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Case Details (Sorted by Age)

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VAERS ID:301726 (history)  Vaccinated:2007-10-20
Age:18.0  Onset:2007-10-20, Days after vaccination: 0
Gender:Female  Submitted:2008-01-03, Days after onset: 75
Location:Unknown  Entered:2008-01-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 10/5/2007)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 12/14/07, did not detect a fetal heartbeat; ultrasound, 12/17/07, did not detect a fetal heartbeat; beta-human chorionic, 10?/??/07, positive
CDC Split Type: WAES0712USA08672
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Foetal heart rate abnormal, Pregnancy test positive, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from an RN concerning an 18 year old female patient who had delivered her first child in January 2007 who on 20-OCT-2007 was vaccinated IM with a a first dose of Gardasil. Within 2 weeks she had a positive pregnancy test at another facility. Her LMP was 05-OCT-2007. Sonagrams on 14-DEC-2007 and 17-DEC-2007 did not detect a fetal heartbeat. It was reported that she "later" miscarried. Medical attention was sought in the office. Her outcome was not reported. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.

VAERS ID:301737 (history)  Vaccinated:2007-12-14
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-28
Location:Maine  Entered:2008-01-04, 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 known
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2765AA IMLA
Administered by: Private     Purchased by: Public
Symptoms: Unevaluable event
SMQs:
Write-up: None

VAERS ID:301788 (history)  Vaccinated:2007-07-16
Age:18.0  Onset:2007-07-16, Days after vaccination: 0
Gender:Female  Submitted:2008-01-07, Days after onset: 175
Location:Texas  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: DEPACOTE, LAMICTAL, SEASONAL
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0523U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pharyngeal oedema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: PT RECEIVED HER FIRST GARDASIL ON 7/16/2007. WHILE PT WAS AT THE OFFICE HAD NO COMPLAINTS. SHE HAD THE GARDASIL WHILE AWAY AT COLLEGE. SHE RETURNED TO US LAST WEEK FOR FU AND REPORTED THAT AFTER BOTH 1ST & 2ND INJECTIONS SHE HAD HIVES AND THROAT SWELLING.

VAERS ID:301970 (history)  Vaccinated:2007-12-31
Age:18.0  Onset:2008-01-01, Days after vaccination: 1
Gender:Female  Submitted:2008-01-04, Days after onset: 3
Location:California  Entered:2008-01-08, 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, BCP''s
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.1448U0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Nausea, headache, dizziness - next day after vaccine administration.

VAERS ID:301999 (history)  Vaccinated:2007-12-14
Age:18.0  Onset:2007-12-15, Days after vaccination: 1
Gender:Female  Submitted:2008-01-04, Days after onset: 20
Location:Michigan  Entered:2008-01-08, 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: 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.1266U2IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness, itching on arm started 1 day after vaccine given; seen 4 days after vaccine with 2 inch area redness, induration, tenderness around vaccine site.

VAERS ID:302068 (history)  Vaccinated:2007-07-26
Age:18.0  Onset:2007-10-20, Days after vaccination: 86
Gender:Female  Submitted:2008-01-08, Days after onset: 80
Location:Ohio  Entered:2008-01-09, 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: Birth control pills
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Nerve conduction study. Labs and Diagnostics: NCS/EMG (+) for mild polyneuropathy.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB184AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2327A0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Areflexia, Electromyogram abnormal, Foot deformity, Guillain-Barre syndrome, Hypoaesthesia, Hyporeflexia, Nerve conduction studies abnormal, Pain in extremity, Polyneuropathy, Sensory loss, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Developed numbness in her feet, right more than left. No weakness of the muscle. Developed sometime in October 2007. Mother reports patient did develop a viral syndrome about a month before the onset of the numbness. She was not seen by any Doctors for that. I saw her on November 11,07 and sent her to see the pediatric neurologist on 11-27-07 . Nerve conduction study showed mild polyneuropathy and diagnosis of Guillain-Barre syndrome was made. No treatment was given. 01/10/2008 MR received for OVs 7/26/07 to 11/20/07 and Neuro report dated 11/27/07. WCC on 7/26/07 with normal exam. Next visit 11/20/07 with c/o "feet falling asleep x 3-4 weeks". PE (+) for decreased sensation R foot, DTRs decreased. Referred to Neuro. Neuro visit 11/27/07 with c/o numbness and foot pain when walking. Reduced sensation upper and lower extremities. OV 12/13/07 with PE (+) for areflexia and distal decreased appreciation of touch and temp. DX: Guillain-Barre Syndrome 9/04/2008 MR received from Neuro including EMG/NCS as reported above. F/U 12/13/07 with numbness ongoing. Seen again 1/03/2008. Pt had some resolution, but numbness returned, most pronounced in R leg and now hands. Unable to elicit DTRs in upper extremities. F/U 8/21/08 with increased pain in feet. DTRs absent in upper and lower extremities with normal sensation. (+) Pes planus.

VAERS ID:302479 (history)  Vaccinated:2007-07-25
Age:18.0  Onset:2007-07-25, Days after vaccination: 0
Gender:Female  Submitted:2008-01-04, Days after onset: 163
Location:Washington  Entered:2008-01-09, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Coccidioidomycosis
Diagnostic Lab Data: serum measles IgG 10/03/07 - positive; serum mumps IgG antibody 09/27/07 - positive; serum rubella IgG 09/27/07 - positive; serum varicella zoster 10/05/07 - negative
CDC Split Type: WAES0707USA04382
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B0BAA0UNUN
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0144R0UNUN
HEPA: HEP A (VAQTA)MERCK & CO. INC.1213F0UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.0171U0UNUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR20001-20UNUN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0652U0UNUN
Administered by: Public     Purchased by: Public
Symptoms: Antibody test negative, Inappropriate schedule of drug administration, Measles antibody positive, Medication error, Mumps antibody test positive, Pain in extremity, Rubella antibody positive
SMQs:
Write-up: Information has been received from a registered nurse concerning an 18 (also reported as 16) year old female with a history in 2003 of Valley Fever who on 25-JUL-2007 was vaccinated in the left upper arm with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (Lot #657879/0652U). Additional suspect vaccination included a first dose of hepatitis A virus vaccine inactivated (MSD) (lot # 656497/1213F) given in the right deltoid, a first dose of hepatitis B virus vaccine rHBsAg (yeast) (MSD) (lot # 650890/0144R) given in the left deltoid, and a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (MSD) (lot # 655620/0171U) given in the right deltoid. Concomitant therapy included a first dose of poliovirus vaccine inactivated (Vero) (IPOL) (lot # 20001-2) given in the right upper arm and a first dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (INFANRIX) (Lot#AC52B03AA) given in the left deltoid. There was no illness at the time of vaccination. No symptoms were reported. There was no product quality complaint involved. Follow up information was received from the nurse who noted that the patient was an un-immunized teen, and she "glitched" and gave her the measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) without thinking about the patient''s age. She received six vaccinations that day. The nurse added that the patient was fine afterwards. Additional follow-up information from the registered nurse indicated that the patient had some slight soreness in her arms from the multiple shots. It was noted that the right deltoid HPV rL1 6 11 16 18 VLP vaccine (yeast) (MSD) (lot # 655620/0171U) injection site was sore for 3-4 days. On 21-SEP-2007 specimens were collected, the patient''s

VAERS ID:302585 (history)  Vaccinated:2007-08-13
Age:18.0  Onset:2007-08-13, Days after vaccination: 0
Gender:Female  Submitted:2007-12-17, Days after onset: 126
Location:Pennsylvania  Entered:2008-01-09, Days after submission: 23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control
Current Illness: Unknown
Preexisting Conditions: The subject was receiving unspecified birth control at the time of vaccination. Medical history and/or concurrent medications were not reported.
Diagnostic Lab Data: UNK
CDC Split Type: A0671306A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B129AA2UNRA
Administered by: Public     Purchased by: Public
Symptoms: Headache, Inappropriate schedule of drug administration, Injection site pain, Local reaction, Wrong drug administered
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a consumer and described the occurrence of headache in a 18-year-old female subject who was vaccinated with Pediarix for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medications included Birth control. On 13 August 2007, the subject presented for vaccination with Gardasil. Instead, on 13 August 2007 at 11:15 the subject was mistakenly vaccinated with Pediarix (unknown, right arm) instead of Gardasil. The consumer reported that she was notified that she received "the third dose of Pediarix". On 13 August 2007, less than one day after vaccination with Pediarix, the subject experienced headache and arm pain at injection site. At the time of reporting the outcome of the events were was unspecified. On 16 October 2007, follow-up was received from the healthcare professional. The reporter indicated that on 13 August 2007, the subject experienced a headache and arm pain at the injection site. she was diagnosed with a local reaction. The headache and arm pain lasted less that twenty four hours. The events resolved on 14 August 2007. The reporter considered that the events were not serious and related to the use of Pediarix. She noted that the events could have been associated with the erroneous administration of Pediarix.

VAERS ID:302459 (history)  Vaccinated:2008-01-10
Age:18.0  Onset:2008-01-10, Days after vaccination: 0
Gender:Male  Submitted:2008-01-11, Days after onset: 1
Location:California  Entered:2008-01-11
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: Anxiety
Diagnostic Lab Data: ECG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURER  IDUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Electrocardiogram, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Syncopy Episode.

VAERS ID:302670 (history)  Vaccinated:2008-01-04
Age:18.0  Onset:2008-01-04, Days after vaccination: 0
Gender:Female  Submitted:2008-01-04, Days after onset: 0
Location:New Jersey  Entered:2008-01-14, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U0IMRL
Administered by: Private     Purchased by: Private
Symptoms: Feeling hot, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Client states she felt "very hot" after vaccination and then fainted. Client felt fine within several minutes.

VAERS ID:302710 (history)  Vaccinated:2007-08-02
Age:18.0  Onset:2007-08-02, Days after vaccination: 0
Gender:Female  Submitted:2008-01-14, Days after onset: 165
Location:Washington  Entered:2008-01-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP=Unknown); Penicillin allergy; Hypersensitivity; Seasonal allergy
Preexisting Conditions:
Diagnostic Lab Data: beta-human chorionic 10/01/07 posit
CDC Split Type: WAES0801USA00401
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.0171U0IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood gonadotrophin decreased, Drug exposure during pregnancy, Pregnancy test positive, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a nurse concerning an 18 year old female with no pertinent medical history, seasonal allergies and allergies to nickel and penicillin who on 02-AUG-2007 was vaccinated intramuscularly (site not reported) with the 1st dose of the 0.5 ml Gardasil (lot#655620/0171U). The patient was concomitantly vaccinated with Varivax (MSD) and DTaP (manufacturer unknown). On 15-AUG-2007, the patient was seen in the emergency room with lowering hcg levels and some vaginal bleeding. On 16-AUG-2007 and 17-AUG-2007, the patient returned to the emergency room with continuing decreasing hcg levels and later had a spontaneous abortion (exact date not reported). On 01-OCT-2007, the patient was vaccinated intramuscularly (site not reported) with the 2nd dose of the 0.5 ml Gardasil (lot#658094/0524U) while pregnant (WAES#0801USA01237). Follow-up information was received from the nurse stating that the exact date of the spontaneous abortion and LMP after the 2nd dose of the Gardasil vaccine is unknown. Upon internal review spontaneous abortion was considered to be an other important medical events. Additional information has been requested.

VAERS ID:302769 (history)  Vaccinated:2007-12-26
Age:18.0  Onset:2008-01-06, Days after vaccination: 11
Gender:Female  Submitted:2008-01-15, Days after onset: 9
Location:Nebraska  Entered:2008-01-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Yaz, Saratem
Current Illness:
Preexisting Conditions: Allergy to Cefzil, codeine
Diagnostic Lab Data: Unknown, done at another facility
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1287U0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Lethargy, Musculoskeletal stiffness, Pyrexia, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Administered 12-26-07; rash 1-6-08; large welts, joint pain, stiffness, lethargy, fever, etc. follow 1 week after rash.

