chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Medication error, Rash, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse (LPN), concerning a 36 year old female patient with tuberculosis, and no known drug allergies, who on 26-MAR-2007 was vaccinated with Gardasil (lot #653736/0014U), as the result of "product confusion."  The nurse stated, "HPV sounds like Hep B."  Concomitant therapy included unspecified therapy for tuberculosis.  In June or July of 2007 ("about 1-2 months ago"), she developed a "rash on her jaw line, below her ear and on her chest."  The LPN stated that a specific treatment had not been recommended for the rash.  At the time of this report, the patient had not recovered.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007.  Initial and follow-up information has been received from a licensed practical nurse, concerning a 36 year old female patient with tuberculosis, and no known drug allergies, who on 26-MAR-2007 was vaccinated with GARDASIL (lot #653736/0014U), as the result of "product confusion."  The nurse stated, "HPV sounds like HEP B."  She did not know why the patient was given the wrong vaccine, except that the names sound alike.  The labels, vials and cartons were not confused.  Concomitant therapy included unspecified theraapy for tuberculosis.  In June or July of 2007, ("about 1-2 months ago"), she developed a "rash on her jaw line, below her ear and on her chest."  The LPN stated that a specific treatment had not been recommended for the rash.  At the time of this report, the patient had not recovered.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female who on 25-JUN-2007 was vaccinated with a third dose of Gardasil (Lot # 657737/0522U).  On 27-JUN-2007 the patient developed unusual swelling of the upper left forearm, and the injection site was very hard and red.  The patient contacted the physician and went for a follow-up visit and was treated with ADVIL, BENADRYL, and ice.  On 29-JUN-2007 the patient recovered.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a 25 year old female licensed practical nurse with sulfonamide allergy who on 31-MAY-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 657006/0188U). On 26-JUL-2007 the patient was vaccinated IM with a 0.5 ml second dose of Gardasil. Concomitant therapy included CELEBREX. On 07-AUG-2007 the patient developed genital warts. Unspecified medical attention was sought. The patient's genital warts persisted. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old female with drug hypersensitivity to codeine, who on 02-AUG-2007 was vaccinated IM in the left deltoid with a second dose of Gardasil.  On 02-AUG-2007 in the late evening, the patient experienced headache, dizziness, nausea and loose stool.  The symptoms lasted 24 hours. On 04-AUG-2007, the patient recovered.  Additional information is not available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea
Clinical narrative: Information has been received from a physician concerning a 16 year old female student, who, on 17-APR-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot#655503/0012U). Since 17-APR-2007 the patient experienced a headache "off and on" and nausea. No treatment was given except over the counter TYLENOL. On 23-JUL-2007 the patient was vaccinated intramuscularly with a second dose of Gardasil (Lot# 655503/0012U). No laboratory diagnostics were performed. The patient was placed on unspecified birth control pills during the same time between doses. No product quality complaint was involved. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hiccups, Tic
Clinical narrative: Information has been received from a certified medical assistant concerning a 16 year old female patient with a penicillin allergy which caused hives who on 15-DEC-2006, was vaccinated IM into the right deltoid with a first 0.5ml dose of Gardasil. Two months ago, on 07-JUN-2007 the patient developed a "tick" and will be seeing a neurologist. On 25-JUN-2007, the patient was vaccinated with a third dose of Gardasil vaccine (Lot# 657737/0552U). Concomitant therapy included LOESTRIN. On 25-JUN-2007, the patient developed severe hiccups. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a nurse concerning a female patient between the ages of 9 and 12 who was vaccinated with a first dose of Gardasil. Within the first several days of being vaccinated, the patient experienced abdominal cramping. It was reported that the patient was pre-pubsecent and was not menstruating. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Axillary pain, Lymph node pain
