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Case Details (Sorted by Age)

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VAERS ID:300538 (history)  Vaccinated:2007-11-01
Age:16.0  Onset:2007-11-01, Days after vaccination: 0
Gender:Female  Submitted:2008-04-07, Days after onset: 158
Location:Kansas  Entered:2007-12-18, Days after submission: 110
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Syncope
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0711USA00717
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Condition aggravated, Immediate post-injection reaction, Pallor, Respiratory arrest, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a health professional concerning a 16 year old white female student with syncope after receiving kindergarten shots et zoole flu vaccine, and no known allergies, who on 01-Nov-2007 was vaccinated IM in the left deltoid, with the second dose of Gardasil (lot #658560/1062U). There was no concomitant medication. The patient had no adverse event after the first dose of Gardasil. On 01-Nov-2007, three seconds after the second dose the patient fainted on exam table. Unknown medical attention was sought. She was sitting and lied down. She was very pale and wasn''t breathing for 5 seconds. She came out of it, got her color back and was fine afterwards. The patient was recovered without treatment. No product quality complaint was involved. No product quality complaint was involved. Follow up information indicated that the patient needed no treatment. No diagnostic work up was done on the patient. No hospitalization or as a out patient.

VAERS ID:300678 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-14
Location:Unknown  Entered:2007-12-18, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0711USA01684
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
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 licensed practical nurse (L.P.N.) concerning a 16 year old female who was vaccinated with GARDASIL, intramuscularly. Subsequently the patient fainted. The patient recovered on an unspecified date. This is one of two reported from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Information has been received from a licensed practical nurse (L.P.N.) concerning a 16 year old female who was vaccinated with GARDASIL, intramuscularly. Subsequently the patient fainted. The patient recovered on an unspecified date. This is one of two patients reported from the same source. Additional information has been requested. Additional information from the nurse on 11-DEC-2007 indicated she was unable to identify the patients involved.

VAERS ID:300686 (history)  Vaccinated:2007-11-01
Age:16.0  Onset:2007-11-01, Days after vaccination: 0
Gender:Female  Submitted:2007-12-14, Days after onset: 43
Location:Ohio  Entered:2007-12-18, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0711USA01739
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Head injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning a 16 year old female who on approximately 01-NOV-2007 was vaccinated with her third dose of Gardasil IM. On approximately 01-NOV-2007 the patient experienced "lightheadedness and had actually fainted". It was reported that the patient did "hit her head when she fainted", but the fall did not require any further medical attention". The patient outcome was not reported. Additional information has been requested.

VAERS ID:300727 (history)  Vaccinated:2007-11-13
Age:16.0  Onset:2007-11-13, Days after vaccination: 0
Gender:Female  Submitted:2007-12-14, Days after onset: 31
Location:Massachusetts  Entered:2007-12-18, Days after submission: 4
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:
CDC 'Split Type': WAES0711USA02913
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
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 physician concerning a "16 year old" female with no pertinent medical history who on 13-NOV-2007 was vaccinated with a first dose of GARDASIL (lot# unknown) 0.5mL IM. Concomitant therapy included MENACTRA (lot# unknown). On 13-NOV-2007 the patient fainted after receiving GARDASIL. Medical attention was sought. No additional information was provided. Additional information has been requested.

VAERS ID:300834 (history)  Vaccinated:2007-06-14
Age:16.0  Onset:2007-07-11, Days after vaccination: 27
Gender:Female  Submitted:2007-12-14, Days after onset: 156
Location:New Jersey  Entered:2007-12-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PREVACID; naproxen
Current Illness: Oesophageal acid reflux; Peanut allergy; Heartburn
Preexisting Conditions: Parvovirus infection
Diagnostic Lab Data: abdominal ultrasound - results not reported; laboratory test 07/??/07 - negative for hepatitis; serum Epstein-Barr 07/??/07 - negative for mononucleosis; laboratory test 07/??/07 - cytomegalovirus negative; laboratory test 07/??/07 - parvov
CDC 'Split Type': WAES0711USA03378
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Arthralgia, Cytomegalovirus antibody negative, Epstein-Barr virus antibody negative, Febrile infection, Laboratory test, Liver function test abnormal, Parvovirus B19 serology negative, Ultrasound abdomen
SMQs:, Liver related investigations, signs and symptoms (narrow), Arthritis (broad)
Write-up: Information has been received from a physician concerning a 16 year old female with oesophageal acid reflux, heartburn and peanut allergy and a history of parvovirus infection who on 01-MAY-2007 was vaccinated with her first dose of Gardasil. Concomitant therapy included naproxen and PREVACID. On 14-JUN-2007 the patient received her second dose of Gardasil. On approximately 11-JUL-2007 "around the second week of July 2007", the patient experienced a febrile illness. She had diffuse arthralgia, elevations in her liver function tests "(70''s and 90''s)", elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST). On 26-JUL-2007 laboratory tests showed AST 97 and ALT 97. On 26-OCT-2007 AST was 237, ALT 257, and gamma-glutamyl transferase (GGTP) was 97. On 07-NOV-2007 the AST was 218, ALT was 227 and GGTP was 28. An abdominal ultrasound was performed, results not reported. The outcome for febrile illness was not reported. The elevation in liver enzymes AST and ALT was not recovered. Diffuse arthralgia was improved. Unspecified medical attention was sought with "a few doctors/specialists" that included a gastroenterologist. Additional information has been requested.

VAERS ID:300856 (history)  Vaccinated:2007-11-14
Age:16.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2007-12-14, Days after onset: 30
Location:Texas  Entered:2007-12-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': WAES0711USA03680
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a health professional concerning a 16 year old female who on 23-Aug-2007 was vaccinated intramuscularly using the pre-filled syringe with her first dose of Gardasil (Lot #655154/1210U). There was no concomitant medication. On 14-Nov-2007 the patient was vaccinated with the second dose of Gardasil and subsequently experienced pain at administration. The patient was given ice packs to apply to the area while in the office. It is unknown if the patient experienced the same pain with the first dose. Subsequently, the patient recovered from pain at administration on the same day. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:300862 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-14
Location:Unknown  Entered:2007-12-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0711USA03916
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Skin papilloma
SMQs:
Write-up: Information has been received from a licensed practical nurse concerning a 16 year old female who on an unspecified date was vaccinated with Gardasil (lot # unknown) injection. Subsequently, on an unspecified date the patient developed warts on hands after receiving Gardasil. Medical attention was sought. The patient''s warts on hands persisted. The patient had received 2 doses of Gardasil. No further information was provided. Additional information has been requested.

VAERS ID:301221 (history)  Vaccinated:2007-11-01
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-14
Location:Unknown  Entered:2007-12-18, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0711USA04796
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a nurse practitioner concerning her 16 year old daughter who in (approximately) November 2007, was vaccinated (site and route not reported) with Gardasil vaccine (dosage and lot# not reported). Two or three weeks after vaccination with Gardasil vaccine, the patient''s injection site was still painful and raised and the patient also had hypo-pigmentation around the injection site. The patient did not received medical attention and the AE did not improve. At the time of this report, the patient had not recovered. This is one of two reports from the same source. Additional information has been requested.

VAERS ID:301222 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-14
Location:Unknown  Entered:2007-12-18, Days after submission: 4
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': WAES0711USA04802
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IM 
Administered by: Other     Purchased by: Other
Symptoms: Influenza like illness, Nausea, Pain, 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 from a nurse practitioner concerning a 16 year old female who on an unspecified date was vaccinated with a first dose of Gardasil vaccine (lot# unknown) IM injection. Subsequently, on an unspecified date after receiving the Gardasil vaccine the patient experienced "flu like symptoms (fever, vomiting, nausea and body aches) for about 5 days. Medical attention was sought. On an unspecified date the patient fully recovered. On an unspecified date the patient received a second dose of Gardasil vaccine but did not experience any AE related symptoms. No further information was provided. Additional information has been requested.

VAERS ID:301224 (history)  Vaccinated:2007-10-25
Age:16.0  Onset:2007-10-25, Days after vaccination: 0
Gender:Female  Submitted:2007-12-14, Days after onset: 50
Location:Pennsylvania  Entered:2007-12-18, 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: Unknown
Current Illness:
Preexisting Conditions: Asthma
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0711USA04852
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.659437/1266U2IMLA
Administered by: Private     Purchased by: Other
Symptoms: Immediate post-injection reaction, Nausea, Pallor, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 16 year old white female with a history of mild asthma who on 25-OCT-2007 was vaccinated in the left deltoid with her third dose of GARDASIL vaccine (yeast) (lot# 659437/1266U). On 25-OCT-2007, 20 minutes after being vaccinated, the patient became nauseous, very pale and shaky. This lasted until the next day. Subsequently, the patient recovered from nauseous, very pale and shaky within 24 hours. Additional information has been requested.

VAERS ID:301229 (history)  Vaccinated:2007-10-21
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-14
Location:Unknown  Entered:2007-12-18, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0711USA04999
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.658558/1061U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician about her daughter who on 21-OCT-2007 was intramuscularly vaccinated with her second dose of GARDASIL vaccine (yeast) (Lot # 658558/1061U). Subsequently the patient experienced a "knot" at the injection site. Additional information has been requested.

VAERS ID:301230 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-14
Location:Ohio  Entered:2007-12-18, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0711USA05031
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IM 
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 physician concerning a 16 year old female patient who on an unspecified date was vaccinated IM with the second dose of Gardasil vaccine (Lot Number not reported). Reporter indicated that the patient had fainted and was fine before leaving the office. No medical attention was sought. Patient outcome was recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:300370 (history)  Vaccinated:2007-10-04
Age:16.0  Onset:2007-11-07, Days after vaccination: 34
Gender:Female  Submitted:2007-12-18, Days after onset: 41
Location:Michigan  Entered:2007-12-19, 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: Ventilan (albuterol)
Current Illness: Pregnancy NOS (LMP = 09/15/5007); Asthma
Preexisting Conditions:
Diagnostic Lab Data: beta-human chorionic 10/11/07 - positive
CDC 'Split Type': WAES0710USA06218
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a physician concerning a 16 year old female with asthma who on 02-AUG-2007 was vaccinated intramuscularly with her first dose of Gardasil. On 04-OCT-2007 she received her second dose of Gardasil intramuscularly. Concomitant therapy included VENTILAN. The patient was determined to be pregnant on 11-Oct-2007 with a pregnancy test. The patient sought unspecified medical attention in the office. Subsequently the patient experienced vaccine exposure during pregnancy. No problems reported. No further details available. Additional information has been requested. Follow up information received on 11-Dec-2007 from the physician stated that the patient had a spontaneous abortion on 07-Nov-2007, approximately 8 weeks from LMP. The products of conception were examined and described as hemorrhagic necrotic dicidua few syncytiotrophoblastic cells involutengehorioric villi.

