chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, No reaction on previous exposure to drug, Urticaria, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning her 25 year old daughter who on 04-APR-2008 was vaccinated with a third dose of GARDASIL (lot# 654539/0742U) prefilled syringe and had a severe reaction. Concomitant therapy included YASMIN. The patient had no problem with the initial 2 doses. On 04-APR-2008 about 25 minutes after receiving the third dose the patient developed hives that completely covered her body and began vomiting. The patient vomited 5 times that day and only had water before the appointment. The patient was seen at the Emergency Room and was given epinephrine, cortisone, and BENADRYL. The patient was sent home with CLARITIN and has been taking since 04-APR-2008. The vomiting had stopped and the hives were almost completely gone. There are a few on her face but they are fading. At the time of reporting the patient was recovering. No further information was available. The reporter felt that vomiting and urticaria were an other important medical events. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Bilogics Evaluation and Research and was released. Additional information has been requested
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging normal, Syncope
Clinical narrative: Information has been received from a nurse concerning a "high school age" female who was vaccinated on an unspecified date with her first dose of GARDASIL (lot# not reported).  Subsequently the patient experienced numbness in her hands and arms and fainted in school.  The patient was brought to the ER but was not admitted.  Per the nurse, the healthcare provider in the ER did not think there was anything wrong with the patient.  The patient was then taken to her family practice physician and she had an MRI which came back normal.  The numbness lasted 2 - 3 weeks and the patient is now fine.  The nurse stated that the patient will not be continuing with the GARDASIL series.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 11-SEP-2007 was vaccinated intramuscularly with her second dose of GARDASIL (lot# reported "0232U").  Within 2 minutes of getting GARDASIL, the patient experienced lightheaded and passed out.  The patient has a history of getting lightheaded with vaccines.  The patient was monitored until feeling better then left the office.  Subsequently, the patient recovered from lightheaded and passing out.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Inappropriate schedule of drug administration, Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning a 13 year old female student who on 30-JAN-2007 was vaccinated IM in the left arm with the first dose of GARDASIL (Lot # 655617/1447F).  On 06-Apr-2007, the patient was vaccinated IM in the left arm with the second dose of GARDASIL (Lot # 656051/0244U) and on 18-MAR-2008, the patient was vaccinated IM in the left arm with the third dose of GARDASIL (Lot # 659964/1978U).  On 30-JAN-2007 the patient passed out in the hallway after the first dose of the vaccine and was monitored until feeling better then allowed to leave.  After the second dose the patient felt a little dizzy and sat in the office for 20 minutes.  The patient was fine after the third dose and sat in the office for 20 minutes.  Patient outcome was recovered.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pain
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with seasonal allergies and an allergy to CECLOR who on 01-APR-2008 was vaccinated IM in the left arm with 0.5 cc dose of GARDASIL (Lot # 0151X).  No concomitant medication.  Medical attention was sought through a call to the office.  Patient outcome was unknown.  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 5/14/2008. Initial and follow up information has been received from a nurse concerning a 17 year old female with seasonal allergies and an allergy to CECLOR. On 01-APR-2008 was vaccinated IM in the left arm with a 0.5 cc dose of GARDASIL (Lot # 0151X). There was no concomitant medication. On 05-APR-2008 the patient's mother called the office reporting the patient had a headache and body aches, asking if the vaccine could be related. It was reported on the next visit that the symptoms subsided after a few days and were most likely viral in nature. On 01-JUN-2008 the patient was vaccinated with a second dose of GARDASIL without issue or complaint of symptoms. On approximately 08-APR-2008, the patient had recovered. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with a dose of GARDASIL. The patient missed her period for two months after receiving both her second and third dose of GARDASIL. Unknown medical attention was sought at the office. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Dizziness, Heart rate decreased, Syncope, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 13 year old female with an upper respiratory tract infection and a history of seasonal allergies who on 07-APR-2008 was IM vaccinated with her second dose of GARDASIL (lot number reported as 654490/0133X). Concomitant therapy included TYLENOL, VICKS DAYQUIL (OLD FORMULA) and VICKS NYQUIL (OLD FORMULA). On 07-APR-2008 the patient fainted. Initially she was dizzy, then collapsed. Additionally she had a urticaria rash on her left amber blood pressure at that time was 142/80 and pulse rate was 47. Fifteen minutes later her blood pressure was 122/68 and pulse rate was 85. There was no sign of anaphylactic shock. The patient had and upper respiratory infection for the past 3 days with some symptoms that include coughing and mucous. The MA also reported that then patient fainted with Dose #1 but did not have any other details. The patient has recovered from the fainting but it is unspecified if her rash has also resolved. The patient sought unspecified medical treatment while at the office. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning a 13 year old female with an upper respiratory tract infection and a history of seasonal allergies who on 07-APR-2008 was IM vaccinated with her second dose of GARDASIL (lot number reported as 654490/0133X). Concomitant therapy included TYLENOL, VICKS DAYQUIL (OLD FORMULA) and VICKS NYQUIL (OLD FORMULA). On 07-APR-2008 the patient fainted. Initially she was dizzy, then collapsed. Additionally she had a urticaria rash on her left amber blood pressure at that time was 142/80 and pulse rate was 47. Fifteen minutes later her blood pressure was 122/68 and pulse rate was 85. There was no sign of anaphylactic shock. The patient had and upper respiratory infection for the past 3 days with some symptoms that include coughing and mucous. The MA also reported that then patient fainted with Dose #1 but did not have any other details. The patient has recovered from the fainting but it is unspecified if her rash has also resolved. The patient sought unspecified medical treatment while at the office. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Oral contraception
Clinical narrative: Information has been received from a health professional concerning a 22 year old female who on 30-JAN-2008 was IM vaccinated with her first dose of GARDASIL (lot number 655327/1287U).  Concomitant therapy included ORTHO TRI-CYCLEN LO.  On 03-APR-2008 the patient was IM vaccinated with her second dose of GARDASIL (lot number 655327/1287U) and experienced injection site pain.  The patient's injection site pain persisted.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Haemorrhage, Immediate post-injection reaction, Skin laceration, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 18 year old female patient with no medical history and no drug allergies  who, on 30-Nov-2007 at 13:40 was vaccinated IM in the left deltoid with a 0.5 mL third dose of GARDASIL (Lot # 658490/0820U). There were no illnesses at the time of the vacination. On 30-Nov-2007, 20 minutes post vaccination at 14:05 the patient felt dizzy while standing at the check out window and immediatley fainted and hit her head against the hallway wall. The patient was bleeding profusely from a head laceration. First aid was performed and the patient was sent to the emergency room via emergency medical service "EMS." The patient recovered on an unspecified date.No further information was provided. Outcome was not reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2008.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a office manager concerning a 22 year old female who on 02-APR-2008 was vaccinated IM with the first dose of GARDASIL (Lot #0151X). Concomitant therapy included hormonal contraceptives (unspecified). On 03-APR-2008, the patient experienced numbness in both of her hands and went away over the weekend (approximately 05-APR-2008). The numbness recurred on 07-APR-2008. Medical attention was sought through a call to the office. Patient outcome was unknown. No product quality complaint was involved. Additional information was received from a health care professional indicating that on 03-APR-2008 the patient experienced numbness in both hands that lasted 2 days. The numbness went away over the weekend but has since returned as of 07-APR-2008.  Additional information has been requested. 02/17/2010 Additional information was received from a health acre professional indicating that there has been no further communictaion from the patient to the office. This is in follow-up to report[s] previously submitted on 5/14/2008. Additional information was received from a health care professional indicating that there has been no further communication from the patient to the office.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Information has been received from a physician assistance concerning a 15 year old female who on 01-APR-2008 was vaccinated with a dose of GARDASIL.  Concomitant therapy included DTAP.  The patient passed out in the office after the vaccination and recovered after a short interval.  No treatment was required.  Medical attention was sought in the office.  The patient was seen in the office because she had been experiencing some dizziness.  The PA thought it might be low blood sugar.  No product quality complaint was involved. Followup information reeived from a nurse indicated that the patient has fainted on other occasions such as having blood drawn. The physician assistant does not believe that this was related to the Gardisil. Followup information received from a nurse indicated that the patient became weak and nauseated after shot of Gardisil, however the patient dis this when lab was drwan as well. The patient laid down for a few minutes and was fine. The office and mother did not think this was an adverse reaction to the vaccine. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Infectious mononucleosis, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter who on 22-OCT-2007 was vaccinated with the first 0.5 ml dose of GARDASIL. The was no concomitant medication. In early February 2008, the patient developed mono. The patient had a high fever of 101 deg F and missed 2 weeks of school. The patient has not yet received the second dose. Unknown medical attention was sought. Patient outcome was recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 17 year old female who on 16-FEB-2008 was vaccinated by injection with her first dose of GARDASIL (lot number unspecified). On 16-Apr-2007 the patient was vaccinated by injection with her second dose of GARDASIL (lot number unspecified). On 05-Mar-2008, the patient was vaccinated by injection with her third dose of GARDASIL (lot number unspecified). On 03-Apr-2008 the patient was vaccinated by injection with her fourth dose of GARDASIL (lot number unspecified). The patient experienced headaches after receiving four doses. Lot numbers were not provided. No additional information was provided. The patient sought unspecified medical attention . Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Erythema
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 24-MAR-2008 was vaccinated with her first dose of GARDASIL (lot number 658556/1060U).  Concomitant therapy included HAVRIX.  The patient was fine in the office then went immediately to dance practice.  During dance practice, she noticed the arm she received the GARDASIL and one side of her body turned red (unspecified which arm and which side).  This red color lasted 30 minutes then she completely recovered.  No further information available.  The patient sought unspecified medical treatment with a call to the office.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood creatine phosphokinase, Cardiac monitoring, Chest pain, Computerised tomogram
Clinical narrative: Information has been received from a consumer, who is the patient's mother, concerning a 15 year old female who in September 2007, was vaccinated with the first dose of GARDASIL (lot# not reported). Concomitant therapy included meningococcal vaccine (unspecified). Per the mother, the patient experienced a headache after receiving the first dose. The patient recovered from her headache. In November 2007, the patient was vaccinated with he second dose of GARDASIL (lot# not reported). Again, the patient experienced headache after receiving the second dose. In March 2008, the patient was vaccinated with a third dose of GARDASIL (lot# not reported) and the patient started to experience a headache that lasted for 3 weeks. The patient also developed chest pain that she is still experiencing until today. The patient was brought to the ER on 08-APR-2008, but was not admitted to the hospital. The mother mentioned that the patient was absent from school 10 days last month because of the symptoms. No further information was provided. Additional information has been requested.  5/29/08 Reviewed ER medical records of 4/2008.  FINAL ER Dx: atypical chest pain  Records of 4/8/08 visit for chest pain, HA & left arm pain intermittently x 1 mo.  Had vertigo since last HPV vax on 3/17/08.  6/3/08 Reviewed PCP medical records & vaccine records.  Patient received HPV #1 0960F on 9/11/2007 unknown site; HPV #2 1266U on 11/16/2007 LUE; HPV #3 1486U on 3/17/2008 LUE.  Nausea, dizziness, HA day after 1st HPV.  On 3/11/08 woke w/heart racing, sharp chest pain & dizziness.  On antibiotic at that time for strep throat dx 3/6/08.  Referred to peds cardio.  On 3/18, parent reported dizziness & nausea day after each HPV vaccine.  Cardio consult 3/15/08 WNL.  07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Information has been received from a health professional concerning a 15 year old female student with chest pain and a viral infection at the time of vaccination, who on 17-Mar-2008 was vaccinated IM in the left deltoid with 0.5 ml third dose of GARDASIL (lot# 659655/1486U). The patient had received all three doses. After each dose the patient developed weakness, dizziness and fainting. Unknown medical attention was sought. At an unknown date the patient recovered. No PQC involved. Follow up information received fromthe patient's mother indicated that the patient experienced episodes of dizziness and nausea after all three doses lasting 1 to 2 days begins day after immunization. She had missed school due to this. Follow up information received from the mother again indicated that on 11-Sep-2007, the patient was vaccinated with her first dose of GARDASIL (lot# 654535/0960F) into the right arm and on 16-Nov-2007 with the second dose of GARDASIL (lot# 659437/1266U) into the left arm. After each dose the next 2 days had dizziness, fatigue enough not to be able to attend school. She had nausea too. The patient has recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram head, Electrocardiogram abnormal, Epstein-Barr virus test, Fatigue, Fibrin D dimer decreased