VAERS ID:302816 (history)  Vaccinated:2008-01-08
Age:18.0  Onset:2008-01-08, Days after vaccination: 0
Gender:Female  Submitted:2008-01-16, Days after onset: 8
Location:Ohio  Entered:2008-01-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: N/A~ ()~~0~In Patient
Other Medications: Pt is also on Depo Provera birth control injections every 3 months and that was also received on the same day.
Current Illness: None
Preexisting Conditions: Possible allergy to Bactrim DS? - Gives her upset stomach so probably not a true allergy.
Diagnostic Lab Data: Patient was not harmed by receiving the vaccine in error.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B128AB IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
SMQs:
Write-up: MA was taking care of a nurse visit for vaccination only and the patient was supposed to be coming in for Gardasil Vaccine but we noticed that she also needed updated on her Tetanus also. MA erroneously gave a Pediarix vaccine to the patient instead of Gardasil or Tdap. The error was not noticed until the patient had left. The patient was notified and I persoanally called the CDC Vaccine Hotline to make sure the patient would be OK.

VAERS ID:302928 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:0000-00-00
Gender:Male  Submitted:2008-01-08
Location:Colorado  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:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Hepatitis B antibody negative
CDC Split Type: A0662995A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB287BA2UNLA
Administered by: Private     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 hepatitis B antibody negative in an 18 year old male subject who was vaccinated with Engerix B for prophylaxis. On an unspecified date the subject received 3rd dose of Engerix B in an unknown deltoid to complete the three dose series. On an unspecified date following completion of the Engerix B series, the subject had a negative titer. The reporter suspected a possible quality issue with the vaccine. At the time of reporting the outcome of the events was unspecified.

VAERS ID:303100 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:0000-00-00
Gender:Male  Submitted:2008-01-08
Location:New Jersey  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: Salbutamol sulphate
Current Illness: Asthma; decreased IGG; plastic bronchitis
Preexisting Conditions: No history of adverse events following previous vaccinations.
Diagnostic Lab Data: Hepatitis B antibody 22Jun2007 negative
CDC Split Type: A0660276A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  UNLA
Administered by: Private     Purchased by: Other
Symptoms: Hepatitis B antibody negative, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)
Write-up: This case was reported by the mother of a consumer and described the occurrence of a 18-year-old male subject not responding to therapy following vaccination with Engerix B for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included asthma, decreased igg and plastic bronchitis. Concurrent medications included Salbutamol sulphate (Albuterol). In 1991 the subject completed the standard dosing schedule for vaccination with Engerix B (unknown). A blood test for titer detection performed on 22 June 2007 revealed non-detectable titers for hepatitis B. The subject was considered to have not responded to therapy. At the time of reporting the event was unresolved. No additional details expected.

VAERS ID:303110 (history)  Vaccinated:2007-03-29
Age:18.0  Onset:2007-04-13, Days after vaccination: 15
Gender:Female  Submitted:2008-01-07, Days after onset: 269
Location:Massachusetts  Entered:2008-01-16, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 10 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: [therapy unspecified]
Current Illness: General symptom
Preexisting Conditions: PMH: Spinal sub-dural hematoma, Asthma, Migraines, Endometriosis, Bipolar Depression, Hep B. Allergy to codeine.
Diagnostic Lab Data: Unknown. Labs and Diagnostics: EMG/NCS suggestive of GBS.
CDC Split Type: WAES0712USA01735
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0188U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abasia, Areflexia, Electromyogram abnormal, Fatigue, Guillain-Barre syndrome, Headache, Muscular weakness, Nerve conduction studies abnormal, Paraesthesia, Sensory loss, Throat irritation, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow)
Write-up: Information has been received from a physician, via a company representative, concerning an 18 year old female patient with a "lengthy medical history" (details not provided), who on 29-MAR-2007 was vaccinated with the first dose of Gardasil (lot #657006/0188U). Concomitant therapy included a "lengthy medication list" (medications not provided). On 13-APR-2007, 15 days after vaccination, the patient experienced symptoms of Guillain Barre syndrome. On 14-APR-2007, she was admitted to the hospital, and was discharged on 22-APR-2007 (details not provided). On 25-APR-2007, the patient was again admitted to the hospital, and released on 27-APR-2007 (details not provided). At the time of this report, the patient was recovering from the event. Additional information has been requested. 02/29/2008 Per email from CDC: CDC''s CISA staff has determined this case to be GBS Brighton level 2. 02/29/2008 MR received from CDC for visits from 5/2007 to 7/2007 from multiple sources including neurology. DX: Guillain-Barre Syndrome. Pt presented to ER 4/12/2007 with c/o leg weakness with PE suggestive of GBS (bilateral ascending paresthesias and weakness). LP defered due to hx of spinal subdural hematoma. Txd with IVIG. Admitted until 4/23/07. Re-admitted 4/25/07 unable to walk and with c/o throat tremors, hand tremors, difficulty lifting objects, and increased fatigue. DTRs in lower extremities absent and decreased vibratory sensation. Improvement noted by 7/2007 OV with new c/o headaches.

VAERS ID:303115 (history)  Vaccinated:2007-10-09
Age:18.0  Onset:2007-10-09, Days after vaccination: 0
Gender:Female  Submitted:2008-01-07, Days after onset: 90
Location:Washington  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: Pregnancy NOS (LMP = 8/29/2007)
Preexisting Conditions:
Diagnostic Lab Data: beta-human chorionic, positive; hematology
CDC Split Type: WAES0712USA02146
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Haematology test, Nasopharyngitis, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received through the Merck pregnancy registry through an 18 year old female consumer who on 09-OCT-2007 was vaccinated with her first dose of Gardasil. Concomitant therapy included hepatitis B virus vaccine (unspecified), varicella virus vaccine live (unspecified), meningococcal vaccine (unspecified) and tetanus toxoid. The patient experienced mild cold symptoms for approximately 1 day following the vaccinations. On 16-OCT-2007, the patient found out she was pregnant (LMP approximately 29-AUG-2007). The patient sought unspecified medical attention with her physician. The patient had a pregnancy test and unspecified blood work performed. Additional information has been requested.

VAERS ID:303123 (history)  Vaccinated:2007-05-18
Age:18.0  Onset:2007-05-25, Days after vaccination: 7
Gender:Female  Submitted:2008-01-07, Days after onset: 227
Location:Massachusetts  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: Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA02328
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0244U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 19 year old female with penicillin allergy who on 18-MAY-2007 was vaccinated (site and route not reported) with the 1st dose of Gardasil (lot# 656051/0244U). On 17-Jul-2007, the patient was vaccinated (site and route not reported) with the 2nd dose of the Gardasil (lot#658100/0525U). On 23-Nov-2007, the patient was vaccinated (site and route not reported) with the 3rd dose of the Gardasil (lot#658560/1062U). On approximately 25-MAY-2007, 24-JUL-2007 and 30-NOV-2007, 7 days post vaccination, the patient developed a rash all over her body. The physician stated that she was only aware of the rash after the 1st dose of the vaccine. The patient was treated, the 1st time with a topical steroid. No diagnostic laboratory tests were performed. The patient recovered. No other information available. Additional information has been requested.

VAERS ID:303153 (history)  Vaccinated:2003-08-21
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-08
Location:Indiana  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:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: A titer taken on 20 April 2007 indicated that the subject was not seroprotected. The subject was negative for hepatitis B antibodies.
CDC Split Type: A0649169A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2UNLA
Administered by: Public     Purchased by: Other
Symptoms: Hepatitis B antibody, Hepatitis B antibody negative
SMQs:
Write-up: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult female subject who was vaccinated with Engerix B vaccine (manufacturer unknown) for prophylaxis. On unspecified dates the subject received unspecified doses of a complete Engerix B vaccine series (manufacturer unknown). At an unspecified time after completing vaccination a Engerix B vaccine series, the subject was found to have lack of seroconversion. The reporter noted that the subject had to have the series as a medical student, but was not sure which series the subject received. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with Engerix B. Follow-up information received later the same day of initial reporting indicated the dates of receipt of Engerix B. The dates were 21 August 2003, 29 March 2003 and 28 February 2003. A titer taken on 20 April 2007 indicated that the subject was not seroprotected following receipt of the Engerix B three dose series completed four years ago. Follow-up information received on 14 May 2007 indicated that the reporter had limited information on this case as the subject was a student that requested a hepatitis titer as a requirement for continuing on at another school. The subject has been lost to follow-up. It was reported that the subject was 22 years old at the time the titer was performed.

VAERS ID:303426 (history)  Vaccinated:2007-09-04
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-07
Location:Unknown  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: Diagnostic laboratory results not reported
CDC Split Type: WAES0712USA01164
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0515U0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Joint sprain, Joint swelling, Laboratory test, Subcutaneous nodule
SMQs:, Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Information has been received from the father of a 16 year old female consumer with no medical history and/or drug reactions/allergies who on 04-Sep-2007 was vaccinated IM with the first 0.5 mL dose of Gardasil (lot not reported). There was no concomitant medication. During the first part of October, 2007, the patient experienced swollen ankle. The patient went to the ER and was diagnosed with ankle sprain. "A couple of days later" her other ankle swelled. At the time of the report the patient was experiencing pain in her ankles, knees, hips, elbows and wrists and she has "subcutaneous nodules" on her arms and legs." Unspecified blood work was performed (results not provided). At the time of the report the patient was recovering. There was no product quality complaint. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/7/2008. Information has been received from the father of a 16 year old female (119 lbs., 62 inches) with no medical history and/or drug reactions/allergies who on 04-SEP-2007 was vaccinated IM with the first 0.5 mL dose of GARDASIL vaccine (Lot #657872/0515U). There was no concomitant medication. During "the first part of October, 2007, the patient experienced swollen ankle. The patient went to the ER and was diagnosed with ankle sprain. "A couple of days later" her other ankle swelled. At the time of the report the patient was experiencing pain in her ankles, knees, hips, elbows and wrists and she has "subcutaneous nodules" on her arm and legs." Unspecified blood work was performed (results not provided). The patient recovered from her experiences on 17-DEC-2007. No further information is expected.

VAERS ID:303431 (history)  Vaccinated:2007-11-21
Age:18.0  Onset:2007-11-21, Days after vaccination: 0
Gender:Female  Submitted:2008-01-07, Days after onset: 47
Location:Pennsylvania  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: Unknown
Current Illness:
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA01222
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0525U0UNUN
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a health care professional concerning an 18 year old white female college student weighing 165 pounds and height of 5'' 3" with a history of asthma and no known drug allergies or illnesses at time of vaccination who on 21-NOV-2007 was vaccinated in the left deltoid with the first dose of Gardasil (lot # 658100/0525U). It was reported that within 5 minutes after vaccination, the patient complained of nausea and dizziness. The patient had stood up. The patient was told to stay seated and was given cold compresses on back of neck and head and was told to lower her head. The patient was also given water and crackers. After 30 minutes the patient was allowed to go home. The patient also complained of left hand tingling after 5 to 10 minutes of vaccination. The patient recovered on 21-NOV-2007. No laboratory diagnostic tests were performed. No further information is available.

VAERS ID:303432 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-07
Location:California  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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA01229
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Pallor
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning an 18 year old female who was vaccinated with a dose of Gardasil. The patient became pale and lightheaded. Subsequently, the patient recovered from pale and lightheaded. Additional information has been requested.

VAERS ID:303436 (history)  Vaccinated:2007-09-13
Age:18.0  Onset:2007-10-15, Days after vaccination: 32
Gender:Female  Submitted:2008-01-07, Days after onset: 84
Location:New York  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: (Therapy unspecified) Albuterol
Current Illness: Pregnancy NOS (LMP = 10/15/2007) Convulsion; Asthma; Papanicolaou smear abnormal
Preexisting Conditions:
Diagnostic Lab Data: Cervical smear 03/15/07 epithelial abnormality and cellular changes suggestive of HPV; cervical smear negative; urine beta-human 09/13/07 negative; urine beta-human 10/15/07 negative; urine beta-human 11/25/07 positive.
CDC Split Type: WAES0712USA01382
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1426F2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Smear cervix abnormal, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a licensed practical nurse concerning a 19 year old female with seizure disorder, asthma, a papanicolaou smear with epithelial abnormality and cellular changes suggestive of HPV on 15-Mar-2007, and a papanicolaou smear that was negative two years earlier, who on 15-Mar-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot #654535/0960F). On 21-Jun-2007 the patient was vaccinated with a second dose of Gardasil (Lot #655617/1447F). On 13-Sep-2007 the patient was vaccinated with a third dose of Gardasil (Lot #655205/1426F). Concomitant therapy included albuterol inhaler as needed and a seizure disorder medication (therapy unspecified) that was stopped on an unknown date by the patient before the pregnancy. On 13-Sep-2007 a urine pregnancy test was taken and was negative. On 15-Oct-2007 the patient experienced a syncopal episode and a urine pregnancy test was negative. On 25-Nov-2007 the patient was seen in the office and a urine pregnancy test was positive. The patient''s last menstrual period was 15-Oct-2007 and her estimated delivery date was 21-Jul-2007. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.

