chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information was obtained on request by the Company from an agency concerning an 18 year old female with no reported medical history and no pre-existing illnesses at time of vaccination who on 18-DEC-2007 was vaccinated IM in the left arm with the second dose of GARDASIL (lot # 655327/1287U).  On 18-DEC-2007 the patient experienced syncope after 1 minute.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a consumer concerning her niece who on an unspecified date was vaccinated with GARDASIL.  The patient broke out in hives 3 days after first shot.  The aunt mentioned that her niece took diphenhydramine hydrochloride (BENADRYL) to help the hives.  She also stated that she would have her niece's parents call.  The patient's outcome is unknown.  No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Malaise, Pallor, Syncope, Tremor
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with a history of mole excision who on 12-NOV-2007 was vaccinated with her first dose of GARDASIL (Lot #659437/1266U). Concomitant therapy included birth control. On 12-NOV-2007, immediately after the vaccination, the patient did not feel well. She experienced a syncopal episode and fainted. The patient collapsed, became unconscious for three to four minutes and started shaking. The patient also experienced pallor. Her blood pressure was normal. Ammonia was held under her nose. She recovered shortly after. The patient was not hospitalized. The nurse did not consider the event to be disabling, an other important event, or life threatening. The registered nurse also noted the patient had a similar experience after a mole was removed. She went home that day with her mother and her vital signs were stable (Pulse=160, blood pressure=112/68). The patient recovered. The patient refused to come back for a second shot of GARDASIL. it was recommended the patient see a neurologist. The patient has not been back to the office since 12-NOV-2007. The nurse reported that she did not feel this adverse experienced was from GARDASIL vaccination. This was all the information the nurse could provide. No additional information is available. Follow up information was received on 5-MAR-2008 from the registered nurse. At approximately 1:33 pm on 12-NOV-2007 the patient  fell back on to the table with mild shaking, foaming at the mouth, and loss of bladder control. It took 3-4 minutes for the patient to come around, she was immediately alert and denied feeling tired. At 4:00 pm the patient's blood pressure was 96/56 and her pulse and 68 beats per minute. The patient was held in the office for 20 minutes. The patient felt well and her mother drove her home. The patient had a follow up with a neurologist (date unspecified) since her last dose. The patient had recovered on an unspecified date. The mother reported that the daughter had a similar episode after node removal. No additional information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure normal, Dizziness, Head injury, Heart rate normal, Hyperhidrosis
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female who on 21-JAN-2008 was vaccinated with her first dose of GARDASIL intramuscularly in the right deltoid. Concomitant medication included MIRCETTE. The patient waited for 20 minutes but when she attempted to leave she became dizzy and sweaty. The patient sat down and proceeded to lean to the side and hit her head on the side of the table. No injury was sustained. The patient was placed on the bed and after 10 minutes the patient was ready to sit up and left after 20 minutes. The patient's blood pressure and heart rate were within normal limits. The patient recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who on approximately 06-FEB-2008 (reported as "sometime last week") was vaccinated with a dose of GARDASIL (lot # not reported).  The physician reported that patient who received the GARDASIL injection had "walked outside of the office and passed out a couple of times."  She was taken to the emergency room (ER).  The patient recovered on an unspecified day.  No further information was provided.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Information has been received from a Certified Nurse ("CN") from a physician's office concerning a 23 year old female patient with asthma and cold who on 15-JAN-2008 was vaccinated IM at 01:30 PM into the left arm with a first dose of GARDASIL (Lot # 659653/1448U). Concomitant therapy included montelukast sodium. The physician's office reported that the patient called approximately one hour after the first injection to report that on 15-JAN-2008 at 02:35 PM she had fine red rash over face. she also reported red itching of her cheeks. She contacted the following day and informed that the stated symptoms resolved after approximately one hour. No further sequelae noted. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood creatine phosphokinase normal, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 14 year old black female with no known drug allergies who on 28-OCT-2007 was vaccinated IM in the right deltoid with the first dose of GARDASIL (Lot# not reported).  There were no concomitant medication reported.  Subsequently on an unspecified date the patient experienced pain bilaterally in both arms up to her shoulders.  On 25-JAN-2008 the patient had a serum creatine kinase test which was reported to be 97 (WNL).  At the time of this report it was unknown if the patient had recovered from the arm pain.  Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil injection. Concomitant therapy included MENACTRA. Subsequently the patient fainted. Unspecified medical attention was sought. At the time of reporting it was unknown if the patient had recovered. No further information was provided this adverse experience. Additional information has been requested. This is one of several reports from the same source.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased, Neuropathy peripheral
