chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Nuclear magnetic resonance imaging normal, Tremor
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with a 0.5 ml second dose of Gardasil.  Two and a half weeks after receiving the second dose of Gardasil the patient experienced tremors in hands.  The patient's tremors in hands persisted.  No product quality complaint was involved.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain, Pain in extremity, Sensation of heaviness
Clinical narrative: Information has been received from a nurse concerning a 27 year old female who on 07-DEC-2007 was vaccinated with the first dose of GARDASIL (Lot# 659055/1522U) and on 07-FEB-2008 was vaccinated IM in the deltoid with the second dose of GARDASIL (Lot# 658556/1060U).  There was no concomitant medication.  On 07-FEB-2008 the patient experienced pain when 2nd dose of GARDASIL was injected into arm.  A week after the vaccination she was still experiencing pain radiating from her deltoid to her fingers.  Patient told the nurse that her arm felt like lead.  She had pain with routine tasks.  The patient did not report pain with her first dose of GARDASIL.  At the time of reporting the patient had not recovered from the pain radiating from her deltoid to her fingers.  Unknown medical attention was sought via phone.  No product quality complaint was involved.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Influenza
Clinical narrative: Information has been received from a 21 year old female who on 08-FEB-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included allergenic extract and corticosteroids (unspecified) for the treatment of acne. On 08-FEB--2008 the patient felt bad and came down with the flu. No further information was provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter, with a history of family history of cancer, who in November 2007, was vaccinated with a dose of Gardasil (lot # not specified).  Concomitant therapy included an unspecified thyroid medication.  Recently (date not specified), her daughter had an abnormal Papanicolaou test (PAP).  At the time of this report, the outcome of the event was unknown.  Her daughter visited a physician for unspecified medical attention.  The patient's sister also experienced an event similar to the above, when vaccinated with Gardasil (WAES #0802USA03171).  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blood thyroid stimulating hormone normal, Fatigue, Malaise, Physical examination normal
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the third dose of GARDASIL.  Per the reporter, the mother of the patient mentioned that the patient experienced fatigue after receiving the third dose of GARDASIL.  The patient sought unspecified medical attention in the physician's office.  Subsequently, the patient recovered "after a few weeks."  The reporter noted that the vaccine series was administered by the patient's pediatrician and that is why a lot number was not available.  No further information was provided.  Follow-up information from B Form (21-FEB-2008):  Patient had malaise develop with the third dose of GARDASIL.  All labs including TSH were normal; physical exam was also normal.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a female (age not specified) who on unspecified dates was vaccinated with her first and second doses of GARDASIL.  The nurse practitioner reported that after the patient received the first dose of GARDASIL (date not specified), underneath her skin where the shot was given was hard and knotting.  The nurse practitioner also reported that when the patient came in for her second shot (date not specified) her arm still was knotting and hard so they gave her the second dose of GARDASIL in her bottom, and after being given the second dose of GARDASIL, where the shot was given became hard and knotty again just like the first time.  No further adverse event information was provided.  The patient did not seek medical attention.  The patient's outcome is unknown.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Electrocardiogram abnormal, Infectious mononucleosis, Laboratory test, Oropharyngeal pain
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 27-NOV-2007 was vaccinated intramuscularly with her third dose of GARDASIL (lot# not reported).  There was no concomitant medication.  In January 2008, the patient experienced mono-like symptoms.  The patient's mono-like symptoms persisted.  The patient had blood work conducted and sought unspecified medical attention.  Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 3/14/2008. Initial information and follow up has been received from a physician and nurse concerning a 15 year old female who on 27-NOV-2007 was vaccinated intramuscularly in the left arm with her third dose of GARDASIL (lot# 657621/0387U). There was no concomitant medication. On 15-JAN-2008 the patient had a sore throat. She went to the ER and was prescribed amoxicillin. On 30-JAN-2008 the patient had another sore throat and was prescribed EMYCIN. On 04-FEB-2008 the patient experienced near syncopal episode at school. On 05-FEB-2008 the patient had an ECG-orthostatic. On 12-FEB-2008 the patient experienced a sore, swollen throat. On 13-FEB-2008 the patient had a neck CT done. On 27-FEB-2008 the patient experienced recurrent tonsillitis. On 17-APR-2008 the patient had a tonsillectomy. The patient had blood work conducted and sought unspecified medical attention. The patient did recover from her sore throat, near syncopal episode, tonsillitis and tonsillectomy. No additional information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngeal oedema, Presyncope, Tonsillectomy, Tonsillitis
