chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle necrosis, Scar, Skin atrophy
Clinical narrative: Initial and follow-up information has been received from a physician and a clinical manager concerning a 24 year old female with a history of pharyngitis streptococcal ("1 to 2 weeks prior to vaccination"), who on approximately 28-FEB-2008 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (lot # 655327/1287U).  Concomitant therapy included hormonal contraceptives (unspecified).  The physician and case manager reported that "on the same day", approximately 28-FEB-2008, the patient "experienced pain and swelling at the injection site that lasted for 6 weeks."  The patient sought medical attention and was seen by the physician.  The physician and clinical manager reported that "the patient was followed-up today", 10-APR-2008, and the physician found signs of scarring and muscle necrosis.  The area was red, hard, and concave."  The patient had not improved.  The patient reported that she had an appointment with a plastic surgeon scheduled for 11-MAY-2008.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 03-APR-2008 was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL (lot # not reported).  Concomitant therapy included Tdap and MENACTRA administered "at the same visit" on 03-APR-2008.  It was reported that as the patient started to leave the office she felt lightheaded.  She sat down and fainted and shortly "came around".  The physician reported that this occurred around 3:00 in the afternoon and the only thing the patient had consumed that day was a soda and a glass of milk.  The patient recovered and left the office.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/10/2008.  Initial and follow up information has been received from a physician and an unspecified reporter concerning a 12 year old female who on 03-APR-2008 was vaccinated intramuscularly in the upper left arm with a 0.5 mL first dose of GARDASIL (lot # 660389/1968U).  Concomitant therapy included MENACTRA administered "at the same visit" on 03-APR-2008.  Initially it was reported that as the patient started to leave the office she felt lightheaded.  She sat down and fainted and shortly "came around".  The physician reported that this occurred around 3:00 in the afternoon.  In follow up it was reported that the patient fainted for a few seconds, had no loss of consciousness, 10 minutes after the shots were given.  In follow up it was also reported that the shots were given at 5:10 pm and the adverse event onset was 5:15 pm.  The patient's blood pressure was 70/60 and the only thing the patient had consumed that day was a soda and a glass of milk.  The patient was given MEDIALYTE SOLUTION) and her blood pressure went up.  The patient recovered and left the office.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Contraception, Rash, Red blood cell sedimentation rate increased, Vasculitis, White blood cell count increased
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with codeine intolerance who on 31-JAN-2008 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (lot # 659657/1487U).  On 01-APR-2008 the patient was vaccinated intramuscularly with a 0.5 mL second dose of GARDASIL (lot # 659180/1758U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 04-APR-2008, "three days later", the patient developed a rash on her legs.  It was reported that she went to the emergency room.  On 07-APR-2008 the patient was followed up at her doctor's office and was diagnosed with vasculitis.  On 09-APR-2008 the patient "had a flare up again".  The nurse reported that she had "many tests done".  At the time of this report the vasculitis persisted.  The patient is being treated with prednisone.  Laboratory tests performed on an unspecified date showed an "elevated sed rate" and an "elevated white count".  Additional information has been requested.  6/3/08  Reviewed PCP medical records for 4/7-5/1/2008. FINAL DX: vasculitis Records reveal on 4/7 visit, patient experienced itchy rash over bilateral LEs, aching in bilateral LEs & muscle spasms.  Had been seen in ER on 4/4, 2 days s/p 2nd HPV vax,  & diagnosed w/vasculitis, unclear etiology.  Had undergone tanning session on day of ER visit.  Intolerant of steroids.  Tx w/antihistamine.  Had no reaction s/p 1st HPV vax.   Exam revealed bilateral LE multiple erythematous round macules & plaques generalized over lower pretibial area.  Returned to office 4/9 w/worsening symptoms of rash & calf pain.  Exam at that time revealed tenderness of bilateral calves w/trace edema, diffuse nodular urticarial erythematous lesions, coalescent purpura mostly over distal tibial area w/sparse involvement over thighs.  Attempted tx w/steroids & additional labs.  Testing for celiac disease (+) on 5/1/08.  6/3/08 Reviewed ER medical records of 4/4/2008. FINAL DX: vasculitis Records reveal patient experienced rash which started at ankles & progressed up to her knees over approx 4-5 hrs w/cramping of calves & stiffness when walking.  Exam revealed scattered 1-3 mm erythematous plaques & macules over LEs, confluent on pretibial areas down to mid dorsum of feet & up to knees.