Clinical narrative: Information has been received from a physician concerning a female who reportedly received her first dose of GARDASIL in her left arm, intramuscularly, around the week of 21-JAN-2008. Since receiving the vaccine, the patient had refused to move her arm and continued to carry it close to her body. The physician reported that the patient began experiencing neuropathy, swelling and injection site redness in her arm and by the end of the third week, she was sent to a neurologist. The physician reported that the patient was now going to physical therapy for her arm because she was still refusing to move it. No lot number was provided. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pruritus, Urticaria
Clinical narrative: Information has been received from a nurse concerning a 21 year old female who on 10-JAN-2008 was vaccinated intramuscularly "in the left arm" with 0.5 mL of her first dose of Gardasil (lot # not reported). There was no concomitant medication. On 19-JAN-2008 the patient experienced hives "on her entire left arm". She took BENADRYL and the symptoms subsided in two days. On 08-FEB-2008 the patient experienced itching "at the injection site" The patient phoned the office to report both episodes. At the time of this report he outcome of the itching was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a 21 year old female who on 10-JAN-2008 was vaccinated intramuscularly "in the left arm" with 0.5 mL of her first dose of Gardasil (lot # not reported). There was no concomitant medication. On 19-JAN-2008 the patient experienced hives "on her entire left arm". She took BENADRYL and the symptoms subsided in two days. On 08-FEB-2008 the patient experienced itching "at the injection site" The patient phoned the office to report both episodes. At the time of this report he outcome of the itching was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pruritus, Urticaria
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient with no illness at the time of vaccination and no previous medical conditions, who on 10-JAN-2008 was vaccinated IM in the left arm with a 0.5 ml dose of GARDASIL. Eight days after vaccination the patient experienced rash on the same arm in which she received the vaccination. It lasted for two days. It was unknown whether medical attention was sought. The patient's outcome is unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient with no illness at the time of vaccination and no previous medical conditions, who on 10-JAN-2008 was vaccinated IM in the left arm with a 0.5 ml dose of GARDASIL. Eight days after vaccination the patient experienced rash on the same arm in which she received the vaccination. It lasted for two days. It was unknown whether medical attention was sought. The patient's outcome is unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Nausea, Weight decreased
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old female patient who on 17-DEC-2007, was vaccinated IM with a 0.5ml dose of Gardasil. On 24-JAN-2008, the patient experienced symptoms of nausea, abdominal pain and a little bit of weight loss. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 3/14/2008. Information has been received from a licensed practical nurse and an other health professional concerning a 15 year old female patient who on 17-DEC-2007, was vaccinated IM with a 0.5ml dose of GARDASIL. On 24-JAN-2008, the patient experienced symptoms of nausea, abdominal pain and a little bit of weight loss. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. On 18-FEB-2008, the patient was vaccinated IM into the left arm with a second dose of GARDASIL (Lot # 659962/1740U). It was reported that the patient had lost weight for 5 months. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Nausea, Vaccine positive rechallenge, Weight decreased
Clinical narrative: This is in follow-up to report(s) previously submitted on 3/14/2008. Information has been received from a physician concerning a 14 year old female with asthma, who on 21-NOV-2007 was intramuscularly vaccinated with her first 0.5 mL dose of GARDASIL (Lot # unknown) and on 24-Jan-2008, the patient was intramuscularly vaccinated in her left arm with her second dose of GARDASIL (Lot # 659439/1267U). Concomitant therapy included antimicrobial (BACTRIM, reported as BACTRIN ES). On 21-NOV-2007, after receiving her first dose, the patient experienced abdominal pain, and nausea. This adverse event did not go away and after it was reintroduced on 24-Jan-2008, with the second dose, the AE became noticeably worse. The patient lost 8 pounds since the AE began. The patient sought unspecified medical treatment. The patient's abdominal pain, nausea, and weight loss persisted. Follow up information indicated that the patient had nausea for several months and had recovered on an unspecified date. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Anorexia, Laboratory test, Weight decreased
