chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Dizziness, Fatigue
Clinical narrative: Information has been received from a certified medical assistant concerning two patients (age and sex not reported) who were vaccinated with Gardasil.  Subsequently, the patients experienced dizziness and fatigue.  The outcome of the events was not reported.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 19 year old female, who, on an unspecified date was vaccinated with a 0.5mL second dose of Gardasil.  Subsequently the patient fainted.  The patient sought unspecified medical attention.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood pressure, Syncope
Clinical narrative: Information has been received from a physician concerning an "11 or 12" year old female who on "13-AUG-2007 or 14-AUG-2007" was vaccinated intramuscularly with the first dose of Gardasil.  Concomitant vaccination included Varivax, MENACTRA and Tdap.  The physician reported that the patient fainted less than ten minutes after receiving the vaccine.  Blood pressure and vital signs were measured (results not provided) and it was reported that the patient was fine shortly afterwards and subsequently recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse concerning her 15 year old daughter who on unspecified dates was vaccinated with the first and second doses of Gardasil (0.5 ml).  Subsequently, following the second dose, the patient broke out in hives on her legs.  Medical attention was sought and the patient was treated with BENADRYL and the symptoms cleared up.  It was reported that the patient did not have this experience after the first dose.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hepatic enzyme abnormal, Laboratory test normal, Liver function test abnormal
Clinical narrative: Information has been received from a physician concerning a female who on 29-MAY-2007 was vaccinated with Gardasil.  On 20-JUN-2007, lab work was done as part of a regular check-up, and transient elevated liver enzymes was noted.  It was reported that the rest of the lab work was normal, and there was no elevation in bilirubin.  The patient was re-tested 3 weeks later, and all results were normal.  The patient was reported to be fine.  Additional information has been requested.  This is one of two reports from the same source.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who in approximately June 2007, was vaccinated with Gardasil (0.5 ml).  The patient subsequently experienced pain at the injection site following the vaccination.  At the time of this report, the injection site pain persisted.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter who in June 2007, was vaccinated with a first dose of Gardasil.  On 16-AUG-2007, the patient was vaccinated with intramuscularly with a 0.5 mL dose of Gardasil.  Concomitant therapy included SYNTHROID, ALLEGRA, DORYX, and YAZ.  On 16-AUG-2007, post vaccination, the patient felt dizzy and fainted.  The patient sought unspecified medical attention.  Subsequently, the patient recovered on 16-AUG-2007.  The patient's mother also reported that the patient "couldn't calm down after vaccination with MMR II (Enders Edmonston, Jeryl Lynn, Wistar RA 27/3) (manufacturer unknown) or DTP as a baby." (WAES 0709USA01120).  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Gaze palsy, Tremor
Clinical narrative: Information has been received from a physician concerning a 17 year old female with a history of fainting when given vaccines and when blood was drawn and asthmas who on 14-AUG-2007 was vaccinated intramuscularly in the right arm with a 0.5 mL first dose of GARDASIL (lot 655849/0263U). There was no concomitant medication. On 14-AUG-2007, post vaccination, the patient experienced shaking of her upper extremities, her eyes rolled back, and her head was shaking for a couple of seconds. The patient had a loss of consciousness for a couple of seconds. Loss of urine and post ictal were both negative. The patient sought unspecified medical attention. After a few minutes, the patient recovered. The patient had an EEG. Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Anxiety, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female between the ages of 11 and 14 years old, who, on an unspecified date, was vaccinated with a dose of Gardasil.  Concomitant vaccinations on the same day were reported as "several other vaccines."  Subsequently the patient experienced "lots of anxiety and passed out within 2 minutes of being vaccinated."  The patient sought unspecified medical attention.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information is not expected.
