chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Injection site pain, Musculoskeletal stiffness, Myositis, Tendonitis
Clinical narrative: Information has been received from a physician concerning a female patient in her 20's who was vaccinated with a first and second dose of Gardasil.  The physician reported that the patient had unusual soreness at the injection site after the first and second injection.  He also reported that the patient had unusual stiffness and weakness with local mechanical trouble after she was given the third dose of Gardasil.  The patient had not recovered as of this report day.  The physician reported that this is one of the three patients who experienced similar experiences.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 09/17/2007.  Initial and follow up information has been received from a physician concerning a 27 year old female who was vaccinated with a first and second dose of GARDASIL.  The physician reported that the patient had unusual soreness at the injection site after the first and second injection.  He also reported that the patient had unusual stiffness nad weakness with local mechanical trouble after she was given the third dose of GARDASIL.  In follow up it was reported that on 27-JUL-2007, patient had shoulder tendenitis and myositis).  On 01-SEP-2007 patient recovered.  The reporter indicated that the patient's adverse event left shoulder tendenitis and myositis were disabling.  The physician reported that this is one of three patient who experienced similar experiences.  Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female patient in her 20's who was vaccinated with a first and second dose of Gardasil.  The physician reported that the patient had unusual soreness at the injection site after the first and second injection.  He also reported that the patient had unusual stiffness and weakness with local mechanical trouble after she was given the third dose of Gardasil.  The patient had not recovered as of this report day.  The physician reported that this is one of the three patients who experienced similar experiences.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 09/17/2007.  Initial and follow up information has been received from a physician concerning a 27 year old female who was vaccinated with a first and second dose of GARDASIL.  The physician reported that the patient had unusual soreness at the injection site after the first and second injection.  He also reported that the patient had unusual stiffness nad weakness with local mechanical trouble after she was given the third dose of GARDASIL.  In follow up it was reported that on 27-JUL-2007, patient had shoulder tendenitis and myositis).  On 01-SEP-2007 patient recovered.  The reporter indicated that the patient's adverse event left shoulder tendenitis and myositis were disabling.  The physician reported that this is one of three patient who experienced similar experiences.  Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered medical assistant concerning a 13 year old female with no pertinent medical history, who on 30-JAN-2007 at 3:00 pm, was vaccinated in the left arm with a first dose of Gardasil (lot # 654389/0961F). On 30-JAN-2007 at 3:00 pm, the patient experienced a brief syncopal episode. The patient was monitored in the office for 10 to 15 minutes vital signs were reported as normal. Subsequently, the patient recovered from a brief syncopal episode and patient was left with her mother who is a registered nurse. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Medical device complication
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female who on 14-AUG-2007 was vaccinated with Gardasil.  On 14-AUG-2007, the spring on the syringe did not release, so she pushed harder on the plungers before withdrawing the syringes from the patient's arm.  The patient complained that the injection hurt.  Unspecified medical attention was sought.  The outcome was not reported.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a 0.5 mL dose of Gardasil.  Immediately following the vaccination, the patient experienced dizziness, nausea and then fainted.  The patient sought unspecified medical attention.  Subsequently, the patient recovered.  This is one of several reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a 0.5 mL dose of Gardasil.  Immediately following the vaccination, the patient experienced dizziness, nausea and then fainted.  The patient sought unspecified medical attention.  Subsequently, the patient recovered.  This is one of several reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with Gardasil (lot# unknown) 0.5 mL injection and fainted. Medical attention was sought.  At the time of reporting it was unknown if the patient had recovered.  No additional information was provided.  No further information is available.  This is one of two reports from the same source.