chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a history of urinary tract infection and no drug allergies, who on approximately 05-NOV-2007 was vaccinated with a first dose of Gardasil vaccine. Concomitant therapy included acyclovir. On 18-NOV-2007, the patient presented to the emergency room with vaginal pain. The patient was prescribed acyclovir and diagnosed with herpes. The patient took some pain medications and stayed home from school for a few days. The patient was re-evaluated and found to be an otherwise health, athletic teenager with her hymenal ring still intact and no history of STD diseases or pertinent medical history. The patient had pain and bilateral erythema at the labia minor and there was a black ulceration observed in that area. The patient's white blood cell count was slightly elevated. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Nausea, Pallor, Tremor
Clinical narrative: Information has been received from a physician concerning a 16 year old white female with a history of mild asthma who on 25-OCT-2007 was vaccinated in the left deltoid with her third dose of GARDASIL vaccine (yeast) (lot# 659437/1266U). On 25-OCT-2007, 20 minutes after being vaccinated, the patient became nauseous, very pale and shaky. This lasted until the next day. Subsequently, the patient recovered from nauseous, very pale and shaky within 24 hours. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient (age not specified) who in early November 2007 had started her period, and was then vaccinated with a dose of GARDASIL vaccine (yeast) (lot # not specified). The physician noted that the patient's period "suddenly stopped" after the vaccination. On approximately 26-NOV-2007 ("just started"), the patient's suddenly started again. The physician questioned if the event was related to GARDASIL vaccine (yeast). At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Ovarian cyst
Clinical narrative: Information has been received from a nurse practitioner concerning her daughter (age not reported) who was vaccinated (date, route and site not reported) with the 1st dose  of the GARDASIL vaccine (yeast) ( lot# not reported). Subsequently, a couple weeks after receiving GARDASIL vaccine (yeast), the patient had an ovarian cyst/mass removed. The nurse practitioner inquired if getting GARDASIL vaccine (yeast) could have caused the cyst. At the time of this report, the outcome of the patient was unknown. This one of two reports from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Breast pain, Ear infection, Gait disturbance, Headache, Muscle spasms
Clinical narrative: Information has been received from a consumer concerning her 21 year daughter with a history of tree allergy, mycotic allergy, pollen allergy, allergy to animal dander and house dust mite allergy who in approximately April or May 2007, was vaccinated with her first dose of GARDASIL vaccine (yeast). On approximately 24-SEP-2007 the patient was vaccinated with her third dose of GARDASIL vaccine (yeast). Concomitant therapy included venlafaxine HCL (EFFEXOR), water pills (therapy unspecified) and hormonal contraceptives (unspecified). On 27-SEP-2007 the patient experienced severe muscle pain in which she can hardly walk, cramps, severe breast pain, headache and stuffy nose. The patient had gone to her OB/GYN for a breast ultrasound. The patient also had an ear infection the day of her vaccine. The patient's severe muscle pain and cramps and severe breast pain, and headache and stuffy nose persisted. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Nasal congestion, Ultrasound scan
Clinical narrative: Information has been received from a consumer concerning her 21 year daughter with a history of tree allergy, mycotic allergy, pollen allergy, allergy to animal dander and house dust mite allergy who in approximately April or May 2007, was vaccinated with her first dose of GARDASIL vaccine (yeast). On approximately 24-SEP-2007 the patient was vaccinated with her third dose of GARDASIL vaccine (yeast). Concomitant therapy included venlafaxine HCL (EFFEXOR), water pills (therapy unspecified) and hormonal contraceptives (unspecified). On 27-SEP-2007 the patient experienced severe muscle pain in which she can hardly walk, cramps, severe breast pain, headache and stuffy nose. The patient had gone to her OB/GYN for a breast ultrasound. The patient also had an ear infection the day of her vaccine. The patient's severe muscle pain and cramps and severe breast pain, and headache and stuffy nose persisted. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a health professional concerning an 18 year old female with a history of Lyme disease who in approximately August 2007, was vaccinated with her first dose of GARDASIL vaccine (yeast). The patient had a Thin Prep PAP HPV DNA test which detected she was high risk for types 16, 18, 31, 35, 39, etc. The patient also had a STD screening performed which was negative for epithelial malignancy. The patient has never had intercourse, has never been sexually active. The health professional questioned whether GARDASIL vaccine (yeast) can cause patients to test positive for HPV DNA. The health professional did confirm the results with the lab. The patient's outcome was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a physician about her daughter who on 21-OCT-2007 was intramuscularly vaccinated with her second dose of GARDASIL vaccine (yeast) (Lot # 658558/1061U). Subsequently the patient experienced a "knot" at the injection site. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on an unspecified date was vaccinated IM with the second dose of Gardasil vaccine (Lot Number not reported). Reporter indicated that the patient had fainted and was fine before leaving the office. No medical attention was sought. Patient outcome was recovered. No product quality complaint was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HEP, HEPA, HPV4
