chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female patient who in April 2009 was vaccinated with a dose of GARDASIL. On the same day, the patient was concomitantly vaccinated with tetanus toxoid. The patient fainted after administration of HPV vaccine and was observed for thirty minutes. Medical attention was sought by an office visit. The patient recovered from syncope. This report is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a physician concerning her niece who was vaccinated with the first dose of GARDASIL on an unspecified date. The patient had an adverse event (details of the adverse event unspecified by reporter). The father of the child called the physician and asked if she should receive additional doses. The physician stated not to continue the series. At the time of the report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on unspecified date was vaccinated with a dose of GARDASIL (lot # was not reported). The nurse reported that the patient experienced vomiting after getting a dose of GARDASIL. There is no further information about individual doses. The outcome of vomiting was unknown. The patient sought medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning an approximately 19 year old female patient who on an unspecified date was vaccinated with first dose of GARDASIL (lot # 661044/0548X) into left arm. On an unspecified date when the patient arrived at home she got "dizzy". The patient sought unspecified medical attention. At the time on the report on 10-AUG-2009 the patient had recovered. Follow up information was received from a physician concerning a female patient with sulfonamide allergy and prior reactions to pertussis vaccine who on 03-AUG-2009 was vaccinated with the first dose of GARDASIL (lot # 661044/0548X) intramuscularly. There were no concomitant medications reported. It was reported that on 04-AUG-2009 (24 hours after injection), the patient experienced dizziness. It was reported that the patient recovered on an unspecified date. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Rash
Clinical narrative: Information has been received from a medical assistant concerning a 18 year old patient with unspecified drug reactions/allergies, "bone disorder and immunocompromised" who in April 2008, was vaccinated with a first dose of GARDASIL (route, dose and lot number not reported). In "June 2008" the patient was vaccinated IM with 0.5 ml second dose of GARDASIL (lot number not reported). There was no concomitant medication. There was no adverse effect after first dose. The medical assistant reported that the patient developed "dry bumps across her forehead", "one week after the second dose of GARDASIL". The patient has been taking BENADRYL (manufacturer/description unknown). At the time of the report the outcome of the patient was recovering. The patient sought unspecified medical attention. The medical assistant contacted during telephone follow-up could not supply the following information: dates of vaccination/therapy, dose number, lot and date of event. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site anaesthesia, Injection site pain, Nausea, Paraesthesia, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old female patient with a history of abnormal papanicolaou smear prior to get the GARDASIL. On 20-AUG-2009 the patient was vaccinated with a dose of GARDASIL (lot #662519/0087Y). Concomitant therapy included CONCERTA (dose and indication unknown). The nurse practitioner reported that on approximately 23-AUG-2009 after the patient received GARDASIL in her left arm, the patient developed fever, the fever lasted for about 48 hours, she also had pain and numbness in her left arm from her shoulder to her elbow, she had nausea and vomiting for 48 hours, during which she vomited twice. The nurse practitioner reported that the patient's legs and toes were tingly for one day and also reported that the pain in her arm is gone now but she still had numbness off and on. The nurse practitioner reported that the patient developed a urinary tract infection and on 04-SEP-2009 the patient developed fever. The patient still had fever when she saw the nurse practitioner on 09-SEP-2009. Therapy with human papillomavirus vaccine was discontinued on an unknown date. At the time of this report the patient's outcome was recovered. The patient sought for unspecified medical attention. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old female patient with a history of abnormal papanicolaou smear prior to get the GARDASIL. On 20-AUG-2009 the patient was vaccinated with a dose of GARDASIL (lot #662519/0087Y). Concomitant therapy included CONCERTA (dose and indication unknown). The nurse practitioner reported that on approximately 23-AUG-2009 after the patient received GARDASIL in her left arm, the patient developed fever, the fever lasted for about 48 hours, she also had pain and numbness in her left arm from her shoulder to her elbow, she had nausea and vomiting for 48 hours, during which she vomited twice. The nurse practitioner reported that the patient's legs and toes were tingly for one day and also reported that the pain in her arm is gone now but she still had numbness off and on. The nurse practitioner reported that the patient developed a urinary tract infection and on 04-SEP-2009 the patient developed fever. The patient still had fever when she saw the nurse practitioner