Clinical narrative: This is in follow-up to report(s) previously submitted on 3/14/2008. Information has been received from a physician concerning a 14 year old female with asthma, who on 21-NOV-2007 was intramuscularly vaccinated with her first 0.5 mL dose of GARDASIL (Lot # unknown) and on 24-Jan-2008, the patient was intramuscularly vaccinated in her left arm with her second dose of GARDASIL (Lot # 659439/1267U). Concomitant therapy included antimicrobial (BACTRIM, reported as BACTRIN ES). On 21-NOV-2007, after receiving her first dose, the patient experienced abdominal pain, and nausea. This adverse event did not go away and after it was reintroduced on 24-Jan-2008, with the second dose, the AE became noticeably worse. The patient lost 8 pounds since the AE began. The patient sought unspecified medical treatment. The patient's abdominal pain, nausea, and weight loss persisted. Follow up information indicated that the patient had nausea for several months and had recovered on an unspecified date. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Dyspnoea, Dyspnoea, Injection site pain, Panic reaction
Clinical narrative: Information has been received from a health professional concerning a 21 year old female who on 14-FEB-2008 was vaccinated with her second dose of Gardasil (lot # 659962/1740U). Concomitant therapy included KLONOPIN. On 14-FEB-2008 the patient experienced shortness of breath and almost passed out. The patient was treated with oxygen and is feeling better. Subsequently the patient experienced pain at injection site after receiving the first dose at an unspecified date. No other information was provided. Additional information has been requested. This in follow-up to report(s) previously on 1/14/2008. Initial and follow up information has been received from a medical assistant and a licensed practical nurse, concerning a 21 year old caucasian female patient with no known allergies and no illness at the time vaccination, who on an unknown date was vaccinated with the first dose of GARDASIL. Concomitant therapy included KLONOPIN. With the first dose, she experienced pain at the injection site: the physician's note indicated that the patient had an episode of "screaming and swearing with first shot." On 14-FEB-2008 she was vaccinated with the second dose, IM in the left deltoid, of GARDASIL (lot # 659962/1740U). Following the second vaccination, the patient "became short of breath and faint," and a physician was called emergently to examine her. The physician's note described the patient as "tachypnoic" and with "acute panic with GARDASIL vaccine."She was noted as being fully conscious and oriented at the examination. Vital signs were "normal". Oxygen was administered, her breathing slowed down with coaching, and she recovered within 20-30 minutes. No diagnostics were ordered. The patient was advised to not receive the third dose in the series. Additional information has been requested. All available medical records will be provided upon request.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope, Screaming, Syncope, Tachypnoea
Clinical narrative: Information has been received from a health professional concerning a 21 year old female who on 14-FEB-2008 was vaccinated with her second dose of Gardasil (lot # 659962/1740U). Concomitant therapy included KLONOPIN. On 14-FEB-2008 the patient experienced shortness of breath and almost passed out. The patient was treated with oxygen and is feeling better. Subsequently the patient experienced pain at injection site after receiving the first dose at an unspecified date. No other information was provided. Additional information has been requested. This in follow-up to report(s) previously on 1/14/2008. Initial and follow up information has been received from a medical assistant and a licensed practical nurse, concerning a 21 year old caucasian female patient with no known allergies and no illness at the time vaccination, who on an unknown date was vaccinated with the first dose of GARDASIL. Concomitant therapy included KLONOPIN. With the first dose, she experienced pain at the injection site: the physician's note indicated that the patient had an episode of "screaming and swearing with first shot." On 14-FEB-2008 she was vaccinated with the second dose, IM in the left deltoid, of GARDASIL (lot # 659962/1740U). Following the second vaccination, the patient "became short of breath and faint," and a physician was called emergently to examine her. The physician's note described the patient as "tachypnoic" and with "acute panic with GARDASIL vaccine."She was noted as being fully conscious and oriented at the examination. Vital signs were "normal". Oxygen was administered, her breathing slowed down with coaching, and she recovered within 20-30 minutes. No diagnostics were ordered. The patient was advised to not receive the third dose in the series. Additional information has been requested. All available medical records will be provided upon request.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her daughter, an 18 year old with a history of tonsillectomy, and heavy periods which cause anaemia. On 07-DEC-2007, the patient was vaccinated with her first dose of Gardasil. On 08-DEC-2007 the patient experienced fine rash on legs. On 08-Feb-2008, the patient received her second dose of Gardasil. Concomitant therapy included ZYRTEC-D and hormonal contraceptives (unspecified). On 09-FEB-2008 the patient experienced fine rash on legs. The patient's fine rash on legs persisted. The patient sought unspecified medical treatment and unspecified lab diagnostics were performed. The report states the therapy was discontinued on 08-Feb-2008. Additional information has been requested. On 14-FEB-2008 the patient was diagnosed with eczema on her legs and stomach. Follow up information indicated the patient recovered on an unknown date. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test negative, Antinuclear antibody negative, Arthralgia, Asthenia, Back pain