Symptoms: Dizziness, Local reaction, Pain in extremity, Skin burning sensation
Clinical narrative: Information has been received from a physician concerning a 23 year old female nurse patient who on an unspecified date was vaccinated IM with the third dose of Gardasil vaccine (Lot number not provided). Concomitant therapy included hepatitis B virus vaccine (unspecified) and hepatitis A virus vaccine (unspecified). Subsequently, the patient experienced localized pain and burning on her left arm. It was reported that the pain went away shortly after receiving the vaccine. The patient outcome was recovered. Unknown medical attention was sought. No product quality complaint was involved. Additional information has been requested. Information has been received from a physician, and from a 23 year old female medical assistant with no known allergies, who on 26-NOV-2007 was vaccinated IM with the third dose of HPV vaccine (lot number not provided). Subsequently the MA experienced localizedpain and burning of the injection site on her left arm. In addition, she felt "slightly dizzy." The MA reported the symptoms lasted "approximately 10 minutes," and she recovered. Unknown medical attention was sought. No product quality complaint was involved.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient who on an unspecified date was vaccinated IM with a dose of Gardasil vaccine (Lot number not provided). It was reported that the patient may have received other vaccines within the same visit, but specifics unknown. The reporter indicated the patient who received the vaccine had fainted. Patient was fine before leaving the office. The patient outcome was recovered. No product quality complaint was involved. Additional information has been requested. Inital and follow-up information has been received from a physician concerning a 13 year old female patient with no known allergies who on 14-NOV-2007 was vaccinated IM with a third dose of HPV vaccine (lot # 659435/1255U). It was reported that the patient started her first injection on 08-MAY-2007 and the date of second injection was not mentioned. The reporter indicated the patient who recieved tha vaccine had fainted. In follow-up information it was reported that the patient stated that she was light headed and little dizzy after the vaccination. He blood pressure was taken and had her lay down and watched her. Syptoms persisted approximately thirty minutes. Patient was fine before leaving the office. The patient outcome was recovered. No product quality complaint was involved.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil vaccine (lot# unknown) injection. Concomitant therapy on the same day included Menactra. Subsequently the patient developed a rash after receiving a dose of Gardasil vaccine. Medical attention was sought. Very little information was provided regarding this adverse experience. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning approximately ten females who were vaccinated with Gardasil vaccine. Subsequently, the patients experienced redness, swelling, pain and tenderness at the injection site. The nurse says the symptoms are more severe with dose 2 but occur sometimes after dose 1. Patients receive the vaccination from their primary physicians and usually come the next day to see her with the symptoms. She tells the patients to use an ice pack and assumes they all recover because none of them have returned. The patients are pre-teens (usually 12 years of age). Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Information has been received from a health professional concerning an 11 year old female who was vaccinated with the first dose of GARDASIL vaccine on 13-NOV-2007. Subsequently the patient experienced redness, swelling, pain, and tenderness at the injection site. The patient complained of pain of 5/10 on the pain scale. The patient recovered from the symptoms.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional concerning an unknown number of female patients who were vaccinated intramuscularly with Gardasil vaccine. Subsequently, the patients experienced injection site pain. The patients are in the office for the administration and comment on the pain after administration. The patients are immigrants and received multiple vaccinations in one visit and they comment that the Gardasil injection is more painful than the others. The nurse says she tells patients before hand that the Gardasil will hurt more than the other vaccine, so she is not sure if that is contributing to the complaints. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a registered nurse, concerning "many patients" who were vaccinated (dates not reported) with a dose of Gardasil vaccine (lot # not reported). The nurse reported that many patients subsequently, "pass out from Gardasil vaccine." No further details were available. Follow up information received from the nurse indicated that "1 out of every 5 or 6 patients pass out or nearly pass out" after vaccination with Gardasil vaccine. She added that the office began to warn patients prior to administering the vaccination, but then the incidence increased; since they stopped warning patients, the incidence "had gone down." She added that the event occurs more in patients receiving their first vaccination and in patients who have not eaten on the morning of vaccination. No further details are available. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Immune system disorder
