chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Rash
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 18 year old female with unspecified allergies and acne and a history of chickenpox and eczema, who on 15-MAY-2007 at 17:25 was vaccinated IM into the left deltoid with a second 0.5 ml dose of GARDASIL (lot# 657736/0389U). Concomitant therapy included hormonal contraceptives (unspecified). On 17-MAY-2007, the patient developed a small fine rash. It was reported that on 15-MAR-2007, the patient received a first dose of Gardasil and did not experience any adverse event. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first 0.5 ml dose of Gardasil. Two days later, the patient developed a full body rash. The patient's full body rash persisted. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning an 11 year old female who was vaccinated with GARDASIL. It was reported that the patient passed out 'almost immediately" after receiving the vaccine. No lot number was provided. The patient sought unspecified medical attention. The patient had her blood pressure measured. It was reported that the "patient was fine". Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007. In follow-up it was reported by the registered nurse concerning an 11 year old, female, with no illness a the time of the vaccination and no pre-existing allergies, birth defects, or medical conditions, who on 16-APR-2007 at 10:00 a.m., was vaccinated in the left deltoid muscle with the first dose of GARDASIL, (Lot # 657005/0314U). It was reported tht immediately after receiving the immunization the patient had a syncopal episode. The patient's mother and the nurse caught the patient before she hit the ground. The patient was pale and diaphoratic, blood pressure was 84/57 mmHg. The patient was put in the Trendelenburg position. The patient's blood pressure rose to 96/54 mmHg. The patient walked out after 10 minutes. It was reported that the patient recovered on 16-APR-2007. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Information has been received from an approximately 34 year old female with an allergy to artificial sweeteners who on an unspecified dates, was vaccinated with the first and second doses of Gardasil. The date that therapy was started was "about 6 months prior to receiving the third dose. On 04-APR-2007, the patient was vaccinated with the third dose of vaccine by injection. Concomitant therapy included Yasmin. On an unspecified date, the patient experienced muscle soreness after being vaccinated. On 21-MAY-2007, all three injection sites became visible. The patient thought it might be due to being out in the sun and being involved in physical activity. She sought unspecified medical attention. At the time of reporting, the patient was recovering. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a nurse practitioner, concerning her friend's daughter, an adolescent female who was vaccinated (date and dose not specified) with a dose of Gardasil. Following the vaccination, the adolescent experienced a headache which lasted about 2 hours. No further information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a physician concerning a female with drug hypersensitivity to codeine who on 09-MAY-2007 was vaccinated with Gardasil. Concomitant therapy included Seasonale. In May 2007, the patient experienced left shoulder pain. An MRI showed that there was a focal fluid collected along the facial plane at the deltoid and infraspinatus muscle. The patient was treated with Advil and Aleve. The patient had begun to get some relief on 22-MAY-2007 but the pain had not resolved. No further details were provided. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a 23 year old female with drug hypersensitivity to codeine who on 09-MAY-2007 was vaccinated with a second dose of GARDASIL in the left deltoid. Concomitant therapy included SEASONALE. No illness at the time of the vaccination was specified. On 09-MAY-2007, the patient experienced left shoulder/deltoid pain. On 18-MAY-2007, an MRI showed that there was a focal fluid collected along the facial plane at the deltoid and infraspinatus muscle. The physician reported "that the MRI was reviewed with a radiologist and fluid collection appears to be edema, not blood, not infection/abscess". The patient was treated with ADVIL with no help and ALEVE with little help. The patient had begun to get some relief on 22-MAY-2007 but the pain had not resolved. The patient was to start physical therapy (date unspecified). The physician reported that the event may be related to the patient's recent GARDASIL. No further details were provided. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site discomfort, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 21 year old female who on 19-APR-2007 was vaccinated with Gardasil (Lot#657622/0388U). On 19-APR-2007 the patient experienced deep muscle pain, her arm still hurts and she cannot lift her arm to dress. It was reported that the patient sought unspecified medical attention. No further details were provided. Follow up information provided by a medical professional stated that on 02-MAY-2007 the patient had daily discomfort only in her deltoid where the injection had been given. At the time of this report it was reported that the patient had not recovered from the discomfort. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, No adverse effect