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 27-NOV-2007 was vaccinated intramuscularly with her third dose of GARDASIL (lot# not reported).  There was no concomitant medication.  In January 2008, the patient experienced mono-like symptoms.  The patient's mono-like symptoms persisted.  The patient had blood work conducted and sought unspecified medical attention.  Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 3/14/2008. Initial information and follow up has been received from a physician and nurse concerning a 15 year old female who on 27-NOV-2007 was vaccinated intramuscularly in the left arm with her third dose of GARDASIL (lot# 657621/0387U). There was no concomitant medication. On 15-JAN-2008 the patient had a sore throat. She went to the ER and was prescribed amoxicillin. On 30-JAN-2008 the patient had another sore throat and was prescribed EMYCIN. On 04-FEB-2008 the patient experienced near syncopal episode at school. On 05-FEB-2008 the patient had an ECG-orthostatic. On 12-FEB-2008 the patient experienced a sore, swollen throat. On 13-FEB-2008 the patient had a neck CT done. On 27-FEB-2008 the patient experienced recurrent tonsillitis. On 17-APR-2008 the patient had a tonsillectomy. The patient had blood work conducted and sought unspecified medical attention. The patient did recover from her sore throat, near syncopal episode, tonsillitis and tonsillectomy. No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with allergic reaction to antibiotics who in January 2007, was vaccinated with her first dose of GARDASIL.  Concomitant therapy included doxycycline hyclate (DORYX).  In January 2007, the patient experienced pain in her arm.  Subsequently, the patient recovered from pain in her arm.  No further information available.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on approximately 07-FEB-2008 was vaccinated with GARDASIL (lot# and series dose not reported).  On approximately 07-FEB-2008 the patient experienced headaches in her left temple region.  The patient's outcome was not reported and she sought unspecified medical attention.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a health care professional concerning a 12 year old female who on 18-JUN-2007 was vaccinated with the first dose of GARDASIL an don 24-AUG-2007 was vaccinated with the second dose of GARDASIL and on 04-JAN-2008 was vaccinated IM with the third (0.5 ml) dose of GARDASIL. There was no concomitant medication. After receiving the third dose the patient experienced injection site reaction. At the time of reporting the patient still had significant pain on the injection site on her right arm and could not even lift her arm to write. Medical attention was sought. Patient had not recovered at the time of reporting. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site mass, Injection site pain
Clinical narrative: An identified patient was vaccinated with her first dose of Gardasil. Subsequently the patient experienced a painful bump at the injection site and incorrect route of administration. No additional follow up is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Drug exposure during pregnancy, Pregnancy test positive, Smear cervix abnormal, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from the Pregnancy Registry through a physician concerning a 16 year old female with menstruation irregular and dysmenorrhoea who on 09-AUG-2007 was vaccinated with the first dose of Gardasil and on 09-Nov-2007 the patient received the second dose. It was reported that the patient now is pregnant. Concomitant therapy included vitamins (unspecified). Follow up information has been received from the physician indicating that in December 2007, the patient experienced urinary tract infection treated with 100 mg oral dose of MACRODANTIN for 21-DEC-2007 to 31-DEC-2007. On 16-JAN-2008 the patient's pap smear revealed LGSIL. On 19-FEB-2008 the patient experienced uterine irritability treated with 0.25 mg SQ dose of TERBUTALIN on 19-FEB-2008. The patient had an ultrasound on 9-JAN-2008 and 7-FEB-2008 because of abdominal pain. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 3/14/2008; 7/8/2008; 10/8/2008.  Initial and follow-up information has been received from a physician and a registered nurse for the Pregnancy Registry for HPV concerning a 16 year old black female patient with menstruation irregular and dysmenorrhoea and a history of BV (bacterial vaginosis) April 2007, and vasomotor syncope, who on 09-Nov-2007 the patient received the second dose.  It was reported that the patient now is pregnant.  The patient was placed on vitamins (unspecified) from December 2007 to January 2008.  