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with the second dose of Gardasil vaccine (date, route, and dose information was unavailable for both the first and second dose of Gardasil vaccine). Subsequently, the patient experienced an immune response reaction. The reporter felt that immune response reaction were not related to therapy with Gardasil vaccine. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a female (age unknown), who on an unspecified date, was vaccinated with a 0.5mL dose of Gardasil vaccine. Subsequently, the patient experienced pain at the injection site. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer regarding her granddaughter who in May 2007, was vaccinated with a first dose of Gardasil vaccine. It was reported that the consumer never had a second dose of the vaccine. When the patient had a recent pap smear, the results came back that she developed "atypical cell." Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nuclear magnetic resonance imaging, Syncope
Clinical narrative: Information has been received from a physician concerning a 25 year old female with no pertinent medical history or drug reactions/allergies, who on 24-MAY-2007 was vaccinated with a first dose of Gardasil (lot# 657737/0522U) 0.5 mL IM. Concomitant therapy included Effexor and NuvaRing. Since the vaccination on 24-MAY-2007, the patient has been experiencing headaches on a daily basis. Medical attention was sought. On 25-JUL-2007, the patient received a second dose of Gardasil (lot#658222/0927U). On 26-NOV-2007, the patient received a third dose of Gardasil vaccine (lot#unknown). The patient experience syncope when she arrived home on the same day and once the next day, 27-NOV-2007. The patient has an appointment with her primary physician and a scheduled magnetic resonance imaging test for 29-NOV-2007. No further information was available. At the time of reporting it was unknown if the patient had recovered. The patient has not recovered from the headaches. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Anorexia, Fatigue, Headache, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 26-NOV-2007 was vaccinated with a first dose of Gardasil vaccine injection. Concomitant therapy on the same day included varicella virus vaccine live (unspecified) and Menactra. On 27-NOV-2007, the patient came back into the office with a fever, no appetite and a headache. Medical attention was sought. Subsequently, on an unspecified date the patient recovered from the events with therapy unspecified. There was no further AE information. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Information has been received from a physician and an other health professional concerning a 12 year old white female who on 26-NOV-2007 at 5:00PM, was vaccinated intramuscularly into the left arm with a second dose of GARDASIL (Lot# 659055/1522U). Concomitant therapy also given on 26-NOV-2007 included intramuscular vaccinations with second doses of VARIVAX (Lot# 656279/1503F: right arm), MENACTRA (Lot# U2390BA: right arm) and BOOSTRIX (Lot# AC528018AB: left arm). There was no illness at the time of vaccination. The physician reported that on 27-NOV-2007 the patient came back into the office with a fever, no apppetite and a headache. Additional information reported by a health professional indicated that on the morning of 27-NOV-2007, the patient had developed fatigue and fever. The physician reported that on an unspecified date the patient recovered. Additional informationm is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Photosensitivity reaction, Rash, Skin exfoliation, Sunburn, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female who on 03-AUG-2007 was vaccinated with Gardasil vaccine (lot # unknown). On 30-AUG-2007, the patient experienced "photosensitivity like reactions." The patient had a sunburn on her face, eye lids and neck and eventually the skin started peeling off those areas. The patient was not exposed to the sun more than usual and was using sunscreen. The patient also experienced rash on her legs. On 05-NOV-2007, the patient was vaccinated with a second dose of Gardasil vaccine (lot # unknown). The patient experienced similar symptoms but not as severe as after the first dose. No further information was provided. At the time of reporting it was unknown if the patient had recovered. Additional information has been requested. Initial and follow-up information has been received from an urse practitioner concerning a 15 year old female who in 30-AUG-2007 was vaccinated with a first dose og HPV vaccine (lot # unknown). On 30-AUG-2007 the patient experienced "photosensitivity like reactions". The patient had a sunburn on her face, eye lids and neck and eventuallly the skin started peeling off those areas. The patient was not exposed to the sun more than usual and was using sunscreen. The patient also experienced rash on her legs. Subsequently, the patient recovered. On 05-NOV-2007 the patient was vaccinated intramuscularly into the left deltoid with a second dose of HPV vaccine (lot # 658563/1063U). The patient experienced similar symptom of eyelids, face and neck peeled, rash on legs, and she felt "on fire". The symptoms were not as severe as after the first dose. The patient did not have a fever or pain. In November 2007, the patient recovered. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a 22 year old female who on an unspecified date was vaccinated with a first dose of Gardasil vaccine. On an unspecified date within a week after the Gardasil vaccine was administered to the patient, the patient experienced an "inguinal lymph node." Medical attention was sought. The physician reported that the patient's lymph node is still swollen. No further information was provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Arthralgia, Bronchospasm, Disorientation, Electrocardiogram
Clinical narrative: Information has been received from a 25 year old female consumer with no pertinent medical history, drug reaction/allergies or concomitant medication use, who on approximately 08-NOV-2007, "3 weeks ago", was vaccinated intramuscularly (site not reported) with the 1st 0.5mL dose of Gardasil vaccine (lot # not reported). The patient reported that post vaccination (1 to - days after being vaccinated), she experienced bronchi spasms, neck and joint pain, abdominal pain, disorientation and hematuria. The patient stated she has gone to the emergency room 2 times and had EKG, MRI and several blood test performed, they have not been able to pinpoint any problems. At the time of this report the patient had not recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Haematuria, Laboratory test, Neck pain, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a 25 year old female consumer with no pertinent medical history, drug reaction/allergies or concomitant medication use, who on approximately 08-NOV-2007, "3 weeks ago", was vaccinated intramuscularly (site not reported) with the 1st 0.5mL dose of Gardasil vaccine (lot # not reported). The patient reported that post vaccination (1 to - days after being vaccinated), she experienced bronchi spasms, neck and joint pain, abdominal pain, disorientation and hematuria. The patient stated she has gone to the emergency room 2 times and had EKG, MRI and several blood test performed, they have not been able to pinpoint any problems. At the time of this report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Back pain
Clinical narrative: Information has been received from a nurse concerning a female (age not reported) who in August 2007 (exact date not reported), was vaccinated (site and route not reported) with the 1st dose of Gardasil vaccine (lot# not reported). On 11-OCT-2007, the patient was vaccinated (site and route not reported) with the 2nd dose of Gardasil vaccine (lot# not reported). The patient reported that post the 2nd vaccination, she developed back pain. It was not reported if the patient received medical attention. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Visual impairment
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with her first 0.5mL dose of Gardasil vaccine. Subsequently, the patient fainted after receiving the vaccination. The nurse caught her so she did not fall. The patient also did not eat before received the vaccination. Subsequently, the patient recovered from fainting. Additional information has been requested.Information has been received from a physician concerning a 17 year old female who on 07-NOV-2007 was vaccinated with her first 0.5ml dose of HPV vaccine in the left deltoid (lot # 658560/162U). Subsequently, the patient stated she saw black and then fainted after receiving the vaccination. The nurese caught her so she did not fall. The patient also did not eat before receiving the vaccination. Subsequently, the patient recovered from fainting and left the office with no problem.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test negative, Human papilloma virus test positive, Smear cervix normal
Clinical narrative: Information has been received from a 20 year old female with a food allergy to salsa and a history of pap smears, who was vaccinated with a three dose series of Gardasil vaccine via injection. Concomitant therapy included NuvaRing. The patient had a pap smear and a HPV test done back in JUL-2007 and both test came out negative. She completed all three doses of Gardasil vaccine and had taken another pap smear and HPV test in NOV-2007. The HPV test came back as "high risk". The pap smear did come back as normal. The patient wanted to know if the Gardasil vaccine may have something to do with the change of test from negative to positive. No lot number was provided. No further information was provided. No further information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site movement impairment, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 25 year old female who on 25-MAY-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (657622/0388U). On 25-MAY-2007 the patient experienced injection site reaction (redness, heat and pain at the injection site). Subsequently, the patient recovered from the injection site reaction. On 27-JUL-2007 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast) (658490/0802U). On 27-JUL-2007 the patient experienced injection site reaction (redness, heat and pain at the injection site). Subsequently, the patient recovered from the the injection site reaction. On 26-NOV-2007 the patient was vaccinated with