reported. Upon internal review the following were considered to other important medical events: premature baby, bronchopulmonary dysplasia, caesarean section, ductus arteriosus and small for dates baby. Additional information has been requested.

VAERS ID:313810 (history)  Vaccinated:2008-04-09
Age:19.0  Onset:2008-04-10, Days after vaccination: 1
Gender:Female  Submitted:2008-04-11, Days after onset: 1
Location:Tennessee  Entered:2008-05-28, Days after submission: 47
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tubersol PPD
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type: TN08014
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB341AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2864AA5IMLA
Administered by: Public     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling in left deltoid where shot was given, approximately 10cm long x 7cm wide x 3cm deep. Red, warm to touch, extended down arm to elbow, painful to move and to touch. Instructed to apply cool compress, if increases remove compress. Referred to physician. Analgesics as needed. Saw MD, diagnosed with possible infection, Started on PREDNISONE and BACTRIM. Improved on 4/11/08, able to move and without pain, swelling and redness decreased.

VAERS ID:313882 (history)  Vaccinated:2008-05-25
Age:19.0  Onset:2008-05-26, Days after vaccination: 1
Gender:Female  Submitted:2008-05-27, Days after onset: 1
Location:Washington  Entered:2008-05-28, 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: 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.1978U0UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2552AA0UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B015AA0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling L upper arm 8 cm wide warm to touch.

VAERS ID:314403 (history)  Vaccinated:2008-05-23
Age:19.0  Onset:2008-05-24, Days after vaccination: 1
Gender:Female  Submitted:2008-06-01, Days after onset: 8
Location:New York  Entered:2008-06-01
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: asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Chills, Fatigue, Headache, Heart rate increased, Injection site pain, Lymphadenopathy, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)
Write-up: Approx 10 hours post-vaccination patient began to have a fever (102.4 F), chills, severe pain at injxn site, headache, joint pain especially in her hands, swollen lymph glands esp. sub-mandibular, nausea, increased heart-rate of 104 beats per minute at rest. This lasted approx 36 hours and after significant resolution patient still was fatigued and had some hand pain.

VAERS ID:314768 (history)  Vaccinated:2008-05-05
Age:19.0  Onset:2008-05-05, Days after vaccination: 0
Gender:Female  Submitted:2008-06-03, Days after onset: 29
Location:Iowa  Entered:2008-06-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Citalopram Hydrobromide 20mg, Mircette, Valtrex
Current Illness: None
Preexisting Conditions: Ehlers-Danlos Syndrome, Dysmenorrhea, Depression
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U2IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt c/o extremely sore arm, tenderness at injection site, and inability to lift arm above head since receiving 3rd Gardasil injection. Injection was given 5/05/08 and patient continued to c/o symptoms 5/20/08. Patient tried ice and ibuprofen with very minimal relief.

VAERS ID:315509 (history)  Vaccinated:2006-10-15
Age:19.0  Onset:2006-12-30, Days after vaccination: 76
Gender:Female  Submitted:2008-06-06, Days after onset: 523
Location:Unknown  Entered:2008-06-09, 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: None
Current Illness: Pregnancy NOS (LMP = Unknown)
Preexisting Conditions:
Diagnostic Lab Data: diagnostic laboratory, "OB panel"
CDC Split Type: WAES0703USA01568
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, Laboratory test, Labour complication
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Initial and follow-up information has been received through the Merck pregnancy registry from a consumer concerning her 19 year old daughter with no pertinent medical history who on approximately 15-OCT-2006 was vaccinated with a first dose of GARDASIL. There were no concomitant medications. On 18-DEC-2006, the patient was vaccinated with a second dose of GARDASIL. On 30-DEC-2006, the patient found out she was pregnant. Unspecified medical attention was sought. In September 2007, the patient gave birth to a healthy female via primary cesarean section because she "just couldn''t push that baby out." The baby weighed 9 pounds and 1 ounce. At the time of the report, both mother and baby were well without any problems. Upon internal review, "just couldn''t push that baby out" was considered to be an other important medical event. Additional information is not expected.

VAERS ID:315513 (history)  Vaccinated:2007-08-01
Age:19.0  Onset:2007-08-01, Days after vaccination: 0
Gender:Female  Submitted:2008-06-06, Days after onset: 310
Location:Wisconsin  Entered:2008-06-09, 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: amoxicillin; hormonal contraceptives; vitamins (unspecified)
Current Illness: Pregnancy NOS (LMP = 6/25/2007); Dental examination
Preexisting Conditions: Dysmenorrhoea
Diagnostic Lab Data: beta-human chorionic, positive blood test
CDC Split Type: WAES0708USA04006
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0524U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Umbilical cord around neck
SMQs:, 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: Information has been received from the pregnancy registry for GARDASIL, via a registered nurse concerning a 19 year old female who on 01-AUG-2007 was vaccinated with her first dose of GARDASIL, (lot # 658094/0524U) 0.5ml, IM. Subsequently, a pregnancy test (blood test) was positive (LMP 25-JUN-2007, EDD 30-MAR-2008). The patient was placed on therapy with a prenatal vitamin, and amoxicillin 500mg for dental work, on an unspecified date. Follow up information from a physician reported that on 15-APR-2008, the patient delivered a 7.2 pound, normal, baby girl with an Apgar score of 6 and 8. The baby was delivered with a nuchal cord that was reduced and the baby was sent to the neo-natal intensive care unit for retractions. It was not reported if the baby was admitted to the NICU. No treatment or outcome information has been reported. Upon internal review, nuchal cord reduction was considered an other important medical event. Additional information has been requested.

VAERS ID:315674 (history)  Vaccinated:2008-06-03
Age:19.0  Onset:2008-06-03, Days after vaccination: 0
Gender:Female  Submitted:2008-06-04, Days after onset: 1
Location:Maryland  Entered:2008-06-09, 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: ORTHOTRICYCLEN
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0525U0UNLA
Administered by: Public     Purchased by: Unknown
Symptoms: Blood pressure, Cold sweat, Disturbance in attention, Dizziness, Feeling cold, Heart rate normal, Hyperhidrosis, Pallor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: 6-3-08 pt. received HPV #1, L delt. via biojector at 2:30 pm. 2:45 pm pt. became pale lightheaded & unable to concentrate. Placed head between legs . At 3 pm given juice, cool cloth to head & laid her back in chair. Approx 3:15 diaphoretic, P 71, BP 120/76. 3:30 pm ambulated to bathroom became lightheaded again. Laid back down cold clammy, diaphoretic, pale. 4 pm pt. states she felt better. Color pink, skin warm to touch.

VAERS ID:316034 (history)  Vaccinated:2007-08-24
Age:19.0  Onset:2007-08-27, Days after vaccination: 3
Gender:Female  Submitted:0000-00-00
Location:Texas  Entered:2008-06-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 6/12/08-records received-PMH:anorexia nervosa. Prior vasovagal syncope.Has had several episodes in past when after heavy night of drinking.
Diagnostic Lab Data: Blood work, ECG, EEG, and C/T scans all normal 6/18/08-records received-EKG normal. BMP WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0469U1IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Alcohol use, Blood test normal, Computerised tomogram normal, Convulsion, Dehydration, Electrocardiogram normal, Electroencephalogram normal, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (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: Seizure - first one was 3 days after her second HPV vaccine. Has since had 3 more seizures: 3/14/08, 5/30/08, 6/4/08. 6/12/08-ER records received for DOS 3/14/08-DX:Syncope likely secondary to dehydration related to alcohol. Presented with nonwitnessed near syncope episode. Drinking alcohol night before and might be dehydrated.