Her LMP was 01-SEP-2007 with an estimated delivery date of 24-JUN-2008.  In the follow-up information the physician indicating that the patient had microcytic anemia of pregnancy (date unspecified).  In December 2007, the patient experienced urinary tract infection treated with 100 mg oral dose of MACRODANTIN from 21-DEC-2007 to 31-DEC-2007.  On 16-JAN-2008 the patient's pap smear revealed low grade squamous intraepithelial lesion (LGSIL), and in February 2008 also showed LGSIL, "HPV effect"/cervical intraepithelial neoplasia (CIN-I) was also noted.  On 19-FEB-2008 the patient experienced uterine irritability treated with 0.15 mg SQ dose of TERBUTALIN.  The patient had an ultrasound on 9-JAN-2008 and 7-FEB-2008 because of abdominal pain.  On 13-JUN-2008 the patient was treated with MACRODANTIN for urinary tract infection.  Unknown medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  In the follow-up information the nurse reported that the patient delivered a full-term male baby, who was healthy and normal, and where no complication for either the mother or the baby.  Both were doing well.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection
Clinical narrative: Information has been received from the Pregnancy Registry through a physician concerning a 16 year old female with menstruation irregular and dysmenorrhoea who on 09-AUG-2007 was vaccinated with the first dose of Gardasil and on 09-Nov-2007 the patient received the second dose. It was reported that the patient now is pregnant. Concomitant therapy included vitamins (unspecified). Follow up information has been received from the physician indicating that in December 2007, the patient experienced urinary tract infection treated with 100 mg oral dose of MACRODANTIN for 21-DEC-2007 to 31-DEC-2007. On 16-JAN-2008 the patient's pap smear revealed LGSIL. On 19-FEB-2008 the patient experienced uterine irritability treated with 0.25 mg SQ dose of TERBUTALIN on 19-FEB-2008. The patient had an ultrasound on 9-JAN-2008 and 7-FEB-2008 because of abdominal pain. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 3/14/2008; 7/8/2008; 10/8/2008.  Initial and follow-up information has been received from a physician and a registered nurse for the Pregnancy Registry for HPV concerning a 16 year old black female patient with menstruation irregular and dysmenorrhoea and a history of BV (bacterial vaginosis) April 2007, and vasomotor syncope, who on 09-Nov-2007 the patient received the second dose.  It was reported that the patient now is pregnant.  The patient was placed on vitamins (unspecified) from December 2007 to January 2008.  Her LMP was 01-SEP-2007 with an estimated delivery date of 24-JUN-2008.  In the follow-up information the physician indicating that the patient had microcytic anemia of pregnancy (date unspecified).  In December 2007, the patient experienced urinary tract infection treated with 100 mg oral dose of MACRODANTIN from 21-DEC-2007 to 31-DEC-2007.  On 16-JAN-2008 the patient's pap smear revealed low grade squamous intraepithelial lesion (LGSIL), and in February 2008 also showed LGSIL, "HPV effect"/cervical intraepithelial neoplasia (CIN-I) was also noted.  On 19-FEB-2008 the patient experienced uterine irritability treated with 0.15 mg SQ dose of TERBUTALIN.  The patient had an ultrasound on 9-JAN-2008 and 7-FEB-2008 because of abdominal pain.  On 13-JUN-2008 the patient was treated with MACRODANTIN for urinary tract infection.  Unknown medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  In the follow-up information the nurse reported that the patient delivered a full-term male baby, who was healthy and normal, and where no complication for either the mother or the baby.  Both were doing well.  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Drug hypersensitivity, Dyspnoea, Injection site erythema, Nausea, Throat tightness
Clinical narrative: Information has been received from a medical assistant concerning a 21 year old female with penicillin allergy (cause edema), anxiety, depression, asthma, migraines, thalasemia and seizure disorder (as a baby) who on 07-AUG-2007 was vaccinated with the first dose of Gardasil (Lot # 657868/0523U), on 05-OCT-2007 was vaccinated with the second dose of Gardasil (Lot # 658558/1061U), and on 08-FEB-2008 was vaccinated IM with the third (0.5 ml) dose of Gardasil (Lot # 658282/1263U).  There was no concomitant medication.  After the first and second doses of Gardasil the patient experienced nausea.  Three hours after receiving the third dose of Gardasil the patient became nauseous, had trouble breathing, and developed hives.  The patient was instructed to take BENADRYL and her symptoms resolved.  Medical attention was sought through a phone call.  No product quality complaint was involved.  