on 09-SEP-2009. Therapy with human papillomavirus vaccine was discontinued on an unknown date. At the time of this report the patient's outcome was recovered. The patient sought for unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient with no pertinent medical history reported and no known drug allergies/drug reactions who on 02-SEP-2009 was vaccinated IM with 0.5 ml dose of GARDASIL (lot number not reported) in the patient's arm. There was no concomitant medication. The physician reported that the patient complained of upper leg pain 30 minutes after receiving GARDASIL and her leg was warm and painful to the touch. The patient was directed to take MOTRIN. However the patient went to the emergency room (date not specified) but was not hospitalized. The symptoms resolved and the patient was released on an unspecified date. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Headache, Herpes zoster, Pyelonephritis
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female with penicillin allergy and no pertinent medical history who on 21-OCT-2008 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot# not reported). There was no concomitant medication. The patient was administered her third dose of GARDASIL on 20-JUL-2009. On 14-AUG-2009, a urine pregnancy test was performed and the patient was determined to be pregnant. No problems reported. Unspecified medical attention was sought. The patient's last menstrual period was 20-JUN-2009. Expected date of delivery was 27-MAR-2010. Follow up information has been received from a registered nurse concerning a 20 year old female patient with penicillin allergy and a history of preeclampsia in 2007 pregnancy and one full time delivery at 37 weeks gestation who on 21-OCT-2008, 12-FEB-2009 and 20-JUL-2009 was vaccinated IM with the first (lot# 661764/0650X), second (lot# 661952/1129X) and third (662300/0100Y) 0.5ml doses respectively of GARDASIL. An ultrasound was performed for dating on 25-AUG-2009 and it showed pregnancy at 6 weeks and 5 days gestation. A maternal serum Alpha-Fetoprotein Screening was performed on 02-NOV-2009, and the result was within normal limits (WNL). Follow up information from a register nurse indicated that on 09-APR-2010 (39 weeks from LMP), the patient delivered a normal male baby (6 lb 8 oz, 20 in length, head circumference 32 and APGAR score 9 at 1 minute /9 at 5 minutes). On 12-AUG-2009, 18-SEP-2009, and 29-DEC-2009, the patient experienced urinary tract infections and was treated with MACROBID. On 09-FEB-2010, the patient experienced shingles. On 29-DEC-2009 and 12-FEB-2010, the patient experienced pyelonephritis and was treated with BACTRIM. On 20-FEB-2010 the patient was treated with cephalexin for suppression. On an unspecified date, the patient experienced headache. On 23-NOV-2009, an ultrasound was performed and showed echogenic focus left ventricle. On 30-NOV-2009, a level II ultrasound was performed and the result was not provided. During the patient's pregnancy, on 05-OCT-2009, the patient was vaccinated with a dose of influenza virus vaccine. There was no complication during delivery. At the time of the report, the patient's status was unknown. The baby's experience has been captured in WAES# 0909USA01379B1. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan abnormal, Urinary tract infection, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female with penicillin allergy and no pertinent medical history who on 21-OCT-2008 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot# not reported). There was no concomitant medication. The patient was administered her third dose of GARDASIL on 20-JUL-2009. On 14-AUG-2009, a urine pregnancy test was performed and the patient was determined to be pregnant. No problems reported. Unspecified medical attention was sought. The patient's last menstrual period was 20-JUN-2009. Expected date of delivery was 27-MAR-2010. Follow up information has been received from a registered nurse concerning a 20 year old female patient with penicillin allergy and a history of preeclampsia in 2007 pregnancy and one full time delivery at 37 weeks gestation who on 21-OCT-2008, 12-FEB-2009 and 20-JUL-2009 was vaccinated IM with the first (lot# 661764/0650X), second (lot# 661952/1129X) and third (662300/0100Y) 0.5ml doses respectively of GARDASIL. An ultrasound was performed for dating on 25-AUG-2009 and it showed pregnancy at 6 weeks and 5 days gestation. A maternal serum Alpha-Fetoprotein Screening was performed on 02-NOV-2009, and the result was within normal limits (WNL). Follow up information from a register nurse indicated that on 09-APR-2010 (39 weeks from LMP), the patient delivered a normal male baby (6 lb 8 oz, 20 in length, head circumference 32 and APGAR score 9 at 1 minute /9 at 5 minutes). On 12-AUG-2009, 18-SEP-2009, and 29-DEC-2009, the patient experienced urinary tract infections and was treated with MACROBID. On 09-FEB-2010, the patient experienced shingles. On 29-DEC-2009 and 12-FEB-2010, the patient experienced pyelonephritis and was treated with BACTRIM. On 20-FEB-2010 the patient was treated with cephalexin for suppression. On an unspecified date, the patient experienced headache. On 23-NOV-2009, an ultrasound was performed and showed echogenic focus left ventricle. On 30-NOV-2009, a level II ultrasound was performed and the result was not provided. During the patient's pregnancy, on 05-OCT-2009, the patient was vaccinated with a dose of influenza virus vaccine. There was no complication during delivery. At the time of the report, the patient's status was unknown. The baby's experience has been captured in WAES# 0909USA01379B1. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL on an unspecified date. Subsequently the patient fainted two seconds after the needle was removed from the patient. The reporter felt that fainting two seconds after needle removed was not related to therapy with GARDASIL. Follow-up information has been received from a medical assistant concerning an 11 year old female who on 22-JUL-2009 was vaccinated with the first dose of GARDASIL (lot#661531/1311X). Concomitant vaccination on the same day included a dose of MENACTRA. It was reported that after the needle was removed, the patient fainted and slumped over onto the medical assistant. The patient came right to. It was noted that they waited for a little bit and then the doctor administered the MENACTRA. The medical assistant also reported that the patient's parent did not call back, so she assumed that the patient was okay, had recovered at the time of the report. Additional information has been requested. This is one of several reports from the same source.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Laboratory test normal, Muscle spasms, Muscle twitching, Nausea
Clinical narrative: Information has been received from an 18 year old female patient with allergic to codeine and not medical history who on 20-JUL-2009 was vaccinated with her first dose of GARDASIL. There was no concomitant medication. After getting the vaccine, the patient experienced dizziness and nausea that went away after the first couple of days. However recently she started experiencing pain in her side and muscle twitching/spasms throughout her body. The patient also lost weight and was very stressed. The patient stated that she was very nervous to receive the vaccine in the first place and had been nervous about possible side effects since. Her physician did not think it was due to the vaccine but rather from stress and prescribed LEXAPRO (manufacturer unspecified) on 10-AUG-2009. The physician also prescribed magnesium oxide (manufacturer unknown). Blood work test had been performed and everything came back normal. At the time of reporting, the patient had not recovered. Additional information has been received from the patient's friend who reported the patient experienced nausea after receiving GARDASIL and a week later she felt better. After recovering from the nausea, she started experiencing muscle spasms, shaking, pain in her "sides". The patient herself came on the line and stated that she went to see her doctor on 11-AUG-2009. Urine test had been performed, and everything was normal. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nervousness, Pain, Stress, Tremor, Urine analysis normal
Clinical narrative: Information has been received from an 18 year old female patient with allergic to codeine and not medical history who on 20-JUL-2009 was vaccinated with her first dose of GARDASIL. There was no concomitant medication. After getting the vaccine, the patient experienced dizziness and nausea that went away after the first couple of days. However recently she started experiencing pain in her side and muscle twitching/spasms throughout her body. The patient also lost weight and was very stressed. The patient stated that she was very nervous to receive the vaccine in the first place and had been nervous about possible side effects since. Her physician did not think it was due to the vaccine but rather from stress and prescribed LEXAPRO (manufacturer unspecified) on 10-AUG-2009. The physician also prescribed magnesium oxide (manufacturer unknown). Blood work test had been performed and everything came back normal. At the time of reporting, the patient had not recovered. Additional information has been received from the patient's friend who reported the patient experienced nausea after receiving GARDASIL and a week later she felt better. After recovering from the nausea, she started experiencing muscle spasms, shaking, pain in her "sides". The patient herself came on the line and stated that she went to see her doctor on 11-AUG-2009. Urine test had been performed, and everything was normal. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Weight decreased
Clinical narrative: Information has been received from an 18 year old female patient with allergic to codeine and not medical history who on 20-JUL-2009 was vaccinated with her first dose of GARDASIL. There was no concomitant medication. After getting the vaccine, the patient experienced dizziness and nausea that went away after the first couple of days. However recently she started experiencing pain in her side and muscle twitching/spasms throughout her body. The patient also lost weight and was very stressed. The patient stated that she was very nervous to receive the vaccine in the first place and had been nervous about possible side effects since. Her physician did not think it was due to the vaccine but rather from stress and prescribed LEXAPRO (manufacturer unspecified) on 10-AUG-2009. The physician also prescribed magnesium oxide (manufacturer unknown). Blood work test had been performed and everything came back normal. At the time of reporting, the patient had not recovered. Additional information has been received from the patient's friend who reported the patient experienced nausea after receiving GARDASIL and a week later she felt better. After recovering from the nausea, she started experiencing muscle spasms, shaking, pain in her "sides". The patient herself came on the line and stated that she went to see her doctor on 11-AUG-2009. Urine test had been performed, and everything was normal. No further information is available.