VAERS ID:316294 (history)  Vaccinated:2007-09-12
Age:19.0  Onset:2007-09-12, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 275
Location:New Jersey  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: Penicillin allergy
Diagnostic Lab Data: urine beta-human, 10/08/07, positive
CDC Split Type: WAES0710USA03349
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial and follow-up information has been received from a physician concerning a 19 year old female with a penicillin allergy who on 12-SEP-2007 was vaccinated with GARDASIL. On 08-OCT-2007 the patient was found to be pregnant. The patient plans to terminate the pregnancy for non medical reasons. The patient''s outcome is unknown. On 20-OCT-2007 the patient had an elective termination 8 7/8 weeks from her last menstrual period. Upon internal review the elective termination was considered to be an other important medical event. Additional information has been requested.

VAERS ID:316788 (history)  Vaccinated:2008-05-02
Age:19.0  Onset:2008-05-03, Days after vaccination: 1
Gender:Female  Submitted:2008-06-13, Days after onset: 41
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:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0805USA00773
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Rash vesicular
SMQs:, Hypersensitivity (narrow)
Write-up: Information has been received from a nurse practitioner concerning a 19 year old female patient with no medical history and no allergies reported who on 02-MAY-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot # 660387/1967U). Concomitant therapy included hormonal contraceptives (unspecified). On 03-MAY-2008, approximately 24 hours after the vaccination, the patient developed a vesicular rash on her lower lip and on the tip of her tongue. The patient was seen in the office on 05-MAY-2008. No diagnostic laboratory testing was performed. At the time of this report, the patient''s outcome was not recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/13/2008. Initial and follow up information has been received from a nurse practitioner concerning a 13 year old female patient with no medical history and no allergies reported who on 03-MAY-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot # 560387/1967U). Concomitant therapy included hormonal contraceptives (unspecified). On 03-MAY-2008, approximately 24 hours after the vaccination, the patient awoke with papules and vesicles on the inside of her upper and lower lip and on the tip of her tongue. No reported difficulty breathing, and no reaction at the vaccination site. On 05-MAY-2008, two days after the incident. The patient was seen in the office. The symptoms were present (papules and vesicles). The nurse practitioner spoke with department who advised the nurse to advise the patient not to complete the series of vaccinations. The nurse then advised the patient. No diagnostic laboratory testing was performed. At the time of this report, the patient''s outcome was recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:316838 (history)  Vaccinated:2008-05-07
Age:19.0  Onset:2008-05-07, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 37
Location:North Carolina  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: YASMIN
Current Illness: Drug hypersensitivity; Drug hypersensitivity; Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: brachial artery, within normal limits
CDC Split Type: WAES0805USA02271
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Brachial pulse normal, Incorrect route of drug administration, Injection site erythema, Injection site irritation
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a health professional concerning a 19 year old female with an allergy to DEMEROL, morphine and penicillin who on 11-OCT-2007 was vaccinated with her first dose of GARDASIL (lot# 658563/1063U). On 03-JAN-2008 the patient was vaccinated with her second dose of GARDASIL (lot# 659439/1267U). On 07-MAY-2008 the patient was vaccinated with her third dose of GARDASIL (lot# 660389/1968U). The third dose may have been administered subcutaneously. Concomitant therapy included YASMIN. On 07-MAY-2008, within 15 minutes of the dose, the patient experienced burning and redness at the injection site. The patient was being treated with BENADRYL, antibiotics and cool compresses applied to the injection site. The patient was seen in the office and her outcome was unknown. Additional information has been requested.

VAERS ID:316845 (history)  Vaccinated:2007-12-26
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-06-13
Location:Ohio  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: stiff hands in AM; Dislocated patella; Knee pain
Preexisting Conditions: Unknown PMH: on BCP. Acne.
Diagnostic Lab Data: X-ray, results not reported; diagnostic laboratory, results not reported; thyroid function test, results not reported LABS: 2/2008 Sed rate 27(H), monospot & Lyme serology (-). 5/1/08 Sed rate 18 (N), anti-CCP $g200(H). CRP 1.2(H). RF 59.9(+). Hand x-rays WNL. diagnostic urinalysis, 05/05/08, 30-40/epithelial cells, trace mucus and bacteria; chest X-ray, no significant abnormality; thyroid function test, TSH-1.6, Reflex TSH 2.1 Free T4 1.10; serum cyclic citrulline, 05/05/05, $g200; Lyme disease assay, 02/29/08, 66, negative; Epstein-Barr virus, 02/20/08, negat; erythrocyte, 02/22/08, 27; serum rheumatoid factor, 05/01/08, 50.7; serum C-reactive protein, 05/05/08, 1.2, high
CDC Split Type: WAES0805USA02344
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER0874U2IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U2IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC904AA IMRA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Borrelia burgdorferi serology negative, C-reactive protein increased, Dyspnoea, Epstein-Barr virus test negative, Exfoliative rash, Grip strength decreased, Joint swelling, Laboratory test, Pain in extremity, Rash erythematous, Red blood cell sedimentation rate increased, Rheumatoid arthritis, Rheumatoid factor positive, Thyroid function test, X-ray limb normal
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (narrow)
Write-up: Information has been received from a nurse (patients mother) concerning her 19 year old daughter, with no concomitant medications, no drug allergies, and no pertinent medical history, who in July 2007 (date unreported), was vaccinated with the first single dose, injection, of GARDASIL (Lot # not specified). The second single dose injection of GARDASIL, (Lot # not specified) was approximately two months later in SEP-2007, (date unreported), and the third single dose injection of GARDASIL, (Lot # not specified) was in DEC-2007; (date unreported). One week following the third dose of GARDASIL the patient initially complained of pain in both knees and then subsequently she had pain in her hands. She also experienced shortness of breath. The patient sought unspecified medical attention and had blood tests, thyroid studies and x-rays (no dates, test names or results were reported). Subsequently, she was diagnosed with rheumatoid arthritis. As of the date of the report 12-MAY-2008, the patient has not recovered. No product quality complaint was involved. Additional information has been requested. 7/4/08 Reviewed rheumatology office notes of 5/1/08-5/19/2008 FINAL DX: rheumatoid arthritis Records reveal patient experienced scaly erythematous rash on dorsum of feet 9/2007 followed by joint pain & swelling. Joint pain persistent daily & worse in AM. Had been tx in 3/2008 w/tapering steroids w/dramatic improvement. NSAIDS not helpful. On exam, had decreased grip strength bilaterally. 8/5/08 Reviewed PCP medical records & vax records. VAX: 5/24/2007: HPV #1, 0389U, IM, LA Hep B #1, 0039U, IM RA 7/27/07: HPV #2, 0802U, IM RA Hep B #2, 0007U, IM LA Menactra, U2367AA, IM LA 12/26/07: HPV #3, 1267U, IM LA Hep B #3, 0874U, IM LA Adacel, C904AA, IM RA Records reveal patient c/o stiff hands in AM on 5/24/07 visit & had just started acne meds. 8/5/08 Reviewed urgent care medical records of 2/29/2008 which included labs already received from rheumatologist. FINAL DX: arthritis Records reveal patient c/o of joint pain, swelling, decreased energy since 12/2007. Patient noted to have s/s thyrotoxicosis, throat erythema. Tx w/IM steroids & NSAIDS. D/C to home. This is in follow-up to report(s) previously submitted on 6/13/2008. Initial and follow up information has been received from a physician and a nurse consumer concerning her 19 year old daughter with no known drug allergies and a history of knee pain due to patellar subluxation (since age 15) and without a family history of arthritis. In July 2007 the patient was vaccinated with a first dose of GARDASIL (Lot # not reported). There were no concomitant medications. In approximately September 2007, two months later, the patient was vaccinated with a second dose of GARDASIL (Lot # not specified) and developed a scaly rash on the dorsum of her feet. In December 2007, the patient was vaccinated with a third dose injection of GARDASIL (Lot # not reported). One week following the third dose she complained of pain in both knee. Subsequently she had pain in her hands. This was followed by pain in the wrists, temporomandibular joints, shoulders, elbows, all the small joints of her hands (worse in the metacarpophalangeal joints) ankles and feet. Swelling occurred in the wrists, MCP joint of the hands, left knee and ankles. She had persisted join pain daily. Morning stiffness was "all over" and lasted all day. She also experienced shortness of breath. Subsequently, the patient was seen at a university hospital and it was thought she had "tendenitis of her left wrist and arthritis." Laboratory tests of February 2007 revealed as sedimentation rate of 27. On 29-SEP-2008 a Heterophile Mean Hernia was negative and Lyme Disease AB serology was negative. In March 2007 she was treated with a MEDROL DOSE PACK which gave her dramatic relief f