VAERS ID:300461 (history)  Vaccinated:2007-11-02
Age:16.0  Onset:2007-11-05, Days after vaccination: 3
Gender:Female  Submitted:2007-12-18, Days after onset: 43
Location:Montana  Entered:2007-12-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergy to Aleve, All Narcotics
Diagnostic Lab Data: X-ray for broken foot in Aug 08.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0927U1UNLA
Administered by: Public     Purchased by: Private
Symptoms: Arthralgia, Lymphadenopathy, Pain in extremity, X-ray
SMQs:, Arthritis (broad)
Write-up: Swollen lymph nodes on neck, under chin, back of head, and in shoulder are. Entire arm very sore when she bends it - mostly joint pain.

VAERS ID:300473 (history)  Vaccinated:2007-02-20
Age:16.0  Onset:2007-03-09, Days after vaccination: 17
Gender:Male  Submitted:2007-03-09, Days after onset: 0
Location:Unknown  Entered:2007-12-19, Days after submission: 285
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atenolol, Ibuprofen, Seroquel
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pruritus generalised, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Pt was given Varicella vaccination on 2/20/07 and had generalized itching and skin breaking out dime size welts on left forearm, chest, trunk on 3/9/07.

VAERS ID:300759 (history)  Vaccinated:2007-11-16
Age:16.0  Onset:2007-11-17, Days after vaccination: 1
Gender:Male  Submitted:2007-12-10, Days after onset: 23
Location:Oregon  Entered:2007-12-21, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cellcept 1 gram Bid; PCN 500mg Bid
Current Illness: None 12/26/07-records received-Mild URI symptoms preceding vaccination but those had largely resolved 2 days prior to vaccinati
Preexisting Conditions: ALPS; thrombocytopenia, anemia, leukopenia; allergic to sulfamethoxazole, trimethoprim 12/26/07-records received-PMH:autoimmune lymphoproliferative syndrome.
Diagnostic Lab Data: CBC (white count corrected to 24 from a high of 55.6, platelets stable at 360 at the time of discharge); CMP; CRP mildly elevated; ESR elevated at 24; CSF had no growth to date x72 hours at the time of discharge; rapid flu positive; blood,
CDC 'Split Type': OR200753
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2512AA1IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0002F1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood culture, C-reactive protein increased, CSF culture negative, Chills, Culture urine, Full blood count, Headache, Hypotension, Influenza serology positive, Leukocytosis, Metabolic function test, Nausea, Pain, Platelet count normal, Pyrexia, Red blood cell sedimentation rate increased, Sepsis, Tachycardia, Tremor, Upper respiratory tract infection, Virus culture, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Fever, Rigors, Leukocytosis, hypotension 12 hr after 23 valent Pneumococcal vaccine Presented like a Septor Pusm. Culture Negative; DATE OF ADMISSION: 11/17/2007; HISTORY OF PRESENT ILLNESS: Patient is s 16-year-old with a chronic medical condition of autoimmune lymphoproliferative syndrome. He has carried this diagnosis since five years of age. It is manifested by recurrent bouts of thrombocytpoenia and in the past, anemia and leukopenia. Patient has had multiple hospitalizations for complications of this, including blood product transfusions in the past. Patient has actually been doing fairly well this fall. He had an episode of thrombocytopenia with platelet counts under 20,000 that necessitated a course of prednisone in 09/07. He was able to be successfully weaned off of this and with adjustment of his other medications he had been doing well for well over a month now. He was in the office yesterday for his influenza vaccine and pneumococcal vaccine 23-valent. He had Prevnar this summer with a recommended booster dose in three months. Patient developed shaking chills, rigors, and fever to 102 deg last night. He was given 1,000 mg of Tylenol at home and a repeat dose in early morning, approximately six hours later. He continues to have shaking chills, headache, nausea, and body aches; Reason for Admission: A 16-year-old boy with ALPS presented with fevers and hypotension. Hospital Course: The patient was transferred from Hospital for rigors, chills, headache, and hypotension that started after the day after receiving a flu and pneumonia Vaccine. He had also had mild URI symptoms preceding the vaccination but those had largely resolved 2 days prior to the vaccination. The patient has a history of ALPS that was diagnosed at 5 years old and has frequently needed hospitalizations with steroid treatment for approximately 1 month at a time. He is generally admitted for thrombocytopenia and receives IVIG with steroid bursts. His most recent hospitalization was early September 2007 for that reason. He had a splenectom

VAERS ID:300766 (history)  Vaccinated:2007-12-06
Age:16.0  Onset:2007-12-06, Days after vaccination: 0
Gender:Female  Submitted:2007-12-21, Days after onset: 15
Location:California  Entered:2007-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Gaze palsy, Hypoaesthesia, Immediate post-injection reaction, Musculoskeletal stiffness, Oxygen supplementation, Salivary hypersecretion
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Pt receive flu and HPV vaccine. Became stiff immediately following HPV. Eyes deviated to (L),increase salivation, (R)arm raised to chest. Placed on floor.Nasal cannula @2L applied. PO 100%. Resp equal and unlabored. Able to focus on father after approx 1 min. Began talking and laughing/crying. Sat pt and given juice(had not eaten since 1100)Visidex 112. PO 99-100% on room air. While sitting in chair, stated difficulty breathing. PO 94-95% on room air. Placed on nasal cannula @2L. States improvement. PO 100%.Resp unlabored. C/o numbness to nose. Cap refill <3secs. Pt talking(tearful at times)and anxious. Dr. notified. Pt to to PED''s ER via wheelchair and monitored and released later.

VAERS ID:300943 (history)  Vaccinated:2007-12-20
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-20
Location:Michigan  Entered:2007-12-26, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2523AA IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1063U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2418AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEUR712065IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1495U1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Incorrect dose administered, Medication error
SMQs:
Write-up: No symptoms or problems but client received 2 influenza vaccines, 2 separate arms at same time during vaccination clinic by 2 nurses. Vaccines were marked correctly but 1 flu vaccine was set up for sibling. Both nurses grabbed flu shot, gave at same time.

VAERS ID:301097 (history)  Vaccinated:2007-12-26
Age:16.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-27
Location:Kansas  Entered:2007-12-27
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: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B002AB0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Expired drug administered
SMQs:
Write-up: None-CDC stated that Tdap should be given right away to assure he is covered. Client was given Tdap that had expired 10-19-07.

VAERS ID:301138 (history)  Vaccinated:2007-12-18
Age:16.0  Onset:2007-12-18, Days after vaccination: 0
Gender:Female  Submitted:2007-12-20, Days after onset: 2
Location:Washington  Entered:2007-12-27, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Skin warm, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 20 cm erythema, tenderness and warmth

VAERS ID:301180 (history)  Vaccinated:2007-12-28
Age:16.0  Onset:2007-12-28, Days after vaccination: 0
Gender:Female  Submitted:2007-12-28, Days after onset: 0
Location:Idaho  Entered:2007-12-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Same~HPV (Gardasil)~1~16~In Patient
Other Medications: Claritin 10 mg, Topicort 0.25% cream, Zyrtec 10mg, Triamicinolone cream 0.1%
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.0928U1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: First time I gave her the HPV shot she fainted and had a small seizure for approx 5 sec. Today, I gave her the 2nd HPV shot, she was sitting this time, had a seizure for approx 5-8 sec, w/ no fainting and was aware this time of her surroundings.

VAERS ID:301190 (history)  Vaccinated:2007-11-28
Age:16.0  Onset:2007-11-29, Days after vaccination: 1
Gender:Male  Submitted:2007-11-29, Days after onset: 0
Location:West Virginia  Entered:2007-12-28, Days after submission: 29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WV0738
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2428AAAP0IM 
TDAP: TDAP (ADACEL)SANOFI PASTEURC2826AAAP0IM 
Administered by: Public     Purchased by: Unknown
Symptoms: Nausea, Rash, Urticaria, Vaccination complication, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Had hives all over, nausea and vomiting day after receiving vaccine. He woke up with rash. Did not have rash when he went to bed. 11/29/07 - went to St. Joseph''s emergency room and doctor called it reaction to vaccine. Treated with Benadryl and oral steroids.

VAERS ID:301732 (history)  Vaccinated:2007-12-18
Age:16.0  Onset:2007-12-19, Days after vaccination: 1
Gender:Female  Submitted:2007-12-20, Days after onset: 1
Location:Oregon  Entered:2008-01-04, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair
Current Illness: None
Preexisting Conditions: Asthma, GERD, Arrhythmia and Leaking Valve
Diagnostic Lab Data: None
CDC 'Split Type': OR200754
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U1IMLA
Administered by: Other     Purchased by: Public
Symptoms: Lip swelling, Pruritus, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: 12/18/07 Gardasil given 12/18/07. 12/19/07 Patient developed swollen lower lip and sl thickness in posterior throat in AM 12/19/07. Had same reaction to food allergy in past. Loratadine 10mg given and symptoms resolved. 12/20/07 Developed 2 large hives on chest and/on back. Loratadine 10mg given. Itching stopped. Hx of milk allergy. Had half and half in cereal both morning then developed symptoms.

VAERS ID:301768 (history)  Vaccinated:2008-01-07
Age:16.0  Onset:2008-01-07, Days after vaccination: 0
Gender:Female  Submitted:2008-01-07, Days after onset: 0
Location:New York  Entered:2008-01-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Asthma
Diagnostic Lab Data: none
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0246U IM 
Administered by: Military     Purchased by: Military
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Urticaria, treatment Benadryl.

VAERS ID:302229 (history)  Vaccinated:2007-12-27
Age:16.0  Onset:2007-12-29, Days after vaccination: 2
Gender:Female  Submitted:2008-01-09, Days after onset: 11
Location:Maryland  Entered:2008-01-10, 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:
Preexisting Conditions: Unknown. PMH: none
Diagnostic Lab Data: Unknown. Labs and Diagnostics: Head CT WNL. CBC and Chem WNL. Drug screen (-). EEG (-). MRI brain WNL.
CDC 'Split Type': WAES0801USA00370
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.UNAVAILABLE0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram normal, Confusional state, Convulsion, Drug screen negative, Electroencephalogram normal, Fall, Foaming at mouth, Full blood count normal, Gaze palsy, Headache, Laboratory test normal, Loss of consciousness, Nuclear magnetic resonance imaging brain normal, Postictal state, 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), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician concerning a 16 year old female patient who on 27-DEC-2007 was vaccinated with a first dose 0.5 ml of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # unknown). The physician reported that patient, on 29-DEC-2007, two days after being vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) experienced a seizure and was subsequently hospitalized. It was reported that at the time of this report patient just had headaches. No further information was provided. Additional information has been requested. 3/26/09 ER record received for DOS 12/29/07 with DX: Seizure-new onset. Pt presented to ER after an episode of loss of consciousness, falling and shaking of extremities, eyes rolling up and foaming at the mouth. Post ictal during EMS ride to ER with confusion. WNL upon arrival at ED. D/C for outpt f/u. No further records available from PCP due to fire in office. Unknown if pt has had further sx or if under a neurologist''s care. 5/19/09 neuro consult received dated 2/5/08 with f/u 3/27/08 with dx: Episode of seizure etiology unclear. Pt had just received HPV vax and there is a suspicion that it may be the triggering cause. PE WNL. No further episodes per parent TC on 5/18/09

VAERS ID:302321 (history)  Vaccinated:2008-01-09
Age:16.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-01-10, Days after onset: 1
Location:Maine  Entered:2008-01-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0  
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER 0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cold sweat, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Daughter became very dizzy and clammy about 10 minutes after taking Gardasil Shot. Felt nauseous and had to lie down.

