chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy skin abnormal, Hyperkeratosis, Lymphocytic infiltration, Papule, Parapsoriasis
Clinical narrative: Information has been received from a medical assistant concerning a 39 year old female with a history of Papanicolaou (PAP) smear abnormal with high risk HPV and genital warts in 2008 and no known drug allergies who on 17-JUN-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot# 0294Y). There was no concomitant medication. On approximately 24-JUN-2009 the patient experienced a non-pruritic erythematous rash all over her body after administration of her first dose of GARDASIL. The patient had been examined by a dermatologist (name not provided) and treated with steroids. No lab diagnostics study was performed. At the time of the report, the patient had not recovered. The patient sought medical attention via an office visit. Follow up information has been received from a medical assistant concerning a 39 year old female with a history of cochleitis, droperidol allergy and no illness at the time of vaccination who on 17-JUN-2009, at 11:40 am, was vaccinated IM in right deltoid with the first 0.5ml dose of GARDASIL (lot# 0294Y). It was reported that firm red papules generalized; some had faded to light brown scars, rash at oral mucosae cleared more than 2 months. A skin, lower abdomen punch biopsy was performed on 02-SEP-2009. The sections showed a punch type biopsy of skin with a wedge-shaped moderately dense to dense perivascular lymphocytic infiltrate involving the superficial and deep vessels. There was a rare eosinophil present. The infiltrate also involved the dermal-epidermal junction where there was hydropic change and scattered necrotic keratinocytes. The overlying epidermis showed hyperkeratosis with neutrophils in the stratum corneum. The features were consistent with an early stage of pityriasis lichenoides. A drug reaction would also have to be considered in the differential. Additional information is not expected.
Age: 39.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash erythematous, Rash generalised, Scar
Clinical narrative: Information has been received from a medical assistant concerning a 39 year old female with a history of Papanicolaou (PAP) smear abnormal with high risk HPV and genital warts in 2008 and no known drug allergies who on 17-JUN-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot# 0294Y). There was no concomitant medication. On approximately 24-JUN-2009 the patient experienced a non-pruritic erythematous rash all over her body after administration of her first dose of GARDASIL. The patient had been examined by a dermatologist (name not provided) and treated with steroids. No lab diagnostics study was performed. At the time of the report, the patient had not recovered. The patient sought medical attention via an office visit. Follow up information has been received from a medical assistant concerning a 39 year old female with a history of cochleitis, droperidol allergy and no illness at the time of vaccination who on 17-JUN-2009, at 11:40 am, was vaccinated IM in right deltoid with the first 0.5ml dose of GARDASIL (lot# 0294Y). It was reported that firm red papules generalized; some had faded to light brown scars, rash at oral mucosae cleared more than 2 months. A skin, lower abdomen punch biopsy was performed on 02-SEP-2009. The sections showed a punch type biopsy of skin with a wedge-shaped moderately dense to dense perivascular lymphocytic infiltrate involving the superficial and deep vessels. There was a rare eosinophil present. The infiltrate also involved the dermal-epidermal junction where there was hydropic change and scattered necrotic keratinocytes. The overlying epidermis showed hyperkeratosis with neutrophils in the stratum corneum. The features were consistent with an early stage of pityriasis lichenoides. A drug reaction would also have to be considered in the differential. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Depression, Mood swings
Clinical narrative: Information has been received from a licensed practical nurse concerning her 12 year old granddaughter with no pertinent medical history and no known drug allergies who was vaccinated with the first dose of GARDASIL "2-3 weeks ago" (approximately 28-JUL-2009) (dose, route, and lot# not reported). There was no concomitant medication. The nurse reported that the patient was experiencing depression and mood swings. The nurse did not think this was related to GARDASIL and thought her granddaughter might be getting her monthly cycle. No lab diagnostics study was performed. The patient sought medical attention through a telephone call to the nurse. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Bone pain, Chills, Injection site pain
Clinical narrative: Information has been received from a "26 year old" female with penicillin allergy and no pertinent medical history who in March or April 2009 was vaccinated with a first dose of GARDASIL (injection, lot# not reported). There was no concomitant medication. The caller reported that she received her third dose of GARDASIL on 15-SEP-2009 and on 16-SEP-2009 woke up and her spine was hurting, and she also started experiencing chills. She was feeling so bad she could not drive. She thought it might be the flu as well. She did not have any experiences with the first dose of GARDASIL, and with the second dose of GARDASIL she experienced a mild pain at the injection site. No diagnostic study was performed. The patient sought medical attention through a telephone call to the office. At the time of the report, the patient had not recovered. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Fatigue