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female who was vaccinated in the deltoid with a first dose of Gardasil. Concomitant vaccination included Menactra into a different injection site. Subsequently a day after vaccination with Gardasil the patient developed pain in her underarm and lymph area in the same arm which lasted 3-4 days. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Local swelling, Soft tissue disorder
Clinical narrative: Information has been received from a physician concerning a female with n allergies who on 028-JUL-2007 was vaccinated with a 0.5 ml third dose of Gardasil. There was no concomitant medication. On 05-JUL-2007 the patient developed a bump around her hands and was swollen over the neck area. A "blood test was performed" results not reported. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There were no adverse events involved with the first and second doses of Gardasil. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old female who on 01-AUG-2007 was vaccinated with a dose of Gardasil. Concomitant vaccination on 01-AUG-2007 included Vaqta and Varivax. On 02-AUG-2007 it was reported via phone by the patient's mother that the patient developed an itchy rash on bottom of her feet and hands. the physician prescribed BENADRYL to relieve the symptoms. On 02-AUG-2007 the patient was going to be seen in the office, and had not recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Viral infection
Clinical narrative: Information has been received from a certified nurse midwife concerning a 21 year old female with asthma, oesophageal acid reflux, penicillin allergy and a history of mononucleosis syndrome (Mono) in 2001 who on 24-MAY-2007 was vaccinated with Gardasil (lot# 657736/0389U) IM left deltoid. Concomitant therapy included LOESTRIN. On 25-MAY-2007 "24 hours after vaccination" the patient experienced high fever and viral type symptoms (type of symptoms unspecified). Medical attention was sought. The patient went to the emergency room. At the time of reporting it is unknown if the patient had recovered. No further information is available. This is one of two reports from the same source. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Eye pruritus, Immediate post-injection reaction, Inappropriate schedule of drug administration, Laboratory test
Clinical narrative: Information has been received from a 30 year old female with a history of loop electrosurgical excision procedure and no drug reactions/allergies who on 02-MAY-2007 was vaccinated with a first dose of Gardasil (lot# unknown) injection. There was no concomitant medication. In 02-MAY-2007, "right after receiving the first dose", the patient experienced itchiness on eyes like crazy and both of her eyes turned pink and then reddish at times. The patient reported that she had never had allergies before, she dose not play outdoors and she doesn't  have any pets. The patient also reported that she would always experience the itchiness on her eyes in the morning and this symptom has started since May 2007 after receiving the first dose of Gardasil. The patient did not seek medical attention. On an unspecified date the patient had blood work and regular check up performed, the results were unknown. Further information was not provided. Additional information has been requested. Follow-up information was received from the registered nurse. On 03-JUL-2007, the patient was vaccinated with a second dose of GARDASIL (lot# 02110) IM in the left deltoid. The lot numbers were updated. The patient had no illness at the time of vaccination. Follow-up information was also received from the consumer. Almost immediately thereafter (within days or a week), the patient's eyes started to itch and water daily, mostly in the mornings. It didn't occur to the patient until a couple of weeks after the second GARDASIL vaccine shot (July) that maybe it was an adverse reaction to the vaccine. At the time of reporting the patient reported that the itching is still present, but it has tapored off a lot. Additional information is not exected.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Lacrimation increased, Ocular hyperaemia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 30 year old female with a history of loop electrosurgical excision procedure and no drug reactions/allergies who on 02-MAY-2007 was vaccinated with a first dose of Gardasil (lot# unknown) injection. There was no concomitant medication. In 02-MAY-2007, "right after receiving the first dose", the patient experienced itchiness on eyes like crazy and both of her eyes turned pink and then reddish at times. The patient reported that she had never had allergies before, she dose not play outdoors and she doesn't  have any pets. The patient also reported that she would always experience the itchiness on her eyes in the morning and this symptom has started since May 2007 after receiving the first dose of Gardasil. The patient did not seek medical attention. On an unspecified date the patient had blood work and regular check up performed, the results were unknown. Further information was not provided. Additional information has been requested. Follow-up information was received from the registered nurse. On 03-JUL-2007, the patient was vaccinated with a second dose of GARDASIL (lot# 02110) IM in the left deltoid. The lot numbers were updated. The patient had no illness at the time of vaccination. Follow-up information was also received from the consumer. Almost immediately thereafter (within days or a week), the patient's eyes started to itch and water daily, mostly in the mornings. It didn't occur to the patient until a couple of weeks after the second GARDASIL vaccine shot (July) that maybe it was an adverse reaction to the vaccine. At the time of reporting the patient reported that the itching is still present, but it has tapored off a lot. Additional information is not exected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Drug administered at inappropriate site, Hepatic function abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with elevated liver enzymes in November 2006 and seasonal allergies who on 12-JAN-2007 was vaccinated with a first dose of Gardasil (lot # 655619/14207F) 0.5mL subcutaneous. Concomitant therapy included (CLARITIN-D). On 20-MAR-2007 the patient was vaccinated with a second dose of Gardasil (lot # unknown) 0.5mL subcutaneous IM. Medical attention was sought. On 19-JUL-2007 the diagnostic laboratory test showed elevated liver enzymes, AST and ALT, but this was down from the test in November 2006. At the time of reporting the patient's elevated liver enzymes, AST and ALT persisted. No additional information at this time. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Arthritis, Body temperature increased, Dehydration, Injection site pain
Clinical narrative: Initial and follow up has been received from a pharmacist concerning her 15 year old daughter who on 03-AUG-2007 at 2:00 p.m. was vaccinated with her 3rd dose of Gardasil, and experienced pain with injection (did not have any pain with previous 2 shots).  At 6:00 p.m. she started having joint aches/pain plus fever of 102.4-102.  The reporter was concerned that her daughter had got a bad lot, since she had been asymptomatic with other doses.  Correct lot information was not available.  The reporter stated that the patient had been taken to the emergency room and was treated with 2 liters as she had passed out twice.  She further stated that her daughter had been nauseated, had arthritis and pain in every joint, but that she was fine the next day.  She believed the events occurred due to her daughter being dehydrated as she had not had anything to drink.  The reporting pharmacist agreed to provide lot number information if available from the Nurse Practitioner who administered the injection.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 09/17/07. Additional follow up information has been received from the pharmacist concerning the student with a sulfa energy. The pharmacist stated that the injection of GARDASIL administered on 03-AUG-2007 stung and hurt a lot more than other shots and that her daughter started running a fever of 102-104 most of the night. She said that all of her joints ached and felt terrible. On 04-AUG-2007 she blacked out twice and was taken to the ER where she received 2 L of normal saline. CBC and chemistry were normal, they were unable to obtain urinalysis. The patient recovered on 05-AUG-2007. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Nausea, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Initial and follow up has been received from a pharmacist concerning her 15 year old daughter who on 03-AUG-2007 at 2:00 p.m. was vaccinated with her 3rd dose of Gardasil, and experienced pain with injection (did not have any pain with previous 2 shots).  At 6:00 p.m. she started having joint aches/pain plus fever of 102.4-102.  The reporter was concerned that her daughter had got a bad lot, since she had been asymptomatic with other doses.  Correct lot information was not available.  The reporter stated that the patient had been taken to the emergency room and was treated with 2 liters as she had passed out twice.  She further stated that her daughter had been nauseated, had arthritis and pain in every joint, but that she was fine the next day.  She believed the events occurred due to her daughter being dehydrated as she had not had anything to drink.  The reporting pharmacist agreed to provide lot number information if available from the Nurse Practitioner who administered the injection.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 09/17/07. Additional follow up information has been received from the pharmacist concerning the student with a sulfa energy. The pharmacist stated that the injection of GARDASIL administered on 03-AUG-2007 stung and hurt a lot more than other shots and that her daughter started running a fever of 102-104 most of the night. She said that all of her joints ached and felt terrible. On 04-AUG-2007 she blacked out twice and was taken to the ER where she received 2 L of normal saline. CBC and chemistry were normal, they were unable to obtain urinalysis. The patient recovered on 05-AUG-2007. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old female with seasonal allergies, allergy to penicillin, sulfonamide antibiotic, Ceftin, and cephalosporin antibiotics who on 31-JUL-2007 was vaccinated with the first dose of Gardasil (lot # 658490/0802U) 0.5 ml IM.  Concomitant therapy included ALLEGRA-D and RETIN-A.  On 31-JUL-2007, 1 hour after being vaccinated, the patient developed hives on her chest, abdomen and back.  Medical attention was sought.  The patient self treated at home with BENADRYL and was fully recovered on 03-AUG-2007.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old female with seasonal allergies, allergy to penicillin, sulfonamide antibiotic, Ceftin, and cephalosporin antibiotics who on 31-JUL-2007 was vaccinated with the first dose of Gardasil (lot # 658490/0802U) 0.5 ml IM.  Concomitant therapy included ALLEGRA-D and RETIN-A.  On 31-JUL-2007, 1 hour after being vaccinated, the patient developed hives on her chest, abdomen and back.  Medical attention was sought.  The patient self treated at home with BENADRYL and was fully recovered on 03-AUG-2007.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Initial and follow up information has been received from a physician, concerning a 15 year old female patient with drug hypersensitivity to cephalosporin, CEFTIN, penicillin and sulfonamide, who on 31-JUL-2007 (previously reported as 01-AUG-2007), at 4:15pm, was vaccinated IM in the left arm, with the first dose of Gardasil (Lot # 658490/0802U).  There was no illness at the time of vaccination.  On 31-JUL-2007, at 6:00pm, the patient developed a rash/hives on her trunk.  The physician indicated an office visit was not required, and did not specify treatment.  On 02-AUG-2007, the patient had recovered from the hives.  No further information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Initial and follow up information has been received from a physician, concerning a 15 year old female patient with drug hypersensitivity to cephalosporin, CEFTIN, penicillin and sulfonamide, who on 31-JUL-2007 (previously reported as 01-AUG-2007), at 4:15pm, was vaccinated IM in the left arm, with the first dose of Gardasil (Lot # 658490/0802U).  There was no illness at the time of vaccination.  On 31-JUL-2007, at 6:00pm, the patient developed a rash/hives on her trunk.  The physician indicated an office visit was not required, and did not specify treatment.  On 02-AUG-2007, the patient had recovered from the hives.  No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female who on 31-JUL-2007 was vaccinated with a first dose of Gardasil (lot # 658282/0929U) 0.5 ml IM.  Concomitant therapy included MENACTRA, albuterol and hormonal contraceptives (unspecified).  On 31-JUL-2007, the patient was administered both vaccines in the same arm and experienced an area of redness, warmth, and tenderness approximately 1-2 inches below the injection site of the vaccines.  The patient sought medical attention.  At the time of reporting, the patient was recovering.  Additional information has been requested.
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil 0.5 ml injection.  Concomitant therapy included TETANUS TOXOID (USP 23) also given on the same date.  Subsequently, the patient experienced "some sort of adverse reaction".  The outcome was not reported.  No further information was provided.  No additional information is available.
Sex: F
Vaccine: HPV4
Symptoms: Muscle atrophy
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil.  Subsequently the patient experienced muscle atrophy.  The patient was referred to an orthopedic physician who stated that the patient's muscle atrophy was related to therapy with Gardasil.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Axillary pain, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a female who on approximately 02-AUG-2007 was vaccinated with a third 0.5 mL dose of Gardasil.  On 02-AUG-2007, the patient contacted the physician's office to report that she had experienced pain at the injection site, which extended to the armpit, after vaccination with her third dose of Gardasil.  The office recommended treatment therapy with BENADRYL.  The patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: Information has been received from a nurse concerning herself who was vaccinated with a dose of Gardasil.  Subsequently the patient developed shingles with one lesion.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse practitioner concerning an 11 year old female who on 25-JUL-2007 was vaccinated with a dose of Gardasil (lot# unknown) 0.5 mL injection.  There was no concomitant medication.  On 25-JUL-2007 the patient felt dizzy after receiving Gardasil.  Medical attention was sought.  The patient laid down for a "few minutes" and felt better.  Subsequently, on 25-JUL-2007 the patient recovered from feeling dizzy.  No further information was provided.  Additional information has been requested.  This report is one of two reports.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Fall, Head injury, Headache, Injection site pain
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 14 year old female patient, was vaccinated with a dose of Gardasil.  "Almost immediately." the patient experienced a severe headache, tingling in her extremities, and severe injection site pain.  While she was checking out, she fainted and hit her head on the counter.  Later that evening, she continued to "feel ill," and her mother took her to the ER, where a computed tomography (CT) was performed (results not provided).  The following day, the patient reported feeling better, but still had a headache and nausea.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Nausea, Paraesthesia, Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 14 year old female patient, was vaccinated with a dose of Gardasil.  "Almost immediately." the patient experienced a severe headache, tingling in her extremities, and severe injection site pain.  While she was checking out, she fainted and hit her head on the counter.  Later that evening, she continued to "feel ill," and her mother took her to the ER, where a computed tomography (CT) was performed (results not provided).  The following day, the patient reported feeling better, but still had a headache and nausea.  Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Epistaxis, Full blood count
Clinical narrative: Information has been received from a Nurse Practitioner concerning an approximately 9 year old female who was vaccinated with the first dose of Gardasil.  Subsequently the patient experienced nose bleeds that started about two hours after the vaccine was administered and has continued every day.  As of 03-AUG-2007, the patient had not recovered.  Medical attention was sought and a CBC was performed (results not reported). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Feeling of body temperature change, Headache, Pyrexia
Clinical narrative: Information has been received from a Registered Nurse concerning her 18 year old daughter who on 31-JUL-2007 was vaccinated with the first dose of Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified).  On 01-AUG-2007 the patient experienced headache, dizziness, tiredness, feeling hot and cold and a slight fever.  The patient treated herself with over the counter cold medicine.  As of 03-AUG-2007, the patient had not recovered.  Medical attention was sought.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Registered Nurse concerning a 20ish year old female who was vaccinated with the first dose of Gardasil.  Concomitant therapy included 2 other vaccines (unspecified).  Subsequently the patient fainted after receiving the vaccines.  The patient recovered and was fine after about 20-30 minutes.  Medical attention was sought.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female who was vaccinated with the first dose of Gardasil and fainted.  Medical attention was sought.  The patient recovered.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site irritation, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 24 year old female patient who on 27-JUN-2007 was vaccinated IM in the left deltoid with the first dose of GARDASIL (Lot #657737/0522U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 27-JUN-2007 the patient experienced constant burning and tenderness at injection site on her left arm.  She also reported that movement of the arm made it worse and was more painful at the end of the day.  It was hard for the patient to flex her tricep muscles.  There was no swelling or redness.  On 01-AUG-2007, the patient returned to the office, and complained of continued burning and tenderness at the site of injection. There was no swelling, redness, or fever. The patient was treated with ibuprofen (WYETH).  As of 03-AUG-2007, the patient had not recovered.  Medical attention was sought.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. At the time of this report, the outcome of the events was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Injection site pain, Musculoskeletal pain
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who was vaccinated from a (single dose vial) third dose of Gardasil.  Subsequently, the patient experienced injection site pain that traveled to her shoulder and back.  The physician's office advised the patient to take TYLENOL.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 19 year old female with a history of mental disorder who was vaccinated with Gardasil and fainted.  The patient's outcome was not reported.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning 2 females who were vaccinated with Gardasil.  Subsequently the patients experienced fainting during the injection.  The girls were extremely anxious about the injection.  The patients' outcomes were not reported.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian cyst
Clinical narrative: Information has been received from a physician concerning an 18 year old female who in March 2007, was vaccinated with the first dose of Gardasil.  In June 2007, the patient was vaccinated with the second dose of Gardasil and developed a right ovarian cyst.  As of 06-AUG-2007, the patient was recovering.  Medical attention was sought.  Follow-up information was received from a licensed practical nurse who reported the patient did not know anything about this event.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Nausea, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 19 year old female with a history of abnormal Papanicolaou smear who on 14-DEC-2006 was vaccinated IM with the first dose of Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified).  On 14-DEC-2006 the patient experienced fever.  In April 2007, the patient experienced fever, nausea and chills after receiving the second dose of Gardasil.  Subsequently, the patient recovered from all of her experiences.  Medical attention was sought.  Additional information has been requested. Initial and follow up information has been received from a nurse practitioner concerning a 19 year old female student with no known drug allergies, and a history of an abnormal papanicolacu smear, who on 14-DEC-2006 was vaccinated IM in the deltoid, with the first dose of GARDASIL (invalid lot #). The patient recalled she possibly had a "cold" at the time of vaccination. On 14-DEC-2006, following the vaccination, she developed a fever, and had chills and nausea. She recovered after 3 days. In April 2007, the patient was vaccinated at a school, with a second dose of GARDASIL (lot # not provided), and gain developed a fever, chills and nausea. The patient recovered this time after 7 days. Treatment was not specified. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure via breast milk
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 25 year old female who on 29-JUN-2007 was vaccinated in the right deltoid with a first dose of Gardasil (Lot #0469U) while nursing.  On approximately 13-JUL-2007, the baby developed a cold.  Subsequently, the baby recovered.  Subsequently the infant developed otitis media (OM).  The infant was treated with amoxicillin for OM.  On approximately 07-AUG-2007, the baby developed a cold.  At the time of the report the infant's outcomes was unknown.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site irritation
Clinical narrative: Information has been received from a nurse practitioner concerning an unknown number of patients (age and gender not reported) who was vaccinated with Gardasil (lot # unknown). The nurse reported that at two separate clinics the patients were complaining about receiving Gardasil in the deltoid so the office began to administer the injection in the hip. No adverse event was involved. Follow-up information was received from a nurse via telephone. The nurse reported that her office had given approximately 100 injections in the hip. The nurse did not have an exact amount. The nurse also reported that patients complain about burning at the injection site. This report is from one of two reports. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a teenage female patient who was vaccinated with a dose of Gardasil.  Subsequently the patient fainted in the physician's office after receiving the vaccination.  Subsequently, the patient recovered while in the office and was sent home.  The patient did not require additional medical attention.  This is one of several reports received from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Pain
Clinical narrative: Initial and follow-up information has been received from a office manager concerning several families, with no pertinent medical history, who were vaccinated IM with a 0.5 ml dose of Gardasil. Subsequently the patient experienced that their vaccination hurt and or had a burning sensation. Subsequently, all the patients recovered. No laboratory or diagnostic tests were performed. At this time, the office manager reported that she had "no idea how many patients complained" since she did not document. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 26-JUL-2007 was vaccinated IM with the first dose of Gardasil (Lot#0530U).  Concomitant therapy included PULMICORT, CLARITIN, albuterol and ORTHO EVRA.  On 26-JUL-2007 post vaccination the patient fainted.  The physician reported that he found out after administering the vaccine that the patient had not eaten that morning.  Subsequently, before leaving the physician's office that day the patient had recovered from the event.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow up information has been received from a physician concerning a 20 year old female with asthma who on 26-JUL-2007 at 10:30 am was vaccinated IM with the first dose of GARDASIL (Lot#0530U). Concomitant therapy included PULMICORT, CLARITIN, albuterol and ORTHO EVRA. On 26-JUL-2007 post vaccination, while at the front desk the patient felt dizzy and fainted. Her vital signs were pulse 72 and BP 100/60 mmHG. Paramedics were called, however the patient refused to go the emergency room. The physician reported that he found out after administering the vaccine that the patient had not eaten that morning. Subsequently, before leaving the physician's office that day the patient had recovered from the event. The patient followed up with her primary care physician. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a licensed practical nurse concerning a 19 year old female, with no pertinent medical history, who in March 2007, was vaccinated IM with a 0.5 ml first dose of GARDASIL.  There was no concomitant medication.  In March 2007, the patient felt dizzy and lightheaded.  The patient had the symptoms one week after the vaccination.  Unspecified medical attention was sought.  Subsequently, the patient recovered from feeling dizzy and lightheaded.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse practitioner concerning an 11 year old female who on 20-AUG-2007 was vaccinated with Gardasil.  On 20-AUG-2007 the patient felt dizzy.  Patient outcome was unknown.  No further information is available.  A 13 year old's experiences were also reported after Gardasil (WAES 0709USA01953).