Additional information has been requested. Followup information received from a nurse indicated that after receiving the third dose of HPV Gardisil vaccine (yeast) on 08-FEB-2008, the patient left the office after 15 minutes waiting time. No complication/adverse reactions noted. Telephone call to office about 3hours later by the patient was complaining of redness on left arm at injection site and facial irritation (hives). The patient was instructed to take diphenhydramine hydrochloride (BENADRYL) and if the symptoms continued to go to the emergency room. During a telephone call from patient at 4:443 pm the patient stated that she did not take diphenhydramine hydrochloride (BENADRYL) and her "throat seems to be closing". She was told to call 911 and go to the emergency room. Telephone call back tp patient indicated that she never went to the emergency room or took diphenhydramine hydrochloride (BENADRYL) and feels fine. The patient had no reaction to the previous two doses of HPV Gardisil vaccine (yeast). Additioanl information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a medical assistant concerning a 21 year old female with penicillin allergy (cause edema), anxiety, depression, asthma, migraines, thalasemia and seizure disorder (as a baby) who on 07-AUG-2007 was vaccinated with the first dose of Gardasil (Lot # 657868/0523U), on 05-OCT-2007 was vaccinated with the second dose of Gardasil (Lot # 658558/1061U), and on 08-FEB-2008 was vaccinated IM with the third (0.5 ml) dose of Gardasil (Lot # 658282/1263U).  There was no concomitant medication.  After the first and second doses of Gardasil the patient experienced nausea.  Three hours after receiving the third dose of Gardasil the patient became nauseous, had trouble breathing, and developed hives.  The patient was instructed to take BENADRYL and her symptoms resolved.  Medical attention was sought through a phone call.  No product quality complaint was involved.  Additional information has been requested. Followup information received from a nurse indicated that after receiving the third dose of HPV Gardisil vaccine (yeast) on 08-FEB-2008, the patient left the office after 15 minutes waiting time. No complication/adverse reactions noted. Telephone call to office about 3hours later by the patient was complaining of redness on left arm at injection site and facial irritation (hives). The patient was instructed to take diphenhydramine hydrochloride (BENADRYL) and if the symptoms continued to go to the emergency room. During a telephone call from patient at 4:443 pm the patient stated that she did not take diphenhydramine hydrochloride (BENADRYL) and her "throat seems to be closing". She was told to call 911 and go to the emergency room. Telephone call back tp patient indicated that she never went to the emergency room or took diphenhydramine hydrochloride (BENADRYL) and feels fine. The patient had no reaction to the previous two doses of HPV Gardisil vaccine (yeast). Additioanl information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated IM with a dose of Gardasil (Lot # not provided). There was no concomitant medication. Patient had become light headed and needed to sit down after immunization. Patient outcome was recovered. No product quality complaint was involved. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Back pain, Diagnostic procedure, Vaccine positive rechallenge, X-ray
Clinical narrative: Information has been received from a mother of a 11 year old female, with no drug allergies or pertinent medical history, who on 05-SEP-2007 was vaccinated with her first dose of Gardasil.  There was no concomitant medication.  On 06-SEP-2007, the patient developed an uncomfortable pain in her back.  On 17-NOV-2007, she was vaccinated with her second dose of Gardasil.  On 18-NOV-2007, the patient developed alot of pain in her lower back which eventually spread to her hips.  The patient sought medical attention.  The patient underwent screening and x-rays.  As of 12-FEB-2007, the patient had not recovered and was going to physical therapy twice a week.  AS of 12-FEB-2007, the patient's mother had not allowed her to receive her third dose of Gardasil.  Additional information has been requested. Follow-up information was received. On an unspecified date the patient also lost feeling in her leg and collapsed 2 weeks after receiving the vaccine. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Blood thyroid stimulating hormone, Full blood count, Laboratory test, Vaccine positive rechallenge
Clinical narrative: Information has been from a health professional concerning a 21 year old female who on 16-MAR-2007 was vaccinated with GARDASIL (yeast, lot # 653736/0014U). Concomitant therapy included birth control pills (unspecified). On approximately 20-MAR-2007 the patient experienced hair loss in circular patches on her head. It continued to occur even after the second dose  (lot # 657872/0515U0. When the patient brushed her hair a lot of hair would fall out, which made her almost bald. She received steroid injections in her head and 2 prescriptions (unknown). The patient was almost back to normal until she received her third dose of (yeast, lot # 657872/0515U) on 28-NOV-2007. The patient started losing hair again and had to get the injections of steroids and use the prescriptions again. Labs performed included CMP, thyroid, Iron and CBC (results not specified). As of 12-FEB-2008, the patient was almost fully recovered. Additional information has been requested.  03/25/2008 MR received for multiple OV beginning 7/12/2007-3/12/2008 with DX:  Alopecia Areata and likely telogen effluria. Eczematous patches on legs. Pt presented with c/o hair loss x 2 months and rash on legs. Diffuse thinning on scalp with areas of total alopecia on crown. Dematitis on legs. OVs 10 & 11/2007 with hair growing well in response to tx. Two new areas noted 12/18/2007. No bald spots noted 3/12/08