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a healthcare worker concerning her 15 year old daughter who on an unspecified date was vaccinated intramuscularly with a 0.5 mL second dose of GARDASIL (lot # not reported).  Concomitant therapy included an injection of tetracycline.  Subsequently the patient developed hives.  At the time of this report the patient had not recovered from the hives.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a consumer concerning her daughter who on 12-FEB-2007 was vaccinated with a first dose of GARDASIL. On 21-APR-2007 the patient was vaccinated with a second dose of GARDASIL. On 21-JUN-2007 the patient received a third dose 2 months after the second dose. The reporter did not provided any other information. Per reporter, the patient did not report any adverse event. No further information was provided. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Information has been received from a medical assistant concerning a female with a codeine allergy who on 19-JAN-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 655619/1427F). Concomitant therapy included MICROGESTIN. On approximately 19-JAN-2007 the patient experienced dizziness and headaches for one week. Subsequently, the patient recovered from dizziness and headaches. On 23-MAR-2007 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# 657006/0188U) and did not experienced any symptoms. The patient sought medical attention by telling the physician about her symptoms. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a health professional concerning a 16 year old female who was vaccinated with her second dose of GARDASIL (lot# not reported) and developed a case of genital warts. Concomitant therapy included rizatriptan benzoate, (dose, duration and indication not reported). Other concomitant therapy included hormonal contraceptives (unspecified). The patient's genital warts persisted and she sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2008. It was reported that no adverse effect occured. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning her daughter with no known drug allergies and no previous medical history who was vaccinated with her first dose of GARDASIL (lot# unspecified). There was no concomitant medication. Subsequently the patient experienced headache dizziness, fever and nausea. She took OTC Tylenol and the symptoms resolved within 24 hours. No other information was available. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning her 19 year old daughter who in 2007 was vaccinated with three dose series (0.5 ml) of GARDASIL (No lot numbers were provided). The patient experienced dizziness after each dose of the three doses series of GARDASIL. The dizziness only lasted approximately 24 hours after each injection. Medical attention was not sought. Patient outcome was recovered on an unspecified date. No product quality complaint was involved. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a nurse concerning a 22 year old female with no previous medical history and no known drug allergies, who on 27-SEP-2007 was vaccinated with a first dose of GARDASIL (Lot # 659435/1263U). On 21-NOV-2007 she was vaccinated with a second dose of GARDASIL (Lot# 659435/1263U. On 11-APR-2008 she was vaccinated IM in the left deltoid with the third 0.5 ml dose of GARDASIL (Lot # 659182/1757U). There was no concomitant medication. On 12-APR-2008 the patient experienced redness, swelling, and hardness at the injection site following the last injection of vaccine. The patient called an office for medical attention. On 16-APR-2008 the patient stated the redness and swelling had resolved. The patient was not treated. The redness and swelling had improved. Unspecified medical attention was sought. Patient outcome was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 24 year old daughter who was vaccinated with the third 0.5 ml dose of GARDASIL. The patient had a PAP smear that showed positive for HPV after she received three doses of GARDASIL. Unknown medical attention was sought with the physician. At the time of reporting, patient had not recovered. No product quality complaint was involved. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a nurse concerning a 24 year old female with no medical history and no known drug allergies who on 08-APR-2008 was vaccinated IM in the left deltoid with the first dose of GARDASIL. There was no concomitant medication. On 08-APR-2008 the patient developed a fever in the evening that lasted through the next day. When the fever broke on 09-APR-2008 or 10-APR-2008 the patient developed a rash. The rash was not at the injection site, but on the right forearm, left side of the face and left forehead. The patient sought medical attention on 11-APR-2008 in the office and was told to take BENADRYL. On 14-APR-2008 the office contacted the patient by phone and the patient indicated that the rash was getting better. No product quality complaint was involved. Additional information has been requested.  