VAERS ID:302337 (history)  Vaccinated:2007-08-08
Age:16.0  Onset:2007-08-08, Days after vaccination: 0
Gender:Female  Submitted:2008-01-10, Days after onset: 155
Location:Pennsylvania  Entered:2008-01-10
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: Migraines, depression 5/6/08-records received-PMH: migrain headaches. Treatment for depression and acne.
Diagnostic Lab Data: 5/6/08-records received-MRI left humerus fairly marked circumferential subcutaneious edema but no locuated fluid collection. Increased T2 signal involving deltoid, triceps and bisceps brachii. Likely reflect myositis. Prominent left axillary lymph noces may be reactive. ANA titer positive 1:320, rheumatoid factor negative. Lyme titer negative. CRP 8.5, sed rate 32.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.031961UNLA
Administered by: Private     Purchased by: Private
Symptoms: Antinuclear antibody positive, Arthralgia, Borrelia burgdorferi serology negative, C-reactive protein increased, Injection site erythema, Injection site pain, Injection site swelling, Myositis, Nuclear magnetic resonance imaging abnormal, Pruritus, Red blood cell sedimentation rate increased, Rheumatoid factor negative
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad)
Write-up: Persistent swelling L UE x6 months with continued tenderness & erythema. No F/U, positive mild pruritis. 5/2/08-records received-1/10/08-seen for C/O left upper extremity arm swelling, tenderness since 8/8/07-pain persistent since that time and now has 1-2 months swelling. Received her 3rd Gardasil injection in right arm without complaints. Seen 1/29/08 for C/O joint pains. Each vaccination produced pain at the site of injection without any erythema or site reaction. By end of series in December experienced migratory arthralgias including hips, knees, feet, toes and hands. Daily pain. Impression:arthralgias and positive ANA titer.

VAERS ID:302445 (history)  Vaccinated:2008-01-08
Age:16.0  Onset:2008-01-09, Days after vaccination: 1
Gender:Female  Submitted:2008-01-11, Days after onset: 2
Location:Virginia  Entered:2008-01-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: The vaccine was Gardasil Manufacture was MERCK I was unable to enter the name of the vaccine given to the patient because you did not have a drop box for it.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site anaesthesia, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient complained of numbness and pain to injection site which lasted for several days.

VAERS ID:302481 (history)  Vaccinated:2007-12-17
Age:16.0  Onset:2007-12-19, Days after vaccination: 2
Gender:Male  Submitted:2008-01-11, Days after onset: 23
Location:Texas  Entered:2008-01-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Seen by ENT; lateral X-ray of neck normal; pending appt with allergy specialist
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2508AA UNLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB17AA UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2420AA UNLA
Administered by: Private     Purchased by: Public
Symptoms: Dyspnoea, Stridor, X-ray normal
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Trouble in breathing at night with stridor lasting for four seconds. He never had asthma. He was getting these episodes 2-3 times a wk.

VAERS ID:302518 (history)  Vaccinated:2007-11-19
Age:16.0  Onset:0000-00-00
Gender:Male  Submitted:2008-01-10
Location:Unknown  Entered:2008-01-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2421AA IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0520U SCUN
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Pt got extra dose of varicella

VAERS ID:302549 (history)  Vaccinated:2008-01-08
Age:16.0  Onset:2008-01-08, Days after vaccination: 0
Gender:Female  Submitted:2008-01-11, Days after onset: 3
Location:Iowa  Entered:2008-01-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None.
Preexisting Conditions: Exercise induced asthma, allergic rhinitis, anxiety and depression
Diagnostic Lab Data: None.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2 LA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: A day after receiving my third Gardasil injection, I got hives on my upper body, specifically my chest, neck, back, shoulders, arms, hands, and face. Dr. prescribed Atarax to relieve itching.

VAERS ID:302555 (history)  Vaccinated:2008-01-07
Age:16.0  Onset:2008-01-07, Days after vaccination: 0
Gender:Male  Submitted:2008-01-13, Days after onset: 6
Location:Georga  Entered:2008-01-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Chills, Headache, Influenza like illness, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: FOUR DAYS OF SEVERE FLU LIKE SYMPTOMS INCLUDING SEVERE HEADACHE, BODY ACHES, LOSS OF APPETITE, CHILLS, FEVER.

VAERS ID:302635 (history)  Vaccinated:2007-11-07
Age:16.0  Onset:2007-11-12, Days after vaccination: 5
Gender:Male  Submitted:2007-11-13, Days after onset: 1
Location:Georga  Entered:2008-01-14, Days after submission: 62
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Asthma inhaler & breathing treatment prn
Current Illness: None known
Preexisting Conditions: History mild asthma, allergic Singular
Diagnostic Lab Data:
CDC 'Split Type': GA07082
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1106F0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2959AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Auricular swelling, Blister, Dizziness, Rash generalised, Swelling face, Vision blurred, Wheezing
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: 11/7/07-had wheezing after vaccine after leaving clinic. 11/13/07-face & ears swollen with blisters, rash over body, wheezing, dizziness, blurred vision, mom took to ER. 11/15/07-wheezing, face swollen, back to ER. Back to school 11/19/07.

VAERS ID:302649 (history)  Vaccinated:2007-11-08
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-11
Location:New York  Entered:2008-01-14, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: Physical exam
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0930U UNUN
Administered by: Private     Purchased by: Public
Symptoms: Anogenital warts, Physical examination
SMQs:
Write-up: Developed genital warts for 2 weeks. Rx: Aldara 5% cream 3 times a week for 6 weeks. Dermatologic.

VAERS ID:302785 (history)  Vaccinated:2008-01-08
Age:16.0  Onset:0000-00-00
Gender:Male  Submitted:2008-01-14
Location:New York  Entered:2008-01-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1106F3UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.151BU0UNRA
Administered by: Other     Purchased by: Unknown
Symptoms: No adverse reaction
SMQs:
Write-up: No Adverse Effects

VAERS ID:302820 (history)  Vaccinated:2008-01-15
Age:16.0  Onset:2008-01-16, Days after vaccination: 1
Gender:Female  Submitted:2008-01-16, Days after onset: 0
Location:Minnesota  Entered:2008-01-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.15184 SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Localized 3cm diameter area around injection site with erythema, edema, warmth, pruritis.

VAERS ID:302836 (history)  Vaccinated:2008-01-14
Age:16.0  Onset:2008-01-14, Days after vaccination: 0
Gender:Female  Submitted:2008-01-16, Days after onset: 2
Location:Colorado  Entered:2008-01-16
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: Allergy to Sulfa
Diagnostic Lab Data: N/A
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2490AA2IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0388U1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Pt developed Hives on body 20 minutes after receiving Influenza TIV and HPV immunizations.

VAERS ID:302903 (history)  Vaccinated:2003-02-05
Age:16.0  Onset:2007-08-07, Days after vaccination: 1644
Gender:Male  Submitted:2008-01-08, Days after onset: 154
Location:Texas  Entered:2008-01-16, 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: No concurrent medication.
Current Illness: Unknown
Preexisting Conditions: The subject received no concurrent medications, and received no concurrent vaccinations with Engerix B Vaccines administered on 04 September 2002 and 05 February 2003. No adverse reactions following previous vaccinations were noted.
Diagnostic Lab Data: Hepatitis B antibody 07Aug2007 negative; Hepatitis B antibody 17Aug2007 negative
CDC 'Split Type': A0676750A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS5367A22UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hepatitis B antibody negative, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 20-year-old male subject who was vaccinated with Engerix B for prophylaxis. Previous and/or concurrent vaccination included diphtheria, tetanus, pertussis given on 2 August 2002 and live attenuated MMR given on 2 August 2002. There were no concurrent medications. On 2 August 2002, 4 September 2002, and 5 February 2003 the subject received the first, second, and third doses of Engerix B (unknown). On 7 August 2007, 4 years after vaccination with Engerix B, 5 years after vaccination with Engerix B, the subject experienced not responding to therapy. Approximately four and half years after completion of the Engerix B series, on 07 August 2007 and 16 August 2007, hepatitis B antibody titers were negative. At the time of reporting the outcome of the event was unspecified.

VAERS ID:303120 (history)  Vaccinated:2007-09-10
Age:16.0  Onset:2007-10-15, Days after vaccination: 35
Gender:Female  Submitted:2008-01-07, Days after onset: 84
Location:Kansas  Entered:2008-01-16, 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: Bronchitis
Diagnostic Lab Data:
CDC 'Split Type': WAES0712USA02310
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0802U1IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site reaction
SMQs:
Write-up: Information has been received from a nurse practitioner, via a company representative, concerning a 14 year old female patient, who was vaccinated on an unspecified date, with the second dose, 0.5 ml, of Gardasil (lot # not reported). Subsequently, the patient experienced a "pit" (dent) on her arm where the injection was given. At the time of this report, the patient had not recovered. Additional information has been requested. Follow-up received 04/16/2008. Initial and follow-up information has been received from a nurse practitioner, concerning a 16 year old (previously reported as 14 year old) femal student with recurrent bronchitis, who on 10-JUL-2007 was vaccinated IM in the left deltoid with the first dose (lot #657006/D188U), and on 10-SEP-2007 was vaccinated in the left deltoid with the second dose, 0.5 ml. of GARDASIL vaccine (lot # 658490/0802U). There was no illness at the time of vaccination. Subsequently, the patient experienced a "pit" (dent), also described as ''dimpling" on her arm where the injection s were given. There was no pain at the injection site. At the time of this report, the outcome of the event was unknown. Additional information is not expected.

VAERS ID:303130 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:2007-11-15
Gender:Female  Submitted:2008-01-07, Days after onset: 53
Location:Unknown  Entered:2008-01-16, 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:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0712USA02374
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Information has been received from a registered nurse concerning a 16 year old female, who, on an unspecified date "several weeks ago", was vaccinated intramuscularly with a 0.5mL first dose of Gardasil. Concomitant therapy included "another vaccine" (therapy unspecified). Subsequently the patient experienced nausea and dizziness. The patient did not seek medical attention. The patient recovered the same day on an unspecified date. No product quality complaint was involved. Additional information has been requested.