VAERS ID:316849 (history)  Vaccinated:2007-10-17
Age:19.0  Onset:2007-10-21, Days after vaccination: 4
Gender:Female  Submitted:2008-06-13, Days after onset: 236
Location:Pennsylvania  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: ascorbic acid; cyanobobaalamin; YAZ; iron (unspecified); omega-3 marine triglyercides
Current Illness: Pregnancy NOS (LMP = 2/21/2008); Asthma; Scoliosis
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA02878
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IM 
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Menstruation irregular, Metrorrhagia, Ultrasound scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Fertility disorders (broad)
Write-up: Information has been received from a Licensed Practical Nurse for the Pregnancy Registry for GARDASIL, concerning her 19 year old daughter with asthma and scoliosis who on 17-OCT-2007 was vaccinated intramuscularly with a first dose of GARDASIL (lot # not reported). The nurse reported that her daughter received her first dose of GARDASIL and afterwards experienced irregular period with spotting. On 23-JAN-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot # not reported) and the patient reported that her period was "not right". The patient believes her LMP was 21-FEB-2008. Concomitant therapy included YAZ, ascorbic acid, cyanocobalamin, omega-3 marine triglycerides and iron (unspecified). The patient also reported that she took YAZ at night time and she forgot to take it one night but then took it the next morning. The patient''s mother believes that the birth control failed because of GARDASIL. The mother also reported that the patient was taking YAZ while she was pregnant. An ultrasound on 13-MAY-2008 showed that the patient was 8 weeks 4 days pregnant. Additional information has been requested.

VAERS ID:316899 (history)  Vaccinated:2008-05-15
Age:19.0  Onset:2008-05-15, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 29
Location:Pennsylvania  Entered:2008-06-16, 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:
Preexisting Conditions: None
Diagnostic Lab Data: X-ray, 05/15/08, normal; electrocardiogram, 05/15/08, normal; diagnostic laboratory, 05/15/08, normal
CDC Split Type: WAES0805USA03782
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0067X0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Electrocardiogram normal, Face injury, Laboratory test normal, Loss of consciousness, X-ray normal
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a secretary of a physician''s office concerning a 19 year old female who on 15-MAY-2008 was vaccinated (route unknown) with a first dose of GARDASIL (Lot # 660393/0067X). On the same day the patient was vaccinated with a dose of tuberculin purified protein derivative (PPD, unspecified). On 15-MAY-2008 the patient passed out 10 to 20 seconds after vaccination and hit her face. The physician attended to the patient and the rescue squad was contacted. She was brought to the emergency room where blood work, x-rays and EKG were performed. All tests results were normal. The patient was not admitted to the hospital and released from the emergency room that same evening. It was also mentioned that this patient is "not apprehensive". Subsequently on 15-MAY-2008 the patient recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:317031 (history)  Vaccinated:2008-05-22
Age:19.0  Onset:2008-05-27, Days after vaccination: 5
Gender:Female  Submitted:2008-06-13, Days after onset: 17
Location:South Carolina  Entered:2008-06-16, 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: Asthma
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0805USA05948
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a physician concerning a 19 year old female with asthma who on 22-MAY-2008 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (Lot # 660387/1967U). Concomitant therapy included SINGULAIR. On 27-MAY-2008 the patient experienced tenderness, redness, pain in the arm, swelling in the left arm, mild erythema covering approximately 5-6 cm, at the injection site, heat at the injection site and discomfort. On 28-MAY-2008, it was reported that "the reactions are worse today". The physician recommended that the patient take TYLENOL or MOTRIN. The patient sought medical attention in the doctor''s office. The physician prescribed DURICEP and ibuprofen (unspecified). On an unspecified date, the patient recovered. No additional information is available. Additional information has been requested. Additional infromation is not expected.

VAERS ID:317061 (history)  Vaccinated:2008-02-21
Age:19.0  Onset:2008-02-23, Days after vaccination: 2
Gender:Female  Submitted:2008-06-13, Days after onset: 110
Location:Alabama  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: Penicillin allergy
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA00988
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1488U0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Feeling hot, Influenza like illness, Pain in extremity, Rash, Skin burning sensation, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of GARDASIL (lot not reported). After receiving the first dose the patient experienced a rash on her abdomen and her arm. The patient took some BENADRYL and got prednisone (manufacturer unknown). The patient came back to the physician''s office because she wanted to get the second shot of GARDASIL (lot not reported). About a week after the shot the patient broke out in to even more extensive rash and had to get prednisone again. The nurse reported she will not administer the third dose of GARDASIL. The patient''s status was not reported. Additional information has been requested. 02/18/2010 Follow up informatino was received. The patient was vaccinated with the first dose of GARDASIL (lot 659699/1086U) via IM in the left deltoid on 21-FEB-2008. The patient was vaccinated with the second dose of GARDASIL (lot 655604/0052X) via IM in the left deltoid on 28-APR-2008. On 23-FEB-2008 after the frist injections the patient developed a rash across abdomen and her legs. On 5-MAY-2008 the patient developed a rash on her right arm and shoulder and a burning feeling-cold type symptoms. The patient recovered on a unspecified date. The patient has penicillin allergy. No further information is expected. Follow-up information was received which reported that the 19 year patient experienced an adverse event after the first dose of GARDASIL. The patient then received a second dose of GARDASIL and had the same adverse event but to a great extend. The patient experienced a rash starting on her arms, then processing down her abdomen and legs. She also had flu like symptoms and joint and arm pain. The patient was prescribed a course of steroids, BENDADRYL and ATIVAN. The registered nurse considered the rash across abdomen and on her legs, a rash on her right arm and shoulder and a burning feeling - cold typ/flu-like symptoms to be an other important medical event. This is an amended report. The nurse considered the rash across the abdomen, on her legs, a rash on her right arm and shoulder, burning feeling, cold type/flue-like symptoms to be other important medical events. Follow-up information was received from a registered nurse (R.N.) who reported that she did not known if the patient recovered from arm pain and joint pain. The nurse did not indicate if the patient would receive the third dose of GARDASIL. Additional information has been requested.