Clinical narrative: Information has been received from a physician and the consumer for the Pregnancy Registry for Gardasil concerning a 17 year old female with no pertinent medical history or drug reactions/allergies who on 20-MAR-2007 was vaccinated with first dose of Gardasil (lot number unknown) 0.5 mL injection. Concomitant therapy included vitamins (unspecified). The patient found out that she became pregnant on 25-MAR-2007. The patient sought medical attention. No ill effects were reported at this time. the estimated date of delivery is 30-DEC-2007. No further details were provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 09-FEB-2007 was vaccinated with Gardasil (Lot #655205/1426F). On 27-APR-2007 the patient received her second dose of Gardasil (Lot #655619/1427F) which was given in her left upper arm. Concomitant therapy included medroxyprogesterone acetate (DEPE-PROVERA) which was given to the patient on 27-APR-2007 in the right arm. It was reported that the patient did not experience any adverse effects with the first dose of the vaccine of Gardasil. However, on approximately 01-MAY-2007 the patient experienced warmth, pain and hardness at the injection site where Gardasil was given. It was reported that the patient sought unspecified medical attention. No further details were provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Urine human chorionic gonadotropin negative
Clinical narrative: Information has been received from a medical assistant concerning herself who was vaccinated with two doses of Gardasil. Subsequently she experienced amenorrhea after each of the 2 doses of Gardasil she received. The first time the patient didn't have her menses for 6 to 8 weeks and now she has not had her menses since her most recent injection in April 2007. The patient took home pregnancy tests both times and was not pregnant. Lot number was not provided. It was reported that the patient sought unspecified medical attention. The patient has not recovered. No further details were provided. The medical assistant also reported that another patient had a similar experience which is reported in WAES # 0705USA04921. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from an office manager concerning about 20-30 females who were vaccinated with Gardasil and have complained about injection site pain. Medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female with a history of fainting who was vaccinated with the first dose of Gardasil and fainted. Medical attention was sought. Additional information has been requested. 10/08/2007 Information has been received from a physician concerning a female patient with a history of fainting with shots who was vaccinated with a first dose of GARDASIL. After getting the vaccination the patient fainted. Unspecified medical attention was sought. It was reported that the patient told the physician she would faint in advance of getting the vaccine. It was stated that she "always faints with shots". At the time of this report the patient recovered. No product quality complaint was involved. The reporter felt that fainted was "not an adverse event from GARDASIL". Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Information has been received from two nurses concerning a 20 year old female patient who was vaccinated with a first dose of Gardasil.  The patient experienced pain in the injection site right after receiving her injection.  The pain lasted approximately 1 hour following the injection.  No medical treatment was sought.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature, Dizziness, Dizziness, Loss of consciousness, Nausea
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated IM with the second dose of Gardasil. Subsequently the patient passed out within 5-10 minutes after receiving the vaccine. The patient went up to the circulation desk to pay before leaving and made it to the parking lot. The physician reported that the patient began to feel some nausea and dizziness so she came back into the physician's office. It was unclear as to when and where the patient passed out. The physician reported that they had taken the patient's blood pressure and let her rest while back in the office and someone came to pick her up . The patient's outcome was not reported. Medical attention was sought. Additional information has been requested. 10/06/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning an 18 year old female with no prior history of drug reactions who was vaccinated intramuscularly into the left deltoid on 07-MAY-2007 at 09:15 AM with the second dose of GARDASIL. Subsequently, the patient passed out within 5-10 minutes after receiving the vaccine. The patient went up to the circulation desk to pay before leaving and made it to the parking lot. The physician reported that the patient began to feel some nausea and dizziness so she came back into the physician's office. It was unclear as to when and where the patient passed out. The physician reported that they had taken the patient's blood pressure and let her rest while back in the office and someone came to pick her up. Medical attention was sought. In additional information received on 11-JUL-2007, the attending physician reported that the patient felt dizzy and lightheaded secondary to the vaccine. Her blood pressure was stable and temperature was OK. On 07-MAY-2007, the patient recovered from the nausea, dizziness, syncope, and being lightheaded. No further information is expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pruritus, Swelling
