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| VAERS ID: | 263225 | Vaccinated: | 2006-07-19 | | Age: | 15.0 | Onset: | 2006-07-19, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2006-09-14, Days after onset: 57 | | Location: | Texas | Entered: | 2006-09-19, Days after submission: 5 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: NONE | | CDC 'Split Type': WAES0608USA06029 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0637F | 0 | | UN | |
| Administered by: Other Purchased by: Other | | Symptoms: Erythema, Injection site pain, Pain | | Write-up: Information has been receiving from a registered nurse concerning a 15 year old female with no medical history who on 19-JUL-2006 was vaccinated in the right deltoid with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F). Subsequently, on approximately 19-JUL-2006, the patient experienced burning at the injection site that lasted approximately 60 to 90 seconds and her arm became red and painful enough to cause the patient to cry. The patient subsequently recovered from the pain in the extremity, erythema, and injection site irritation. Additional information has been requested. The registered nurse also reported that the patient's sister experienced pain in the extremity, erythema, and injection site irritation following vaccination with HPV rLi 6 11 16 18 VLP vaccine (yeast) (LOT#653937/0637F). |
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| VAERS ID: | 263226 | Vaccinated: | 2006-07-27 | | Age: | 21.0 | Onset: | 2006-08-03, Days after vaccination: 7 | | Gender: | Female | Submitted: | 2006-09-14, Days after onset: 42 | | Location: | New York | Entered: | 2006-09-19, Days after submission: 5 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0608USA06089 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0688F | 0 | IM | LA | |
| Administered by: Private Purchased by: Private | | Symptoms: Arthralgia, Influenza, Influenza like illness, Pyrexia | | Write-up: Information has been received from a physician concerning a 24 year old female patient who in approximately August 2006, was vaccinated with a dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced pain in joints and developed low grade fever. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested. 01/05/2007 Follow up information has been received, the physician reported that the patient was recovered from her symptoms and stated "all it was was a one day flu". Additional follow up information has been received from the physician concerning her 24 year old daughter, a student, who on 27-JUL-2006 was vaccinated IM in left arm with her first dose of GARDASIL, lot #653735/0688F. It was reported that on 03-AUG-2006 she developed flu like symptoms. No further information is available. |
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| VAERS ID: | 263227 | Vaccinated: | 2006-08-07 | | Age: | 20.0 | Onset: | 2006-08-07, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2006-09-14, Days after onset: 38 | | Location: | Massachusetts | Entered: | 2006-09-19, Days after submission: 5 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: NONE | | Previous Vaccinations: | | Other Medications: YAZ | | Preexisting Conditions: NONE | | CDC 'Split Type': WAES0608USA06260 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0702F | 0 | IM | | |
| Administered by: Other Purchased by: Other | | Symptoms: Pain | | Write-up: Information has been received from a 20 year old female patient who on 07-AUG-2006 was vaccinated intramuscularly with her first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653650/0702F). Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). The patient stated that "right after getting the shot" she experienced pain in the upper arm on and off throughout the day. She also stated that the pain"feels like she has a knife in her arm". Unspecified medical attention was sought. The patient was treated with Ibuprofen. As of the report date, she was recovering. Additional information has been requested. |
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| VAERS ID: | 263228 | Vaccinated: | 2006-08-25 | | Age: | 27.0 | Onset: | 2006-08-25, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2006-09-14, Days after onset: 20 | | Location: | Rhode Island | Entered: | 2006-09-19, Days after submission: 5 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0608USA06297 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0702F | | | UN | |
| Administered by: Other Purchased by: Other | | Symptoms: Skin burning sensation | | Write-up: Information has been received from a nurse practitioner concerning a 27 year old female who on 25-AUG-2006 was vaccinated with a dose of HPV rLi 6 11 16 18 VLP vaccine (yeast), lot#653650/0702F. During the administration of the vaccine, part of the fluid went into the patient's arm, the patient's arm, the patient pulled away and the remainder went on the skin (no adverse reaction noted). The patient complained of burning during administration. Medical attention was sought. The patient received a repeat dose with no burning noted. Patient's status was reported as recovered. Additional information has been requested. |
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| VAERS ID: | 263229 | Vaccinated: | 2006-07-19 | | Age: | 17.0 | Onset: | 2006-07-19, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2006-09-14, Days after onset: 57 | | Location: | Texas | Entered: | 2006-09-19, Days after submission: 5 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: NONE | | CDC 'Split Type': WAES0608USA06310 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0637F | 0 | | UN | |
| Administered by: Other Purchased by: Other | | Symptoms: Erythema, Pain | | Write-up: Information has been received from a registered nurse concerning a 17 year old female with no medical history who on 19-JUL-2006 was vaccinated in the right deltoid with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F). Subsequently on approximately site that lasted approximately 60 to 90 seconds and her arm became red and painful enough to cause the patient to cry. The patient subsequently recovered from the pain in the extremity, erythema, and injection site irritation. Additional information has been requested. The registered nurse also reported that the patient's sister experienced pain in the extremity, erythema,and injection site irritation following vaccination with HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F). |
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| VAERS ID: | 263230 | Vaccinated: | 2006-07-27 | | Age: | 18.0 | Onset: | 2006-08-01, Days after vaccination: 5 | | Gender: | Female | Submitted: | 2006-09-14, Days after onset: 44 | | Location: | New York | Entered: | 2006-09-19, Days after submission: 5 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0608USA06470 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0688F | 0 | IM | UN | |