VAERS ID:316500 (history)  Vaccinated:2008-01-29
Age:19.0  Onset:2008-02-29, Days after vaccination: 31
Gender:Male  Submitted:0000-00-00
Location:Illinois  Entered:2008-06-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 80 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Labs and Diagnostics: CSF-no oligoclonal bands. CSF albumin 49.7. CSF IGG synthesis high at 4.7. CSF protein 79.3. CSF cx (-), otherwise WNL. CXR (+) for infiltrates in the L perihilar region
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFFLA050AA0IMLA
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB103AA0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0868U0SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2566AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2775AA0IMRA
Administered by: Military     Purchased by: Military
Symptoms: Blood product transfusion, CSF culture negative, CSF oligoclonal band absent, CSF protein increased, Chest X-ray abnormal, Constipation, Depression, Endotracheal intubation, Extubation, Guillain-Barre syndrome, Hand fracture, Hypoaesthesia, Inappropriate antidiuretic hormone secretion, Joint contracture, Movement disorder, Muscular weakness, Pain in extremity, Respiratory distress, Vital capacity decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Demyelination (narrow), Depression (excl suicide and self injury) (narrow), Hypersensitivity (broad), Arthritis (broad)
Write-up: See copy of medical records for initial visits. Patient was admitted to hospital and still an inpatient as of 5/13/08. DX: GBS. Hospital progress notes also attached. 7/22/2008 MR received for DOS 3/03-5/23/2008 with D/C DX: Guillain-Barre Syndrome. 2ndary DX: SIADH, constipation, R hand 5th metacarpal fracture and depression. Pt presented on 3/3/08 with 4 day hx of progressive ascending numbness and motor weakness which began at the ankles to the upper extremities. Pt developed respiratory distress and decreased vital capacity and was intubated on 3/09/08 x 7 days and extubated. No further respiratory issues. Tx with IVIG. Pt then developed SIADH and was tx with fluid restriction. Pt showed some sensation and motor function improvement although now c/o depression and continued pain in the feet. Choriform movements noted by neurology and tx with clonazapam with resolution of sx. Pt developed bilateral ankle contractures. D/C 5/23/08 to continue outpt rehab.

VAERS ID:316501 (history)  Vaccinated:2008-03-14
Age:19.0  Onset:2008-04-19, Days after vaccination: 36
Gender:Male  Submitted:0000-00-00
Location:Illinois  Entered:2008-06-18
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 7/21/08-records received-preceded by URI symptoms for 3 weeks with cough, sputum yellow, runny nose, congestion
Preexisting Conditions: None
Diagnostic Lab Data: 7/21/08-records received-LP revealed increased protein 297.1, WBC 12.8, lymph% 90 and mono %10. CSF culture no organisms seen. EMG conduction block and mild prolongation of latency, findings are suggestive of acute demyelinating neuropathy though there is an axonal component as well. MRI brain/cervical spine unremarkable.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA050AA0IMRA
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB108AA0IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1311U0SCLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2570AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2864AA0UNRA
Administered by: Military     Purchased by: Unknown
Symptoms: Areflexia, Asthenia, Balance disorder, Blood product transfusion, CSF culture negative, CSF lymphocyte count increased, CSF monocyte count decreased, CSF protein increased, CSF white blood cell count increased, Diarrhoea, Dysaesthesia, Electromyogram abnormal, Facial palsy, Gait disturbance, Guillain-Barre syndrome, Hyperaesthesia, Hypoaesthesia, Lumbar puncture, Muscular weakness, Nervous system disorder, Nuclear magnetic resonance imaging brain normal, Paraesthesia, Peripheral sensory neuropathy
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Vestibular disorders (broad), Malignant lymphomas (broad), Noninfectious diarrhoea (narrow)
Write-up: See copy of medical records for initial visit. Patient was admitted in hospital. He is still hospitalized as of 5/7/08. Dx- Peripheral Nerve disease and peripheral sensory neuropathy. 7/21/08-Records received for DOS 4/26-5/9/08-DC DX:Guillain-Barre syndrome. AIDP and left facial palsy. Presented with numbness in both legs and hand balancing problem, sensory changes numbness of abdomen, muscular weakness. One loose stool. Treated with IVIG. Transferred to rehab, stay complicated by left facial palsy on 5/4/08. PE: DTR decreased.

VAERS ID:316504 (history)  Vaccinated:2008-06-10
Age:19.0  Onset:2008-06-10, Days after vaccination: 0
Gender:Female  Submitted:2008-06-10, Days after onset: 0
Location:Wisconsin  Entered:2008-06-18, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)SANOFI PASTEURU2019AB0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hyperhidrosis, Nausea, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Tingling; Sweaty; Nausea

VAERS ID:316553 (history)  Vaccinated:2008-06-18
Age:19.0  Onset:2008-06-18, Days after vaccination: 0
Gender:Male  Submitted:2008-06-18, Days after onset: 0
Location:Arizona  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: None
Current Illness: None
Preexisting Conditions: Visually impaired (Blind)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB223AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2542AA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2844AA IMLA
Administered by: Private     Purchased by: Public
Symptoms: Dizziness, Fall
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad)
Write-up: Patient received Tdap, Hep A, MCV vaccines. Approximately 10 minutes later patient stood up, became dizzy, and fell to the floor. He remained awake and alert throughout. He was helped up and sat in a chair. He attempted to stand again approximately 15 later, and again became dizzy and fell to the floor. He was again helped into a chair, and given water to drink. He rested for 20+ minutes, then stood, and walked out without further incident.

VAERS ID:317453 (history)  Vaccinated:2007-08-13
Age:19.0  Onset:2007-08-15, Days after vaccination: 2
Gender:Male  Submitted:2008-05-30, Days after onset: 289
Location:Florida  Entered:2008-06-18, Days after submission: 19
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: diagnostic laboratory 08/21/2007 - Elevated IgM
CDC Split Type: WAES0708USA05739
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood immunoglobulin M increased, Parotid gland enlargement
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a physician concerning a 19-year-old male who on 13-AUG-2007 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) or mumps virus vaccine live (Wistar RA 27/3 strain) (MSD). On 15-AUG-2007, the patient developed swelling of the parotid gland a couple of days after vaccination. IgM was also elevated on 21-AUG-2007. The "physician believes these were from the immunization." The patient sought unspecified medical attention. At the time of the report the patient''s status was recovering and it was reported the "patient is doing much better now." A product quality complaint was not involved. Follow-up information was received on 07-NOV-2007 via a phone call from a physician. He stated that the patient received the vaccination while still living in another country. It is not known which vaccine was administered as the vaccination did not occur at the doctor''s office. The doctor saw the patient for treatment after the symptoms had developed. Additional information has been requested.

VAERS ID:317473 (history)  Vaccinated:0000-00-00
Age:19.0  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: WAES0710USA01111
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Lymphadenopathy
SMQs:
Write-up: Information has been received from a nurse practitioner concerning a 19 year old female who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was reported that the patient developed swollen lymph node on the side of her neck after vaccination. It was reported that the patient was not administered vaccine in their office. A product quality complaint is not involved. No further information is available.