Clinical narrative: Information has been received from a physician concerning a 20 year old female who in May 2007 was vaccinated with 0.5 ml of the third dose of Gardasil. The patient experienced injection site was red, swollen, and puffed up about a half an inch. The reaction went away about 72 hours after the injection. Medical attention was sought. Additional information has been requested. 10/08/2007 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning her 22 year old daughter with an allergy to chocolate, who on 17-MAY-2007, was vaccinated intramuscularly in the left deltoid with 0.5 ml third dose of GARDASIL (Lot# 657622/0388U). The patient developed a penny size of redness, swelling, and itching that lasted approximately four to five days post vaccination (also reported as 72 hours post vaccination). The patient sought unspecified medical attention. No lab diagnostic studies were taken and there were no illnesses at the time of vaccination. The patient recovered on 21-MAY-2007. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Abdominal pain upper
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with 0.5 ml of Gardasil. subsequently the patient experienced stomach pain after receiving the vaccine. The patient's outcome was not reported. Medical attention was sought. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fall, Syncope
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female who on 21-MAR-2007 at 3:30 pm was vaccinated with 0.5 ml of the first dose of Gardasil (Lot #653736/0014U) in right deltoid. Concomitant therapy on 21-MAR-2007 at 3:30 pm included MENACTRA (lot # U2228AA) in right deltoid, and BOOSTRIX (lot # C2638AA) in left deltoid. On 21-MAR-2007, at 3:30 pm (previously reported as 10 to 15 minutes after vaccination) the patient experienced fainting. On 21-MAR-2007, the patient recovered from fainting. Additional information is not expected. 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 registered nurse concerning an 18 year old female who on 21-MAR-2007 at 3:30 pm was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot #653736/0014U) in right deltoid. Concomitant therapy on 21-MAR-2007 at 3:31 pm included MENACTRA (lot # U2228AA) in right deltoid, and at 3:32 pm included BOOSTRIX (lot # C2638AA) in left deltoid. After the injections were administered, the patient voiced no difficulties, denied discomfort, and no abnormalities in appearance were observed. The patient walked 10 yards to the front reception desk. She visited as paperwork was being completed while she stood at the counter. On 21-MAR-2007, at 3:37 pm (previously reported as 10 to 15 minutes after vaccination) the patient slid onto the floor with syncope. On 21-MAR-2007, the patient recovered from fainting. After syncope went to doctor's office for previously scheduled appointment with no problems upon exam. A telephone call was made later to the patient later that evening with no residual effects. The patient's mother has telephoned to schedule the patient's second GARDASIL injection. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 20 year old female who in approximately April 2007, was vaccinated with a dose of Gardasil.  In approximately April 2007, the patient experienced syncope when receiving the vaccination.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: DTAP, HPV4, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a female with no known allergies who was vaccinated with a dose of Gardasil, Varivax (MSD), MENACTRA and DTaP.  Subsequently, the patient experienced syncope that lasted two to three minutes.  It was reported that the patient required no treatment, hospitalization or resuscitation and had no illness at the time of vaccination.  The patient was recovered.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Somnolence
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old white female student with no pertinent medical history who on 13-MAR-2007 was vaccinated intramuscularly, into the left deltoid, with a second dose of Gardasil (lot #).  On 15-MAR-2007 the patient developed a rash on her face, she "wanted to sleep all day and for some reason wanted to cry."  Unspecified medical attention was sought.  On approximately 18-MAR-2007, the patient recovered.  There were no laboratory or diagnostic tests performed.  It was noted that the night before the second dose of Gardasil was administered, the patient had eaten shellfish.  Although there was no history of shellfish allergy, there was a family history of shellfish allergy.  No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Mood swings
