chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a Licensed Practical Nurse (LPN) concerning a 22 year old female mathematician with a penicillin allergy and no pertinent medical history who was vaccinated with Gardasil on 25-MAY-2007, IM in to left arm with a first dose of GARDASIL lot #657736/0389U. Concomitant therapy included TRIPHASIL. In follow up it was reported that the patient received injection and remained seated for several minutes after injection. On 25-MAY-2007, at 02:00 PM she walked to front desk area to pay co-pay, while standing patient fell over towards left on nurse. The nurse grabbed patient and lowered to ground. The patient fainted five to minutes after receiving her first dose of Gardasil on 25-May-2007. Patient fainted and the nurse used ammonium acetate to revive patient. The patient revived and fully recovered within 15 minutes. No other information was reported. Additional information has been requested. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 13 year old female who was vaccinated with Gardasil.  Subsequently the patient experienced malaise, not feeling well, and body aches and pains after the first and second dose.  No other information was reported.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient between 17 and 18 years old who was vaccinated with Gardasil. The patient fainted after her first administration of Gardasil. She had also had her blood drawn at the same time and also received a dose of Menactra. The patient recovered. No other information was reported. Continued on Additional Page
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning a female teenager, probably between 17 and 18 year old patient who in May 2007, was vaccinated with a second dose of Gardasil. The patient developed amenorrhea after the second injection. The physician felt that amenorrhea was not related to therapy with Gardasil. It was unknown if the the patient sought medical attention. The outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician and follow up information has been received from a nurse concerning a female patient between the ages of 11 and 19 who was vaccinated with a first dose of Gardasil. It was reported that the patient sat for a minute (after receiving the injection) and when she got up to leave she fainted in the hallway. Her outcome was not reported. The physician reported that lot numbers were not available, however, the physician will forward other information including the lot numbers. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007.  Follow up information has been received from a health professional concerning the 12 year old female student with no medical history who on 30-APR-2007 received her second IM dose of GARDASIL, lot #657621/0387U.  The immunization was followed by a warm sensation all over.  The patient laid down for 10 minutes and felt better with no further incident. No treatment was necessary.  She was reported as recovered after an unspecified time.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Initial information has been received from a physician and follow up information has been received from a nurse concerning a female patient between the ages of 11 and 19 who was vaccinated with a dose of Gardasil, it was reported that the patient sat for a minute (after receiving the injection) and when she got up to leave she fainted in the hallway. Her outcome was not reported. The physician reported that lot numbers were not available, however the physician will forward other information including the lot numbers. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a physician, a nurse and a healthcare professional, concerning a 17 year old, female student, with no significant medical history and no known allergies, who was vaccinated IM, on 26-APR-2007 at 1:15pm, with the first dose of GARDASIL (Lot #65617/0384U). There was no illness at the time of vaccination. It was reported that the patient felt lightheaded immediately (at 3:15pm) after receiving the injection and sat, or was laid on the floor. It was confirmed that the patient had recovered on the same day, 26-APR-2007. No further information is expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Initial information has been received from a physician and follow up information has been received from a nurse concerning a female patient between the ages of 11 and 19 who was vaccinated IM with a dose of Gardasil. It was reported that the patient sat for a minute (after receiving the injection) and when she got up to leave she fainted in the hallway. Her outcome was not reported. The physician reported that lot numbers were not available, however, the physician will forward other information including the lot numbers. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Follow up information has been received from a health professional concerning the 12 year old female with no medical history who on 02-MAY-2007 at 11:30 a.m. was vaccinated IM with her first dose of GARDASIL, lot #657621/0387U. At 11:30 a.m. she gathered her belongings, walked into the hallway, and fainted to the floor. She laid in the hallway for approximately 10 minutes, had orange juice, felt better and left the office. No treatment was necessary. She was reported as recovered on 02-MAY-2007. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Initial information has been received from a physician and follow up information has been received from a nurse concerning a female patient between the ages of 11 and 19 who was vaccinated IM with a dose of Gardasil. It was reported that the patient sat for a minute (after receiving the injection) and when she got up to leave she fainted in the hallway. Her outcome was not reported. The physician reported that lot numbers were not available, however, the physician will forward other information including the lot numbers. Additional information has been requested.This is in follow-up to report (s) previously submitted on 6/14/2007. Follow-up information has been received from a healthcare professional concerning the 14 year old female student who on 26-Apr-2007 at 2:15 p.m. received her first IM dose of GARDASIL, LOT # 657617/0384u. At 2:15 p.m. the patient experienced dizziness (also reported as within 5 minutes of receiving immunization patient excperienced dizziness). The patient laid down on the exam table and was "within normal limits after 10 minutes on the table". No treatment was necessary. Addional information is not expected.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Nausea, Vertigo
Clinical narrative: Information has been received from a medical assistant concerning a 35 year old female with genital herpes who on 27-NOV-2006 and 29-JAN-2007 was vaccinated IM with 0.5 ml of Gardasil (Lot #653978/0955F and 654741/0013U). Concomitant therapy included Valtrex as needed. On 30-JAN-2007 the patient experienced vertigo and nausea. The vertigo and nausea resolved on its own by 2 PM. Medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced hair loss two weeks after vaccination. Medical attention was sought. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old female with no drug reactions/allergies a history of hernia surgery (March or April 2007) who on 17-MAY-2007 was vaccinated IM in her left deltoid with 0.5 ml Gardasil (lot # 655618/0186U). There was no concomitant medication. On 21-MAY-2007 the patient experienced hair loss after receiving her first dose of Gardasil. The patient was presently losing large clumps of hair. When she showered the hair loss was so great her hair clogged the drain. The patient had an appointment with her physician on 29-MAY-2007. The patient's hair loss persisted. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Wrong technique in drug usage process
Clinical narrative: Information has been received from a physician assistant concerning a 24 year old female who on 16-APR-2007 was vaccinated IM with 0.5 ml of the second dose of Gardasil (Lot #657617/0384U). On 16-APR-2007 the patient received the vaccine but the needle hit the bone in her upper arm an she has has soreness and pain in the site since then. The patient did not have any adverse symptoms after the first dose. Medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Breast pain, Menstruation delayed, Metrorrhagia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the second dose of Gardasil. Subsequently the patient has not had a period since her vaccination and has slight vaginal spotting and sore breasts. The physician did not perform a pregnancy test. Medical attention was sought. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a female who on an unspecified dates was vaccinated with the first and second dose of GARDASIL (lot number unknown). The physician reported the patient has not had a period since her second vaccination. The patient has slight vaginal spotting and sore breasts. The physician did not perform a pregnancy test. Medical attention was sought. Additional information is not provided. Further information is not available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site mass, Injection site pain, Oedema peripheral, Pain
Clinical narrative: Information has been received from a health professional concerning her 17 year old daughter who on 25-MAY-2007 was vaccinated IM in deltoid with a second dose of Gardasil. On 25-MAY-2007 the patient experienced pain next to the injection site after vaccination and her arm started to swell. Two days later bumps appeared on the same arm. She was given over the counter ibuprofen (Motrin) for pain. The reporter reported that patient experienced mild pain at the injection site after getting her first dose of Gardasil. The patient has not recovered. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a health professional concerning her 17 year old daughter who on 25-MAY-2007 at 03:30 PM was vaccinated IM in left deltoid with a second dose of GARDASIL lot #657621/0387U. On 25-MAY-2007 the patient experienced pain next to the injection site after vaccination and her arm started to swell. Two days later bumps appeared on the same arm. She was given over the counter MOTRIN for pain. The reporter reported that patient experienced mild pain at the injection site after getting her first dose of GARDASIL. In follow up information it was reported that on 25-MAY-2007, at 06:30 PM patient had "hard painful lump adjacent to injection site with multiple raised smaller non painful bumps down and around the same arm". It was reported that on 01-JUN-2007 patient recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a health professional concerning her 17 year old daughter who on 25-MAY-2007 was vaccinated IM in deltoid with a second dose of Gardasil. On 25-MAY-2007 the patient experienced pain next to the injection site after vaccination and her arm started to swell. Two days later bumps appeared on the same arm. She was given over the counter ibuprofen (Motrin) for pain. The reporter reported that patient experienced mild pain at the injection site after getting her first dose of Gardasil. The patient has not recovered. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a health professional concerning her 17 year old daughter who on 25-MAY-2007 at 03:30 PM was vaccinated IM in left deltoid with a second dose of GARDASIL lot #657621/0387U. On 25-MAY-2007 the patient experienced pain next to the injection site after vaccination and her arm started to swell. Two days later bumps appeared on the same arm. She was given over the counter MOTRIN for pain. The reporter reported that patient experienced mild pain at the injection site after getting her first dose of GARDASIL. In follow up information it was reported that on 25-MAY-2007, at 06:30 PM patient had "hard painful lump adjacent to injection site with multiple raised smaller non painful bumps down and around the same arm". It was reported that on 01-JUN-2007 patient recovered. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Discomfort, Incorrect route of drug administration, Injection site haematoma
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female who on 24-MAY-2007 was vaccinated with Gardasil vaccine(yeast) subcutaneously. The patient experienced an injection site hematoma and reported the injection was "uncomfortable". Subsequently, the patient recovered. Additional information has been requested. This in follow-up to report(s) previuously submitted on 6/14/2007. Follow up information received from the medical assistant stated that on 25-MAY-2007, the patient developed a sight hematoma. It was reported that  on an unspecified daie the patient had recovered and was "fine". Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, Syncope
Clinical narrative: Information has been received from a 23 year old female with no drug reactions/allergies and no medical history who on 29-MAR-2007 was vaccinated with her first dose of Gardasil, 0.5 ml, intramuscularly. There was no concomitant medication. On 29-MAR-2007 the patient fainted after receiving the first dose of the Gardasil. The patient sought unspecified medical attention. On 29-MAR-2007, the patient recovered from fainting. Additional information is not expected. Information has been received from a registered nurse concerning a 23 year old female with no pertinent medical history who on 28-MAR-2007 was vaccinated with her first dose of GARDASIL, 0.5 ml, intramuscular administration.  Concomitant therapy included VALTREX.  Subsequently, the patient fainted after receiving her initial dose of GARDASIL and recovered that same day.  The nurse reported that the GARDASIL was improperly stored at room temperature for three weeks prior to use (approximately 07-MAR-2007).  Approximately two months later (28-MAY-2007) the patient received her second dose of GARDASIL.  It was reported that the patient's second dose had been stored at room temperature for five days prior to use (approximately 23-MAY-2007).  Product Quality Control (PQC) was not involved.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with a dose of Gardasil. Subsequently the patient experienced rash at injection site and itching at injection site. The patient's rash at injection site and itching at injection site persisted. The patient sought unspecified medical attention. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a health professional concerning an approximately 23 year old female with a sulfa allergy and no other medical history who was vaccinated with a dose of GARDASIL (lot # 655324/0089U). Concomitant therapy included unspecified birth control pills and acidophilus. Subsequently the patient experienced rash at injection site and itching at injection site. The patient's rash at injection site and itching at injection site subsided with no treatment required. The patient told the nurse she will not complete the series at the office. No additional information was available. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Injection site pain
Clinical narrative: Information has been received from a Licensed Visiting Nurse (LVN) concerning a 16 year old female patient who was vaccinated IM with her first dose of Gardasil. Almost immediately, the patient burst into tears. She commented on how much the vaccination hurt. She repeatedly said she was not dizzy although it took her a long time to get out of the chair. Medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Medical device complication