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter, with an allergy to pollen and a history of tonsillectomy, who on 04-OCT-2007 and 04-Dec-2007 was vaccinated with her first and second doses, respectively of Gardasil (lot #s not reported). "Sometime later in December 2007", the patient began to have breathing problems (NOS), sometimes accompanied by a rapid heart beat. Also, it was reported that she has been much more fatigued than usual. It was reported that periodically, some of these episodes have been very severe and temporarily incapacitate her. Usually, the breathing problems last for one or two minutes and then they dissipate. The patient's breathing problems and fatigue persisted. Unspecified medical attention was sought. A CAT scan endoscopy and echocardiogram are schedule to be done in March, 2008. Additional information has been requested. Follow-up information was received from the physician and nurse who reported that the patient was an active dancer who developed shortness of breath after dancing. She was referred for an allergy and asthma evaluation as well as a cardiac evaluation. Her allergy and asthma tests as well as echocariogram were negative, and she was ruled out as having cardiac, asthma or allergy problems. On an unspecified date she was diagnosed with excercise induce reactive airways disease and bronchospasm. The doctor stated that the rapid heart beat and breathing problems (shortness of breath) were symptoms of this. These events (as well as the fatigue) were considered non-serious. At the time of this report the patient still continued to occasionally have this breathing related reaction after she danced but was reported as stable. The physician also reported that on 18-FEB-2008, the patient was evaluated for joint pain and achey muscles (also considered non-serious). The patient was diagnosed with arthralgia and bronchospasm. All lab work including CBC, ANA, ESR and others were within normal limits (labs not provided). On 26-FEB-2008, the patient was seen in the office and she reported that her joint pain and achey muscles were better at that time. During the visit she presented with a complaint of back pain and lump on the left side of her throat (onset date 25-FEB-2008). The patient was diagnosed with sinusitis and treated with AMOXICILLIN 500 mg TID x 10 days. At the time of this report it was unknown if the patient had recovered from these events.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Bronchial hyperreactivity, Bronchospasm, Dyspnoea, Dyspnoea, Echocardiogram normal
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter, with an allergy to pollen and a history of tonsillectomy, who on 04-OCT-2007 and 04-Dec-2007 was vaccinated with her first and second doses, respectively of Gardasil (lot #s not reported). "Sometime later in December 2007", the patient began to have breathing problems (NOS), sometimes accompanied by a rapid heart beat. Also, it was reported that she has been much more fatigued than usual. It was reported that periodically, some of these episodes have been very severe and temporarily incapacitate her. Usually, the breathing problems last for one or two minutes and then they dissipate. The patient's breathing problems and fatigue persisted. Unspecified medical attention was sought. A CAT scan endoscopy and echocardiogram are schedule to be done in March, 2008. Additional information has been requested. Follow-up information was received from the physician and nurse who reported that the patient was an active dancer who developed shortness of breath after dancing. She was referred for an allergy and asthma evaluation as well as a cardiac evaluation. Her allergy and asthma tests as well as echocariogram were negative, and she was ruled out as having cardiac, asthma or allergy problems. On an unspecified date she was diagnosed with excercise induce reactive airways disease and bronchospasm. The doctor stated that the rapid heart beat and breathing problems (shortness of breath) were symptoms of this. These events (as well as the fatigue) were considered non-serious. At the time of this report the patient still continued to occasionally have this breathing related reaction after she danced but was reported as stable. The physician also reported that on 18-FEB-2008, the patient was evaluated for joint pain and achey muscles (also considered non-serious). The patient was diagnosed with arthralgia and bronchospasm. All lab work including CBC, ANA, ESR and others were within normal limits (labs not provided). On 26-FEB-2008, the patient was seen in the office and she reported that her joint pain and achey muscles were better at that time. During the visit she presented with a complaint of back pain and lump on the left side of her throat (onset date 25-FEB-2008). The patient was diagnosed with sinusitis and treated with AMOXICILLIN 500 mg TID x 10 days. At the time of this report it was unknown if the patient had recovered from these events.