VAERS ID:303135 (history)  Vaccinated:2007-11-21
Age:16.0  Onset:2007-11-23, Days after vaccination: 2
Gender:Female  Submitted:2008-01-07, Days after onset: 45
Location:Missouri  Entered:2008-01-16, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: renal ultrasound, 12/03/07, normal; abdominal ultrasound, 12/03/07, normal; WBC count, 11/27/07, elevated; serum hepatitis B, 11/27/07, negative
CDC 'Split Type': WAES0712USA01738
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNLA
Administered by: Other     Purchased by: Other
Symptoms: Abnormal behaviour, Crying, Hepatitis B test negative, Lymphadenopathy, Metrorrhagia, Nausea, Ultrasound abdomen normal, Ultrasound kidney normal, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Information has been received from a consumer, concerning her 16 year old daughter with no pertinent medical history, who on 21-NOV-2007 was vaccinated in the left arm, with the first dose of Gardasil (lot # not reported). There was no concomitant medication. On 23-NOV-2007 the patient experienced spotting that lasted for 11 days. She also developed an "enlarged lymph, like an almond sized node" in her groin and left arm pit, vomiting and nausea, "has always been crying," and is not acting like herself (dates not specified). On 27-NOV-2007, the patient had labwork performed, inclusive of a screen for hepatitis B, with results indicative only of an elevated white blood count. On 03-DEC-2007, the had an ultrasound of her spleen and kidneys, with no abnormal results found. At the time of this report the outcome of "spotting" was recovered, and the outcome of all remaining events was not recovered. Additional information has been requested.

VAERS ID:303415 (history)  Vaccinated:2007-08-15
Age:16.0  Onset:2007-11-26, Days after vaccination: 103
Gender:Female  Submitted:2008-01-07, Days after onset: 42
Location:Louisiana  Entered:2008-01-16, 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: None
Current Illness: Pregnancy NOS (LMP = 6/15/2007)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound 11/05/07 baby was moving; beta-human chorionic
CDC 'Split Type': WAES0710USA03082
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Blood human chorionic gonadotropin, Blood urine present, Drug exposure during pregnancy, Ultrasound abdomen normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Retroperitoneal fibrosis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a consumer concerning her 16 year old daughter who on approximately 15-AUG-2007 "two months ago" was vaccinated with a dose of Gardasil. There was no concomitant medication. The consumer was not sure whether it was her daughter''s first or second dose. It was reported that her daughter is currently four months pregnant (approximate LMP 15-JUN-2007). Her pregnancy was confirmed by a pregnancy test. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. No product quality complaint was involved. Follow up information indicated that the patient had back pain starting on 26-NOV-2007 and also urinated a little bit of blood. She went to the emergency room on 27-NOV-2007 and was checked to see if she was having any contractions and sent her home. No ultrasound was done at that time. An ultrasound was done on 05-NOV-2007 and the baby was moving and another ultrasound was scheduled for 14-DEC-2007. Additional information has been requested.

VAERS ID:303429 (history)  Vaccinated:2007-11-28
Age:16.0  Onset:2007-11-28, Days after vaccination: 0
Gender:Female  Submitted:2008-01-07, Days after onset: 40
Location:Illinois  Entered:2008-01-16, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Seasonal allergy
Diagnostic Lab Data: None
CDC 'Split Type': WAES0712USA01175
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site bruising, Injection site mass, Pain in extremity
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a registered nurse concerning her 16 year old daughter, with a history of seasonal allergy and no other pertinent medical history who on 28-NOV-2007 was vaccinated subcutaneously in the arm with a dose of GARDASIL. On 29-NOV-2007 the patient''s arm hurt and it was bruised with a lump on the arm where she was vaccinated. Unspecified medical attention was sought. The patient recovered on 02-DEC-2007. No diagnostic laboratory tests were performed. No product quality complaint was involved. Additional information has been requested.

VAERS ID:303442 (history)  Vaccinated:2007-03-20
Age:16.0  Onset:2007-03-20, Days after vaccination: 0
Gender:Female  Submitted:2008-01-07, Days after onset: 293
Location:Oregon  Entered:2008-01-16, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': WAES0712USA01403
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0014U1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Injection site bruising, Injection site pain, Injection site reaction
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning a 16 year old female with no pertinent medical history and no drug reaction/allergies who on 17-JAN-2007 was vaccinated with her first dose of GARDASIL. Concomitant therapy included pantoprazole sodium (PROTONIX). On 20-MAR-2007 the patient received her second dose of GARDASIL (lot# 653736/0014U) subcutaneously, 0.5ml once. After receiving the second dose subcutaneously the patient had an injection site reaction. The reaction consisted of pain and bruising at the injection site. No laboratory studies were performed. The patient eventually recovered on 03-APR-2007. She received the third dose of intramuscularly on 29-SEP-2007 without an incident. Medical attention was sought, the patient saw a physician. Additional information has been requested. 04/07/2008 Information has been received from a physician concerning a 16 year old female with no pertinent medical history and no drug reactions/allergies who on 17-JAN-2007 was vaccinated with her first dose of GARDASIL. Concomitant therapy included PROTONIX. On 20-Mar-2007 the patient received her second dose of GARDASIL (lot# 653736/0014U) subcutaneously, 0.5mL once. After receiving the second dose subcutaneously the patient had an injection site reaction. The reaction consisted of pain and bruising at the injection site (also reported as 06-NOV-2007). No laboratory studies were performed. The patient eventually recovered on 03-APR-2007 (also reported as 27-NOV-2007). She received the third dose intramuscularly on 29-SEP-2007 without an incident. Medical attention was sought, the patietn saw a physician. Additional information has been requested.

VAERS ID:302969 (history)  Vaccinated:2008-01-11
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-11
Location:Wisconsin  Entered:2008-01-17, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2541AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1578U0SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Incorrect dose administered
SMQs:
Write-up: 2 doses of Menactra given.

VAERS ID:302981 (history)  Vaccinated:2008-01-08
Age:16.0  Onset:2008-01-08, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:New York  Entered:2008-01-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: 6 days prior appendencitis
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.128702IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Epistaxis, Limb discomfort, Sensation of heaviness, Tremor
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: 1640 female with epistaxis evening of vaccination adm. following day pt dev. L. arm shaking, tremor. L arm felt heavy, achy and was shaking P142 bmp. Resolved, until following day felt L. arm heaviness and pain-resolved. Pt seen recovered at exam.

VAERS ID:303554 (history)  Vaccinated:2007-11-06
Age:16.0  Onset:2007-11-06, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 70
Location:California  Entered:2008-01-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0711USA03895
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Medical device complication, Pain, Stress
SMQs:
Write-up: Information has been received from a physician concerning patient who on 06-NOV-2007 was vaccinated with Gardasil. After administering a prefilled syringe to a patient the needle did not fully retract that the safety device did not fully cover the needle. Because of this the syringe became out of alignment. The patient''s outcome was unknown. Product quality complaint was involved. Follow-up information was received from a physician. On 18-DEC-2007 the patient was vaccinated with a second dose of Gardasil (lot# 655327/1287U) 0.5 mL IM in the right deltoid. The physician used a Gardasil prefilled syringe and the safety mechanism failed to activate. Medical attention was sought. The physician felt that this increased stress and pain for the patient. At the time of reporting it was unknown if the patient recovered. No other information was provided. The SR # is 1-2166964843. Additional information is requested.

VAERS ID:303557 (history)  Vaccinated:2007-12-05
Age:16.0  Onset:2007-12-05, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 41
Location:Unknown  Entered:2008-01-21, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0712USA02573
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
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: Information has been received from a physician''s assistant concerning a 16 year old female who on 20-SEP-2007 and 05-DEC-2007 was vaccinated with a first a second dose of Gardasil. On 05-DEC-2007 the patient went into the waiting room and fainted, fell to the floor. Paramedics came in and the patient was out for about 20 seconds. They elevated her legs and she seemed alright. There was no major injury. The representative (also reported as the nurse) called the patient''s father on 08-DEC-2007. Additional information has been requested.

VAERS ID:303558 (history)  Vaccinated:2007-10-11
Age:16.0  Onset:2007-10-12, Days after vaccination: 1
Gender:Female  Submitted:2008-01-15, Days after onset: 95
Location:Texas  Entered:2008-01-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: beta-human chorionic negative
CDC 'Split Type': WAES0712USA02599
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0387U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Pelvic pain, Pregnancy test negative, Vaginal discharge
SMQs:
Write-up: Information has been received from a physician concerning a 16 year old female who on 09-AUG-2007 was vaccinated with her first dose of Gardasil (lot# 656049/0187U). On 11-OCT-2007 the patient was vaccinated with her second dose of Gardasil (lot# 657621/0387U). On 12-OCT-2007 the patient experienced pelvic pain which did not subside and an unspecified vaginal discharge. On 18-OCT-2007 the patient was seen by the physician and the physician noted an absence of dysuria and fever. The patient was referred to a gynecologist. Additional information has been requested.

VAERS ID:303576 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-15
Location:Unknown  Entered:2008-01-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0712USA02645
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Lymphadenopathy
SMQs:
Write-up: Information has been received from a health professional concerning a 16 year old female who was vaccinated intramuscularly with Gardasil and experienced lymphadenopathy. The patient sought unspecified medical attention and her outcome was not reported. Additional information has been requested.

VAERS ID:303671 (history)  Vaccinated:2007-09-17
Age:16.0  Onset:2007-09-19, Days after vaccination: 2
Gender:Female  Submitted:2008-01-15, Days after onset: 118
Location:Unknown  Entered:2008-01-21, 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: None
Current Illness:
Preexisting Conditions: Papanicolaou smear abnormal; biopsy cervix
Diagnostic Lab Data: None
CDC 'Split Type': WAES0712USA03752
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1061U IMUN
Administered by: Other     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse practitioner, concerning a 16 year old female patient with no known allergies and a history of an abnormal Papanicolaou (Pap) smear and a cervical biopsy, who on 17-SEP-2007 was vaccinated IM, with a dose, 0.5 ml, of Gardasil (lot #658558/1061U). There was no concomitant medication. On 19-SEP-2007, 48 hours after vaccination, the patient developed hives. The patient''s mother contacted the physician, but no treatment was required and the hives subsequently resolved (duration not specified). Additional information has been requested.

VAERS ID:303683 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-15
Location:Minnesota  Entered:2008-01-21, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': WAES0712USA06028
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Nausea, Pallor
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning a 16 year old female with no pertinent medical history who in August 2007, was vaccinated with a first dose of Gardasil. There was no concomitant medication. In August 2007, in the office, the patient became "queasy, pale, lightheaded and dizzy". There was no laboratory or diagnostic tests performed. In August 200, "after about a half hour" the patient recovered. Additional information has been requested.

VAERS ID:303687 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-15
Location:Florida  Entered:2008-01-21, 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: antimicrobial (unspecified)
Current Illness: Acne
Preexisting Conditions: The mother reported that her daughter had no reactions after her first dose of the vaccine.
Diagnostic Lab Data:
CDC 'Split Type': WAES0712USA06364
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from the mother of a consumer concerning her 16 year old daughter with acne who on an unspecified date in June 2007, was vaccinated with the first dose of Gardasil (Lot# not reported). Concomitant therapy included antimicrobial (unspecified). On an unspecified date in October 2007, the patient was vaccinated with the second dose of Gardasil (Lot# not reported). Subsequently within 24 hours post vaccination her daughter developed a rash, which began as a few bumps on her torso in the mid-back and on her stomach area under the breast bone". The consumer reported that over the past several weeks the rash became more pronounced and her daughter was seen by a dermatologist. The date of this appointment and any treatment information was not provided. The mother reported that her daughter had no reactions after her first dose of the vaccine. At the time of this report the patient had not recovered from the rash. Additional information has been requested.