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age unknown) with a "dreadful" fear of needles since she was a little girl, who on 15-AUG-2007 was vaccinated with a first dose of Gardasil.  Concomitant vaccinations included hepatitis A virus vaccine (unspecified), MENACTRA and ADACEL.  On 15-AUG-2007, after all doses of vaccinations were administered, the patient fainted.  The patient sought unspecified medical attention.  On 15-AUG-2007 the patient recovered and left the office after a short period of time.  No product quality complaint was involved.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash generalised
Clinical narrative: Information has been received from a medical technologist concerning a 26 year old female with an allergy to CEFTIN who on 15-AUG-2007 was vaccinated intramuscularly with a 0.5 ml dose of Gardasil (lot 657872/0515U).  The patient was concomitantly administered DEPO-PROVERA on 15-AUG-2007.  During the evening of 15-AUG-2007, the patient developed a rash all over her body with itching.  The patient contacted the office and was advised by the physician to take two BENADRYL.  The patient recovered on the morning of 16-AUG-2007.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. The patient had no difficulty breathing or swallowing. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Fungal infection, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a 22 year old female with amoxicillin allergy and no medical history who on 12-JUL-2007 was vaccinated IM with a first 0.5 ml dose of Gardasil (lot# 657736/0389U).  Concomitant therapy included TRINESSA.  On 14-JUL-2007, the patient experienced prolonged soreness in her arm.  It was noted that the patient did not have a lump at the injection site just soreness and pain and it was not constant.  It pained her when she moved her hand up and down.  The patient began to take DIFLUCAN for a yeast infection (onset date unknown).  At the time of this report, the patient had not recovered from soreness and pain in her arm and the outcome of yeast infection was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 16-AUG-2007 was vaccinated with Gardasil.  Concomitant therapy included Tdap and MENACTRA.  On 16-AUG-2007 the patient fainted.  Unspecified medical attention was sought.  On 16-AUG-2007, the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: HEPA, HPV4, MMR, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a physician's assistant (PA), via a company representative, concerning a female patient (age not specified), who on an unknown date was vaccinated with a dose of Gardasil.  Concomitant therapy at the same visit included MENACTRA, VAQTA (MSD), and MMR (MSD).  The PA reported that after Gardasil was administered, the patient fainted.  The PA helped her to lie down for "awhile."  The patient recovered on the same day, "before leaving the office."  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site haemorrhage, Medical device complication, Underdose
Clinical narrative: Initial and follow up information has been received from a healthcare professional (HCP), concerning a female patient (age not specified), who was vaccinated on an unknown date with a dose of Gardasil.  As the vaccine administrator gave the injection, the "prefilled Gardasil syringe misfired when the spring malfunctioned, leaking the Gardasil fluid."  The reporter felt that the patient may have received an incomplete dose of the vaccine.  Follow up information from the HCP indicated that the patient's mother had called the doctor's office to report that her daughter "had bleeding from the injection site for the entire day of vaccination."  The HCP stated that the staff was not aware of any bleeding when the patient left the office on the day of vaccination, and did not feel it was related to the prefilled syringe.  The patient sought unspecified medical attention.  This report involved a product quality complaint (SR 1-980720378).  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Swelling
Clinical narrative: Information has been received by a registered nurse concerning a 22 year old female, who on 13-AUG-2007 was vaccinated with a dose of Gardasil (Lot# 657621/0387U).  There was no concomitant medication.  On 14-AUG-2007 the patient was treated with BENADRYL and was continuing to take it by prescription.  On 14-AUG-2007 the patient developed a rash and external swelling throughout the body.  On 15-AUG-2007 and 16-AUG-2007 the patient saw a doctor.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female, who, on an unspecified date, was vaccinated with a dose of Gardasil (Lot # 655165/1425F or 658488/0930U).  Subsequently the patient fainted after administration (also reported as the patient "didn't completely faint, but was close to it").  The patient recovered on an unspecified date without incident after sitting in the office.  She went home without complication.  This is one of 3 reports from the same source.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Depressed level of consciousness, Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse, via a company representative, concerning a 20 year old female patient, who on approximately 17-JUN-2007 ("two months ago") was vaccinated with the first dose, 0.5ml, of Gardasil.  On 17-JUN-2007, the patient fainted following the vaccination. On 17-AUG-2007, the patient was vaccinated with the second dose, 0.5ml, of Gardasil, and again fainted following the vaccination.  