07/08/08 This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow up information has been received from a nurse concerning a 24 year old female with no medical history and no known drug allergies who on 08-APR-2008 was vaccinated IM in the left deltoid with the first dose of GARDASIL. There was no concomitant medication. On 08-APR-2008 the patient developed a fever in the evening that lasted through the next day. When the fever broke on 09-APR-2008 or 10-APR-2008 the patient developed a rash. The rash was not at the injection site, but on the right forearm, left side of the face and left forehead. The patient sought medical attention on 11-APR-2008 in the office and was told to take BENADRYL 50 mg. On 14-APR-2008 the office contacted the patient by phone and the patient indicated that the rash was getting better. Followup indicated that patient outcome was recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a medical technologist, concerning a female patient (age not specified), who on an unknown dates was vaccinated with the first and second doses of GARDASIL. Subsequently, during a routine cervical cancer screen, the patient was found to be positive for both low risk and high risk human papilloma virus (HPV). At the time of this report, the patient had not recovered. No further information was available. Additional information has been requested. This is one of 2 reports from the same source.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a medical assistant concerning a female in her early 20's who in February 2008, was vaccinated with her first dose of GARDASIL (lot# unknown, injection site and route not reported). There was no concomitant medication. In February 2008, the patient developed a lump after her first vaccination. The patient came in today on 14-Apr-2008 (two months after the first vaccination) for her second dose and still had a "small lump" above the injection site. The second of the vaccine was not administered due to the lump. The physician of the patient could not be identified (group practice) at the time of the report. The patient was reported as not recovered. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with no known drug allergies and no previous medical history who on 10-APR-2008 was vaccinated with GARDASIL (lot#659964/1978U) route and site not reported. There was no concomitant medication. The nurse indicated that the patient developed a rash on 14-Apr-2008 after she was given the vaccination. The rash is on the patient's trunk and spread to her arms and feet. No further information is available from the nurse. The patient's outcome was reported as not recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope
Clinical narrative: Information has been received from a company representative concerning a 13 year old female who on 10-APR-2008 was vaccinated IM with her first dose of GARDASIL (lot# unknown, site not reported). Concomitant therapy included VARIVAX. The patient was given the vaccination standing up and subsequently fainted. She was sent to the hospital emergency room because she fell but was not hospitalized. The patient recovered. No further information was available. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a 11 year old female who in approximately January or February 2008, was vaccinated with the first dose of GARDASIL. The patient recently (approximately April 2008) came in for her second dose of GARDASIL. The patient experienced excruciating pain at the injection site after the first dose of the vaccine. The patient outcome was recovered. The duration of the pain was not provided. It is unknown whether medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a first dose of GARDASIL (route and lot# not provided) was one day late on getting her menstrual cycle. She might be pregnant (to be determined by office). Physician did not want to provide more information yet. He might call back. The patient had an appointment with the physician (date unknown). The patient's outcome unknown. No product quality complaint was involved. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Information has been received from a health professional concerning a 22 year old female who on approximately 25-MAR-2008 was vaccinated intramuscularly with her first dose of GARDASIL vaccine (lot# not reported). On approximately 27-MAR-2008 the patient experienced pain in her shoulder and disabled range of motion in her arm. She was seen in the doctors office, but her outcome was not reported. Additional information has been requested. 02/18/2010 She does have problems with abduction and putting her hand behind her head. The patient received Ibuprofen and was told to follow up with personal care provider and the problem resolved on its own.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Hepatic enzyme increased, Laboratory test abnormal, Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly on an unspecified date with her third dose of GARDASIL (lot# not reported).  Concomitant therapy included hepatitis A vaccine (unspecified) on the same day.  Subsequently the patient fainted at her home that day.  Her father is also a  physician sent her for bloodwork.  The results showed her liver enzymes were elevated.  Subsequently the patient recovered from fainting.  Additional information has been requested.  10/08/08 This is in follow-up to report(s) previously submitted on 5/14/2008. Information has been received from a physician concerning a 18 year old female who was vaccinated intramuscularly in the right deltoid on 27-DEC-2007 with her third dose of GARDASIL (lot# 659437/1266U). Concomitant therapy included VAQTA (lot# 657304/0246U) on the same day. Subsequently the patient was dizzy and fainted at her home that same day. Her father who is also a physician sent her for bloodwork. The results showed her liver enzymes were elevated. Subsequently, the patient recovered from fainting and being dizzy. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Injection site pain, Laboratory test