VAERS ID:303926 (history)  Vaccinated:2007-12-19
Age:16.0  Onset:2007-12-19, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 27
Location:Florida  Entered:2008-01-21, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: blood pressure 12/19/07 102/6
CDC 'Split Type': WAES0712USA09050
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood pressure, 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 licensed practical nurse concerning a 16 year old white female with no pertinent medical history or drug reactions/allergies or illness at the time of vaccination on 19-DEC-2007 was vaccinated with GARDASIL (lot# 659439/1267U) IM in the left deltoid at 9:35 AM. There was no concomitant medication. On 19-DEC-2007 at 9:40AM, the patient was very apprehensive about receiving the vaccination. Approximately 5 minutes later (child was sitting in the chair) child had a syncope episode lasting 2 - 5 seconds. There was no LOC (loss of consciousness). The patient was lifted by the mother onto the exam table and was in a supine position with legs elevated with a cold pack on legs and and neck. The blood pressure measurement was 102/64. The patient was continued to be monitored for 15 to 20 minutes. On 19-DEC-2007, the patient recovered. Additional information is not expected.

VAERS ID:304007 (history)  Vaccinated:2007-10-15
Age:16.0  Onset:2007-10-15, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 92
Location:Maine  Entered:2008-01-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0801USA01897
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Medication error, No adverse reaction
SMQs:
Write-up: Information has been received from a registered nurse concerning a 16 year old female who on 15-OCT-2007, was vaccinated with a dose of GARDASIL (possible lot#''s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. This is one of several reports from the same source.

VAERS ID:304010 (history)  Vaccinated:2007-10-17
Age:16.0  Onset:2007-10-17, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 90
Location:Maine  Entered:2008-01-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0801USA01900
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Medication error, No adverse reaction
SMQs:
Write-up: Information has been received from a registered nurse concerning a 16 year old female who on 17-OCT-2007, was vaccinated with a dose of GARDASIL (possible lot#''s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. This is one of several reports from the same source.

VAERS ID:303233 (history)  Vaccinated:2007-12-06
Age:16.0  Onset:2007-12-08, Days after vaccination: 2
Gender:Female  Submitted:2008-01-14, Days after onset: 37
Location:Pennsylvania  Entered:2008-01-22, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Chest pain 2 days after HPV # 1

VAERS ID:303242 (history)  Vaccinated:2007-11-28
Age:16.0  Onset:2007-11-28, Days after vaccination: 0
Gender:Female  Submitted:2008-01-16, Days after onset: 49
Location:Connecticut  Entered:2008-01-22, 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: 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.0171U1IMLA
Administered by: Other     Purchased by: Public
Symptoms: Pruritus, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Received HPV #2 (GARASIL) on 11/28/07 at approximately 0800 hrs. Itchy, generalized rash started in afternoon, covering entire body. Mom gave "some pills" to stop rash. Rash resolved that evening.

VAERS ID:303346 (history)  Vaccinated:2007-11-12
Age:16.0  Onset:2007-11-12, Days after vaccination: 0
Gender:Female  Submitted:2008-01-23, Days after onset: 72
Location:Pennsylvania  Entered:2008-01-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Pain, Rash erythematous, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Bright red rash and pain over entire body within hours after shot. Hives by the following day. Given Benadryl with relief. Sent home from school.

VAERS ID:303548 (history)  Vaccinated:2007-12-28
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-24
Location:Unknown  Entered:2008-01-25, 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: None
Diagnostic Lab Data: None
CDC 'Split Type': WAES0801USA03228
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0928U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Dyskinesia, Loss of consciousness, Vaccine positive rechallenge
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), Dyskinesia (narrow), 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 licensed practical nurse concerning a 16 year old female who on 02-NOV-2007 was vaccinated with her first dose of Gardasil (Lot #658554/0928U) via injection and on 28-DEC-2007 was vaccinated with her second dose of Gardasil (Lot #658554/0928U). There was no concomitant medication. The nurse said that the patient was not pregnant during the two visits but the medical assistant said that the patient jerked and "went out immediately" after each dose and she seemed to be having a seizure. The patient recovered both times while she was in the office. They will not be administering dose 3. The patient did not receive any other vaccinations during her visits. She has no pertinent medical history and no lab/diagnostic studies were performed. No other details were available. A seizure was considered to be an other important medical event. Additional information has been requested.

VAERS ID:303568 (history)  Vaccinated:2008-01-21
Age:16.0  Onset:2008-01-21, Days after vaccination: 0
Gender:Female  Submitted:2008-01-25, Days after onset: 4
Location:New Jersey  Entered:2008-01-25
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: EKG done normal
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U2IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest discomfort, Dizziness, Electrocardiogram normal, Palpitations
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: C/O Few seconds L chest sensation, lightheaded. "I thought it was a muscle flutter" 1 hour after receiving HPV # 3. Today, 1 day later, C/O "my heart is racing. Pulse 105 and regular.

VAERS ID:303635 (history)  Vaccinated:2007-04-11
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-24
Location:Pennsylvania  Entered:2008-01-25, 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: Claritin, Topomax, Tritodine, Prilosec, Ortho Tricycline
Current Illness: Depression
Preexisting Conditions: NKDA
Diagnostic Lab Data: Tris, MRI
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0387U2IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Lipodystrophy acquired, Muscle atrophy, Nuclear magnetic resonance imaging, X-ray
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Lipodystrophy (narrow)
Write-up: Left deltoid 4 1/2 x 3 cm area muscle atrophy. 3mm deep lipodystrophy. No loss of function. Referral to MD.

VAERS ID:303648 (history)  Vaccinated:2007-06-27
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-25
Location:Virginia  Entered:2008-01-25
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.1265U IMRL
TDAP: TDAP (ADACEL)SANOFI PASTEURC2739AA IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Contusion, Injection site pain, Injection site swelling, Urticaria, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Mother and patient report pain, swelling at injection site, hives all over body with HPV #1 and #2. Also bruising 2x2 inches with #1 and #2. #3 not given.

VAERS ID:303739 (history)  Vaccinated:2008-01-15
Age:16.0  Onset:2008-01-21, Days after vaccination: 6
Gender:Female  Submitted:2008-01-23, Days after onset: 2
Location:Massachusetts  Entered:2008-01-28, 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: Linczolid
Current Illness: None
Preexisting Conditions: Osteomyelitis; Allergy: PCN, Ceclor, Cefaclor 1/29/08-records received-PMH: MRSA osteomyelitis of 4th toe 7/18/07 discharged with PICC. Birth defect of 4th toe, surgery included pin and screw placement.
Diagnostic Lab Data: 1/29/08-records received-Calcium 6.4. PTH elevated 1027. Renal ultrasound normal, x-ray writsts normal.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blepharospasm, Blood calcium decreased, Blood parathyroid hormone increased, Hypoaesthesia, Hypocalcaemia, Muscle twitching, Musculoskeletal stiffness, Paraesthesia, Pseudohypoparathyroidism, Speech disorder, Ultrasound kidney normal, X-ray limb normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), 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), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Chronic kidney disease (broad), Arthritis (broad), Tumour lysis syndrome (broad)
Write-up: Twitching started 1/21 in lower eyelids, also complained of tingling spread to face and hands; felt she couldn''t move her upper lip and altered speech. Symptoms most of evening. Awoke 1/22 - face felt normal but hands (L) numb and tingling, thumb flexed. Still complained of tingling on visit - sent to neurology.1/29/08-records received for DOS 1/24/08- DX: Hypocalcemia. Pseudohypoparathyroidism. C/O hand and leg tingling. Perioral and bilateral hand tingling and eyelid twitching. Started 4 days PTA developed episodic periorbital nonradiation nonpainful tingling. Pins and needls sensation in hands as well as numbness of left hand. Lockin up of fingers in flexed position.

VAERS ID:303858 (history)  Vaccinated:2008-01-22
Age:16.0  Onset:2008-01-22, Days after vaccination: 0
Gender:Female  Submitted:2008-01-22, Days after onset: 0
Location:New Jersey  Entered:2008-01-29, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEUR2644AA5IMLA
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Gaze palsy, Muscle rigidity, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: After 2 vaccines were given to pt. she started to pass out (faint). Mom shouted pt was having a seizure. Pt. was shaking, rigid & eyes were rolling back for very short time 4-5 seconds.

VAERS ID:304109 (history)  Vaccinated:2007-11-14
Age:16.0  Onset:2007-11-14, Days after vaccination: 0
Gender:Female  Submitted:2008-01-25, Days after onset: 72
Location:Vermont  Entered:2008-02-01, 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: Yaz
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Labs EKG - Seen by cardiologist ER LABS: CBC, chemistry, cardiac enzymes, UA all WNL. Hospital LABS: EKG revealed bracycardia. Echocardiogrm WNL. Stress test WNL.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0929U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2182AA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Bradycardia, Cardiac enzymes normal, Cardiac stress test normal, Cardiovascular disorder, Dizziness, Echocardiogram normal, Electrocardiogram, Eye movement disorder, Fatigue, Feeling hot, Full blood count normal, Gaze palsy, Hypotonia, Intensive care, Laboratory test, Laboratory test normal, Loss of consciousness, Nausea, Oxygen supplementation, Pallor, Syncope, Syncope vasovagal, Urine analysis normal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Immediately after shots - became Faint with pulse 50; Next Am had syncopal episode -$g ER -$g hosp Adm. with significant bradycardia -$g cardiac work-up; now on Atenolol. 2/1/08 Reviewed ER medical records of 11/15/07 which reveal patient experienced feeling lightheaded, warmth & nauseated. Felt faint, lost consciousness & collapsed for approx 1 min witnessed by parent. Recovered at the scene. In ER placed on O2. Had additional episodes of syncope w/HR 30''s while laying on gurney in ER. Noted to have eye twitching, pallor & eyes rolling back in head, flaccid. Awoke immediately but was very tired. Transferred to higher level of care. FINAL ER Dx: syncope of unknown cause. 2/8/08 Reviewed hospital medical records which reveal patient admitted to PICU 11/15-11/16/2007. Cardio consult done. Syncopal episodes felt to be neurocardiogenic w/significant cardioinhibitory component, resulting in secondary bardycardia/asystole & syncope. Tx w/meds & hydration & d/c to home w/cardio f/u. FINAL DX: syncope, probably neurally-mediated syncope; periods of marked bradycardia.

VAERS ID:304133 (history)  Vaccinated:2008-01-08
Age:16.0  Onset:2008-01-09, Days after vaccination: 1
Gender:Female  Submitted:2008-02-01, Days after onset: 23
Location:Alabama  Entered:2008-02-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported
Preexisting Conditions:
Diagnostic Lab Data: None.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB175AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0384U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2407AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Dizziness, Gastroenteritis viral, Malaise, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Onset, 01/09/08-nausea, vomiting, dizziness, abdominal pain. Pt. out of school 01/10-01/11/08. Returned to school 1/14/08 but "felt bad". Seen by doctor 1/16/08 and dx as "stomach virus gastroenteritis. Out of school 1/15/08-1/17/08. Mother made report on 1/16/08. Follow up call on 1/18/08 revealed no hx of fever or rash.