VAERS ID:317574 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:2007-09-01
Gender:Male  Submitted:2009-05-29, Days after onset: 636
Location:Unknown  Entered:2008-06-18, Days after submission: 345
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory - detectable measles IgM antibodies in serum, diagnostic laboratory - measles virus RNA by RT-PCR in throat swab
CDC Split Type: WAES0803USA01348
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Chills, Conjunctivitis, Laboratory test, Measles antibody positive, Myalgia, Pyrexia, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician via a newsletter. It was reported that male college roommates, aged 18 and 19 years, on unknown dates, had received 2 documented doses of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). They had fever, chills, and myalgia on 09-SEP-2007 and 10-SEP-2007, respectively; one had conjunctivitis. Both had a rash on 11-Sep-2007, detectable measles IgM antibodies in serum, and measles virus RNA by RT-PCT in throat swab specimens. No further information is available. This is in follow-up to report (s) previously submitted on 5/30/2008. Information has been received from a physician via a newsletter. It was reported that male college roommates, aged 18 and 19 years, on unknown dates, had received 2 documented doses of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). They had fever, chills, and myalgia on 09-SEP-2007 and 10-SEP-2007, respectively, one had conjuntivitis. Both had a rash on 11-SEP-2007, detectable measles IgM antibodies in serum, and measles virus RNA by RT-PCT in throat swab specimens. No further information is available.

VAERS ID:316594 (history)  Vaccinated:2008-05-02
Age:19.0  Onset:2008-05-03, Days after vaccination: 1
Gender:Female  Submitted:2008-06-13, Days after onset: 41
Location:Unknown  Entered:2008-06-19, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0805USA01381
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Other     Purchased by: Other
Symptoms: Lip swelling, Swollen tongue, Tongue disorder
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse practitioner concerning a 19 year old female with pertinent medical history reported as unspecified, who on 02-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast), 0.5 ml, (Lot # and route not specified). Concomitant therapy included hormonal contraceptives (unspecified). On 03-MAY-2008 the mother of the patient called the office and reported that her daughter''s lip swelled and there were sores and bumps on her upper and lower lip and on her tongue. The patient was told to take diphenhydramine HCL (BENADRYJ for the reactions. At the time of report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:316613 (history)  Vaccinated:2008-05-30
Age:19.0  Onset:2008-05-30, Days after vaccination: 0
Gender:Male  Submitted:2008-06-16, Days after onset: 17
Location:Nebraska  Entered:2008-06-19, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: MVI & CLARITIN daily, took ZYRTEC & MUCINEX DM prior to incident
Current Illness: Seasonal allergies
Preexisting Conditions: NKDA - seasonal allergies - hospitalized for croup in past. PMH: asthma
Diagnostic Lab Data: WBC 10.1; Hgb 14.9; Hct 43.4; Plt 202; Gram Hbs #1; Na 138; K+ 3.1; C1 104; BiCarb 24; Bun 8; Creat 0.8; Gluc 110l Catt 9.4; AST 21; ALT 23; Alk Phos 89; Total Bili 1 LABS: CT scan of head & CXR WNL. EEG WNL. MRI brain revealed very mi
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2381AA IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2775AA IMRA
Administered by: Private     Purchased by: Public
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood alkaline phosphatase normal, Blood bicarbonate normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium decreased, Blood sodium normal, Blood urea decreased, Chest X-ray normal, Computerised tomogram normal, Convulsion, Disorientation, Electroencephalogram normal, Fall, Gaze palsy, Granulocyte count, Haematocrit normal, Haemoglobin normal, Injection site erythema, Injection site warmth, Nuclear magnetic resonance imaging brain abnormal, Platelet count normal, Tremor, Vaccination complication, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Brought from home to ER by ambulance due to seizure activity, convulsions. Found by father after hearing thud. Patient was on ground, disoriented, shaking, eyes rolled back into head. Epi pen enroute to hospital. Arrived ER at 2045. Answering questions and stable vital signs in ER. Given Benadryl 50mg IV and Solumedrol 125 mg IVP in ER. 6/27/08 Reviewed hospital medical records of 5/30-5/31/2008. FINAL DX: convulsions Records reveal patient experienced fall, disoriented, shaking, eyes rolled back into head. Tx w/epi, steroids, antihistamine. Admitted overnight for observation. No further seizure activity noted. Referred for outpatient neuro consult. 7/11/08 Reviewed neuro records of 6/2/2008. FINAL DX:convulsion, probably vaccine related Records reveal patient experienced seizure & seen in ER where injection sites were noted to by red & hot. No treatment ordered & was to have repeat MRI in 6 mos.

VAERS ID:316677 (history)  Vaccinated:2008-06-17
Age:19.0  Onset:2008-06-17, Days after vaccination: 0
Gender:Female  Submitted:2008-06-17, Days after onset: 0
Location:South Carolina  Entered:2008-06-19, 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: seasonal allergies
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0073X0IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Dizziness, Feeling hot, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: C/O feel faint, throat closing up, but eased somewhat after drinking water. Also c/o feeling really hot.

VAERS ID:316736 (history)  Vaccinated:2008-06-20
Age:19.0  Onset:2008-06-20, Days after vaccination: 0
Gender:Female  Submitted:2008-06-20, Days after onset: 0
Location:South Carolina  Entered:2008-06-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB058CA0IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0169-20IMRA
MMR: MEASLES + MUMPS + RUBELLA (VIRIVAC)MERCK & CO. INC.0869U0SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1506U0SCRA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF316AA0SCLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling and redness to site within 45 minutes. Treated with 50 mg of Benadryl IV push.

VAERS ID:317073 (history)  Vaccinated:2008-06-23
Age:19.0  Onset:2008-06-23, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:California  Entered:2008-06-23
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
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1811IMRA
HEP: HEP B (FOREIGN)MERCK & CO. INC.1609V2IMRA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURW09003A0IDLA
Administered by: Military     Purchased by: Military
Symptoms: Hyperhidrosis, Hypoaesthesia, Nausea, Pallor, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Diaphoresis, pallor, nausea, numbness, paresthesia on bilateral fingers.

VAERS ID:317120 (history)  Vaccinated:2007-05-01
Age:19.0  Onset:2007-06-01, Days after vaccination: 31
Gender:Female  Submitted:2008-06-23, Days after onset: 388
Location:Texas  Entered:2008-06-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Apgar score low; Hearing loss 7/10/08-records received-Onset of syncope 2 years ago,
Diagnostic Lab Data: 7/10/08-records received-MRI-chronic white matter disease likely from birth. EEG normal.
CDC Split Type: WAES0806USA03438
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Amenorrhoea, Conversion disorder, Convulsion, Electroencephalogram normal, Epilepsy, Nuclear magnetic resonance imaging, Somnolence, Syncope, Vaccine positive rechallenge, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician concerning an 18 year old female with a history of Apgar score low and congenital hearing loss who in May 2007, was vaccinated with a first dose of GARDASIL 0.5 mL IM. Concomitant therapy included LOESTRIN. In June 2007, the patient experienced a grand mal seizure. The patient received her second dose of GARDASIL in July 2007. In July 2007 and August 2007 the patient experienced a seizure again and was hospitalized. The patient was seen by a neurologist. The neurologist prescribed the patient KLONOPIN. Subsequently the patient experienced 15 pound weight loss and amenorrhea. The patient was then seen by a psychiatrist who stated that he believed the seizures were due to physiological and prescribed additional medications (therapy unspecified). At the time of reporting the patient was recovering. No additional information was available. The reporter considered the events of grand mal seizure, seizure, weight loss and amenorrhea to be other medical events. Additional information has been requested. 7/9/08-records received-evaluation 1/4/08-fainting spells and seizures-Impression:conversion disorder with mixed presentation with symptoms of motor and sensory deficits as well as psychogenic seizures. Experiencing extreme psychological stress unable to deal with, derives secondary gain from the symptoms and gain attention. 7/10/08-records received for DOS 8/13/07- 8/17/07-Assessment:spells, these do not seem to be seizure with maintined consciousness during the spells. Consider psychosomatic etiology. Onset of syncope 2 years ago, circumstances of syncope burning sensation followed by altered sensorium, recalls the entire envents which last 10-12 minutes). Increasing in frequency, college entrance examination. Developed stuttering speech pattern, crying spells and jerking spell while in waiting room. 8/31/07-Condition improved. 7/10/08-records received for DOS 8/9-8/12/07-DC DX: epilepsy. Prolonged complex seizures. Somnolent due to phenobarital.