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of Gardasil.  Subsequently, the patient experienced mood swings after receiving the vaccine.  At the time of this report the patient's outcome was unknown.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Laceration, Suture insertion, Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old female with a history of ear tube surgery as a child and with no known drug allergies who on 08-MAY-2007 was vaccinated IM with a first 0.5 ml dose of Gardasil (Lot# 654540/1161F). The patient fainted 7 to 10 minutes after receiving the vaccine and sustained a laceration of her lower lip. The laceration was repaired in the office by placement of 4 sutures. On 14-MAY-2007, the sutures were removed, the laceration was completely healed without complication and the patient fully recovered. No laboratory diagnostic studies were performed. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This is in follow-up report(s) previously submitted on 6/14/2007. Information has been received from a registered nurse concerning a 19 year old female who in December 2006, was vaccinated with her second dose of Gardasil (lot number unknown). Subsequently the patient experienced pain at the injection site for 1 week after her vaccination.  There was no treatment required.  Subsequently, the patient recovered.  Additional information has been requested. No further information was available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Drug exposure during pregnancy, Laboratory test, Nausea, Ultrasound abdomen
Clinical narrative: Information has been received through a pregnancy registry from two licensed practical nurses concerning a 21 year old female with asthma and type II diabetes mellitus who on 23-MAR-2007 was vaccinated with the first dose of Gardasil (lot #655618/0186U).  On 18-APR-2007 the patient had a positive pregnancy test.  The patient was vaccinated with the second dose on 23-MAY-2007 Gardasil (lot #657617/0384U).  (It was also reported that this was the patients first dose).  Concomitant therapy included prenatal vitamins (unspecified) and folic acid.  Subsequently, on 23-MAY-2007 within one hour of the vaccine, the patient experienced dizziness, nausea and vomiting.  The patient was prescribed promethazine hydrochloride (PHENERGAN) and symptoms are resolving.  Patient had prenatal blood work and abdominal ultrasound, results not reported.  The patient is pregnant with twins.  The last menstrual period was 26-FEB-2007 with estimated delivery date is 03-DEC-2007.  (The last menstrual period was also reported as 03-MAR-2007).  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received through a pregnancy registry from two licensed practical nurses concerning a 21 year old female with asthma and type II diabetes mellitus who on 23-MAR-2007 was vaccinated with the first dose of Gardasil (lot #655618/0186U).  On 18-APR-2007 the patient had a positive pregnancy test.  The patient was vaccinated with the second dose on 23-MAY-2007 Gardasil (lot #657617/0384U).  (It was also reported that this was the patients first dose).  Concomitant therapy included prenatal vitamins (unspecified) and folic acid.  Subsequently, on 23-MAY-2007 within one hour of the vaccine, the patient experienced dizziness, nausea and vomiting.  The patient was prescribed promethazine hydrochloride (PHENERGAN) and symptoms are resolving.  Patient had prenatal blood work and abdominal ultrasound, results not reported.  The patient is pregnant with twins.  The last menstrual period was 26-FEB-2007 with estimated delivery date is 03-DEC-2007.  (The last menstrual period was also reported as 03-MAR-2007).  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a licensed visiting nurse concerning a female who was vaccinated with Gardasil.  Subsequently the patient fainted after being vaccinated with Gardasil.  Subsequently the patient recovered.  Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Inappropriate schedule of drug administration, Influenza like illness
Clinical narrative: Information has been received from a 28 year old female consumer, who was vaccinated with the first dose (date unspecified) of Gardasil.  Subsequently she reported that she felt dizzy; the outcome of feeling dizzy was not provided.  The patient was later vaccinated with the second dose (date unspecified) of Gardasil and experienced flu-like symptoms.  She reported her symptoms had improved, though it was unknown if she had recovered at the time of this report.  The consumer refused to provide additional information.  No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a 22 year old female who was vaccinated with her first dose of Gardasil.  Subsequently the patient developed little bumps all over her body for a few days after the vaccination.  The outcome was not reported.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated IM with Gardasil (Lot # not reported). The patient experienced pain when Gardasil was administered. Additional information is not expected. This is one of several reports received from the same source.