chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, No reaction on previous exposure to drug, Pyrexia, Vomiting
Clinical narrative: Initial information and follow up has been received from a nurse practitioner concerning a 13 year old white female who on 14-NOV-2007 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (lot# 659437/1266U). There was no concomitant medication. On 15-JAN-2008 the patient was vaccinated intramuscularly in the left arm with her second dose of GARDASIL (lot# 656049/0187U). On 15-JAN-2008 the patient experienced headaches, vomiting and a fever. Subsequently the patient recovered from headaches, vomiting and a fever several days after the vaccination. She had no symptoms after the first GARDASIL. The patient sought medical attention by calling the office. On 16_MAY-2008 the patient was vaccinated intramuscularly in the left arm with the third dose of GARDASIL (lot# 659657/1487) with less reaction. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Vaccine positive rechallenge
Clinical narrative: Initial information and follow up has been received from a nurse concerning a 26 year old female who on 22-APR-2008 was vaccinated in the left deltoid with her third dose of GARDASIL (lot# 659964/1978U0. On 22-APR-2008 the patient stated that she developed a white area around the injection site from the last two injections. The nurse did see a vague white area- half circle to the left of what looks like the needle stick. Also looks like white vague outline of a bandaid. The patient sought unspecified medical attention and her outcome was not reported. On 14-SEP-2007 the patient was vaccinated in the left deltoid with her first dose of GARDASIL (lot# 658554/0928U). On 16-NOV-2007 the patient was vaccinated in the left deltoid with her second dose of GARDASIL (lot# 659437/1266U).
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Brachial pulse normal, Incorrect route of drug administration, Injection site erythema, Injection site irritation
Clinical narrative: Information has been received from a health professional concerning a 19 year old female with an allergy to DEMEROL, morphine and penicillin who on 11-OCT-2007 was vaccinated with her first dose of GARDASIL (lot# 658563/1063U). On 03-JAN-2008 the patient was vaccinated with her second dose of GARDASIL (lot# 659439/1267U). On 07-MAY-2008 the patient was vaccinated with her third dose of GARDASIL (lot# 660389/1968U). The third dose may have been administered subcutaneously. Concomitant therapy included YASMIN. On 07-MAY-2008, within 15 minutes of the dose, the patient experienced burning and redness at the injection site. The patient was being treated with BENADRYL, antibiotics and cool compresses applied to the injection site. The patient was seen in the office and her outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning two female patients who were vaccinated with their second dose of GARDASIL (lot number unspecified) and developed urticaria. The patients are not patients of the reporting physician and no patient specific information was provided. The physician asked not to be contacted. No other information to report.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a caller concerning her daughter who missed her menstrual period after receiving the second dose of GARDASIL (lot# not reported). The caller did not want to report any additional information.  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female with a history of papilloma viral infection and abnormal pap test (NOV-2007), with no known allergies, and no concomitant medications, who on 05-MAY-2008 was vaccinated with the first dose of GARDASIL, 0.5 ml, IM to the right deltoid, (Lot# 0152X).  That same evening when the patient arrived home she had a rash on both arms, on her trunk, and descending down to her thighs.  The patient telephoned the office and was treated with over the counter Benadryl, she recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a registered nurse concerning a female who on 07-FEB-2008 was vaccinated IM in the left deltoid with the first dose of GARDASIL (lot# 655327/1287U).  In approximately March 2008, the patient developed irregular menstrual cycles.  In the last couple of months, the patient has been having about 2 periods a month compared to her usual 1 cycle monthly.  The patient sought unspecified medical attention by contacting her physician's office.  The patient's irregular menstrual cycles have persisted.  There are no other details.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 22 year old female with no concomitant medications or pertinent medical history, who on 09-MAY-2008 was vaccinated with the first dose of GARDASIL, 0.5ml, IM, (Lot # 659182/1757U).  Later that same day she developed diarrhea, was afebrile and had no nausea or vomiting.  The patient sought medical attention over the phone and was advised by the doctor to take IMODIUM as needed.  As of the date of the report (12-MAY-2008), she continued with diarrhea, and had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a healthcare worker concerning a 17 year old female with concomitant medications, allergies, and pertinent medical history reported as none, who on 13-NOV-2007 was vaccinated with the first dose of GARDASIL.  A second dose of GARDASIL (Lot # 659657/1487U), 0.5ml, IM was given on an unspecified date.  The patient is experiencing hair loss, reportedly starting "two weeks ago" (01-MAY-2008).  The patient sought medical attention over the telephone.  No outcome information was reported.  No product quality complaint was involved.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash macular
Clinical narrative: Information has been received from a nurse concerning a 20 year old female with pertinent medical history, allergies and concomitant medications reported as none, who on 06-MAY-2008 was vaccinated with the first dose of GARDASIL, 0.5ml, IM, (lot# 659964/1978U).  On 07-MAY-2008, one day after receiving GARDASIL, the patient developed red, blotchy areas on both arms.  The areas of redness were intermittent, reappearing at night.  Unspecified medical attention was sought via the telephone and and resolved completely on 09-MAY-2008 without treatment.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Medical device complication, Pharmaceutical product complaint, Syncope
Clinical narrative: Information has been received from a healthcare worker concerning a 15 year old female who on 07-NOV-2007 was vaccinated with a first dose of GARDASIL (lot # not reported).  On 10-JAN-2008 the patient was vaccinated with a second dose of GARDASIL (lot # not reported).  On 12-MAY-2008 the patient was vaccinated with a third dose of GARDASIL (lot # 0152X).  It was reported that "when attempting to administer the GARDASIL syringe, the plunger would not depress.  According to the medical assistant, the white plastic tray was crushed at the end.  The plastic seal was loose and up at the damaged end.  The carton was not damaged.  The syringe was removed from the package and the needle was placed on the syringe.  The needle was in the patient's arm and the plunger would not depress.  When the needle was removed from the arm, the safety device activated.  The syringe was discarded because the patient fainted and the medical assistant needed to put the syringe in a safe place."  It was also reported that "they have been using the syringe for a while and are familiar with its use.  The product was ordered directly from Merck.  This was a product quality complaint.  The patient was vaccinated successfully with another prefilled syringe.  There were no problems reported.  The SR# is 13050492422.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Menstruation irregular, Metrorrhagia, Ultrasound scan
Clinical narrative: Information has been received from a Licensed Practical Nurse for the Pregnancy Registry for GARDASIL, concerning her 19 year old daughter with asthma and scoliosis who on 17-OCT-2007 was vaccinated intramuscularly with a first dose of GARDASIL (lot # not reported). The nurse reported that her daughter received her first dose of GARDASIL and afterwards experienced irregular period with spotting. On 23-JAN-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot # not reported) and the patient reported that her period was "not right". The patient believes her LMP was 21-FEB-2008. Concomitant therapy included YAZ, ascorbic acid, cyanocobalamin, omega-3 marine triglycerides and iron (unspecified). The patient also reported that she took YAZ at night time and she forgot to take it one night but then took it the next morning. The patient's mother believes that the birth control failed because of GARDASIL. The mother also reported that the patient was taking YAZ while she was pregnant. An ultrasound on 13-MAY-2008 showed that the patient was 8 weeks 4 days pregnant. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia facial
Clinical narrative: Information has been received from a health department administrator concerning a female in her "early twenties" who was vaccinated on an unspecified date with a "second dose" of GARDASIL (lot # not reported). The administrator reported that the patient received the second dose of HPV rL1 6 11 16 18 VLP vacine (yeast) and later the same day, the patient called to report that she was experiencing numbness on one side of her face. The administrator also reported that the patient was advised to go the emergency room. The patient was not admitted to the hospital. The patient's outcome was not reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Injection site pain, Vaccine positive rechallenge
Clinical narrative: Initial and follow up information has been received from a physician's office and an 18 year old female consumer for the pregnancy registry for GARDASIL with breast pain while on YAZ who in early December 2007 was vaccinated with her first dose of GARDASIL (lot number unknown).  Concomitant therapy included YAZ.  On the same day in early December, the patient experienced pain at injection site.  Subsequently, by the next day, the patient recovered from pain at the injection site.  On 14-FEB-2008 the patient was vaccinated with her second dose of GARDASIL (lot number unknown).  On 14-Feb-2008 the patient experienced pain at the injection site.  Subsequently, by the next day, the patient recovered from pain at the injection site.  In early April 2008 the patient found out she was 3-4 weeks pregnant (LMP = 27-FEB-2008) and "will not be getting her third dose".  The consumer also reported breast pain while on YAZ from October 2007 until approximately 20-Feb-2008 to the manufacturer.  Blood tests for hepatitis and to confirm pregnancy were performed.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure, Limb injury
Clinical narrative: Information has been received from a health professional that on approximately 29-Apr-2008, a vial of GARDASOL (lot # 659182/1757U) shattered when she opened it. She cut her left hand on the broken glass. Subsequently, the health professional experienced accidental exposure. The patient flushed her hand with running water and cleaned it with alcohol. The patient sought unspecified medical attention in the office. Subsequently, the patient recovered from the cut on her left hand in about a week. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female who on unspecified dates was vaccinated with her first and second doses of GARDASIL (Lot #s not reported).  On an unspecified date, after receiving the third dose of GARDASIL, the patient had "an abnormal PAP".  The patient sought unspecified medical attention.  The patient outcome is unknown.  No further information was provided.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Pneumonia primary atypical, Weight increased
Clinical narrative: Information has been received from a consumer concerning her 10 year old granddaughter who in "late 2007" was vaccinated with her first dose of GARDASIL (Lot #, site and route not reported).  In "early 2008", the patient was vaccinated with her second dose of GARDASIL (Lot #, site and route not reported).  Subsequently the patient experienced weight gain after the first dose of GARDASIL.  It was reported that the weight gain started "within months of the first dose".  The patient "now has walking pneumonia" for which she is taking DELSYM.  The patient sought unspecified medical attention.  The patient's weight gain and walking pneumonia persisted.  No additional information was provided.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 25-APR-2008 was vaccinated intramuscularly in the deltoid with her second dose of GARDASIL (Lot # not reported).  On 25-APR-2008 the "patient's body felt very stiff" and she fainted after receiving her second dose of GARDASIL.  The patient sought unspecified medical attention.  On an unspecified date, the patient recovered from the "body felt very stiff" and fainting.  No additional information was provided.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/13/2008.  In a follow up telephone call the Licensed Practical Nurse (L.P.N.) reporteed that patient turned white and also fainted. However, the patient had previously informed her that she was "not good with needles". No other informatio is available at this time. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising
Clinical narrative: Information has been received from a physician concerning a 13 year old female with no previous medical history or no known drug allergies, who in April 2008, was vaccinated IM in the left arm with a 0.5 ml first dose of GARDASIL (lot# 658094/0524U).  There was no concomitant medication.  For the first week after the vaccination the patient would develop a "bruised area" at the injection site after someone touches or hits the area.  Unknown medical attention was sought via telephone.  The bruising resolved one week after the injection.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 06/13/2008. Initial and follow up information has been recieved form a physicain concerning a 13 year old female with no previous medical history or no known drug allergies, who on 14-Apr-2008 (also reported as April 2008)m was vaccinated intramuscularly in the left deltoid with a 0.5 ml first dose of GARDASIL (lot # 658094/0524U). There was no concomitant medication. On 14-Apr-2008 (also reported as for the first week after the vaccination) the patient developed several areas of brusing all over her body not just at the injection site and "red bumps that may have been potechiac". Also reported as "bruised area" at the injection site after someone touches or hits the area. Unknown medical attention was sought via telephone. The bruising and red bumps resolved after one week. On 16-Jun-2008, the patient had a CBC, PT and PTT performed which were all within normal limits. A previous CBC performed 04-Apr-2008 was also within normal limits. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Arthritis, Joint swelling, Laboratory test, Musculoskeletal stiffness
Clinical narrative: Information has been received from a physician concerning a 21 year old female with Asthma who on 03-OCT-2007 was vaccinated IM in deltoid with a first dose of GARDASIL (Lot# 658556/1060U). On 05-Dec-2007 the patient received IM deltoid the second (lot# 659435/1265U) and IM deltoid the third dose on 31-Mar-2008 (lot# 659964/1978U). The patient experienced arthritis like symptoms after receiving each of the three doses. The patient experienced pain and stiffness in both hands, feet and her right knee. The patient first experienced the symptoms after the first dose. The symptoms improved by the time the patient was due for the second dose but never completely resolved. When the patient received the second dose the symptoms returned and the same pattern of improvement and return of symptoms was experienced when the patient received the third. It was noted that the symptoms improved but never completely resolved. The patient was treated with anti-inflammatory medications VENTILAN and NAPROXEN. The patient was seen by a physician. The patient was recovering. Follow up information received indicated that on 10-Oct-2007, the patient experienced bilateral, symmetric joint pain and swelling in hands and feet. The patient was being evaluated by Rheumatology for rheumatoid arthritis. Diagnostic laboratory tests were pending. At the time of reporting the patient had not recovered. Additional information has been requested.  7/4/08 Reviewed GYN office records of 3/31/2008.  Requested additional vax records & office records. Records reveal patient experienced usual state of good health w/o complaints on day of final vaccination.   7/11/08 Received vax records & GYN office records.  No complaints noted on any vaccination dates.  5/12/2008 pt presented w/joint pain.  Stated 1 wk after initial injection, developed stiffness & swelling of right hand w/limited ROM of fingers & stiff throughout the day.  Also had bilateral foot pain & swelling, unable to wear high heel shoes.  Right knee pain.  Stated symptoms worsened after each Gardasil shot.  Was seeing a rheumatologist at that time.  10/10/08 Reviewed rheumatology medical records of 4/4-9/12/2008. FINAL DX: probable rheumatoid arthritis Records reveal patient experienced finger, knee & toe joint pain, AM stiffness & swelling since 11/2007 after received initial HPV4 vaccine on 10/3/07 which responded to steroid therapy.  Began methotrexate 5/2008 s/p labs (+) for RA.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 21 year old female with Asthma who on 03-OCT-2007 was vaccinated IM in deltoid with a first dose of GARDASIL (Lot# 658556/1060U). On 05-Dec-2007 the patient received IM deltoid the second (lot# 659435/1265U) and IM deltoid the third dose on 31-Mar-2008 (lot# 659964/1978U). The patient experienced arthritis like symptoms after receiving each of the three doses. The patient experienced pain and stiffness in both hands, feet and her right knee. The patient first experienced the symptoms after the first dose. The symptoms improved by the time the patient was due for the second dose but never completely resolved. When the patient received the second dose the symptoms returned and the same pattern of improvement and return of symptoms was experienced when the patient received the third. It was noted that the symptoms improved but never completely resolved. The patient was treated with anti-inflammatory medications VENTILAN and NAPROXEN. The patient was seen by a physician. The patient was recovering. Follow up information received indicated that on 10-Oct-2007, the patient experienced bilateral, symmetric joint pain and swelling in hands and feet. The patient was being evaluated by Rheumatology for rheumatoid arthritis. Diagnostic laboratory tests were pending. At the time of reporting the patient had not recovered. Additional information has been requested.  7/4/08 Reviewed GYN office records of 3/31/2008.  Requested additional vax records & office records. Records reveal patient experienced usual state of good health w/o complaints on day of final vaccination.   7/11/08 Received vax records & GYN office records.  No complaints noted on any vaccination dates.  5/12/2008 pt presented w/joint pain.  Stated 1 wk after initial injection, developed stiffness & swelling of right hand w/limited ROM of fingers & stiff throughout the day.  Also had bilateral foot pain & swelling, unable to wear high heel shoes.  Right knee pain.  Stated symptoms worsened after each Gardasil shot.  Was seeing a rheumatologist at that time.  10/10/08 Reviewed rheumatology medical records of 4/4-9/12/2008. FINAL DX: probable rheumatoid arthritis Records reveal patient experienced finger, knee & toe joint pain, AM stiffness & swelling since 11/2007 after received initial HPV4 vaccine on 10/3/07 which responded to steroid therapy.  Began methotrexate 5/2008 s/p labs (+) for RA.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, No reaction on previous exposure to drug, Rash
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old female with allergies and pertinent medical history reported as none, who on 18-MAR-2008 was vaccinated with the first dose of GARDASIL (lot # 659055/1522U), 0.5ml, IM to the left arm and no reaction developed. Concomitant therapy included YAZ. On 13-MAY-2008 the patient was vaccinated with the second dose of GARDASIL (lot # 659182/1957U, 0.5ml, IM to the left arm). Following vaccination, the patient was observed for 15 minutes and no reaction was experienced. Per the patient's mother who is a nurse, a rash developed three hours afterwards. The rash started at the injection site, spread to the right arm, the patient's stomach and face, the patient took BENADRYL. The next morning, 14-MAY-2008, the patient's rash resolved and the patient's mother telephoned the doctor's office to report the event. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Thyroid function test normal, Vaccine positive rechallenge, Weight increased