VAERS ID:317188 (history)  Vaccinated:2008-06-13
Age:19.0  Onset:2008-06-13, Days after vaccination: 0
Gender:Male  Submitted:2008-06-20, Days after onset: 7
Location:Delaware  Entered:2008-06-24, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2564AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Headache, Pain in extremity
SMQs:, Neuroleptic malignant syndrome (broad)
Write-up: Pt c/o headache after flying to another state that day. Took MOTRIN 400 mg and felt better 2 hr later. Sore arm as well 6/14/08 c/o headache again/low grade temp. MOTRIN again with relief.

VAERS ID:317384 (history)  Vaccinated:2008-06-24
Age:19.0  Onset:2008-06-24, Days after vaccination: 0
Gender:Male  Submitted:2008-06-25, Days after onset: 1
Location:Michigan  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: unknown
Current Illness: no
Preexisting Conditions: allergic to Amoxicillin (hives)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB526AA0IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB224BA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2623AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Dizziness, Hypotension, Pallor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Became light-headed, pale, hypotensive after receiving 2nd of 3 shots. Assisted to reclining position, juice given, VS monitored. Was allowed to ambulate 15 minutes after first becoming light-headed. Discharged with Mom after 25 minutes. Follow up phone call on 06/25/2008: client was feeling fine, no further problems. Inst. to call private provider as needed.

VAERS ID:317405 (history)  Vaccinated:2008-06-19
Age:19.0  Onset:2008-06-25, Days after vaccination: 6
Gender:Female  Submitted:2008-06-25, Days after onset: 0
Location:Georgia  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: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS183AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0802U0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Feeling cold, Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad)
Write-up: Client called with c/o of muscle aching and being "cold" yesterday 6-24-08. Denies fever and states has just minimal soreness at injection site. States aching started on 60-24-08 at injection site of HPV vaccine and spread to entire body and lasted only one day 6-24-08.

VAERS ID:317422 (history)  Vaccinated:2008-02-11
Age:19.0  Onset:2008-02-11, Days after vaccination: 0
Gender:Female  Submitted:2008-06-25, Days after onset: 134
Location:South Dakota  Entered:2008-06-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations: Nausea, dizziness, shortness of breath~Hep B (Engerix-B)~1~0~In Patient
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No relevant medical history was noted and no history of adverse events following previous vaccinations was noted. Reportedly, the subjects mother mentioned a possible reaction in the past to morphine. No specific details were provided. The subject has no history of alcohol or tobacco use.
Diagnostic Lab Data: UNK
CDC Split Type: A0719183A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB438AA1IMLA
Administered by: Other     Purchased by: Private
Symptoms: Anaphylactic reaction, Arteriovenous malformation, Dizziness, Dyspnoea, Gait disturbance, Headache, Hypoaesthesia, Malaise, Nausea, Pharmaceutical product complaint, Tremor
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Congenital, familial and genetic disorders (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of nausea in a 19-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 11 February 2008 the subject received 1st dose of ENGERIX B at 1.0 ml in the left arm. One hour after vaccination with ENGERIX B, the subject experienced nausea and dizziness. On 15 February 2008, four days after vaccination with ENGERIX B, the subject experienced shortness of breath and had been sick for 36 hours straight. This was considered to be a systemic reaction. The events resolved and were considered by the reporter to be probably related to treatment with ENGERIX B. On 25 March 2008, the subject received the 2nd dose of ENGERIX B (no other vaccines were administered) and within a short period of time began shaking, complained of dizziness, numbness in her arm and leg and had an unsteady gait. This was considered to be a systemic reaction. The subject was transported to the local emergency room via EMS and was released. The subject was still experiencing numbness at the time of reporting. The outcome of the other events was unspecified. No further vaccinations with ENGERIX B are planned. Additional information received on 27 March 2008 questioned the quality of the ENGERIX B administered to the subject. This was considered to be a product complaint. Follow-up information received on 20 June 2008 indicated that the subject may have a history of reaction to morphine. Details were not specified. Both the 1st and 2nd doses of ENGERIX B were given intramuscularly. On 25 March 2008, the day the subject received the 2nd dose of ENGERIX B, it was reported that the subject experienced an anaphylactic reaction which resolved by 30 March 2008. The reaction was considered to be possibly related to treatment with ENGERIX B. The subject was hospitalized and during hospitalization, an arterial venous malformation in the brain was found. The reporter stated that the subject was "probably" born with this defect. The subject

VAERS ID:317597 (history)  Vaccinated:2007-01-05
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-14
Location:Unknown  Entered:2008-06-26, Days after submission: 43
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: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)MICHIGAN DEPT PUB HLTHFAV103 UNUN
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Induration, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Developed redness, pain, swelling, induration within 4 hrs of receiving her first anthrax vaccine.

VAERS ID:317614 (history)  Vaccinated:2008-03-16
Age:19.0  Onset:0000-00-00
Gender:Male  Submitted:2008-03-18
Location:North Carolina  Entered:2008-06-26, Days after submission: 100
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: C-Reactive Protein Site/Specimen 17 Mar 2008 1521 Units Ref Rng; C-Reactive Protein SERUM 3.6 (H) mg/dl (0.5); Brain Natriuretic Peptide Site/Specimen 17 Mar 2008 1521 Units Ref Rng; Natriuretic Peptide B-Type SERUM 354 (H) pg/mL (5-125); Creatine Kinase MB Site/Specimen 17 Mar 2008 1521 Units Ref Rng; CKMB SERUM 41.070 (H) ng/mL (0-6.73); Troponin T Cardiac Site/Specimen 17 Mar 2008 1521 Units Ref Rng; Troponin T SERUM 0.500 (H) ng/mL (0.00-0.029); Creatine Kinase MB Panel Site/Specimen 17 Mar 2008 1521 Units Ref Rng; CKMB SERUM 39.950 (H) ng/mL (0-6.73); Creatine Kinase MB Index SERUM 6.1 (H) (0-2.5)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURER   UN
Administered by: Military     Purchased by: Military
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Brain natriuretic peptide increased, C-reactive protein increased, Chest pain, Troponin increased
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: SM developed chest pain in evening 5 days after receiving smallpox vaccine.