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Feeling cold, Loss of consciousness, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female who on 23-AUG-2007 was vaccinated at 11:15 am with the third dose of Gardasil. Afterwards, the patient experienced dizziness for a couple minutes. She sat down, had a cup of water and walked to the waiting room. About 5 minutes later, she passed out. She was cold, clammy, and pale. When she finally came to, the patient was watched for about 20 minutes. The patient felt nauseated. She received no other vaccines that day. She had eaten breakfast. When she left the office, she still felt nauseous. No further details were provided.  This is one of 2 reports from the same source (WAES 0708USA04690).  Additional infromation is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female who on 23-AUG-2007 was vaccinated at 11:15 am with the third dose of Gardasil. Afterwards, the patient experienced dizziness for a couple minutes. She sat down, had a cup of water and walked to the waiting room. About 5 minutes later, she passed out. She was cold, clammy, and pale. When she finally came to, the patient was watched for about 20 minutes. The patient felt nauseated. She received no other vaccines that day. She had eaten breakfast. When she left the office, she still felt nauseous. No further details were provided.  This is one of 2 reports from the same source (WAES 0708USA04690).  Additional infromation is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female (demographics not provided) who on 14-AUG-2007 was vaccinated with Gardasil (Lot# not reported).  That same day post vaccination the patient experienced dizziness.  Unspecified medical attention was sought.  Subsequently, on an unspecified date the patient recovered from dizziness.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 14-AUG-2007 was vaccinated with the first dose of Gardasil (Lot # and route of vaccination not provided). Post vaccination that same day the patient fainted. Unspecified medical attention was sought. The physician reported that the patient did not appear to be injured, her vital signs were stable (actual value not provided). The physician reported that the patient was recovering in the office. Additional information has been requested.
Sex: F
Vaccine: DTAP, HPV4, IPV
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (demographics not provided) who on an unspecified date was vaccinated with Gardasil (lot # not provided).  Concomitant therapy included DTAP-IPV.  Subsequently at an unspecified time post vaccination the patient experienced syncope.  The patient sought unspecified medical attention.  Subsequently, on an unspecified date the patient recovered from the syncope.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on an unknown date was vaccinated IM into the upper arm with an entire dose of Gardasil. After vaccination, the patient experienced syncope. Unspecified medical attention was sought. On an unknown date, the patient recovered. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Dizziness, Head injury, Laboratory test, Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient who on 06-AUG-2007, was vaccinated with a dose of Gardasil. On 06-AUG-2007 after receiving the vaccine, the patient felt dizzy and lightheaded. It was reported that the patient hit her head on the receptionist counter however she never lost consciousness. Unspecified medical attention was sought. Laboratory diagnostic studies included a blood pressure measurement. On an unknown date, the patient recovered. No product quality complaint was involved. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Information has been received from a healthcare professional concerning a 19 year old female patient with no known drug allergies who on 06-AUG-2007 at 11:30 AM, was vaccinated into the left deltoid with a first dose of GARDASIL (Lot# 658100/0525U). On 06-AUG-2007 (reported as beginning at 11:00) after receiving the vaccine, the patient experienced dizziness, lightheaded and faintness. It was reported that the patient collapsed in the lobby hitting her head on the receptionist counter however she never lost consciousness. She was helped up and put in a resting position. Her blood pressure was checked every 5 to 10 minutes. The patient was discharged home about one hour later. On 06-AUG-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Paraesthesia oral, Syncope
Clinical narrative: Information has been received from a nurse concerning a 15 year old female patient who on 30-JUL-2007 was vaccinated IM with a first dose of Gardasil lot #658488/0930U.  The nurse reported that the patient "fainted" after getting the Gardasil injection.  She also reported that the patient experienced "tingling around the lips and her fingers after she recovered from fainting."  The physician provided the patient with ice.  No further information was provided.  The patient "left office feeling better".  