VAERS ID:303450 (history)  Vaccinated:2007-05-21
Age:18.0  Onset:2007-05-21, Days after vaccination: 0
Gender:Female  Submitted:2008-01-07, Days after onset: 231
Location:New Hampshire  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: Pregnancy NOS (LMP = 3/1/2007); asthma exercise induced
Preexisting Conditions: Herpes simplex; papilloma viral infection
Diagnostic Lab Data: beta-human chorionic, positive; Pap test; positive; prenatal screening tests (not specified) were normal; ultrasound, 11/30/07, results not listed; serum alpha-fetoprotein, 08/17/07, negative
CDC Split Type: WAES0712USA01486
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0389U0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Injection site nodule, Laboratory test normal, Smear cervix abnormal, Ultrasound scan
SMQs:, Tumour markers (narrow), Extravasation events (injections, infusions and implants) (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: This is in follow-up to report(s) previously submitted on 1/7/2008; 4/7/2008. Information has been received through the Merck pregnancy registry through a health professional concerning an 18 year old female with a history of Herpes simplex, a positive Human Papillomavirus test and sports induced asthma, who on 21-MAY-2007 was vaccinated intramuscularly in the left deltoid with her first dose of Gardasil (Lot # 657736/0389U). On 21-MAY-2007, the patient developed a bump on her left arm at the injection site. The bump on her arm resolved without treatment. On 12-JUL-2007, the patient was vaccinated intramuscularly in the right deltoid with her second dose of Gardasil (Lot # 658100/0525U). On an unspecified date the patient found out she was pregnant (LMP approximately 01-MAR-2007). On 16-AUG-2007, the patient reported the pregnancy at an office visit. On 17-AUG-2007, the patient had a serum alpha-fetoprotein test which was negative. On 30-NOV-2007, the patient had an ultrasound for screening. Prenatal screening tests (not specified) were normal. Concomitant medications include VALTREX to prevent a Herpes simplex outbreak at the time of delivery. Additional information has been requested. Follow up information indicated that on 02-Jan-2008, the patient delivered a normal female baby at 39 weeks from the LMP. The baby weighed 2267 grams and had an apgar score of 8/9. It was also reported that the baby "size was less than dates." No further information is available.

VAERS ID:302923 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-17
Location:Arizona  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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site induration, Wrong technique in drug usage process
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient reported that vaccine was administered via IM injection to the dorsogluteal region two months ago and has resulted in a "hole" or depression of the tissue at the injection site.

VAERS ID:302944 (history)  Vaccinated:2007-06-01
Age:18.0  Onset:2007-06-01, Days after vaccination: 0
Gender:Female  Submitted:2008-01-16, Days after onset: 229
Location:New York  Entered:2008-01-17, 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
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA02179
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
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: Information has been received from a physician''s assistant concerning an 18 year old female who in June 2007, was vaccinated with a first dose of Gardasil (lot# unknown) 0.5 mL injection. In June 2007, on an unspecified date the patient experienced "seizures and became code blue" after receiving Gardasil. Medical attention was sought. No further information was provided. Upon internal review, seizure is considered to be an other medical event (OME). Additional information has been requested.

VAERS ID:303087 (history)  Vaccinated:2008-01-02
Age:18.0  Onset:2008-01-02, Days after vaccination: 0
Gender:Female  Submitted:2008-01-04, Days after onset: 2
Location:Georgia  Entered:2008-01-18, Days after submission: 14
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: Allergic to Mangos
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS0608F2IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2771AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Hypoaesthesia, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Client called to report numbness in left arm, 2 hours after receiving shots on 1/2/08. Arm (Lt) is swollen and red; also she is unable to tolerate any pressure or carry anything heavy.

VAERS ID:303541 (history)  Vaccinated:2007-02-14
Age:18.0  Onset:2007-03-14, Days after vaccination: 28
Gender:Female  Submitted:2008-01-15, Days after onset: 307
Location:Kentucky  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: albuterol
Current Illness: Pregnancy NOS (LMP = 2/28/2007); asthma; penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: total serum human, 02/13/07, negative; complete blood cell, ?/?/07; serum rheumatoid factor, ?/?/07; erythrocyte ABO antigen, ?/?/07; serum hepatitis B Ab, ?/?/07; serum rubella IgG, ?/?/07; HIV antibody screen, ?/?/07; rapid plasma reagin,
CDC Split Type: WAES0705USA00917
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1427F1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test, Delivery, Drug exposure during pregnancy, Full blood count, HIV test, Hepatitis B antibody, Pregnancy test negative, Premature labour, Rheumatoid factor, Rubella antibody test, Syphilis test, Uterine contractions during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a registered nurse through the Merck Pregnancy registry concerning an 18 year old white female with asthma and a penicillin allergy with a history of 0 pregnancies and 0 live births who on 29-NOV-2006 was vaccinated with a dose of Gardasil (Lot 654540/0800F). On 13-FEB-2007, an HCG level was performed and was negative. On 14-FEB-2007, she received her second vaccination (Lot 655619/1427F). Concomitant therapy included albuterol. On approximately 14-MAR-2007 the patient became pregnant (LMP 23-FEB-2007). Laboratory diagnostic studies performed included CBC, prenatal antibody screen, RPR, blood type and screen, hepatitis B screening, rubella status and HIV screening. Results were not provided for these tests. On 11-APR-2007, the patient started taking prenatal vitamins daily. As of 03-MAY-2007, the patient had not reported any difficulties with her pregnancy. On 05-OCT-2007, the patient was given BRETHINE 5 mg and PROCARDIA 10 mg every 4 hours for pre-term labor to stop her contractions. There were reported to have discontinued on 14-NOV-2007. On 20-NOV-2007, the patient gave birth to a liveborn female weighing 7 lbs. 11 oz. She was 38 weeks from her last menstrual period. The infant was reported to be normal and there were no congenital anomalies. The infant was reported to have jaundice but no other symptoms. At the time of this report the infant''s and the patient''s outcome was unknown. No product quality complaint was involved. Additional information is not expected.

VAERS ID:303551 (history)  Vaccinated:2007-02-05
Age:18.0  Onset:2007-03-05, Days after vaccination: 28
Gender:Female  Submitted:2008-01-15, Days after onset: 316
Location:Pennsylvania  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: Pregnancy NOS (LMP = 3/5/2007); Bipolar disorder
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound 05/17/07 normal; ultrasound 07/26/07, normal
CDC Split Type: WAES0711USA03418
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1447F1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Haemorrhage, Ultrasound abdomen normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Initial and follow-up information has been received from the Pregnancy Registry via a registered nurse concerning an 19 year old white female with bipolar disorder who on 05-DEC-2006 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (Lot #653736/0868F). On 05-FEB-2007, the patient was vaccinated intramuscularly with a 0.5 ml second dose of Gardasil (Lot #655617/1447F). There was no concomitant medication. Subsequently, the patient was pregnant. Her last menstrual period was on 05-MAR-2007 and the estimated date of delivery was 10-DEC-2007. On 17-MAY-2007, and ultrasound was performed for bleeding and was found to be normal. The patient had an office visit. At the time of the report the patient''s outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/15/2008. Initial and follow-up information has been received from the Merck Pregnancy Registry via a registered nurse concerning an 19 year old female with bipolar disorder who on 05-DEC-2006 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (Lot #653736/0868F). On 05-FEB-2007 the patient was vaccinated intramuscularly with a 0.5 ml second dose of GARDASIL (Lot #655617/1447F). There was no concomitant medication. Subsequently the patient was pregnant. Her last menstrual period was on 05-MAR-2007 and the estimated date of delivery was 10-DEC-2007. On 17-MAY-2007 an ultrasound was performed for bleeding and was found to be normal. The patient had an office visit. At the time of the report the patient''s outcome was unknown. Follow-up information was received from the registered nurse. The patient had a healthy baby girl on 20-DEC-2007 weighing 8 pounds 7 ounces the length of the baby was 30 inches and the apgar score was 6/9. The patient was 41 wees from LMP. Pre-eclampsia complication was seen during the pregnancy. The baby had shoulder dystocia. On 26-JUL-2007 the patient had an ultrasound and was normal. Additional information is not expected.

VAERS ID:303574 (history)  Vaccinated:0000-00-00
Age:18.0  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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hypersensitivity
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA02636
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Injection site pruritus, Vaccine positive rechallenge
SMQs:
Write-up: Information has been received from the mother of an 18 year old female consumer with a history of "reaction to dioxycycline" who in March 2007, was vaccinated with the first dose of Gardasil. On May 2007 the patient was vaccinated with the second dose of Gardasil. Subsequently the patient experienced itching on the injection site and headache after receiving the first and second dose of Gardasil. The patient''s mother reported the patient''s status as "patient is fine." Additional information has been requested.

VAERS ID:303684 (history)  Vaccinated:2007-04-30
Age:18.0  Onset:2007-05-30, Days after vaccination: 30
Gender:Female  Submitted:2008-01-15, Days after onset: 230
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: Unknown
CDC Split Type: WAES0712USA06045
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anogenital warts, Condition aggravated, Inappropriate schedule of drug administration
SMQs:
Write-up: Information has been received from a physician concerning an 18 year old female patient who on 30-APR-2007 was vaccinated with a first dose of Gardasil. She received her second dose of Gardasil on 12-DEC-2007. The physician reported that the patient developed a "flare up" of genital warts after receiving the second injection. The patient reported that the non specific increase in amount of genital warts began about one month after the patient received the first dose of Gardasil on 30-APR-2007. The physician stated he did not examine the patient and the symptoms were self reported. Additionally, the patient reported the increase in genital warts to the patient''s gynecologist (unspecified name). No other symptoms and no other information available at the time of this report. The outcome was unknown. Additional information has been requested.

VAERS ID:303810 (history)  Vaccinated:0000-00-00
Age:18.0  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:
Current Illness:
Preexisting Conditions: Hypersensitivity
Diagnostic Lab Data: MRSA 12/??/07 - results not available
CDC Split Type: WAES0712USA08391
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMGM
Administered by: Other     Purchased by: Other
Symptoms: Drug administered at inappropriate site, Folliculitis, Furuncle, Incisional drainage, Injection site erythema, Injection site mass, Injection site pain, Methicillin-resistant Staphylococcus aureus test
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a registered nurse, concerning her 18 year old daughter with hypersensitivity to para-amino benzoic acid (PABA) in sunblock, who at the end of November 2007, was vaccinated IM in the right buttock, with a dose of GARDASIL (lot # not reported). Concomitant therapy included ethinyl estradiol/norethindrone acetate (LOESTRIN). In December 2007 (two weeks after vaccination), her daughter, who regularly shaved her genital area, developed folliculitis of the genital area. In addition, she developed a boil at the injection site, on the right buttock that became hard, painful and red. The nurse contacted her daughter''s physician, who referred her to a surgeon. The surgeon lanced the area, and prescribed trimethoprim/sulfamethoxazole (BACTRIM) as treatment. The wound continued to drain, but was less painful. A lab test was performed fro methicillin-resistant Staphylococcus aureus test (MRSA) (results not yet available). At the time of this report, the nurse reported her daughter was recovering from the events. The nurse reported her daughter had never before developed folliculitis and questioned a relationship to GARDASIL. Additional information has been requested.