VAERS ID:317645 (history)  Vaccinated:2007-11-05
Age:19.0  Onset:2007-11-10, Days after vaccination: 5
Gender:Female  Submitted:2008-06-25, Days after onset: 227
Location:Maryland  Entered:2008-06-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergic rhinitis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0019U1IMLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site pain, 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 (broad)
Write-up: She reportedly received her second Hep A (into her left deltoid (above her SP scar) November 2007. She noted immediately that this shot was significantly more painful than her previous shots. The next am the area was swollen, red, and tender to touch. She denies fever, chills, myalgia, lightheadedness, etc. The site remained swollen and tender. After about 3 days she noted very pruritic satellite papules. She would scratch to the point of excoriation. Topical steroid cream and Claritin were ineffective. The inflammation/papules spontaneously resolved after about 7-10 days. About 2 weeks later she noted a quarter-sized area of swelling and tenderness at the same site. Over the next few days it expanded to approximately 3" in diameter with peripheral small pruritic papules (neither vesicles nor pustules). She denied preceding trauma to the area. Over the past 6 months, the localized reaction has recurred in cyclic fashion about every 2 weeks, lasting about 7-10 days (four times). The reactions are neither worse nor better in severity or duration. Always involves exactly the same location over her deltoid. Reaction is not related to exercise, identifiable exposures, foods, medications, or her menses.

VAERS ID:317736 (history)  Vaccinated:0000-00-00
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-06-23
Location:Nevada  Entered:2008-06-27, Days after submission: 4
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
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETHVV04003A  UN
Administered by: Military     Purchased by: Unknown
Symptoms: Injection site discolouration, Injection site erythema, Injection site inflammation, Injection site rash, Rash generalised
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Smallpox site inflamed causing a dark, red, bumpy appearance around it. Approximately 1 to 2 inches around the site. Small, red bumps appeared about 3 weeks after the vaccination. They appeared on my face, arms, legs, and starting of the back.

VAERS ID:318022 (history)  Vaccinated:2008-06-20
Age:19.0  Onset:2008-06-21, Days after vaccination: 1
Gender:Female  Submitted:2008-06-24, Days after onset: 3
Location:Washington  Entered:2008-07-01, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1578U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 24 hours after inj. started with swelling measuring 4x5 " on arm- then yellow blisters, hot to touch. Quite painful. Now resolving- 4 days later

VAERS ID:318136 (history)  Vaccinated:2008-06-30
Age:19.0  Onset:2008-07-01, Days after vaccination: 1
Gender:Male  Submitted:2008-07-02, Days after onset: 1
Location:Michigan  Entered:2008-07-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: doryx 100mg, hyoscyamine .375mg
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: Unknown
Symptoms: Asthenia, Headache, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad)
Write-up: body aches, headache at base of skull, weakness, 100F fever treated with tylenol

VAERS ID:318447 (history)  Vaccinated:2008-06-09
Age:19.0  Onset:2008-06-11, Days after vaccination: 2
Gender:Female  Submitted:2008-06-11, Days after onset: 0
Location:Nevada  Entered:2008-07-08, Days after submission: 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: Scoliosis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1926U SCRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2904AA IMLA
Administered by: Other     Purchased by: Public
Symptoms: Erythema, Local reaction, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Received MMR on right arm on 6-9-09. 6-11-08, right arm localized redness (4cm x 3.5cm), slight itching. No pain. Treated with 1% hydrocortisone cream BID prn itching.

VAERS ID:318581 (history)  Vaccinated:2008-05-09
Age:19.0  Onset:2008-05-16, Days after vaccination: 7
Gender:Male  Submitted:2008-07-09, Days after onset: 54
Location:Florida  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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0043X0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Anorexia, Epstein-Barr virus test negative, Lethargy, Lymphadenopathy, Pharyngolaryngeal pain, Pyrexia, Rash, Streptococcus identification test negative, Urticaria, Vomiting, Weight decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: The patient developed a fever ranging from 100-102 for 7 days, severe swelling of the lymph glands bilatterally in the neck, sore throat, lethargy, vomiting on the 5th day a rash occurring on the trunk on the 8th day after onset of symptoms, hives on the trunk on the 9th day, loss of appetite, weight loss of 11 lbs. in one week. The patient tested negative for strep and monnonucleosis

VAERS ID:318618 (history)  Vaccinated:2008-07-05
Age:19.0  Onset:2008-07-06, Days after vaccination: 1
Gender:Female  Submitted:2008-07-09, Days after onset: 3
Location:Alaska  Entered:2008-07-09
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2864AA IMLA
Administered by: Other     Purchased by: Public
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient developed a raised red spot at site of injection. On the afternoon the day after the injection it was 1 inch by her estimate. When I saw her 2 days after it was raised, indurated 5x5 1/2 cm. I saw her again day 3 and it was now 8.5x7cm with more induration. I started her on BENADRYL and SEPTRA for a DDX of reaction vs cellulitis. I saw her day 4. The erythema was still 15x7 but fading and felt better.

VAERS ID:318666 (history)  Vaccinated:2008-06-13
Age:19.0  Onset:2008-06-13, Days after vaccination: 0
Gender:Female  Submitted:2008-07-10, Days after onset: 27
Location:Illinois  Entered:2008-07-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YAZ Birth Control Pill
Current Illness: None
Preexisting Conditions: Allergy: Polyhistamine
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0250X0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Chest discomfort, Chest pain, Crying, Depressed level of consciousness, Dizziness, Dyspnoea, Fatigue, Flushing, Hot flush, Hyperhidrosis, Hypoaesthesia, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad)
Write-up: Within 1-2 minute(s) of injection, patient experienced weakness, wheezing, (L) arm went numb, felt like a brick was on her chest & had trouble breating-chest pain, hot flash & sweats, facial flushing, dizzy, slow to respond, began crying (Experienced lasted about 1 minute) Next day, patient was still weak & tired.

VAERS ID:318686 (history)  Vaccinated:2008-07-01
Age:19.0  Onset:2008-07-02, Days after vaccination: 1
Gender:Female  Submitted:2008-07-10, Days after onset: 8
Location:California  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: Healthy.
Preexisting Conditions: Healthy without pre-existing health problems.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Diarrhoea, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)
Write-up: Day after injection had dizziness, nausea and diarrhea. Symptoms intensified and were the worst 2 days after receiving injection. Symptoms did not resolve until 8 days later. Not treatment was given for symptoms.

VAERS ID:318718 (history)  Vaccinated:2008-06-23
Age:19.0  Onset:2008-06-26, Days after vaccination: 3
Gender:Unknown  Submitted:2008-07-07, Days after onset: 11
Location:Texas  Entered:2008-07-11, Days after submission: 4
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: CT face with contrast: Mild reactive submandibular and sublingual lymph nodes. Small amount of edema along the left masticator space; however no drainable fluid collection present.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER  SCUN
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURER   UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram abnormal, Face oedema, Hypoaesthesia facial, Lymphadenopathy, Mass, Pain in jaw, Paraesthesia, Pyrexia, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Osteonecrosis (broad), Hypersensitivity (narrow)
Write-up: Swelling, pain and numbness of lt jaw beginning 3 ds post spv. Sxs began with tingling and numbness in left face and the next day lt side of face was swollen. Now has palpable "lump" on lt face. SPV given on lt deltoid. Had axillary LAD. but no cervical LAD. Attempt made to drain lesion but no fluid obtained. Low grade fever, which was now resolved.