The nurse stated "it was difficult to bring her out of it," but confirmed that after being awakened, the patient fully recovered and walked out of the office.  She added that the episodes lasted "a few minutes."  The patient sought unspecified medical attention.  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 registered nurse and a licensed practical nurse (LPN), concerning a 20 year old female student with no known allergies and no previous history of fainting with other injections, who on 14-JUN-2007 was vaccinated with the first dose, 0.5ml, of GARDASIL (lot #657622/0388U). There was no illness at the time of vacination. Following the vaccination she fainted, and was observed by the staff for "at least 30 minutes," with vital signs reported as stable. On 06-AUG-2007 (previously reported as 17-AUG-2007), the patient was vaccinated with the second dose, 0.5ml, of GARDASIL (lot #657868/0523U), and again fainted following the vaccination. The RN indicated that the patient "came out of it almost immediately." However, the LPN who administered the vaccine stated that the episodes lasted "a few minutes," and added that it was difficult to bring her out of it." The RN stated that the patient was again observed for at least 30 minutes with stable vital signs. The patient fully recovered and walked out of the office. The patient sought unspecified medical attention. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female who on 16-AUG-2007 was vaccinated with a third dose of Gardasil.  On 16-AUG-2007 the patient experienced dizziness and passed out for 10 seconds while still in the office.  The patient was given some juice.  On 16-AUG-2007 the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil.  Subsequently the patient's test results showed positive for HPV.  Unspecified medical attention was sought.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a father concerning his daughter who was vaccinated with a 0.5 ml second dose of Gardasil.  Subsequently the patient has been "getting dizzy".  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia, Urine human chorionic gonadotropin negative
Clinical narrative: Information has been received from a licensed practical nurse concerning a colleague's 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: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia, Oligomenorrhoea, Urine human chorionic gonadotropin negative
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 year old female who on 26-JUL-2007 was vaccinated with a second dose of Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified).  Subsequently the patient experienced a menstrual period that was two weeks long and much heavier than usual.  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 outcome was unknown.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Immediate post-injection reaction, Suture insertion, Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female, who on 15-AUG-2007 was vaccinated with a first dose of Gardasil.  Concomitant suspect vaccination included hepatitis A vaccine (inactive) (MSD) (dose not reported).  A few minutes after receiving Gardasil the patient fainted.  She hit her head during the fall and had to get 3 stitches.  On 15-AUG-2007 the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 17-AUG-2007 was vaccinated with a 0.5 ml third dose of Gardasil.  Suspect vaccination on 17-AUG-2007 included varicella virus vaccine live (MSD).  Other concomitant vaccination included a dose of MENACTRA.  On 17-AUG-2007 the patient fainted.  Unspecified medical attention was sought.  On 17-AUG-2007 the patient recovered.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Loss of consciousness, Tremor
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who was vaccinated with a first 0.5ml dose of Gardasil (Lot# 658490/0802U).  Concomitant therapy included MENACTRA.  After receiving the vaccine, the patient experienced dizziness and passed out for a couple of minutes.  Upon awakening, the patient experienced shaking.  Unspecified medical attention was sought.  Subsequently, the patient had recovered.  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. Information has been received from a physician concerning a 14 year old white female patient with no medical history who was vaccinated into the left deltoid with a first 0.5ml dose of GARDASIL (Lot# 658090/0802U). Concomitant therapy included MENACTRA. After receiving the vaccine, the patient experienced dizziness and fell forward. She was caught by the medical assistant. It was reported that she "came to" within seconds and has no memory of the incident. Laboratory diagnostic studies included blood pressure measurements. The patient's initial blood pressure was 90/60, after having apple juice it was 110/60. On 06-AUG-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Influenza like illness, Nausea, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female who on 23-JUL-2007 was vaccinated with a first dose of Gardasil (lot# unknown) IM.  Concomitant therapy included hormonal contraceptives (unspecified), TRAMADOLOR, baclofen, EFFEXOR XR and AMBIEN.  On 23-JUL-2007 following vaccination with GARDASIL the patient developed nausea, vomiting, flu-like symptoms and fatigue.  The patient did not seek medical attention.  On an unspecified date the patient recovered from nausea, vomiting and flu-like symptoms.  