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient who on 10-JUL-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included Hepatitis B vaccine, recomb (manufacturer unspecified). The physician stated that patient developed an unusual rash after she got her injection. He stated that the rash was in the injection site area, and it was perfectly circular and flat and approximately 5 cm in diameter. There was also a smaller rash of approximately 1.5 cm which overlapped the larger rash. Unspecified medical attention was sought by the patient. The patient had not recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. In follow up report the physician indicated that patient had "Tinea corporis at the injection site. We thought to be coincidence and reported that there was no adverse reaction". Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Information has been received from a physician concerning a female patient with no allergies, who on approximately 17-JUL-2007 "about four weeks ago", was vaccinated IM with a third 0.5 ml dose of Gardasil.  "Recently" the patient experienced a painful knot at the injection site where the last dose was given.  Unspecified medical attention was sought.  No diagnostic laboratory studies were performed.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 year old female who on 14-AUG-2007 was vaccinated with a dose of Gardasil (lot# 658100/0525U). On 14-AUG-2007 the patient experienced syncope, dizziness and fatigue. Unspecified medical attention was sought. The patient's syncope and dizziness and fatigue persisted. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Nodule, Pain in extremity
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no medical history, who on 13-AUG-2007 was vaccinated with Gardasil.  Concomitant therapy given into the same arm included a dose of MENACTRA.  On 13-AUG-2007, the patient experienced pain and a knot in her arm.  Unspecified medical attention was sought.  No laboratory diagnostic studies were performed.  The patient's pain in arm and knot in arm persisted.  No product quality complaint was involved.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Medical device complication
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 14-AUG-2007 was vaccinated with Gardasil. On 14-AUG-2007, the spring on the syringe did not release, so she pushed harder on the plungers before withdrawing the syringes from the patient's arm. The patient complained that the injection hurt. Unspecified medical attention was sought. The outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a 0.5 mL dose of Gardasil. Immediately following the vaccination, the patient experienced dizziness, nausea and then fainted. The patient sought unspecified medical attention. Subsequently, the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a certified nurse midwife concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with Gardasil (lot# unknown).  On an unspecified date the patient experienced a high fever.  Medical attention was sought.  The patient went to the emergency room.  At the time of reporting it is unknown if the patient had recovered.  No further information is available.  This is one of two reports from the same source.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an approximately 11 year old female who on an unspecified date was vaccinated in the right arm with the first dose of GARDASIL. The patient was also vaccinated in the left arm with a dose of MENACTRA and DTaP. Subsequently the patient developed swelling and redness at injection site. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Lipids normal, Skin hyperpigmentation
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 27-JUL-2007 was vaccinated with a dose of Gardasil (lot 654885/1424F).  There was no concomitant medication.  On 03-AUG-2007, the patient returned to the clinic with complaint of hyperpigmentation patch on right wrist.  The physician was not sure if the patient's hyperpigmentation was due to vaccination with Gardasil or other causes.  Laboratory evaluations on 03-AUG-2007 revealed normal lipid profile.  At the time of this report, the patient had not recovered and was still being treated.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Metrorrhagia
Clinical narrative: Information has been received from a medical assistant concerning an unknown number of females (age not reported) who on unspecified dates was vaccinated with Gardasil (lot#s unknown). On unspecified dates "a couple" of patients developed menstrual spotting after vaccination with Gardasil. Medical attention was sought. No other information was available. On unspecified dates the females had recovered. Attempts were being made to obtain additional identifying information to distinguish the unidentified patients mentioned in the report. Follow-up information was received from a medical assistant via telephone. The nurse reported that she could not provide any additional patient details. The nurse confirmed that there were 3 patients who reported menstrual spotting following vaccination with Gardasil. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no pertinent medical history, who was very nervous and hyperventilation before receiving the vaccinations and it was reported that the physician "laid the patient down." On 15-AUG-2007 the patient was vaccinated with a first dose of Gardasil (lot # 657872/0515U). Concomitant suspect vaccine on 15-AUG-2007 included Varivax. Other concomitant vaccine on 15-AUG-2007 included MENACTRA. On 15-AUG-2007 after receiving all three vaccinations the patient stood up and fainted. Unspecified medical attention was sought. On 15-AUG-2007, the patient recovered from fainting. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Syncope