Clinical narrative: Initial and follow-up information has been received from a physician and a medical assistant concerning a 13 year old female patient who on 29-MAY-2007 was scheduled to be vaccinated with a dose of Gardasil (Lot #655324/0089U). However, when the medical assistant attempted to administer the vaccination, "the plunger would not depress," and blood was aspirated into the syringe. The CMA added that she had made 2 unsuccessful attempts to get the syringe to work. The physician reported that "the UltraSafe mechanism had not activated," so the patient did not get the vaccination, and had to be rescheduled " due to a defective (Gardasil) syringe." Follow up information received from a nurse, confirmed the above events, and added that actually there was no medication in the syringe. She reported the patient still has not received the vaccination. No further information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Arthralgia, Flushing, Full blood count normal, Headache
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 15 year old female patient who on 15-FEB-2007 was vaccinated with a first dose of  Gardasil lot #655619/1427F. On 17-FEB-2007 the patient developed a fever of 105 degrees and experienced headaches, nausea, vomiting, body aches, abdominal pain and she was "flush all over". These symptoms lasted for ten days before dissipating. On 22-FEB-2007 five days after the adverse symptoms began, the patient was given cetirizine hydrochloride (ZYRTEC) and patient said she felt a little better and her headaches stopped. The nurse who provided this information works in a health department and the name of the patient's prescribing physician was not provided. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report(s0 previously submitted on 6/14/2007. Inital and follow up information has been received from a health care professional concerning a 15 year old female student with sulfonamide allergy who in 15-FEB-2007, at 02:30 PM was vaccinated IM in the left deltoid with a first dose of GARDASIL vaccine (yeast) Lot #659619/1427F. On 17-FEB-2007, the patient developed a fever of 105 degrees and experienced headaches, nausea, vomiting, body aches, abdominal pain and she was  "flush all over. These symptoms lasted for ten dayus before dissipating. On 22-FEB-2007 five days after the adverse symptoms began, the patient was given ZYRTEC and patient said she felt a little better and her headaches stopped. The nurse who provided this information woks in a health department and the name of the patient's prescribing physician was not provided. Subsequently, the patient recovered. In follow up it was indicated thta on 18-FREB-2007 patient had severe headache not relieved with acetaminophen or ibuprofen (previously reported that headache started on 17-FEB-2007 and stopped on 22-FEB-2007. Patient had fever 105 degrees x2 days then fever 102 degrees x3 days. It was mentioned that on 18-FEB-2007 patient  also had body aches, flushed skin, joint pain, nausea, vomiting. Symptoms lasted approximately 10 days. Lab drawn with normal complete blood cell count. It was reported that patient required x2 doctor's visit. The patient recovered. No additional information was expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 15 year old female patient who on 15-FEB-2007 was vaccinated with a first dose of  Gardasil lot #655619/1427F. On 17-FEB-2007 the patient developed a fever of 105 degrees and experienced headaches, nausea, vomiting, body aches, abdominal pain and she was "flush all over". These symptoms lasted for ten days before dissipating. On 22-FEB-2007 five days after the adverse symptoms began, the patient was given cetirizine hydrochloride (ZYRTEC) and patient said she felt a little better and her headaches stopped. The nurse who provided this information works in a health department and the name of the patient's prescribing physician was not provided. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report(s0 previously submitted on 6/14/2007. Inital and follow up information has been received from a health care professional concerning a 15 year old female student with sulfonamide allergy who in 15-FEB-2007, at 02:30 PM was vaccinated IM in the left deltoid with a first dose of GARDASIL vaccine (yeast) Lot #659619/1427F. On 17-FEB-2007, the patient developed a fever of 105 degrees and experienced headaches, nausea, vomiting, body aches, abdominal pain and she was  "flush all over. These symptoms lasted for ten dayus before dissipating. On 22-FEB-2007 five days after the adverse symptoms began, the patient was given ZYRTEC and patient said she felt a little better and her headaches stopped. The nurse who provided this information woks in a health department and the name of the patient's prescribing physician was not provided. Subsequently, the patient recovered. In follow up it was indicated thta on 18-FREB-2007 patient had severe headache not relieved with acetaminophen or ibuprofen (previously reported that headache started on 17-FEB-2007 and stopped on 22-FEB-2007. Patient had fever 105 