On 25-JUL-2007 the patient recovered from fatigue following the injection.  No further information was provided.  Additional information has been requested. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Methicillin-resistant staphylococcal aureus test positive, Road traffic accident, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received for the Pregnancy Registry for Gardasil from a nurse concerning a 17 year old female patient with sulfonamide allergy (rash) who on 15-JAN-2007 was vaccinated with a first dose of Gardasil.  The nurse reported that the patient completed the Gardasil series was found to be pregnant on 09-AUG-2007 when she was admitted to the emergency room due to a car accident.  Her urine test was positive for pregnancy in the emergency room.  No other details were available.  The outcome was unknown.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a mother concerning her 16 year old daughter with coeliac disease and lactose allergic reaction who on 16-AUG-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil.  Concomitant therapy included ADDERALL TABLETS.  On 17-AUG-2007 the patient experienced nausea and dizziness.  Unspecified medical attention was sought.  The patient's nausea and dizziness persisted.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Flatulence, Injection site pain, Nausea, Pyrexia, Viral infection
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 14 year old female patient, who on an unknown date was vaccinated with a first dose of Gardasil. It was reported that the patient experienced pain at the injection site after her first dose of the vaccine.  On 13-AUG-2007 (previously reported as 12-AUG-2007) at 16:20, the patient was vaccinated intramuscularly in the left arm with a second dose of Gardasil (Lot# 657872/0515U). On 17-AUG-2007 at 10:40 (previously reported as 16-AUG-2007), the patient experienced a low grade fever, pain, nausea, vomiting and flatulence. It was reported that the symptoms were believed to have been a viral infection as other family members had the same signs and symptoms about 1 week later. No medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. On 26-NOV-2007 the patient was vaccinated with a third dose of GARDASIL. The patient did not experience a reaction to the third dose. Additional information has been requested. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 14 year old female patient, who on an unknown date was vaccinated with a first dose of Gardasil. It was reported that the patient experienced pain at the injection site after her first dose of the vaccine.  On 13-AUG-2007 (previously reported as 12-AUG-2007) at 16:20, the patient was vaccinated intramuscularly in the left arm with a second dose of Gardasil (Lot# 657872/0515U). On 17-AUG-2007 at 10:40 (previously reported as 16-AUG-2007), the patient experienced a low grade fever, pain, nausea, vomiting and flatulence. It was reported that the symptoms were believed to have been a viral infection as other family members had the same signs and symptoms about 1 week later. No medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. On 26-NOV-2007 the patient was vaccinated with a third dose of GARDASIL. The patient did not experience a reaction to the third dose. Additional information has been requested. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 17 year old female patient who on 26-JUN-2007 was vaccinated IM in deltoid with Gardasil lot #0469U.  Concomitant therapy included ORTHO TRI-CYCLEN LO.  The patient developed hair loss after the vaccination.  The patient saw a dermatologist who said the hair was growing back underneath.  No further information was available.  The patient was recovering.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 14 year old female with asthma who on 23-APR-2007 was vaccinated with a second dose of Gardasil dose of (lot 657617/0384U). Concomitant therapy included albuterol. On 24-APR-2007, the patient experienced numbness, pain, and weakness down both of her arms. The patient stayed home from school for three days. The patient did not seek medical attention. On 27-APR-2007, the patient recovered. On 17-AUG-2007, the patient was seen by the physician to receive the third dose of Gardasil. The patient's mother discussed with the physician the patient's experienced after the second dose of Gardasil, and the physician decided not to continue with the rest of the series. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope vasovagal
Clinical narrative: Information has been received from a registered nurse concerning a "20 to 25% of female patients who were vaccinated intramuscularly (IM) with Gardasil. Subsequently, "in the past few months" (reported on 20-AU-2007), the patients had vasovagal reactions. The nurse reported that these patients were mostly in their teens and older. All patients were fine after about 10 minutes of lying down. The patient sought/received medical attention while in the office. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information 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 registered nurse that she did not have an exact number of patients who had a vasovagal reaction. The office did not keep a list. The registered nurse listed the following Lot numbers related to the Gardasil vaccine and the vasovagal reactions; 657737/0522U, 658222/0927U and "03884".