Clinical narrative: Information has been received from a pharmacist concerning a female who on approximately 10-AUG-2007 was vaccinated with a dose of Gardasil (lot # 653736/0014U).  On approximately 10-AUG-2007 the patient felt nauseous and fainted, "went straight down."  At the time of the report the outcome was unknown.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Muscle spasms, Pain in extremity, Paraesthesia
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 20 year old female student with penicillin allergy who on 06-AUG-2007 at 9:15 am, was vaccinated IM in the left deltoid with a 0.5 ml second dose of Gardasil (lot # 655324/0089U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 06-AUG-2007 at approximately 9:30 am, the patient experienced increased left arm pain and was unable to lift the left arm completely, muscle spasms in her arm along with numbness and tingling in her fingers.  She had alternated heat and cold application to the injection site.  She had massaged her arm with "icy hot gel and Jergens lotion."  On 15-AUG-2007 at 10:11 am, she telephoned the office and at 3:15 pm, the patient was examined in the office.  It was reported no redness or swelling.  The patient was referred to a neurologist of further evaluation.  The patient's symptoms persisted.  No laboratory or diagnostic tests were performed.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Reaction to previous exposure to any vaccine, Syncope
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with a history of syncope after injections who on 13-AUG-2007 was vaccinated with a first dose of Gardasil (lot# unknown).  Concomitant vaccinations included MENACTRA and Tdap (manufacturer unknown).  On 13-AUG-2007 the patient fainted.  The patient fully recovered and was sent on her way.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Nervousness, Vision blurred
Clinical narrative: Initial and follow-up information has been received from a physician and a health professional concerning a 17 year old female who on 08-AUG-2007 was vaccinated with a first dose of Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified). On 13-AUG-2007 the patient experienced dizziness, difficulty breathing and blurred vision.  Unspecified medical attention was sought.  At the time of the report, the status of the patient was unknown.  No laboratory or diagnostic tests were performed.  In follow-up the health professional reported that the physician did not believe the patient's symptoms were related to the vaccination with an onset of at least 3 days after the vaccination and were not reported to a health professional until one week following the vaccination.  The physician reported that the patient is a "nervous" person who may have "exaggerated" the experience.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count, Injection site mass, Injection site nodule
Clinical narrative: Information has been received from a registered nurse concerning a 16 female, with no pertinent medical history, who on 19-DEC-2006 was vaccinated IM with a 0.5 ml dose of Gardasil (lot # 653938/0954F).  There was no concomitant medication.  Subsequently 5 weeks after her second dose the patient developed a right upper arm mass at the injection site.  She was seen by an orthopedic physician who diagnosed the mass as a granuloma.  The orthopedic physician reported that the vaccine was "self contained" in the granuloma.  The patient had a complete blood cell count (results not reported).  Subsequently, the patient recovered.  At the time of the report, the patient has not had the third dose.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site mass
Clinical narrative: Information has been received from a physician concerning a 25 year old female who on an unspecified date was vaccinated subcutaneously with a second dose of Gardasil.  On 24-JUL-2007 the patient developed an injection site bump that lasted about 3-4 days.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on 14-AUG-2007 was vaccinated with a first dose of Gardasil (658094/0524U). Concomitant vaccination given on the same day included BOOSTRIX and MENACTRA. On 14-AUG-2007 the patient experienced syncope. Unspecified medical attention was sought. On 14-AUg-2007 the patient recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female with a history of syncope and fatigability of knees and no drug reactions/allergies who on 26-JUL-2007 was vaccinated with a first dose of Gardasil (655503/0012U expiry date 13-JUN-2009) in the left arm at 3:30 PM.  Concomitant therapy included MENACTRA.  On 26-JUL-2007 during the vaccination the patient was sitting.  There was no illness at the time of the vaccination.  After receiving the vaccination, as she stood up at approximately 3:35PM the patient buckled at the knees and fainted.  The healthcare professional helped the patient to the floor carefully as the patient was fainting and made sure the patient remained conscious and called in the physician.  The patient's vitals were taken and sat the patient up.  The patient (athlete) reported that she had not eaten all day.  The patient was given a trail mix bar and juice and was retained in the office for 20 minutes.  Follow-up was made the following day.  The patient did not seek medical attention.  On 26-JUL-2007 the patient had recovered.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia, Urine human chorionic gonadotropin negative