VAERS ID:304148 (history)  Vaccinated:2008-01-16
Age:16.0  Onset:2008-01-18, Days after vaccination: 2
Gender:Male  Submitted:2008-02-04, Days after onset: 17
Location:Alabama  Entered:2008-02-04
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Cerebral palsy, mental retardation, VP shunt, seizure disorder. Allergies include pecans, Augmentin, Ceclor, & latex. PMH: Dandy-Walker syndrome, fetal-alcohol syndrome, blindness, CP/MR, seizure disorder, VP shunt, and possible congenital cardiac abnormalities. Allergy to latex.
Diagnostic Lab Data: Labs and Diagnostics: CRP 1.88. Tracheal aspirate (+) for abundant Strep pneumoniae and rare Candida albicans and Neisseria sp. Gram stain showed abundant WBCs and Gram (+) cocci. Blood cx (-). Admission CBC with WBC 2.17, RBC 4.38 and platelets 81K with WBCs and platelets up to normal by 1/25/07. UA with 1+ protein and 3+ blood. UC (+) for Enterococcus faecalis Group D. Swallow study-ok to resume po. EEG showed background spikes. CXR (+) for possible aspiration pneumonia
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2377BB0  
TDAP: TDAP (ADACEL)SANOFI PASTEURC2631AA0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Barium swallow normal, Blood culture negative, C-reactive protein increased, Candidiasis, Chest X-ray abnormal, Convulsion, Crying, Culture positive, Culture urine positive, Electroencephalogram abnormal, Endotracheal intubation, Enterococcal infection, Extubation, Full blood count, Gram stain positive, Mechanical ventilation, Neisseria infection, Oral intake reduced, Platelet count decreased, Pneumonia aspiration, Pyrexia, Red blood cell count decreased, Retching, Status epilepticus, Streptococcus identification test positive, Urine analysis abnormal, White blood cell count decreased
SMQs:, Angioedema (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: History of fever (up to 103), dry heaves for 3 days before hospitilization. Admitted to hospital on 1/21 with continued fever & dry heaves, & on 1/22 developed seizures and status epilepticus, & required mechanical ventilation for approx 24 hours, & developed pneumonia. 02/15/2008 MR received for DOS 1/22-2/1/2008 with D/C Dx: Increased seizure activity. Aspiration pneumonia. Pt presented to ER with fever, decreased po intake, dry heaves and crying. No seizures noted in admission H&P however pt developed prolonged seizure activity requiring intubation. Pt was found to have aspiration pneumonia. Pt was extubated after several days and remained seizure free until 1/31/2007. Pt developed seizure activity (generalized tonic-clonic) lasting ~3 minutes. Txd with abx and seizure meds adjusted. Seizure free and afebrile x 48hrs prior to d/c.

VAERS ID:304245 (history)  Vaccinated:2008-01-25
Age:16.0  Onset:2008-01-25, Days after vaccination: 0
Gender:Female  Submitted:2008-01-25, Days after onset: 0
Location:Arizona  Entered:2008-02-04, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Same~HPV (Gardasil)~1~15~In Patient
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0928U2UNLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Dizziness, light headed, prolonged observed in office. Rx Meclizine. Mom claims similar symptoms lasted 1 wk after the 1st Gardasil dose.

VAERS ID:304298 (history)  Vaccinated:2007-11-13
Age:16.0  Onset:2007-12-15, Days after vaccination: 32
Gender:Female  Submitted:2008-02-05, Days after onset: 52
Location:North Carolina  Entered:2008-02-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: JRA
Diagnostic Lab Data: Please contact pediatric rheumatologist
CDC 'Split Type':
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Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.UNKNOWN BY PARE1  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Condition aggravated, Joint range of motion decreased, Joint swelling, Oedema peripheral, Pain in extremity, Rash pustular
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: This form is being completed by parent who is a physician. 16 yo female with 2 y h/o JRA, stable on 20 mg piroxicam q day. H/O only 3 mild flares. Pt received 3 vaccines at regular healthy child visit on 8/23/07: first dose ever of MCV4, Hep A, and HPV. On 11/13/07 she received 2nd dose of HPV. In mid December (specific time to onset unknown) she developed multiple, scattered, small painful pustules on her toes filled with clear liquid and two swollen and painful toes. Over the following weeks her wrists, multiple toes and joints of her fingers swelled and became quite painful with reduced range of motion. She visited her pediatric rheumatologist for a regularly scheduled visit on Jan 2. "low dose" Methotrexate q week and folic acid were initiated. Little improvement in symptoms at this time.

VAERS ID:304337 (history)  Vaccinated:2008-01-22
Age:16.0  Onset:2008-01-22, Days after vaccination: 0
Gender:Female  Submitted:2008-01-22, Days after onset: 0
Location:Louisiana  Entered:2008-02-05, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~DTaP (no brand name)~3~1~In Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None 2/14/08-records received-HX of psoriasis.
Diagnostic Lab Data: Accu check; CBC; CMP; EEG & EKG 2/14/08-records received-EEG normal awake and drowsy EEG. Labs within normal limits.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2323AA IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Blood glucose, Convulsion, Dizziness, Dyskinesia, Electrocardiogram, Electroencephalogram normal, Full blood count normal, Gaze palsy, Immediate post-injection reaction, Laboratory test normal, Metabolic function test, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Seizure like episode lasting approx 10 seconds. 2/14/08-records received for DOS 1/22/08- Became light-headed after vaccination, eye began rolling back, unresponsive to voice. Began jerking movements of right and left arm and head. Post ictal state. 5/27/08-DC Summary received for DOS 1/22-1/23/08-DC DX: Reaction to HPV vaccine. Light headed few seconds after vaccination.

VAERS ID:304355 (history)  Vaccinated:2008-01-28
Age:16.0  Onset:2008-01-28, Days after vaccination: 0
Gender:Male  Submitted:2008-02-05, Days after onset: 8
Location:South Carolina  Entered:2008-02-05
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: seasonal allergies/ mild cerbral palsy/ prematurity 32 wks
Diagnostic Lab Data: CBC normal. Chem 7 normal. CPK normal. UA normal. FLU antigen A and B normal.
CDC 'Split Type':
Vaccination
Manufacturer
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Dose
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Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2429AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Blood creatine phosphokinase normal, Chills, Full blood count normal, Influenza serology negative, Injection site pain, Laboratory test normal, Pain, Pyrexia, Urine analysis normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)
Write-up: Pain at the site of injection on the day of administration. Fever spike to 100 with chills, body aches and joint pains for 2 days.

VAERS ID:304459 (history)  Vaccinated:2008-02-04
Age:16.0  Onset:2008-02-04, Days after vaccination: 0
Gender:Female  Submitted:2008-02-06, Days after onset: 2
Location:New York  Entered:2008-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0930U1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Burning sensation, Lip swelling, Pruritus, Swelling face, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Hypersensitivity (narrow)
Write-up: About 1 hr after Gardasil dose developed hives face, arms, neck, chest on & off x2 days. Itchy and burning. Also lip swelling and face swelling. Some symptomatic relief with Benadryl on PE. Mild lip and face swelling. Prescribed Allegra 180 mg QD x3 d. Events still evolving.

VAERS ID:304564 (history)  Vaccinated:2007-04-26
Age:16.0  Onset:2007-05-01, Days after vaccination: 5
Gender:Female  Submitted:2008-02-07, Days after onset: 282
Location:Unknown  Entered:2008-02-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Advair, Menactra
Current Illness: Pregnancy NOS (LMP=Unknown); Drug hypersensitivity; Penicillin allergy
Preexisting Conditions: Asthma
Diagnostic Lab Data: Beta-Human Chorionic 05/01/07 positive
CDC 'Split Type': WAES0705USA01148
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1426F IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a nurse, for the Pregnancy Registry for Gardasil, concerning a 17 year old female with drug hypersensitivity and penicillin allergy and a history of asthma. on 26-APR-2007 the patient was vaccinated with Gardasil (Lot#655205/1426F). Concomitant therapy included ADVAIR and MENACTRA. On 01-MAY-2007 the patient''s mother notified the office that her daughter tested positive to a home pregnancy test. It was reported that the patient sought unspecified medical attention. No further information is available at this time. Follow up information received from the pediatrician, indicated that the patient had a spontaneous abortion, on/or at less than 20 weeks of gestation (date not specified). The outcome of spontaneous abortion was not specified. No further details were provided. Upon internal review, spontaneous abortion was considered to be serious as an other important medical event. Additional information is not expected.

VAERS ID:304598 (history)  Vaccinated:2008-01-29
Age:16.0  Onset:2008-01-29, Days after vaccination: 0
Gender:Female  Submitted:2008-01-30, Days after onset: 1
Location:New York  Entered:2008-02-08, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0530U0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Dizziness, Headache, Nausea, Vertigo
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)
Write-up: After receiving Gardasil vaccine - pt became nauseated, dizzy and c/o head swirling, severe headaches. Symptoms gone after about 15 mins.

VAERS ID:304602 (history)  Vaccinated:2008-01-31
Age:16.0  Onset:2008-01-31, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:California  Entered:2008-02-08
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
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Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2419AA0UNLA
Administered by: Private     Purchased by: Other
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Intermittent pain center of chest lasting ~5 min since given injection 24 hours prior.

VAERS ID:304627 (history)  Vaccinated:2008-02-07
Age:16.0  Onset:2008-02-07, Days after vaccination: 0
Gender:Female  Submitted:2008-02-07, Days after onset: 0
Location:New York  Entered:2008-02-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: unknown~HPV (Gardasil)~2~15~In Patient
Other Medications:
Current Illness: Positive patient started menses
Preexisting Conditions: Allergy: dust/pollen; asthma
Diagnostic Lab Data: 98%; RR=24; BP=70/40; T=97. Patient observed over 2 hour: BP=90/60; Pulse=70; RR=24 98%.
CDC 'Split Type':
Vaccination
Manufacturer
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Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB24AA1IMUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.0388U2IMUN
Administered by: Public     Purchased by: Public
Symptoms: Anxiety, Chills, Dizziness, Headache, Hypotension, Pallor, Respiratory rate increased, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: 2/7/08: After receiving Gardasil & Hep A =$g dizziness, pale, alot shivering. 98%; RR=24; BP=70/40; T=97 =$g Pt. given water/oxygen, reclined on examination table =$g Patient observed over 2 hour: BP=90/60; Pulse=70; RR=24 98%. Pt was also given Benadryl & Prolone P.O. This was questionable allergy vs vasovagal reaction. 10/30/07 Pt s/p flu & Gardasil =$g "felt throat closing in & rush of blood to head =$g O2 sat-100%, positive able to talk. It was felt pt had an anxiety attack to vaccine during that visit.