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 04-AUG-2009 was vaccinated with the first dose of GARDASIL (lot number unknown) in her right arm. Concomitant therapy included MENACTRA and VAQTA (manufacturer unknown). On 05-AUG-2009 the patient experienced hives and rashes on various parts of body including her inner thighs. The hives and rashes were not at the injection site. The patient was not recovered. Unspecified medical attention was sought. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Lethargy, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 24 year old female with no pertinent medical history and no drug allergies who on 24-FEB-2009 and on 24-APR-2009 was vaccinated with the first and second doses of GARDASIL (lot#661952/1129X). There was no concomitant medication. "Two days after the second dose", on 26-APR-2009 the patient felt lethargic and dizzy. She did not seek medical attention. No lab diagnostics studies were performed. One week after the beginning of the symptoms, the patient recovered. Follow-up information has been received from a certified medical assistant who reported that at 1:30 PM on 24-APR-2009 the patient was vaccinated with the second dose of GARDASIL (lot#661952/1129X) IM in her deltoid. Two days after the vaccination, the patient developed vomiting, fatigue and dizziness. Medical attention was not sought. The patient recovered approximately one week later. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with no pertinent medical history and no drug allergy who on 18-MAY-2009 was vaccinated with the first dose of GARDASIL (lot# 0074). On 18-MAY-2009 after vaccination the patient has persistent aching in her left deltoid which is the area where she received the vaccination. She was seen in office and has been prescribed over the counter ibuprofen. No lab diagnostic studies were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 29 year old female with no pertinent medical history and no drug allergy who on 10-AUG-2009 was vaccinated with the first dose of GARDASIL (lot# 662300/0100Y). There was no concomitant medication. On 11-AUG-2009 after vaccination the patient has been experiencing fever and body aches. The patient had called the physician for medical attention. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. Follow-up information received from a medical assistant who reported that the patient also experienced vomiting for 1-2 days and was prescribed with TYLENOL. The patient's outcome was unknown because the patient hadn't called back or followed up with the office. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning an around 14 year old female who was vaccinated IM with her first dose of GARDASIL and then "passed out". After fifteen minutes, the patient recovered. The patient did not seek medical attention. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Weight increased
Clinical narrative: Information has been received from a 19 year old female with attention deficit disorder (ADD) who on 13-MAY-2008 was vaccinated with the first dose of GARDASIL (LOT # was not provided). Concomitant therapy included ADDERALL TABLETS. The results of blood work were unknown. The patient received her second dose in October 2008 and her third dose in February 2009. The patient experienced rapid weight gain (40 pounds) ever since she had her first dose of GARDASIL. The patient also mentioned they skipped a dose and started the process all over again. The outcome of the event was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Fatigue, Pregnancy test positive
Clinical narrative: Information has been received from a 26 year old female with no known drug reactions/allergies and a history of depression, for the Pregnancy Registry for GARDASIL (LOT # was not provided), who two years ago, in August 2007 was vaccinated with the first dose of GARDASIL and last week, on approximately 09-AUG-2009 received the second dose of GARDASIL. Concomitant therapy included WELLBUTRIN and "CONCETRA". On 12-AUG-2009 blood test of the patient came back positive for pregnancy. The patient's last menstrual period (LMP) was last month July 2009. The patient also reported that she had been experiencing tiredness for weeks now. She sought nurse practitioner's attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal, Vaginitis bacterial