VAERS ID:318906 (history)  Vaccinated:2007-08-13
Age:19.0  Onset:2007-08-13, Days after vaccination: 0
Gender:Female  Submitted:2008-07-08, Days after onset: 330
Location:Indiana  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: Pregnancy NOS (LMP = 8/1/2007); Seasonal allergy
Preexisting Conditions:
Diagnostic Lab Data: Urine beta-human, positive
CDC Split Type: WAES0709USA00534
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial and follow up information has been received from a healthcare worker and a certified medical assistant through the Pregnancy Registry for GARDASIL regarding a 19 year old female with a history of seasonal allergies who on 04-JUN-2007 was vaccinated with her first dose of GARDASIL (Lot # 655617/1447F; site and route not reported). On 13-Aug-2007, the patient was vaccinated with her second dose of GARDASIL (Lot #, site and route not reported). On 05-Sep-2007 it was reported that the patient was pregnant. The patient sought unspecified medical attention in the office. The patient had a urine pregnancy test which was positive. "The LMP is unspecified, but the physician believes that the patient is within the first month of pregnancy." On 08-MAY-2008, the patient delivered a normal baby boy (9lbs, 5 oz and 22 1/4 inches) at 40 weeks gestation. The baby''s Apgar scores were 8 and 9. The baby was healthy "other than slight jaundice treated with bili light". There were no congenital anomalies or abnormalities. There were no complications with the pregnancy, labor or delivery. Additional information is not expected.

VAERS ID:318947 (history)  Vaccinated:2007-08-20
Age:19.0  Onset:2008-05-12, Days after vaccination: 266
Gender:Female  Submitted:2008-07-08, Days after onset: 57
Location:Pennsylvania  Entered:2008-07-11, 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: Sulfonamide allergy; Irritable bowel syndrome; Condyloma acuminatum
Preexisting Conditions: Immunisation
Diagnostic Lab Data: Pap test, 05/12/08, positive, Detected HPV DNA; low grade squamous intraepithelial lesion; Pap test, 04/20/08, negative, HPV DNA not detected; negative for intraepithelial lesion or malignancy; cervix culture, 05/12/08, result not reported
CDC Split Type: WAES0806USA00310
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1060U2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Anogenital warts, Cervical dysplasia, Rhinorrhoea, Smear cervix abnormal, Smear cervix normal
SMQs:, Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad)
Write-up: Information has been received from a physician concerning a 19 year old female with a sulfonamide allergy who on 16-FEB-2007 was vaccinated IM with a first 0.5 ml dose of GARDASIL (Lot# 656049/0187U) in the right deltoid. On 20-APR-2007 she was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot #657621/0387U) in the left deltoid. On 20-AUG-2007 she was vaccinated IM with a third 0.5 ml dose of GARDASIL (Lot #658556/1060U) in the left deltoid. Concomitant therapy included ORTHO TRI-CYCLEN. The patient had a negative papanicolaou test on 20-APR-2008 and a positive test on 12-MAY-2008. The patient sought medical attention in the office. At the time of the report the patient''s outcome was unknown. Additional information has been requested. 10/08/08 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 a healthcare professional concerning a 19 year old female with a sulfonamide allergy, irritable bowel syndrome, condyloma acuminatum, and carrier of genetic disease (PKU), a history of immunizations and a family history of IBS (mother), acute ischemia (paternal grandmother), acute myocardial infarction, heart transplant recipient and cancer (maternal grandmother), acute myocardial infarction, diabetes mellitus and hypertension (maternal grandfather). On 16-FEB-2007 at 3:00 PM the patient was vaccinated IM with a first 0.5 ml dose of GARDASIL (Lot# 656049/0187U) in the right deltoid. On 20-APR-2007 at 3:00 PM, she was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot #657621/0387U) in the left deltoid. On 20-AUG-2007 at 9:00 AM, she was vaccinated IM with a third 0.5 ml dose GARDASIL (Lot #658556/1060U) in the left deltoid. Concomitant therapy included OTHRO TRI-CYCLEN and multivitamins. On 20-APR-2008, the patient had a papanicolaou test, negative for intraepithelial lesion or malignancy and HPV DNA (high risk) was not detected. On 12-MAY-2008, the patient was seen for an office visit and presented for an annual papanicolaou test. The patient wanted "skin tags" checked in private area and a red spot. On physical examination the genitalia showed abnormalities on left inner thigh with a condyloma (flat) and a small carbuncle. Pelvic examination showed cervical discharge, mucoid cervical discharge and a sample was taken for papanicolaou smear and cultures (culture results not reported). The patient''s papanicolaou test was positive for low grade squamous intraepithelial lesion and HPV DNA (High Risk) was detected. The patient assessment included condyloma acuminatum. The patient also presented with mucous drainge "X weeks". The patient had self treated with over the counter allergy, cold and sinus medications. On physical exam the nasal examination showed purulent nasal discharge on both sides without sinus tenderness. The patient assessment included an allergy and sinusitis. Additionally, the patient''s active problems included folliculitis. Treatment ordered included cefuroxime axetil 250 mg tablet, take one tablet every 12 hours, ALDARA cream 5% apply to affected areas three times weekly, wash off after 6-10 hours, over the counter CLARITAN or ZYRTEC, rest fluids and to call if symptoms worsen. The physician counseled the patient regarding diet, exercise and sexual practices. At the time of the report the outcome was unknown. Previous vaccinations included IPV (unspecified) (21-OCT-1978, 22-DEC-1998, 04-APR-1990 and 18-AUG-1992), diptheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (22-DEC-1998, 15-FEB-1989, 04-APR-1990 and 18-AUG-1992), HIB (unspecified carrier) (08-AUG-1990), MMR II (manufacturer unknown) (13-NOV-1999 and 01-SEP-1993), HEP B (manufacturer unknown) (03-JUL-1995, 22-AUG-1995 and 12-MAR-1996), ADACEL (03-APR-2006), tuberculin purified protein derivative (03-APR-2006) and meningococcal AC polysaccharide vaccine (03-APR-2006). Additional information is not expected.

VAERS ID:318955 (history)  Vaccinated:2007-11-16
Age:19.0  Onset:2007-11-16, Days after vaccination: 0
Gender:Female  Submitted:2008-07-08, Days after onset: 234
Location:Illinois  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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA05020
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1425F1UNLA
Administered by: Public     Purchased by: Private
Symptoms: Medication error, No adverse event
SMQs:
Write-up: Information has been received from a health professional concerning a female patient who on 20-AUG-2007 was vaccinated with a first dose of GARDASIL (Lot# 655165/1425F). On 16-NOV-2007, the patient was vaccinated into the left arm with a second dose of improperly stored GARDASIL (Lot# 655165/1425F). No adverse symptoms were noted. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information is not expected.

VAERS ID:318975 (history)  Vaccinated:2007-08-01
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-08
Location:Unknown  Entered:2008-07-11, 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: allergenic extract
Current Illness: Pollen allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA00593
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0  
Administered by: Other     Purchased by: Other
Symptoms: Nasopharyngitis
SMQs:
Write-up: Information has been received from a mother concerning her 19 year old daughter with pollen allergy who in AUG-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included allergenic extract. She never received the second dose because when she was scheduled she had a bad cold. The patient did not seek medical attention. At the time of the report, the patient recovered from the bad cold. This one of two reports from the same source. Additional information is not expected.

VAERS ID:318828 (history)  Vaccinated:2008-03-20
Age:19.0  Onset:2008-03-20, Days after vaccination: 0
Gender:Female  Submitted:2008-07-10, Days after onset: 112
Location:Unknown  Entered:2008-07-14, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness,