chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Genital ulceration
Clinical narrative: Information has been received from an infectious disease physician concerning an approximately 13 year old female who was vaccinated with Gardasil. Subsequently the patient experienced genital ulcers 24 hours after the vaccination. The patient sought medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a nurse practitioner concerning a female in her "mid teens" who, on an unspecified date, was vaccinated with Gardasil. Concomitant therapy included hepatitis B virus vaccine (unspecified). Subsequently the patient developed a rash all over her body. The patient went to the emergency room but hospitalization is unspecified. Subsequently, the patient recovered from the rash all over her body. Additional information has been requested. The product quality complaint unit was not involved.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on April 2007, was vaccinated with Gardasil.  Subsequently the patient experienced an outbreak of genital warts.  The patient's outbreak of genital warts persisted.  Additional information has been requested.  The product quality complaint unit was not involved.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on 03-OCT-2006 was vaccinated with a dose of  GARDASIL.  The nurse reported that the patient had received the first and second doses of GARDASIL (the second dose was two months late)  and experienced swelling of the injection site arm. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received concerning a 21 year old female with penicillin allergy who was vaccinated with Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently the patient experienced pain in the arm she was administered Gardasil. The pain radiated up her shoulder an into her back. She was not able to lift her arm without pain. She tried using a heating pad and an ice pack but neither helped. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Initial information has been received from a physician and follow up information has been received from a nurse concerning a female patient between the ages of 11 and 19 who was vaccinated with a first dose of Gardasil.  It was reported that the patient sat for a minute (after receiving the injection) and when she got up to leave she fainted in the hallway.  Her outcome was not reported.  The physician reported that lot numbers were not available, however, the physician will forward other information including the lot numbers.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007. Follow-up information has been received from a health professional concerning the 19 year old female student with no medical history who on 20Mar-2007 at 3:15 p.m. was vaccinated IM with her first dose of GARDASIL, lot # 655618/0186U. Concomitant medication included a second dose of VAQTA (manufacturer not reported). At 3:15 p.m. the patient experienced dizziness (also reported as within 5 minutes of administration the patient experineced dizziness). The dizziness lasted approximately 5 minutes. The patient laid down on teh exam table and walked out on her own after 10 minutes. Additional infomation is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from an approximately 21 year old female who on 30-APR-2007 was vaccinated with Gardasil.  There was no concomitant medication.  On 01-MAY-2007 the patient experienced small bumps which spread across her upper torso (not red or itchy) approximately 12 hours after her 1st dose.  As of 05-MAY-2007, the patient was not recovered.  At the time of this report, the patient had not sought medical attention.  No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Swelling
Clinical narrative: Information has been received from a physician concerning an 18 year old female stude3nt who on 30-JAN-2007 was vaccinated with her first dose of Gardasil there were no symptoms after the first dose. On 04-APR-2007 the patient was vaccinated with her second dose of Gardasil. On approximately 04-APR-2007 patient had swelling for 2 days and then resolved. On 25-APR-2007 when the patient experienced induration at injection site. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Drug administered at inappropriate site, Pain
Clinical narrative: Information has been received from a registered nurse concerning a college-aged female who was vaccinated with Gardasil in the past in the gluteal area from another provider and there was less pain.  The patient also experienced burning pain after vaccination.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood bilirubin increased, Stomach discomfort
Clinical narrative: Information has been received from a physician and a nurse concerning her 12 year old daughter who in early February 2007 was vaccinated IM with 0.5 ml of Gardasil.  There was no concomitant medication.  In early April 2007, the patient was vaccinated IM, in the left deltoid, with a second dose of Gardasil.  A couple days after the patient's second vaccination, she experienced "high abdominal pain" and an upset stomach.  The patient was taken to the emergency room because the pain had not subsided however she was not admitted.  She was diagnosed with a high level of bilirubin.  Subsequently, she was treated with Zantac and recovered from the events.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a college-aged female who in the past was vaccinated with a dose of Gardasil in the gluteal area from another provider and there was less pain.  It was reported that the patient experienced burning pain after receiving the vaccination.  This is one of several reports received from the same source.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007.  Follow-up information was received from the registered nurse.  On an unspecified date the patient requested the injection to be administered at an alternate site due to post-injection pain after the first dose.  The patient was vaccinated with the second dose of GARDASIL 0.5 mL in the gluteal area.  It was reported that the patient experienced burning pain after receiving the vaccination.  At the time of reporting the patient had recovered.  This is one of several reports received from the same source.  Further information is not available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Skin lesion, Throat irritation, Treponema test negative
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female with allergies to penicillin and amoxicillin who on 02-APR-2007 was vaccinated IM with a second dose of 0.5 ml of Gardasil (Lot # 654702/0011U). Concomitant therapy included EFFEXOR and ORTHO TRI-CYCLEN. On 21-APR-2007, the patient experienced an itchy throat without respiratory distress, but did not seek medical attention. On 01-MAY-2007, the patient was seen by the nurse practitioner who described the circular lesions. 04-MAY-2007, the patient developed lesions, which manifested as circular with white spots, on her hands and at the achilles tendon of the feet after she received the second dose of Gardasil No fever was noted. The "target" appearance resolved in three days. On an unspecified date, a rapid plasma reagin card test was performed, the result of which was negative. The patient outcome was unknown. Additional information has been requested.  Additional infromation is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a physician concerning his 15 year old daughter with no drug reactions/allergies and no reported medical history who in approximately February 2007, was vaccinated in the left arm with the first dose of Gardasil. there was no concomitant medication. Three days post-vaccination, the patient developed supraclavicular adenopathy on her left side and a fever of 100.5F. She was treated with ibuprofen and acetaminophen. Subsequently, the patient recovered in two weeks. Additional information has been requested. This is one of two reports received from the same source.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on 02-MAY-2007 was vaccinated with the first dose of Gardasil. Ten minutes after receiving the vaccination, the patient passed out. Subsequently, the patient recovered on 02-MAY-2007 and was noted to be fine. Additional information has been requested. 07/08/2008 Initial and follow up information has been received from a nurse concerning a 13 year old female student who on 02-MAY-2007 was vaccinated with the first dose of GARDASIL. Ten minutes after receiving the vaccination, the patient passed out. Subsequently, the patient recovered on 02-MAY-2007 and was noted to be fine. In follow up information from the doctor's office it was reported that patient felt very faint on 03-MAY-2008 (previously reported as patient passed out on 02-MAY-2008). She recovered on the same day. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Injection site reaction
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female who on 27-FEB-2007 and 02-MAY-2007 was vaccinated with her first and second doses of GARDASIL vaccine (yeast) (lots 655619/1427F and 657621/0387U).  There was no concomitant medication.  There was no adverse experience following the first dose.  On 03-MAY-2007, 16 hours after the second dose, the patient experienced flu like symptoms, chills, muscle aches, joint aches, headache, and nausea.  The patient was treated with Tylenol and rest and was recovering, but on 07-MAY-2007 she still reported lethargy and muscle spasms, right arm (injection arm).  Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Information has been received  froma anurse practitioner concerning a 21 year old female (weight 169 #, height 68") who on 27-FEB-2007 was vaccinated with her first dose of GARDASIL vaccine(yeast) (Lot# 655619/1427P). On 03-MAY-2007m at 1 pm, the patient was vaccinated with her second dose of GARDASIL vaccine (yeast) ( Lot #657621/0387U) IM in the right deltois. There was no concomitant medication. There was no adverse experience following the first dose. On  04-MAY-2007 at 4 am, 14 hours after the sceond dose, the patient experienced flu like symptoms. chills,muscle acheesz, joint aches, headache and nausea. Lethargy, malaise and muscle spams in the right arm continued for 4-5 days. The patient was treated with acetaminophen (Tylenol) and rest. ON 07-MAY-2007, the patient still reported lathargy an muscle spasms, right arm (injection arm). On 11-MAY-2007, the patient had recovered from the events. Additional information is not expected
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Lethargy, Muscle spasms, Myalgia, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female who on 27-FEB-2007 and 02-MAY-2007 was vaccinated with her first and second doses of GARDASIL vaccine (yeast) (lots 655619/1427F and 657621/0387U).  There was no concomitant medication.  There was no adverse experience following the first dose.  On 03-MAY-2007, 16 hours after the second dose, the patient experienced flu like symptoms, chills, muscle aches, joint aches, headache, and nausea.  The patient was treated with Tylenol and rest and was recovering, but on 07-MAY-2007 she still reported lethargy and muscle spasms, right arm (injection arm).  Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Information has been received  froma anurse practitioner concerning a 21 year old female (weight 169 #, height 68") who on 27-FEB-2007 was vaccinated with her first dose of GARDASIL vaccine(yeast) (Lot# 655619/1427P). On 03-MAY-2007m at 1 pm, the patient was vaccinated with her second dose of GARDASIL vaccine (yeast) ( Lot #657621/0387U) IM in the right deltois. There was no concomitant medication. There was no adverse experience following the first dose. On  04-MAY-2007 at 4 am, 14 hours after the sceond dose, the patient experienced flu like symptoms. chills,muscle acheesz, joint aches, headache and nausea. Lethargy, malaise and muscle spams in the right arm continued for 4-5 days. The patient was treated with acetaminophen (Tylenol) and rest. ON 07-MAY-2007, the patient still reported lathargy an muscle spasms, right arm (injection arm). On 11-MAY-2007, the patient had recovered from the events. Additional information is not expected
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from the mother of a 13 year old female who on 17-NOV-2006 was vaccinated with her second dose of Gardasil.  There was no concomitant medication.  It was reported that starting in January 2007, the patient had not menstruated.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Syncope
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with Gardasil.  Subsequently the patient experienced tingling down in her arm and she fainted shortly thereafter.  The healthcare worker also reported on another patient (WAES# 0705USA03439).  No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal pain lower, Back pain, Dizziness, Headache
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female who on 20-APR-2007 was vaccinated with the second dose of Gardasil, lot# 657622/0388U.  There was no concomitant medication.  On 20-APR-2007 within a few minutes after the vaccination the patient felt light headed and dizzy and had to lie down.  She was monitored at the physician's office for 25 minutes and hydrated with water, and she recovered and felt she was able to drive home.  While the patient was driving home, she developed a severe headache, vertigo and lower abdominal pain.  She felt she had to pull off the road and fell asleep.  When she awoke, she felt well enough to drive home but the symptoms had not fully recovered.  That same day, approximately 6 hours later, the patient developed abdominal cramps, back pain, was nauseous and felt like she had a low grade fever.  The patient took IBUPROFEN and OTC TYLENOL which was effective and she slept.  The next day, on 22-APR-2007 the patient had a very mild case of nausea, but no back pain and no abdominal pain.  The nurse stated that the patient called the office sometime the week of 30-APR-2007 on an unrelated issue and then mentioned the adverse event she experienced when she arrived home.  It was reported that within 24 hours all the symptoms had resolved and the patient had recovered.  The nurse indicated that she previously reported a similar adverse event for another patient (reference WAES# 0612USA02247).  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia, Vertigo
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female who on 20-APR-2007 was vaccinated with the second dose of Gardasil, lot# 657622/0388U.  There was no concomitant medication.  On 20-APR-2007 within a few minutes after the vaccination the patient felt light headed and dizzy and had to lie down.  She was monitored at the physician's office for 25 minutes and hydrated with water, and she recovered and felt she was able to drive home.  While the patient was driving home, she developed a severe headache, vertigo and lower abdominal pain.  She felt she had to pull off the road and fell asleep.  When she awoke, she felt well enough to drive home but the symptoms had not fully recovered.  That same day, approximately 6 hours later, the patient developed abdominal cramps, back pain, was nauseous and felt like she had a low grade fever.  The patient took IBUPROFEN and OTC TYLENOL which was effective and she slept.  The next day, on 22-APR-2007 the patient had a very mild case of nausea, but no back pain and no abdominal pain.  The nurse stated that the patient called the office sometime the week of 30-APR-2007 on an unrelated issue and then mentioned the adverse event she experienced when she arrived home.  It was reported that within 24 hours all the symptoms had resolved and the patient had recovered.  The nurse indicated that she previously reported a similar adverse event for another patient (reference WAES# 0612USA02247).  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning several females who were vaccinated with Gardasil.  Subsequently all the patients experienced stinging at site.  Subsequently, the patients recovered.  On 14-MAY-2007 the nurse indicated that she could not confirm a number of patients but that she had given over 100 shots and all of the female patients "complain after receiving it."  She also reported that "it did not matter what shot in the series it was."  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Information has been received from a physician's assistant concerning a 17 year old white female (132 lbs, 5'4") with an amoxicillin allergy who on 15-JAN-2007 was vaccinated by a nurse with Gardasil, lot # 655617/1447F in the left arm.  On 15-JAN-2007 the patient experienced severe dizziness and arm pain for 2 days.  On 18-JAN-2007 the patient recovered.  No treatment was sought.  Additional information has been requested. Initial and follow up information has been received frm a physician's assistant concerning a 17 year old female with an AMOXICILLN allergy who on 15-JAN-2007 was vaccinated by a nurse with GARDASIL, lot # 655617/1447F in the left upper arm. The patient had no known illnesses at the time of vaccination. On 15-JAN-2007 the patient experinced severe dizziness and arm pain for 2 days. On 18-JAN-2007 the patient recovered.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Nausea, Oedema peripheral, Pharyngeal oedema, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 30 year old female with no pertinent medical history who on 07-MAY-2007 was vaccinated intramuscularly with Gardasil (lot #657736/0389U).  Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING).  On 07-MAY-2007, five hours after receiving the first dose of the vaccination, the patient experienced a feeling like her throat was swollen and nausea.  On 08-MAY-2007 the patient experienced swelling of the face, swelling of both hands, tiny bumps on both hands and low grade fever of 100.9F.  The patient was examined by a physician and prescribed oral diphenhydramine hydrochloride (Benadryl).  At the time of the report the patient had not recovered.  There were no laboratory or diagnostic tests performed.  Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a health professional concerning a 30 year old female, with no pertinent medical history, who on 07-MAY-2007 at 2:00 pm was vaccinated in the right deltoid with a first dose of GARDASIL (lot # 657736/0389U). Concomitant therapy included NUVARING. On 07-MAY-2007 at 7:00 pm the patient experienced a feeling like her throat was swollen, nausea and swelling of both hands with tiny bumps. On 08-MAY-2007 the patient experienced swelling of the face and low grade fever of 100.9F. The patient was examined by a physician and prescribed oral BENADRYL. There were no laboratory or diagnostic tests performed. On 09-MAY-2007, the patient recovered from a feeling like her throat was swollen, nausea, swelling of the face, swelling of both hands, tiny bumps on both hands and low grade fever of 100.9F. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Swelling face
Clinical narrative: Information has been received from a health professional concerning a 30 year old female with no pertinent medical history who on 07-MAY-2007 was vaccinated intramuscularly with Gardasil (lot #657736/0389U).  Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING).  On 07-MAY-2007, five hours after receiving the first dose of the vaccination, the patient experienced a feeling like her throat was swollen and nausea.  On 08-MAY-2007 the patient experienced swelling of the face, swelling of both hands, tiny bumps on both hands and low grade fever of 100.9F.  The patient was examined by a physician and prescribed oral diphenhydramine hydrochloride (Benadryl).  At the time of the report the patient had not recovered.  There were no laboratory or diagnostic tests performed.  Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a health professional concerning a 30 year old female, with no pertinent medical history, who on 07-MAY-2007 at 2:00 pm was vaccinated in the right deltoid with a first dose of GARDASIL (lot # 657736/0389U). Concomitant therapy included NUVARING. On 07-MAY-2007 at 7:00 pm the patient experienced a feeling like her throat was swollen, nausea and swelling of both hands with tiny bumps. On 08-MAY-2007 the patient experienced swelling of the face and low grade fever of 100.9F. The patient was examined by a physician and prescribed oral BENADRYL. There were no laboratory or diagnostic tests performed. On 09-MAY-2007, the patient recovered from a feeling like her throat was swollen, nausea, swelling of the face, swelling of both hands, tiny bumps on both hands and low grade fever of 100.9F. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Dizziness, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning an 18 year old female student with no drug allergies, no medical history, and no illnesses at the time of vaccination, who on 13-FEB-2007 was vaccinated intramuscularly in the right arm with a first dose of Gardasil (Lot# 654741/1208F).  Subsequently, in an unspecified date, the patient experienced a fever of 102 F and dizziness. The patient sought unsoecified medical attention. The patient recovered on an unspecified date. No further information was available.  Additional information has been requested.  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Corrective lens user, Vision blurred, Visual acuity tests abnormal
Clinical narrative: Information has been received from a health professional concerning a 24 year old female who on 05-FEB-2007 was vaccinated with Gardasil.  Concomitant therapy included DEPO-PROVERA.  On approximately 19-FEB-2007 the patient experienced blurry vision.  The patient's vision "was negative 600 and is now negative 700."  The nurse practitioner reported that Gardasil would not be reintroduced.  Additional information has been requested. This is in follow-up to reports previously submitted on 06/14/2007. Initial and follow-u information has been received from a health professional concerning a 24 year old female with a history of and no illness at the time of vaccination who on 05-FEB-2007 was vaccinated at 16:20 in the right arm with a first dose of GARDASIL (lot # 655619/1427F). Concomitant vaccinations included a fifth dose of DEPO-PROVERA (Lot # 06P601) in the left arm. On approximately 19-FEB-2007 the patient experienced blurry vision in the left eye even with contacts and glasses. The patient saw an eye doctor and her vision for the past two years was negative 600 and is now negative 700. The nurse practioner reported that GARDASIL would not be reintroduced. At the time of this report, the patient had not recovered. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female with no pertinent medical history or a history of drug reactions or allergies who on 01-MAY-2007 was vaccinated with her first dose of Gardasil, 0.5 ml, IM, left deltoid.  There was no concomitant medication.  On 05-MAY-2007 the patient developed hives.  The patient was instructed to take diphenhydramine (BENADRYL).  No laboratory tests were done.  As of 08-MAY-2007, the patient was recovering.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Breast pain, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 year old female who on 14-APR-2007 was vaccinated with the second Gardasil (date of first dose not reported). Subsequently, the patient experienced breast pain. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-uo to previously submitted on 6/14/2007. Information has been received from a certified medical assistant concerning a 17 year old female who on 11-Oct-2006 was vaccinated in the right deltoid with a first dose of GARDASIL (lot 653978/0955F). On 14-APR-2007, the patient was vaccinated in the left deltoid with a second dose of GARDASIL (lot 657617/0384U). The patient had no illness at the time of vaccination. On 17-APR-2007, the patient experienced bilateral breast pain. The patient sought unspecified medical attention. The outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Breast cyst
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/10/2007.  Information has been received from a certified medical assistant concerning a 13 year old female who on 11-OCT-2006 was vaccinated in the right deltoid with a first dose of GARDASIL (lot 653978/0955F).  On 20-APR-2007, the patient was vaccinated in the right deltoid with the second Gardasil (lot 657617/0384U).  The patient had no illness at the time of vaccination.  Subsequently, the patient developed three fluid-filled cysts in her breast. The cysts were then drained. The results of the drainage and the patient's outcome were not reported. The patient subsequently recovered.  No additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Dizziness, Erythema, Hot flush, Hyperhidrosis
Clinical narrative: Information has been received from a physician and a nurse concerning a 17 year old female who in April 2007, was vaccinated with Gardasil (lot number unknown).  Right after administration of the vaccine, the patient experienced hot flashes, reddening of the face, dizziness and sweating on her head.  The patient had an unspecified blood test performed (results not provided) and sought unspecified medical attention.  Subsequently, the patient recovered from hot flashes, reddening of the face, dizziness and sweating on her head the same day as the vaccination.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction
Clinical narrative: Information has been received from a physician and a nurse concerning a 17 year old female who in April 2007, was vaccinated with Gardasil (lot number unknown).  Right after administration of the vaccine, the patient experienced hot flashes, reddening of the face, dizziness and sweating on her head.  The patient had an unspecified blood test performed (results not provided) and sought unspecified medical attention.  Subsequently, the patient recovered from hot flashes, reddening of the face, dizziness and sweating on her head the same day as the vaccination.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who on 27-MAR-2007 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. On 29-MAR-2007 (2 days after vaccination) the patient developed hives on her chest, back and upper extremities. The patient sought unspecified medical attention. The registered nurse reported that the patient had used a tanning bed earlier on the same day as the reaction. On an unspecified date, the patient recovered. There was no product quality complaint involved. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a licensed practical head nurse concerning a female who in March 2007, was vaccinated with Gardasil. Almost immediately after the vaccination, the patient experienced pain, tingling and numbness down the arm. Subsequently, the patient recovered from pain, tingling and numbness by the time and the patient left the office. this is one of two reports from the same source. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse concerning a female (age not reported) who on 09-MAY-2007 was vaccinated with a 0.5 mL dose of Gardasil (lot unavailable).  Concomitant vaccination included unspecified "tetanus vaccine".  On 09-MAY-2007 the patient "got dizzy after receiving Gardasil.  The patient sought unspecified medical attention.  On 09-MAY-2007, the patient recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Paraesthesia
Clinical narrative: Information has been received from a medical assistant and a 23 year old medical secretary concerning herself who on 18-SEP-2006 was vaccinated intramuscularly with the first 0.5 mL dose of Gardasil (lot #"069F").  On 28-SEP-2006, the patient was vaccinated intramuscularly with the second 0.5 mL dose of Gardasil (lot #653937/0637F).  On 22-FEB-2007 the patient was vaccinated with the third dose of Gardasil (lot #653937/0637F).  The patient reported that she "experienced a 20 minute period of parasthesia (numbness and tingling) in the arm after the first and second dose of the vaccine were administered."  Patient stated she "did not have the same experience after receiving the third dose."  The patient sought unspecified.  The patient recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician and an LPN concerning a 14 year old female who on 05-MAR-2007 at 10:45 a.m. was vaccinated in the right deltoid with the first 0.5 mL dose of Gardasil (lot# 655619/1427F). Concomitant vaccination given in the right deltoid on 05-MAR-2007 included MENACTRA (lot # U1947AA). It was reported that the patient was vaccinated on day 4 of her menses. Her menses stopped for 2 days and re-started on 07-MAR-2007 and continued through 13-MAR-2007 (described as a normal cycle. During this time she had normal cramps and no treatment was given. Her cycle returned to normal occurring 28 days later. The patient reported that she is on a normal 28-day menstrual cycle since the age of 13 years. The patient was not on birth control. No further information is expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Menstruation irregular
Clinical narrative: Information has been received from an office staff concerning her 14 year old daughter who was vaccinated with the first 0.5 mL dose of Gardasil and two days later had her first menstrual cycle. The patient had no menses in between shots and had her second menstrual cycle after receiving the second dose of Gardasil. The patient also experienced injection site pain. The patient sought unspecified medical attention. The patient's status was not reported. There was no product quality complaint involved. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Migraine
Clinical narrative: Information has been received from a medical assistant concerning a female (age not reported) with a history of migraines who was vaccinated with a dose of Gardasil.  The medical assistant reported that 48 to 72 hours after vaccination was administered, the patient experienced migraine.  The patient sought unspecified medical attention.  The patient's status was not reported.  There was no product quality complaint involved.  Additional information has been requested. This is in follow-up to report (s) previously sumbmitted on 6/14/2007. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Migraine, Vaccine positive rechallenge
Clinical narrative: Information has been received from a medical assistant concerning a female (age not reported) with a history of migraines who was vaccinated with a dose of Gardasil.  The medical assistant reported that 48 to 72 hours after vaccination was administered, the patient experienced migraine.  The patient sought unspecified medical attention.  The patient's status was not reported.  There was no product quality complaint involved.  Additional information has been requested. This is in follow-up to report (s) previously sumbmitted on 6/14/2007. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Migraine
Clinical narrative: Information has been received from a certified medical assistant concerning a 19 year old female with asthma, sulfonamide allergy and penicillin allergy and a previous history of migraine headaches who on 02-FEB-2007 was vaccinated with her first dose of Gardasil, 0.5 ml intramuscularly (Lot#655503/0012U). Concomitant therapy included montelukast sodium and ORTHO TRI-CYCLEN LO. In February 2007, the patient experienced a migraine headache after her first dose of Gardasil. On 03-APR-2007, the patient was vaccinated with her second dose of Gardasil, 0.5 ml intramuscularly (Lot#656051/0244U). In April 2007 the patient experienced a migraine headache after her second dose of Gardasil. The interval between the Gardasil dose and the onset of the headaches was unknown. Each headache resolved and the patient was fully recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Migraine, Vaccine positive rechallenge