degrees x2 days then fever 102 degrees x3 days. It was mentioned that on 18-FEB-2007 patient  also had body aches, flushed skin, joint pain, nausea, vomiting. Symptoms lasted approximately 10 days. Lab drawn with normal complete blood cell count. It was reported that patient required x2 doctor's visit. The patient recovered. No additional information was expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information (and additional information on 23-OCT-2007) has been received from a physician concerning her 21 year old daughter with a penicillin allergy who in January 2007, was vaccinated with a first dose of Gardasil. Concomitant therapy included Levora. In April 2007, the patient was vaccinated with a second dose of Gardasil. The patient was vaccinated in the morning and by the evening had developed a headache. The patient sought unspecified medical attention. The headache lasted 4 hours and was treated with TYLENOL. The vaccination was not administered at the physician's office. The patient picked up the vaccine at the pharmacy, and her mother, who was a physician, administered the vaccine at home. The patient did not develop a headache afte rthe first injection.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse concerning a female patient (age not reported) who unspecified dates was vaccinated with a first and second dose of Gardasil. The patient felt faint after receiving the first dose of Gardasil. The patient sought unspecified medical attention. The patient did not end up fainting and recovered the same day. The patient did not have this experience after receiving her second dose of Gardasil. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning his 17 year old daughter who on 25-APR-2007 was vaccinated with 0.5 mL second dose of Gardasil. There was no concomitant medication. Shortly after administration of the dose, the patient experienced swelling and pain at the injection site. The swelling had gone down, but there was still a nodule present at the injection site that was painful when pressure was applied to it. No form of treatment was used to help with the symptoms. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female who "two weeks ago" on 16-MAY-2007 was vaccinated with her first dose of Gardasil 0.5 ml intramuscularly. After receiving the vaccination on 16-MAY-2007, the patient turned white, grabbed her mother's arm and then fainted. Subsequently, the patient recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female in her 20's who in the past few months , in 2007, was vaccinated IM with 0.5 ml Gardasil. Subsequently the patient experienced syncope after the first and second doses of Gardasil. No treatment was required, and no lab diagnostic studies were performed. Subsequently, the patient recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth, Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a 24 year old female who in  2007 was vaccinated with the first dose of 0.5 ml Gardasil intramuscularly. There were no adverse events. The second Gardasil 0.5 ml dose was given intramuscularly on 29-MAY-2007. On 30-MAY-2007 the patient experienced significant rash and hives. The patient's significant rash and hives persisted. No lab testing was performed. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a physician and a health care professional concerning a 23 year old female who in 2007 was vaccinated intramuscularly with the first 0.5 ml dose of the GARDASIL. There were no adverse events. The second GARDASIL (Lot # 657622/0388U) 0.5 ml dose was given intramuscularly on 29-MAY-2007. On 29-MAY-2007, the patient experienced injection site warmth, redness, and hives around the site. The outcome of the patient's injection site redness, warmth and hives was unknown. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Frostbite, Hypoaesthesia, Skin discolouration
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a Nurse Practitioner concerning a 14 year old female with no history of drug reactions/allergies and a history of asthma who on an unspecified date was vaccinated with Gardasil. Concomitant therapy included several other unspecified vaccines concomitantly and Necon. Subsequently on an unspecified date the patient developed frostbite of the toes/foot. The frostbite occurred some time in February in 40 degree weather outdoors at a football game with socks and shoes. The patient was still experiencing numbness and discoloration of toes. The vaccination was administered at another unspecified practice. The patient sought unspecified medical attention but did not undergo lab tests. As of 30-MAY-2007 the patient was recovering. Additional information has been requested. Further information is not available.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Feeling abnormal, Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Information has been received from a 27 year old female who was vaccinated with Gardasil. Concomitant therapy Ortho Tri-Cyclen. On 17-MAY-2007 the patient experienced injection site pain, dizziness and mental fogginess that lasted four days after receiving therapy with Gardasil. Subsequently, the patient recovered from injection site pain, dizziness and mental fogginess. Additional information is not expected. 