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Initial and follow-up information has been received from a registered nurse and a medical assistant concerning about 20 female patients who "within the last month," in approximately August 2007, were vaccinated with Gardasil. Immediately after receiving the Gardasil vaccinations the patients experienced pain at the injection site. These were not all first dose cases as the patients were all at different staging doses in the series. The medical assistant reported that when they first started giving the vaccine, they received no complaints. But as the girls were coming back for their second and third doses as well as the patients when received the first dose of Gardasil, they were complaining of pain. Subsequently the patients recovered. On 23-AUG-2007 the medical assistant reported that she could not provided any additional patient details or lot number of the Gardasil. 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.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Skin disorder, Skin warm
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with a first dose of Gardasil (lot# unknown). Concomitant therapy included bupropion HCl (WELLBUTRIN) and ethinyl estradiol/norgestimate (ORTHO TRI CYCLEN). On an unspecified date the patient was vaccinated with a second dose of Gardasil (lot# unknown) injection. The patient developed injection site redness, a knot under the skin was hot to the touch. Medical attention was sought. At the time of reporting it was unknown if the patient had recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 31-MAY-2007 was vaccinated with Gardasil (lot# 657737/0522U) injection. Concomitant vaccination included (Menactra). On 31-MAY-2007 the patient fainted after after receiving Gardasil. Medical attention was sought. On 31-MAY-2007 the patient recovered. No additional information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Feeling abnormal, Somnolence
Clinical narrative: Information has been received from a consumer, concerning her daughter (age not specified) with no known allergies, who on an unknown date was vaccinated with the first dose of Gardasil (Lot # not provided). The mother reported that after her daughter went home, she complained of "not feeling right," and was weak and sleepy. Her daughter did not require treatment, and recovered after 3 days. The mother reported that 2 months later, the pediatrician decided not to administer the second dose of Gardasil. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, UNK, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a physician's assistant (PA), via a company representative, concerning her 17 year old daughter, who on an unknown date was vaccinated with the first dose of Gardasil (Lot # not specified). Concomitant therapy included (VARIVAX) (MSD) and an additional unspecified vaccine. The PA stated that her daughter, "after receiving her first dose of (Gardasil) fainted." At the time of this report, her daughter had recovered (duration and date not specified). The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Initial and follow up information has been received from a physician concerning a 16 year old female who on approximately 07-AUG-2007 was vaccinated with the first dose of Gardasil (Lot# not provided). The physician reported that 10 minutes post vaccination the patient developed a severe headache. The physician reported that when the patient arrived at the office she had not eaten that day and they gave her something to eat (not specified) prior to giving her the vaccination. Subsequently, on an unspecified date the patient recovered from the severe headache. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a pharmacist concerning a female who on 15-AUG-2007 was vaccinated with a dose of Gardasil (lot# 657005/0314U). On 15-AUG-2007, after the vaccination, the patient felt faint and nauseous. At the time of the report, the outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a mother concerning her 16 year old daughter with no pertinent medical history and no drug reaction or allergies who in July 2007, was vaccinated with the first dose of Gardasil. Concomitant therapy included fexodenadine hydrochloride (+) pseudoephedrine hydrochloride (ALLEGRA-D). The patient's mother reported that her daughter fainted after receiving her first dose of Gardasil in July 2007. It was reported by the patient's mother that her daughter had never fainted before this incident. The lot number was not available. The patient sought unspecified medical attention. At the time of the report, the patient had recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who in February 2007, was vaccinated with a first dose of Gardasil. On 19-APR-2007, the patient was vaccinated intramuscularly with a 0.5 mL second dose of Gardasil. During the first dose of post vaccination with Gardasil, the patient developed a low grade fever (measurements not reported), nausea and vomiting. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Information has been received from a physician concerning a female who on approximately 13-AUG-2007, "about a week ago," was vaccinated with the first dose of Gardasil. On 20-AUG-2007, the patient developed a hard knot on her arm at injection site. The patient sought unspecified medical attention. At the time of this report, the patient was not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with idiopathic thrombocytopenia purpura, eczema, penicillin allergy and a drug hypersensitivity to nitrofurantoin (macrobid) (shortness of breath, systemic reaction) who on 27-JUN-2007 was vaccinated IM with 0.5 mL first dose of Gardasil (Lot#657737/0522U). Concomitant therapy included eythinyl estradiol/norgestimate (ORTHO TRI CYCLEN) and ranitidine HCl (ZANTAC). 7-10 days post vaccination on approximately 04-JUL-2007 the patient experienced an injection site reaction. The symptoms were described as a raised injection site, abouth the size of a half dollar. The patient reported that a day and a half later (date not specified) the reaction resolved. The patient reported the event to the nurse following the appointment. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abortion induced, Drug exposure during pregnancy, Ultrasound scan