Clinical narrative: Information has been received from a physician for the merck pregnancy registry concerning a 16 year old female with no previous medical history or no drug allergies, who on 18-MAR-2008 was vaccinated with a first 0.5 ml dose of GARDASIL. There was no concomitant medication. On 14-Apr-2008 the patient found out that she was 7 weeks pregnant. The patient also experienced soreness at the injection site. Unknown medical attention was sought. The patient's outcome was not reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Blood thyroid stimulating hormone normal, Facet joint syndrome, Full blood count normal, Inappropriate schedule of drug administration, Laboratory test normal
Clinical narrative: Information has been received from a physician concerning a 27 year old female with no previous medical history or no known drug allergies, who on 15-FEB-2008 was vaccinated IM with a 0.5 ml first dose of HPV rL1 6 11 18 VLP vaccine (yeast) (lot# 655327-1287U). There was no concomitant medication. On 16-MAR-2008 the patient experienced tingling and formication of both hands, feet, and bilateral anterior thighs. The patient was examined in the office on 21-MAR-2008. Neurological exam was normal. Complete blood count, metabolic panel, and thyroid stimulating hormone levels were normal. The patient was examined by an unspecified neurologist in early April 2008. Nerve conduction testing on the right leg and neurological exam were normal. The physician added that the patient received an unspecified steroid injection in the sacr-iliac joint 2 weeks prior to the onset of symptoms. Medical attention was sought in the office. At the time of reporting the patient was recovering. No product quality was involved. 5/27/08-records received-office visit 2/15/08-Current problems: acne vulgaris, depression with anxiety, dizziness. 3/21/08-C/O tingling sensation began 5 days ago, mild intensity, constant. Paresthesia in both hands (stocking glove distribution) both feet and both anterior thighs. Not associated with numbness or weakness just odd sensation. Two weeks prior had steroid injections in back followed by week of nocturia now resolved. Currently fighting a cold.  May likely be a side effect from steroid injections. Two weeks later seen for C/O nausea and wave of dizziness, intermittent, decrease in appetite and weight loss, diarrhea. Currently on Flexeril. Heart races when dizzy. Mild cough and chest congestion. Felt like passing out. Feet seem more cold, although hands and feet are always cold. Irregular period, 2 weeks early. spotting for 7-8 days. Skin crawling sensation intermittent 1 month after first HPV vaccine.Symptoms worsen with fatigue and when anxious. Feels worse after eating cake. Neuro consult 4/4/08-Sensory symptoms cause unknown.  This is in follow-up to report(s) previously submitted on 5/14/2008.  Follow up information received from the physician indicated concomitant medication included TAZORAC, KLARON and Brevoxyl wash.  On 15-Mar-2008 (previously reported as 16-Mar-2008) the patient experienced tingling/paraesthias/skin "crawling" sensation both hands, both feet , no numbness, weakness.  Normal reflexes, Normal exam.   At the time of reporting the patient had not recovered.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Metabolic function test, Nerve conduction studies normal, Neurological examination normal, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 27 year old female with no previous medical history or no known drug allergies, who on 15-FEB-2008 was vaccinated IM with a 0.5 ml first dose of HPV rL1 6 11 18 VLP vaccine (yeast) (lot# 655327-1287U). There was no concomitant medication. On 16-MAR-2008 the patient experienced tingling and formication of both hands, feet, and bilateral anterior thighs. The patient was examined in the office on 21-MAR-2008. Neurological exam was normal. Complete blood count, metabolic panel, and thyroid stimulating hormone levels were normal. The patient was examined by an unspecified neurologist in early April 2008. Nerve conduction testing on the right leg and neurological exam were normal. The physician added that the patient received an unspecified steroid injection in the sacr-iliac joint 2 weeks prior to the onset of symptoms. Medical attention was sought in the office. At the time of reporting the patient was recovering. No product quality was involved. 5/27/08-records received-office visit 2/15/08-Current problems: acne vulgaris, depression with anxiety, dizziness. 3/21/08-C/O tingling sensation began 5 days ago, mild intensity, constant. Paresthesia in both hands (stocking glove distribution) both feet and both anterior thighs. Not associated with numbness or weakness just odd sensation. Two weeks prior had steroid injections in back followed by week of nocturia now resolved. Currently fighting a cold.  