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced a rash on her arms, face and behind her knees. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blister, Mouth ulceration, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter who on 11-JUL-2007, 20-SEP-2007, 26-JAN-2008 was vaccinated with her first, second and third dose of Gardasil, respectively. It was reported that the patient did not have a reaction to the first or second dose. Within two weeks after her third dose she experienced a high fever and blisters down her throat. It was reported that she missed work and school due to the reaction. The consumer's sister also had a similar reaction to Gardasil (WAES#0710USA03615). Additional information has been requested.  follow up 2/12/2010- follow up information received from the physician regarding a 14 year old caucasian female patient (previously reported as 17 years old) with no previous medical history or no illness at the time of vaccination, who on 11-jul-2007. at 10:04 am was vaccinated IM in the left arm with the first dose of HPV 6 11 16 18 vaccine (yeast) (lot# 658100/05250) and on 20-sep-2007 at 6: 46 pm, was vaccinated IM in the left arm with the second dose of HPV 11 16 18 vlp vaccine (yeast) lot# 657736/0389u. on 31-jul-2007, the patient experienced a fever began 2 weeks following the 1st vaccination. also experienced oral ulcers. fever persisted x 1 week. again developed fever and mouth sores 2 weeks following dose 2. no reactions after the third vaccination.  the patient recovered 1-2 weeks after onset of symptoms.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning her 18 year old daughter who, on unspecified dates, was vaccinated with first, second, and third doses of Gardasil. Subsequently, after each dose the patient experienced severe pain at the injection site. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site erythema, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician, concerning an 18 year old female patient with allergic reaction to KEFLEX that involved a facial rash, who was vaccinated with the first dose of Gardasil (date and lot # not specified).  Concomitant therapy included MICROGEST.  Subsequently the patient developed a "ring of erythema" around the injection site, from which she recovered (duration not specified).  On an unspecified date, the patient was administered the second dose of Gardasil, and again she developed a "ring of erythema' around the injection site.  The patient contacted the physician (details not provided).  After an unknown duration, she recovered.  Additional information has been requested. This is a follow-up to report (s) previously submitted on 3/14/2008.  Initial and follow up information has been received from a physician, concerning an 18 year old female patient , a student with seasonal allergies and reported allergy reaction to KEFLEX (caused facial rash date not specified), who was vaccinated with the first dose of GARDASIL (date and lot # not specified).  Concomitant therapy included MICROGEST.  Subsequently teh patient developed a 2-3 cm "ring of erythema" around the injection site, from which she recovered (duration not specified).  Following the erythema she developed a "persistent hypopigmentation around site."  On 04-FEB-2008, while experiencing axillary lymphadenopathy and being treated with KEFLEX, the patient was vaccinated , IM in the left arm, with the second dose of GARDASIL (date and lot # not provided).  She again developed a "ring of erythema" around the injection site.  Followed by persistent hypopigmentation around the site.  The patient contacted the physician (details not provided).  After an unknown duration, she recovered from a ring of erythema around her injection site:  the outcome of persistent hypopigmentation around site, and axiliary lymphodenopathy was not specified.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter, with a history of family history of cancer, who in June 2007, was vaccinated with the first dose, 0.5 ml, of Gardasil (lot # not specified). There was no concomitant medication. In January 2008, seven months after the vaccination, her daughter had a Papanicolaou test (PAP) and tested positive for human papilloma virus. At the time of this report, her daughter had not recovered. Her daughter visited a physician for unspecified medical attention. The patient's sister also experienced an event similar to the above, when vaccinated with Gardasil (WAES #0802USA03516). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 year old female with drug hypersensitivity to CECLOR, ZITHROMAX and no pertinent medical history who on 12-FEB-2008 was vaccinated with a first dose of GARDASIL (lot # 655670/1459U). Concomitant therapy included LOESTRIN. On13-FEB-2008, the patient experienced a fever of 101.9 degrees Fahrenheit, nausea, and vomiting. The patient sought medical attention and was examined by her physician and was instructed to take BENADRYL, TYLENOL, and increase fluid intake. No diagnostic tests were performed. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: White blood cell count decreased