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter with no pertinent medical history and no known drug allergies, who on 01-MAR-2008 was vaccinated with the first dose of GARDASIL (lot# not provided). There was no concomitant medication. In September 2008 ("six months after the first dose"), the patient experienced tiredness, fatigue, exhaustion and anemia. Patient sought unspecified medical attention. No lab/diagnostic studies performed. Therapy with GARDASIL was discontinued. At the time of this report the patient had not recovered from tiredness, fatigue, exhaustion or anemia. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Loss of consciousness, Skin papilloma
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female patient with allergy to OVCON and a history of irregular menses and pelvic pain who on 16-MAR-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 659184/0843X). On 14-MAY-2009 the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number 661953/1130X). On 17-SEP-2009 the patient was vaccinated IM with the third 0.5 ml dose of GARDASIL (lot number 661953/1130X). Concomitant therapy included TRI-SPRINTEC. Sometime after the second dose the patient developed warts in her genital area, her hip and elbow. On 17-SEP-2009 the patient saw a doctor in the office. There were no lab studies performed. The patient was prescribed ALDARA cream. At the time of the report, the patient had not recovered. Follow-up information has been received from the medical assistant concerning the female patient who on 14-MAY-2009 at 14:06 pm was vaccinated IM in the right deltoid with the second dose of GARDASIL (lot number 682953/1130X). Subsequently the patient developed warts on genitalis, hip and elbow. It was reported that the patient experienced loss of consciousness after the first dose of GARDASIL. The outcome of the patient was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Laboratory test normal, Thyroid function test normal
Clinical narrative: Information has been received from a physician concerning a female patient in her mid-20s with no pertinent medical history or known drug allergies who on approximately 24-JUL-2009 (two months ago) was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (lot number not provided). There was no concomitant medication. Subsequently, the patient's hair was falling out. Therapy with GARDASIL was discontinued and the patient had not received any further doses. The patient called the physician. The result of the thyroid check was negative. The patient did not recover from the hair's falling out. Follow-up information has been received from a health professional concerning a 25 year old patient with allergies to hydrocodone and ZOFRAN who on 24-JUL-2009 was vaccinated with the first dose of GARDASIL (lot# 659054/0315Y) at 11:45. It was reported that the patient called to let them know that she had hair loss after her first injection of GARDASIL. The patient's lab work was done at other doctor's office. All of the patient's labs were normal and the patient thought the hair loss was from the shot. There was no illness at the time of vaccination. At the time of the report, the patient's status was unknown. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on an unspecified date was vaccinated with the first 0.5ml dose of GARDASIL (lot#, route and site of administration not reported). Subsequently, the patient experienced neck and leg pain and tingling. Unspecified medical attention was sought. At the time of this report, the patient had recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix normal, Cervical dysplasia, Cytology abnormal, Endocervical curettage, Human papilloma virus test positive
Clinical narrative: Information has been received from a physician concerning an 18 year old female with a history of condyloma diagnosed prior to all three doses of GARDASIL in 2007 who in 2007 was vaccinated with three doses of GARDASIL injection. When the patient's physician performed a Pap test and result showed that she had a "high risk for HPV". The physician did not remember the dates for the individual doses for GARDASIL but the patient finished all three doses in 2007. The patient sought unspecified medical attention. Follow-up information has been received from the physician and medical records concerning the 18 year old female cashier with no known drug allergies and no illness at time of vaccination who on 24-JUL-2007 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot # 0469U) in her left arm, the second dose of GARDASIL (lot # 0530U) in her left arm on 24-SEP-2007, and the third dose of GARDASIL (lot # 655327/1287U) in her left arm. It was noted on cytology report of 14-JUL-2008 that the patient on 2007-07-24 had a pap that was HPV+. On 12-AUG-2009, the patient experienced high risk for