VAERS ID:304004 (history)  Vaccinated:2007-10-12
Age:18.0  Onset:2007-10-12, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 95
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: WAES0801USA01894
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 an 18 year old female who on 12-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:304006 (history)  Vaccinated:2007-10-15
Age:18.0  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: WAES0801USA01896
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 an 18 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:303475 (history)  Vaccinated:2007-07-25
Age:18.0  Onset:2007-12-17, Days after vaccination: 145
Gender:Female  Submitted:2008-01-23, Days after onset: 37
Location:New Jersey  Entered:2008-01-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: Bell''s palsy PMH: left side Bell''s palsy in infancy
Diagnostic Lab Data: Unknown LABS: CBC, ESR & chemistry WNL. B. burgdorderi abnormal but not indicative of Lyme dx. EMG/NCS done which revealed early demyelinating process involving left ulnar nerve.
CDC Split Type: WAES0801USA03098
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0525U0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2380BA0 RA
Administered by: Other     Purchased by: Other
Symptoms: Areflexia, Borrelia burgdorferi serology, Cerebellar syndrome, Demyelination, Electromyogram abnormal, Eye pain, Full blood count normal, Gait disturbance, Guillain-Barre syndrome, Headache, Hypoaesthesia, IIIrd nerve paresis, Immunoglobulins, Laboratory test normal, Miller Fisher syndrome, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain normal, Nystagmus, Paraesthesia, Red blood cell sedimentation rate normal, Sensorimotor disorder, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Ocular motility disorders (narrow)
Write-up: Initial and follow up information has been received from a registered nurse, concerning a 19 year old female patient with a history of left sided Bell''s palsy (year unknown), who on 25-JUL-2007 was vaccinated with the first dose of Gardasil (lot # 658100/0525U). Concomitant therapy included birth control pills (unspecified manufacturer). On approximately 17-DEC-2007, the patient "developed symptoms" and on 31-DEC-2007 she was hospitalized with "probable Miller-Fisher variant of Guillain Barre syndrome." Her symptoms included ophthalmoparesis and areflexia with stocking-glove distribution. Treatment included immunoglobulin, IgG. On 01-JAN-2008 (previously reported as 07-JAN-2008), the patient was discharged from the hospital. The nurse indicated the patient had a follow up visit scheduled with a neurologist on 07-JAN-2008, though she had no knowledge of the results or findings from the visit. The nurse mentioned that the patient had not received subsequent doses of Gardasil, due to concern about the administration of IgG while in the hospital. At the time of this report, the outcome of the event was unknown. Additional information has been requested. 1/25/08 Follow up initiated at request of CDC. 1/25/08 Received vax record which reveals patient received Menactra U2380BA & Gardisil 0525U on 7/25/07. Admitted to hospital 12/31/07 after outpatient vs to neurologist. Numbness & tingling in hand started approx 2 wks prior & spread to left arm. Developed difficulty focusing, eye pain & numbness in both feet. Exam revealed ophthalmoparesis, areflexia & stocking/glove sensory disturbance. MRI of brain reviewed which was WNL. Nerve conduction studies done which was abnormal. Neuro hospital admit dx: probable Miller Fisher variant of Guillain-Barre syndrome. 2/5/08 Reviewed hospital medical records which reveal patient experienced numbness & tingling of hand & feet, difficulty focusing & eye pain starting approx 12/16/2007. On admit had limited extraocular movements w/left lateral gaze nystagmus, dysmetria on fin

VAERS ID:303527 (history)  Vaccinated:2008-01-18
Age:18.0  Onset:2008-01-19, Days after vaccination: 1
Gender:Male  Submitted:2008-01-24, Days after onset: 5
Location:Wisconsin  Entered:2008-01-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Penicillin allergy/seasonal pollen allergies.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis, Pain, Pyrexia, Vaccination complication, Viral infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad)
Write-up: 1/19/8-Fevers, high of 103.2 degrees, chills, sore body, weak, headache. 1/20/8-Fevers, high of 103.4 degrees, chills, sore body, weak, headache. 1/21/8-Fevers, lower 101.8 degrees, sore body, chills, sweats. 1/22/8-Fevers, 101.7 degrees. 1/23/8-Lower fever in morning 100.9 degrees, went to hospital, ER in AM (fever for 5 days). 1/24/8-No fever in morning today. Prescribed antibiotic at hospital. Hospital Dr. believes he had bad reaction to shot first 2 days plus/or then a virus.

VAERS ID:303636 (history)  Vaccinated:2008-01-24
Age:18.0  Onset:2008-01-25, Days after vaccination: 1
Gender:Female  Submitted:2008-01-25, Days after onset: 0
Location:Pennsylvania  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: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1061U0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Lip swelling, Local swelling, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Swelling of neck, face, lips.

VAERS ID:303856 (history)  Vaccinated:2007-12-24
Age:18.0  Onset:2007-12-24, Days after vaccination: 0
Gender:Female  Submitted:2008-01-08, Days after onset: 15
Location:Pennsylvania  Entered:2008-01-29, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2542AA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2844AA IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURZ09222 IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1584U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Erythema, Skin warm, Tenderness
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (broad)
Write-up: Immunizations given 12/24/07. Eve of 12/24, left upper outer arm became red & warm to touch. By 12/25 pm, area was very red, tender & temp was 100.8 and red area was size of mom''s hand (fist). By 12/26 pm red area was size of mom''s outstretched hand and temp was 100.2. She was seen by Dr. 12/26, 12/27 & 12/28. Rx-Keflex 500 mg QID x5 days.

VAERS ID:303918 (history)  Vaccinated:2007-09-03
Age:18.0  Onset:2007-09-03, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 134
Location:Unknown  Entered:2008-01-29, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions: Asthma
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA08677
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Asthma, Hypoaesthesia, Nausea, Sinusitis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: Information has been received from a health professional concerning an 18 year old white female with asthma who on 03-SEP-2007 was vaccinated with her third dose of GARDASIL intramuscularly in the left deltoid at 12:00. Within 15 minutes of the vaccine the patient felt nauseous followed by a feeling like an asthma attack was occurring. The patient tried her inhaler but it did not help. She collapsed in her dorm room. Emergency services were called and the patient was given oxygen. The medics inserted an IV but never used. The patient complained of feeling numb and the medics helped to unclench her hands and feet. She was taken to the emergency room at a hospital where the symptoms subsided. The patient checked herself out after 2 hours in the emergency room. The patient denied receiving any medication. The patient developed a serious sinus infection and felt weak for 2-3 days after the vaccine. The patient did not use her inhaler the first two times. The patient''s first GARDASIL vaccination was on 27-FEB-2007 and her second dose was on 27-APR-2007. Additional information has been requested. This is in follow-up report(s) previously submitted on 1/15/2008. The patient''s first GARDASIL vaccination was on 27-FEB-2007 and her second dose was on 27-APR-2007. Follow up information was received on 21-FEB-2008 and it was reported that the patient is presently doing well. No other information is expected.

VAERS ID:303906 (history)  Vaccinated:2008-01-22
Age:18.0  Onset:2008-01-27, Days after vaccination: 5
Gender:Female  Submitted:2008-01-30, Days after onset: 3
Location:Arizona  Entered:2008-01-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: ADHD/MOD MR/SEIZURE D/O
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0388U IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2324A1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Condition aggravated, Petit mal epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow)
Write-up: PATIENT HAD A ABSENCE SEIZURE IN HOME ON 01/27/2008. PATIENT HAS HISTORY OF SEIZURES DIS-ORDER. NO RECENT ILLNESS OR FEVERS.

VAERS ID:304344 (history)  Vaccinated:2007-08-29
Age:18.0  Onset:2008-01-28, Days after vaccination: 152
Gender:Male  Submitted:2008-02-05, Days after onset: 8
Location:California  Entered:2008-02-05
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History of meningitis at age 8 3/24/08-records received- PMH: bacterial meningitis at age 8 and multiple URIs and bronchitis infections.
Diagnostic Lab Data: CSF WBC 15,000 (95% PMNs), Gram stain - gram negative diplococci, CSF culture positive for Neisseria meningitidis serogroup Y. 3/24/08-records received-CSF positive gram stain cocci in pairs and chains with 15000 WBC, 2 RBC. CBC, WBC 39.2 with 94% segs, 2 lymp and 4 monos. Hypotensive. Head CT negative. Normal fibrinogen.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2383BA IM 
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Military     Purchased by: Military
Symptoms: Arthralgia, CSF culture positive, CSF white blood cell count increased, Computerised tomogram normal, Diarrhoea, Dry throat, Gram stain, Headache, Hypotension, Malaise, Meningitis meningococcal, Musculoskeletal stiffness, Neutrophil percentage increased, Pharyngolaryngeal pain, Photophobia, Productive cough, Pyrexia, Sputum discoloured, Tachycardia, Vomiting, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Arthritis (broad), Noninfectious diarrhoea (narrow)
Write-up: Patient vaccinated on 8/29/07 with Menactra. Was admitted facility with severe meningococcal meningitis on 1/28/08. Serogroup Y by public health lab. Patient recovering well. He is currently under my care I contacted Sanofi Pasteur about the case and they requested that I submit a VAERS. 3/24/08-records received for DOS 1/29-2/4/08-DC DX: Bacterial Meningitis, Neisseria Meningitidis. Presented with 2 day C/O fever, and not feeling well, 2 days of emesis with concurrent loose stools. Headache with neck stiffness and cough productive of green sputum with dry sore throat. Photophobia. Bilateral joint pain to upper and lower extremities. Temp 103, tachycardic.

VAERS ID:304438 (history)  Vaccinated:2008-02-05
Age:18.0  Onset:2008-02-05, Days after vaccination: 0
Gender:Female  Submitted:2008-02-06, Days after onset: 1
Location:Maryland  Entered:2008-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Had a Cold
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Fainting and seizure.

VAERS ID:304462 (history)  Vaccinated:2008-02-04
Age:18.0  Onset:2008-02-04, Days after vaccination: 0
Gender:Female  Submitted:2008-02-06, Days after onset: 2
Location:Texas  Entered:2008-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control; Tuberculin PPD, Sanofi Pasteur Limited, C2670AA, RA, 1 previous dose
Current Illness:
Preexisting Conditions: NKDA; no defects
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.1148U3UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0928U0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2430AA0UNLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site inflammation, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Circular, red, inflamed area 50x40 mm to L arm. HPV and meningococcal vaccine administered in same arm. Pain began same evening of vaccine administration. Pt. took Aleve and hot shower, let hot water run on arm.

VAERS ID:304534 (history)  Vaccinated:2007-12-13
Age:18.0  Onset:2007-12-13, Days after vaccination: 0
Gender:Male  Submitted:2008-02-07, Days after onset: 56
Location:Washington  Entered:2008-02-07
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
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2865AA IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:
Write-up: Patient received DTaP instead of Tdap.

VAERS ID:304623 (history)  Vaccinated:2007-06-21
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-08
Location:New York  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: Pregnancy NOS (LMP=2/24/2007) Environmental allergy; Urinary Tract infection; Sinusitis; Back pain; Rib pain; Hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: ultrasound 11/13/07 twin pregnancy
CDC Split Type: WAES0801USA01354
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0523U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Breech delivery, Caesarean section, Drug exposure during pregnancy, Transfusion, Twin pregnancy, Ultrasound abdomen abnormal
SMQs:, Retroperitoneal fibrosis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a physician for the Merck Pregnancy Registry for Gardasil concerning an 18 year old healthy female with an environmental allergy who on 21-JUN-2007 was vaccinated with a first dose of Gardasil (lot# 657868/0523U). Concomitant therapy included on 21-JUN-2007 BACTRIM DS TABLETS BID for a UTI, on 06-JUL-2007, AUGMENTIN 875 mg BID for sinusitis, between 18-JUL-2007 to 22-AUG-2007 and ibuprofen 600 mg every 8 hours for back and rib pain. On 21-AUG-2008 the patient was vaccinated with a second dose of Gardasil (lot#657006/0188U). In October 2007 the patient had ciprofloxacin for UTI, ZYRTEC for allergies and on 26-OCT-2007 Z-PAK for sinusitis. The patient''s last menstrual period was approximately 24-FEB-2007 and became pregnant. On 13-NOV-2007, the patient had an ultrasound and the results showed a twin pregnancy; the dates were too late to obtain. The patient was unaware that she was pregnant. On 01-DEC-2007 the patient delivered normal healthy twin boys weighing 5 pounds 1 ounce and a baby boy weighing 6 pounds 7 ounces. The patient required a c-section because one of the twins was breech. The patient also required a blood transfusion. The babies were "fine". On 24-DEC-2007 the patient was vaccinated with a third dose of Gardasil (lot# 658488/0930U). At the time of reporting the patient had recovered. Upon internal review breech delivery is considered to be an other medical event. Additional information is not expected.