Clinical narrative: Information has been received from a certified medical assistant concerning a 19 year old female with asthma, sulfonamide allergy and penicillin allergy and a previous history of migraine headaches who on 02-FEB-2007 was vaccinated with her first dose of Gardasil, 0.5 ml intramuscularly (Lot#655503/0012U). Concomitant therapy included montelukast sodium and ORTHO TRI-CYCLEN LO. In February 2007, the patient experienced a migraine headache after her first dose of Gardasil. On 03-APR-2007, the patient was vaccinated with her second dose of Gardasil, 0.5 ml intramuscularly (Lot#656051/0244U). In April 2007 the patient experienced a migraine headache after her second dose of Gardasil. The interval between the Gardasil dose and the onset of the headaches was unknown. Each headache resolved and the patient was fully recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: Information has been received from a physician concerning a teenage female who received her first and second doses of Gardasil in the buttocks. Subsequently the patient experienced pain at the site for a unspecified duration. Subsequently, the patient recovered from pain. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced vomiting. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning teenage female patient with a history of fainting when given injections, who was vaccinated (date unspecified) with the first dose, 0.5ml, of Gardasil. The physician reported that the patient fainted after the vaccine was administered, but at the time of this report had recovered (dates not specified). The patient sought unspecified medical attention. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Hyperaesthesia, Pain, Rash, Rash erythematous
Clinical narrative: Information has been received from a health professional, a female receptionist, who on 12-FEB-2007 was vaccinated with the first dose of Gardasil (Lot #654885/1424F). Concomitant therapy included hormonal contraceptives (unspecified). Following the vaccination, on 12-FEB-2007, the patient developed a red bumpy rash that was in the shape of the latex-free band-aid that she had used, and was painful to the touch. On approximately 26-FEB-2007 ("two weeks" later), the patient recovered from the events. On 13-APR-2007, the patient was vaccinated with the second dose of Gardasil (Lot #654885/1424F). Once again, on the day of vaccination, the patient experienced the red bumpy rash, painful to the touch, and in the shape of the band aid she had used. As with the first occurrence, on approximately 27-APR-2007 ("two weeks" later), the patient recovered from the rash. The patient sought unspecified medical attention. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a 25 year old female, with no prior history of a band aid reaction, who on 12-FEB-2007, was vaccinated with the first dose of GARDASIL (Lot #654885/1424F). Concomitant therapy included hormonal contraceptives (unspecified). There was no illness at the time of vaccination. Following the vaccination, on 12-FEB-2007, the patient developed a red bumpy rash that was in the shape of the latex-free band-aid that she had used, and was painful to the touch. On approximately 26-FEB-2007 ("two weeks later"), the patient recovered from the events. On 13-APR-2007, the patient was vaccinated in the left deltoid, at 1:30pm, with the second dose of GARDASIL (Lot #654885/1424F). Once again, on 14-APR-2007 (previously reported as the day of vaccination), the patient experienced the red bumpy rash, painful to the touch, and in the shape of the band aid she had used. Treatment included a topical cream (unspecified). As with the first occurrence, on approximately 27-APR-2007 ("two weeks later"), the patient recovered from the rash. The patient sought unspecified medical attention. No further information was expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Skin reaction
Clinical narrative: Information has been received from a health professional, a female receptionist, who on 12-FEB-2007 was vaccinated with the first dose of Gardasil (Lot #654885/1424F). Concomitant therapy included hormonal contraceptives (unspecified). Following the vaccination, on 12-FEB-2007, the patient developed a red bumpy rash that was in the shape of the latex-free band-aid that she had used, and was painful to the touch. On approximately 26-FEB-2007 ("two weeks" later), the patient recovered from the events. On 13-APR-2007, the patient was vaccinated with the second dose of Gardasil (Lot #654885/1424F). Once again, on the day of vaccination, the patient experienced the red bumpy rash, painful to the touch, and in the shape of the band aid she had used. As with the first occurrence, on approximately 27-APR-2007 ("two weeks" later), the patient recovered from the rash. The patient sought unspecified medical attention. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a 25 year old female, with no prior history of a band aid reaction, who on 12-FEB-2007, was vaccinated with the first dose of GARDASIL (Lot #654885/1424F). Concomitant therapy included hormonal contraceptives (unspecified). There was no illness at the time of vaccination. Following the vaccination, on 12-FEB-2007, the patient developed a red bumpy rash that was in the shape of the latex-free band-aid that she had used, and was painful to the touch. On approximately 26-FEB-2007 ("two weeks later"), the patient recovered from the events. On 13-APR-2007, the patient was vaccinated in the left deltoid, at 1:30pm, with the second dose of GARDASIL (Lot #654885/1424F). Once again, on 14-APR-2007 (previously reported as the day of vaccination), the patient experienced the red bumpy rash, painful to the touch, and in the shape of the band aid she had used. Treatment included a topical cream (unspecified). As with the first occurrence, on approximately 27-APR-2007 ("two weeks later"), the patient recovered from the rash. The patient sought unspecified medical attention. No further information was expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: Information has been received from a physician concerning a 15 year old female who in April 2007, was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. There was no concomitant medication. Approximately 6 to 8 hours after vaccination, the patient experienced shortness of breath. Her symptoms lasted "all night long" and resolved by the next morning. Unspecified medical attention was sought. Subsequently, the patient recovered from shortness of breath. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with pertinent medical history and drug reactions/allergies reported as none who on 09-MAR-2007 was vaccinated with the first dose of Gardasil (lot #655849/0263U), 0.5 ml, IM in the deltoid. Concomitant therapy included montelukast sodium (MSD). Subsequently on an unspecified date, the patient experienced hair loss after her first dose of Gardasil. The patient sought unspecified medical attention. The patient's hair loss persisted. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 17 year old female who in February 2007 was vaccinated with the first dose of Gardasil. A second dose of Gardasil was received on an unspecified date. Concomitant medication was not reported. In 2007, the patient experienced injection site redness. The patient sought unspecified medical attention. The outcome of the event was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Ear pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil. Concomitant medication was not reported. The evening of 08-MAY-2007, the patient experienced fever. On 09-MAY-2007, the patient experienced ear ache but was afebrile. The patient sought unspecified medical attention. The outcome of the event was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated in the left arm with Gardasil. Subsequently, the patient developed adenopathy on the left side of her neck and a fever of 102F. She was treated with ibuprofen and acetaminophen. She missed one day of school as a result of her symptoms. Subsequently, the patient received in two weeks. Additional information has been requested. This is one of two reports received from the same source.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Syncope
Clinical narrative: This is in follow-up to report (s) previously submitted on 6/14/2007.  Information has been received from a registered nurse concerning a 24 year old female teacher (weight 133#, height 62") who on 23-APR-2007 was vaccinated with the first dose (also reported as the second dose) of GARDASIL (lot #657617/0384U), IM in the deltoid.  Concomitant medication was not reported.  On 23-APR-2007 approximately 5 minutes after vaccine was administered, the patient fainted.  The patient was treated with a cold pack to her head and she was instructed to lie down.  The patient's blood pressure was 130/70.  Subsequently that same day, the patient recovered from fainting and left the physicians office unassisted.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Body temperature, Hypoaesthesia, Malaise
Clinical narrative: Information has been received from a secretary concerning a female who was vaccinated with her 3rd dose of Gardasil.  Subsequently the patient experienced severe body aches, rash on face and arms, and numbness.  Unspecified medical attention was sought.  Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a secretary and a physician concerning a 17 year old female who was vaccinated with third dose of GARDASIL. Two days after the vaccination, the patient experienced severe body aches, rash on face and arms, numbness, low grade fever, general malaise and abdominal pain. Unspecified medical attention was sought. She denied any headaches, burning with urination, no nausea, vomiting nor diarrhea. Vital signs were stable. The patient was non toxic and in no acute distress. Ear, nose, and throat were unremarkable. Abdomen is soft and depressible. Active bowel sounds. There was slight epigastric tenderness. No mass, no guarding, nor rebounding. A urinalysis test reported 5 - 10 white blood count with a few bacteria. The physician explained to the patient and her father that this may be related to something other than GARDASIL. The patient was given PREVACID 30 mg capsule once a day as needed for the epigastric pain. BACTRIM DS twice a day for 3 days and to drink fluids. At the time of the report, the patient's outcome was unknown. Additional information is not expected.