VAERS ID:304637 (history)  Vaccinated:2008-01-22
Age:16.0  Onset:2008-01-27, Days after vaccination: 5
Gender:Female  Submitted:2008-01-29, Days after onset: 2
Location:Texas  Entered:2008-02-08, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol cold & allergy
Current Illness: None
Preexisting Conditions: Allergies 8/20/08-records received-PMH severe constipation. Recurrent strep throat.
Diagnostic Lab Data: CBC, ANA, Sedimentation rate, throat culture, CRK. All tests were within normal limits. 8/20/08-records received-Negative ANA and RF and normal ESR. CRP 8.1, Complement 4 41, Absolute neutrophils 10.8, AST 60, ALT 117.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2409AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Activities of daily living impaired, Alanine aminotransferase increased, Antinuclear antibody negative, Arthralgia, Aspartate aminotransferase increased, C-reactive protein increased, Complement factor C4 increased, Constipation, Culture throat negative, Diarrhoea, Dysgraphia, Erythema, Full blood count normal, Joint swelling, Myofascial pain syndrome, Nausea, Neutrophil count increased, Pharyngolaryngeal pain, Pruritus, Pyrexia, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Sleep disorder, Tenderness, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (narrow)
Write-up: Sore throat, joint pain (hands, elbows) started 1/27/08. Unable to write well with right hand. Joint pain moderate. Missed one day of school. 8/20/08-records received-presented to physician office 2/14/08 with C/O pain involving wrists and fingers began on 1/27/08 and on 1/29/08 pain in ankles, elbows and left TMJ with some swelling of right ankle and left knee, diffuse swelling of wrist and fingers, tenderness and morning stiffness. Pain interferes with sleep, unable to write. Fever, nausea and vomiting, abdominal pain. Erythema and pruritis, daily headaches, dry cough, diarrhea, occasional constipation. PE: full ROM, tenderness noted. Neuro exam normal. Impression: Marked myofascial pain with tenderness. No additional visits to clinic.

VAERS ID:304660 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:2008-01-21
Gender:Female  Submitted:2008-02-08, Days after onset: 18
Location:Unknown  Entered:2008-02-11, 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:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Pap test 01/21/08 diagnosed with cervical dysphasia Pap test, 01/21?/08, high risk HPV
CDC 'Split Type': WAES0801USA05848
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IJUN
Administered by: Other     Purchased by: Military
Symptoms: Cervical dysplasia, Smear cervix abnormal
SMQs:, Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad)
Write-up: Information has been received from a nurse practitioner concerning a 16 year old female not pregnant who was vaccinated with a 0.5 mL dose of Gardasil. On approximately 21-JAN-2008 (reported as last week) the patient was diagnosed with cervical dysphasia. The patient''s cervical dysphasia persisted. The nurse practitioner reported that she did not know if the patient finished all three doses of Gardasil. On approximately 21-JAN-2008 (reported as last week) a "PAP test" was performed. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/8/2008; 2/15/2008; 2/27/2008. In follow-up it was reported by the nurse practitioner that the patient a 16 year old female received GARDASIL vaccine from another provider. It was reported that the patient came to the nurse practitioner later for PAP which came back as high risk human papilloma virus on liguid prep. Typing was not done. Additional follow up form the NP indicated that she "wasn''t the one seeing this patient when GARDASIL vaccine was started - she may have been infected prior." No further details were provided. Additional information is not expected.

VAERS ID:304664 (history)  Vaccinated:2007-12-31
Age:16.0  Onset:2007-12-31, Days after vaccination: 0
Gender:Female  Submitted:2008-02-08, Days after onset: 39
Location:Tennessee  Entered:2008-02-11, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
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': WAES0802USA00845
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cerebrovascular accident, Paralysis, Walking aid user
SMQs:, Ischaemic cerebrovascular conditions (narrow), Haemorrhagic cerebrovascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Information has been received from a physician concerning a 16 year old female who on approximately 31-DEC-2007 was vaccinated with the first dose of Gardasil and experienced a stroke. The patient was admitted to the hospital where she remained for 3 weeks. The patient experienced an unspecified partial paralysis. After 3 weeks, the patient was discharged and could walk with the assistance of a walker. As of 04-FEB-2008, the patient was recovering. The physician felt that the stroke and partial paralysis were disabling. No further information is available.

VAERS ID:304718 (history)  Vaccinated:2008-01-30
Age:16.0  Onset:2008-02-08, Days after vaccination: 9
Gender:Male  Submitted:2008-02-11, Days after onset: 3
Location:Ohio  Entered:2008-02-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA03422 IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.086UU SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2423AA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2759AA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0593U SCLA
Administered by: Other     Purchased by: Public
Symptoms: Erythema, Hypoaesthesia, Pain, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Varicella vaccination given L upper arm sq. on 1/30/08. Father (physician) states pt c/o redness, swelling, warmth, pain & slight numbness on 2/8/08, area 3"x5". Sx slightly worse on 2/9/08. Pt began on Amox. 500 mg one TID x10 days.

VAERS ID:304757 (history)  Vaccinated:2008-01-15
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-06
Location:Pennsylvania  Entered:2008-02-12, 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: PPD, Sanofi Pasteur, C2678AA, ID LFA, 0 doses
Current Illness: None
Preexisting Conditions: NKA
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0930U0IMRA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.1117F0SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2407AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B013AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Expired drug administered, Inappropriate schedule of drug administration
SMQs:
Write-up: No adverse events - MMRV was administered on 1/15/08 -$g client age 16 and vaccine expired on 1/11/08. No adverse event-only reporting dlt inappropriate age & expired vaccine.

VAERS ID:304765 (history)  Vaccinated:2008-01-17
Age:16.0  Onset:2008-01-17, Days after vaccination: 0
Gender:Female  Submitted:2008-02-06, Days after onset: 20
Location:Louisiana  Entered:2008-02-12, 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: denies
Current Illness: None except prev. activity like this after speaking to mother but never a problem at time of vaccines
Preexisting Conditions:
Diagnostic Lab Data: unknown
CDC 'Split Type': LA080204
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB377AA2IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2370AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Convulsion, Gaze palsy, Grunting, Incontinence, Nausea, Tonic clonic movements
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient had seizure activity - eyes rolled back, clonic-tonic, muscular contractures, verbal grunting noise, voided on self. Nausea reported after seizure type activity. Lasted approximately 2 minutes. After history - child had done this at a concert 2 wks ago and at school. No app and follow up until today.

VAERS ID:304873 (history)  Vaccinated:2007-09-28
Age:16.0  Onset:2008-01-03, Days after vaccination: 97
Gender:Female  Submitted:2008-02-12, Days after onset: 40
Location:Virginia  Entered:2008-02-14, 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: None
Current Illness:
Preexisting Conditions: None PMH: Headache 2 months prior. Allergic to Amoxicillin. Recently stopped oral contraceptives.
Diagnostic Lab Data: spinal tap; diagnostic procedure. Labs and Diagnostics: MRI brain with no lesion or infarction. LP with normal pressure, cell count, glucose, and protein. CSF cx (-).
CDC 'Split Type': WAES0802USA00868
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0929U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Benign intracranial hypertension, Blepharitis, Blindness, CSF culture negative, CSF test normal, Diagnostic procedure, Fundoscopy abnormal, Headache, Lumbar puncture, Nuclear magnetic resonance imaging brain normal, Papilloedema, Refraction disorder, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Glaucoma (narrow), Optic nerve disorders (narrow), Cardiomyopathy (broad), Retinal disorders (narrow), Periorbital and eyelid disorders (narrow), Ocular infections (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a nurse concerning her 16 year old daughter with no medical history or concomitant therapies who in July 2007, was vaccinated with her first dose of Gardasil. In September 2007, the patient was vaccinated with her second dose of Gardasil. After the second dose, the patient fainted and also had a headache. She then developed a pseudo cerebral tumor which started to cause blindness. She had a spinal tap and also had the fluid drained to relieve the pressure she was having. No further information was provided. Subsequently, the patient recovered from fainting, her headache, the pseudo cerebral tumor and blindness. The blindness was considered to be an other important medical event. Additional information has been requested. 02/29/2008 MR received from neurologist for OV 1/17/2008 with Dx: Pseudotumor cerebri. Pt presented with some loss of vision in the L eye and headache x 2 weeks with papilledema noted on fundoscopic exam. PE WNL except papilledema. 3/27/2008 Additional records received from opthomology consults 1/18/08 and 1/30/08 and f/u neurology 2/28/08. Seen by ophth 1/18/08 with visual field changes with h/a. PE (+) for optic nerve edema. DX: Pseudotumor cerebri. Mild blepharitis, mild refractive error L eye. Ophth consult 1/30/08 with report of improved visual acuity and no h/a. Edema still present on optic nerve exam, improved from last visit. Neuro f/u with improvement noted in visual field and h/a.

VAERS ID:304945 (history)  Vaccinated:2008-02-13
Age:16.0  Onset:2008-02-13, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 1
Location:North Carolina  Entered:2008-02-14
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: migraines
Diagnostic Lab Data: Brain CT - negative, Cervical spine films - negative
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram normal, Dizziness, Fall, Head injury, Nausea, Scan brain, Spinal X-ray normal, Syncope vasovagal, Tonic convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: 2 minutes after receiving the Gardasil vaccine patient had vagal episode and hit left frontal area of head on cement floor. Resulted in 20 second tonic seizure. After seizure patient remained dizzy and nauseated. Taken to ER for cervical spine films and head CT - both negative. Patient discharged from ER with Zofran and Motrin. Almost 24 hours later patient still dizzy and nauseated.

VAERS ID:304946 (history)  Vaccinated:2008-02-14
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:New York  Entered:2008-02-14
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: Non Applicable
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2392BA1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
SMQs:
Write-up: Patient was given the Menactra Vaccine on 11/6/07. The patient was then given the Menactra vaccine agian on 2/14/08. The patient did complain of any side effects.

VAERS ID:304987 (history)  Vaccinated:2008-02-07
Age:16.0  Onset:2008-02-09, Days after vaccination: 2
Gender:Female  Submitted:2008-02-14, Days after onset: 5
Location:Pennsylvania  Entered:2008-02-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Strattera
Current Illness: No
Preexisting Conditions: NKA; no birth defects; Hx ADD; ear surg; LGSIL. PMH: ADHD, anxiety, R knee strain. (+) HPV. NKDA.
Diagnostic Lab Data: Labs and Diagnostics: CBC with normal WBC and dfferential, Hgb 11.8. Electrolytes WNL. UA with 3-5 WBCs, 3-5 RBCs and few bacteria. Complement C3 and C4 decreased at 63 and 7.2. Parvovirus B19 IgG (+). RF (-). CRP 3.6. dsDNA AutoAb 734.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Activities of daily living impaired, Anaemia, Antinuclear antibody positive, Arthralgia, Asthenia, Bacteria urine, Blood electrolytes normal, Blood iron decreased, Borrelia burgdorferi serology negative, C-reactive protein increased, Complement factor C3 decreased, Complement factor C4 decreased, Double stranded DNA antibody, Drug screen negative, Full blood count, Gait disturbance, Haemoglobin decreased, Histone antibody positive, Hypocomplementaemia, Injection site reaction, Joint stiffness, Joint swelling, Musculoskeletal stiffness, Myalgia, Parvovirus B19 serology positive, Pyrexia, Red blood cell sedimentation rate increased, Red blood cells urine positive, Rheumatoid factor negative, Spinal X-ray normal, Systemic lupus erythematosus, Urine analysis abnormal, White blood cells urine positive, X-ray limb normal
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: Received Gardasil injection #3 on 2/7/08. Few days later developed neck stiffness and joint pain/stiffness, tightness both legs & L arm where inj./fever on 3rd day x24 hrs. Can barely walk. Sent to ER. 03/17/2008 MR recieved for DOS 2/18-21/2008 with DX: Severe polyarthragia and weakness 2'' to SLE. Systemic Lupus Erythematosus. ADD. Anemia. Pt presented with hisory of joint pain and swelling, generalized weakness progressing to the point of having difficulty getting out of bed. PE (+) for tenderness of both feet, ankles and hands. Decreased hand grip. Rheumatology consult with assessment of polyarthralgias, fevers, myalgias and hypocomplementemia.