HPV. On 14-JUL-2008, gynecological cytology test was performed and the result was negative for intraepithelial lesion or malignancy. Base on the cytology result, reflex high risk HPV DNA testing was not performed. On 12-AUG-2009, gynecological cytology test was performed and the result was atypical squamous cells of undetermined significance. As requested, sample was submitted for high risk HPV DNA testing. The result was cervical high risk HPV, DNA test positive. On 22-SEP-2009, microscopic diagnosis was performed. The patient underwent cervical biopsy and endocervix curettage. Clinical information was that the biopsy of the cervix revealed benign endocervical tissue with no evidence of dysplasia. The endocervix curettage revealed benign endocervical glandular fragments with no evidence of dysplasia. At the time of report, the patient's outcome was unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Microscopy, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning an 18 year old female with a history of condyloma diagnosed prior to all three doses of GARDASIL in 2007 who in 2007 was vaccinated with three doses of GARDASIL injection. When the patient's physician performed a Pap test and result showed that she had a "high risk for HPV". The physician did not remember the dates for the individual doses for GARDASIL but the patient finished all three doses in 2007. The patient sought unspecified medical attention. Follow-up information has been received from the physician and medical records concerning the 18 year old female cashier with no known drug allergies and no illness at time of vaccination who on 24-JUL-2007 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot # 0469U) in her left arm, the second dose of GARDASIL (lot # 0530U) in her left arm on 24-SEP-2007, and the third dose of GARDASIL (lot # 655327/1287U) in her left arm. It was noted on cytology report of 14-JUL-2008 that the patient on 2007-07-24 had a pap that was HPV+. On 12-AUG-2009, the patient experienced high risk for HPV. On 14-JUL-2008, gynecological cytology test was performed and the result was negative for intraepithelial lesion or malignancy. Base on the cytology result, reflex high risk HPV DNA testing was not performed. On 12-AUG-2009, gynecological cytology test was performed and the result was atypical squamous cells of undetermined significance. As requested, sample was submitted for high risk HPV DNA testing. The result was cervical high risk HPV, DNA test positive. On 22-SEP-2009, microscopic diagnosis was performed. The patient underwent cervical biopsy and endocervix curettage. Clinical information was that the biopsy of the cervix revealed benign endocervical tissue with no evidence of dysplasia. The endocervix curettage revealed benign endocervical glandular fragments with no evidence of dysplasia. At the time of report, the patient's outcome was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Nasal congestion
Clinical narrative: Information has been received from a consumer concerning to her 17 year old daughter who on 15-JUL-2009 was vaccinated with the first dose of GARDASIL (Lot # not provided) 0.5 ml. Concomitant therapy included NASONEX. The patient was scheduled to receive the second dose on 16-SEP-2009. On 12-SEP-2009 the patient experienced cough and stuffy nose. The patient did not seek medical attention. At the time of  this report, the patient was not recovered. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea
Clinical narrative: Information has been received from a physician concerning his medical assistant's 15 year old daughter with seasonal allergies who on the "last month" in August 2009 was vaccinated with her first dose of GARDASIL. There was no concomitant medication reported. The same night post vaccination the patient experienced nausea but no vomiting. Next day post vaccination the patient developed a "severe headache" which lasted for 3 days. The patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Muscle disorder, Nausea
Clinical narrative: Information has been received from a nurse concerning a 20 year old female patient who in June 2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL. Two weeks after the vaccination the patient developed severe headaches, lightheadedness and nausea. The patient experienced these symptoms for 2 months during which time she was on muscle relaxers and pain medication. The patient had sought medical attention, treated by physician. The patient recovered two months after the onset of symptoms. The patient decided to discontinue the series. Severe headaches, lightheadedness and nausea were considered to be disabling. It was reported that the nurse felt muscle relaxants could be disabling. On 15-SEP-2009 follow-up information received from a registered nurse indicated that a female patient with a medical history of pulmonary stenosis at the age of two which required "balloon surgery" (exact date not reported) and Lasix eye surgery (date not provided) who was vaccinated with the first and only dose of GARDASIL (Lot#658271/0558X) on 11-JUN-2009. There was no listing of any concomitant medications and the patient did not receive any other vaccinations at the time of her GARDASIL vaccination. When the patient did not show up for her second appointment, the nurse called her to follow-up. It was at this time that the patient reported to the nurse that she had developed the severe headaches, lightheadedness and nausea after her first GARDASIL vaccination. The nurse reported that she did not say that she felt the muscle relaxants were disabling. The nurse also said that the patient did not miss work or school due her muscle relaxant use. The nurse confirmed that the patient told her that it took two months for the patient's symptoms to resolve, but they had indeed resolved (date was not known by the nurse). The nurse further noted that the patient would not be finishing the GARDASIL series and she was not sure if they would see the patient again. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Infertility female
Clinical narrative: Information has been received from a physician concerning a friend of a friend's daughter a 17 year old female who was vaccinated with a dose of GARDASIL. The patient was experiencing fertility problem after administration of GARDASIL. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Rash, Skin exfoliation
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on 23-MAR-2009 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (lot # 661841/0653X). On 05-JUN-2009 the patient was vaccinated intramuscularly the second dose of GARDASIL (lot # 662229/1497X). Concomitant vaccination on the same day included ADACEL and a dose of MENACTRA. Subsequently, after the second dose of GARDASIL, the patient experienced rash and her skin started peeling. It was unknown if the patient experienced any adverse event after the first dose. The patient sought unspecified medical attention. It was unspecified if lab studies were performed. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Tension
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female who in June 2009, was vaccinated with the second 0.5mL dose of GARDASIL (LOT# and route not reported). The patient received the first 0.5mL dose of GARDASIL on an unspecified date. In June 2009, after the patient received the second dose of GARDASIL, the patient tensed up and passed up for a couple of seconds, then recovered immediately. No lab diagnostics study was performed. The patient was seen by a nurse. No further information was available at this time of the report. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue
Clinical narrative: Information has been received from a nurse concerning a female patient who "about 3 weeks ago" (on approximately 03-SEP-2009), was vaccinated intramuscularly with a 0.5mL dose of GARDASIL (dose, LOT# not reported). On 24-SEP-2009, the patient called the office and reported that she had felt fatigued ever since. No lab diagnostic study was performed. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a female receptionist at the physician's office concerning herself who on an unknown date was vaccinated with a dose of GARDASIL. After getting the vaccine, she experienced fainted. Subsequently, the patient recovered from fainted. It was unspecified if the patient sought medical attention. No further information is available.
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL. Concomitant therapy included influenza virus vaccine (name and manufacturer unknown). Lot# was not provided. The patient developed hives after getting GARDASIL and influenza virus vaccine together. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old female with no pertinent medical history and no drug allergies, who on 04-MAY-2009 was vaccinated with her first "standard" dose of GARDASIL (IM, lot # 1702X), and received her second dose on 29-JUN-2009 (IM, lot # 1702X). There was no concomitant medication. On 29-JUN-2009 the patient experienced dizziness, lightheadedness and shortness of breath after the second vaccination. The symptom lasted for approximately one hour. There were no labs and diagnostic tests performed. The patient did not seek for medical attention. The patient had recovered on 29-JUN-2009. Follow up information has been received from a nurse practitioner indicating that on 14-SEP-2009 the 25 year old female patient who was seen for her AE stated that she had dizziness, lightheadedness and shortness of breath for 1 hour after the second vaccination on 29-JUN-2009. Then the patient returned to work. The patient did not seek medical care. The patient recovered with spontaneous resolution. There was no illness at the time of vaccination. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Palpitations
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported). Subsequently the patient experienced chest pain and palpitations. On an unspecified date the patient was vaccinated with a second dose of GARDASIL (lot number, injection site and route not reported). The patient's chest pain and palpitations got worse after the second dose. The patient's primary care provider referred the patient to the reporting physician. The outcome of the patient's events was unknown. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Dizziness, Injection site pain, Nausea, Neurological examination normal