May likely be a side effect from steroid injections. Two weeks later seen for C/O nausea and wave of dizziness, intermittent, decrease in appetite and weight loss, diarrhea. Currently on Flexeril. Heart races when dizzy. Mild cough and chest congestion. Felt like passing out. Feet seem more cold, although hands and feet are always cold. Irregular period, 2 weeks early. spotting for 7-8 days. Skin crawling sensation intermittent 1 month after first HPV vaccine.Symptoms worsen with fatigue and when anxious. Feels worse after eating cake. Neuro consult 4/4/08-Sensory symptoms cause unknown.  This is in follow-up to report(s) previously submitted on 5/14/2008.  Follow up information received from the physician indicated concomitant medication included TAZORAC, KLARON and Brevoxyl wash.  On 15-Mar-2008 (previously reported as 16-Mar-2008) the patient experienced tingling/paraesthias/skin "crawling" sensation both hands, both feet , no numbness, weakness.  Normal reflexes, Normal exam.   At the time of reporting the patient had not recovered.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Bacterial DNA test, Chlamydia identification test negative, Human papilloma virus test positive
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2008: 7/8/2008. Information has been received from a mother concerning her 17 year old daughter with depression and no known drug allergies, who on 28-MAR-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified), LEXAPRO and ABILIFY.  The patient also received MENACTRA on the same day she received GARDASIL.  Four days after receiving her first dose of GARDASIL the patient tested HPV positive.  Medical attention was sought via telephone.  The patient had not recovered.  No product quality complaint was involved.  Follow up information received from the physician indicated that the patient received her GARDASIL in another physician's office. Follow up information was received on 01-JUL-2008. A health care professional reaported that the patient received the dose of GARDASIL at another office. She also reported that the patient was seen at their office on 31-MAR-2008 for an annual pap smear which came back with positivefor HPV. The laboratory results were as follow: Cervical HPV came back positive: hybrid capture 2 tests for high risk HPV types 16/18/31/33/35/39/45/51/52/56/58/59/66. Chlamydia PCR and gonorrhoeae were not detected. Additional information is not expected. This is in follow-up to report(s) previously submitted on 5/14/2008. Follow up information received from the physician indicated that the patient received her GARDASIL in another physician's office. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Menstruation delayed, Pregnancy test negative
Clinical narrative: Information has been received from a health professional concerning an 8 year old female who on 30-JAN-2008 was vaccinated IM with a first dose of GARDASIL (lot#656050/0245U). There was no concomitant medication. The patient had her period in January but did not get it in February and March. The office did a pregnancy test before administering the second dose and it was negative. The office went ahead and administered the second dose of GARDASIL (lot# 659655/1486U) on 31-Mar-2008. No medical attention was sought. The office did not follow up on the patient yet to see if her menstrual cycle was back to normal. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a health professional concerning an 18 year old female with no previous medical history or no known drug allergies, who was vaccinated with 3 dose series of GARDASIL.  The patient received the first two doses in an other location (lot# not provided).  She also received MMR and DTAP (manufacturer unknown) with the first dose.  The patient was vaccinated IM with a 0.5 ml third dose of GARDASIL at this location (lot# 655620/0171U).  No concomitant medication.  After this she experienced amenorrhea.  The same happened after the second dose and she was given a PROVERA challenge to restart the menstrual cycle, which it did.  The patient's mother called the office to report the patient had amenorrhea again after receiving the third dose.  Unknown medical attention was sought via phone.  The patient's outcome reported as not recovered.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from an office manager at the physician's office concerning a female consumer who on 31-OCT-2007 was vaccinated with a first dose of GARDASIL (lot # 657736/0389U). It was reported that "after the 1st dose", the patient has her period in November and December; however she did not have it in January, February and March. On 06-MAR-2008 the patient received her second dose of GARDASIL (lot # 659655/1486U). It was reported that the patient was not pregnant. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a 20 year old female who on 04-APR-2008 was vaccinated intramuscularly in the left arm with a 0.5 mL first dose of GARDASIL (lot # 659182/1757U). The nurse reported that by 11-APR-2008 the patient had a rash on both wrists. The nurse also reported that the rash was more prominent on the left wrist. On 14-APR-2008 the patient called the doctor's office and reported that she will follow up with her primary care provider. It was reported that therapy with GARDASIL will be discontinued "pending outcome". Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning an "18 to 19 year old" female consumer who on an unspecified date in April 2008, was vaccinated intramuscularly with a "second dose" of GARDASIL (lot # not reported).  There was no concomitant medication.  The nurse reported that the patient "fainted ten minutes after vaccination".  The nurse noted that "the patients who read the GARDASIL fact sheet prior to vaccination seemed more prone to fainting".  It was also reported that "most of the patients did not have breakfast and this may play a role because the vaccinations were given early in the day".  The patient sought unspecified medical attention during an office visit.  The patient recovered from fainting "on the same day".  This is one of several reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who was vaccinated with a dose of GARDASIL (lot not reported). Subsequently the patient developed warts on her back after vaccination. It reported that the patient implied the patient was not sexually active. The warts were treated topically. The patient's warts persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional concerning females who were vaccinated with GARDASIL (lot# not provided).  Subsequently 2 out of 3 patients experienced pain at the injection site that lasted for several days post-vaccination.  There was no prevalence in the series of the doses in terms of pain intensity.  Subsequently, the patients recovered from pain at the injection site.  The patients sought unspecified medical attention at the doctor's office.  A phone call was placed on 22-APR-2008 to obtain more information.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Syncope
Clinical narrative: Information has been received from a nurse concerning a 15 year old female with no known drug allergies, who was vaccinated with the first dose of GARDASIL (lot# 0152X) (date and route of vaccination was not reported).  There was no concomitant medication.  About ten minutes after the vaccination the patient fainted a physician nearby evaluated her. They propped the patient feet up. She was vaery pale. She came to in 2 minutes. Observed for 20 minutes and discharged home. It was unknown whether medical attention was sought.  The patient's outcome is unknown.  No product quality complaint was involved.  Additional information has been requested. The patient was recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL (lot # not reported). The physician reported that " the patient experienced dizziness while still in the office and this subsided". The patient sought unspecified medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ, VARCEL
Symptoms: Inappropriate schedule of drug administration, Syncope
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on 15-APR-2008 was vaccinated with her first dose of GARDASIL (lot# not provided). Concomitant therapy included VARIVAX, (duration and dose not reported). Other concomitant therapy included MENACTRA and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 15-APR-2008 the patient fainted after receiving the first dose of GARDASIL. The patient was recovering from fainting. She sought medical attention in the clinic. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 14-APR-2008 was vaccinated with a third dose of GARDSIL (lot 3 not reported). Dates and lots of the previous two vaccinations were not reported. The physician reported that the patient's "parent phoned the office on 15 or 16- APR-2008 to state the patient had experienced a rash at injection site." The patient sought unspecified medical attention during the phone call. A the of this report the patient had not recovered from the rash. Additional information has been requested.  1/5/10 follow up - injection site rash: Urticaria initial  and follow up information has been received from a physician concerning a 12 yr old female student with seasonal allergies who on  16-apr-2008 (previously reported on 14-apr-2008) was vaccinated intramuscularly inton the right arm with a third dose of HPV 6 11 16 18 VLP vaccine. dates and lots of the previous two vaccinations were not reported. the physician reported that the patient's  parent phoned the office on 15 or 16 apr 2008 to state that the patient had experienced a  rash at the injection site. the patient sought unspecified medical attention.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a 17 year old female consumer who on an unspecified day was vaccinated IM with a first dose of GARDASIL and received her second injection approximately on 09-APR-2008.  She reported that she experienced nausea and vomiting after receiving the first dose of vaccine.  She reported these side effects on 09-APR-2008 after she received the second dose of GARDASIL.  No side effects had been reported from the patient after receiving her second dose as of this date.  The outcome was unknown.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, IPV, MNQ
Symptoms: Inappropriate schedule of drug administration, Syncope