Clinical narrative: Information has been received from a certified medical assistant concerning a female who on 04-JUN-2007 was vaccinated with a first dose of GARDASIL. The patient received a second and a third dose of GARDASIL on 31-JUL-2007 and 28-DEC-2008 respectively. The patient had an abnormal pap and was positive for HPV. The patient had normal pap tests in 2006, 2007 and 2008. At the time of this report the patient had not recovered. Follow-up information was received from a physician via medical records. It was reported that the patient is a 21 year old female student. On 04-JUN-2007, the patient was vaccinated with a first dose of GARDASIL (lot# 657621/0387U) IM into her left deltoid. The patient received the second and a third doses of GARDASIL on 31-JUL-2007 (IM into her left deltoid, lot# 658094/0524U) and on 28-DEC-2008 (IM into her left deltoid, lot# 658488/0930U) respectively. On 03-AUG-2009, a PAP test was performed and revealed atypical squamous cells of undetermined significance. Bacteria (coccobacilli) was also present morphologically consistent with shift in vaginal flora, which was a bacterial vaginosis. The patient was positive for high risk HPV. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Palpitations
Clinical narrative: Information has been received from a physician who mentioned one of her patient's knew someone who developed palpitations after getting a dose of GARDASIL (Lot number not reported). Subsequently on an unspecified date the patient experienced palpitations. This patient's physician attributed the symptoms to GARDASIL. Physician did not have any other information since it was not her patient. At the time of reporting the patient's status was unknown. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a 25 year old female with allergies (gets allergy shots every five years) who on 19-JAN-2009 was vaccinated with the second dose of GARDASIL (LOT # was not provided) and fainted right after. The patient indicated she was fine after the first dose of GARDASIL. Subsequently the patient recovered from fainted and had no other symptoms. It was unknown that the patient sought medical attention. No further information is available.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a consumer concerning her 10 year old daughter with no pertinent medical history and no drug allergies who on 13-AUG-2009 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. On 13-AUG-2009 the patient had a headache. The patient did not seek for medical attention. No lab diagnostics studies were performed. 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: Dizziness, Dyspnoea, Full blood count normal, Hypoaesthesia, Metabolic function test
Clinical narrative: Information has been received from a nurse concerning a 16 year old female with no pertinent medical history and no known allergies who on 20-JUL-2009 was vaccinated with the second dose of GARDASIL (injection, lot# 662300/0100Y). Concomitant therapy included albuterol inhaler and DEPO-PROVERA. The nurse reported that "the patient received the second dose of GARDASIL in the glut on 20-JUL-2009 and later that evening around 6:00 PM the patient started to feel dizzy, short of breath and collapsed. So the patient took her albuterol inhaler (manufacturer unspecified) and took short deep breaths and was fine. Then on the evening of 21-JUL-2009 the patient was doing the dishes and her left leg went numb which had later resolved. Then on 22-JUL-2009 the patient went into see her physician who did a complete blood cell count (CBC) test and a comprehensive metabolic panel (CMP) test and the results came back fine. Then on 23-JUL-2009 the nurse called the patient back and the patient was doing fine." Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 16 year old female with no pertinent medical history and no known allergies who on 20-JUL-2009 was vaccinated with the second dose of GARDASIL (injection, lot# 662300/0100Y). Concomitant therapy included albuterol inhaler and DEPO-PROVERA. The nurse reported that "the patient received the second dose of GARDASIL in the glut on 20-JUL-2009 and later that evening around 6:00 PM the patient started to feel dizzy, short of breath and collapsed. So the patient took her albuterol inhaler (manufacturer unspecified) and took short deep breaths and was fine. Then on the evening of 21-JUL-2009 the patient was doing the dishes and her left leg went numb which had later resolved. Then on 22-JUL-2009 the patient went into see her physician who did a complete blood cell count (CBC) test and a comprehensive metabolic panel (CMP) test and the results came back fine. Then on 23-JUL-2009 the nurse called the patient back and the patient was doing fine." Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy skin abnormal, Laser therapy, Skin hypopigmentation, Vitiligo
Clinical narrative: Information has been received from an office manager concerning her 13 year old daughter who on 14-Sep-2004, was vaccinated with the first dose of 0.5 ml of GARDASIL. On 14-Nov-2006, the patient received the second dose of 0.5 ml of GARDASIL and on 15-MAR-2007, the patient received her third 0.5 ml dose of GARDASIL. One year later, on 15-Apr-2009, the patient saw her pediatrician because of a loss of pigmentation in the skin of her face. The patient was referred to a dermatologist who, after performing a skin biopsy, diagnosed the patient with vitiligo. The patient has had several laser treatments to try to help the vitiligo which have been unsuccessful. At the time of the report vitiligo subsisted.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from registered nurse concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot#, route and site of administration not reported). Subsequently, the patient fainted, at the doctor's office, after being vaccinated with GARDASIL. The patient was monitored by the doctor and then released. At the time of this report, the patient had recovered. It was reported that the patient may have fainted because she had not eaten. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female patient who on 14-SEP-2009 was vaccinated with the third dose of GARDASIL (lot # 0670Y, intramuscular route). The patient received her first dose on 31-DEC-2008 and her second dose on 19-Mar-2009. There was no concomitant medication. The registered nurse reported that 12 hours after the third dose the patient began to feel achy, tired and nauseous; about an hour to two after that, the patient experienced fever of 103.4 degrees F. The registered nurse reported that the patient took ADVIL throughout the night and on 15-SEP-2009 the patient had a low grade temperature of 99.6 degrees F. No lab diagnostic studies were performed. The patient sought medical attention by calling the physician's office. On 16-SEP-2009 the patient was recovered. Follow-up information was received from the registered nurse who reported that the 18 year old female patient with no known allergies, on 12-SEP-2009 was vaccinated at home with the third dose of GARDASIL (lot # 0670Y) intramuscularly into her right deltoid at 19:00 hours. The nurse reported that the patient's mother called on 13-SEP-2009, advising that she had given the patient 12 hours earlier HPV vaccine, and the patient reported feeling "achy" all day; and that at 19:00 hours the patient had a temperature of 103.4 degrees with fatigue and nausea. On 14-SEP-2009, the patient recovered. There was no illness at the time of vaccination. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a Registered Nurse concerning a female patient who on an unspecified date was vaccinated with a third dose of GARDASIL (lot # not reported). After third dose of vaccine a patient's laboratory work test came back positive for Human Papilloma Virus (HPV). The patient sought medical attention office visit and spoke to the nurse. The patient's outcome was unknown. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter with no known drug allergies who in "June 2009", was vaccinated IM with a first 0.5ml dose of GARDASIL (lot# not reported). There was no concomitant medication. The caller stated that "in June 2009, her daughter experienced stomach pain just after she got her period. She just started getting her period in May 2009. The pain lasted for 2 days and got away until her next period. The first time this happened was around the time she got a dose of GARDASIL. But she was unsure if it happened before or after the vaccine was given." The patient sought unspecified medical attention. No lab diagnostic study was performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a pharmacy student concerning a female with no drug allergies who in December 2009, was vaccinated with the third dose of GARDASIL (lot# not reported). After receiving GARDASIL (unspecified which dose), on an unspecified date the patient experienced hair loss. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Basophil count normal, Blood thyroid stimulating hormone normal, Eosinophil count normal, Haematocrit normal
Clinical narrative: Information has been received from a physician's assistant concerning a 23 year old female patient with no pertinent medical history and not known allergies, who on 28-JUL-2009 was vaccinated with the first dose of GARDASIL (lot not reported). On 29-SEP-2009, the patient has been vaccinated with the second dose of GARDASIL (lot not reported). Concomitant therapy included YAZ. The physician's assistant reported that the patient started to experienced generalized thinning of her scalp hair "almost immediately" after the second dose of GARDASIL. On an unknown date, the hair loss resolved. Patient's outcome at the time of the report was recovered. The patient sought medical attention through an office visit. Follow up information has been received from the physician's assistant via medical records concerning the female patient who on 29-SEP-2009 at 17:52 was vaccinated with the second dose of GARDASIL (lot number 661453/0249Y) into left deltoid. On 29-SEP-2009, almost immediately after injection, the patient experienced hair loss which began to resolve as of appointment date on 10-FEB-2010, the patient was recovering from hair loss. On 26-JAN-2010, which blood cell count, red blood cell count, hemoglobin, hematocrit, MCV, MCH, MCHC, RDW, platelet count, MPV, segs (polys), lymphocytes, monocytes, eosinophils, basophils and TSH were performed which were in normal range. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Haemoglobin normal, Lymphocyte count normal, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal
Clinical narrative: Information has been received from a physician's assistant concerning a 23 year old female patient with no pertinent medical history and not known allergies, who on 28-JUL-2009 was vaccinated with the first dose of GARDASIL (lot not reported). On 29-SEP-2009, the patient has been vaccinated with the second dose of GARDASIL (lot not reported). Concomitant therapy included YAZ. The physician's assistant reported that the patient started to experienced generalized thinning of her scalp hair "almost immediately" after the second dose of GARDASIL. On an unknown date, the hair loss resolved. Patient's outcome at the time of the report was recovered. The patient sought medical attention through an office visit. Follow up information has been received from the physician's assistant via medical records concerning the female patient who on 29-SEP-2009 at 17:52 was vaccinated with the second dose of GARDASIL (lot number 661453/0249Y) into left deltoid. On 29-SEP-2009, almost immediately after injection, the patient experienced hair loss which began to resolve as of appointment date on 10-FEB-2010, the patient was recovering from hair loss. On 26-JAN-2010, which blood cell count, red blood cell count, hemoglobin, hematocrit, MCV, MCH, MCHC, RDW, platelet count, MPV, segs (polys), lymphocytes, monocytes, eosinophils, basophils and TSH were performed which were in normal range. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Mean platelet volume normal, Monocyte count normal, Neutrophil count, Platelet count normal, Red blood cell count normal