Clinical narrative: Information has been received from a physician concerning a female who on 28-SEP-2009 at 11:30 was vaccinated with a first dose of GARDASIL in her left arm. The physician stated that the patient was lightheaded, had blurred vision, nausea and left arm pain that was radiating from shoulder down to her wrist. Neurological exam was normal, but the physician stated that mother of child does not think that she was her usual self. The patient was in the emergency room. The patient's outcome is unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Vision blurred
Clinical narrative: Information has been received from a physician concerning a female who on 28-SEP-2009 at 11:30 was vaccinated with a first dose of GARDASIL in her left arm. The physician stated that the patient was lightheaded, had blurred vision, nausea and left arm pain that was radiating from shoulder down to her wrist. Neurological exam was normal, but the physician stated that mother of child does not think that she was her usual self. The patient was in the emergency room. The patient's outcome is unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Vasculitis
Clinical narrative: Information has been received from a consumer concerning her 18 year old granddaughter who on an unspecified date was vaccinated with a dose of GARDASIL (route, dose not reported). Subsequently the patient experienced vasculitis. It is unknown if the patient sought medical attention. Follow-up information was received from the grandmother who reported that her granddaughter was currently having a fourth "vasculitis attack". She had not sought medical attention for the most recent "attack". In the past, the pediatrician had prescribed a steroid cream for her symptoms. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with penicillin allergy (AMOXIL) and no pertinent medical history who on 13-JUL-2009 was vaccinated with her first dose of GARDASIL. On 23-SEP-2009 the patient received her second dose of GARDASIL. There was no concomitant medication. The patient complained of numbness on her left arm after receiving her second dose of GARDASIL. The numbness was from her wrist to her elbow. According to the physician, the area looked normal. At the time of the report the patient had not recovered. The patient sought medical attention. No diagnostic tests were performed. In follow up, the physician indicated that the patient's elbow pain and numbness from the elbow to the hand resolved within 6 hours. She also stated that, the patient denied any trauma to the elbow or arm. The vaccine injection site was not tender and showed no signs of inflammation or discoloration. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse at the physician's office concerning an "11 year old" female who on 08-JUN-2009 was vaccinated with her first dose of GARDASIL, and on 10-AUG-2009 the patient received her second 0.5ml dose. "Right after the second dose", the patient developed hives. It was unknown if the patient sought medical attention. At the time of the report, the patient recovered (date unspecified). It was unknown if the patient had any reactions after the first dose. "Only two doses were administered". No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a patient who may have been vaccinated with a dose of MENACTRA instead of the second dose of GARDASIL due to an office error. The nurse stated that the office documented that the patient was given GARDASIL but the lot number they recorded was indicating MENACTRA. The nurse did not have the lot number available to provide on the phone. She did not specify which dose this error was related to (first, second or third). No adverse reactions were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with a dose of GARDASIL. The patient experienced two episodes of fainting after administration of the GARDASIL. The patient sought medical attention with a physician. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who in 2007 was vaccinated intramuscularly with three 0.5 mL doses of GARDASIL (Lot number was not provided). Subsequently the patient had been diagnosed with an abnormal pap smear. The patient sought unspecified medical attention. The physician performed a colposcopy on an unspecified date but the results were not provided. The 2009 pap smear was positive for HPV high risk for types 16, 18. The patient did recover from the abnormal pap smear. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Pruritus generalised, Toothache
Clinical narrative: Information has been received from a consumer concerning to her 19 year old daughter with sulfa and penicillin allergies who on 24-SEP-2009 was vaccinated with a first dose of GARDASIL (Lot # was not provided). Concomitant therapy included Generic LEXAPRO. On 24-SEP-2009 the patient experienced that her whole body was itching, her entire arm and lips went numb, her teeth hurt and she developed a headache. The patient has sought medical attention. At the time of this report, the patient recovered on 25-Sep-2009. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a medical assistant concerning a 19 year old female patient who in July 2008, was vaccinated with her first dose of GARDASIL (Lot number not provided). The patient did not have any other vaccinations. A PAP smear on 15-JUL-2009 was positive for one or more of the following types: 16, 18, 31, 35, 39, 45, 51, 52, 56, 58, 59, or 68. Medical attention was sought in the office. At the time of the report, the patient had not recovered. Follow-up information has been received from the medical assistant concerning a female cashier. It was reported that the patient never followed up for additional two vaccines. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a office medical assistant concerning a 21 year old female patient who on 15-JUL-2009 was vaccinated with the first dose of GARDASIL (Lot# 661846/1312X). There was no concomitant medication. Three days later the patient experienced a fever, body aches and a headache that lasted for about three days and then subsided. Then on 16-SEP-2009 the patient was vaccinated with the second dose of GARDASIL (Lot# 662404/0312Y). There was no concomitant medication. About three days later the patient experienced fever, body aches, and headache that lasted for three days and then subsided. The patient had not sought medical attention. At the time of report the patient's status was recovered. Follow up information has been received from a medical assistant concerning a 21 year old female patient with no pertinent medical history, no known drug allergies and no illness at the time of vaccination who on 15-JUL-2009 was vaccinated IM into right hip with the first dose of GARDASIL (Lot# 661846/1312X). Then on 16-SEP-2009 the patient was vaccinated with the second dose of GARDASIL (Lot# 662404/0312Y) (dose and route not reported). The patient informed that after second injection she had reaction beginning 3 days after each injection consisting of fever, body aches and headache. Onset was sudden and then abruptly subsided. No lab diagnostic study was performed. At the time of the report, the patient had recovered. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a licensed practical nurse and a nurse practitioner concerning a 23 year old female patient with no pertinent medical history or drug reactions who on 14-SEP-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# 663452/0671Y). Concomitant therapy included NUVARING. On 15-SEP-2009 the patient fainted at lunchtime. Medical attention was sought via called the office. No laboratory diagnostics studies were performed. At the time of this report, the patient was recovering. Follow-up information has been received from the licensed practical nurse regarding the 23 year old female patient (105.4Lb and 63 inches) who on 14-SEP-2009 at 11:50 a.m. was vaccinated intramuscularly in the left deltoid with the first 0.5ml dose of GARDASIL (lot# 663452/0671Y). The licensed practical nurse reported that the patient had a granola bar for breakfast. One hour after lunch, the patient was sitting at computer desk and started to feel dizzy. Then the patient fainted at her work station. The patient did not hit the floor. She woke up and went home. It was reported that the patient did not had other symptoms since. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, VARCEL
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter with no pertinent medical history or drug reactions who in July 2009, was vaccinated with the first dose of GARDASIL (lot#, route and site of administration not reported) while she had her menstrual cycle. Concomitant vaccination included meningococcal vaccine (unspecified) (manufacturer unknown) and chickenpox vaccine (manufacturer unknown). It was reported that the patient hadn't had her menstrual cycle since she received her first dose of GARDASIL. Unspecified medical attention was sought. No laboratory diagnostics studies were performed. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate decreased, Hypotension, Streptococcus test, Streptococcus test negative, Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on unspecified date was vaccinated with a dose of GARDASIL, 0.5 ml, IM, (Lot # not provided). Physician reported that a patient fainted and her heart rate went down to 48 and her blood pressure was low. The patient had a temperature before the vaccination of 100 degrees. She came in for a sick visit. The patient had a negative strep test. The patient has sought medical attention. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 22 year old female patient who on 27-MAR-2008 was vaccinated with a second dose of 0.5 ml of GARDASIL (LOT# 659182/1757U), intramuscularly. The patient was diagnosed with low grade human papilloma virus (HPV). Papanicolaou tests were performed in 2008, which were positive for low grade HPV. The patient sought medical attention at a clinic. At the time of the report, the outcome of the patient was unknown. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a 22 year old female with no pertinent medical history or drug reactions/allergies who in August 2008, was vaccinated orally with her first dose of GARDASIL. In January 2009 she completed her GARDASIL series. "Back in March or April 2009", she started to experience hair loss. The patient saw the physician for help. At the time of reporting, the patient's hair loss persisted. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Infectious mononucleosis