Clinical narrative: Information has been received from a nurse practitioner concerning "around 12 year old" female who on an unspecified date was vaccinated with a first dose of Gardasil 0.5 mL injection.  On an unspecified date after receiving the Gardasil the patient experienced a depressed white cell count.  Medical attention was sought.  At the time of reporting it was unknown if the patient had recovered.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician's assistant concerning a 20 year old female with syncope episodes in the past after receiving other vaccines who on 13-FEB-2008 was vaccinated with a first dose of GARDASIL IM. On 13-FEB-2008 the patient fainted. The representative reported that the "patient had not eaten breakfast before being vaccinated". On 13-FEB-2008, the patient "was fine before leaving the office." No further information was provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning her 16 year old daughter with no pertinent medical history or drug reactions/allergies who on 24-OCT-2007 was vaccinated with a first dose of GARDASIL 0.5 mL IM.  There was no concomitant medication.  On 24-OCT-2007 the patient fainted after receiving the first dose.  Medical attention was sought.  Subsequently, on 24-OCT-2007, the patient recovered.  On 06-FEB-2008, the patient received a second dose of GARDASIL and did not faint.  No further information was available.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Injection site mass, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a 13 year old female with no reported medical history who on 15-MAY-2007 was vaccinated with her first dose of GARDASIL (lot number not given) intramuscularly and on 6-DEC-2007 was vaccinated with her second dose of GARDASIL. The nurse reported that on 15-MAY-2007 the patient developed a fever of 101 degrees Fahrenheit and also had a knot in her arm at the injection site after receiving the first and in December 2007 developed a fever of 101 degrees Fahrenheit and also had a knot in her arm at the injection site after receiving the second dose. The patient outcome was unknown at the time of reporting. No further information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/14/2008.  Information has been received from a nurse concerning a 11 year old female student with no reported medical history who on 15-MAY-2007 was vaccinated with her first dose of GARDASIL (LOT#654369/0961F) intramuscularly to the right deltoid and on 6-DEC-2007 was vaccinated with her second dose of GARDASIL (LOT# 658556/1050U) intramuscularly to the left deltoid.  There were no illnesses reported at the time of vaccination.  The nurse reported that on 15-MAY-2007 and 06-DEC-2007, following vaccination with GARDASIL, the patient developed a fever of 101 degrees farenheit and also had a knot in her arm at the injection site.  The patients outcome was unknown at the time of reporting.  No product quality complaint was involved.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia, Ultrasound scan
Clinical narrative: Information has been received from a 24 year old female who was vaccinated with the first two doses of GARDASIL on unspecified dates (lot# not reported).  At the time she received the first two doses she had her menstrual cycle and after receiving it both times she had severe bleeding to the point where it soaked through everything.  The patient went to the hospital and had an internal and external ultrasound done, but the physicians could not determine why this was happening.  The patient was not admitted to the hospital.  The patient did receive the third dose of GARDASIL on an unspecified date and was fine (lot# not reported).  The patient did recover from the heavy bleeding.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 24 year old daughter with a history of reaction to erythromycin who on 05-FEB-2008 was vaccinated with the initial dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). Shortly after receiving GARDASIL (approximately 05-FEB-20080 the patient became nauseous. The nausea subsided on 09-FEB-2008. On 10-FEB-2008 the patient developed hives. The physician was notified and BENADRYL was prescribed. BENADRYL helped initially but as of 18-FEB-2008, the hives persisted. The patient's mother indicated that the physician told the family he did not believe the hives were related to therapy with GARDASIL. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician concerning a female (age and gender unknown), who, on an unspecified date, was vaccinated with a dose of GARDASIL. Subsequently, the patient was diagnosed with guillain-barre syndrome. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Upon internal review, guillain-barre syndrome was considered to be an other important medical event. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a female licensed practical nurse who on 13-FEB-2008 was vaccinated with the second dose of GARDASIL. On 13-FEB-2008 the patient experienced soreness at the injection site. She reported that she thought the dose was administered subcutaneously. The outcome of the event was not reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with a history of seasonal allergies and no known drug allergies who on 20-DEC-2007 was vaccinated with the first dose of GARDASIL (Lot # 659435/1265U).  Concomitant therapy included montelukast sodium (MSD) and ethinyl estradiol/norethindrone (NECON).  One to two days after receiving GARDASIL vaccine (approximately 21-DEC-2007), the patient developed a rash on her face and arms.  The patient reported the rash at the next office visit.  Subsequently, the patiente recovered.  Additional information has been requested.  follow up 2/15/2010 - 21 dec 2007 the patient developed a urticarial rash with large hives or wheels. the patients reported the rash at the next office visit. the duration of the urticarial rash was 24 - 48 hours. subsequently, the patient recovered on 25-dec-2007. the second injection has not been administered.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Computerised tomogram normal, Convulsion, Full blood count, Laboratory test
Clinical narrative: Seizure - less than 2 hours after vaccine. 30 sec, generalized.  4/1/08 Reviewed hospital medical records of 3/11-3/12//2008. FINAL DX: Seizure, suspect pertussis reaction. Records reveal patient experienced jerking movements, stiffness, eyes rolled back, unable to cry.  Brought to ER where temp 99.9 & appeared sleepy but no further problems noted.  Admitted overnight for observation.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Presyncope
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 14-FEB-2008 was vaccinated with the first dose of GARDASIL. The patient became very tired approximately 3 hours after receiving her first dose of GARDASIL. Unknown medical attention was sought. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested. follow up 2/15/2010 -  medical attention was sought. no product quality complaint was involved. follow up information received from a physician indicated that the patient suddenly felt tired/dizzy/pre-syncopal episode about 3 hours after hpv vaccine (yeast). the episode lasted 10 minutes. the patient outcome was recovered.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes virus infection
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with the second doses of GARDASIL. A week after the patient experienced herpetic lesions at the the front of her legs where the underwear touches. Patient denied having any sexual history. Unknown medical attention was sought. Patient outcome is unknown. no product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Arrhythmia
Clinical narrative: Information has been received from a nurse practitioner concerning a her daughter who was vaccinated IM with a 0.5 ml dose of GARDASIL and a short time after being vaccinated developed cardiac arrhythmia. Unknown medical attention was sought. Patient outcome was unknown. No product quality complaint was involved. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a single female who was vaccinated on unspecified dates with three doses of GARDASIL. The patient had an abnormal PAP test since receiving the vaccination and needed a colposcopy. The patient did not have positive PAP test prior to receiving the vaccination. Medical attention was sought in the office. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested. Follow up information was received indicating that the patient did not receive the vaccination.  This report is related to reports WAES # 0803USA01379, 0803USA01380, 0803USA01381 with the same source.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Hypotension, Presyncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female with seasonal allergic rhinitis who on 19-OCT-2007 was vaccinated in the right deltoid with the first dose of GARDASIL. Concomitant therapy included ALLEGRA, ADACEL, MENACTRA and hepatitis A vaccine (unspecified). On 19-OCT_2007 the patient experienced near syncopal episodes (likely vasovagal) that lasted 5 minutes and mild hypotension with spontaneous recovery. Subsequently, the patient recovered from near syncopal episodes and mild hypotension. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female on an unspecified date who was vaccinated intramuscularly with her first dose of GARDASIL (lot# not reported).  Subsequently the patient fainted after receiving the vaccine.  The patient felt better after 20 minutes and left the office.  Subsequently, the patient recovered from fainting.  Additional information has been requested. Follow-up received 07/11/2008.  Vaccinated 30-JAN-2008 in the left deltoid, lot #659962/1740U. The patient had not eaten, but improved quickly after drinking juice. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Hyperhidrosis