VAERS ID:304615 (history)  Vaccinated:2008-02-06
Age:18.0  Onset:2008-02-06, Days after vaccination: 0
Gender:Male  Submitted:2008-02-09, Days after onset: 3
Location:Oklahoma  Entered:2008-02-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2549AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Headache, Pharyngolaryngeal pain, Pyrexia, Tonsillitis
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow)
Write-up: 2 hours after receiving vaccine started fever, HA, chills and sore throat. Was diagnosed with tonsillitis 2 days later and treated with Zithromax.

VAERS ID:304854 (history)  Vaccinated:2008-01-16
Age:18.0  Onset:2008-01-16, Days after vaccination: 0
Gender:Male  Submitted:2008-01-18, Days after onset: 2
Location:Wisconsin  Entered:2008-02-13, Days after submission: 26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: ?Augmentin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2331AA0UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Asthenia, Axillary pain, Back pain, Chest pain, Feeling abnormal, Mobility decreased, Musculoskeletal pain, Pain in extremity, Pallor, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: 1-16-08 6:00pm c/o R arm pain. 1-17-08 A.M. c/o that R arm hurt so much he couldn''t sleep on it. 1-17-08 4:15p.m.-notified me he felt "awful". At 6:00-assessed-very weak, pale, felt "awful", pain into axilla & shoulder & across chest & down back next to spinal area. So painful-didn''t want me to even touch him. Had difficulty raising arm due to pain. Ibuprofen 800mg given. 1-18-08-mostly better. No redness or swelling at site. 1-23-08-R arm pain fully resolved & normal ROM returned.

VAERS ID:304880 (history)  Vaccinated:2008-01-31
Age:18.0  Onset:2008-01-31, Days after vaccination: 0
Gender:Female  Submitted:2008-02-13, Days after onset: 13
Location:Unknown  Entered:2008-02-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP=Unknown)
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA01815
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ovarian enlargement, Pain
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 for the Merck Pregnancy Registry for Gardasil from an 18 year old female with no pertinent medical history or drug reactions/allergies who on 31-JAN-2008 was vaccinated with a first dose of Gardasil injection. There was no concomitant medication. On 03-FEB-2008 or 04-FEB-2008 (3 to 4 days) after receiving the first dose of Gardasil the patient miscarried. The patient was approximately 2 weeks pregnant. The patient was unaware she was pregnant until she miscarried. The physician stated to the patient that her left ovary was swollen. The patient was in alot of pain. The patient was scheduled for a CT scan next week. At the time of reporting the patient has not recovered. On approximately 20-JAN-2008 was the patient''s date of last menstrual period. The patient''s estimated date of delivery was 26-OCT-2008. No additional information was provided. Upon internal review miscarriage was considered to be an other medical event. Additional information is not expected.

VAERS ID:305056 (history)  Vaccinated:2007-10-23
Age:18.0  Onset:2007-10-23, Days after vaccination: 0
Gender:Female  Submitted:2008-02-15, Days after onset: 115
Location:Alabama  Entered:2008-02-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: No~ ()~NULL~~In Patient|No~ ()~NULL~~In Sibling1|No~ ()~NULL~~In Sibling2
Other Medications: none
Current Illness: No
Preexisting Conditions: Environmental (took claritin) Febrile seizures as a child, depression
Diagnostic Lab Data:
CDC Split Type: AL0806
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0927U0IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0287U1SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2609AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Chills, Pyrexia, Skin warm
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: 102 degree fever, chills, skin felt like it was "on fire", lasted 2-3 days.

VAERS ID:305075 (history)  Vaccinated:2008-01-07
Age:18.0  Onset:2008-01-15, Days after vaccination: 8
Gender:Male  Submitted:2008-02-14, Days after onset: 30
Location:Texas  Entered:2008-02-18, 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:
Current Illness:
Preexisting Conditions: The patient had no illness and it was unknown if they had been taking any concomitant medications at the time of vaccination. The patient had no known drug allergies and no past medical history.
Diagnostic Lab Data: None reported. Labs and Diagnostics: LP with 35 WBCs, 87% Lymphs, 7 polys, 6 monos. CSF protein and glucose normal at 42 and 63. CSF Albumin, IgG, IgA, IgM all WNL. Myelin Basic protein 3.4. No oligoclonal bands. CSF cx (-).
CDC Split Type: 200800460
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500497P IN 
HEPA: HEP A (VAQTA)MERCK & CO. INC.U259B UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2391B UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Albumin CSF normal, Blindness, CSF culture negative, CSF glucose normal, CSF lymphocyte count increased, CSF monocyte count decreased, CSF myelin basic protein normal, CSF neutrophil count increased, CSF oligoclonal band absent, CSF protein normal, CSF white blood cell count increased, Eye pain, Headache, Lumbar puncture, Optic neuritis, Papilloedema, Visual acuity reduced
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Ocular infections (broad), Malignant lymphomas (broad)
Write-up: Initial report was received from a physician on 11 February 2008. An 18-year-old male patient with no past medical history, had received an injection of Menactra, lot number U2391BA (route/site not reported), and an injection of Hepatitis A vaccine, lot number U2598 (manufacturer Merck, route/site not reported), and a dose of FluMist, manufacturer Wyeth (lot number not reported), on 07 January 2008 and approximately one to two weeks later, he complained of a headache and began loosing his vision. He was diagnosed by an ophthalmologist as having optic neuritis and began receiving corrective treatment with high dose steroids. At the time of the report, the patient had not recovered from the event. No further information was provided. 02/20/2008 MR received from PCP which included vax record and WCC of 1/7/08. Record is somewhat illegible. F/U TC 2/12/08 with DX of optic neuritis made by another MD (ophthamologist). 06/04/2008 MR received from ophthamolgist beginning 02/05-28/2008 with DX: Optic Neuritis. Pt presented with c/o foggy vision, eye pain and H/A which started after immunizations. Swollen nerves noted on exam. Return visit 2/8/08 with worsening vision and H/As. Tx with steroids. Disc edema bilaterally noted on photography of fundus. Improvement noted by 2/28/08.

VAERS ID:305120 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-18
Location:Unknown  Entered:2008-02-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA02071
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Head injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a certified nurse midwife concerning an 18 year old female who on an unspecified date was vaccinated with dose unspecified of Gardasil. On an unspecified date, the patient fainted in the physician''s office waiting room after receiving the vaccination. The patient hit her head on the counter and sustained unspecified head trauma. The patient was hospitalized. At the time of reporting, the outcome was unknown. Additional information has been requested.

VAERS ID:305159 (history)  Vaccinated:2008-02-12
Age:18.0  Onset:2008-02-12, Days after vaccination: 0
Gender:Female  Submitted:2008-02-13, Days after onset: 1
Location:Wisconsin  Entered:2008-02-19, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: Allergy amoxicillin; childhood asthma-resolved at this time
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0188U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2147AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Headache, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Friends noticed rash above bilateral eyebrows, L cheek. Rash observed by PHN above eyes bilaterally. No urticaria, no hives, no rash/reaction at injection sites. Headache began 10pm on 2/12/08 continuing through 2/13/08 when seen by PHN.

VAERS ID:305203 (history)  Vaccinated:2008-01-30
Age:18.0  Onset:2008-01-31, Days after vaccination: 1
Gender:Female  Submitted:2008-02-19, Days after onset: 19
Location:Montana  Entered:2008-02-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoxetine 20mg once daily; Benzaclin 1.5% gel
Current Illness: None
Preexisting Conditions: Depression
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1249U0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Skin lesion
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Erythemic area at injection site 6 cm in diameter, swollen, hot, tender, pruritic and with 3 super imposed pox like lesions still present 20 days after vaccinations. Some resolution since onset. Advised her to try Benadryl.

VAERS ID:305305 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA00520
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Pain
SMQs:, Peripheral neuropathy (broad)
Write-up: It was reported in an internet news article that an 18 year old female was vaccinated with Gardasil. In the article an infectious disease expert stated that "this vaccine stings a lot". The 18 year old college freshman consumer reported "it sure does". "She said other shots tend to hurt only at the moment of the needle stick, and not after the vaccine plunges in". She further stated, "it burns". The consumer felt that the pain and burn was related to therapy with Gardasil. No further information is available.

VAERS ID:305315 (history)  Vaccinated:2007-12-21
Age:18.0  Onset:2007-12-23, Days after vaccination: 2
Gender:Female  Submitted:2008-02-14, Days after onset: 53
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA00560
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1446U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Eye pain, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad)
Write-up: Information has been received from a registered nurse concerning an 18 year old female with no medical history and no known allergies who on 21-DEC-2007 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil (Lot #659441/1446U). There was no concomitant medication. On 23-DEC-2007 the patient''s mother called the nurse practitioner and reported that her daughter woke up that morning with pain over her left eye and nausea. No laboratory diagnostic studies were performed. On 27-DEC-2007, the patient''s mother called again and stated that the symptoms had resolved. No product quality complaint was involved. Additional information has been requested. 02/12/2010 Follow up information from the registred nurse indicated that the patient had received a second dose of GARDASIL on 10-MAR-2008 and experienced no adverse symptoms. No product quality compliant was involved. Additonal information has been requested.

VAERS ID:305428 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Texas  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: Convulsion
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA00892
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0523U0IMUN
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Pharyngeal oedema, Urticaria, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a licensed practical nurse concerning an 18 year old female with seizure disorder who on 16-JUL-2007 was vaccinated IM with a 0.5 ml first dose of GARDASIL (lot #657868/0523U). Concomitant therapy included DEPAKOTE, SEASONALE and LAMICTAL. Subsequently the patient experienced hives and "throat swelling." Subsequently, the patient recovered. On an unspecified date, the patient was vaccinated with a second dose of GARDASIL. Subsequently the patient experienced hives and "throat swelling." Subsequently, the patient recovered. The patient reported the event at an unrelated office visit. Additional information has been requested.

VAERS ID:305436 (history)  Vaccinated:2008-01-07
Age:18.0  Onset:2008-01-07, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 38
Location:Georgia  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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: skull x-ray, 01/07/08, negative; spinal x-ray, 01/07/08, negatine
CDC Split Type: WAES0801USA00999
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Skull X-ray normal, Spinal X-ray normal, 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 female who on 07-JAN-2008 was vaccinated with her first dose of 0.5 ml Gardasil intramuscularly. The patient fainted after she was given the vaccine. No other information was available. As of 07-JAN-2008 the patient recovered from her experience. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008. Information has been received from a licensed practical nurse concerning a 19 year old white female who on 07-JAN-2008 was vaccinated with her first dose of GARDASIL (Lot #655439/1257U) intramuscularly in the left arm at 10:00 am. There was no concomitant medication. The patient fainted after she was given the vaccine. No other information was available. As of 07-JAN-2008 the patient recovered from her experience. Follow up information has been received from the licensed practical nurse on 28-FEB-2008. It was reported that on 07-JAN-2008 at 10:00 am the patient fainted and hit her head and hurt her neck. The patient was evaluated and neck and skull x-rays were performed. Both skull and cervical spine x-rays were negative. The patient was watched for about an hour and released to her mother. No further information is expected.

VAERS ID:305437 (history)  Vaccinated:2008-01-04
Age:18.0  Onset:2008-01-04, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 41
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA01016
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U2IMRA
Administered by: Other     Purchased by: Other
Symptoms: Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad)
Write-up: Information has been received from a physician concerning an 18 year old female who on 04-JAN-2008 was vaccinated with her third dose of 0.5 ml of GARDASIL (Lot #659055/1522U) intramuscularly. There was no concomitant medication. Subsequently the patient developed myalgia. The patient received the vaccine in the right deltoid and has developed the myalgia on the entire left side of her body. The patient received her first dose of GARDASIL on 21-JUN-2007 and her dose on 06-AUG-2007. The patient''s outcome was not reported. No further information is available. Additional information has been received.

VAERS ID:305451 (history)  Vaccinated:2007-07-19
Age:18.0  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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0801USA01642
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Facial palsy
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: Information has been received from a physician concerning an 18 year old female who on 19-JUL-2007 was vaccinated with the first dose of GARDASIL. Per the reporter, the patient experienced bells palsy "one to two weeks after receiving GARDASIL." The patient sought unspecified medical attention. Subsequently, the patient recovered from bells palsy seven weeks after diagnosed, but could not move her mouth for three weeks. The patient refuses to receive the second and third dose of GARDASIL. No lot number was provided and no further information was provided. Additional information has been requested.