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Initial and follow up information has been received from a physician and a nurse, concerning an unknown number of female patients who were vaccinated with a dose of Gardasil.  The physician indicated that 10 to 15 minutes after the vaccination was administered, "about a quarter" (25%) of the patients had fainted.  At the time of this report, the outcome of the events were unknown.  The patients did not seek medical attention.  Follow up information from the nurse indicated that there was no "trend" to the patients fainting, and it occurred with different lot numbers.  She stated that they will keep track of these episodes in the future.  No further information on individual patients was available.  No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female college student (age not specified), who on approximately 24-NOV-2006 ("9 months ago") was vaccinated with the first dose of Gardasil (lot # not provided). Concomitant therapy included hormonal contraceptives (unspecified). Following the vaccination (duration of time not specified), she developed hives and swelling of her arm. After "about a week" she recovered from the events. The patient sought unspecfieid medical attention. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a licensed practical nurse concerning a 26 year old female with an allergy to penicillin, amoxicillin, morphine and acyclovir who on 21-AUG-2007 was vaccinated with the first dose of Gardasil (lot# 654539/0742U) intramuscularly in the left deltoid of the upper arm.  Concomitant therapy included birth control (unspecified) and vitamins (unspecified).  On 23-AUG-2007 the patient broke out in rash from the waist up, red but not itchy.  She did not feel right.  She felt "crappy".  The patient had not recovered.  No lab testing was performed.  Additional information has been requested. This is in follow-up report(s) previously submitted on 9/17/2007. Information has been received from a licensed practical nurse concerning a 25 year old white social worker female with an allergy to penicillin, amoxicillin, morphine, and acyclovir who on 21-AUG-2007 was vaccinated with the first dose of GARDASIL (lot# 654539/0742U) intramuscularly in the left deltoid of the upper arm. Concomitant therapy included birth control (unspecifed) and vitamins (unspecified). On 24-AUG-2007, three days after the vaccination, the patient broke out in rash from waist up, red, itchy. She did not feel right. She felt "crappy". Unknown medical attention was sought. The patient had recovered. No product quality compliant involved. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 13-AUG-2007 was vaccinated intramuscularly with a second dose of Gardasil (lot#65822/0927U). On 13-AUG-2007 the patient described the vaccine as being "very painful." The patient did not seek medical attention. On 13-AUG-2007 the patient recovered before leaving the physician's office. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 10-AUG-2007 was vaccinated IM with a first dose of Gardasil (Lot # 658222/0927U).  Concomitant vaccination included MENACTRA.  On 10-AUG-2007 the patient felt woozy after the vaccination but didn't feel completely faint.  It was reported that the patient had not eaten all day.  The physician had the patient stay for an hour.  The patient left the office fully recovered.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Vomiting
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 14 year old female patient, who on an unknown date was vaccinated with the first dose of Gardasil (Lot # not provided).  The day after the vaccination, she developed a swollen arm and started to vomit.  At the time of this report, the outcome of the event was unknown.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Urinary tract infection, Urine analysis
Clinical narrative: Information has been received from the pregnancy registry via a physician concerning an 18 year old female who on 22-AUG-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 658822/0927U). Concomitant therapy included DEPO-PROVERA. The physician stated that the patient was diagnosed with a urinary tract infection on 22-AUG-2007. The patient had a urinalysis (results not reported). On 24-AUG-2007 the patient spoke with the physician by phone to report she was two weeks pregnant. The patient last menstrual period was 10-AUG-2007 and estimated of delivery was 15-MAY-2008. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with a dose of Gardasil.  Subsequently the patient became woozy "almost immediately after vaccination".  Medical attention was not sought.  The patient recovered before leaving the office.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated intramuscularly with a dose of Gardasil.  