Clinical narrative: Information has been received from a consumer, who is the patient's mother, concerning a 15 year old female who in September 2007, was vaccinated with the first dose of GARDASIL (lot# not reported). Concomitant therapy included meningococcal vaccine (unspecified). Per the mother, the patient experienced a headache after receiving the first dose. The patient recovered from her headache. In November 2007, the patient was vaccinated with he second dose of GARDASIL (lot# not reported). Again, the patient experienced headache after receiving the second dose. In March 2008, the patient was vaccinated with a third dose of GARDASIL (lot# not reported) and the patient started to experience a headache that lasted for 3 weeks. The patient also developed chest pain that she is still experiencing until today. The patient was brought to the ER on 08-APR-2008, but was not admitted to the hospital. The mother mentioned that the patient was absent from school 10 days last month because of the symptoms. No further information was provided. Additional information has been requested.  5/29/08 Reviewed ER medical records of 4/2008.  FINAL ER Dx: atypical chest pain  Records of 4/8/08 visit for chest pain, HA & left arm pain intermittently x 1 mo.  Had vertigo since last HPV vax on 3/17/08.  6/3/08 Reviewed PCP medical records & vaccine records.  Patient received HPV #1 0960F on 9/11/2007 unknown site; HPV #2 1266U on 11/16/2007 LUE; HPV #3 1486U on 3/17/2008 LUE.  Nausea, dizziness, HA day after 1st HPV.  On 3/11/08 woke w/heart racing, sharp chest pain & dizziness.  On antibiotic at that time for strep throat dx 3/6/08.  Referred to peds cardio.  On 3/18, parent reported dizziness & nausea day after each HPV vaccine.  Cardio consult 3/15/08 WNL.  07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Information has been received from a health professional concerning a 15 year old female student with chest pain and a viral infection at the time of vaccination, who on 17-Mar-2008 was vaccinated IM in the left deltoid with 0.5 ml third dose of GARDASIL (lot# 659655/1486U). The patient had received all three doses. After each dose the patient developed weakness, dizziness and fainting. Unknown medical attention was sought. At an unknown date the patient recovered. No PQC involved. Follow up information received fromthe patient's mother indicated that the patient experienced episodes of dizziness and nausea after all three doses lasting 1 to 2 days begins day after immunization. She had missed school due to this. Follow up information received from the mother again indicated that on 11-Sep-2007, the patient was vaccinated with her first dose of GARDASIL (lot# 654535/0960F) into the right arm and on 16-Nov-2007 with the second dose of GARDASIL (lot# 659437/1266U) into the left arm. After each dose the next 2 days had dizziness, fatigue enough not to be able to attend school. She had nausea too. The patient has recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Mononucleosis heterophile test positive, Spinal X-ray normal, Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer, who is the patient's mother, concerning a 15 year old female who in September 2007, was vaccinated with the first dose of GARDASIL (lot# not reported). Concomitant therapy included meningococcal vaccine (unspecified). Per the mother, the patient experienced a headache after receiving the first dose. The patient recovered from her headache. In November 2007, the patient was vaccinated with he second dose of GARDASIL (lot# not reported). Again, the patient experienced headache after receiving the second dose. In March 2008, the patient was vaccinated with a third dose of GARDASIL (lot# not reported) and the patient started to experience a headache that lasted for 3 weeks. The patient also developed chest pain that she is still experiencing until today. The patient was brought to the ER on 08-APR-2008, but was not admitted to the hospital. The mother mentioned that the patient was absent from school 10 days last month because of the symptoms. No further information was provided. Additional information has been requested.  5/29/08 Reviewed ER medical records of 4/2008.  FINAL ER Dx: atypical chest pain  Records of 4/8/08 visit for chest pain, HA & left arm pain intermittently x 1 mo.  Had vertigo since last HPV vax on 3/17/08.  6/3/08 Reviewed PCP medical records & vaccine records.  Patient received HPV #1 0960F on 9/11/2007 unknown site; HPV #2 1266U on 11/16/2007 LUE; HPV #3 1486U on 3/17/2008 LUE.  Nausea, dizziness, HA day after 1st HPV.  On 3/11/08 woke w/heart racing, sharp chest pain & dizziness.  On antibiotic at that time for strep throat dx 3/6/08.  Referred to peds cardio.  On 3/18, parent reported dizziness & nausea day after each HPV vaccine.  Cardio consult 3/15/08 WNL.  07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Information has been received from a health professional concerning a 15 year old female student with chest pain and a viral infection at the time of vaccination, who on 17-Mar-2008 was vaccinated IM in the left deltoid with 0.5 ml third dose of GARDASIL (lot# 659655/1486U). The patient had received all three doses. After each dose the patient developed weakness, dizziness and fainting. Unknown medical attention was sought. At an unknown date the patient recovered. No PQC involved. Follow up information received fromthe patient's mother indicated that the patient experienced episodes of dizziness and nausea after all three doses lasting 1 to 2 days begins day after immunization. She had missed school due to this. Follow up information received from the mother again indicated that on 11-Sep-2007, the patient was vaccinated with her first dose of GARDASIL (lot# 654535/0960F) into the right arm and on 16-Nov-2007 with the second dose of GARDASIL (lot# 659437/1266U) into the left arm. After each dose the next 2 days had dizziness, fatigue enough not to be able to attend school. She had nausea too. The patient has recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray
Clinical narrative: Information has been received from a consumer, who is the patient's mother, concerning a 15 year old female who in September 2007, was vaccinated with the first dose of GARDASIL (lot# not reported). Concomitant therapy included meningococcal vaccine (unspecified). Per the mother, the patient experienced a headache after receiving the first dose. The patient recovered from her headache. In November 2007, the patient was vaccinated with he second dose of GARDASIL (lot# not reported). Again, the patient experienced headache after receiving the second dose. In March 2008, the patient was vaccinated with a third dose of GARDASIL (lot# not reported) and the patient started to experience a headache that lasted for 3 weeks. The patient also developed chest pain that she is still experiencing until today. The patient was brought to the ER on 08-APR-2008, but was not admitted to the hospital. The mother mentioned that the patient was absent from school 10 days last month because of the symptoms. No further information was provided. Additional information has been requested.  5/29/08 Reviewed ER medical records of 4/2008.  FINAL ER Dx: atypical chest pain  Records of 4/8/08 visit for chest pain, HA & left arm pain intermittently x 1 mo.  Had vertigo since last HPV vax on 3/17/08.  6/3/08 Reviewed PCP medical records & vaccine records.  Patient received HPV #1 0960F on 9/11/2007 unknown site; HPV #2 1266U on 11/16/2007 LUE; HPV #3 1486U on 3/17/2008 LUE.  Nausea, dizziness, HA day after 1st HPV.  On 3/11/08 woke w/heart racing, sharp chest pain & dizziness.  On antibiotic at that time for strep throat dx 3/6/08.  Referred to peds cardio.  On 3/18, parent reported dizziness & nausea day after each HPV vaccine.  Cardio consult 3/15/08 WNL.  07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Information has been received from a health professional concerning a 15 year old female student with chest pain and a viral infection at the time of vaccination, who on 17-Mar-2008 was vaccinated IM in the left deltoid with 0.5 ml third dose of GARDASIL (lot# 659655/1486U). The patient had received all three doses. After each dose the patient developed weakness, dizziness and fainting. Unknown medical attention was sought. At an unknown date the patient recovered. No PQC involved. Follow up information received fromthe patient's mother indicated that the patient experienced episodes of dizziness and nausea after all three doses lasting 1 to 2 days begins day after immunization. She had missed school due to this. Follow up information received from the mother again indicated that on 11-Sep-2007, the patient was vaccinated with her first dose of GARDASIL (lot# 654535/0960F) into the right arm and on 16-Nov-2007 with the second dose of GARDASIL (lot# 659437/1266U) into the left arm. After each dose the next 2 days had dizziness, fatigue enough not to be able to attend school. She had nausea too. The patient has recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 12 year old female who was vaccinated IM with the first 0.5 ml dose of GARDASIL.  The patient developed pain, swelling, and edema at the injection site.  Unknown medical attention was sought in the office.  Patient outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Clonus, Dizziness, Dyskinesia, Nausea, Pallor
Clinical narrative: Initial and follow up information  has been received from a physician, concerning a 15 year old female patient with a history of "fainted once with a blood draw," who on an unspecified date, was vaccinated IM with the second dose, 0.5 ml, of GARDASIL (lot # 659655/1486U). After vaccination, the patient became pale, and felt shaky; the physician indicated that "it could have been a complicated fainting spell." The patient "had 10 seconds of jerking- some clonus." She recovered, but "Thurs. still dizzy & nauseated." The outcome of dizzy and nauseated was not specified. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tremor
Clinical narrative: Initial and follow up information  has been received from a physician, concerning a 15 year old female patient with a history of "fainted once with a blood draw," who on an unspecified date, was vaccinated IM with the second dose, 0.5 ml, of GARDASIL (lot # 659655/1486U). After vaccination, the patient became pale, and felt shaky; the physician indicated that "it could have been a complicated fainting spell." The patient "had 10 seconds of jerking- some clonus." She recovered, but "Thurs. still dizzy & nauseated." The outcome of dizzy and nauseated was not specified. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no previous medical history and no known drug allergies, who on 04-APR-2008 was vaccinated with the first dose of GARDASIL (lot# 6596551486U).  There was no concomitant medication.  The patient had three syncopal episodes beginning 24 hours after receiving the vaccination.  The patient sought treatment for the syncopal episode in the emergency room.  The episodes were described as lasting 10 seconds in duration with full loss of consciousness.  The patient was evaluated in the physician's office on 07-Apr-2008 and had fully recovered with no need for treatment.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Information has been received from a physician concerning a adolescent female who was vaccinated with a third dose of GARDASIL (date, route and Lot# not provided).  Two months post vaccination the patient experienced vomiting and stomach cramps.  Unknown medical attention was sought.  The patient's outcome was unknown.  The reporting physician was not the primary physician.  