| Administered by: Private Purchased by: Private | | Symptoms: Arthralgia, Pyrexia | | Write-up: Information has been received from a physician concerning a 19 year old female patient who in approximately August 2006, was vaccinated with a dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently,the patient experienced pain in joints and developed low grade fever. Unspecified medical attention was sought. The physician reported that the patient was recovered from her symptoms and stated "all it was was a one day flu. Additional information is expected. |
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| VAERS ID: | 263231 | Vaccinated: | 2006-08-01 | | Age: | 18.0 | Onset: | 2006-08-01, Days after vaccination: 0 | | Gender: | Male | Submitted: | 2006-09-14, Days after onset: 44 | | Location: | New York | Entered: | 2006-09-19, Days after submission: 5 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Unknown | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0608USA06471 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | | | UN | UN | |
| Administered by: Other Purchased by: Other | | Symptoms: Arthralgia, Influenza, Pyrexia | | Write-up: Information has been received from a physician concerning an 18 year old male patient who in approximately August 2006, was vaccinated with a dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced pain in joints and developed low grade fever. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested. Follow up information has been received: the physician reported that the patient was recovered from his symptoms and stated "all it was was a one day flu". Additional information is expected. |
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| VAERS ID: | 263232 | Vaccinated: | 2006-08-21 | | Age: | 26.0 | Onset: | 2006-08-21, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2006-09-14, Days after onset: 24 | | Location: | New Jersey | Entered: | 2006-09-19, Days after submission: 5 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: diagnostic laboratory 08/21/2006 "comprehensive metabolic panel tests", electrocardiogram 08/21/06, absolute neutrophil 08/21/06 7.9 K/ul 2.0-609, total urine ketones 08/21/06 >-80 negative, urine bacteria screen 08/21/2006 4+, urine WBC co | | Previous Vaccinations: | | Other Medications: ORTHO TRI CYCLEN | | Preexisting Conditions: NONE | | CDC 'Split Type': WAES0608USA06478 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0702F | 0 | | UN | |
| Administered by: Public Purchased by: Private | | Symptoms: Laboratory test abnormal, Unevaluable event | | Write-up: Information has been received from an other health professional concerning a 26 year old female in sales with no pre-existing allergies, birth defects or medical conditions reported. On 21-AUG-2006, in the pm, the patient was vaccinated in the left deltoid with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653650/0702F). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI CYCLEN). There were no illness noted at the time of vaccination. On 21-AUG-2006, in the pm, the patient experienced an unspecified adverse event. The patient went to the emergency room and it was reported that she "went home that day". On 21-AUG-2006, the patient underwent a complete blood count (CBC), comprehensive metabolic panel, estimated glomerular filtration rate (GFR), urine microscopic analysis, urinalysis and an electrocardiogram (EKG). On 21-AUG-2006, the patient's laboratory data revealed an absolute neutrophil count noted as 7.9 K/ul, urine ketones noted as >-80, a urine white blood cell count noted as 30-40/hpf and urine bacteria noted as 4+. On 21-AUG-2006, the patient recovered from the events. Additional information has been requested. |
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| VAERS ID: | 263233 | Vaccinated: | 2006-08-07 | | Age: | 26.0 | Onset: | 2006-08-07, Days after vaccination: 0 | | Gender: | Female | Submitted: | 2006-09-14, Days after onset: 38 | | Location: | Unknown | Entered: | 2006-09-19, Days after submission: 5 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: NONE | | Previous Vaccinations: | | Other Medications: NONE | | Preexisting Conditions: NONE | | CDC 'Split Type': WAES0608USA06605 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0696F | | IM | | |
| Administered by: Other Purchased by: Other | | Symptoms: Unevaluable event | | Write-up: Information has been received from a 26 year old female licensed practical nurse with no pertinent medical history and no known allergies or adverse drug reactions reported who on 07-AUG-2006 was vaccinated intramuscularly with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0696F). There were no concomitant medications reported. The licensed practical nurse reported that she received HPV rLi 6 11 16 18 VLP vaccine (yeast) in her deltoid from a pre-filled syringe. It was reported that when the injection was completed, the nurse administering it "let go of the plunger before taking it out of her arm" and the "spring shot the syringe out of the arm like a dart". It was reported that "some fluid leaked out of her arm". The licensed practical nurse reported that it "stung a little when the vaccine was administered" and then resolved in a few moments. The area of the spill was cleansed with alcohol. The patient sought unspecified medical attention. There were no laboratory diagnostic studies performed. At the time of this report, the patient had recovered from the events. Additional information has been requested. |
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| VAERS ID: | 263235 | Vaccinated: | 2006-08-18 | | Age: | 23.0 | Onset: | 2006-08-23, Days after vaccination: 5 | | Gender: | Female | Submitted: | 2007-01-05, Days after onset: 135 | | Location: | North Carolina | Entered: | 2006-09-19, Days after submission: 108 | |
| Life Threatening Illness? No |
| Died? No |
| Disability? No |
| Recovered? Yes | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: | | Previous Vaccinations: | | Other Medications: Unknown | | Preexisting Conditions: Unknown | | CDC 'Split Type': WAES0608USA06869 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | HPV4 | MERCK & CO. INC. | 0637F | | IM | UN | |
| Administered by: Private Purchased by: Private | | Symptoms: Rash | | Write-up: This is in follow-up to report(s) previously submitted on 9/14/2006. Information has been received from a physician concerning a 23 year old female with no known drug allergies was vaccinated intramuscularly on 18-AUG-2006 at 15:00 in the deltoid muscle with GARDASIL (yeast). On 24-AUG-2006 the patient developed a rash with itching and minimal swelling on the back of her neck, arms, ribs, back and behind her left knee. Follow up information stated that the patient was treated with Benadryl, 50 mg and topical hydrocortisone cream. It was reported that on 24-AUG-2006 the patient had recovered. Additional information is not expected. |
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