Clinical narrative: Information has been received from a physician assistant concerning a 20 year old female with pertinent medical history reported as none and drug allergies not specified, who on 14-NOV-2007 was vaccinated with the first dose of GARDASIL (lot # 655154/1210U).  Concomitant therapy included YAZ.  The second dose of GARDASIL (lot # 655327/1287U) was given on 16-JAN-2008.  Between these two doses the patient gained 15 pounds.  The third dose of GARDASIL (lot # 0152X), was given on 07-MAY-2008.  Between the second and third dose the patient gained 25 pounds.  She gained a total of 40 pounds in about 5 to 6 months.  On an unspecified date, the patient sought medical attention by her primary care provider and had thyroid tests completed which were reported as negative.  At the time of reporting, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a consumer reported on behalf of her daughter, concerning a 12 year old female with a history of "sugar goes down a little low" (hypoglycaemia), who was vaccinated on unspecified dates with 2 doses of GARDASIL. The mother reported that after her daughter started receiving her first and second doses of GARDASIL her menstrual cycle became severely heavy and required her to take birth control pills, ORTHO-NOVUM 1/35. The patient sought unspecified medical attention and had an MRI performed with no abnormal results found. The patient reportedly recovered. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported), who was vaccinated in approximately MAY 2008, with a dose of GARDASIL.  The physician reported that within 15 minutes after she was vaccinated she fainted.  Subsequently the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Pruritus generalised
Clinical narrative: Information has been received from a physician concerning a female (age unreported) with concomitant medications reported as none, allergies and pertinent medical history not specified, who on an unspecified date was vaccinated with the second dose of GARDASIL, 0.5 ml, IM.  Subsequently the patient experienced warmth and itching all over her torso.  Unspecified medical attention was sought and the reaction subsided within an hour after the vaccine was given.  No product quality complaint was involved.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician assistant concerning several female patients (ages unknown), who, on unspecified dates were vaccinated with doses of GARDASIL. Subsequently, the patient experienced fainted. The patient sought unspecified medical attention. At the time of the report, the outcomes of the patients were unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a female patient who on 17-MAY-2007 was vaccinated with a first dose of GARDASIL (lot # 657736/0389U) and on 19-JUL-2008 she was vaccinated with a second dose of GARDASIL (lot # 658222/0927U).  On 19-NOV-2007 she was vaccinated IM with a third dose 0.5 mL of GARDASIL (lot # 659439/1267).  The physician reported that on approximately one month after the third injection the patient experienced redness, swelling and warmth at the site of the GARDASIL administration.  The patient sought medical attention from the physician.  At the time of this report the patient had not recovered.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Axillary pain
Clinical narrative: Information has been received from a Medical Assistant (MA) concerning a 23 year old female patient with dysmenorrhoea, penicillin allergy and sulfonamide allergy who on 12-MAY-2008 was vaccinated IM into left deltoid muscle with 0.5 mL of GARDASIL (lot # 659055/1522U). Concomitant therapy included ATIVAN, LUPRON and ESTROGENS, PREMPRO. The MA reported that on 12-MAY-2008 the patient developed a "deep soreness" of the left axilla. There was no redness or swelling. No further information available. The patient had not recovered as of this report date. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle twitching
Clinical narrative: Information has been received from a nurse concerning her 15 year old daughter with a history of "zones out" who was vaccinated on an unspecified date with her second dose of GARDASIL (lot# not reported). There was no concomitant medication. In January 2008, the patient experienced twitching of her hands and feet. The patient's twitching of her hands and feet persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated on unspecified dates with all three doses of GARDASIL (lot#'s not reported). Subsequently the developed condyloma after completing the three dose series. The patient's outcome was not reported and she sought unspecified medical attention in the office on an unspecified date. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a mother concerning her daughter with pertinent medical history, allergies and concomitant medication not reported who approximately 15-MAR-2008 (two months ago) was vaccinated with a dose of GARDASIL and hasn't had her period since. The outcome and causality of the event was not reported. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Laboratory test