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a health professional concerning a 25 year old female with a history of seasonal allergy who on 16-MAY-2007 was vaccinated IM with Gardasil (Lot #656051/0244U).  Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ).  On 16-MAY-2007 the patient developed a lump at the injection site.  As of 23-MAY-2007, the patient had not recovered.  Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 10 year old female who on 22-MAY-2007 was vaccinated IM with 0.5 ml of the first dose of Gardasil.  Concomitant therapy included Varivax (MSD) and hepatitis A virus vaccine (unspecified).  On 22-MAY-2007 the patient experienced injection site redness, swelling and itching.  As of 23-MAY-2007, the patient had not recovered from her experience.  Medical attention was sought.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Sleep disorder
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a registered nurse concerning a 22 year old female with no illness at the time of being vaccinated and a history of an allergy to acetaminophen (+) hydrocodone bitartrate (VICODIN), headaches, and knee surgery who on 13-APR-2007 was vaccinated with a first dose of Gardasil (lot #657617/0384U) in the left arm in the morning. Concomitant therapy included JASMIN 28, and PROZAC. On 13-APR-2007, the patient experienced general pain at the injection site since the injection.  On 24-APR-2007, in the PM, the injection site became red and hot, "bubbled up".  The throbbing was waking her up.  The patient visited the office on 27-APR-2007.  On 27-APR-2007, there was no redness or lump or swelling noted; events resolved.  No further information is available. Additional information was received from a nurse practitioner. After the first dose of vaccine, the patient developed swelling of her left arm at the injection site "to the site of a softball" as per the patient. Medical attention was sought. The nurse practitioner saw the patient on 27-APR-2007 and her assessment was unremarkable. On 15-JUN-2007, the patient returned to the office for her second dose of GARDASIL (lot # 65786/0523U) 0.5 ml IM in the right arm and was observed after the injection. The patient began to complain of tingling in her right hand, and stiffness and tenderness at the right shoulder. At the time of reporting, the patient was recovering. No additional information was available at the time of reporting.
Sex: F
Vaccine: HPV4
Symptoms: Fungal infection, Vaginal discharge
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with the first dose of Gardasil.  Subsequently the patient experienced continuous vaginal discharge and symptoms of a yeast infection.  As of 23-MAY-2007, the patient had not recovered.  Medical attention was sought.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with the first dose of GARDASIL. Subsequently the patient expired breathing problems after the vaccine was administered. Subsequently, the patient recovered from the breathing problems after given Benadryl. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning her 12 year old daughter who was vaccinated with Gardasil. Concomitant therapy included Menactra. Within 24 hours post vaccination, the reporter indicated that her daughter developed swelling, warmth and redness at the injection site. The symptoms resolved within a week. Unspecified medical attention was sought. No other information was available. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 05-APR-2007 was vaccinated with Gardasil (Lot#654702/0011U). On 05-APR-2007 post vaccination the patient developed a red swollen arm. Unspecified medical attention was sought. Subsequently on 09-APR-2007 the patient recovered from the red swollen arm. Additional information has been requested. In follow-up it was reported from a physician concerning a 15 year old female student whose reported weight was 158  pounds and whose reported height was 66 3/4 inches who on 05-APR-2007 was vaccinated intramuscularly into the left arm with the first dose of GARDASIL vaccine (yeast) (Lot #654702/0023U). It was reorted that on 05-APR-2007, the patient developed left shoulder and upper arm swelling and pain which lasted for 3 days. The patient recovered on 09-APR-2007. It was reported that the patient recovered. No additional information is expected.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Injection site erythema, Injection site warmth, Skin lesion, Skin ulcer, Tenderness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female experienced injection site erythema, injection site warmth, skin ulcer and tenderness following vaccination with Gardasil. The patient experienced on the left deltoid site a 5 cm x 3  1/2 cm circular erythematous tender area that was warm to the touch, and a lesion that was very tender. No further information is available. The original reporting source was not provided. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Syncope