Clinical narrative: Information has been received from a licensed practical nurse concerning her 15 year old daughter who was vaccinated with a first dose of Gardasil. Subsequently the patient developed a heavier than normal menstrual period. A urine pregnancy test was performed before the vaccination, and the patient was not pregnant. Unspecified medical attention was sought. At the time of the report the patient's second menstrual cycle returned to normal. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Muscle rigidity, Tremor
Clinical narrative: Information has been received from a medical assistant concerning a 15 year old female with no pertinent medical history who on 15-AUG-2007 was vaccinated intramuscularly with a 0.5ml first dose of Gardasil (Lot # 658490/0802U).  There was no concomitant medication.  On 15-AUG-2007 the patient experienced shaking and became rigid and blacked out.  Unspecified medical attention was sought.  There was no laboratory or diagnostic tests performed.  On 15-AUG-2007 the patient recovered.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MEN
Symptoms: Inappropriate schedule of drug administration, Injection site irritation, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old female with no drug allergies and no medical history, who on 15-AUG-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot# 655620/0171U). Concomitant vaccinations included DTaP and meningococcal vaccine (unspecified). On 15-AUG-2007 the patient experienced pain and burning during administration. The pain lasted for 30 minutes after receiving the vaccination. The patient sought unspecified medical attention. No laboratory diagnostics were performed. On 15-AUG-2007 the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Mass, Skin warm
Clinical narrative: Information has been received from a physician concerning a 15 year old female, who on 10-MAR-2007 was vaccinated in her left arm with a first dose of Gardasil (Lot# 653735/0688F).  Concomitant suspect vaccination included Varivax (dose not reported) administered subcutaneously in her left arm.  Other concomitant vaccination included HAVRIX administered in her right arm.  On 10-MAR-2007 the patient developed a warm tennis ball size lump in her arm apparently from shoulder to elbow.  The patient was treated with ice and MOTRIN.  The patient recovered on an unspecified date.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow up information has been received from a physician concerning a 15 year old female student with asthma, stress, and incontinence, who on 10-MAR-2007 at 10:00 was vaccinated intramuscularly in her left arm with a second dose (also reported as a first dose) of GARDASIL (Lot# 658558/1061U) (also reported as Lot# 653735/0688F). Concomitant suspect vaccination included a second dose of VARIVAX (Lot# 656125/1312F) (MSD) administered at 10:00 subcutaneously in her left arm. Other concomitant vaccination included a first dose of HAVRIX (Lot# AHAVB162BA) administered at 10:00 intramuscularly in her right arm. There were no illnesses at the time of the vaccination. On 11-MAR-2007 at 10:00 (previously reported as 10-MAR-2007 and 12-MAR-2007 at 08:30) the patient developed a warm tennis ball size lump in her arm apparently from shoulder to elbow. Also reported a 4 cm reddened, hard area at injection site in left arm. The patient also developed redness that extended to her elbow, tenderness, and some swelling in her arm. The patient was treated with ice and MOTRIN. No laboratory diagnostics were performed. The patient's symptoms lasted one week. On 14-MAR-2007 (also reported as 17-MAR-2007) the patient recovered. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Nausea, Visual disturbance