Clinical narrative: Information has been received from a nurse concerning a 26 year old female with a history of an ovarian cyst in March 2008, low grade squamous intraepithelial lesion and sulfonamide allergy who on 29-FEB-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 655327/1287U).   Concomitant therapy included ORTHO TRI-CYCLEN LO.  On 08-MAY-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# 0151X).  On 10-MAY-2008 the patient experienced pain at the injection site.  She had relief when treated with ice and TYLENOL, but the pain at the injection site persisted when the treatment was discontinued.  The patient sought medical attention by calling the office.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/13/2008. Initial information and follow up has been received froma nurse concerning a 26 year old female with a history of an ovarian cyst in March 2008, low grade squamous intraepithellal lesion and sulfonamide allergy who on 29-FEB-2008 was vaccinated intramuscularly with her first dose of GARDASIL vaccine (lot# 655327/1287U). Concomitant therapy included ORTHO TRI-CYCLEN LO. On 08-MAY-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL vaccine (lot# 0151X). On 10-MAY-2008 the patient experienced pain at the injection site. She had relief when treated with ice and TYLENOL. The patient sought medical attention by calling the office on 16-MAY-2008. The patient recovered after 8 days from pain at the injection site.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning an unspecified number of patients who were vaccinated with a dose of GARDASIL. The patients experienced pain when they received the injection. It was unknown whether medical attention was sought. Patient outcome was not reported. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram normal, Face injury, Laboratory test normal, Loss of consciousness, X-ray normal
Clinical narrative: Information has been received from a secretary of a physician's office concerning a 19 year old female who on 15-MAY-2008 was vaccinated (route unknown) with a first dose of GARDASIL (Lot # 660393/0067X).  On the same day the patient was vaccinated with a dose of tuberculin purified protein derivative (PPD, unspecified).  On 15-MAY-2008 the patient passed out 10 to 20 seconds after vaccination and hit her face.  The physician attended to the patient and the rescue squad was contacted.  She was brought to the emergency room where blood work, x-rays and EKG were performed.  All tests results were normal.  The patient was not admitted to the hospital and released from the emergency room that same evening.  It was also mentioned that this patient is "not apprehensive".  Subsequently on 15-MAY-2008 the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia facial, Injection site pain
Clinical narrative: Information has been received from a health professional from a physician's office a 25 year old female with type 2 diabetes mellitus and a history of migraines who on 18-OCT-2007 and 11-DEC-2007 was vaccinated intramuscularly with a 0.5 mL first and second dose of GARDASIL (Lot #'s 658563/1063U and 659441/1446U), respectively. Concomitant therapy included NUVARING and LEVAQUIN. The caller reported that the patient was in the office today (16-MAY-2008) to receive the third dose of GARDASIL. At that time the patient stated that "the day after receiving the second dose, on 12-DEC-2007, she experienced pain in her arm at injection site and numbness in her face lasting 4 days". The patient was seen by her family doctor for symptoms. The third dose of GARDASIL was not administered. No laboratory diagnostic studies were performed. Subsequently, on approximately 16-DEC-2007 the patient recovered. No product complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Epstein-Barr virus test negative, Fatigue, Full blood count normal
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with asthma and no known drug allergies, who on 03-MAY-2008 was vaccinated IM with a 0.5 ml first dose of GARDASIL (lot# not provided). Concomitant therapy included AUGMENTIN. On 09-MAY-2008 the patient experienced nausea, vomiting, fatigue, dizziness and weakness. The patient was seen by the physician. At the time of reporting the patient was feeling better. The patient was recovering. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Metabolic function test normal, Nausea, Urine analysis normal, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with asthma and no known drug allergies, who on 03-MAY-2008 was vaccinated IM with a 0.5 ml first dose of GARDASIL (lot# not provided). Concomitant therapy included AUGMENTIN. On 09-MAY-2008 the patient experienced nausea, vomiting, fatigue, dizziness and weakness. The patient was seen by the physician. At the time of reporting the patient was feeling better. The patient was recovering. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Disturbance in attention, Loss of consciousness, Syncope, Tremor