Clinical narrative: Information has been received from a physician's assistant concerning a 23 year old female patient with no pertinent medical history and not known allergies, who on 28-JUL-2009 was vaccinated with the first dose of GARDASIL (lot not reported). On 29-SEP-2009, the patient has been vaccinated with the second dose of GARDASIL (lot not reported). Concomitant therapy included YAZ. The physician's assistant reported that the patient started to experienced generalized thinning of her scalp hair "almost immediately" after the second dose of GARDASIL. On an unknown date, the hair loss resolved. Patient's outcome at the time of the report was recovered. The patient sought medical attention through an office visit. Follow up information has been received from the physician's assistant via medical records concerning the female patient who on 29-SEP-2009 at 17:52 was vaccinated with the second dose of GARDASIL (lot number 661453/0249Y) into left deltoid. On 29-SEP-2009, almost immediately after injection, the patient experienced hair loss which began to resolve as of appointment date on 10-FEB-2010, the patient was recovering from hair loss. On 26-JAN-2010, which blood cell count, red blood cell count, hemoglobin, hematocrit, MCV, MCH, MCHC, RDW, platelet count, MPV, segs (polys), lymphocytes, monocytes, eosinophils, basophils and TSH were performed which were in normal range. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Red cell distribution width normal, White blood cell count normal
Clinical narrative: Information has been received from a physician's assistant concerning a 23 year old female patient with no pertinent medical history and not known allergies, who on 28-JUL-2009 was vaccinated with the first dose of GARDASIL (lot not reported). On 29-SEP-2009, the patient has been vaccinated with the second dose of GARDASIL (lot not reported). Concomitant therapy included YAZ. The physician's assistant reported that the patient started to experienced generalized thinning of her scalp hair "almost immediately" after the second dose of GARDASIL. On an unknown date, the hair loss resolved. Patient's outcome at the time of the report was recovered. The patient sought medical attention through an office visit. Follow up information has been received from the physician's assistant via medical records concerning the female patient who on 29-SEP-2009 at 17:52 was vaccinated with the second dose of GARDASIL (lot number 661453/0249Y) into left deltoid. On 29-SEP-2009, almost immediately after injection, the patient experienced hair loss which began to resolve as of appointment date on 10-FEB-2010, the patient was recovering from hair loss. On 26-JAN-2010, which blood cell count, red blood cell count, hemoglobin, hematocrit, MCV, MCH, MCHC, RDW, platelet count, MPV, segs (polys), lymphocytes, monocytes, eosinophils, basophils and TSH were performed which were in normal range. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Acne, Alopecia, Condition aggravated
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with a history of acne and no known allergies who "about 4 months ago", in approximately September 2009, was vaccinated with the first 0.5 ml dose of GARDASIL. "About 2 months ago", in approximately November 2009, the patient was vaccinated with the second 0.5 ml dose of GARDASIL. There was no lot number reported. Concomitant therapy included birth control pill (unspecified). "About 2 weeks after the second dose", the patient began to experience hair loss and acne outbreaks on her face. The patient had a history of acne, but after treatment with ACCCUTANE (manufacturer unspecified) she had not had an outbreak in over 2 years until now. As of 27-Jan-2010 the hair loss has stopped and the patient is resuming therapy with ACCUTANE for the acne. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report, the patient was recovering. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who on unspecified dates was vaccinated with two doses of GARDASIL (lot number not reported). Subsequently the patient had an abnormal Papanicolaou smear (PAP), positive for human papillomavirus (HPV). The patient visited the physician in the office. The patient was scheduled for a colposcopy. At the time of the report, the outcome of the patient was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Face injury, Syncope