Clinical narrative: Information has been received from a nurse concerning an 18 year old female who on 09-MAY-2007 was vaccinated with the first dose of Gardasil (Lot # 657621/0387U). On 09-MAY-2007 the patient fainted after receiving the first dose of Gardasil. On 09-May-2007, the patient was apprehansive about getting a shot and she had two freinds with her for support. The patient received the injection and did fine, she sat in the exam room, then went out to the waiting room to wait 20 minutes with her freinds. The receptionist called for the nurse as the patient felt faint. The patient appeared pale and fainted while sitting in chair. A cold wet towel was placed on the patient's face and the patient woke up. The patient was taken back to an exam room and laid down. Her vital signs were taken and blood pressue was 80/40 and then 100/64. The patient was given pretzels and fluid. The nurse reported that the patient had not eaten that am. Subsequently on 09-May-2007, the patient recovered from fainting. Unspecified medical attention was sought. No additional information was provided. Additional information has been requested. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Hepatic enzyme increased, Syncope, Vomiting
Clinical narrative: Information has been received from a company representative as reported by a nurse concerning a female (age not reported) who in approximately May 2007 "within the last couple of weeks", was vaccinated with a dose of Gardasil (lot# not provided). In approximately May 2007 'within the last two weeks or so", the patient experienced vomiting and fainting after receiving the first dose of the vaccine. The patient was hospitalized for about 5 days. Liver enzyme tests were performed indicating that "she may have some liver enzyme elevation." The patient was complaining about GI upset. Subsequently the patient recovered. There was no product quality complaint involved. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with Gardasil. Subsequently the patient experienced amenorrhea. No further details were provided. The medical assistant also reported the same adverse experience for herself which was captured in WAES #0705USA04044. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with a history of asthma who was vaccinated with a first dose of Gardasil. Within twenty-four hours after receiving the vaccine, the patient experienced difficulty breathing. Unspecified medical attention was sought. At the time of this report the patient had recovered. It was reported that the patient will not complete the series. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a "couple of female patients" who were vaccinated with a 0.5 ml dose of Gardasil. Subsequently, the patients' experienced syncope. The nurse stated that the events were not reported because there were no adverse outcomes and most of the patients' had a history of fainting. Unspecified medical attention was sought. At the time of this report, the patients' recovered. No product quality complaint was involved. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning two females who were vaccinated with Gardasil. Subsequently the patients both developed fever and vomiting. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested. 07/06/07 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 concerning two females who were vaccinated with GARDASIL. Subsequently the patients both developed fever and vomiting. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. In follow up, it was reported by the physician's nurse that the patient was 14 years old and was vaccinated with her first dose of GARDASIL. The nurse was unsure how long the fever and vomiting lasted. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a 25 year old female patient with no medical history or allergies, who on 25-APR-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included Zovia 1/50E. It was noted the patient received the vaccine at another practice. On 18-MAY-2007, the patient experienced numbness in the left leg which spread to the left foot. The numbness has since spread to all of her extremities. The numbness was sporadic and there was no pattern to the numbness. The patient was examined by an internist (name unspecified) who has ordered blood tests (unspecified). At the time of this report the patient has not recovered. No product quality complaint was involved. The internist suspected that Gardasil may be responsible for the numbness. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Abscess, Dizziness, Erythema, Fasciitis