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with no known drug allergies or pertinent medical history who on 17-JUN-2009 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (Lot number not provided). On 17-AUG-2009 the patient was vaccinated intramuscularly with the second 0.5 mL dose of GARDASIL (Lot number not provided). There was no concomitant medication. In approximately July 2009, the patient experienced amenorrhea. Her last menstrual period was in June 2009. In early August 2009, the patient was diagnosed with mononucleosis, but has recovered completely. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of the report, the patient's amenorrhea persisted. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a 24 year old female doctor of pharmacy with no known drug reactions/allergies or pertinent medical history who "a few years ago" was vaccinated with the 3 doses of GARDASIL. Concomitant therapy included YASMIN. It was reported that on 15-SEP-2009 the patient got PAP results that said there was detected about 10 HPV types which include 16 and 18 HPV DNA. The patient sought medical attention by an office visit. It was noted that the doctor of pharmacy would be going to another physician for more tests. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Gastrooesophageal reflux disease, Headache, Injection site haematoma, Injection site pain
Clinical narrative: Information has been received from an 18 year old female consumer, who was vaccinated with two doses of GARDASIL (per dosing schedule). The first dose was received on approximately 18-JUL-2009 and the second dose on 18-SEP-2009. Consumer stated that she developed pain, swelling and bruising at the injection site moments after receiving her first and second dose. Two days after her second dose, on approximately 20-SEP-2009, she experienced swelling of her glands in the underarm and neck area, leg pain, tiredness, acid reflux, nausea and headaches. At the time of the report the consumer had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Lymphadenopathy, Nausea, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Information has been received from an 18 year old female consumer, who was vaccinated with two doses of GARDASIL (per dosing schedule). The first dose was received on approximately 18-JUL-2009 and the second dose on 18-SEP-2009. Consumer stated that she developed pain, swelling and bruising at the injection site moments after receiving her first and second dose. Two days after her second dose, on approximately 20-SEP-2009, she experienced swelling of her glands in the underarm and neck area, leg pain, tiredness, acid reflux, nausea and headaches. At the time of the report the consumer had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage
Clinical narrative: Information has been received from a healthcare worker who indicated that a patient stated that they knew someone who bled for a couple weeks after they received a dose of GARDASIL (dose, duration and lot number not reported). At the time of the report, the patient's status was unknown. It was noted that the patient who experienced this was not a patient of the physician she was visiting. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Migraine, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with two doses of GARDASIL (route and lot number not reported). The patient developed severe migraines after the second dose. The patient was under a neurologist care and had not recovered. The neurologist advised the patient not to receive the third dose of GARDASIL. This is one of several reports from the same source. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound scan, Vaginal haemorrhage
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female with anxiety, depression, self mutilation and ampicillin allergy who on 22-MAR-2007 was vaccinated IM with the first 0.5 mL dose of GARDASIL. On 30-JUL-2008 the patient was vaccinated IM with the second 0.5 mL dose of GARDASIL and on 03-JUL-2009 was vaccinated IM with the third 0.5 mL dose of GARDASIL (LOT# 661764/0650X). Concomitant therapy included albuterol and QVAR. Subsequently, the patient experienced vaginal bleeding and found out that she was pregnant when she went to see her Obstetrician/Gynecologist. Ultrasound was done. The date of last menstrual period was on 25-JUL-2009 and the estimated delivery date will be on 01-MAY-2010. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient with no pertinent medical history and no known drug reactions/allergies who on 28-SEP-2009 was vaccinated with the third 0.5ml dose of GARDASIL. There was no concomitant medication. After getting the third dose, the patient developed 103 degree fever. It was reported that the patient didn't experience any adverse effect on first or second dose of GARDASIL. Unspecified medical attention was sought. There were no laboratory diagnostic studies performed. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old female patient, unspecified if she is pregnant, with no pertinent medical history or drug reactions/allergies; who on 03-SEP-2009 was vaccinated with her first dose of GARDASIL, 0.5 ml, intramuscular. There was no concomitant medication. The nurse reported the patient called the office to report she "was late for her period". The date of the last menstrual period was not available. The patient would be scheduled for an evaluation in the office. At the time of the report the patient had not recovered. No laboratory diagnostics studies were performed. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Incorrect storage of drug, Injection site haematoma