Clinical narrative: Information has been received from a nurse concerning a female who on an unspecified date was vaccinated with her second dose of GARDASIL (Lot # not reported). "Either the day of or the day after receiving her second dose", the patient's face became red and diaphoretic. The reporter stated that it has not been decided whether they are going to continue the rest of the series. The patient sought unspecified medical attention by calling the office. No further information was provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 17 year old female with asthma and allergies to naproxen and ibuprofen, who on 07-AUG-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # not reported). On 15-OCT-2007, the patient was vaccinated intramuscularly with her dose of GARDASIL (Lot # not reported). On 18-FEB-2008, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # 659657/1487U). Concomitant therapy included LOESTRIN and albuterol inhaler. About 15 minutes after receiving the third vaccination, the patient developed hives and itching on both arms. The patient was treated with BENADRYL and SOLU-MEDROL. No additional information provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Urticaria
Clinical narrative: Information has been received from a health professional concerning a female who on an unspecified date was vaccinated intramuscularly with her first dose of GARDASIL (Lot # not provided).  After receiving the vaccination, the patient "broke out in hives all over her body and had to be taken to the ER."  Specific information regarding the ER visit were not provided.  The reporter indicated that laboratory tests were performed; however, no specifics were provided.  On an unspecified date, the patient recovered from hives all over her body.  No additional information was provided.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with Gardasil. On approximately 18-FEB-2008 the patient experienced hives. The patient's outcome was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Rash pruritic
Clinical narrative: Information has been received from a Licensed Visiting Nurse concerning a 14 year old female who on 13-AUG-2007 was vaccinated with the first dose of Gardasil (659655/1486U). On 15-FEB-2008 the patient received the second dose of Gardasil and experienced pruritic rash all over her torso and swelling on her hands. She was prescribed Zyrtec for the symptoms. As of 19-FEB-2008, the patient was recovering. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Drug administered at inappropriate site, Sensation of heaviness
Clinical narrative: Information has been received from a physician concerning a 26 year old female (164 lbs., 62 in.) who on 15-FEB-2008 was vaccinated in the left buttocks with the first dose of GARDASIL (Lot #659655/1486U).  Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA).  On 17-FEB-2008 the patient experienced heaviness in her left arm, tightness in the left side of her chest and the veins in her left leg felt constricted.  The patient was taken to the emergency room but it was not known if she was admitted.  No additional information is available. Follow-up information was received from a physician. The physician reported " I have had a possible two adverse reactions to GARDASIL from lot #1486U" and has requested a lot check. 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. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a company representative who called to report that a news program ran about GARDASIL. A young lady was interviewed who received GARDASIL. The woman confirmed that it was painful but worth it because the vaccine can prevent cervical cancer. The anchor woman was the health link manager. The anchor woman reported that the vaccine can cause fainting and pain. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Loss of consciousness
Clinical narrative: Information has been received from a Nurse concerning a female who on 18-FEB-2008 or 19-FEB-2008 was vaccinated with her second dose of Gardasil (lot# not provided). The patient passed out and fell in the exam table after vaccine administration. The patient was brought to the hospital but it was not reported whether the patient was admitted to the hospital. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling, Inappropriate schedule of drug administration, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 27 year old female with a history of seasonal allergies who on 14-FEB-2008 was vaccinated IM, in the right deltoid with her third dose of GARDASIL (lot# 659655/1486U). On 17-FEB-2008 the patient experienced puffiness at injection site, swelling in the right arm and eye puffiness. It is unknown if the patient had this same reaction with the first and second doses of the vaccine. The patient sought unspecified medical attention. The patient took BENADRYL and subsequently recovered from puffiness at injection site, right arm swelling and eye puffiness on 19-FEB-2008. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Sensation of heaviness
Clinical narrative: Information has been received from a health professional concerning many patients, ages 12-15 years, who were vaccinated with GARDASOL (lot# Not provided). The reporter could not provide the exact number of patients, but estimated that every 7 out of 10 patients experienced heavy arm. On an unspecified date the patients recovered from heavy arm. The patients sought unspecified medical attention. Additional information has been requested.