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Full blood count normal, Heart rate increased, Myalgia, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter, with an allergy to pollen and a history of tonsillectomy, who on 04-OCT-2007 and 04-Dec-2007 was vaccinated with her first and second doses, respectively of Gardasil (lot #s not reported). "Sometime later in December 2007", the patient began to have breathing problems (NOS), sometimes accompanied by a rapid heart beat. Also, it was reported that she has been much more fatigued than usual. It was reported that periodically, some of these episodes have been very severe and temporarily incapacitate her. Usually, the breathing problems last for one or two minutes and then they dissipate. The patient's breathing problems and fatigue persisted. Unspecified medical attention was sought. A CAT scan endoscopy and echocardiogram are schedule to be done in March, 2008. Additional information has been requested. Follow-up information was received from the physician and nurse who reported that the patient was an active dancer who developed shortness of breath after dancing. She was referred for an allergy and asthma evaluation as well as a cardiac evaluation. Her allergy and asthma tests as well as echocariogram were negative, and she was ruled out as having cardiac, asthma or allergy problems. On an unspecified date she was diagnosed with excercise induce reactive airways disease and bronchospasm. The doctor stated that the rapid heart beat and breathing problems (shortness of breath) were symptoms of this. These events (as well as the fatigue) were considered non-serious. At the time of this report the patient still continued to occasionally have this breathing related reaction after she danced but was reported as stable. The physician also reported that on 18-FEB-2008, the patient was evaluated for joint pain and achey muscles (also considered non-serious). The patient was diagnosed with arthralgia and bronchospasm. All lab work including CBC, ANA, ESR and others were within normal limits (labs not provided). On 26-FEB-2008, the patient was seen in the office and she reported that her joint pain and achey muscles were better at that time. During the visit she presented with a complaint of back pain and lump on the left side of her throat (onset date 25-FEB-2008). The patient was diagnosed with sinusitis and treated with AMOXICILLIN 500 mg TID x 10 days. At the time of this report it was unknown if the patient had recovered from these events.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Sensation of foreign body, Sinusitis
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter, with an allergy to pollen and a history of tonsillectomy, who on 04-OCT-2007 and 04-Dec-2007 was vaccinated with her first and second doses, respectively of Gardasil (lot #s not reported). "Sometime later in December 2007", the patient began to have breathing problems (NOS), sometimes accompanied by a rapid heart beat. Also, it was reported that she has been much more fatigued than usual. It was reported that periodically, some of these episodes have been very severe and temporarily incapacitate her. Usually, the breathing problems last for one or two minutes and then they dissipate. The patient's breathing problems and fatigue persisted. Unspecified medical attention was sought. A CAT scan endoscopy and echocardiogram are schedule to be done in March, 2008. Additional information has been requested. Follow-up information was received from the physician and nurse who reported that the patient was an active dancer who developed shortness of breath after dancing. She was referred for an allergy and asthma evaluation as well as a cardiac evaluation. Her allergy and asthma tests as well as echocariogram were negative, and she was ruled out as having cardiac, asthma or allergy problems. On an unspecified date she was diagnosed with excercise induce reactive airways disease and bronchospasm. The doctor stated that the rapid heart beat and breathing problems (shortness of breath) were symptoms of this. These events (as well as the fatigue) were considered non-serious. At the time of this report the patient still continued to occasionally have this breathing related reaction after she danced but was reported as stable. The physician also reported that on 18-FEB-2008, the patient was evaluated for joint pain and achey muscles (also considered non-serious). The patient was diagnosed with arthralgia and bronchospasm. All lab work including CBC, ANA, ESR and others were within normal limits (labs not provided). On 26-FEB-2008, the patient was seen in the office and she reported that her joint pain and achey muscles were better at that time. During the visit she presented with a complaint of back pain and lump on the left side of her throat (onset date 25-FEB-2008). The patient was diagnosed with sinusitis and treated with AMOXICILLIN 500 mg TID x 10 days. At the time of this report it was unknown if the patient had recovered from these events.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Urine human chorionic gonadotropin positive, Vomiting
Clinical narrative: Information has been received from the boyfriend of a consumer concerning a 16 year who "last month, January 2008", on an unspecified date, was vaccinated with Gardasil (lot # unspecified) and had a positive urine pregnancy test "2 weeks ago" (approximately 01-Feb-2008).  Consumer reported that the patient started throwing up 2 days ago (approximately 12-Feb-2008).  Consumer noted that the patient is thinking of having abortion.  At the time of this report, pregnancy had not been terminated.  At the time of the report, the patient was recovering from the vomiting.  No further information was provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Menorrhagia, Pain, Paraesthesia