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with acne with a history of 0 pregnancies and 0 live births who on 31-JUL-2007 was vaccinated IM with the first dose of with Gardasil included benzoyl peroxide (+) clindamycin phosphate (BENZACLIN), gel BID for the treatment of acne. On 15-AUG-2007 the patient experienced abdominal pain and an ultrasound was performed which confirmed a pregnancy. it was believed that the patient was 7 weeks pregnant and that her due date was 01-APR-2008. At the time of this report it was unknown if the patient had recovered from the abdominal pain. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007.  Follow up information was received from the nurse which stated that on 24-AUG-2007 the patient had an elective abortion.  Additional information was not provided.  At the time of the report the patient had recovered from the event.  Upon internal medical review the elective abortion was considered to be an other medical event.  Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Facial palsy, Hypoaesthesia, Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 32 year old female who on 07-MAR-2007 was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #0211U) and a second dose on 30-MAY-2007. On 18-AUG-2007 the patient began to experience neurological disturbances, generalized swelling of the body, drooping of her face, numbness of her hands, pain in her fingers, pain in her joints and abnormal thought processes. The patient called the doctor. As of 20-AUG-2007 the patient had not yet recovered. Additional information has been requested. 10/29/07-rcords received for DOS 3/7-10/11/07-Seen for routine exam and on 3/29 and 4/4/07- for breast biopsy. 8/20/07-seeing neurologist for C/O swollen face, drooping, numbness of fingers. Myalgias, arthralgias. 9/5/07-continues with neuro symptoms. Guillain-Barre has been rulled out. DX possible autoimmune syndrome with selective malabsorption.  11/7/07-neuro consult records received for DOS 8/16/07-Impression: Symptoms of paresthesia all over, unsure of etiology. Sensory-type seizure is possible.Complex partial seizures may also be possible explanation for transient episode of confusion. Neurological examination is nonfocal.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling, Thinking abnormal
Clinical narrative: Information has been received from a physician concerning a 32 year old female who on 07-MAR-2007 was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #0211U) and a second dose on 30-MAY-2007. On 18-AUG-2007 the patient began to experience neurological disturbances, generalized swelling of the body, drooping of her face, numbness of her hands, pain in her fingers, pain in her joints and abnormal thought processes. The patient called the doctor. As of 20-AUG-2007 the patient had not yet recovered. Additional information has been requested. 10/29/07-rcords received for DOS 3/7-10/11/07-Seen for routine exam and on 3/29 and 4/4/07- for breast biopsy. 8/20/07-seeing neurologist for C/O swollen face, drooping, numbness of fingers. Myalgias, arthralgias. 9/5/07-continues with neuro symptoms. Guillain-Barre has been rulled out. DX possible autoimmune syndrome with selective malabsorption.  11/7/07-neuro consult records received for DOS 8/16/07-Impression: Symptoms of paresthesia all over, unsure of etiology. Sensory-type seizure is possible.Complex partial seizures may also be possible explanation for transient episode of confusion. Neurological examination is nonfocal.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who on an unspecified date was vaccinated with a dose of Gardasil (lot# 658282/0929U).  On an unspecified date the patient felt dizzy after receiving Gardasil.  The patient laid down for a "few minutes" and felt better.  No further information was provided.  Additional information is not expected.  This report is one of two reports.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a 0.5 ml first dose of Gardasil.  Subsequently the patient experienced hair loss.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 17 year old female patient, who on an unknown date was vaccinated with the first dose of Gardasil.  Concomitant therapy at the visit included MENACTRA and ADACEL.  The physician stated that the patient passed out twice after receiving the Gardasil.  She first passed out in the exam room, and then 10 minutes later she passed out again as she was walking to the bathroom.  The patient's systolic blood pressure was recorded as 60mmHg, and the staff "could not get a reading for the bottom number."  The staff called 911, and the patient was taken to the emergency room, where she was tested and released on the same day.  At the time of this report, the patient had recovered from the events.  Additional information has been requested. This is in follow-up to reports: previously submitted on 9/17/2007. Initial and follow up information has been received from a physician and a registered nurse, concerning a 17 year old female student, with no pertinent medical conditions, who on 10-JUL-2007, at approximately 10:30 am, was vaccinated IM in the arm with the first dose of GARDASIL (lot #655165/1425F). Concomitant vaccine therapy at the visit included the first dose, IM in the arm, of MENACTRA (lot #V2062AA) and the first dose, IM in the arm, of ADACEL (lot #AC524P12AA). There was no illness at the time of vaccination. The physician stated that the patient passed out twice after receiving the GARDASIL vaccine. She first passed out in the exam room, and was laid down for a few minutes. Then 10 minutes later, after she got up, she passed again as she was walking to the bathroom. The patient's systolic blood pressure was recorded as 60 mmHg and the staff "could not get a reading for the bottom number." The staff called 911 and the patient was taken to the emergency room, where she was treated and released on the same day, 30-JUL-2007, and had recovered from the events. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Eyelid oedema, Rash