Clinical narrative: Information has been received from a consumer concerning her daughter (age not reported) who on 14-MAY-2008 was vaccinated with a first dose of GARDASIL. On 17-MAY-2008, three days later the patient felt weak, was shaky, loss of consciousness and fainted. Medical attention was not sought. At the time of reporting it was unknown if the patient had recovered. Additional information has been requested.  07/04/2008 Reviewed PCP medical records of 5/14/08.  Vax record included but no Lot Numbers available.  Records reveal patient experienced major depression & insomnia for approx 6 mos on day of vaccination.  Started on psych meds & referred for counseling.  Had dropped out of school, stating financial concerns as part of depression. This is in follow-up information has been received from a consumer concerning her 20 year old daughter who on 14-MAY-2008 was vaccinated with a first dose of GARDASIL (lot number 600387/1967U) IM the left arm at 3:30PM. On 15-MAY-2008, the patient felt weak, was shaky, loss of concentration and fainted. Medical attention was not sought. On an unspecified date the patient had recovered. Additional information is not expected.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Pruritus, Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old patient (gender not reported) who on 19-NOV-2007 was vaccinated with a first dose of GARDASIL.  The nurse reported that on an unspecified date the patient had itching after the first dose of GARDASIL that lasted until the second dose was given (date unspecified).  The patient than had a rash and itching with the second dose (date unspecified).  The third dose has not been given yet.  At the time of reporting it was unknown if the patient had recovered.  No further information was available from the nurse.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Epstein-Barr virus infection
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with no pertinent medical history and no drug allergies/reactions who on 19-MAr-2008 was vaccinated with a first dose of GARDASIL (lot # 659962/1740U) 0.5 ml IM. Concomitant therapy included oral hormonal contraceptives (unspecified). Subsequently, after receiving the first dose of vaccine, the patient was diagnosed with Epstein-Barr virus. The patient sought medical attention with another physician. At the time of reporting, the outcome was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site induration, Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a certified medical assistant concerning a 23 to 25 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL.  Subsequently, the patient experienced a painful, indented, discolored area where the first vaccination was administered.  On an unspecified date, the patient returned for the second vaccination with GARDASIL, and had a painful, white area a half dollar to dollar in size where the first vaccination was administered.  When the area was palpated, an indentation in the deltoid was noted.  The patient received the second dose of GARDASIL.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Joint range of motion decreased, Malaise, Tenderness
Clinical narrative: Information has been received from a physician concerning a 25 year old female with asthma, anaemia and arthritis who on an unspecified date was vaccinated with the first dose of GARDASIL.  The second dose of GARDASIL was given 08-APR-2008.  Concomitant therapy included montelukast sodium (MSD), daily multivitamins (unspecified), vitamin D (unspecified), iron (unspecified), B-12 injection, SYNTHROID, MOBIC and RELPAX.  On 29-APR-2008 the patient called the doctor's office complaining that the injected arm was tender, she had limited range of motion in the arm, and she had feelings of malaise.  The patient was seen in the doctor's office on 01-MAY-2008 and was treated with over the counter MOTRIN.  No outcome information has been provided.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a medical assistant concerning a 24 year old female who on 30-JAN-2008 was vaccinated via intramuscular route with the first dose GARDASIL, 0.5ml/once. Concomitant therapy included YAZ. The reporter stated that on 09-MAY-2008 the patient developed injection site pain after receiving a second dose of GARDASIL (Lot # 660389/1968U). The medical assistant stated that the patient called the office and complained of soreness and pain at the injection site but said there was no lump or swelling. The reporter said that the patient did not have any reactions when she received her first dose of GARDASIL. No further information was available. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Fatigue, Headache, Pain, Syncope
Clinical narrative: Information has been received from a consumer concerning her 20 year old daughter, with no pertinent medical history who on 14-MAY-2008 was vaccinated with a first 0.5 ml dose of GARDASIL. There was no concomitant medication. In May 2008, a few days after vaccination, the patient experienced aches and pain, fatigue, mental confusion and headaches. It was also reported that the patient fainted while standing in line at a store. The patient did not seek medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse concerning a 20 year old female with eczema who on 15-MAY-2008 was vaccinated with her first dose of GARDASIL (lot# not reported).  There was no concomitant medication.  On 15-MAY-2008, 4 hours after vaccination, the patient experienced hives all over her neck and arm.  The patient sought medical attention in the office on 19-MAY-2008 and the hives were all over her body.  The patient's hives persisted.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Computerised tomogram, Fall, Immediate post-injection reaction, Spinal X-ray