Clinical narrative: Information has been received from a health professional concerning a 17 year old female with a history of factor V Leiden mutation who on 06-FEB-2008 was vaccinated IM with the first dose of Gardasil (655327/1287U).  On 08-FEB-2008 the patient experienced numbness, pain, strange feelings that included tingling on her left arm, body ache, headaches and heavier than usual menstrual cycles.  The patient sought unspecified medical attention in the physician's office on 08-FEB-2008 and was prescribed ADVIL.  No other details were provided.  Additional information has been requested. 02/12/2010 The patient's mother called the office on 08-FEB-2008 indicating that the patient was complaining of let arm numbness, pain, tingling, strange feelings in the arm, headaches, body aches and heavier than usual menses since receiving GARDASIL on 06-FEB-2008. The patient was seen in the office on 08-FEB-2008 and assessed by the doctor. The patient was given a prescription for Advil (200mg TID PRN). By 11-DEB-2008 the patient had not improved. On 12-FEB-2008 the patient was referred to her pediatrician. The patient was seen by her pediatrician who felt the synptoms may have been more viral related (other than the arm tingling). The patient recovered from all symptoms "13-FEB-2008 - 15-FEB-2008." Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female who on an unspecified date was vaccinated with the first dose of Gardasil. Subsequently the patient developed a very slight case of hives. On an unspecified date, the patient was vaccinated with the second dose of Gardasil and subsequently developed hives all over her body. It was reported that the first case of hives was not as bad as the one after her second dose of the vaccine. Unspecified medical attention was sought. The physician decided to administer the third dose of the vaccine. At the time of this report, the outcome of the hives was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female who on 07-FEB-2008 was vaccinated intramuscularly, with her second dose of GARDASIL (lot # unspecified), and experienced pain in her arm right after. The patient reported that the pain in her arm has not resolved and that she has trouble lifting it. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with the third dose of Gardasil.  Subsequently, "a week post vaccination" the patient experienced joint pain in her upper shoulder opposite the arm she received her vaccination and then over time the pain moved to other joints in her body.  No further information was provided and no lot number was given.  Follow-up information: The nurse was called on 14-FEB-2008 for additional information on this case and stated that she did not have time to discuss the case.  The nurse was called again on 21-FEB-2008 and stated that she has not yet pulled the patient's chart.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dizziness, Inappropriate schedule of drug administration, Injection site induration, Insomnia
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old patient with a history of abnormal PAP smears who on 10-JAN-2007 and 07-Mar-2007 was vaccinated with first and second doses, respectively, of Gardasil (lot # 653937/0637F).  On 12-FEB-2008 the patient was vaccinated intramuscularly into left deltoid, with 0.5 ml of her third dose of Gardasil (lot# 659441/1446U).  Concomitant therapy included ORTHO-CYCLEN.  That same day the patient played volleyball.  She reported that she did not sleep well that evening.  On 13-Feb-2008, the patient developed pain in her left arm and shoulder.  She reported that her neck and upper back also hurt and were stiff.  She reported that she experienced dizziness and fainted.  Later that evening she reported she experienced chills and had a fever (value not reported).  She was told to take BENADRYL and ibuprofen.  At the time of this report the patient's symptoms have resolved except for the slight hardness at the injection site.  Unspecified medical attention was sought.  No further information is available.  Additional information has been requested. This is in  follow-up to report(s) previously submitted on 3/14/2008.  Initial and follow-up information have been received from a nurse practitioner concerning a 24 year old patient with no known drug allergies and a history of abnormal PAP smears who on 10-JAN-2007 and 07-Mar-2007 was vaccinated with first and second doses, respectively of GARDASIL (lot # 653937/0637P).  On 12-FEB-2008 the patient was vaccinated intramuscularly into left deltoid, with 0.5 ml of her third dose of GARDASIL (lot# 659441/1446U).  Concomitant therapy included ORTHO-CYCLEN.  Later that same day in the evening, the patient played volleyball.  She later reported that she did not sleep well that evening.  On 13-Feb-2008, the patient was seen in the physician office.  She reported that on 11-Feb-2008 at 2:18 pm she had developed pain in her left arm and shoulder, that her neck and upper back also hurt and were stiff.  She reported that she had experienced dizziness and fainted.  Later that evening she reported she experienced chills and had a fever (value not reported).  She was told to take BENADRYL and IBUPROFEN.  The patient denied shortness of breath, tightness in throat or rash.  It was reported that the patient stated that she had eating breakfaskt that morning.  It was also reported that the patient denied any injury with volleyball activitiy.  At the time of this report the patient's symptoms have resolved (dates of recovery NOS) except for the slight hardness at the injection site.  