07/06/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a 27 year old female who was vaccinated with a dose of GARDASIL. Concomitant therapy included ORTHO TRI-CYCLEN. On 17-MAY-2007, the patient experienced injection site pain, dizziness, was tired, tingling and mental fogginess that lasted four days after receiving therapy with GARDASIL. It was also reported that the patient experienced pain in her arm which lasted for 5 days. No medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a 27 year old female who was vaccinated with Gardasil. Concomitant therapy Ortho Tri-Cyclen. On 17-MAY-2007 the patient experienced injection site pain, dizziness and mental fogginess that lasted four days after receiving therapy with Gardasil. Subsequently, the patient recovered from injection site pain, dizziness and mental fogginess. Additional information is not expected. 07/06/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a 27 year old female who was vaccinated with a dose of GARDASIL. Concomitant therapy included ORTHO TRI-CYCLEN. On 17-MAY-2007, the patient experienced injection site pain, dizziness, was tired, tingling and mental fogginess that lasted four days after receiving therapy with GARDASIL. It was also reported that the patient experienced pain in her arm which lasted for 5 days. No medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: DTP, HEPA, HPV4, MNQ
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 12 year old female who was vaccinated with Gardasil. Concomitant therapy included DPT and Menactra. Subsequently the patient experienced dizziness and a lightheaded woozy feeling after receiving therapy with Gardasil. Subsequently, the patient recovered from dizziness and lightheaded woozy feeling. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial information has been received from a physician and a licensed practical nurse concerning a 11 year old female who on 16-MAY-2007 was vaccinated with a first dose of GARDASIL (lot # 655620/0171U). On 16-MAY-2007, concomitant therapy included IM dose of DTP, IM dose of MENACTRA and IM dose of hepatitis A virus vaccine (manufacturer unknown). On 16-MAY-2007, experienced dizziness lasting about 15 minutes. On 16-MAY-2007, the patient recovered from dizziness and the lightheaded woozy feeling. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: This is in follow-up to report (s) previously submitted on 6/14/2007 information has been received from a physician concerning an 20 year old female. Medical history and concomitant therapies not reported. On an unspecified date the patient was vaccinated with the first dose of Gardasil. Subsequently the patient experienced an outbreak of genital warts. On an unspecified date the patient was vaccinated with the second dose of Gardasil. Subsequently the patient experienced another outbreak of genital warts. The patient sought unspecified medical attention. As of 30-MAY-2007 the patient did not receive a third dose and patient outcome was not reported. Additional information has been requested. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site pain, Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who 30-MAY-2007 was vaccinated with a dose of Gardasil. The patient was concomitantly vaccinated with a dose of Menactra. The patient reported to the nurse that the Gardasil injection was more painful than Menactra. Subsequently, the patient passed out in the waiting room after Gardasil. The patient sought unspecified medical attention. The patient recovered from the event on 30-MAY-2007. No further information is available.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 32 year old female who on 15-NOV-2006 was vaccinated with the first dose Gardasil 0.5 ml IM. On an unspecified date the patient received the second dose Gardasil. On 16-MAY-2007 the patient received the third dose of Gardasil 0.5 ml IM. On 17-MAY-2007 the patient experienced pain, swelling and tenderness at the injection site of the right deltoid muscle. The physician also mentioned that the patient had trouble lifting her arm due to pain. The physician prescribed ibuprofen (Motrin). The patient was examined by the physician on 05-21-2007 and the symptoms were resolving. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 13 year old female with a history of lightheadedness who on 25-MAY-2007 was vaccinated with the first dose of Gardasil 0.5 ml. Concomitant therapy included DTaP (unspecified) and Menactra. The physician reported that the patient fainted the day after receiving the vaccine. The patient was sitting and fainted when she stood up. The patient sought unspecified medical attention. As of 30-MAY-2007 the patient had recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female who on 19-APR-2007 was vaccinated with Gardasil. On approximately 31-MAY-2007 the patient developed injection site redness and injection site swelling. The patient has not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypotonia, Loss of consciousness, Malaise