VAERS ID:305623 (history)  Vaccinated:2007-12-17
Age:18.0  Onset:2007-12-18, Days after vaccination: 1
Gender:Female  Submitted:2008-02-14, Days after onset: 58
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: WAES0801USA02048
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0710U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Headache, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Information has been received from a physician concerning an 18 year old female who on 20-OCT-2007 was vaccinated with a first dose of Gardasil (lot# unknown). On 17-DEC-2008 the patient was vaccinated with a second dose of Gardasil (lot# "0710U", expiration date 04-JUL-2009) IM injection. On 18-DEC-2007, "within 24 hours" the patient experienced headaches, body aches, fever, nausea, and dizziness for eight days after receiving her second dose of the Gardasil vaccine. Medical attention was sought. The physician reported that the patient was seen for an office visit for her symptoms on 22-DEC-2007, and then again on 24-DEC-2007 where she was beginning to feel better. The physician reported that the patient called the office on 26-DEC-2007 and said she was feeling better. "The patient is fine now". No further information was provided. Additional information has been requested.

VAERS ID:305629 (history)  Vaccinated:2007-12-18
Age:18.0  Onset:2007-12-18, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 58
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: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA02289
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)SANOFI PASTEUR02435AA IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0187U0IMLL
Administered by: Public     Purchased by: Public
Symptoms: Decreased appetite, Fatigue, Feeling hot, Influenza like illness, Injection site discomfort, 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 an 18 year old female (previously reported as "older" female) who was vaccinated in December 2007 ("right before Christmas"), with the first dose of Gardasil (lot # not reported). Concomitantly, the patient received influenza virus vaccine (unspecified). It was reported the patient experienced "a whoosh/warm feeling going through her leg, the shot felt uncomfortable and the area was tender." The nurse stated that within 15 minutes after the vaccination, the patient felt sick with flu-like symptoms, including body aches and malaise, as well as nausea. It was reported that there were flu symptoms going around the town. The nurse reported that the symptoms lasted for 1 1/2 days. It was reported that another patient experienced symptoms after receiving Gardasil, (WAES # 0801USA02008). Additional information is not expected. This is in follow-up to report(s) previously submitted on 2/14/2008. Initial and follow up information has been received from a registered nurse concerning an 18 year old caucasian female with no pertinent medical history, who was vaccinated IM in the left thigh, on 18-DEC-2007 at 8:55 am, with the first dose of GARDASIL (lot # 656049/0187U). Concomitantly, the patient received the first dose, IM in the left arm, of influenza virus vaccine (SP, lot #02435AA). There was no illness at the time of vaccination. It was reported the patient experienced "a whoosh/warm feeling going through her upper leg, the shot felt uncomfortable and the area was tender." The nurse stated that within 15 minutes after the vaccination, the patient felt sick with flu-like symptoms, including headache and body aches and malaise, as well as nausea. She also reported fatigue and no appetite. It was reported that there were flu symptoms going around the town. The nurse reported that the symptoms lasted for 1 1/2 days, with recovery noted on 20-DEC-2007. It was reported that another patient experienced symptoms after receiving GARDASIL. (WAES # 0801USA02008). Additional information is not expected.

VAERS ID:305660 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA02734
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: 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 an 18 year old female with no known allergies who was vaccinated with Gardasil. There was no concomitant medication. Subsequently the patient experienced arm swelling at injection site. The patient sought unspecified medical attention. The outcome of the patient was not reported. Additional information has been requested.

VAERS ID:305666 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA02796
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Malaise
SMQs:
Write-up: Information has been received from an 18 year old female consumer, who on an unspecified date was vaccinated with the second dose of Gardasil (lot # not reported). The consumer reported "I got very sick just after I received my second Gardasil shot." The outcome and duration of the event were not specified. The consumer did not seek medical attention. No further information is available.

VAERS ID:305814 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Florida  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:
CDC Split Type: WAES0801USA03332
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site rash, Malaise
SMQs:, Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning an 18 year old female who was vaccinated with the first dose of GARDASIL. Per the reporter, the patient experienced a bad rash at the injection site that lasted a few days and felt ill. Subsequently, the patient recovered from the bad rash at the injection site and feeling ill. The patient sought unspecified medical attention. The patient''s mother decided that the patient would not go on to receive the second and third doses. No further information was provided. Additional information has been requested.

VAERS ID:305833 (history)  Vaccinated:2007-12-07
Age:18.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Female  Submitted:2008-02-14, Days after onset: 68
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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA02972
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0171U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Pruritus generalised, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse practitioner concerning an 18 year old female with no medical history and no drug allergies, who on 07-DEC-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot# 655620/0171U). There was no concomitant medication. On 08-DEC-2007 the patient developed a "full body rash." The patient reported that the rash was itchy. No shortness of breath or difficulty breathing was reported. The rash resolved within one week. The patient recovered on 14-DEC-2007. On 14-JAN-2008 the patient was seen in the office. No laboratory diagnostics were performed. No product quality complaint was involved. Additional information has been requested.

VAERS ID:305840 (history)  Vaccinated:2008-01-14
Age:18.0  Onset:2008-01-14, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 31
Location:Illinois  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA03151
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U1UNUN
Administered by: Private     Purchased by: Private
Symptoms: Contusion, Flushing, Head injury, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad)
Write-up: Initial and follow-up information has been received from a physician and an other healthcare professional concerning an 18 year old female who on 14-JAN-2008 was vaccinated with a second 0.5 mL dose of Gardasil (659439/1267U). At 10:30, on 14-JAN-2008, the patient experienced fainting (she passed out and fell to the floor) and head injury (contusion). The patient reported that she felt flushed then doesn''t know what happened. Post incident the patient was oriented and alert x3 and sustained a reddened area to left side of forehead (previously reported as head injury (contusion). Unspecified medical attention was sought. Outcome unknown. There was no product quality complaint. This is one of several reports received from the same source. Additional information is not expected.

VAERS ID:305913 (history)  Vaccinated:2008-01-16
Age:18.0  Onset:2008-01-17, Days after vaccination: 1
Gender:Female  Submitted:2008-02-14, Days after onset: 28
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDERRALL TABLETS; INITREX (SUMATRIPTAN)
Current Illness: Attention deficit/hyperactivity disorder
Preexisting Conditions: Attention deficit/hyperactivity disorder; Drug hypersensitivity
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA03672
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning an 18 year old female with an allergy to chloral hydrate capsule and a history of migraine and attention deficit/hyperactivity order who on 05-SEP-2007 (lot number:0724U/657756) and 09-NOV-2007 was vaccinated with her first and second d dose of GARDASIL (lot number: 0530U) and her third dose on 16-JAN-2008. Concomitant therapy included sumatriptan (IMITREX (sumatriptan)) and ADDERALL TABLETS. On 17-JAN-2008 the patient experienced incorrect schedule and pain at injection site. The patient''s incorrect schedule and pain at injection site persisted. No further information is available.

VAERS ID:305917 (history)  Vaccinated:2007-11-10
Age:18.0  Onset:2007-11-11, Days after vaccination: 1
Gender:Female  Submitted:2008-02-14, Days after onset: 95
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: CHEMET
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0801USA03769
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Lip swelling, Oedema mouth, Pharyngeal oedema
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a pharmacist concerning an 18 year old female who on 10-NOV-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included CHEMET. The patient has been receiving CHEMET for mercury poisoning and was to complete a 2 year course of treatment. The patient had been taking CHEMET four times per day for several months without problem. On 11-NOV-2007 the patient experienced lip swelling, mouth swelling and throat swelling. The patient contacted her physician by phone and was suggested to stop the CHEMET. The patient discontinued the CHEMET and the symptoms resolved without treatment. After 3 weeks, the patient restarted taking CHEMET and the lip, mouth, and throat swelling returned the next day. The patient has discontinued CHEMET and has fully recovered. The patient will not receive further doses of Gardasil. No further information is available. Additional information is not expected.

VAERS ID:305931 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA04311
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anogenital warts
SMQs:
Write-up: Information has been received from a physician, via a company representative, concerning an 18 year old female patient, who was vaccinated with the first dose of Gardasil (date, dosing details and lot # not reported), and subsequently "came down with genital warts." The patient completed the second and third dose of the vaccination series. At the time of this report, the outcome of the event was unknown. The reporting physician did not feel that the genital warts were related to therapy with Gardasil. Additional information has been requested.

VAERS ID:305952 (history)  Vaccinated:2007-12-26
Age:18.0  Onset:2007-12-27, Days after vaccination: 1
Gender:Female  Submitted:2008-02-14, Days after onset: 49
Location:New Jersey  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA04448
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1210U1UNUN
Administered by: Private     Purchased by: Other
Symptoms: Pruritus, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a health professional concerning an 18 year old female patient with no medical history who on 31-OCT-2007, was vaccinated into the right deltoid with a first dose of Gardasil (Lot# 0530U). On 26-DEC-2007, the patient was vaccinated into the left deltoid with a second dose of Gardasil (Lot# 655154/1210U). On 27-DEC-2007, the patient complained of her face being very swollen and itchy. She was advised to take BENADRYL 50 mg PO and if it did not get any better to go to the emergency room. No laboratory diagnostic tests were performed. At the time of this report, the patient''s outcome was unknown. Additional information has been requested.

VAERS ID:305967 (history)  Vaccinated:2008-01-15
Age:18.0  Onset:2008-01-16, Days after vaccination: 1
Gender:Female  Submitted:2008-02-14, Days after onset: 29
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA04579
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Presyncope
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a consumer concerning her daughter who in approximately June 2007, was vaccinated with the first dose of GARDASIL. The patient received the third dose of GARDASIL on 15-JAN-2008. On 16-JAN-2008 the patient experienced pain around the injection site. The pain began escalating since then, and radiated down to her elbow. The mother did not know which arm the reaction occurred. The mother also reported that the patient almost fainted after receiving her first dose of GARDASIL. There were no reported reactions after receiving the second dose. No further information is available.

VAERS ID:305970 (history)  Vaccinated:2007-11-16
Age:18.0  Onset:2007-11-16, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 90
Location:Michigan  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Migraine
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA04627
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0469U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Migraine, Rash, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a registered nurse concerning an 18 year old female with a history of migraines and no known drug allergies who on 16-NOV-2007 was vaccinated with the first dose GARDASIL 0.5 mL IM (Lot # 0469U). Concomitant therapy included YASMIN. On 16-NOV-2007 shortly after she received the first dose, the patient developed a migraine. She received the second dose on 21-JAN-2008 (Lot # 655327/1287U). On the evening of 22-JAN-2008, the patient experienced an itchy rash on both arms, legs and trunk which was spreading up her neck by the morning of 23-JAN-2008. The nurse reported that the patient had recently been sitting in a hot tub with friends for a few hours a day. The rash was not evaluated by a health care professional but was reported by the patient to the office. The nurse indicated the rash was not thought to be hives or indicative of hypersensitivity. Th rash was treated with topical BENADRYL. As of 23-JAN-2008, the patient was recovering. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008. Initial and follow-up information has been received from a registered nurse concerning an 18 year old female with a history of migraines and no known drug allergies who on 16-NOV-2007 was vaccinated with the first dose of GARDASIL IM (Lot # 0469U). Concomitant therapy included YASMIN. On 16-NOV-2007 shortly after she received the first dose, the patient developed a migraine. She received the second dose on 21-JAN-2009 (Lot # 655327/1287U). On the evening of 22-JAN-2009, the patient experienced an itchy rash on both arms, legs and trunk which was spreading up her neck by the morning of 23-JAN-2009 and to the entire body later. On an unspecified date the patient had headache. The nurse reported that the patient had recently been sitting in a hot tub with friends for a few hours a day. The patient called back later that day to admit that the rash may have been due to chemicals in the water versus the second dose of GARDASIL. The rash was not evaluated by a health care professional but was reported by the patient to the office. The nurse indicated the rash was not thought to be hives or indicative of hypersensitivity. The rash was treated with topical BENADRYL. On an unspecified date the patient had recovered. Additional information is not expected.