No further information available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old patient with a history of abnormal PAP smears who on 10-JAN-2007 and 07-Mar-2007 was vaccinated with first and second doses, respectively, of Gardasil (lot # 653937/0637F).  On 12-FEB-2008 the patient was vaccinated intramuscularly into left deltoid, with 0.5 ml of her third dose of Gardasil (lot# 659441/1446U).  Concomitant therapy included ORTHO-CYCLEN.  That same day the patient played volleyball.  She reported that she did not sleep well that evening.  On 13-Feb-2008, the patient developed pain in her left arm and shoulder.  She reported that her neck and upper back also hurt and were stiff.  She reported that she experienced dizziness and fainted.  Later that evening she reported she experienced chills and had a fever (value not reported).  She was told to take BENADRYL and ibuprofen.  At the time of this report the patient's symptoms have resolved except for the slight hardness at the injection site.  Unspecified medical attention was sought.  No further information is available.  Additional information has been requested. This is in  follow-up to report(s) previously submitted on 3/14/2008.  Initial and follow-up information have been received from a nurse practitioner concerning a 24 year old patient with no known drug allergies and a history of abnormal PAP smears who on 10-JAN-2007 and 07-Mar-2007 was vaccinated with first and second doses, respectively of GARDASIL (lot # 653937/0637P).  On 12-FEB-2008 the patient was vaccinated intramuscularly into left deltoid, with 0.5 ml of her third dose of GARDASIL (lot# 659441/1446U).  Concomitant therapy included ORTHO-CYCLEN.  Later that same day in the evening, the patient played volleyball.  She later reported that she did not sleep well that evening.  On 13-Feb-2008, the patient was seen in the physician office.  She reported that on 11-Feb-2008 at 2:18 pm she had developed pain in her left arm and shoulder, that her neck and upper back also hurt and were stiff.  She reported that she had experienced dizziness and fainted.  Later that evening she reported she experienced chills and had a fever (value not reported).  She was told to take BENADRYL and IBUPROFEN.  The patient denied shortness of breath, tightness in throat or rash.  It was reported that the patient stated that she had eating breakfaskt that morning.  It was also reported that the patient denied any injury with volleyball activitiy.  At the time of this report the patient's symptoms have resolved (dates of recovery NOS) except for the slight hardness at the injection site.  No further information available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, who is also the patient's mother, concerning a 16 year old female who in May 2007, was vaccinated with the first dose of Gardasil.  In July 2007, the patient was vaccinated with the second dose of Gardasil.  Per the reporter, "the patient fainted after receiving her second dose of Gardasil in July 2007.  She has since had her third dose and did not faint."  The patient sought unspecified medical attention.  No further information was given.  Additional information has been requested. Follow-up received on 4/16/2008. Follow up information (returned correspondence) received 04-MAR-2008. The physician no longer works at the previously provided location. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site haemorrhage, Injection site pain
Clinical narrative: Information has been received from a consumer concerning her 23 year old daughter with no medical history, and no drug reactions/allergies, who on 08-FEb-2008 was vaccinated with her second doe of GARDASIL (lot# unspecified). Concomitant therapy included YAZ. Consumer reported that her daughter experienced "extreme" bleeding at the injection site after receiving the second dose of GARDASIL and the injection was very painful. Unspecified medical attention was sought. Subsequently, the patient recovered from her experiences. No further information was provided regarding these adverse experiences. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a female with multiple drug allergies who on 07-FEB-2008 in the morning, was vaccinated intramuscularly with 0.5 ml of her first dose of Gardasil (lot# 659962/1740U).  Concomitant therapy included LOESTRIN 24 FE).  In the afternoon on 08-FEB-2008, the patient developed hives.  She was seen by her primary care Doctor and she was placed on a high dose of BENADRYL (dose not specified) on 11-Feb-2008.  At the time of this report, the hives were "getting better" but not resolved.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Fatigue, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with Kleine-Levin syndrome who on 19-OCT-2007 was vaccinated with the first dose of Gardasil (lot # 658560/1062U).  Concomitant therapy included ORTHO TRI-CYCLEN LO.  On approximately 19-OCT-2007 the patient experienced vomiting, memory loss and extreme fatigue "almost to the point of paralysis."  Approximately a week later, the patient recovered from vomiting, memory loss and extreme fatigue.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Injection site pain, Syncope
Clinical narrative: Information has been received from a consumer regarding her daughter who was vaccinated with three (0.5 ml) doses of GARDASIL. There was no concomitant medication. The patient experienced minor injection site pain after first and second doses of GARDASIL, fainted and bruised knee after third dose of GARDASIL. At the time of reporting, the patient had not recovered. The lot numbers were not provided. Unknown medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Urticaria