Clinical narrative: Information has been received from a health professional concerning an 11 year old female who was vaccinated intramuscularly on an unspecified date with her first dose of GARDASIL (lot# not reported). Concomitant therapy included DTAP-IPV and MENACTRA. Subsequently the patient experienced syncope after receiving GARDASIL. She sought unspecified medical attention and her outcome was not reported. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 13 year old female patient, who on 14-APR-2008 was vaccinated IM with a dose of GARDASIL. Concomitant suspect therapy included a dose of VARIVAX, and a dose of MENACTRA. On 14-APR-2008 the patient experienced headaches, vomiting, nausea and dizziness. At the time of this report, the outcome of the events was not specified. The patient sought unspecified medical attention. Additional information has bee requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from an office manager concerning a female who was vaccinated IM with a 0.5 ml dose of GARDASIL (dose # unknown).  Within minutes the patient fainted.  The patient was transported to Emergency room where she was treated and released.  She had recovered.  This is one of two cases from the same source (WAES# 0804USA02539).  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a 14 year old female with no pertinent medical history or drug reactions/allergies who in June 2007 was vaccinated with a first dose of GARDASIL 0.5 mL IM.  There was no concomitant medication.  On 04-APR-2008 the patient was vaccinated with a second dose of GARDASIL 0.5 mL IM.  The patient was at the physician's office when she experienced syncope and she remained there until she recovered and was able to leave.  Unspecified medical attention was sought at the physician's office.  On 04-APR-2008 the patient recovered.  No further information was available.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus generalised, Urticaria
Clinical narrative: Information has been received from a physician concerning a 22 year old female with history of pollen allergy who on 15-APR-2008 was vaccinated IM in the right upper arm with a 0.5 mL dose of GARDASIL (lot # 655327/1287U). Concomitant therapy included ALLEGRA and ORTHO EVRA. On 15-APR-2008 the patient experienced generalized hives and itching, as well as redness, tenderness and swelling at the injection site of the right arm, several hours after receiving the vaccine on 15-APR-2008. The patient called the office on 16-APR-2008 and reported that the hives had resolved but she still had generalized itchiness. No treatment was recommended. There was no laboratory test performed. The patient was reported to be recovering. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a nurse concerning an "18 to 19 year old" female consumer who on unspecified date in April 2008, was vaccinated with a "second dose" of GARDASIL (lot # not reported). There was no concomitant medication. The nurse reported that the patient "fainted ten minutes after vaccination." The nurse noted that "the patients who read the GARDASIL fact sheet prior to vaccination seemed more prone to fainting". It was reported that "most of the patients did not have breakfast and this may play a role because the vaccinations were given early in the day". The patient sought unspecified medical attention during an office visit. The patient recovered from fainting "on the same day". This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning an "18 to 19 year old" female consumer who on an unspecified date in April 2008, was vaccinated with a "second dose of GARDASIL (lot # not reported). There was no concomitant medication. The nurse reported that the patient "fainted ten minutes after vaccination". The nurse noted that "the patients who read the GARDASIL fact sheet prior to vaccination seemed more prone to fainting". It was also reported that "most of the patients did not have breakfast and this may play a role because the vaccinations were given early in the day". The patient sought unspecified medical attention during an office visit. The patient recovered from fainting "on the same day". This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning an "18 to 19 year old" female consumer who on an unspecified date in April 2008, was vaccinated with a "second dose" of GARDASIL (lot # not reported). There was no concomitant medication. The nurse reported that the patient "fainted ten minutes after vaccination". The nurse note that "the patients who read the GARDASIL fact sheet prior to vaccination seemed more prone to fainting". It was reported that "most of the patients did not have breakfast and this may play a role because the vaccinations were given early in the day". The patient sought unspecified medical attention during an office visit. The patient recovered from fainting "on the same day". This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a company representative reporting that a physician reported that a female (age not reported) who during the week of 07-APR-2008 was vaccinated with the first dose of GARDASIL (lot not reported) and experienced hives all over her body. By the next morning the hives were gone. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pallor