Clinical narrative: Information has been received from a medical assistant concerning a 15 year old female with no drug allergies and no medical history, who on 15-AUG-2007 was vaccinated in the left arm with a second dose of Gardasil. The first dose was given on 20-JUN-2007. There was no concomitant medication. Shortly after receiving the vaccination at 09:15am the patient felt "queasy." The patient was directed to sit down and the only observation was that the patient was "clammy." The patient reported a short period of "loss of vision", but the healthcare worker stated that she had her eyes closed. The patient never lost consciousness, and after 10 minutes, she was treated with an ice pack and some juice (the patient never ate breakfast) the patient felt fine and left the office. No laboratory diagnostic were performed. On 15-AUG-2007 the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female with no drug allergies and no medical history, who on 14-MAY-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot# 657621/0387U).  Concomitant therapy included ORTHO TRI-CYCLEN.  Several weeks after the first dose, on 23-JUL-2007 the patient developed a generalized rash.  On 30-JUL-2007 the patient was vaccinated in the left deltoid with a second dose of GARDASIL (Lot# 658490/0802U).  No laboratory diagnostics were performed.  The patient sought unspecified medical attention.  At the time of the report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 9/17/2007. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Disorientation, Dizziness, Fatigue, Nausea
Clinical narrative: Initial and folluw-up information has been received from a physician concerning a 26 year old white female with a history of Infectious mononucleosis, and genital herpes, who on 19-FEB-2007 was vaccinated with a 0.5mL first dose of Gardasil.  On 17-APR-2007 the patient was vaccinated intramuscularly in the right deltoid with a second dose of Gardasil.  There were no illnesses at the time of the vaccination.  On 17-APR-2007 (also reported on 18-APR-2007) the patient felt disoriented, "out of sorts", weak, nauseous, dizzy, and fatigue for three weeks after the second Gardasil vaccine.  The patient sought unspecified medical attention.  After approximately three weeks, the patient recovered.  No laboratory diagnostics were performed.  After approximately three weeks, the patient recovered spontaneously. No product quality complaint was involved.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning an 18 year old female, who, on 30-JUL-2007 at 11:35, was vaccinated intramuscularly in the right arm with a first dose of Gardasil (Lot# 657868/0523U) (previously reported as lot # 0523U,  which was a valid lot # for Varivax (Oka/Merck). On 15-AUG-2007 at 12:04, the patient got vagal. Subsequently, the patient fainted after administration and "passed out" for 30 seconds.  It was unknown if the office used a single dose vial or a pre-filled syringe. The patient's blood pressure was 102/70. The patient stayed at the office for 25 minutes and was given fluids. The patient's blood pressure was then 110/60. The patient stated that "she does this all the time." The patient did not seek medical attention. It was noted that the patient was not pregnant at the time.  The patient recovered and was fine before leaving the office.  No product quality complaint was involved.  Additional information has been requested. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Laboratory test
Clinical narrative: Initial and follow-up information has been received from an Urgent Care physician concerning an 11 year old female who on 09-AUG-2007 was vaccinated IM in the left arm with a 0.5ml first dose of Gardasil.  Concomitant vaccination in the right arm included Tdap.  On 09-AUG-2007 the left deltoid muscle was enlarged, induration, tender and had redness tracked to mid to upper arm.  On 12-AUG-2007 the patient was seen in the Urgent Care with an enlarged, indurated, tender, red and blanched arm.  Laboratory data revealed white blood cell count was 6.6, absolute granulocyte count was 3.9, lymphocyte count was 2.4, and urine pH was 200.  The physician was concerned that the injection infiltrated the subcutaneous tissue.  The physician reported there were no fever or chills.  The injection site was treated with ice and nonsteroidal anti-inflammatory drug (unspecified).  The physician recommended follow-up with her primary care physician.  At the time of the report, the outcome was unknown.  Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Lymphocyte count normal, Pallor, White blood cell count normal, pH urine abnormal
Clinical narrative: Initial and follow-up information has been received from an Urgent Care physician concerning an 11 year old female who on 09-AUG-2007 was vaccinated IM in the left arm with a 0.5ml first dose of Gardasil.  Concomitant vaccination in the right arm included Tdap.  On 09-AUG-2007 the left deltoid muscle was enlarged, induration, tender and had redness tracked to mid to upper arm.  On 12-AUG-2007 the patient was seen in the Urgent Care with an enlarged, indurated, tender, red and blanched arm.  Laboratory data revealed white blood cell count was 6.6, absolute granulocyte count was 3.9, lymphocyte count was 2.4, and urine pH was 200.  The physician was concerned that the injection infiltrated the subcutaneous tissue.  The physician reported there were no fever or chills.  The injection site was treated with ice and nonsteroidal anti-inflammatory drug (unspecified).  The physician recommended follow-up with her primary care physician.  At the time of the report, the outcome was unknown.