the third dose of GARDASIL vaccine (yeast) (659055/1522U). On 26-NOV-2007 the patient experienced injection site reaction (redness, heat and pain at the injection site), injection site arm is numb and unable to lift arm above shoulder. The patient's injection site reaction, injection site arm is numb and unable to lift arm above shoulder persisted. The reporter felt that injection site reaction (redness), injection site reaction (heat), injection site reaction (pain), injection site arm is numb and unable to lift arm above shoulder were not related to therapy with GARDASIL vaccine (yeast). Additional information has been requested. This is in follow-up to report previously submitted on 12/14/2007. Information has been received from a health professional concerning a 25 year old female who on 25-MAY-2007 was vaccinated with the first dose of GARDASIL vaccine (657622/0388U). On 25-MAY-2007 the patient experienced injection site reaction (redness, heat and pain at the injection site). Subsecuently, the patient recovered from the injectionsite reaction. On 27-JUL-2007 the patient was vaccinated with the second dose of GARDASIL (658490/0802U). On 27-JUL-2007 the patient experienced injection site reaction (redness, heat and pain at the injection site). Subsequently, the patient recovered from the injection site reaction. On 26-NOV-2007 the patient was vaccinated intramuscularly in the left deltoid with the third dose of GARDASIL vaccine (659055/1522U). On 26-NOV-2007 the patient experienced injection site reaction (redness, heat, and pain at the injection site), injection site arm is numb and unable to lift arm above shoulder. The patient's injection site reaction , injection site arm is numb and unable to lift arm above shoulder persisted. The reporter felt that injection site reaction, injection site arm is numb and unable to lift arm above shoulder were not related to therapy wiht GARDASIL vaccine. In information received on 09-JAN-2008, it was reported that the patient now 26 years old, has recovered from the injection site reaction, injection site arm is numb and unable to lift arm above shoulder. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning a 25 year old female who on 25-MAY-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (657622/0388U). On 25-MAY-2007 the patient experienced injection site reaction (redness, heat and pain at the injection site). Subsequently, the patient recovered from the injection site reaction. On 27-JUL-2007 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast) (658490/0802U). On 27-JUL-2007 the patient experienced injection site reaction (redness, heat and pain at the injection site). Subsequently, the patient recovered from the the injection site reaction. On 26-NOV-2007 the patient was vaccinated with the third dose of GARDASIL vaccine (yeast) (659055/1522U). On 26-NOV-2007 the patient experienced injection site reaction (redness, heat and pain at the injection site), injection site arm is numb and unable to lift arm above shoulder. The patient's injection site reaction, injection site arm is numb and unable to lift arm above shoulder persisted. The reporter felt that injection site reaction (redness), injection site reaction (heat), injection site reaction (pain), injection site arm is numb and unable to lift arm above shoulder were not related to therapy with GARDASIL vaccine (yeast). Additional information has been requested. This is in follow-up to report previously submitted on 12/14/2007. Information has been received from a health professional concerning a 25 year old female who on 25-MAY-2007 was vaccinated with the first dose of GARDASIL vaccine (657622/0388U). On 25-MAY-2007 the patient experienced injection site reaction (redness, heat and pain at the injection site). Subsecuently, the patient recovered from the injectionsite reaction. On 27-JUL-2007 the patient was vaccinated with the second dose of GARDASIL (658490/0802U). On 27-JUL-2007 the patient experienced injection site reaction (redness, heat and pain at the injection site). Subsequently, the patient recovered from the injection site reaction. On 26-NOV-2007 the patient was vaccinated intramuscularly in the left deltoid with the third dose of GARDASIL vaccine (659055/1522U). On 26-NOV-2007 the patient experienced injection site reaction (redness, heat, and pain at the injection site), injection site arm is numb and unable to lift arm above shoulder. The patient's injection site reaction , injection site arm is numb and unable to lift arm above shoulder persisted. The reporter felt that injection site reaction, injection site arm is numb and unable to lift arm above shoulder were not related to therapy wiht GARDASIL vaccine. In information received on 09-JAN-2008, it was reported that the patient now 26 years old, has recovered from the injection site reaction, injection site arm is numb and unable to lift arm above shoulder. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site induration, Injection site pain, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning 4 females (age not reported) with no pertinent medical history or drug reactions/allergies who on an unspecified date were vaccinated with GARDASIL vaccine (yeast) (lot# unknown). There was no concomitant medication. The nurse reported that 4 patients received GARDASIL vaccine (yeast) due to nursing error. Each patient received 0.25 mL dose of GARDASIL vaccine (yeast) given subsequently near the wrist on 17-OCT-2007. The person was administered the doses split a 0.5mL dose of GARDASIL vaccine (yeast) equally among the 4 patients. They were supposed to receive a tuberculin test. The day after administration, each patient developed an injection site reaction right above the wrist. The injection site was red, hard to the touch and painful. One of these patients was seen by the nurse and the other 3 patients called her office. Medical attention was sought. At the time of reporting the patient had not recovered. Follow-up information was received. A 24 year old white female patient who on 17-OCT-2007 was vaccinated with GARDASIL vaccine (yeast) (lot# 658282/1263U). On 18-OCT-2007 the patient was given a 1/4 dose of GARDASIL vaccine (yeast) by mistake. The patient was to receive a tuberculin test instead. On an unspecified date one week later the patient recovered. Follow-up information was received from a licensed practical nurse. The LPN reported that one vial of purified protein derivative (PPD) was delivered to one office one day. On the following day one vial of GARDASIL vaccine (yeast) was delivered to the same office. The medical assistant who was located in the office, in error drew the medication that would be used for the PPD test from GARDASIL vaccine (yeast) vial instead of the prescribed PPD vial. The LPN stated that the error was not due to Product Confusion. As a result of this error, the GARDASIL vaccine (yeast) vaccination would only be administered at another office and not in the current office to assure that this error would no occur again. The patient that received GARDASIL vaccine (yeast) was treated with cold/warm compresses and recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper
Clinical narrative: Information has been received from a health professional concerning a female (age not reported) who on an unspecified date was vaccinated with a second dose of Gardasil vaccine (lot# unknown). Subsequently, the patient experienced severe stomach pain. Medical attention was sought. The nurse recommended that the patient go to the local ER. No additional information was provided. At the time of reporting it was unknown if the patient had recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness, Hallucination, Nausea, Pregnancy test negative
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old female with a history of Papanicolaou smear abnormal and loop electrosurgical excision procedure who on 26-NOV-2007 was vaccinated with Gardasil vaccine (lot# 659437/1266U) 0.5 mL IM. Concomitant therapy included Kariva. On 27-NOV-2007, the patient experienced dizziness, abdominal cramps and abdominal pain. The patient stated that she "felt like she was going to black out." On 28-NOV-2007, the patient is experiencing hallucinations, dizziness, nausea, and still feels as though she is going to "black out". The patient stated that she has been talking to people that are not there. The physician instructed the patient to go to the emergency room. No further information is available. Follow-up information was received from the medical assistant. As of 29-NOV-2007, the patient had fully recovered from the afore-mentioned adverse experiences and is not symptom free. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning 4 females (ages not reported) with no pertinent medical history or drug reactions/allergies who on an unspecified date were vaccinated with GARDASIL (lot# unknown). There was no concomitant medication. The nurse reported that 4 patients received GARDASIL due to a nursing error. Each patient received 0.25 mL dose of GARDASIL given subcutaneously near the wrist on 17-OCT-2007. The person who administered the doses split a 0.5mL dose of GARDASIL equally among the 4 patients. They were supposed to receive a tuberculin test. The day after administration, each patient developed an injection site reaction right above the wrist. The injection site red, hard to the touch and painful. One of these patients was seen by the nurse and the other 3 patients called her office. Medical attention was sought. At the time of reporting the patient had not recovered. Follow-up information was received. A 24 year old white female patient who on 17-OCT-2007 was vaccinated with GARDASIL (lot# 658282/1263U). On 18-OCT-2007 the patient was given a 1/4 dose of GARDASIL by mistake. The patient was to receive a tuberculin test instead. On an unspecified date one week later the patient recovered. Follow-up information was received from a licensed practical nurse. The LPN that one vial of PPD was delivered to one office one day. On the following day one vial of GARDASIL was delivered to the same office. The medical assistant who was located in the office, in error draw the medication that would be used for the PPD test from the GARDASIL vial instead of the prescribed PPD vial. The LPN stated that the error was not due to Product Confusion. As a result of this error, the GARDASIL vaccination would only be administered at another office and not in the current office to assure that this error would not occur again. The patient that received GARDASIL was treated with cold/warm compresses and recovered. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Underdose, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning 4 females (ages not reported) with no pertinent medical history or drug reactions/allergies who on an unspecified date were vaccinated with GARDASIL (lot# unknown). There was no concomitant medication. The nurse reported that 4 patients received GARDASIL due to a nursing error. Each patient received 0.25 mL dose of GARDASIL given subcutaneously near the wrist on 17-OCT-2007. The person who administered the doses split a 0.5mL dose of GARDASIL equally among the 4 patients. They were supposed to receive a tuberculin test. The day after administration, each patient developed an injection site reaction right above the wrist. The injection site red, hard to the touch and painful. One of these patients was seen by the nurse and the other 3 patients called her office. Medical attention was sought. At the time of reporting the patient had not recovered. Follow-up information was received. A 24 year old white female patient who on 17-OCT-2007 was vaccinated with GARDASIL (lot# 658282/1263U). On 18-OCT-2007 the patient was given a 1/4 dose of GARDASIL by mistake. The patient was to receive a tuberculin test instead. On an unspecified date one week later the patient recovered. Follow-up information was received from a licensed practical nurse. The LPN that one vial of PPD was delivered to one office one day. On the following day one vial of GARDASIL was delivered to the same office. The medical assistant who was located in the office, in error draw the medication that would be used for the PPD test from the GARDASIL vial instead of the prescribed PPD vial. The LPN stated that the error was not due to Product Confusion. As a result of this error, the GARDASIL vaccination would only be administered at another office and not in the current office to assure that this error would not occur again. The patient that received GARDASIL was treated with cold/warm compresses and recovered. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site induration, Injection site pain, Medication error
Clinical narrative: Information has been received from a licensed practical nurse concerning 4 females (ages not reported) with no pertinent medical history or drug reactions/allergies who on an unspecified date were vaccinated with Gardasil vaccine (lot# unknown). There was no concomitant medication. The nurse reported that 4 patients received Gardasil vaccine due to a nursing error. Each patient received .25 mL dose of Gardasil given subcutaneously near the wrist on 17-OCT-2007. The person who administered the doses split a 0.5mL dose of Gardasil vaccine equally among the 4 patients. They were supposed to receive a tuberculin test. The day after administration, each patient developed an injection site reaction right above the wrist. The injection site was red, hard to the touch and painful. One of these patient was seen by the nurse and the other 3 patients called her office. Medical attention was sought. At the time of reporting the patient had not recovered. Follow-up information was received. A 25 year old white female patient who on 10-OCT-2007 was vaccinated with Gardasil vaccine (lot# 658285/1263U). On 18-OCT-2007, the patient was given a 1/4 dose of Gardasil vaccine by mistake. The patient was to receive a tuberculin test instead. On an unspecified date one week later the patient recovered. Follow-up information was received from a licensed practical nurse. The LPN reported that one vial of PPD was delivered to the office one day. On the following day one vial of Gardasil vaccine was delivered to the same office. The medical assistant who was located in the office, in error drew the medication that would be used for the PPD test from the Gardasil vial instead of the prescribed PPD vial. The LPN stated that the error was not due to product confusion. As a result of this error, the Gardasil vaccination would only be administered at another office and not in the current office to assure that this error would not occur again. The patient that received Gardasil vaccine was treated with cold/warm compresses and recovered. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning "a few patients" (ages and genders unknown), Who, on an unspecified dates, were vaccinated with a dose GARDASIL. Subsequently the patients experienced pain at the injection site. At the time of the report, the outcomes of the patients were unknown. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Blood pressure, Dizziness, Heart rate, Tinnitus
Clinical narrative: Information has been received from a licensed practical nurse concerning a 10 year old white female student with no medical history and no drug allergies, who on 20-NOV-2007 at 10:37 was vaccinated intramuscularly in the left arm with a second dose of Gardasil vaccine (Lot# 659437/1266U). Concomitant suspect vaccination included a second dose of Varivax (Lot# 658414/1026U) administered subcutaneously in the left arm at 10:30. There were no illnesses at the time of the vaccination. On 20-NOV-2007, at 10:40 the patient experienced ringing of ears and lightheadedness. The patients blood pressure was 90/60 and her pulse was 70. The patient recovered on 20-NOV-2007. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Biopsy skin, Condition aggravated, Epstein-Barr virus antibody negative, Fatigue