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient, with no medical history reported, who on 15-MAY-2008 was vaccinated with the first dose of GARDASIL (Lot #660387/1967U).   Concomitant therapy included a dose of MENACTRA and a dose of ADACEL.  On 15-MAY-2008 approximately three to four minutes after receiving the vaccine, the patient fell head first to the ground.  She was taken to the emergency room but it was unknown if the patient was admitted.  Diagnostic testing performed included a computed axial tomography and a cervical spine series, no results reported.  At the time of this report the events had improved and the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who in April 2008, was vaccinated a first dose of GARDASIL 0.5 mL IM. There was no concomitant medication. In April 2008, the patient experienced nausea and fever within 30 minutes of her first GARDASIL vaccination. Medical attention was sought. This was the patient's first and only dose of GARDASIL. Subsequently, the patient recovered from nausea and fever the next day. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from an office manager concerning a 17 year old female who on 19-OCT-2007 was vaccinated with the first dose of GARDASIL, 0.5 ml, lot # 658563/1063U. There were no problems noted after the first dose. On 19-MAY-2008 after receiving the second dose of GARDASIL, 0.5 ml, lot # 659182/1757U, the patient fainted. It was reported that the patient sought medical attention in the office and recovered on 19-MAY-2008. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Condition aggravated
Clinical narrative: Information has been received from a pharmacist concerning a female patient with avascular necrosis who was vaccinated with a dose of GARDASIL. Subsequently, the patient experienced worsening of her joint pain. The reporter was unable to provide the interval between the vaccine and the onset of the increased joint pain. At the time of this report, the patient has not recovered. No product quality complaint was involved. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 21 year old female with a history of a high risk life style (behaviour disorder), who was vaccinated with the series of GARDASIL on unreported dates.  Subsequently, after the completion of the GARDASIL series, on an unspecified date, the patient had an abnormal Pap test.  It was reported that the patient sought unspecified medical attention, but no treatment or outcome information has been provided.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Erythema nodosum, Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a 25 year old female who on 03-JUL-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot# not reported). Concomitant therapy included DEPO-PROVERA. On 20-SEP-2007 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# not reported). On 25-SEP-2007 the patient experienced joint aches and right hip numbness and pain. She was seen by a rheumatologist and was diagnosed with erythema nodosum from GARDASIL. She was advised to not get the third dose in the series and was seen in the office on 26-MAR-2008 and she reported no problems. Subsequently, the patient recovered from joint aches and right hip numbness and pain. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea, Rash, Vomiting
Clinical narrative: Information has been received from a nurse practi concerning a 17 year old female who on 19-MAY-2008 was vaccinated IM with a 0.5 ml first dose of GARDASIL (lot# 655604/0052X). On 20-MAY-2008 the patient experienced nausea, vomiting, diarrhea and "pin point" rash on her face. Unknown medical attention was sought by calling the practice. At the time of reporting the patient had not recovered from nausea, vomiting, diarrhea and pin point rash on her face. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Acne, Diarrhoea, Headache, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with penicillin allergy who on 11-FEB-2008 was vaccinated intramuscularly with a first dose of GARDASIL (lot # reported as "1448J").  Subsequently the patient experienced an outbreak of large pimples on her face.  On an unspecified date the patient recovered from the outbreak of large pimples on her face.  Concomitant therapy included APRI.  On 11-APR-2008 the patient was vaccinated intramuscularly with a second dose of GARDASIL (lot # reported as "1757J").  On 11-APR-2008 the patient experienced diarrhea, abdominal pain, fever, headache and outbreak of large pimples on her face.  Subsequently, on 13-APR-2008, the patient recovered from diarrhea, abdominal pain, fever, headache, and outbreak of large pimples on her face.  The patient sought unspecified medical attention by calling the physician.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female with penicillin allergy who on 11-FEB-2008 was vaccinated intramuscularly with a first dose of GARDASIL (lot # reported as "1448J").  Subsequently the patient experienced an outbreak of large pimples on her face.  On an unspecified date the patient recovered from the outbreak of large pimples on her face.  Concomitant therapy included APRI.  On 11-APR-2008 the patient was vaccinated intramuscularly with a second dose of GARDASIL (lot # reported as "1757J").  On 11-APR-2008 the patient experienced diarrhea, abdominal pain, fever, headache and outbreak of large pimples on her face.  Subsequently, on 13-APR-2008, the patient recovered from diarrhea, abdominal pain, fever, headache, and outbreak of large pimples on her face.  The patient sought unspecified medical attention by calling the physician.  Additional information has been requested.