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female with a fever at the time of vaccination who a few months ago was vaccinated with a 0.5 ml first dose of Gardasil.  There was no concomitant medication.  Subsequently the patient fainted.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with a dose of Gardasil.  Concomitant therapy included "multiple vaccinations" given on the same day.  Five minutes after receiving the vaccine, the patient experienced syncope.   Unspecified medical attention was sought.  Subsequently, the patient recovered quickly.  No product quality complaint was involved.  Additional information has been requested. 02/23/2010 Follow up information from the physician states that her patients have had not adverse effects. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with a second dose of Gardasil.  Subsequently, the patient experienced significant pain around the injection site which lasted for a week or longer after receiving the vaccine.  Unspecified medical attention was sought.  It was also reported that the same reaction occurred after the first dose of Gardasil.  No product quality complaint was involved.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Condition aggravated, Diarrhoea, Laboratory test normal
Clinical narrative: Information has been received from a registered nurse and a father concerning his 18 year old daughter with a history of "something related to irritable bowel syndrome" and "gastrointestinal problems" over the last 10 years who on 24-JUL-2007 was vaccinated IM with a first 0.5 ml dose of Gardasil.  Concomitant therapy included LOESTRIN.  On 10-AUG-2007 the patient experienced severe abdominal pain and diarrhea.  It was reported that she experienced pain when she was "up and moving around" but not when she was laying down.  On 13-AUG-2007 the patient went to the emergency room .  There she received a "gastrointestinal work-up" that was reported as normal.  The patient was not admitted to the hospital.  The patient's severe abdominal pain and diarrhea persisted.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Chills, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 19 year old female who on an unspecified date was vaccinated with a first dose of Gardasil (lot # 653938/0954F).  On an unspecified date the patient was vaccinated with a second dose of Gardasil (lot # 655617/1447F).  On 12-JUL-2007 the patient was vaccinated IM with a third dose of Gardasil (lot # 658100/0525U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 12-JUL-2007 the patient experienced a fever of 102 F and chills.  Unspecified medical attention was sought.  On an unspecified date, the patient recovered from fever and chills.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia oral
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who on approximately 10-AUG-2007, was vaccinated with a 0.5mL first dose of Gardasil.  Subsequently, the patient experienced a numb tongue.  The patient sought unspecified medical attention.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 15 year old female patient with no pertinent medical history, who on 16-AUG-2007 was vaccinated with the first dose of Gardasil (Lot #658490/0802U).  There was no concomitant medication.  On 16-AUG-2007, after the vaccination and while the patient was leaving the office, she fainted.  The physician called the "rescue squad," however, the patient was not taken to the hospital.  She was monitored and then released to home.  The patient recovered on the same day, 16-AUG-2007.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Genital discomfort, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a mother concerning her 21 year old daughter with no pertinent medical history, who in June 2007, was vaccinated with a 0.5 ml first dose of GARDASIL.  There was no concomitant medication.  Subsequently, the patient experienced uncomfortable feeling in genital area.  On 06-AUG-2007 the patient had a cervical smear that reported the presence of papilloma viral infection.  On 15-AUG-2007 the patient was vaccinated with a second dose of GARDASIL.  The patient's papilloma viral infection persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning 1 female patient who on an unspecified date was vaccinated with Gardasil (lot#'s unknown) 0.5 mL injection and fainted.  Medical attention was sought.  At the time of reporting it was unknown if the patient had recovered.  No additional information was provided.  No further information is available.  This report is one of two reports from the same source.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Information has been received from a physician concerning a 23 year old female with no pertinent medical history, who on 03-APR-2007 was vaccinated IM with a first dose of Gardasil (lot # 655322/0092U).  On 15-JUN-2007 was vaccinated IM with a second dose of Gardasil (lot # 0210U).  Concomitant therapy included hormonal contraceptives (unspecified).  On approximately 15-JUL-2007 the patient experienced migraine headache.  The patient was evaluated by a neurologist.  At the time of the report, the status was unknown.