Clinical narrative: Information has been received from a nurse concerning her 14 year old daughter who on 26-APR-2007 was vaccinated IM with 0.5 ml of Gardasil. On 26-MAY-2007 after she was vaccinated, the patient experienced dizziness and passed out. The patient sought unspecified medical attention. Subsequently, the patient recovered from the events. Additional information has been requested. In follow-up it was reported by the licensed practical nurse (LPN), concerning her white, 14 year old, student daughter, whose reported weight was 123 pounds and whose reported height was 65.2 inches who on 26-May-2007 was vaccinated intramuscularly (IM) with 0.5 ml of Gardasil (lot #657622/03880).  It was reported that on 25-May-2007 after the patient received the Gardasil, the patient said that she didn't feel very well and everything was black.  She was assisted to a lying position and while she was getting ready to lie down she went limp and passed out for 3 minutes.  Her name was called 2-3 times and she came "to".  I t was reported thst the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female patient with a urinary tract infection who on 29-MAY-2007 was vaccinated IM with Gardasil. Concomitant therapy included Menactra. That same day, the patient experienced pain and swelling at the injection site. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Headache, Hyperhidrosis
Clinical narrative: Information has been received from a nurse concerning a 2 patients who were vaccinated IM with Gardasil. Subsequently the patients experienced a headache and sweating. This is one of several reports received from the same source. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated IM with a 0.5 mL dose of Gardasil. Subsequently, post vaccination, the patient experienced tingling of the same arm she was vaccinated. The patient sought unspecified medical attention. The patient's outcome was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Sinus congestion
Clinical narrative: Information has been received from a licensed visiting nurse (LVN) for the pregnancy registry for Gardasil concerning a 20 year old female with abdominal pain and inguinal lymphadenopathy (treated with doxycline therapy) and  a history of recurrent upper respiratory sinus infections who on 30-NOV-2006 was vaccinated with the first dose of Gardasil. On 01-FEB-2007, the patient was vaccinated with the second dose of Gardasil. On 09-MAY-2007, the patient was seen in her physician's office with a complaint of sinus congestion. On this visit, the patient reported that she was pregnant, and had seen her gynecologist one month ago. The patient's outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007. Follow up phone call information was obtained from a licensed vocational nurse who reported that the patient vaginally delivered a healthy and normal infant, full-term, without complications. No additional information is expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 13 year old female who was vaccinated with a dose of Gardasil. Subsequently, the patient developed a bad rash after the vaccination. The patient visited and urgent care center for unspecified treatment. The patient's outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Head injury, Skull X-ray, Syncope
Clinical narrative: Information has been received from a medical assistant concerning an 11 year old female who was vaccinated with the first dose of Gardasil. Concomitant therapy included DTaP (unspecified) (+) Menactra, both administered in the opposite arm. It was reported that 20 seconds after vaccination with Gardasil, the patient fainted. The patient recovered after five to ten seconds, although, bumped her head on the floor. X-rays of the patient's head were taken (results not reported). The outcome of the patient's head injury was unknown. Additional information has been requested. This is one of two reports received fro the same source. This is in follow-up to report(s) previously submitted on 6/14/2007.  Initial and follow-up information has been received from a medical assistant concerning an 11 year old female student with a history of headaches who on 30-MAY-2007 at 1:45 pm was vaccinated in the left arm with the first dose of GARDASIL (LOT# 654885/1424F).  Concomitant therapy included INFANRIX (Lot # U1986AA) and MENACTRA (Lot # U2142AA), both administered in the opposite arm at 1:45pm.  It was reported that the patient sat down for5-10 minutes after the vaccinations.  When she got up, "she gave about 10 steps and fainted.  She hit herself on the head."  The patient was observed and a head computed axial scan was performed.  The result was normal and showed no infarct, mass or bleed.  The outcome of the patient's head injury was unknown.  This in one of two reports received from the same source.  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female who in approximately May 2007, was vaccinated with Gardasil. Subsequently the patient experienced a red welt at injection site. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician's assistant concerning a 22 year old female with a history of an unspecified reaction to Lortab who on 14-MAR-2007 was vaccinated with her second dose of Gardasil (lot# 657617/0384U). Concomitant therapy included unspecified birth control. The patient experienced pain at the injection site. As of 31-MAY-2007 she was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Tachycardia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced tachycardia. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female who on 24-MAY-2007 was vaccinated with Gardasil. Concomitant therapy included Tdap, given at the same time. On 24-MAY-2007 the patient was extremely nauseous after her vaccinations. Subsequently, the patient recovered. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a nurse practitioner concerning an 18 year old female who on 24-MAY-2007 was vaccinated with a first dose of GARDASIL (lot # unknown). Concomitant therapy included Tdap (manufacturer unknown), given at the same time. On 24-MAY-2007 the patient was extremely nauseous post-vaccinations. Medical attention was sought. On 24-MAY-2007 the patient recovered. Further information is not available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with Gardasil. Subsequently the patient fainted. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 12 year old  female who was vaccinated with Gardasil, 0.5 mL IM. Subsequently, the patient experienced vomiting and dizziness. Therapy with human papillomavirus vaccine was discontinued. Subsequently, the patient recovered from vomiting and dizziness. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 16-MAY-2007 was vaccinated with her first dose of Gardasil. Concomitant therapy included Menactra. On 16-MAY-2007 the patient fainted. Subsequently, the patient recovered from fainted. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a nurse practitioner concerning a 17 year old female who on 16-MAY-2007 was vaccinated with her first dose of GARDASIL (lot # unknown). Concomitant therapy included MENACTRA given on the same day. On 16-MAY-2007 the patient fainted after being vaccinated. Medical attention was sought. On 16-MAY-2007 the patient recovered. Therapy was discontinued. Further information is not available.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 22-NOV-2006 was vaccinated with Gardasil. On 22-NOV-2006 the patient passed out in the lobby 5 minutes after she was vaccinated. The patient recovered. It was noted that the patient's mother has a history of syncope. Subsequently, the patient received dose 2 and dose 3 without any adverse experience. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Dizziness
Clinical narrative: Information has been received from a health professional concerning an 11 year old female who on 27-MAR-207 was vaccinated with Gardasil (lot number 657736/0389U). Two months later, on 29-MAY-2007, she received her third dose of the vaccination (lot number 657736/0389U). On 30-May-2007 the patient experienced dizziness, felt lightheaded and developed an elevated temperature. Degree of fever is unknown. At the time of this report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Three to four days after she received the vaccination, she experienced nausea, vomiting and fever. The physician felt that the nausea, vomiting and fever were not related to therapy with Gardasil. He noted that he had a lot of patients with the flu. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a registered nurse, concerning a 12 year old female patient, who in May 2007, was vaccinated with a dose of Gardasil. Two days after the vaccination, the patient had a "breakthrough menstrual period;" the patient's LMP was 2 weeks prior to the vaccination. The nurse clarified, this was not 'spotting," but rather a "normal flow period," and confirmed that the patient had not experienced anything similar prior to the vaccination. The patient sought unspecified medical attention. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotonia, Injection site pain, Loss of consciousness, Syncope
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a licensed practical nurse concerning a 16 year old female who was vaccinated IM with the second 0.5 ml dose of GARDASIL. On 17-MAY-2007 after receiving the vaccine the patient fainted and was unconscious for 1-2 minutes. The licensed practical nurse reported the patient complained of pain as injection was given and suddenly slumped in the chair. They were able to arouse the patient by calling her name. The staff watched the patient for 10-15 minutes after she was asked to lie down. The patient reported to the staff that she thought she was swimming. The patient recovered quickly and was clear and ambulatory when she left the clinic. The patient sought unspecified medical attention. No treatment was required. Subsequently, the patient recovered from fainting. The patient did not experience any adverse symptoms after the first dose. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site pain
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient experienced injection site soreness and dizziness. Unspecified medical attention was sought. Additional information has been requested.