VAERS ID:305985 (history)  Vaccinated:2007-10-19
Age:18.0  Onset:2007-12-03, Days after vaccination: 45
Gender:Female  Submitted:2008-02-14, Days after onset: 73
Location:Arizona  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Attention deficit disorder
Diagnostic Lab Data: Pap test 12/03/07 - low grade positive for HPV
CDC Split Type: WAES0801USA047252
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
SMQs:
Write-up: Information has been received from a physician concerning an 18 year old female with a history of attention deficit disorder who on 16-APR-2007 was vaccinated with her first dose of GARDASIL. The patient received her second dose of GARDASIL on 14-Jun-2007. On 19-Oct-2007, the patient received her third dose of GARDASIL. On 03-DEC-2007 the patient had a routine PAP test which was low grade positive for HPV. The patient sought unspecified medical treatment with an office visit. Subsequently the patient has not recovered. Additional information has been requested.

VAERS ID:306029 (history)  Vaccinated:2008-01-21
Age:18.0  Onset:2008-01-22, Days after vaccination: 1
Gender:Female  Submitted:2008-02-14, Days after onset: 23
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No reaction on previous exposure to vaccine
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA05072
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Injection site erythema, Injection site rash, Injection site swelling, Nasal congestion, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning an 18 year old female, who on 21-JAN-2008 was vaccinated with a 0.5mL first dose of Gardasil (lot# 659439/1267U). On 22-JAN-2008 the patient developed an injection site rash. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested. Follow-up received 04/16/2008. Initial and follow-up information has been received by a physician concerning an 18 year old female, who on 25-OCT-2007 was vaccinated with a 0.5ml first does of GARISIL (Lot # 659439/1267U). There were no reactions reported after the first dose. On 21-JAN-2008 the patient was vaccinated with a second dose of GARDASIL. On 22-JAN-2008 within 24 hours of the second dose the patient developed an injection site rash, rash on her trunk, and swelling and redness at the injection site. The physician reported that there were no breathing problems or any reactions that would have indicated anaphylaxis. The physician spoke to the patient''s mother in regards to the signs and symptoms reported. The patient was unable to come to the office for a visit until 28-JAN-2008. Over the next few days the patient experienced viral like signs and symptoms including a headache, stuffy nose, and intermitten fever. On 28-JAN-2008 the patient was seen at the office for viral like symptoms. It was reported that at the time of the office visit there was no rash. The patient recovered from the rash on an unspecified date. No product quality complaint was involved. Additional information is not expected.

VAERS ID:306086 (history)  Vaccinated:2008-01-28
Age:18.0  Onset:2008-01-28, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 17
Location:New Mexico  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cough; Nasal congestion; Sore throat
Preexisting Conditions: Unknown
Diagnostic Lab Data: throat culture 01/??/08 - negative
CDC Split Type: WAES0801USA05877
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Culture negative, Dyspnoea, Feeling abnormal, Hypoaesthesia, Muscle spasms, Panic attack, Streptococcus identification test negative, Syncope, Upper respiratory tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning an 18 year old female who on 28-JAN-2008 was vaccinated with a second dose of Gardasil (lot #659964/1740U). Concomitant therapy included hepatitis A vaccine (inactive). The patient came to the physician''s office for a sore throat, cough and congestion. On28-JAN-2008 the patient experienced an 8 minute episode of feeling panicky, short of breathe, feeling "out of it" and had numbness and cramps in her hands. Unspecified medical attention was sought. The physician diagnosed her with syncope, upper respiratory infection and panic attack. A strep throat test came back negative. As of 29-JAN-2008 the patient was recovering. Additional information has been requested.

VAERS ID:306088 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA05959
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Bone pain, Cold sweat, Joint warmth, Pain, Varicose vein, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Osteonecrosis (broad), Arthritis (broad)
Write-up: Information has been received from a newspaper article concerning an 18 year old female who in September 2007, was vaccinated with a first dose of Gardasil. It was reported that shortly after the shot, the patient felt an overwhelming aching heat in her kneecaps and ankles. After 24 hours, it spread to the majority of her bones. Approximately one month after the shot, her body practically went through "withdrawals from missing the vaccinations". The patient once again had aching bones and "this time cold sweats were involved." The patient''s eyesight had been more blurred since vaccination with HPV vaccine. The patient developed her first varicose veins all over her thighs and ankles, and her bones hurt from even the softest pressure. The outcome of the patient''s experience was unknown. Additional information is not expected.

VAERS ID:306104 (history)  Vaccinated:2008-01-30
Age:18.0  Onset:2008-01-30, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 15
Location:Montana  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA06063
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U0UNUN
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 nurse concerning an 18 year old female who on 30-JAN-2008 was vaccinated with Gardasil (lot# 659657/1487U). There was no concomitant medication. On 30-JAN_2008 the patient "received her first dose of Gardasil (lot# 659657/1487U) and sat down for a couple of minutes (not 15 minutes as recommended in the guidelines) and when she tried to get up and leave, she fainted. The patient did not eat lunch prior to the vaccine." Unspecified medical attention was sought. Subsequently, the patient recovered from the fainting episode. No product quality complaint was involved. Additional information has been requested. Follow-up received 04/16/2008. No further information is available.

VAERS ID:305236 (history)  Vaccinated:2008-02-18
Age:18.0  Onset:2008-02-19, Days after vaccination: 1
Gender:Female  Submitted:2008-02-20, Days after onset: 1
Location:Florida  Entered:2008-02-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Ceclor
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt. noted severe pain at injection site 2/18/08 that radiated into forearm over the next 24 hours. Approx. 24 hours after the inj. her 4th and 5th fingers and ulnar apect of her left hand felt tingling with mild pain at the tips of her fingers. Her sx have continued. No erythema or drainage at inj. site. Normal ROM and sensation in fingers. She had taken ibuprofen 2/19/18 x 1. She is instructed to take ibuprofen 3x daily and apply warm compresses to the inj site.

VAERS ID:305354 (history)  Vaccinated:2008-02-19
Age:18.0  Onset:2008-02-20, Days after vaccination: 1
Gender:Female  Submitted:2008-02-21, Days after onset: 1
Location:Florida  Entered:2008-02-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Dysmenorrhea
Diagnostic Lab Data: BUN 7, Sodium 138, Potassium 4.4, Chloride 107, CO2 28.6, Calcium 9.8, Glucose 115 (after load of choc milk at home), Creatinine 0.56 - WBC 6.37, 80.7% Neutrophils, 11% Lymphocytes, 7.4% Monocytes, 0.3% Bands, 0.3% Eosinophils, 0.3% Basophils, Hemoglobin 14.5 (high) Hematocrit 42.9 ( (high), Platelets 264 000. Urine HCG (pregancy test) negative. Tilt test was negative in the Emergency room.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1209U2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Balance disorder, Band neutrophil count decreased, Basophil percentage, Blood calcium, Blood chloride, Blood creatinine, Blood glucose increased, Blood potassium, Blood sodium normal, Blood urea, Burning sensation, Carbon dioxide normal, Dizziness, Eosinophil count, Haematocrit, Haemoglobin, Headache, Lymphocyte percentage, Malaise, Monocyte percentage, Muscular weakness, Neutrophil percentage, Pain, Platelet count, Syncope, Tilt table test, Urine human chorionic gonadotropin negative, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Immediatley after the administration she described a burning sensation, as she never had it before. It Improved. Later that day she developed a frontal headache lasting many hours, that needed NSAIDs to improve. Next morning while taking a shower, she felt dizzy and fainted. Was assisted by family member and later transfered to an ER department, where all tests were considered normal and she was stable. Second day after the shot, she come complaining of malaise, feeling "wobbly", with decreased lower extremities strength and genealized body aches, like "when the flu is starting".

VAERS ID:305458 (history)  Vaccinated:2008-01-24
Age:18.0  Onset:2008-01-25, Days after vaccination: 1
Gender:Male  Submitted:2008-02-18, Days after onset: 24
Location:Arizona  Entered:2008-02-22, 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: None
Current Illness: None
Preexisting Conditions: Patient has signs of allergic rhinitis, denied meds.
Diagnostic Lab Data: None ordered
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2421AA UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2689AA UNRA
Administered by: Private     Purchased by: Public
Symptoms: Feeling cold, Headache, Pharyngolaryngeal pain
SMQs:
Write-up: Patient developed a sore throat day after the vaccines. Lasted few days & went away. Then started low grade headaches & felt chilly. No fever. No swelling or redness of the injection site.

VAERS ID:305475 (history)  Vaccinated:2008-02-12
Age:18.0  Onset:2008-02-13, Days after vaccination: 1
Gender:Female  Submitted:2008-02-22, Days after onset: 9
Location:South Carolina  Entered:2008-02-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: penicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1486U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dysphagia, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (narrow)
Write-up: Patient reported tongue swelling and difficulty swallowing on the day after the vaccine was given. Symptoms were mild and were not brought to my attention for 10 days. She is still having some tongue swelling after 10 days, however she appears perfectly fine. She has no difficulty breathing or swallowing.

VAERS ID:305581 (history)  Vaccinated:2008-02-22
Age:18.0  Onset:2008-02-22, Days after vaccination: 0
Gender:Female  Submitted:2008-02-25, Days after onset: 3
Location:New York  Entered:2008-02-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B019AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Paraesthesia, Skin warm, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Rapid onset of localized swelling of about 1.5cm and mild redness. Warm and tender to the touch. Within 5 minutes began to have tingling of the arm. Was given Benadryl 25mg PO with good effect.

VAERS ID:306353 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:2007-12-24
Gender:Female  Submitted:2008-03-03, Days after onset: 70
Location:New Jersey  Entered:2008-03-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 12/24/2007)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA01240
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion, 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: Initial and follow up information has been received through the Merck pregnancy registry from a licensed practical nurse concerning an 18 year old female who was vaccinated with GARDASIL. The patient became pregnant after receiving all 3 doses of GARDASIL (dates not specified). The patient''s last menstrual period (LMP) was 24-DEC-2007. The estimated date of delivery was 29-SEP-2008. The patient sought medical attention. Follow up information indicated that in February, at 6 or 7 weeks gestation, the patient''s pregnancy was aborted. No further was provided. Upon internal review, abortion at "weeks from LMP 6 or 7" was considered to be serious as an other important medical event. This is one several reports from the same source. Additional information has been requested.

VAERS ID:306707 (history)  Vaccinated:2008-02-21
Age:18.0  Onset:2008-02-22, Days after vaccination: 1
Gender:Male  Submitted:2008-02-26, Days after onset: 4
Location:Illinois  Entered:2008-03-07, Days after submission: 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: The patient had no concurrent illnesses, pre-existing medical conditions, or use of other medications at the time of the vaccinations on 21 February 2008. The patient also has no prior history of adverse events with prior vaccination. He also had not received any other vaccinations with four weeks of 21 February 2008.
Diagnostic Lab Data:
CDC Split Type: 200800563
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0800U0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2551A0UNRA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Musculoskeletal stiffness, Pain
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: Initial report received on 22 February 2008 from a health care professional. A 17-year-old male patient, with no concurrent illnesses, or pre-existing medical history, had received a first, right deltoid dose of Menactra (lot number U2551AA); a second right forearm dose of Tubersol (lot number C2682AA); and a first, left deltoid dose of Hepatitis A (manufacturer Merck, lot number 0800U) on 21 February 2008 at 15:00 p.m. The route of administration was not reported for any of the vaccines, or the tuberculin test. Eighteen hours post-vaccination, and post tuberculin test, which was around 09:00 a.m. on 22 February 2008, the patient woke up with a stiff neck, generalized achiness, and dizziness. The patient was evaluated by his physician on the same day and was found to be afebrile. The patient was at the physician''s office when this report was filed. Treatments received, and diagnostic tests performed were not provided. At the time of this report, the patient had not recovered.

VAERS ID:306683 (history)  Vaccinated:2008-03-07
Age:18.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Male  Submitted:2008-03-08, Days after onset: 1
Location:Tennessee  Entered:2008-03-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: iodine
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS438011C0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Back pain, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Hypersensitivity (narrow)
Write-up: Donor c/o itching and had a rash the approximate size of a 50 cent piece on lt side of lower back also c/o lower back pain.