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a physician concerning a 23 year old female with migraines, who on 03-APR-2007 was vaccinated IM with a first dose of GARDASIL (lot # 655322/0092U). On 15-JUN-2007 the patient was vaccinated IM with a second dose of GARDASIL (lot # 0210U). Concomitant therapy included YASMIN. On approximately 15-JUL-2007 the patient experienced a migraine headache. It was reported that the patient experienced her first migraine followed by nausea caused by flashing lights for several minutes during her junior year of college every week lasting several hours for one month and sought no medical attention at that time. Since then the patient did not experience a migraine until receiving her first dose of GARDASIL. The patient reported that she experienced migraines in early April 2007 that lasted 4 to 5 hours, then every 1 to 2 weeks until early July 2007. It was noted that the patient was under severe stress at work. The patient was evaluated by a neurologist and no prescription was given. The neurologist advised the patient that she was having migraines. It was reported that the patient was under significant stress at that time. The patient had not experienced a migraine headache since early July 2007 but was concerned that the migraines were caused by the vaccination. At the time of the report, the status was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a pharmacist concerning her 17 year old daughter with no pertinent medical history, who on 17-JUL-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil.  There was no concomitant medication.  On 19-JUL-2007 the patient experienced tingling in her hands and feet.  On 22-JUL-2007, the patient recovered from tingling in hands and feet.  The patient did not seek medical attention spontaneously.  No laboratory or diagnostic tests were performed.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea, Neck pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a first dose of GARDASIL.  Subsequently, right after the vaccination the patient experienced pain in vaccinated arm, pain in chest, pain in neck, and shortness of breath.  Unspecified medical attention was sought.  The symptoms lasted a few days and then the patient recovered.  On an unspecified date was vaccinated with a second dose of GARDASIL.  Subsequently, right after the vaccination the patient experienced pain in vaccinated arm, pain in chest, pain in neck, and shortness of breath.  Unspecified medical attention was sought.  The symptoms lasted a few days and then the patient recovered.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a physician conderning a 16 year old female student with allergic rhinitis, who, on 21-FEB-2007, was vaccinated intramuscularly in the left detoid with a first dose of GARDASIL (Lot# 65410/0962F). There were no illnesses at the time of the vaccination. On 21-FEB-2007 right after the vaccination the patient experienced pain in vaccinated arm, pain in chest, pain in neck, and shortness of breathe that lasted a few minutes as shot was given and removed. It was reported that there was no wheezing. Unspecified medical attention was sought. No laboratory diagnostics were performed. The patient recovered right after the shot was given (previously reported as the symptoms lasted a few days and then the patient recovered). On 30- APR-2007, the patient was vaccinated intramuscularly in the left deltoid with a second dose of GARDASIL (Lot# 657736/0389U). There were no illness at the time of the vaccination. On 30-APR-2007 right after the vaccination the patient experienced pain in vaccinated arm, pain in chest, pain in neck, and shortness of breath that lasted a few minutes as shot was given and removed. It was reported that there was no wheezing. Unspecified right after shot was given (previously reported as the symptoms lasted a few days and then the patient recovered). Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 13 year old female patient who on 06-AUG-2007 was vaccinated with a second dose of Gardasil lot #657868/0523U.  The reporter mentioned that patient developed an extended menstrual period after vaccination with the second dose of Gardasil.  No further information known at this time.  Patient's mother contacted the doctor's office for the event.  The outcome was unknown.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Immediate post-injection reaction, Pallor, Presyncope
Clinical narrative: Initial and follow up information has been received from a health professional concerning a 20 year old female patient who on 16-AUG-2007, at 09:00 AM was vaccinated IM in to left deltoid with a first dose of Gardasil lot #658094/0524U.  The reporter reported that about 2 minutes after at 09:05 AM she became dizzy with a near syncope episode.  She became pale and her skin became clammy.  She was assisted to put her head between knees and applied a cool compress to her forehead and back of the neck.  She regained color.  Patient mentioned that she felt "normal".  Additional information is not expected.