Clinical narrative: Information has been received from a pharmacist, concerning a female patient (age not specified), with a sulfonamide allergy, who on 13-AUG-2007 was vaccinated with a dose of Gardasil (Lot # not provided).  Concomitant therapy included ORTHO TRI-CYCLEN.  On approximately 17-AUG-2007 (possibly 18-AUG-2007) the patient developed a rash on her abdomen and lower legs, and had a swollen eye.  The patient was given BENADRYL, and instructed to go to the emergency room.  At the time of this report, the patient had not recovered.  Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Herpes zoster, Rash, Wrong drug administered
Clinical narrative: This is in follow-up to report(s) previously submitted on 9/17/2007. Information has been received from a 76 year old female consumer who on 29-JAN-2007 was vaccinated with Gardasil.  The patient reported that she had asked her physician if there was a vaccine for shingles.  The physician stated that one was recommended for her age and the patient was subsequently vaccinated with Gardasil.  On 11-JUL-2007, while on a cruise, the patient experienced "terrible pain" in her back.  On 13-JUL-2007, the patient broke out in a rash.  On 14-JUL-2007, the patient went to the hospital and was told she had shingles.  The patient informed the physician that she received a vaccine "not to get shingles".  The patient reported that the event "ruined 4 days of her 8 day cruise".  The patient subsequently had four visits to her physician and medication to treat the shingles.  At the time of this report, the patient had not recovered.  No further information is available. It has been determined that WAES # 0708USA03786 is a duplicate of WAES # 0708USA02052, therefore WAES # 0708USA03786 is being deleted from our files and the reports consolidated into WAES # 0708USA02052.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: Information has been received from a physician concerning a 20 year old female with no pertinent medical history who on 17-AUG-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (658222/0927U).  There was no concomitant medication.  On 17-AUG-2007 the patient developed shortness of breath, coughing, and wheezing and contacted a physician.  There were no laboratory or diagnostic testes performed.  At the time of the report the patient had not recovered.  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 20 year old female with no pertinent medical history who on 17-AUG-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (658222/0927U). There was no concomitant medication. On 20-AUG-2007 in the evening the patient developed shortness of breath, coughing, and wheezing that persisted over the weekend. She contacted a physician. There were no laboratory or diagnostic tests performed. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test, Allergy to plants, Blood immunoglobulin G increased, Discomfort, Dysphagia
Clinical narrative: Information has been received from a physician concerning his 22 year old daughter with an allergy to "Kombuka" who on approximately 28-DEC-2006 was vaccinated with a first dose of Gardasil.  There were no concomitant medications.  On approximately 04-JAN-2007 within a week of vaccination the patient developed an oral food reaction while eating mussels.  Symptoms were described as discomfort at the back of the throat, itchiness, feeling as if the tongue was swelling, and difficulty swallowing.  It was noted that the tongue did not actually swell.  The patient was treated with BENADRYL.  Subsequently the patient recovered.  On 17-AUG-2007 the patient was vaccinated with a third dose of Gardasil.  Subsequently, the patient developed similar symptoms of tightening of the upper throat, discomfort, and flu-like symptoms.  The patient was treated with BENADRYL.  Subsequently, 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 concerning his 22 year old daughter with an allergy ot "Kombuka", unspecified food and pollen who on approximately 28-DEC-2006 was vaccinated with a first dose of GARDASIL.  There were no concomitant medication.  On approximately 04-JAN-2007 within a week of vaccination the patient developed an oral food reaction while eating mussels.  Symptoms were described as discomfort at the back of the throat, itchiness, feeling as if the tongue was swelling, and difficulty swalling.  It was noted that the tongue did not actually swell.  The patient was treated with BENADRYL. Subsequently the patient recovered.  On an unspecified date the patient was vaccinated with a second dose of GARDASIL.  Subsequently, the patient had a milder similar reaction and recovered.  On 17-AUG-2007 the patient was vaccinated with a third dose of GARDASIL.  Subsequenlty, the patient developed similar symptoms of difficulty swallowing, flushing and dizziness.  The episodes were self limited lasting 30-60 minutes occuring approximately 4-5 times over two weeks.  It was unrelated to other counts.  The patient was treated with oral BENADRYL and may have had a positive or negative response.  It was reported that the reactions were milder and similar to the reactions after the first and second doses.  It was thought to be a food allergy but probably wasn't.  The patient had 5 physicians visits:  2 primary care physician (PCP) visits, 2 allergist visits and and 1 ears nose and thoat (ENT) visit.  At the time fo the report the patient's outcome was unknown.  Additional information is not expected.