Clinical narrative: Initial and follow-up information has been received from a medical assistant and a physician concerning a female who on unspecified date was vaccinated with the first dose of GARDASIL SQ in the buttocks. On an unspecified date, the patient was vaccinated with the second dose of GARDASIL. It was reported the route of dose 2 was correct but it was learned that the vaccine had been frozen and thawed previously. Post the first vaccination, the patient's buttocks were bruised for 1 month time. Unspecified medical attention was sought. At the time of the report, the patient recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a 14 year old female consumer who "about 3 months prior" was vaccinated with GARDASIL. On an unspecified date the consumer experienced headaches. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Inappropriate schedule of drug administration, Influenza like illness, Injection site erythema, Injection site reaction
Clinical narrative: Information has been received from a medical assistant concerning her 16 year old healthy daughter who received 5 doses of GARDASIL in less than 2 years period. The initial dose of GARDASIL was given 1 and a half years ago (exact date unknown). At this time the patient completed the 3 doses series on schedule. In July 2009, the patient was vaccinated with a fourth dose of GARDASIL. On 25-SEP-2009, the patient was vaccinated with a fifth dose of GARDASIL. There was no concomitant medication. After the fifth vaccination, the patient experienced an injection site reaction. Her arm was hot, red, swollen and painful. She was unable to move her arm. The patient also experienced flu like symptoms including nausea, malaise and severe headache. Unspecified medical attention was sought. The patient slept and did not feel well most of the weekend but felt better on 27-SEP-2009 in the evening. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Injection site warmth, Malaise, Nausea
Clinical narrative: Information has been received from a medical assistant concerning her 16 year old healthy daughter who received 5 doses of GARDASIL in less than 2 years period. The initial dose of GARDASIL was given 1 and a half years ago (exact date unknown). At this time the patient completed the 3 doses series on schedule. In July 2009, the patient was vaccinated with a fourth dose of GARDASIL. On 25-SEP-2009, the patient was vaccinated with a fifth dose of GARDASIL. There was no concomitant medication. After the fifth vaccination, the patient experienced an injection site reaction. Her arm was hot, red, swollen and painful. She was unable to move her arm. The patient also experienced flu like symptoms including nausea, malaise and severe headache. Unspecified medical attention was sought. The patient slept and did not feel well most of the weekend but felt better on 27-SEP-2009 in the evening. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter who on 21-AUG-2009 was vaccinated with the first dose of GARDASIL in her buttocks and she was fine. On 18-SEP-2009 the patient received her second dose of GARDASIL and it was given above her thigh area (almost near the hip and this dose was painful). At the time of the report the patient had recovered. The patient did not seek medical attention. No laboratory tests were performed. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a medical assistant concerning a 20 year old female patient with no pertinent medical history and no known drug reactions/allergies who on 17-MAR-2009 was vaccinated with the first 0.5ml dose of GARDASIL IM. On 28-MAY-2009 the patient was vaccinated with the second 0.5ml dose of GARDASIL (lot# 0162Y) IM. Concomitant therapy included DIFLUCAN which was taken when the first dose of GARDASIL was given. On 07-JUN-2009, 10 days after the second vaccination, the patient developed a rash. The patient called the physician. There were no laboratory diagnostic studies performed. On an unspecified date, the patient recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female with allergic reaction to bee sting and a history of Bell's palsy who was vaccinated with her first dose of GARDASIL (IM, 0.5ml, lot # 659184/0843X) on 30-OCT-2008, the second dose (IM, 0.5ml, lot # 661952/1129X) on 16-MAR-2009 and the third dose (IM, 0.5ml, lot # 662300/0100Y) on 26-AUG-2009. Concomitant therapy included FEMCON FE. On 26-AUG-2009 the patient experienced tenderness at injection site after administration of the third dose. She was now experiencing shoulder, neck and arm pain. She was unable to move her arm because of the pain. There were no labs and diagnostic tests performed. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on unspecified dates was vaccinated with all three 0.5ml doses of GARDASIL (lot # not provided). Recently the patient had a Papanicolaou (PAP) test and results came in as abnormal PAP and HPV positive. But the HPV type was unknown. At the time of the report, the patient had not recovered. Additional information has been requested.