No product quality complaint was involved.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 25 year old female who on 28-MAR-2008 was vaccinated with her first dose of GARDASIL (lot# not reported).  On 07-APR-2008 the patient experienced hives all over her body, mildly itchy.  She called the nurse on 08-APR-2008 to report the hives.  The patient has no medication or food allergies, but mild lactose intolerance.  She has not been exposed to any new things.  She was taking antihistamines and the hives were improving; no trouble breathing or swallowing.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2008.  GARDASIL Vaccine (lot # 659435/1265U). On 06-APR-2008 the patient experienced hives all over her body, midly itchy. She called the nurse on 08-APR-2008 to report the hives.  She was taking antihistamines and the hives improved on 10-APR-2008; no problem breathing or swallowing. The decision was made to not continue with the series. No additionla information is expected.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lip swelling, Oedema peripheral, Swelling face, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner through the patient's mother concerning her 19 year old daughter with an allergy to penicillin and sulfanomide who on 02-JAN-2008 was vaccinated IM in the deltoid with the first 0.5 ml dose of GARDASIL (Lot # 659055/1522U) and on 05-MAR-2008 was vaccinated IM in the deltoid with the second 0.5 ml dose of GARDASIL (Lot # 659657/1487U). Concomitant therapy included LEVORA. Approximately two weeks after receiving the first dose of GARDASIL the patient experienced swelling of lips. Approximately two weeks after receiving the second dose of GARDASIL the patient experienced more severe swelling of lips, swelling of the face and swelling of the hands. The patient was treated by an unspecified primary care physician after the second occurrence of swelling with unspecified steroids. The symptoms resolved by an unspecified date. No other symptoms or treatment reported. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/5008. Initial and follow up information has been received from a nurse practitioner through the paitent's mother concerning her 19 year old daughter with an allergy to penicillin and sulfonamide who on 02-JAN-2008 was vaccinated IM in the deltoid with the first 0.5 ml dose of GARDASIL vaccine (Lot # 659059/1522U) and on 05-MAR-2008 was vaccinated IM in the deltoid with the second 0.5 ml dose of GARDASIL vaccine (Lot # 539657/1487U). Other medication included 10 mg PO LEVORA started on02-JAN-2008 for dysmenorrhoea. Phone call from patient's mother on 09-APR-2008 indicated that the patient has swelling of lips 2 weeks after vaccine (16-JAN-2008). The second dose of the vaccine, 2 weeks after injection (19-MAR-2008) the patient noted swelling of lips, face and hands. The patient was treated by an unspecified primary care physician after the second occurrence of swellilng with prednisolone. The symptoms resolved by an unspecified date. No other symptoms or treatment reported. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lip swelling, Oedema peripheral, Rash papular, Swelling face
Clinical narrative: Information has been received from a nurse practitioner through the patient's mother concerning her 19 year old daughter with an allergy to penicillin and sulfanomide who on 02-JAN-2008 was vaccinated IM in the deltoid with the first 0.5 ml dose of GARDASIL (Lot # 659055/1522U) and on 05-MAR-2008 was vaccinated IM in the deltoid with the second 0.5 ml dose of GARDASIL (Lot # 659657/1487U). Concomitant therapy included LEVORA. Approximately two weeks after receiving the first dose of GARDASIL the patient experienced swelling of lips. Approximately two weeks after receiving the second dose of GARDASIL the patient experienced more severe swelling of lips, swelling of the face and swelling of the hands. The patient was treated by an unspecified primary care physician after the second occurrence of swelling with unspecified steroids. The symptoms resolved by an unspecified date. No other symptoms or treatment reported. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/5008. Initial and follow up information has been received from a nurse practitioner through the paitent's mother concerning her 19 year old daughter with an allergy to penicillin and sulfonamide who on 02-JAN-2008 was vaccinated IM in the deltoid with the first 0.5 ml dose of GARDASIL vaccine (Lot # 659059/1522U) and on 05-MAR-2008 was vaccinated IM in the deltoid with the second 0.5 ml dose of GARDASIL vaccine (Lot # 539657/1487U). Other medication included 10 mg PO LEVORA started on02-JAN-2008 for dysmenorrhoea. Phone call from patient's mother on 09-APR-2008 indicated that the patient has swelling of lips 2 weeks after vaccine (16-JAN-2008). The second dose of the vaccine, 2 weeks after injection (19-MAR-2008) the patient noted swelling of lips, face and hands. The patient was treated by an unspecified primary care physician after the second occurrence of swellilng with prednisolone. The symptoms resolved by an unspecified date. No other symptoms or treatment reported. No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Erythema, Immediate post-injection reaction, Local reaction, Sensation of heaviness