VAERS ID:306715 (history)  Vaccinated:2007-01-29
Age:18.0  Onset:2007-04-09, Days after vaccination: 70
Gender:Female  Submitted:2008-03-07, Days after onset: 333
Location:Texas  Entered:2008-03-10, 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: Chlamydial infection
Diagnostic Lab Data: ultrasound 10/04/07 routine prenatal care; cesarean section 12/28/07; urine beta-human 04/30/07
CDC Split Type: WAES0706USA00029
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1447F0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Caesarean section, Complication of delivery, Drug exposure during pregnancy, Foetal disorder, Labour complication, Ultrasound scan, Urine human chorionic gonadotropin positive, Uterine atony
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial and follow up information has been received via the Merck pregnancy registry, from a registered nurse, concerning an 18 year old female with no known allergies and a history of chlamydial infection (2006), who on 27-NOV-2006 was vaccinated IM in the left arm, with the first dose, 0.5ml, of Gardasil (Lot #653937/0637F), and on 29-JAN-2007 with the second dose, IM in the left arm, 0.5ml, of Gardasil (Lot #655617/1447F). On 30-APR-2007, the patient presented to the office, and a urine pregnancy test performed was positive; other labwork was within normal range. The patient reported a questionable LMP date of 09-APR-2007, with an estimated date of delivery of 14-JAN-2008. Follow up information included that on 30-APR-2007, prenatal vitamins (PRIMACARE ONE) were initiated. On 04-OCT-2007, an ultrasound was performed for routine prenatal care (result not specified). There were no illnesses or infections during pregnancy. The patient experienced complications during labor and delivery, due to uterine atony and a non-reassuring fetal heart rate and a Cesarean section was required; however, on 28-DEC-2007, at 41 weeks gestation, she delivered a normal female infant (no abnormalities and no congenital anomalies), weight 8 lb 1oz, Apgar score 8/9. Upon internal review, non-reassuring fetal heart rate and uterine atony were considered to be serious as other important medical events. Additional information is not expected.

VAERS ID:306809 (history)  Vaccinated:2008-02-25
Age:18.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-03-10, Days after onset: 12
Location:Massachusetts  Entered:2008-03-11, 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: None
Current Illness: Asthma; Allergic reaction to antibiotics
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA00362
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Joint range of motion decreased, Pain, Pruritus, Pyrexia, Swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Information has been received from a licensed practical nurse concerning her 18 year old daughter, with "possible asthma" and an allergy to sulfamethoxazole (+) trimethoprim (SEPTRA), who on 25-FEB-2008 was vaccinated with the third dose of Gardasil. There was no concomitant medication reported. On 26-FEB-2008 the patient experienced a systemic reaction about "24 hours after vaccination with her third dose of Gardasil." The reaction was not anaphylactic. Her daughter developed hives, swelling, itching, pain, fever and had difficulty moving her joints. She was taken to the emergency room and given prednisone and diphenyhydramine hydrochloride (BENADRYL). No diagnostic laboratory studies were performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Hives, swelling, itching, pain, fever, and difficulty moving her joints were considered to be other important medical events. Additional information has been requested.

VAERS ID:306834 (history)  Vaccinated:2008-02-26
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-04
Location:Florida  Entered:2008-03-11, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U3UNRA
Administered by: Other     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: No adverse event - reporting patient received a 4th dose of Gardasil. Patient tolerated well, no problems.

VAERS ID:306836 (history)  Vaccinated:2008-02-25
Age:18.0  Onset:2008-02-25, Days after vaccination: 0
Gender:Female  Submitted:2008-02-28, Days after onset: 3
Location:Missouri  Entered:2008-03-11, 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:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0073X1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2383BA0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Chest discomfort, Dyspnoea, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Patient calls on phone 2-26-08 stating she had hives several hours after injection. She took Benadryl and used hydrocortisone cream. By the next morning these were better. She then developed some intermittent chest discomfort and shortness of air. Instructed patient to go to ER. Patient did not go. Spoke to her on 2-27-08, was better.

VAERS ID:307039 (history)  Vaccinated:2008-03-11
Age:18.0  Onset:2008-03-12, Days after vaccination: 1
Gender:Female  Submitted:2008-03-13, Days after onset: 1
Location:Georgia  Entered:2008-03-13
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 (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB217BA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0522U0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1790U1SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Back of left arm swollen 1 1/2" x 2", red, warm to touch. Advised cool pack 20 min QID. Advil every 6 hours.

VAERS ID:307054 (history)  Vaccinated:2008-02-12
Age:18.0  Onset:2008-02-12, Days after vaccination: 0
Gender:Female  Submitted:2008-03-13, Days after onset: 29
Location:Unknown  Entered:2008-03-14, 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: Pregnancy NOS (LMP = 1/22/2008); Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA01259
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
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 for the Pregnancy Registry for Gardasil from an 18 year old female consumer with Amoxicillin allergy who on 12-FEB-2008 was vaccinated with a first dose of Gardasil (route, site and lot # not reported). There were no concomitant therapies. Her last menstrual period was on 22-JAN-2008 and expected delivery date (EDC) being 28-OCT-2008. She later found out that she had a miscarriage on 06-MAR-2008. The consumer did not report if any laboratory tests were done. No other information was available at this time. Upon internal review "miscarriage" was determined to be an other important medical event. Additional information has been requested.

VAERS ID:307142 (history)  Vaccinated:2008-02-22
Age:18.0  Onset:2008-02-22, Days after vaccination: 0
Gender:Male  Submitted:2008-03-14, Days after onset: 20
Location:Georgia  Entered:2008-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Had cold symptoms @ time of immunization.
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA274BA IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash, Skin lesion, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 2 hours after immunization broke out in rash each lesion approx size of a quarter. Skin hot to touch but no fever. Seen in ER @ 6PM. Gave Benadryl po, Albuterol 2mg tab & Loratidine.

VAERS ID:307465 (history)  Vaccinated:2007-12-19
Age:18.0  Onset:2007-12-19, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 85
Location:Unknown  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA00445
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Head injury, Skin laceration, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Follow up information has been received from a physician''s assistant concerning an 18 year old female with no previous medical history, who on 19-DEC-2007 was vaccinated with her first dose of Gardasil (lot number: 659055/1522U). No concomitant medications. On 19-DEC-2007, after the injection the patient got up to check out window and had syncopal episode. She hit her head on the plexiglass partition at the window with a minor laceration and bump. EMS was called second degree to patient hitting head, but the patient refused to go the hospital for evaluation. The physician assistant called the patient the next day and she felt well. No other adverse reactions. No further information is available.

VAERS ID:307512 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-14
Location:Unknown  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0802USA01349
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Other     Purchased by: Other
Symptoms: Dysmenorrhoea, Menstruation irregular
SMQs:, Fertility disorders (broad)
Write-up: Information has been received from a health professional concerning an 18 year old female who was vaccinated intramuscularly with the second dose of Gardasil (date unspecified). Per the reporter the patient''s period started early and she experienced very bad cramps. Subsequently, the patient recovered from her period starting early and very bad cramps. No further information is available. No further information is available.

VAERS ID:307563 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-14
Location:Indiana  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA01887
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Vaccine positive rechallenge
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning her 18 year old daughter who was vaccinated on unspecified dates intramuscularly with 0.5 mL of Gardasil (lot numbers not reported). It was reported that the patient experienced severe pain at the injection site during administration of all three doses of Gardasil. The physician reported that "the pain resolved without requiring treatment and the patient completely recovered." No further information is available.

VAERS ID:307593 (history)  Vaccinated:2007-12-18
Age:18.0  Onset:2007-12-18, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 86
Location:Unknown  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA02199
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1287U1IMUN
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 was obtained on request by the Company from an agency concerning an 18 year old female with no reported medical history and no pre-existing illnesses at time of vaccination who on 18-DEC-2007 was vaccinated IM in the left arm with the second dose of GARDASIL (lot # 655327/1287U). On 18-DEC-2007 the patient experienced syncope after 1 minute. Additional information has been requested.

VAERS ID:307595 (history)  Vaccinated:2007-11-12
Age:18.0  Onset:2007-11-12, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 122
Location:Unknown  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: Mole excision; General symptom
Diagnostic Lab Data: blood pressure 11/12/07 112/68; total heartbeat count 11/12/07 160
CDC Split Type: WAES0802USA02355
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Condition aggravated, Foaming at mouth, Loss of consciousness, Malaise, Pallor, Syncope, Tremor, Urinary incontinence
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), Convulsions (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a registered nurse concerning an 18 year old female with a history of mole excision who on 12-NOV-2007 was vaccinated with her first dose of GARDASIL (Lot #659437/1266U). Concomitant therapy included birth control. On 12-NOV-2007, immediately after the vaccination, the patient did not feel well. She experienced a syncopal episode and fainted. The patient collapsed, became unconscious for three to four minutes and started shaking. The patient also experienced pallor. Her blood pressure was normal. Ammonia was held under her nose. She recovered shortly after. The patient was not hospitalized. The nurse did not consider the event to be disabling, an other important event, or life threatening. The registered nurse also noted the patient had a similar experience after a mole was removed. She went home that day with her mother and her vital signs were stable (Pulse=160, blood pressure=112/68). The patient recovered. The patient refused to come back for a second shot of GARDASIL. it was recommended the patient see a neurologist. The patient has not been back to the office since 12-NOV-2007. The nurse reported that she did not feel this adverse experienced was from GARDASIL vaccination. This was all the information the nurse could provide. No additional information is available. Follow up information was received on 5-MAR-2008 from the registered nurse. At approximately 1:33 pm on 12-NOV-2007 the patient fell back on to the table with mild shaking, foaming at the mouth, and loss of bladder control. It took 3-4 minutes for the patient to come around, she was immediately alert and denied feeling tired. At 4:00 pm the patient''s blood pressure was 96/56 and her pulse and 68 beats per minute. The patient was held in the office for 20 minutes. The patient felt well and her mother drove her home. The patient had a follow up with a neurologist (date unspecified) since her last dose. The patient had recovered on an unspecified date. The mother reported that the daughter had a similar episode af

VAERS ID:307606 (history)  Vaccinated:2007-12-07
Age:18.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Female  Submitted:2008-07-08, Days after onset: 212
Location:Missouri  Entered:2008-03-17, Days after submission: 113
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: Tonsillectomy; Heavy periods; Anaemia
Diagnostic Lab Data: [procedure unspecified]
CDC Split Type: WAES0802USA03368
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Rash, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a consumer concerning her daughter, an 18 year old with a history of tonsillectomy, and heavy periods which cause anaemia. On 07-DEC-2007, the patient was vaccinated with her first dose of Gardasil. On 08-DEC-2007 the patient experienced fine rash on legs. On 08-Feb-2008, the patient received her second dose of Gardasil. Concomitant therapy included ZYRTEC-D and hormonal contraceptives (unspecified). On 09-FEB-2008 the patient experienced fine rash on legs. The patient''s fine rash on legs persisted. The patient sought unspecified medical treatment and unspecified lab diagnostics were performed. The report states the therapy was discontinued on 08-Feb-2008. Additional information has been requested. On 14-FEB-2008 the patient was diagnosed with eczema on her legs and stomach. Follow up information indicated the patient recovered on an unknown date. Additional information has been requested.

VAERS ID:307618 (history)  Vaccinated:2007-10-19
Age:18.0  Onset:2007-10-19, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 147
Location:Unknown  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO TRI-CYCLEN LO
Current Illness: Kleine-Levin syndrome
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA03425
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Amnesia, Fatigue, Vomiting
SMQs:, Acute pancreatitis (broad), Dementia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a nurse practitioner concerning an 18 year old female with Kleine-Levin syndrome who on 19-OCT-2007 was vaccinated with the first dose of Gardasil (lot # 658560/1062U). Concomitant therapy included ORTHO TRI-CYCLEN LO. On approximately 19-OCT-2007 the patient experienced vomiting, memory loss and extreme fatigue "almost to the point of paralysis." Approximately a week later, the patient recovered from vomiting, memory loss and extreme fatigue. Additional information has been requested.

VAERS ID:307667 (history)  Vaccinated:0000-00-00
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-14
Location:Unknown  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic reaction to antibiotics
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA03705
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Pain in extremity
SMQs:
Write-up: Information has been received from a consumer concerning her 18 year old daughter with allergic reaction to antibiotics who in January 2007, was vaccinated with her first dose of GARDASIL. Concomitant therapy included doxycycline hyclate (DORYX). In January 2007, the patient experienced pain in her arm. Subsequently, the patient recovered from pain in her arm. No further information available. Additional information has been requested.

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