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated on an unspecified date with her third dose of GARDASIL (lot# 654272/0073X). Subsequently the patient experienced excruciating pain in the right arm and turned all white. Patient had no problems after the first and second dose of GARDASIL. The patient's outcome was not reported and she sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with three doses of GARDASIL. It was reported that patient was positive for GARDASIL getting all three doses of vaccination. The patient did not get the vaccination at the reporting physician's office. The physician reported that the patient was High Risk for HPV. No other information to report. The outcome was reported as patient positive for HPV at the time of this report. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: Information has been received from a medical assistant concerning a female in her early 20s, who on 17-APR-208 was vaccinated with the first dose of GARDASIL in the gluteal region. This was administered in another office so details about administration such as dose or route were unspecified. On 17-APR-2008 the patient experienced pain at the injection site. Unknown medical attention was sought in the office. The patient's outcome is unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nasal congestion, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a female who on 15-JAN-2008 was vaccinated with her first dose of GARDASIL (lot# 660387/1967U). On an unspecified date the patient was vaccinated with her second dose of GARDASIL (lot# not provided). Subsequently the patient experienced nausea, vomiting, headache and stuffy nose since she was given the second dose. The patient was recovering from nausea, vomiting, headache and stuff nose. She sought medical attention by calling the nurse. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Skull fracture, Syncope
Clinical narrative: Information has been received from a physician concerning a male patient who was vaccinated with a dose of GARDASIL. The physician reported that after receiving the vaccination, the patient fainted, hit her head and ended up getting a skull fracture. The patient sought unspecified medical attention. The reporting physician is not the physician of the patient. At the time of this report, the outcome was unknown. No product quality complaint was involved. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician's assistant as told her by the patient's primary care physician concerning a 14 year old female who was vaccinated with a dose (dose number unknown) of GARDASIL on an unspecified date (lot number, route and site not reported). Subsequently the patient was diagnosed with Guillain-Barre Syndrome after receiving GARDASIL. The patient sought unspecified medical attention (date not reported). The patient's outcome was not reported. No further information was provided. The reporter considered Gullain-Barre Syndrome to be an other important medical event. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Somnolence
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated on an unspecified date with GARDASIL (lot# not provided). Concomitant therapy included DEPO-PROVERA. Subsequently the patient experienced extreme drowsiness within an hour after receiving the GARDASIL. Subsequently, the patient recovered from extreme drowsiness the next day. The patient sought medical attention by speaking with the physician. This is one of several reports received from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 23 year old female who on 15-APR-2008 was vaccinated with a first dose of GARDASIL (lot # not reported). The medical assistant reported "that same evening the client called the doctor office mail stating she had a fever of 100F, nausea and vomiting." Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Delivery, Drug exposure during pregnancy, Injection site bruising, Pain in extremity
Clinical narrative: Information has been received from a 21 year old female consumer with hydrocodone allergy who on 24-MAR-2008 was vaccinated with a first dose of GARDASIL (lot # not reported). Concomitant therapy included Tdap. It was reported that the patient was approximately six weeks pregnant (estimated LMP 20-OCT-2007) when she received dose of GARDASIL. It was also reported that the patient developed a bruise at the injection and her arm was sore for several days. The patient sought unspecified medical attention. Additional information has been requested. Follow up information has been received from the patient who had no problems and delivered her baby at 39 weeks and 1 day gestation. She said the baby was healthy and normal. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a female who on 12-OCT-2007 was vaccinated with a first dose of GARDASIL (lot # not reported). On 12-DEC-2007 the patient was vaccinated with a second dose of GARDASIL (lot # not reported). Subsequently the patient developed soreness and redness at the injection site which lasted for one week. It was reported that the patient "did not have this reaction after the first dose of GARDASIL." The patient sought unspecified medical attention. Additional information has been requested.