Clinical narrative: Information has been received from a mother concerning her 16 year old daughter with no known medical history or allergies who on 01-DEC-2007 was vaccinated (route unknown) with a first dose of Gardasil (Lot # unknown).  Concomitant therapy included hormonal contraceptives (unspecified).  Two to three days after vaccination, on approximately 02-DEC-2007, the patient experienced hives on her back, stomach, chest, legs, & arms.  "Some areas are spotty and some places it looks like big welts".  The patient has been taking steroids on and off since December.  The last steroid she took was prednisone, and the hives came back when the medication was over.  The physician also put her on ZYRTEC. The patient's hives on her back, stomach, chest, legs, & arms persisted.  It was reported that the patient visited the doctor's office.  Unspecified blood work was performed, and no results were provided.  No product quality complaint was involved.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL 0.5 mL injection.  The patient did not experience any adverse experience after the first dose.  On an unspecified date the patient was vaccinated with a second dose of GARDASIL 0.5 mL injection and developed hives.  On an unspecified date the patient was vaccinated with a third dose of GARDASIL 0.5 mL injection and developed a rash.  Medical attention was sought.  At the time of reporting the patient had not recovered from the hives or rash.  No further information was provided.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician's office staff, concerning a 13 year old female patient with hypothyroidism and a history of no reaction on previous exposure to vaccine (dose 1 on 16-NOV-2007) who on 12-FEB-2008 was vaccinated with the second dose of Gardasil (lot #659439/1267U).  Concomitant therapy included SYNTHROID.  On 12-FEB-2008, following the vaccination, the patient called the office to report she had developed a rash behind her knees, ears & on her abdomen following the vaccination with Gardasil.  She described the rash as: "looks like small bites and some are the size of a quarter."  Treatment was not specified.  At the time of this report, the patient had not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloedema
Clinical narrative: Information has been received from a physician concerning a female (age unknown) who on an unknown date was vaccinated intramuscularly with a first dose of GARDASIL (Lot # unknown).  Subsequently on an unknown date, the patient developed "papilledema".  Unspecified medical attention was sought.  Outcome unknown.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a physician concerning a female (age unknown) with unknown medical history who "may have had psychological issues", was vaccinated "last year" in 2007 (route unknown) with a dose of Gardasil (Lot # unknown).  The physician reports that last year a patient in one of the Urgent cares had an anaphylactic reaction after receiving the vaccine.  The patient was told to go the ER.  Unspecified medical attention was sought.  Outcome unknown.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a female (age not reported) who on an unspecified date was vaccinated with GARDASIL injection.  Concomitant therapy included MENACTRA.  Subsequently the patient fainted.  Unspecified medical attention was sought.  At the time of reporting it was unknown if the patient had recovered.  No further information was provided regarding this adverse experience.  Additional information has been requested.  This is one of several reports from the same source.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: Information has been received from a nurse practitioner concerning a 34 year old female, with type 2 diabetes, who on 06-DEC-2007 was vaccinated with her first dose of GARDASIL (lot # 659653/1448U).  The patient developed shortness of breath for about 24 hours after her first dose of GARDASIL.  The patient sought medical attention.  No labs or diagnostic studies were performed.  The patient recovered from shortness of breath.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Throat tightness, Urticaria
Clinical narrative: Information has been received from a member of a physician's office staff concerning a 19 year old female who was vaccinated with her first dose of GARDASIL. The patient experienced closing and tightening of the throat right after administration of GARDASIL. The patient also developed hives on an unspecified part of the body. The patient sought medical attention. The patient recovered a couple of days after receiving GARDASIL. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Information has been received from a nurse concerning her 11 year old daughter who on unspecified dates was vaccinated with the first and second doses of GARDASIL.  The patient developed an injection site reaction after the second dose of GARDASIL.  The patient reported pain at the injection site and swelling at the site and down the arm.  Ice was applied and the next morning the patient awoke with body aches and the injection site had the appearance of an inverted nipple.  Medical attention was sought in the office.  Patient outcome was recovered.  At time of reporting the patient had not received the third dose of the vaccine.  No product quality complaint was involved.  Additional information has been requested.