VAERS ID:304990 (history)  Vaccinated:2007-08-13
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2007-08-21
Location:California  Entered:2008-02-14, Days after submission: 177
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:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1280F2UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0171U0UNLA
Administered by: Unknown     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
SMQs:
Write-up: None. Pt. didn''t need Hep A 3. Already has received Hep A 1 7-26-00, Hep A 2 6-9-03.

VAERS ID:305055 (history)  Vaccinated:2008-02-13
Age:16.0  Onset:0000-00-00
Gender:Male  Submitted:2008-02-15
Location:Florida  Entered:2008-02-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: MOTHER DENIED AT TIME OF VACCINATION
Preexisting Conditions: TODAY MOTHER STATED THAT CHILD HAS THROMBOCYTOPENIA
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0379U1IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB211AA1IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03011SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1308U1SCRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2824AA1IDLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1506U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash papular, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad)
Write-up: MOTHER STATES THAT RASH APPEARED APPROX. 2 HRS. AFTER HE RECEIVED VACCINES. RASH APPEARS ASYMMTRICAL, PINK IN COLOR, AND RAISED. RASH COVERS NECK, TORSO, ARMS, LEGS, FEET AND HANDS. DENIES ANY RESP. OR SWALLOWNIG DIFFICULTY.

VAERS ID:305121 (history)  Vaccinated:2007-11-01
Age:16.0  Onset:2007-11-01, Days after vaccination: 0
Gender:Female  Submitted:2008-02-18, Days after onset: 109
Location:Pennsylvania  Entered:2008-02-19, 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:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': WAES0802USA02114
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a consumer concerning her 16 year old daughter with no medical history and no drug allergies, who in November 2007, was vaccinated IM with a 0.5 mL first dose of Gardasil. Concomitant vaccination included Recombivax. Subsequently, the patient was pregnant. In November 2007, the patient had a miscarriage at approximately 16 weeks. The gestation period at the time of the first dose was unknown. The patient was hospitalized for approximately 2-3 days. No laboratory diagnostics were performed. The patient did not discontinue her dosing schedule. The patient was vaccinated with a second dose of Gardasil on 08-FEB-2008. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Upon internal review miscarriage was determined to be an other important medical event. Additional information has been requested.

VAERS ID:305137 (history)  Vaccinated:2008-02-18
Age:16.0  Onset:2008-02-18, Days after vaccination: 0
Gender:Female  Submitted:2008-02-19, Days after onset: 1
Location:Virginia  Entered:2008-02-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1063U2IMLA
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 HAD SYNCOPAL EPISODE AFTER VACCINE WAS ADMINISTERED.

VAERS ID:305156 (history)  Vaccinated:2008-02-04
Age:16.0  Onset:2008-02-04, Days after vaccination: 0
Gender:Female  Submitted:2008-02-11, Days after onset: 7
Location:New York  Entered:2008-02-19, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Guillain Barre Syndrome 2/05, Bactrim 3/10/08-records received-PMH: GBS 3 years ago, diagnosed by EMG. Chronic headaches and stomaches may be related to anxiety. Bladder infection 2 weeks ago.
Diagnostic Lab Data: MRI spine negative 3/10/08-records received-MRI lumbar spine, normal.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Burning sensation, Ear pain, Eyelid oedema, Facial pain, Fatigue, Headache, Hypoaesthesia, Lethargy, Muscular weakness, Nuclear magnetic resonance imaging normal, Pain in extremity, Rash, Tenderness
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: Pain in face, ears. Pain and weakness and numbness in legs. Improved 2/11/08 still with headache & leg pains. 3/10/08-records received for DOS 2/5-2/6/08-Admission diagnoses weakness, decreased sensation and facial pain. Condition improved at time of discharge. C/O facial pain, leg pain, weakness, headache one hour after vaccination. Face felt burning and shooting pain to ears. Shooting pain in legs, trouble walking, tired, lethargic. Rash and swelling of eyes. PE: tenderness in palpation of spine, decreased sensation below L1.

VAERS ID:305168 (history)  Vaccinated:2008-02-05
Age:16.0  Onset:2008-02-06, Days after vaccination: 1
Gender:Male  Submitted:2008-02-11, Days after onset: 5
Location:Pennsylvania  Entered:2008-02-19, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Cold Sx
Preexisting Conditions: None
Diagnostic Lab Data: CAT Scan
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2546AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B021AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Computerised tomogram, Head injury, Loss of consciousness, Suture insertion
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: Child was getting ready for school on 2/6, passed out, hit head. Mom had to take to ER and had 6 sutures put in. Child received vaccines 2/5/2008.

VAERS ID:305433 (history)  Vaccinated:2007-12-28
Age:16.0  Onset:2007-12-28, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 48
Location:California  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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0801USA00969
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0755U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a registered nurse concerning a 16 year old white female with no allergies, who, on 28-DEC-2007 at 15:30 was vaccinated intramuscularly in the left deltoid with a first dose of Gardasil (Lot# 658219/0755U). On 25-DEC-2007 at 15:30 the patient had fainted in the office and became alert within seconds after laying down. The patient was monitored for 15 to 20 minutes in the office. It was reported that the patient was fine when she left the office with her parent. No ill effects were noted. The patient recovered on 28-DEC-2007. No product quality complaint was involved. Additional information has been requested.

VAERS ID:305439 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:California  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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0801USA01026
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: Information has been received from a physician concerning a 16 year old female who on an unspecified date was vaccinated with Gardasil (lot# unknown) injection. Subsequently the patient experienced heavy vaginal bleeding after the first dose of Gardasil. Medical attention was sought. The patient experienced this for 10 to 12 days and it only stopped when (estrogens, conjugated) PREMARIN (manufacturer unknown) was administered. Therapy with human papillomavirus vaccine was discontinued. Subsequently, the patient recovered from heavy vaginal bleeding on an unspecified date. No further information was available. Additional information has been requested.

VAERS ID:305619 (history)  Vaccinated:2007-12-21
Age:16.0  Onset:2007-12-21, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 55
Location:North Dakota  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: Unknown
Diagnostic Lab Data: None
CDC 'Split Type': WAES0801USA02008
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1063U0IMUN
Administered by: Public     Purchased by: Public
Symptoms: Decreased appetite, Feeling hot, Influenza like illness, Injection site pain, Malaise, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Initial and follow up information has been received from a registered nurse (previously reported as a licensed practical nurse) concerning a 13 year old female patient, who in late December 2007 ("right before Christmas") was vaccinated with the first dose of Gardasil (lot # not reported). The patient did not receive a concomitant vaccine (previously reported that patient received influenza virus vaccine on same day). Within 15 minutes of the vaccination, the patient experienced "a whoosh/warm feeling going through her upper leg, the shot felt uncomfortable and the area was tender." The nurse added that the patient had flu-like symptoms, including body aches and malaise, as well as nausea. The symptoms lasted for 1 1/2 days. It was reported that there were flu symptoms going around the town. No further information was provided. It was reported that another patient experienced symptoms after receiving the Gardasil. (WAES # 0801USA02289). Additional information is not expected. 04/07/2008 Initial and follow up information has been received from a registered nurse (previously reported as a licensed practical nurse) concerning a 15 year old female student patient who in late December 2007 ("right before Christmas") was vaccinated with the first dose of GARDASIL (lot # not reported). The patient did not receive a concomitant vaccine (previously reported that patient received influenza virus vaccine on same day). Within 15 minutes of the vaccination, the patient experienced "a whoosh/warm feeling going through her upper leg, the spot felt uncomfortable and the area was tender". The nurse added that the patient had flu-like symptoms, including body aches and malaise, as well as nausea. The symptoms lasted for 1 1/2 days. It was reported that there were flu symptoms going around the town. No further information was provided. In follow-up it was reported that on 21-DEC-2007, the patient a 15 year old female student with no illness at the time of vaccination and no pre-existing allergies, birth defects or medical conditions was vaccinated intramuscularly into the "LT" with the first dose of GARDASIL, (Lot # 658563/106U). It was reported that the patient felt injection: immediate warmth throughout, became sick later in the day i.e. body aches, nausea, tired and no appetite. It was reported that another patient experienced symptoms after receiving the GARDASIL, (WAES # 0801USA02289). Additional information is not expected.

VAERS ID:305620 (history)  Vaccinated:2007-09-25
Age:16.0  Onset:2007-09-25, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 142
Location:New Jersey  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: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0801USA02013
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
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 certified medical assistant concerning an 18 year old female. It was reported that the patient fainted after receiving her first dose Gardasil. Lot number was not available. The patient recovered and no further information was given. Additional information has been requested.

VAERS ID:305635 (history)  Vaccinated:2007-08-06
Age:16.0  Onset:2007-08-06, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 192
Location:Unknown  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: doxycycline
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type': WAES0801USA02467
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0012U0IMUN
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 16 year old female who on 06-AUG-2007 was vaccinated intramuscularly with the first dose of GARDASIL. Concomitant therapy included doxycycline. On 06-AUG-2007 the patient fainted while leaving the office. The patient was brought back into the office and monitored for 30 minutes. Subsequently, the patient recovered from fainting while leaving the office. The patient has not received the second dose of GARDASIL and no further information is available. Additional information has been requested.

VAERS ID:305636 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
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:
CDC 'Split Type': WAES0801USA02469
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a health professional concerning a 16 year old female who was vaccinated with the third dose of GARDASIL. The mother of the patient stated that shortly after vaccination, the patient experienced swelling at the injection site and redness at the injection site. The patient sought unspecified medical attention. At the time of report, the patient was recovering from swelling at the injection site and redness at the injection site. No other information is available. Additional information has been requested.

VAERS ID:305908 (history)  Vaccinated:0000-00-00
Age:16.0  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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tetanus toxoid
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0801USA03560
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site vesicles
SMQs:
Write-up: Information has been received from a physician concerning a 16 year old female who was vaccinated with Gardasil. Concomitant therapy included tetanus toxoid in the same arm. The patient developed a blister at the injection site. The patient''s sister also received the first dose of Gardasil and had the same adverse event (WAES #0801USA01424). Subsequently, the patient recovered. No further information was provided regarding this adverse experience. This is one of several reports from the same source. Additional information has been requested.

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