Clinical narrative: Information has been received from the mother of a consumer concerning her 15 year old daughter with an allergic reaction to Septra and an allergy to Suprax who on 06-DEC-2006 was vaccinated with Gardasil. Concomitant therapy included Augmentin and Flonase. On 06-DEC-2006 the patient experienced soreness at injection site for a day or two. In February 2007, the patient was vaccinated with her second dose and experienced soreness at injection site for a day or two. On 05-MAY-2007 the patient was vaccinated with her third dose of Gardasil. On 23-MAY-2007 the patient experienced swelling in the injection arm and tenderness in the injection arm. And on 24-MAY-2007 the patient's arm turned red. The patient's swelling and tenderness in the injection arm and reddened arm persisted. It was reported that the patient sought unspecified medical attention. No further details were provided. Additional information has been requested. This is in follow-up to report previously submitted on 5/24/2007. Information has been received from a mother concerning her 15 year old stundent daughter with no medical history or illness at the time of vaccination and with allergies to SEPTRA and SUPRAX who on 04-MAY-2007 was vaccinated intramusculary into the left deltoid with a third 0.5ml dose of GARDASIL (lot# 655617/ 1447F). It was noted that the patient received her first dose of GARDASIL on 06-DEC-2006 and experienced soreness at injection site for a day or two. In addition, the patient was vaccinated with her second dose of GARDASIL in February 2007 and experienced soreness at injection site for a day or two. Concomitant therapy included FLONASE. On 11-MAY-2007 the patient developed a stuffy nose, was dizzy and had an upset stomach. On 19-MAY-2007, the symptoms remained and AUGMENTIN 875 mg BID was prescribed. On 23-MAY-2007 the patient's arm turned red. On 25-MAY-2007, an MRI of the shoulder was preformed and showed cellulitis and fasciitis of the left deltoid with a focal myositis and early abscess. The patient was switched from AUGMENTIN to Clindamycin. On 27-MAY-2007, the patient recovered (also reported as "almost 100% resolution"). No product quality comlaint was involved. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site cellulitis, Injection site pain, Myositis, Nasal congestion, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from the mother of a consumer concerning her 15 year old daughter with an allergic reaction to Septra and an allergy to Suprax who on 06-DEC-2006 was vaccinated with Gardasil. Concomitant therapy included Augmentin and Flonase. On 06-DEC-2006 the patient experienced soreness at injection site for a day or two. In February 2007, the patient was vaccinated with her second dose and experienced soreness at injection site for a day or two. On 05-MAY-2007 the patient was vaccinated with her third dose of Gardasil. On 23-MAY-2007 the patient experienced swelling in the injection arm and tenderness in the injection arm. And on 24-MAY-2007 the patient's arm turned red. The patient's swelling and tenderness in the injection arm and reddened arm persisted. It was reported that the patient sought unspecified medical attention. No further details were provided. Additional information has been requested. This is in follow-up to report previously submitted on 5/24/2007. Information has been received from a mother concerning her 15 year old stundent daughter with no medical history or illness at the time of vaccination and with allergies to SEPTRA and SUPRAX who on 04-MAY-2007 was vaccinated intramusculary into the left deltoid with a third 0.5ml dose of GARDASIL (lot# 655617/ 1447F). It was noted that the patient received her first dose of GARDASIL on 06-DEC-2006 and experienced soreness at injection site for a day or two. In addition, the patient was vaccinated with her second dose of GARDASIL in February 2007 and experienced soreness at injection site for a day or two. Concomitant therapy included FLONASE. On 11-MAY-2007 the patient developed a stuffy nose, was dizzy and had an upset stomach. On 19-MAY-2007, the symptoms remained and AUGMENTIN 875 mg BID was prescribed. On 23-MAY-2007 the patient's arm turned red. On 25-MAY-2007, an MRI of the shoulder was preformed and showed cellulitis and fasciitis of the left deltoid with a focal myositis and early abscess. The patient was switched from AUGMENTIN to Clindamycin. On 27-MAY-2007, the patient recovered (also reported as "almost 100% resolution"). No product quality comlaint was involved. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling, Tenderness
Clinical narrative: Information has been received from the mother of a consumer concerning her 15 year old daughter with an allergic reaction to Septra and an allergy to Suprax who on 06-DEC-2006 was vaccinated with Gardasil. Concomitant therapy included Augmentin and Flonase. On 06-DEC-2006 the patient experienced soreness at injection site for a day or two. In February 2007, the patient was vaccinated with her second dose and experienced soreness at injection site for a day or two. On 05-MAY-2007 the patient was vaccinated with her third dose of Gardasil. On 23-MAY-2007 the patient experienced swelling in the injection arm and tenderness in the injection arm. And on 24-MAY-2007 the patient's arm turned red. The patient's swelling and tenderness in the injection arm and reddened arm persisted. It was reported that the patient sought unspecified medical attention. No further details were provided. Additional information has been requested. This is in follow-up to report previously submitted on 5/24/2007. Information has been received from a mother concerning her 15 year old stundent daughter with no medical history or illness at the time of vaccination and with allergies to SEPTRA and SUPRAX