Clinical narrative: Information has been received from a nurse concerning a 24 year old female who on 09-APR-2008 was vaccinated IM in the right arm with the first 0.5 ml dose of GARDASIL (Lot # 660387/1967U).  Concomitant therapy included vitamins (unspecified).  On 09-APR-2008 the patient experienced immediate local reaction to the right arm (injection site arm), developed redness up to inches in diameter, increased warmth, pain down arm into chest, heaviness in the right arm and heaviness in chest.  The office has been observing the patient and the redness has begun to lessen.  Patient outcome is unknown.  Medical attention was sought in the office.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/4/2008.  The redness, warmth, and pain down arm and into chest lasted approximately 30 minutes before the symptoms abated.  The patient had no respiratory distress.  Unknown medical attention was sought in the office.  No product quality complaint was involved.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Skin warm
Clinical narrative: Information has been received from a nurse concerning a 24 year old female who on 09-APR-2008 was vaccinated IM in the right arm with the first 0.5 ml dose of GARDASIL (Lot # 660387/1967U).  Concomitant therapy included vitamins (unspecified).  On 09-APR-2008 the patient experienced immediate local reaction to the right arm (injection site arm), developed redness up to inches in diameter, increased warmth, pain down arm into chest, heaviness in the right arm and heaviness in chest.  The office has been observing the patient and the redness has begun to lessen.  Patient outcome is unknown.  Medical attention was sought in the office.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/4/2008.  The redness, warmth, and pain down arm and into chest lasted approximately 30 minutes before the symptoms abated.  The patient had no respiratory distress.  Unknown medical attention was sought in the office.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received from a health professional concerning a female who during the week of 31-MAR-2008 was vaccinated with the first dose of GARDASIL (lot# not reported).  Concomitant therapy included vaccination with the first dose of MENACTRA.  After receiving both vaccinations the patient immediately fainted and hit her head as she fell.  Per the reporter, she came to right away.  The patient was observed in the office and later sent home.  There is no additional information at this time.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 11 year old female with no reported medical history and no drug reactions/allergies who on 12-JUN-2007 was vaccinated with a dose of GARDASIL (lot # 657868/0523U).  Concomitant therapy included a dose of Tdap.  On 13-JUN-2007 the patient developed a moderately severe injection site reaction.  The patient was seen by a physician on 14-JUN-2007.  The patient was prescribed an unspecified antibiotic for the treatment of pain, swelling and redness in the left arm.  The patient fully recovered on an unspecified date.  No other symptoms or treatment reported.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain, Syncope
Clinical narrative: Information has been received from a registered nurse concerning 3 patients who were vaccinated with a dose of GARDASIL.  It was reported that the patients were between the ages of 14-19 years old and in the last 3 weeks have experienced fainting and/or site pain that lasts up to 5 to 7 days after vaccination with GARDASIL.  The nurse did not specify if the 3 patients experienced both the fainting and pain or one or the other.  The patient's status was not reported.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female patient who on 08-APR-2008 was vaccinated intramuscularly with the second 0.5 mL dose of GARDASIL.  Concomitant therapy included an unspecified immunization.  It was reported that she then had blood work drawn and fainted after the blood draw.  The nurse mentioned that the parents believe that the patient had a seizure and that it was caused from the GARDASIL.  The nurse mentioned that the patient did not have a seizure.  The patient recovered in the office and was discharged home.  No diagnostic laboratory testing was performed.  The patient is going to be having an electrocardiogram performed for follow up.  The parents have requested that the patient not receive any additional doses of GARDASIL.  No product quality complaint was involved.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site pruritus, Injection site urticaria, Local reaction, No reaction on previous exposure to drug, Pruritus
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2008. Information has been received from a physician concerning a 16 year old female with no medical history who on 10-APR-2007 was vaccinated with the first dose of GARDASIL (lot not reported).  On 29-JUN-2007 the patient was vaccinated with the second dose of GARDASIL (lot not reported).  On 10-APR-2008 the patient was vaccinated with the third dose of GARDASIL (lot 660387/1967U).  Concomitant therapy included a dose of MENACTRA.  On 31-MAR-2008 after receiving the third dose of GARDASIL the patient developed hives later in the day.  The hives resolved within 24 to 48 hours.  The patient was instructed to take BENADRYL for the hives.  It was also reported that the patient had no adverse reactions of any kind with the two previous doses of GARDASIL (lot not reported).  