Subsequently, almost immediately after receiving the vaccination the patient became very lightheaded.  The patient did not seek medical attention.  The patient recovered within five minutes after the vaccine was administered.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated intramuscularly with a dose of Gardasil.  Subsequently, almost immediately after receiving the vaccination, the patient became very lightheaded.  The patient did not seek medical attention.  The patient recovered within five minute after the vaccine was administered.  No product quality complaint was involved.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 17 year old female who on 16-JUN-2007 was vaccinated with her first dose of Gardasil, 0.5 mL injection (Lot # 658556/U). After her first dose of Gardasil, on 17-JUN-2007 the patient developed bruising the size of a baseball on her right arm around the injection site. On an unspecified date the patient recovered from bruising around the injection site. On an unspecified date the patient received her second dose of Gardasil on her left arm and did not report any bruising. It was reported that the patient sought medical attention in the office. PQC was not involved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Hypotension, Syncope
Clinical narrative: Information has been received from an emergency medical technician concerning a 22 year old female student with no pertinent medical history , who on 14-AUG-2007 at 11:15 am was vaccinated IM in the left deltoid with a first dose of Gardasil (lot # 658556/1060U).  On 14-AUG-2007 at 11:30 am, the patient experienced a syncopal episode and hypotension that lasted 5-10 seconds.  The patient had not had a recollection of the event.  On 14-AUG-2007, the patient recovered from syncopal episode and hypotension.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated on an unspecified date with a first dose of Gardasil. Subsequently the patient fainted. The patient fully recovered without complication. The patient was vaccinated on an unspecified date with a second dose of Gardasil. Subsequently the patient developed a migraine headache. The patient contacted the office. The patient fully recovered without complication. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Dizziness, Fall, Head injury, Syncope
Clinical narrative: Information has been received from a physician's assistant concerning a 13 year old female with no known drug allergies who on 08-AUG-2007 was vaccinated IM in the left deltoid with the second vaccination of Gardasil (Lot # 655620/0171U).  The date of the patient's first vaccination was not reported.  It was reported that the patient was not instructed to wait the minimum 15 minutes post vaccination and left the office with her family.  As she walked to the car she reported that she felt dizzy.  She then fell and hit the occipital area of her head.  Paramedics were called and the patient was transported to the ER.  A head CT scan was performed which was normal.  The event was diagnosed as a syncopal episode.  At the time of the report it was unknown if the patient had recovered from the event.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site bruising, Injection site extravasation, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning her 19 year old daughter who on an unspecified date was vaccinated in the buttocks with a first dose of Gardasil.  Subsequently the patient developed pain at the injection site that was "black and blue".  On 23-AUG-2007 the patient was vaccinated in the buttocks with a 1.5 inch needle with a 10 cc syringe second dose of Gardasil.  Subsequently the "drug leaked out."  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Genital lesion, Herpes simplex serology negative, Influenza like illness, Pharyngolaryngeal pain, Throat lesion
Clinical narrative: Information has been received from a physician concerning his daughter who was vaccinated with Gardasil. A few days after Gardasil, she experienced flu-like symptoms, sore throat, and lesions on her throat. A few days after that, she experienced cutaneous lesions in her genital area. She was tested for herpes which was negative. "BBC" and complete work were performed (results not provided). The patient subsequently recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning female patients who were vaccinated with a dose of Gardasil.  Subsequently the patients fainted.  Subsequently, the patients recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning female patients who was vaccinated with a dose of Gardasil. Subsequently the patients fainted. Subsequently, the patients recovered. Additional information has been requested.