Clinical narrative: Information has been received from a health professional concerning a 25 year old female patient with no pertinent medical history and no known allergies who on 27-JAN-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 665547/1318Y). There was no concomitant medication. 8-10 minutes after the vaccination, the patient fainted and hit her face in the office. The office staff contacted local paramedics who evaluated the patient in the office. The patient was found to be fully recovered and the patient declined further evaluation. There were no lab studies performed. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Local swelling, Neck pain
Clinical narrative: Information has been received from a male patient concerning himself who on approximately 17-JAN-2010 ("last week") was vaccinated with the first 0.5ml dose of GARDASIL (lot# not reported). He reported that he was experiencing pain and swelling the backside of neck and underneath the jaw. At the time of this report, the patient had not recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a consumer concerning her daughter, who on 10-JUN-2009 was vaccinated with the first dose of GARDASIL. The patient was not able to received the second dose as required because was sick. The patient received the second dose of GARDASIL on 10-OCT-2009. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who a few months ago, was vaccinated intramuscularly, with the first 0.5ml dose of GARDASIL and the doctor had her remain in the office for 20 minutes. When the patient got home she had shortness of breath. The patient called the doctor that night (It was also reported that the patient did not seek medical attention). No treatment was required. Therapy with GARDASIL was discontinued. On an unspecified date, the patient recovered from this event. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Lymphocyte percentage, Mean platelet volume normal, Neutrophil percentage
Clinical narrative: Information has been received from a 13 year old female patient with no pertinent medical history, drug reactions or allergies reported who in June 2009, was vaccinated with a second dose of GARDASIL (route and lot # unknown). There was no concomitant medication. The patient reported that since "last 3-5 weeks", on approximately 24-DEC-2009, she was experiencing hair loss and bald spots after receiving the second dose of the vaccine. No lab diagnostic studies performed. The patient sought medical attention at the physician's office. At the time of the report the patient had not recovered. Additional information has been received from a certified medical assistant concerning a 14 year (also reported as 13 year old) old female who on 30-JUN-2009 was vaccinated with the first dose of GARDASIL (Lot number 662404/0312Y) intramuscularly in the left deltoid at 15:37. On 23-JUN-2009, the patient was vaccinated with the first dose of PEDIARIX (Lot number AC52802768A) intramuscularly in the left deltoid at 16:15 and the first dose of MENACTRA (lot number U2815AA) intramuscularly in the right deltoid at 16:15. On 06-OCT-2009, the patient received dose of GARDASIL (lot number 660612/0229X) intramuscularly in the left deltoid at 15:04. There were no illnesses reported at time of vaccination. The patient was seen at the physician on 28-JAN-2010 for hair thinning. The onset of the symptoms was approximately 14-JAN-2010, 1-2 weeks prior to the appointment. On 29-JAN-2010 the laboratory tests were within normal limits except for mean platelet volume 7.2, blood neutrophil count 66% and blood lymphocyte count 25. At the time of report the patient present status was unknown. Additional information was received from the registered nurse who reported that there was no further work up on the patient, so the current status of the patient was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a pharmacist concerning a female who on an unspecified date, was vaccinated with a dose of GARDASIL (unknown which dose). The pharmacist mentioned that a while ago the patient received GARDASIL and fainted. The patient sought unspecified medical attention. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Haemoglobin, Menstruation delayed
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female patient who on 16-SEP-2009 was vaccinated with the second 0.5ml dose of GARDASIL IM. There was no concomitant medication. The patient hadn't had her period since 15-OCT-2009. The patient sought unspecified medical attention. Blood hemoglobin test was performed (result unspecified). On 27-JAN-2010, the patient received the third 0.5 ml dose of GARDASIL IM. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with an unspecified number of GARDASIL. After receiving the vaccine the patient presented with CIN 2. The physician did not specify if the patient completed the series of GARDASIL. At the time of the report, the outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning an 11 year old female patient with no pertinent medical history who on 22-JUN-2009 was vaccinated with the second 0.5 ml dose of GARDASIL. On 22-JUN-2009 the patient pass out and fell on the floor, experiencing a severe episode of syncope after getting the second dose of GARDASIL. The patient sought unspecified medical attention. No laboratory tests were done. On 22-JUN-2009, the patient recovered. This is one of several reports from the same source. Additional information has been requested. Upon internal review it was determined that the primary source country was previously incorrectly entered. Therefore, WAES # 0907USA03365 is being deleted from our files and WAES # 1001USA03700 has been created to correct the source country.