Additional information has been requested. Follow up information was received on 11-JUN-2008. The patient's mother reported that the patient developed large local reaction to GARDASIL vaccine after the second dose (no hives per nursed notes). After the patient received the third dose of GARDASIL vaccine, the nurse planned to observe the patient and within a few minutes of the third dose of GARDASIL vaccine, the patient developed hives and utcgubg at the vaccine site (right arm) and at the base of the neck posturely. There was no trouble breathing. The patient was instructed to take BENADRYL and to speak with an allergist. It was recommended the patient take another dose of BENADRYL in the afternoon. The patient was observed at the doctor's office for an hour and the hives faded and no more developed. A phone call was placed to the patient's mother the next day and it was reported that the hives had resolved by the following morning. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2008. Information has been received from a physician concerning a 16 year old female with no medical history who on 10-APR-2007 was vaccinated with the first dose of GARDASIL (lot not reported).  On 29-JUN-2007 the patient was vaccinated with the second dose of GARDASIL (lot not reported).  On 10-APR-2008 the patient was vaccinated with the third dose of GARDASIL (lot 660387/1967U).  Concomitant therapy included a dose of MENACTRA.  On 31-MAR-2008 after receiving the third dose of GARDASIL the patient developed hives later in the day.  The hives resolved within 24 to 48 hours.  The patient was instructed to take BENADRYL for the hives.  It was also reported that the patient had no adverse reactions of any kind with the two previous doses of GARDASIL (lot not reported).  Additional information has been requested. Follow up information was received on 11-JUN-2008. The patient's mother reported that the patient developed large local reaction to GARDASIL vaccine after the second dose (no hives per nursed notes). After the patient received the third dose of GARDASIL vaccine, the nurse planned to observe the patient and within a few minutes of the third dose of GARDASIL vaccine, the patient developed hives and utcgubg at the vaccine site (right arm) and at the base of the neck posturely. There was no trouble breathing. The patient was instructed to take BENADRYL and to speak with an allergist. It was recommended the patient take another dose of BENADRYL in the afternoon. The patient was observed at the doctor's office for an hour and the hives faded and no more developed. A phone call was placed to the patient's mother the next day and it was reported that the hives had resolved by the following morning. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Eye disorder, Injection site swelling, Injection site warmth, Pruritus, Urticaria
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no reported medical history who on 21-MAR-2008 was vaccinated with the second dose of GARDASIL (lot number not reported). There was no concomitant medication. On 21-MAR-2008 the patient experienced itchiness, bumps on her eyes, swelling and warmth at injection site. The patient was rushed to the ER on 23-MAR-2008 but not hospitalized. The patient was rushed to the ER again on 25-MAR-2008 after breaking out in hives all over her body and also not hospitalized. Subsequently, on an unspecified date the patient recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old patient who on an unspecified date, was vaccinated with a dose of GARDASIL (lot number unspecified) and fainted post vaccination.  The physician was not certain if the event occurred after the patient's first or second vaccination with GARDASIL but knew it was definitely not with administration of the third dose.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow-up information has been received from a physician and from a nurse practitioner concerning a 14 year old female with allergy to penicillin, who on an unspecified date was vaccinated with a second dose of GARDASIL (lot number unspecified), fainted and was pale post vaccination. Subsequently, the patient recovered from her experiences. No other information was available. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a health professional concerning a female who was IM vaccinated with her first dose of GARDASIL (lot number unspecified). Subsequently the patient experienced a red mark where the band aid came into contact with skin at injection site, which was not from the stickiness of the band aid. The patient sought unspecified medical treatment. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Contraception, Erythema, Induration, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a physician and a clinical manager concerning a 24 year old female with a history of pharyngitis streptococcal ("1 to 2 weeks prior to vaccination"), who on approximately 28-FEB-2008 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (lot # 655327/1287U).  Concomitant therapy included hormonal contraceptives (unspecified).  The physician and case manager reported that "on the same day", approximately 28-FEB-2008, the patient "experienced pain and swelling at the injection site that lasted for 6 weeks."  The patient sought medical attention and was seen by the physician.  The physician and clinical manager reported that "the patient was followed-up today", 10-APR-2008, and the physician found signs of scarring and muscle necrosis.  The area was red, hard, and concave."  The patient had not improved.  The patient reported that she had an appointment with a plastic surgeon scheduled for 11-MAY-2008.  Additional information has been requested.