Clinical narrative: Information has been received from a nurse concerning her 17 year old daughter with cystic acne, warts on her right lower leg and no known allergies/drug reaction who on 20-AUG-2007 was vaccinated intramuscularly(site not reported) with the 1st 0.5ml dose of GARDASIL(lot# not reported). On 17-OCT-2007, the patient was vaccinated intramuscularly(site not reported) with the 2nd 0.5ml dose of GARDASIL (lot# not reported). Concomitant therapy included YAZ. The nurse reported that her daughter experienced an increase in the number and size of pre-existing warts on her right lower leg 2 weeks post the 2nd vaccination. The patient also developed several warts on her face. The patient was evaluated by her dermatologist, who performed a biopsy on the lesions on 28-NOV-2007. The results of the biopsy are pending. The patient has been scheduled for a allergy consult in the near future. The nurse added that her daughter was experiencing increased fatigue and hair thinning "for several months". The patient did received unspecified medical attention and Thyroid function test(normal) and a mononucleosis test (negative) were performed. At the time of this report the patient had not recovered. Additional information has been requested. Information has been received from a nurse and a nurse practitioner concerning the nurse's 17 year old daughter. A student, with cystic acne, warts on her right lower leg and no known allergies/drug reactions, who on 20-AUG-2007 was vaccinated intramuscularly in the left deltoid, with the first dose, 0.5ml, of HPV vaccine (lot # 0530U). On 17-OCT-2007, the patient was vaccinated intramuscularly in the left deltoid, with the second dose, 0.5ml, of HPV vaccine (lot # 65453970242U). There was no illness at the time of vaccination. The nurse reported that her daughter experienced an increase in the number and size of pre-existing warts on her right lower leg, 2 weeks after the second vaccination. The patient also developed several warts on her face. The patient was evaluated by her dermatologist, who performed a biopsy on the lesions on 26-NOV-2007. The results of the biopsy are pending. The patient has been scheduled for an allergy consult in the near future. The nurse added that her daughter was experiencing increased fatigue and hair thinning "for several months". The nurse practitioner reported that the onset of all symptoms was in early November 2007. The patient received unspecified medical attention, and thryoid function tests and a monomnucleosis test were performed. At the time of this report the patient's symptoms were improving. Additional information has been requested. Follow-up information from the NP indicated that on 22-FEB-2008, the patient was considered to be recovered from the events, and now vaccinated IM in the left deltoid with the third dose of GARDASIL (lot #655322/1211U). Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma, Thyroid function test normal
Clinical narrative: Information has been received from a nurse concerning her 17 year old daughter with cystic acne, warts on her right lower leg and no known allergies/drug reaction who on 20-AUG-2007 was vaccinated intramuscularly(site not reported) with the 1st 0.5ml dose of GARDASIL(lot# not reported). On 17-OCT-2007, the patient was vaccinated intramuscularly(site not reported) with the 2nd 0.5ml dose of GARDASIL (lot# not reported). Concomitant therapy included YAZ. The nurse reported that her daughter experienced an increase in the number and size of pre-existing warts on her right lower leg 2 weeks post the 2nd vaccination. The patient also developed several warts on her face. The patient was evaluated by her dermatologist, who performed a biopsy on the lesions on 28-NOV-2007. The results of the biopsy are pending. The patient has been scheduled for a allergy consult in the near future. The nurse added that her daughter was experiencing increased fatigue and hair thinning "for several months". The patient did received unspecified medical attention and Thyroid function test(normal) and a mononucleosis test (negative) were performed. At the time of this report the patient had not recovered. Additional information has been requested. Information has been received from a nurse and a nurse practitioner concerning the nurse's 17 year old daughter. A student, with cystic acne, warts on her right lower leg and no known allergies/drug reactions, who on 20-AUG-2007 was vaccinated intramuscularly in the left deltoid, with the first dose, 0.5ml, of HPV vaccine (lot # 0530U). On 17-OCT-2007, the patient was vaccinated intramuscularly in the left deltoid, with the second dose, 0.5ml, of HPV vaccine (lot # 65453970242U). There was no illness at the time of vaccination. The nurse reported that her daughter experienced an increase in the number and size of pre-existing warts on her right lower leg, 2 weeks after the second vaccination. The patient also developed several warts on her face. The patient was evaluated by her dermatologist, who performed a biopsy on the lesions on 26-NOV-2007. The results of the biopsy are pending. The patient has been scheduled for an allergy consult in the near future. The nurse added that her daughter was experiencing increased fatigue and hair thinning "for several months". The nurse practitioner reported that the onset of all symptoms was in early November 2007. The patient received unspecified medical attention, and thryoid function tests and a monomnucleosis test were performed. At the time of this report the patient's symptoms were improving. Additional information has been requested. Follow-up information from the NP indicated that on 22-FEB-2008, the patient was considered to be recovered from the events, and now vaccinated IM in the left deltoid with the third dose of GARDASIL (lot #655322/1211U). Additional information is not expected.