who on 04-MAY-2007 was vaccinated intramusculary into the left deltoid with a third 0.5ml dose of GARDASIL (lot# 655617/ 1447F). It was noted that the patient received her first dose of GARDASIL on 06-DEC-2006 and experienced soreness at injection site for a day or two. In addition, the patient was vaccinated with her second dose of GARDASIL in February 2007 and experienced soreness at injection site for a day or two. Concomitant therapy included FLONASE. On 11-MAY-2007 the patient developed a stuffy nose, was dizzy and had an upset stomach. On 19-MAY-2007, the symptoms remained and AUGMENTIN 875 mg BID was prescribed. On 23-MAY-2007 the patient's arm turned red. On 25-MAY-2007, an MRI of the shoulder was preformed and showed cellulitis and fasciitis of the left deltoid with a focal myositis and early abscess. The patient was switched from AUGMENTIN to Clindamycin. On 27-MAY-2007, the patient recovered (also reported as "almost 100% resolution"). No product quality comlaint was involved. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who in April 2007, was vaccinated with Gardasil. There was no concomitant medication. In April 2007, the patient fainted after receiving the vaccine. It was reported that the patient's blood pressure was taken. No further details were provided. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 19 year old female with a history of type I diabetes mellitus who on 17-MAY-2007 was vaccinated with Gardasil. Concomitant therapy included insulin. On 19-MAY-2007 the patient experienced vomiting. It was reported that the patient sought unspecified medical attention. Subsequently, the patient recovered from vomiting. No further details were provided. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 27-MAR-2007 was vaccinated with a first dose of Gardasil (lot not reported) and a second dose on 21-MAY-2007 (Lot# 657737/0522U). There were no concomitant medications. During this second injection on 21-MAY-2007 the patient experienced tingling and numbness in her arm immediately upon injection which continued for the rest of the day. It was her entire arm, but "not to the point of non-function". She needed no prescription treatment and subsequently recovered from tingling in arm and numbness in her arm. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a pharmacist and the patient's mother concerning a 12 year old female who on 29-JAN-2007 was vaccinated with the first dose of Gardasil. On 30-MAR-2007 the patient received a second dose of Gardasil. On 04-APR-2007 the patient was diagnosed with genital warts. The patient had no other symptoms. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pain in extremity, Paraesthesia, Paraesthesia oral
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 health professional and a physician concerning an 18 year old female patient with drug hypersensitivity to morphine, convulsion disorder, graves disase, bipolar disorder and anxiety who on 25-MAY-2007 at 7:30 am was vaccinated in left arm with a second dose of GARDASIL (lot # 0212U). One hour after the injection the patient experienced tingling of her right and left fingers, hands, lips and bridge of her nose and eyelids, left arm sorness, and headache. On 25-MAY-2007, the patient recovered from tingling of her right and left fingers, hands, lips, and bridge of her nose and eyelids, left arm sorness and headache.The patient sought unspecified medical attention. No further information is available. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated IM with Gardasil (date unknown). Three weeks after the patient received her second dose of Gardasil, she experienced numbness in her arms and legs and went to the hospital. It was not clear if the patient was admitted or not. However, at the hospital, the patient underwent testing. One test was described as a "drop test." During this test, the patient's arms were released from above her head and "it dropped on her face." Subsequently, the patient recovered from the numbness in her arms and legs. The physician noted that the patient was fine after she received her first dose of Gardasil. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hyperhidrosis
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated IM with Gardasil. Subsequently two to three days after the patient was vaccinated, she experienced a headache and sweating. The patient sought unspecified medical attention. This is one of several reports received from the same source. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Nausea, Pain
Clinical narrative: Information has been received from a healthcare worker concerning a 26 year old female with allergic reaction to Cipro who on 19-MAR-2007 was vaccinated with Gardasil 9Lot # 656049/0187U). Concomitant therapy included Estrostep and acne medication. On 19-MAR-2007 the patient experienced abdominal cramping, diarrhea, nausea, body aching and fatigue for 24 hours after receiving her first dose of the vaccine. The next day, 20-MAR-2007, the patient fully recovered from abdominal cramping, diarrhea, nausea, body aching and fatigue. Additional information has been requested.